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Pityriasis rosea carries few risks for pregnant women
according to a review of 33 patients.
“Though generally considered benign, PR may be associated with an increased risk of birth complications if acquired during pregnancy,” and previous studies have shown increased rates of complications including miscarriage and neonatal hypotonia in these patients, wrote Julian Stashower of the University of Virginia, Charlottesville, and colleagues.
In a retrospective study published in the Journal of the American Academy of Dermatology, the researchers assessed pregnancy outcomes in women who developed PR during pregnancy. They were identified from medical records at three institutions between September 2010 and June 2020. Diagnosis of PR, a papulosquamous skin eruption associated with human herpesvirus (HHV)–6/7 reactivation, was based on history and physical examination.
Overall, 8 of the 33 women (24%) had birth complications; the rates of preterm delivery, spontaneous pregnancy loss in clinically detectable pregnancies, and oligohydramnios were 6%, 0%, and 3%, respectively. The average onset of PR during pregnancy was earlier among women with complications, compared with those without complications (10.75 weeks’ gestation vs. 15.21 weeks’ gestation), but the difference was not statistically significant.
The researchers noted that their findings differed from the most recent study of PR in pregnancy, which included 60 patients and found a notably higher incidence of overall birth complications (50%), as well as higher incidence of neonatal hypotonia (25%), and miscarriage (13%).
The previous study also showed an increased risk of birth complications when PR onset occurred prior to 15 weeks’ gestation, but the current study did not reflect that finding, they wrote.
The current study findings were limited by several factors including the small sample size, retrospective design, and lack of confirmation of PR with HHV-6/7 testing, as well as lack of exclusion of atypical PR cases, the researchers noted. However, the results suggest that birth complications associated with PR may be lower than previously reported. “Further research is needed to guide future care and fully elucidate this possible association, which has important implications for both pregnant women with PR and their providers.”
The study received no outside funding. The researchers had no financial conflict to disclose.
according to a review of 33 patients.
“Though generally considered benign, PR may be associated with an increased risk of birth complications if acquired during pregnancy,” and previous studies have shown increased rates of complications including miscarriage and neonatal hypotonia in these patients, wrote Julian Stashower of the University of Virginia, Charlottesville, and colleagues.
In a retrospective study published in the Journal of the American Academy of Dermatology, the researchers assessed pregnancy outcomes in women who developed PR during pregnancy. They were identified from medical records at three institutions between September 2010 and June 2020. Diagnosis of PR, a papulosquamous skin eruption associated with human herpesvirus (HHV)–6/7 reactivation, was based on history and physical examination.
Overall, 8 of the 33 women (24%) had birth complications; the rates of preterm delivery, spontaneous pregnancy loss in clinically detectable pregnancies, and oligohydramnios were 6%, 0%, and 3%, respectively. The average onset of PR during pregnancy was earlier among women with complications, compared with those without complications (10.75 weeks’ gestation vs. 15.21 weeks’ gestation), but the difference was not statistically significant.
The researchers noted that their findings differed from the most recent study of PR in pregnancy, which included 60 patients and found a notably higher incidence of overall birth complications (50%), as well as higher incidence of neonatal hypotonia (25%), and miscarriage (13%).
The previous study also showed an increased risk of birth complications when PR onset occurred prior to 15 weeks’ gestation, but the current study did not reflect that finding, they wrote.
The current study findings were limited by several factors including the small sample size, retrospective design, and lack of confirmation of PR with HHV-6/7 testing, as well as lack of exclusion of atypical PR cases, the researchers noted. However, the results suggest that birth complications associated with PR may be lower than previously reported. “Further research is needed to guide future care and fully elucidate this possible association, which has important implications for both pregnant women with PR and their providers.”
The study received no outside funding. The researchers had no financial conflict to disclose.
according to a review of 33 patients.
“Though generally considered benign, PR may be associated with an increased risk of birth complications if acquired during pregnancy,” and previous studies have shown increased rates of complications including miscarriage and neonatal hypotonia in these patients, wrote Julian Stashower of the University of Virginia, Charlottesville, and colleagues.
In a retrospective study published in the Journal of the American Academy of Dermatology, the researchers assessed pregnancy outcomes in women who developed PR during pregnancy. They were identified from medical records at three institutions between September 2010 and June 2020. Diagnosis of PR, a papulosquamous skin eruption associated with human herpesvirus (HHV)–6/7 reactivation, was based on history and physical examination.
Overall, 8 of the 33 women (24%) had birth complications; the rates of preterm delivery, spontaneous pregnancy loss in clinically detectable pregnancies, and oligohydramnios were 6%, 0%, and 3%, respectively. The average onset of PR during pregnancy was earlier among women with complications, compared with those without complications (10.75 weeks’ gestation vs. 15.21 weeks’ gestation), but the difference was not statistically significant.
The researchers noted that their findings differed from the most recent study of PR in pregnancy, which included 60 patients and found a notably higher incidence of overall birth complications (50%), as well as higher incidence of neonatal hypotonia (25%), and miscarriage (13%).
The previous study also showed an increased risk of birth complications when PR onset occurred prior to 15 weeks’ gestation, but the current study did not reflect that finding, they wrote.
The current study findings were limited by several factors including the small sample size, retrospective design, and lack of confirmation of PR with HHV-6/7 testing, as well as lack of exclusion of atypical PR cases, the researchers noted. However, the results suggest that birth complications associated with PR may be lower than previously reported. “Further research is needed to guide future care and fully elucidate this possible association, which has important implications for both pregnant women with PR and their providers.”
The study received no outside funding. The researchers had no financial conflict to disclose.
FROM THE JOURNAL OF THE AMERICAN ACADEMY OF DERMATOLOGY
Eliminating hepatitis by 2030: HHS releases new strategic plan
In an effort to counteract alarming trends in rising hepatitis infections, the U.S. Department of Health and Human Services has developed and released its Viral Hepatitis National Strategic Plan 2021-2025, which aims to eliminate viral hepatitis infection in the United States by 2030.
An estimated 3.3 million people in the United States were chronically infected with hepatitis B (HBV) and hepatitis C (HCV) as of 2016. In addition, the country “is currently facing unprecedented hepatitis A (HAV) outbreaks, while progress in preventing hepatitis B has stalled, and hepatitis C rates nearly tripled from 2011 to 2018,” according to the HHS.
The new plan, “A Roadmap to Elimination for the United States,” builds upon previous initiatives the HHS has made to tackle the diseases and was coordinated by the Office of the Assistant Secretary for Health through the Office of Infectious Disease and HIV/AIDS Policy.
The plan focuses on HAV, HBV, and HCV, which have the largest impact on the health of the nation, according to the HHS. The plan addresses populations with the highest burden of viral hepatitis based on nationwide data so that resources can be focused there to achieve the greatest impact. Persons who inject drugs are a priority population for all three hepatitis viruses. HAV efforts will also include a focus on the homeless population. HBV efforts will also focus on Asian and Pacific Islander and the Black, non-Hispanic populations, while HCV efforts will include a focus on Black, non-Hispanic people, people born during 1945-1965, people with HIV, and the American Indian/Alaska Native population.
Goal-setting
There are five main goals outlined in the plan, according to the HHS:
- Prevent new hepatitis infections.
- Improve hepatitis-related health outcomes of people with viral hepatitis.
- Reduce hepatitis-related disparities and health inequities.
- Improve hepatitis surveillance and data use.
- Achieve integrated, coordinated efforts that address the viral hepatitis epidemics among all partners and stakeholders.
“The United States will be a place where new viral hepatitis infections are prevented, every person knows their status, and every person with viral hepatitis has high-quality health care and treatment and lives free from stigma and discrimination. This vision includes all people, regardless of age, sex, gender identity, sexual orientation, race, ethnicity, religion, disability, geographic location, or socioeconomic circumstance,” according to the HHS vision statement.
In an effort to counteract alarming trends in rising hepatitis infections, the U.S. Department of Health and Human Services has developed and released its Viral Hepatitis National Strategic Plan 2021-2025, which aims to eliminate viral hepatitis infection in the United States by 2030.
An estimated 3.3 million people in the United States were chronically infected with hepatitis B (HBV) and hepatitis C (HCV) as of 2016. In addition, the country “is currently facing unprecedented hepatitis A (HAV) outbreaks, while progress in preventing hepatitis B has stalled, and hepatitis C rates nearly tripled from 2011 to 2018,” according to the HHS.
The new plan, “A Roadmap to Elimination for the United States,” builds upon previous initiatives the HHS has made to tackle the diseases and was coordinated by the Office of the Assistant Secretary for Health through the Office of Infectious Disease and HIV/AIDS Policy.
The plan focuses on HAV, HBV, and HCV, which have the largest impact on the health of the nation, according to the HHS. The plan addresses populations with the highest burden of viral hepatitis based on nationwide data so that resources can be focused there to achieve the greatest impact. Persons who inject drugs are a priority population for all three hepatitis viruses. HAV efforts will also include a focus on the homeless population. HBV efforts will also focus on Asian and Pacific Islander and the Black, non-Hispanic populations, while HCV efforts will include a focus on Black, non-Hispanic people, people born during 1945-1965, people with HIV, and the American Indian/Alaska Native population.
Goal-setting
There are five main goals outlined in the plan, according to the HHS:
- Prevent new hepatitis infections.
- Improve hepatitis-related health outcomes of people with viral hepatitis.
- Reduce hepatitis-related disparities and health inequities.
- Improve hepatitis surveillance and data use.
- Achieve integrated, coordinated efforts that address the viral hepatitis epidemics among all partners and stakeholders.
“The United States will be a place where new viral hepatitis infections are prevented, every person knows their status, and every person with viral hepatitis has high-quality health care and treatment and lives free from stigma and discrimination. This vision includes all people, regardless of age, sex, gender identity, sexual orientation, race, ethnicity, religion, disability, geographic location, or socioeconomic circumstance,” according to the HHS vision statement.
In an effort to counteract alarming trends in rising hepatitis infections, the U.S. Department of Health and Human Services has developed and released its Viral Hepatitis National Strategic Plan 2021-2025, which aims to eliminate viral hepatitis infection in the United States by 2030.
An estimated 3.3 million people in the United States were chronically infected with hepatitis B (HBV) and hepatitis C (HCV) as of 2016. In addition, the country “is currently facing unprecedented hepatitis A (HAV) outbreaks, while progress in preventing hepatitis B has stalled, and hepatitis C rates nearly tripled from 2011 to 2018,” according to the HHS.
The new plan, “A Roadmap to Elimination for the United States,” builds upon previous initiatives the HHS has made to tackle the diseases and was coordinated by the Office of the Assistant Secretary for Health through the Office of Infectious Disease and HIV/AIDS Policy.
The plan focuses on HAV, HBV, and HCV, which have the largest impact on the health of the nation, according to the HHS. The plan addresses populations with the highest burden of viral hepatitis based on nationwide data so that resources can be focused there to achieve the greatest impact. Persons who inject drugs are a priority population for all three hepatitis viruses. HAV efforts will also include a focus on the homeless population. HBV efforts will also focus on Asian and Pacific Islander and the Black, non-Hispanic populations, while HCV efforts will include a focus on Black, non-Hispanic people, people born during 1945-1965, people with HIV, and the American Indian/Alaska Native population.
Goal-setting
There are five main goals outlined in the plan, according to the HHS:
- Prevent new hepatitis infections.
- Improve hepatitis-related health outcomes of people with viral hepatitis.
- Reduce hepatitis-related disparities and health inequities.
- Improve hepatitis surveillance and data use.
- Achieve integrated, coordinated efforts that address the viral hepatitis epidemics among all partners and stakeholders.
“The United States will be a place where new viral hepatitis infections are prevented, every person knows their status, and every person with viral hepatitis has high-quality health care and treatment and lives free from stigma and discrimination. This vision includes all people, regardless of age, sex, gender identity, sexual orientation, race, ethnicity, religion, disability, geographic location, or socioeconomic circumstance,” according to the HHS vision statement.
Consensus bundle has potential to affect postpartum morbidity, mortality
Health care professionals miss an important opportunity if they do not use a holistic patient-centered approach in providing support to their postpartum patients, advised Alison M. Stuebe, MD, MSc, of the division of maternal-fetal medicine at the University of North Carolina at Chapel Hill, and colleagues.
Too often, the emphasis for health care professionals is on less common, highly morbid complications, while their patients’ needs are focused more on daily functioning.
More than half of maternal deaths occur not during delivery, but in the days, weeks, and months following birth. Many serious complications and management of less-emergent conditions such as flu-like symptoms go unnoticed or result in treatment delays. Routinely asking women who present for care whether they have been pregnant during the past year could go a long way in helping clinicians connect the dots for conditions they might not otherwise consider, suggested Dr. Stuebe and colleagues.
In response to what is becoming a growing burden of postpartum maternal morbidity and mortality in the United States, Dr. Stuebe and associates, in coordination with the Alliance of Innovation in Maternal Health, prepared a comprehensive consensus statement on postpartum care basics. The work came out of a day-long planning meeting of an interdisciplinary work group funded by AIMH to develop the maternal safety bundle, which established 28 goals across four phases – readiness, recognition and prevention, response, and reporting. Each phase is intended to occur as part of a coordinated effort between women experiencing pregnancy and their health care providers, with involvement from multiple clinical settings and health systems.
America needs to change the way it treats its new mothers
In a separate interview, Dr. Stuebe shared additional insights into the development of the consensus statement: “This article is part of a broader movement to change the way America treats new mothers. For too long, we’ve lavished attention on women in the weeks before birth and then left them alone to manage recovery, plunging hormones, sleepless nights, and new baby care. The goal of this article is to set out the ways that we can better support women in this critical transition period.
“We need to start during pregnancy, by working with women to plan for the fourth trimester and identify a care team that will support her and her baby. After birth, we need to adapt those plans and make sure she has the emotional and material support she needs to navigate the coming months. Many of these decisions are deeply personal, and we need to center the values and preferences of the woman and her family.”
Dr. Stuebe also spotlighted a new University of North Carolina–based program designed to support shared decision-making. Their Trimester Project team partnered with mothers to design NewMomHealth.com, the first national postpartum resource designed by and for new mothers, which is in the process of launching a culturally adapted Spanish-language site, saludmadre.com, in partnership with Urban Strategies.
Readiness prepares mothers, HCPs, and clinical settings for the fourth trimester
In the first phase, Readiness, there are three key parties involved: the woman experiencing pregnancy, the health care providers (HCPs) supporting her, and the clinical settings involved in her care. Each player has specific goals to achieve in this phase, women are responsible for four goals, health care providers have two goals, and clinical settings have five.
Prenatally, every woman should work with health care providers to develop a comprehensive, individualized postpartum care plan that designates a postpartum clinical “home” for addressing any care needed between birth and the “comprehensive postpartum visit.” The plan encourages the patient and her health care team give attention to social support, birth recovery, infant care and feeding plans, thoughts concerning future pregnancies, and specifically use of contraception, as well as any chronic health concerns and overall emotional well-being.
The plan should consist of a postpartum care team that includes friends and family and ensures that medical, material, and social support are available in the weeks following birth for both mother and baby.
The authors emphasized the importance for clinicians to develop a keen awareness of “reproductive justice,” which respects a woman’s right “to maintain personal bodily autonomy, have children, not have children, and parent the children we have in safe and sustainable communities.” They encouraged adopting a sensitivity to concerns deeply rooted in the history of family planning, which is perceived to have been “fraught by coercive tactics to incentivize sterilization and contraceptive implants among marginalized groups.” With this in mind, they urged clinicians to respectfully ask about the patient’s intentions before making any suggestions concerning future births and family planning preferences.
HCP readiness ensures that each woman “has a documented postpartum care plan and care team identified in the prenatal period.” HCPs are also responsible for developing and maintaining “a working knowledge of evidence-based evaluation and management of common issues facing the mother-infant dyad.”
Clinical setting readiness ensures that woman-centered postpartum care and education have been developed and optimized using adult learning principles whenever possible. Diversity of family structures, cultural traditions, and parenting practices are fully embraced. Dr. Stuebe and colleagues emphasized that traditional top-down teaching methods are ineffective and should be avoided.
Clinical setting readiness also ensures that systems are developed to pair families with community-based resources that provide medical follow-up as well as social and material support. Clinical protocols and reimbursement options should be available that give women easy access to preferred contraception. Systems should be in place that facilitate prompt, pertinent communication between in- and outpatient providers. Lastly, and perhaps most importantly, clinical setting readiness demands the development of protocols to screen and treat key postpartum concerns, such as depression, substance use disorders, family violence, and even incontinence in coordination with locally identified specialists.
Recognition and prevention promotes accountability and establishes key guidelines
Recognition and prevention require coordinated participation between women experiencing pregnancy and the clinical environments supporting their care. In this phase, women are responsible for three goals; clinical environments have four goals.
Women are to be identified and respected as the expert most knowledgeable of their own needs, cautioned the authors. They should also be empowered to trust their instincts, seeking care as early and as often as needed in the weeks after they give birth. Postpartum care needs to be viewed as an ongoing process, not just a singular encounter.
Women also need to take ownership for their postpartum care plan, reviewing and revising it as needed in coordination with their health care providers before maternity discharge is complete. Every plan should include a comprehensive list of warning signs and recommended action plans when faced with life-threatening complications, a list of resources for lactation support, and a “first-call” phone number that identifies the postpartum medical providers available to address breastfeeding issues and for postpartum care visits, including prescheduled dates and times.
Lastly, women are to take responsibility for attending their postpartum visit. Although new guidance suggests that the comprehensive visit take place no later than 12 weeks post partum, it also recognizes multiple visits may be required to address individual needs. All women should have contact with a maternal care provider within 3 weeks post partum, the American College of Obstetricians and Gynecologists recommends.
Responsibility for recognition and prevention in the clinical setting begins with determining guidelines for early postpartum visits, considering chronic conditions such as hypertension, diabetes, or substance abuse disorder and risk for postpartum conditions such as wound complications or postpartum depression, the authors wrote. Ongoing care between inpatient and outpatient settings as well as between maternal and infant care providers is coordinated to ensure health and well-being of both patients. Screening and treatment of common comorbidities such as mental health issues, smoking, and substance use as well as issues related to unstable housing and food insecurities are also addressed in the clinical environment. Lastly, clinicians are tasked with ensuring that every patient has selected a primary care provider for ongoing care.
Response ensures key parties and resources are connected at every step
In the response phase, clinical settings and health care providers are the key participants and they have two goals each.
Every clinical setting is tasked with implementing treatment protocols and providing needed care or facilitating referral in a timely fashion. The importance of a “warm hand-off” and “face-to-face introduction to the specialist to whom the patient is being referred” is encouraged. They are also responsible for keeping an updated inventory of community resources on hand for such unmet needs as 24-hour hotlines, food banks, diaper banks, lactation support groups, and home-visiting programs.
Every health care provider is tasked with developing strategies designed to reach women who do not attend their comprehensive postpartum visit. They are also responsible for assessing the severity of identified needs, and arranging immediate transportation to appropriate facilities in life-threatening circumstances. In nonacute cases, the woman and her care providers work with her to make appropriate decisions.
Reporting gives health systems the opportunity to assess and improve
Sole responsibility in the reporting phase falls to every health system. In this phase, they have a total of six goals.
Health systems are ideally organized to convene strategy-sharing sessions with inpatient as well as outpatient professionals to evaluate successes and opportunities for improvement. They are equally qualified to identify and monitor such quality measures as postpartum emergency department utilization and readmission rates. They are tasked with working toward quality metrics that compare postpartum outcomes and prenatal intentions, including patient receipt of preferred contraception or completion of planned breastfeeding duration.
Health systems are expected to conduct quality improvement measures designed to reduce postpartum morbidity when preventable. They are also the logical choice for maintaining a clearinghouse for resources, in collaboration with the community, that is designed to meet the postpartum needs of women.
Lastly, they play an important role in ensuring that reimbursement policies are structured such that they do not disincentivize postpartum visits.
The consensus bundle encourages change in the way America treats its new mothers
Angela Bianco, MD, maternal and fetal medicine specialist at Mount Sinai Hospital, New York, also interviewed separately, noted: “I think the fact that ACOG has created a postpartum bundle for providers to use for guidance is long overdue. The current prenatal care paradigm focuses on numerous/intensive prenatal visits but only a single postpartum visit. Many women report feeling ill-equipped to navigate the challenges that arise post delivery, including self-care, newborn care, and breastfeeding. In addition, most women experience the impact of dramatic hormonal fluctuations resulting in mood alterations. Add profound sleep deprivation to this and the result is often some degree of postpartum blues and/or depression. The importance of anticipatory guidance for our patients cannot be underestimated. Helping to facilitate potential social support structures be in place prior to the birth is optimal. Providers should reinforce the importance of access to a variety of tools, including digital apps, community support groups, and 24/7 web access services. Moving forward, it should be considered unconscionable to send a new mother home without ensuring the appropriate resources are in place. Postpartum care should be tailored to a woman’s needs and may require multiple visits and/or referrals.”
Dr. Stuebe and colleagues, as well as Dr. Bianco, disclosed receiving honoraria for various projects. Funding for the study was supported by the Alliance for Innovation on Maternal and Child Health, which is funded by a grant from the Health Resources and Services Administration.
Health care professionals miss an important opportunity if they do not use a holistic patient-centered approach in providing support to their postpartum patients, advised Alison M. Stuebe, MD, MSc, of the division of maternal-fetal medicine at the University of North Carolina at Chapel Hill, and colleagues.
Too often, the emphasis for health care professionals is on less common, highly morbid complications, while their patients’ needs are focused more on daily functioning.
More than half of maternal deaths occur not during delivery, but in the days, weeks, and months following birth. Many serious complications and management of less-emergent conditions such as flu-like symptoms go unnoticed or result in treatment delays. Routinely asking women who present for care whether they have been pregnant during the past year could go a long way in helping clinicians connect the dots for conditions they might not otherwise consider, suggested Dr. Stuebe and colleagues.
In response to what is becoming a growing burden of postpartum maternal morbidity and mortality in the United States, Dr. Stuebe and associates, in coordination with the Alliance of Innovation in Maternal Health, prepared a comprehensive consensus statement on postpartum care basics. The work came out of a day-long planning meeting of an interdisciplinary work group funded by AIMH to develop the maternal safety bundle, which established 28 goals across four phases – readiness, recognition and prevention, response, and reporting. Each phase is intended to occur as part of a coordinated effort between women experiencing pregnancy and their health care providers, with involvement from multiple clinical settings and health systems.
America needs to change the way it treats its new mothers
In a separate interview, Dr. Stuebe shared additional insights into the development of the consensus statement: “This article is part of a broader movement to change the way America treats new mothers. For too long, we’ve lavished attention on women in the weeks before birth and then left them alone to manage recovery, plunging hormones, sleepless nights, and new baby care. The goal of this article is to set out the ways that we can better support women in this critical transition period.
“We need to start during pregnancy, by working with women to plan for the fourth trimester and identify a care team that will support her and her baby. After birth, we need to adapt those plans and make sure she has the emotional and material support she needs to navigate the coming months. Many of these decisions are deeply personal, and we need to center the values and preferences of the woman and her family.”
Dr. Stuebe also spotlighted a new University of North Carolina–based program designed to support shared decision-making. Their Trimester Project team partnered with mothers to design NewMomHealth.com, the first national postpartum resource designed by and for new mothers, which is in the process of launching a culturally adapted Spanish-language site, saludmadre.com, in partnership with Urban Strategies.
Readiness prepares mothers, HCPs, and clinical settings for the fourth trimester
In the first phase, Readiness, there are three key parties involved: the woman experiencing pregnancy, the health care providers (HCPs) supporting her, and the clinical settings involved in her care. Each player has specific goals to achieve in this phase, women are responsible for four goals, health care providers have two goals, and clinical settings have five.
Prenatally, every woman should work with health care providers to develop a comprehensive, individualized postpartum care plan that designates a postpartum clinical “home” for addressing any care needed between birth and the “comprehensive postpartum visit.” The plan encourages the patient and her health care team give attention to social support, birth recovery, infant care and feeding plans, thoughts concerning future pregnancies, and specifically use of contraception, as well as any chronic health concerns and overall emotional well-being.
The plan should consist of a postpartum care team that includes friends and family and ensures that medical, material, and social support are available in the weeks following birth for both mother and baby.
The authors emphasized the importance for clinicians to develop a keen awareness of “reproductive justice,” which respects a woman’s right “to maintain personal bodily autonomy, have children, not have children, and parent the children we have in safe and sustainable communities.” They encouraged adopting a sensitivity to concerns deeply rooted in the history of family planning, which is perceived to have been “fraught by coercive tactics to incentivize sterilization and contraceptive implants among marginalized groups.” With this in mind, they urged clinicians to respectfully ask about the patient’s intentions before making any suggestions concerning future births and family planning preferences.
HCP readiness ensures that each woman “has a documented postpartum care plan and care team identified in the prenatal period.” HCPs are also responsible for developing and maintaining “a working knowledge of evidence-based evaluation and management of common issues facing the mother-infant dyad.”
Clinical setting readiness ensures that woman-centered postpartum care and education have been developed and optimized using adult learning principles whenever possible. Diversity of family structures, cultural traditions, and parenting practices are fully embraced. Dr. Stuebe and colleagues emphasized that traditional top-down teaching methods are ineffective and should be avoided.
Clinical setting readiness also ensures that systems are developed to pair families with community-based resources that provide medical follow-up as well as social and material support. Clinical protocols and reimbursement options should be available that give women easy access to preferred contraception. Systems should be in place that facilitate prompt, pertinent communication between in- and outpatient providers. Lastly, and perhaps most importantly, clinical setting readiness demands the development of protocols to screen and treat key postpartum concerns, such as depression, substance use disorders, family violence, and even incontinence in coordination with locally identified specialists.
Recognition and prevention promotes accountability and establishes key guidelines
Recognition and prevention require coordinated participation between women experiencing pregnancy and the clinical environments supporting their care. In this phase, women are responsible for three goals; clinical environments have four goals.
Women are to be identified and respected as the expert most knowledgeable of their own needs, cautioned the authors. They should also be empowered to trust their instincts, seeking care as early and as often as needed in the weeks after they give birth. Postpartum care needs to be viewed as an ongoing process, not just a singular encounter.
Women also need to take ownership for their postpartum care plan, reviewing and revising it as needed in coordination with their health care providers before maternity discharge is complete. Every plan should include a comprehensive list of warning signs and recommended action plans when faced with life-threatening complications, a list of resources for lactation support, and a “first-call” phone number that identifies the postpartum medical providers available to address breastfeeding issues and for postpartum care visits, including prescheduled dates and times.
Lastly, women are to take responsibility for attending their postpartum visit. Although new guidance suggests that the comprehensive visit take place no later than 12 weeks post partum, it also recognizes multiple visits may be required to address individual needs. All women should have contact with a maternal care provider within 3 weeks post partum, the American College of Obstetricians and Gynecologists recommends.
Responsibility for recognition and prevention in the clinical setting begins with determining guidelines for early postpartum visits, considering chronic conditions such as hypertension, diabetes, or substance abuse disorder and risk for postpartum conditions such as wound complications or postpartum depression, the authors wrote. Ongoing care between inpatient and outpatient settings as well as between maternal and infant care providers is coordinated to ensure health and well-being of both patients. Screening and treatment of common comorbidities such as mental health issues, smoking, and substance use as well as issues related to unstable housing and food insecurities are also addressed in the clinical environment. Lastly, clinicians are tasked with ensuring that every patient has selected a primary care provider for ongoing care.
Response ensures key parties and resources are connected at every step
In the response phase, clinical settings and health care providers are the key participants and they have two goals each.
Every clinical setting is tasked with implementing treatment protocols and providing needed care or facilitating referral in a timely fashion. The importance of a “warm hand-off” and “face-to-face introduction to the specialist to whom the patient is being referred” is encouraged. They are also responsible for keeping an updated inventory of community resources on hand for such unmet needs as 24-hour hotlines, food banks, diaper banks, lactation support groups, and home-visiting programs.
Every health care provider is tasked with developing strategies designed to reach women who do not attend their comprehensive postpartum visit. They are also responsible for assessing the severity of identified needs, and arranging immediate transportation to appropriate facilities in life-threatening circumstances. In nonacute cases, the woman and her care providers work with her to make appropriate decisions.
Reporting gives health systems the opportunity to assess and improve
Sole responsibility in the reporting phase falls to every health system. In this phase, they have a total of six goals.
Health systems are ideally organized to convene strategy-sharing sessions with inpatient as well as outpatient professionals to evaluate successes and opportunities for improvement. They are equally qualified to identify and monitor such quality measures as postpartum emergency department utilization and readmission rates. They are tasked with working toward quality metrics that compare postpartum outcomes and prenatal intentions, including patient receipt of preferred contraception or completion of planned breastfeeding duration.
Health systems are expected to conduct quality improvement measures designed to reduce postpartum morbidity when preventable. They are also the logical choice for maintaining a clearinghouse for resources, in collaboration with the community, that is designed to meet the postpartum needs of women.
Lastly, they play an important role in ensuring that reimbursement policies are structured such that they do not disincentivize postpartum visits.
The consensus bundle encourages change in the way America treats its new mothers
Angela Bianco, MD, maternal and fetal medicine specialist at Mount Sinai Hospital, New York, also interviewed separately, noted: “I think the fact that ACOG has created a postpartum bundle for providers to use for guidance is long overdue. The current prenatal care paradigm focuses on numerous/intensive prenatal visits but only a single postpartum visit. Many women report feeling ill-equipped to navigate the challenges that arise post delivery, including self-care, newborn care, and breastfeeding. In addition, most women experience the impact of dramatic hormonal fluctuations resulting in mood alterations. Add profound sleep deprivation to this and the result is often some degree of postpartum blues and/or depression. The importance of anticipatory guidance for our patients cannot be underestimated. Helping to facilitate potential social support structures be in place prior to the birth is optimal. Providers should reinforce the importance of access to a variety of tools, including digital apps, community support groups, and 24/7 web access services. Moving forward, it should be considered unconscionable to send a new mother home without ensuring the appropriate resources are in place. Postpartum care should be tailored to a woman’s needs and may require multiple visits and/or referrals.”
Dr. Stuebe and colleagues, as well as Dr. Bianco, disclosed receiving honoraria for various projects. Funding for the study was supported by the Alliance for Innovation on Maternal and Child Health, which is funded by a grant from the Health Resources and Services Administration.
Health care professionals miss an important opportunity if they do not use a holistic patient-centered approach in providing support to their postpartum patients, advised Alison M. Stuebe, MD, MSc, of the division of maternal-fetal medicine at the University of North Carolina at Chapel Hill, and colleagues.
Too often, the emphasis for health care professionals is on less common, highly morbid complications, while their patients’ needs are focused more on daily functioning.
More than half of maternal deaths occur not during delivery, but in the days, weeks, and months following birth. Many serious complications and management of less-emergent conditions such as flu-like symptoms go unnoticed or result in treatment delays. Routinely asking women who present for care whether they have been pregnant during the past year could go a long way in helping clinicians connect the dots for conditions they might not otherwise consider, suggested Dr. Stuebe and colleagues.
In response to what is becoming a growing burden of postpartum maternal morbidity and mortality in the United States, Dr. Stuebe and associates, in coordination with the Alliance of Innovation in Maternal Health, prepared a comprehensive consensus statement on postpartum care basics. The work came out of a day-long planning meeting of an interdisciplinary work group funded by AIMH to develop the maternal safety bundle, which established 28 goals across four phases – readiness, recognition and prevention, response, and reporting. Each phase is intended to occur as part of a coordinated effort between women experiencing pregnancy and their health care providers, with involvement from multiple clinical settings and health systems.
America needs to change the way it treats its new mothers
In a separate interview, Dr. Stuebe shared additional insights into the development of the consensus statement: “This article is part of a broader movement to change the way America treats new mothers. For too long, we’ve lavished attention on women in the weeks before birth and then left them alone to manage recovery, plunging hormones, sleepless nights, and new baby care. The goal of this article is to set out the ways that we can better support women in this critical transition period.
“We need to start during pregnancy, by working with women to plan for the fourth trimester and identify a care team that will support her and her baby. After birth, we need to adapt those plans and make sure she has the emotional and material support she needs to navigate the coming months. Many of these decisions are deeply personal, and we need to center the values and preferences of the woman and her family.”
Dr. Stuebe also spotlighted a new University of North Carolina–based program designed to support shared decision-making. Their Trimester Project team partnered with mothers to design NewMomHealth.com, the first national postpartum resource designed by and for new mothers, which is in the process of launching a culturally adapted Spanish-language site, saludmadre.com, in partnership with Urban Strategies.
Readiness prepares mothers, HCPs, and clinical settings for the fourth trimester
In the first phase, Readiness, there are three key parties involved: the woman experiencing pregnancy, the health care providers (HCPs) supporting her, and the clinical settings involved in her care. Each player has specific goals to achieve in this phase, women are responsible for four goals, health care providers have two goals, and clinical settings have five.
Prenatally, every woman should work with health care providers to develop a comprehensive, individualized postpartum care plan that designates a postpartum clinical “home” for addressing any care needed between birth and the “comprehensive postpartum visit.” The plan encourages the patient and her health care team give attention to social support, birth recovery, infant care and feeding plans, thoughts concerning future pregnancies, and specifically use of contraception, as well as any chronic health concerns and overall emotional well-being.
The plan should consist of a postpartum care team that includes friends and family and ensures that medical, material, and social support are available in the weeks following birth for both mother and baby.
The authors emphasized the importance for clinicians to develop a keen awareness of “reproductive justice,” which respects a woman’s right “to maintain personal bodily autonomy, have children, not have children, and parent the children we have in safe and sustainable communities.” They encouraged adopting a sensitivity to concerns deeply rooted in the history of family planning, which is perceived to have been “fraught by coercive tactics to incentivize sterilization and contraceptive implants among marginalized groups.” With this in mind, they urged clinicians to respectfully ask about the patient’s intentions before making any suggestions concerning future births and family planning preferences.
HCP readiness ensures that each woman “has a documented postpartum care plan and care team identified in the prenatal period.” HCPs are also responsible for developing and maintaining “a working knowledge of evidence-based evaluation and management of common issues facing the mother-infant dyad.”
Clinical setting readiness ensures that woman-centered postpartum care and education have been developed and optimized using adult learning principles whenever possible. Diversity of family structures, cultural traditions, and parenting practices are fully embraced. Dr. Stuebe and colleagues emphasized that traditional top-down teaching methods are ineffective and should be avoided.
Clinical setting readiness also ensures that systems are developed to pair families with community-based resources that provide medical follow-up as well as social and material support. Clinical protocols and reimbursement options should be available that give women easy access to preferred contraception. Systems should be in place that facilitate prompt, pertinent communication between in- and outpatient providers. Lastly, and perhaps most importantly, clinical setting readiness demands the development of protocols to screen and treat key postpartum concerns, such as depression, substance use disorders, family violence, and even incontinence in coordination with locally identified specialists.
Recognition and prevention promotes accountability and establishes key guidelines
Recognition and prevention require coordinated participation between women experiencing pregnancy and the clinical environments supporting their care. In this phase, women are responsible for three goals; clinical environments have four goals.
Women are to be identified and respected as the expert most knowledgeable of their own needs, cautioned the authors. They should also be empowered to trust their instincts, seeking care as early and as often as needed in the weeks after they give birth. Postpartum care needs to be viewed as an ongoing process, not just a singular encounter.
Women also need to take ownership for their postpartum care plan, reviewing and revising it as needed in coordination with their health care providers before maternity discharge is complete. Every plan should include a comprehensive list of warning signs and recommended action plans when faced with life-threatening complications, a list of resources for lactation support, and a “first-call” phone number that identifies the postpartum medical providers available to address breastfeeding issues and for postpartum care visits, including prescheduled dates and times.
Lastly, women are to take responsibility for attending their postpartum visit. Although new guidance suggests that the comprehensive visit take place no later than 12 weeks post partum, it also recognizes multiple visits may be required to address individual needs. All women should have contact with a maternal care provider within 3 weeks post partum, the American College of Obstetricians and Gynecologists recommends.
Responsibility for recognition and prevention in the clinical setting begins with determining guidelines for early postpartum visits, considering chronic conditions such as hypertension, diabetes, or substance abuse disorder and risk for postpartum conditions such as wound complications or postpartum depression, the authors wrote. Ongoing care between inpatient and outpatient settings as well as between maternal and infant care providers is coordinated to ensure health and well-being of both patients. Screening and treatment of common comorbidities such as mental health issues, smoking, and substance use as well as issues related to unstable housing and food insecurities are also addressed in the clinical environment. Lastly, clinicians are tasked with ensuring that every patient has selected a primary care provider for ongoing care.
Response ensures key parties and resources are connected at every step
In the response phase, clinical settings and health care providers are the key participants and they have two goals each.
Every clinical setting is tasked with implementing treatment protocols and providing needed care or facilitating referral in a timely fashion. The importance of a “warm hand-off” and “face-to-face introduction to the specialist to whom the patient is being referred” is encouraged. They are also responsible for keeping an updated inventory of community resources on hand for such unmet needs as 24-hour hotlines, food banks, diaper banks, lactation support groups, and home-visiting programs.
Every health care provider is tasked with developing strategies designed to reach women who do not attend their comprehensive postpartum visit. They are also responsible for assessing the severity of identified needs, and arranging immediate transportation to appropriate facilities in life-threatening circumstances. In nonacute cases, the woman and her care providers work with her to make appropriate decisions.
Reporting gives health systems the opportunity to assess and improve
Sole responsibility in the reporting phase falls to every health system. In this phase, they have a total of six goals.
Health systems are ideally organized to convene strategy-sharing sessions with inpatient as well as outpatient professionals to evaluate successes and opportunities for improvement. They are equally qualified to identify and monitor such quality measures as postpartum emergency department utilization and readmission rates. They are tasked with working toward quality metrics that compare postpartum outcomes and prenatal intentions, including patient receipt of preferred contraception or completion of planned breastfeeding duration.
Health systems are expected to conduct quality improvement measures designed to reduce postpartum morbidity when preventable. They are also the logical choice for maintaining a clearinghouse for resources, in collaboration with the community, that is designed to meet the postpartum needs of women.
Lastly, they play an important role in ensuring that reimbursement policies are structured such that they do not disincentivize postpartum visits.
The consensus bundle encourages change in the way America treats its new mothers
Angela Bianco, MD, maternal and fetal medicine specialist at Mount Sinai Hospital, New York, also interviewed separately, noted: “I think the fact that ACOG has created a postpartum bundle for providers to use for guidance is long overdue. The current prenatal care paradigm focuses on numerous/intensive prenatal visits but only a single postpartum visit. Many women report feeling ill-equipped to navigate the challenges that arise post delivery, including self-care, newborn care, and breastfeeding. In addition, most women experience the impact of dramatic hormonal fluctuations resulting in mood alterations. Add profound sleep deprivation to this and the result is often some degree of postpartum blues and/or depression. The importance of anticipatory guidance for our patients cannot be underestimated. Helping to facilitate potential social support structures be in place prior to the birth is optimal. Providers should reinforce the importance of access to a variety of tools, including digital apps, community support groups, and 24/7 web access services. Moving forward, it should be considered unconscionable to send a new mother home without ensuring the appropriate resources are in place. Postpartum care should be tailored to a woman’s needs and may require multiple visits and/or referrals.”
Dr. Stuebe and colleagues, as well as Dr. Bianco, disclosed receiving honoraria for various projects. Funding for the study was supported by the Alliance for Innovation on Maternal and Child Health, which is funded by a grant from the Health Resources and Services Administration.
FROM OBSTETRICS AND GYNECOLOGY
Normal FLIP findings usually ruled out esophageal motility disorders
Most patients with normal findings on functional luminal imaging probe (FLIP) showed no clinical evidence of a major esophageal motor disorder, even when their high-resolution manometry (HRM) test results were abnormal, according to the results of a single-center retrospective cohort study.
Among 111 study participants with normal FLIP findings, 79% also showed no evidence of a major esophageal motor disorder on esophageal high-resolution manometry (HRM), wrote Alexandra J. Baumann, DO, of Northwestern University, Chicago, and associates. “Among the remaining 21% with apparent disagreement with HRM, [those] with normal FLIP panometry carried overall clinical impressions of not having a major esophageal motor disorder and subsequently were treated conservatively without the need for surgical interventions,” they reported. For patients with normal upper endoscopy and normal FLIP panometry, “the initial clinical management strategy could be directed toward addressing gastroesophageal reflux or a functional syndrome,” they wrote in Clinical Gastroenterology and Hepatology.
FLIP uses high-resolution impedance planimetry to evaluate esophageal lumen parameters, distensibility, and contractility in response to distension. Although HRM is standard for evaluating esophageal motility, false negatives and positives can result from challenges with interpreting outflow obstructions and normal lower-esophageal sphincter relaxation pressures among patients with clinical achalasia.
Hence, the researchers evaluated correlations between FLIP and HRM in 111 patients with esophageal symptoms and nonobstructive endoscopy findings who were evaluated at the Esophageal Center of Northwestern University between 2012 and 2019. Gastroenterologists performed additional studies, such as barium esophagrams, at their discretion. By study design, all patients had normal FLIP results, defined as an esophagogastric junction distensibility index above 3.0 mm2 per mm Hg and a normal contractile response (that is, normal repetitive retrograde contractions and a repetitive antegrade contraction pattern that met the Rule-of-6s). Three clinicians evaluated and reached consensus on each FLIP study. Esophageal HRM data were interpreted based on the Chicago classification system (version 3.0).
Patients with normal FLIP panometry findings “did not have a clinical impression of a major esophageal motor disorder,” the researchers reported. In all, 23 (21%) patients with normal FLIP results had discrepant (abnormal) HRM findings, most of which were false positives or equivocal.
For example, among 20 patients whose HRM suggested an esophagogastric junction outflow obstruction, 17 showed normal bolus transit on supine swallows and 16 showed normalization of integrated relaxation pressure after adjunctive maneuvers. Similarly, among 10 patients who underwent a barium esophagram, 8 showed normal emptying, 1 showed a temporary delay but no retention, and 1 had an incomplete study. “The overall clinical impression was not of an achalasia variant in any of these 20 patients with [esophagogastric junction outflow obstruction] on HRM, and thus none underwent botulinum toxin injection, pneumatic dilation, or lower-esophageal sphincter myotomy at our center,” the researchers wrote. Among 17 patients who were available for clinical follow-up, 4 underwent empiric dilation, of whom none had mucosal disruption. One patient was diagnosed with dysphagia lusoria based on cross-sectional imaging, while the rest were managed conservatively.
Similarly, among 10 patients with at least 50% ineffective swallows on HRM, 5 showed normal barium emptying and 9 were managed conservatively (the remaining patient underwent cricopharyngeal dilation for concurrent oropharyngeal dysphagia). The strong correlation between HRM and esophagrams in this study indicates that“[n]ormal findings from FLIP panometry can be used to exclude esophageal motility disorders at the time of endoscopy, possibly reducing the need for high-resolution manometry evaluation of some patients,” the investigators concluded. “However, further longitudinal studies are needed to support this approach.”
The work was supported by the Public Health Service and the American College of Gastroenterology. Dr. Baumann reported having no conflicts of interest. Four coinvestigators disclosed relevant ties to Crospon, Given Imaging, Ironwood, Medtronic, Sandhill Scientific, Torax, and other companies..
SOURCE: Baumann AJ et al. Clin Gastroenterol Hepatol 2020 Mar 20. doi: 10.1016/j.cgh.2020.03.040.
Endoscopy is often the first step in the evaluation of dysphagia and other esophageal symptoms such as chest pain. When endoscopy is negative for a cause of these esophageal symptoms and biopsies rule out eosinophilic esophagitis, an esophageal motility disorder should be excluded, and high-resolution esophageal manometry is considered the standard method for this purpose.
Functional lumen imaging probe (FLIP) panometry offers the opportunity to evaluate esophageal motor function during sedated endoscopy, and it can be easily added to the endoscopic procedure if there are no findings to explain esophageal symptoms. The prospect of establishing the presence of normal esophageal motility and ruling out a major motility disorder during endoscopy is very attractive because it would increase diagnostic efficiency while also obviating the need for an additional and potentially uncomfortable study for the patient. This study by Buamann and colleagues explores the yield of normal FLIP panometry to predict the presence of normal esophageal motility and rule out a major motility disorder. Their study showed that manometry was negative for a major motility disorder in 88 of 111 (79%) patients with normal FLIP panometry. Manometry revealed a major motility disorder in 23 patients with normal FLIP topography, mainly because of esophagogastric junction outflow obstruction (EGJOO) seen in 20 patients, along with absent contractility in 2, and distal esophageal spasm in 1. The EGJOO was for the most part not confirmed by adjunctive swallows on manometry or by esophagram, and aggressive therapies were not needed, indicating likely falsely positive EGJOO diagnosed by manometry. These are very encouraging results. If the findings are confirmed in larger prospective studies, it would be reasonable to consider modifying our paradigm for the evaluation of esophageal symptoms, and FLIP panometry could be considered as a screening tool to rule out a clinically significant major motility disorders during the initial endoscopic evaluation for esophageal symptoms.
Marcelo F. Vela, MD, MSCR, AGAF, is professor of medicine, director of Esophageal Disorders, and program director of Esophageal Fellowship in the division of gastroenterology and hepatology at Mayo Clinic Arizona in Scottsdale. He reports being a consultant for Medtronic and receiving research support from Diversatek.
Endoscopy is often the first step in the evaluation of dysphagia and other esophageal symptoms such as chest pain. When endoscopy is negative for a cause of these esophageal symptoms and biopsies rule out eosinophilic esophagitis, an esophageal motility disorder should be excluded, and high-resolution esophageal manometry is considered the standard method for this purpose.
Functional lumen imaging probe (FLIP) panometry offers the opportunity to evaluate esophageal motor function during sedated endoscopy, and it can be easily added to the endoscopic procedure if there are no findings to explain esophageal symptoms. The prospect of establishing the presence of normal esophageal motility and ruling out a major motility disorder during endoscopy is very attractive because it would increase diagnostic efficiency while also obviating the need for an additional and potentially uncomfortable study for the patient. This study by Buamann and colleagues explores the yield of normal FLIP panometry to predict the presence of normal esophageal motility and rule out a major motility disorder. Their study showed that manometry was negative for a major motility disorder in 88 of 111 (79%) patients with normal FLIP panometry. Manometry revealed a major motility disorder in 23 patients with normal FLIP topography, mainly because of esophagogastric junction outflow obstruction (EGJOO) seen in 20 patients, along with absent contractility in 2, and distal esophageal spasm in 1. The EGJOO was for the most part not confirmed by adjunctive swallows on manometry or by esophagram, and aggressive therapies were not needed, indicating likely falsely positive EGJOO diagnosed by manometry. These are very encouraging results. If the findings are confirmed in larger prospective studies, it would be reasonable to consider modifying our paradigm for the evaluation of esophageal symptoms, and FLIP panometry could be considered as a screening tool to rule out a clinically significant major motility disorders during the initial endoscopic evaluation for esophageal symptoms.
Marcelo F. Vela, MD, MSCR, AGAF, is professor of medicine, director of Esophageal Disorders, and program director of Esophageal Fellowship in the division of gastroenterology and hepatology at Mayo Clinic Arizona in Scottsdale. He reports being a consultant for Medtronic and receiving research support from Diversatek.
Endoscopy is often the first step in the evaluation of dysphagia and other esophageal symptoms such as chest pain. When endoscopy is negative for a cause of these esophageal symptoms and biopsies rule out eosinophilic esophagitis, an esophageal motility disorder should be excluded, and high-resolution esophageal manometry is considered the standard method for this purpose.
Functional lumen imaging probe (FLIP) panometry offers the opportunity to evaluate esophageal motor function during sedated endoscopy, and it can be easily added to the endoscopic procedure if there are no findings to explain esophageal symptoms. The prospect of establishing the presence of normal esophageal motility and ruling out a major motility disorder during endoscopy is very attractive because it would increase diagnostic efficiency while also obviating the need for an additional and potentially uncomfortable study for the patient. This study by Buamann and colleagues explores the yield of normal FLIP panometry to predict the presence of normal esophageal motility and rule out a major motility disorder. Their study showed that manometry was negative for a major motility disorder in 88 of 111 (79%) patients with normal FLIP panometry. Manometry revealed a major motility disorder in 23 patients with normal FLIP topography, mainly because of esophagogastric junction outflow obstruction (EGJOO) seen in 20 patients, along with absent contractility in 2, and distal esophageal spasm in 1. The EGJOO was for the most part not confirmed by adjunctive swallows on manometry or by esophagram, and aggressive therapies were not needed, indicating likely falsely positive EGJOO diagnosed by manometry. These are very encouraging results. If the findings are confirmed in larger prospective studies, it would be reasonable to consider modifying our paradigm for the evaluation of esophageal symptoms, and FLIP panometry could be considered as a screening tool to rule out a clinically significant major motility disorders during the initial endoscopic evaluation for esophageal symptoms.
Marcelo F. Vela, MD, MSCR, AGAF, is professor of medicine, director of Esophageal Disorders, and program director of Esophageal Fellowship in the division of gastroenterology and hepatology at Mayo Clinic Arizona in Scottsdale. He reports being a consultant for Medtronic and receiving research support from Diversatek.
Most patients with normal findings on functional luminal imaging probe (FLIP) showed no clinical evidence of a major esophageal motor disorder, even when their high-resolution manometry (HRM) test results were abnormal, according to the results of a single-center retrospective cohort study.
Among 111 study participants with normal FLIP findings, 79% also showed no evidence of a major esophageal motor disorder on esophageal high-resolution manometry (HRM), wrote Alexandra J. Baumann, DO, of Northwestern University, Chicago, and associates. “Among the remaining 21% with apparent disagreement with HRM, [those] with normal FLIP panometry carried overall clinical impressions of not having a major esophageal motor disorder and subsequently were treated conservatively without the need for surgical interventions,” they reported. For patients with normal upper endoscopy and normal FLIP panometry, “the initial clinical management strategy could be directed toward addressing gastroesophageal reflux or a functional syndrome,” they wrote in Clinical Gastroenterology and Hepatology.
FLIP uses high-resolution impedance planimetry to evaluate esophageal lumen parameters, distensibility, and contractility in response to distension. Although HRM is standard for evaluating esophageal motility, false negatives and positives can result from challenges with interpreting outflow obstructions and normal lower-esophageal sphincter relaxation pressures among patients with clinical achalasia.
Hence, the researchers evaluated correlations between FLIP and HRM in 111 patients with esophageal symptoms and nonobstructive endoscopy findings who were evaluated at the Esophageal Center of Northwestern University between 2012 and 2019. Gastroenterologists performed additional studies, such as barium esophagrams, at their discretion. By study design, all patients had normal FLIP results, defined as an esophagogastric junction distensibility index above 3.0 mm2 per mm Hg and a normal contractile response (that is, normal repetitive retrograde contractions and a repetitive antegrade contraction pattern that met the Rule-of-6s). Three clinicians evaluated and reached consensus on each FLIP study. Esophageal HRM data were interpreted based on the Chicago classification system (version 3.0).
Patients with normal FLIP panometry findings “did not have a clinical impression of a major esophageal motor disorder,” the researchers reported. In all, 23 (21%) patients with normal FLIP results had discrepant (abnormal) HRM findings, most of which were false positives or equivocal.
For example, among 20 patients whose HRM suggested an esophagogastric junction outflow obstruction, 17 showed normal bolus transit on supine swallows and 16 showed normalization of integrated relaxation pressure after adjunctive maneuvers. Similarly, among 10 patients who underwent a barium esophagram, 8 showed normal emptying, 1 showed a temporary delay but no retention, and 1 had an incomplete study. “The overall clinical impression was not of an achalasia variant in any of these 20 patients with [esophagogastric junction outflow obstruction] on HRM, and thus none underwent botulinum toxin injection, pneumatic dilation, or lower-esophageal sphincter myotomy at our center,” the researchers wrote. Among 17 patients who were available for clinical follow-up, 4 underwent empiric dilation, of whom none had mucosal disruption. One patient was diagnosed with dysphagia lusoria based on cross-sectional imaging, while the rest were managed conservatively.
Similarly, among 10 patients with at least 50% ineffective swallows on HRM, 5 showed normal barium emptying and 9 were managed conservatively (the remaining patient underwent cricopharyngeal dilation for concurrent oropharyngeal dysphagia). The strong correlation between HRM and esophagrams in this study indicates that“[n]ormal findings from FLIP panometry can be used to exclude esophageal motility disorders at the time of endoscopy, possibly reducing the need for high-resolution manometry evaluation of some patients,” the investigators concluded. “However, further longitudinal studies are needed to support this approach.”
The work was supported by the Public Health Service and the American College of Gastroenterology. Dr. Baumann reported having no conflicts of interest. Four coinvestigators disclosed relevant ties to Crospon, Given Imaging, Ironwood, Medtronic, Sandhill Scientific, Torax, and other companies..
SOURCE: Baumann AJ et al. Clin Gastroenterol Hepatol 2020 Mar 20. doi: 10.1016/j.cgh.2020.03.040.
Most patients with normal findings on functional luminal imaging probe (FLIP) showed no clinical evidence of a major esophageal motor disorder, even when their high-resolution manometry (HRM) test results were abnormal, according to the results of a single-center retrospective cohort study.
Among 111 study participants with normal FLIP findings, 79% also showed no evidence of a major esophageal motor disorder on esophageal high-resolution manometry (HRM), wrote Alexandra J. Baumann, DO, of Northwestern University, Chicago, and associates. “Among the remaining 21% with apparent disagreement with HRM, [those] with normal FLIP panometry carried overall clinical impressions of not having a major esophageal motor disorder and subsequently were treated conservatively without the need for surgical interventions,” they reported. For patients with normal upper endoscopy and normal FLIP panometry, “the initial clinical management strategy could be directed toward addressing gastroesophageal reflux or a functional syndrome,” they wrote in Clinical Gastroenterology and Hepatology.
FLIP uses high-resolution impedance planimetry to evaluate esophageal lumen parameters, distensibility, and contractility in response to distension. Although HRM is standard for evaluating esophageal motility, false negatives and positives can result from challenges with interpreting outflow obstructions and normal lower-esophageal sphincter relaxation pressures among patients with clinical achalasia.
Hence, the researchers evaluated correlations between FLIP and HRM in 111 patients with esophageal symptoms and nonobstructive endoscopy findings who were evaluated at the Esophageal Center of Northwestern University between 2012 and 2019. Gastroenterologists performed additional studies, such as barium esophagrams, at their discretion. By study design, all patients had normal FLIP results, defined as an esophagogastric junction distensibility index above 3.0 mm2 per mm Hg and a normal contractile response (that is, normal repetitive retrograde contractions and a repetitive antegrade contraction pattern that met the Rule-of-6s). Three clinicians evaluated and reached consensus on each FLIP study. Esophageal HRM data were interpreted based on the Chicago classification system (version 3.0).
Patients with normal FLIP panometry findings “did not have a clinical impression of a major esophageal motor disorder,” the researchers reported. In all, 23 (21%) patients with normal FLIP results had discrepant (abnormal) HRM findings, most of which were false positives or equivocal.
For example, among 20 patients whose HRM suggested an esophagogastric junction outflow obstruction, 17 showed normal bolus transit on supine swallows and 16 showed normalization of integrated relaxation pressure after adjunctive maneuvers. Similarly, among 10 patients who underwent a barium esophagram, 8 showed normal emptying, 1 showed a temporary delay but no retention, and 1 had an incomplete study. “The overall clinical impression was not of an achalasia variant in any of these 20 patients with [esophagogastric junction outflow obstruction] on HRM, and thus none underwent botulinum toxin injection, pneumatic dilation, or lower-esophageal sphincter myotomy at our center,” the researchers wrote. Among 17 patients who were available for clinical follow-up, 4 underwent empiric dilation, of whom none had mucosal disruption. One patient was diagnosed with dysphagia lusoria based on cross-sectional imaging, while the rest were managed conservatively.
Similarly, among 10 patients with at least 50% ineffective swallows on HRM, 5 showed normal barium emptying and 9 were managed conservatively (the remaining patient underwent cricopharyngeal dilation for concurrent oropharyngeal dysphagia). The strong correlation between HRM and esophagrams in this study indicates that“[n]ormal findings from FLIP panometry can be used to exclude esophageal motility disorders at the time of endoscopy, possibly reducing the need for high-resolution manometry evaluation of some patients,” the investigators concluded. “However, further longitudinal studies are needed to support this approach.”
The work was supported by the Public Health Service and the American College of Gastroenterology. Dr. Baumann reported having no conflicts of interest. Four coinvestigators disclosed relevant ties to Crospon, Given Imaging, Ironwood, Medtronic, Sandhill Scientific, Torax, and other companies..
SOURCE: Baumann AJ et al. Clin Gastroenterol Hepatol 2020 Mar 20. doi: 10.1016/j.cgh.2020.03.040.
FROM CLINICAL GASTROENTEROLOGY AND HEPATOLOGY
Color-imaging endoscopy improves detection of upper GI cancer
Use of linked-color imaging for upper gastrointestinal tract endoscopy improves the detection of neoplasms in comparison with conventional white-light imaging, according to results from a randomized trial involving more than 1,500 patients.
Linked-color imaging (LCI) is an advanced illumination technique that combines white light with narrow-band short-wavelength light to enhance the contrast of red and white hues during endoscopy, making it easier to recognize subtle differences in mucosal color.
At present, LCI is available only on systems manufactured by Fujifilm (that is, the Lasereo endoscopic system marketed in Japan and the Eluxeo system in the United States and Europe). The system includes the light source and a processor and can be used with various endoscopes.
“Combined with previous studies that show the efficacy of LCI in detecting large intestinal neoplasia, our findings make a strong case for wider adoption of this modality in surveillance of the entire endoscopically accessible digestive tract,” senior investigator and gastroenterologist Mototsugu Kato, MD, of the Hakodate National Hospital, Hokkaido, Japan, said in a press release.
The randomized trial was conducted at 19 Japanese hospitals by 58 expert endoscopists, all of whom were experienced with LCI.
“We need further research to confirm [LCI’s] efficacy in the hands of general clinicians for upper GI screening” of an average-risk population, Dr. Kato said.
Results from the trial were published in Annals of Internal Medicine.
Approached for comment, gastroenterologist Marvin Ryou, MD, director of endoscopic innovation at Brigham and Women’s Hospital, Boston, said that he has used Fujifilm’s LCI technology mostly for polyp detection on colonoscopy and has found it useful.
LCI “has been shown to be helpful for the detection of colonic neoplasia, and this Japanese multicenter study provides additional evidence of utility in foregut neoplasm detection. I would look forward to future studies of LCI in an average-risk population,” he said.
Details of the randomized trial
All of the trial participants had previous or current gastrointestinal cancer and were undergoing upper GI endoscopic surveillance. Patients were a little older than 70 years on average, and more than 75% were men.
The patients underwent two examinations during their endoscopy sessions, one performed with LCI, and the other with conventional white-light imaging (WLI). The endoscopy system used in the study allowed the scope to switch between the two modalities, as well as others.
Overall, 750 patients were randomly assigned to undergo LCI first and then WLI; 752 underwent WLI first and then LCI.
In both groups, lesions were most common in the stomach, followed by the esophagus and the pharynx.
Neoplastic lesions in the pharynx, esophagus, or stomach – confirmed by histology – were detected in 60 patients (8%) with LCI versus 36 patients (4.8%) with WLI. This translated to a 1.67 times higher rate of detection.
First-pass WLI missed 26 lesions that were picked up by second-pass LCI. Five lesions were missed by LCI and were subsequently detected by WLI, which translated to a greater than 80% reduction in missed lesions with LCI.
Procedure time was longer with LCI than WLI, but mean differences were less than 20 seconds.
The investigators said that there is a possibility of overdiagnosis with both systems, but perhaps more so with LCI. Overall, WLI detected 121 lesions on first pass, 30.6% of which were neoplastic; first-pass LCI detected 185 lesions, 35.7% of which were neoplastic.
The trial was funded by Fujifilm. One investigator has received a grant and another has received research funding from Fujifilm. Dr. Ryou is a consultant for the company.
A version of this article first appeared on Medscape.com.
Use of linked-color imaging for upper gastrointestinal tract endoscopy improves the detection of neoplasms in comparison with conventional white-light imaging, according to results from a randomized trial involving more than 1,500 patients.
Linked-color imaging (LCI) is an advanced illumination technique that combines white light with narrow-band short-wavelength light to enhance the contrast of red and white hues during endoscopy, making it easier to recognize subtle differences in mucosal color.
At present, LCI is available only on systems manufactured by Fujifilm (that is, the Lasereo endoscopic system marketed in Japan and the Eluxeo system in the United States and Europe). The system includes the light source and a processor and can be used with various endoscopes.
“Combined with previous studies that show the efficacy of LCI in detecting large intestinal neoplasia, our findings make a strong case for wider adoption of this modality in surveillance of the entire endoscopically accessible digestive tract,” senior investigator and gastroenterologist Mototsugu Kato, MD, of the Hakodate National Hospital, Hokkaido, Japan, said in a press release.
The randomized trial was conducted at 19 Japanese hospitals by 58 expert endoscopists, all of whom were experienced with LCI.
“We need further research to confirm [LCI’s] efficacy in the hands of general clinicians for upper GI screening” of an average-risk population, Dr. Kato said.
Results from the trial were published in Annals of Internal Medicine.
Approached for comment, gastroenterologist Marvin Ryou, MD, director of endoscopic innovation at Brigham and Women’s Hospital, Boston, said that he has used Fujifilm’s LCI technology mostly for polyp detection on colonoscopy and has found it useful.
LCI “has been shown to be helpful for the detection of colonic neoplasia, and this Japanese multicenter study provides additional evidence of utility in foregut neoplasm detection. I would look forward to future studies of LCI in an average-risk population,” he said.
Details of the randomized trial
All of the trial participants had previous or current gastrointestinal cancer and were undergoing upper GI endoscopic surveillance. Patients were a little older than 70 years on average, and more than 75% were men.
The patients underwent two examinations during their endoscopy sessions, one performed with LCI, and the other with conventional white-light imaging (WLI). The endoscopy system used in the study allowed the scope to switch between the two modalities, as well as others.
Overall, 750 patients were randomly assigned to undergo LCI first and then WLI; 752 underwent WLI first and then LCI.
In both groups, lesions were most common in the stomach, followed by the esophagus and the pharynx.
Neoplastic lesions in the pharynx, esophagus, or stomach – confirmed by histology – were detected in 60 patients (8%) with LCI versus 36 patients (4.8%) with WLI. This translated to a 1.67 times higher rate of detection.
First-pass WLI missed 26 lesions that were picked up by second-pass LCI. Five lesions were missed by LCI and were subsequently detected by WLI, which translated to a greater than 80% reduction in missed lesions with LCI.
Procedure time was longer with LCI than WLI, but mean differences were less than 20 seconds.
The investigators said that there is a possibility of overdiagnosis with both systems, but perhaps more so with LCI. Overall, WLI detected 121 lesions on first pass, 30.6% of which were neoplastic; first-pass LCI detected 185 lesions, 35.7% of which were neoplastic.
The trial was funded by Fujifilm. One investigator has received a grant and another has received research funding from Fujifilm. Dr. Ryou is a consultant for the company.
A version of this article first appeared on Medscape.com.
Use of linked-color imaging for upper gastrointestinal tract endoscopy improves the detection of neoplasms in comparison with conventional white-light imaging, according to results from a randomized trial involving more than 1,500 patients.
Linked-color imaging (LCI) is an advanced illumination technique that combines white light with narrow-band short-wavelength light to enhance the contrast of red and white hues during endoscopy, making it easier to recognize subtle differences in mucosal color.
At present, LCI is available only on systems manufactured by Fujifilm (that is, the Lasereo endoscopic system marketed in Japan and the Eluxeo system in the United States and Europe). The system includes the light source and a processor and can be used with various endoscopes.
“Combined with previous studies that show the efficacy of LCI in detecting large intestinal neoplasia, our findings make a strong case for wider adoption of this modality in surveillance of the entire endoscopically accessible digestive tract,” senior investigator and gastroenterologist Mototsugu Kato, MD, of the Hakodate National Hospital, Hokkaido, Japan, said in a press release.
The randomized trial was conducted at 19 Japanese hospitals by 58 expert endoscopists, all of whom were experienced with LCI.
“We need further research to confirm [LCI’s] efficacy in the hands of general clinicians for upper GI screening” of an average-risk population, Dr. Kato said.
Results from the trial were published in Annals of Internal Medicine.
Approached for comment, gastroenterologist Marvin Ryou, MD, director of endoscopic innovation at Brigham and Women’s Hospital, Boston, said that he has used Fujifilm’s LCI technology mostly for polyp detection on colonoscopy and has found it useful.
LCI “has been shown to be helpful for the detection of colonic neoplasia, and this Japanese multicenter study provides additional evidence of utility in foregut neoplasm detection. I would look forward to future studies of LCI in an average-risk population,” he said.
Details of the randomized trial
All of the trial participants had previous or current gastrointestinal cancer and were undergoing upper GI endoscopic surveillance. Patients were a little older than 70 years on average, and more than 75% were men.
The patients underwent two examinations during their endoscopy sessions, one performed with LCI, and the other with conventional white-light imaging (WLI). The endoscopy system used in the study allowed the scope to switch between the two modalities, as well as others.
Overall, 750 patients were randomly assigned to undergo LCI first and then WLI; 752 underwent WLI first and then LCI.
In both groups, lesions were most common in the stomach, followed by the esophagus and the pharynx.
Neoplastic lesions in the pharynx, esophagus, or stomach – confirmed by histology – were detected in 60 patients (8%) with LCI versus 36 patients (4.8%) with WLI. This translated to a 1.67 times higher rate of detection.
First-pass WLI missed 26 lesions that were picked up by second-pass LCI. Five lesions were missed by LCI and were subsequently detected by WLI, which translated to a greater than 80% reduction in missed lesions with LCI.
Procedure time was longer with LCI than WLI, but mean differences were less than 20 seconds.
The investigators said that there is a possibility of overdiagnosis with both systems, but perhaps more so with LCI. Overall, WLI detected 121 lesions on first pass, 30.6% of which were neoplastic; first-pass LCI detected 185 lesions, 35.7% of which were neoplastic.
The trial was funded by Fujifilm. One investigator has received a grant and another has received research funding from Fujifilm. Dr. Ryou is a consultant for the company.
A version of this article first appeared on Medscape.com.
Family physicians can help achieve national goals on STIs
Among these are the U.S. Department of Health and Human Services’ first “Sexually Transmitted Infections (STIs) National Strategic Plan for the United States,” which has a strong encompassing vision.
“The United States will be a place where sexually transmitted infections are prevented and where every person has high-quality STI prevention care, and treatment while living free from stigma and discrimination. The vision includes all people, regardless of age, sex, gender identity, sexual orientation, race, ethnicity, religion, disability, geographic location, or socioeconomic circumstance,” the new HHS plan states.1
Family physicians can and should play important roles in helping our country meet this plan’s goals particularly by following two important updated clinical guidelines, one from the U.S. Preventive Services Task Force (USPSTF) and another from the Centers for Disease Control and Prevention (CDC).
This strategic plan includes the following five overarching goals with associated objectives:
- Prevent New STIs.
- Improve the health of people by reducing adverse outcomes of STIs.
- Accelerate progress in STI research, technology, and innovation.
- Reduce STI-related health disparities and health inequities.
- Achieve integrated, coordinated efforts that address the STI epidemic.1
In my opinion, family physicians have important roles to play in order for each of these goals to be achieved.Unfortunately, there are approximately 20 million new cases of STIs each year, and the U.S. has seen increases in the rates of STIs in the past decade.
“Sexually transmitted infections are frequently asymptomatic, which may delay diagnosis and treatment and lead persons to unknowingly transmit STIs to others,” according to a new recommendation statement from the USPSTF.2 STIs may lead to serious health consequences for patients, cause harms to a mother and infant during pregnancy, and lead to cases of cancer among other concerning outcomes. As such, following the HHS new national strategic plan is critical for us to address the needs of our communities.
Preventing new STIs
Family physicians can be vital in achieving the first goal of the plan by helping to prevent new STIs. In August 2020, the USPSTF updated its guideline on behavioral counseling interventions to prevent STIs. In my opinion, the USPSTF offers some practical improvements from the earlier version of this guideline.
The task force provides a grade B recommendation that all sexually active adolescents and adults at increased risk for STIs be provided with behavioral counseling to prevent STIs. The guideline indicates that behavioral counseling interventions reduce the likelihood of those at increased risk for acquiring STIs.2
The 2014 guideline had recommended intensive interventions with a minimum of 30 minutes of counseling. Many family physicians may have found this previous recommendation impractical to implement. These updated recommendations now include a variety of interventions, such as those that take less than 30 minutes.
Although interventions with more than 120 minutes of contact time had the most effect, those with less than 30 minutes still demonstrated statistically significant fewer acquisitions of STIs during follow-up. These options include in-person counseling, and providing written materials, websites, videos, and telephone and text support to patients. These interventions can be delivered directly by the family physician, or patients may be referred to other settings or the media interventions.
The task force’s updated recommendation statement refers to a variety of resources that can be used to identify these interventions. Many of the studies reviewed for this guideline were conducted in STI clinics, and the guideline authors recommended further studies in primary care as opportunities for more generalizability.
In addition to behavioral counseling for STI prevention, family physicians can help prevent STIs in their patients through HPV vaccination and HIV pre-exposure prophylaxis (PrEP provision) within their practices. As the first contact for health care for many patients, we have an opportunity to significantly impact this first goal of prevention.
Treating STIs
Within the second goal of the national strategic plan is treatment of STIs, which family physicians should include in their practices as well as the diagnosis of STIs.
In December 2020, an update to the CDC’s treatment guideline for gonococcal infection was released. Prior to the publishing of this updated recommendation, the CDC recommended combination therapy of 250 mg intramuscular (IM) dose of ceftriaxone and either doxycycline or azithromycin. This recommendation has been changed to a single 500-mg IM dose of ceftriaxone for uncomplicated urogenital, anorectal, and pharyngeal gonorrhea. If chlamydia cannot be excluded, then the addition of oral doxycycline 100 mg twice daily for 7 days is recommended for nonpregnant persons, and 1 g oral azithromycin for pregnant persons. The previous treatment was recommended based on a concern for gonococcal resistance.
This updated guideline reflects increasing concerns for antimicrobial stewardship and emerging azithromycin resistance. It does not recommend a test-of-cure for urogenital or rectal gonorrhea, though did recommend a test-of-cure 7-14 days after treatment of pharyngeal gonorrhea. The guideline also recommends testing for reinfection 3-12 months after treatment as the rate of reinfection ranges from 7% to 12% among those previously treated.3
For some offices, the provision of the IM injection may be challenging, though having this medication in stock with the possibility of provision can greatly improve access and ease of treatment for patients. Family physicians can incorporate these updated recommendations along with those for other STIs such as chlamydia and syphilis with standing orders for treatment and testing within their offices.
Accelerating progress in STI research
Family physicians can also support the national strategic plan by participating in studies looking at the impact of behavioral counseling in the primary care office as opposed to in STI clinics. In addition, by following the STI treatment and screening guidelines, family physicians will contribute to the body of knowledge of prevalence, treatment failure, and reinfection rates of STIs. We can also help advance the research by providing feedback on interventions that have success within our practices.
Reducing STI-related health disparities and inequities
Family physicians are also in important places to support the strategic plan’s fourth goal of reducing health disparities and health inequities.
If we continue to ask the questions to identify those at high risk and ensure that we are offering appropriate STI prevention, care, and treatment services within our clinics, we can expand access to all who need services and improve equity. By offering these services within the primary care office, we may be able to decrease the stigma some may feel going to an STI clinic for services.
By incorporating additional screening and counseling in our practices we may identify some patients who were not aware that they were at risk for an STI and offer them preventive services.
Achieving integrated and coordinated efforts
Finally, as many family physicians have integrated practices, we are uniquely poised to support the fifth goal of the strategic plan of achieving integrated and coordinated efforts addressing the STI epidemic. In our practices we can participate in, lead, and refer to programs for substance use disorders, viral hepatitis, STIs, and HIV as part of full scope primary care.
Family physicians and other primary care providers should work to support the entire strategic plan to ensure that we are fully caring for our patients and communities and stopping the past decade’s increase in STIs. We have an opportunity to use this strategy and make a large impact in our communities.
Dr. Wheat is a family physician at Erie Family Health Center in Chicago. She is program director of Northwestern’s McGaw Family Medicine residency program at Humboldt Park, Chicago. Dr. Wheat serves on the editorial advisory board of Family Practice News. You can contact her at [email protected].
References
1. U.S. Department of Health and Human Services. 2020. Sexually Transmitted Infections National Strategic Plan for the United States: 2021-2025. Washington.
2. U.S. Preventive Services Task Force. Behavioral counseling interventions to prevent sexually transmitted infections: U.S. Preventive Services Task Force Recommendation Statement. JAMA. 2020;324(7):674-81. doi: 10.1001/jama.2020.13095.
3. St. Cyr S et al. Update to CDC’s Treatment Guideline for Gonococcal Infection, 2020. MMWR Morb Mortal Wkly Rep 2020;69:1911-6. doi: 10.15585/mmwr.mm6950a6external_icon.
Among these are the U.S. Department of Health and Human Services’ first “Sexually Transmitted Infections (STIs) National Strategic Plan for the United States,” which has a strong encompassing vision.
“The United States will be a place where sexually transmitted infections are prevented and where every person has high-quality STI prevention care, and treatment while living free from stigma and discrimination. The vision includes all people, regardless of age, sex, gender identity, sexual orientation, race, ethnicity, religion, disability, geographic location, or socioeconomic circumstance,” the new HHS plan states.1
Family physicians can and should play important roles in helping our country meet this plan’s goals particularly by following two important updated clinical guidelines, one from the U.S. Preventive Services Task Force (USPSTF) and another from the Centers for Disease Control and Prevention (CDC).
This strategic plan includes the following five overarching goals with associated objectives:
- Prevent New STIs.
- Improve the health of people by reducing adverse outcomes of STIs.
- Accelerate progress in STI research, technology, and innovation.
- Reduce STI-related health disparities and health inequities.
- Achieve integrated, coordinated efforts that address the STI epidemic.1
In my opinion, family physicians have important roles to play in order for each of these goals to be achieved.Unfortunately, there are approximately 20 million new cases of STIs each year, and the U.S. has seen increases in the rates of STIs in the past decade.
“Sexually transmitted infections are frequently asymptomatic, which may delay diagnosis and treatment and lead persons to unknowingly transmit STIs to others,” according to a new recommendation statement from the USPSTF.2 STIs may lead to serious health consequences for patients, cause harms to a mother and infant during pregnancy, and lead to cases of cancer among other concerning outcomes. As such, following the HHS new national strategic plan is critical for us to address the needs of our communities.
Preventing new STIs
Family physicians can be vital in achieving the first goal of the plan by helping to prevent new STIs. In August 2020, the USPSTF updated its guideline on behavioral counseling interventions to prevent STIs. In my opinion, the USPSTF offers some practical improvements from the earlier version of this guideline.
The task force provides a grade B recommendation that all sexually active adolescents and adults at increased risk for STIs be provided with behavioral counseling to prevent STIs. The guideline indicates that behavioral counseling interventions reduce the likelihood of those at increased risk for acquiring STIs.2
The 2014 guideline had recommended intensive interventions with a minimum of 30 minutes of counseling. Many family physicians may have found this previous recommendation impractical to implement. These updated recommendations now include a variety of interventions, such as those that take less than 30 minutes.
Although interventions with more than 120 minutes of contact time had the most effect, those with less than 30 minutes still demonstrated statistically significant fewer acquisitions of STIs during follow-up. These options include in-person counseling, and providing written materials, websites, videos, and telephone and text support to patients. These interventions can be delivered directly by the family physician, or patients may be referred to other settings or the media interventions.
The task force’s updated recommendation statement refers to a variety of resources that can be used to identify these interventions. Many of the studies reviewed for this guideline were conducted in STI clinics, and the guideline authors recommended further studies in primary care as opportunities for more generalizability.
In addition to behavioral counseling for STI prevention, family physicians can help prevent STIs in their patients through HPV vaccination and HIV pre-exposure prophylaxis (PrEP provision) within their practices. As the first contact for health care for many patients, we have an opportunity to significantly impact this first goal of prevention.
Treating STIs
Within the second goal of the national strategic plan is treatment of STIs, which family physicians should include in their practices as well as the diagnosis of STIs.
In December 2020, an update to the CDC’s treatment guideline for gonococcal infection was released. Prior to the publishing of this updated recommendation, the CDC recommended combination therapy of 250 mg intramuscular (IM) dose of ceftriaxone and either doxycycline or azithromycin. This recommendation has been changed to a single 500-mg IM dose of ceftriaxone for uncomplicated urogenital, anorectal, and pharyngeal gonorrhea. If chlamydia cannot be excluded, then the addition of oral doxycycline 100 mg twice daily for 7 days is recommended for nonpregnant persons, and 1 g oral azithromycin for pregnant persons. The previous treatment was recommended based on a concern for gonococcal resistance.
This updated guideline reflects increasing concerns for antimicrobial stewardship and emerging azithromycin resistance. It does not recommend a test-of-cure for urogenital or rectal gonorrhea, though did recommend a test-of-cure 7-14 days after treatment of pharyngeal gonorrhea. The guideline also recommends testing for reinfection 3-12 months after treatment as the rate of reinfection ranges from 7% to 12% among those previously treated.3
For some offices, the provision of the IM injection may be challenging, though having this medication in stock with the possibility of provision can greatly improve access and ease of treatment for patients. Family physicians can incorporate these updated recommendations along with those for other STIs such as chlamydia and syphilis with standing orders for treatment and testing within their offices.
Accelerating progress in STI research
Family physicians can also support the national strategic plan by participating in studies looking at the impact of behavioral counseling in the primary care office as opposed to in STI clinics. In addition, by following the STI treatment and screening guidelines, family physicians will contribute to the body of knowledge of prevalence, treatment failure, and reinfection rates of STIs. We can also help advance the research by providing feedback on interventions that have success within our practices.
Reducing STI-related health disparities and inequities
Family physicians are also in important places to support the strategic plan’s fourth goal of reducing health disparities and health inequities.
If we continue to ask the questions to identify those at high risk and ensure that we are offering appropriate STI prevention, care, and treatment services within our clinics, we can expand access to all who need services and improve equity. By offering these services within the primary care office, we may be able to decrease the stigma some may feel going to an STI clinic for services.
By incorporating additional screening and counseling in our practices we may identify some patients who were not aware that they were at risk for an STI and offer them preventive services.
Achieving integrated and coordinated efforts
Finally, as many family physicians have integrated practices, we are uniquely poised to support the fifth goal of the strategic plan of achieving integrated and coordinated efforts addressing the STI epidemic. In our practices we can participate in, lead, and refer to programs for substance use disorders, viral hepatitis, STIs, and HIV as part of full scope primary care.
Family physicians and other primary care providers should work to support the entire strategic plan to ensure that we are fully caring for our patients and communities and stopping the past decade’s increase in STIs. We have an opportunity to use this strategy and make a large impact in our communities.
Dr. Wheat is a family physician at Erie Family Health Center in Chicago. She is program director of Northwestern’s McGaw Family Medicine residency program at Humboldt Park, Chicago. Dr. Wheat serves on the editorial advisory board of Family Practice News. You can contact her at [email protected].
References
1. U.S. Department of Health and Human Services. 2020. Sexually Transmitted Infections National Strategic Plan for the United States: 2021-2025. Washington.
2. U.S. Preventive Services Task Force. Behavioral counseling interventions to prevent sexually transmitted infections: U.S. Preventive Services Task Force Recommendation Statement. JAMA. 2020;324(7):674-81. doi: 10.1001/jama.2020.13095.
3. St. Cyr S et al. Update to CDC’s Treatment Guideline for Gonococcal Infection, 2020. MMWR Morb Mortal Wkly Rep 2020;69:1911-6. doi: 10.15585/mmwr.mm6950a6external_icon.
Among these are the U.S. Department of Health and Human Services’ first “Sexually Transmitted Infections (STIs) National Strategic Plan for the United States,” which has a strong encompassing vision.
“The United States will be a place where sexually transmitted infections are prevented and where every person has high-quality STI prevention care, and treatment while living free from stigma and discrimination. The vision includes all people, regardless of age, sex, gender identity, sexual orientation, race, ethnicity, religion, disability, geographic location, or socioeconomic circumstance,” the new HHS plan states.1
Family physicians can and should play important roles in helping our country meet this plan’s goals particularly by following two important updated clinical guidelines, one from the U.S. Preventive Services Task Force (USPSTF) and another from the Centers for Disease Control and Prevention (CDC).
This strategic plan includes the following five overarching goals with associated objectives:
- Prevent New STIs.
- Improve the health of people by reducing adverse outcomes of STIs.
- Accelerate progress in STI research, technology, and innovation.
- Reduce STI-related health disparities and health inequities.
- Achieve integrated, coordinated efforts that address the STI epidemic.1
In my opinion, family physicians have important roles to play in order for each of these goals to be achieved.Unfortunately, there are approximately 20 million new cases of STIs each year, and the U.S. has seen increases in the rates of STIs in the past decade.
“Sexually transmitted infections are frequently asymptomatic, which may delay diagnosis and treatment and lead persons to unknowingly transmit STIs to others,” according to a new recommendation statement from the USPSTF.2 STIs may lead to serious health consequences for patients, cause harms to a mother and infant during pregnancy, and lead to cases of cancer among other concerning outcomes. As such, following the HHS new national strategic plan is critical for us to address the needs of our communities.
Preventing new STIs
Family physicians can be vital in achieving the first goal of the plan by helping to prevent new STIs. In August 2020, the USPSTF updated its guideline on behavioral counseling interventions to prevent STIs. In my opinion, the USPSTF offers some practical improvements from the earlier version of this guideline.
The task force provides a grade B recommendation that all sexually active adolescents and adults at increased risk for STIs be provided with behavioral counseling to prevent STIs. The guideline indicates that behavioral counseling interventions reduce the likelihood of those at increased risk for acquiring STIs.2
The 2014 guideline had recommended intensive interventions with a minimum of 30 minutes of counseling. Many family physicians may have found this previous recommendation impractical to implement. These updated recommendations now include a variety of interventions, such as those that take less than 30 minutes.
Although interventions with more than 120 minutes of contact time had the most effect, those with less than 30 minutes still demonstrated statistically significant fewer acquisitions of STIs during follow-up. These options include in-person counseling, and providing written materials, websites, videos, and telephone and text support to patients. These interventions can be delivered directly by the family physician, or patients may be referred to other settings or the media interventions.
The task force’s updated recommendation statement refers to a variety of resources that can be used to identify these interventions. Many of the studies reviewed for this guideline were conducted in STI clinics, and the guideline authors recommended further studies in primary care as opportunities for more generalizability.
In addition to behavioral counseling for STI prevention, family physicians can help prevent STIs in their patients through HPV vaccination and HIV pre-exposure prophylaxis (PrEP provision) within their practices. As the first contact for health care for many patients, we have an opportunity to significantly impact this first goal of prevention.
Treating STIs
Within the second goal of the national strategic plan is treatment of STIs, which family physicians should include in their practices as well as the diagnosis of STIs.
In December 2020, an update to the CDC’s treatment guideline for gonococcal infection was released. Prior to the publishing of this updated recommendation, the CDC recommended combination therapy of 250 mg intramuscular (IM) dose of ceftriaxone and either doxycycline or azithromycin. This recommendation has been changed to a single 500-mg IM dose of ceftriaxone for uncomplicated urogenital, anorectal, and pharyngeal gonorrhea. If chlamydia cannot be excluded, then the addition of oral doxycycline 100 mg twice daily for 7 days is recommended for nonpregnant persons, and 1 g oral azithromycin for pregnant persons. The previous treatment was recommended based on a concern for gonococcal resistance.
This updated guideline reflects increasing concerns for antimicrobial stewardship and emerging azithromycin resistance. It does not recommend a test-of-cure for urogenital or rectal gonorrhea, though did recommend a test-of-cure 7-14 days after treatment of pharyngeal gonorrhea. The guideline also recommends testing for reinfection 3-12 months after treatment as the rate of reinfection ranges from 7% to 12% among those previously treated.3
For some offices, the provision of the IM injection may be challenging, though having this medication in stock with the possibility of provision can greatly improve access and ease of treatment for patients. Family physicians can incorporate these updated recommendations along with those for other STIs such as chlamydia and syphilis with standing orders for treatment and testing within their offices.
Accelerating progress in STI research
Family physicians can also support the national strategic plan by participating in studies looking at the impact of behavioral counseling in the primary care office as opposed to in STI clinics. In addition, by following the STI treatment and screening guidelines, family physicians will contribute to the body of knowledge of prevalence, treatment failure, and reinfection rates of STIs. We can also help advance the research by providing feedback on interventions that have success within our practices.
Reducing STI-related health disparities and inequities
Family physicians are also in important places to support the strategic plan’s fourth goal of reducing health disparities and health inequities.
If we continue to ask the questions to identify those at high risk and ensure that we are offering appropriate STI prevention, care, and treatment services within our clinics, we can expand access to all who need services and improve equity. By offering these services within the primary care office, we may be able to decrease the stigma some may feel going to an STI clinic for services.
By incorporating additional screening and counseling in our practices we may identify some patients who were not aware that they were at risk for an STI and offer them preventive services.
Achieving integrated and coordinated efforts
Finally, as many family physicians have integrated practices, we are uniquely poised to support the fifth goal of the strategic plan of achieving integrated and coordinated efforts addressing the STI epidemic. In our practices we can participate in, lead, and refer to programs for substance use disorders, viral hepatitis, STIs, and HIV as part of full scope primary care.
Family physicians and other primary care providers should work to support the entire strategic plan to ensure that we are fully caring for our patients and communities and stopping the past decade’s increase in STIs. We have an opportunity to use this strategy and make a large impact in our communities.
Dr. Wheat is a family physician at Erie Family Health Center in Chicago. She is program director of Northwestern’s McGaw Family Medicine residency program at Humboldt Park, Chicago. Dr. Wheat serves on the editorial advisory board of Family Practice News. You can contact her at [email protected].
References
1. U.S. Department of Health and Human Services. 2020. Sexually Transmitted Infections National Strategic Plan for the United States: 2021-2025. Washington.
2. U.S. Preventive Services Task Force. Behavioral counseling interventions to prevent sexually transmitted infections: U.S. Preventive Services Task Force Recommendation Statement. JAMA. 2020;324(7):674-81. doi: 10.1001/jama.2020.13095.
3. St. Cyr S et al. Update to CDC’s Treatment Guideline for Gonococcal Infection, 2020. MMWR Morb Mortal Wkly Rep 2020;69:1911-6. doi: 10.15585/mmwr.mm6950a6external_icon.
Circadian rhythms, part 2: Can treating cutaneous conditions at different times of the day improve outcomes?
We continue with a focus on when possible, as well as clinical studies that may shed light on how to time skin care treatments.
It is important to remember that several studies in the last 20 years have revealed cutaneous tendencies based on the time of day. For instance, sebum production is known to be highest around noon, and pH also peaks during the day and is at its lowest at night.1-5
Skin aging
In 2019, Dong and associates showed that blue light at 410 nm reduces PER1 transcription in keratinocytes, indicating that epidermal cells have the capacity to directly sense light and regulate their own clock gene expression. With the introduction of blue light at night, circadian rhythm is disrupted as epidermal skin cells act as if it is daytime. The investigators also considered blue light–induced damage to skin cells at various doses and exposure times in comparison with cells that remained unexposed to light. The production of reactive oxygen species increased in the exposed cells, as did DNA impairment and the emergence of inflammatory mediators, all of which have the potential to hasten aging.6
Early this year, Dong and associates demonstrated that melatonin can dose-dependently stimulate PER1 clock gene expression in normal human dermal fibroblasts and normal human epidermal keratinocytes, and verified that the MT-1 melatonin receptor in such fibroblasts manifests a marked decline with age. The researchers concluded that the melatonin pathway contributes significantly in cutaneous aging and impairment, and that its relationship with skin circadian rhythm points to a possible role in slowing the rate of skin aging through the modulation of cutaneous melatonin receptors.7
Wound healing
In 2019, Walker and associates investigated the effects of dim artificial light at night on wound healing in female C57BL/6 mice, and found that those conditions prior to wounding reduced healing. They concluded that such information might warrant consideration in prescribing treatment.8
Atopic dermatitis
Vaughn and associates contended that alterations in circadian rhythm may contribute to the development of atopic dermatitis.9 A good example of the impact of circadian rhythms on cutaneous health is the nocturnal exacerbation of atopic dermatitis, particularly in children.10
Psoriasis
According to Plikus and associates, recent evidence has emerged showing that the circadian clock regulates UVB-induced DNA damage and cutaneous cancers, and it is also associated with the immune-mediated disorder psoriasis.11
Clinical studies
In 2018, Deshayes and associates conducted a clinical study to evaluate the precursors and stem cell attributes of hHF (human hair follicle keratinocytes), hEpi (human interfollicular epidermal keratinocytes), and hHFDP (hair follicle dermal papilla stem cells) in response to clock pathway changes caused by long-term deregulation of circadian rhythms. A total of 20 women participated in the study, 10 in each group (day workers were the control group and compared with shift workers). Two 3-mm fresh punch biopsies were collected from the occipital region of each participant. The investigators reported that chronic circadian rhythm deregulation influenced clock pathway protein expression and correlated with changes in hHF, hEpi, and hHFDP. They concluded that their findings represented the first data in humans suggesting that deregulation of the clock pathway modulates regenerative activity in human cutaneous and hair precursor cells.12
Later that year, Wu and associates reported on the role of the circadian clock in the transcriptional regulation of human epidermis. Investigators sampled 20 human participants through a 24-hour period and a population of 219 people once, finding a potent circadian oscillator in human epidermis at the population level, hundreds of rhythmically expressed genes, as well as a biomarker set for human epidermis that can, with one sample, highlight circadian phase within a 3-hour time frame. The team concluded that rhythms in human epidermis persist at the population level, and that they were able to present an effective single-sample circadian biomarker.13 This is important, as Morris pointed out, because the standard practice for measuring an individual’s internal clock is to use a dim-light melatonin onset assay over the course of a day.14 In 2019, Jia and associates studied the skin surface lipid profiles of young women to evaluate and characterize circadian human facial surface lipid composition. The investigators identified significant markers of circadian rhythm, with glycerolipids most affected. They ascribed changes in skin barrier function, such as variable pH and transepidermal water loss, to alterations in triacylglycerol levels as well as free fatty acid chain lengths and content that were affected by variations in circadian rhythm.15
Sleep and the timing of topicals
Based on their recent review of the literature on circadian rhythm and skin, Lyons and associates argued that an understanding of circadian rhythm helps dermatologists in recommending the optimal times for patients to apply topical medications. They added that urging patients to get sufficient sleep is important because DNA repair of the skin occurs best at that time.16
Conclusions
Doctors have known for half a century that timing drug delivery to a patient’s circadian clock can enhance outcomes. Chronobiological research into how circadian rhythms work at the cellular level, and in cutaneous cells in particular, is a fascinating and expanding area of inquiry that could help dermatologists more accurately recommend timing for skin care regimens. Much more research, especially in clinical trials, is necessary to further elucidate how to best work with the skin’s natural rhythms.
Dr. Baumann is a private practice dermatologist, researcher, author, and entrepreneur who practices in Miami. She founded the Cosmetic Dermatology Center at the University of Miami in 1997. Dr. Baumann has written two textbooks and a New York Times Best Sellers book for consumers. Dr. Baumann has received funding for advisory boards and/or clinical research trials from Allergan, Galderma, Revance, Evolus, and Burt’s Bees. She is the CEO of Skin Type Solutions, a company that independently tests skin care products and makes recommendations to physicians on skin care technologies. Write to her at [email protected].
References
1. Mehling A et al. Skin Pharmacol Physiol. 2006;19(4):182-9.
2. Latreille J et al. Skin Pharmacol Physiol. 2004 May-Jun;17(3):133-40.
3. Le Fur I et al. J Invest Dermatol. 2001 Sep;117(3):718-24.
4. Verschoore M et al. Chronobiol Int. 1993 Oct;10(5):349-59.
5. Yosipovitch G et al. J Invest Dermatol. 1998 Jan;110(1):20-3.
6. Dong K et al. Int J Cosmet Sci. 2019 Dec;41(6):558-62.
7. Dong K et al. Int J Mol Sci. 2020 Jan 3;21(1):326.
8. Walker WH II et al. Arch Dermatol Res. 2019 Sep;311(7):573-6.
9. Vaughn AR et al. Pediatr Dermatol. 2018 Jan;35(1):152-7.
10. Fishbein AB et al. J Allergy Clin Immunol. 2015 Nov;136(5):1170-7.
11. Plikus MV et al. J Biol Rhythms. 2015 Jun;30(3):163-82.
12. Deshayes N et al. Eur J Dermatol. 2018 Aug 1;28(4):467-75.
13. Wu G et al. Proc Natl Acad Sci U S A. 2018 Nov 27;115(48):12313-8.
14. Morris A. Nat Rev Endocrinol. 2018 Dec;15(1):3.
15. Jia Y et al. Exp Dermatol. 2019 Jul;28(7):858-62.
16. Lyons AB et al. J Clin Aesthet Dermatol. 2019 Sep;12(9):42-5.
We continue with a focus on when possible, as well as clinical studies that may shed light on how to time skin care treatments.
It is important to remember that several studies in the last 20 years have revealed cutaneous tendencies based on the time of day. For instance, sebum production is known to be highest around noon, and pH also peaks during the day and is at its lowest at night.1-5
Skin aging
In 2019, Dong and associates showed that blue light at 410 nm reduces PER1 transcription in keratinocytes, indicating that epidermal cells have the capacity to directly sense light and regulate their own clock gene expression. With the introduction of blue light at night, circadian rhythm is disrupted as epidermal skin cells act as if it is daytime. The investigators also considered blue light–induced damage to skin cells at various doses and exposure times in comparison with cells that remained unexposed to light. The production of reactive oxygen species increased in the exposed cells, as did DNA impairment and the emergence of inflammatory mediators, all of which have the potential to hasten aging.6
Early this year, Dong and associates demonstrated that melatonin can dose-dependently stimulate PER1 clock gene expression in normal human dermal fibroblasts and normal human epidermal keratinocytes, and verified that the MT-1 melatonin receptor in such fibroblasts manifests a marked decline with age. The researchers concluded that the melatonin pathway contributes significantly in cutaneous aging and impairment, and that its relationship with skin circadian rhythm points to a possible role in slowing the rate of skin aging through the modulation of cutaneous melatonin receptors.7
Wound healing
In 2019, Walker and associates investigated the effects of dim artificial light at night on wound healing in female C57BL/6 mice, and found that those conditions prior to wounding reduced healing. They concluded that such information might warrant consideration in prescribing treatment.8
Atopic dermatitis
Vaughn and associates contended that alterations in circadian rhythm may contribute to the development of atopic dermatitis.9 A good example of the impact of circadian rhythms on cutaneous health is the nocturnal exacerbation of atopic dermatitis, particularly in children.10
Psoriasis
According to Plikus and associates, recent evidence has emerged showing that the circadian clock regulates UVB-induced DNA damage and cutaneous cancers, and it is also associated with the immune-mediated disorder psoriasis.11
Clinical studies
In 2018, Deshayes and associates conducted a clinical study to evaluate the precursors and stem cell attributes of hHF (human hair follicle keratinocytes), hEpi (human interfollicular epidermal keratinocytes), and hHFDP (hair follicle dermal papilla stem cells) in response to clock pathway changes caused by long-term deregulation of circadian rhythms. A total of 20 women participated in the study, 10 in each group (day workers were the control group and compared with shift workers). Two 3-mm fresh punch biopsies were collected from the occipital region of each participant. The investigators reported that chronic circadian rhythm deregulation influenced clock pathway protein expression and correlated with changes in hHF, hEpi, and hHFDP. They concluded that their findings represented the first data in humans suggesting that deregulation of the clock pathway modulates regenerative activity in human cutaneous and hair precursor cells.12
Later that year, Wu and associates reported on the role of the circadian clock in the transcriptional regulation of human epidermis. Investigators sampled 20 human participants through a 24-hour period and a population of 219 people once, finding a potent circadian oscillator in human epidermis at the population level, hundreds of rhythmically expressed genes, as well as a biomarker set for human epidermis that can, with one sample, highlight circadian phase within a 3-hour time frame. The team concluded that rhythms in human epidermis persist at the population level, and that they were able to present an effective single-sample circadian biomarker.13 This is important, as Morris pointed out, because the standard practice for measuring an individual’s internal clock is to use a dim-light melatonin onset assay over the course of a day.14 In 2019, Jia and associates studied the skin surface lipid profiles of young women to evaluate and characterize circadian human facial surface lipid composition. The investigators identified significant markers of circadian rhythm, with glycerolipids most affected. They ascribed changes in skin barrier function, such as variable pH and transepidermal water loss, to alterations in triacylglycerol levels as well as free fatty acid chain lengths and content that were affected by variations in circadian rhythm.15
Sleep and the timing of topicals
Based on their recent review of the literature on circadian rhythm and skin, Lyons and associates argued that an understanding of circadian rhythm helps dermatologists in recommending the optimal times for patients to apply topical medications. They added that urging patients to get sufficient sleep is important because DNA repair of the skin occurs best at that time.16
Conclusions
Doctors have known for half a century that timing drug delivery to a patient’s circadian clock can enhance outcomes. Chronobiological research into how circadian rhythms work at the cellular level, and in cutaneous cells in particular, is a fascinating and expanding area of inquiry that could help dermatologists more accurately recommend timing for skin care regimens. Much more research, especially in clinical trials, is necessary to further elucidate how to best work with the skin’s natural rhythms.
Dr. Baumann is a private practice dermatologist, researcher, author, and entrepreneur who practices in Miami. She founded the Cosmetic Dermatology Center at the University of Miami in 1997. Dr. Baumann has written two textbooks and a New York Times Best Sellers book for consumers. Dr. Baumann has received funding for advisory boards and/or clinical research trials from Allergan, Galderma, Revance, Evolus, and Burt’s Bees. She is the CEO of Skin Type Solutions, a company that independently tests skin care products and makes recommendations to physicians on skin care technologies. Write to her at [email protected].
References
1. Mehling A et al. Skin Pharmacol Physiol. 2006;19(4):182-9.
2. Latreille J et al. Skin Pharmacol Physiol. 2004 May-Jun;17(3):133-40.
3. Le Fur I et al. J Invest Dermatol. 2001 Sep;117(3):718-24.
4. Verschoore M et al. Chronobiol Int. 1993 Oct;10(5):349-59.
5. Yosipovitch G et al. J Invest Dermatol. 1998 Jan;110(1):20-3.
6. Dong K et al. Int J Cosmet Sci. 2019 Dec;41(6):558-62.
7. Dong K et al. Int J Mol Sci. 2020 Jan 3;21(1):326.
8. Walker WH II et al. Arch Dermatol Res. 2019 Sep;311(7):573-6.
9. Vaughn AR et al. Pediatr Dermatol. 2018 Jan;35(1):152-7.
10. Fishbein AB et al. J Allergy Clin Immunol. 2015 Nov;136(5):1170-7.
11. Plikus MV et al. J Biol Rhythms. 2015 Jun;30(3):163-82.
12. Deshayes N et al. Eur J Dermatol. 2018 Aug 1;28(4):467-75.
13. Wu G et al. Proc Natl Acad Sci U S A. 2018 Nov 27;115(48):12313-8.
14. Morris A. Nat Rev Endocrinol. 2018 Dec;15(1):3.
15. Jia Y et al. Exp Dermatol. 2019 Jul;28(7):858-62.
16. Lyons AB et al. J Clin Aesthet Dermatol. 2019 Sep;12(9):42-5.
We continue with a focus on when possible, as well as clinical studies that may shed light on how to time skin care treatments.
It is important to remember that several studies in the last 20 years have revealed cutaneous tendencies based on the time of day. For instance, sebum production is known to be highest around noon, and pH also peaks during the day and is at its lowest at night.1-5
Skin aging
In 2019, Dong and associates showed that blue light at 410 nm reduces PER1 transcription in keratinocytes, indicating that epidermal cells have the capacity to directly sense light and regulate their own clock gene expression. With the introduction of blue light at night, circadian rhythm is disrupted as epidermal skin cells act as if it is daytime. The investigators also considered blue light–induced damage to skin cells at various doses and exposure times in comparison with cells that remained unexposed to light. The production of reactive oxygen species increased in the exposed cells, as did DNA impairment and the emergence of inflammatory mediators, all of which have the potential to hasten aging.6
Early this year, Dong and associates demonstrated that melatonin can dose-dependently stimulate PER1 clock gene expression in normal human dermal fibroblasts and normal human epidermal keratinocytes, and verified that the MT-1 melatonin receptor in such fibroblasts manifests a marked decline with age. The researchers concluded that the melatonin pathway contributes significantly in cutaneous aging and impairment, and that its relationship with skin circadian rhythm points to a possible role in slowing the rate of skin aging through the modulation of cutaneous melatonin receptors.7
Wound healing
In 2019, Walker and associates investigated the effects of dim artificial light at night on wound healing in female C57BL/6 mice, and found that those conditions prior to wounding reduced healing. They concluded that such information might warrant consideration in prescribing treatment.8
Atopic dermatitis
Vaughn and associates contended that alterations in circadian rhythm may contribute to the development of atopic dermatitis.9 A good example of the impact of circadian rhythms on cutaneous health is the nocturnal exacerbation of atopic dermatitis, particularly in children.10
Psoriasis
According to Plikus and associates, recent evidence has emerged showing that the circadian clock regulates UVB-induced DNA damage and cutaneous cancers, and it is also associated with the immune-mediated disorder psoriasis.11
Clinical studies
In 2018, Deshayes and associates conducted a clinical study to evaluate the precursors and stem cell attributes of hHF (human hair follicle keratinocytes), hEpi (human interfollicular epidermal keratinocytes), and hHFDP (hair follicle dermal papilla stem cells) in response to clock pathway changes caused by long-term deregulation of circadian rhythms. A total of 20 women participated in the study, 10 in each group (day workers were the control group and compared with shift workers). Two 3-mm fresh punch biopsies were collected from the occipital region of each participant. The investigators reported that chronic circadian rhythm deregulation influenced clock pathway protein expression and correlated with changes in hHF, hEpi, and hHFDP. They concluded that their findings represented the first data in humans suggesting that deregulation of the clock pathway modulates regenerative activity in human cutaneous and hair precursor cells.12
Later that year, Wu and associates reported on the role of the circadian clock in the transcriptional regulation of human epidermis. Investigators sampled 20 human participants through a 24-hour period and a population of 219 people once, finding a potent circadian oscillator in human epidermis at the population level, hundreds of rhythmically expressed genes, as well as a biomarker set for human epidermis that can, with one sample, highlight circadian phase within a 3-hour time frame. The team concluded that rhythms in human epidermis persist at the population level, and that they were able to present an effective single-sample circadian biomarker.13 This is important, as Morris pointed out, because the standard practice for measuring an individual’s internal clock is to use a dim-light melatonin onset assay over the course of a day.14 In 2019, Jia and associates studied the skin surface lipid profiles of young women to evaluate and characterize circadian human facial surface lipid composition. The investigators identified significant markers of circadian rhythm, with glycerolipids most affected. They ascribed changes in skin barrier function, such as variable pH and transepidermal water loss, to alterations in triacylglycerol levels as well as free fatty acid chain lengths and content that were affected by variations in circadian rhythm.15
Sleep and the timing of topicals
Based on their recent review of the literature on circadian rhythm and skin, Lyons and associates argued that an understanding of circadian rhythm helps dermatologists in recommending the optimal times for patients to apply topical medications. They added that urging patients to get sufficient sleep is important because DNA repair of the skin occurs best at that time.16
Conclusions
Doctors have known for half a century that timing drug delivery to a patient’s circadian clock can enhance outcomes. Chronobiological research into how circadian rhythms work at the cellular level, and in cutaneous cells in particular, is a fascinating and expanding area of inquiry that could help dermatologists more accurately recommend timing for skin care regimens. Much more research, especially in clinical trials, is necessary to further elucidate how to best work with the skin’s natural rhythms.
Dr. Baumann is a private practice dermatologist, researcher, author, and entrepreneur who practices in Miami. She founded the Cosmetic Dermatology Center at the University of Miami in 1997. Dr. Baumann has written two textbooks and a New York Times Best Sellers book for consumers. Dr. Baumann has received funding for advisory boards and/or clinical research trials from Allergan, Galderma, Revance, Evolus, and Burt’s Bees. She is the CEO of Skin Type Solutions, a company that independently tests skin care products and makes recommendations to physicians on skin care technologies. Write to her at [email protected].
References
1. Mehling A et al. Skin Pharmacol Physiol. 2006;19(4):182-9.
2. Latreille J et al. Skin Pharmacol Physiol. 2004 May-Jun;17(3):133-40.
3. Le Fur I et al. J Invest Dermatol. 2001 Sep;117(3):718-24.
4. Verschoore M et al. Chronobiol Int. 1993 Oct;10(5):349-59.
5. Yosipovitch G et al. J Invest Dermatol. 1998 Jan;110(1):20-3.
6. Dong K et al. Int J Cosmet Sci. 2019 Dec;41(6):558-62.
7. Dong K et al. Int J Mol Sci. 2020 Jan 3;21(1):326.
8. Walker WH II et al. Arch Dermatol Res. 2019 Sep;311(7):573-6.
9. Vaughn AR et al. Pediatr Dermatol. 2018 Jan;35(1):152-7.
10. Fishbein AB et al. J Allergy Clin Immunol. 2015 Nov;136(5):1170-7.
11. Plikus MV et al. J Biol Rhythms. 2015 Jun;30(3):163-82.
12. Deshayes N et al. Eur J Dermatol. 2018 Aug 1;28(4):467-75.
13. Wu G et al. Proc Natl Acad Sci U S A. 2018 Nov 27;115(48):12313-8.
14. Morris A. Nat Rev Endocrinol. 2018 Dec;15(1):3.
15. Jia Y et al. Exp Dermatol. 2019 Jul;28(7):858-62.
16. Lyons AB et al. J Clin Aesthet Dermatol. 2019 Sep;12(9):42-5.
What's the diagnosis?
Nipple eczema is a dermatitis of the nipple and areola with clinical features such as erythema, fissures, scaling, pruritus, and crusting.1,2 It is classically associated with atopic dermatitis (AD), though it may occur as an isolated condition less commonly. While it may affect female adolescents, nipple eczema has also been reported in boys and breastfeeding women.3,4 The overall risk of incidence of nipple dermatitis has also been shown to increase with age.5 Nipple eczema is considered a cutaneous finding of AD, and is listed as a minor diagnostic criteria for AD in the Hanifin-Rajka criteria.6 The patient had not related his history of AD, which was elicited after finding typical antecubital eczematous dermatitis, and he had not been actively treating it.
Diagnosis and differential
Nipple eczema may be a challenging diagnosis for various reasons. For example, a unilateral presentation and the changes in the eczematous lesions overlying the nipple and areola’s varying textures and colors can make it difficult for clinicians to identify.3 Many children and adolescents, including our patient, are initially diagnosed as having impetigo and treated with antibiotics. The diagnosis of nipple eczema is made clinically, and management straightforward (see below). However, additional testing may be appropriate including patch testing for allergic contact dermatitis or bacterial cultures if bacterial infection or superinfection is considered.7,8 The differential diagnosis for nipple eczema includes impetigo, gynecomastia, scabies, and allergic contact dermatitis.
Impetigo typically presents with honey-colored crusts or pustules caused by infection with Staphylococcus aureus or Streptococcus. Patients with AD have higher rates of colonization with S. aureus and impetiginized eczema in common. Impetigo of the nipple and areola is more common in breastfeeding women as skin cracking from lactation can lead to exposure to bacteria from the infant’s mouth.9 Treatments involve topical or oral antibiotics.
Gynecomastia is the development of male breast tissue with most cases hypothesized to be caused by an imbalance between androgens and estrogens.10 Some other causes include direct skin contact with topical estrogen sprays and recreational use of marijuana and heroin.11 It is usually a benign exam finding in adolescent boys. However, clinical findings such as overlying skin changes, rapidly enlarging masses, and constitutional symptoms are concerning in the setting of gynecomastia and warrant further evaluation.
Scabies, which is caused by the infestation of scabies mites, is a common infectious skin disease. The classic presentation includes a rash that is intensely itchy, especially at night. Crusted scabies of the nipples may be difficult to distinguish from nipple eczema. Areas of frequent involvement of scabies include palms, between fingers, armpits, groin, between toes, and feet. Treatments include treating all household members with permethrin cream and washing all clothes and bedding in contact with a scabies-infected patient in high heat, or oral ivermectin in certain circumstances.12
Allergic contact dermatitis is a common cause of breast and nipple dermatitis and should be considered within the differential diagnosis of nipple eczema with atopic dermatitis, or as an exacerbator.7,9 Patients in particular who present with bilateral involvement extending to the periareolar skin, or unusual bilateral focal patterns suggestive for contact allergy should be considered for allergic contact dermatitis evaluation with patch tests. A common causative agent for allergic contact dermatitis of the breast and nipple includes Cl+Me-isothiazolinone, commonly found in detergents and fabric softeners.7 Primary treatment includes avoidance of the offending agents.
Treatment
Topical corticosteroids are first-line treatment for treating nipple eczema. Low-potency topical steroids can be used for maintenance and mild eczema while more potent steroids are useful for more severe cases. In addition to topical medication therapy, frequent emollient use to protect the skin barrier and the elimination of any irritants are essential to a successful treatment course. Unilateral nipple eczema can also be secondary to inadequate treatment of AD, demonstrating the importance of addressing the underlying AD with therapy.3
Our patient was diagnosed with nipple eczema based on clinical presentation of an eczematous left nipple in the setting of active atopic dermatitis and minimal improvement on topical antibiotic. He was started on a 3-week course of fluocinonide 0.05% topical ointment (a potent topical corticosteroid) twice daily for 2 weeks with plans to transition to triamcinolone 0.1% topical ointment several times a week.
Ms. Park is a pediatric dermatology research associate in the division of pediatric and adolescent dermatology, University of California, San Diego, and Rady Children’s Hospital, San Diego. Dr. Eichenfield is vice chair of the department of dermatology and professor of dermatology and pediatrics at the University of California, San Diego, and Rady Children’s Hospital. Neither Ms. Park nor Dr. Eichenfield have any relevant financial disclosures.
References
1. Pediatr Dermatol. 2005;22(1):64-6.
2. Am J Dermatopathol. 2015;37(4):284-8.
3. Pediatr Dermatol. 2015;32(5):718-22.
4. J Cutan Med Surg. 2004;8(2):126-30.
5. Pediatr Dermatol. 2012;29(5):580-3.
6. Dermatologica. 1988;177(6):360-4.
7. Ann Dermatol. 2014;26(3):413-4.
8. BMJ Case Rep. 2020;13(8).
9. J Am Acad Dermatol. 2019;80(6):1483-94.
10. Pediatr Endocrinol Rev. 2017;14(4):371-7.
11. JAMA. 2010;304(9):953.
12. JAMA. 2018;320(6):612.
Nipple eczema is a dermatitis of the nipple and areola with clinical features such as erythema, fissures, scaling, pruritus, and crusting.1,2 It is classically associated with atopic dermatitis (AD), though it may occur as an isolated condition less commonly. While it may affect female adolescents, nipple eczema has also been reported in boys and breastfeeding women.3,4 The overall risk of incidence of nipple dermatitis has also been shown to increase with age.5 Nipple eczema is considered a cutaneous finding of AD, and is listed as a minor diagnostic criteria for AD in the Hanifin-Rajka criteria.6 The patient had not related his history of AD, which was elicited after finding typical antecubital eczematous dermatitis, and he had not been actively treating it.
Diagnosis and differential
Nipple eczema may be a challenging diagnosis for various reasons. For example, a unilateral presentation and the changes in the eczematous lesions overlying the nipple and areola’s varying textures and colors can make it difficult for clinicians to identify.3 Many children and adolescents, including our patient, are initially diagnosed as having impetigo and treated with antibiotics. The diagnosis of nipple eczema is made clinically, and management straightforward (see below). However, additional testing may be appropriate including patch testing for allergic contact dermatitis or bacterial cultures if bacterial infection or superinfection is considered.7,8 The differential diagnosis for nipple eczema includes impetigo, gynecomastia, scabies, and allergic contact dermatitis.
Impetigo typically presents with honey-colored crusts or pustules caused by infection with Staphylococcus aureus or Streptococcus. Patients with AD have higher rates of colonization with S. aureus and impetiginized eczema in common. Impetigo of the nipple and areola is more common in breastfeeding women as skin cracking from lactation can lead to exposure to bacteria from the infant’s mouth.9 Treatments involve topical or oral antibiotics.
Gynecomastia is the development of male breast tissue with most cases hypothesized to be caused by an imbalance between androgens and estrogens.10 Some other causes include direct skin contact with topical estrogen sprays and recreational use of marijuana and heroin.11 It is usually a benign exam finding in adolescent boys. However, clinical findings such as overlying skin changes, rapidly enlarging masses, and constitutional symptoms are concerning in the setting of gynecomastia and warrant further evaluation.
Scabies, which is caused by the infestation of scabies mites, is a common infectious skin disease. The classic presentation includes a rash that is intensely itchy, especially at night. Crusted scabies of the nipples may be difficult to distinguish from nipple eczema. Areas of frequent involvement of scabies include palms, between fingers, armpits, groin, between toes, and feet. Treatments include treating all household members with permethrin cream and washing all clothes and bedding in contact with a scabies-infected patient in high heat, or oral ivermectin in certain circumstances.12
Allergic contact dermatitis is a common cause of breast and nipple dermatitis and should be considered within the differential diagnosis of nipple eczema with atopic dermatitis, or as an exacerbator.7,9 Patients in particular who present with bilateral involvement extending to the periareolar skin, or unusual bilateral focal patterns suggestive for contact allergy should be considered for allergic contact dermatitis evaluation with patch tests. A common causative agent for allergic contact dermatitis of the breast and nipple includes Cl+Me-isothiazolinone, commonly found in detergents and fabric softeners.7 Primary treatment includes avoidance of the offending agents.
Treatment
Topical corticosteroids are first-line treatment for treating nipple eczema. Low-potency topical steroids can be used for maintenance and mild eczema while more potent steroids are useful for more severe cases. In addition to topical medication therapy, frequent emollient use to protect the skin barrier and the elimination of any irritants are essential to a successful treatment course. Unilateral nipple eczema can also be secondary to inadequate treatment of AD, demonstrating the importance of addressing the underlying AD with therapy.3
Our patient was diagnosed with nipple eczema based on clinical presentation of an eczematous left nipple in the setting of active atopic dermatitis and minimal improvement on topical antibiotic. He was started on a 3-week course of fluocinonide 0.05% topical ointment (a potent topical corticosteroid) twice daily for 2 weeks with plans to transition to triamcinolone 0.1% topical ointment several times a week.
Ms. Park is a pediatric dermatology research associate in the division of pediatric and adolescent dermatology, University of California, San Diego, and Rady Children’s Hospital, San Diego. Dr. Eichenfield is vice chair of the department of dermatology and professor of dermatology and pediatrics at the University of California, San Diego, and Rady Children’s Hospital. Neither Ms. Park nor Dr. Eichenfield have any relevant financial disclosures.
References
1. Pediatr Dermatol. 2005;22(1):64-6.
2. Am J Dermatopathol. 2015;37(4):284-8.
3. Pediatr Dermatol. 2015;32(5):718-22.
4. J Cutan Med Surg. 2004;8(2):126-30.
5. Pediatr Dermatol. 2012;29(5):580-3.
6. Dermatologica. 1988;177(6):360-4.
7. Ann Dermatol. 2014;26(3):413-4.
8. BMJ Case Rep. 2020;13(8).
9. J Am Acad Dermatol. 2019;80(6):1483-94.
10. Pediatr Endocrinol Rev. 2017;14(4):371-7.
11. JAMA. 2010;304(9):953.
12. JAMA. 2018;320(6):612.
Nipple eczema is a dermatitis of the nipple and areola with clinical features such as erythema, fissures, scaling, pruritus, and crusting.1,2 It is classically associated with atopic dermatitis (AD), though it may occur as an isolated condition less commonly. While it may affect female adolescents, nipple eczema has also been reported in boys and breastfeeding women.3,4 The overall risk of incidence of nipple dermatitis has also been shown to increase with age.5 Nipple eczema is considered a cutaneous finding of AD, and is listed as a minor diagnostic criteria for AD in the Hanifin-Rajka criteria.6 The patient had not related his history of AD, which was elicited after finding typical antecubital eczematous dermatitis, and he had not been actively treating it.
Diagnosis and differential
Nipple eczema may be a challenging diagnosis for various reasons. For example, a unilateral presentation and the changes in the eczematous lesions overlying the nipple and areola’s varying textures and colors can make it difficult for clinicians to identify.3 Many children and adolescents, including our patient, are initially diagnosed as having impetigo and treated with antibiotics. The diagnosis of nipple eczema is made clinically, and management straightforward (see below). However, additional testing may be appropriate including patch testing for allergic contact dermatitis or bacterial cultures if bacterial infection or superinfection is considered.7,8 The differential diagnosis for nipple eczema includes impetigo, gynecomastia, scabies, and allergic contact dermatitis.
Impetigo typically presents with honey-colored crusts or pustules caused by infection with Staphylococcus aureus or Streptococcus. Patients with AD have higher rates of colonization with S. aureus and impetiginized eczema in common. Impetigo of the nipple and areola is more common in breastfeeding women as skin cracking from lactation can lead to exposure to bacteria from the infant’s mouth.9 Treatments involve topical or oral antibiotics.
Gynecomastia is the development of male breast tissue with most cases hypothesized to be caused by an imbalance between androgens and estrogens.10 Some other causes include direct skin contact with topical estrogen sprays and recreational use of marijuana and heroin.11 It is usually a benign exam finding in adolescent boys. However, clinical findings such as overlying skin changes, rapidly enlarging masses, and constitutional symptoms are concerning in the setting of gynecomastia and warrant further evaluation.
Scabies, which is caused by the infestation of scabies mites, is a common infectious skin disease. The classic presentation includes a rash that is intensely itchy, especially at night. Crusted scabies of the nipples may be difficult to distinguish from nipple eczema. Areas of frequent involvement of scabies include palms, between fingers, armpits, groin, between toes, and feet. Treatments include treating all household members with permethrin cream and washing all clothes and bedding in contact with a scabies-infected patient in high heat, or oral ivermectin in certain circumstances.12
Allergic contact dermatitis is a common cause of breast and nipple dermatitis and should be considered within the differential diagnosis of nipple eczema with atopic dermatitis, or as an exacerbator.7,9 Patients in particular who present with bilateral involvement extending to the periareolar skin, or unusual bilateral focal patterns suggestive for contact allergy should be considered for allergic contact dermatitis evaluation with patch tests. A common causative agent for allergic contact dermatitis of the breast and nipple includes Cl+Me-isothiazolinone, commonly found in detergents and fabric softeners.7 Primary treatment includes avoidance of the offending agents.
Treatment
Topical corticosteroids are first-line treatment for treating nipple eczema. Low-potency topical steroids can be used for maintenance and mild eczema while more potent steroids are useful for more severe cases. In addition to topical medication therapy, frequent emollient use to protect the skin barrier and the elimination of any irritants are essential to a successful treatment course. Unilateral nipple eczema can also be secondary to inadequate treatment of AD, demonstrating the importance of addressing the underlying AD with therapy.3
Our patient was diagnosed with nipple eczema based on clinical presentation of an eczematous left nipple in the setting of active atopic dermatitis and minimal improvement on topical antibiotic. He was started on a 3-week course of fluocinonide 0.05% topical ointment (a potent topical corticosteroid) twice daily for 2 weeks with plans to transition to triamcinolone 0.1% topical ointment several times a week.
Ms. Park is a pediatric dermatology research associate in the division of pediatric and adolescent dermatology, University of California, San Diego, and Rady Children’s Hospital, San Diego. Dr. Eichenfield is vice chair of the department of dermatology and professor of dermatology and pediatrics at the University of California, San Diego, and Rady Children’s Hospital. Neither Ms. Park nor Dr. Eichenfield have any relevant financial disclosures.
References
1. Pediatr Dermatol. 2005;22(1):64-6.
2. Am J Dermatopathol. 2015;37(4):284-8.
3. Pediatr Dermatol. 2015;32(5):718-22.
4. J Cutan Med Surg. 2004;8(2):126-30.
5. Pediatr Dermatol. 2012;29(5):580-3.
6. Dermatologica. 1988;177(6):360-4.
7. Ann Dermatol. 2014;26(3):413-4.
8. BMJ Case Rep. 2020;13(8).
9. J Am Acad Dermatol. 2019;80(6):1483-94.
10. Pediatr Endocrinol Rev. 2017;14(4):371-7.
11. JAMA. 2010;304(9):953.
12. JAMA. 2018;320(6):612.
A 12-year-old boy presents to the dermatology clinic with a 1-month history of crusting and watery sticky drainage from the left nipple. Given concern for a possible skin infection, the patient was initially treated with mupirocin ointment for several weeks but without improvement. The affected area is sometimes itchy but not painful. He reports no prior history of similar problems.
On physical exam, he is noted to have an eczematous left nipple with edema, xerosis, and scaling overlying the entire areola. There is no evidence of visible discharge, pustules, or honey-colored crusts in the area. The extensor surfaces of his arms bilaterally have skin-colored follicular papules, and his antecubital fossa display erythematous scaling plaques with mild lichenification and excoriations.
Pressure builds on CDC to prioritize both diabetes types for vaccine
The American Diabetes Association, along with 18 other organizations, has sent a letter to the U.S. Centers for Disease Control and Prevention urging them to rank people with type 1 diabetes as equally high risk for COVID-19 severity, and therefore vaccination, as those with type 2 diabetes.
On Jan. 12, the CDC recommended states vaccinate all Americans over age 65 and those with underlying health conditions that make them more vulnerable to COVID-19.
Currently, type 2 diabetes is listed among 12 conditions that place adults “at increased risk of severe illness from the virus that causes COVID-19,” with the latter defined as “hospitalization, admission to the intensive care unit, intubation or mechanical ventilation, or death.”
On the other hand, the autoimmune condition type 1 diabetes is among 11 conditions the CDC says “might be at increased risk” for COVID-19, but limited data were available at the time of the last update on Dec. 23, 2020.
“States are utilizing the CDC risk classification when designing their vaccine distribution plans. This raises an obvious concern as it could result in the approximately 1.6 million with type 1 diabetes receiving the vaccination later than others with the same risk,” states the ADA letter, sent to the CDC on Jan. 13.
Representatives from the Endocrine Society, American Association of Clinical Endocrinology, Pediatric Endocrine Society, Association of Diabetes Care & Education Specialists, and JDRF, among others, cosigned the letter.
Newer data show those with type 1 diabetes at equally high risk
While acknowledging that “early data did not provide as much clarity about the extent to which those with type 1 diabetes are at high risk,” the ADA says newer evidence has emerged, as previously reported by this news organization, that “convincingly demonstrates that COVID-19 severity is more than tripled in individuals with type 1 diabetes.”
The letter also cites another study showing that people with type 1 diabetes “have a 3.3-fold greater risk of severe illness, are 3.9 times more likely to be hospitalized with COVID-19, and have a 3-fold increase in mortality compared to those without type 1 diabetes.”
Those risks, they note, are comparable to the increased risk established for those with type 2 diabetes, as shown in a third study from Scotland, published last month.
Asked for comment, CDC representative Kirsten Nordlund said in an interview, “This list is a living document that will be periodically updated by CDC, and it could rapidly change as the science evolves.”
In addition, Ms. Nordlund said, “Decisions about transitioning to subsequent phases should depend on supply; demand; equitable vaccine distribution; and local, state, or territorial context.”
“Phased vaccine recommendations are meant to be fluid and not restrictive for jurisdictions. It is not necessary to vaccinate all individuals in one phase before initiating the next phase; phases may overlap,” she noted. More information is available here.
Tennessee gives type 1 and type 2 diabetes equal priority for vaccination
Meanwhile, at least one state, Tennessee, has updated its guidance to include both types of diabetes as being priority for COVID-19 vaccination.
Vanderbilt University pediatric endocrinologist Justin M. Gregory, MD, said in an interview: “I was thrilled when our state modified its guidance on December 30th to include both type 1 and type 2 diabetes in the ‘high-risk category.’ Other states have not modified that guidance though.”
It’s unclear how this might play out on the ground, noted Dr. Gregory, who led one of the three studies demonstrating increased COVID-19 risk for people with type 1 diabetes.
“To tell you the truth, I don’t really know how individual organizations dispensing the vaccination [will handle] people who come to their facility saying they have ‘diabetes.’ Individual states set the vaccine-dispensing guidance and individual county health departments and health care systems mirror that guidance,” he said.
Thus, he added, “Although it’s possible an individual nurse may take the ‘I’ll ask you no questions, and you’ll tell me no lies’ approach if someone with type 1 diabetes says they have ‘diabetes’, websites and health department–recorded telephone messages are going to tell people with type 1 diabetes they have to wait further back in line if that is what their state’s guidance directs.”
A version of this article first appeared on Medscape.com.
The American Diabetes Association, along with 18 other organizations, has sent a letter to the U.S. Centers for Disease Control and Prevention urging them to rank people with type 1 diabetes as equally high risk for COVID-19 severity, and therefore vaccination, as those with type 2 diabetes.
On Jan. 12, the CDC recommended states vaccinate all Americans over age 65 and those with underlying health conditions that make them more vulnerable to COVID-19.
Currently, type 2 diabetes is listed among 12 conditions that place adults “at increased risk of severe illness from the virus that causes COVID-19,” with the latter defined as “hospitalization, admission to the intensive care unit, intubation or mechanical ventilation, or death.”
On the other hand, the autoimmune condition type 1 diabetes is among 11 conditions the CDC says “might be at increased risk” for COVID-19, but limited data were available at the time of the last update on Dec. 23, 2020.
“States are utilizing the CDC risk classification when designing their vaccine distribution plans. This raises an obvious concern as it could result in the approximately 1.6 million with type 1 diabetes receiving the vaccination later than others with the same risk,” states the ADA letter, sent to the CDC on Jan. 13.
Representatives from the Endocrine Society, American Association of Clinical Endocrinology, Pediatric Endocrine Society, Association of Diabetes Care & Education Specialists, and JDRF, among others, cosigned the letter.
Newer data show those with type 1 diabetes at equally high risk
While acknowledging that “early data did not provide as much clarity about the extent to which those with type 1 diabetes are at high risk,” the ADA says newer evidence has emerged, as previously reported by this news organization, that “convincingly demonstrates that COVID-19 severity is more than tripled in individuals with type 1 diabetes.”
The letter also cites another study showing that people with type 1 diabetes “have a 3.3-fold greater risk of severe illness, are 3.9 times more likely to be hospitalized with COVID-19, and have a 3-fold increase in mortality compared to those without type 1 diabetes.”
Those risks, they note, are comparable to the increased risk established for those with type 2 diabetes, as shown in a third study from Scotland, published last month.
Asked for comment, CDC representative Kirsten Nordlund said in an interview, “This list is a living document that will be periodically updated by CDC, and it could rapidly change as the science evolves.”
In addition, Ms. Nordlund said, “Decisions about transitioning to subsequent phases should depend on supply; demand; equitable vaccine distribution; and local, state, or territorial context.”
“Phased vaccine recommendations are meant to be fluid and not restrictive for jurisdictions. It is not necessary to vaccinate all individuals in one phase before initiating the next phase; phases may overlap,” she noted. More information is available here.
Tennessee gives type 1 and type 2 diabetes equal priority for vaccination
Meanwhile, at least one state, Tennessee, has updated its guidance to include both types of diabetes as being priority for COVID-19 vaccination.
Vanderbilt University pediatric endocrinologist Justin M. Gregory, MD, said in an interview: “I was thrilled when our state modified its guidance on December 30th to include both type 1 and type 2 diabetes in the ‘high-risk category.’ Other states have not modified that guidance though.”
It’s unclear how this might play out on the ground, noted Dr. Gregory, who led one of the three studies demonstrating increased COVID-19 risk for people with type 1 diabetes.
“To tell you the truth, I don’t really know how individual organizations dispensing the vaccination [will handle] people who come to their facility saying they have ‘diabetes.’ Individual states set the vaccine-dispensing guidance and individual county health departments and health care systems mirror that guidance,” he said.
Thus, he added, “Although it’s possible an individual nurse may take the ‘I’ll ask you no questions, and you’ll tell me no lies’ approach if someone with type 1 diabetes says they have ‘diabetes’, websites and health department–recorded telephone messages are going to tell people with type 1 diabetes they have to wait further back in line if that is what their state’s guidance directs.”
A version of this article first appeared on Medscape.com.
The American Diabetes Association, along with 18 other organizations, has sent a letter to the U.S. Centers for Disease Control and Prevention urging them to rank people with type 1 diabetes as equally high risk for COVID-19 severity, and therefore vaccination, as those with type 2 diabetes.
On Jan. 12, the CDC recommended states vaccinate all Americans over age 65 and those with underlying health conditions that make them more vulnerable to COVID-19.
Currently, type 2 diabetes is listed among 12 conditions that place adults “at increased risk of severe illness from the virus that causes COVID-19,” with the latter defined as “hospitalization, admission to the intensive care unit, intubation or mechanical ventilation, or death.”
On the other hand, the autoimmune condition type 1 diabetes is among 11 conditions the CDC says “might be at increased risk” for COVID-19, but limited data were available at the time of the last update on Dec. 23, 2020.
“States are utilizing the CDC risk classification when designing their vaccine distribution plans. This raises an obvious concern as it could result in the approximately 1.6 million with type 1 diabetes receiving the vaccination later than others with the same risk,” states the ADA letter, sent to the CDC on Jan. 13.
Representatives from the Endocrine Society, American Association of Clinical Endocrinology, Pediatric Endocrine Society, Association of Diabetes Care & Education Specialists, and JDRF, among others, cosigned the letter.
Newer data show those with type 1 diabetes at equally high risk
While acknowledging that “early data did not provide as much clarity about the extent to which those with type 1 diabetes are at high risk,” the ADA says newer evidence has emerged, as previously reported by this news organization, that “convincingly demonstrates that COVID-19 severity is more than tripled in individuals with type 1 diabetes.”
The letter also cites another study showing that people with type 1 diabetes “have a 3.3-fold greater risk of severe illness, are 3.9 times more likely to be hospitalized with COVID-19, and have a 3-fold increase in mortality compared to those without type 1 diabetes.”
Those risks, they note, are comparable to the increased risk established for those with type 2 diabetes, as shown in a third study from Scotland, published last month.
Asked for comment, CDC representative Kirsten Nordlund said in an interview, “This list is a living document that will be periodically updated by CDC, and it could rapidly change as the science evolves.”
In addition, Ms. Nordlund said, “Decisions about transitioning to subsequent phases should depend on supply; demand; equitable vaccine distribution; and local, state, or territorial context.”
“Phased vaccine recommendations are meant to be fluid and not restrictive for jurisdictions. It is not necessary to vaccinate all individuals in one phase before initiating the next phase; phases may overlap,” she noted. More information is available here.
Tennessee gives type 1 and type 2 diabetes equal priority for vaccination
Meanwhile, at least one state, Tennessee, has updated its guidance to include both types of diabetes as being priority for COVID-19 vaccination.
Vanderbilt University pediatric endocrinologist Justin M. Gregory, MD, said in an interview: “I was thrilled when our state modified its guidance on December 30th to include both type 1 and type 2 diabetes in the ‘high-risk category.’ Other states have not modified that guidance though.”
It’s unclear how this might play out on the ground, noted Dr. Gregory, who led one of the three studies demonstrating increased COVID-19 risk for people with type 1 diabetes.
“To tell you the truth, I don’t really know how individual organizations dispensing the vaccination [will handle] people who come to their facility saying they have ‘diabetes.’ Individual states set the vaccine-dispensing guidance and individual county health departments and health care systems mirror that guidance,” he said.
Thus, he added, “Although it’s possible an individual nurse may take the ‘I’ll ask you no questions, and you’ll tell me no lies’ approach if someone with type 1 diabetes says they have ‘diabetes’, websites and health department–recorded telephone messages are going to tell people with type 1 diabetes they have to wait further back in line if that is what their state’s guidance directs.”
A version of this article first appeared on Medscape.com.
Coping with vaccine refusal
Do you accept new families into your practice who have already chosen to not have their children immunized? What about families who have been in your practice for several months or years? In 2016 the American Academy of Pediatrics published a clinical report in which it stated that, under some circumstances, dismissing families who refuse to vaccinate is permissible. Have you felt sufficiently supported by that statement and dismissed any families after multiple attempts at education on your part?
In a Pediatrics Perspective article in the December issue of Pediatrics, two philosophers and a physician make the argument that, while in some situations dismissing a family who refuses vaccines may be “an ethically acceptable option” refusing to accept a family with the same philosophy is not. It is an interesting paper and worth reading regardless of whether or not you already accept and continue to tolerate vaccine deniers in your practice.
The Pediatrics Perspective is certainly not the last word on the ethics of caring for families who deny their children care that we believe is critical to their health and the welfare of the community at large. There has been a lot of discussion about the issue but little has been written about how we as the physicians on the front line are coping emotionally with what the authors of the paper call the “burdens associated with treating” families who refuse to follow our guidance.
It is hard not to feel angry when a family you have invested valuable office time in discussing the benefits and safety of vaccines continues to disregard what you see as the facts. The time you have spent with them is not just income-generating time for your practice, it is time stolen from other families who are more willing to follow your recommendations. In how many visits will you continue to raise the issue? Unless I saw a glimmer of hope I would usually stop after two wasted encounters. But, the issue would still linger as the elephant in the examination room for as long as I continued to see the patient.
How have you expressed your anger? Have you been argumentative or rude? You may have been able maintain your composure and remain civil and appear caring, but I suspect the anger is still gnawing at you. And, there is still the frustration and feeling of impotence. You may have questioned your ability as an educator. You should get over that notion quickly. There is ample evidence that most vaccine deniers are not going to be convinced by even the most carefully presented information. I suggest you leave it to others to try their hands at education. Let them invest their time while you tend to the needs of your other patients. You can try being a fear monger and, while fear can be effective, you have better ways to spend your office day than telling horror stories.
If vaccine denial makes you feel powerless, you should get over that pretty quickly as well and accept the fact that you are simply an advisor. If you believe that most of the families in your practice are following your recommendations as though you had presented them on stone tablets, it is time for a wakeup call.
Finally, there is the most troubling emotion associated with vaccine refusal and that is fear, the fear of being sued. Establishing a relationship with a family is one that requires mutual trust and certainly vaccine refusal will put that trust in question, particularly if you have done a less than adequate job of hiding your anger and frustration with their unfortunate decision.
For now, vaccine refusal is just another one of those crosses that those of us in primary care must bear together wearing the best face we can put forward. That doesn’t mean we can’t share those emotions with our peers. Misery does love company.
Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Other than a Littman stethoscope he accepted as a first-year medical student in 1966, Dr. Wilkoff reports having nothing to disclose. Email him at [email protected].
Do you accept new families into your practice who have already chosen to not have their children immunized? What about families who have been in your practice for several months or years? In 2016 the American Academy of Pediatrics published a clinical report in which it stated that, under some circumstances, dismissing families who refuse to vaccinate is permissible. Have you felt sufficiently supported by that statement and dismissed any families after multiple attempts at education on your part?
In a Pediatrics Perspective article in the December issue of Pediatrics, two philosophers and a physician make the argument that, while in some situations dismissing a family who refuses vaccines may be “an ethically acceptable option” refusing to accept a family with the same philosophy is not. It is an interesting paper and worth reading regardless of whether or not you already accept and continue to tolerate vaccine deniers in your practice.
The Pediatrics Perspective is certainly not the last word on the ethics of caring for families who deny their children care that we believe is critical to their health and the welfare of the community at large. There has been a lot of discussion about the issue but little has been written about how we as the physicians on the front line are coping emotionally with what the authors of the paper call the “burdens associated with treating” families who refuse to follow our guidance.
It is hard not to feel angry when a family you have invested valuable office time in discussing the benefits and safety of vaccines continues to disregard what you see as the facts. The time you have spent with them is not just income-generating time for your practice, it is time stolen from other families who are more willing to follow your recommendations. In how many visits will you continue to raise the issue? Unless I saw a glimmer of hope I would usually stop after two wasted encounters. But, the issue would still linger as the elephant in the examination room for as long as I continued to see the patient.
How have you expressed your anger? Have you been argumentative or rude? You may have been able maintain your composure and remain civil and appear caring, but I suspect the anger is still gnawing at you. And, there is still the frustration and feeling of impotence. You may have questioned your ability as an educator. You should get over that notion quickly. There is ample evidence that most vaccine deniers are not going to be convinced by even the most carefully presented information. I suggest you leave it to others to try their hands at education. Let them invest their time while you tend to the needs of your other patients. You can try being a fear monger and, while fear can be effective, you have better ways to spend your office day than telling horror stories.
If vaccine denial makes you feel powerless, you should get over that pretty quickly as well and accept the fact that you are simply an advisor. If you believe that most of the families in your practice are following your recommendations as though you had presented them on stone tablets, it is time for a wakeup call.
Finally, there is the most troubling emotion associated with vaccine refusal and that is fear, the fear of being sued. Establishing a relationship with a family is one that requires mutual trust and certainly vaccine refusal will put that trust in question, particularly if you have done a less than adequate job of hiding your anger and frustration with their unfortunate decision.
For now, vaccine refusal is just another one of those crosses that those of us in primary care must bear together wearing the best face we can put forward. That doesn’t mean we can’t share those emotions with our peers. Misery does love company.
Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Other than a Littman stethoscope he accepted as a first-year medical student in 1966, Dr. Wilkoff reports having nothing to disclose. Email him at [email protected].
Do you accept new families into your practice who have already chosen to not have their children immunized? What about families who have been in your practice for several months or years? In 2016 the American Academy of Pediatrics published a clinical report in which it stated that, under some circumstances, dismissing families who refuse to vaccinate is permissible. Have you felt sufficiently supported by that statement and dismissed any families after multiple attempts at education on your part?
In a Pediatrics Perspective article in the December issue of Pediatrics, two philosophers and a physician make the argument that, while in some situations dismissing a family who refuses vaccines may be “an ethically acceptable option” refusing to accept a family with the same philosophy is not. It is an interesting paper and worth reading regardless of whether or not you already accept and continue to tolerate vaccine deniers in your practice.
The Pediatrics Perspective is certainly not the last word on the ethics of caring for families who deny their children care that we believe is critical to their health and the welfare of the community at large. There has been a lot of discussion about the issue but little has been written about how we as the physicians on the front line are coping emotionally with what the authors of the paper call the “burdens associated with treating” families who refuse to follow our guidance.
It is hard not to feel angry when a family you have invested valuable office time in discussing the benefits and safety of vaccines continues to disregard what you see as the facts. The time you have spent with them is not just income-generating time for your practice, it is time stolen from other families who are more willing to follow your recommendations. In how many visits will you continue to raise the issue? Unless I saw a glimmer of hope I would usually stop after two wasted encounters. But, the issue would still linger as the elephant in the examination room for as long as I continued to see the patient.
How have you expressed your anger? Have you been argumentative or rude? You may have been able maintain your composure and remain civil and appear caring, but I suspect the anger is still gnawing at you. And, there is still the frustration and feeling of impotence. You may have questioned your ability as an educator. You should get over that notion quickly. There is ample evidence that most vaccine deniers are not going to be convinced by even the most carefully presented information. I suggest you leave it to others to try their hands at education. Let them invest their time while you tend to the needs of your other patients. You can try being a fear monger and, while fear can be effective, you have better ways to spend your office day than telling horror stories.
If vaccine denial makes you feel powerless, you should get over that pretty quickly as well and accept the fact that you are simply an advisor. If you believe that most of the families in your practice are following your recommendations as though you had presented them on stone tablets, it is time for a wakeup call.
Finally, there is the most troubling emotion associated with vaccine refusal and that is fear, the fear of being sued. Establishing a relationship with a family is one that requires mutual trust and certainly vaccine refusal will put that trust in question, particularly if you have done a less than adequate job of hiding your anger and frustration with their unfortunate decision.
For now, vaccine refusal is just another one of those crosses that those of us in primary care must bear together wearing the best face we can put forward. That doesn’t mean we can’t share those emotions with our peers. Misery does love company.
Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Other than a Littman stethoscope he accepted as a first-year medical student in 1966, Dr. Wilkoff reports having nothing to disclose. Email him at [email protected].