In the past two decades, the incidence rate of opioid use disorder (OUD) among pregnant women has increased by more than 400%, constituting a United States public health crisis.¹ Newborns exposed to intrauterine opioids are at risk for the postnatal withdrawal syndrome known as neonatal abstinence syndrome (NAS), which requires increased hospital resources, such as neonatal intensive care unit (NICU) admission and prolonged length of stay.² Given the medical and psychosocial challenges associated with maternal OUD and NAS, a multidisciplinary, patient-centered approach to hospital care for affected newborns and their mothers is warranted. A large and growing body of research has focused on the epidemiology of NAS and approaches for its prevention, screening, and management. This review appraises updates to the literature within the past five years, with an emphasis on considerations for newborn discharge to promote optimal care for this population.

NAS is a complex disorder arising from the abrupt cessation of placental transfer of opioids after birth, although other maternal substances, including benzodiazepines and other antidepressants, have been less commonly implicated.² The term neonatal opioid withdrawal syndrome is sometimes used to indicate withdrawal from opioids specifically.³ The central and autonomic nervous systems and the gastrointestinal system (eg, tremors, increased muscle tone, high-pitched crying, feeding difficulties) are affected in NAS, with most newborns demonstrating symptoms within the first few days of life.⁴ Previously reported factors associated with NAS include opioid type, timing of exposure during pregnancy, maternal tobacco use, infant sex, and gestational age.⁵ Literature demonstrates that concurrent exposure to other prenatal substances, particularly antidepressants, benzodiazepines, and gabapentin, is significantly associated with increased risk of NAS.⁶ Recent studies also suggest that expression of NAS may relate to newborn genetic variations, particularly at the OPRM1, COMT, and CYP2B6 gene sites.^{7, 8}

State health departments have increasingly deemed NAS as a reportable diagnosis for public health surveillance, which relies on the accurate diagnosis and documentation of NAS during birth hospitalization.⁹ The diagnosis codes for NAS include the International Classification of Diseases, Ninth Revision, Clinical Modification code (ICD-9-CM) 779.5 and the International Classification of Diseases, Tenth Revision, Clinical Modification ICD-10-CM code P96.1.¹⁰ However, given the variation in the presentation and severity of NAS, no consensus has been established with regard to a standardized case definition for reporting across hospitals and states.⁹ In fact, NAS should be conceptualized as a continuum of withdrawal symptoms along which every infant with intrauterine opioid exposure resides; this continuum ranges from minor findings, which do not affect the infant’s ability to grow and develop, to severe withdrawal, resulting in excessive weight loss, dehydration, or seizures.^3,11 Ultimately, the diagnosis of NAS is made clinically based on cardinal symptoms in the setting of known or highly suspected opioid exposure. In a recent study of Tennessee Medicaid claims data, >25% of infants with a confirmed diagnosis code for NAS did not receive pharmacotherapy.¹⁰ Pharmacologic treatment of NAS, therefore, may be more appropriately considered as a marker of disease severity, rather than a requirement for diagnosis.

Although the opioid crisis and resulting rise in NAS have affected communities across the US, substantial statewide variation exists, with extremes ranging from 0.7 per 1,000 births affected by NAS in Hawaii to 33.4 per 1,000 births in West Virginia.¹² Within states, increased maternal OUD and NAS rates have also disproportionately affected rural communities possibly due to reduced access to healthcare and mental health services and poor economic conditions.¹³ A recent national study demonstrated that the proportion of newborns with NAS who were born in rural hospitals increased from 12.9% to 21.2% over the past decade; these rural newborns with NAS are more likely to be publicly insured and to require transfer after birth than newborns in urban hospitals.¹⁴ These data suggest a particular need among rural communities for increased resources targeting NAS care as well as maternal OUD prevention and treatment.

The American College of Obstetricians and Gynecologists (ACOG) recommends early universal screening for maternal substance use at the first prenatal visit with a validated screening tool; examples include the 4Ps (parents, partners, past, and pregnancy), CRAFFT (car, relax, alone, forget, friends, trouble), and the National Institute on Drug Abuse quick screen, which have all been well studied and have a high sensitivity for detecting substance use and misuse.¹⁵

Toxicology Screening

Toxicology testing for both mother and newborn is helpful in identifying or confirming intrauterine exposures, particularly in cases of polysubstance use or when a newborn manifests signs of NAS but whose mother denies opioid use. All toxicology testing should be performed with the mother’s consent, and any potential legal or mandatory ramifications of a positive test should be considered. Although universal maternal toxicology testing improves the identification of newborns at risk for NAS, this approach remains controversial; most hospitals use a risk-based approach for maternal toxicology testing.^16,17

Newborn toxicology testing can be performed from samples of hair, urine, meconium, and umbilical cord. Although frequently used, newborn urine testing has the shortest window of detection, ie, the last few days prior to delivery (Table 1). Meconium drug testing has been considered the gold standard and can detect exposures from the last 20 weeks of gestation, providing information on chronic exposures.¹⁸ In a recent survey, 10% of hospitals reported using umbilical cord toxicology as the primary method for detecting intrauterine exposures.¹⁷ This approach allows greater ease of specimen collection but may not yield results that are exactly equivalent to meconium testing.¹⁹

Close monitoring for development of NAS after birth is indicated for all newborns with confirmed or suspected intrauterine opioid exposure. Although the current American Academy of Pediatrics (AAP) guidelines recommend three days of newborn observation for exposure to short-acting opioids and five to seven days for longer acting opioids, substantial variation has been described across US hospitals in policies related to newborn length of stay for NAS observation.^{17, 20} In most hospitals, monitoring for NAS occurs in the routine postpartum unit (ie, level 1 nursery), with transfer to the NICU if pharmacologic treatment is indicated.¹⁷

The most widely used assessment tool for NAS is the Finnegan Neonatal Abstinence Scoring System (FNASS) or the modified FNASS, which assigns points for the 21 most common opioid withdrawal symptoms based on perceived severity.^{17, 21} This tool allows for assessment of symptoms, helps determine need for pharmacologic intervention, and can guide monitoring of symptoms and weaning of therapy. A commonly used score cutoff of 8 is based on prior research validating scores >8 as indicative of withdrawal symptoms as opposed to normal newborn findings.²² Despite its popularity and widespread usage, FNASS has limitations, including the need for the newborn to be stimulated or disturbed to produce an accurate assessment and scoring for nonspecific signs of withdrawal, including sneezing, yawning, and stuffiness. Recent work has attempted to simplify and shorten the FNASS to elements that are unique and specific for withdrawal.^23,24 Further research is needed to establish the validity of common scoring practices (ie, use of 8 as a cutoff) to determine the need for pharmacologic treatment.²⁵

Recent studies suggest that simple, function-based assessments, such as the Eat, Sleep, Console (ESC) approach developed by Grossman and colleagues, may serve as an alternative to the FNASS for evaluating withdrawal.^26,27 With ESC, the need for pharmacotherapy is evaluated by the newborn’s ability to (1) eat (breastfeed successfully or eat at least 1oz per feed), (2) sleep uninterrupted for at least one hour, and (3) be consoled within 10 minutes. To date, research on the implementation of ESC has primarily focused on reducing length of stay and need for pharmacologic treatment in the context of quality improvement initiatives.^26,27 Further prospective studies are warranted that compare ESC to traditional approaches involving the FNASS, and that evaluate post-discharge outcomes including newborn weight gain, ongoing withdrawal symptoms at home, and readmission.

In recent years, research increasingly supports the critical role of nonpharmacological care in management of all opioid-exposed newborns, regardless of NAS severity.^{11,27, 28} Rooming-in of mothers or caregivers has been shown to decrease the need for pharmacologic treatment, shorten the length of stay, and reduce hospital costs.^28,29 Other well-established practices include maintaining a low stimulus environment for infants with low lighting and sound, swaddling, maximizing caregiver contact with kangaroo care and skin to skin, and minimizing interventions. Therapeutic modalities, such as massage and music therapy, have been used for infants with NAS, but no evidence has supported their use. Recent studies have increasingly supported the use of acupuncture as an emerging modality in treating NAS. ³⁰

Feeding

Breastfeeding is encouraged for mothers who are stable on their methadone or buprenorphine maintenance treatment, are not using heroin or other illicit drugs, and have no other contraindications to breastfeeding, such as human immunodeficiency virus.³¹ Despite the known benefits of breastfeeding, which include decreased NAS severity, decreased need for pharmacological treatment, and shortened length of hospital stay, breastfeeding rates among mothers with OUD are low.³¹ Hospital policies that can promote maternal success in breastfeeding include tailored breastfeeding support, rooming in, and early, consistent maternal education on the benefits and safety of breastfeeding.³² A small percentage of hospitals use donor breastmilk for this population, although data on outcomes are limited.¹⁷ For formula-fed newborns, emerging research suggests that early initiation of high-calorie (22-24 kcal/ounce) formula may be beneficial to prevent excessive weight loss and poor weight gain after intrauterine opioid exposure.³³

When supportive therapy fails to adequately control symptoms of withdrawal, pharmacological management is initiated to improve infant discomfort, allow for adequate feeding and nutrition, and facilitate parental bonding (Table 2).¹¹ Opioids are the primary agent used for pharmacologic treatment, and morphine is the most commonly utilized.¹⁷ Morphine is a short-acting opioid and can be prescribed either as a weight-based weaning protocol or symptom-based regimen. Methadone is also widely used, and as a long-acting opioid, it has the advantage of twice daily dosing after the initial loading dose. Recently, buprenorphine, a partial mu opioid agonist with a long half-life, has emerged as a promising primary opioid treatment agent and has been shown to reduce the length of stay and the number of opioid treatment days compared with morphine and methadone.³⁶

When the signs and symptoms of NAS are not effectively controlled with a primary opioid or in the case of polysubstance exposure, adjunctive agents are often used, with phenobarbital and clonidine being the most common (Table 3).¹¹ Regardless of opioid agent used, multicenter quality improvement initiatives demonstrate that having a standardized weaning protocol is critical to minimizing the overall length of stay and reducing the need for adjunctive agents.^38,39 Additionally, modeling tools such as pharmacometrics for methadone and buprenorphine have shown promise in optimizing dose selection.^40,41 Modeling may include pharmacodynamic data (ie, clinical response to treatment), pharmacokinetics (ie, measures of drug distribution and clearance), and other factors, such as patient demographics, intrauterine exposure type, and symptom severity. Future studies should examine weight versus symptom-based dosing regimens as well as compare weaning schedules versus “as needed” dosing regimens.¹¹

The need for comprehensive medical and psychosocial supports for mothers with OUD cannot be overstated, given the high rates of concurrent illicit or other substance use, comorbid depression and anxiety, physical and sexual trauma, poverty and homelessness, intravenous drug use, and sex-related risk patterns.¹⁵ Significant issues of healthcare-associated stigma and criminality also affect this population. As of 2019, 23 states and the District of Columbia classify substance use during pregnancy as child abuse under civil child-welfare statutes, potentially resulting in termination of parental rights.⁴² Studies of mothers with OUD have demonstrated that they often experience guilt, shame, and fear of loss of custody, all of which can impede their trust in hospital providers and future engagement in care.⁴³ They also report frustration with and mistrust of NAS scoring assessments, which they can perceive to be disruptive and potentially biased.⁴⁴ Multiple approaches should be considered to standardize and improve the hospital experience for this population, in a way that emphasizes the mother’s role as a capable, respected participant in her newborn’s care.

Maternal Support

A coordinated, multidisciplinary approach to comprehensively support mothers with OUD should involve team members from pediatrics, neonatology, obstetrics, nursing, social work, case management, and lactation.³⁵ This support includes screening for adequate resources and a safe, supportive, drug-free home environment as well as evaluating co-occurring mental health conditions. Referrals should be provided as needed to social services, postpartum psychiatry or behavioral health services, OUD treatment and relapse-prevention programs, and harm reduction services (eg, naloxone training). In addition to the healthcare team, other community members can be enlisted to serve as a trusted, consistent, and nonjudgmental support during the hospitalization; examples may include a peer support (another mother with OUD), an OUD program caseworker, or a doula.⁴⁴

Clinical Pathways

Hospitals should establish clinical pathways for women with OUD to standardize care and communication across the continuum of care for themselves and their newborn, with input from all healthcare team members involved (prenatal, intrapartum, and postpartum).³⁵ Early, consistent information should be provided regarding expected newborn hospital course, including toxicology testing, NAS monitoring, possible NICU admission, and involvement of social work.

Provider Training

Educational opportunities in the form of continuing medical education, in-service trainings, etc., should be provided for clinical staff who care for mothers with OUD and their newborns, regarding issues of substance use, stigma, bias, and trauma-informed care.³⁵ Online training resources are available through the American Society of Addiction Medicine, the ACOG, AAP, the Centers for Disease Control and Prevention, and the Substance Abuse and Mental Health Services Administration.

Regardless of whether or not NAS is treated pharmacologically, newborns with opioid exposure may experience residual symptoms of withdrawal that persist for months.⁴ Current research suggests increased risk for morbidity, emergency department utilization, and rehospitalization after discharge in this population as well as difficulty in accessing and engaging with pediatric preventative care.^{45, 46}

A clear plan should be established upon discharge to ensure optimal newborn care and follow-up. A complete record of the newborn’s hospital stay, including maternal toxicology screenings and summary of any social work documentation, should be communicated to the primary care provider upon discharge. Close postdischarge monitoring involves addressing parenting knowledge gaps, assessing illness and injury risk, and evaluating for the presence of ongoing withdrawal symptoms.⁴ Primary care providers can also play a key role in assessing maternal stress, coping, and parenting skills as well as helping families connect to resources. Further research is warranted on how pediatric primary care systems can better build maternal trust, address parenting needs, and engage this population in routine well-child care.⁴⁷

Child Welfare, Early Intervention, and Other Services

In general, newborn safety and keeping families intact should be prioritized, with disposition into foster care only in cases of concern for child maltreatment or neglect. Under the Child Abuse Prevention and Treatment Act (CAPTA), states are required to develop Plans of Safe Care for women and newborns affected by OUD, with the goal of fostering collaboration between healthcare and social service organizations around care of these families.⁴⁸ Given the variable interpretation of Plans of Safe Care across the U.S., providers should be knowledgeable about state and local statutes and reporting requirements related to parental substance use.

As part of Plans of Safe Care, providers may be well-positioned to initiate referrals for early intervention, home visiting, and other programs designed to provide developmental or wrap-around support for families. Under Part C of the Individuals with Disabilities Education Act, many states offer early intervention on the basis of NAS as an automatic qualifying diagnosis; however, attrition of eligible families along the referral and enrollment process is substantial.⁴⁹ A standardized approach to discharging opioid-exposed newborns includes referrals to available resources and discussion of their importance with families and may increase utilization and decrease variation in care.⁵⁰

Maternal OUD presents a unique combination of medical and psychosocial challenges that affect hospital care for mothers and their newborns. Optimal care for this population warrants a multidisciplinary team of providers who are knowledgeable, collaborative, and mindful of the important role of the mother as a key participant in her newborn’s care. Despite a large and growing body of research focused on NAS prevention, screening, and treatment, ongoing efforts are needed to create hospital policies and clinical pathways that are responsive to the healthcare needs of this population, navigate sensitive issues of criminality and stigma, and ultimately support maternal parenting success.

Disclosures

The authors have no financial relationships and conflicts of interest relevant to this article to disclose.

Funding

Funding for this work was provided by Cincinnati Children’s Hospital Medical Center and Nemours/AI duPont Hospital for Children.

In the past two decades, the incidence rate of opioid use disorder (OUD) among pregnant women has increased by more than 400%, constituting a United States public health crisis.¹ Newborns exposed to intrauterine opioids are at risk for the postnatal withdrawal syndrome known as neonatal abstinence syndrome (NAS), which requires increased hospital resources, such as neonatal intensive care unit (NICU) admission and prolonged length of stay.² Given the medical and psychosocial challenges associated with maternal OUD and NAS, a multidisciplinary, patient-centered approach to hospital care for affected newborns and their mothers is warranted. A large and growing body of research has focused on the epidemiology of NAS and approaches for its prevention, screening, and management. This review appraises updates to the literature within the past five years, with an emphasis on considerations for newborn discharge to promote optimal care for this population.

NAS is a complex disorder arising from the abrupt cessation of placental transfer of opioids after birth, although other maternal substances, including benzodiazepines and other antidepressants, have been less commonly implicated.² The term neonatal opioid withdrawal syndrome is sometimes used to indicate withdrawal from opioids specifically.³ The central and autonomic nervous systems and the gastrointestinal system (eg, tremors, increased muscle tone, high-pitched crying, feeding difficulties) are affected in NAS, with most newborns demonstrating symptoms within the first few days of life.⁴ Previously reported factors associated with NAS include opioid type, timing of exposure during pregnancy, maternal tobacco use, infant sex, and gestational age.⁵ Literature demonstrates that concurrent exposure to other prenatal substances, particularly antidepressants, benzodiazepines, and gabapentin, is significantly associated with increased risk of NAS.⁶ Recent studies also suggest that expression of NAS may relate to newborn genetic variations, particularly at the OPRM1, COMT, and CYP2B6 gene sites.^{7, 8}

State health departments have increasingly deemed NAS as a reportable diagnosis for public health surveillance, which relies on the accurate diagnosis and documentation of NAS during birth hospitalization.⁹ The diagnosis codes for NAS include the International Classification of Diseases, Ninth Revision, Clinical Modification code (ICD-9-CM) 779.5 and the International Classification of Diseases, Tenth Revision, Clinical Modification ICD-10-CM code P96.1.¹⁰ However, given the variation in the presentation and severity of NAS, no consensus has been established with regard to a standardized case definition for reporting across hospitals and states.⁹ In fact, NAS should be conceptualized as a continuum of withdrawal symptoms along which every infant with intrauterine opioid exposure resides; this continuum ranges from minor findings, which do not affect the infant’s ability to grow and develop, to severe withdrawal, resulting in excessive weight loss, dehydration, or seizures.^3,11 Ultimately, the diagnosis of NAS is made clinically based on cardinal symptoms in the setting of known or highly suspected opioid exposure. In a recent study of Tennessee Medicaid claims data, >25% of infants with a confirmed diagnosis code for NAS did not receive pharmacotherapy.¹⁰ Pharmacologic treatment of NAS, therefore, may be more appropriately considered as a marker of disease severity, rather than a requirement for diagnosis.

Although the opioid crisis and resulting rise in NAS have affected communities across the US, substantial statewide variation exists, with extremes ranging from 0.7 per 1,000 births affected by NAS in Hawaii to 33.4 per 1,000 births in West Virginia.¹² Within states, increased maternal OUD and NAS rates have also disproportionately affected rural communities possibly due to reduced access to healthcare and mental health services and poor economic conditions.¹³ A recent national study demonstrated that the proportion of newborns with NAS who were born in rural hospitals increased from 12.9% to 21.2% over the past decade; these rural newborns with NAS are more likely to be publicly insured and to require transfer after birth than newborns in urban hospitals.¹⁴ These data suggest a particular need among rural communities for increased resources targeting NAS care as well as maternal OUD prevention and treatment.

The American College of Obstetricians and Gynecologists (ACOG) recommends early universal screening for maternal substance use at the first prenatal visit with a validated screening tool; examples include the 4Ps (parents, partners, past, and pregnancy), CRAFFT (car, relax, alone, forget, friends, trouble), and the National Institute on Drug Abuse quick screen, which have all been well studied and have a high sensitivity for detecting substance use and misuse.¹⁵

Toxicology Screening

Toxicology testing for both mother and newborn is helpful in identifying or confirming intrauterine exposures, particularly in cases of polysubstance use or when a newborn manifests signs of NAS but whose mother denies opioid use. All toxicology testing should be performed with the mother’s consent, and any potential legal or mandatory ramifications of a positive test should be considered. Although universal maternal toxicology testing improves the identification of newborns at risk for NAS, this approach remains controversial; most hospitals use a risk-based approach for maternal toxicology testing.^16,17

Newborn toxicology testing can be performed from samples of hair, urine, meconium, and umbilical cord. Although frequently used, newborn urine testing has the shortest window of detection, ie, the last few days prior to delivery (Table 1). Meconium drug testing has been considered the gold standard and can detect exposures from the last 20 weeks of gestation, providing information on chronic exposures.¹⁸ In a recent survey, 10% of hospitals reported using umbilical cord toxicology as the primary method for detecting intrauterine exposures.¹⁷ This approach allows greater ease of specimen collection but may not yield results that are exactly equivalent to meconium testing.¹⁹

Close monitoring for development of NAS after birth is indicated for all newborns with confirmed or suspected intrauterine opioid exposure. Although the current American Academy of Pediatrics (AAP) guidelines recommend three days of newborn observation for exposure to short-acting opioids and five to seven days for longer acting opioids, substantial variation has been described across US hospitals in policies related to newborn length of stay for NAS observation.^{17, 20} In most hospitals, monitoring for NAS occurs in the routine postpartum unit (ie, level 1 nursery), with transfer to the NICU if pharmacologic treatment is indicated.¹⁷

The most widely used assessment tool for NAS is the Finnegan Neonatal Abstinence Scoring System (FNASS) or the modified FNASS, which assigns points for the 21 most common opioid withdrawal symptoms based on perceived severity.^{17, 21} This tool allows for assessment of symptoms, helps determine need for pharmacologic intervention, and can guide monitoring of symptoms and weaning of therapy. A commonly used score cutoff of 8 is based on prior research validating scores >8 as indicative of withdrawal symptoms as opposed to normal newborn findings.²² Despite its popularity and widespread usage, FNASS has limitations, including the need for the newborn to be stimulated or disturbed to produce an accurate assessment and scoring for nonspecific signs of withdrawal, including sneezing, yawning, and stuffiness. Recent work has attempted to simplify and shorten the FNASS to elements that are unique and specific for withdrawal.^23,24 Further research is needed to establish the validity of common scoring practices (ie, use of 8 as a cutoff) to determine the need for pharmacologic treatment.²⁵

Recent studies suggest that simple, function-based assessments, such as the Eat, Sleep, Console (ESC) approach developed by Grossman and colleagues, may serve as an alternative to the FNASS for evaluating withdrawal.^26,27 With ESC, the need for pharmacotherapy is evaluated by the newborn’s ability to (1) eat (breastfeed successfully or eat at least 1oz per feed), (2) sleep uninterrupted for at least one hour, and (3) be consoled within 10 minutes. To date, research on the implementation of ESC has primarily focused on reducing length of stay and need for pharmacologic treatment in the context of quality improvement initiatives.^26,27 Further prospective studies are warranted that compare ESC to traditional approaches involving the FNASS, and that evaluate post-discharge outcomes including newborn weight gain, ongoing withdrawal symptoms at home, and readmission.

In recent years, research increasingly supports the critical role of nonpharmacological care in management of all opioid-exposed newborns, regardless of NAS severity.^{11,27, 28} Rooming-in of mothers or caregivers has been shown to decrease the need for pharmacologic treatment, shorten the length of stay, and reduce hospital costs.^28,29 Other well-established practices include maintaining a low stimulus environment for infants with low lighting and sound, swaddling, maximizing caregiver contact with kangaroo care and skin to skin, and minimizing interventions. Therapeutic modalities, such as massage and music therapy, have been used for infants with NAS, but no evidence has supported their use. Recent studies have increasingly supported the use of acupuncture as an emerging modality in treating NAS. ³⁰

Feeding

Breastfeeding is encouraged for mothers who are stable on their methadone or buprenorphine maintenance treatment, are not using heroin or other illicit drugs, and have no other contraindications to breastfeeding, such as human immunodeficiency virus.³¹ Despite the known benefits of breastfeeding, which include decreased NAS severity, decreased need for pharmacological treatment, and shortened length of hospital stay, breastfeeding rates among mothers with OUD are low.³¹ Hospital policies that can promote maternal success in breastfeeding include tailored breastfeeding support, rooming in, and early, consistent maternal education on the benefits and safety of breastfeeding.³² A small percentage of hospitals use donor breastmilk for this population, although data on outcomes are limited.¹⁷ For formula-fed newborns, emerging research suggests that early initiation of high-calorie (22-24 kcal/ounce) formula may be beneficial to prevent excessive weight loss and poor weight gain after intrauterine opioid exposure.³³

When supportive therapy fails to adequately control symptoms of withdrawal, pharmacological management is initiated to improve infant discomfort, allow for adequate feeding and nutrition, and facilitate parental bonding (Table 2).¹¹ Opioids are the primary agent used for pharmacologic treatment, and morphine is the most commonly utilized.¹⁷ Morphine is a short-acting opioid and can be prescribed either as a weight-based weaning protocol or symptom-based regimen. Methadone is also widely used, and as a long-acting opioid, it has the advantage of twice daily dosing after the initial loading dose. Recently, buprenorphine, a partial mu opioid agonist with a long half-life, has emerged as a promising primary opioid treatment agent and has been shown to reduce the length of stay and the number of opioid treatment days compared with morphine and methadone.³⁶

When the signs and symptoms of NAS are not effectively controlled with a primary opioid or in the case of polysubstance exposure, adjunctive agents are often used, with phenobarbital and clonidine being the most common (Table 3).¹¹ Regardless of opioid agent used, multicenter quality improvement initiatives demonstrate that having a standardized weaning protocol is critical to minimizing the overall length of stay and reducing the need for adjunctive agents.^38,39 Additionally, modeling tools such as pharmacometrics for methadone and buprenorphine have shown promise in optimizing dose selection.^40,41 Modeling may include pharmacodynamic data (ie, clinical response to treatment), pharmacokinetics (ie, measures of drug distribution and clearance), and other factors, such as patient demographics, intrauterine exposure type, and symptom severity. Future studies should examine weight versus symptom-based dosing regimens as well as compare weaning schedules versus “as needed” dosing regimens.¹¹

The need for comprehensive medical and psychosocial supports for mothers with OUD cannot be overstated, given the high rates of concurrent illicit or other substance use, comorbid depression and anxiety, physical and sexual trauma, poverty and homelessness, intravenous drug use, and sex-related risk patterns.¹⁵ Significant issues of healthcare-associated stigma and criminality also affect this population. As of 2019, 23 states and the District of Columbia classify substance use during pregnancy as child abuse under civil child-welfare statutes, potentially resulting in termination of parental rights.⁴² Studies of mothers with OUD have demonstrated that they often experience guilt, shame, and fear of loss of custody, all of which can impede their trust in hospital providers and future engagement in care.⁴³ They also report frustration with and mistrust of NAS scoring assessments, which they can perceive to be disruptive and potentially biased.⁴⁴ Multiple approaches should be considered to standardize and improve the hospital experience for this population, in a way that emphasizes the mother’s role as a capable, respected participant in her newborn’s care.

Maternal Support

A coordinated, multidisciplinary approach to comprehensively support mothers with OUD should involve team members from pediatrics, neonatology, obstetrics, nursing, social work, case management, and lactation.³⁵ This support includes screening for adequate resources and a safe, supportive, drug-free home environment as well as evaluating co-occurring mental health conditions. Referrals should be provided as needed to social services, postpartum psychiatry or behavioral health services, OUD treatment and relapse-prevention programs, and harm reduction services (eg, naloxone training). In addition to the healthcare team, other community members can be enlisted to serve as a trusted, consistent, and nonjudgmental support during the hospitalization; examples may include a peer support (another mother with OUD), an OUD program caseworker, or a doula.⁴⁴

Clinical Pathways

Hospitals should establish clinical pathways for women with OUD to standardize care and communication across the continuum of care for themselves and their newborn, with input from all healthcare team members involved (prenatal, intrapartum, and postpartum).³⁵ Early, consistent information should be provided regarding expected newborn hospital course, including toxicology testing, NAS monitoring, possible NICU admission, and involvement of social work.

Provider Training

Educational opportunities in the form of continuing medical education, in-service trainings, etc., should be provided for clinical staff who care for mothers with OUD and their newborns, regarding issues of substance use, stigma, bias, and trauma-informed care.³⁵ Online training resources are available through the American Society of Addiction Medicine, the ACOG, AAP, the Centers for Disease Control and Prevention, and the Substance Abuse and Mental Health Services Administration.

Regardless of whether or not NAS is treated pharmacologically, newborns with opioid exposure may experience residual symptoms of withdrawal that persist for months.⁴ Current research suggests increased risk for morbidity, emergency department utilization, and rehospitalization after discharge in this population as well as difficulty in accessing and engaging with pediatric preventative care.^{45, 46}

A clear plan should be established upon discharge to ensure optimal newborn care and follow-up. A complete record of the newborn’s hospital stay, including maternal toxicology screenings and summary of any social work documentation, should be communicated to the primary care provider upon discharge. Close postdischarge monitoring involves addressing parenting knowledge gaps, assessing illness and injury risk, and evaluating for the presence of ongoing withdrawal symptoms.⁴ Primary care providers can also play a key role in assessing maternal stress, coping, and parenting skills as well as helping families connect to resources. Further research is warranted on how pediatric primary care systems can better build maternal trust, address parenting needs, and engage this population in routine well-child care.⁴⁷

Child Welfare, Early Intervention, and Other Services

In general, newborn safety and keeping families intact should be prioritized, with disposition into foster care only in cases of concern for child maltreatment or neglect. Under the Child Abuse Prevention and Treatment Act (CAPTA), states are required to develop Plans of Safe Care for women and newborns affected by OUD, with the goal of fostering collaboration between healthcare and social service organizations around care of these families.⁴⁸ Given the variable interpretation of Plans of Safe Care across the U.S., providers should be knowledgeable about state and local statutes and reporting requirements related to parental substance use.

As part of Plans of Safe Care, providers may be well-positioned to initiate referrals for early intervention, home visiting, and other programs designed to provide developmental or wrap-around support for families. Under Part C of the Individuals with Disabilities Education Act, many states offer early intervention on the basis of NAS as an automatic qualifying diagnosis; however, attrition of eligible families along the referral and enrollment process is substantial.⁴⁹ A standardized approach to discharging opioid-exposed newborns includes referrals to available resources and discussion of their importance with families and may increase utilization and decrease variation in care.⁵⁰

Maternal OUD presents a unique combination of medical and psychosocial challenges that affect hospital care for mothers and their newborns. Optimal care for this population warrants a multidisciplinary team of providers who are knowledgeable, collaborative, and mindful of the important role of the mother as a key participant in her newborn’s care. Despite a large and growing body of research focused on NAS prevention, screening, and treatment, ongoing efforts are needed to create hospital policies and clinical pathways that are responsive to the healthcare needs of this population, navigate sensitive issues of criminality and stigma, and ultimately support maternal parenting success.

Disclosures

The authors have no financial relationships and conflicts of interest relevant to this article to disclose.

Funding

Funding for this work was provided by Cincinnati Children’s Hospital Medical Center and Nemours/AI duPont Hospital for Children.

In the past two decades, the incidence rate of opioid use disorder (OUD) among pregnant women has increased by more than 400%, constituting a United States public health crisis.¹ Newborns exposed to intrauterine opioids are at risk for the postnatal withdrawal syndrome known as neonatal abstinence syndrome (NAS), which requires increased hospital resources, such as neonatal intensive care unit (NICU) admission and prolonged length of stay.² Given the medical and psychosocial challenges associated with maternal OUD and NAS, a multidisciplinary, patient-centered approach to hospital care for affected newborns and their mothers is warranted. A large and growing body of research has focused on the epidemiology of NAS and approaches for its prevention, screening, and management. This review appraises updates to the literature within the past five years, with an emphasis on considerations for newborn discharge to promote optimal care for this population.

NAS is a complex disorder arising from the abrupt cessation of placental transfer of opioids after birth, although other maternal substances, including benzodiazepines and other antidepressants, have been less commonly implicated.² The term neonatal opioid withdrawal syndrome is sometimes used to indicate withdrawal from opioids specifically.³ The central and autonomic nervous systems and the gastrointestinal system (eg, tremors, increased muscle tone, high-pitched crying, feeding difficulties) are affected in NAS, with most newborns demonstrating symptoms within the first few days of life.⁴ Previously reported factors associated with NAS include opioid type, timing of exposure during pregnancy, maternal tobacco use, infant sex, and gestational age.⁵ Literature demonstrates that concurrent exposure to other prenatal substances, particularly antidepressants, benzodiazepines, and gabapentin, is significantly associated with increased risk of NAS.⁶ Recent studies also suggest that expression of NAS may relate to newborn genetic variations, particularly at the OPRM1, COMT, and CYP2B6 gene sites.^{7, 8}

State health departments have increasingly deemed NAS as a reportable diagnosis for public health surveillance, which relies on the accurate diagnosis and documentation of NAS during birth hospitalization.⁹ The diagnosis codes for NAS include the International Classification of Diseases, Ninth Revision, Clinical Modification code (ICD-9-CM) 779.5 and the International Classification of Diseases, Tenth Revision, Clinical Modification ICD-10-CM code P96.1.¹⁰ However, given the variation in the presentation and severity of NAS, no consensus has been established with regard to a standardized case definition for reporting across hospitals and states.⁹ In fact, NAS should be conceptualized as a continuum of withdrawal symptoms along which every infant with intrauterine opioid exposure resides; this continuum ranges from minor findings, which do not affect the infant’s ability to grow and develop, to severe withdrawal, resulting in excessive weight loss, dehydration, or seizures.^3,11 Ultimately, the diagnosis of NAS is made clinically based on cardinal symptoms in the setting of known or highly suspected opioid exposure. In a recent study of Tennessee Medicaid claims data, >25% of infants with a confirmed diagnosis code for NAS did not receive pharmacotherapy.¹⁰ Pharmacologic treatment of NAS, therefore, may be more appropriately considered as a marker of disease severity, rather than a requirement for diagnosis.

Although the opioid crisis and resulting rise in NAS have affected communities across the US, substantial statewide variation exists, with extremes ranging from 0.7 per 1,000 births affected by NAS in Hawaii to 33.4 per 1,000 births in West Virginia.¹² Within states, increased maternal OUD and NAS rates have also disproportionately affected rural communities possibly due to reduced access to healthcare and mental health services and poor economic conditions.¹³ A recent national study demonstrated that the proportion of newborns with NAS who were born in rural hospitals increased from 12.9% to 21.2% over the past decade; these rural newborns with NAS are more likely to be publicly insured and to require transfer after birth than newborns in urban hospitals.¹⁴ These data suggest a particular need among rural communities for increased resources targeting NAS care as well as maternal OUD prevention and treatment.

The American College of Obstetricians and Gynecologists (ACOG) recommends early universal screening for maternal substance use at the first prenatal visit with a validated screening tool; examples include the 4Ps (parents, partners, past, and pregnancy), CRAFFT (car, relax, alone, forget, friends, trouble), and the National Institute on Drug Abuse quick screen, which have all been well studied and have a high sensitivity for detecting substance use and misuse.¹⁵

Toxicology Screening

Toxicology testing for both mother and newborn is helpful in identifying or confirming intrauterine exposures, particularly in cases of polysubstance use or when a newborn manifests signs of NAS but whose mother denies opioid use. All toxicology testing should be performed with the mother’s consent, and any potential legal or mandatory ramifications of a positive test should be considered. Although universal maternal toxicology testing improves the identification of newborns at risk for NAS, this approach remains controversial; most hospitals use a risk-based approach for maternal toxicology testing.^16,17

Newborn toxicology testing can be performed from samples of hair, urine, meconium, and umbilical cord. Although frequently used, newborn urine testing has the shortest window of detection, ie, the last few days prior to delivery (Table 1). Meconium drug testing has been considered the gold standard and can detect exposures from the last 20 weeks of gestation, providing information on chronic exposures.¹⁸ In a recent survey, 10% of hospitals reported using umbilical cord toxicology as the primary method for detecting intrauterine exposures.¹⁷ This approach allows greater ease of specimen collection but may not yield results that are exactly equivalent to meconium testing.¹⁹

Close monitoring for development of NAS after birth is indicated for all newborns with confirmed or suspected intrauterine opioid exposure. Although the current American Academy of Pediatrics (AAP) guidelines recommend three days of newborn observation for exposure to short-acting opioids and five to seven days for longer acting opioids, substantial variation has been described across US hospitals in policies related to newborn length of stay for NAS observation.^{17, 20} In most hospitals, monitoring for NAS occurs in the routine postpartum unit (ie, level 1 nursery), with transfer to the NICU if pharmacologic treatment is indicated.¹⁷

The most widely used assessment tool for NAS is the Finnegan Neonatal Abstinence Scoring System (FNASS) or the modified FNASS, which assigns points for the 21 most common opioid withdrawal symptoms based on perceived severity.^{17, 21} This tool allows for assessment of symptoms, helps determine need for pharmacologic intervention, and can guide monitoring of symptoms and weaning of therapy. A commonly used score cutoff of 8 is based on prior research validating scores >8 as indicative of withdrawal symptoms as opposed to normal newborn findings.²² Despite its popularity and widespread usage, FNASS has limitations, including the need for the newborn to be stimulated or disturbed to produce an accurate assessment and scoring for nonspecific signs of withdrawal, including sneezing, yawning, and stuffiness. Recent work has attempted to simplify and shorten the FNASS to elements that are unique and specific for withdrawal.^23,24 Further research is needed to establish the validity of common scoring practices (ie, use of 8 as a cutoff) to determine the need for pharmacologic treatment.²⁵

Recent studies suggest that simple, function-based assessments, such as the Eat, Sleep, Console (ESC) approach developed by Grossman and colleagues, may serve as an alternative to the FNASS for evaluating withdrawal.^26,27 With ESC, the need for pharmacotherapy is evaluated by the newborn’s ability to (1) eat (breastfeed successfully or eat at least 1oz per feed), (2) sleep uninterrupted for at least one hour, and (3) be consoled within 10 minutes. To date, research on the implementation of ESC has primarily focused on reducing length of stay and need for pharmacologic treatment in the context of quality improvement initiatives.^26,27 Further prospective studies are warranted that compare ESC to traditional approaches involving the FNASS, and that evaluate post-discharge outcomes including newborn weight gain, ongoing withdrawal symptoms at home, and readmission.

In recent years, research increasingly supports the critical role of nonpharmacological care in management of all opioid-exposed newborns, regardless of NAS severity.^{11,27, 28} Rooming-in of mothers or caregivers has been shown to decrease the need for pharmacologic treatment, shorten the length of stay, and reduce hospital costs.^28,29 Other well-established practices include maintaining a low stimulus environment for infants with low lighting and sound, swaddling, maximizing caregiver contact with kangaroo care and skin to skin, and minimizing interventions. Therapeutic modalities, such as massage and music therapy, have been used for infants with NAS, but no evidence has supported their use. Recent studies have increasingly supported the use of acupuncture as an emerging modality in treating NAS. ³⁰

Feeding

Breastfeeding is encouraged for mothers who are stable on their methadone or buprenorphine maintenance treatment, are not using heroin or other illicit drugs, and have no other contraindications to breastfeeding, such as human immunodeficiency virus.³¹ Despite the known benefits of breastfeeding, which include decreased NAS severity, decreased need for pharmacological treatment, and shortened length of hospital stay, breastfeeding rates among mothers with OUD are low.³¹ Hospital policies that can promote maternal success in breastfeeding include tailored breastfeeding support, rooming in, and early, consistent maternal education on the benefits and safety of breastfeeding.³² A small percentage of hospitals use donor breastmilk for this population, although data on outcomes are limited.¹⁷ For formula-fed newborns, emerging research suggests that early initiation of high-calorie (22-24 kcal/ounce) formula may be beneficial to prevent excessive weight loss and poor weight gain after intrauterine opioid exposure.³³

When supportive therapy fails to adequately control symptoms of withdrawal, pharmacological management is initiated to improve infant discomfort, allow for adequate feeding and nutrition, and facilitate parental bonding (Table 2).¹¹ Opioids are the primary agent used for pharmacologic treatment, and morphine is the most commonly utilized.¹⁷ Morphine is a short-acting opioid and can be prescribed either as a weight-based weaning protocol or symptom-based regimen. Methadone is also widely used, and as a long-acting opioid, it has the advantage of twice daily dosing after the initial loading dose. Recently, buprenorphine, a partial mu opioid agonist with a long half-life, has emerged as a promising primary opioid treatment agent and has been shown to reduce the length of stay and the number of opioid treatment days compared with morphine and methadone.³⁶

When the signs and symptoms of NAS are not effectively controlled with a primary opioid or in the case of polysubstance exposure, adjunctive agents are often used, with phenobarbital and clonidine being the most common (Table 3).¹¹ Regardless of opioid agent used, multicenter quality improvement initiatives demonstrate that having a standardized weaning protocol is critical to minimizing the overall length of stay and reducing the need for adjunctive agents.^38,39 Additionally, modeling tools such as pharmacometrics for methadone and buprenorphine have shown promise in optimizing dose selection.^40,41 Modeling may include pharmacodynamic data (ie, clinical response to treatment), pharmacokinetics (ie, measures of drug distribution and clearance), and other factors, such as patient demographics, intrauterine exposure type, and symptom severity. Future studies should examine weight versus symptom-based dosing regimens as well as compare weaning schedules versus “as needed” dosing regimens.¹¹

The need for comprehensive medical and psychosocial supports for mothers with OUD cannot be overstated, given the high rates of concurrent illicit or other substance use, comorbid depression and anxiety, physical and sexual trauma, poverty and homelessness, intravenous drug use, and sex-related risk patterns.¹⁵ Significant issues of healthcare-associated stigma and criminality also affect this population. As of 2019, 23 states and the District of Columbia classify substance use during pregnancy as child abuse under civil child-welfare statutes, potentially resulting in termination of parental rights.⁴² Studies of mothers with OUD have demonstrated that they often experience guilt, shame, and fear of loss of custody, all of which can impede their trust in hospital providers and future engagement in care.⁴³ They also report frustration with and mistrust of NAS scoring assessments, which they can perceive to be disruptive and potentially biased.⁴⁴ Multiple approaches should be considered to standardize and improve the hospital experience for this population, in a way that emphasizes the mother’s role as a capable, respected participant in her newborn’s care.

Maternal Support

A coordinated, multidisciplinary approach to comprehensively support mothers with OUD should involve team members from pediatrics, neonatology, obstetrics, nursing, social work, case management, and lactation.³⁵ This support includes screening for adequate resources and a safe, supportive, drug-free home environment as well as evaluating co-occurring mental health conditions. Referrals should be provided as needed to social services, postpartum psychiatry or behavioral health services, OUD treatment and relapse-prevention programs, and harm reduction services (eg, naloxone training). In addition to the healthcare team, other community members can be enlisted to serve as a trusted, consistent, and nonjudgmental support during the hospitalization; examples may include a peer support (another mother with OUD), an OUD program caseworker, or a doula.⁴⁴

Clinical Pathways

Hospitals should establish clinical pathways for women with OUD to standardize care and communication across the continuum of care for themselves and their newborn, with input from all healthcare team members involved (prenatal, intrapartum, and postpartum).³⁵ Early, consistent information should be provided regarding expected newborn hospital course, including toxicology testing, NAS monitoring, possible NICU admission, and involvement of social work.

Provider Training

Educational opportunities in the form of continuing medical education, in-service trainings, etc., should be provided for clinical staff who care for mothers with OUD and their newborns, regarding issues of substance use, stigma, bias, and trauma-informed care.³⁵ Online training resources are available through the American Society of Addiction Medicine, the ACOG, AAP, the Centers for Disease Control and Prevention, and the Substance Abuse and Mental Health Services Administration.

Regardless of whether or not NAS is treated pharmacologically, newborns with opioid exposure may experience residual symptoms of withdrawal that persist for months.⁴ Current research suggests increased risk for morbidity, emergency department utilization, and rehospitalization after discharge in this population as well as difficulty in accessing and engaging with pediatric preventative care.^{45, 46}

A clear plan should be established upon discharge to ensure optimal newborn care and follow-up. A complete record of the newborn’s hospital stay, including maternal toxicology screenings and summary of any social work documentation, should be communicated to the primary care provider upon discharge. Close postdischarge monitoring involves addressing parenting knowledge gaps, assessing illness and injury risk, and evaluating for the presence of ongoing withdrawal symptoms.⁴ Primary care providers can also play a key role in assessing maternal stress, coping, and parenting skills as well as helping families connect to resources. Further research is warranted on how pediatric primary care systems can better build maternal trust, address parenting needs, and engage this population in routine well-child care.⁴⁷

Child Welfare, Early Intervention, and Other Services

In general, newborn safety and keeping families intact should be prioritized, with disposition into foster care only in cases of concern for child maltreatment or neglect. Under the Child Abuse Prevention and Treatment Act (CAPTA), states are required to develop Plans of Safe Care for women and newborns affected by OUD, with the goal of fostering collaboration between healthcare and social service organizations around care of these families.⁴⁸ Given the variable interpretation of Plans of Safe Care across the U.S., providers should be knowledgeable about state and local statutes and reporting requirements related to parental substance use.

As part of Plans of Safe Care, providers may be well-positioned to initiate referrals for early intervention, home visiting, and other programs designed to provide developmental or wrap-around support for families. Under Part C of the Individuals with Disabilities Education Act, many states offer early intervention on the basis of NAS as an automatic qualifying diagnosis; however, attrition of eligible families along the referral and enrollment process is substantial.⁴⁹ A standardized approach to discharging opioid-exposed newborns includes referrals to available resources and discussion of their importance with families and may increase utilization and decrease variation in care.⁵⁰

Maternal OUD presents a unique combination of medical and psychosocial challenges that affect hospital care for mothers and their newborns. Optimal care for this population warrants a multidisciplinary team of providers who are knowledgeable, collaborative, and mindful of the important role of the mother as a key participant in her newborn’s care. Despite a large and growing body of research focused on NAS prevention, screening, and treatment, ongoing efforts are needed to create hospital policies and clinical pathways that are responsive to the healthcare needs of this population, navigate sensitive issues of criminality and stigma, and ultimately support maternal parenting success.

Disclosures

The authors have no financial relationships and conflicts of interest relevant to this article to disclose.

Funding

Funding for this work was provided by Cincinnati Children’s Hospital Medical Center and Nemours/AI duPont Hospital for Children.

Urinary tract infections (UTIs) are the most common bacterial infection and one of the most common reasons for hospitalization in young infants.^1,2 The American Academy of Pediatrics (AAP) has published several clinical practice guidelines for the evaluation and management of febrile children ages 2-24 months with first-time UTIs, most recently in 2011 and affirmed in 2016.³ These guidelines do not provide recommendations for infants aged <2 months, which leads to uncertainty regarding the diagnosis and management of UTIs for infants in this age group. We assess the applicability of the AAP UTI Guideline’s action statements for infants aged <2 months presenting with first-time UTIs, with an emphasis on recent evidence. Because the considerations for bacterial infections differ for febrile infants aged <2 months compared with older infants, we do not discuss action statements one and two (determination of the likelihood of UTIs and decision to test urine) and statement seven (medical evaluation for fever after first UTI).³ Additionally, because concomitant bacteremia and meningitis are more common in this age group than in older infants, we review some of the controversies surrounding the diagnosis and treatment of these disease entities.

“Action Statement 3: To establish the diagnosis of UTI, clinicians should require both urinalysis results that suggest infection (pyuria and/or bacteriuria) and the presence of at least 50,000 colony-forming units (CFUs) per mL of a uropathogen cultured from a urine specimen obtained through catheterization or SPA.”³

To distinguish asymptomatic bacteriuria or contamination from a true UTI, the AAP Guideline requires both a positive urinalysis (UA) and culture for a diagnosis of a UTI.³ Historically, the UA was considered to be poorly sensitive for infections in young infants, with older studies reporting sensitivities ranging from 40% to 82% using urine culture as the gold standard.^4-7 Thus, infants aged <2 months with positive urine cultures and negative UAs are often treated as having true UTIs, though this practice varies by institution.⁸ Possible explanations for the low UA sensitivity in this population include rapid bladder emptying, immature immune systems, and inability to concentrate urine. However, a negative UA plus a positive urine culture could also represent a “true negative” UA and a “false positive” culture, a finding that may be more common in young infants in whom sterile urine obtainment is often challenging.

Two recent studies have addressed this issue by evaluating the UA sensitivity in patients with bacteremic UTIs, as growth of the same pathogenic organism from the blood and urine almost certainly represents true infection.^9,10 In a retrospective study of 203 infants aged <3 months with bacteremic UTIs, the presence of any leukocyte esterase (LE) or pyuria (>3 white blood cells per high-powered field [WBC/HPF]) had a sensitivity of 99.5% (95% CI: 98.5%-100%) and specificity of 93.9% (95% CI: 87.8%-93.2%).⁹ In a prospective, multicenter study of 4,147 febrile infants aged ≤60 days, of whom 27 infants had bacteremic UTIs, a positive UA (any LE, >5 WBC/HPF, or nitrite) had a sensitivity and specificity of 1.00 (95% CI: 0.87-1.00) and 0.91 (95% CI: 0.90-0.91), respectively.¹⁰ Although screening tests may appear to have higher sensitivity in more severely diseased populations (“spectrum bias”),¹¹ it is not clear that infants with bacteremic UTIs are definitively sicker than infants with nonbacteremic UTIs (see “bacteremic UTI” section below). Additionally, this study found similarly excellent sensitivity (0.94 [95% CI: 0.90-0.96]) and specificity (0.91 [95% CI: 0.90-0.91]) of the UA among infants with nonbacteremic UTIs, including infants <28 days old.¹⁰

UA sensitivity (using urine culture as the gold standard) may be lower for non-Escherichia coli UTIs.^9,10,12 In a retrospective study that included 90 infants <2 months old with UTIs, urine cultures yielding Pseudomonas aeruginosa, Enterococcus, or Klebsiella species were significantly less likely (odds ratio [95% CI]: 0.19 [0.06-0.60]; 0.14 [0.07-0.28]; 0.34 [0.17-0.68], respectively) to have pyuria (≥5 WBC/HPF) or LE (1+ or greater) than urine cultures yielding E. coli.,¹² though an alternative explanation for this finding is that these organisms may be more likely to cause asymptomatic bacteriuria or contamination.¹³

The appropriate CFU/mL threshold to define a UTI and the extent that this threshold should vary by urine collection methods are still unclear. In the aforementioned bacteremic UTI study,⁹ 12 patients with E. coli bacteremia had urine cultures with <50,000 CFU/mL plus pyuria (WBC or LE) in the UA, indicating that true UTIs may occur with <50,000 CFU/mL.

Based on these recent studies, we believe that the recommendation to incorporate UA results into the diagnoses of UTIs can be applied to infants <2 months old, as well as consideration for a UTI for colony counts of ≥10,000 CFU/mL if the UA is positive. For infants with positive urine cultures and negative UAs who have not received antibiotics, we suggest repeating both studies if treatment is being considered. For those who have started antibiotics, the pretest probability of a UTI, initial illness severity, and risks and benefits of continuing treatment should be considered.

“Action Statement 4a: When initiating treatment, the clinician should base the choice of route of administration on practical considerations. Initiating treatment orally or parenterally is equally efficacious. The clinician should base the choice of agent on local antimicrobial sensitivity patterns (if available) and should adjust the choice according to sensitivity testing of the isolated uropathogen.”³

Most infants <2 months old with UTIs are hospitalized initially because of fever. Therefore, the decision point for most clinicians is not whether to hospitalize but for how long to hospitalize and treat with intravenous (IV) antibiotics prior to discharging home on oral antibiotics. Although all-oral antibiotic regimens are used to treat UTIs in older infants and children,^14-18 to our knowledge, there are no randomized controlled trials (RCTs) comparing all-IV vs all-oral antibiotics or a longer vs shorter initial IV course that include infants <1 month old. In the trials that do include infants aged 1-2 months,^14,18 the number of subjects in this age group is too small to draw conclusions, a finding supported by a 2014 Cochrane review.¹⁹ An adequately powered RCT of different IV antibiotic durations in this age group would be challenging. For example, nearly 1,000 subjects would be needed to demonstrate a statistically significant difference between a 5% and 10% relapse risk between groups, a difference that some may find clinically important.

The paucity of evidence in this age group may explain the considerable variability in the approach to IV antibiotic duration in young infants. Concerns about enteral absorption and underdeveloped immune systems may prompt some physicians to treat the youngest patients more aggressively. One study demonstrated that the proportion of patients <2 months old receiving prolonged courses (≥4 days) of IV antibiotics for UTIs in 46 U.S. children’s hospitals ranged from 0% to 67%.²⁰ Similar variability across hospitals has been described in other observational studies^21,22 and across subspecialties in one survey of pediatricians.²³

Several observational studies provide additional evidence supporting shorter IV courses. In two studies that examined administrative databases, there was no difference in treatment failure rates between infants aged <2 months²⁰ and <6 months²¹ receiving longer (≥4 days) vs shorter IV courses. In a study of 172 infants <1 month old with UTIs, the median IV duration was 4 days (range 2-12 days), and no subjects experienced treatment failure or relapse.²⁴ In a multicenter study of 251 infants <3 months old with bacteremic UTIs, mean IV antibiotic durations ranged from 5.5–12 days, and no patient had a relapsed bacteremic UTI. Six infants (2.4%) had a relapsed UTI without bacteremia, with no association between IV antibiotic duration and relapse.²²

Based on the available data and known risks of hospitalization and prolonged IV therapy, a reasonable approach for infants <1 month old would be to hospitalize for two to three days while awaiting blood and cerebral spinal fluid (CSF) culture results. Given the possibility of Enterococcus or Enterobacteriaceae that are resistant to third-generation cephalosporins, standard therapy of ampicillin and gentamicin for febrile neonates is reasonable, assuming there is no concern for meningitis. Antibiotics should be narrowed when susceptibilities are known. Once culture results return and signs and symptoms have resolved, discharge home on oral antibiotics is justifiable based on the available literature. For well-appearing infants aged 1-2 months with a presumptive UTI (based on UA results), if hospitalization is not warranted for other reasons, then we recommend outpatient treatment with oral or intramuscular therapy based on local susceptibilities (typically a cephalosporin) and close follow-up for one to two days while awaiting culture results. Although empiric cephalosporin therapy may not provide 100% coverage for all potential organisms, clinical deterioration is uncommon in infants and children receiving discordant therapy.²⁵

“Action Statement 4b: The clinician should choose 7 to 14 days as the duration of antimicrobial therapy.”³

The AAP’s recommendation to provide antibiotics (by oral or parenteral route) for a minimum of seven days total stems from a 2002 meta-analysis comparing long (7-14 days) vs short (≤3 days) courses, where the pooled relative risk of treatment failure with short-course therapy was 1.94 (95% CI: 1.19-3.15).²⁶ However, in this analysis, the trials that demonstrated inferiority with short courses were all trials that used single doses of antibiotics, and a similar Cochrane review comparing 2-4 days with 7-14 days demonstrated no differences in outcomes.²⁷ Therefore, shorter total courses, but not a single dose, are probably appropriate for most UTIs in children. Although there are no obvious biologic reasons why longer total courses would be needed in young infants, there are unfortunately limited data comparing different total antibiotic durations in this age group. We believe that 7-14 days of total therapy is a reasonable recommendation for infants <2 months old, and that future studies should investigate shorter total courses.

“Action Statement 5: Febrile infants with UTIs should undergo renal and bladder ultrasonography (RBUS).”³

The AAP Guideline acknowledges that the RBUS is a poor screening test for the detection of genitourinary abnormalities in infants.³ The RBUS can be normal in infants with vesicoureteral reflux (VUR) or show nonspecific findings of unclear clinical significance.²⁸ In a prospective study of 220 infants <3 months old by Tsai et al, 9/39 infants (23%) with grade III-V VUR had normal RBUS.²⁹ Studies that included older infants have found a similar false-negative rate of 0%-40% for detecting grade IV-V VUR by RBUS.²⁸ Nonetheless, since a RBUS is safe and noninvasive, we feel that the benefits of screening for abnormalities such as hydronephrosis (that could indicate posterior urethral valves or ureteropelvic junction obstruction) outweigh the risks (eg, false positives, overdiagnosis, and cost) of performing a RBUS after a first-time UTI.

“Action Statement 6a: Voiding cystourethrography (VCUG) should not be performed routinely after the first febrile UTI; VCUG is indicated if RBUS reveals hydronephrosis, scarring, or other findings that would suggest either high-grade VUR or obstructive uropathy, as well as in other atypical or complex clinical circumstances.”³

“Action Statement 6b: Further evaluation should be conducted if there is a recurrence of febrile UTI.”³

The RBUS may be normal in infants with VUR. Therefore, the AAP’s recommendation to perform a VCUG only if the RBUS is abnormal or after a recurrent UTI concedes that there will be infants with VUR who are missed after the first UTI.³

The United Kingdom’s National Institute for Health and Care Excellence guideline recommends a VCUG for infants <6 months old with a bacteremic or non-E. coli UTI.³⁰ Whether high-grade VUR is more common in young infants with bacteremic UTIs than nonbacteremic UTIs remains inconclusive. In the Honkinen et al. study that included 87 infants <3 months old with bacteremic UTIs, the prevalence of grade IV-V VUR (10%) and obstruction (7%) was higher than that of the 88 nonbacteremic infants (2% grade IV-V VUR and 2% with obstruction). In the multicenter study of 251 infants <3 months old with bacteremic UTIs, the prevalence of grade IV-V VUR was 12.1%.³¹ This is higher than that of the nonbacteremic infants in Honkinen et al.’s study³² but more similar to the prevalence of grade IV-V VUR found in Tsai et al. (8.2%) and Ismaili et al.’s (7.0%) studies of UTIs in general.^29,33

There does appear to be a higher prevalence of urinary tract abnormalities in young infants with non-E. coli vs E. coli UTIs.^31,32,34,35 The odds of an abnormal VCUG was 8.0 (95% CI: 2.3-28) times higher for non-E. coli than E. coli UTIs in the study of 251 bacteremic infants.³¹ In a study of 122 infants <3 months old, the odds of grade III-V VUR was 10 (95% CI 2.6-41) times higher for non-E. coli than E. coli UTIs.³⁵

However, the need for early detection of VUR is controversial, and VCUGs are invasive, involve ionizing radiation, and may require sedation. Two recent trials (one which included only children with VUR and another in which 42% of subjects had VUR) demonstrated a modest effect of prophylactic antibiotics in preventing recurrent UTIs (>5,000 doses of antibiotics needed to prevent one UTI recurrence), but the effect size did not differ by the presence or degree of VUR, and neither demonstrated any benefit in reducing future renal scarring.^{36, 37} The benefit of surgical interventions for VUR also remains unclear, though studies are limited.³⁸ Overall, there is no evidence suggesting that infants <2 months old require more vigilance for VUR detection than the 2-24 month age group.

Bacteremic UTI

The prevalence of bacteremia in infants ≤60 days old with UTIs was 9% in a study conducted from 2008 to 2013 in 26 EDs and has ranged from 3% to 17% in older studies.^{10, 22} Many studies have described similar clinical and laboratory findings in young infants with bacteremic and nonbacteremic UTIs.^39-41 Despite this, bacteremic UTIs have been associated with prolonged parenteral antibiotic courses, resulting in longer hospitalizations and increased costs.⁴⁰ Two recent multicenter studies of infants with bacteremic UTIs (251 infants <3 months old²² and 115 infants ≤60 days old⁴²) demonstrated variable IV courses and no association between IV duration and relapsed UTI. The latter study showed no risk difference in the adjusted 30-day UTI recurrence (risk difference 3%, 95% CI: −5.8 to 12.7) or all-cause reutilization (risk difference 3%, 95% CI: −14.5 to 20.6) between long and short IV groups.⁴² Neither study had patients with relapsed bacteremic UTIs or reported that patients suffered clinical deterioration while on oral antibiotics.^22,42

Based on these data demonstrating that adverse outcomes are rare in infants with bacteremic UTIs and not associated with parenteral antibiotic duration, we recommend short parenteral courses (2-3 days) with conversion to oral therapy once infants have clinically improved.

Positive Urinalysis and Testing for Meningitis

Multiple risk stratification algorithms for febrile infants aged ≤60 days categorize infants with a positive UA (and therefore likely UTI) as high-risk for having concomitant bacteremia or meningitis, for which lumbar puncture (LP) is typically recommended.^43-45 The risk of not testing CSF is the potential to insufficiently treat meningitis because treatment for UTIs and meningitis differ in dosing, route, and duration. Recent studies have challenged the practice of routine LPs for infants aged 1-2 months with a suspected UTI due to the low prevalence (0%-0.3%) of concomitant meningitis.^39,46-48 A meta-analysis of 20 studies reporting rates of concomitant meningitis with UTI in infants aged 29-90 days found a pooled prevalence of 0.25% (95% CI: 0.09%-0.70%).⁴⁹ Furthermore, a study of febrile infants ages 29-60 days found that the prevalence of meningitis did not differ between those with a positive vs negative UA (3/337 [0.9%] vs 5/498 [1.0%], respectively), suggesting that a positive UA alone should not modify the pretest probability of meningitis in this age group.⁵⁰

Two studies have also examined the risk of delayed meningitis among infants ≤60 days old treated for UTIs without CSF testing. A northern California study that examined 345 episodes among 341 UA-positive infants aged 29-60 days found zero cases (95% CI: 0%-1.1%) of delayed meningitis within 30 days of evaluation.⁵⁰ A multicenter study of well-appearing febrile infants aged 7-60 days found 0/505 cases (95% CI: 0%-0.6%) of delayed meningitis within 7 days of discharge; 407 (81%) were aged 31-60 days.⁵¹ In summary, studies have shown a low rate of concomitant meningitis and a low risk of delayed meningitis in infants aged 1-2 months treated for UTI without CSF testing. Given this, clinically targeted (eg, based on ill appearance and/or lethargy), rather than routine, CSF testing in this age group can be considered.

While the AAP UTI Guideline is directed toward 2-24-month-old infants, recent evidence suggests that action statements 3-6 apply to infants <2 months old. Incorporation of pyuria as a diagnostic criterion for UTIs, early transition to oral therapy, and selective VCUG testing are all warranted based on the available evidence and consideration of known risks and benefits. Future studies with larger sample sizes that include infants <2 months old would be beneficial to ensure that the available studies, which have relatively small cohorts, do not suffer from type II error. We propose that future studies examine shorter (<7 days) vs longer total antibiotic duration, shorter vs longer initial IV antibiotics (especially in infants <1 month old or with bacteremic UTIs), and whether RBUS can be performed in a targeted manner. RCTs comparing universal vs targeted imaging strategies would help ascertain whether the increased diagnostic yield that accompanies more aggressive imaging strategies translates into improved outcomes. Application of these AAP guidelines to the <2-month age group and enhancement of the evidence base can promote the high-value care of young infants with UTIs.

Urinary tract infections (UTIs) are the most common bacterial infection and one of the most common reasons for hospitalization in young infants.^1,2 The American Academy of Pediatrics (AAP) has published several clinical practice guidelines for the evaluation and management of febrile children ages 2-24 months with first-time UTIs, most recently in 2011 and affirmed in 2016.³ These guidelines do not provide recommendations for infants aged <2 months, which leads to uncertainty regarding the diagnosis and management of UTIs for infants in this age group. We assess the applicability of the AAP UTI Guideline’s action statements for infants aged <2 months presenting with first-time UTIs, with an emphasis on recent evidence. Because the considerations for bacterial infections differ for febrile infants aged <2 months compared with older infants, we do not discuss action statements one and two (determination of the likelihood of UTIs and decision to test urine) and statement seven (medical evaluation for fever after first UTI).³ Additionally, because concomitant bacteremia and meningitis are more common in this age group than in older infants, we review some of the controversies surrounding the diagnosis and treatment of these disease entities.

“Action Statement 3: To establish the diagnosis of UTI, clinicians should require both urinalysis results that suggest infection (pyuria and/or bacteriuria) and the presence of at least 50,000 colony-forming units (CFUs) per mL of a uropathogen cultured from a urine specimen obtained through catheterization or SPA.”³

To distinguish asymptomatic bacteriuria or contamination from a true UTI, the AAP Guideline requires both a positive urinalysis (UA) and culture for a diagnosis of a UTI.³ Historically, the UA was considered to be poorly sensitive for infections in young infants, with older studies reporting sensitivities ranging from 40% to 82% using urine culture as the gold standard.^4-7 Thus, infants aged <2 months with positive urine cultures and negative UAs are often treated as having true UTIs, though this practice varies by institution.⁸ Possible explanations for the low UA sensitivity in this population include rapid bladder emptying, immature immune systems, and inability to concentrate urine. However, a negative UA plus a positive urine culture could also represent a “true negative” UA and a “false positive” culture, a finding that may be more common in young infants in whom sterile urine obtainment is often challenging.

Two recent studies have addressed this issue by evaluating the UA sensitivity in patients with bacteremic UTIs, as growth of the same pathogenic organism from the blood and urine almost certainly represents true infection.^9,10 In a retrospective study of 203 infants aged <3 months with bacteremic UTIs, the presence of any leukocyte esterase (LE) or pyuria (>3 white blood cells per high-powered field [WBC/HPF]) had a sensitivity of 99.5% (95% CI: 98.5%-100%) and specificity of 93.9% (95% CI: 87.8%-93.2%).⁹ In a prospective, multicenter study of 4,147 febrile infants aged ≤60 days, of whom 27 infants had bacteremic UTIs, a positive UA (any LE, >5 WBC/HPF, or nitrite) had a sensitivity and specificity of 1.00 (95% CI: 0.87-1.00) and 0.91 (95% CI: 0.90-0.91), respectively.¹⁰ Although screening tests may appear to have higher sensitivity in more severely diseased populations (“spectrum bias”),¹¹ it is not clear that infants with bacteremic UTIs are definitively sicker than infants with nonbacteremic UTIs (see “bacteremic UTI” section below). Additionally, this study found similarly excellent sensitivity (0.94 [95% CI: 0.90-0.96]) and specificity (0.91 [95% CI: 0.90-0.91]) of the UA among infants with nonbacteremic UTIs, including infants <28 days old.¹⁰

UA sensitivity (using urine culture as the gold standard) may be lower for non-Escherichia coli UTIs.^9,10,12 In a retrospective study that included 90 infants <2 months old with UTIs, urine cultures yielding Pseudomonas aeruginosa, Enterococcus, or Klebsiella species were significantly less likely (odds ratio [95% CI]: 0.19 [0.06-0.60]; 0.14 [0.07-0.28]; 0.34 [0.17-0.68], respectively) to have pyuria (≥5 WBC/HPF) or LE (1+ or greater) than urine cultures yielding E. coli.,¹² though an alternative explanation for this finding is that these organisms may be more likely to cause asymptomatic bacteriuria or contamination.¹³

The appropriate CFU/mL threshold to define a UTI and the extent that this threshold should vary by urine collection methods are still unclear. In the aforementioned bacteremic UTI study,⁹ 12 patients with E. coli bacteremia had urine cultures with <50,000 CFU/mL plus pyuria (WBC or LE) in the UA, indicating that true UTIs may occur with <50,000 CFU/mL.

Based on these recent studies, we believe that the recommendation to incorporate UA results into the diagnoses of UTIs can be applied to infants <2 months old, as well as consideration for a UTI for colony counts of ≥10,000 CFU/mL if the UA is positive. For infants with positive urine cultures and negative UAs who have not received antibiotics, we suggest repeating both studies if treatment is being considered. For those who have started antibiotics, the pretest probability of a UTI, initial illness severity, and risks and benefits of continuing treatment should be considered.

“Action Statement 4a: When initiating treatment, the clinician should base the choice of route of administration on practical considerations. Initiating treatment orally or parenterally is equally efficacious. The clinician should base the choice of agent on local antimicrobial sensitivity patterns (if available) and should adjust the choice according to sensitivity testing of the isolated uropathogen.”³

Most infants <2 months old with UTIs are hospitalized initially because of fever. Therefore, the decision point for most clinicians is not whether to hospitalize but for how long to hospitalize and treat with intravenous (IV) antibiotics prior to discharging home on oral antibiotics. Although all-oral antibiotic regimens are used to treat UTIs in older infants and children,^14-18 to our knowledge, there are no randomized controlled trials (RCTs) comparing all-IV vs all-oral antibiotics or a longer vs shorter initial IV course that include infants <1 month old. In the trials that do include infants aged 1-2 months,^14,18 the number of subjects in this age group is too small to draw conclusions, a finding supported by a 2014 Cochrane review.¹⁹ An adequately powered RCT of different IV antibiotic durations in this age group would be challenging. For example, nearly 1,000 subjects would be needed to demonstrate a statistically significant difference between a 5% and 10% relapse risk between groups, a difference that some may find clinically important.

The paucity of evidence in this age group may explain the considerable variability in the approach to IV antibiotic duration in young infants. Concerns about enteral absorption and underdeveloped immune systems may prompt some physicians to treat the youngest patients more aggressively. One study demonstrated that the proportion of patients <2 months old receiving prolonged courses (≥4 days) of IV antibiotics for UTIs in 46 U.S. children’s hospitals ranged from 0% to 67%.²⁰ Similar variability across hospitals has been described in other observational studies^21,22 and across subspecialties in one survey of pediatricians.²³

Several observational studies provide additional evidence supporting shorter IV courses. In two studies that examined administrative databases, there was no difference in treatment failure rates between infants aged <2 months²⁰ and <6 months²¹ receiving longer (≥4 days) vs shorter IV courses. In a study of 172 infants <1 month old with UTIs, the median IV duration was 4 days (range 2-12 days), and no subjects experienced treatment failure or relapse.²⁴ In a multicenter study of 251 infants <3 months old with bacteremic UTIs, mean IV antibiotic durations ranged from 5.5–12 days, and no patient had a relapsed bacteremic UTI. Six infants (2.4%) had a relapsed UTI without bacteremia, with no association between IV antibiotic duration and relapse.²²

Based on the available data and known risks of hospitalization and prolonged IV therapy, a reasonable approach for infants <1 month old would be to hospitalize for two to three days while awaiting blood and cerebral spinal fluid (CSF) culture results. Given the possibility of Enterococcus or Enterobacteriaceae that are resistant to third-generation cephalosporins, standard therapy of ampicillin and gentamicin for febrile neonates is reasonable, assuming there is no concern for meningitis. Antibiotics should be narrowed when susceptibilities are known. Once culture results return and signs and symptoms have resolved, discharge home on oral antibiotics is justifiable based on the available literature. For well-appearing infants aged 1-2 months with a presumptive UTI (based on UA results), if hospitalization is not warranted for other reasons, then we recommend outpatient treatment with oral or intramuscular therapy based on local susceptibilities (typically a cephalosporin) and close follow-up for one to two days while awaiting culture results. Although empiric cephalosporin therapy may not provide 100% coverage for all potential organisms, clinical deterioration is uncommon in infants and children receiving discordant therapy.²⁵

“Action Statement 4b: The clinician should choose 7 to 14 days as the duration of antimicrobial therapy.”³

The AAP’s recommendation to provide antibiotics (by oral or parenteral route) for a minimum of seven days total stems from a 2002 meta-analysis comparing long (7-14 days) vs short (≤3 days) courses, where the pooled relative risk of treatment failure with short-course therapy was 1.94 (95% CI: 1.19-3.15).²⁶ However, in this analysis, the trials that demonstrated inferiority with short courses were all trials that used single doses of antibiotics, and a similar Cochrane review comparing 2-4 days with 7-14 days demonstrated no differences in outcomes.²⁷ Therefore, shorter total courses, but not a single dose, are probably appropriate for most UTIs in children. Although there are no obvious biologic reasons why longer total courses would be needed in young infants, there are unfortunately limited data comparing different total antibiotic durations in this age group. We believe that 7-14 days of total therapy is a reasonable recommendation for infants <2 months old, and that future studies should investigate shorter total courses.

“Action Statement 5: Febrile infants with UTIs should undergo renal and bladder ultrasonography (RBUS).”³

The AAP Guideline acknowledges that the RBUS is a poor screening test for the detection of genitourinary abnormalities in infants.³ The RBUS can be normal in infants with vesicoureteral reflux (VUR) or show nonspecific findings of unclear clinical significance.²⁸ In a prospective study of 220 infants <3 months old by Tsai et al, 9/39 infants (23%) with grade III-V VUR had normal RBUS.²⁹ Studies that included older infants have found a similar false-negative rate of 0%-40% for detecting grade IV-V VUR by RBUS.²⁸ Nonetheless, since a RBUS is safe and noninvasive, we feel that the benefits of screening for abnormalities such as hydronephrosis (that could indicate posterior urethral valves or ureteropelvic junction obstruction) outweigh the risks (eg, false positives, overdiagnosis, and cost) of performing a RBUS after a first-time UTI.

“Action Statement 6a: Voiding cystourethrography (VCUG) should not be performed routinely after the first febrile UTI; VCUG is indicated if RBUS reveals hydronephrosis, scarring, or other findings that would suggest either high-grade VUR or obstructive uropathy, as well as in other atypical or complex clinical circumstances.”³

“Action Statement 6b: Further evaluation should be conducted if there is a recurrence of febrile UTI.”³

The RBUS may be normal in infants with VUR. Therefore, the AAP’s recommendation to perform a VCUG only if the RBUS is abnormal or after a recurrent UTI concedes that there will be infants with VUR who are missed after the first UTI.³

The United Kingdom’s National Institute for Health and Care Excellence guideline recommends a VCUG for infants <6 months old with a bacteremic or non-E. coli UTI.³⁰ Whether high-grade VUR is more common in young infants with bacteremic UTIs than nonbacteremic UTIs remains inconclusive. In the Honkinen et al. study that included 87 infants <3 months old with bacteremic UTIs, the prevalence of grade IV-V VUR (10%) and obstruction (7%) was higher than that of the 88 nonbacteremic infants (2% grade IV-V VUR and 2% with obstruction). In the multicenter study of 251 infants <3 months old with bacteremic UTIs, the prevalence of grade IV-V VUR was 12.1%.³¹ This is higher than that of the nonbacteremic infants in Honkinen et al.’s study³² but more similar to the prevalence of grade IV-V VUR found in Tsai et al. (8.2%) and Ismaili et al.’s (7.0%) studies of UTIs in general.^29,33

There does appear to be a higher prevalence of urinary tract abnormalities in young infants with non-E. coli vs E. coli UTIs.^31,32,34,35 The odds of an abnormal VCUG was 8.0 (95% CI: 2.3-28) times higher for non-E. coli than E. coli UTIs in the study of 251 bacteremic infants.³¹ In a study of 122 infants <3 months old, the odds of grade III-V VUR was 10 (95% CI 2.6-41) times higher for non-E. coli than E. coli UTIs.³⁵

However, the need for early detection of VUR is controversial, and VCUGs are invasive, involve ionizing radiation, and may require sedation. Two recent trials (one which included only children with VUR and another in which 42% of subjects had VUR) demonstrated a modest effect of prophylactic antibiotics in preventing recurrent UTIs (>5,000 doses of antibiotics needed to prevent one UTI recurrence), but the effect size did not differ by the presence or degree of VUR, and neither demonstrated any benefit in reducing future renal scarring.^{36, 37} The benefit of surgical interventions for VUR also remains unclear, though studies are limited.³⁸ Overall, there is no evidence suggesting that infants <2 months old require more vigilance for VUR detection than the 2-24 month age group.

Bacteremic UTI

The prevalence of bacteremia in infants ≤60 days old with UTIs was 9% in a study conducted from 2008 to 2013 in 26 EDs and has ranged from 3% to 17% in older studies.^{10, 22} Many studies have described similar clinical and laboratory findings in young infants with bacteremic and nonbacteremic UTIs.^39-41 Despite this, bacteremic UTIs have been associated with prolonged parenteral antibiotic courses, resulting in longer hospitalizations and increased costs.⁴⁰ Two recent multicenter studies of infants with bacteremic UTIs (251 infants <3 months old²² and 115 infants ≤60 days old⁴²) demonstrated variable IV courses and no association between IV duration and relapsed UTI. The latter study showed no risk difference in the adjusted 30-day UTI recurrence (risk difference 3%, 95% CI: −5.8 to 12.7) or all-cause reutilization (risk difference 3%, 95% CI: −14.5 to 20.6) between long and short IV groups.⁴² Neither study had patients with relapsed bacteremic UTIs or reported that patients suffered clinical deterioration while on oral antibiotics.^22,42

Based on these data demonstrating that adverse outcomes are rare in infants with bacteremic UTIs and not associated with parenteral antibiotic duration, we recommend short parenteral courses (2-3 days) with conversion to oral therapy once infants have clinically improved.

Positive Urinalysis and Testing for Meningitis

Multiple risk stratification algorithms for febrile infants aged ≤60 days categorize infants with a positive UA (and therefore likely UTI) as high-risk for having concomitant bacteremia or meningitis, for which lumbar puncture (LP) is typically recommended.^43-45 The risk of not testing CSF is the potential to insufficiently treat meningitis because treatment for UTIs and meningitis differ in dosing, route, and duration. Recent studies have challenged the practice of routine LPs for infants aged 1-2 months with a suspected UTI due to the low prevalence (0%-0.3%) of concomitant meningitis.^39,46-48 A meta-analysis of 20 studies reporting rates of concomitant meningitis with UTI in infants aged 29-90 days found a pooled prevalence of 0.25% (95% CI: 0.09%-0.70%).⁴⁹ Furthermore, a study of febrile infants ages 29-60 days found that the prevalence of meningitis did not differ between those with a positive vs negative UA (3/337 [0.9%] vs 5/498 [1.0%], respectively), suggesting that a positive UA alone should not modify the pretest probability of meningitis in this age group.⁵⁰

Two studies have also examined the risk of delayed meningitis among infants ≤60 days old treated for UTIs without CSF testing. A northern California study that examined 345 episodes among 341 UA-positive infants aged 29-60 days found zero cases (95% CI: 0%-1.1%) of delayed meningitis within 30 days of evaluation.⁵⁰ A multicenter study of well-appearing febrile infants aged 7-60 days found 0/505 cases (95% CI: 0%-0.6%) of delayed meningitis within 7 days of discharge; 407 (81%) were aged 31-60 days.⁵¹ In summary, studies have shown a low rate of concomitant meningitis and a low risk of delayed meningitis in infants aged 1-2 months treated for UTI without CSF testing. Given this, clinically targeted (eg, based on ill appearance and/or lethargy), rather than routine, CSF testing in this age group can be considered.

While the AAP UTI Guideline is directed toward 2-24-month-old infants, recent evidence suggests that action statements 3-6 apply to infants <2 months old. Incorporation of pyuria as a diagnostic criterion for UTIs, early transition to oral therapy, and selective VCUG testing are all warranted based on the available evidence and consideration of known risks and benefits. Future studies with larger sample sizes that include infants <2 months old would be beneficial to ensure that the available studies, which have relatively small cohorts, do not suffer from type II error. We propose that future studies examine shorter (<7 days) vs longer total antibiotic duration, shorter vs longer initial IV antibiotics (especially in infants <1 month old or with bacteremic UTIs), and whether RBUS can be performed in a targeted manner. RCTs comparing universal vs targeted imaging strategies would help ascertain whether the increased diagnostic yield that accompanies more aggressive imaging strategies translates into improved outcomes. Application of these AAP guidelines to the <2-month age group and enhancement of the evidence base can promote the high-value care of young infants with UTIs.

Urinary tract infections (UTIs) are the most common bacterial infection and one of the most common reasons for hospitalization in young infants.^1,2 The American Academy of Pediatrics (AAP) has published several clinical practice guidelines for the evaluation and management of febrile children ages 2-24 months with first-time UTIs, most recently in 2011 and affirmed in 2016.³ These guidelines do not provide recommendations for infants aged <2 months, which leads to uncertainty regarding the diagnosis and management of UTIs for infants in this age group. We assess the applicability of the AAP UTI Guideline’s action statements for infants aged <2 months presenting with first-time UTIs, with an emphasis on recent evidence. Because the considerations for bacterial infections differ for febrile infants aged <2 months compared with older infants, we do not discuss action statements one and two (determination of the likelihood of UTIs and decision to test urine) and statement seven (medical evaluation for fever after first UTI).³ Additionally, because concomitant bacteremia and meningitis are more common in this age group than in older infants, we review some of the controversies surrounding the diagnosis and treatment of these disease entities.

“Action Statement 3: To establish the diagnosis of UTI, clinicians should require both urinalysis results that suggest infection (pyuria and/or bacteriuria) and the presence of at least 50,000 colony-forming units (CFUs) per mL of a uropathogen cultured from a urine specimen obtained through catheterization or SPA.”³

To distinguish asymptomatic bacteriuria or contamination from a true UTI, the AAP Guideline requires both a positive urinalysis (UA) and culture for a diagnosis of a UTI.³ Historically, the UA was considered to be poorly sensitive for infections in young infants, with older studies reporting sensitivities ranging from 40% to 82% using urine culture as the gold standard.^4-7 Thus, infants aged <2 months with positive urine cultures and negative UAs are often treated as having true UTIs, though this practice varies by institution.⁸ Possible explanations for the low UA sensitivity in this population include rapid bladder emptying, immature immune systems, and inability to concentrate urine. However, a negative UA plus a positive urine culture could also represent a “true negative” UA and a “false positive” culture, a finding that may be more common in young infants in whom sterile urine obtainment is often challenging.

Two recent studies have addressed this issue by evaluating the UA sensitivity in patients with bacteremic UTIs, as growth of the same pathogenic organism from the blood and urine almost certainly represents true infection.^9,10 In a retrospective study of 203 infants aged <3 months with bacteremic UTIs, the presence of any leukocyte esterase (LE) or pyuria (>3 white blood cells per high-powered field [WBC/HPF]) had a sensitivity of 99.5% (95% CI: 98.5%-100%) and specificity of 93.9% (95% CI: 87.8%-93.2%).⁹ In a prospective, multicenter study of 4,147 febrile infants aged ≤60 days, of whom 27 infants had bacteremic UTIs, a positive UA (any LE, >5 WBC/HPF, or nitrite) had a sensitivity and specificity of 1.00 (95% CI: 0.87-1.00) and 0.91 (95% CI: 0.90-0.91), respectively.¹⁰ Although screening tests may appear to have higher sensitivity in more severely diseased populations (“spectrum bias”),¹¹ it is not clear that infants with bacteremic UTIs are definitively sicker than infants with nonbacteremic UTIs (see “bacteremic UTI” section below). Additionally, this study found similarly excellent sensitivity (0.94 [95% CI: 0.90-0.96]) and specificity (0.91 [95% CI: 0.90-0.91]) of the UA among infants with nonbacteremic UTIs, including infants <28 days old.¹⁰

UA sensitivity (using urine culture as the gold standard) may be lower for non-Escherichia coli UTIs.^9,10,12 In a retrospective study that included 90 infants <2 months old with UTIs, urine cultures yielding Pseudomonas aeruginosa, Enterococcus, or Klebsiella species were significantly less likely (odds ratio [95% CI]: 0.19 [0.06-0.60]; 0.14 [0.07-0.28]; 0.34 [0.17-0.68], respectively) to have pyuria (≥5 WBC/HPF) or LE (1+ or greater) than urine cultures yielding E. coli.,¹² though an alternative explanation for this finding is that these organisms may be more likely to cause asymptomatic bacteriuria or contamination.¹³

The appropriate CFU/mL threshold to define a UTI and the extent that this threshold should vary by urine collection methods are still unclear. In the aforementioned bacteremic UTI study,⁹ 12 patients with E. coli bacteremia had urine cultures with <50,000 CFU/mL plus pyuria (WBC or LE) in the UA, indicating that true UTIs may occur with <50,000 CFU/mL.

Based on these recent studies, we believe that the recommendation to incorporate UA results into the diagnoses of UTIs can be applied to infants <2 months old, as well as consideration for a UTI for colony counts of ≥10,000 CFU/mL if the UA is positive. For infants with positive urine cultures and negative UAs who have not received antibiotics, we suggest repeating both studies if treatment is being considered. For those who have started antibiotics, the pretest probability of a UTI, initial illness severity, and risks and benefits of continuing treatment should be considered.

“Action Statement 4a: When initiating treatment, the clinician should base the choice of route of administration on practical considerations. Initiating treatment orally or parenterally is equally efficacious. The clinician should base the choice of agent on local antimicrobial sensitivity patterns (if available) and should adjust the choice according to sensitivity testing of the isolated uropathogen.”³

Most infants <2 months old with UTIs are hospitalized initially because of fever. Therefore, the decision point for most clinicians is not whether to hospitalize but for how long to hospitalize and treat with intravenous (IV) antibiotics prior to discharging home on oral antibiotics. Although all-oral antibiotic regimens are used to treat UTIs in older infants and children,^14-18 to our knowledge, there are no randomized controlled trials (RCTs) comparing all-IV vs all-oral antibiotics or a longer vs shorter initial IV course that include infants <1 month old. In the trials that do include infants aged 1-2 months,^14,18 the number of subjects in this age group is too small to draw conclusions, a finding supported by a 2014 Cochrane review.¹⁹ An adequately powered RCT of different IV antibiotic durations in this age group would be challenging. For example, nearly 1,000 subjects would be needed to demonstrate a statistically significant difference between a 5% and 10% relapse risk between groups, a difference that some may find clinically important.

The paucity of evidence in this age group may explain the considerable variability in the approach to IV antibiotic duration in young infants. Concerns about enteral absorption and underdeveloped immune systems may prompt some physicians to treat the youngest patients more aggressively. One study demonstrated that the proportion of patients <2 months old receiving prolonged courses (≥4 days) of IV antibiotics for UTIs in 46 U.S. children’s hospitals ranged from 0% to 67%.²⁰ Similar variability across hospitals has been described in other observational studies^21,22 and across subspecialties in one survey of pediatricians.²³

Several observational studies provide additional evidence supporting shorter IV courses. In two studies that examined administrative databases, there was no difference in treatment failure rates between infants aged <2 months²⁰ and <6 months²¹ receiving longer (≥4 days) vs shorter IV courses. In a study of 172 infants <1 month old with UTIs, the median IV duration was 4 days (range 2-12 days), and no subjects experienced treatment failure or relapse.²⁴ In a multicenter study of 251 infants <3 months old with bacteremic UTIs, mean IV antibiotic durations ranged from 5.5–12 days, and no patient had a relapsed bacteremic UTI. Six infants (2.4%) had a relapsed UTI without bacteremia, with no association between IV antibiotic duration and relapse.²²

Based on the available data and known risks of hospitalization and prolonged IV therapy, a reasonable approach for infants <1 month old would be to hospitalize for two to three days while awaiting blood and cerebral spinal fluid (CSF) culture results. Given the possibility of Enterococcus or Enterobacteriaceae that are resistant to third-generation cephalosporins, standard therapy of ampicillin and gentamicin for febrile neonates is reasonable, assuming there is no concern for meningitis. Antibiotics should be narrowed when susceptibilities are known. Once culture results return and signs and symptoms have resolved, discharge home on oral antibiotics is justifiable based on the available literature. For well-appearing infants aged 1-2 months with a presumptive UTI (based on UA results), if hospitalization is not warranted for other reasons, then we recommend outpatient treatment with oral or intramuscular therapy based on local susceptibilities (typically a cephalosporin) and close follow-up for one to two days while awaiting culture results. Although empiric cephalosporin therapy may not provide 100% coverage for all potential organisms, clinical deterioration is uncommon in infants and children receiving discordant therapy.²⁵

“Action Statement 4b: The clinician should choose 7 to 14 days as the duration of antimicrobial therapy.”³

The AAP’s recommendation to provide antibiotics (by oral or parenteral route) for a minimum of seven days total stems from a 2002 meta-analysis comparing long (7-14 days) vs short (≤3 days) courses, where the pooled relative risk of treatment failure with short-course therapy was 1.94 (95% CI: 1.19-3.15).²⁶ However, in this analysis, the trials that demonstrated inferiority with short courses were all trials that used single doses of antibiotics, and a similar Cochrane review comparing 2-4 days with 7-14 days demonstrated no differences in outcomes.²⁷ Therefore, shorter total courses, but not a single dose, are probably appropriate for most UTIs in children. Although there are no obvious biologic reasons why longer total courses would be needed in young infants, there are unfortunately limited data comparing different total antibiotic durations in this age group. We believe that 7-14 days of total therapy is a reasonable recommendation for infants <2 months old, and that future studies should investigate shorter total courses.

“Action Statement 5: Febrile infants with UTIs should undergo renal and bladder ultrasonography (RBUS).”³

The AAP Guideline acknowledges that the RBUS is a poor screening test for the detection of genitourinary abnormalities in infants.³ The RBUS can be normal in infants with vesicoureteral reflux (VUR) or show nonspecific findings of unclear clinical significance.²⁸ In a prospective study of 220 infants <3 months old by Tsai et al, 9/39 infants (23%) with grade III-V VUR had normal RBUS.²⁹ Studies that included older infants have found a similar false-negative rate of 0%-40% for detecting grade IV-V VUR by RBUS.²⁸ Nonetheless, since a RBUS is safe and noninvasive, we feel that the benefits of screening for abnormalities such as hydronephrosis (that could indicate posterior urethral valves or ureteropelvic junction obstruction) outweigh the risks (eg, false positives, overdiagnosis, and cost) of performing a RBUS after a first-time UTI.

“Action Statement 6a: Voiding cystourethrography (VCUG) should not be performed routinely after the first febrile UTI; VCUG is indicated if RBUS reveals hydronephrosis, scarring, or other findings that would suggest either high-grade VUR or obstructive uropathy, as well as in other atypical or complex clinical circumstances.”³

“Action Statement 6b: Further evaluation should be conducted if there is a recurrence of febrile UTI.”³

The RBUS may be normal in infants with VUR. Therefore, the AAP’s recommendation to perform a VCUG only if the RBUS is abnormal or after a recurrent UTI concedes that there will be infants with VUR who are missed after the first UTI.³

The United Kingdom’s National Institute for Health and Care Excellence guideline recommends a VCUG for infants <6 months old with a bacteremic or non-E. coli UTI.³⁰ Whether high-grade VUR is more common in young infants with bacteremic UTIs than nonbacteremic UTIs remains inconclusive. In the Honkinen et al. study that included 87 infants <3 months old with bacteremic UTIs, the prevalence of grade IV-V VUR (10%) and obstruction (7%) was higher than that of the 88 nonbacteremic infants (2% grade IV-V VUR and 2% with obstruction). In the multicenter study of 251 infants <3 months old with bacteremic UTIs, the prevalence of grade IV-V VUR was 12.1%.³¹ This is higher than that of the nonbacteremic infants in Honkinen et al.’s study³² but more similar to the prevalence of grade IV-V VUR found in Tsai et al. (8.2%) and Ismaili et al.’s (7.0%) studies of UTIs in general.^29,33

There does appear to be a higher prevalence of urinary tract abnormalities in young infants with non-E. coli vs E. coli UTIs.^31,32,34,35 The odds of an abnormal VCUG was 8.0 (95% CI: 2.3-28) times higher for non-E. coli than E. coli UTIs in the study of 251 bacteremic infants.³¹ In a study of 122 infants <3 months old, the odds of grade III-V VUR was 10 (95% CI 2.6-41) times higher for non-E. coli than E. coli UTIs.³⁵

However, the need for early detection of VUR is controversial, and VCUGs are invasive, involve ionizing radiation, and may require sedation. Two recent trials (one which included only children with VUR and another in which 42% of subjects had VUR) demonstrated a modest effect of prophylactic antibiotics in preventing recurrent UTIs (>5,000 doses of antibiotics needed to prevent one UTI recurrence), but the effect size did not differ by the presence or degree of VUR, and neither demonstrated any benefit in reducing future renal scarring.^{36, 37} The benefit of surgical interventions for VUR also remains unclear, though studies are limited.³⁸ Overall, there is no evidence suggesting that infants <2 months old require more vigilance for VUR detection than the 2-24 month age group.

Bacteremic UTI

The prevalence of bacteremia in infants ≤60 days old with UTIs was 9% in a study conducted from 2008 to 2013 in 26 EDs and has ranged from 3% to 17% in older studies.^{10, 22} Many studies have described similar clinical and laboratory findings in young infants with bacteremic and nonbacteremic UTIs.^39-41 Despite this, bacteremic UTIs have been associated with prolonged parenteral antibiotic courses, resulting in longer hospitalizations and increased costs.⁴⁰ Two recent multicenter studies of infants with bacteremic UTIs (251 infants <3 months old²² and 115 infants ≤60 days old⁴²) demonstrated variable IV courses and no association between IV duration and relapsed UTI. The latter study showed no risk difference in the adjusted 30-day UTI recurrence (risk difference 3%, 95% CI: −5.8 to 12.7) or all-cause reutilization (risk difference 3%, 95% CI: −14.5 to 20.6) between long and short IV groups.⁴² Neither study had patients with relapsed bacteremic UTIs or reported that patients suffered clinical deterioration while on oral antibiotics.^22,42

Based on these data demonstrating that adverse outcomes are rare in infants with bacteremic UTIs and not associated with parenteral antibiotic duration, we recommend short parenteral courses (2-3 days) with conversion to oral therapy once infants have clinically improved.

Positive Urinalysis and Testing for Meningitis

Multiple risk stratification algorithms for febrile infants aged ≤60 days categorize infants with a positive UA (and therefore likely UTI) as high-risk for having concomitant bacteremia or meningitis, for which lumbar puncture (LP) is typically recommended.^43-45 The risk of not testing CSF is the potential to insufficiently treat meningitis because treatment for UTIs and meningitis differ in dosing, route, and duration. Recent studies have challenged the practice of routine LPs for infants aged 1-2 months with a suspected UTI due to the low prevalence (0%-0.3%) of concomitant meningitis.^39,46-48 A meta-analysis of 20 studies reporting rates of concomitant meningitis with UTI in infants aged 29-90 days found a pooled prevalence of 0.25% (95% CI: 0.09%-0.70%).⁴⁹ Furthermore, a study of febrile infants ages 29-60 days found that the prevalence of meningitis did not differ between those with a positive vs negative UA (3/337 [0.9%] vs 5/498 [1.0%], respectively), suggesting that a positive UA alone should not modify the pretest probability of meningitis in this age group.⁵⁰

Two studies have also examined the risk of delayed meningitis among infants ≤60 days old treated for UTIs without CSF testing. A northern California study that examined 345 episodes among 341 UA-positive infants aged 29-60 days found zero cases (95% CI: 0%-1.1%) of delayed meningitis within 30 days of evaluation.⁵⁰ A multicenter study of well-appearing febrile infants aged 7-60 days found 0/505 cases (95% CI: 0%-0.6%) of delayed meningitis within 7 days of discharge; 407 (81%) were aged 31-60 days.⁵¹ In summary, studies have shown a low rate of concomitant meningitis and a low risk of delayed meningitis in infants aged 1-2 months treated for UTI without CSF testing. Given this, clinically targeted (eg, based on ill appearance and/or lethargy), rather than routine, CSF testing in this age group can be considered.

While the AAP UTI Guideline is directed toward 2-24-month-old infants, recent evidence suggests that action statements 3-6 apply to infants <2 months old. Incorporation of pyuria as a diagnostic criterion for UTIs, early transition to oral therapy, and selective VCUG testing are all warranted based on the available evidence and consideration of known risks and benefits. Future studies with larger sample sizes that include infants <2 months old would be beneficial to ensure that the available studies, which have relatively small cohorts, do not suffer from type II error. We propose that future studies examine shorter (<7 days) vs longer total antibiotic duration, shorter vs longer initial IV antibiotics (especially in infants <1 month old or with bacteremic UTIs), and whether RBUS can be performed in a targeted manner. RCTs comparing universal vs targeted imaging strategies would help ascertain whether the increased diagnostic yield that accompanies more aggressive imaging strategies translates into improved outcomes. Application of these AAP guidelines to the <2-month age group and enhancement of the evidence base can promote the high-value care of young infants with UTIs.

Challenges in conducting and completing studies of drugs in vulnerable populations, such as hospitalized children, include weak study designs and lack of sufficient sample sizes to achieve adequate power.¹ Limitations in the amount of blood that can be safely drawn in children and low parental consent rates due to concerns for anemia or pain, if venipuncture is required, lead to an insufficient number of patients enrolled in traditional clinical studies.² Thus, sample size targets are often not met. Recognizing the limited pediatric data for many drugs routinely prescribed off-label in children, the Food and Drug Administration implemented the Best Pharmaceuticals Children Act and the Pediatric Research Equity Act (PREA) in 2003; these legislative acts require clinical studies to assess the safety and efficacy of new drugs in children.¹ While studies conducted under these acts have provided important information for the clinical care of children, only one-third of mandatory pediatric postmarketing studies of the 114 new drugs and new indications subject to PREA requirements between 2007 and 2014 had been completed within seven years.³

Despite the challenges in conducting studies of drugs in children, robust pediatric data must be generated in children, especially in those with medical complexity or with chronic medical diseases and who have significant risk of experiencing adverse drug events. Data in adults cannot simply be extrapolated to children. In addition, studies from healthy children may not apply to hospitalized pediatric patients because of significant physiologic changes that occur in children who are ill enough to be hospitalized. Opportunistic sampling can provide robust drug disposition data and overcome some of the challenges encountered by traditional drug studies. In this Methodologic Progress Note, we describe the utility of opportunistic sampling as a research tool for hospitalists, in partnership with clinical pharmacologists, to study drug pharmacokinetics (PK) in hospitalized children.

Opportunistic sampling relies on the use of blood samples that are ordered for clinical purposes, and its use is endorsed by the Pediatric Trials Network.^2,5 Opportunistic sampling approaches have two types: sparse sampling and scavenged or remnant sampling. In sparse opportunistic sampling, additional blood is obtained at the same time clinical samples are ordered, avoiding the need for additional punctures.⁵ This approach requires bedside personnel to obtain additional blood that is sent to the research team for further processing. Scavenged sampling relies on leftover residual blood from clinical samples.^2,5 After the clinical laboratory performs the laboratory test ordered by the clinical team, the research team can scavenge residual blood for measurement of drug concentrations. When drug concentrations are measured from multiple patients, clinical pharmacologists can perform population PK modeling to characterize the pharmacokinetics of the drug and its variability within the population level.

The Figure shows how scavenged samples from hypothetical patients could be used to generate a PK curve. In this example, three patients are admitted for osteomyelitis and treated with the same antibiotic administered every eight hours, as shown by the theoretical concentration versus time profiles in the top panel. To determine the effectiveness of treatment and timing of transition to enteral antibiotics, the clinical team orders C-reactive protein (CRP) approximately every 48 hours for each patient. Each patient has his/her first dose of antibiotic at a different time of day depending on the time of admission or surgical drainage. Therefore, the timing of the blood draw with respect to the most recent antibiotic dose varies between patients even if blood draws are ordered at the same time for all patients (ie, 4 am lab draw). For patient 1, the blood draws occur approximately three to five hours after the second and eighth antibiotic doses (Figure, top panel). After the clinical laboratory measures the CRP, the research team scavenges residual blood from the lab samples and measures antibiotic concentrations. The antibiotic concentrations are then plotted on a concentration vs time after most recent dose. (Figure, bottom panel). Patient 2 has blood drawn five to seven hours after the first and seventh antibiotic doses. The third patient has blood drawn within two hours after the second and eighth antibiotic doses. As more samples are collected from additional patients, population PK modeling provides a robust description of the central tendency of the concentration vs time profile. More important, as more patients are included, the interpatient variability in concentrations can be described within the population, which often cannot be performed well with the smaller numbers of patients enrolled in traditional PK studies.

Opportunistic sampling has advantages over traditional intensive PK studies that often require multiple blood draws (typically >8-10) within one dosing interval to adequately describe the phases of absorption, distribution, metabolism, and elimination. The number of vascular punctures can be painful if blood cannot be drawn from existing vascular access, and the large amount of blood (sometimes >1 mL/sample) required for these studies can be impractical, burdensome, and even dangerous in young children and neonates. Scavenged sampling reduces the risk of anemia because no additional blood is drawn beyond what is obtained for clinical purposes, and it does not disrupt nursing workflow or add to nursing workload. Approval to use scavenged blood requires approval from the institutional review board. At some institutions, the consent to treat form on admission may address the use of scavenged samples and therefore allow for waiver of consent. In addition, the consent process may occur retroactively after samples are collected. These methods lead to increased enrollment.

Limitations in this approach are that drugs may degrade over time in whole blood or processed samples. Therefore, the process by which the clinical laboratory stores the residual blood after clinical tests must be understood, and the stability of the drug or metabolite of interest in blood or plasma over time must be ensured. In addition, residual blood may not be present after a clinical test, and recording times of the drug administration and lab draws may be inaccurate.^2,5

Challenges in conducting and completing studies of drugs in vulnerable populations, such as hospitalized children, include weak study designs and lack of sufficient sample sizes to achieve adequate power.¹ Limitations in the amount of blood that can be safely drawn in children and low parental consent rates due to concerns for anemia or pain, if venipuncture is required, lead to an insufficient number of patients enrolled in traditional clinical studies.² Thus, sample size targets are often not met. Recognizing the limited pediatric data for many drugs routinely prescribed off-label in children, the Food and Drug Administration implemented the Best Pharmaceuticals Children Act and the Pediatric Research Equity Act (PREA) in 2003; these legislative acts require clinical studies to assess the safety and efficacy of new drugs in children.¹ While studies conducted under these acts have provided important information for the clinical care of children, only one-third of mandatory pediatric postmarketing studies of the 114 new drugs and new indications subject to PREA requirements between 2007 and 2014 had been completed within seven years.³

Despite the challenges in conducting studies of drugs in children, robust pediatric data must be generated in children, especially in those with medical complexity or with chronic medical diseases and who have significant risk of experiencing adverse drug events. Data in adults cannot simply be extrapolated to children. In addition, studies from healthy children may not apply to hospitalized pediatric patients because of significant physiologic changes that occur in children who are ill enough to be hospitalized. Opportunistic sampling can provide robust drug disposition data and overcome some of the challenges encountered by traditional drug studies. In this Methodologic Progress Note, we describe the utility of opportunistic sampling as a research tool for hospitalists, in partnership with clinical pharmacologists, to study drug pharmacokinetics (PK) in hospitalized children.

Opportunistic sampling relies on the use of blood samples that are ordered for clinical purposes, and its use is endorsed by the Pediatric Trials Network.^2,5 Opportunistic sampling approaches have two types: sparse sampling and scavenged or remnant sampling. In sparse opportunistic sampling, additional blood is obtained at the same time clinical samples are ordered, avoiding the need for additional punctures.⁵ This approach requires bedside personnel to obtain additional blood that is sent to the research team for further processing. Scavenged sampling relies on leftover residual blood from clinical samples.^2,5 After the clinical laboratory performs the laboratory test ordered by the clinical team, the research team can scavenge residual blood for measurement of drug concentrations. When drug concentrations are measured from multiple patients, clinical pharmacologists can perform population PK modeling to characterize the pharmacokinetics of the drug and its variability within the population level.

The Figure shows how scavenged samples from hypothetical patients could be used to generate a PK curve. In this example, three patients are admitted for osteomyelitis and treated with the same antibiotic administered every eight hours, as shown by the theoretical concentration versus time profiles in the top panel. To determine the effectiveness of treatment and timing of transition to enteral antibiotics, the clinical team orders C-reactive protein (CRP) approximately every 48 hours for each patient. Each patient has his/her first dose of antibiotic at a different time of day depending on the time of admission or surgical drainage. Therefore, the timing of the blood draw with respect to the most recent antibiotic dose varies between patients even if blood draws are ordered at the same time for all patients (ie, 4 am lab draw). For patient 1, the blood draws occur approximately three to five hours after the second and eighth antibiotic doses (Figure, top panel). After the clinical laboratory measures the CRP, the research team scavenges residual blood from the lab samples and measures antibiotic concentrations. The antibiotic concentrations are then plotted on a concentration vs time after most recent dose. (Figure, bottom panel). Patient 2 has blood drawn five to seven hours after the first and seventh antibiotic doses. The third patient has blood drawn within two hours after the second and eighth antibiotic doses. As more samples are collected from additional patients, population PK modeling provides a robust description of the central tendency of the concentration vs time profile. More important, as more patients are included, the interpatient variability in concentrations can be described within the population, which often cannot be performed well with the smaller numbers of patients enrolled in traditional PK studies.

Opportunistic sampling has advantages over traditional intensive PK studies that often require multiple blood draws (typically >8-10) within one dosing interval to adequately describe the phases of absorption, distribution, metabolism, and elimination. The number of vascular punctures can be painful if blood cannot be drawn from existing vascular access, and the large amount of blood (sometimes >1 mL/sample) required for these studies can be impractical, burdensome, and even dangerous in young children and neonates. Scavenged sampling reduces the risk of anemia because no additional blood is drawn beyond what is obtained for clinical purposes, and it does not disrupt nursing workflow or add to nursing workload. Approval to use scavenged blood requires approval from the institutional review board. At some institutions, the consent to treat form on admission may address the use of scavenged samples and therefore allow for waiver of consent. In addition, the consent process may occur retroactively after samples are collected. These methods lead to increased enrollment.

Limitations in this approach are that drugs may degrade over time in whole blood or processed samples. Therefore, the process by which the clinical laboratory stores the residual blood after clinical tests must be understood, and the stability of the drug or metabolite of interest in blood or plasma over time must be ensured. In addition, residual blood may not be present after a clinical test, and recording times of the drug administration and lab draws may be inaccurate.^2,5

Challenges in conducting and completing studies of drugs in vulnerable populations, such as hospitalized children, include weak study designs and lack of sufficient sample sizes to achieve adequate power.¹ Limitations in the amount of blood that can be safely drawn in children and low parental consent rates due to concerns for anemia or pain, if venipuncture is required, lead to an insufficient number of patients enrolled in traditional clinical studies.² Thus, sample size targets are often not met. Recognizing the limited pediatric data for many drugs routinely prescribed off-label in children, the Food and Drug Administration implemented the Best Pharmaceuticals Children Act and the Pediatric Research Equity Act (PREA) in 2003; these legislative acts require clinical studies to assess the safety and efficacy of new drugs in children.¹ While studies conducted under these acts have provided important information for the clinical care of children, only one-third of mandatory pediatric postmarketing studies of the 114 new drugs and new indications subject to PREA requirements between 2007 and 2014 had been completed within seven years.³

Despite the challenges in conducting studies of drugs in children, robust pediatric data must be generated in children, especially in those with medical complexity or with chronic medical diseases and who have significant risk of experiencing adverse drug events. Data in adults cannot simply be extrapolated to children. In addition, studies from healthy children may not apply to hospitalized pediatric patients because of significant physiologic changes that occur in children who are ill enough to be hospitalized. Opportunistic sampling can provide robust drug disposition data and overcome some of the challenges encountered by traditional drug studies. In this Methodologic Progress Note, we describe the utility of opportunistic sampling as a research tool for hospitalists, in partnership with clinical pharmacologists, to study drug pharmacokinetics (PK) in hospitalized children.

Opportunistic sampling relies on the use of blood samples that are ordered for clinical purposes, and its use is endorsed by the Pediatric Trials Network.^2,5 Opportunistic sampling approaches have two types: sparse sampling and scavenged or remnant sampling. In sparse opportunistic sampling, additional blood is obtained at the same time clinical samples are ordered, avoiding the need for additional punctures.⁵ This approach requires bedside personnel to obtain additional blood that is sent to the research team for further processing. Scavenged sampling relies on leftover residual blood from clinical samples.^2,5 After the clinical laboratory performs the laboratory test ordered by the clinical team, the research team can scavenge residual blood for measurement of drug concentrations. When drug concentrations are measured from multiple patients, clinical pharmacologists can perform population PK modeling to characterize the pharmacokinetics of the drug and its variability within the population level.

The Figure shows how scavenged samples from hypothetical patients could be used to generate a PK curve. In this example, three patients are admitted for osteomyelitis and treated with the same antibiotic administered every eight hours, as shown by the theoretical concentration versus time profiles in the top panel. To determine the effectiveness of treatment and timing of transition to enteral antibiotics, the clinical team orders C-reactive protein (CRP) approximately every 48 hours for each patient. Each patient has his/her first dose of antibiotic at a different time of day depending on the time of admission or surgical drainage. Therefore, the timing of the blood draw with respect to the most recent antibiotic dose varies between patients even if blood draws are ordered at the same time for all patients (ie, 4 am lab draw). For patient 1, the blood draws occur approximately three to five hours after the second and eighth antibiotic doses (Figure, top panel). After the clinical laboratory measures the CRP, the research team scavenges residual blood from the lab samples and measures antibiotic concentrations. The antibiotic concentrations are then plotted on a concentration vs time after most recent dose. (Figure, bottom panel). Patient 2 has blood drawn five to seven hours after the first and seventh antibiotic doses. The third patient has blood drawn within two hours after the second and eighth antibiotic doses. As more samples are collected from additional patients, population PK modeling provides a robust description of the central tendency of the concentration vs time profile. More important, as more patients are included, the interpatient variability in concentrations can be described within the population, which often cannot be performed well with the smaller numbers of patients enrolled in traditional PK studies.

Opportunistic sampling has advantages over traditional intensive PK studies that often require multiple blood draws (typically >8-10) within one dosing interval to adequately describe the phases of absorption, distribution, metabolism, and elimination. The number of vascular punctures can be painful if blood cannot be drawn from existing vascular access, and the large amount of blood (sometimes >1 mL/sample) required for these studies can be impractical, burdensome, and even dangerous in young children and neonates. Scavenged sampling reduces the risk of anemia because no additional blood is drawn beyond what is obtained for clinical purposes, and it does not disrupt nursing workflow or add to nursing workload. Approval to use scavenged blood requires approval from the institutional review board. At some institutions, the consent to treat form on admission may address the use of scavenged samples and therefore allow for waiver of consent. In addition, the consent process may occur retroactively after samples are collected. These methods lead to increased enrollment.

Limitations in this approach are that drugs may degrade over time in whole blood or processed samples. Therefore, the process by which the clinical laboratory stores the residual blood after clinical tests must be understood, and the stability of the drug or metabolite of interest in blood or plasma over time must be ensured. In addition, residual blood may not be present after a clinical test, and recording times of the drug administration and lab draws may be inaccurate.^2,5

Pediatric hospital medicine (PHM) is in the midst of an exciting period of growth. In 2016, the American Board of Medical Specialties approved the petition for PHM to become the newest pediatric subspecialty, taking PHM on a divergent path from the Focused Practice in Hospital Medicine designation established for adult hospitalists. Establishment as a subspecialty has allowed PHM to define the unique skills and qualifications that hospitalists bring to patients and the healthcare system. These skills and qualifications are delineated in the PHM core competencies and national fellowship curriculum.^1,2 In order to realize the vision of PHM to improve care for hospitalized children described by Roberts et al.,³ concerted efforts are needed to train and retain a workforce that is equipped with the skills to catalyze improvements in inpatient pediatric care. We discuss challenges and opportunities facing PHM in workforce development, sustainability of clinical work models, and interhospital collaboration.

The development of PHM as a subspecialty was driven by a number of factors.⁴ The acuity of hospitalized children has increased significantly, with a population comprised of more children with complex chronic conditions and/or technology dependence, serious complications of acute conditions, and acute mental health problems. At the same time, the medical and behavioral conditions seen by outpatient general pediatricians have become more complex and time intensive, with these practitioners less likely to work in inpatient settings. Hospitalist care has positive impacts on healthcare efficiency and value, and both parents and primary care pediatricians report high levels of satisfaction with the healthcare delivered by PHM services.⁴

A national count of the number of pediatric hospitalists is currently lacking. Conservative estimates suggest that at least 3,000 pediatric hospitalists currently practice in the United States.⁵ These hospitalists have highly varied scopes of practice and work across diverse settings—more diverse, perhaps, than any other pediatric subspecialty. Although difficult to quantify, we estimate that approximately one-third of pediatric hospitalists in the US work in community hospitals and the remainder practice at children’s hospitals.⁶ Many of the needs of hospitalized children differ across these settings, and the roles and challenges faced by hospitalists in these settings correspondingly differ. Community hospitalists frequently take active roles in newborn care and emergency department consultation, often without the support of other pediatric subspecialties.⁷ In contrast, hospitalists working at children’s hospitals more frequently care for highly complex patients, often collaborate across multiple specialties and assume nonclinical roles in quality improvement (QI), research, and medical education.

Residents graduating in July 2019 were the last cohort of residents eligible to pursue PHM subspecialty certification via the practice pathway. Accordingly, future residency graduates interested in PHM subspecialty certification will need to complete a PHM fellowship at an accredited program in the US or Canada. Since 2008, PHM fellowship directors have met yearly to collaborate and share best practices,⁸ developing the two-year fellowship curriculum that forms the basis for the American Board of Pediatrics training pathway.² The curriculum allows significant flexibility to meet diverse needs, including tailored content for fellows planning to practice in community settings, fellows planning research careers, medicine-pediatrics hospitalist careers, and those desiring increased training in QI, medical education, or leadership/administration.² In the spring of 2019, Pediatric Research in Inpatient Settings (PRIS) leadership, directors of existing PHM fellowship programs, and national academic society representatives met to develop a fellows’ research curriculum, training resources, and guidelines around scholarship expectations.⁹ This collaboration aims to accelerate the growth of high-quality clinical training and scholarship to benefit hospitalized children across many different settings.

Such collaboration is essential to address an emerging workforce challenge in PHM. Although the number of PHM fellowship positions is expected to grow in the coming years, there is currently a shortage relative to the anticipated demand. With approximately 2,800 US pediatric residents graduating annually and data indicating that 7% of graduating residents enter and remain in PHM for at least five years,^10,11 almost 200 fellowship spots may be needed each year. As of November 2019, 77 fellowship positions were available for residents graduating in 2020,¹² which is less than half of the potential demand. To address this mismatch, the PHM Fellowship Directors’ Council has led an annual training for new and potential fellowship directors, and 18 new programs are under development.¹³ However, this growth may be inadequate to meet the needs of the field. The extent to which limited PHM fellowship positions will adversely affect the pipeline of pediatricians pursuing PHM is unknown.

Efforts to support institutions in creating and expanding fellowship programs will be needed to address the potential shortage of fellowship positions. Continued guidance from the PHM Fellowship Directors’ Council in the many aspects of fellowship program development (eg, curriculum design, assessment) will be crucial in this endeavor. Furthermore, given that fellowships must support fellows to conduct scholarly work and demonstrate evidence of robust faculty scholarly activities to attain accreditation, an essential area of focus is faculty development. Considering barriers such as lack of time, mentorship, and resources, some divisions interested in starting a fellowship may find it challenging to achieve these standards.¹⁴ However, hospitalists are often engaged in areas such as QI and medical education, and there is potential to turn ongoing work into meaningful scholarship with appropriate guidance. Many of our supporting organizations (eg, Academic Pediatric Association, American Academy of Pediatrics, and Society of Hospital Medicine) provide training programs for faculty in areas such as educational scholarship, research, and QI; however, more may be needed. Leaders of PHM programs will need to be mindful and creative in accessing local, regional, and national resources to invest in faculty development.

As a group, pediatric hospitalists report high levels of satisfaction with their jobs.¹¹ Despite this finding, there are a number of threats to the sustainability of current work models, some of which are unique to pediatrics given the overall lower patient volumes and greater seasonal variation compared with adult hospital medicine. Both university and community-based hospitalist programs report high weekend, overnight, and in-house clinical effort.^7,15 Recent studies reported that a significant proportion of PHM program leaders (50% of division directors at university-affiliated programs and 37% of community program leaders) perceive their program to be unsustainable.^7,15 Among university-affiliated programs, a higher burden of weekend work as well as university employment were associated with perceived unsustainability, while no specific program or employer characteristic was associated with this perception in community programs.

These findings indicate that efforts are needed to address PHM program sustainability and that different work models and interventions may be needed for university-based and community PHM programs. Wide variability exists in the ways that programs address overall clinical burden, with strategies including census caps, seasonal expansion of coverage, and formal back-up systems.^7,15 Additional potential solutions may include differential weighting or financial incentives for nights and weekends, support for nonclinical work, loan repayment programs, and competitive salaries.¹¹ In addition, structuring clinical and nonclinical roles to facilitate career development and advancement may enhance career longevity.¹⁵ Lessons learned from pediatric emergency medicine (PEM), which developed as a field a few decades ahead of PHM, may predict future challenges. A 2015 survey of PEM faculty found that despite a 15% decrease in weekly work hours over a 15-year period, a substantial number of PEM faculty report concerns about burnout, with 40% reporting a plan to decrease their clinical workload and 13% planning to leave the field within five years.¹⁶ Like PEM, the field of PHM may benefit from the development of best practice guidelines to improve well-being and career longevity.¹⁷

The culture of collaboration within PHM places the field in a solid position to address both workforce challenges and barriers to high-quality care for hospitalized children. There are several hospital-based learning networks actively working to strengthen our knowledge base and improve healthcare quality. The PRIS network (www.prisnetwork.org) aims to improve healthcare for children through multihospital studies, boasting 114 sites in the US and Canada. Numerous collaborative projects have linked hospitalists across programs to tackle problems ranging from handoff communication¹⁸ to eliminating monitor overuse.¹⁹ The Value in Inpatient Pediatrics network has similarly leveraged collaborations across multiple children’s and community hospitals to improve transitions of care²⁰ and care for common conditions such as bronchiolitis, febrile infants, and asthma.²¹ These networks serve as models of effective collaboration between children’s hospitals and community hospitals, more of which is needed to increase research and QI initiatives in community hospitals, where the majority of US children receive their hospital-based care.^6,22

With the rapid growth of scholarly networks in research, QI, and education, PHM has a solid infrastructure on which to base continued development as a subspeciality. Building on this infrastructure will be essential in order to address current challenges in workforce development, fellowship training, and program sustainability. Ultimately, achieving a strong, stable, and skilled workforce will enable PHM to fulfill its promise of improving the care of children across the diversity of settings where they receive their hospital-based care.

Disclosures

Dr. Leyenaar provides consultative services to the American Board of Pediatrics Foundation, which is not associated with this manuscript. Drs. Wang and Shaughnessy have no disclosures

Pediatric hospital medicine (PHM) is in the midst of an exciting period of growth. In 2016, the American Board of Medical Specialties approved the petition for PHM to become the newest pediatric subspecialty, taking PHM on a divergent path from the Focused Practice in Hospital Medicine designation established for adult hospitalists. Establishment as a subspecialty has allowed PHM to define the unique skills and qualifications that hospitalists bring to patients and the healthcare system. These skills and qualifications are delineated in the PHM core competencies and national fellowship curriculum.^1,2 In order to realize the vision of PHM to improve care for hospitalized children described by Roberts et al.,³ concerted efforts are needed to train and retain a workforce that is equipped with the skills to catalyze improvements in inpatient pediatric care. We discuss challenges and opportunities facing PHM in workforce development, sustainability of clinical work models, and interhospital collaboration.

The development of PHM as a subspecialty was driven by a number of factors.⁴ The acuity of hospitalized children has increased significantly, with a population comprised of more children with complex chronic conditions and/or technology dependence, serious complications of acute conditions, and acute mental health problems. At the same time, the medical and behavioral conditions seen by outpatient general pediatricians have become more complex and time intensive, with these practitioners less likely to work in inpatient settings. Hospitalist care has positive impacts on healthcare efficiency and value, and both parents and primary care pediatricians report high levels of satisfaction with the healthcare delivered by PHM services.⁴

A national count of the number of pediatric hospitalists is currently lacking. Conservative estimates suggest that at least 3,000 pediatric hospitalists currently practice in the United States.⁵ These hospitalists have highly varied scopes of practice and work across diverse settings—more diverse, perhaps, than any other pediatric subspecialty. Although difficult to quantify, we estimate that approximately one-third of pediatric hospitalists in the US work in community hospitals and the remainder practice at children’s hospitals.⁶ Many of the needs of hospitalized children differ across these settings, and the roles and challenges faced by hospitalists in these settings correspondingly differ. Community hospitalists frequently take active roles in newborn care and emergency department consultation, often without the support of other pediatric subspecialties.⁷ In contrast, hospitalists working at children’s hospitals more frequently care for highly complex patients, often collaborate across multiple specialties and assume nonclinical roles in quality improvement (QI), research, and medical education.

Residents graduating in July 2019 were the last cohort of residents eligible to pursue PHM subspecialty certification via the practice pathway. Accordingly, future residency graduates interested in PHM subspecialty certification will need to complete a PHM fellowship at an accredited program in the US or Canada. Since 2008, PHM fellowship directors have met yearly to collaborate and share best practices,⁸ developing the two-year fellowship curriculum that forms the basis for the American Board of Pediatrics training pathway.² The curriculum allows significant flexibility to meet diverse needs, including tailored content for fellows planning to practice in community settings, fellows planning research careers, medicine-pediatrics hospitalist careers, and those desiring increased training in QI, medical education, or leadership/administration.² In the spring of 2019, Pediatric Research in Inpatient Settings (PRIS) leadership, directors of existing PHM fellowship programs, and national academic society representatives met to develop a fellows’ research curriculum, training resources, and guidelines around scholarship expectations.⁹ This collaboration aims to accelerate the growth of high-quality clinical training and scholarship to benefit hospitalized children across many different settings.

Such collaboration is essential to address an emerging workforce challenge in PHM. Although the number of PHM fellowship positions is expected to grow in the coming years, there is currently a shortage relative to the anticipated demand. With approximately 2,800 US pediatric residents graduating annually and data indicating that 7% of graduating residents enter and remain in PHM for at least five years,^10,11 almost 200 fellowship spots may be needed each year. As of November 2019, 77 fellowship positions were available for residents graduating in 2020,¹² which is less than half of the potential demand. To address this mismatch, the PHM Fellowship Directors’ Council has led an annual training for new and potential fellowship directors, and 18 new programs are under development.¹³ However, this growth may be inadequate to meet the needs of the field. The extent to which limited PHM fellowship positions will adversely affect the pipeline of pediatricians pursuing PHM is unknown.

Efforts to support institutions in creating and expanding fellowship programs will be needed to address the potential shortage of fellowship positions. Continued guidance from the PHM Fellowship Directors’ Council in the many aspects of fellowship program development (eg, curriculum design, assessment) will be crucial in this endeavor. Furthermore, given that fellowships must support fellows to conduct scholarly work and demonstrate evidence of robust faculty scholarly activities to attain accreditation, an essential area of focus is faculty development. Considering barriers such as lack of time, mentorship, and resources, some divisions interested in starting a fellowship may find it challenging to achieve these standards.¹⁴ However, hospitalists are often engaged in areas such as QI and medical education, and there is potential to turn ongoing work into meaningful scholarship with appropriate guidance. Many of our supporting organizations (eg, Academic Pediatric Association, American Academy of Pediatrics, and Society of Hospital Medicine) provide training programs for faculty in areas such as educational scholarship, research, and QI; however, more may be needed. Leaders of PHM programs will need to be mindful and creative in accessing local, regional, and national resources to invest in faculty development.

As a group, pediatric hospitalists report high levels of satisfaction with their jobs.¹¹ Despite this finding, there are a number of threats to the sustainability of current work models, some of which are unique to pediatrics given the overall lower patient volumes and greater seasonal variation compared with adult hospital medicine. Both university and community-based hospitalist programs report high weekend, overnight, and in-house clinical effort.^7,15 Recent studies reported that a significant proportion of PHM program leaders (50% of division directors at university-affiliated programs and 37% of community program leaders) perceive their program to be unsustainable.^7,15 Among university-affiliated programs, a higher burden of weekend work as well as university employment were associated with perceived unsustainability, while no specific program or employer characteristic was associated with this perception in community programs.

These findings indicate that efforts are needed to address PHM program sustainability and that different work models and interventions may be needed for university-based and community PHM programs. Wide variability exists in the ways that programs address overall clinical burden, with strategies including census caps, seasonal expansion of coverage, and formal back-up systems.^7,15 Additional potential solutions may include differential weighting or financial incentives for nights and weekends, support for nonclinical work, loan repayment programs, and competitive salaries.¹¹ In addition, structuring clinical and nonclinical roles to facilitate career development and advancement may enhance career longevity.¹⁵ Lessons learned from pediatric emergency medicine (PEM), which developed as a field a few decades ahead of PHM, may predict future challenges. A 2015 survey of PEM faculty found that despite a 15% decrease in weekly work hours over a 15-year period, a substantial number of PEM faculty report concerns about burnout, with 40% reporting a plan to decrease their clinical workload and 13% planning to leave the field within five years.¹⁶ Like PEM, the field of PHM may benefit from the development of best practice guidelines to improve well-being and career longevity.¹⁷

The culture of collaboration within PHM places the field in a solid position to address both workforce challenges and barriers to high-quality care for hospitalized children. There are several hospital-based learning networks actively working to strengthen our knowledge base and improve healthcare quality. The PRIS network (www.prisnetwork.org) aims to improve healthcare for children through multihospital studies, boasting 114 sites in the US and Canada. Numerous collaborative projects have linked hospitalists across programs to tackle problems ranging from handoff communication¹⁸ to eliminating monitor overuse.¹⁹ The Value in Inpatient Pediatrics network has similarly leveraged collaborations across multiple children’s and community hospitals to improve transitions of care²⁰ and care for common conditions such as bronchiolitis, febrile infants, and asthma.²¹ These networks serve as models of effective collaboration between children’s hospitals and community hospitals, more of which is needed to increase research and QI initiatives in community hospitals, where the majority of US children receive their hospital-based care.^6,22

With the rapid growth of scholarly networks in research, QI, and education, PHM has a solid infrastructure on which to base continued development as a subspeciality. Building on this infrastructure will be essential in order to address current challenges in workforce development, fellowship training, and program sustainability. Ultimately, achieving a strong, stable, and skilled workforce will enable PHM to fulfill its promise of improving the care of children across the diversity of settings where they receive their hospital-based care.

Disclosures

Dr. Leyenaar provides consultative services to the American Board of Pediatrics Foundation, which is not associated with this manuscript. Drs. Wang and Shaughnessy have no disclosures

Pediatric hospital medicine (PHM) is in the midst of an exciting period of growth. In 2016, the American Board of Medical Specialties approved the petition for PHM to become the newest pediatric subspecialty, taking PHM on a divergent path from the Focused Practice in Hospital Medicine designation established for adult hospitalists. Establishment as a subspecialty has allowed PHM to define the unique skills and qualifications that hospitalists bring to patients and the healthcare system. These skills and qualifications are delineated in the PHM core competencies and national fellowship curriculum.^1,2 In order to realize the vision of PHM to improve care for hospitalized children described by Roberts et al.,³ concerted efforts are needed to train and retain a workforce that is equipped with the skills to catalyze improvements in inpatient pediatric care. We discuss challenges and opportunities facing PHM in workforce development, sustainability of clinical work models, and interhospital collaboration.

The development of PHM as a subspecialty was driven by a number of factors.⁴ The acuity of hospitalized children has increased significantly, with a population comprised of more children with complex chronic conditions and/or technology dependence, serious complications of acute conditions, and acute mental health problems. At the same time, the medical and behavioral conditions seen by outpatient general pediatricians have become more complex and time intensive, with these practitioners less likely to work in inpatient settings. Hospitalist care has positive impacts on healthcare efficiency and value, and both parents and primary care pediatricians report high levels of satisfaction with the healthcare delivered by PHM services.⁴

A national count of the number of pediatric hospitalists is currently lacking. Conservative estimates suggest that at least 3,000 pediatric hospitalists currently practice in the United States.⁵ These hospitalists have highly varied scopes of practice and work across diverse settings—more diverse, perhaps, than any other pediatric subspecialty. Although difficult to quantify, we estimate that approximately one-third of pediatric hospitalists in the US work in community hospitals and the remainder practice at children’s hospitals.⁶ Many of the needs of hospitalized children differ across these settings, and the roles and challenges faced by hospitalists in these settings correspondingly differ. Community hospitalists frequently take active roles in newborn care and emergency department consultation, often without the support of other pediatric subspecialties.⁷ In contrast, hospitalists working at children’s hospitals more frequently care for highly complex patients, often collaborate across multiple specialties and assume nonclinical roles in quality improvement (QI), research, and medical education.

Residents graduating in July 2019 were the last cohort of residents eligible to pursue PHM subspecialty certification via the practice pathway. Accordingly, future residency graduates interested in PHM subspecialty certification will need to complete a PHM fellowship at an accredited program in the US or Canada. Since 2008, PHM fellowship directors have met yearly to collaborate and share best practices,⁸ developing the two-year fellowship curriculum that forms the basis for the American Board of Pediatrics training pathway.² The curriculum allows significant flexibility to meet diverse needs, including tailored content for fellows planning to practice in community settings, fellows planning research careers, medicine-pediatrics hospitalist careers, and those desiring increased training in QI, medical education, or leadership/administration.² In the spring of 2019, Pediatric Research in Inpatient Settings (PRIS) leadership, directors of existing PHM fellowship programs, and national academic society representatives met to develop a fellows’ research curriculum, training resources, and guidelines around scholarship expectations.⁹ This collaboration aims to accelerate the growth of high-quality clinical training and scholarship to benefit hospitalized children across many different settings.

Such collaboration is essential to address an emerging workforce challenge in PHM. Although the number of PHM fellowship positions is expected to grow in the coming years, there is currently a shortage relative to the anticipated demand. With approximately 2,800 US pediatric residents graduating annually and data indicating that 7% of graduating residents enter and remain in PHM for at least five years,^10,11 almost 200 fellowship spots may be needed each year. As of November 2019, 77 fellowship positions were available for residents graduating in 2020,¹² which is less than half of the potential demand. To address this mismatch, the PHM Fellowship Directors’ Council has led an annual training for new and potential fellowship directors, and 18 new programs are under development.¹³ However, this growth may be inadequate to meet the needs of the field. The extent to which limited PHM fellowship positions will adversely affect the pipeline of pediatricians pursuing PHM is unknown.

Efforts to support institutions in creating and expanding fellowship programs will be needed to address the potential shortage of fellowship positions. Continued guidance from the PHM Fellowship Directors’ Council in the many aspects of fellowship program development (eg, curriculum design, assessment) will be crucial in this endeavor. Furthermore, given that fellowships must support fellows to conduct scholarly work and demonstrate evidence of robust faculty scholarly activities to attain accreditation, an essential area of focus is faculty development. Considering barriers such as lack of time, mentorship, and resources, some divisions interested in starting a fellowship may find it challenging to achieve these standards.¹⁴ However, hospitalists are often engaged in areas such as QI and medical education, and there is potential to turn ongoing work into meaningful scholarship with appropriate guidance. Many of our supporting organizations (eg, Academic Pediatric Association, American Academy of Pediatrics, and Society of Hospital Medicine) provide training programs for faculty in areas such as educational scholarship, research, and QI; however, more may be needed. Leaders of PHM programs will need to be mindful and creative in accessing local, regional, and national resources to invest in faculty development.

As a group, pediatric hospitalists report high levels of satisfaction with their jobs.¹¹ Despite this finding, there are a number of threats to the sustainability of current work models, some of which are unique to pediatrics given the overall lower patient volumes and greater seasonal variation compared with adult hospital medicine. Both university and community-based hospitalist programs report high weekend, overnight, and in-house clinical effort.^7,15 Recent studies reported that a significant proportion of PHM program leaders (50% of division directors at university-affiliated programs and 37% of community program leaders) perceive their program to be unsustainable.^7,15 Among university-affiliated programs, a higher burden of weekend work as well as university employment were associated with perceived unsustainability, while no specific program or employer characteristic was associated with this perception in community programs.

These findings indicate that efforts are needed to address PHM program sustainability and that different work models and interventions may be needed for university-based and community PHM programs. Wide variability exists in the ways that programs address overall clinical burden, with strategies including census caps, seasonal expansion of coverage, and formal back-up systems.^7,15 Additional potential solutions may include differential weighting or financial incentives for nights and weekends, support for nonclinical work, loan repayment programs, and competitive salaries.¹¹ In addition, structuring clinical and nonclinical roles to facilitate career development and advancement may enhance career longevity.¹⁵ Lessons learned from pediatric emergency medicine (PEM), which developed as a field a few decades ahead of PHM, may predict future challenges. A 2015 survey of PEM faculty found that despite a 15% decrease in weekly work hours over a 15-year period, a substantial number of PEM faculty report concerns about burnout, with 40% reporting a plan to decrease their clinical workload and 13% planning to leave the field within five years.¹⁶ Like PEM, the field of PHM may benefit from the development of best practice guidelines to improve well-being and career longevity.¹⁷

The culture of collaboration within PHM places the field in a solid position to address both workforce challenges and barriers to high-quality care for hospitalized children. There are several hospital-based learning networks actively working to strengthen our knowledge base and improve healthcare quality. The PRIS network (www.prisnetwork.org) aims to improve healthcare for children through multihospital studies, boasting 114 sites in the US and Canada. Numerous collaborative projects have linked hospitalists across programs to tackle problems ranging from handoff communication¹⁸ to eliminating monitor overuse.¹⁹ The Value in Inpatient Pediatrics network has similarly leveraged collaborations across multiple children’s and community hospitals to improve transitions of care²⁰ and care for common conditions such as bronchiolitis, febrile infants, and asthma.²¹ These networks serve as models of effective collaboration between children’s hospitals and community hospitals, more of which is needed to increase research and QI initiatives in community hospitals, where the majority of US children receive their hospital-based care.^6,22

With the rapid growth of scholarly networks in research, QI, and education, PHM has a solid infrastructure on which to base continued development as a subspeciality. Building on this infrastructure will be essential in order to address current challenges in workforce development, fellowship training, and program sustainability. Ultimately, achieving a strong, stable, and skilled workforce will enable PHM to fulfill its promise of improving the care of children across the diversity of settings where they receive their hospital-based care.

Disclosures

Dr. Leyenaar provides consultative services to the American Board of Pediatrics Foundation, which is not associated with this manuscript. Drs. Wang and Shaughnessy have no disclosures

Traditional mentorship models may not be adequate for academic hospitalists. The traditional dyadic mentorship model, in which a senior principal investigator and research mentee collaborate for career advancement, is well suited for basic science or clinical research. In contrast, areas of academic hospital medicine such as quality improvement, medical education, hospital operations, point-of-care ultrasound, and clinical expertise may be less suited to this traditional mentoring model. In addition, experienced mentors are limited and those available are often overcommitted or have inadequate time due to responsibilities with other leadership roles. Senior mentors may also be limited because of our specialty’s focus on clinical practice rather than longitudinal research or projects.⁹ There are other limitations of traditional mentorship that are applicable to all fields of academic medicine, including disparate goals, expectations, levels of commitment, and the inherent power differential between the mentor and mentee.¹⁰

In this perspective, we discuss our experience with implementing an alternative and complementary mentorship strategy called facilitated peer mentorship with junior faculty hospitalists in the Division of General Internal Medicine at New York–Presbyterian/Weill Cornell Medical Center.

In facilitated peer mentoring programs, faculty typically work collaboratively in groups of three to five with other faculty who are of similar rank, and a faculty member of a higher academic rank works with the group in meeting their scholarly goals.¹¹ The role of the facilitator is to ensure a safe and respectful learning environment, foster peer collaboration, and redirect the group to draw upon their own experiences. Each junior faculty member serves as both a mentor and mentee for each other with bidirectional feedback, guidance, and support in a group setting. This model emphasizes collaboration, peer networking, empowerment, and the development of personal awareness.¹⁰ A number of academic medical centers have used peer mentoring as a response to the challenges encountered in the traditional dyad model.¹² To our knowledge, the only published example of a peer mentoring model in academic hospital medicine is in the form of a research-in-progress conference.¹³ While this example addresses peer-mentored research, there is a gap in other areas of academic hospital medicine with mentoring needs—most of all in personal development and career satisfaction.

We piloted a 12-month facilitated peer mentoring program for new hospitalists. The goal of the program was for junior faculty hospitalists to develop a better understanding of their own identity and core values that would enable them to more confidently navigate career choices, enhance their work vitality and career satisfaction, and develop their potential for leadership roles in academic hospital medicine. Each year, a cohort of four to five incoming hospitalists from different backgrounds, interests, and experience were grouped with a more experienced colleague at an associate professor rank who expressed interest and was selected by our section chief to lead the program. The program was required for new hospitalists and consisted of six 90-minute sessions every two months. The attendance rate was 100% and was ensured by scheduling all sessions at the beginning of the academic year with dates agreed upon by all participants. An e-mail reminder was sent one week prior to each session. Each session had assigned readings and an agenda for discussions (see Table for details).

Our evaluation of the program after two years with two separate cohorts included qualitative feedback through an anonymous survey for participants; in addition, qualitative feedback was collected in a one-hour, in-person discussion and reflection with each cohort. We learned several lessons from the feedback we received from program participants. First, our impression was that the career experience of the junior faculty member had a significant impact on the perceived value of group meetings. For those who entered the hospitalist workforce immediately upon completing their terminal training in internal medicine, the exercise of considering different career versions of themselves had added value in promoting thinking outside-the-box for career opportunities within hospital medicine. Academic hospitalists and general internists more broadly, tend to have broad interests that fuel their passions but may also make it more difficult to define long-term goals. One junior faculty member paired her life interests in global medical education with building an international collaboration with other academic hospitalist programs; another faculty member gained confidence and expanded her network of collaborators by designing a research pilot study on hospitalist-initiated end-of-life discussions. In both cases, the junior faculty identified the facilitated peer mentoring program as a strong influence in finding these opportunities. Peer mentoring at the time of entry into the field of hospital medicine, when many have undefined career goals, can be helpful for navigating this issue at the start of a career. On the other hand, those who had already worked as a hospitalist for one or two years and joined the program found less value in career planning exercises.

Second, junior faculty differed in their desire for scope and depth of the curriculum. Some preferred more frequent sessions with more premeeting readings and self-assessments in fewer topics that were covered more longitudinally. A proposed example of a longitudinal topic was defining and refining existing mentoring relationships. Others found it useful to cover more ground with a potpourri of themes; they wanted to cover different knowledge, skills, and attitudes considered important for personal growth and career development, such as negotiation, leading teams, and managing conflict. We recommend the goals of the peer group be defined collaboratively at the beginning of new groups to respond to the needs of the group.

Third, junior faculty varied in how they viewed the goal of the program on a spectrum ranging from social support to mentorship. On one end of the spectrum, the program provided a safe venue for colleagues to convene periodically to discuss work challenges; this group found the support from peers to be helpful. On the other end, some found value in the coaching and mentoring from peers and the experienced facilitator that guided personal growth and career development.

Our pilot program has several limitations. This is a single-center program with a relatively small number of participants; thus, our experience may be unique to our institution and not representative of all academic hospital medicine programs. We also did not obtain any quantitative metrics of evaluation—mixed methods should be used in the future for more rigorous program evaluation. Finally, our peer mentoring model may not cover all domains of mentoring such as sponsorship for career advancement, provision of resources, and promotion of scholarship, though we mentioned an anecdote of scholarship that resulted from networking and redefining of goals that were facilitated through this program. Scholarship is certainly an important feature of academic medicine—other peer mentoring programs may consider forming groups based on research interests to address this gap. A tailored curriculum toward research and scholarship may garner more interest and benefit from participants interested in advancement of scholarship activities.

Overall, the field of hospital medicine is growing rapidly with junior faculty who need effective mentorship. Facilitated peer mentorship among small groups of junior faculty is a feasible and pragmatic mentorship model that can complement more traditional mentorship models. We discovered wide-ranging and contrasting experiences in our program, which suggests that peer mentorship is not a one-size-fits-all approach. However, facilitated peer mentorship can be a highly adaptable and alternative approach to mentorship for diverse groups of hospitalists, including general internal medicine, pediatrics, and other subspecialties. Future studies including multicenter, randomized trials comparing peer mentoring and traditional dyadic mentoring are needed. It is imperative for the field to investigate best practices in mentorship to sustain the rapid growth of hospital medicine and training the new generation of academic hospitalists.

Traditional mentorship models may not be adequate for academic hospitalists. The traditional dyadic mentorship model, in which a senior principal investigator and research mentee collaborate for career advancement, is well suited for basic science or clinical research. In contrast, areas of academic hospital medicine such as quality improvement, medical education, hospital operations, point-of-care ultrasound, and clinical expertise may be less suited to this traditional mentoring model. In addition, experienced mentors are limited and those available are often overcommitted or have inadequate time due to responsibilities with other leadership roles. Senior mentors may also be limited because of our specialty’s focus on clinical practice rather than longitudinal research or projects.⁹ There are other limitations of traditional mentorship that are applicable to all fields of academic medicine, including disparate goals, expectations, levels of commitment, and the inherent power differential between the mentor and mentee.¹⁰

In this perspective, we discuss our experience with implementing an alternative and complementary mentorship strategy called facilitated peer mentorship with junior faculty hospitalists in the Division of General Internal Medicine at New York–Presbyterian/Weill Cornell Medical Center.

In facilitated peer mentoring programs, faculty typically work collaboratively in groups of three to five with other faculty who are of similar rank, and a faculty member of a higher academic rank works with the group in meeting their scholarly goals.¹¹ The role of the facilitator is to ensure a safe and respectful learning environment, foster peer collaboration, and redirect the group to draw upon their own experiences. Each junior faculty member serves as both a mentor and mentee for each other with bidirectional feedback, guidance, and support in a group setting. This model emphasizes collaboration, peer networking, empowerment, and the development of personal awareness.¹⁰ A number of academic medical centers have used peer mentoring as a response to the challenges encountered in the traditional dyad model.¹² To our knowledge, the only published example of a peer mentoring model in academic hospital medicine is in the form of a research-in-progress conference.¹³ While this example addresses peer-mentored research, there is a gap in other areas of academic hospital medicine with mentoring needs—most of all in personal development and career satisfaction.

We piloted a 12-month facilitated peer mentoring program for new hospitalists. The goal of the program was for junior faculty hospitalists to develop a better understanding of their own identity and core values that would enable them to more confidently navigate career choices, enhance their work vitality and career satisfaction, and develop their potential for leadership roles in academic hospital medicine. Each year, a cohort of four to five incoming hospitalists from different backgrounds, interests, and experience were grouped with a more experienced colleague at an associate professor rank who expressed interest and was selected by our section chief to lead the program. The program was required for new hospitalists and consisted of six 90-minute sessions every two months. The attendance rate was 100% and was ensured by scheduling all sessions at the beginning of the academic year with dates agreed upon by all participants. An e-mail reminder was sent one week prior to each session. Each session had assigned readings and an agenda for discussions (see Table for details).

Our evaluation of the program after two years with two separate cohorts included qualitative feedback through an anonymous survey for participants; in addition, qualitative feedback was collected in a one-hour, in-person discussion and reflection with each cohort. We learned several lessons from the feedback we received from program participants. First, our impression was that the career experience of the junior faculty member had a significant impact on the perceived value of group meetings. For those who entered the hospitalist workforce immediately upon completing their terminal training in internal medicine, the exercise of considering different career versions of themselves had added value in promoting thinking outside-the-box for career opportunities within hospital medicine. Academic hospitalists and general internists more broadly, tend to have broad interests that fuel their passions but may also make it more difficult to define long-term goals. One junior faculty member paired her life interests in global medical education with building an international collaboration with other academic hospitalist programs; another faculty member gained confidence and expanded her network of collaborators by designing a research pilot study on hospitalist-initiated end-of-life discussions. In both cases, the junior faculty identified the facilitated peer mentoring program as a strong influence in finding these opportunities. Peer mentoring at the time of entry into the field of hospital medicine, when many have undefined career goals, can be helpful for navigating this issue at the start of a career. On the other hand, those who had already worked as a hospitalist for one or two years and joined the program found less value in career planning exercises.

Second, junior faculty differed in their desire for scope and depth of the curriculum. Some preferred more frequent sessions with more premeeting readings and self-assessments in fewer topics that were covered more longitudinally. A proposed example of a longitudinal topic was defining and refining existing mentoring relationships. Others found it useful to cover more ground with a potpourri of themes; they wanted to cover different knowledge, skills, and attitudes considered important for personal growth and career development, such as negotiation, leading teams, and managing conflict. We recommend the goals of the peer group be defined collaboratively at the beginning of new groups to respond to the needs of the group.

Third, junior faculty varied in how they viewed the goal of the program on a spectrum ranging from social support to mentorship. On one end of the spectrum, the program provided a safe venue for colleagues to convene periodically to discuss work challenges; this group found the support from peers to be helpful. On the other end, some found value in the coaching and mentoring from peers and the experienced facilitator that guided personal growth and career development.

Our pilot program has several limitations. This is a single-center program with a relatively small number of participants; thus, our experience may be unique to our institution and not representative of all academic hospital medicine programs. We also did not obtain any quantitative metrics of evaluation—mixed methods should be used in the future for more rigorous program evaluation. Finally, our peer mentoring model may not cover all domains of mentoring such as sponsorship for career advancement, provision of resources, and promotion of scholarship, though we mentioned an anecdote of scholarship that resulted from networking and redefining of goals that were facilitated through this program. Scholarship is certainly an important feature of academic medicine—other peer mentoring programs may consider forming groups based on research interests to address this gap. A tailored curriculum toward research and scholarship may garner more interest and benefit from participants interested in advancement of scholarship activities.

Overall, the field of hospital medicine is growing rapidly with junior faculty who need effective mentorship. Facilitated peer mentorship among small groups of junior faculty is a feasible and pragmatic mentorship model that can complement more traditional mentorship models. We discovered wide-ranging and contrasting experiences in our program, which suggests that peer mentorship is not a one-size-fits-all approach. However, facilitated peer mentorship can be a highly adaptable and alternative approach to mentorship for diverse groups of hospitalists, including general internal medicine, pediatrics, and other subspecialties. Future studies including multicenter, randomized trials comparing peer mentoring and traditional dyadic mentoring are needed. It is imperative for the field to investigate best practices in mentorship to sustain the rapid growth of hospital medicine and training the new generation of academic hospitalists.

Traditional mentorship models may not be adequate for academic hospitalists. The traditional dyadic mentorship model, in which a senior principal investigator and research mentee collaborate for career advancement, is well suited for basic science or clinical research. In contrast, areas of academic hospital medicine such as quality improvement, medical education, hospital operations, point-of-care ultrasound, and clinical expertise may be less suited to this traditional mentoring model. In addition, experienced mentors are limited and those available are often overcommitted or have inadequate time due to responsibilities with other leadership roles. Senior mentors may also be limited because of our specialty’s focus on clinical practice rather than longitudinal research or projects.⁹ There are other limitations of traditional mentorship that are applicable to all fields of academic medicine, including disparate goals, expectations, levels of commitment, and the inherent power differential between the mentor and mentee.¹⁰

In this perspective, we discuss our experience with implementing an alternative and complementary mentorship strategy called facilitated peer mentorship with junior faculty hospitalists in the Division of General Internal Medicine at New York–Presbyterian/Weill Cornell Medical Center.

In facilitated peer mentoring programs, faculty typically work collaboratively in groups of three to five with other faculty who are of similar rank, and a faculty member of a higher academic rank works with the group in meeting their scholarly goals.¹¹ The role of the facilitator is to ensure a safe and respectful learning environment, foster peer collaboration, and redirect the group to draw upon their own experiences. Each junior faculty member serves as both a mentor and mentee for each other with bidirectional feedback, guidance, and support in a group setting. This model emphasizes collaboration, peer networking, empowerment, and the development of personal awareness.¹⁰ A number of academic medical centers have used peer mentoring as a response to the challenges encountered in the traditional dyad model.¹² To our knowledge, the only published example of a peer mentoring model in academic hospital medicine is in the form of a research-in-progress conference.¹³ While this example addresses peer-mentored research, there is a gap in other areas of academic hospital medicine with mentoring needs—most of all in personal development and career satisfaction.

We piloted a 12-month facilitated peer mentoring program for new hospitalists. The goal of the program was for junior faculty hospitalists to develop a better understanding of their own identity and core values that would enable them to more confidently navigate career choices, enhance their work vitality and career satisfaction, and develop their potential for leadership roles in academic hospital medicine. Each year, a cohort of four to five incoming hospitalists from different backgrounds, interests, and experience were grouped with a more experienced colleague at an associate professor rank who expressed interest and was selected by our section chief to lead the program. The program was required for new hospitalists and consisted of six 90-minute sessions every two months. The attendance rate was 100% and was ensured by scheduling all sessions at the beginning of the academic year with dates agreed upon by all participants. An e-mail reminder was sent one week prior to each session. Each session had assigned readings and an agenda for discussions (see Table for details).

Our evaluation of the program after two years with two separate cohorts included qualitative feedback through an anonymous survey for participants; in addition, qualitative feedback was collected in a one-hour, in-person discussion and reflection with each cohort. We learned several lessons from the feedback we received from program participants. First, our impression was that the career experience of the junior faculty member had a significant impact on the perceived value of group meetings. For those who entered the hospitalist workforce immediately upon completing their terminal training in internal medicine, the exercise of considering different career versions of themselves had added value in promoting thinking outside-the-box for career opportunities within hospital medicine. Academic hospitalists and general internists more broadly, tend to have broad interests that fuel their passions but may also make it more difficult to define long-term goals. One junior faculty member paired her life interests in global medical education with building an international collaboration with other academic hospitalist programs; another faculty member gained confidence and expanded her network of collaborators by designing a research pilot study on hospitalist-initiated end-of-life discussions. In both cases, the junior faculty identified the facilitated peer mentoring program as a strong influence in finding these opportunities. Peer mentoring at the time of entry into the field of hospital medicine, when many have undefined career goals, can be helpful for navigating this issue at the start of a career. On the other hand, those who had already worked as a hospitalist for one or two years and joined the program found less value in career planning exercises.

Second, junior faculty differed in their desire for scope and depth of the curriculum. Some preferred more frequent sessions with more premeeting readings and self-assessments in fewer topics that were covered more longitudinally. A proposed example of a longitudinal topic was defining and refining existing mentoring relationships. Others found it useful to cover more ground with a potpourri of themes; they wanted to cover different knowledge, skills, and attitudes considered important for personal growth and career development, such as negotiation, leading teams, and managing conflict. We recommend the goals of the peer group be defined collaboratively at the beginning of new groups to respond to the needs of the group.

Third, junior faculty varied in how they viewed the goal of the program on a spectrum ranging from social support to mentorship. On one end of the spectrum, the program provided a safe venue for colleagues to convene periodically to discuss work challenges; this group found the support from peers to be helpful. On the other end, some found value in the coaching and mentoring from peers and the experienced facilitator that guided personal growth and career development.

Our pilot program has several limitations. This is a single-center program with a relatively small number of participants; thus, our experience may be unique to our institution and not representative of all academic hospital medicine programs. We also did not obtain any quantitative metrics of evaluation—mixed methods should be used in the future for more rigorous program evaluation. Finally, our peer mentoring model may not cover all domains of mentoring such as sponsorship for career advancement, provision of resources, and promotion of scholarship, though we mentioned an anecdote of scholarship that resulted from networking and redefining of goals that were facilitated through this program. Scholarship is certainly an important feature of academic medicine—other peer mentoring programs may consider forming groups based on research interests to address this gap. A tailored curriculum toward research and scholarship may garner more interest and benefit from participants interested in advancement of scholarship activities.

Overall, the field of hospital medicine is growing rapidly with junior faculty who need effective mentorship. Facilitated peer mentorship among small groups of junior faculty is a feasible and pragmatic mentorship model that can complement more traditional mentorship models. We discovered wide-ranging and contrasting experiences in our program, which suggests that peer mentorship is not a one-size-fits-all approach. However, facilitated peer mentorship can be a highly adaptable and alternative approach to mentorship for diverse groups of hospitalists, including general internal medicine, pediatrics, and other subspecialties. Future studies including multicenter, randomized trials comparing peer mentoring and traditional dyadic mentoring are needed. It is imperative for the field to investigate best practices in mentorship to sustain the rapid growth of hospital medicine and training the new generation of academic hospitalists.

“How much teaching time will I get in my first year on faculty?” Leaders at academic hospitalist programs know to expect this question from almost every applicant. We also know that we will be graded on our response; the more resident-covered service time, the better. For some applicants, this question is a key litmus test. Some prospective faculty choose to pursue academic hospital medicine because of their own experiences on the wards during residency. They recall the excitement of leading a team of interns and students under the wing of a seasoned attending, replete with chalk talks, clinical pearls, and inspired learners. Teaching time is more quantifiable than mentorship quality and academic opportunity, more important than salary and patient load for some, and more familiar than relative value unit expectations.

Over the past two decades, academic hospitalist programs have steadily grown,¹ but their teaching footprints have not.^2,3 Although historically some academic hospitalists spent almost 100% of their clinical time on teaching services, work hour rules and diversification of resident clinical time toward outpatient and subspecialty activities have decreased the amount of general medicine ward time for residents.² In addition, as academic medical centers broadened their clinical networks, inpatient volumes exceeded the capacity of teaching services. Finally, several large academic medical centers and healthcare networks are acquiring or building additional hospitals, increasing the number of medical beds that are staffed by hospitalists without residents.⁴

In our experience, as academic healthcare systems continue to grow and hospital medicine programs rapidly expand to meet clinical needs, the percentage of clinical time spent on a traditional ward teaching service continues to decrease. In several academic hospitalist programs, the majority of faculty effort is now devoted to direct care,⁵ with limited resident-covered ward time spread across a larger group of faculty. The 2018 State of Hospital Medicine Report suggests that our experience is not unique with academic programs caring for adults reporting that 31% of clinical work was on traditional ward teaching services, 16% on direct care services with intermittent learners, and 53% on nonteaching services.⁵

This current state of affairs raises a number of questions as follows:

• How can hospitalist program leaders take advantage of existing resident teaching opportunities?
• How should those teaching opportunities be allocated?
• What nontraditional teaching venues exist in academic medicine?
• How can faculty develop their teaching skills in an environment with limited traditional ward teaching time.

We believe that these changes require us to redefine what it means to be an academic hospitalist, both for existing faculty and for prospective faculty whose views of academic hospital medicine may have been shaped by role models seen only in their clinical teaching role.

Is reduced teaching time the new normal or will the pendulum swing back toward more resident teaching time for academic hospitalists? The former is likely the case. None of the current trends in medical education point to an expansion of residents in the inpatient setting. Although there may be some opportunities to assume general medicine attending time is currently covered by primary care physicians and subspecialists, in several programs, hospitalists already cover the overwhelming majority of general medicine teaching services.

Although there may be occasional opportunities for academic hospitalist programs to develop new teaching roles with residents or fellows (for example, by expanding to community sites with residency programs or to subspecialty teaching services, or by creating hospital medicine fellowships and resident or student electives), the reality is that we as hospitalists will need to adapt to direct care as the plurality of our work.

How should we allocate traditional teaching time among our faculty? Since it is a coveted—but relatively scarce—resource, teaching time should be allocated thoughtfully. Based on our collective experience, academic hospitalist groups have taken a variety of approaches to this challenge, including forming separate clinical groups at the same institution (a teaching faculty group and a nonteaching group),⁶ requiring all hospitalists to do some amount of direct care to facilitate distribution of teaching time or having merit or seniority-based teaching time allocation (based on teaching evaluations, formal teaching roles such as program director status, or years on faculty).

Each approach to assigning teaching time has its challenges. Hospitalist leaders must manage these issues through transparency about the selection process for teaching rotations and open discussion of teaching evaluations with faculty. It is also critical that the recruitment process set appropriate expectations for faculty candidates. Highlighting academic opportunities outside of teaching residents, including leadership roles, quality improvement work, and research, may encourage applicants and current hospitalists to explore more varied career trajectories. Hospitalists focusing on these other paths may elect to have less teaching time, freeing up opportunities for dedicated clinician educators.

What other ward-based teaching opportunities might be available for academic hospitalists who do not have the opportunity to attend on traditional resident teaching teams? As supervisory requirements for residents have been strengthened, expansion of teaching into the evening and overnight hours to supervise new admissions to the teaching services has been one approach to augment teaching footprints.^7,8

In addition, nontraditional teaching teams such as attending/intern teams (without a supervising resident) or attending/subintern (fourth-year medical student) teams have been developed at some institutions.⁹ Although allowing for additional exposure to learners, these models require a more hands-on approach than traditional teaching teams, particularly at the start of the academic year. Finally, as hospitalist teams have grown to include advanced practice providers (APPs), some programs have established formal teaching programs to address professional development needs of these healthcare professionals.^10,11

How do we help junior faculty who have the potential to be talented educators succeed in teaching when they have limited opportunities to engage with residents on clinical services? One approach is to encourage hospitalists to participate in resident didactic sessions such as “morning report” and noon conference. Another approach is to focus on teaching other learners. For example, several academic medical centers provide opportunities for hospitalists to engage in student teaching, either on the wards or via classroom instruction. In addition, as mentioned previously, APPs who are new to hospital medicine are an engaged audience and represent an opportunity for hospitalist educators to utilize and hone their teaching skills. Finally, organizing lectures for nursing colleagues is another way for the faculty to practice “chalk talks” and develop teaching portfolios.

Hospitalists can also leverage their expertise to build systems in which academic hospitalists are teaching each other, creating a culture of continuous learning. These activities may include case conferences, morbidity and mortality conferences, journal clubs, clinical topic updates developed by and for hospitalists, simulation exercises, and other group learning sessions. Giving hospitalists the opportunity to teach each other allows for professional growth that is not dependent on the presence of traditional learners.

Philosophically, a key question is “What makes ‘academic’ academic?” Traditionally, academic hospitalist positions were synonymous with resident teaching or, for a small number of academic hospitalists, significant funded research. In an era where teaching residents may no longer be part of the job description for many hospitalists at academic medical centers, what distinguishes these positions from 100% clinical positions and what are the implications for academic hospital medicine?

Although data regarding why hospitalists seek “nonteaching” positions at academic medical centers are lacking, we believe that these jobs remain popular due to opportunities that are perceived to be unique to academic medical centers. These include more flexible scheduling (academic programs may be less likely to have seven-on/seven-off schedules), exposure to research and cutting-edge technology, opportunities to care for tertiary and quaternary care patients, collaboration with academic peers and experts in the field, and interaction with a range of learners, including medical, pharmacy, advanced practitioner, and other students.

Understanding the motivation of candidates who apply for academic hospital medicine positions—aside from supervising/teaching residents—will be an important goal for academic hospitalist leaders to ensure future success in staffing growing programs and creating sustainable academic hospitalist careers. As resident teaching time decreases, implementing robust faculty or professional development programs to address the broader interests and needs of academic hospitalist faculty will be increasingly important. Sehgal et al. described one such program for faculty development,¹² and a more recent paper outlines a faculty development program focused on quality improvement and patient safety.¹³ These types of programs provide opportunities for academic hospitalists to engage in academic pursuits that are independent of residency programs.

Therefore, what do we tell the eager faculty applicant? First, we should not hide from the honest answer, ie, new faculty may not get as much resident teaching time as they would like or expect. Although we want hospitalists to maintain integral involvement in residency training programs, we also want to build a culture of clinical excellence, scholarship, and continuous learning that is not dependent on directly teaching residents. We should highlight the unique opportunities of academic hospital medicine, including teaching other learners, caring for tertiary/quaternary care patients, working with colleagues who are leaders in their field, and engaging in research and quality improvement work. By capitalizing on these opportunities, we can actively redefine what makes “academic” academic and ensure that we sustain academic hospital medicine as a desirable and rewarding career.

Disclosures

The authors have nothing to disclose.

“How much teaching time will I get in my first year on faculty?” Leaders at academic hospitalist programs know to expect this question from almost every applicant. We also know that we will be graded on our response; the more resident-covered service time, the better. For some applicants, this question is a key litmus test. Some prospective faculty choose to pursue academic hospital medicine because of their own experiences on the wards during residency. They recall the excitement of leading a team of interns and students under the wing of a seasoned attending, replete with chalk talks, clinical pearls, and inspired learners. Teaching time is more quantifiable than mentorship quality and academic opportunity, more important than salary and patient load for some, and more familiar than relative value unit expectations.

Over the past two decades, academic hospitalist programs have steadily grown,¹ but their teaching footprints have not.^2,3 Although historically some academic hospitalists spent almost 100% of their clinical time on teaching services, work hour rules and diversification of resident clinical time toward outpatient and subspecialty activities have decreased the amount of general medicine ward time for residents.² In addition, as academic medical centers broadened their clinical networks, inpatient volumes exceeded the capacity of teaching services. Finally, several large academic medical centers and healthcare networks are acquiring or building additional hospitals, increasing the number of medical beds that are staffed by hospitalists without residents.⁴

In our experience, as academic healthcare systems continue to grow and hospital medicine programs rapidly expand to meet clinical needs, the percentage of clinical time spent on a traditional ward teaching service continues to decrease. In several academic hospitalist programs, the majority of faculty effort is now devoted to direct care,⁵ with limited resident-covered ward time spread across a larger group of faculty. The 2018 State of Hospital Medicine Report suggests that our experience is not unique with academic programs caring for adults reporting that 31% of clinical work was on traditional ward teaching services, 16% on direct care services with intermittent learners, and 53% on nonteaching services.⁵

This current state of affairs raises a number of questions as follows:

• How can hospitalist program leaders take advantage of existing resident teaching opportunities?
• How should those teaching opportunities be allocated?
• What nontraditional teaching venues exist in academic medicine?
• How can faculty develop their teaching skills in an environment with limited traditional ward teaching time.

We believe that these changes require us to redefine what it means to be an academic hospitalist, both for existing faculty and for prospective faculty whose views of academic hospital medicine may have been shaped by role models seen only in their clinical teaching role.

Is reduced teaching time the new normal or will the pendulum swing back toward more resident teaching time for academic hospitalists? The former is likely the case. None of the current trends in medical education point to an expansion of residents in the inpatient setting. Although there may be some opportunities to assume general medicine attending time is currently covered by primary care physicians and subspecialists, in several programs, hospitalists already cover the overwhelming majority of general medicine teaching services.

Although there may be occasional opportunities for academic hospitalist programs to develop new teaching roles with residents or fellows (for example, by expanding to community sites with residency programs or to subspecialty teaching services, or by creating hospital medicine fellowships and resident or student electives), the reality is that we as hospitalists will need to adapt to direct care as the plurality of our work.

How should we allocate traditional teaching time among our faculty? Since it is a coveted—but relatively scarce—resource, teaching time should be allocated thoughtfully. Based on our collective experience, academic hospitalist groups have taken a variety of approaches to this challenge, including forming separate clinical groups at the same institution (a teaching faculty group and a nonteaching group),⁶ requiring all hospitalists to do some amount of direct care to facilitate distribution of teaching time or having merit or seniority-based teaching time allocation (based on teaching evaluations, formal teaching roles such as program director status, or years on faculty).

Each approach to assigning teaching time has its challenges. Hospitalist leaders must manage these issues through transparency about the selection process for teaching rotations and open discussion of teaching evaluations with faculty. It is also critical that the recruitment process set appropriate expectations for faculty candidates. Highlighting academic opportunities outside of teaching residents, including leadership roles, quality improvement work, and research, may encourage applicants and current hospitalists to explore more varied career trajectories. Hospitalists focusing on these other paths may elect to have less teaching time, freeing up opportunities for dedicated clinician educators.

What other ward-based teaching opportunities might be available for academic hospitalists who do not have the opportunity to attend on traditional resident teaching teams? As supervisory requirements for residents have been strengthened, expansion of teaching into the evening and overnight hours to supervise new admissions to the teaching services has been one approach to augment teaching footprints.^7,8

In addition, nontraditional teaching teams such as attending/intern teams (without a supervising resident) or attending/subintern (fourth-year medical student) teams have been developed at some institutions.⁹ Although allowing for additional exposure to learners, these models require a more hands-on approach than traditional teaching teams, particularly at the start of the academic year. Finally, as hospitalist teams have grown to include advanced practice providers (APPs), some programs have established formal teaching programs to address professional development needs of these healthcare professionals.^10,11

How do we help junior faculty who have the potential to be talented educators succeed in teaching when they have limited opportunities to engage with residents on clinical services? One approach is to encourage hospitalists to participate in resident didactic sessions such as “morning report” and noon conference. Another approach is to focus on teaching other learners. For example, several academic medical centers provide opportunities for hospitalists to engage in student teaching, either on the wards or via classroom instruction. In addition, as mentioned previously, APPs who are new to hospital medicine are an engaged audience and represent an opportunity for hospitalist educators to utilize and hone their teaching skills. Finally, organizing lectures for nursing colleagues is another way for the faculty to practice “chalk talks” and develop teaching portfolios.

Hospitalists can also leverage their expertise to build systems in which academic hospitalists are teaching each other, creating a culture of continuous learning. These activities may include case conferences, morbidity and mortality conferences, journal clubs, clinical topic updates developed by and for hospitalists, simulation exercises, and other group learning sessions. Giving hospitalists the opportunity to teach each other allows for professional growth that is not dependent on the presence of traditional learners.

Philosophically, a key question is “What makes ‘academic’ academic?” Traditionally, academic hospitalist positions were synonymous with resident teaching or, for a small number of academic hospitalists, significant funded research. In an era where teaching residents may no longer be part of the job description for many hospitalists at academic medical centers, what distinguishes these positions from 100% clinical positions and what are the implications for academic hospital medicine?

Although data regarding why hospitalists seek “nonteaching” positions at academic medical centers are lacking, we believe that these jobs remain popular due to opportunities that are perceived to be unique to academic medical centers. These include more flexible scheduling (academic programs may be less likely to have seven-on/seven-off schedules), exposure to research and cutting-edge technology, opportunities to care for tertiary and quaternary care patients, collaboration with academic peers and experts in the field, and interaction with a range of learners, including medical, pharmacy, advanced practitioner, and other students.

Understanding the motivation of candidates who apply for academic hospital medicine positions—aside from supervising/teaching residents—will be an important goal for academic hospitalist leaders to ensure future success in staffing growing programs and creating sustainable academic hospitalist careers. As resident teaching time decreases, implementing robust faculty or professional development programs to address the broader interests and needs of academic hospitalist faculty will be increasingly important. Sehgal et al. described one such program for faculty development,¹² and a more recent paper outlines a faculty development program focused on quality improvement and patient safety.¹³ These types of programs provide opportunities for academic hospitalists to engage in academic pursuits that are independent of residency programs.

Therefore, what do we tell the eager faculty applicant? First, we should not hide from the honest answer, ie, new faculty may not get as much resident teaching time as they would like or expect. Although we want hospitalists to maintain integral involvement in residency training programs, we also want to build a culture of clinical excellence, scholarship, and continuous learning that is not dependent on directly teaching residents. We should highlight the unique opportunities of academic hospital medicine, including teaching other learners, caring for tertiary/quaternary care patients, working with colleagues who are leaders in their field, and engaging in research and quality improvement work. By capitalizing on these opportunities, we can actively redefine what makes “academic” academic and ensure that we sustain academic hospital medicine as a desirable and rewarding career.

Disclosures

The authors have nothing to disclose.

“How much teaching time will I get in my first year on faculty?” Leaders at academic hospitalist programs know to expect this question from almost every applicant. We also know that we will be graded on our response; the more resident-covered service time, the better. For some applicants, this question is a key litmus test. Some prospective faculty choose to pursue academic hospital medicine because of their own experiences on the wards during residency. They recall the excitement of leading a team of interns and students under the wing of a seasoned attending, replete with chalk talks, clinical pearls, and inspired learners. Teaching time is more quantifiable than mentorship quality and academic opportunity, more important than salary and patient load for some, and more familiar than relative value unit expectations.

Over the past two decades, academic hospitalist programs have steadily grown,¹ but their teaching footprints have not.^2,3 Although historically some academic hospitalists spent almost 100% of their clinical time on teaching services, work hour rules and diversification of resident clinical time toward outpatient and subspecialty activities have decreased the amount of general medicine ward time for residents.² In addition, as academic medical centers broadened their clinical networks, inpatient volumes exceeded the capacity of teaching services. Finally, several large academic medical centers and healthcare networks are acquiring or building additional hospitals, increasing the number of medical beds that are staffed by hospitalists without residents.⁴

In our experience, as academic healthcare systems continue to grow and hospital medicine programs rapidly expand to meet clinical needs, the percentage of clinical time spent on a traditional ward teaching service continues to decrease. In several academic hospitalist programs, the majority of faculty effort is now devoted to direct care,⁵ with limited resident-covered ward time spread across a larger group of faculty. The 2018 State of Hospital Medicine Report suggests that our experience is not unique with academic programs caring for adults reporting that 31% of clinical work was on traditional ward teaching services, 16% on direct care services with intermittent learners, and 53% on nonteaching services.⁵

This current state of affairs raises a number of questions as follows:

• How can hospitalist program leaders take advantage of existing resident teaching opportunities?
• How should those teaching opportunities be allocated?
• What nontraditional teaching venues exist in academic medicine?
• How can faculty develop their teaching skills in an environment with limited traditional ward teaching time.

We believe that these changes require us to redefine what it means to be an academic hospitalist, both for existing faculty and for prospective faculty whose views of academic hospital medicine may have been shaped by role models seen only in their clinical teaching role.

Is reduced teaching time the new normal or will the pendulum swing back toward more resident teaching time for academic hospitalists? The former is likely the case. None of the current trends in medical education point to an expansion of residents in the inpatient setting. Although there may be some opportunities to assume general medicine attending time is currently covered by primary care physicians and subspecialists, in several programs, hospitalists already cover the overwhelming majority of general medicine teaching services.

Although there may be occasional opportunities for academic hospitalist programs to develop new teaching roles with residents or fellows (for example, by expanding to community sites with residency programs or to subspecialty teaching services, or by creating hospital medicine fellowships and resident or student electives), the reality is that we as hospitalists will need to adapt to direct care as the plurality of our work.

How should we allocate traditional teaching time among our faculty? Since it is a coveted—but relatively scarce—resource, teaching time should be allocated thoughtfully. Based on our collective experience, academic hospitalist groups have taken a variety of approaches to this challenge, including forming separate clinical groups at the same institution (a teaching faculty group and a nonteaching group),⁶ requiring all hospitalists to do some amount of direct care to facilitate distribution of teaching time or having merit or seniority-based teaching time allocation (based on teaching evaluations, formal teaching roles such as program director status, or years on faculty).

Each approach to assigning teaching time has its challenges. Hospitalist leaders must manage these issues through transparency about the selection process for teaching rotations and open discussion of teaching evaluations with faculty. It is also critical that the recruitment process set appropriate expectations for faculty candidates. Highlighting academic opportunities outside of teaching residents, including leadership roles, quality improvement work, and research, may encourage applicants and current hospitalists to explore more varied career trajectories. Hospitalists focusing on these other paths may elect to have less teaching time, freeing up opportunities for dedicated clinician educators.

What other ward-based teaching opportunities might be available for academic hospitalists who do not have the opportunity to attend on traditional resident teaching teams? As supervisory requirements for residents have been strengthened, expansion of teaching into the evening and overnight hours to supervise new admissions to the teaching services has been one approach to augment teaching footprints.^7,8

In addition, nontraditional teaching teams such as attending/intern teams (without a supervising resident) or attending/subintern (fourth-year medical student) teams have been developed at some institutions.⁹ Although allowing for additional exposure to learners, these models require a more hands-on approach than traditional teaching teams, particularly at the start of the academic year. Finally, as hospitalist teams have grown to include advanced practice providers (APPs), some programs have established formal teaching programs to address professional development needs of these healthcare professionals.^10,11

How do we help junior faculty who have the potential to be talented educators succeed in teaching when they have limited opportunities to engage with residents on clinical services? One approach is to encourage hospitalists to participate in resident didactic sessions such as “morning report” and noon conference. Another approach is to focus on teaching other learners. For example, several academic medical centers provide opportunities for hospitalists to engage in student teaching, either on the wards or via classroom instruction. In addition, as mentioned previously, APPs who are new to hospital medicine are an engaged audience and represent an opportunity for hospitalist educators to utilize and hone their teaching skills. Finally, organizing lectures for nursing colleagues is another way for the faculty to practice “chalk talks” and develop teaching portfolios.

Hospitalists can also leverage their expertise to build systems in which academic hospitalists are teaching each other, creating a culture of continuous learning. These activities may include case conferences, morbidity and mortality conferences, journal clubs, clinical topic updates developed by and for hospitalists, simulation exercises, and other group learning sessions. Giving hospitalists the opportunity to teach each other allows for professional growth that is not dependent on the presence of traditional learners.

Philosophically, a key question is “What makes ‘academic’ academic?” Traditionally, academic hospitalist positions were synonymous with resident teaching or, for a small number of academic hospitalists, significant funded research. In an era where teaching residents may no longer be part of the job description for many hospitalists at academic medical centers, what distinguishes these positions from 100% clinical positions and what are the implications for academic hospital medicine?

Although data regarding why hospitalists seek “nonteaching” positions at academic medical centers are lacking, we believe that these jobs remain popular due to opportunities that are perceived to be unique to academic medical centers. These include more flexible scheduling (academic programs may be less likely to have seven-on/seven-off schedules), exposure to research and cutting-edge technology, opportunities to care for tertiary and quaternary care patients, collaboration with academic peers and experts in the field, and interaction with a range of learners, including medical, pharmacy, advanced practitioner, and other students.

Understanding the motivation of candidates who apply for academic hospital medicine positions—aside from supervising/teaching residents—will be an important goal for academic hospitalist leaders to ensure future success in staffing growing programs and creating sustainable academic hospitalist careers. As resident teaching time decreases, implementing robust faculty or professional development programs to address the broader interests and needs of academic hospitalist faculty will be increasingly important. Sehgal et al. described one such program for faculty development,¹² and a more recent paper outlines a faculty development program focused on quality improvement and patient safety.¹³ These types of programs provide opportunities for academic hospitalists to engage in academic pursuits that are independent of residency programs.

Therefore, what do we tell the eager faculty applicant? First, we should not hide from the honest answer, ie, new faculty may not get as much resident teaching time as they would like or expect. Although we want hospitalists to maintain integral involvement in residency training programs, we also want to build a culture of clinical excellence, scholarship, and continuous learning that is not dependent on directly teaching residents. We should highlight the unique opportunities of academic hospital medicine, including teaching other learners, caring for tertiary/quaternary care patients, working with colleagues who are leaders in their field, and engaging in research and quality improvement work. By capitalizing on these opportunities, we can actively redefine what makes “academic” academic and ensure that we sustain academic hospital medicine as a desirable and rewarding career.

Disclosures

The authors have nothing to disclose.

Hip fractures are a significant cause of morbidity and mortality among elderly patients. Patients with fragility hip fractures often carry multiple comorbid diagnoses with a significant risk of perioperative complications. After hip fracture, 30-day mortality has been reported as 3.3% to 17.2% with one-year mortality as high as 50%.¹

Multidisciplinary care,^2-5 surgery within 24 hours (h),^6-12 use of regional peripheral nerve blocks,^13-16 restrictive blood transfusion strategies,^17,18 tranexamic acid (TXA) use,¹⁹ pharmacologic deep venous thrombosis (DVT) prophylaxis,²⁰ surgical site infection prevention protocols,²¹ early mobilization,²² and nutritional optimization^23-25 have been individually shown to improve outcomes in hip fracture patients.

Our program sought to define, standardize, and implement evidence-based best practices to improve clinical care and outcomes of patients with hip fractures. We convened a Center for Musculoskeletal Care (CMC) Hip Fracture Oversight Group that included surgeons and advanced practice providers from Orthopedics; physicians from Internal Medicine Hospitalist, Geriatrics, Emergency Medicine, and Anesthesia; and representatives from rehabilitation services, nursing, care management, pharmacy, and performance improvement. With clinical input from all involved services, we developed evidence-based protocols to standardize the care of patients with fragility hip fractures from the time of the patient’s evaluation in the emergency room to discharge and outpatient rehabilitation. The program was operationalized in February 2016.

This project was considered by the Yale University institutional review board (IRB) to be a quality improvement and, therefore, exempted from IRB approval.

Yale-New Haven Hospital is composed of two main campuses. The York Street Campus (YSC) is the Level 1 Trauma Center. The St. Raphael’s Campus (SRC) houses the CMC nursing units for elective lower extremity arthroplasty and spine procedures. Prior to 2016, patients with hip fractures were cared for equally at both Yale-New Haven Hospital campuses. Patients were admitted to both medical and surgical services with no standardization of hip fracture care processes. Surgeons were assigned based on availability. Frequently, patients were added on to the operating room (OR) schedule and did not undergo surgery until off-hours and after a prolonged waiting period.

Medical comanagement of patients with fragility hip fractures at our institution predated the start of our CMC Integrated Fragility Hip Fracture Program (IFHFP). Comanagement was instituted in 2012 at YSC and in 2014 at SRC but without standardized protocols. The IFHFP began in February 2016 with the centralization of all patients with fragility hip fractures to the SRC at Yale-New Haven Hospital. Emergency medical services directed patients with suspected hip fractures to the designated campus. A dedicated hip fracture OR was allocated daily with a hip fracture surgeon assigned by a shared community and faculty surgeon call schedule. Patients were encouraged but not required to accept care from the on-call hip fracture surgical attending. Anesthesia was notified of the arrival of a patient with a hip fracture in the emergency department, and if the patient consented and qualified, a single-shot femoral nerve block was performed. Patients were screened for nasal staphylococcal colonization and treated with povidone-iodine nasal decolonization, chlorhexidine wash, and antibiotics determined by staphylococcal status and type of surgical procedure planned. Preoperative and postoperative order sets were implemented that dictated the care processes as outlined in Table 1. Surgeons determined the choice of operative intervention as per usual; this included internal fixation and partial or total hip replacement. Detailed medical and surgical protocols are included in Appendix A.

There were 275 consecutive patients with hip fractures admitted to SRC in the baseline year (January 1, 2015 to December 31, 2015) and 434 patients with hip fractures admitted in the intervention year (January 1, 2018, to December 31, 2018) after consolidation of the program to the single Yale-New Haven Campus and implementation of standardized care processes. Patient demographic data including age, sex, ethnicity, body mass index, and American Society of Anesthesiologists physical status classification were evaluated for the baseline year and intervention year and reported in Table 2. There were no differences in the demographics of patients between baseline and intervention years.

From baseline year to intervention year, 30-day mortality, transfusion, adverse effects of drugs, length of stay, unexpected return to OR, and time to OR were all significantly reduced. Mortality within 30 days decreased from 8.0% to 2.8%. The results are displayed in Table 3. No significant difference was seen in the incidence of venous thromboembolism, sepsis, myocardial infarctions, readmission at 30 days, or mechanical surgical fixation complications.

Patients with fragility hip fractures are a medically complex and vulnerable population. The goal of the CMC IFHFP was to standardize the care of these high-risk patients in an effort to reduce time to the OR, perioperative medical complications, time spent in the hospital, and ultimately mortality.

The barriers to implementing coordinated, multidisciplinary care are significant. In our case, we had a fragmented care model with fragility hip fracture patients cared for at two campuses, on different nursing units, with both community and faculty surgeons providing operative care, and with no predesignated primary team. We structured our program for equal sharing of call between community and faculty surgeons. However, there was distrust among the physician groups: Primary care physicians were concerned that their referral lines with orthopedic surgical colleagues would be fractured by the new shared call. Surgeons doubted that patients would be distributed equally among community and faculty practices. Hospitalists feared that comanagement would mean surgeons abdicating responsibility for care. Surgeons worried that routine medical involvement would delay surgery and prolong the length of stay with excessive testing. In order to achieve consensus, address concerns, and allay fears, we engaged the primary care and surgeon leadership for their support at the onset of the program and held monthly large group meetings and many smaller sessions to advance objectives. We meticulously tracked data and frequently reported out to the involved groups.

As it is well established that operative intervention on a hip fracture is best completed within 24 h to optimize a patient’s clinical outcomes, critical interventions were the designation of a hip fracture OR starting midday and expectation that surgery be performed the day after admission for medically cleared patients. Surgeons were able to book elective cases or outpatient clinic time in the morning. The morning hours prior to surgery allowed time for any final medical optimization, preoperative nursing care, and family discussions. Most surgeries were then completed by the primary OR staff during standard operating hours. Patients were out of the postanesthesia care unit and settled back on the orthopedic nursing unit in the early evening without a prolonged period of nil per os, bed rest, or sleep interruption.

While our protocol expected surgery the day after admission for medically cleared patients, we used surgery within 24 h as a simple metric to compare baseline with intervention outcomes. With our hip fracture OR block time beginning midday, the majority of our medically cleared hip fracture patients would receive surgical treatment within 24 h of admission. Our data show a significant improvement in timeliness of surgical intervention from 41.8% of patients to the OR within 24 h in 2015 to 55% in 2018. In 2017, we conducted an interval four-month audit involving a detailed chart review of all patients for whom surgery was delayed beyond 24 h from hospital admission. Chart review identified anticoagulation as the primary reason for surgical delay. Of patients who were eligible for surgery (medically stabilized and not therapeutically anticoagulated), 90% underwent surgery within 24 h during this four-month period in 2017. This compares to an overall rate of surgery within 24 h of 57% during the calendar year 2017. We did not perform a subgroup analysis of outcomes in patients with time to OR of 24-36 h. From this study, we are therefore unable to draw any conclusion regarding time to surgery and mortality.

Our dedicated OR hip fracture block time was changed from 7:30 am to 12:30 pm during 2016 per surgeon request (Figure). Patients admitted within the 24-hour time period from 7 am the day prior to 7 am the day of the OR block time undergo surgery in the 12:30 pm time slot. Any patient admitted from 7 am until 12:30 pm is not scheduled until the following day’s OR block time and would hence have a surgical delay of 30 h or more. To better understand the impact of the later OR block time, we included the outcome variable of time to OR of greater than 24 h but less than or equal to 36 h. We demonstrated a significant increase in the proportion of patients going to the OR in 24 h without an increase in patients waiting for 24 to 36 h for their surgery.

Transfusion rate reduction from 46.6% to 28.1% was achieved primarily by the implementation and strict enforcement of a policy to avoid transfusing asymptomatic patients with hemoglobin >7.0 g/dL. In addition, we recommended TXA using standard perioperative arthroplasty dosing of 1 g intravenously (IV) at the time of incision followed by 1 g IV 3 h later in the postanaesthesia care unit. However, adherence to TXA recommendations was poor. A year-long audit (February 2017 to February 2018) demonstrated that only 29% of patients undergoing hip fracture surgery received the recommended TXA. After the conclusion of the study period of this review, we revised our TXA protocol to include an infusion at the time of admission and subsequent perioperative doses. The expanded TXA protocol (with clear exclusion criteria) has been “hard-wired” into our electronic perioperative order sets. We are tracking TXA compliance on a weekly basis. We anticipate that earlier TXA administration and improved compliance will further reduce transfusion rates.

We reduced the adverse effects of medications with two initiatives: First, dedicated hip fracture order sets with medications selected and dosed specifically for the geriatric population were launched at the onset of the IFHFP in 2016. Second, in coordination with our regional anesthesia team, patients who met criteria underwent a single-shot femoral nerve block upon diagnosis of the hip fracture. Patients reported up to 24 h of nonnarcotic pain relief with the femoral nerve block.

Prior to the introduction of the IFHFP, surgeons determined DVT prophylaxis based on their personal preference. Many of our surgeons were concerned that standardizing DVT prophylaxis to enoxaparin would increase the risk of surgical site bleeding, hematoma, infection, and reoperation. With data tracking and periodic reporting, we were able to reassure our surgeons: We demonstrated a reduction in the rate of patients unexpectedly requiring a return to the OR from 5.1% in 2015 to 0% in 2018.

We did not find a significant difference in mechanical complications due to surgical fixation during the index admission. Most mechanical complications do not present within the index admission and, therefore, would not be identified by this metric. Furthermore, in this phase of the program, we did not seek to change or standardize intraoperative surgical processes outside of surgical site infection prevention measures. Surgical technical quality and variation among surgeons is an area of ongoing evaluation within our program. We have begun a surgical quality review process with an expert review of postoperative radiography, beginning with fixation of nondisplaced femoral neck fractures, feedback to surgeons, and tracking of mechanical complications beyond the index admission. The surgical quality outcomes will be presented in a future manuscript.

Anticoagulation use is common in patients with hip fractures because of the high prevalence of comorbid conditions such as atrial fibrillation and venous thromboembolic disease. Direct oral anticoagulants (DOACs) are now commonly used in place of the vitamin K antagonist, warfarin. Our inability to efficiently reverse the DOACs compounded by surgeon unfamiliarity with these agents led to extreme caution in the timing of OR, with most patients delayed a full 48 h from the last dose of their prescribed DOAC. After recognizing the impact of anticoagulation on the timing of surgery, we convened a multidisciplinary group to determine rational guidelines for the timing of surgery in patients on chronic anticoagulation based on the bleeding risk of the planned operative procedure. These guidelines were instituted in December 2018, so their impact is not reflected in this review.

Our results showing a reduction in length of stay and mortality cannot be explained by any one intervention. We propose that the standardization of all processes and protocols, the establishment of clear expectations among all the medical and nursing personnel, and the shorter time spent waiting for surgery all contributed to the length of stay reduction. Likewise, the decrease in time to OR, reduction in time spent in the hospital, fewer transfusions, adverse effects of medication, and surgical complications requiring a return to the OR have all likely contributed to the significant reduction in mortality. The efforts of the orthopedic nursing team certainly contributed: The CMC nurses led the efforts to standardize surgical site infection bundle care, reduce indwelling bladder catheter use, and together with physical therapy, mobilize patients out of bed for meals postoperatively. The strong focus on teamwork, data tracking, feedback and accountability, and the desire for continued improvement may have been the strongest drivers in this program’s success.

Our results showed a nonsignificant increase in 30-day readmission from 9.1% to 12.5%. One limitation of this study is that we did not track specific readmission diagnoses to better understand trends in diagnoses or indications for hospital readmission. Going forward, we are reviewing readmissions to better understand opportunities to improve our inpatient processes and transitions of care.

This an evolving project. We have expanded our use of TXA in an effort to further reduce transfusion rates. We have adjusted our protocols for patients admitted on DOACs and warfarin to allow more rapid surgical intervention. We have initiated a surgical quality review process in which surgical fixation is reviewed with timely feedback to the operating surgeon. We are working closely with the skilled nursing facilities to extend our rehabilitation and nursing care protocols beyond the acute care setting. We are measuring patient engagement with a brief discharge survey specific to the CMC IFHFP. We continue to seek feedback from our referring primary care physicians to improve communication at times of care transition.

One of the limitations of a quality improvement project such as this one is the inability to identify the effect of each individual intervention. We can conclude that the totality of the multidisciplinary project reduced mortality in our hip fracture population, but we cannot report the relative effect of each process change. Another center seeking to replicate this success cannot determine from this research how to prioritize their resources to achieve a similar outcome.

How we care for the fragility hip fracture patient after hospital discharge is critical and unaddressed in this current study. A limitation of our current program is the lack of consistent postdischarge bone health management—which we are working to address. Also related to postdischarge management, we have partnered with a network of preferred skilled nursing facilities to standardize the care and decrease the length of stay. These data will be published separately.

We understand that our experience at the CMC is unique and specific to our care environment. This is a single site study and may not be generalizable to other centers. Nonetheless, the principles of multidisciplinary care, evidence-based protocol development, technological integration of protocols through order sets, and data tracking with feedback and accountability are the essential elements of our success that can be generalized to other institutions.

The CMC at Yale School of Medicine and Yale-New Haven Hospital IFHFP provides a model for implementing well-documented evidence-based interventions to standardize the care of patients with fragility hip fractures. The IFHFP yielded reduced mortality, length of stay, blood transfusion utilization, adverse effects of medications, unexpected return to the OR, and time to the OR.

Acknowledgments

The authors thank the work of the Center for Musculoskeletal Care Hip Fracture Oversight Group, program surgeons, and community primary care leaders: Olukemi Akande, MD, Mark Altman, MD, Diren Arsoy, MD, John Aversa, MD, Michael Connair, MD, Leo Cooney, MD, Kenneth Donohue, MD, David Gibson, MD, Gail Haesche, RN, MS, ACM-RN, Carol Just, MSN, NEA-BC, RN, Patricia Kenyon, RN, ACM, Francis Lee MD, Michael Leslie, MD, Michael Lucchini, MD, Christopher Lynch, MD, Rowland Mayor, MD, Tara Messina, PT, Lorraine Novella, RN, Paul Oliver, PA-C, Vivek Parwani, MD, Joseph Quaranta, MD, Lee Rubin, MD, Derek Shia, MD, Jeff Sumner, MD, John Tarutis, Arya Varthi, MD, Anuruddha Walaliyadda, MD, Daniel Wiznia, MD, Shirvinda Wijesekera, MD, Joseph Wu, MD, Brad Yoo, MD, and James Yue, MD.

Hip fractures are a significant cause of morbidity and mortality among elderly patients. Patients with fragility hip fractures often carry multiple comorbid diagnoses with a significant risk of perioperative complications. After hip fracture, 30-day mortality has been reported as 3.3% to 17.2% with one-year mortality as high as 50%.¹

Multidisciplinary care,^2-5 surgery within 24 hours (h),^6-12 use of regional peripheral nerve blocks,^13-16 restrictive blood transfusion strategies,^17,18 tranexamic acid (TXA) use,¹⁹ pharmacologic deep venous thrombosis (DVT) prophylaxis,²⁰ surgical site infection prevention protocols,²¹ early mobilization,²² and nutritional optimization^23-25 have been individually shown to improve outcomes in hip fracture patients.

Our program sought to define, standardize, and implement evidence-based best practices to improve clinical care and outcomes of patients with hip fractures. We convened a Center for Musculoskeletal Care (CMC) Hip Fracture Oversight Group that included surgeons and advanced practice providers from Orthopedics; physicians from Internal Medicine Hospitalist, Geriatrics, Emergency Medicine, and Anesthesia; and representatives from rehabilitation services, nursing, care management, pharmacy, and performance improvement. With clinical input from all involved services, we developed evidence-based protocols to standardize the care of patients with fragility hip fractures from the time of the patient’s evaluation in the emergency room to discharge and outpatient rehabilitation. The program was operationalized in February 2016.

This project was considered by the Yale University institutional review board (IRB) to be a quality improvement and, therefore, exempted from IRB approval.

Yale-New Haven Hospital is composed of two main campuses. The York Street Campus (YSC) is the Level 1 Trauma Center. The St. Raphael’s Campus (SRC) houses the CMC nursing units for elective lower extremity arthroplasty and spine procedures. Prior to 2016, patients with hip fractures were cared for equally at both Yale-New Haven Hospital campuses. Patients were admitted to both medical and surgical services with no standardization of hip fracture care processes. Surgeons were assigned based on availability. Frequently, patients were added on to the operating room (OR) schedule and did not undergo surgery until off-hours and after a prolonged waiting period.

Medical comanagement of patients with fragility hip fractures at our institution predated the start of our CMC Integrated Fragility Hip Fracture Program (IFHFP). Comanagement was instituted in 2012 at YSC and in 2014 at SRC but without standardized protocols. The IFHFP began in February 2016 with the centralization of all patients with fragility hip fractures to the SRC at Yale-New Haven Hospital. Emergency medical services directed patients with suspected hip fractures to the designated campus. A dedicated hip fracture OR was allocated daily with a hip fracture surgeon assigned by a shared community and faculty surgeon call schedule. Patients were encouraged but not required to accept care from the on-call hip fracture surgical attending. Anesthesia was notified of the arrival of a patient with a hip fracture in the emergency department, and if the patient consented and qualified, a single-shot femoral nerve block was performed. Patients were screened for nasal staphylococcal colonization and treated with povidone-iodine nasal decolonization, chlorhexidine wash, and antibiotics determined by staphylococcal status and type of surgical procedure planned. Preoperative and postoperative order sets were implemented that dictated the care processes as outlined in Table 1. Surgeons determined the choice of operative intervention as per usual; this included internal fixation and partial or total hip replacement. Detailed medical and surgical protocols are included in Appendix A.

There were 275 consecutive patients with hip fractures admitted to SRC in the baseline year (January 1, 2015 to December 31, 2015) and 434 patients with hip fractures admitted in the intervention year (January 1, 2018, to December 31, 2018) after consolidation of the program to the single Yale-New Haven Campus and implementation of standardized care processes. Patient demographic data including age, sex, ethnicity, body mass index, and American Society of Anesthesiologists physical status classification were evaluated for the baseline year and intervention year and reported in Table 2. There were no differences in the demographics of patients between baseline and intervention years.

From baseline year to intervention year, 30-day mortality, transfusion, adverse effects of drugs, length of stay, unexpected return to OR, and time to OR were all significantly reduced. Mortality within 30 days decreased from 8.0% to 2.8%. The results are displayed in Table 3. No significant difference was seen in the incidence of venous thromboembolism, sepsis, myocardial infarctions, readmission at 30 days, or mechanical surgical fixation complications.

Patients with fragility hip fractures are a medically complex and vulnerable population. The goal of the CMC IFHFP was to standardize the care of these high-risk patients in an effort to reduce time to the OR, perioperative medical complications, time spent in the hospital, and ultimately mortality.

The barriers to implementing coordinated, multidisciplinary care are significant. In our case, we had a fragmented care model with fragility hip fracture patients cared for at two campuses, on different nursing units, with both community and faculty surgeons providing operative care, and with no predesignated primary team. We structured our program for equal sharing of call between community and faculty surgeons. However, there was distrust among the physician groups: Primary care physicians were concerned that their referral lines with orthopedic surgical colleagues would be fractured by the new shared call. Surgeons doubted that patients would be distributed equally among community and faculty practices. Hospitalists feared that comanagement would mean surgeons abdicating responsibility for care. Surgeons worried that routine medical involvement would delay surgery and prolong the length of stay with excessive testing. In order to achieve consensus, address concerns, and allay fears, we engaged the primary care and surgeon leadership for their support at the onset of the program and held monthly large group meetings and many smaller sessions to advance objectives. We meticulously tracked data and frequently reported out to the involved groups.

As it is well established that operative intervention on a hip fracture is best completed within 24 h to optimize a patient’s clinical outcomes, critical interventions were the designation of a hip fracture OR starting midday and expectation that surgery be performed the day after admission for medically cleared patients. Surgeons were able to book elective cases or outpatient clinic time in the morning. The morning hours prior to surgery allowed time for any final medical optimization, preoperative nursing care, and family discussions. Most surgeries were then completed by the primary OR staff during standard operating hours. Patients were out of the postanesthesia care unit and settled back on the orthopedic nursing unit in the early evening without a prolonged period of nil per os, bed rest, or sleep interruption.

While our protocol expected surgery the day after admission for medically cleared patients, we used surgery within 24 h as a simple metric to compare baseline with intervention outcomes. With our hip fracture OR block time beginning midday, the majority of our medically cleared hip fracture patients would receive surgical treatment within 24 h of admission. Our data show a significant improvement in timeliness of surgical intervention from 41.8% of patients to the OR within 24 h in 2015 to 55% in 2018. In 2017, we conducted an interval four-month audit involving a detailed chart review of all patients for whom surgery was delayed beyond 24 h from hospital admission. Chart review identified anticoagulation as the primary reason for surgical delay. Of patients who were eligible for surgery (medically stabilized and not therapeutically anticoagulated), 90% underwent surgery within 24 h during this four-month period in 2017. This compares to an overall rate of surgery within 24 h of 57% during the calendar year 2017. We did not perform a subgroup analysis of outcomes in patients with time to OR of 24-36 h. From this study, we are therefore unable to draw any conclusion regarding time to surgery and mortality.

Our dedicated OR hip fracture block time was changed from 7:30 am to 12:30 pm during 2016 per surgeon request (Figure). Patients admitted within the 24-hour time period from 7 am the day prior to 7 am the day of the OR block time undergo surgery in the 12:30 pm time slot. Any patient admitted from 7 am until 12:30 pm is not scheduled until the following day’s OR block time and would hence have a surgical delay of 30 h or more. To better understand the impact of the later OR block time, we included the outcome variable of time to OR of greater than 24 h but less than or equal to 36 h. We demonstrated a significant increase in the proportion of patients going to the OR in 24 h without an increase in patients waiting for 24 to 36 h for their surgery.

Transfusion rate reduction from 46.6% to 28.1% was achieved primarily by the implementation and strict enforcement of a policy to avoid transfusing asymptomatic patients with hemoglobin >7.0 g/dL. In addition, we recommended TXA using standard perioperative arthroplasty dosing of 1 g intravenously (IV) at the time of incision followed by 1 g IV 3 h later in the postanaesthesia care unit. However, adherence to TXA recommendations was poor. A year-long audit (February 2017 to February 2018) demonstrated that only 29% of patients undergoing hip fracture surgery received the recommended TXA. After the conclusion of the study period of this review, we revised our TXA protocol to include an infusion at the time of admission and subsequent perioperative doses. The expanded TXA protocol (with clear exclusion criteria) has been “hard-wired” into our electronic perioperative order sets. We are tracking TXA compliance on a weekly basis. We anticipate that earlier TXA administration and improved compliance will further reduce transfusion rates.

We reduced the adverse effects of medications with two initiatives: First, dedicated hip fracture order sets with medications selected and dosed specifically for the geriatric population were launched at the onset of the IFHFP in 2016. Second, in coordination with our regional anesthesia team, patients who met criteria underwent a single-shot femoral nerve block upon diagnosis of the hip fracture. Patients reported up to 24 h of nonnarcotic pain relief with the femoral nerve block.

Prior to the introduction of the IFHFP, surgeons determined DVT prophylaxis based on their personal preference. Many of our surgeons were concerned that standardizing DVT prophylaxis to enoxaparin would increase the risk of surgical site bleeding, hematoma, infection, and reoperation. With data tracking and periodic reporting, we were able to reassure our surgeons: We demonstrated a reduction in the rate of patients unexpectedly requiring a return to the OR from 5.1% in 2015 to 0% in 2018.

We did not find a significant difference in mechanical complications due to surgical fixation during the index admission. Most mechanical complications do not present within the index admission and, therefore, would not be identified by this metric. Furthermore, in this phase of the program, we did not seek to change or standardize intraoperative surgical processes outside of surgical site infection prevention measures. Surgical technical quality and variation among surgeons is an area of ongoing evaluation within our program. We have begun a surgical quality review process with an expert review of postoperative radiography, beginning with fixation of nondisplaced femoral neck fractures, feedback to surgeons, and tracking of mechanical complications beyond the index admission. The surgical quality outcomes will be presented in a future manuscript.

Anticoagulation use is common in patients with hip fractures because of the high prevalence of comorbid conditions such as atrial fibrillation and venous thromboembolic disease. Direct oral anticoagulants (DOACs) are now commonly used in place of the vitamin K antagonist, warfarin. Our inability to efficiently reverse the DOACs compounded by surgeon unfamiliarity with these agents led to extreme caution in the timing of OR, with most patients delayed a full 48 h from the last dose of their prescribed DOAC. After recognizing the impact of anticoagulation on the timing of surgery, we convened a multidisciplinary group to determine rational guidelines for the timing of surgery in patients on chronic anticoagulation based on the bleeding risk of the planned operative procedure. These guidelines were instituted in December 2018, so their impact is not reflected in this review.

Our results showing a reduction in length of stay and mortality cannot be explained by any one intervention. We propose that the standardization of all processes and protocols, the establishment of clear expectations among all the medical and nursing personnel, and the shorter time spent waiting for surgery all contributed to the length of stay reduction. Likewise, the decrease in time to OR, reduction in time spent in the hospital, fewer transfusions, adverse effects of medication, and surgical complications requiring a return to the OR have all likely contributed to the significant reduction in mortality. The efforts of the orthopedic nursing team certainly contributed: The CMC nurses led the efforts to standardize surgical site infection bundle care, reduce indwelling bladder catheter use, and together with physical therapy, mobilize patients out of bed for meals postoperatively. The strong focus on teamwork, data tracking, feedback and accountability, and the desire for continued improvement may have been the strongest drivers in this program’s success.

Our results showed a nonsignificant increase in 30-day readmission from 9.1% to 12.5%. One limitation of this study is that we did not track specific readmission diagnoses to better understand trends in diagnoses or indications for hospital readmission. Going forward, we are reviewing readmissions to better understand opportunities to improve our inpatient processes and transitions of care.

This an evolving project. We have expanded our use of TXA in an effort to further reduce transfusion rates. We have adjusted our protocols for patients admitted on DOACs and warfarin to allow more rapid surgical intervention. We have initiated a surgical quality review process in which surgical fixation is reviewed with timely feedback to the operating surgeon. We are working closely with the skilled nursing facilities to extend our rehabilitation and nursing care protocols beyond the acute care setting. We are measuring patient engagement with a brief discharge survey specific to the CMC IFHFP. We continue to seek feedback from our referring primary care physicians to improve communication at times of care transition.

One of the limitations of a quality improvement project such as this one is the inability to identify the effect of each individual intervention. We can conclude that the totality of the multidisciplinary project reduced mortality in our hip fracture population, but we cannot report the relative effect of each process change. Another center seeking to replicate this success cannot determine from this research how to prioritize their resources to achieve a similar outcome.

How we care for the fragility hip fracture patient after hospital discharge is critical and unaddressed in this current study. A limitation of our current program is the lack of consistent postdischarge bone health management—which we are working to address. Also related to postdischarge management, we have partnered with a network of preferred skilled nursing facilities to standardize the care and decrease the length of stay. These data will be published separately.

We understand that our experience at the CMC is unique and specific to our care environment. This is a single site study and may not be generalizable to other centers. Nonetheless, the principles of multidisciplinary care, evidence-based protocol development, technological integration of protocols through order sets, and data tracking with feedback and accountability are the essential elements of our success that can be generalized to other institutions.

The CMC at Yale School of Medicine and Yale-New Haven Hospital IFHFP provides a model for implementing well-documented evidence-based interventions to standardize the care of patients with fragility hip fractures. The IFHFP yielded reduced mortality, length of stay, blood transfusion utilization, adverse effects of medications, unexpected return to the OR, and time to the OR.

Acknowledgments

The authors thank the work of the Center for Musculoskeletal Care Hip Fracture Oversight Group, program surgeons, and community primary care leaders: Olukemi Akande, MD, Mark Altman, MD, Diren Arsoy, MD, John Aversa, MD, Michael Connair, MD, Leo Cooney, MD, Kenneth Donohue, MD, David Gibson, MD, Gail Haesche, RN, MS, ACM-RN, Carol Just, MSN, NEA-BC, RN, Patricia Kenyon, RN, ACM, Francis Lee MD, Michael Leslie, MD, Michael Lucchini, MD, Christopher Lynch, MD, Rowland Mayor, MD, Tara Messina, PT, Lorraine Novella, RN, Paul Oliver, PA-C, Vivek Parwani, MD, Joseph Quaranta, MD, Lee Rubin, MD, Derek Shia, MD, Jeff Sumner, MD, John Tarutis, Arya Varthi, MD, Anuruddha Walaliyadda, MD, Daniel Wiznia, MD, Shirvinda Wijesekera, MD, Joseph Wu, MD, Brad Yoo, MD, and James Yue, MD.

Hip fractures are a significant cause of morbidity and mortality among elderly patients. Patients with fragility hip fractures often carry multiple comorbid diagnoses with a significant risk of perioperative complications. After hip fracture, 30-day mortality has been reported as 3.3% to 17.2% with one-year mortality as high as 50%.¹

Multidisciplinary care,^2-5 surgery within 24 hours (h),^6-12 use of regional peripheral nerve blocks,^13-16 restrictive blood transfusion strategies,^17,18 tranexamic acid (TXA) use,¹⁹ pharmacologic deep venous thrombosis (DVT) prophylaxis,²⁰ surgical site infection prevention protocols,²¹ early mobilization,²² and nutritional optimization^23-25 have been individually shown to improve outcomes in hip fracture patients.

Our program sought to define, standardize, and implement evidence-based best practices to improve clinical care and outcomes of patients with hip fractures. We convened a Center for Musculoskeletal Care (CMC) Hip Fracture Oversight Group that included surgeons and advanced practice providers from Orthopedics; physicians from Internal Medicine Hospitalist, Geriatrics, Emergency Medicine, and Anesthesia; and representatives from rehabilitation services, nursing, care management, pharmacy, and performance improvement. With clinical input from all involved services, we developed evidence-based protocols to standardize the care of patients with fragility hip fractures from the time of the patient’s evaluation in the emergency room to discharge and outpatient rehabilitation. The program was operationalized in February 2016.

This project was considered by the Yale University institutional review board (IRB) to be a quality improvement and, therefore, exempted from IRB approval.

Yale-New Haven Hospital is composed of two main campuses. The York Street Campus (YSC) is the Level 1 Trauma Center. The St. Raphael’s Campus (SRC) houses the CMC nursing units for elective lower extremity arthroplasty and spine procedures. Prior to 2016, patients with hip fractures were cared for equally at both Yale-New Haven Hospital campuses. Patients were admitted to both medical and surgical services with no standardization of hip fracture care processes. Surgeons were assigned based on availability. Frequently, patients were added on to the operating room (OR) schedule and did not undergo surgery until off-hours and after a prolonged waiting period.

Medical comanagement of patients with fragility hip fractures at our institution predated the start of our CMC Integrated Fragility Hip Fracture Program (IFHFP). Comanagement was instituted in 2012 at YSC and in 2014 at SRC but without standardized protocols. The IFHFP began in February 2016 with the centralization of all patients with fragility hip fractures to the SRC at Yale-New Haven Hospital. Emergency medical services directed patients with suspected hip fractures to the designated campus. A dedicated hip fracture OR was allocated daily with a hip fracture surgeon assigned by a shared community and faculty surgeon call schedule. Patients were encouraged but not required to accept care from the on-call hip fracture surgical attending. Anesthesia was notified of the arrival of a patient with a hip fracture in the emergency department, and if the patient consented and qualified, a single-shot femoral nerve block was performed. Patients were screened for nasal staphylococcal colonization and treated with povidone-iodine nasal decolonization, chlorhexidine wash, and antibiotics determined by staphylococcal status and type of surgical procedure planned. Preoperative and postoperative order sets were implemented that dictated the care processes as outlined in Table 1. Surgeons determined the choice of operative intervention as per usual; this included internal fixation and partial or total hip replacement. Detailed medical and surgical protocols are included in Appendix A.

There were 275 consecutive patients with hip fractures admitted to SRC in the baseline year (January 1, 2015 to December 31, 2015) and 434 patients with hip fractures admitted in the intervention year (January 1, 2018, to December 31, 2018) after consolidation of the program to the single Yale-New Haven Campus and implementation of standardized care processes. Patient demographic data including age, sex, ethnicity, body mass index, and American Society of Anesthesiologists physical status classification were evaluated for the baseline year and intervention year and reported in Table 2. There were no differences in the demographics of patients between baseline and intervention years.

From baseline year to intervention year, 30-day mortality, transfusion, adverse effects of drugs, length of stay, unexpected return to OR, and time to OR were all significantly reduced. Mortality within 30 days decreased from 8.0% to 2.8%. The results are displayed in Table 3. No significant difference was seen in the incidence of venous thromboembolism, sepsis, myocardial infarctions, readmission at 30 days, or mechanical surgical fixation complications.

Patients with fragility hip fractures are a medically complex and vulnerable population. The goal of the CMC IFHFP was to standardize the care of these high-risk patients in an effort to reduce time to the OR, perioperative medical complications, time spent in the hospital, and ultimately mortality.

The barriers to implementing coordinated, multidisciplinary care are significant. In our case, we had a fragmented care model with fragility hip fracture patients cared for at two campuses, on different nursing units, with both community and faculty surgeons providing operative care, and with no predesignated primary team. We structured our program for equal sharing of call between community and faculty surgeons. However, there was distrust among the physician groups: Primary care physicians were concerned that their referral lines with orthopedic surgical colleagues would be fractured by the new shared call. Surgeons doubted that patients would be distributed equally among community and faculty practices. Hospitalists feared that comanagement would mean surgeons abdicating responsibility for care. Surgeons worried that routine medical involvement would delay surgery and prolong the length of stay with excessive testing. In order to achieve consensus, address concerns, and allay fears, we engaged the primary care and surgeon leadership for their support at the onset of the program and held monthly large group meetings and many smaller sessions to advance objectives. We meticulously tracked data and frequently reported out to the involved groups.

As it is well established that operative intervention on a hip fracture is best completed within 24 h to optimize a patient’s clinical outcomes, critical interventions were the designation of a hip fracture OR starting midday and expectation that surgery be performed the day after admission for medically cleared patients. Surgeons were able to book elective cases or outpatient clinic time in the morning. The morning hours prior to surgery allowed time for any final medical optimization, preoperative nursing care, and family discussions. Most surgeries were then completed by the primary OR staff during standard operating hours. Patients were out of the postanesthesia care unit and settled back on the orthopedic nursing unit in the early evening without a prolonged period of nil per os, bed rest, or sleep interruption.

While our protocol expected surgery the day after admission for medically cleared patients, we used surgery within 24 h as a simple metric to compare baseline with intervention outcomes. With our hip fracture OR block time beginning midday, the majority of our medically cleared hip fracture patients would receive surgical treatment within 24 h of admission. Our data show a significant improvement in timeliness of surgical intervention from 41.8% of patients to the OR within 24 h in 2015 to 55% in 2018. In 2017, we conducted an interval four-month audit involving a detailed chart review of all patients for whom surgery was delayed beyond 24 h from hospital admission. Chart review identified anticoagulation as the primary reason for surgical delay. Of patients who were eligible for surgery (medically stabilized and not therapeutically anticoagulated), 90% underwent surgery within 24 h during this four-month period in 2017. This compares to an overall rate of surgery within 24 h of 57% during the calendar year 2017. We did not perform a subgroup analysis of outcomes in patients with time to OR of 24-36 h. From this study, we are therefore unable to draw any conclusion regarding time to surgery and mortality.

Our dedicated OR hip fracture block time was changed from 7:30 am to 12:30 pm during 2016 per surgeon request (Figure). Patients admitted within the 24-hour time period from 7 am the day prior to 7 am the day of the OR block time undergo surgery in the 12:30 pm time slot. Any patient admitted from 7 am until 12:30 pm is not scheduled until the following day’s OR block time and would hence have a surgical delay of 30 h or more. To better understand the impact of the later OR block time, we included the outcome variable of time to OR of greater than 24 h but less than or equal to 36 h. We demonstrated a significant increase in the proportion of patients going to the OR in 24 h without an increase in patients waiting for 24 to 36 h for their surgery.

Transfusion rate reduction from 46.6% to 28.1% was achieved primarily by the implementation and strict enforcement of a policy to avoid transfusing asymptomatic patients with hemoglobin >7.0 g/dL. In addition, we recommended TXA using standard perioperative arthroplasty dosing of 1 g intravenously (IV) at the time of incision followed by 1 g IV 3 h later in the postanaesthesia care unit. However, adherence to TXA recommendations was poor. A year-long audit (February 2017 to February 2018) demonstrated that only 29% of patients undergoing hip fracture surgery received the recommended TXA. After the conclusion of the study period of this review, we revised our TXA protocol to include an infusion at the time of admission and subsequent perioperative doses. The expanded TXA protocol (with clear exclusion criteria) has been “hard-wired” into our electronic perioperative order sets. We are tracking TXA compliance on a weekly basis. We anticipate that earlier TXA administration and improved compliance will further reduce transfusion rates.

We reduced the adverse effects of medications with two initiatives: First, dedicated hip fracture order sets with medications selected and dosed specifically for the geriatric population were launched at the onset of the IFHFP in 2016. Second, in coordination with our regional anesthesia team, patients who met criteria underwent a single-shot femoral nerve block upon diagnosis of the hip fracture. Patients reported up to 24 h of nonnarcotic pain relief with the femoral nerve block.

Prior to the introduction of the IFHFP, surgeons determined DVT prophylaxis based on their personal preference. Many of our surgeons were concerned that standardizing DVT prophylaxis to enoxaparin would increase the risk of surgical site bleeding, hematoma, infection, and reoperation. With data tracking and periodic reporting, we were able to reassure our surgeons: We demonstrated a reduction in the rate of patients unexpectedly requiring a return to the OR from 5.1% in 2015 to 0% in 2018.

We did not find a significant difference in mechanical complications due to surgical fixation during the index admission. Most mechanical complications do not present within the index admission and, therefore, would not be identified by this metric. Furthermore, in this phase of the program, we did not seek to change or standardize intraoperative surgical processes outside of surgical site infection prevention measures. Surgical technical quality and variation among surgeons is an area of ongoing evaluation within our program. We have begun a surgical quality review process with an expert review of postoperative radiography, beginning with fixation of nondisplaced femoral neck fractures, feedback to surgeons, and tracking of mechanical complications beyond the index admission. The surgical quality outcomes will be presented in a future manuscript.

Anticoagulation use is common in patients with hip fractures because of the high prevalence of comorbid conditions such as atrial fibrillation and venous thromboembolic disease. Direct oral anticoagulants (DOACs) are now commonly used in place of the vitamin K antagonist, warfarin. Our inability to efficiently reverse the DOACs compounded by surgeon unfamiliarity with these agents led to extreme caution in the timing of OR, with most patients delayed a full 48 h from the last dose of their prescribed DOAC. After recognizing the impact of anticoagulation on the timing of surgery, we convened a multidisciplinary group to determine rational guidelines for the timing of surgery in patients on chronic anticoagulation based on the bleeding risk of the planned operative procedure. These guidelines were instituted in December 2018, so their impact is not reflected in this review.

Our results showing a reduction in length of stay and mortality cannot be explained by any one intervention. We propose that the standardization of all processes and protocols, the establishment of clear expectations among all the medical and nursing personnel, and the shorter time spent waiting for surgery all contributed to the length of stay reduction. Likewise, the decrease in time to OR, reduction in time spent in the hospital, fewer transfusions, adverse effects of medication, and surgical complications requiring a return to the OR have all likely contributed to the significant reduction in mortality. The efforts of the orthopedic nursing team certainly contributed: The CMC nurses led the efforts to standardize surgical site infection bundle care, reduce indwelling bladder catheter use, and together with physical therapy, mobilize patients out of bed for meals postoperatively. The strong focus on teamwork, data tracking, feedback and accountability, and the desire for continued improvement may have been the strongest drivers in this program’s success.

Our results showed a nonsignificant increase in 30-day readmission from 9.1% to 12.5%. One limitation of this study is that we did not track specific readmission diagnoses to better understand trends in diagnoses or indications for hospital readmission. Going forward, we are reviewing readmissions to better understand opportunities to improve our inpatient processes and transitions of care.

This an evolving project. We have expanded our use of TXA in an effort to further reduce transfusion rates. We have adjusted our protocols for patients admitted on DOACs and warfarin to allow more rapid surgical intervention. We have initiated a surgical quality review process in which surgical fixation is reviewed with timely feedback to the operating surgeon. We are working closely with the skilled nursing facilities to extend our rehabilitation and nursing care protocols beyond the acute care setting. We are measuring patient engagement with a brief discharge survey specific to the CMC IFHFP. We continue to seek feedback from our referring primary care physicians to improve communication at times of care transition.

One of the limitations of a quality improvement project such as this one is the inability to identify the effect of each individual intervention. We can conclude that the totality of the multidisciplinary project reduced mortality in our hip fracture population, but we cannot report the relative effect of each process change. Another center seeking to replicate this success cannot determine from this research how to prioritize their resources to achieve a similar outcome.

How we care for the fragility hip fracture patient after hospital discharge is critical and unaddressed in this current study. A limitation of our current program is the lack of consistent postdischarge bone health management—which we are working to address. Also related to postdischarge management, we have partnered with a network of preferred skilled nursing facilities to standardize the care and decrease the length of stay. These data will be published separately.

We understand that our experience at the CMC is unique and specific to our care environment. This is a single site study and may not be generalizable to other centers. Nonetheless, the principles of multidisciplinary care, evidence-based protocol development, technological integration of protocols through order sets, and data tracking with feedback and accountability are the essential elements of our success that can be generalized to other institutions.

The CMC at Yale School of Medicine and Yale-New Haven Hospital IFHFP provides a model for implementing well-documented evidence-based interventions to standardize the care of patients with fragility hip fractures. The IFHFP yielded reduced mortality, length of stay, blood transfusion utilization, adverse effects of medications, unexpected return to the OR, and time to the OR.

Acknowledgments

The authors thank the work of the Center for Musculoskeletal Care Hip Fracture Oversight Group, program surgeons, and community primary care leaders: Olukemi Akande, MD, Mark Altman, MD, Diren Arsoy, MD, John Aversa, MD, Michael Connair, MD, Leo Cooney, MD, Kenneth Donohue, MD, David Gibson, MD, Gail Haesche, RN, MS, ACM-RN, Carol Just, MSN, NEA-BC, RN, Patricia Kenyon, RN, ACM, Francis Lee MD, Michael Leslie, MD, Michael Lucchini, MD, Christopher Lynch, MD, Rowland Mayor, MD, Tara Messina, PT, Lorraine Novella, RN, Paul Oliver, PA-C, Vivek Parwani, MD, Joseph Quaranta, MD, Lee Rubin, MD, Derek Shia, MD, Jeff Sumner, MD, John Tarutis, Arya Varthi, MD, Anuruddha Walaliyadda, MD, Daniel Wiznia, MD, Shirvinda Wijesekera, MD, Joseph Wu, MD, Brad Yoo, MD, and James Yue, MD.

Examining disparities in health-related quality of life (HRQoL) outcomes in children provides a unique patient-centered perspective on pediatric health services equity.^1,2 Prior studies have demonstrated the relationship between minority race, low socioeconomic status, and lower maternal education with poorer HRQoL outcomes in children.^3-6 Some studies have also shown a dose-response relationship between social disadvantage markers and poorer child health status.^7,8 Furthermore, the associations between social disadvantage and poor access to care,^9-11 and between poor access to care and lower HRQoL, are also well established.^12-14

Examining HRQoL before and after hospitalization can further our understanding of how disparities in HRQoL may change once children engage with the medical system for an acute illness.¹⁵ Children requiring hospitalization constitute a useful population for examination of this question as they represent a group of children with variable social disadvantage markers and access to outpatient care.¹⁶ Although interventions to address social determinants of health for patients with social disadvantages have been associated with within-group improvements in HRQoL, none have assessed changes in disparities as an outcome.¹⁷ Furthermore, many of these studies were conducted in the outpatient setting,^18,19 whereas hospitalization provides an additional point of care to address the social determinants of health for vulnerable families.²⁰ Even for short hospitalizations, the 24/7 nature of hospital care provides the opportunity for frequent interactions with clinicians, nurses, and support staff to clarify illness-related questions, discuss other health concerns and unmet needs, and connect with social services or community resources. These opportunities may be particularly important for families with a higher number of social disadvantage markers and even more beneficial to those with difficulty accessing needed care from their primary medical home.

In this study, we focused on children with common respiratory illnesses (asthma, bronchiolitis, and pneumonia), which constitute the majority of childhood hospitalizations.²¹ Additionally, we only focused on the child’s physical functioning component of HRQoL because this component is most likely to improve after hospitalization for children with an acute respiratory illness.²² A prior study examining HRQoL before and after hospitalization demonstrated that most children return to and/or surpass their baseline physical functioning by 1 month after hospital discharge.²³

Our primary objective was to examine associations between several markers of social disadvantage, access to care, and child physical functioning before and after hospitalization for acute respiratory illness. Second, we aimed to understand if access to care (defined as perceived difficulty/delays getting care) acts as an independent predictor of improvement in physical functioning from baseline to follow-up and/or if it modifies the relationship between social disadvantage and improvement in physical functioning (Appendix Figure).

Study Design and Population

This study was nested within a multicenter, prospective cohort study of children who were hospitalized for asthma, bronchiolitis, or pneumonia between July 2014 and June 2016 at one of five children’s hospitals in the Pediatric Research in Inpatient Settings Network.²⁴

We approached families for study participation within 72 hours of admission to the hospital using a standard protocol. Patients and their caregivers were eligible to participate in the study if the patient was 2 weeks to 16 years old and if the primary caregiver’s preferred language for medical communication was either English or Spanish. Patients with chronic medical conditions (except asthma), with moderate to severe developmental delay, with a history of prematurity <32 weeks, or who received care in the intensive care unit were excluded. Patients could only participate in the study once.

The study team set out to enroll an even number of patients across all three conditions. If a patient’s discharge diagnosis differed from their admission diagnosis (eg, from bronchiolitis to pneumonia), discharge diagnosis was used for condition group assignment. If the discharge diagnosis was not one of these three respiratory conditions, we excluded the patient from further analysis.

Data Collection

We collected data using two surveys. The first survey was administered within 72 hours of admission. This survey asked questions related to (1) caregiver-reported markers of social disadvantage, (2) caregiver perceptions of access to care, and (3) caregiver- and patient-reported assessments of physical functioning. The second survey was administered within 2 to 8 weeks after the patient’s discharge and included a second assessment of physical functioning.

Social Disadvantage

Patients were considered to have a marker of social disadvantage if their caregiver reported (1) being of non-White race and/or Hispanic ethnicity, (2) primarily speaking a language other than English at home and not speaking English very well (ie, limited English proficiency), (3) attaining at most a high school or equivalent degree, or (4) having a =/<$30,000 annual household income.

Access to Care

We used the following survey item from the 2009-2010 National Survey of Children with Special Health Care Needs²⁵ to measure caregiver perceptions of access to care: “In the last six months, did you have any difficulties or delays getting care for your child because there were waiting lists, backlogs, or other problems getting an appointment?” We narrowed the original assessment time frame from 12 months to 6 months to provide a more proximal assessment of access in relation to the hospitalization.

Child Physical Functioning

We assessed child physical functioning using the physical functioning domain of the Pediatric Quality of Life Inventory (PedsQL) 4.0 Generic Core Scales and PedsQL Infant Scales, which have been validated for use in the inpatient setting.²² Caregivers completed one of these scales based on their child’s age. Assenting patients 8 to 16 years old completed the self-report PedsQL 4.0 Generic Core Scales instrument. When completing the first PedsQL survey, caregivers and patients reflected on the previous month before their child (or they) became ill to obtain a baseline physical functioning assessment.²³ When completing the second PedsQL survey, caregivers and patients reflected on the past 7 days to obtain a follow-up assessment.

All study procedures were approved by the Western Institutional Review Board (IRB) or the participating hospitals’ IRB.

Statistical Analysis

Patients with no missing data for all four social disadvantage markers were categorized based on the number of markers they reported: none, one, two, or three or more markers. We combined patients with three and four social disadvantage markers into one group to maximize power for the analyses. We dichotomized the access to care variable and coded response options as “no difficulty/delays accessing care” if the caregiver chose “Never” and “any difficulty/delays accessing care” if they chose “Sometimes/Usually/Always.”

For each patient–caregiver dyad, PedsQL items were scored using a standard method in which higher scores reflected better functioning.²² A single set of PedsQL scores was used for each patient–caregiver dyad. We used self-reported patient scores if the patient completed the PedsQL instrument; otherwise, we used proxy-reported caregiver scores. Intraclass correlations between child self-report and parent proxy-report demonstrate moderate to good agreement above age 8 years.²⁶ We computed a change in the physical functioning score by subtracting the baseline score from the follow-up score. The minimal clinically important difference (MCID) for the PedsQL instrument is 4.5 points, which we used to identify clinically meaningful differences.¹³

Analysis of variance models were constructed to test for differences in mean baseline and follow-up PedsQL scores (dependent variable) between the following independent variables: (1) social disadvantage groups and (2) those who reported having any difficulty/delays accessing care compared with those who did not. Only patient–caregiver dyads with both baseline and follow-up assessments were included in these analyses. Mixed-effects linear regression models were constructed to identify clinically meaningful differences in PedsQL scores between groups (MCID =/> 4.5) with adjustment for patient age, gender, respiratory condition, days between surveys, and hospital site as fixed effects. Site-specific random effects were included to account for within-hospital clustering. A similarly adjusted mixed-effects linear regression model was constructed to examine whether having any difficulty/delays accessing care modified the association between social disadvantage and PedsQL change scores (eg, an improvement from baseline to follow-up).

Because 17% of respondents had missing data for at least one social disadvantage marker, sensitivity analyses were conducted using multiple imputation to account for missing social disadvantage markers using chained equations.²⁷ Sensitivity analyses were also conducted to adjust for severity of illness using vital sign data within the first 24 hours, which could only be validly captured on patients with asthma within our dataset. By restricting this latter analysis to patients with asthma, we were able to examine the relationships of interest in a population with chronic disease.

The study sample included 1,860 patients, of which 1,325 had both baseline and follow-up PedsQL data (71%). Descriptive statistics were similar between those who completed the baseline and follow-up surveys (Table 1).

Twenty-two percent of patients had >/=3 social disadvantages and 30% of caregivers reported having any difficulty/delays accessing care. The mean follow-up PedsQL score was higher than the baseline score (90.4 vs 82.5; Table 1).

Social Disadvantage Markers and PedsQL Scores

The number of social disadvantage markers was inversely related to mean baseline PedsQL scores, but there was no difference in mean follow-up PedsQL scores between social disadvantage groups (Table 2). In adjusted analyses, the mean baseline PedsQL score was −6.1 points (95% CI: −8.7, −3.5) lower for patients with >/= 3 social disadvantage markers compared with patients with no social disadvantage markers, which exceeded the scale’s MCID.

Difficulty/Delays Accessing Care and PedsQL Scores

Having any difficulty/delays accessing care was significantly associated with lower baseline and follow-up PedsQL scores (Table 2). In adjusted analyses, the difference in baseline scores was 5.2 points (95% CI: −7.2, −3.2), which exceedes the scale’s MCID.

Interaction Between Social Disadvantage Markers, Difficulty/Delays Accessing Care, and Change in PedsQL Scores from Baseline to Follow-Up

While having =/>2 social disadvantage markers and difficulty/delays accessing care were each positively associated with changes in PedsQL scores from baseline to follow-up (Table 3), only patients with =/> 3 social disadvantage markers exceeded the PedsQL MCID. In stratified analyses, patients with a combination of social disadvantage makers and difficulties/delays accessing care had lower baseline PedsQL scores and greater change in PedsQL scores from baseline to follow-up compared with those without difficulties/delays accessing care (Figure). However, having any difficulty/delays accessing care did not significantly modify the relationship between social disadvantage and change in PedsQL scores, as none of the interaction terms were significant (Table 3, Model 3).

Sensitivity Analysis

Baseline, follow-up, and change in PedsQL scores were similar to our main analysis after performing multiple imputation for missing social disadvantage markers (Supplemental Table 1). Findings were also similar for patients with a diagnosis of asthma only; however, changes in PedsQL scores were greater in magnitude (Appendix Table 2).

This study examined the relationship between social disadvantage and child physical functioning before and after hospitalization for acute respiratory illness. Study findings indicated that patients with higher numbers of social disadvantage markers reported lower PedsQL scores before hospitalization; however, differences in PedsQL scores were not apparent after hospitalization. Patients who experienced difficulty/delays accessing care also reported lower PedsQL scores at baseline. This difference was still significant but did not exceed the PedsQL MCID threshold after hospitalization. Difficulty/delays accessing care appeared to be an additional social disadvantage marker; however, it did not modify the relationship between social disadvantage and improvement in physical functioning.

The study findings at baseline are consistent with prior studies demonstrating a negative association between social disadvantage markers and HRQoL and a cumulative effect based on the number of social disadvantages.^3,4,7,8 This study adds to the existing literature by examining how this relationship changes after hospitalization. As evidenced by the lack of association between social disadvantage markers and follow-up PedsQL scores, our findings suggest that receipt of inpatient care improved perceptions of physical functioning to a greater extent for patients with more social disadvantage markers (especially patients with =/> 3 social disadvantage markers). There are several potential reasons for these findings.

Social disadvantage was associated with lower child physical functioning before hospitalization, but differences were not apparent after hospitalization for children with acute respiratory illness. Caregiver-perceived difficulty/delays accessing care was found to be an additional predictor of lower physical functioning at baseline but did not significantly alter the association between social disadvantage and improvement in physical functioning over time. Further studies are needed to understand how hospital care may differentially impact child physical functioning for patients with higher social disadvantage makers in order to sustain improvements in HRQoL disparities.

Acknowledgments

The authors thank the following individuals of the Pediatric Respiratory Illness Measurement System (PRIMES) study team for their contributions to this work: Karen M. Wilson, New York, New York; Ricardo A. Quinonez, Houston, Texas; Joyee G. Vachani, Houston, Texas; and Amy Tyler, Aurora, Colorado. We would also like to thank the Pediatric Research in Inpatient Settings Network for facilitating this work.

Examining disparities in health-related quality of life (HRQoL) outcomes in children provides a unique patient-centered perspective on pediatric health services equity.^1,2 Prior studies have demonstrated the relationship between minority race, low socioeconomic status, and lower maternal education with poorer HRQoL outcomes in children.^3-6 Some studies have also shown a dose-response relationship between social disadvantage markers and poorer child health status.^7,8 Furthermore, the associations between social disadvantage and poor access to care,^9-11 and between poor access to care and lower HRQoL, are also well established.^12-14

Examining HRQoL before and after hospitalization can further our understanding of how disparities in HRQoL may change once children engage with the medical system for an acute illness.¹⁵ Children requiring hospitalization constitute a useful population for examination of this question as they represent a group of children with variable social disadvantage markers and access to outpatient care.¹⁶ Although interventions to address social determinants of health for patients with social disadvantages have been associated with within-group improvements in HRQoL, none have assessed changes in disparities as an outcome.¹⁷ Furthermore, many of these studies were conducted in the outpatient setting,^18,19 whereas hospitalization provides an additional point of care to address the social determinants of health for vulnerable families.²⁰ Even for short hospitalizations, the 24/7 nature of hospital care provides the opportunity for frequent interactions with clinicians, nurses, and support staff to clarify illness-related questions, discuss other health concerns and unmet needs, and connect with social services or community resources. These opportunities may be particularly important for families with a higher number of social disadvantage markers and even more beneficial to those with difficulty accessing needed care from their primary medical home.

In this study, we focused on children with common respiratory illnesses (asthma, bronchiolitis, and pneumonia), which constitute the majority of childhood hospitalizations.²¹ Additionally, we only focused on the child’s physical functioning component of HRQoL because this component is most likely to improve after hospitalization for children with an acute respiratory illness.²² A prior study examining HRQoL before and after hospitalization demonstrated that most children return to and/or surpass their baseline physical functioning by 1 month after hospital discharge.²³

Our primary objective was to examine associations between several markers of social disadvantage, access to care, and child physical functioning before and after hospitalization for acute respiratory illness. Second, we aimed to understand if access to care (defined as perceived difficulty/delays getting care) acts as an independent predictor of improvement in physical functioning from baseline to follow-up and/or if it modifies the relationship between social disadvantage and improvement in physical functioning (Appendix Figure).

Study Design and Population

This study was nested within a multicenter, prospective cohort study of children who were hospitalized for asthma, bronchiolitis, or pneumonia between July 2014 and June 2016 at one of five children’s hospitals in the Pediatric Research in Inpatient Settings Network.²⁴

We approached families for study participation within 72 hours of admission to the hospital using a standard protocol. Patients and their caregivers were eligible to participate in the study if the patient was 2 weeks to 16 years old and if the primary caregiver’s preferred language for medical communication was either English or Spanish. Patients with chronic medical conditions (except asthma), with moderate to severe developmental delay, with a history of prematurity <32 weeks, or who received care in the intensive care unit were excluded. Patients could only participate in the study once.

The study team set out to enroll an even number of patients across all three conditions. If a patient’s discharge diagnosis differed from their admission diagnosis (eg, from bronchiolitis to pneumonia), discharge diagnosis was used for condition group assignment. If the discharge diagnosis was not one of these three respiratory conditions, we excluded the patient from further analysis.

Data Collection

We collected data using two surveys. The first survey was administered within 72 hours of admission. This survey asked questions related to (1) caregiver-reported markers of social disadvantage, (2) caregiver perceptions of access to care, and (3) caregiver- and patient-reported assessments of physical functioning. The second survey was administered within 2 to 8 weeks after the patient’s discharge and included a second assessment of physical functioning.

Social Disadvantage

Patients were considered to have a marker of social disadvantage if their caregiver reported (1) being of non-White race and/or Hispanic ethnicity, (2) primarily speaking a language other than English at home and not speaking English very well (ie, limited English proficiency), (3) attaining at most a high school or equivalent degree, or (4) having a =/<$30,000 annual household income.

Access to Care

We used the following survey item from the 2009-2010 National Survey of Children with Special Health Care Needs²⁵ to measure caregiver perceptions of access to care: “In the last six months, did you have any difficulties or delays getting care for your child because there were waiting lists, backlogs, or other problems getting an appointment?” We narrowed the original assessment time frame from 12 months to 6 months to provide a more proximal assessment of access in relation to the hospitalization.

Child Physical Functioning

We assessed child physical functioning using the physical functioning domain of the Pediatric Quality of Life Inventory (PedsQL) 4.0 Generic Core Scales and PedsQL Infant Scales, which have been validated for use in the inpatient setting.²² Caregivers completed one of these scales based on their child’s age. Assenting patients 8 to 16 years old completed the self-report PedsQL 4.0 Generic Core Scales instrument. When completing the first PedsQL survey, caregivers and patients reflected on the previous month before their child (or they) became ill to obtain a baseline physical functioning assessment.²³ When completing the second PedsQL survey, caregivers and patients reflected on the past 7 days to obtain a follow-up assessment.

All study procedures were approved by the Western Institutional Review Board (IRB) or the participating hospitals’ IRB.

Statistical Analysis

Patients with no missing data for all four social disadvantage markers were categorized based on the number of markers they reported: none, one, two, or three or more markers. We combined patients with three and four social disadvantage markers into one group to maximize power for the analyses. We dichotomized the access to care variable and coded response options as “no difficulty/delays accessing care” if the caregiver chose “Never” and “any difficulty/delays accessing care” if they chose “Sometimes/Usually/Always.”

For each patient–caregiver dyad, PedsQL items were scored using a standard method in which higher scores reflected better functioning.²² A single set of PedsQL scores was used for each patient–caregiver dyad. We used self-reported patient scores if the patient completed the PedsQL instrument; otherwise, we used proxy-reported caregiver scores. Intraclass correlations between child self-report and parent proxy-report demonstrate moderate to good agreement above age 8 years.²⁶ We computed a change in the physical functioning score by subtracting the baseline score from the follow-up score. The minimal clinically important difference (MCID) for the PedsQL instrument is 4.5 points, which we used to identify clinically meaningful differences.¹³

Analysis of variance models were constructed to test for differences in mean baseline and follow-up PedsQL scores (dependent variable) between the following independent variables: (1) social disadvantage groups and (2) those who reported having any difficulty/delays accessing care compared with those who did not. Only patient–caregiver dyads with both baseline and follow-up assessments were included in these analyses. Mixed-effects linear regression models were constructed to identify clinically meaningful differences in PedsQL scores between groups (MCID =/> 4.5) with adjustment for patient age, gender, respiratory condition, days between surveys, and hospital site as fixed effects. Site-specific random effects were included to account for within-hospital clustering. A similarly adjusted mixed-effects linear regression model was constructed to examine whether having any difficulty/delays accessing care modified the association between social disadvantage and PedsQL change scores (eg, an improvement from baseline to follow-up).

Because 17% of respondents had missing data for at least one social disadvantage marker, sensitivity analyses were conducted using multiple imputation to account for missing social disadvantage markers using chained equations.²⁷ Sensitivity analyses were also conducted to adjust for severity of illness using vital sign data within the first 24 hours, which could only be validly captured on patients with asthma within our dataset. By restricting this latter analysis to patients with asthma, we were able to examine the relationships of interest in a population with chronic disease.

The study sample included 1,860 patients, of which 1,325 had both baseline and follow-up PedsQL data (71%). Descriptive statistics were similar between those who completed the baseline and follow-up surveys (Table 1).

Twenty-two percent of patients had >/=3 social disadvantages and 30% of caregivers reported having any difficulty/delays accessing care. The mean follow-up PedsQL score was higher than the baseline score (90.4 vs 82.5; Table 1).

Social Disadvantage Markers and PedsQL Scores

The number of social disadvantage markers was inversely related to mean baseline PedsQL scores, but there was no difference in mean follow-up PedsQL scores between social disadvantage groups (Table 2). In adjusted analyses, the mean baseline PedsQL score was −6.1 points (95% CI: −8.7, −3.5) lower for patients with >/= 3 social disadvantage markers compared with patients with no social disadvantage markers, which exceeded the scale’s MCID.

Difficulty/Delays Accessing Care and PedsQL Scores

Having any difficulty/delays accessing care was significantly associated with lower baseline and follow-up PedsQL scores (Table 2). In adjusted analyses, the difference in baseline scores was 5.2 points (95% CI: −7.2, −3.2), which exceedes the scale’s MCID.

Interaction Between Social Disadvantage Markers, Difficulty/Delays Accessing Care, and Change in PedsQL Scores from Baseline to Follow-Up

While having =/>2 social disadvantage markers and difficulty/delays accessing care were each positively associated with changes in PedsQL scores from baseline to follow-up (Table 3), only patients with =/> 3 social disadvantage markers exceeded the PedsQL MCID. In stratified analyses, patients with a combination of social disadvantage makers and difficulties/delays accessing care had lower baseline PedsQL scores and greater change in PedsQL scores from baseline to follow-up compared with those without difficulties/delays accessing care (Figure). However, having any difficulty/delays accessing care did not significantly modify the relationship between social disadvantage and change in PedsQL scores, as none of the interaction terms were significant (Table 3, Model 3).

Sensitivity Analysis

Baseline, follow-up, and change in PedsQL scores were similar to our main analysis after performing multiple imputation for missing social disadvantage markers (Supplemental Table 1). Findings were also similar for patients with a diagnosis of asthma only; however, changes in PedsQL scores were greater in magnitude (Appendix Table 2).

This study examined the relationship between social disadvantage and child physical functioning before and after hospitalization for acute respiratory illness. Study findings indicated that patients with higher numbers of social disadvantage markers reported lower PedsQL scores before hospitalization; however, differences in PedsQL scores were not apparent after hospitalization. Patients who experienced difficulty/delays accessing care also reported lower PedsQL scores at baseline. This difference was still significant but did not exceed the PedsQL MCID threshold after hospitalization. Difficulty/delays accessing care appeared to be an additional social disadvantage marker; however, it did not modify the relationship between social disadvantage and improvement in physical functioning.

The study findings at baseline are consistent with prior studies demonstrating a negative association between social disadvantage markers and HRQoL and a cumulative effect based on the number of social disadvantages.^3,4,7,8 This study adds to the existing literature by examining how this relationship changes after hospitalization. As evidenced by the lack of association between social disadvantage markers and follow-up PedsQL scores, our findings suggest that receipt of inpatient care improved perceptions of physical functioning to a greater extent for patients with more social disadvantage markers (especially patients with =/> 3 social disadvantage markers). There are several potential reasons for these findings.

Social disadvantage was associated with lower child physical functioning before hospitalization, but differences were not apparent after hospitalization for children with acute respiratory illness. Caregiver-perceived difficulty/delays accessing care was found to be an additional predictor of lower physical functioning at baseline but did not significantly alter the association between social disadvantage and improvement in physical functioning over time. Further studies are needed to understand how hospital care may differentially impact child physical functioning for patients with higher social disadvantage makers in order to sustain improvements in HRQoL disparities.

Acknowledgments

The authors thank the following individuals of the Pediatric Respiratory Illness Measurement System (PRIMES) study team for their contributions to this work: Karen M. Wilson, New York, New York; Ricardo A. Quinonez, Houston, Texas; Joyee G. Vachani, Houston, Texas; and Amy Tyler, Aurora, Colorado. We would also like to thank the Pediatric Research in Inpatient Settings Network for facilitating this work.

Examining disparities in health-related quality of life (HRQoL) outcomes in children provides a unique patient-centered perspective on pediatric health services equity.^1,2 Prior studies have demonstrated the relationship between minority race, low socioeconomic status, and lower maternal education with poorer HRQoL outcomes in children.^3-6 Some studies have also shown a dose-response relationship between social disadvantage markers and poorer child health status.^7,8 Furthermore, the associations between social disadvantage and poor access to care,^9-11 and between poor access to care and lower HRQoL, are also well established.^12-14

Examining HRQoL before and after hospitalization can further our understanding of how disparities in HRQoL may change once children engage with the medical system for an acute illness.¹⁵ Children requiring hospitalization constitute a useful population for examination of this question as they represent a group of children with variable social disadvantage markers and access to outpatient care.¹⁶ Although interventions to address social determinants of health for patients with social disadvantages have been associated with within-group improvements in HRQoL, none have assessed changes in disparities as an outcome.¹⁷ Furthermore, many of these studies were conducted in the outpatient setting,^18,19 whereas hospitalization provides an additional point of care to address the social determinants of health for vulnerable families.²⁰ Even for short hospitalizations, the 24/7 nature of hospital care provides the opportunity for frequent interactions with clinicians, nurses, and support staff to clarify illness-related questions, discuss other health concerns and unmet needs, and connect with social services or community resources. These opportunities may be particularly important for families with a higher number of social disadvantage markers and even more beneficial to those with difficulty accessing needed care from their primary medical home.

In this study, we focused on children with common respiratory illnesses (asthma, bronchiolitis, and pneumonia), which constitute the majority of childhood hospitalizations.²¹ Additionally, we only focused on the child’s physical functioning component of HRQoL because this component is most likely to improve after hospitalization for children with an acute respiratory illness.²² A prior study examining HRQoL before and after hospitalization demonstrated that most children return to and/or surpass their baseline physical functioning by 1 month after hospital discharge.²³

Our primary objective was to examine associations between several markers of social disadvantage, access to care, and child physical functioning before and after hospitalization for acute respiratory illness. Second, we aimed to understand if access to care (defined as perceived difficulty/delays getting care) acts as an independent predictor of improvement in physical functioning from baseline to follow-up and/or if it modifies the relationship between social disadvantage and improvement in physical functioning (Appendix Figure).

Study Design and Population

This study was nested within a multicenter, prospective cohort study of children who were hospitalized for asthma, bronchiolitis, or pneumonia between July 2014 and June 2016 at one of five children’s hospitals in the Pediatric Research in Inpatient Settings Network.²⁴

We approached families for study participation within 72 hours of admission to the hospital using a standard protocol. Patients and their caregivers were eligible to participate in the study if the patient was 2 weeks to 16 years old and if the primary caregiver’s preferred language for medical communication was either English or Spanish. Patients with chronic medical conditions (except asthma), with moderate to severe developmental delay, with a history of prematurity <32 weeks, or who received care in the intensive care unit were excluded. Patients could only participate in the study once.

The study team set out to enroll an even number of patients across all three conditions. If a patient’s discharge diagnosis differed from their admission diagnosis (eg, from bronchiolitis to pneumonia), discharge diagnosis was used for condition group assignment. If the discharge diagnosis was not one of these three respiratory conditions, we excluded the patient from further analysis.

Data Collection

We collected data using two surveys. The first survey was administered within 72 hours of admission. This survey asked questions related to (1) caregiver-reported markers of social disadvantage, (2) caregiver perceptions of access to care, and (3) caregiver- and patient-reported assessments of physical functioning. The second survey was administered within 2 to 8 weeks after the patient’s discharge and included a second assessment of physical functioning.

Social Disadvantage

Patients were considered to have a marker of social disadvantage if their caregiver reported (1) being of non-White race and/or Hispanic ethnicity, (2) primarily speaking a language other than English at home and not speaking English very well (ie, limited English proficiency), (3) attaining at most a high school or equivalent degree, or (4) having a =/<$30,000 annual household income.

Access to Care

We used the following survey item from the 2009-2010 National Survey of Children with Special Health Care Needs²⁵ to measure caregiver perceptions of access to care: “In the last six months, did you have any difficulties or delays getting care for your child because there were waiting lists, backlogs, or other problems getting an appointment?” We narrowed the original assessment time frame from 12 months to 6 months to provide a more proximal assessment of access in relation to the hospitalization.

Child Physical Functioning

We assessed child physical functioning using the physical functioning domain of the Pediatric Quality of Life Inventory (PedsQL) 4.0 Generic Core Scales and PedsQL Infant Scales, which have been validated for use in the inpatient setting.²² Caregivers completed one of these scales based on their child’s age. Assenting patients 8 to 16 years old completed the self-report PedsQL 4.0 Generic Core Scales instrument. When completing the first PedsQL survey, caregivers and patients reflected on the previous month before their child (or they) became ill to obtain a baseline physical functioning assessment.²³ When completing the second PedsQL survey, caregivers and patients reflected on the past 7 days to obtain a follow-up assessment.

All study procedures were approved by the Western Institutional Review Board (IRB) or the participating hospitals’ IRB.

Statistical Analysis

Patients with no missing data for all four social disadvantage markers were categorized based on the number of markers they reported: none, one, two, or three or more markers. We combined patients with three and four social disadvantage markers into one group to maximize power for the analyses. We dichotomized the access to care variable and coded response options as “no difficulty/delays accessing care” if the caregiver chose “Never” and “any difficulty/delays accessing care” if they chose “Sometimes/Usually/Always.”

For each patient–caregiver dyad, PedsQL items were scored using a standard method in which higher scores reflected better functioning.²² A single set of PedsQL scores was used for each patient–caregiver dyad. We used self-reported patient scores if the patient completed the PedsQL instrument; otherwise, we used proxy-reported caregiver scores. Intraclass correlations between child self-report and parent proxy-report demonstrate moderate to good agreement above age 8 years.²⁶ We computed a change in the physical functioning score by subtracting the baseline score from the follow-up score. The minimal clinically important difference (MCID) for the PedsQL instrument is 4.5 points, which we used to identify clinically meaningful differences.¹³

Analysis of variance models were constructed to test for differences in mean baseline and follow-up PedsQL scores (dependent variable) between the following independent variables: (1) social disadvantage groups and (2) those who reported having any difficulty/delays accessing care compared with those who did not. Only patient–caregiver dyads with both baseline and follow-up assessments were included in these analyses. Mixed-effects linear regression models were constructed to identify clinically meaningful differences in PedsQL scores between groups (MCID =/> 4.5) with adjustment for patient age, gender, respiratory condition, days between surveys, and hospital site as fixed effects. Site-specific random effects were included to account for within-hospital clustering. A similarly adjusted mixed-effects linear regression model was constructed to examine whether having any difficulty/delays accessing care modified the association between social disadvantage and PedsQL change scores (eg, an improvement from baseline to follow-up).

Because 17% of respondents had missing data for at least one social disadvantage marker, sensitivity analyses were conducted using multiple imputation to account for missing social disadvantage markers using chained equations.²⁷ Sensitivity analyses were also conducted to adjust for severity of illness using vital sign data within the first 24 hours, which could only be validly captured on patients with asthma within our dataset. By restricting this latter analysis to patients with asthma, we were able to examine the relationships of interest in a population with chronic disease.

The study sample included 1,860 patients, of which 1,325 had both baseline and follow-up PedsQL data (71%). Descriptive statistics were similar between those who completed the baseline and follow-up surveys (Table 1).

Twenty-two percent of patients had >/=3 social disadvantages and 30% of caregivers reported having any difficulty/delays accessing care. The mean follow-up PedsQL score was higher than the baseline score (90.4 vs 82.5; Table 1).

Social Disadvantage Markers and PedsQL Scores

The number of social disadvantage markers was inversely related to mean baseline PedsQL scores, but there was no difference in mean follow-up PedsQL scores between social disadvantage groups (Table 2). In adjusted analyses, the mean baseline PedsQL score was −6.1 points (95% CI: −8.7, −3.5) lower for patients with >/= 3 social disadvantage markers compared with patients with no social disadvantage markers, which exceeded the scale’s MCID.

Difficulty/Delays Accessing Care and PedsQL Scores

Having any difficulty/delays accessing care was significantly associated with lower baseline and follow-up PedsQL scores (Table 2). In adjusted analyses, the difference in baseline scores was 5.2 points (95% CI: −7.2, −3.2), which exceedes the scale’s MCID.

Interaction Between Social Disadvantage Markers, Difficulty/Delays Accessing Care, and Change in PedsQL Scores from Baseline to Follow-Up

While having =/>2 social disadvantage markers and difficulty/delays accessing care were each positively associated with changes in PedsQL scores from baseline to follow-up (Table 3), only patients with =/> 3 social disadvantage markers exceeded the PedsQL MCID. In stratified analyses, patients with a combination of social disadvantage makers and difficulties/delays accessing care had lower baseline PedsQL scores and greater change in PedsQL scores from baseline to follow-up compared with those without difficulties/delays accessing care (Figure). However, having any difficulty/delays accessing care did not significantly modify the relationship between social disadvantage and change in PedsQL scores, as none of the interaction terms were significant (Table 3, Model 3).

Sensitivity Analysis

Baseline, follow-up, and change in PedsQL scores were similar to our main analysis after performing multiple imputation for missing social disadvantage markers (Supplemental Table 1). Findings were also similar for patients with a diagnosis of asthma only; however, changes in PedsQL scores were greater in magnitude (Appendix Table 2).

This study examined the relationship between social disadvantage and child physical functioning before and after hospitalization for acute respiratory illness. Study findings indicated that patients with higher numbers of social disadvantage markers reported lower PedsQL scores before hospitalization; however, differences in PedsQL scores were not apparent after hospitalization. Patients who experienced difficulty/delays accessing care also reported lower PedsQL scores at baseline. This difference was still significant but did not exceed the PedsQL MCID threshold after hospitalization. Difficulty/delays accessing care appeared to be an additional social disadvantage marker; however, it did not modify the relationship between social disadvantage and improvement in physical functioning.

The study findings at baseline are consistent with prior studies demonstrating a negative association between social disadvantage markers and HRQoL and a cumulative effect based on the number of social disadvantages.^3,4,7,8 This study adds to the existing literature by examining how this relationship changes after hospitalization. As evidenced by the lack of association between social disadvantage markers and follow-up PedsQL scores, our findings suggest that receipt of inpatient care improved perceptions of physical functioning to a greater extent for patients with more social disadvantage markers (especially patients with =/> 3 social disadvantage markers). There are several potential reasons for these findings.

Social disadvantage was associated with lower child physical functioning before hospitalization, but differences were not apparent after hospitalization for children with acute respiratory illness. Caregiver-perceived difficulty/delays accessing care was found to be an additional predictor of lower physical functioning at baseline but did not significantly alter the association between social disadvantage and improvement in physical functioning over time. Further studies are needed to understand how hospital care may differentially impact child physical functioning for patients with higher social disadvantage makers in order to sustain improvements in HRQoL disparities.

Acknowledgments

The authors thank the following individuals of the Pediatric Respiratory Illness Measurement System (PRIMES) study team for their contributions to this work: Karen M. Wilson, New York, New York; Ricardo A. Quinonez, Houston, Texas; Joyee G. Vachani, Houston, Texas; and Amy Tyler, Aurora, Colorado. We would also like to thank the Pediatric Research in Inpatient Settings Network for facilitating this work.

The patient-physician relationship is critical for ensuring the delivery of high-quality healthcare. Successful patient-physician relationships arise from shared trust, knowledge, mutual respect, and effective verbal and nonverbal communication. The ways in which patients experience healthcare and their satisfaction with physicians affect a myriad of important health outcomes, such as adherence to treatment and outcomes for conditions such as hypertension and diabetes mellitus.^1-5 One method for potentially enhancing patient satisfaction is through understanding how patients wish their physicians to dress^6-8 and tailoring attire to match these expectations. In addition to our systematic review,⁹ a recent large-scale, multicenter study in the United States revealed that most patients perceive physician attire as important, but that preferences for specific types of attire are contextual.^9,10 For example, elderly patients preferred physicians in formal attire and white coat, while scrubs with white coat or scrubs alone were preferred for emergency department (ED) physicians and surgeons, respectively. Moreover, regional variation regarding attire preference was also observed in the US, with preferences for more formal attire in the South and less formal in the Midwest.

Geographic variation, regarding patient preferences for physician dress, is perhaps even more relevant internationally. In particular, Japan is considered to have a highly contextualized culture that relies on nonverbal and implicit communication. However, medical professionals have no specific dress code and, thus, don many different kinds of attire. In part, this may be because it is not clear whether or how physician attire impacts patient satisfaction and perceived healthcare quality in Japan.^11-13 Although previous studies in Japan have suggested that physician attire has a considerable influence on patient satisfaction, these studies either involved a single department in one hospital or a small number of respondents.^14-17 Therefore, we performed a multicenter, cross-sectional study to understand patients’ preferences for physician attire in different clinical settings and in different geographic regions in Japan.

Study Population

We conducted a cross-sectional, questionnaire-based study from 2015 to 2017, in four geographically diverse hospitals in Japan. Two of these hospitals, Tokyo Joto Hospital and Juntendo University Hospital, are located in eastern Japan whereas the others, Kurashiki Central Hospital and Akashi Medical Center, are in western Japan.

Questionnaires were printed and randomly distributed by research staff to outpatients in waiting rooms and inpatients in medical wards who were 20 years of age or older. We placed no restriction on ward site or time of questionnaire distribution. Research staff, including physicians, nurses, and medical clerks, were instructed to avoid guiding or influencing participants’ responses. Informed consent was obtained by the staff; only those who provided informed consent participated in the study. Respondents could request assistance with form completion from persons accompanying them if they had difficulties, such as physical, visual, or hearing impairments. All responses were collected anonymously. The study was approved by the ethics committees of all four hospitals.

Questionnaire

We used a modified version of the survey instrument from a prior study.¹⁰ The first section of the survey showed photographs of either a male or female physician with 7 unique forms of attire, including casual, casual with white coat, scrubs, scrubs with white coat, formal, formal with white coat, and business suit (Figure 1). Given the Japanese context of this study, the language was translated to Japanese and photographs of physicians of Japanese descent were used. Photographs were taken with attention paid to achieving constant facial expressions on the physicians as well as in other visual cues (eg, lighting, background, pose). The physician’s gender and attire in the first photograph seen by each respondent were randomized to prevent bias in ordering, priming, and anchoring; all other sections of the survey were identical.

Respondents were first asked to rate the standalone, randomized physician photograph using a 1-10 scale across five domains (ie, how knowledgeable, trustworthy, caring, and approachable the physician appeared and how comfortable the physician’s appearance made the respondent feel), with a score of 10 representing the highest rating. Respondents were subsequently given 7 photographs of the same physician wearing various forms of attire. Questions were asked regarding preference of attire in varied clinical settings (ie, primary care, ED, hospital, surgery, overall preference). To identify the influence of and respondent preferences for physician dress and white coats, a Likert scale ranging from 1 (strongly disagree) to 5 (strongly agree) was employed. The scale was trichotomized into “disagree” (1, 2), “neither agree nor disagree” (3), and “agree” (4, 5) for analysis. Demographic data, including age, gender, education level, nationality (Japanese or non-Japanese), and number of physicians seen in the past year were collected.

Outcomes and Sample Size Calculation

The primary outcome of attire preference was calculated as the mean composite score of the five individual rating domains (ie, knowledgeable, trustworthy, caring, approachable, and comfortable), with the highest score representing the most preferred form of attire. We also assessed variation in preferences for physician attire by respondent characteristics, such as age and gender.

Sample size estimation was based on previous survey methodology.¹⁰ The Likert scale range for identifying influence of and respondent preferences for physician dress and white coats was 1-5 (“strongly disagree” to “strongly agree”). The scale range for measuring preferences for the randomized attire photograph was 1-10. An assumption of normality was made regarding responses on the 1-10 scale. An estimated standard deviation of 2.2 was assumed, based on prior findings.¹⁰ Based on these assumptions and the inclusion of at least 816 respondents (assuming a two-sided alpha error of 0.05), we expected to have 90% capacity to detect differences for effect sizes of 0.50 on the 1-10 scale.

Statistical Analyses

Paper-based survey data were entered independently and in duplicate by the study team. Respondents were not required to answer all questions; therefore, the denominator for each question varied. Data were reported as mean and standard deviation (SD) or percentages, where appropriate. Differences in the mean composite rating scores were assessed using one-way ANOVA with the Tukey method for pairwise comparisons. Differences in proportions for categorical data were compared using the Z-test. Chi-squared tests were used for bivariate comparisons between respondent age, gender, and level of education and corresponding respondent preferences. All analyses were performed using Stata 14 MP/SE (Stata Corp., College Station, Texas, USA).

Characteristics of Participants

Between December 1, 2015 and October 30, 2017, a total of 2,020 surveys were completed by patients across four academic hospitals in Japan. Of those, 1,960 patients (97.0%) completed the survey in its entirety. Approximately half of the respondents were 65 years of age or older (49%), of female gender (52%), and reported receiving care in the outpatient setting (53%). Regarding use of healthcare, 91% had seen more than one physician in the year preceding the time of survey completion (Table 1).

Ratings of Physician Attire

Compared with all forms of attire depicted in the survey’s first standalone photograph, respondents rated “casual attire with white coat” the highest (Figure 2). The mean composite score for “casual attire with white coat” was 7.1 (standard deviation [SD] = 1.8), and this attire was set as the referent group. Cronbach’s alpha, for the five items included in the composite score, was 0.95. However, “formal attire with white coat” was rated almost as highly as “casual attire with white coat” with an overall mean composite score of 7.0 (SD = 1.6).

Variation in Preference for Physician Attire by Clinical Setting

Preferences for physician attire varied by clinical care setting. Most respondents preferred “casual attire with white coat” or “formal attire with white coat” in both primary care and hospital settings, with a slight preference for “casual attire with white coat.” In contrast, respondents preferred “scrubs without white coat” in the ED and surgical settings. When asked about their overall preference, respondents reported they felt their physician should wear “formal attire with white coat” (35%) or “casual attire with white coat” (30%; Table 2). When comparing the group of photographs of physicians with white coats to the group without white coats (Figure 1), respondents preferred physicians wearing white coats overall and specifically when providing care in primary care and hospital settings. However, they preferred physicians without white coats when providing care in the ED (P < .001). With respect to surgeons, there was no statistically significant difference between preference for white coats and no white coats. These results were similar for photographs of both male and female physicians.

When asked whether physician dress was important to them and if physician attire influenced their satisfaction with the care received, 61% of participants agreed that physician dress was important, and 47% agreed that physician attire influenced satisfaction (Appendix Table 1). With respect to appropriateness of physicians dressing casually over the weekend in clinical settings, 52% responded that casual wear was inappropriate, while 31% had a neutral opinion.

Participants were asked whether physicians should wear a white coat in different clinical settings. Nearly two-thirds indicated a preference for white coats in the office and hospital (65% and 64%, respectively). Responses regarding whether emergency physicians should wear white coats were nearly equally divided (Agree, 37%; Disagree, 32%; Neither Agree nor Disagree, 31%). However, “scrubs without white coat” was most preferred (56%) when patients were given photographs of various attire and asked, “Which physician would you prefer to see when visiting the ER?” Responses to the question “Physicians should always wear a white coat when seeing patients in any setting” varied equally (Agree, 32%; Disagree, 34%; Neither Agree nor Disagree, 34%).

Variation in Preference for Physician Attire by Respondent Demographics

When comparing respondents by age, those 65 years or older preferred “formal attire with white coat” more so than respondents younger than 65 years (Appendix Table 2). This finding was identified in both primary care (36% vs 31%, P < .001) and hospital settings (37% vs 30%, P < .001). Additionally, physician attire had a greater impact on older respondents’ satisfaction and experience (Appendix Table 3). For example, 67% of respondents 65 years and older agreed that physician attire was important, and 54% agreed that attire influenced satisfaction. Conversely, for respondents younger than 65 years, the proportion agreeing with these statements was lower (56% and 41%, both P < .001). When comparing older and younger respondents, those 65 years and older more often preferred physicians wearing white coats in any setting (39% vs 26%, P < .001) and specifically in their office (68% vs 61%, P = .002), the ED (40% vs 34%, P < .001), and the hospital (69% vs 60%, P < .001).

When comparing male and female respondents, male respondents more often stated that physician dress was important to them (men, 64%; women, 58%; P = .002). When comparing responses to the question “Overall, which clothes do you feel a doctor should wear?”, between the eastern and western Japanese hospitals, preferences for physician attire varied.

Variation in Expectations Between Male and Female Physicians

When comparing the ratings of male and female physicians, female physicians were rated higher in how caring (P = .005) and approachable (P < .001) they appeared. However, there were no significant differences in the ratings of the three remaining domains (ie, knowledgeable, trustworthy, and comfortable) or the composite score.

This report is the first multicenter Japanese study to examine patients’ preferences for physician attire. Most Japanese respondents perceived that physician dress is important, and nearly half agreed that physician dress influences their satisfaction with care. Overall, “casual attire with white coat” and “formal attire with white coat” tended to be the preferred option for respondents; however, this varied widely across context of care delivery. “Scrubs without white coat” was the preferred attire for physicians in the ED and surgery department. Elderly patients preferred physicians in formal attire regardless of where care was being received. Collectively, these findings have important implications for how delivery of care in Japan is approached.

Since we employed the same methodology as previous studies conducted in the US¹⁰ and Switzerland,¹⁸ a notable strength of our approach is that comparisons among these countries can be drawn. For example, physician attire appears to hold greater importance in Japan than in the US and Switzerland. Among Japanese participants, 61% agreed that physician dress is important (US, 53%; Switzerland, 36%), and 47% agreed that physician dress influenced how satisfied they were with their care (US, 36%; Switzerland, 23%).¹⁰ This result supports the notion that nonverbal and implicit communications (such as physician dress) may carry more importance among Japanese people.^11-13

Regarding preference ratings for type of dress among respondents in Japan, “casual attire with white coat” received the highest mean composite score rating, with “formal attire with white coat” rated second overall. In contrast, US respondents rated “formal attire with white coat” highest and “scrubs with white coat” second.¹⁰ Our result runs counter to our expectation in that we expected Japanese respondents to prefer formal attire, since Japan is one of the most formal cultures in the world. One potential explanation for this difference is that the casual style chosen for this study was close to the smart casual style (slightly casual). Most hospitals and clinics in Japan do not allow physicians to wear jeans or polo shirts, which were chosen as the casual attire in the previous US study.

When examining various care settings and physician types, both Japanese and US respondents were more likely to prefer physicians wearing a white coat in the office or hospital.¹⁰ However, Japanese participants preferred both “casual attire with white coat” and “formal attire with white coat” equally in primary care or hospital settings. A smaller proportion of US respondents preferred “casual attire with white coat” in primary care (11%) and hospital settings (9%), but more preferred “formal attire with white coat” for primary care (44%) and hospital physicians (39%). In the ED setting, 32% of participants in Japan and 18% in the US disagreed with the idea that physicians should wear a white coat. Among Japanese participants, “scrubs without white coat” was rated highest for emergency physicians (56%) and surgeons (47%), while US preferences were 40% and 42%, respectively.¹⁰ One potential explanation is that scrubs-based attire became popular among Japanese ED and surgical contexts as a result of cultural influence and spread from western countries.^{19, 20}

With respect to perceptions regarding physician attire on weekends, 52% of participants considered it inappropriate for a physician to dress casually over the weekend, compared with only 30% in Switzerland and 21% in the US.^11,12 Given Japan’s level of formality and the fact that most Japanese physicians continue to work over the weekend,^21-23 Japanese patients tend to expect their physicians to dress in more formal attire during these times.

Previous studies in Japan have demonstrated that older patients gave low ratings to scrubs and high ratings to white coat with any attire,^15,17 and this was also the case in our study. Perhaps elderly patients reflect conservative values in their preferences of physician dress. Their perceptions may be less influenced by scenes portraying physicians in popular media when compared with the perceptions of younger patients. Though a 2015 systematic review and studies in other countries revealed white coats were preferred regardless of exact dress,^9,24-26 they also showed variation in preferences for physician attire. For example, patients in Saudi Arabia preferred white coat and traditional ethnic dress,²⁵ whereas mothers of pediatric patients in Saudi Arabia preferred scrubs for their pediatricians.²⁷ Therefore, it is recommended for internationally mobile physicians to choose their dress depending on a variety of factors including country, context, and patient age group.

Our study has limitations. First, because some physicians presented the surveys to the patients, participants may have responded differently. Second, participants may have identified photographs of the male physician model as their personal healthcare provider (one author, K.K.). To avoid this possible bias, we randomly distributed 14 different versions of physician photographs in the questionnaire. Third, although physician photographs were strictly controlled, the “formal attire and white coat” and “casual attire and white coat” photographs appeared similar, especially given that the white coats were buttoned. Also, the female physician depicted in the photographs did not have the scrub shirt tucked in, while the male physician did. These nuances may have affected participant ratings between groups. Fourth, we did not blind researchers or data collectors in the process of data collection and entry. Fifth, we asked participants to indicate their age using categories. The age group “35-54 years” covered a wide range of patients, and we may have obtained more granular detail if we had chosen different age groups. Sixth, our cohort included a higher proportion of older people who needed medical treatment for their comorbidities and who had not received high levels of education. This resulted in a seemingly high proportion of lower education levels in our cohort. Lastly, patient experience and satisfaction can be comprised not only by physician attire, but also physician behavior and attitude, which this survey could not elicit. Thus, additional studies are needed to identify and quantify all determinants of patient experience with their physicians.

In conclusion, patient preferences for physician attire were examined using a multicenter survey with a large sample size and robust survey methodology, thus overcoming weaknesses of previous studies into Japanese attire. Japanese patients perceive that physician attire is important and influences satisfaction with their care, more so than patients in other countries, like the US and Switzerland. Geography, settings of care, and patient age play a role in preferences. As a result, hospitals and health systems may use these findings to inform dress code policy based on patient population and context, recognizing that the appearance of their providers affects the patient-physician relationship. Future research should focus on better understanding the various cultural and societal customs that lead to patient expectations of physician attire.

Acknowledgments

The authors thank Drs. Fumi Takemoto, Masayuki Ueno, Kazuya Sakai, Saori Kinami, and Toshio Naito for their assistance with data collection at their respective sites. Additionally, the authors thank Dr. Yoko Kanamitsu for serving as a model for photographs.

The patient-physician relationship is critical for ensuring the delivery of high-quality healthcare. Successful patient-physician relationships arise from shared trust, knowledge, mutual respect, and effective verbal and nonverbal communication. The ways in which patients experience healthcare and their satisfaction with physicians affect a myriad of important health outcomes, such as adherence to treatment and outcomes for conditions such as hypertension and diabetes mellitus.^1-5 One method for potentially enhancing patient satisfaction is through understanding how patients wish their physicians to dress^6-8 and tailoring attire to match these expectations. In addition to our systematic review,⁹ a recent large-scale, multicenter study in the United States revealed that most patients perceive physician attire as important, but that preferences for specific types of attire are contextual.^9,10 For example, elderly patients preferred physicians in formal attire and white coat, while scrubs with white coat or scrubs alone were preferred for emergency department (ED) physicians and surgeons, respectively. Moreover, regional variation regarding attire preference was also observed in the US, with preferences for more formal attire in the South and less formal in the Midwest.

Geographic variation, regarding patient preferences for physician dress, is perhaps even more relevant internationally. In particular, Japan is considered to have a highly contextualized culture that relies on nonverbal and implicit communication. However, medical professionals have no specific dress code and, thus, don many different kinds of attire. In part, this may be because it is not clear whether or how physician attire impacts patient satisfaction and perceived healthcare quality in Japan.^11-13 Although previous studies in Japan have suggested that physician attire has a considerable influence on patient satisfaction, these studies either involved a single department in one hospital or a small number of respondents.^14-17 Therefore, we performed a multicenter, cross-sectional study to understand patients’ preferences for physician attire in different clinical settings and in different geographic regions in Japan.

Study Population

We conducted a cross-sectional, questionnaire-based study from 2015 to 2017, in four geographically diverse hospitals in Japan. Two of these hospitals, Tokyo Joto Hospital and Juntendo University Hospital, are located in eastern Japan whereas the others, Kurashiki Central Hospital and Akashi Medical Center, are in western Japan.

Questionnaires were printed and randomly distributed by research staff to outpatients in waiting rooms and inpatients in medical wards who were 20 years of age or older. We placed no restriction on ward site or time of questionnaire distribution. Research staff, including physicians, nurses, and medical clerks, were instructed to avoid guiding or influencing participants’ responses. Informed consent was obtained by the staff; only those who provided informed consent participated in the study. Respondents could request assistance with form completion from persons accompanying them if they had difficulties, such as physical, visual, or hearing impairments. All responses were collected anonymously. The study was approved by the ethics committees of all four hospitals.

Questionnaire

We used a modified version of the survey instrument from a prior study.¹⁰ The first section of the survey showed photographs of either a male or female physician with 7 unique forms of attire, including casual, casual with white coat, scrubs, scrubs with white coat, formal, formal with white coat, and business suit (Figure 1). Given the Japanese context of this study, the language was translated to Japanese and photographs of physicians of Japanese descent were used. Photographs were taken with attention paid to achieving constant facial expressions on the physicians as well as in other visual cues (eg, lighting, background, pose). The physician’s gender and attire in the first photograph seen by each respondent were randomized to prevent bias in ordering, priming, and anchoring; all other sections of the survey were identical.

Respondents were first asked to rate the standalone, randomized physician photograph using a 1-10 scale across five domains (ie, how knowledgeable, trustworthy, caring, and approachable the physician appeared and how comfortable the physician’s appearance made the respondent feel), with a score of 10 representing the highest rating. Respondents were subsequently given 7 photographs of the same physician wearing various forms of attire. Questions were asked regarding preference of attire in varied clinical settings (ie, primary care, ED, hospital, surgery, overall preference). To identify the influence of and respondent preferences for physician dress and white coats, a Likert scale ranging from 1 (strongly disagree) to 5 (strongly agree) was employed. The scale was trichotomized into “disagree” (1, 2), “neither agree nor disagree” (3), and “agree” (4, 5) for analysis. Demographic data, including age, gender, education level, nationality (Japanese or non-Japanese), and number of physicians seen in the past year were collected.

Outcomes and Sample Size Calculation

The primary outcome of attire preference was calculated as the mean composite score of the five individual rating domains (ie, knowledgeable, trustworthy, caring, approachable, and comfortable), with the highest score representing the most preferred form of attire. We also assessed variation in preferences for physician attire by respondent characteristics, such as age and gender.

Sample size estimation was based on previous survey methodology.¹⁰ The Likert scale range for identifying influence of and respondent preferences for physician dress and white coats was 1-5 (“strongly disagree” to “strongly agree”). The scale range for measuring preferences for the randomized attire photograph was 1-10. An assumption of normality was made regarding responses on the 1-10 scale. An estimated standard deviation of 2.2 was assumed, based on prior findings.¹⁰ Based on these assumptions and the inclusion of at least 816 respondents (assuming a two-sided alpha error of 0.05), we expected to have 90% capacity to detect differences for effect sizes of 0.50 on the 1-10 scale.

Statistical Analyses

Paper-based survey data were entered independently and in duplicate by the study team. Respondents were not required to answer all questions; therefore, the denominator for each question varied. Data were reported as mean and standard deviation (SD) or percentages, where appropriate. Differences in the mean composite rating scores were assessed using one-way ANOVA with the Tukey method for pairwise comparisons. Differences in proportions for categorical data were compared using the Z-test. Chi-squared tests were used for bivariate comparisons between respondent age, gender, and level of education and corresponding respondent preferences. All analyses were performed using Stata 14 MP/SE (Stata Corp., College Station, Texas, USA).

Characteristics of Participants

Between December 1, 2015 and October 30, 2017, a total of 2,020 surveys were completed by patients across four academic hospitals in Japan. Of those, 1,960 patients (97.0%) completed the survey in its entirety. Approximately half of the respondents were 65 years of age or older (49%), of female gender (52%), and reported receiving care in the outpatient setting (53%). Regarding use of healthcare, 91% had seen more than one physician in the year preceding the time of survey completion (Table 1).

Ratings of Physician Attire

Compared with all forms of attire depicted in the survey’s first standalone photograph, respondents rated “casual attire with white coat” the highest (Figure 2). The mean composite score for “casual attire with white coat” was 7.1 (standard deviation [SD] = 1.8), and this attire was set as the referent group. Cronbach’s alpha, for the five items included in the composite score, was 0.95. However, “formal attire with white coat” was rated almost as highly as “casual attire with white coat” with an overall mean composite score of 7.0 (SD = 1.6).

Variation in Preference for Physician Attire by Clinical Setting

Preferences for physician attire varied by clinical care setting. Most respondents preferred “casual attire with white coat” or “formal attire with white coat” in both primary care and hospital settings, with a slight preference for “casual attire with white coat.” In contrast, respondents preferred “scrubs without white coat” in the ED and surgical settings. When asked about their overall preference, respondents reported they felt their physician should wear “formal attire with white coat” (35%) or “casual attire with white coat” (30%; Table 2). When comparing the group of photographs of physicians with white coats to the group without white coats (Figure 1), respondents preferred physicians wearing white coats overall and specifically when providing care in primary care and hospital settings. However, they preferred physicians without white coats when providing care in the ED (P < .001). With respect to surgeons, there was no statistically significant difference between preference for white coats and no white coats. These results were similar for photographs of both male and female physicians.

When asked whether physician dress was important to them and if physician attire influenced their satisfaction with the care received, 61% of participants agreed that physician dress was important, and 47% agreed that physician attire influenced satisfaction (Appendix Table 1). With respect to appropriateness of physicians dressing casually over the weekend in clinical settings, 52% responded that casual wear was inappropriate, while 31% had a neutral opinion.

Participants were asked whether physicians should wear a white coat in different clinical settings. Nearly two-thirds indicated a preference for white coats in the office and hospital (65% and 64%, respectively). Responses regarding whether emergency physicians should wear white coats were nearly equally divided (Agree, 37%; Disagree, 32%; Neither Agree nor Disagree, 31%). However, “scrubs without white coat” was most preferred (56%) when patients were given photographs of various attire and asked, “Which physician would you prefer to see when visiting the ER?” Responses to the question “Physicians should always wear a white coat when seeing patients in any setting” varied equally (Agree, 32%; Disagree, 34%; Neither Agree nor Disagree, 34%).

Variation in Preference for Physician Attire by Respondent Demographics

When comparing respondents by age, those 65 years or older preferred “formal attire with white coat” more so than respondents younger than 65 years (Appendix Table 2). This finding was identified in both primary care (36% vs 31%, P < .001) and hospital settings (37% vs 30%, P < .001). Additionally, physician attire had a greater impact on older respondents’ satisfaction and experience (Appendix Table 3). For example, 67% of respondents 65 years and older agreed that physician attire was important, and 54% agreed that attire influenced satisfaction. Conversely, for respondents younger than 65 years, the proportion agreeing with these statements was lower (56% and 41%, both P < .001). When comparing older and younger respondents, those 65 years and older more often preferred physicians wearing white coats in any setting (39% vs 26%, P < .001) and specifically in their office (68% vs 61%, P = .002), the ED (40% vs 34%, P < .001), and the hospital (69% vs 60%, P < .001).

When comparing male and female respondents, male respondents more often stated that physician dress was important to them (men, 64%; women, 58%; P = .002). When comparing responses to the question “Overall, which clothes do you feel a doctor should wear?”, between the eastern and western Japanese hospitals, preferences for physician attire varied.

Variation in Expectations Between Male and Female Physicians

When comparing the ratings of male and female physicians, female physicians were rated higher in how caring (P = .005) and approachable (P < .001) they appeared. However, there were no significant differences in the ratings of the three remaining domains (ie, knowledgeable, trustworthy, and comfortable) or the composite score.

This report is the first multicenter Japanese study to examine patients’ preferences for physician attire. Most Japanese respondents perceived that physician dress is important, and nearly half agreed that physician dress influences their satisfaction with care. Overall, “casual attire with white coat” and “formal attire with white coat” tended to be the preferred option for respondents; however, this varied widely across context of care delivery. “Scrubs without white coat” was the preferred attire for physicians in the ED and surgery department. Elderly patients preferred physicians in formal attire regardless of where care was being received. Collectively, these findings have important implications for how delivery of care in Japan is approached.

Since we employed the same methodology as previous studies conducted in the US¹⁰ and Switzerland,¹⁸ a notable strength of our approach is that comparisons among these countries can be drawn. For example, physician attire appears to hold greater importance in Japan than in the US and Switzerland. Among Japanese participants, 61% agreed that physician dress is important (US, 53%; Switzerland, 36%), and 47% agreed that physician dress influenced how satisfied they were with their care (US, 36%; Switzerland, 23%).¹⁰ This result supports the notion that nonverbal and implicit communications (such as physician dress) may carry more importance among Japanese people.^11-13

Regarding preference ratings for type of dress among respondents in Japan, “casual attire with white coat” received the highest mean composite score rating, with “formal attire with white coat” rated second overall. In contrast, US respondents rated “formal attire with white coat” highest and “scrubs with white coat” second.¹⁰ Our result runs counter to our expectation in that we expected Japanese respondents to prefer formal attire, since Japan is one of the most formal cultures in the world. One potential explanation for this difference is that the casual style chosen for this study was close to the smart casual style (slightly casual). Most hospitals and clinics in Japan do not allow physicians to wear jeans or polo shirts, which were chosen as the casual attire in the previous US study.

When examining various care settings and physician types, both Japanese and US respondents were more likely to prefer physicians wearing a white coat in the office or hospital.¹⁰ However, Japanese participants preferred both “casual attire with white coat” and “formal attire with white coat” equally in primary care or hospital settings. A smaller proportion of US respondents preferred “casual attire with white coat” in primary care (11%) and hospital settings (9%), but more preferred “formal attire with white coat” for primary care (44%) and hospital physicians (39%). In the ED setting, 32% of participants in Japan and 18% in the US disagreed with the idea that physicians should wear a white coat. Among Japanese participants, “scrubs without white coat” was rated highest for emergency physicians (56%) and surgeons (47%), while US preferences were 40% and 42%, respectively.¹⁰ One potential explanation is that scrubs-based attire became popular among Japanese ED and surgical contexts as a result of cultural influence and spread from western countries.^{19, 20}

With respect to perceptions regarding physician attire on weekends, 52% of participants considered it inappropriate for a physician to dress casually over the weekend, compared with only 30% in Switzerland and 21% in the US.^11,12 Given Japan’s level of formality and the fact that most Japanese physicians continue to work over the weekend,^21-23 Japanese patients tend to expect their physicians to dress in more formal attire during these times.

Previous studies in Japan have demonstrated that older patients gave low ratings to scrubs and high ratings to white coat with any attire,^15,17 and this was also the case in our study. Perhaps elderly patients reflect conservative values in their preferences of physician dress. Their perceptions may be less influenced by scenes portraying physicians in popular media when compared with the perceptions of younger patients. Though a 2015 systematic review and studies in other countries revealed white coats were preferred regardless of exact dress,^9,24-26 they also showed variation in preferences for physician attire. For example, patients in Saudi Arabia preferred white coat and traditional ethnic dress,²⁵ whereas mothers of pediatric patients in Saudi Arabia preferred scrubs for their pediatricians.²⁷ Therefore, it is recommended for internationally mobile physicians to choose their dress depending on a variety of factors including country, context, and patient age group.

Our study has limitations. First, because some physicians presented the surveys to the patients, participants may have responded differently. Second, participants may have identified photographs of the male physician model as their personal healthcare provider (one author, K.K.). To avoid this possible bias, we randomly distributed 14 different versions of physician photographs in the questionnaire. Third, although physician photographs were strictly controlled, the “formal attire and white coat” and “casual attire and white coat” photographs appeared similar, especially given that the white coats were buttoned. Also, the female physician depicted in the photographs did not have the scrub shirt tucked in, while the male physician did. These nuances may have affected participant ratings between groups. Fourth, we did not blind researchers or data collectors in the process of data collection and entry. Fifth, we asked participants to indicate their age using categories. The age group “35-54 years” covered a wide range of patients, and we may have obtained more granular detail if we had chosen different age groups. Sixth, our cohort included a higher proportion of older people who needed medical treatment for their comorbidities and who had not received high levels of education. This resulted in a seemingly high proportion of lower education levels in our cohort. Lastly, patient experience and satisfaction can be comprised not only by physician attire, but also physician behavior and attitude, which this survey could not elicit. Thus, additional studies are needed to identify and quantify all determinants of patient experience with their physicians.

In conclusion, patient preferences for physician attire were examined using a multicenter survey with a large sample size and robust survey methodology, thus overcoming weaknesses of previous studies into Japanese attire. Japanese patients perceive that physician attire is important and influences satisfaction with their care, more so than patients in other countries, like the US and Switzerland. Geography, settings of care, and patient age play a role in preferences. As a result, hospitals and health systems may use these findings to inform dress code policy based on patient population and context, recognizing that the appearance of their providers affects the patient-physician relationship. Future research should focus on better understanding the various cultural and societal customs that lead to patient expectations of physician attire.

Acknowledgments

The authors thank Drs. Fumi Takemoto, Masayuki Ueno, Kazuya Sakai, Saori Kinami, and Toshio Naito for their assistance with data collection at their respective sites. Additionally, the authors thank Dr. Yoko Kanamitsu for serving as a model for photographs.

The patient-physician relationship is critical for ensuring the delivery of high-quality healthcare. Successful patient-physician relationships arise from shared trust, knowledge, mutual respect, and effective verbal and nonverbal communication. The ways in which patients experience healthcare and their satisfaction with physicians affect a myriad of important health outcomes, such as adherence to treatment and outcomes for conditions such as hypertension and diabetes mellitus.^1-5 One method for potentially enhancing patient satisfaction is through understanding how patients wish their physicians to dress^6-8 and tailoring attire to match these expectations. In addition to our systematic review,⁹ a recent large-scale, multicenter study in the United States revealed that most patients perceive physician attire as important, but that preferences for specific types of attire are contextual.^9,10 For example, elderly patients preferred physicians in formal attire and white coat, while scrubs with white coat or scrubs alone were preferred for emergency department (ED) physicians and surgeons, respectively. Moreover, regional variation regarding attire preference was also observed in the US, with preferences for more formal attire in the South and less formal in the Midwest.

Geographic variation, regarding patient preferences for physician dress, is perhaps even more relevant internationally. In particular, Japan is considered to have a highly contextualized culture that relies on nonverbal and implicit communication. However, medical professionals have no specific dress code and, thus, don many different kinds of attire. In part, this may be because it is not clear whether or how physician attire impacts patient satisfaction and perceived healthcare quality in Japan.^11-13 Although previous studies in Japan have suggested that physician attire has a considerable influence on patient satisfaction, these studies either involved a single department in one hospital or a small number of respondents.^14-17 Therefore, we performed a multicenter, cross-sectional study to understand patients’ preferences for physician attire in different clinical settings and in different geographic regions in Japan.

Study Population

We conducted a cross-sectional, questionnaire-based study from 2015 to 2017, in four geographically diverse hospitals in Japan. Two of these hospitals, Tokyo Joto Hospital and Juntendo University Hospital, are located in eastern Japan whereas the others, Kurashiki Central Hospital and Akashi Medical Center, are in western Japan.

Questionnaires were printed and randomly distributed by research staff to outpatients in waiting rooms and inpatients in medical wards who were 20 years of age or older. We placed no restriction on ward site or time of questionnaire distribution. Research staff, including physicians, nurses, and medical clerks, were instructed to avoid guiding or influencing participants’ responses. Informed consent was obtained by the staff; only those who provided informed consent participated in the study. Respondents could request assistance with form completion from persons accompanying them if they had difficulties, such as physical, visual, or hearing impairments. All responses were collected anonymously. The study was approved by the ethics committees of all four hospitals.

Questionnaire

We used a modified version of the survey instrument from a prior study.¹⁰ The first section of the survey showed photographs of either a male or female physician with 7 unique forms of attire, including casual, casual with white coat, scrubs, scrubs with white coat, formal, formal with white coat, and business suit (Figure 1). Given the Japanese context of this study, the language was translated to Japanese and photographs of physicians of Japanese descent were used. Photographs were taken with attention paid to achieving constant facial expressions on the physicians as well as in other visual cues (eg, lighting, background, pose). The physician’s gender and attire in the first photograph seen by each respondent were randomized to prevent bias in ordering, priming, and anchoring; all other sections of the survey were identical.

Respondents were first asked to rate the standalone, randomized physician photograph using a 1-10 scale across five domains (ie, how knowledgeable, trustworthy, caring, and approachable the physician appeared and how comfortable the physician’s appearance made the respondent feel), with a score of 10 representing the highest rating. Respondents were subsequently given 7 photographs of the same physician wearing various forms of attire. Questions were asked regarding preference of attire in varied clinical settings (ie, primary care, ED, hospital, surgery, overall preference). To identify the influence of and respondent preferences for physician dress and white coats, a Likert scale ranging from 1 (strongly disagree) to 5 (strongly agree) was employed. The scale was trichotomized into “disagree” (1, 2), “neither agree nor disagree” (3), and “agree” (4, 5) for analysis. Demographic data, including age, gender, education level, nationality (Japanese or non-Japanese), and number of physicians seen in the past year were collected.

Outcomes and Sample Size Calculation

The primary outcome of attire preference was calculated as the mean composite score of the five individual rating domains (ie, knowledgeable, trustworthy, caring, approachable, and comfortable), with the highest score representing the most preferred form of attire. We also assessed variation in preferences for physician attire by respondent characteristics, such as age and gender.

Sample size estimation was based on previous survey methodology.¹⁰ The Likert scale range for identifying influence of and respondent preferences for physician dress and white coats was 1-5 (“strongly disagree” to “strongly agree”). The scale range for measuring preferences for the randomized attire photograph was 1-10. An assumption of normality was made regarding responses on the 1-10 scale. An estimated standard deviation of 2.2 was assumed, based on prior findings.¹⁰ Based on these assumptions and the inclusion of at least 816 respondents (assuming a two-sided alpha error of 0.05), we expected to have 90% capacity to detect differences for effect sizes of 0.50 on the 1-10 scale.

Statistical Analyses

Paper-based survey data were entered independently and in duplicate by the study team. Respondents were not required to answer all questions; therefore, the denominator for each question varied. Data were reported as mean and standard deviation (SD) or percentages, where appropriate. Differences in the mean composite rating scores were assessed using one-way ANOVA with the Tukey method for pairwise comparisons. Differences in proportions for categorical data were compared using the Z-test. Chi-squared tests were used for bivariate comparisons between respondent age, gender, and level of education and corresponding respondent preferences. All analyses were performed using Stata 14 MP/SE (Stata Corp., College Station, Texas, USA).

Characteristics of Participants

Between December 1, 2015 and October 30, 2017, a total of 2,020 surveys were completed by patients across four academic hospitals in Japan. Of those, 1,960 patients (97.0%) completed the survey in its entirety. Approximately half of the respondents were 65 years of age or older (49%), of female gender (52%), and reported receiving care in the outpatient setting (53%). Regarding use of healthcare, 91% had seen more than one physician in the year preceding the time of survey completion (Table 1).

Ratings of Physician Attire

Compared with all forms of attire depicted in the survey’s first standalone photograph, respondents rated “casual attire with white coat” the highest (Figure 2). The mean composite score for “casual attire with white coat” was 7.1 (standard deviation [SD] = 1.8), and this attire was set as the referent group. Cronbach’s alpha, for the five items included in the composite score, was 0.95. However, “formal attire with white coat” was rated almost as highly as “casual attire with white coat” with an overall mean composite score of 7.0 (SD = 1.6).

Variation in Preference for Physician Attire by Clinical Setting

Preferences for physician attire varied by clinical care setting. Most respondents preferred “casual attire with white coat” or “formal attire with white coat” in both primary care and hospital settings, with a slight preference for “casual attire with white coat.” In contrast, respondents preferred “scrubs without white coat” in the ED and surgical settings. When asked about their overall preference, respondents reported they felt their physician should wear “formal attire with white coat” (35%) or “casual attire with white coat” (30%; Table 2). When comparing the group of photographs of physicians with white coats to the group without white coats (Figure 1), respondents preferred physicians wearing white coats overall and specifically when providing care in primary care and hospital settings. However, they preferred physicians without white coats when providing care in the ED (P < .001). With respect to surgeons, there was no statistically significant difference between preference for white coats and no white coats. These results were similar for photographs of both male and female physicians.

When asked whether physician dress was important to them and if physician attire influenced their satisfaction with the care received, 61% of participants agreed that physician dress was important, and 47% agreed that physician attire influenced satisfaction (Appendix Table 1). With respect to appropriateness of physicians dressing casually over the weekend in clinical settings, 52% responded that casual wear was inappropriate, while 31% had a neutral opinion.

Participants were asked whether physicians should wear a white coat in different clinical settings. Nearly two-thirds indicated a preference for white coats in the office and hospital (65% and 64%, respectively). Responses regarding whether emergency physicians should wear white coats were nearly equally divided (Agree, 37%; Disagree, 32%; Neither Agree nor Disagree, 31%). However, “scrubs without white coat” was most preferred (56%) when patients were given photographs of various attire and asked, “Which physician would you prefer to see when visiting the ER?” Responses to the question “Physicians should always wear a white coat when seeing patients in any setting” varied equally (Agree, 32%; Disagree, 34%; Neither Agree nor Disagree, 34%).

Variation in Preference for Physician Attire by Respondent Demographics

When comparing respondents by age, those 65 years or older preferred “formal attire with white coat” more so than respondents younger than 65 years (Appendix Table 2). This finding was identified in both primary care (36% vs 31%, P < .001) and hospital settings (37% vs 30%, P < .001). Additionally, physician attire had a greater impact on older respondents’ satisfaction and experience (Appendix Table 3). For example, 67% of respondents 65 years and older agreed that physician attire was important, and 54% agreed that attire influenced satisfaction. Conversely, for respondents younger than 65 years, the proportion agreeing with these statements was lower (56% and 41%, both P < .001). When comparing older and younger respondents, those 65 years and older more often preferred physicians wearing white coats in any setting (39% vs 26%, P < .001) and specifically in their office (68% vs 61%, P = .002), the ED (40% vs 34%, P < .001), and the hospital (69% vs 60%, P < .001).

When comparing male and female respondents, male respondents more often stated that physician dress was important to them (men, 64%; women, 58%; P = .002). When comparing responses to the question “Overall, which clothes do you feel a doctor should wear?”, between the eastern and western Japanese hospitals, preferences for physician attire varied.

Variation in Expectations Between Male and Female Physicians

When comparing the ratings of male and female physicians, female physicians were rated higher in how caring (P = .005) and approachable (P < .001) they appeared. However, there were no significant differences in the ratings of the three remaining domains (ie, knowledgeable, trustworthy, and comfortable) or the composite score.

This report is the first multicenter Japanese study to examine patients’ preferences for physician attire. Most Japanese respondents perceived that physician dress is important, and nearly half agreed that physician dress influences their satisfaction with care. Overall, “casual attire with white coat” and “formal attire with white coat” tended to be the preferred option for respondents; however, this varied widely across context of care delivery. “Scrubs without white coat” was the preferred attire for physicians in the ED and surgery department. Elderly patients preferred physicians in formal attire regardless of where care was being received. Collectively, these findings have important implications for how delivery of care in Japan is approached.

Since we employed the same methodology as previous studies conducted in the US¹⁰ and Switzerland,¹⁸ a notable strength of our approach is that comparisons among these countries can be drawn. For example, physician attire appears to hold greater importance in Japan than in the US and Switzerland. Among Japanese participants, 61% agreed that physician dress is important (US, 53%; Switzerland, 36%), and 47% agreed that physician dress influenced how satisfied they were with their care (US, 36%; Switzerland, 23%).¹⁰ This result supports the notion that nonverbal and implicit communications (such as physician dress) may carry more importance among Japanese people.^11-13

Regarding preference ratings for type of dress among respondents in Japan, “casual attire with white coat” received the highest mean composite score rating, with “formal attire with white coat” rated second overall. In contrast, US respondents rated “formal attire with white coat” highest and “scrubs with white coat” second.¹⁰ Our result runs counter to our expectation in that we expected Japanese respondents to prefer formal attire, since Japan is one of the most formal cultures in the world. One potential explanation for this difference is that the casual style chosen for this study was close to the smart casual style (slightly casual). Most hospitals and clinics in Japan do not allow physicians to wear jeans or polo shirts, which were chosen as the casual attire in the previous US study.

When examining various care settings and physician types, both Japanese and US respondents were more likely to prefer physicians wearing a white coat in the office or hospital.¹⁰ However, Japanese participants preferred both “casual attire with white coat” and “formal attire with white coat” equally in primary care or hospital settings. A smaller proportion of US respondents preferred “casual attire with white coat” in primary care (11%) and hospital settings (9%), but more preferred “formal attire with white coat” for primary care (44%) and hospital physicians (39%). In the ED setting, 32% of participants in Japan and 18% in the US disagreed with the idea that physicians should wear a white coat. Among Japanese participants, “scrubs without white coat” was rated highest for emergency physicians (56%) and surgeons (47%), while US preferences were 40% and 42%, respectively.¹⁰ One potential explanation is that scrubs-based attire became popular among Japanese ED and surgical contexts as a result of cultural influence and spread from western countries.^{19, 20}

With respect to perceptions regarding physician attire on weekends, 52% of participants considered it inappropriate for a physician to dress casually over the weekend, compared with only 30% in Switzerland and 21% in the US.^11,12 Given Japan’s level of formality and the fact that most Japanese physicians continue to work over the weekend,^21-23 Japanese patients tend to expect their physicians to dress in more formal attire during these times.

Previous studies in Japan have demonstrated that older patients gave low ratings to scrubs and high ratings to white coat with any attire,^15,17 and this was also the case in our study. Perhaps elderly patients reflect conservative values in their preferences of physician dress. Their perceptions may be less influenced by scenes portraying physicians in popular media when compared with the perceptions of younger patients. Though a 2015 systematic review and studies in other countries revealed white coats were preferred regardless of exact dress,^9,24-26 they also showed variation in preferences for physician attire. For example, patients in Saudi Arabia preferred white coat and traditional ethnic dress,²⁵ whereas mothers of pediatric patients in Saudi Arabia preferred scrubs for their pediatricians.²⁷ Therefore, it is recommended for internationally mobile physicians to choose their dress depending on a variety of factors including country, context, and patient age group.

Our study has limitations. First, because some physicians presented the surveys to the patients, participants may have responded differently. Second, participants may have identified photographs of the male physician model as their personal healthcare provider (one author, K.K.). To avoid this possible bias, we randomly distributed 14 different versions of physician photographs in the questionnaire. Third, although physician photographs were strictly controlled, the “formal attire and white coat” and “casual attire and white coat” photographs appeared similar, especially given that the white coats were buttoned. Also, the female physician depicted in the photographs did not have the scrub shirt tucked in, while the male physician did. These nuances may have affected participant ratings between groups. Fourth, we did not blind researchers or data collectors in the process of data collection and entry. Fifth, we asked participants to indicate their age using categories. The age group “35-54 years” covered a wide range of patients, and we may have obtained more granular detail if we had chosen different age groups. Sixth, our cohort included a higher proportion of older people who needed medical treatment for their comorbidities and who had not received high levels of education. This resulted in a seemingly high proportion of lower education levels in our cohort. Lastly, patient experience and satisfaction can be comprised not only by physician attire, but also physician behavior and attitude, which this survey could not elicit. Thus, additional studies are needed to identify and quantify all determinants of patient experience with their physicians.

In conclusion, patient preferences for physician attire were examined using a multicenter survey with a large sample size and robust survey methodology, thus overcoming weaknesses of previous studies into Japanese attire. Japanese patients perceive that physician attire is important and influences satisfaction with their care, more so than patients in other countries, like the US and Switzerland. Geography, settings of care, and patient age play a role in preferences. As a result, hospitals and health systems may use these findings to inform dress code policy based on patient population and context, recognizing that the appearance of their providers affects the patient-physician relationship. Future research should focus on better understanding the various cultural and societal customs that lead to patient expectations of physician attire.

Acknowledgments

The authors thank Drs. Fumi Takemoto, Masayuki Ueno, Kazuya Sakai, Saori Kinami, and Toshio Naito for their assistance with data collection at their respective sites. Additionally, the authors thank Dr. Yoko Kanamitsu for serving as a model for photographs.

Point-of-care ultrasonography (POCUS) can transform healthcare delivery through its diagnostic and therapeutic expediency.¹ POCUS has been shown to bolster diagnostic accuracy, reduce procedural complications, decrease inpatient length of stay, and improve patient satisfaction by encouraging the physician to be present at the bedside.^2-8

POCUS has become widespread across a variety of clinical settings as more investigations have demonstrated its positive impact on patient care.^1,9-12 This includes the use of POCUS by trainees, who are now utilizing this technology as part of their assessments of patients.^13,14 However, trainees may be performing these examinations with minimal oversight, and outside of emergency medicine, there are few guidelines on how to effectively teach POCUS or measure competency.^13,14 While POCUS is rapidly becoming a part of inpatient care, teaching physicians may have little experience in ultrasound or the expertise to adequately supervise trainees.¹⁴ There is a growing need to study what trainees can learn and how this knowledge is acquired.

Previous investigations have demonstrated that inexperienced users can be taught to use POCUS to identify a variety of pathological states.^2,3,15-23 Most of these curricula used a single lecture series as their pedagogical vehicle, and they variably included junior medical trainees. More importantly, the investigations did not explore whether personal access to handheld ultrasound devices (HUDs) improved learning. In theory, improved access to POCUS devices increases opportunities for authentic and deliberate practice, which may be needed to improve trainee skill with POCUS beyond the classroom setting.¹⁴

This study aimed to address several ongoing gaps in knowledge related to learning POCUS. First, we hypothesized that personal HUD access would improve trainees’ POCUS-­related knowledge and interpretive ability as a result of increased practice opportunities. Second, we hypothesized that trainees who receive personal access to HUDs would be more likely to perform POCUS examinations and feel more confident in their interpretations. Finally, we hypothesized that repeated exposure to POCUS-related lectures would result in greater improvements in knowledge as compared with a single lecture series.

Participants and Setting

The 2017 intern class (n = 47) at an academic internal medicine residency program participated in the study. Control data were obtained from the 2016 intern class (historical control; n = 50) and the 2018 intern class (contemporaneous control; n = 52). The Stanford University Institutional Review Board approved this study.

Study Design

The 2017 intern class (n = 47) received POCUS didactics from June 2017 to June 2018. To evaluate if increased access to HUDs improved learning outcomes, the 2017 interns were randomized 1:1 to receive their own personal HUD that could be used for patient care and/or self-directed learning (n = 24) vs no-HUD (n = 23; Figure). Learning outcomes were assessed over the course of 1 year (see “Outcomes” below) and were compared with the 2016 and 2018 controls. The 2016 intern class had completed a year of training but had not received formalized POCUS didactics (historical control), whereas the 2018 intern class was assessed at the beginning of their year (contemporaneous control; Figure). In order to make comparisons based on intern experience, baseline data for the 2017 intern class were compared with the 2018 intern class, whereas end-of-study data for 2017 interns were compared with 2016 interns.

Outcomes

The primary outcome was the difference in assessment scores at the end of the study period between interns randomized to receive a HUD and those who were not. Secondary outcomes included differences in HUD usage rates, lecture attendance, and assessment scores. To assess whether repeated lecture exposure resulted in greater amounts of learning, this study evaluated for assessment score improvements after each lecture block. Finally, trainee attitudes toward POCUS and their confidence in their interpretative ability were measured at the beginning and end of the study period.

Curriculum Implementation

The lectures were administered as once-weekly didactics of 1-hour duration to interns rotating on the inpatient wards rotation. This rotation is 4 weeks long, and each intern will experience the rotation two to four times per year. Each lecture contained two parts: (1) 20-30 minutes of didactics via Microsoft PowerPoint^TM and (2) 30-40 minutes of supervised practice using HUDs on standardized patients. Four lectures were given each month: (1) introduction to POCUS and ultrasound physics, (2) thoracic/lung ultrasound, (3) echocardiography, and (4) abdominal POCUS. The lectures consisted of contrasting cases of normal/abnormal videos and clinical vignettes. These four lectures were repeated each month as new interns rotated on service. Some interns experienced the same content multiple times, which was intentional in order to assess their rates of learning over time. Lecture contents were based on previously published guidelines and expert consensus for teaching POCUS in internal medicine.^{13, 24-26} Content from the Accreditation Council for Graduate Medical Education (ACGME) and the American College of Emergency Physicians (ACEP) was also incorporated because these organizations had published relevant guidelines for teaching POCUS.^13,26 Further development of the lectures occurred through review of previously described POCUS-relevant curricula.^27-32

Handheld Ultrasound Devices

This study used the Philips Lumify^TM, a United States Food and Drug Administration–approved device. Interns randomized to HUDs received their own device at the start of the rotation. It was at their discretion to use the device outside of the course. All devices were approved for patient use and were encrypted in compliance with our information security office. For privacy reasons, any saved patient images were not reviewed by the researchers. Interns were encouraged to share their findings with supervising physicians during rounds, but actual oversight was not measured. Interns not randomized to HUDs could access a single community device that was shared among all residents and fellows in the hospital. Interns reported the average number of POCUS examinations performed each week via a survey sent during the last week of the rotation.

Assessment Design and Implementation

Assessments evaluating trainee knowledge were administered before, during, and after the study period (Figure). For the 2017 cohort, assessments were also administered at the start and end of the ward month to track knowledge acquisition. Assessment contents were selected from POCUS guidelines for internal medicine and adaptation of the ACGME and ACEP guidelines.^13,24,26 Additional content was obtained from major society POCUS tutorials and deidentified images collected by the study authors.^13,24,33 In keeping with previously described methodology, the images were shown for approximately 12 seconds, followed by five additional seconds to allow the learner to answer the question.³² Final assessment contents were determined by the authors using the Delphi method.³⁴ A sample assessment can be found in the Appendix Material.

Surveys

Surveys were administered alongside the assessments to the 2016-2018 intern classes. These surveys assessed trainee attitudes toward POCUS and were based on previously validated assessments.^27,28,30 Attitudes were measured using 5-point Likert scales.

Statistical Analysis

For the primary outcome, we performed generalized binomial mixed-effect regressions using the survey periods, randomization group, and the interaction of the two as independent variables after adjusting for attendance and controlling of intra-intern correlations. The bivariate unadjusted analysis was performed to display the distribution of overall correctness on the assessments. Wilcoxon signed rank test was used to determine score significance for dependent score variables (R-­Statistical Programming Language, Vienna, Austria).

Baseline Characteristics

There were 149 interns who participated in this study (Figure). Assessment/survey completion rates were as follows: 2016 control: 68.0%; 2017 preintervention: 97.9%; 2017 postintervention: 89.4%; and 2018 control: 100%. The 2017 interns reported similar amounts of prior POCUS exposure in medical school (Table 1).

Primary Outcome: Assessment Scores (HUD vs no HUD)

There were no significant differences in assessment scores at the end of the study between interns randomized to personal HUD access vs those to no-HUD access (Table 1). HUD interns reported performing POCUS assessments on patients a mean 6.8 (standard deviation [SD] 2.2) times per week vs 6.4 (SD 2.9) times per week in the no-HUD arm (P = .66). The mean lecture attendance was 75.0% and did not significantly differ between the HUD arms (Table 1).

Secondary Outcomes

Impact of Repeating Lectures

The 2017 interns demonstrated significant increases in preblock vs postblock assessment scores after first-time exposure to the lectures (median preblock score 0.61 [interquartile range (IQR), 0.53-0.70] vs postblock score 0.81 [IQR, 0.72-0.86]; P < .001; Table 2). However, intern performance on the preblock vs postblock assessments after second-time exposure to the curriculum failed to improve (median second preblock score 0.78 [IQR, 0.69-0.83] vs postblock score 0.81 [IQR, 0.64-0.89]; P = .94). Intern performance on individual domains of knowledge for each block is listed in Appendix Table 1.

Intervention Performance vs Controls

The 2016 historical control had significantly higher scores compared with the 2017 preintervention group (P < .001; Appendix Table 2). The year-long lecture series resulted in significant increases in median scores for the 2017 group (median preintervention score 0.55 [0.41-0.61] vs median postintervention score 0.84 [0.71-0.90]; P = .006; Appendix Table 1). At the end of the study, the 2017 postintervention scores were significantly higher across multiple knowledge domains compared with the 2016 historical control (Appendix Table 2).

Survey Results

Notably, the 2017 intern class at the end of the intervention did not have significantly different assessment scores for several disease-specific domains, compared with the 2016 control (Appendix Table 2). Nonetheless, the 2017 intern class reported higher levels of confidence in these same domains despite similar scores (Supplementary Figure). The HUD group seldomly cited a lack of confidence in their abilities as a barrier to performing POCUS examinations (17.6%), compared with the no-HUD group (50.0%), despite nearly identical assessment scores between the two groups (Table 1).

Previous guidelines have recommended increased HUD access for learners,^13,24,35,36 but there have been few investigations that have evaluated the impact of such access on learning POCUS. One previous investigation found that hospitalists who carried HUDs were more likely to identify heart failure on bedside examination.³⁷ In contrast, our study found no improvement in interpretative ability when randomizing interns to carry HUDs for patient care. Notably, interns did not perform more POCUS examinations when given HUDs. We offer several explanations for this finding. First, time-motion studies have demonstrated that internal medicine interns spend less than 15% of their time toward direct patient care.³⁸ It is possible that the demands of being an intern impeded their ability to perform more POCUS examinations on their patients, regardless of HUD access. Alternatively, the interns randomized to no personal access may have used the community device more frequently as a result of the lecture series. Given the cost of HUDs, further studies are needed to assess the degree to which HUD access will improve trainee interpretive ability, especially as more training programs consider the creation of ultrasound curricula.^{10,11,24,39,40}

This study was unique because it followed interns over a year-long course that repeated the same material to assess rates of learning with repeated exposure. Learners improved their scores after the first, but not second, block. Furthermore, the median scores were nearly identical between the first postblock assessment and second preblock assessment (0.81 vs 0.78), suggesting that knowledge was retained between blocks. Together, these findings suggest there may be limitations of traditional lectures that use standardized patient models for practice. Supplementary pedagogies, such as in-the-moment feedback with actual patients, may be needed to promote mastery.^14,35

Despite no formal curriculum, the 2016 intern class (historical control) had learned POCUS to some degree based on their higher assessment scores compared with the 2017 intern class during the preintervention period. Such learning may be informal, and yet, trainees may feel confident in making clinical decisions without formalized training, accreditation, or oversight. As suggested by this study, adding regular didactics or giving trainees HUDs may not immediately solve this issue. For assessment items in which the 2017 interns did not significantly differ from the controls, they nonetheless reported higher confidence in their abilities. Similarly, interns randomized to HUDs less frequently cited a lack of confidence in their abilities, despite similar scores to the no-HUD group. Such confidence may be incongruent with their actual knowledge or ability to safely use POCUS. This phenomenon of misplaced confidence is known as the Dunning–Kruger effect, and it may be common with ultrasound learning.⁴¹ While confidence can be part of a holistic definition of competency,¹⁴ these results raise the concern that trainees may have difficulty assessing their own competency level with POCUS.³⁵

There are several limitations to this study. It was performed at a single institution with limited sample size. It examined only intern physicians because of funding constraints, which limits the generalizability of these findings among medical trainees. Technical ability assessments (including obtaining and interpreting images) were not included. We were unable to track the timing or location of the devices’ usage, and the interns’ self-reported usage rates may be subject to recall bias. To our knowledge, there were no significant lapses in device availability/functionality. Intern physicians in the HUD arm did not receive formal feedback on personally acquired patient images, which may have limited the intervention’s impact.

In conclusion, internal medicine interns who received personal HUDs were not better at recognizing normal/abnormal findings on image assessments, and they did not report performing more POCUS examinations. Since the minority of a trainee’s time is spent toward direct patient care, offering trainees HUDs without substantial guidance may not be enough to promote mastery. Notably, trainees who received HUDs felt more confident in their abilities, despite no objective increase in their actual skill. Finally, interns who received POCUS-related lectures experienced significant benefit upon first exposure to the material, while repeated exposures did not improve performance. Future investigations should stringently track trainee POCUS usage rates with HUDs and assess whether image acquisition ability improves as a result of personal access.

Point-of-care ultrasonography (POCUS) can transform healthcare delivery through its diagnostic and therapeutic expediency.¹ POCUS has been shown to bolster diagnostic accuracy, reduce procedural complications, decrease inpatient length of stay, and improve patient satisfaction by encouraging the physician to be present at the bedside.^2-8

POCUS has become widespread across a variety of clinical settings as more investigations have demonstrated its positive impact on patient care.^1,9-12 This includes the use of POCUS by trainees, who are now utilizing this technology as part of their assessments of patients.^13,14 However, trainees may be performing these examinations with minimal oversight, and outside of emergency medicine, there are few guidelines on how to effectively teach POCUS or measure competency.^13,14 While POCUS is rapidly becoming a part of inpatient care, teaching physicians may have little experience in ultrasound or the expertise to adequately supervise trainees.¹⁴ There is a growing need to study what trainees can learn and how this knowledge is acquired.

Previous investigations have demonstrated that inexperienced users can be taught to use POCUS to identify a variety of pathological states.^2,3,15-23 Most of these curricula used a single lecture series as their pedagogical vehicle, and they variably included junior medical trainees. More importantly, the investigations did not explore whether personal access to handheld ultrasound devices (HUDs) improved learning. In theory, improved access to POCUS devices increases opportunities for authentic and deliberate practice, which may be needed to improve trainee skill with POCUS beyond the classroom setting.¹⁴

This study aimed to address several ongoing gaps in knowledge related to learning POCUS. First, we hypothesized that personal HUD access would improve trainees’ POCUS-­related knowledge and interpretive ability as a result of increased practice opportunities. Second, we hypothesized that trainees who receive personal access to HUDs would be more likely to perform POCUS examinations and feel more confident in their interpretations. Finally, we hypothesized that repeated exposure to POCUS-related lectures would result in greater improvements in knowledge as compared with a single lecture series.

Participants and Setting

The 2017 intern class (n = 47) at an academic internal medicine residency program participated in the study. Control data were obtained from the 2016 intern class (historical control; n = 50) and the 2018 intern class (contemporaneous control; n = 52). The Stanford University Institutional Review Board approved this study.

Study Design

The 2017 intern class (n = 47) received POCUS didactics from June 2017 to June 2018. To evaluate if increased access to HUDs improved learning outcomes, the 2017 interns were randomized 1:1 to receive their own personal HUD that could be used for patient care and/or self-directed learning (n = 24) vs no-HUD (n = 23; Figure). Learning outcomes were assessed over the course of 1 year (see “Outcomes” below) and were compared with the 2016 and 2018 controls. The 2016 intern class had completed a year of training but had not received formalized POCUS didactics (historical control), whereas the 2018 intern class was assessed at the beginning of their year (contemporaneous control; Figure). In order to make comparisons based on intern experience, baseline data for the 2017 intern class were compared with the 2018 intern class, whereas end-of-study data for 2017 interns were compared with 2016 interns.

Outcomes

The primary outcome was the difference in assessment scores at the end of the study period between interns randomized to receive a HUD and those who were not. Secondary outcomes included differences in HUD usage rates, lecture attendance, and assessment scores. To assess whether repeated lecture exposure resulted in greater amounts of learning, this study evaluated for assessment score improvements after each lecture block. Finally, trainee attitudes toward POCUS and their confidence in their interpretative ability were measured at the beginning and end of the study period.

Curriculum Implementation

The lectures were administered as once-weekly didactics of 1-hour duration to interns rotating on the inpatient wards rotation. This rotation is 4 weeks long, and each intern will experience the rotation two to four times per year. Each lecture contained two parts: (1) 20-30 minutes of didactics via Microsoft PowerPoint^TM and (2) 30-40 minutes of supervised practice using HUDs on standardized patients. Four lectures were given each month: (1) introduction to POCUS and ultrasound physics, (2) thoracic/lung ultrasound, (3) echocardiography, and (4) abdominal POCUS. The lectures consisted of contrasting cases of normal/abnormal videos and clinical vignettes. These four lectures were repeated each month as new interns rotated on service. Some interns experienced the same content multiple times, which was intentional in order to assess their rates of learning over time. Lecture contents were based on previously published guidelines and expert consensus for teaching POCUS in internal medicine.^{13, 24-26} Content from the Accreditation Council for Graduate Medical Education (ACGME) and the American College of Emergency Physicians (ACEP) was also incorporated because these organizations had published relevant guidelines for teaching POCUS.^13,26 Further development of the lectures occurred through review of previously described POCUS-relevant curricula.^27-32

Handheld Ultrasound Devices

This study used the Philips Lumify^TM, a United States Food and Drug Administration–approved device. Interns randomized to HUDs received their own device at the start of the rotation. It was at their discretion to use the device outside of the course. All devices were approved for patient use and were encrypted in compliance with our information security office. For privacy reasons, any saved patient images were not reviewed by the researchers. Interns were encouraged to share their findings with supervising physicians during rounds, but actual oversight was not measured. Interns not randomized to HUDs could access a single community device that was shared among all residents and fellows in the hospital. Interns reported the average number of POCUS examinations performed each week via a survey sent during the last week of the rotation.

Assessment Design and Implementation

Assessments evaluating trainee knowledge were administered before, during, and after the study period (Figure). For the 2017 cohort, assessments were also administered at the start and end of the ward month to track knowledge acquisition. Assessment contents were selected from POCUS guidelines for internal medicine and adaptation of the ACGME and ACEP guidelines.^13,24,26 Additional content was obtained from major society POCUS tutorials and deidentified images collected by the study authors.^13,24,33 In keeping with previously described methodology, the images were shown for approximately 12 seconds, followed by five additional seconds to allow the learner to answer the question.³² Final assessment contents were determined by the authors using the Delphi method.³⁴ A sample assessment can be found in the Appendix Material.

Surveys

Surveys were administered alongside the assessments to the 2016-2018 intern classes. These surveys assessed trainee attitudes toward POCUS and were based on previously validated assessments.^27,28,30 Attitudes were measured using 5-point Likert scales.

Statistical Analysis

For the primary outcome, we performed generalized binomial mixed-effect regressions using the survey periods, randomization group, and the interaction of the two as independent variables after adjusting for attendance and controlling of intra-intern correlations. The bivariate unadjusted analysis was performed to display the distribution of overall correctness on the assessments. Wilcoxon signed rank test was used to determine score significance for dependent score variables (R-­Statistical Programming Language, Vienna, Austria).

Baseline Characteristics

There were 149 interns who participated in this study (Figure). Assessment/survey completion rates were as follows: 2016 control: 68.0%; 2017 preintervention: 97.9%; 2017 postintervention: 89.4%; and 2018 control: 100%. The 2017 interns reported similar amounts of prior POCUS exposure in medical school (Table 1).

Primary Outcome: Assessment Scores (HUD vs no HUD)

There were no significant differences in assessment scores at the end of the study between interns randomized to personal HUD access vs those to no-HUD access (Table 1). HUD interns reported performing POCUS assessments on patients a mean 6.8 (standard deviation [SD] 2.2) times per week vs 6.4 (SD 2.9) times per week in the no-HUD arm (P = .66). The mean lecture attendance was 75.0% and did not significantly differ between the HUD arms (Table 1).

Secondary Outcomes

Impact of Repeating Lectures

The 2017 interns demonstrated significant increases in preblock vs postblock assessment scores after first-time exposure to the lectures (median preblock score 0.61 [interquartile range (IQR), 0.53-0.70] vs postblock score 0.81 [IQR, 0.72-0.86]; P < .001; Table 2). However, intern performance on the preblock vs postblock assessments after second-time exposure to the curriculum failed to improve (median second preblock score 0.78 [IQR, 0.69-0.83] vs postblock score 0.81 [IQR, 0.64-0.89]; P = .94). Intern performance on individual domains of knowledge for each block is listed in Appendix Table 1.

Intervention Performance vs Controls

The 2016 historical control had significantly higher scores compared with the 2017 preintervention group (P < .001; Appendix Table 2). The year-long lecture series resulted in significant increases in median scores for the 2017 group (median preintervention score 0.55 [0.41-0.61] vs median postintervention score 0.84 [0.71-0.90]; P = .006; Appendix Table 1). At the end of the study, the 2017 postintervention scores were significantly higher across multiple knowledge domains compared with the 2016 historical control (Appendix Table 2).

Survey Results

Notably, the 2017 intern class at the end of the intervention did not have significantly different assessment scores for several disease-specific domains, compared with the 2016 control (Appendix Table 2). Nonetheless, the 2017 intern class reported higher levels of confidence in these same domains despite similar scores (Supplementary Figure). The HUD group seldomly cited a lack of confidence in their abilities as a barrier to performing POCUS examinations (17.6%), compared with the no-HUD group (50.0%), despite nearly identical assessment scores between the two groups (Table 1).

Previous guidelines have recommended increased HUD access for learners,^13,24,35,36 but there have been few investigations that have evaluated the impact of such access on learning POCUS. One previous investigation found that hospitalists who carried HUDs were more likely to identify heart failure on bedside examination.³⁷ In contrast, our study found no improvement in interpretative ability when randomizing interns to carry HUDs for patient care. Notably, interns did not perform more POCUS examinations when given HUDs. We offer several explanations for this finding. First, time-motion studies have demonstrated that internal medicine interns spend less than 15% of their time toward direct patient care.³⁸ It is possible that the demands of being an intern impeded their ability to perform more POCUS examinations on their patients, regardless of HUD access. Alternatively, the interns randomized to no personal access may have used the community device more frequently as a result of the lecture series. Given the cost of HUDs, further studies are needed to assess the degree to which HUD access will improve trainee interpretive ability, especially as more training programs consider the creation of ultrasound curricula.^{10,11,24,39,40}

This study was unique because it followed interns over a year-long course that repeated the same material to assess rates of learning with repeated exposure. Learners improved their scores after the first, but not second, block. Furthermore, the median scores were nearly identical between the first postblock assessment and second preblock assessment (0.81 vs 0.78), suggesting that knowledge was retained between blocks. Together, these findings suggest there may be limitations of traditional lectures that use standardized patient models for practice. Supplementary pedagogies, such as in-the-moment feedback with actual patients, may be needed to promote mastery.^14,35

Despite no formal curriculum, the 2016 intern class (historical control) had learned POCUS to some degree based on their higher assessment scores compared with the 2017 intern class during the preintervention period. Such learning may be informal, and yet, trainees may feel confident in making clinical decisions without formalized training, accreditation, or oversight. As suggested by this study, adding regular didactics or giving trainees HUDs may not immediately solve this issue. For assessment items in which the 2017 interns did not significantly differ from the controls, they nonetheless reported higher confidence in their abilities. Similarly, interns randomized to HUDs less frequently cited a lack of confidence in their abilities, despite similar scores to the no-HUD group. Such confidence may be incongruent with their actual knowledge or ability to safely use POCUS. This phenomenon of misplaced confidence is known as the Dunning–Kruger effect, and it may be common with ultrasound learning.⁴¹ While confidence can be part of a holistic definition of competency,¹⁴ these results raise the concern that trainees may have difficulty assessing their own competency level with POCUS.³⁵

There are several limitations to this study. It was performed at a single institution with limited sample size. It examined only intern physicians because of funding constraints, which limits the generalizability of these findings among medical trainees. Technical ability assessments (including obtaining and interpreting images) were not included. We were unable to track the timing or location of the devices’ usage, and the interns’ self-reported usage rates may be subject to recall bias. To our knowledge, there were no significant lapses in device availability/functionality. Intern physicians in the HUD arm did not receive formal feedback on personally acquired patient images, which may have limited the intervention’s impact.

In conclusion, internal medicine interns who received personal HUDs were not better at recognizing normal/abnormal findings on image assessments, and they did not report performing more POCUS examinations. Since the minority of a trainee’s time is spent toward direct patient care, offering trainees HUDs without substantial guidance may not be enough to promote mastery. Notably, trainees who received HUDs felt more confident in their abilities, despite no objective increase in their actual skill. Finally, interns who received POCUS-related lectures experienced significant benefit upon first exposure to the material, while repeated exposures did not improve performance. Future investigations should stringently track trainee POCUS usage rates with HUDs and assess whether image acquisition ability improves as a result of personal access.

Point-of-care ultrasonography (POCUS) can transform healthcare delivery through its diagnostic and therapeutic expediency.¹ POCUS has been shown to bolster diagnostic accuracy, reduce procedural complications, decrease inpatient length of stay, and improve patient satisfaction by encouraging the physician to be present at the bedside.^2-8

POCUS has become widespread across a variety of clinical settings as more investigations have demonstrated its positive impact on patient care.^1,9-12 This includes the use of POCUS by trainees, who are now utilizing this technology as part of their assessments of patients.^13,14 However, trainees may be performing these examinations with minimal oversight, and outside of emergency medicine, there are few guidelines on how to effectively teach POCUS or measure competency.^13,14 While POCUS is rapidly becoming a part of inpatient care, teaching physicians may have little experience in ultrasound or the expertise to adequately supervise trainees.¹⁴ There is a growing need to study what trainees can learn and how this knowledge is acquired.

Previous investigations have demonstrated that inexperienced users can be taught to use POCUS to identify a variety of pathological states.^2,3,15-23 Most of these curricula used a single lecture series as their pedagogical vehicle, and they variably included junior medical trainees. More importantly, the investigations did not explore whether personal access to handheld ultrasound devices (HUDs) improved learning. In theory, improved access to POCUS devices increases opportunities for authentic and deliberate practice, which may be needed to improve trainee skill with POCUS beyond the classroom setting.¹⁴

This study aimed to address several ongoing gaps in knowledge related to learning POCUS. First, we hypothesized that personal HUD access would improve trainees’ POCUS-­related knowledge and interpretive ability as a result of increased practice opportunities. Second, we hypothesized that trainees who receive personal access to HUDs would be more likely to perform POCUS examinations and feel more confident in their interpretations. Finally, we hypothesized that repeated exposure to POCUS-related lectures would result in greater improvements in knowledge as compared with a single lecture series.

Participants and Setting

The 2017 intern class (n = 47) at an academic internal medicine residency program participated in the study. Control data were obtained from the 2016 intern class (historical control; n = 50) and the 2018 intern class (contemporaneous control; n = 52). The Stanford University Institutional Review Board approved this study.

Study Design

The 2017 intern class (n = 47) received POCUS didactics from June 2017 to June 2018. To evaluate if increased access to HUDs improved learning outcomes, the 2017 interns were randomized 1:1 to receive their own personal HUD that could be used for patient care and/or self-directed learning (n = 24) vs no-HUD (n = 23; Figure). Learning outcomes were assessed over the course of 1 year (see “Outcomes” below) and were compared with the 2016 and 2018 controls. The 2016 intern class had completed a year of training but had not received formalized POCUS didactics (historical control), whereas the 2018 intern class was assessed at the beginning of their year (contemporaneous control; Figure). In order to make comparisons based on intern experience, baseline data for the 2017 intern class were compared with the 2018 intern class, whereas end-of-study data for 2017 interns were compared with 2016 interns.

Outcomes

The primary outcome was the difference in assessment scores at the end of the study period between interns randomized to receive a HUD and those who were not. Secondary outcomes included differences in HUD usage rates, lecture attendance, and assessment scores. To assess whether repeated lecture exposure resulted in greater amounts of learning, this study evaluated for assessment score improvements after each lecture block. Finally, trainee attitudes toward POCUS and their confidence in their interpretative ability were measured at the beginning and end of the study period.

Curriculum Implementation

The lectures were administered as once-weekly didactics of 1-hour duration to interns rotating on the inpatient wards rotation. This rotation is 4 weeks long, and each intern will experience the rotation two to four times per year. Each lecture contained two parts: (1) 20-30 minutes of didactics via Microsoft PowerPoint^TM and (2) 30-40 minutes of supervised practice using HUDs on standardized patients. Four lectures were given each month: (1) introduction to POCUS and ultrasound physics, (2) thoracic/lung ultrasound, (3) echocardiography, and (4) abdominal POCUS. The lectures consisted of contrasting cases of normal/abnormal videos and clinical vignettes. These four lectures were repeated each month as new interns rotated on service. Some interns experienced the same content multiple times, which was intentional in order to assess their rates of learning over time. Lecture contents were based on previously published guidelines and expert consensus for teaching POCUS in internal medicine.^{13, 24-26} Content from the Accreditation Council for Graduate Medical Education (ACGME) and the American College of Emergency Physicians (ACEP) was also incorporated because these organizations had published relevant guidelines for teaching POCUS.^13,26 Further development of the lectures occurred through review of previously described POCUS-relevant curricula.^27-32

Handheld Ultrasound Devices

This study used the Philips Lumify^TM, a United States Food and Drug Administration–approved device. Interns randomized to HUDs received their own device at the start of the rotation. It was at their discretion to use the device outside of the course. All devices were approved for patient use and were encrypted in compliance with our information security office. For privacy reasons, any saved patient images were not reviewed by the researchers. Interns were encouraged to share their findings with supervising physicians during rounds, but actual oversight was not measured. Interns not randomized to HUDs could access a single community device that was shared among all residents and fellows in the hospital. Interns reported the average number of POCUS examinations performed each week via a survey sent during the last week of the rotation.

Assessment Design and Implementation

Assessments evaluating trainee knowledge were administered before, during, and after the study period (Figure). For the 2017 cohort, assessments were also administered at the start and end of the ward month to track knowledge acquisition. Assessment contents were selected from POCUS guidelines for internal medicine and adaptation of the ACGME and ACEP guidelines.^13,24,26 Additional content was obtained from major society POCUS tutorials and deidentified images collected by the study authors.^13,24,33 In keeping with previously described methodology, the images were shown for approximately 12 seconds, followed by five additional seconds to allow the learner to answer the question.³² Final assessment contents were determined by the authors using the Delphi method.³⁴ A sample assessment can be found in the Appendix Material.

Surveys

Surveys were administered alongside the assessments to the 2016-2018 intern classes. These surveys assessed trainee attitudes toward POCUS and were based on previously validated assessments.^27,28,30 Attitudes were measured using 5-point Likert scales.

Statistical Analysis

For the primary outcome, we performed generalized binomial mixed-effect regressions using the survey periods, randomization group, and the interaction of the two as independent variables after adjusting for attendance and controlling of intra-intern correlations. The bivariate unadjusted analysis was performed to display the distribution of overall correctness on the assessments. Wilcoxon signed rank test was used to determine score significance for dependent score variables (R-­Statistical Programming Language, Vienna, Austria).

Baseline Characteristics

There were 149 interns who participated in this study (Figure). Assessment/survey completion rates were as follows: 2016 control: 68.0%; 2017 preintervention: 97.9%; 2017 postintervention: 89.4%; and 2018 control: 100%. The 2017 interns reported similar amounts of prior POCUS exposure in medical school (Table 1).

Primary Outcome: Assessment Scores (HUD vs no HUD)

There were no significant differences in assessment scores at the end of the study between interns randomized to personal HUD access vs those to no-HUD access (Table 1). HUD interns reported performing POCUS assessments on patients a mean 6.8 (standard deviation [SD] 2.2) times per week vs 6.4 (SD 2.9) times per week in the no-HUD arm (P = .66). The mean lecture attendance was 75.0% and did not significantly differ between the HUD arms (Table 1).

Secondary Outcomes

Impact of Repeating Lectures

The 2017 interns demonstrated significant increases in preblock vs postblock assessment scores after first-time exposure to the lectures (median preblock score 0.61 [interquartile range (IQR), 0.53-0.70] vs postblock score 0.81 [IQR, 0.72-0.86]; P < .001; Table 2). However, intern performance on the preblock vs postblock assessments after second-time exposure to the curriculum failed to improve (median second preblock score 0.78 [IQR, 0.69-0.83] vs postblock score 0.81 [IQR, 0.64-0.89]; P = .94). Intern performance on individual domains of knowledge for each block is listed in Appendix Table 1.

Intervention Performance vs Controls

The 2016 historical control had significantly higher scores compared with the 2017 preintervention group (P < .001; Appendix Table 2). The year-long lecture series resulted in significant increases in median scores for the 2017 group (median preintervention score 0.55 [0.41-0.61] vs median postintervention score 0.84 [0.71-0.90]; P = .006; Appendix Table 1). At the end of the study, the 2017 postintervention scores were significantly higher across multiple knowledge domains compared with the 2016 historical control (Appendix Table 2).

Survey Results

Notably, the 2017 intern class at the end of the intervention did not have significantly different assessment scores for several disease-specific domains, compared with the 2016 control (Appendix Table 2). Nonetheless, the 2017 intern class reported higher levels of confidence in these same domains despite similar scores (Supplementary Figure). The HUD group seldomly cited a lack of confidence in their abilities as a barrier to performing POCUS examinations (17.6%), compared with the no-HUD group (50.0%), despite nearly identical assessment scores between the two groups (Table 1).

Previous guidelines have recommended increased HUD access for learners,^13,24,35,36 but there have been few investigations that have evaluated the impact of such access on learning POCUS. One previous investigation found that hospitalists who carried HUDs were more likely to identify heart failure on bedside examination.³⁷ In contrast, our study found no improvement in interpretative ability when randomizing interns to carry HUDs for patient care. Notably, interns did not perform more POCUS examinations when given HUDs. We offer several explanations for this finding. First, time-motion studies have demonstrated that internal medicine interns spend less than 15% of their time toward direct patient care.³⁸ It is possible that the demands of being an intern impeded their ability to perform more POCUS examinations on their patients, regardless of HUD access. Alternatively, the interns randomized to no personal access may have used the community device more frequently as a result of the lecture series. Given the cost of HUDs, further studies are needed to assess the degree to which HUD access will improve trainee interpretive ability, especially as more training programs consider the creation of ultrasound curricula.^{10,11,24,39,40}

This study was unique because it followed interns over a year-long course that repeated the same material to assess rates of learning with repeated exposure. Learners improved their scores after the first, but not second, block. Furthermore, the median scores were nearly identical between the first postblock assessment and second preblock assessment (0.81 vs 0.78), suggesting that knowledge was retained between blocks. Together, these findings suggest there may be limitations of traditional lectures that use standardized patient models for practice. Supplementary pedagogies, such as in-the-moment feedback with actual patients, may be needed to promote mastery.^14,35

Despite no formal curriculum, the 2016 intern class (historical control) had learned POCUS to some degree based on their higher assessment scores compared with the 2017 intern class during the preintervention period. Such learning may be informal, and yet, trainees may feel confident in making clinical decisions without formalized training, accreditation, or oversight. As suggested by this study, adding regular didactics or giving trainees HUDs may not immediately solve this issue. For assessment items in which the 2017 interns did not significantly differ from the controls, they nonetheless reported higher confidence in their abilities. Similarly, interns randomized to HUDs less frequently cited a lack of confidence in their abilities, despite similar scores to the no-HUD group. Such confidence may be incongruent with their actual knowledge or ability to safely use POCUS. This phenomenon of misplaced confidence is known as the Dunning–Kruger effect, and it may be common with ultrasound learning.⁴¹ While confidence can be part of a holistic definition of competency,¹⁴ these results raise the concern that trainees may have difficulty assessing their own competency level with POCUS.³⁵

There are several limitations to this study. It was performed at a single institution with limited sample size. It examined only intern physicians because of funding constraints, which limits the generalizability of these findings among medical trainees. Technical ability assessments (including obtaining and interpreting images) were not included. We were unable to track the timing or location of the devices’ usage, and the interns’ self-reported usage rates may be subject to recall bias. To our knowledge, there were no significant lapses in device availability/functionality. Intern physicians in the HUD arm did not receive formal feedback on personally acquired patient images, which may have limited the intervention’s impact.

In conclusion, internal medicine interns who received personal HUDs were not better at recognizing normal/abnormal findings on image assessments, and they did not report performing more POCUS examinations. Since the minority of a trainee’s time is spent toward direct patient care, offering trainees HUDs without substantial guidance may not be enough to promote mastery. Notably, trainees who received HUDs felt more confident in their abilities, despite no objective increase in their actual skill. Finally, interns who received POCUS-related lectures experienced significant benefit upon first exposure to the material, while repeated exposures did not improve performance. Future investigations should stringently track trainee POCUS usage rates with HUDs and assess whether image acquisition ability improves as a result of personal access.