Article

Insomnia disorder is common throughout the lifespan, affecting up to 22% of the population.¹ Insomnia has a negative effect on patients’ quality of life and is associated with reported worse health-related quality of life, greater overall work impairment, and higher utilization of health care resources compared to patients without insomnia.²

Fortunately, many validated diagnostic tools are available to support physicians in the care of affected patients. In addition, many pharmacologic and nonpharmacologic treatment options exist. This review endeavors to help you refine the care you provide to patients across the lifespan by reviewing the evidence-based strategies for the diagnosis and treatment of insomnia in children, adolescents, and adults.

Defining insomnia

The Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5) defines insomnia disorder as a predominant complaint of dissatisfaction with sleep quantity or quality, associated with 1 or more of the following³:

1. Difficulty initiating sleep. (In children, this may manifest as difficulty initiating sleep without caregiver intervention.)

2. Difficulty maintaining sleep, characterized by frequent awakenings or problems returning to sleep after awakenings. (In children, this may manifest as difficulty returning to sleep without caregiver intervention.)

3. Early-morning awakening with inability to return to sleep.

Sleep difficulty must be present for at least 3 months and must occur at least 3 nights per week to be classified as persistent insomnia.³ If symptoms last fewer than 3 months, insomnia is considered acute, which has a different DSM-5 code ("other specified insomnia disorder").³ Primary insomnia is its own diagnosis that cannot be defined by other sleep-wake ­cycle disorders, mental health conditions, or medical diagnoses that cause sleep disturbances, nor is it attributable to the physiologic effects of a substance (eg, substance use disorders, medication effects).³

Studies have shown that older adults who sleep fewer than 5 hours per night have an increased risk for diabetes and metabolic syndrome.

The International Classification of Sleep Disorders, 3rd edition (ICSD-3) notably consolidates all insomnia diagnoses (ie, “primary” and “comorbid”) under a single diagnosis (“chronic insomnia disorder”), which is a distinction from the DSM-5 diagnosis in terms of classification.⁴ Diagnosis of insomnia requires the presence of 3 criteria: (1) persistence of sleep difficulty, (2) adequate opportunity for sleep, and (3) associated daytime dysfunction.⁵

How insomnia affects specific patient populations

Children and adolescents. Appropriate screening, diagnosis, and interventions for insomnia in children and adolescents are associated with better health outcomes, including improved attention, behavior, learning, memory, emotional regulation, quality of life, and mental and physical health.⁶ In one study of insomnia in the pediatric population (N = 1038), 41% of parents reported symptoms of sleep disturbances in their children.⁷ Pediatric insomnia can lead to impaired attention, poor academic performance, and behavioral disturbances.⁷ In addition, there is a high prevalence of sleep disturbances in children with neurodevelopmental disorders.⁸

Insomnia is the most prevalent sleep disorder in adolescents but frequently goes unrecognized, and therefore is underdiagnosed and undertreated.⁹ Insomnia in adolescents is associated with depression and suicidality.^9-12 Growing evidence also links it to anorexia nervosa,¹³ substance use disorders,¹⁴ and impaired neurocognitive function.¹⁵

Continue to: Pregnant women

Pregnant women. Sleep disorders in pregnancy are common and influenced by multiple factors. A meta-analysis found that 57% to 74% of women in various trimesters of pregnancy reported subthreshold symptoms of insomnia¹⁶; however, changes in sleep duration and sleep quality during pregnancy may be related to hormonal, physiologic, metabolic, psychological, and posture mechanisms.^17,18

Sleep quality also worsens as pregnancy progresses.¹⁶ Insomnia coupled with poor sleep quality has been shown to increase the risk for postpartum depression, premature delivery, prolonged labor, and cesarean delivery, as well as preeclampsia, gestational hypertension, stillbirth, and large-for-­gestational-age infants.^19,20

Older adults. Insomnia is a common complaint in the geriatric population and is associated with significant morbidity, as well as higher rates of depression and suicidality.²¹ Circadian rhythms change and sleep cycles advance as people age, leading to a decrease in total sleep time, earlier sleep onset, earlier awakenings,and increased frequency of waking after sleep onset.^21,22 Advanced age, polypharmacy, and high medical comorbidity increase insomnia prevalence.²³

Technology use prior to bedtime is prevalent and associated with sleep and circadian rhythm disturbances.

Studies have shown that older adults who sleep fewer than 5 hours per night have an increased risk for diabetes and metabolic syndrome.²¹ Sleep loss also has been linked to increased rates of hypertension, coronary ­ar­tery disease, myocardial infarction, and possibly stroke.^21,22 Poor sleep has been associated with increased rates of cortical atrophy in community-dwelling older adults.²¹ Daytime drowsiness increases fall risk.²² Older adults with self-reported decreased physical function also had increased rates of insomnia and increased rates of daytime sleepiness.²²

Making the diagnosis: What to ask, tools to use

Clinical evaluation is most helpful for diagnosing insomnia.²⁴ A complete work-up includes physical examination, review of medications and supplements, evaluation of a 2-week sleep diary (kept by the patient, parent, or caregiver), and assessment using a validated sleep-quality rating scale.²⁴ Be sure to obtain a complete health history, including medical events, substance use, and psychiatric history.²⁴

Continue to: Inquire about sleep initiation...

Inquire about sleep initiation, sleep maintenance, and early awakening, as well as behavioral and environmental factors that may contribute to sleep concerns.^10,18 Consider medical sleep disorders that have overlapping symptoms with insomnia, including obstructive sleep apnea (OSA), restless leg syndrome (RLS), or circadian rhythm sleep-wake disorders. If there are co-occurring chronic medical problems, reassess insomnia symptoms after the other medical diagnoses are controlled.

TABLE 1^25-29 includes a list of validated screening tools for insomnia and where they can be accessed. Recommended screening tools for children and adolescents include daytime sleepiness questionnaires, comprehensive sleep instruments, and self-assessments.^25,30 Although several studies of insomnia in pregnancy have used tools listed in TABLE 1,^25-29 only the Insomnia Severity Index has been validated for use with this population.^26,27 Diagnosis of insomnia in older adults requires a comprehensive sleep history collected from the patient, partners, or caregivers.²¹

Measuring sleep performance

Several aspects of insomnia (defined in ­TABLE 2^31-33) are targeted as outcome measures when treating patients. Sleep-onset latency, total sleep time, and wake-after-sleep onset are all formally measured by polysomnography.^31-33 Use polysomnography when you suspect OSA, narcolepsy, idiopathic hypersomnia, periodic limb movement disorder, RLS, REM behavior disorder (characterized by the loss of normal muscle atonia and dream enactment behavior that is violent in nature³⁴), or parasomnias. Home polysomnography testing is appropriate for adult patients who meet criteria for OSA and have uncomplicated insomnia.³⁵ Self-reporting (use of sleep logs) and actigraphy (measurement by wearable monitoring devices) may be more accessible methods for gathering sleep data from patients. Use of wearable consumer sleep technology such as heart rate monitors with corresponding smartphone applications (eg, Fitbit, Jawbone Up devices, and the Whoop device) are increasing as a means of monitoring sleep as well as delivering insomnia interventions.³⁶

Actigraphy has been shown to produce significantly distinct results from self-­reporting when measuring total sleep time, sleep-onset latency, wake-after-sleep onset, and sleep efficiency in adult and pediatric patients with insomnia.³⁷ Actigraphy yields distinct estimates of sleep patterns when compared to sleep logs, which suggests that while both measures are often correlated, actigraphy has utility in assessing sleep continuity in conjunction with sleep logs in terms of diagnostic and posttreatment ­assessment.³⁷

Continue to: Treatment options

Treatment options: Start with the nonpharmacologic

Both nonpharmacologic and pharmacologic interventions are available for the treatment of insomnia. Starting with nonpharmacologic options is preferred.

Nonpharmacologic interventions

Sleep hygiene. Poor sleep hygiene can contribute to insomnia but does not cause it.³¹ Healthy sleep habits include keeping the sleep environment quiet, free of interruptions, and at an adequate temperature; adhering to a regular sleep schedule; avoiding naps; going to bed when drowsy; getting out of bed if not asleep within 15 to 20 minutes and returning when drowsy; exercising regularly; and avoiding caffeine, nicotine, alcohol, and other substances that interfere with sleep.²⁴ Technology use prior to bedtime is prevalent and associated with sleep and circadian rhythm disturbances.³⁸

Sleep hygiene education is often insufficient on its own.³¹ But it has been shown to benefit older adults with insomnia.^19,32

Sleep hygiene during pregnancy emphasizes drinking fluids only in the daytime to avoid awakening to urinate at night, avoiding specific foods to decrease heartburn, napping only in the early part of the day, and sleeping on either the left or the right side of the body with knees and hips bent and a pillow under pressure points in the second and third trimesters.^18,39

Pediatric insomnia. Sleep hygiene is an important first-line treatment for pediatric insomnia, especially among children with attention-deficit/hyperactivity disorder.⁴⁰

Continue to: CBT-I

Cognitive behavioral therapy for insomnia (CBT-I). US and European guidelines recommend CBT-I—a multicomponent, nonpharmacologic, insomnia-focused psychotherapy—as a first-line treatment for short- and long-term insomnia^32,41,42 across a wide range of patient demographics.^17,43-47 CBT-I is a multiweek intensive treatment that combines sleep hygiene practices with cognitive therapy and behavioral interventions, including stimulus control, sleep restriction, and relaxation training.^32,48 CBT-I monotherapy has been shown to have greater efficacy than sleep hygiene education for patients with insomnia, especially for those with medical or psychiatric comorbidities.⁴⁹ It also has been shown to be effective when delivered in person or even digitally.^50-52 For example, CBT-I Coach is a mobile application for people who are already engaged in CBT-I with a health care provider; it provides a structured program to alleviate symptoms.⁵³

Although CBT-I methods are appropriate for adolescents and school-aged children, evaluations of the efficacy of the individual components (stimulus control, arousal reduction, cognitive therapy, improved sleep hygiene practices, and sleep restriction) are needed to understand what methods are most effective in this population.⁹

Cognitive and/or behavioral Interventions. Cognitive therapy (to change negative thoughts about sleep) and behavioral interventions (eg, changes to sleep routines, sleep restriction, moving the child’s bedtime to match the time of falling asleep [bedtime fading],⁴¹ stimulus control)^9,43,54-56 may be used independently. Separate meta-analyses support the use of cognitive and behavioral interventions for adolescent insomnia,^9,43 school-aged children with insomnia and sleep difficulties,^43,49 and adolescents with sleep difficulties and daytime fatigue.⁴¹ The trials for children and adolescents followed the same recommendations for treatment as CBT-I but often used fewer components of the treatment, resulting in focused cognitive or behavioral interventions.

Cognitive behavioral therapy for insomnia is a first-line treatment for short- and long-term insomnia across a wide range of patients.

One controlled evaluation showed support for separate cognitive and behavioral techniques for insomnia in children.⁵⁴ A meta-analysis (6 studies; N = 529) found that total sleep time, as measured with actigraphy, improved among school-aged children and adolescents with insomnia after treatment with 4 or more types of cognitive or behavioral therapy sessions.⁴³ Sleep-onset latency, measured by actigraphy and sleep diaries, decreased in the intervention group.⁴³

A controlled evaluation of CBT for behavioral insomnia in school-aged children (N = 42) randomized participants to CBT (n = 21) or waitlist control (n = 21).⁵⁴ The 6 CBT sessions combined behavioral sleep medicine techniques (ie, sleep restriction) with anxiety treatment techniques (eg, cognitive restructuring).⁵⁴ Those in the intervention group showed statistically significant improvement in sleep latency, wake-after-sleep onset, and sleep efficiency (all P ≤ .003), compared with controls.⁵⁴ Total sleep time was unaffected by the intervention. A notable change was the number of patients who still had an insomnia diagnosis postintervention. Among children in the CBT group, 14.3% met diagnostic criteria vs 95% of children in the control group.⁵⁴ Similarly, at the 1-month ­follow-up, 9.5% of CBT group members still had insomnia, compared with 86.7% of the control group participants.⁵⁴

Continue to: Multiple randomized and nonranomized studies...

Multiple randomized and nonrandomized studies have found that infants also respond to behavioral interventions, such as establishing regular daytime and sleep routines, reducing environmental noises or distractions, and allowing for self-soothing at bedtime.⁵⁵ A controlled trial (N = 279) of newborns and their mothers evaluated sleep interventions that included guidance on bedtime sleep routines, starting the routine 30 to 45 minutes before bedtime, choosing age-appropriate calming bedtime activities, not using feeding as the last step before bedtime, and offering the child choices with their routine.⁵⁶ The intervention group ­demonstrated longer sleep duration (624.6 ± 67.6 minutes vs 602.9 ± 76.1 minutes; P = .01) at 40 weeks postintervention compared with the control group.⁵⁶

The clinically significant outcomes of this study are related to the guidance offered to parents to help infants achieve longer sleep. More intervention-group infants were allowed to self-soothe to sleep without being held or fed, had earlier bedtimes, and fell asleep ≤ 15 minutes after being put into bed than their counterparts in the control group.⁵⁶

Exercise. As a sole intervention, exercise for insomnia is readily available and low cost, but it is not universally effective. One study of patients older than 60 years (N = 43) showed that a 16-week moderate exercise regimen slightly improved total sleep time by an average of 42 minutes (P = .05), sleep-onset latency improved an average of 11.5 minutes (P = .007), and global sleep quality improved by 3.4 points as measured by the Pittsburgh Sleep Quality Index (PSQI; P ≤ .01).⁵⁷ No significant improvements occurred in sleep efficiency. Exercise is one of several nonpharmacologic alternatives for treating insomnia in pregnancy.⁵⁸

As a sole intervention, exercise for insomnia is readily available and low cost, but it is not universally effective.

A lack of uniformity in patient populations, intervention protocols, and outcome measures confounded results of 2 systematic reviews that included comparisons of yoga or tai chi as standalone alternatives to CBT-I for insomnia treatment.^58,59 Other interventions, such as mindfulness or relaxation training, have been studied as insomnia interventions, but no conclusive evidence about their efficacy exists.^45,59

Pharmacologic interventions

Pharmacologic treatment should not be the sole intervention for the treatment of insomnia but should be used in combination with nonpharmacologic interventions.³² Of note, only low-quality evidence exists for any pharmacologic interventions for insomnia.³² The decision to prescribe medications should rely on the predominant sleep complaint, with sleep maintenance and sleep-onset latency as the guiding factors.³² Medications used for insomnia treatment (TABLE 3^32,60,61)are classified according to these and other sleep outcomes described in TABLE 1.^25-29 Prescribe them at the lowest dose and for the shortest amount of time possible.^32,62 Avoid medications listed in TABLE 4^{32,36,59,60,62-69} because data showing clinically significant improvements in insomnia are lacking, and analysis for potential harms is inadequate.³²

Continue to: Melatonin is not recommended

Melatonin is not recommended for treating insomnia in adults, pregnant patients, older adults, or most children because its effects are clinically insignificant,³² residual sedation has been reported,⁶⁰ and no analysis of harms has been undertaken.³² Despite this, melatonin is frequently utilized for insomnia, and patients take over-the-counter melatonin for a myriad of sleep complaints. Melatonin is indicated in the treatment of insomnia in children with neurodevelopmental disorders. (See discussion in "Prescribing for children.")

Hypnotics are medications licensed for short-term sleep promotion in adults and can induce tolerance and dependence.³² Nonbenzodiazepine-receptor agonists at clinical doses do not appear to suppress REM sleep, although there are reports of increases in latency to REM sleep.⁷⁰

Antidepressants. Although treatment of insomnia with antidepressants is widespread, evidence of their efficacy is unclear.^32,62 The tolerability and safety of antidepressants for insomnia also are uncertain due to limited reporting of adverse events.³²

The use of sedating antidepressants may be driven by concern over the longer-term use of hypnotics and the limited availability of psychological treatments including CBT-I.³² Sedating antidepressants are indicated for comorbid or secondary insomnia (attributable to mental health conditions, medical conditions, other sleep disorders, or substance use or misuse); however, there are few clinical trials studying them for primary insomnia treatment.⁶² Antidepressants—­tricyclic antidepressants included—can reduce the amount of REM sleep and increase REM sleep-onset latency.^71,72

Antihistamines and antipsychotics. Although antihistamines (eg, hydroxyzine, diphenhydramine) and antipsychotics frequently are prescribed off-label for primary insomnia, there is a lack of evidence to support either type of medication for this purpose.^36,62,73 H1-antihistamines such as hydroxyzine increase REM-onset latency and reduce the duration of REM sleep.⁷³ Depending on the specific medication, second-­generation antipsychotics such as olanzapine and quetiapine have mixed effects on REM sleep parameters.⁶⁵

Continue to: Prescribing for children

Prescribing for children. There is no FDA-approved medication for the treatment of insomnia in children.⁵² However, melatonin has shown promising results for treating insomnia in children with neurodevelopmental disorders. A systematic review (13 trials­; N = 682) with meta-analysis (9 studies; n = 541) showed that melatonin significantly improved total sleep time compared with placebo (mean difference [MD] = 48.26 minutes; 95% CI, 36.78-59.73).⁸ In 11 studies (n = 581), sleep-onset latency improved significantly with melatonin use.⁸ No difference was noted in the frequency of wake-after-sleep onset.⁸ No medication-related adverse events were reported. Heterogeneity (I² = 31%) and inconsistency among included studies shed doubt on the findings; therefore, further research is needed.⁸

Prescribing in pregnancy. Prescribing medications to treat insomnia in pregnancy is complex and controversial. No consistency exists among guidelines and recommendations for treating insomnia in the pregnant population. Pharmacotherapy for insomnia is frequently prescribed off-label in pregnant patients. Examples include benzodiazepine-receptor agonists, antidepressants, and gamma-aminobutyric acid–reuptake inhibitors.⁴⁵

Pharmacotherapy in pregnancy is a unique challenge, wherein clinicians consider not only the potential drug toxicity to the fetus but also the potential changes in the pregnant patient’s pharmacokinetics that influence appropriate medication doses.^39,74 Worth noting: Zolpidem has been associated with preterm birth, cesarean birth, and low-birth-weight infants.^45,74 The lack of clinical trials of pharmacotherapy in pregnant patients results in a limited understanding of medication effects on long-term health and safety outcomes in this population.^39,74

There is no FDA-approved medication for the treatment of insomnia in children.

A review of 3 studies with small sample sizes found that when antidepressants or antihistamines were taken during pregnancy, neither had significant adverse effects on mother or child.⁶⁸ Weigh the risks of medications with the risk for disease burden and apply a shared decision-making approach with the patient, including providing an accurate assessment of risks and safety information regarding medication use.³⁹ Online resources such as ReproTox (www.reprotox.org) and MotherToBaby (https://mothertobaby.org) are available to support clinicians treating pregnant and lactating patients.³⁹

Prescribing for older adults. Treatment of insomnia in older adults requires a multifactorial approach.²² For all older adults, start interventions with nonpharmacologic treatments for insomnia followed by treatment of any underlying medical and psychiatric disorders that affect sleep.²¹ If medications are required, start with the lowest dose and titrate upward slowly. Use sedating low-dose antidepressants for insomnia only when the older patient has comorbid depression.⁶⁰ Although nonbenzodiazepine-receptor agonists have improved safety profiles compared with benzodiazepines, their use for older adults should be limited because of adverse effects that include dementia, serious injury, and falls with fractures.⁶⁰

Keep these points in mind

Prescribing medications to treat insomnia in pregnancy is complex and controversial.

Poor sleep has many detrimental health effects and can significantly affect quality of life for patients across the lifespan. Use nonpharmacologic interventions—such as sleep hygiene education, CBT-I, and cognitive/behavioral therapies—as first-line treatments. When utilizing pharmacotherapy for insomnia, consider the patient’s distressing symptoms of insomnia as guideposts for prescribing. Use pharmacologic treatments intermittently, short term, and in conjunction with nonpharmacologic options.

CORRESPONDENCE
Angela L. Colistra, PhD, LPC, CAADC, CCS, 707 Hamilton Street, 8th floor, LVHN Department of Family Medicine, Allentown, PA 18101; [email protected]

Insomnia disorder is common throughout the lifespan, affecting up to 22% of the population.¹ Insomnia has a negative effect on patients’ quality of life and is associated with reported worse health-related quality of life, greater overall work impairment, and higher utilization of health care resources compared to patients without insomnia.²

Fortunately, many validated diagnostic tools are available to support physicians in the care of affected patients. In addition, many pharmacologic and nonpharmacologic treatment options exist. This review endeavors to help you refine the care you provide to patients across the lifespan by reviewing the evidence-based strategies for the diagnosis and treatment of insomnia in children, adolescents, and adults.

Defining insomnia

The Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5) defines insomnia disorder as a predominant complaint of dissatisfaction with sleep quantity or quality, associated with 1 or more of the following³:

1. Difficulty initiating sleep. (In children, this may manifest as difficulty initiating sleep without caregiver intervention.)

2. Difficulty maintaining sleep, characterized by frequent awakenings or problems returning to sleep after awakenings. (In children, this may manifest as difficulty returning to sleep without caregiver intervention.)

3. Early-morning awakening with inability to return to sleep.

Sleep difficulty must be present for at least 3 months and must occur at least 3 nights per week to be classified as persistent insomnia.³ If symptoms last fewer than 3 months, insomnia is considered acute, which has a different DSM-5 code ("other specified insomnia disorder").³ Primary insomnia is its own diagnosis that cannot be defined by other sleep-wake ­cycle disorders, mental health conditions, or medical diagnoses that cause sleep disturbances, nor is it attributable to the physiologic effects of a substance (eg, substance use disorders, medication effects).³

Studies have shown that older adults who sleep fewer than 5 hours per night have an increased risk for diabetes and metabolic syndrome.

The International Classification of Sleep Disorders, 3rd edition (ICSD-3) notably consolidates all insomnia diagnoses (ie, “primary” and “comorbid”) under a single diagnosis (“chronic insomnia disorder”), which is a distinction from the DSM-5 diagnosis in terms of classification.⁴ Diagnosis of insomnia requires the presence of 3 criteria: (1) persistence of sleep difficulty, (2) adequate opportunity for sleep, and (3) associated daytime dysfunction.⁵

How insomnia affects specific patient populations

Children and adolescents. Appropriate screening, diagnosis, and interventions for insomnia in children and adolescents are associated with better health outcomes, including improved attention, behavior, learning, memory, emotional regulation, quality of life, and mental and physical health.⁶ In one study of insomnia in the pediatric population (N = 1038), 41% of parents reported symptoms of sleep disturbances in their children.⁷ Pediatric insomnia can lead to impaired attention, poor academic performance, and behavioral disturbances.⁷ In addition, there is a high prevalence of sleep disturbances in children with neurodevelopmental disorders.⁸

Insomnia is the most prevalent sleep disorder in adolescents but frequently goes unrecognized, and therefore is underdiagnosed and undertreated.⁹ Insomnia in adolescents is associated with depression and suicidality.^9-12 Growing evidence also links it to anorexia nervosa,¹³ substance use disorders,¹⁴ and impaired neurocognitive function.¹⁵

Continue to: Pregnant women

Pregnant women. Sleep disorders in pregnancy are common and influenced by multiple factors. A meta-analysis found that 57% to 74% of women in various trimesters of pregnancy reported subthreshold symptoms of insomnia¹⁶; however, changes in sleep duration and sleep quality during pregnancy may be related to hormonal, physiologic, metabolic, psychological, and posture mechanisms.^17,18

Sleep quality also worsens as pregnancy progresses.¹⁶ Insomnia coupled with poor sleep quality has been shown to increase the risk for postpartum depression, premature delivery, prolonged labor, and cesarean delivery, as well as preeclampsia, gestational hypertension, stillbirth, and large-for-­gestational-age infants.^19,20

Older adults. Insomnia is a common complaint in the geriatric population and is associated with significant morbidity, as well as higher rates of depression and suicidality.²¹ Circadian rhythms change and sleep cycles advance as people age, leading to a decrease in total sleep time, earlier sleep onset, earlier awakenings,and increased frequency of waking after sleep onset.^21,22 Advanced age, polypharmacy, and high medical comorbidity increase insomnia prevalence.²³

Technology use prior to bedtime is prevalent and associated with sleep and circadian rhythm disturbances.

Studies have shown that older adults who sleep fewer than 5 hours per night have an increased risk for diabetes and metabolic syndrome.²¹ Sleep loss also has been linked to increased rates of hypertension, coronary ­ar­tery disease, myocardial infarction, and possibly stroke.^21,22 Poor sleep has been associated with increased rates of cortical atrophy in community-dwelling older adults.²¹ Daytime drowsiness increases fall risk.²² Older adults with self-reported decreased physical function also had increased rates of insomnia and increased rates of daytime sleepiness.²²

Making the diagnosis: What to ask, tools to use

Clinical evaluation is most helpful for diagnosing insomnia.²⁴ A complete work-up includes physical examination, review of medications and supplements, evaluation of a 2-week sleep diary (kept by the patient, parent, or caregiver), and assessment using a validated sleep-quality rating scale.²⁴ Be sure to obtain a complete health history, including medical events, substance use, and psychiatric history.²⁴

Continue to: Inquire about sleep initiation...

Inquire about sleep initiation, sleep maintenance, and early awakening, as well as behavioral and environmental factors that may contribute to sleep concerns.^10,18 Consider medical sleep disorders that have overlapping symptoms with insomnia, including obstructive sleep apnea (OSA), restless leg syndrome (RLS), or circadian rhythm sleep-wake disorders. If there are co-occurring chronic medical problems, reassess insomnia symptoms after the other medical diagnoses are controlled.

TABLE 1^25-29 includes a list of validated screening tools for insomnia and where they can be accessed. Recommended screening tools for children and adolescents include daytime sleepiness questionnaires, comprehensive sleep instruments, and self-assessments.^25,30 Although several studies of insomnia in pregnancy have used tools listed in TABLE 1,^25-29 only the Insomnia Severity Index has been validated for use with this population.^26,27 Diagnosis of insomnia in older adults requires a comprehensive sleep history collected from the patient, partners, or caregivers.²¹

Measuring sleep performance

Several aspects of insomnia (defined in ­TABLE 2^31-33) are targeted as outcome measures when treating patients. Sleep-onset latency, total sleep time, and wake-after-sleep onset are all formally measured by polysomnography.^31-33 Use polysomnography when you suspect OSA, narcolepsy, idiopathic hypersomnia, periodic limb movement disorder, RLS, REM behavior disorder (characterized by the loss of normal muscle atonia and dream enactment behavior that is violent in nature³⁴), or parasomnias. Home polysomnography testing is appropriate for adult patients who meet criteria for OSA and have uncomplicated insomnia.³⁵ Self-reporting (use of sleep logs) and actigraphy (measurement by wearable monitoring devices) may be more accessible methods for gathering sleep data from patients. Use of wearable consumer sleep technology such as heart rate monitors with corresponding smartphone applications (eg, Fitbit, Jawbone Up devices, and the Whoop device) are increasing as a means of monitoring sleep as well as delivering insomnia interventions.³⁶

Actigraphy has been shown to produce significantly distinct results from self-­reporting when measuring total sleep time, sleep-onset latency, wake-after-sleep onset, and sleep efficiency in adult and pediatric patients with insomnia.³⁷ Actigraphy yields distinct estimates of sleep patterns when compared to sleep logs, which suggests that while both measures are often correlated, actigraphy has utility in assessing sleep continuity in conjunction with sleep logs in terms of diagnostic and posttreatment ­assessment.³⁷

Continue to: Treatment options

Treatment options: Start with the nonpharmacologic

Both nonpharmacologic and pharmacologic interventions are available for the treatment of insomnia. Starting with nonpharmacologic options is preferred.

Nonpharmacologic interventions

Sleep hygiene. Poor sleep hygiene can contribute to insomnia but does not cause it.³¹ Healthy sleep habits include keeping the sleep environment quiet, free of interruptions, and at an adequate temperature; adhering to a regular sleep schedule; avoiding naps; going to bed when drowsy; getting out of bed if not asleep within 15 to 20 minutes and returning when drowsy; exercising regularly; and avoiding caffeine, nicotine, alcohol, and other substances that interfere with sleep.²⁴ Technology use prior to bedtime is prevalent and associated with sleep and circadian rhythm disturbances.³⁸

Sleep hygiene education is often insufficient on its own.³¹ But it has been shown to benefit older adults with insomnia.^19,32

Sleep hygiene during pregnancy emphasizes drinking fluids only in the daytime to avoid awakening to urinate at night, avoiding specific foods to decrease heartburn, napping only in the early part of the day, and sleeping on either the left or the right side of the body with knees and hips bent and a pillow under pressure points in the second and third trimesters.^18,39

Pediatric insomnia. Sleep hygiene is an important first-line treatment for pediatric insomnia, especially among children with attention-deficit/hyperactivity disorder.⁴⁰

Continue to: CBT-I

Cognitive behavioral therapy for insomnia (CBT-I). US and European guidelines recommend CBT-I—a multicomponent, nonpharmacologic, insomnia-focused psychotherapy—as a first-line treatment for short- and long-term insomnia^32,41,42 across a wide range of patient demographics.^17,43-47 CBT-I is a multiweek intensive treatment that combines sleep hygiene practices with cognitive therapy and behavioral interventions, including stimulus control, sleep restriction, and relaxation training.^32,48 CBT-I monotherapy has been shown to have greater efficacy than sleep hygiene education for patients with insomnia, especially for those with medical or psychiatric comorbidities.⁴⁹ It also has been shown to be effective when delivered in person or even digitally.^50-52 For example, CBT-I Coach is a mobile application for people who are already engaged in CBT-I with a health care provider; it provides a structured program to alleviate symptoms.⁵³

Although CBT-I methods are appropriate for adolescents and school-aged children, evaluations of the efficacy of the individual components (stimulus control, arousal reduction, cognitive therapy, improved sleep hygiene practices, and sleep restriction) are needed to understand what methods are most effective in this population.⁹

Cognitive and/or behavioral Interventions. Cognitive therapy (to change negative thoughts about sleep) and behavioral interventions (eg, changes to sleep routines, sleep restriction, moving the child’s bedtime to match the time of falling asleep [bedtime fading],⁴¹ stimulus control)^9,43,54-56 may be used independently. Separate meta-analyses support the use of cognitive and behavioral interventions for adolescent insomnia,^9,43 school-aged children with insomnia and sleep difficulties,^43,49 and adolescents with sleep difficulties and daytime fatigue.⁴¹ The trials for children and adolescents followed the same recommendations for treatment as CBT-I but often used fewer components of the treatment, resulting in focused cognitive or behavioral interventions.

Cognitive behavioral therapy for insomnia is a first-line treatment for short- and long-term insomnia across a wide range of patients.

One controlled evaluation showed support for separate cognitive and behavioral techniques for insomnia in children.⁵⁴ A meta-analysis (6 studies; N = 529) found that total sleep time, as measured with actigraphy, improved among school-aged children and adolescents with insomnia after treatment with 4 or more types of cognitive or behavioral therapy sessions.⁴³ Sleep-onset latency, measured by actigraphy and sleep diaries, decreased in the intervention group.⁴³

A controlled evaluation of CBT for behavioral insomnia in school-aged children (N = 42) randomized participants to CBT (n = 21) or waitlist control (n = 21).⁵⁴ The 6 CBT sessions combined behavioral sleep medicine techniques (ie, sleep restriction) with anxiety treatment techniques (eg, cognitive restructuring).⁵⁴ Those in the intervention group showed statistically significant improvement in sleep latency, wake-after-sleep onset, and sleep efficiency (all P ≤ .003), compared with controls.⁵⁴ Total sleep time was unaffected by the intervention. A notable change was the number of patients who still had an insomnia diagnosis postintervention. Among children in the CBT group, 14.3% met diagnostic criteria vs 95% of children in the control group.⁵⁴ Similarly, at the 1-month ­follow-up, 9.5% of CBT group members still had insomnia, compared with 86.7% of the control group participants.⁵⁴

Continue to: Multiple randomized and nonranomized studies...

Multiple randomized and nonrandomized studies have found that infants also respond to behavioral interventions, such as establishing regular daytime and sleep routines, reducing environmental noises or distractions, and allowing for self-soothing at bedtime.⁵⁵ A controlled trial (N = 279) of newborns and their mothers evaluated sleep interventions that included guidance on bedtime sleep routines, starting the routine 30 to 45 minutes before bedtime, choosing age-appropriate calming bedtime activities, not using feeding as the last step before bedtime, and offering the child choices with their routine.⁵⁶ The intervention group ­demonstrated longer sleep duration (624.6 ± 67.6 minutes vs 602.9 ± 76.1 minutes; P = .01) at 40 weeks postintervention compared with the control group.⁵⁶

The clinically significant outcomes of this study are related to the guidance offered to parents to help infants achieve longer sleep. More intervention-group infants were allowed to self-soothe to sleep without being held or fed, had earlier bedtimes, and fell asleep ≤ 15 minutes after being put into bed than their counterparts in the control group.⁵⁶

Exercise. As a sole intervention, exercise for insomnia is readily available and low cost, but it is not universally effective. One study of patients older than 60 years (N = 43) showed that a 16-week moderate exercise regimen slightly improved total sleep time by an average of 42 minutes (P = .05), sleep-onset latency improved an average of 11.5 minutes (P = .007), and global sleep quality improved by 3.4 points as measured by the Pittsburgh Sleep Quality Index (PSQI; P ≤ .01).⁵⁷ No significant improvements occurred in sleep efficiency. Exercise is one of several nonpharmacologic alternatives for treating insomnia in pregnancy.⁵⁸

As a sole intervention, exercise for insomnia is readily available and low cost, but it is not universally effective.

A lack of uniformity in patient populations, intervention protocols, and outcome measures confounded results of 2 systematic reviews that included comparisons of yoga or tai chi as standalone alternatives to CBT-I for insomnia treatment.^58,59 Other interventions, such as mindfulness or relaxation training, have been studied as insomnia interventions, but no conclusive evidence about their efficacy exists.^45,59

Pharmacologic interventions

Pharmacologic treatment should not be the sole intervention for the treatment of insomnia but should be used in combination with nonpharmacologic interventions.³² Of note, only low-quality evidence exists for any pharmacologic interventions for insomnia.³² The decision to prescribe medications should rely on the predominant sleep complaint, with sleep maintenance and sleep-onset latency as the guiding factors.³² Medications used for insomnia treatment (TABLE 3^32,60,61)are classified according to these and other sleep outcomes described in TABLE 1.^25-29 Prescribe them at the lowest dose and for the shortest amount of time possible.^32,62 Avoid medications listed in TABLE 4^{32,36,59,60,62-69} because data showing clinically significant improvements in insomnia are lacking, and analysis for potential harms is inadequate.³²

Continue to: Melatonin is not recommended

Melatonin is not recommended for treating insomnia in adults, pregnant patients, older adults, or most children because its effects are clinically insignificant,³² residual sedation has been reported,⁶⁰ and no analysis of harms has been undertaken.³² Despite this, melatonin is frequently utilized for insomnia, and patients take over-the-counter melatonin for a myriad of sleep complaints. Melatonin is indicated in the treatment of insomnia in children with neurodevelopmental disorders. (See discussion in "Prescribing for children.")

Hypnotics are medications licensed for short-term sleep promotion in adults and can induce tolerance and dependence.³² Nonbenzodiazepine-receptor agonists at clinical doses do not appear to suppress REM sleep, although there are reports of increases in latency to REM sleep.⁷⁰

Antidepressants. Although treatment of insomnia with antidepressants is widespread, evidence of their efficacy is unclear.^32,62 The tolerability and safety of antidepressants for insomnia also are uncertain due to limited reporting of adverse events.³²

The use of sedating antidepressants may be driven by concern over the longer-term use of hypnotics and the limited availability of psychological treatments including CBT-I.³² Sedating antidepressants are indicated for comorbid or secondary insomnia (attributable to mental health conditions, medical conditions, other sleep disorders, or substance use or misuse); however, there are few clinical trials studying them for primary insomnia treatment.⁶² Antidepressants—­tricyclic antidepressants included—can reduce the amount of REM sleep and increase REM sleep-onset latency.^71,72

Antihistamines and antipsychotics. Although antihistamines (eg, hydroxyzine, diphenhydramine) and antipsychotics frequently are prescribed off-label for primary insomnia, there is a lack of evidence to support either type of medication for this purpose.^36,62,73 H1-antihistamines such as hydroxyzine increase REM-onset latency and reduce the duration of REM sleep.⁷³ Depending on the specific medication, second-­generation antipsychotics such as olanzapine and quetiapine have mixed effects on REM sleep parameters.⁶⁵

Continue to: Prescribing for children

Prescribing for children. There is no FDA-approved medication for the treatment of insomnia in children.⁵² However, melatonin has shown promising results for treating insomnia in children with neurodevelopmental disorders. A systematic review (13 trials­; N = 682) with meta-analysis (9 studies; n = 541) showed that melatonin significantly improved total sleep time compared with placebo (mean difference [MD] = 48.26 minutes; 95% CI, 36.78-59.73).⁸ In 11 studies (n = 581), sleep-onset latency improved significantly with melatonin use.⁸ No difference was noted in the frequency of wake-after-sleep onset.⁸ No medication-related adverse events were reported. Heterogeneity (I² = 31%) and inconsistency among included studies shed doubt on the findings; therefore, further research is needed.⁸

Prescribing in pregnancy. Prescribing medications to treat insomnia in pregnancy is complex and controversial. No consistency exists among guidelines and recommendations for treating insomnia in the pregnant population. Pharmacotherapy for insomnia is frequently prescribed off-label in pregnant patients. Examples include benzodiazepine-receptor agonists, antidepressants, and gamma-aminobutyric acid–reuptake inhibitors.⁴⁵

Pharmacotherapy in pregnancy is a unique challenge, wherein clinicians consider not only the potential drug toxicity to the fetus but also the potential changes in the pregnant patient’s pharmacokinetics that influence appropriate medication doses.^39,74 Worth noting: Zolpidem has been associated with preterm birth, cesarean birth, and low-birth-weight infants.^45,74 The lack of clinical trials of pharmacotherapy in pregnant patients results in a limited understanding of medication effects on long-term health and safety outcomes in this population.^39,74

There is no FDA-approved medication for the treatment of insomnia in children.

A review of 3 studies with small sample sizes found that when antidepressants or antihistamines were taken during pregnancy, neither had significant adverse effects on mother or child.⁶⁸ Weigh the risks of medications with the risk for disease burden and apply a shared decision-making approach with the patient, including providing an accurate assessment of risks and safety information regarding medication use.³⁹ Online resources such as ReproTox (www.reprotox.org) and MotherToBaby (https://mothertobaby.org) are available to support clinicians treating pregnant and lactating patients.³⁹

Prescribing for older adults. Treatment of insomnia in older adults requires a multifactorial approach.²² For all older adults, start interventions with nonpharmacologic treatments for insomnia followed by treatment of any underlying medical and psychiatric disorders that affect sleep.²¹ If medications are required, start with the lowest dose and titrate upward slowly. Use sedating low-dose antidepressants for insomnia only when the older patient has comorbid depression.⁶⁰ Although nonbenzodiazepine-receptor agonists have improved safety profiles compared with benzodiazepines, their use for older adults should be limited because of adverse effects that include dementia, serious injury, and falls with fractures.⁶⁰

Keep these points in mind

Prescribing medications to treat insomnia in pregnancy is complex and controversial.

Poor sleep has many detrimental health effects and can significantly affect quality of life for patients across the lifespan. Use nonpharmacologic interventions—such as sleep hygiene education, CBT-I, and cognitive/behavioral therapies—as first-line treatments. When utilizing pharmacotherapy for insomnia, consider the patient’s distressing symptoms of insomnia as guideposts for prescribing. Use pharmacologic treatments intermittently, short term, and in conjunction with nonpharmacologic options.

CORRESPONDENCE
Angela L. Colistra, PhD, LPC, CAADC, CCS, 707 Hamilton Street, 8th floor, LVHN Department of Family Medicine, Allentown, PA 18101; [email protected]

Insomnia disorder is common throughout the lifespan, affecting up to 22% of the population.¹ Insomnia has a negative effect on patients’ quality of life and is associated with reported worse health-related quality of life, greater overall work impairment, and higher utilization of health care resources compared to patients without insomnia.²

Fortunately, many validated diagnostic tools are available to support physicians in the care of affected patients. In addition, many pharmacologic and nonpharmacologic treatment options exist. This review endeavors to help you refine the care you provide to patients across the lifespan by reviewing the evidence-based strategies for the diagnosis and treatment of insomnia in children, adolescents, and adults.

Defining insomnia

The Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5) defines insomnia disorder as a predominant complaint of dissatisfaction with sleep quantity or quality, associated with 1 or more of the following³:

1. Difficulty initiating sleep. (In children, this may manifest as difficulty initiating sleep without caregiver intervention.)

2. Difficulty maintaining sleep, characterized by frequent awakenings or problems returning to sleep after awakenings. (In children, this may manifest as difficulty returning to sleep without caregiver intervention.)

3. Early-morning awakening with inability to return to sleep.

Sleep difficulty must be present for at least 3 months and must occur at least 3 nights per week to be classified as persistent insomnia.³ If symptoms last fewer than 3 months, insomnia is considered acute, which has a different DSM-5 code ("other specified insomnia disorder").³ Primary insomnia is its own diagnosis that cannot be defined by other sleep-wake ­cycle disorders, mental health conditions, or medical diagnoses that cause sleep disturbances, nor is it attributable to the physiologic effects of a substance (eg, substance use disorders, medication effects).³

Studies have shown that older adults who sleep fewer than 5 hours per night have an increased risk for diabetes and metabolic syndrome.

The International Classification of Sleep Disorders, 3rd edition (ICSD-3) notably consolidates all insomnia diagnoses (ie, “primary” and “comorbid”) under a single diagnosis (“chronic insomnia disorder”), which is a distinction from the DSM-5 diagnosis in terms of classification.⁴ Diagnosis of insomnia requires the presence of 3 criteria: (1) persistence of sleep difficulty, (2) adequate opportunity for sleep, and (3) associated daytime dysfunction.⁵

How insomnia affects specific patient populations

Children and adolescents. Appropriate screening, diagnosis, and interventions for insomnia in children and adolescents are associated with better health outcomes, including improved attention, behavior, learning, memory, emotional regulation, quality of life, and mental and physical health.⁶ In one study of insomnia in the pediatric population (N = 1038), 41% of parents reported symptoms of sleep disturbances in their children.⁷ Pediatric insomnia can lead to impaired attention, poor academic performance, and behavioral disturbances.⁷ In addition, there is a high prevalence of sleep disturbances in children with neurodevelopmental disorders.⁸

Insomnia is the most prevalent sleep disorder in adolescents but frequently goes unrecognized, and therefore is underdiagnosed and undertreated.⁹ Insomnia in adolescents is associated with depression and suicidality.^9-12 Growing evidence also links it to anorexia nervosa,¹³ substance use disorders,¹⁴ and impaired neurocognitive function.¹⁵

Continue to: Pregnant women

Pregnant women. Sleep disorders in pregnancy are common and influenced by multiple factors. A meta-analysis found that 57% to 74% of women in various trimesters of pregnancy reported subthreshold symptoms of insomnia¹⁶; however, changes in sleep duration and sleep quality during pregnancy may be related to hormonal, physiologic, metabolic, psychological, and posture mechanisms.^17,18

Sleep quality also worsens as pregnancy progresses.¹⁶ Insomnia coupled with poor sleep quality has been shown to increase the risk for postpartum depression, premature delivery, prolonged labor, and cesarean delivery, as well as preeclampsia, gestational hypertension, stillbirth, and large-for-­gestational-age infants.^19,20

Older adults. Insomnia is a common complaint in the geriatric population and is associated with significant morbidity, as well as higher rates of depression and suicidality.²¹ Circadian rhythms change and sleep cycles advance as people age, leading to a decrease in total sleep time, earlier sleep onset, earlier awakenings,and increased frequency of waking after sleep onset.^21,22 Advanced age, polypharmacy, and high medical comorbidity increase insomnia prevalence.²³

Technology use prior to bedtime is prevalent and associated with sleep and circadian rhythm disturbances.

Studies have shown that older adults who sleep fewer than 5 hours per night have an increased risk for diabetes and metabolic syndrome.²¹ Sleep loss also has been linked to increased rates of hypertension, coronary ­ar­tery disease, myocardial infarction, and possibly stroke.^21,22 Poor sleep has been associated with increased rates of cortical atrophy in community-dwelling older adults.²¹ Daytime drowsiness increases fall risk.²² Older adults with self-reported decreased physical function also had increased rates of insomnia and increased rates of daytime sleepiness.²²

Making the diagnosis: What to ask, tools to use

Clinical evaluation is most helpful for diagnosing insomnia.²⁴ A complete work-up includes physical examination, review of medications and supplements, evaluation of a 2-week sleep diary (kept by the patient, parent, or caregiver), and assessment using a validated sleep-quality rating scale.²⁴ Be sure to obtain a complete health history, including medical events, substance use, and psychiatric history.²⁴

Continue to: Inquire about sleep initiation...

Inquire about sleep initiation, sleep maintenance, and early awakening, as well as behavioral and environmental factors that may contribute to sleep concerns.^10,18 Consider medical sleep disorders that have overlapping symptoms with insomnia, including obstructive sleep apnea (OSA), restless leg syndrome (RLS), or circadian rhythm sleep-wake disorders. If there are co-occurring chronic medical problems, reassess insomnia symptoms after the other medical diagnoses are controlled.

TABLE 1^25-29 includes a list of validated screening tools for insomnia and where they can be accessed. Recommended screening tools for children and adolescents include daytime sleepiness questionnaires, comprehensive sleep instruments, and self-assessments.^25,30 Although several studies of insomnia in pregnancy have used tools listed in TABLE 1,^25-29 only the Insomnia Severity Index has been validated for use with this population.^26,27 Diagnosis of insomnia in older adults requires a comprehensive sleep history collected from the patient, partners, or caregivers.²¹

Measuring sleep performance

Several aspects of insomnia (defined in ­TABLE 2^31-33) are targeted as outcome measures when treating patients. Sleep-onset latency, total sleep time, and wake-after-sleep onset are all formally measured by polysomnography.^31-33 Use polysomnography when you suspect OSA, narcolepsy, idiopathic hypersomnia, periodic limb movement disorder, RLS, REM behavior disorder (characterized by the loss of normal muscle atonia and dream enactment behavior that is violent in nature³⁴), or parasomnias. Home polysomnography testing is appropriate for adult patients who meet criteria for OSA and have uncomplicated insomnia.³⁵ Self-reporting (use of sleep logs) and actigraphy (measurement by wearable monitoring devices) may be more accessible methods for gathering sleep data from patients. Use of wearable consumer sleep technology such as heart rate monitors with corresponding smartphone applications (eg, Fitbit, Jawbone Up devices, and the Whoop device) are increasing as a means of monitoring sleep as well as delivering insomnia interventions.³⁶

Actigraphy has been shown to produce significantly distinct results from self-­reporting when measuring total sleep time, sleep-onset latency, wake-after-sleep onset, and sleep efficiency in adult and pediatric patients with insomnia.³⁷ Actigraphy yields distinct estimates of sleep patterns when compared to sleep logs, which suggests that while both measures are often correlated, actigraphy has utility in assessing sleep continuity in conjunction with sleep logs in terms of diagnostic and posttreatment ­assessment.³⁷

Continue to: Treatment options

Treatment options: Start with the nonpharmacologic

Both nonpharmacologic and pharmacologic interventions are available for the treatment of insomnia. Starting with nonpharmacologic options is preferred.

Nonpharmacologic interventions

Sleep hygiene. Poor sleep hygiene can contribute to insomnia but does not cause it.³¹ Healthy sleep habits include keeping the sleep environment quiet, free of interruptions, and at an adequate temperature; adhering to a regular sleep schedule; avoiding naps; going to bed when drowsy; getting out of bed if not asleep within 15 to 20 minutes and returning when drowsy; exercising regularly; and avoiding caffeine, nicotine, alcohol, and other substances that interfere with sleep.²⁴ Technology use prior to bedtime is prevalent and associated with sleep and circadian rhythm disturbances.³⁸

Sleep hygiene education is often insufficient on its own.³¹ But it has been shown to benefit older adults with insomnia.^19,32

Sleep hygiene during pregnancy emphasizes drinking fluids only in the daytime to avoid awakening to urinate at night, avoiding specific foods to decrease heartburn, napping only in the early part of the day, and sleeping on either the left or the right side of the body with knees and hips bent and a pillow under pressure points in the second and third trimesters.^18,39

Pediatric insomnia. Sleep hygiene is an important first-line treatment for pediatric insomnia, especially among children with attention-deficit/hyperactivity disorder.⁴⁰

Continue to: CBT-I

Cognitive behavioral therapy for insomnia (CBT-I). US and European guidelines recommend CBT-I—a multicomponent, nonpharmacologic, insomnia-focused psychotherapy—as a first-line treatment for short- and long-term insomnia^32,41,42 across a wide range of patient demographics.^17,43-47 CBT-I is a multiweek intensive treatment that combines sleep hygiene practices with cognitive therapy and behavioral interventions, including stimulus control, sleep restriction, and relaxation training.^32,48 CBT-I monotherapy has been shown to have greater efficacy than sleep hygiene education for patients with insomnia, especially for those with medical or psychiatric comorbidities.⁴⁹ It also has been shown to be effective when delivered in person or even digitally.^50-52 For example, CBT-I Coach is a mobile application for people who are already engaged in CBT-I with a health care provider; it provides a structured program to alleviate symptoms.⁵³

Although CBT-I methods are appropriate for adolescents and school-aged children, evaluations of the efficacy of the individual components (stimulus control, arousal reduction, cognitive therapy, improved sleep hygiene practices, and sleep restriction) are needed to understand what methods are most effective in this population.⁹

Cognitive and/or behavioral Interventions. Cognitive therapy (to change negative thoughts about sleep) and behavioral interventions (eg, changes to sleep routines, sleep restriction, moving the child’s bedtime to match the time of falling asleep [bedtime fading],⁴¹ stimulus control)^9,43,54-56 may be used independently. Separate meta-analyses support the use of cognitive and behavioral interventions for adolescent insomnia,^9,43 school-aged children with insomnia and sleep difficulties,^43,49 and adolescents with sleep difficulties and daytime fatigue.⁴¹ The trials for children and adolescents followed the same recommendations for treatment as CBT-I but often used fewer components of the treatment, resulting in focused cognitive or behavioral interventions.

Cognitive behavioral therapy for insomnia is a first-line treatment for short- and long-term insomnia across a wide range of patients.

One controlled evaluation showed support for separate cognitive and behavioral techniques for insomnia in children.⁵⁴ A meta-analysis (6 studies; N = 529) found that total sleep time, as measured with actigraphy, improved among school-aged children and adolescents with insomnia after treatment with 4 or more types of cognitive or behavioral therapy sessions.⁴³ Sleep-onset latency, measured by actigraphy and sleep diaries, decreased in the intervention group.⁴³

A controlled evaluation of CBT for behavioral insomnia in school-aged children (N = 42) randomized participants to CBT (n = 21) or waitlist control (n = 21).⁵⁴ The 6 CBT sessions combined behavioral sleep medicine techniques (ie, sleep restriction) with anxiety treatment techniques (eg, cognitive restructuring).⁵⁴ Those in the intervention group showed statistically significant improvement in sleep latency, wake-after-sleep onset, and sleep efficiency (all P ≤ .003), compared with controls.⁵⁴ Total sleep time was unaffected by the intervention. A notable change was the number of patients who still had an insomnia diagnosis postintervention. Among children in the CBT group, 14.3% met diagnostic criteria vs 95% of children in the control group.⁵⁴ Similarly, at the 1-month ­follow-up, 9.5% of CBT group members still had insomnia, compared with 86.7% of the control group participants.⁵⁴

Continue to: Multiple randomized and nonranomized studies...

Multiple randomized and nonrandomized studies have found that infants also respond to behavioral interventions, such as establishing regular daytime and sleep routines, reducing environmental noises or distractions, and allowing for self-soothing at bedtime.⁵⁵ A controlled trial (N = 279) of newborns and their mothers evaluated sleep interventions that included guidance on bedtime sleep routines, starting the routine 30 to 45 minutes before bedtime, choosing age-appropriate calming bedtime activities, not using feeding as the last step before bedtime, and offering the child choices with their routine.⁵⁶ The intervention group ­demonstrated longer sleep duration (624.6 ± 67.6 minutes vs 602.9 ± 76.1 minutes; P = .01) at 40 weeks postintervention compared with the control group.⁵⁶

The clinically significant outcomes of this study are related to the guidance offered to parents to help infants achieve longer sleep. More intervention-group infants were allowed to self-soothe to sleep without being held or fed, had earlier bedtimes, and fell asleep ≤ 15 minutes after being put into bed than their counterparts in the control group.⁵⁶

Exercise. As a sole intervention, exercise for insomnia is readily available and low cost, but it is not universally effective. One study of patients older than 60 years (N = 43) showed that a 16-week moderate exercise regimen slightly improved total sleep time by an average of 42 minutes (P = .05), sleep-onset latency improved an average of 11.5 minutes (P = .007), and global sleep quality improved by 3.4 points as measured by the Pittsburgh Sleep Quality Index (PSQI; P ≤ .01).⁵⁷ No significant improvements occurred in sleep efficiency. Exercise is one of several nonpharmacologic alternatives for treating insomnia in pregnancy.⁵⁸

As a sole intervention, exercise for insomnia is readily available and low cost, but it is not universally effective.

A lack of uniformity in patient populations, intervention protocols, and outcome measures confounded results of 2 systematic reviews that included comparisons of yoga or tai chi as standalone alternatives to CBT-I for insomnia treatment.^58,59 Other interventions, such as mindfulness or relaxation training, have been studied as insomnia interventions, but no conclusive evidence about their efficacy exists.^45,59

Pharmacologic interventions

Pharmacologic treatment should not be the sole intervention for the treatment of insomnia but should be used in combination with nonpharmacologic interventions.³² Of note, only low-quality evidence exists for any pharmacologic interventions for insomnia.³² The decision to prescribe medications should rely on the predominant sleep complaint, with sleep maintenance and sleep-onset latency as the guiding factors.³² Medications used for insomnia treatment (TABLE 3^32,60,61)are classified according to these and other sleep outcomes described in TABLE 1.^25-29 Prescribe them at the lowest dose and for the shortest amount of time possible.^32,62 Avoid medications listed in TABLE 4^{32,36,59,60,62-69} because data showing clinically significant improvements in insomnia are lacking, and analysis for potential harms is inadequate.³²

Continue to: Melatonin is not recommended

Melatonin is not recommended for treating insomnia in adults, pregnant patients, older adults, or most children because its effects are clinically insignificant,³² residual sedation has been reported,⁶⁰ and no analysis of harms has been undertaken.³² Despite this, melatonin is frequently utilized for insomnia, and patients take over-the-counter melatonin for a myriad of sleep complaints. Melatonin is indicated in the treatment of insomnia in children with neurodevelopmental disorders. (See discussion in "Prescribing for children.")

Hypnotics are medications licensed for short-term sleep promotion in adults and can induce tolerance and dependence.³² Nonbenzodiazepine-receptor agonists at clinical doses do not appear to suppress REM sleep, although there are reports of increases in latency to REM sleep.⁷⁰

Antidepressants. Although treatment of insomnia with antidepressants is widespread, evidence of their efficacy is unclear.^32,62 The tolerability and safety of antidepressants for insomnia also are uncertain due to limited reporting of adverse events.³²

The use of sedating antidepressants may be driven by concern over the longer-term use of hypnotics and the limited availability of psychological treatments including CBT-I.³² Sedating antidepressants are indicated for comorbid or secondary insomnia (attributable to mental health conditions, medical conditions, other sleep disorders, or substance use or misuse); however, there are few clinical trials studying them for primary insomnia treatment.⁶² Antidepressants—­tricyclic antidepressants included—can reduce the amount of REM sleep and increase REM sleep-onset latency.^71,72

Antihistamines and antipsychotics. Although antihistamines (eg, hydroxyzine, diphenhydramine) and antipsychotics frequently are prescribed off-label for primary insomnia, there is a lack of evidence to support either type of medication for this purpose.^36,62,73 H1-antihistamines such as hydroxyzine increase REM-onset latency and reduce the duration of REM sleep.⁷³ Depending on the specific medication, second-­generation antipsychotics such as olanzapine and quetiapine have mixed effects on REM sleep parameters.⁶⁵

Continue to: Prescribing for children

Prescribing for children. There is no FDA-approved medication for the treatment of insomnia in children.⁵² However, melatonin has shown promising results for treating insomnia in children with neurodevelopmental disorders. A systematic review (13 trials­; N = 682) with meta-analysis (9 studies; n = 541) showed that melatonin significantly improved total sleep time compared with placebo (mean difference [MD] = 48.26 minutes; 95% CI, 36.78-59.73).⁸ In 11 studies (n = 581), sleep-onset latency improved significantly with melatonin use.⁸ No difference was noted in the frequency of wake-after-sleep onset.⁸ No medication-related adverse events were reported. Heterogeneity (I² = 31%) and inconsistency among included studies shed doubt on the findings; therefore, further research is needed.⁸

Prescribing in pregnancy. Prescribing medications to treat insomnia in pregnancy is complex and controversial. No consistency exists among guidelines and recommendations for treating insomnia in the pregnant population. Pharmacotherapy for insomnia is frequently prescribed off-label in pregnant patients. Examples include benzodiazepine-receptor agonists, antidepressants, and gamma-aminobutyric acid–reuptake inhibitors.⁴⁵

Pharmacotherapy in pregnancy is a unique challenge, wherein clinicians consider not only the potential drug toxicity to the fetus but also the potential changes in the pregnant patient’s pharmacokinetics that influence appropriate medication doses.^39,74 Worth noting: Zolpidem has been associated with preterm birth, cesarean birth, and low-birth-weight infants.^45,74 The lack of clinical trials of pharmacotherapy in pregnant patients results in a limited understanding of medication effects on long-term health and safety outcomes in this population.^39,74

There is no FDA-approved medication for the treatment of insomnia in children.

A review of 3 studies with small sample sizes found that when antidepressants or antihistamines were taken during pregnancy, neither had significant adverse effects on mother or child.⁶⁸ Weigh the risks of medications with the risk for disease burden and apply a shared decision-making approach with the patient, including providing an accurate assessment of risks and safety information regarding medication use.³⁹ Online resources such as ReproTox (www.reprotox.org) and MotherToBaby (https://mothertobaby.org) are available to support clinicians treating pregnant and lactating patients.³⁹

Prescribing for older adults. Treatment of insomnia in older adults requires a multifactorial approach.²² For all older adults, start interventions with nonpharmacologic treatments for insomnia followed by treatment of any underlying medical and psychiatric disorders that affect sleep.²¹ If medications are required, start with the lowest dose and titrate upward slowly. Use sedating low-dose antidepressants for insomnia only when the older patient has comorbid depression.⁶⁰ Although nonbenzodiazepine-receptor agonists have improved safety profiles compared with benzodiazepines, their use for older adults should be limited because of adverse effects that include dementia, serious injury, and falls with fractures.⁶⁰

Keep these points in mind

Prescribing medications to treat insomnia in pregnancy is complex and controversial.

Poor sleep has many detrimental health effects and can significantly affect quality of life for patients across the lifespan. Use nonpharmacologic interventions—such as sleep hygiene education, CBT-I, and cognitive/behavioral therapies—as first-line treatments. When utilizing pharmacotherapy for insomnia, consider the patient’s distressing symptoms of insomnia as guideposts for prescribing. Use pharmacologic treatments intermittently, short term, and in conjunction with nonpharmacologic options.

CORRESPONDENCE
Angela L. Colistra, PhD, LPC, CAADC, CCS, 707 Hamilton Street, 8th floor, LVHN Department of Family Medicine, Allentown, PA 18101; [email protected]

Key clinical point: Over 68-week continuous treatment, 4 mg and 2 mg baricitinib plus topical corticosteroids (TCS) showed clinically meaningful efficacy in patients with moderate-to-severe atopic dermatitis (AD).

Major finding: The proportions of patients with a validated Investigator’s Global Assessment for AD score of 0/1 at weeks 32/68 in the 4 mg baricitinib intent-to-treat, 4 mg baricitinib responder or partial responder (RPR), and 2 mg baricitinib RPR cohorts were 21.6%/23.5%, 31.7%/34.9%, and 45.3%/30.2%, respectively; Eczema Area and Severity Index 75 response rates were 46.1%/43.1%, 57.1%/49.2%, and 69.8%/58.5%, respectively.

Study details: This ongoing extension study of BREEZE-AD7 (BREEZE-AD3) included 292 patients with moderate-to-severe AD, of which RPR receiving 2 mg baricitinib +TCS/4 mg baricitinib + TCS continued their original treatment, nonresponders receiving 2 mg baricitinib were reassigned to receive 2 mg or 4 mg baricitinib, and nonresponders receiving 4 mg baricitinib continued their treatment.

Disclosures: This study was funded by Eli Lilly and Company, under license from Incyte Corporation. Some authors reported ties with various organizations, including Eli Lilly. Four authors declared being employees and stockholders of Eli Lilly.

Source: Silverberg JI et al. Long-term efficacy (up to 68 weeks) of baricitinib in combination with topical corticosteroids in adult patients with moderate-to-severe atopic dermatitis: Analysis of treatment responders, partial responders and nonresponders originating from study BREEZE-AD7. J Eur Acad Dermatol Venereol. 2023 (Dec 14, 2022). Doi: 10.1111/jdv.18816

Key clinical point: Over 68-week continuous treatment, 4 mg and 2 mg baricitinib plus topical corticosteroids (TCS) showed clinically meaningful efficacy in patients with moderate-to-severe atopic dermatitis (AD).

Major finding: The proportions of patients with a validated Investigator’s Global Assessment for AD score of 0/1 at weeks 32/68 in the 4 mg baricitinib intent-to-treat, 4 mg baricitinib responder or partial responder (RPR), and 2 mg baricitinib RPR cohorts were 21.6%/23.5%, 31.7%/34.9%, and 45.3%/30.2%, respectively; Eczema Area and Severity Index 75 response rates were 46.1%/43.1%, 57.1%/49.2%, and 69.8%/58.5%, respectively.

Study details: This ongoing extension study of BREEZE-AD7 (BREEZE-AD3) included 292 patients with moderate-to-severe AD, of which RPR receiving 2 mg baricitinib +TCS/4 mg baricitinib + TCS continued their original treatment, nonresponders receiving 2 mg baricitinib were reassigned to receive 2 mg or 4 mg baricitinib, and nonresponders receiving 4 mg baricitinib continued their treatment.

Disclosures: This study was funded by Eli Lilly and Company, under license from Incyte Corporation. Some authors reported ties with various organizations, including Eli Lilly. Four authors declared being employees and stockholders of Eli Lilly.

Source: Silverberg JI et al. Long-term efficacy (up to 68 weeks) of baricitinib in combination with topical corticosteroids in adult patients with moderate-to-severe atopic dermatitis: Analysis of treatment responders, partial responders and nonresponders originating from study BREEZE-AD7. J Eur Acad Dermatol Venereol. 2023 (Dec 14, 2022). Doi: 10.1111/jdv.18816

Key clinical point: Over 68-week continuous treatment, 4 mg and 2 mg baricitinib plus topical corticosteroids (TCS) showed clinically meaningful efficacy in patients with moderate-to-severe atopic dermatitis (AD).

Major finding: The proportions of patients with a validated Investigator’s Global Assessment for AD score of 0/1 at weeks 32/68 in the 4 mg baricitinib intent-to-treat, 4 mg baricitinib responder or partial responder (RPR), and 2 mg baricitinib RPR cohorts were 21.6%/23.5%, 31.7%/34.9%, and 45.3%/30.2%, respectively; Eczema Area and Severity Index 75 response rates were 46.1%/43.1%, 57.1%/49.2%, and 69.8%/58.5%, respectively.

Study details: This ongoing extension study of BREEZE-AD7 (BREEZE-AD3) included 292 patients with moderate-to-severe AD, of which RPR receiving 2 mg baricitinib +TCS/4 mg baricitinib + TCS continued their original treatment, nonresponders receiving 2 mg baricitinib were reassigned to receive 2 mg or 4 mg baricitinib, and nonresponders receiving 4 mg baricitinib continued their treatment.

Disclosures: This study was funded by Eli Lilly and Company, under license from Incyte Corporation. Some authors reported ties with various organizations, including Eli Lilly. Four authors declared being employees and stockholders of Eli Lilly.

Source: Silverberg JI et al. Long-term efficacy (up to 68 weeks) of baricitinib in combination with topical corticosteroids in adult patients with moderate-to-severe atopic dermatitis: Analysis of treatment responders, partial responders and nonresponders originating from study BREEZE-AD7. J Eur Acad Dermatol Venereol. 2023 (Dec 14, 2022). Doi: 10.1111/jdv.18816

Key clinical point: Patients with moderate-to-severe atopic dermatitis (AD) experienced a significantly greater reduction in itch as early as 4 days after treatment with 200 mg abrocitinib compared with dupilumab and placebo.

Major finding: At day 4 after treatment, a significantly higher proportion of patients achieved a ≥4-point improvement in Peak Pruritus Numerical Rating Scale score in the 200 mg abrocitinib group (18.6%) than in the placebo (6.0%; P < .003) and dupilumab (5.6%; P < .001) groups.

Study details: This post hoc analysis of JADE COMPARE included 837 adult patients with moderate-to-severe AD who were randomly assigned to receive oral abrocitinib (200 or 100 mg), subcutaneous dupilumab (300 mg), or placebo with medicated topical therapy for 16 weeks.

Disclosures: This study was funded by Pfizer Inc. Some authors reported ties with various organizations, including Pfizer. Six authors declared being current or former employees and shareholders of Pfizer.

Source: Ständer S et al. Early itch response with abrocitinib is associated with later efficacy outcomes in patients with moderate-to-severe atopic dermatitis: Subgroup analysis of the randomized phase III JADE COMPARE trial. Am J Clin Dermatol. 2022 (Dec 13). Doi: 10.1007/s40257-022-00738-4

Key clinical point: Patients with moderate-to-severe atopic dermatitis (AD) experienced a significantly greater reduction in itch as early as 4 days after treatment with 200 mg abrocitinib compared with dupilumab and placebo.

Major finding: At day 4 after treatment, a significantly higher proportion of patients achieved a ≥4-point improvement in Peak Pruritus Numerical Rating Scale score in the 200 mg abrocitinib group (18.6%) than in the placebo (6.0%; P < .003) and dupilumab (5.6%; P < .001) groups.

Study details: This post hoc analysis of JADE COMPARE included 837 adult patients with moderate-to-severe AD who were randomly assigned to receive oral abrocitinib (200 or 100 mg), subcutaneous dupilumab (300 mg), or placebo with medicated topical therapy for 16 weeks.

Disclosures: This study was funded by Pfizer Inc. Some authors reported ties with various organizations, including Pfizer. Six authors declared being current or former employees and shareholders of Pfizer.

Source: Ständer S et al. Early itch response with abrocitinib is associated with later efficacy outcomes in patients with moderate-to-severe atopic dermatitis: Subgroup analysis of the randomized phase III JADE COMPARE trial. Am J Clin Dermatol. 2022 (Dec 13). Doi: 10.1007/s40257-022-00738-4

Key clinical point: Patients with moderate-to-severe atopic dermatitis (AD) experienced a significantly greater reduction in itch as early as 4 days after treatment with 200 mg abrocitinib compared with dupilumab and placebo.

Major finding: At day 4 after treatment, a significantly higher proportion of patients achieved a ≥4-point improvement in Peak Pruritus Numerical Rating Scale score in the 200 mg abrocitinib group (18.6%) than in the placebo (6.0%; P < .003) and dupilumab (5.6%; P < .001) groups.

Study details: This post hoc analysis of JADE COMPARE included 837 adult patients with moderate-to-severe AD who were randomly assigned to receive oral abrocitinib (200 or 100 mg), subcutaneous dupilumab (300 mg), or placebo with medicated topical therapy for 16 weeks.

Disclosures: This study was funded by Pfizer Inc. Some authors reported ties with various organizations, including Pfizer. Six authors declared being current or former employees and shareholders of Pfizer.

Source: Ständer S et al. Early itch response with abrocitinib is associated with later efficacy outcomes in patients with moderate-to-severe atopic dermatitis: Subgroup analysis of the randomized phase III JADE COMPARE trial. Am J Clin Dermatol. 2022 (Dec 13). Doi: 10.1007/s40257-022-00738-4

I offer screening mammograms to my patients starting at age 40. I have developed a little script to explain that I recommend them routinely by age 50, but at younger ages, individual decision-making is required because the science to support breast cancer screening has more tradeoffs in younger patients.¹ Some patients have questions; many immediately know their preferences.

“Well, do it, don’t do it, but I recommend it,” the radiologist said. The conversation was over.

For me, personally, I felt comfortable waiting until sometime after age 40 to start screening. I have a reassuring family history; my mother has 5 sisters, without any breast or ovarian cancer among them. When, in my mid-40s, I told a doctor that I preferred to wait until I was closer to age 50 to get a mammogram, she urged me to begin screening immediately. Even as a physician, the drive to be a “good patient” was strong. I made the mammogram appointment.

Like many patients, my first mammogram was not normal.^2,3 After a second round of tests, and then a third, the radiologist gave me the results: Everything is fine. It is just normal breast tissue. To be on the safe side, you should do a follow-up mammogram and ultrasound in 6 months.

I asked why I needed to do follow-up imaging if the only thing that multiple diagnostic tests had shown was normal tissue—not a cyst, nor a fibroadenoma or any other abnormality.

“Well, do it, don’t do it, but I recommend it,” the radiologist said. The conversation was over.

My experience as a patient came to mind when I read this month’s article on shared decision-making by Mackwood et al.⁴ The authors discuss principles and techniques for shared decision-making in practice, which include enlisting the patient as the expert in their own values, and putting forth the health care professional as a source of reliable information when the evidence supports more than one reasonable strategy in a health care decision.

Aligning values, science, and action can be challenging, to be sure. It can be made easier through long-term relationships, such as the ones that family physicians have with their patients. One of the benefits of longitudinal practice is coming to know what our patients prefer instead of having to start from scratch with each visit. The belief that our values will be mutually respected is part of what builds trust in a doctor–patient relationship. We can use tools to support information delivery at the patient’s health literacy level to make the science more understandable. This in turn makes it easier for patients to integrate the science into their own value system.

Continue to: One of the most critical...

One of the most critical aspects of shared decision-making is also one of the hardest. As physicians, we need to be comfortable with a patient making a choice that we might not make ourselves. Perhaps we would choose to observe an otitis media in our own afebrile 6-year-old, or maybe we would not opt for semaglutide to treat our own obesity. Patients can have a different set of values and experiences driving their decision-making. The principles of shared decision-making teach us that our training and experience are not the priority in every situation.

In my case, the radiologist may have assumed that because I had gone through all of the testing, I believed that screening did far more good than harm and that I would be back in 6 months. From my point of view, I saw the screening as more of a mixed bag; it was possibly doing good, but at the risk of doing harm with false-positives and the possibility of overdiagnosis. She also may have been pressed for time and not had any available point-of-care tools to help explain her decision-making process. I left without understanding what the evidence was for close-interval follow-up, let alone having a chance to share in the decision-making process.

Shared decision-making and evidence-based medicine are closely connected concepts; the decision rests on the evidence, and the evidence cannot be applied to patients without asking their perspectives.⁵ Mackwood et al⁴ point out that shared decision-making can be implemented with little to no increase in the time we spend with patients, and at no substantial increase in costs of care.

Shared decision-making is a skill. Like any skill, the more we practice, the more capable we will become with it. And frankly, it doesn’t hurt to remember how we’ve felt when we’ve been the patient wearing that ­paper gown.

I offer screening mammograms to my patients starting at age 40. I have developed a little script to explain that I recommend them routinely by age 50, but at younger ages, individual decision-making is required because the science to support breast cancer screening has more tradeoffs in younger patients.¹ Some patients have questions; many immediately know their preferences.

“Well, do it, don’t do it, but I recommend it,” the radiologist said. The conversation was over.

For me, personally, I felt comfortable waiting until sometime after age 40 to start screening. I have a reassuring family history; my mother has 5 sisters, without any breast or ovarian cancer among them. When, in my mid-40s, I told a doctor that I preferred to wait until I was closer to age 50 to get a mammogram, she urged me to begin screening immediately. Even as a physician, the drive to be a “good patient” was strong. I made the mammogram appointment.

Like many patients, my first mammogram was not normal.^2,3 After a second round of tests, and then a third, the radiologist gave me the results: Everything is fine. It is just normal breast tissue. To be on the safe side, you should do a follow-up mammogram and ultrasound in 6 months.

I asked why I needed to do follow-up imaging if the only thing that multiple diagnostic tests had shown was normal tissue—not a cyst, nor a fibroadenoma or any other abnormality.

“Well, do it, don’t do it, but I recommend it,” the radiologist said. The conversation was over.

My experience as a patient came to mind when I read this month’s article on shared decision-making by Mackwood et al.⁴ The authors discuss principles and techniques for shared decision-making in practice, which include enlisting the patient as the expert in their own values, and putting forth the health care professional as a source of reliable information when the evidence supports more than one reasonable strategy in a health care decision.

Aligning values, science, and action can be challenging, to be sure. It can be made easier through long-term relationships, such as the ones that family physicians have with their patients. One of the benefits of longitudinal practice is coming to know what our patients prefer instead of having to start from scratch with each visit. The belief that our values will be mutually respected is part of what builds trust in a doctor–patient relationship. We can use tools to support information delivery at the patient’s health literacy level to make the science more understandable. This in turn makes it easier for patients to integrate the science into their own value system.

Continue to: One of the most critical...

One of the most critical aspects of shared decision-making is also one of the hardest. As physicians, we need to be comfortable with a patient making a choice that we might not make ourselves. Perhaps we would choose to observe an otitis media in our own afebrile 6-year-old, or maybe we would not opt for semaglutide to treat our own obesity. Patients can have a different set of values and experiences driving their decision-making. The principles of shared decision-making teach us that our training and experience are not the priority in every situation.

In my case, the radiologist may have assumed that because I had gone through all of the testing, I believed that screening did far more good than harm and that I would be back in 6 months. From my point of view, I saw the screening as more of a mixed bag; it was possibly doing good, but at the risk of doing harm with false-positives and the possibility of overdiagnosis. She also may have been pressed for time and not had any available point-of-care tools to help explain her decision-making process. I left without understanding what the evidence was for close-interval follow-up, let alone having a chance to share in the decision-making process.

Shared decision-making and evidence-based medicine are closely connected concepts; the decision rests on the evidence, and the evidence cannot be applied to patients without asking their perspectives.⁵ Mackwood et al⁴ point out that shared decision-making can be implemented with little to no increase in the time we spend with patients, and at no substantial increase in costs of care.

Shared decision-making is a skill. Like any skill, the more we practice, the more capable we will become with it. And frankly, it doesn’t hurt to remember how we’ve felt when we’ve been the patient wearing that ­paper gown.

I offer screening mammograms to my patients starting at age 40. I have developed a little script to explain that I recommend them routinely by age 50, but at younger ages, individual decision-making is required because the science to support breast cancer screening has more tradeoffs in younger patients.¹ Some patients have questions; many immediately know their preferences.

“Well, do it, don’t do it, but I recommend it,” the radiologist said. The conversation was over.

For me, personally, I felt comfortable waiting until sometime after age 40 to start screening. I have a reassuring family history; my mother has 5 sisters, without any breast or ovarian cancer among them. When, in my mid-40s, I told a doctor that I preferred to wait until I was closer to age 50 to get a mammogram, she urged me to begin screening immediately. Even as a physician, the drive to be a “good patient” was strong. I made the mammogram appointment.

Like many patients, my first mammogram was not normal.^2,3 After a second round of tests, and then a third, the radiologist gave me the results: Everything is fine. It is just normal breast tissue. To be on the safe side, you should do a follow-up mammogram and ultrasound in 6 months.

I asked why I needed to do follow-up imaging if the only thing that multiple diagnostic tests had shown was normal tissue—not a cyst, nor a fibroadenoma or any other abnormality.

“Well, do it, don’t do it, but I recommend it,” the radiologist said. The conversation was over.

My experience as a patient came to mind when I read this month’s article on shared decision-making by Mackwood et al.⁴ The authors discuss principles and techniques for shared decision-making in practice, which include enlisting the patient as the expert in their own values, and putting forth the health care professional as a source of reliable information when the evidence supports more than one reasonable strategy in a health care decision.

Aligning values, science, and action can be challenging, to be sure. It can be made easier through long-term relationships, such as the ones that family physicians have with their patients. One of the benefits of longitudinal practice is coming to know what our patients prefer instead of having to start from scratch with each visit. The belief that our values will be mutually respected is part of what builds trust in a doctor–patient relationship. We can use tools to support information delivery at the patient’s health literacy level to make the science more understandable. This in turn makes it easier for patients to integrate the science into their own value system.

Continue to: One of the most critical...

One of the most critical aspects of shared decision-making is also one of the hardest. As physicians, we need to be comfortable with a patient making a choice that we might not make ourselves. Perhaps we would choose to observe an otitis media in our own afebrile 6-year-old, or maybe we would not opt for semaglutide to treat our own obesity. Patients can have a different set of values and experiences driving their decision-making. The principles of shared decision-making teach us that our training and experience are not the priority in every situation.

In my case, the radiologist may have assumed that because I had gone through all of the testing, I believed that screening did far more good than harm and that I would be back in 6 months. From my point of view, I saw the screening as more of a mixed bag; it was possibly doing good, but at the risk of doing harm with false-positives and the possibility of overdiagnosis. She also may have been pressed for time and not had any available point-of-care tools to help explain her decision-making process. I left without understanding what the evidence was for close-interval follow-up, let alone having a chance to share in the decision-making process.

Shared decision-making and evidence-based medicine are closely connected concepts; the decision rests on the evidence, and the evidence cannot be applied to patients without asking their perspectives.⁵ Mackwood et al⁴ point out that shared decision-making can be implemented with little to no increase in the time we spend with patients, and at no substantial increase in costs of care.

Shared decision-making is a skill. Like any skill, the more we practice, the more capable we will become with it. And frankly, it doesn’t hurt to remember how we’ve felt when we’ve been the patient wearing that ­paper gown.

Key clinical point: Compared with topical corticosteroids (TCS) alone, lebrikizumab+TCS significantly improved outcomes in patients with moderate-to-severe atopic dermatitis (AD).

Major finding: At week 16, a significantly higher proportion of patients in the lebrikizumab+TCS vs placebo+TCS group achieved an Investigator’s Global Assessment score of 0 or 1 (41.2% vs 22.1%; P  =  .01) and a 75% improvement in the Eczema Area and Severity Index (69.5% vs 42.2%; P < .001). The frequencies of patient-reported serious adverse events (AE) were similar in both groups (<2%); most treatment-emergent AE were of mild or moderate severity.

Study details: Findings are from a multicenter phase 3 study, ADhere, including 211 patients aged ≥ 12 years with moderate-to-severe AD who were randomly assigned to receive lebrikizumab+TCS (n = 145) or placebo+TCS (n = 66).

Disclosures: This study was sponsored by Dermira, Inc; a wholly-owned subsidiary of Eli Lilly and Company. Some authors reported ties with various organizations, including Eli Lilly. Six authors declared being employees or stockholders of Eli Lilly.

Source: Simpson EL et al for the ADhere Investigators. Efficacy and safety of lebrikizumab in combination with topical corticosteroids in adolescents and adults with moderate-to-severe atopic dermatitis: A randomized clinical trial (ADhere). JAMA Dermatol. 2023 (Jan 11). Doi: 10.1001/jamadermatol.2022.5534

Key clinical point: Compared with topical corticosteroids (TCS) alone, lebrikizumab+TCS significantly improved outcomes in patients with moderate-to-severe atopic dermatitis (AD).

Major finding: At week 16, a significantly higher proportion of patients in the lebrikizumab+TCS vs placebo+TCS group achieved an Investigator’s Global Assessment score of 0 or 1 (41.2% vs 22.1%; P  =  .01) and a 75% improvement in the Eczema Area and Severity Index (69.5% vs 42.2%; P < .001). The frequencies of patient-reported serious adverse events (AE) were similar in both groups (<2%); most treatment-emergent AE were of mild or moderate severity.

Study details: Findings are from a multicenter phase 3 study, ADhere, including 211 patients aged ≥ 12 years with moderate-to-severe AD who were randomly assigned to receive lebrikizumab+TCS (n = 145) or placebo+TCS (n = 66).

Disclosures: This study was sponsored by Dermira, Inc; a wholly-owned subsidiary of Eli Lilly and Company. Some authors reported ties with various organizations, including Eli Lilly. Six authors declared being employees or stockholders of Eli Lilly.

Source: Simpson EL et al for the ADhere Investigators. Efficacy and safety of lebrikizumab in combination with topical corticosteroids in adolescents and adults with moderate-to-severe atopic dermatitis: A randomized clinical trial (ADhere). JAMA Dermatol. 2023 (Jan 11). Doi: 10.1001/jamadermatol.2022.5534

Key clinical point: Compared with topical corticosteroids (TCS) alone, lebrikizumab+TCS significantly improved outcomes in patients with moderate-to-severe atopic dermatitis (AD).

Major finding: At week 16, a significantly higher proportion of patients in the lebrikizumab+TCS vs placebo+TCS group achieved an Investigator’s Global Assessment score of 0 or 1 (41.2% vs 22.1%; P  =  .01) and a 75% improvement in the Eczema Area and Severity Index (69.5% vs 42.2%; P < .001). The frequencies of patient-reported serious adverse events (AE) were similar in both groups (<2%); most treatment-emergent AE were of mild or moderate severity.

Study details: Findings are from a multicenter phase 3 study, ADhere, including 211 patients aged ≥ 12 years with moderate-to-severe AD who were randomly assigned to receive lebrikizumab+TCS (n = 145) or placebo+TCS (n = 66).

Disclosures: This study was sponsored by Dermira, Inc; a wholly-owned subsidiary of Eli Lilly and Company. Some authors reported ties with various organizations, including Eli Lilly. Six authors declared being employees or stockholders of Eli Lilly.

Source: Simpson EL et al for the ADhere Investigators. Efficacy and safety of lebrikizumab in combination with topical corticosteroids in adolescents and adults with moderate-to-severe atopic dermatitis: A randomized clinical trial (ADhere). JAMA Dermatol. 2023 (Jan 11). Doi: 10.1001/jamadermatol.2022.5534

Shared decision-making (SDM), a methodology for improving patient communication, education, and outcomes in preference-sensitive health care decisions, debuted in 1989 with the Ottawa Decision Support Framework¹ and the creation of the Foundation for Informed Medical Decision Making (now the Informed Medical Decisions Foundation).² SDM enhances care by actively involving patients as partners in their health care choices. This approach can not only increase patient knowledge and satisfaction with care but also has a beneficial effect on adherence and outcomes.^3-5

Despite the significant benefits of SDM, overall uptake of SDM practices remains low—even in situations in which SDM is a requirement for reimbursement, such as in lung cancer screening.^6-8 The ever-shifting list of conditions that warrant the implementation of SDM in a family practice can be daunting. Our review seeks to highlight current best practices, review common situations in which SDM would be beneficial, and describe tools and frameworks that can facilitate effective SDM conversations in the typical primary care practice.

Preference-sensitive care

SDM is designed to enhance the role of patient preference, considering a patient’s own personal values for managing clinical conditions when more than one reasonable strategy exists. Such situations are often referred to as preference-­sensitive conditions—ie, since evidence is limited on a single “best” treatment approach, patients’ values should impact decision-making.⁹ Examples of common preference-sensitive situations that include preventive care, screening, and chronic disease management are outlined in TABLE 1.

How to engage patients

In preference-sensitive care situations, SDM endeavors to address uncertainty by laying out what the options are, as well as providing risk and benefit data. This helps inform patients and guides providers about individual patient preference on whether to screen (eg, for average-risk female patients, breast cancer screening between ages 40-50 years). SDM can assist with determining whether to screen and if so, at what interval (eg, at 1- or 2-year intervals), while acknowledging that no single decision would be “best” for every patient.

While there are formalized tools to provide information to patients and help them consider their values and choices,^3,10 SDM does not hinge on the use of an explicit tool.^11-18 There are many approaches to and interpretations of SDM; the Ottawa Decision Support Framework reviews and details these many considerations at length in its 2020 revision.¹⁹ TABLE 2^{11,15-17,20-22} highlights various SDM frameworks and the steps involved.

These 3 elements are commonamong SDM frameworks

In a 2019 systematic review, the following 3 elements were highlighted as the most prevalent over time across SDM frameworks and could be considered core to any meaningful SDM process²³:

Explicit effort by 2 or more experts. The patient is an expert in their own values. The clinician, as an expert in relevant medical knowledge, clarifies that the current medical situation will benefit from incorporating the patient’s preferences to arrive at an appropriate shared decision.

Continue to: Effort to provide relevant...

Effort to provide relevant, evidence-based information. The clinician provides treatment options applicable to the patient, including the risks and benefits of each (potentially using one of the decision aids in the following section), to facilitate a values-based discussion and decision.

Patient support and assistance. The clinician assists the patient in navigating next steps based on the treatment decision and arranges necessary follow-up.

Various case studies and examples of SDM conversations have been published.^15-17,24 Video examples of optimal²⁵ and less than optimal²⁶ SDM conversations are available on the Massachusetts General Hospital Health Decision Sciences Center website (https://mghdecisionsciences.org/) under the section “Tools & Training >> Videos about Shared Decision-Making.”²⁷

SDM and motivational interviewing: Both can serve you well

SDM and motivational interviewing share many common elements,²⁸ and it’s useful to take advantage of both techniques. Preference-­sensitive care situations may require a combination of approaches.

Overall uptake of shared decision-making practices remains low, even in situations such as lung cancer screening, in which SDM is a requirement for reimbursement.

For example, motivational interviewing may be a beneficial tool when dealing with a patient who is initially against colon cancer screening (evidence clearly favors screening in some form over no screening) and has a history of avoiding medical care. Through an SDM approach, motivational interviewing may identify an opportunity to prioritize the patient’s preference to minimize medical intervention by ensuring that the patient is familiar with noninvasive colon cancer screening options. After sufficiently eliciting a patient value aligned with screening and engaging the patient’s own motivations for follow-through, a more thorough SDM conversation can then help clarify the best options.

Continue to: A proposed framework...

A proposed framework for identifying whether SDM or motivational interviewing is appropriate is featured in the FIGURE. In their paper, Elwyn et al²⁹ further define and discuss the distinguishing features and roles of SDM and behavioral support interventions, such as motivational interviewing.

Tools to facilitate SDM conversations

Decision aids

SDM has historically been operationalized for study through the use of decision aids: formally structured materials describing, in detail, the available treatment options under consideration, including the relative risks and benefits. Frequently, such tools are framed from a patient perspective, with digestible information presented in a multimedia format (eg, visual risk representations of “1 out of 10” in an icon array vs “10%”), leveraging effective risk communication strategies (eg, absolute risk rates vs relative risks and “balanced framing”). For instance, the physician would note that 1 out of 10 patients have an outcome and 9 out of 10 do not.

Additional information on risk communication skills is available at the Agency for Healthcare Research and Quality’s webpage on the SHARE approach (www.ahrq.gov/health-literacy/professional-training/shared-decision/tool/resource-5.html).³⁰ Decision aids have been shown to enhance health literacy, increase patient knowledge and understanding, and promote the frequency of “values-concordant” choices.³

Point-of-care decision support

A more recent trend in SDM is increased development and use of point-of-care decision support tools that emphasize information reflecting individual patient circumstances (eg, leveraging heart risk calculators to individualize risk conversations when considering statins for primary prevention of heart disease based on lipids and other demographic factors). An advantage to using such tools is that they provide “just-in-time” detailed and personalized evidence-based information, guiding the discussion and minimizing the need for an extensive advance review of each topic by emphasizing the “key facts.” To ensure effective use of SDM tools, avoid oversaturating patients with data, maintain a focus on patient values, and engage in a 2-way discussion that considers the unique mix of preferences and circumstances.

Proprietorship of tools and decision aids

Until recently, SDM materials were compiled primarily within not-for-profit entities such as the Informed Medical Decisions Foundation, which became a division of Healthwise in 2014.² In recent years, there has been an increasing trend of for-profit companies acquiring or developing their own decision aids and decision-support tools, eg, EBSCO Health (Option Grid³¹ and Health Decision³²) and Wolters Kluwer (EMMI³³). The extensive work of curating SDM and educational tools to keep up with best medical evidence is costly, and the effort to defray costs can give rise to potential conflicts of interest. Therefore, the interests of the creators of such tools—whether commercial or academic—should always be considered when evaluating the use of a given decision-support tool.

Contunue to: An online listing...

An online listing of publicly available decision aids is maintained by the Ottawa Hospital Research Institute,³⁴ which reviews decision-aid quality by objective criteria in addition to providing direct links to resources.³⁵ EBSCO health’s DynaMed Decisions also maintains a list of shared decision-making tools (https://decisions.dynamed.com/).

Effectiveness of decision aids

There is a robust body of research focused on decision aids for SDM. An example is a 2017 Cochrane review that concluded SDM facilitated by decision aids significantly improved patient engagement and satisfaction and increased patient knowledge, accuracy in risk perception, and congruency in making value-aligned care choices. Beyond decision aids, studies show SDM practices increase patient knowledge, engagement, and satisfaction, particularly among low-literacy or disadvantaged groups.^4,36,37

Barriers to implementation

Clinicians frequently cite time constraints as a barrier to successfully implementing SDM in practice, although studies that explicitly compare the time/cost of SDM to “usual care” are limited.³⁸ A Cochrane review of 105 studies evaluating the use of decision aids vs usual care found that only 10 studies examined the effects of decision aids on the length of the office visit.³ Two of these studies (one evaluating decision aids for prenatal diagnostic screening and the other for atrial fibrillation) found a median increase in visit length of 2.6 minutes (24 vs 21; 7.5% increase); the other 8 studies reported no increase in visit length.³

Avoid oversaturating patients with data, maintain a focus on patient values, and engage in a 2-way discussion that considers the unique mix of patient preferences and circumstances.

Studies focusing on the time impact of using SDM in an office visit, rather than decision aids as a proxy for SDM, are few. A study by Braddock et al³⁹ assessed the elements of SDM, measuring the quality and the time-efficiency of 141 surgical decision-making interactions between patients and 89 orthopedic surgeons. Researchers found 57% of the discussions had elements of SDM sufficient to meet a “reasonable minimum” standard (eg, nature of the decision, patient’s role, patient’s preference). These conversations took 20 minutes compared to a median of 16 minutes for a more typical conversation.³⁹ The study used audiotaped interviews, which were coded and scored based on the presence of SDM elements; treatment choice, outcomes of the choices, and satisfaction were not reported. A separate study by Loh et al⁵ looking at SDM in primary care for patients with depression sought to determine whether patient participation in the decision-making process improved treatment adherence, outcomes, and patient satisfaction without increasing consultation time. This study, which included 23 physicians and 405 patients, found improved participation and satisfaction outcomes in the intervention group and no difference in consultation time between the intervention and control groups.⁵

Care costs appear similar

The impact of SDM on cost and patient-­centered clinical outcomes is not well defined. One study by Arterburn et al⁴⁰ found decision aids and SDM lowered the rates of elective surgery for hip and knee arthritis, as well as associated health system costs. However, other studies suggest this phenomenon likely varies by demographic, demonstrating that certain populations with a generally lower baseline preference for surgery on average chose surgery more often after SDM interventions.^41,42 Evidence does support patient acceptability and efficacy for SDM in longitudinal care when the approach is incorporated into decisions over multiple visits or long-term decisions for chronic conditions.⁴ Studies comparing patient groups receiving decision aids to usual care have shown similar or lower overall care costs for the decision-aid group.³

Continue to: Limitations to the evidence

Limitations to the evidence

Systematic reviews routinely note substantial heterogeneity in the literature on SDM use, owing to variable definitions of what steps are essential to constitute an SDM intervention and a wide variety of outcome measures used, as well as the broad range of conditions to which SDM is potentially applicable.^{3,4,10,36,37,43-45} While efforts in SDM education, uptake, and study frequently adapt frameworks such as those outlined in TABLE 2,^{11,15-17,20-22} there is as yet no one consensus on the “best” approach to SDM, and explicit study of any given approach is limited.^{18,23,36,44-46} There remains a clear need to improve the uptake of existing reporting standards to ensure the future evidence base will be of high quality.⁴⁴ In the meantime, a large portion of the impetus for expanding the use of SDM remains based on principles of effective communication and championing a patient-centered philosophy of care.

Cultivating an effective approach

An oft-cited objection to the use of SDM in day-to-day clinical care is that it “takes too much time.”⁴⁷ Like all excellent communication skills, SDM is best incorporated into a clinician’s approach to patient care. With practice, we have found this can be accomplished during routine patient encounters—eg, when providing general counsel, giving advice, providing education, answering questions. Given the interdependent relationship between evidence-based medicine and SDM, particularly in preference-sensitive conditions, SDM skills can facilitate efficient decision-making and patient satisfaction.⁴⁸ To that end, clinician training on SDM techniques, especially those that emphasize the 3 core elements, can be particularly beneficial. These broadly applicable skills can be leveraged in an “SDM mindset,” even outside traditional preference-sensitive care situations, to enhance clinician–patient rapport, relationship, and satisfaction.

The future of SDM

More than 2 decades after SDM was introduced to clinical care, there remains much to do to improve uptake in primary care settings. An important strategy to increase the successful uptake of SDM for the typical clinician and patient is to emphasize the approach to framing the topic and discussion rather than to overemphasize decision aids.²³ Continuing the trend of well-designed and accessible tools for clinical decision support at the point of care for clinicians, in addition to the sustained evolution of decision aids for patients, should help minimize the need for extensive background knowledge on a topic, increase accessibility, and enable an effective partnership with patients in their health care decisions.⁴⁶ Ongoing, well-structured study and the use of common proposed standards in developing these tools and studying SDM implementation will provide long-term quality assurance.⁴⁴

SDM has a role to play in health equity

SDM has a clear role to play in addressing health inequities. Values vary from person to person, and individuals exist along a variety of cultural, community, and other spectra that strongly influence their perception of what is most important to them. Moreover, clinicians’ assumptions typically do not correspond to a patient’s actual desire to engage in SDM nor to their overall likelihood of choosing any given treatment option.⁴⁶ While many clinicians believe patients do not participate in SDM because they simply do not wish to, a systematic review and thematic synthesis by Joseph-Williams et al⁴⁶ suggested a great number of patients are instead unable to take part in SDM due to barriers such as a lack of time availability, challenges in the structure of the health care system itself, and factors specific to the clinician–patient interaction such as patients feeling as though they don’t have “permission” to participate in SDM.

Shared decision-making may reduce disparities in populations disproportionately affected by certain health conditions.

SDM may improve health equity, adherence, and outcomes in certain groups. For example, SDM has been suggested as a potential means to address disparities in outcomes for populations disproportionately affected by hypertension.²⁴ The increased implementation of SDM practices, coupled with a genuine partnership between patients and care teams, may improve patient–clinician communication, enhance understanding of patient concerns and goals, and perhaps ultimately increase patient engagement and adherence.

Continue to: Being the change

Effective framing of medical decisions in the context of best medical evidence and eliciting patient values supports continued evolution in health care delivery. The traditional, physician-directed patriarchal “one-size-fits-all” approach has evolved. Through the continued development and implementation of SDM techniques, the clinician’s approach to care will continue to advance.

When done well, SDM increases the likelihood that patients will receive the best care possible.

Ultimately, patients and clinicians both benefit from the use of SDM—the patient benefits from explicit framing of the medical facts most relevant to their decision, and the physician benefits from enhanced knowledge of the patient’s values and considerations. When done well, SDM increases the likelihood that patients will receive the best care possible, concordant with their values and preferences and within the context of their unique circumstances, leading to improved knowledge, adherence, outcomes, and satisfaction.

CORRESPONDENCE
Matthew Mackwood, MD, One Medical Center Drive, Lebanon, NH 03756; [email protected]

Shared decision-making (SDM), a methodology for improving patient communication, education, and outcomes in preference-sensitive health care decisions, debuted in 1989 with the Ottawa Decision Support Framework¹ and the creation of the Foundation for Informed Medical Decision Making (now the Informed Medical Decisions Foundation).² SDM enhances care by actively involving patients as partners in their health care choices. This approach can not only increase patient knowledge and satisfaction with care but also has a beneficial effect on adherence and outcomes.^3-5

Despite the significant benefits of SDM, overall uptake of SDM practices remains low—even in situations in which SDM is a requirement for reimbursement, such as in lung cancer screening.^6-8 The ever-shifting list of conditions that warrant the implementation of SDM in a family practice can be daunting. Our review seeks to highlight current best practices, review common situations in which SDM would be beneficial, and describe tools and frameworks that can facilitate effective SDM conversations in the typical primary care practice.

Preference-sensitive care

SDM is designed to enhance the role of patient preference, considering a patient’s own personal values for managing clinical conditions when more than one reasonable strategy exists. Such situations are often referred to as preference-­sensitive conditions—ie, since evidence is limited on a single “best” treatment approach, patients’ values should impact decision-making.⁹ Examples of common preference-sensitive situations that include preventive care, screening, and chronic disease management are outlined in TABLE 1.

How to engage patients

In preference-sensitive care situations, SDM endeavors to address uncertainty by laying out what the options are, as well as providing risk and benefit data. This helps inform patients and guides providers about individual patient preference on whether to screen (eg, for average-risk female patients, breast cancer screening between ages 40-50 years). SDM can assist with determining whether to screen and if so, at what interval (eg, at 1- or 2-year intervals), while acknowledging that no single decision would be “best” for every patient.

While there are formalized tools to provide information to patients and help them consider their values and choices,^3,10 SDM does not hinge on the use of an explicit tool.^11-18 There are many approaches to and interpretations of SDM; the Ottawa Decision Support Framework reviews and details these many considerations at length in its 2020 revision.¹⁹ TABLE 2^{11,15-17,20-22} highlights various SDM frameworks and the steps involved.

These 3 elements are commonamong SDM frameworks

In a 2019 systematic review, the following 3 elements were highlighted as the most prevalent over time across SDM frameworks and could be considered core to any meaningful SDM process²³:

Explicit effort by 2 or more experts. The patient is an expert in their own values. The clinician, as an expert in relevant medical knowledge, clarifies that the current medical situation will benefit from incorporating the patient’s preferences to arrive at an appropriate shared decision.

Continue to: Effort to provide relevant...

Effort to provide relevant, evidence-based information. The clinician provides treatment options applicable to the patient, including the risks and benefits of each (potentially using one of the decision aids in the following section), to facilitate a values-based discussion and decision.

Patient support and assistance. The clinician assists the patient in navigating next steps based on the treatment decision and arranges necessary follow-up.

Various case studies and examples of SDM conversations have been published.^15-17,24 Video examples of optimal²⁵ and less than optimal²⁶ SDM conversations are available on the Massachusetts General Hospital Health Decision Sciences Center website (https://mghdecisionsciences.org/) under the section “Tools & Training >> Videos about Shared Decision-Making.”²⁷

SDM and motivational interviewing: Both can serve you well

SDM and motivational interviewing share many common elements,²⁸ and it’s useful to take advantage of both techniques. Preference-­sensitive care situations may require a combination of approaches.

Overall uptake of shared decision-making practices remains low, even in situations such as lung cancer screening, in which SDM is a requirement for reimbursement.

For example, motivational interviewing may be a beneficial tool when dealing with a patient who is initially against colon cancer screening (evidence clearly favors screening in some form over no screening) and has a history of avoiding medical care. Through an SDM approach, motivational interviewing may identify an opportunity to prioritize the patient’s preference to minimize medical intervention by ensuring that the patient is familiar with noninvasive colon cancer screening options. After sufficiently eliciting a patient value aligned with screening and engaging the patient’s own motivations for follow-through, a more thorough SDM conversation can then help clarify the best options.

Continue to: A proposed framework...

A proposed framework for identifying whether SDM or motivational interviewing is appropriate is featured in the FIGURE. In their paper, Elwyn et al²⁹ further define and discuss the distinguishing features and roles of SDM and behavioral support interventions, such as motivational interviewing.

Tools to facilitate SDM conversations

Decision aids

SDM has historically been operationalized for study through the use of decision aids: formally structured materials describing, in detail, the available treatment options under consideration, including the relative risks and benefits. Frequently, such tools are framed from a patient perspective, with digestible information presented in a multimedia format (eg, visual risk representations of “1 out of 10” in an icon array vs “10%”), leveraging effective risk communication strategies (eg, absolute risk rates vs relative risks and “balanced framing”). For instance, the physician would note that 1 out of 10 patients have an outcome and 9 out of 10 do not.

Additional information on risk communication skills is available at the Agency for Healthcare Research and Quality’s webpage on the SHARE approach (www.ahrq.gov/health-literacy/professional-training/shared-decision/tool/resource-5.html).³⁰ Decision aids have been shown to enhance health literacy, increase patient knowledge and understanding, and promote the frequency of “values-concordant” choices.³

Point-of-care decision support

A more recent trend in SDM is increased development and use of point-of-care decision support tools that emphasize information reflecting individual patient circumstances (eg, leveraging heart risk calculators to individualize risk conversations when considering statins for primary prevention of heart disease based on lipids and other demographic factors). An advantage to using such tools is that they provide “just-in-time” detailed and personalized evidence-based information, guiding the discussion and minimizing the need for an extensive advance review of each topic by emphasizing the “key facts.” To ensure effective use of SDM tools, avoid oversaturating patients with data, maintain a focus on patient values, and engage in a 2-way discussion that considers the unique mix of preferences and circumstances.

Proprietorship of tools and decision aids

Until recently, SDM materials were compiled primarily within not-for-profit entities such as the Informed Medical Decisions Foundation, which became a division of Healthwise in 2014.² In recent years, there has been an increasing trend of for-profit companies acquiring or developing their own decision aids and decision-support tools, eg, EBSCO Health (Option Grid³¹ and Health Decision³²) and Wolters Kluwer (EMMI³³). The extensive work of curating SDM and educational tools to keep up with best medical evidence is costly, and the effort to defray costs can give rise to potential conflicts of interest. Therefore, the interests of the creators of such tools—whether commercial or academic—should always be considered when evaluating the use of a given decision-support tool.

Contunue to: An online listing...

An online listing of publicly available decision aids is maintained by the Ottawa Hospital Research Institute,³⁴ which reviews decision-aid quality by objective criteria in addition to providing direct links to resources.³⁵ EBSCO health’s DynaMed Decisions also maintains a list of shared decision-making tools (https://decisions.dynamed.com/).

Effectiveness of decision aids

There is a robust body of research focused on decision aids for SDM. An example is a 2017 Cochrane review that concluded SDM facilitated by decision aids significantly improved patient engagement and satisfaction and increased patient knowledge, accuracy in risk perception, and congruency in making value-aligned care choices. Beyond decision aids, studies show SDM practices increase patient knowledge, engagement, and satisfaction, particularly among low-literacy or disadvantaged groups.^4,36,37

Barriers to implementation

Clinicians frequently cite time constraints as a barrier to successfully implementing SDM in practice, although studies that explicitly compare the time/cost of SDM to “usual care” are limited.³⁸ A Cochrane review of 105 studies evaluating the use of decision aids vs usual care found that only 10 studies examined the effects of decision aids on the length of the office visit.³ Two of these studies (one evaluating decision aids for prenatal diagnostic screening and the other for atrial fibrillation) found a median increase in visit length of 2.6 minutes (24 vs 21; 7.5% increase); the other 8 studies reported no increase in visit length.³

Avoid oversaturating patients with data, maintain a focus on patient values, and engage in a 2-way discussion that considers the unique mix of patient preferences and circumstances.

Studies focusing on the time impact of using SDM in an office visit, rather than decision aids as a proxy for SDM, are few. A study by Braddock et al³⁹ assessed the elements of SDM, measuring the quality and the time-efficiency of 141 surgical decision-making interactions between patients and 89 orthopedic surgeons. Researchers found 57% of the discussions had elements of SDM sufficient to meet a “reasonable minimum” standard (eg, nature of the decision, patient’s role, patient’s preference). These conversations took 20 minutes compared to a median of 16 minutes for a more typical conversation.³⁹ The study used audiotaped interviews, which were coded and scored based on the presence of SDM elements; treatment choice, outcomes of the choices, and satisfaction were not reported. A separate study by Loh et al⁵ looking at SDM in primary care for patients with depression sought to determine whether patient participation in the decision-making process improved treatment adherence, outcomes, and patient satisfaction without increasing consultation time. This study, which included 23 physicians and 405 patients, found improved participation and satisfaction outcomes in the intervention group and no difference in consultation time between the intervention and control groups.⁵

Care costs appear similar

The impact of SDM on cost and patient-­centered clinical outcomes is not well defined. One study by Arterburn et al⁴⁰ found decision aids and SDM lowered the rates of elective surgery for hip and knee arthritis, as well as associated health system costs. However, other studies suggest this phenomenon likely varies by demographic, demonstrating that certain populations with a generally lower baseline preference for surgery on average chose surgery more often after SDM interventions.^41,42 Evidence does support patient acceptability and efficacy for SDM in longitudinal care when the approach is incorporated into decisions over multiple visits or long-term decisions for chronic conditions.⁴ Studies comparing patient groups receiving decision aids to usual care have shown similar or lower overall care costs for the decision-aid group.³

Continue to: Limitations to the evidence

Limitations to the evidence

Systematic reviews routinely note substantial heterogeneity in the literature on SDM use, owing to variable definitions of what steps are essential to constitute an SDM intervention and a wide variety of outcome measures used, as well as the broad range of conditions to which SDM is potentially applicable.^{3,4,10,36,37,43-45} While efforts in SDM education, uptake, and study frequently adapt frameworks such as those outlined in TABLE 2,^{11,15-17,20-22} there is as yet no one consensus on the “best” approach to SDM, and explicit study of any given approach is limited.^{18,23,36,44-46} There remains a clear need to improve the uptake of existing reporting standards to ensure the future evidence base will be of high quality.⁴⁴ In the meantime, a large portion of the impetus for expanding the use of SDM remains based on principles of effective communication and championing a patient-centered philosophy of care.

Cultivating an effective approach

An oft-cited objection to the use of SDM in day-to-day clinical care is that it “takes too much time.”⁴⁷ Like all excellent communication skills, SDM is best incorporated into a clinician’s approach to patient care. With practice, we have found this can be accomplished during routine patient encounters—eg, when providing general counsel, giving advice, providing education, answering questions. Given the interdependent relationship between evidence-based medicine and SDM, particularly in preference-sensitive conditions, SDM skills can facilitate efficient decision-making and patient satisfaction.⁴⁸ To that end, clinician training on SDM techniques, especially those that emphasize the 3 core elements, can be particularly beneficial. These broadly applicable skills can be leveraged in an “SDM mindset,” even outside traditional preference-sensitive care situations, to enhance clinician–patient rapport, relationship, and satisfaction.

The future of SDM

More than 2 decades after SDM was introduced to clinical care, there remains much to do to improve uptake in primary care settings. An important strategy to increase the successful uptake of SDM for the typical clinician and patient is to emphasize the approach to framing the topic and discussion rather than to overemphasize decision aids.²³ Continuing the trend of well-designed and accessible tools for clinical decision support at the point of care for clinicians, in addition to the sustained evolution of decision aids for patients, should help minimize the need for extensive background knowledge on a topic, increase accessibility, and enable an effective partnership with patients in their health care decisions.⁴⁶ Ongoing, well-structured study and the use of common proposed standards in developing these tools and studying SDM implementation will provide long-term quality assurance.⁴⁴

SDM has a role to play in health equity

SDM has a clear role to play in addressing health inequities. Values vary from person to person, and individuals exist along a variety of cultural, community, and other spectra that strongly influence their perception of what is most important to them. Moreover, clinicians’ assumptions typically do not correspond to a patient’s actual desire to engage in SDM nor to their overall likelihood of choosing any given treatment option.⁴⁶ While many clinicians believe patients do not participate in SDM because they simply do not wish to, a systematic review and thematic synthesis by Joseph-Williams et al⁴⁶ suggested a great number of patients are instead unable to take part in SDM due to barriers such as a lack of time availability, challenges in the structure of the health care system itself, and factors specific to the clinician–patient interaction such as patients feeling as though they don’t have “permission” to participate in SDM.

Shared decision-making may reduce disparities in populations disproportionately affected by certain health conditions.

SDM may improve health equity, adherence, and outcomes in certain groups. For example, SDM has been suggested as a potential means to address disparities in outcomes for populations disproportionately affected by hypertension.²⁴ The increased implementation of SDM practices, coupled with a genuine partnership between patients and care teams, may improve patient–clinician communication, enhance understanding of patient concerns and goals, and perhaps ultimately increase patient engagement and adherence.

Continue to: Being the change

Effective framing of medical decisions in the context of best medical evidence and eliciting patient values supports continued evolution in health care delivery. The traditional, physician-directed patriarchal “one-size-fits-all” approach has evolved. Through the continued development and implementation of SDM techniques, the clinician’s approach to care will continue to advance.

When done well, SDM increases the likelihood that patients will receive the best care possible.

Ultimately, patients and clinicians both benefit from the use of SDM—the patient benefits from explicit framing of the medical facts most relevant to their decision, and the physician benefits from enhanced knowledge of the patient’s values and considerations. When done well, SDM increases the likelihood that patients will receive the best care possible, concordant with their values and preferences and within the context of their unique circumstances, leading to improved knowledge, adherence, outcomes, and satisfaction.

CORRESPONDENCE
Matthew Mackwood, MD, One Medical Center Drive, Lebanon, NH 03756; [email protected]

Shared decision-making (SDM), a methodology for improving patient communication, education, and outcomes in preference-sensitive health care decisions, debuted in 1989 with the Ottawa Decision Support Framework¹ and the creation of the Foundation for Informed Medical Decision Making (now the Informed Medical Decisions Foundation).² SDM enhances care by actively involving patients as partners in their health care choices. This approach can not only increase patient knowledge and satisfaction with care but also has a beneficial effect on adherence and outcomes.^3-5

Despite the significant benefits of SDM, overall uptake of SDM practices remains low—even in situations in which SDM is a requirement for reimbursement, such as in lung cancer screening.^6-8 The ever-shifting list of conditions that warrant the implementation of SDM in a family practice can be daunting. Our review seeks to highlight current best practices, review common situations in which SDM would be beneficial, and describe tools and frameworks that can facilitate effective SDM conversations in the typical primary care practice.

Preference-sensitive care

SDM is designed to enhance the role of patient preference, considering a patient’s own personal values for managing clinical conditions when more than one reasonable strategy exists. Such situations are often referred to as preference-­sensitive conditions—ie, since evidence is limited on a single “best” treatment approach, patients’ values should impact decision-making.⁹ Examples of common preference-sensitive situations that include preventive care, screening, and chronic disease management are outlined in TABLE 1.

How to engage patients

In preference-sensitive care situations, SDM endeavors to address uncertainty by laying out what the options are, as well as providing risk and benefit data. This helps inform patients and guides providers about individual patient preference on whether to screen (eg, for average-risk female patients, breast cancer screening between ages 40-50 years). SDM can assist with determining whether to screen and if so, at what interval (eg, at 1- or 2-year intervals), while acknowledging that no single decision would be “best” for every patient.

While there are formalized tools to provide information to patients and help them consider their values and choices,^3,10 SDM does not hinge on the use of an explicit tool.^11-18 There are many approaches to and interpretations of SDM; the Ottawa Decision Support Framework reviews and details these many considerations at length in its 2020 revision.¹⁹ TABLE 2^{11,15-17,20-22} highlights various SDM frameworks and the steps involved.

These 3 elements are commonamong SDM frameworks

In a 2019 systematic review, the following 3 elements were highlighted as the most prevalent over time across SDM frameworks and could be considered core to any meaningful SDM process²³:

Explicit effort by 2 or more experts. The patient is an expert in their own values. The clinician, as an expert in relevant medical knowledge, clarifies that the current medical situation will benefit from incorporating the patient’s preferences to arrive at an appropriate shared decision.

Continue to: Effort to provide relevant...

Effort to provide relevant, evidence-based information. The clinician provides treatment options applicable to the patient, including the risks and benefits of each (potentially using one of the decision aids in the following section), to facilitate a values-based discussion and decision.

Patient support and assistance. The clinician assists the patient in navigating next steps based on the treatment decision and arranges necessary follow-up.

Various case studies and examples of SDM conversations have been published.^15-17,24 Video examples of optimal²⁵ and less than optimal²⁶ SDM conversations are available on the Massachusetts General Hospital Health Decision Sciences Center website (https://mghdecisionsciences.org/) under the section “Tools & Training >> Videos about Shared Decision-Making.”²⁷

SDM and motivational interviewing: Both can serve you well

SDM and motivational interviewing share many common elements,²⁸ and it’s useful to take advantage of both techniques. Preference-­sensitive care situations may require a combination of approaches.

Overall uptake of shared decision-making practices remains low, even in situations such as lung cancer screening, in which SDM is a requirement for reimbursement.

For example, motivational interviewing may be a beneficial tool when dealing with a patient who is initially against colon cancer screening (evidence clearly favors screening in some form over no screening) and has a history of avoiding medical care. Through an SDM approach, motivational interviewing may identify an opportunity to prioritize the patient’s preference to minimize medical intervention by ensuring that the patient is familiar with noninvasive colon cancer screening options. After sufficiently eliciting a patient value aligned with screening and engaging the patient’s own motivations for follow-through, a more thorough SDM conversation can then help clarify the best options.

Continue to: A proposed framework...

A proposed framework for identifying whether SDM or motivational interviewing is appropriate is featured in the FIGURE. In their paper, Elwyn et al²⁹ further define and discuss the distinguishing features and roles of SDM and behavioral support interventions, such as motivational interviewing.

Tools to facilitate SDM conversations

Decision aids

SDM has historically been operationalized for study through the use of decision aids: formally structured materials describing, in detail, the available treatment options under consideration, including the relative risks and benefits. Frequently, such tools are framed from a patient perspective, with digestible information presented in a multimedia format (eg, visual risk representations of “1 out of 10” in an icon array vs “10%”), leveraging effective risk communication strategies (eg, absolute risk rates vs relative risks and “balanced framing”). For instance, the physician would note that 1 out of 10 patients have an outcome and 9 out of 10 do not.

Additional information on risk communication skills is available at the Agency for Healthcare Research and Quality’s webpage on the SHARE approach (www.ahrq.gov/health-literacy/professional-training/shared-decision/tool/resource-5.html).³⁰ Decision aids have been shown to enhance health literacy, increase patient knowledge and understanding, and promote the frequency of “values-concordant” choices.³

Point-of-care decision support

A more recent trend in SDM is increased development and use of point-of-care decision support tools that emphasize information reflecting individual patient circumstances (eg, leveraging heart risk calculators to individualize risk conversations when considering statins for primary prevention of heart disease based on lipids and other demographic factors). An advantage to using such tools is that they provide “just-in-time” detailed and personalized evidence-based information, guiding the discussion and minimizing the need for an extensive advance review of each topic by emphasizing the “key facts.” To ensure effective use of SDM tools, avoid oversaturating patients with data, maintain a focus on patient values, and engage in a 2-way discussion that considers the unique mix of preferences and circumstances.

Proprietorship of tools and decision aids

Until recently, SDM materials were compiled primarily within not-for-profit entities such as the Informed Medical Decisions Foundation, which became a division of Healthwise in 2014.² In recent years, there has been an increasing trend of for-profit companies acquiring or developing their own decision aids and decision-support tools, eg, EBSCO Health (Option Grid³¹ and Health Decision³²) and Wolters Kluwer (EMMI³³). The extensive work of curating SDM and educational tools to keep up with best medical evidence is costly, and the effort to defray costs can give rise to potential conflicts of interest. Therefore, the interests of the creators of such tools—whether commercial or academic—should always be considered when evaluating the use of a given decision-support tool.

Contunue to: An online listing...

An online listing of publicly available decision aids is maintained by the Ottawa Hospital Research Institute,³⁴ which reviews decision-aid quality by objective criteria in addition to providing direct links to resources.³⁵ EBSCO health’s DynaMed Decisions also maintains a list of shared decision-making tools (https://decisions.dynamed.com/).

Effectiveness of decision aids

There is a robust body of research focused on decision aids for SDM. An example is a 2017 Cochrane review that concluded SDM facilitated by decision aids significantly improved patient engagement and satisfaction and increased patient knowledge, accuracy in risk perception, and congruency in making value-aligned care choices. Beyond decision aids, studies show SDM practices increase patient knowledge, engagement, and satisfaction, particularly among low-literacy or disadvantaged groups.^4,36,37

Barriers to implementation

Clinicians frequently cite time constraints as a barrier to successfully implementing SDM in practice, although studies that explicitly compare the time/cost of SDM to “usual care” are limited.³⁸ A Cochrane review of 105 studies evaluating the use of decision aids vs usual care found that only 10 studies examined the effects of decision aids on the length of the office visit.³ Two of these studies (one evaluating decision aids for prenatal diagnostic screening and the other for atrial fibrillation) found a median increase in visit length of 2.6 minutes (24 vs 21; 7.5% increase); the other 8 studies reported no increase in visit length.³

Avoid oversaturating patients with data, maintain a focus on patient values, and engage in a 2-way discussion that considers the unique mix of patient preferences and circumstances.

Studies focusing on the time impact of using SDM in an office visit, rather than decision aids as a proxy for SDM, are few. A study by Braddock et al³⁹ assessed the elements of SDM, measuring the quality and the time-efficiency of 141 surgical decision-making interactions between patients and 89 orthopedic surgeons. Researchers found 57% of the discussions had elements of SDM sufficient to meet a “reasonable minimum” standard (eg, nature of the decision, patient’s role, patient’s preference). These conversations took 20 minutes compared to a median of 16 minutes for a more typical conversation.³⁹ The study used audiotaped interviews, which were coded and scored based on the presence of SDM elements; treatment choice, outcomes of the choices, and satisfaction were not reported. A separate study by Loh et al⁵ looking at SDM in primary care for patients with depression sought to determine whether patient participation in the decision-making process improved treatment adherence, outcomes, and patient satisfaction without increasing consultation time. This study, which included 23 physicians and 405 patients, found improved participation and satisfaction outcomes in the intervention group and no difference in consultation time between the intervention and control groups.⁵

Care costs appear similar

The impact of SDM on cost and patient-­centered clinical outcomes is not well defined. One study by Arterburn et al⁴⁰ found decision aids and SDM lowered the rates of elective surgery for hip and knee arthritis, as well as associated health system costs. However, other studies suggest this phenomenon likely varies by demographic, demonstrating that certain populations with a generally lower baseline preference for surgery on average chose surgery more often after SDM interventions.^41,42 Evidence does support patient acceptability and efficacy for SDM in longitudinal care when the approach is incorporated into decisions over multiple visits or long-term decisions for chronic conditions.⁴ Studies comparing patient groups receiving decision aids to usual care have shown similar or lower overall care costs for the decision-aid group.³

Continue to: Limitations to the evidence

Limitations to the evidence

Systematic reviews routinely note substantial heterogeneity in the literature on SDM use, owing to variable definitions of what steps are essential to constitute an SDM intervention and a wide variety of outcome measures used, as well as the broad range of conditions to which SDM is potentially applicable.^{3,4,10,36,37,43-45} While efforts in SDM education, uptake, and study frequently adapt frameworks such as those outlined in TABLE 2,^{11,15-17,20-22} there is as yet no one consensus on the “best” approach to SDM, and explicit study of any given approach is limited.^{18,23,36,44-46} There remains a clear need to improve the uptake of existing reporting standards to ensure the future evidence base will be of high quality.⁴⁴ In the meantime, a large portion of the impetus for expanding the use of SDM remains based on principles of effective communication and championing a patient-centered philosophy of care.

Cultivating an effective approach

An oft-cited objection to the use of SDM in day-to-day clinical care is that it “takes too much time.”⁴⁷ Like all excellent communication skills, SDM is best incorporated into a clinician’s approach to patient care. With practice, we have found this can be accomplished during routine patient encounters—eg, when providing general counsel, giving advice, providing education, answering questions. Given the interdependent relationship between evidence-based medicine and SDM, particularly in preference-sensitive conditions, SDM skills can facilitate efficient decision-making and patient satisfaction.⁴⁸ To that end, clinician training on SDM techniques, especially those that emphasize the 3 core elements, can be particularly beneficial. These broadly applicable skills can be leveraged in an “SDM mindset,” even outside traditional preference-sensitive care situations, to enhance clinician–patient rapport, relationship, and satisfaction.

The future of SDM

More than 2 decades after SDM was introduced to clinical care, there remains much to do to improve uptake in primary care settings. An important strategy to increase the successful uptake of SDM for the typical clinician and patient is to emphasize the approach to framing the topic and discussion rather than to overemphasize decision aids.²³ Continuing the trend of well-designed and accessible tools for clinical decision support at the point of care for clinicians, in addition to the sustained evolution of decision aids for patients, should help minimize the need for extensive background knowledge on a topic, increase accessibility, and enable an effective partnership with patients in their health care decisions.⁴⁶ Ongoing, well-structured study and the use of common proposed standards in developing these tools and studying SDM implementation will provide long-term quality assurance.⁴⁴

SDM has a role to play in health equity

SDM has a clear role to play in addressing health inequities. Values vary from person to person, and individuals exist along a variety of cultural, community, and other spectra that strongly influence their perception of what is most important to them. Moreover, clinicians’ assumptions typically do not correspond to a patient’s actual desire to engage in SDM nor to their overall likelihood of choosing any given treatment option.⁴⁶ While many clinicians believe patients do not participate in SDM because they simply do not wish to, a systematic review and thematic synthesis by Joseph-Williams et al⁴⁶ suggested a great number of patients are instead unable to take part in SDM due to barriers such as a lack of time availability, challenges in the structure of the health care system itself, and factors specific to the clinician–patient interaction such as patients feeling as though they don’t have “permission” to participate in SDM.

Shared decision-making may reduce disparities in populations disproportionately affected by certain health conditions.

SDM may improve health equity, adherence, and outcomes in certain groups. For example, SDM has been suggested as a potential means to address disparities in outcomes for populations disproportionately affected by hypertension.²⁴ The increased implementation of SDM practices, coupled with a genuine partnership between patients and care teams, may improve patient–clinician communication, enhance understanding of patient concerns and goals, and perhaps ultimately increase patient engagement and adherence.

Continue to: Being the change

Effective framing of medical decisions in the context of best medical evidence and eliciting patient values supports continued evolution in health care delivery. The traditional, physician-directed patriarchal “one-size-fits-all” approach has evolved. Through the continued development and implementation of SDM techniques, the clinician’s approach to care will continue to advance.

When done well, SDM increases the likelihood that patients will receive the best care possible.

Ultimately, patients and clinicians both benefit from the use of SDM—the patient benefits from explicit framing of the medical facts most relevant to their decision, and the physician benefits from enhanced knowledge of the patient’s values and considerations. When done well, SDM increases the likelihood that patients will receive the best care possible, concordant with their values and preferences and within the context of their unique circumstances, leading to improved knowledge, adherence, outcomes, and satisfaction.

CORRESPONDENCE
Matthew Mackwood, MD, One Medical Center Drive, Lebanon, NH 03756; [email protected]

THE CASE

A 42-year-old man with a history of bipolar disorder with psychotic features, asthma, and chronic pain was brought to the emergency department (ED) by his father due to altered mental status, coughing, and vomiting. The patient was unable to recall events earlier in the day in detail but stated that he remembered using his inhaler for his cough, which seemed to precipitate his vomiting. The patient’s home medications were listed as albuterol 90 mcg, methadone 90 mg/d, and quetiapine 100 mg.

While in the ED, the patient was tachycardic (heart rate, 102 bpm), but all other vital signs were normal. He was agitated and at one point required restraints. On exam, he had epigastric tenderness to palpation, and his lungs were clear to auscultation bilaterally.

Blood work was notable for an elevated lipase level of 729 U/L (normal range, 0-160 U/L). Complete blood count, comprehensive metabolic panel, urinalysis, chest x-ray, and alcohol levels were unremarkable. Computed tomography of the abdomen/pelvis and ultrasound of the abdomen showed excess stool and gallbladder sludge without cholecystitis.

The patient was treated symptomatically with intravenous fluids, ondansetron, and lor­azepam. He was admitted with a working diagnosis of acute pancreatitis and possible acute psychosis in the setting of schizophrenia.

A few hours after presentation, the patient returned to his baseline mental status. Over the next 24 hours, his lipase level trended down to normal.

THE DIAGNOSIS

After the patient’s discharge, the pharmacist from his primary care provider’s office called as part of the routine post-hospital follow-up and a medication reconciliation was performed. During this call, the patient stated he had used 2 different nasal sprays prior to his ED pres­entation.

The pharmacist asked him to read the names of each medication. He related the first was naloxone and the second, fluticasone (neither of which was included on his medication list). Upon further questioning, the pharmacist elicited clarification from the patient that he had, in fact, taken 2 doses of naloxone, shortly after which his vomiting began.

Continue to: This additional history...

This additional history suggested the patient’s true diagnosis was acute opioid withdrawal precipitated by his accidental self-administration of naloxone.

DISCUSSION

Naloxone is a pure mu-opioid receptor antagonist that is used for opioid overdose.¹ In the past decade, in response to the opioid epidemic, naloxone has become increasingly available in the community as a way of decreasing opioid-related deaths.^1,2 The US Food and Drug Administration recommends that all patients who are prescribed opioids for pain or opioid use disorder, as well as those who are at increased risk for opioid overdose, should be prescribed naloxone and educated on its use. Patients who received a naloxone prescription from their primary care provider have been found to have 47% fewer opioid-related ED visits.³

Quick effects, potential for complications. Use of naloxone can rapidly induce opioid withdrawal symptoms, including gastrointestinal effects, tachycardia, and agitation, as well as diaphoresis, shivering, lacrimation, tremor, anxiety, mydriasis, and hypertension. Naloxone use can also lead to severe complications, such as violent behaviors, ventricular tachycardia or fibrillation, asystole, or pulmonary edema, in the period immediately following administration.⁴ These effects most often subside within 20 to 60 minutes after administration of naloxone, as the antagonist effect wears off.

The treatment of naloxone toxicity is supportive, with particular attention paid to the patient’s mental and respiratory status.

Our patient was advised by his primary care physician on the proper use of all of his medications, including nasal sprays. The clinic pharmacist also met with him for an additional educational session on the proper use of naloxone.

Continue to: THE TAKEAWAY

THE TAKEAWAY

Given the widespread use of naloxone, proper education and counselling regarding this medication is crucial. Patients should be advised of what to expect after its use. In addition, physicians should always maintain updated patient medication lists, ensuring that they include naloxone if it has been prescribed for use as needed for opioid reversal, to assist in the emergency treatment of affected patients.⁵

CORRESPONDENCE
Erik Weitz, DO, Troy Beaumont Family Medicine Residency, 44250 Dequindre Road, Sterling Heights, MI 48314; [email protected]

THE CASE

A 42-year-old man with a history of bipolar disorder with psychotic features, asthma, and chronic pain was brought to the emergency department (ED) by his father due to altered mental status, coughing, and vomiting. The patient was unable to recall events earlier in the day in detail but stated that he remembered using his inhaler for his cough, which seemed to precipitate his vomiting. The patient’s home medications were listed as albuterol 90 mcg, methadone 90 mg/d, and quetiapine 100 mg.

While in the ED, the patient was tachycardic (heart rate, 102 bpm), but all other vital signs were normal. He was agitated and at one point required restraints. On exam, he had epigastric tenderness to palpation, and his lungs were clear to auscultation bilaterally.

Blood work was notable for an elevated lipase level of 729 U/L (normal range, 0-160 U/L). Complete blood count, comprehensive metabolic panel, urinalysis, chest x-ray, and alcohol levels were unremarkable. Computed tomography of the abdomen/pelvis and ultrasound of the abdomen showed excess stool and gallbladder sludge without cholecystitis.

The patient was treated symptomatically with intravenous fluids, ondansetron, and lor­azepam. He was admitted with a working diagnosis of acute pancreatitis and possible acute psychosis in the setting of schizophrenia.

A few hours after presentation, the patient returned to his baseline mental status. Over the next 24 hours, his lipase level trended down to normal.

THE DIAGNOSIS

After the patient’s discharge, the pharmacist from his primary care provider’s office called as part of the routine post-hospital follow-up and a medication reconciliation was performed. During this call, the patient stated he had used 2 different nasal sprays prior to his ED pres­entation.

The pharmacist asked him to read the names of each medication. He related the first was naloxone and the second, fluticasone (neither of which was included on his medication list). Upon further questioning, the pharmacist elicited clarification from the patient that he had, in fact, taken 2 doses of naloxone, shortly after which his vomiting began.

Continue to: This additional history...

This additional history suggested the patient’s true diagnosis was acute opioid withdrawal precipitated by his accidental self-administration of naloxone.

DISCUSSION

Naloxone is a pure mu-opioid receptor antagonist that is used for opioid overdose.¹ In the past decade, in response to the opioid epidemic, naloxone has become increasingly available in the community as a way of decreasing opioid-related deaths.^1,2 The US Food and Drug Administration recommends that all patients who are prescribed opioids for pain or opioid use disorder, as well as those who are at increased risk for opioid overdose, should be prescribed naloxone and educated on its use. Patients who received a naloxone prescription from their primary care provider have been found to have 47% fewer opioid-related ED visits.³

Quick effects, potential for complications. Use of naloxone can rapidly induce opioid withdrawal symptoms, including gastrointestinal effects, tachycardia, and agitation, as well as diaphoresis, shivering, lacrimation, tremor, anxiety, mydriasis, and hypertension. Naloxone use can also lead to severe complications, such as violent behaviors, ventricular tachycardia or fibrillation, asystole, or pulmonary edema, in the period immediately following administration.⁴ These effects most often subside within 20 to 60 minutes after administration of naloxone, as the antagonist effect wears off.

The treatment of naloxone toxicity is supportive, with particular attention paid to the patient’s mental and respiratory status.

Our patient was advised by his primary care physician on the proper use of all of his medications, including nasal sprays. The clinic pharmacist also met with him for an additional educational session on the proper use of naloxone.

Continue to: THE TAKEAWAY

THE TAKEAWAY

Given the widespread use of naloxone, proper education and counselling regarding this medication is crucial. Patients should be advised of what to expect after its use. In addition, physicians should always maintain updated patient medication lists, ensuring that they include naloxone if it has been prescribed for use as needed for opioid reversal, to assist in the emergency treatment of affected patients.⁵

CORRESPONDENCE
Erik Weitz, DO, Troy Beaumont Family Medicine Residency, 44250 Dequindre Road, Sterling Heights, MI 48314; [email protected]

THE CASE

A 42-year-old man with a history of bipolar disorder with psychotic features, asthma, and chronic pain was brought to the emergency department (ED) by his father due to altered mental status, coughing, and vomiting. The patient was unable to recall events earlier in the day in detail but stated that he remembered using his inhaler for his cough, which seemed to precipitate his vomiting. The patient’s home medications were listed as albuterol 90 mcg, methadone 90 mg/d, and quetiapine 100 mg.

While in the ED, the patient was tachycardic (heart rate, 102 bpm), but all other vital signs were normal. He was agitated and at one point required restraints. On exam, he had epigastric tenderness to palpation, and his lungs were clear to auscultation bilaterally.

Blood work was notable for an elevated lipase level of 729 U/L (normal range, 0-160 U/L). Complete blood count, comprehensive metabolic panel, urinalysis, chest x-ray, and alcohol levels were unremarkable. Computed tomography of the abdomen/pelvis and ultrasound of the abdomen showed excess stool and gallbladder sludge without cholecystitis.

The patient was treated symptomatically with intravenous fluids, ondansetron, and lor­azepam. He was admitted with a working diagnosis of acute pancreatitis and possible acute psychosis in the setting of schizophrenia.

A few hours after presentation, the patient returned to his baseline mental status. Over the next 24 hours, his lipase level trended down to normal.

THE DIAGNOSIS

After the patient’s discharge, the pharmacist from his primary care provider’s office called as part of the routine post-hospital follow-up and a medication reconciliation was performed. During this call, the patient stated he had used 2 different nasal sprays prior to his ED pres­entation.

The pharmacist asked him to read the names of each medication. He related the first was naloxone and the second, fluticasone (neither of which was included on his medication list). Upon further questioning, the pharmacist elicited clarification from the patient that he had, in fact, taken 2 doses of naloxone, shortly after which his vomiting began.

Continue to: This additional history...

This additional history suggested the patient’s true diagnosis was acute opioid withdrawal precipitated by his accidental self-administration of naloxone.

DISCUSSION

Naloxone is a pure mu-opioid receptor antagonist that is used for opioid overdose.¹ In the past decade, in response to the opioid epidemic, naloxone has become increasingly available in the community as a way of decreasing opioid-related deaths.^1,2 The US Food and Drug Administration recommends that all patients who are prescribed opioids for pain or opioid use disorder, as well as those who are at increased risk for opioid overdose, should be prescribed naloxone and educated on its use. Patients who received a naloxone prescription from their primary care provider have been found to have 47% fewer opioid-related ED visits.³

Quick effects, potential for complications. Use of naloxone can rapidly induce opioid withdrawal symptoms, including gastrointestinal effects, tachycardia, and agitation, as well as diaphoresis, shivering, lacrimation, tremor, anxiety, mydriasis, and hypertension. Naloxone use can also lead to severe complications, such as violent behaviors, ventricular tachycardia or fibrillation, asystole, or pulmonary edema, in the period immediately following administration.⁴ These effects most often subside within 20 to 60 minutes after administration of naloxone, as the antagonist effect wears off.

The treatment of naloxone toxicity is supportive, with particular attention paid to the patient’s mental and respiratory status.

Our patient was advised by his primary care physician on the proper use of all of his medications, including nasal sprays. The clinic pharmacist also met with him for an additional educational session on the proper use of naloxone.

Continue to: THE TAKEAWAY

THE TAKEAWAY

Given the widespread use of naloxone, proper education and counselling regarding this medication is crucial. Patients should be advised of what to expect after its use. In addition, physicians should always maintain updated patient medication lists, ensuring that they include naloxone if it has been prescribed for use as needed for opioid reversal, to assist in the emergency treatment of affected patients.⁵

CORRESPONDENCE
Erik Weitz, DO, Troy Beaumont Family Medicine Residency, 44250 Dequindre Road, Sterling Heights, MI 48314; [email protected]

ILLUSTRATIVE CASE

A 17-year-old high school football player presents to the emergency department (ED) after a helmet-to-helmet tackle in a game earlier that day. After the tackle, he experienced immediate confusion. Once he returned to his feet, he felt dizzy and nauseated and began to develop a headache. When his symptoms failed to resolve within a few hours, his mother brought him to the hospital for an evaluation. In the ED, he receives a diagnosis of concussion, and his mother asks for recommendations on how he can recover as quickly as possible.

Traumatic brain injuries account for an estimated 2.5 million ED visits annually in the United States.² Concussions are the most common form of traumatic brain injury, with adolescents contributing to the highest incidence of concussions.^3,4 An estimated 1.6 to 3.8 million people experience a sports-related concussion annually.⁵

Time to recovery is a clinical endpoint that matters greatly to our young, physically active patients, who are often eager to return to their daily activities as soon as possible. Guidelines frequently recommend cognitive and physical rest for 24 to 48 hours immediately following a concussion, but the use of screens during this cognitive rest period remains uncertain.^6,7 International guidelines and the Centers for Disease Control and ­Prevention recommend symptom-limited activities—including screen time—during the initial period of a concussion.^6,7 Although this gradual approach is standard of care, it has been unclear if abstaining completely from certain activities during the initial days of a concussion has any impact on recovery time.

Recent studies have examined physical activity to clarify the optimal timing of physical rest after a concussion. Among adolescents with concussions, strict rest for 5 days does not appear to improve symptoms compared with rest for 1 to 2 days.⁸ Additionally, physical activity within 7 days of acute head injury may help reduce symptoms and prevent postconcussive symptoms.^9,10

This same level of clarity has been lacking for cognitive rest and screen time. The use of screens is a part of most patients’ daily activities, particularly among adolescents and young adults. One report found that students ages 8 to 18 years engage in approximately 7 hours of daily screen time, excluding that related to schoolwork.¹¹ This trial evaluated the relationship between screen time abstinence within 48 hours of a concussion and time to symptom resolution.

STUDY SUMMARY

Symptom duration was significantly reduced by cutting screen time

This single-site, parallel-design, randomized clinical trial examined the effectiveness of limiting screen time exposure within the first 48 hours after a concussion in reducing the time to resolution of concussive symptoms in 125 patients. ¹ Patients were included if they were 12 to 25 years old (mean age, 17 years) and presented within 24 hours of sustaining a concussion (as defined on the Acute Concussion Evaluation–Emergency Department tool) to the pediatric or adult ED at a US tertiary medical center.

A shared decision-making discussion should center on the idea that 48 hours of screen time abstinence could be well worth the increased likelihood of total recovery at Day 10.

Patients were randomized to either ­engage in screen time as tolerated or to abstain from screen time for 48 hours following their injury. Screen modalities included television, phones, video games, and computers/­tablets. The Post-Concussive Symptom Scale (PCSS; 0-132) was used to characterize 22 symptoms from 0 (absent) to 6 (severe) daily for 10 days. Patients also self-reported the amount of screen time they engaged in during Days 1 to 3 of the study period and completed an activity survey on Days 4 to 10. Among the participants, 76% completed the PCSS form until symptom resolution or until Day 10 (the end of the study period).

Continue to: The primary outcome...

The primary outcome was days to resolution of concussive symptoms, defined as a PCSS score ≤ 3. The median baseline PCSS score was 21 in the screen time–permitted group and 24.5 in the screen time–abstinent group. The screen time–permitted group reported a median screen time of 630 minutes during the intervention period, compared with 130 minutes in the screen time–abstinent group, and was less likely to recover during the study period than the screen time–­abstinent group (hazard ratio = 0.51; 95% CI, 0.29-0.90). The screen time–permitted group had a significantly longer median recovery time compared with the screen time–­abstinent group (8.0 vs 3.5 days; P = .03).

WHAT'S NEW?

Exploring the role of screen time during the cognitive rest period

This study provides evidence supporting the recommendation that adolescent and young adult patients abstain from screen time in the first 48 hours following a concussion to decrease time to symptom resolution, thus shortening the timeline to return to their usual daily activities.

CAVEATS

Self-reporting of data may introduce bias

This study used a self-reporting method to collect data, which could have resulted in underreporting or overreporting of screen time and potentially introduced recall and reporting bias. The screen time–abstinent group did not completely abstain from all screen time, with a self-reported average of 5 to 10 minutes of daily screen time to complete the required research surveys, so it is not immediately clear what extent of abstinence vs significant screen time reduction led to the clinical endpoints observed. Furthermore, this study did not ask patients to differentiate between active screen time (eg, texting and gaming) and passive screen time (eg, watching videos), which may differentially impact symptom resolution.

CHALLENGES TO IMPLEMENTATION

Turning off the ever-present screen may present obstacles

This intervention is easy to recommend, with few barriers to implementation. It’s worth noting that screens are often used in a patient’s school or job, and 48 hours of abstinence from these activities is a difficult ask when much of our society’s education, entertainment, and productivity revolve around the use of technology. When appropriate, a shared decision-making discussion between patient and physician should center on the idea that 48 hours of screen time abstinence could be well worth the increased likelihood of total recovery at Day 10, as opposed to the risk for persistent and prolonged symptoms that interfere with the patient’s lifestyle.

ILLUSTRATIVE CASE

A 17-year-old high school football player presents to the emergency department (ED) after a helmet-to-helmet tackle in a game earlier that day. After the tackle, he experienced immediate confusion. Once he returned to his feet, he felt dizzy and nauseated and began to develop a headache. When his symptoms failed to resolve within a few hours, his mother brought him to the hospital for an evaluation. In the ED, he receives a diagnosis of concussion, and his mother asks for recommendations on how he can recover as quickly as possible.

Traumatic brain injuries account for an estimated 2.5 million ED visits annually in the United States.² Concussions are the most common form of traumatic brain injury, with adolescents contributing to the highest incidence of concussions.^3,4 An estimated 1.6 to 3.8 million people experience a sports-related concussion annually.⁵

Time to recovery is a clinical endpoint that matters greatly to our young, physically active patients, who are often eager to return to their daily activities as soon as possible. Guidelines frequently recommend cognitive and physical rest for 24 to 48 hours immediately following a concussion, but the use of screens during this cognitive rest period remains uncertain.^6,7 International guidelines and the Centers for Disease Control and ­Prevention recommend symptom-limited activities—including screen time—during the initial period of a concussion.^6,7 Although this gradual approach is standard of care, it has been unclear if abstaining completely from certain activities during the initial days of a concussion has any impact on recovery time.

Recent studies have examined physical activity to clarify the optimal timing of physical rest after a concussion. Among adolescents with concussions, strict rest for 5 days does not appear to improve symptoms compared with rest for 1 to 2 days.⁸ Additionally, physical activity within 7 days of acute head injury may help reduce symptoms and prevent postconcussive symptoms.^9,10

This same level of clarity has been lacking for cognitive rest and screen time. The use of screens is a part of most patients’ daily activities, particularly among adolescents and young adults. One report found that students ages 8 to 18 years engage in approximately 7 hours of daily screen time, excluding that related to schoolwork.¹¹ This trial evaluated the relationship between screen time abstinence within 48 hours of a concussion and time to symptom resolution.

STUDY SUMMARY

Symptom duration was significantly reduced by cutting screen time

This single-site, parallel-design, randomized clinical trial examined the effectiveness of limiting screen time exposure within the first 48 hours after a concussion in reducing the time to resolution of concussive symptoms in 125 patients. ¹ Patients were included if they were 12 to 25 years old (mean age, 17 years) and presented within 24 hours of sustaining a concussion (as defined on the Acute Concussion Evaluation–Emergency Department tool) to the pediatric or adult ED at a US tertiary medical center.

A shared decision-making discussion should center on the idea that 48 hours of screen time abstinence could be well worth the increased likelihood of total recovery at Day 10.

Patients were randomized to either ­engage in screen time as tolerated or to abstain from screen time for 48 hours following their injury. Screen modalities included television, phones, video games, and computers/­tablets. The Post-Concussive Symptom Scale (PCSS; 0-132) was used to characterize 22 symptoms from 0 (absent) to 6 (severe) daily for 10 days. Patients also self-reported the amount of screen time they engaged in during Days 1 to 3 of the study period and completed an activity survey on Days 4 to 10. Among the participants, 76% completed the PCSS form until symptom resolution or until Day 10 (the end of the study period).

Continue to: The primary outcome...

The primary outcome was days to resolution of concussive symptoms, defined as a PCSS score ≤ 3. The median baseline PCSS score was 21 in the screen time–permitted group and 24.5 in the screen time–abstinent group. The screen time–permitted group reported a median screen time of 630 minutes during the intervention period, compared with 130 minutes in the screen time–abstinent group, and was less likely to recover during the study period than the screen time–­abstinent group (hazard ratio = 0.51; 95% CI, 0.29-0.90). The screen time–permitted group had a significantly longer median recovery time compared with the screen time–­abstinent group (8.0 vs 3.5 days; P = .03).

WHAT'S NEW?

Exploring the role of screen time during the cognitive rest period

This study provides evidence supporting the recommendation that adolescent and young adult patients abstain from screen time in the first 48 hours following a concussion to decrease time to symptom resolution, thus shortening the timeline to return to their usual daily activities.

CAVEATS

Self-reporting of data may introduce bias

This study used a self-reporting method to collect data, which could have resulted in underreporting or overreporting of screen time and potentially introduced recall and reporting bias. The screen time–abstinent group did not completely abstain from all screen time, with a self-reported average of 5 to 10 minutes of daily screen time to complete the required research surveys, so it is not immediately clear what extent of abstinence vs significant screen time reduction led to the clinical endpoints observed. Furthermore, this study did not ask patients to differentiate between active screen time (eg, texting and gaming) and passive screen time (eg, watching videos), which may differentially impact symptom resolution.

CHALLENGES TO IMPLEMENTATION

Turning off the ever-present screen may present obstacles

This intervention is easy to recommend, with few barriers to implementation. It’s worth noting that screens are often used in a patient’s school or job, and 48 hours of abstinence from these activities is a difficult ask when much of our society’s education, entertainment, and productivity revolve around the use of technology. When appropriate, a shared decision-making discussion between patient and physician should center on the idea that 48 hours of screen time abstinence could be well worth the increased likelihood of total recovery at Day 10, as opposed to the risk for persistent and prolonged symptoms that interfere with the patient’s lifestyle.

ILLUSTRATIVE CASE

A 17-year-old high school football player presents to the emergency department (ED) after a helmet-to-helmet tackle in a game earlier that day. After the tackle, he experienced immediate confusion. Once he returned to his feet, he felt dizzy and nauseated and began to develop a headache. When his symptoms failed to resolve within a few hours, his mother brought him to the hospital for an evaluation. In the ED, he receives a diagnosis of concussion, and his mother asks for recommendations on how he can recover as quickly as possible.

Traumatic brain injuries account for an estimated 2.5 million ED visits annually in the United States.² Concussions are the most common form of traumatic brain injury, with adolescents contributing to the highest incidence of concussions.^3,4 An estimated 1.6 to 3.8 million people experience a sports-related concussion annually.⁵

Time to recovery is a clinical endpoint that matters greatly to our young, physically active patients, who are often eager to return to their daily activities as soon as possible. Guidelines frequently recommend cognitive and physical rest for 24 to 48 hours immediately following a concussion, but the use of screens during this cognitive rest period remains uncertain.^6,7 International guidelines and the Centers for Disease Control and ­Prevention recommend symptom-limited activities—including screen time—during the initial period of a concussion.^6,7 Although this gradual approach is standard of care, it has been unclear if abstaining completely from certain activities during the initial days of a concussion has any impact on recovery time.

Recent studies have examined physical activity to clarify the optimal timing of physical rest after a concussion. Among adolescents with concussions, strict rest for 5 days does not appear to improve symptoms compared with rest for 1 to 2 days.⁸ Additionally, physical activity within 7 days of acute head injury may help reduce symptoms and prevent postconcussive symptoms.^9,10

This same level of clarity has been lacking for cognitive rest and screen time. The use of screens is a part of most patients’ daily activities, particularly among adolescents and young adults. One report found that students ages 8 to 18 years engage in approximately 7 hours of daily screen time, excluding that related to schoolwork.¹¹ This trial evaluated the relationship between screen time abstinence within 48 hours of a concussion and time to symptom resolution.

STUDY SUMMARY

Symptom duration was significantly reduced by cutting screen time

This single-site, parallel-design, randomized clinical trial examined the effectiveness of limiting screen time exposure within the first 48 hours after a concussion in reducing the time to resolution of concussive symptoms in 125 patients. ¹ Patients were included if they were 12 to 25 years old (mean age, 17 years) and presented within 24 hours of sustaining a concussion (as defined on the Acute Concussion Evaluation–Emergency Department tool) to the pediatric or adult ED at a US tertiary medical center.

A shared decision-making discussion should center on the idea that 48 hours of screen time abstinence could be well worth the increased likelihood of total recovery at Day 10.

Patients were randomized to either ­engage in screen time as tolerated or to abstain from screen time for 48 hours following their injury. Screen modalities included television, phones, video games, and computers/­tablets. The Post-Concussive Symptom Scale (PCSS; 0-132) was used to characterize 22 symptoms from 0 (absent) to 6 (severe) daily for 10 days. Patients also self-reported the amount of screen time they engaged in during Days 1 to 3 of the study period and completed an activity survey on Days 4 to 10. Among the participants, 76% completed the PCSS form until symptom resolution or until Day 10 (the end of the study period).

Continue to: The primary outcome...

The primary outcome was days to resolution of concussive symptoms, defined as a PCSS score ≤ 3. The median baseline PCSS score was 21 in the screen time–permitted group and 24.5 in the screen time–abstinent group. The screen time–permitted group reported a median screen time of 630 minutes during the intervention period, compared with 130 minutes in the screen time–abstinent group, and was less likely to recover during the study period than the screen time–­abstinent group (hazard ratio = 0.51; 95% CI, 0.29-0.90). The screen time–permitted group had a significantly longer median recovery time compared with the screen time–­abstinent group (8.0 vs 3.5 days; P = .03).

WHAT'S NEW?

Exploring the role of screen time during the cognitive rest period

This study provides evidence supporting the recommendation that adolescent and young adult patients abstain from screen time in the first 48 hours following a concussion to decrease time to symptom resolution, thus shortening the timeline to return to their usual daily activities.

CAVEATS

Self-reporting of data may introduce bias

This study used a self-reporting method to collect data, which could have resulted in underreporting or overreporting of screen time and potentially introduced recall and reporting bias. The screen time–abstinent group did not completely abstain from all screen time, with a self-reported average of 5 to 10 minutes of daily screen time to complete the required research surveys, so it is not immediately clear what extent of abstinence vs significant screen time reduction led to the clinical endpoints observed. Furthermore, this study did not ask patients to differentiate between active screen time (eg, texting and gaming) and passive screen time (eg, watching videos), which may differentially impact symptom resolution.

CHALLENGES TO IMPLEMENTATION

Turning off the ever-present screen may present obstacles

This intervention is easy to recommend, with few barriers to implementation. It’s worth noting that screens are often used in a patient’s school or job, and 48 hours of abstinence from these activities is a difficult ask when much of our society’s education, entertainment, and productivity revolve around the use of technology. When appropriate, a shared decision-making discussion between patient and physician should center on the idea that 48 hours of screen time abstinence could be well worth the increased likelihood of total recovery at Day 10, as opposed to the risk for persistent and prolonged symptoms that interfere with the patient’s lifestyle.

A skin scraping and potassium hydroxide (KOH) prep confirmed the presence of branching hyphae, consistent with tinea corporis. The large size of this plaque could have easily made this diagnosis more difficult. When tinea corporis is suspected, look at the edge of the plaque; there is often thin scale and sometimes small pustules corresponding to follicular involvement.

Commonly called by the misnomer “ringworm,” tinea corporis is a skin infection caused by a wide variety of dermatophytes and affects all ages, sexes, and skin types. Trichophyton, Microsporum, and Epidermophyton species are frequently isolated.¹ Patients with atopic dermatitis or weakened immunity may be more susceptible to more frequent or long-lasting episodes. Diabetes may have contributed to the extent of the disease in this case.

Patients with tinea corporis present with one or several annular patches to plaques that grow in size. When the source of contagion is an animal, inflammation can be dramatic. In the case above, there was minimal to no itching and the patient didn’t notice the rash; thus, it was able to enlarge for months.

Treatment options include systemic and topical antifungal therapy. Consideration should be given to the severity of the disease and causal organism. Azoles, terbinafine, and ciclopirox are common treatment options. Topical therapy with an appropriately selected antifungal for 1 to 6 weeks, based on clinical response, is safe and effective. It is important to consider other foci of infection, including the feet and hands. More extensive disease may be treated with oral therapy such as terbinafine, fluconazole, or itraconazole.

Because of the extent of the disease and the challenge of effective coverage with topical therapy, this patient was treated with oral terbinafine 250 mg daily for 3 weeks. The plaque cleared completely.

‌

Photos and text for Photo Rounds Friday courtesy of Jonathan Karnes, MD (copyright retained). Dr. Karnes is the medical director of MDFMR Dermatology Services, Augusta, ME.

A skin scraping and potassium hydroxide (KOH) prep confirmed the presence of branching hyphae, consistent with tinea corporis. The large size of this plaque could have easily made this diagnosis more difficult. When tinea corporis is suspected, look at the edge of the plaque; there is often thin scale and sometimes small pustules corresponding to follicular involvement.

Commonly called by the misnomer “ringworm,” tinea corporis is a skin infection caused by a wide variety of dermatophytes and affects all ages, sexes, and skin types. Trichophyton, Microsporum, and Epidermophyton species are frequently isolated.¹ Patients with atopic dermatitis or weakened immunity may be more susceptible to more frequent or long-lasting episodes. Diabetes may have contributed to the extent of the disease in this case.

Patients with tinea corporis present with one or several annular patches to plaques that grow in size. When the source of contagion is an animal, inflammation can be dramatic. In the case above, there was minimal to no itching and the patient didn’t notice the rash; thus, it was able to enlarge for months.

Treatment options include systemic and topical antifungal therapy. Consideration should be given to the severity of the disease and causal organism. Azoles, terbinafine, and ciclopirox are common treatment options. Topical therapy with an appropriately selected antifungal for 1 to 6 weeks, based on clinical response, is safe and effective. It is important to consider other foci of infection, including the feet and hands. More extensive disease may be treated with oral therapy such as terbinafine, fluconazole, or itraconazole.

Because of the extent of the disease and the challenge of effective coverage with topical therapy, this patient was treated with oral terbinafine 250 mg daily for 3 weeks. The plaque cleared completely.

‌

Photos and text for Photo Rounds Friday courtesy of Jonathan Karnes, MD (copyright retained). Dr. Karnes is the medical director of MDFMR Dermatology Services, Augusta, ME.

A skin scraping and potassium hydroxide (KOH) prep confirmed the presence of branching hyphae, consistent with tinea corporis. The large size of this plaque could have easily made this diagnosis more difficult. When tinea corporis is suspected, look at the edge of the plaque; there is often thin scale and sometimes small pustules corresponding to follicular involvement.

Commonly called by the misnomer “ringworm,” tinea corporis is a skin infection caused by a wide variety of dermatophytes and affects all ages, sexes, and skin types. Trichophyton, Microsporum, and Epidermophyton species are frequently isolated.¹ Patients with atopic dermatitis or weakened immunity may be more susceptible to more frequent or long-lasting episodes. Diabetes may have contributed to the extent of the disease in this case.

Patients with tinea corporis present with one or several annular patches to plaques that grow in size. When the source of contagion is an animal, inflammation can be dramatic. In the case above, there was minimal to no itching and the patient didn’t notice the rash; thus, it was able to enlarge for months.

Treatment options include systemic and topical antifungal therapy. Consideration should be given to the severity of the disease and causal organism. Azoles, terbinafine, and ciclopirox are common treatment options. Topical therapy with an appropriately selected antifungal for 1 to 6 weeks, based on clinical response, is safe and effective. It is important to consider other foci of infection, including the feet and hands. More extensive disease may be treated with oral therapy such as terbinafine, fluconazole, or itraconazole.

Because of the extent of the disease and the challenge of effective coverage with topical therapy, this patient was treated with oral terbinafine 250 mg daily for 3 weeks. The plaque cleared completely.

‌

Photos and text for Photo Rounds Friday courtesy of Jonathan Karnes, MD (copyright retained). Dr. Karnes is the medical director of MDFMR Dermatology Services, Augusta, ME.

THE COMPARISON

A Vitiligo in a young Hispanic female, which spared the area under a ring. The patient has spotty return of pigment on the hand after narrowband ultraviolet B (UVB) treatment.

B Vitiligo on the hand in a young Hispanic male.

Vitiligo is a chronic autoimmune disorder characterized by areas of depigmented white patches on the skin due to the loss of melanocytes in the epidermis. Various theories on the pathogenesis of vitiligo exist; however, autoimmune destruction of melanocytes remains the leading hypothesis, followed by intrinsic defects in melanocytes.¹

Vitiligo is associated with various autoimmune diseases but is most frequently reported in conjunction with thyroid disorders.²

Epidemiology

Vitiligo affects approximately 1% of the US population and up to 8% worldwide.² There is no difference in prevalence between races or genders. Females typically acquire the disease earlier than males. Onset may occur at any age, although about half of patients will have vitiligo by 20 years of age.¹

Key clinical features in people with darker skin tones

Bright white patches are characteristic of vitiligo. The patches typically are asymptomatic and often affect the hands (FIGURES A and B), perioral skin, feet, and scalp, as well as areas more vulnerable to friction and trauma, such as the elbows and knees.² Trichrome lesions—consisting of varying zones of white (depigmented), lighter brown (hypopigmented), and normal skin—are most commonly seen in individuals with darker skin. Trichrome vitiligo is considered an actively progressing variant of vitiligo.²

An important distinction when making the diagnosis is evaluating for segmental vs nonsegmental vitiligo. Although nonsegmental vitiligo—the more common subtype—is characterized by symmetric distribution and a less predictable course, segmental vitiligo manifests in a localized and unilateral distribution, often avoiding extension past the midline. Segmental vitiligo typically manifests at a younger age and follows a more rapidly stabilizing course.³

Worth noting

Given that stark contrasts between pigmented and depigmented lesions are more prominent in darker skin tones, vitiligo can be more socially stigmatizing and psychologically devastating in these patients.^4,5

Continue to: Treatment of vitiligo...

Treatment of vitiligo includes narrowband UVB (NB-UVB) light phototherapy, excimer laser, topical corticosteroids, topical calcineurin inhibitors such as tacrolimus and pimecrolimus, and surgical melanocyte transplantation.¹ In July 2022, ruxolitinib cream 1.5% was approved by the US Food and Drug Administration (FDA) for nonsegmental vitiligo in patients ages 12 years and older.^6,7 It is the only FDA-approved therapy for vitiligo. It is thought to work by inhibiting the Janus kinase–signal transducers and activators of the transcription pathway.⁶ However, topical ruxolitinib is expensive, costing more than $2000 for 60 g.⁸

Health disparity highlight

A 2021 study reviewing the coverage policies of 15 commercial health care insurance companies, 50 BlueCross BlueShield plans, Medicaid, Medicare, and Veterans Affairs plans found inequities in the insurance coverage patterns for therapies used to treat vitiligo. There were 2 commonly cited reasons for denying coverage for therapies: vitiligo was considered cosmetic and therapies were not FDA approved.⁷ In comparison, NB-UVB light phototherapy for psoriasis is not considered cosmetic and has a much higher insurance coverage rate.^9,10 The out-of-pocket cost for a patient to purchase their own NB-UVB light phototherapy is more than $5000.¹¹ Not all patients of color are economically disadvantaged, but in the United States, Black and Hispanic populations experience disproportionately higher rates of poverty (19% and 17%, respectively) compared to their White counterparts (8%).¹²

Final thoughts

FDA approval of new drugs or new treatment indications comes after years of research discovery and large-scale trials. This pursuit of new discovery, however, is uneven. Vitiligo has historically been understudied and underfunded for research; this is common among several conditions adversely affecting people of color in the United States.¹³

THE COMPARISON

A Vitiligo in a young Hispanic female, which spared the area under a ring. The patient has spotty return of pigment on the hand after narrowband ultraviolet B (UVB) treatment.

B Vitiligo on the hand in a young Hispanic male.

Vitiligo is a chronic autoimmune disorder characterized by areas of depigmented white patches on the skin due to the loss of melanocytes in the epidermis. Various theories on the pathogenesis of vitiligo exist; however, autoimmune destruction of melanocytes remains the leading hypothesis, followed by intrinsic defects in melanocytes.¹

Vitiligo is associated with various autoimmune diseases but is most frequently reported in conjunction with thyroid disorders.²

Epidemiology

Vitiligo affects approximately 1% of the US population and up to 8% worldwide.² There is no difference in prevalence between races or genders. Females typically acquire the disease earlier than males. Onset may occur at any age, although about half of patients will have vitiligo by 20 years of age.¹

Key clinical features in people with darker skin tones

Bright white patches are characteristic of vitiligo. The patches typically are asymptomatic and often affect the hands (FIGURES A and B), perioral skin, feet, and scalp, as well as areas more vulnerable to friction and trauma, such as the elbows and knees.² Trichrome lesions—consisting of varying zones of white (depigmented), lighter brown (hypopigmented), and normal skin—are most commonly seen in individuals with darker skin. Trichrome vitiligo is considered an actively progressing variant of vitiligo.²

An important distinction when making the diagnosis is evaluating for segmental vs nonsegmental vitiligo. Although nonsegmental vitiligo—the more common subtype—is characterized by symmetric distribution and a less predictable course, segmental vitiligo manifests in a localized and unilateral distribution, often avoiding extension past the midline. Segmental vitiligo typically manifests at a younger age and follows a more rapidly stabilizing course.³

Worth noting

Given that stark contrasts between pigmented and depigmented lesions are more prominent in darker skin tones, vitiligo can be more socially stigmatizing and psychologically devastating in these patients.^4,5

Continue to: Treatment of vitiligo...

Treatment of vitiligo includes narrowband UVB (NB-UVB) light phototherapy, excimer laser, topical corticosteroids, topical calcineurin inhibitors such as tacrolimus and pimecrolimus, and surgical melanocyte transplantation.¹ In July 2022, ruxolitinib cream 1.5% was approved by the US Food and Drug Administration (FDA) for nonsegmental vitiligo in patients ages 12 years and older.^6,7 It is the only FDA-approved therapy for vitiligo. It is thought to work by inhibiting the Janus kinase–signal transducers and activators of the transcription pathway.⁶ However, topical ruxolitinib is expensive, costing more than $2000 for 60 g.⁸

Health disparity highlight

A 2021 study reviewing the coverage policies of 15 commercial health care insurance companies, 50 BlueCross BlueShield plans, Medicaid, Medicare, and Veterans Affairs plans found inequities in the insurance coverage patterns for therapies used to treat vitiligo. There were 2 commonly cited reasons for denying coverage for therapies: vitiligo was considered cosmetic and therapies were not FDA approved.⁷ In comparison, NB-UVB light phototherapy for psoriasis is not considered cosmetic and has a much higher insurance coverage rate.^9,10 The out-of-pocket cost for a patient to purchase their own NB-UVB light phototherapy is more than $5000.¹¹ Not all patients of color are economically disadvantaged, but in the United States, Black and Hispanic populations experience disproportionately higher rates of poverty (19% and 17%, respectively) compared to their White counterparts (8%).¹²

Final thoughts

FDA approval of new drugs or new treatment indications comes after years of research discovery and large-scale trials. This pursuit of new discovery, however, is uneven. Vitiligo has historically been understudied and underfunded for research; this is common among several conditions adversely affecting people of color in the United States.¹³

THE COMPARISON

A Vitiligo in a young Hispanic female, which spared the area under a ring. The patient has spotty return of pigment on the hand after narrowband ultraviolet B (UVB) treatment.

B Vitiligo on the hand in a young Hispanic male.

Vitiligo is a chronic autoimmune disorder characterized by areas of depigmented white patches on the skin due to the loss of melanocytes in the epidermis. Various theories on the pathogenesis of vitiligo exist; however, autoimmune destruction of melanocytes remains the leading hypothesis, followed by intrinsic defects in melanocytes.¹

Vitiligo is associated with various autoimmune diseases but is most frequently reported in conjunction with thyroid disorders.²

Epidemiology

Vitiligo affects approximately 1% of the US population and up to 8% worldwide.² There is no difference in prevalence between races or genders. Females typically acquire the disease earlier than males. Onset may occur at any age, although about half of patients will have vitiligo by 20 years of age.¹

Key clinical features in people with darker skin tones

Bright white patches are characteristic of vitiligo. The patches typically are asymptomatic and often affect the hands (FIGURES A and B), perioral skin, feet, and scalp, as well as areas more vulnerable to friction and trauma, such as the elbows and knees.² Trichrome lesions—consisting of varying zones of white (depigmented), lighter brown (hypopigmented), and normal skin—are most commonly seen in individuals with darker skin. Trichrome vitiligo is considered an actively progressing variant of vitiligo.²

An important distinction when making the diagnosis is evaluating for segmental vs nonsegmental vitiligo. Although nonsegmental vitiligo—the more common subtype—is characterized by symmetric distribution and a less predictable course, segmental vitiligo manifests in a localized and unilateral distribution, often avoiding extension past the midline. Segmental vitiligo typically manifests at a younger age and follows a more rapidly stabilizing course.³

Worth noting

Given that stark contrasts between pigmented and depigmented lesions are more prominent in darker skin tones, vitiligo can be more socially stigmatizing and psychologically devastating in these patients.^4,5

Continue to: Treatment of vitiligo...

Treatment of vitiligo includes narrowband UVB (NB-UVB) light phototherapy, excimer laser, topical corticosteroids, topical calcineurin inhibitors such as tacrolimus and pimecrolimus, and surgical melanocyte transplantation.¹ In July 2022, ruxolitinib cream 1.5% was approved by the US Food and Drug Administration (FDA) for nonsegmental vitiligo in patients ages 12 years and older.^6,7 It is the only FDA-approved therapy for vitiligo. It is thought to work by inhibiting the Janus kinase–signal transducers and activators of the transcription pathway.⁶ However, topical ruxolitinib is expensive, costing more than $2000 for 60 g.⁸

Health disparity highlight

A 2021 study reviewing the coverage policies of 15 commercial health care insurance companies, 50 BlueCross BlueShield plans, Medicaid, Medicare, and Veterans Affairs plans found inequities in the insurance coverage patterns for therapies used to treat vitiligo. There were 2 commonly cited reasons for denying coverage for therapies: vitiligo was considered cosmetic and therapies were not FDA approved.⁷ In comparison, NB-UVB light phototherapy for psoriasis is not considered cosmetic and has a much higher insurance coverage rate.^9,10 The out-of-pocket cost for a patient to purchase their own NB-UVB light phototherapy is more than $5000.¹¹ Not all patients of color are economically disadvantaged, but in the United States, Black and Hispanic populations experience disproportionately higher rates of poverty (19% and 17%, respectively) compared to their White counterparts (8%).¹²

Final thoughts

FDA approval of new drugs or new treatment indications comes after years of research discovery and large-scale trials. This pursuit of new discovery, however, is uneven. Vitiligo has historically been understudied and underfunded for research; this is common among several conditions adversely affecting people of color in the United States.¹³