User login
Triage, L&D, postpartum care during the COVID-19 pandemic
The meteoric rise in the number of test-positive and clinical cases of COVID-19 because of infection with the SARS coronavirus (SARS-CoV-2) in states and cities across the United States has added urgency to the efforts to develop protocols for hospital triage, admission, labor and delivery management, and other aspects of obstetrical care.
Emerging data suggest that, while SARS-CoV-2 is less lethal overall than the severe acute respiratory syndrome coronavirus (SARS-CoV) and Middle East respiratory syndrome coronavirus (MERS-CoV) proved to be, it is significantly more contagious. Although a severe disease, the limited worldwide data so far available (as of early May) do not indicate that pregnant women are at greater risk of severe disease, compared with the general population. However, there remains a critical need for data on maternal and perinatal outcomes in women infected with SARS-CoV-2.
Multiple physiological changes in pregnancy, from reduced cell-based immune competence to changes in respiratory tract and pulmonary function – e.g., edema of the respiratory tract, increases in secretions and oxygen consumption, elevation of the diaphragm, and decrease in functional residual capacity – have historically contributed to worse obstetric outcomes in pregnant women who have had viral pneumonias. Furthermore, limited published experience with COVID-19 in China suggests worse perinatal outcomes in some affected pregnancies, including prematurity and perinatal death.
With evolution of the pandemic and accumulation of experience, it is expected that data-driven guidelines on assessment and management of infected pregnant women will contribute to improved maternal and perinatal outcomes. What is clear now, however, is that,
Here are my recommendations, based on a currently limited body of literature on COVID-19 and other communicable viral respiratory disorders, as well my experience in the greater Detroit area, a COVID-19 hot spot.
Preparing for hospital evaluation and admission
The obstetric triage or labor and delivery (L&D) unit should be notified prior to the arrival of a patient suspected of or known to be infected with the virus. This will minimize staff exposure and allow sufficient time to prepare appropriate accommodations, equipment, and supplies for the patient’s care. Hospital infection control should be promptly notified by L&D of the expected arrival of such a patient. Placement ideally should be in a negative-pressure room, which allows outside air to flow into the room but prevents contaminated air from escaping. In the absence of a negative-pressure room, an infection isolation area should be utilized.
The patient and one accompanying support individual should wear either medical-grade masks brought from home or supplied upon entry to the hospital or homemade masks or bandanas. This will reduce the risk of viral transmission to hospital workers and other individuals encountered in the hospital prior to arriving in L&D. An ideal setup is to have separate entry areas, access corridors, and elevators for patients known or suspected to have COVID-19 infection. The patient and visitor should be expeditiously escorted to the prepared area for evaluation. Patients who are not known or suspected to be infected ideally should be tested.
Screening of patients & support individuals
Proper screening of patients and support individuals is critical to protecting both patients and staff in the L&D unit. This should include an expanded questionnaire that asks about disturbances of smell and taste and GI symptoms like loss of appetite – not only the more commonly queried symptoms of fever, shortness of breath, coughing, and exposure to someone who may have been ill.
Recent studies regarding presenting symptoms cast significant doubt, in fact, on the validity of patients with “asymptomatic COVID-19.” Over 15% of patients with confirmed infection in one published case series had solely GI symptoms and almost all had some digestive symptoms, for example, and almost 90% in another study had absent or reduced sense of smell and/or taste.1,2 In fact, the use of the term “paucisymptomatic” rather than “asymptomatic” may be most appropriate.
Support individuals also should undergo temperature screening, ideally with laser noncontact thermometers on entry to the hospital or triage.
Visitor policy
The number of visitors/support individuals should be kept to a minimum to reduce transmission risk. The actual number will be determined by hospital or state policy, but up to one visitor in the labor room appears reasonable. Very strong individual justification should be required to exceed this threshold! The visitor should not only be screened for an expanded list of symptoms, but they also should be queried for underlying illnesses (e.g., diabetes, cardiovascular disease, significant lung disease, undergoing cancer therapy) as well as for age over 65 years, each of which increase the chances of severe COVID-19 disease should infection occur. The visitor should be informed of such risks and, especially when accompanying a patient with known or suspected COVID-19, provided the option of voluntarily revoking their visitor status. A visitor with known or suspected COVID-19 infection based on testing or screening should not be allowed into the L&D unit.
In addition, institutions may be considered to have obligations to the visitor/support person beyond screening. These include instructions in proper mask usage, hand washing, and limiting the touching of surfaces to lower infection risk.
“Visitor relays” where one visitor replaces another should be strongly discouraged. Visitors should similarly not be allowed to wander around the hospital (to use phones, for instance); transiting back and forth to obtain food and coffee should be kept to a strict minimum. For visitors accompanying COVID-19–-infected women, “visitor’s plates” provided by the hospital at reasonable cost is a much-preferred arrangement for obtaining meals during the course of the hospital stay. In addition, visitors should be sent out of the room during the performance of aerosolizing procedures.
Labor and delivery management
The successful management of patients with COVID-19 requires a rigorous infection control protocol informed by guidelines from national entities, such as the Centers for Disease Control and Prevention, the Society for Maternal-Fetal Medicine, and the American College of Obstetricians and Gynecologists, and by state health departments when available.
Strict limits on the number of obstetricians and other health care workers (HCWs) entering the patient’s room should be enforced and documented to minimize risk to the HCWs attending to patients who have a positive diagnosis or who are under investigation. Only in cases of demonstrable clinical benefit should repeat visits by the same or additional HCWs be permitted. Conventional and electronic tablets present an excellent opportunity for patient follow-up visits without room entry. In our institution, this has been successfully piloted in nonpregnant patients. Obstetricians and others caring for obstetrical patients – especially those who are infected or under investigation for infection – should always wear a properly fitted N95 mask.
Because patients with COVID-19 may have or go on to develop a constellation of organ abnormalities (e.g., cardiovascular, renal, pulmonary), it is vital that a standardized panel of baseline laboratory studies be developed for pregnant patients. This will minimize the need for repeated blood draws and other testing which may increase HCW exposure.
A negative screen based on nonreport of symptoms, lack of temperature elevation, and reported nonexposure to individuals with COVID-19 symptoms still has limitations in terms of disease detection. A recent report from a tertiary care hospital in New York City found that close to one-third of pregnant patients with confirmed COVID-19 admitted over a 2-week period had no viral symptoms or instructive history on initial admission.3 This is consistent with our clinical experience. Most importantly, therefore, routine quantitative reverse transcription polymerase chain reaction testing should be performed on all patients admitted to the L&D unit.
Given the reported variability in the accuracy of polymerase chain reaction testing induced by variable effectiveness of sampling techniques, stage of infection, and inherent test accuracy issues, symptomatic patients with a negative test should first obtain clearance from infectious disease specialists before isolation precautions are discontinued. Repeat testing in 24 hours, including testing of multiple sites, may subsequently yield a positive result in persistently symptomatic patients.
Intrapartum management
As much as possible, standard obstetric indications should guide the timing and route of delivery. In the case of a COVID-19–positive patient or a patient under investigation, nonobstetric factors may bear heavily on decision making, and management flexibility is of great value. For example, in cases of severe or critical disease status, evidence suggests that early delivery regardless of gestational age can improve maternal oxygenation; this supports the liberal use of C-sections in these circumstances. In addition, shortening labor length as well as duration of hospitalization may be expected to reduce the risk of transmission to HCWs, other staff, and other patients.
High rates of cesarean delivery unsurprisingly have been reported thus far: One review of 108 case reports and series of test-positive COVID-19 pregnancies found a 92% C-section rate, and another review and meta-analysis of studies of SARS, MERS, and COVID-19 during pregnancy similarly found that the majority of patients – 84% across all coronavirus infections and 91% in COVID-19 pregnancies – were delivered by C-section.4,5 Given these high rates of cesarean deliveries, the early placement of neuraxial anesthesia while the patient is stable appears to be prudent and obviates the need for intubation, the latter of which is associated with increased aerosol generation and increased virus transmission risk.
Strict protocols for the optimal protection of staff should be observed, including proper personal protective equipment (PPE) protection. Protocols have been detailed in various guidelines and publications; they include the wearing of shoe covers, gowns, N95 masks, goggles, face shields, and two layers of gloves.
For institutions that currently do not offer routine COVID-19 testing to pregnant patients – especially those in areas of outbreaks – N95 masks and eye protection should still be provided to all HCWs involved in the intrapartum management of untested asymptomatic patients, particularly those in the active phase of labor. This protection is justified given the limitations of symptom- and history-based screening and the not-uncommon experience of the patient with a negative screen who subsequently develops the clinical syndrome.
Obstetric management of labor requires close patient contact that potentially elevates the risk of contamination and infection. During the active stage of labor, patient shouting, rapid mouth breathing, and other behaviors inherent to labor all increase the risk of aerosolization of oronasal secretions. In addition, nasal-prong oxygen administration is believed to independently increase the risk of aerosolization of secretions. The casual practice of nasal oxygen application should thus be discontinued and, where felt to be absolutely necessary, a mask should be worn on top of the prongs.
Regarding operative delivery, each participating obstetric surgeon should observe guidelines and recommendations of governing national organizations and professional groups – including the American College of Surgeons – regarding the safe conduct of operations on patients with COVID-19. Written guidelines should be tailored as needed to the performance of C-sections and readily available in L&D. Drills and simulations are generally valuable, and expertise and support should always be available in the labor room to assist with donning and doffing of PPE.
Postpartum care
Expeditious separation of the COVID-19–positive mother from her infant is recommended, including avoidance of delayed cord clamping because of insufficient evidence of benefit to the infant. Insufficient evidence exists to support vertical transmission, but the possibility of maternal-infant transmission is clinically accepted based on small case reports of infection in a neonate at 30 hours of life and in infants of mothers with suspected or confirmed COVID-19.6,7 Accordingly, it is recommended that the benefit of early infant separation should be discussed with the mother. If approved, the infant should be kept in a separate isolation area and observed.
There is no evidence of breast milk transmission of the virus. For those electing to breastfeed, the patient should be provided with a breast pump to express and store the milk for subsequent bottle feeding. For mothers who elect to room in with the infant, a separation distance of 6 feet is recommended with an intervening barrier curtain. For COVID-19–positive mothers who elect breastfeeding, meticulous hand and face washing, continuous wearing of a mask, and cleansing of the breast prior to feeding needs to be maintained.
Restrictive visiting policies of no more than one visitor should be maintained. For severely or critically ill patients with COVID-19, it has been suggested that no visitors be allowed. As with other hospitalizations of COVID-19 patients, the HCW contact should be kept at a justifiable minimum to reduce the risk of transmission.
Protecting the obstetrician and other HCWs
Protecting the health of obstetricians and other HCWs is central to any successful strategy to fight the COVID-19 epidemic. For the individual obstetrician, careful attention to national and local hospital guidelines is required as these are rapidly evolving.
Physicians and their leadership must maintain an ongoing dialogue with hospital leadership to continually upgrade and optimize infection prevention and control measures, and to uphold best practices. The experience in Wuhan, China, illustrates the effectiveness of the proper use of PPE along with population control measures to reduce infections in HCWs. Prior to understanding the mechanism of virus transmission and using protective equipment, infection rates of 3%-29% were reported among HCWs. With the meticulous utilization of mitigation strategies and population control measures – including consistent use of PPE – the rate of infection of HCWs reportedly fell to zero.
In outpatient offices, all staff and HCWs should wear masks at all times and engage in social distancing and in frequent hand sanitization. Patients should be strongly encouraged to wear masks during office visits and on all other occasions when they will be in physical proximity to other individuals outside of the home.
Reports from epidemic areas describe transmission from household sources as a significant cause of HCW infection. The information emphasizes the need for ongoing vigilance and attention to sanitization measures even when at home with one’s family. An additional benefit is reduced risk of transmission from HCWs to family members.
Dr. Bahado-Singh is professor and chair of obstetrics and gynecology at Oakland University, Rochester, Mich., and health system chair for obstetrics and gynecology at Beaumont Health System.
References
1. Luo S et al. Clin Gastroenterol Hepatol. 2020 Mar 20. doi: 10.1016/j.cgh.2020.03.043.
2. Lechien JR et al. Eur Arch Otorhinolaryngol. 2020 Apr 6. doi: 10.1007/s00405-020-05965-1.
3. Breslin N et al. Am J Obstet Gynecol MFM. 2020 Apr 9. doi: 10.1016/j.ajogmf.2020.100118.
4. Zaigham M, Andersson O. Acta Obstet Gynecol Scand. 2020 Apr 7. doi: 10.1111/aogs.13867.
5. Di Mascio D et al. Am J Obstet Gynecol MFM. 2020 Mar 25. doi: 10.1016/j.ajogmf.2020.100107.
6. Ital J. Pediatr 2020;46(1) doi: 10.1186/s13052-020-0820-x.
7. Int J Gynaecol Obstet. 2020;149(2):130-6.
*This article was updated 5/6/2020.
The meteoric rise in the number of test-positive and clinical cases of COVID-19 because of infection with the SARS coronavirus (SARS-CoV-2) in states and cities across the United States has added urgency to the efforts to develop protocols for hospital triage, admission, labor and delivery management, and other aspects of obstetrical care.
Emerging data suggest that, while SARS-CoV-2 is less lethal overall than the severe acute respiratory syndrome coronavirus (SARS-CoV) and Middle East respiratory syndrome coronavirus (MERS-CoV) proved to be, it is significantly more contagious. Although a severe disease, the limited worldwide data so far available (as of early May) do not indicate that pregnant women are at greater risk of severe disease, compared with the general population. However, there remains a critical need for data on maternal and perinatal outcomes in women infected with SARS-CoV-2.
Multiple physiological changes in pregnancy, from reduced cell-based immune competence to changes in respiratory tract and pulmonary function – e.g., edema of the respiratory tract, increases in secretions and oxygen consumption, elevation of the diaphragm, and decrease in functional residual capacity – have historically contributed to worse obstetric outcomes in pregnant women who have had viral pneumonias. Furthermore, limited published experience with COVID-19 in China suggests worse perinatal outcomes in some affected pregnancies, including prematurity and perinatal death.
With evolution of the pandemic and accumulation of experience, it is expected that data-driven guidelines on assessment and management of infected pregnant women will contribute to improved maternal and perinatal outcomes. What is clear now, however, is that,
Here are my recommendations, based on a currently limited body of literature on COVID-19 and other communicable viral respiratory disorders, as well my experience in the greater Detroit area, a COVID-19 hot spot.
Preparing for hospital evaluation and admission
The obstetric triage or labor and delivery (L&D) unit should be notified prior to the arrival of a patient suspected of or known to be infected with the virus. This will minimize staff exposure and allow sufficient time to prepare appropriate accommodations, equipment, and supplies for the patient’s care. Hospital infection control should be promptly notified by L&D of the expected arrival of such a patient. Placement ideally should be in a negative-pressure room, which allows outside air to flow into the room but prevents contaminated air from escaping. In the absence of a negative-pressure room, an infection isolation area should be utilized.
The patient and one accompanying support individual should wear either medical-grade masks brought from home or supplied upon entry to the hospital or homemade masks or bandanas. This will reduce the risk of viral transmission to hospital workers and other individuals encountered in the hospital prior to arriving in L&D. An ideal setup is to have separate entry areas, access corridors, and elevators for patients known or suspected to have COVID-19 infection. The patient and visitor should be expeditiously escorted to the prepared area for evaluation. Patients who are not known or suspected to be infected ideally should be tested.
Screening of patients & support individuals
Proper screening of patients and support individuals is critical to protecting both patients and staff in the L&D unit. This should include an expanded questionnaire that asks about disturbances of smell and taste and GI symptoms like loss of appetite – not only the more commonly queried symptoms of fever, shortness of breath, coughing, and exposure to someone who may have been ill.
Recent studies regarding presenting symptoms cast significant doubt, in fact, on the validity of patients with “asymptomatic COVID-19.” Over 15% of patients with confirmed infection in one published case series had solely GI symptoms and almost all had some digestive symptoms, for example, and almost 90% in another study had absent or reduced sense of smell and/or taste.1,2 In fact, the use of the term “paucisymptomatic” rather than “asymptomatic” may be most appropriate.
Support individuals also should undergo temperature screening, ideally with laser noncontact thermometers on entry to the hospital or triage.
Visitor policy
The number of visitors/support individuals should be kept to a minimum to reduce transmission risk. The actual number will be determined by hospital or state policy, but up to one visitor in the labor room appears reasonable. Very strong individual justification should be required to exceed this threshold! The visitor should not only be screened for an expanded list of symptoms, but they also should be queried for underlying illnesses (e.g., diabetes, cardiovascular disease, significant lung disease, undergoing cancer therapy) as well as for age over 65 years, each of which increase the chances of severe COVID-19 disease should infection occur. The visitor should be informed of such risks and, especially when accompanying a patient with known or suspected COVID-19, provided the option of voluntarily revoking their visitor status. A visitor with known or suspected COVID-19 infection based on testing or screening should not be allowed into the L&D unit.
In addition, institutions may be considered to have obligations to the visitor/support person beyond screening. These include instructions in proper mask usage, hand washing, and limiting the touching of surfaces to lower infection risk.
“Visitor relays” where one visitor replaces another should be strongly discouraged. Visitors should similarly not be allowed to wander around the hospital (to use phones, for instance); transiting back and forth to obtain food and coffee should be kept to a strict minimum. For visitors accompanying COVID-19–-infected women, “visitor’s plates” provided by the hospital at reasonable cost is a much-preferred arrangement for obtaining meals during the course of the hospital stay. In addition, visitors should be sent out of the room during the performance of aerosolizing procedures.
Labor and delivery management
The successful management of patients with COVID-19 requires a rigorous infection control protocol informed by guidelines from national entities, such as the Centers for Disease Control and Prevention, the Society for Maternal-Fetal Medicine, and the American College of Obstetricians and Gynecologists, and by state health departments when available.
Strict limits on the number of obstetricians and other health care workers (HCWs) entering the patient’s room should be enforced and documented to minimize risk to the HCWs attending to patients who have a positive diagnosis or who are under investigation. Only in cases of demonstrable clinical benefit should repeat visits by the same or additional HCWs be permitted. Conventional and electronic tablets present an excellent opportunity for patient follow-up visits without room entry. In our institution, this has been successfully piloted in nonpregnant patients. Obstetricians and others caring for obstetrical patients – especially those who are infected or under investigation for infection – should always wear a properly fitted N95 mask.
Because patients with COVID-19 may have or go on to develop a constellation of organ abnormalities (e.g., cardiovascular, renal, pulmonary), it is vital that a standardized panel of baseline laboratory studies be developed for pregnant patients. This will minimize the need for repeated blood draws and other testing which may increase HCW exposure.
A negative screen based on nonreport of symptoms, lack of temperature elevation, and reported nonexposure to individuals with COVID-19 symptoms still has limitations in terms of disease detection. A recent report from a tertiary care hospital in New York City found that close to one-third of pregnant patients with confirmed COVID-19 admitted over a 2-week period had no viral symptoms or instructive history on initial admission.3 This is consistent with our clinical experience. Most importantly, therefore, routine quantitative reverse transcription polymerase chain reaction testing should be performed on all patients admitted to the L&D unit.
Given the reported variability in the accuracy of polymerase chain reaction testing induced by variable effectiveness of sampling techniques, stage of infection, and inherent test accuracy issues, symptomatic patients with a negative test should first obtain clearance from infectious disease specialists before isolation precautions are discontinued. Repeat testing in 24 hours, including testing of multiple sites, may subsequently yield a positive result in persistently symptomatic patients.
Intrapartum management
As much as possible, standard obstetric indications should guide the timing and route of delivery. In the case of a COVID-19–positive patient or a patient under investigation, nonobstetric factors may bear heavily on decision making, and management flexibility is of great value. For example, in cases of severe or critical disease status, evidence suggests that early delivery regardless of gestational age can improve maternal oxygenation; this supports the liberal use of C-sections in these circumstances. In addition, shortening labor length as well as duration of hospitalization may be expected to reduce the risk of transmission to HCWs, other staff, and other patients.
High rates of cesarean delivery unsurprisingly have been reported thus far: One review of 108 case reports and series of test-positive COVID-19 pregnancies found a 92% C-section rate, and another review and meta-analysis of studies of SARS, MERS, and COVID-19 during pregnancy similarly found that the majority of patients – 84% across all coronavirus infections and 91% in COVID-19 pregnancies – were delivered by C-section.4,5 Given these high rates of cesarean deliveries, the early placement of neuraxial anesthesia while the patient is stable appears to be prudent and obviates the need for intubation, the latter of which is associated with increased aerosol generation and increased virus transmission risk.
Strict protocols for the optimal protection of staff should be observed, including proper personal protective equipment (PPE) protection. Protocols have been detailed in various guidelines and publications; they include the wearing of shoe covers, gowns, N95 masks, goggles, face shields, and two layers of gloves.
For institutions that currently do not offer routine COVID-19 testing to pregnant patients – especially those in areas of outbreaks – N95 masks and eye protection should still be provided to all HCWs involved in the intrapartum management of untested asymptomatic patients, particularly those in the active phase of labor. This protection is justified given the limitations of symptom- and history-based screening and the not-uncommon experience of the patient with a negative screen who subsequently develops the clinical syndrome.
Obstetric management of labor requires close patient contact that potentially elevates the risk of contamination and infection. During the active stage of labor, patient shouting, rapid mouth breathing, and other behaviors inherent to labor all increase the risk of aerosolization of oronasal secretions. In addition, nasal-prong oxygen administration is believed to independently increase the risk of aerosolization of secretions. The casual practice of nasal oxygen application should thus be discontinued and, where felt to be absolutely necessary, a mask should be worn on top of the prongs.
Regarding operative delivery, each participating obstetric surgeon should observe guidelines and recommendations of governing national organizations and professional groups – including the American College of Surgeons – regarding the safe conduct of operations on patients with COVID-19. Written guidelines should be tailored as needed to the performance of C-sections and readily available in L&D. Drills and simulations are generally valuable, and expertise and support should always be available in the labor room to assist with donning and doffing of PPE.
Postpartum care
Expeditious separation of the COVID-19–positive mother from her infant is recommended, including avoidance of delayed cord clamping because of insufficient evidence of benefit to the infant. Insufficient evidence exists to support vertical transmission, but the possibility of maternal-infant transmission is clinically accepted based on small case reports of infection in a neonate at 30 hours of life and in infants of mothers with suspected or confirmed COVID-19.6,7 Accordingly, it is recommended that the benefit of early infant separation should be discussed with the mother. If approved, the infant should be kept in a separate isolation area and observed.
There is no evidence of breast milk transmission of the virus. For those electing to breastfeed, the patient should be provided with a breast pump to express and store the milk for subsequent bottle feeding. For mothers who elect to room in with the infant, a separation distance of 6 feet is recommended with an intervening barrier curtain. For COVID-19–positive mothers who elect breastfeeding, meticulous hand and face washing, continuous wearing of a mask, and cleansing of the breast prior to feeding needs to be maintained.
Restrictive visiting policies of no more than one visitor should be maintained. For severely or critically ill patients with COVID-19, it has been suggested that no visitors be allowed. As with other hospitalizations of COVID-19 patients, the HCW contact should be kept at a justifiable minimum to reduce the risk of transmission.
Protecting the obstetrician and other HCWs
Protecting the health of obstetricians and other HCWs is central to any successful strategy to fight the COVID-19 epidemic. For the individual obstetrician, careful attention to national and local hospital guidelines is required as these are rapidly evolving.
Physicians and their leadership must maintain an ongoing dialogue with hospital leadership to continually upgrade and optimize infection prevention and control measures, and to uphold best practices. The experience in Wuhan, China, illustrates the effectiveness of the proper use of PPE along with population control measures to reduce infections in HCWs. Prior to understanding the mechanism of virus transmission and using protective equipment, infection rates of 3%-29% were reported among HCWs. With the meticulous utilization of mitigation strategies and population control measures – including consistent use of PPE – the rate of infection of HCWs reportedly fell to zero.
In outpatient offices, all staff and HCWs should wear masks at all times and engage in social distancing and in frequent hand sanitization. Patients should be strongly encouraged to wear masks during office visits and on all other occasions when they will be in physical proximity to other individuals outside of the home.
Reports from epidemic areas describe transmission from household sources as a significant cause of HCW infection. The information emphasizes the need for ongoing vigilance and attention to sanitization measures even when at home with one’s family. An additional benefit is reduced risk of transmission from HCWs to family members.
Dr. Bahado-Singh is professor and chair of obstetrics and gynecology at Oakland University, Rochester, Mich., and health system chair for obstetrics and gynecology at Beaumont Health System.
References
1. Luo S et al. Clin Gastroenterol Hepatol. 2020 Mar 20. doi: 10.1016/j.cgh.2020.03.043.
2. Lechien JR et al. Eur Arch Otorhinolaryngol. 2020 Apr 6. doi: 10.1007/s00405-020-05965-1.
3. Breslin N et al. Am J Obstet Gynecol MFM. 2020 Apr 9. doi: 10.1016/j.ajogmf.2020.100118.
4. Zaigham M, Andersson O. Acta Obstet Gynecol Scand. 2020 Apr 7. doi: 10.1111/aogs.13867.
5. Di Mascio D et al. Am J Obstet Gynecol MFM. 2020 Mar 25. doi: 10.1016/j.ajogmf.2020.100107.
6. Ital J. Pediatr 2020;46(1) doi: 10.1186/s13052-020-0820-x.
7. Int J Gynaecol Obstet. 2020;149(2):130-6.
*This article was updated 5/6/2020.
The meteoric rise in the number of test-positive and clinical cases of COVID-19 because of infection with the SARS coronavirus (SARS-CoV-2) in states and cities across the United States has added urgency to the efforts to develop protocols for hospital triage, admission, labor and delivery management, and other aspects of obstetrical care.
Emerging data suggest that, while SARS-CoV-2 is less lethal overall than the severe acute respiratory syndrome coronavirus (SARS-CoV) and Middle East respiratory syndrome coronavirus (MERS-CoV) proved to be, it is significantly more contagious. Although a severe disease, the limited worldwide data so far available (as of early May) do not indicate that pregnant women are at greater risk of severe disease, compared with the general population. However, there remains a critical need for data on maternal and perinatal outcomes in women infected with SARS-CoV-2.
Multiple physiological changes in pregnancy, from reduced cell-based immune competence to changes in respiratory tract and pulmonary function – e.g., edema of the respiratory tract, increases in secretions and oxygen consumption, elevation of the diaphragm, and decrease in functional residual capacity – have historically contributed to worse obstetric outcomes in pregnant women who have had viral pneumonias. Furthermore, limited published experience with COVID-19 in China suggests worse perinatal outcomes in some affected pregnancies, including prematurity and perinatal death.
With evolution of the pandemic and accumulation of experience, it is expected that data-driven guidelines on assessment and management of infected pregnant women will contribute to improved maternal and perinatal outcomes. What is clear now, however, is that,
Here are my recommendations, based on a currently limited body of literature on COVID-19 and other communicable viral respiratory disorders, as well my experience in the greater Detroit area, a COVID-19 hot spot.
Preparing for hospital evaluation and admission
The obstetric triage or labor and delivery (L&D) unit should be notified prior to the arrival of a patient suspected of or known to be infected with the virus. This will minimize staff exposure and allow sufficient time to prepare appropriate accommodations, equipment, and supplies for the patient’s care. Hospital infection control should be promptly notified by L&D of the expected arrival of such a patient. Placement ideally should be in a negative-pressure room, which allows outside air to flow into the room but prevents contaminated air from escaping. In the absence of a negative-pressure room, an infection isolation area should be utilized.
The patient and one accompanying support individual should wear either medical-grade masks brought from home or supplied upon entry to the hospital or homemade masks or bandanas. This will reduce the risk of viral transmission to hospital workers and other individuals encountered in the hospital prior to arriving in L&D. An ideal setup is to have separate entry areas, access corridors, and elevators for patients known or suspected to have COVID-19 infection. The patient and visitor should be expeditiously escorted to the prepared area for evaluation. Patients who are not known or suspected to be infected ideally should be tested.
Screening of patients & support individuals
Proper screening of patients and support individuals is critical to protecting both patients and staff in the L&D unit. This should include an expanded questionnaire that asks about disturbances of smell and taste and GI symptoms like loss of appetite – not only the more commonly queried symptoms of fever, shortness of breath, coughing, and exposure to someone who may have been ill.
Recent studies regarding presenting symptoms cast significant doubt, in fact, on the validity of patients with “asymptomatic COVID-19.” Over 15% of patients with confirmed infection in one published case series had solely GI symptoms and almost all had some digestive symptoms, for example, and almost 90% in another study had absent or reduced sense of smell and/or taste.1,2 In fact, the use of the term “paucisymptomatic” rather than “asymptomatic” may be most appropriate.
Support individuals also should undergo temperature screening, ideally with laser noncontact thermometers on entry to the hospital or triage.
Visitor policy
The number of visitors/support individuals should be kept to a minimum to reduce transmission risk. The actual number will be determined by hospital or state policy, but up to one visitor in the labor room appears reasonable. Very strong individual justification should be required to exceed this threshold! The visitor should not only be screened for an expanded list of symptoms, but they also should be queried for underlying illnesses (e.g., diabetes, cardiovascular disease, significant lung disease, undergoing cancer therapy) as well as for age over 65 years, each of which increase the chances of severe COVID-19 disease should infection occur. The visitor should be informed of such risks and, especially when accompanying a patient with known or suspected COVID-19, provided the option of voluntarily revoking their visitor status. A visitor with known or suspected COVID-19 infection based on testing or screening should not be allowed into the L&D unit.
In addition, institutions may be considered to have obligations to the visitor/support person beyond screening. These include instructions in proper mask usage, hand washing, and limiting the touching of surfaces to lower infection risk.
“Visitor relays” where one visitor replaces another should be strongly discouraged. Visitors should similarly not be allowed to wander around the hospital (to use phones, for instance); transiting back and forth to obtain food and coffee should be kept to a strict minimum. For visitors accompanying COVID-19–-infected women, “visitor’s plates” provided by the hospital at reasonable cost is a much-preferred arrangement for obtaining meals during the course of the hospital stay. In addition, visitors should be sent out of the room during the performance of aerosolizing procedures.
Labor and delivery management
The successful management of patients with COVID-19 requires a rigorous infection control protocol informed by guidelines from national entities, such as the Centers for Disease Control and Prevention, the Society for Maternal-Fetal Medicine, and the American College of Obstetricians and Gynecologists, and by state health departments when available.
Strict limits on the number of obstetricians and other health care workers (HCWs) entering the patient’s room should be enforced and documented to minimize risk to the HCWs attending to patients who have a positive diagnosis or who are under investigation. Only in cases of demonstrable clinical benefit should repeat visits by the same or additional HCWs be permitted. Conventional and electronic tablets present an excellent opportunity for patient follow-up visits without room entry. In our institution, this has been successfully piloted in nonpregnant patients. Obstetricians and others caring for obstetrical patients – especially those who are infected or under investigation for infection – should always wear a properly fitted N95 mask.
Because patients with COVID-19 may have or go on to develop a constellation of organ abnormalities (e.g., cardiovascular, renal, pulmonary), it is vital that a standardized panel of baseline laboratory studies be developed for pregnant patients. This will minimize the need for repeated blood draws and other testing which may increase HCW exposure.
A negative screen based on nonreport of symptoms, lack of temperature elevation, and reported nonexposure to individuals with COVID-19 symptoms still has limitations in terms of disease detection. A recent report from a tertiary care hospital in New York City found that close to one-third of pregnant patients with confirmed COVID-19 admitted over a 2-week period had no viral symptoms or instructive history on initial admission.3 This is consistent with our clinical experience. Most importantly, therefore, routine quantitative reverse transcription polymerase chain reaction testing should be performed on all patients admitted to the L&D unit.
Given the reported variability in the accuracy of polymerase chain reaction testing induced by variable effectiveness of sampling techniques, stage of infection, and inherent test accuracy issues, symptomatic patients with a negative test should first obtain clearance from infectious disease specialists before isolation precautions are discontinued. Repeat testing in 24 hours, including testing of multiple sites, may subsequently yield a positive result in persistently symptomatic patients.
Intrapartum management
As much as possible, standard obstetric indications should guide the timing and route of delivery. In the case of a COVID-19–positive patient or a patient under investigation, nonobstetric factors may bear heavily on decision making, and management flexibility is of great value. For example, in cases of severe or critical disease status, evidence suggests that early delivery regardless of gestational age can improve maternal oxygenation; this supports the liberal use of C-sections in these circumstances. In addition, shortening labor length as well as duration of hospitalization may be expected to reduce the risk of transmission to HCWs, other staff, and other patients.
High rates of cesarean delivery unsurprisingly have been reported thus far: One review of 108 case reports and series of test-positive COVID-19 pregnancies found a 92% C-section rate, and another review and meta-analysis of studies of SARS, MERS, and COVID-19 during pregnancy similarly found that the majority of patients – 84% across all coronavirus infections and 91% in COVID-19 pregnancies – were delivered by C-section.4,5 Given these high rates of cesarean deliveries, the early placement of neuraxial anesthesia while the patient is stable appears to be prudent and obviates the need for intubation, the latter of which is associated with increased aerosol generation and increased virus transmission risk.
Strict protocols for the optimal protection of staff should be observed, including proper personal protective equipment (PPE) protection. Protocols have been detailed in various guidelines and publications; they include the wearing of shoe covers, gowns, N95 masks, goggles, face shields, and two layers of gloves.
For institutions that currently do not offer routine COVID-19 testing to pregnant patients – especially those in areas of outbreaks – N95 masks and eye protection should still be provided to all HCWs involved in the intrapartum management of untested asymptomatic patients, particularly those in the active phase of labor. This protection is justified given the limitations of symptom- and history-based screening and the not-uncommon experience of the patient with a negative screen who subsequently develops the clinical syndrome.
Obstetric management of labor requires close patient contact that potentially elevates the risk of contamination and infection. During the active stage of labor, patient shouting, rapid mouth breathing, and other behaviors inherent to labor all increase the risk of aerosolization of oronasal secretions. In addition, nasal-prong oxygen administration is believed to independently increase the risk of aerosolization of secretions. The casual practice of nasal oxygen application should thus be discontinued and, where felt to be absolutely necessary, a mask should be worn on top of the prongs.
Regarding operative delivery, each participating obstetric surgeon should observe guidelines and recommendations of governing national organizations and professional groups – including the American College of Surgeons – regarding the safe conduct of operations on patients with COVID-19. Written guidelines should be tailored as needed to the performance of C-sections and readily available in L&D. Drills and simulations are generally valuable, and expertise and support should always be available in the labor room to assist with donning and doffing of PPE.
Postpartum care
Expeditious separation of the COVID-19–positive mother from her infant is recommended, including avoidance of delayed cord clamping because of insufficient evidence of benefit to the infant. Insufficient evidence exists to support vertical transmission, but the possibility of maternal-infant transmission is clinically accepted based on small case reports of infection in a neonate at 30 hours of life and in infants of mothers with suspected or confirmed COVID-19.6,7 Accordingly, it is recommended that the benefit of early infant separation should be discussed with the mother. If approved, the infant should be kept in a separate isolation area and observed.
There is no evidence of breast milk transmission of the virus. For those electing to breastfeed, the patient should be provided with a breast pump to express and store the milk for subsequent bottle feeding. For mothers who elect to room in with the infant, a separation distance of 6 feet is recommended with an intervening barrier curtain. For COVID-19–positive mothers who elect breastfeeding, meticulous hand and face washing, continuous wearing of a mask, and cleansing of the breast prior to feeding needs to be maintained.
Restrictive visiting policies of no more than one visitor should be maintained. For severely or critically ill patients with COVID-19, it has been suggested that no visitors be allowed. As with other hospitalizations of COVID-19 patients, the HCW contact should be kept at a justifiable minimum to reduce the risk of transmission.
Protecting the obstetrician and other HCWs
Protecting the health of obstetricians and other HCWs is central to any successful strategy to fight the COVID-19 epidemic. For the individual obstetrician, careful attention to national and local hospital guidelines is required as these are rapidly evolving.
Physicians and their leadership must maintain an ongoing dialogue with hospital leadership to continually upgrade and optimize infection prevention and control measures, and to uphold best practices. The experience in Wuhan, China, illustrates the effectiveness of the proper use of PPE along with population control measures to reduce infections in HCWs. Prior to understanding the mechanism of virus transmission and using protective equipment, infection rates of 3%-29% were reported among HCWs. With the meticulous utilization of mitigation strategies and population control measures – including consistent use of PPE – the rate of infection of HCWs reportedly fell to zero.
In outpatient offices, all staff and HCWs should wear masks at all times and engage in social distancing and in frequent hand sanitization. Patients should be strongly encouraged to wear masks during office visits and on all other occasions when they will be in physical proximity to other individuals outside of the home.
Reports from epidemic areas describe transmission from household sources as a significant cause of HCW infection. The information emphasizes the need for ongoing vigilance and attention to sanitization measures even when at home with one’s family. An additional benefit is reduced risk of transmission from HCWs to family members.
Dr. Bahado-Singh is professor and chair of obstetrics and gynecology at Oakland University, Rochester, Mich., and health system chair for obstetrics and gynecology at Beaumont Health System.
References
1. Luo S et al. Clin Gastroenterol Hepatol. 2020 Mar 20. doi: 10.1016/j.cgh.2020.03.043.
2. Lechien JR et al. Eur Arch Otorhinolaryngol. 2020 Apr 6. doi: 10.1007/s00405-020-05965-1.
3. Breslin N et al. Am J Obstet Gynecol MFM. 2020 Apr 9. doi: 10.1016/j.ajogmf.2020.100118.
4. Zaigham M, Andersson O. Acta Obstet Gynecol Scand. 2020 Apr 7. doi: 10.1111/aogs.13867.
5. Di Mascio D et al. Am J Obstet Gynecol MFM. 2020 Mar 25. doi: 10.1016/j.ajogmf.2020.100107.
6. Ital J. Pediatr 2020;46(1) doi: 10.1186/s13052-020-0820-x.
7. Int J Gynaecol Obstet. 2020;149(2):130-6.
*This article was updated 5/6/2020.
Obstetrics during the COVID-19 pandemic
The identification of the SARS coronavirus (SARS-CoV-2) and emergence of the associated infectious respiratory disease, COVID-19, in late 2019 catapulted the citizens of the world, especially those in the health care professions, into an era of considerable uncertainty. At this moment in human history, calm reassurance – founded in fact and evidence – seems its greatest need. Much of the focus within the biomedical community has been on containment, prevention, and treatment of this highly contagious and, for some, extremely virulent disease.
However, for ob.gyns on the front lines of the COVID-19 fight, there is the additional challenge of caring for at least two patients simultaneously: the mother and her unborn baby. Studies in mother-baby dyads, while being published at an incredible pace, are still quite scarce. In addition, published reports are limited by the small sample size of the patient population (many are single-case reports), lack of uniformity in the timing and types of clinical samples collected, testing delays, and varying isolation protocols in cases where the mother has confirmed SARS-CoV-2.
Five months into a pandemic that has swept the world, we still know very little about COVID-19 infection in the general population, let alone the obstetric one. We do not know if having and resolving COVID-19 infection provides any long-term protection against future disease. We do not know if vertical transmission of SARS-CoV-2 occurs. We do not know if maternal infection confers any immunologic benefit to the neonate. The list goes on.
What we do know is that taking extra precautions works. Use of personal protective equipment saves health care practitioner and patient lives. Prohibiting or restricting visitors to only one person in hospitals reduces risk of transmission to vulnerable patients.
Additionally, we know that leading with compassion is vital to easing patient – and practitioner – anxiety and stress. Most importantly, we know that people are extraordinarily resilient, especially when it comes to safeguarding the health of their families.
To address some of the major concerns that many ob.gyns. have regarding their risk of coronavirus exposure when caring for patients, we have invited Ray Bahado-Singh, MD, professor and chair of obstetrics and gynecology at Oakland University, Rochester, Mich., and health system chair for obstetrics and gynecology at Beaumont Health System, who works in a suburb of Detroit, one of our nation’s COVID-19 hot spots.
Dr. Reece, who specializes in maternal-fetal medicine, is executive vice president for medical affairs at the University of Maryland School of Medicine as well as the John Z. and Akiko K. Bowers Distinguished Professor and dean of the school of medicine. He is the medical editor of this column. He said he had no relevant financial disclosures. Contact him at [email protected].
The identification of the SARS coronavirus (SARS-CoV-2) and emergence of the associated infectious respiratory disease, COVID-19, in late 2019 catapulted the citizens of the world, especially those in the health care professions, into an era of considerable uncertainty. At this moment in human history, calm reassurance – founded in fact and evidence – seems its greatest need. Much of the focus within the biomedical community has been on containment, prevention, and treatment of this highly contagious and, for some, extremely virulent disease.
However, for ob.gyns on the front lines of the COVID-19 fight, there is the additional challenge of caring for at least two patients simultaneously: the mother and her unborn baby. Studies in mother-baby dyads, while being published at an incredible pace, are still quite scarce. In addition, published reports are limited by the small sample size of the patient population (many are single-case reports), lack of uniformity in the timing and types of clinical samples collected, testing delays, and varying isolation protocols in cases where the mother has confirmed SARS-CoV-2.
Five months into a pandemic that has swept the world, we still know very little about COVID-19 infection in the general population, let alone the obstetric one. We do not know if having and resolving COVID-19 infection provides any long-term protection against future disease. We do not know if vertical transmission of SARS-CoV-2 occurs. We do not know if maternal infection confers any immunologic benefit to the neonate. The list goes on.
What we do know is that taking extra precautions works. Use of personal protective equipment saves health care practitioner and patient lives. Prohibiting or restricting visitors to only one person in hospitals reduces risk of transmission to vulnerable patients.
Additionally, we know that leading with compassion is vital to easing patient – and practitioner – anxiety and stress. Most importantly, we know that people are extraordinarily resilient, especially when it comes to safeguarding the health of their families.
To address some of the major concerns that many ob.gyns. have regarding their risk of coronavirus exposure when caring for patients, we have invited Ray Bahado-Singh, MD, professor and chair of obstetrics and gynecology at Oakland University, Rochester, Mich., and health system chair for obstetrics and gynecology at Beaumont Health System, who works in a suburb of Detroit, one of our nation’s COVID-19 hot spots.
Dr. Reece, who specializes in maternal-fetal medicine, is executive vice president for medical affairs at the University of Maryland School of Medicine as well as the John Z. and Akiko K. Bowers Distinguished Professor and dean of the school of medicine. He is the medical editor of this column. He said he had no relevant financial disclosures. Contact him at [email protected].
The identification of the SARS coronavirus (SARS-CoV-2) and emergence of the associated infectious respiratory disease, COVID-19, in late 2019 catapulted the citizens of the world, especially those in the health care professions, into an era of considerable uncertainty. At this moment in human history, calm reassurance – founded in fact and evidence – seems its greatest need. Much of the focus within the biomedical community has been on containment, prevention, and treatment of this highly contagious and, for some, extremely virulent disease.
However, for ob.gyns on the front lines of the COVID-19 fight, there is the additional challenge of caring for at least two patients simultaneously: the mother and her unborn baby. Studies in mother-baby dyads, while being published at an incredible pace, are still quite scarce. In addition, published reports are limited by the small sample size of the patient population (many are single-case reports), lack of uniformity in the timing and types of clinical samples collected, testing delays, and varying isolation protocols in cases where the mother has confirmed SARS-CoV-2.
Five months into a pandemic that has swept the world, we still know very little about COVID-19 infection in the general population, let alone the obstetric one. We do not know if having and resolving COVID-19 infection provides any long-term protection against future disease. We do not know if vertical transmission of SARS-CoV-2 occurs. We do not know if maternal infection confers any immunologic benefit to the neonate. The list goes on.
What we do know is that taking extra precautions works. Use of personal protective equipment saves health care practitioner and patient lives. Prohibiting or restricting visitors to only one person in hospitals reduces risk of transmission to vulnerable patients.
Additionally, we know that leading with compassion is vital to easing patient – and practitioner – anxiety and stress. Most importantly, we know that people are extraordinarily resilient, especially when it comes to safeguarding the health of their families.
To address some of the major concerns that many ob.gyns. have regarding their risk of coronavirus exposure when caring for patients, we have invited Ray Bahado-Singh, MD, professor and chair of obstetrics and gynecology at Oakland University, Rochester, Mich., and health system chair for obstetrics and gynecology at Beaumont Health System, who works in a suburb of Detroit, one of our nation’s COVID-19 hot spots.
Dr. Reece, who specializes in maternal-fetal medicine, is executive vice president for medical affairs at the University of Maryland School of Medicine as well as the John Z. and Akiko K. Bowers Distinguished Professor and dean of the school of medicine. He is the medical editor of this column. He said he had no relevant financial disclosures. Contact him at [email protected].
AAP releases updated guidance on male teen sexual, reproductive health
The American Academy of Pediatrics’ Committee on Adolescence has updated its guidance on addressing sexual reproductive health in male adolescents.
Since the last guidance was published by AAP in 2011, new data have been released that focus on adolescent male sexual behavior, their use of media, sexually transmitted infections (STIs), vaccination for human papillomavirus (HPV), discussions surrounding consent, and information for LGBT individuals.
“Of all these recommendations, the most significant changes are to provide more STI screening for higher risk males and vaccinate all males for HPV starting as early as age 9 years old,” lead author Laura K. Grubb, MD, director of adolescent medicine at Floating Hospital for Children at Tufts Medical Center, Boston, said in an interview.
AAP recommends pediatricians consider the following when discussing sexuality and reproductive health with adolescent males:
- Discuss the topics of sex and sexuality during routine visits and appropriate opportunities, taking the time to screen for sexual activity and identifying who is at higher risk.
- Ask male adolescent patients about social media use, how often they view pornography, and how they perceive sexually explicit material. If there is a concern that sexually explicit content is having an adverse effect on the patient, pediatricians should counsel patients and their parents on how to safely and sensibly use the Internet and social media.
- Screen for nonconsensual sexual activity during well visits and other visits, as appropriate. The principles of consent and nonconsent in the context of sexual activity should be discussed.
- For patients who are sexually active, screen for sexual problems, including any mental health issues and sexual dysfunction, and initiate counseling or pharmacotherapy where warranted.
- Coach male adolescent patients on broaching discussions about sex and family planning with their partners, including joint decision making on sexual and reproductive health. Contraception and barrier methods should be discussed and encouraged as appropriate.
- Assess each patient for appropriate STI risk, testing, and treatment/prevention for HIV, syphilis, chlamydia, and gonorrhea.
- Consider HPV vaccination for children at least 9 years old and start administration starting at 11 years old. according to the guidance.
Dr. Grubb said she hopes this guidance helps start a conversation between pediatricians and their adolescent male patients. “Talk with your male adolescents about puberty, sexuality, and reproductive health! When pediatricians are informed about these issues and take the initiative to discuss these topics with adolescent males, they are uniquely situated to help them navigate this challenging time safely and confidently.”
“I am especially excited about the significant resources this report provides for pediatricians in the supplemental document,” Dr. Grubb added. “There are so many great resources out there, especially on the Internet, for adolescents, parents, and pediatricians.”
Kelly Curran, MD, adolescent medicine specialist and assistant professor of pediatrics at the University of Oklahoma Health Sciences Center, said in an interview that the guidance information on sexting, “sextortion,” and sexual dysfunction are important updates for pediatricians. Sextortion is defined as the “threatened dissemination of explicit, intimate, or embarrassing images of a sexual nature without consent, usually for the purpose of procuring additional images, sexual acts, money, or something else.”
“We have all seen how social media and technology has transformed adolescence, especially with the rise of sexting. We must remember that males are often the victims of ‘sextortion’ and sexual assault, especially sexual minority youth, and men may not have the support and services to which female victims have access,” said Dr. Curran, who was not a member of the committee.
Another important area where pediatricians can help educate adolescent males and their parents is the concept of consent during sexual encounters.
“As we as a society are having more frank discussions around sexual assault and rape, I think it is essential there is a continued dialogue with young people about consent. Pediatricians have an important role to play in the discussion with their patients, especially in regard to paying attention to verbal and nonverbal cues, and recognizing that consent is an ongoing process, instead of a ‘one time thing,’ ” said Dr. Curran, who is a member of the Pediatric News editorial advisory board.
One area of the new AAP guidance that surprised Dr. Curran was the number of adolescent males reporting sexual dysfunction – 4%. “While it’s something I ask about periodically in young men, I haven’t been consistently asking in visits for those who are at risk,” she said. “This guideline reminds me to screen more frequently, especially as patients may be too embarrassed to ask.”
Concerning STI screening, Dr. Curran feels guidelines from the Centers for Disease Control and Prevention and the United States Preventive Services Task Force (USPSTF) don’t go far enough, and the AAP’s guidance to provide routine STI risk assessment for all patients is more appropriate.
“We know that STIs are on the rise and adolescents experience high rates of STI, yet there are only routine screening guidelines for adolescent and young adult women and ‘at-risk’ populations or in areas of higher prevalence,” she said. “In my experience, all sexually active adolescents are ‘at risk.’ I think there should be universal screening of all sexually active adolescents and young adults.”
The paper had no funding source, and the authors reported no relevant conflicts of interest. Dr. Curran also reported no relevant conflicts of interest.
SOURCE: Grubb L et al. Pediatrics. 2020 Apr 27;145(5):e20200627.
The American Academy of Pediatrics’ Committee on Adolescence has updated its guidance on addressing sexual reproductive health in male adolescents.
Since the last guidance was published by AAP in 2011, new data have been released that focus on adolescent male sexual behavior, their use of media, sexually transmitted infections (STIs), vaccination for human papillomavirus (HPV), discussions surrounding consent, and information for LGBT individuals.
“Of all these recommendations, the most significant changes are to provide more STI screening for higher risk males and vaccinate all males for HPV starting as early as age 9 years old,” lead author Laura K. Grubb, MD, director of adolescent medicine at Floating Hospital for Children at Tufts Medical Center, Boston, said in an interview.
AAP recommends pediatricians consider the following when discussing sexuality and reproductive health with adolescent males:
- Discuss the topics of sex and sexuality during routine visits and appropriate opportunities, taking the time to screen for sexual activity and identifying who is at higher risk.
- Ask male adolescent patients about social media use, how often they view pornography, and how they perceive sexually explicit material. If there is a concern that sexually explicit content is having an adverse effect on the patient, pediatricians should counsel patients and their parents on how to safely and sensibly use the Internet and social media.
- Screen for nonconsensual sexual activity during well visits and other visits, as appropriate. The principles of consent and nonconsent in the context of sexual activity should be discussed.
- For patients who are sexually active, screen for sexual problems, including any mental health issues and sexual dysfunction, and initiate counseling or pharmacotherapy where warranted.
- Coach male adolescent patients on broaching discussions about sex and family planning with their partners, including joint decision making on sexual and reproductive health. Contraception and barrier methods should be discussed and encouraged as appropriate.
- Assess each patient for appropriate STI risk, testing, and treatment/prevention for HIV, syphilis, chlamydia, and gonorrhea.
- Consider HPV vaccination for children at least 9 years old and start administration starting at 11 years old. according to the guidance.
Dr. Grubb said she hopes this guidance helps start a conversation between pediatricians and their adolescent male patients. “Talk with your male adolescents about puberty, sexuality, and reproductive health! When pediatricians are informed about these issues and take the initiative to discuss these topics with adolescent males, they are uniquely situated to help them navigate this challenging time safely and confidently.”
“I am especially excited about the significant resources this report provides for pediatricians in the supplemental document,” Dr. Grubb added. “There are so many great resources out there, especially on the Internet, for adolescents, parents, and pediatricians.”
Kelly Curran, MD, adolescent medicine specialist and assistant professor of pediatrics at the University of Oklahoma Health Sciences Center, said in an interview that the guidance information on sexting, “sextortion,” and sexual dysfunction are important updates for pediatricians. Sextortion is defined as the “threatened dissemination of explicit, intimate, or embarrassing images of a sexual nature without consent, usually for the purpose of procuring additional images, sexual acts, money, or something else.”
“We have all seen how social media and technology has transformed adolescence, especially with the rise of sexting. We must remember that males are often the victims of ‘sextortion’ and sexual assault, especially sexual minority youth, and men may not have the support and services to which female victims have access,” said Dr. Curran, who was not a member of the committee.
Another important area where pediatricians can help educate adolescent males and their parents is the concept of consent during sexual encounters.
“As we as a society are having more frank discussions around sexual assault and rape, I think it is essential there is a continued dialogue with young people about consent. Pediatricians have an important role to play in the discussion with their patients, especially in regard to paying attention to verbal and nonverbal cues, and recognizing that consent is an ongoing process, instead of a ‘one time thing,’ ” said Dr. Curran, who is a member of the Pediatric News editorial advisory board.
One area of the new AAP guidance that surprised Dr. Curran was the number of adolescent males reporting sexual dysfunction – 4%. “While it’s something I ask about periodically in young men, I haven’t been consistently asking in visits for those who are at risk,” she said. “This guideline reminds me to screen more frequently, especially as patients may be too embarrassed to ask.”
Concerning STI screening, Dr. Curran feels guidelines from the Centers for Disease Control and Prevention and the United States Preventive Services Task Force (USPSTF) don’t go far enough, and the AAP’s guidance to provide routine STI risk assessment for all patients is more appropriate.
“We know that STIs are on the rise and adolescents experience high rates of STI, yet there are only routine screening guidelines for adolescent and young adult women and ‘at-risk’ populations or in areas of higher prevalence,” she said. “In my experience, all sexually active adolescents are ‘at risk.’ I think there should be universal screening of all sexually active adolescents and young adults.”
The paper had no funding source, and the authors reported no relevant conflicts of interest. Dr. Curran also reported no relevant conflicts of interest.
SOURCE: Grubb L et al. Pediatrics. 2020 Apr 27;145(5):e20200627.
The American Academy of Pediatrics’ Committee on Adolescence has updated its guidance on addressing sexual reproductive health in male adolescents.
Since the last guidance was published by AAP in 2011, new data have been released that focus on adolescent male sexual behavior, their use of media, sexually transmitted infections (STIs), vaccination for human papillomavirus (HPV), discussions surrounding consent, and information for LGBT individuals.
“Of all these recommendations, the most significant changes are to provide more STI screening for higher risk males and vaccinate all males for HPV starting as early as age 9 years old,” lead author Laura K. Grubb, MD, director of adolescent medicine at Floating Hospital for Children at Tufts Medical Center, Boston, said in an interview.
AAP recommends pediatricians consider the following when discussing sexuality and reproductive health with adolescent males:
- Discuss the topics of sex and sexuality during routine visits and appropriate opportunities, taking the time to screen for sexual activity and identifying who is at higher risk.
- Ask male adolescent patients about social media use, how often they view pornography, and how they perceive sexually explicit material. If there is a concern that sexually explicit content is having an adverse effect on the patient, pediatricians should counsel patients and their parents on how to safely and sensibly use the Internet and social media.
- Screen for nonconsensual sexual activity during well visits and other visits, as appropriate. The principles of consent and nonconsent in the context of sexual activity should be discussed.
- For patients who are sexually active, screen for sexual problems, including any mental health issues and sexual dysfunction, and initiate counseling or pharmacotherapy where warranted.
- Coach male adolescent patients on broaching discussions about sex and family planning with their partners, including joint decision making on sexual and reproductive health. Contraception and barrier methods should be discussed and encouraged as appropriate.
- Assess each patient for appropriate STI risk, testing, and treatment/prevention for HIV, syphilis, chlamydia, and gonorrhea.
- Consider HPV vaccination for children at least 9 years old and start administration starting at 11 years old. according to the guidance.
Dr. Grubb said she hopes this guidance helps start a conversation between pediatricians and their adolescent male patients. “Talk with your male adolescents about puberty, sexuality, and reproductive health! When pediatricians are informed about these issues and take the initiative to discuss these topics with adolescent males, they are uniquely situated to help them navigate this challenging time safely and confidently.”
“I am especially excited about the significant resources this report provides for pediatricians in the supplemental document,” Dr. Grubb added. “There are so many great resources out there, especially on the Internet, for adolescents, parents, and pediatricians.”
Kelly Curran, MD, adolescent medicine specialist and assistant professor of pediatrics at the University of Oklahoma Health Sciences Center, said in an interview that the guidance information on sexting, “sextortion,” and sexual dysfunction are important updates for pediatricians. Sextortion is defined as the “threatened dissemination of explicit, intimate, or embarrassing images of a sexual nature without consent, usually for the purpose of procuring additional images, sexual acts, money, or something else.”
“We have all seen how social media and technology has transformed adolescence, especially with the rise of sexting. We must remember that males are often the victims of ‘sextortion’ and sexual assault, especially sexual minority youth, and men may not have the support and services to which female victims have access,” said Dr. Curran, who was not a member of the committee.
Another important area where pediatricians can help educate adolescent males and their parents is the concept of consent during sexual encounters.
“As we as a society are having more frank discussions around sexual assault and rape, I think it is essential there is a continued dialogue with young people about consent. Pediatricians have an important role to play in the discussion with their patients, especially in regard to paying attention to verbal and nonverbal cues, and recognizing that consent is an ongoing process, instead of a ‘one time thing,’ ” said Dr. Curran, who is a member of the Pediatric News editorial advisory board.
One area of the new AAP guidance that surprised Dr. Curran was the number of adolescent males reporting sexual dysfunction – 4%. “While it’s something I ask about periodically in young men, I haven’t been consistently asking in visits for those who are at risk,” she said. “This guideline reminds me to screen more frequently, especially as patients may be too embarrassed to ask.”
Concerning STI screening, Dr. Curran feels guidelines from the Centers for Disease Control and Prevention and the United States Preventive Services Task Force (USPSTF) don’t go far enough, and the AAP’s guidance to provide routine STI risk assessment for all patients is more appropriate.
“We know that STIs are on the rise and adolescents experience high rates of STI, yet there are only routine screening guidelines for adolescent and young adult women and ‘at-risk’ populations or in areas of higher prevalence,” she said. “In my experience, all sexually active adolescents are ‘at risk.’ I think there should be universal screening of all sexually active adolescents and young adults.”
The paper had no funding source, and the authors reported no relevant conflicts of interest. Dr. Curran also reported no relevant conflicts of interest.
SOURCE: Grubb L et al. Pediatrics. 2020 Apr 27;145(5):e20200627.
FROM PEDIATRICS
Menstrual cup use with copper IUDs linked to higher expulsion rates
Citing menstrual cup use for menstrual hygiene as “increasingly popular,” researchers led by Jill Long, MD, MPH, studied women participating in a prospective contraceptive efficacy trial of two copper IUDs to evaluate the relationship between menstrual cup use and IUD expulsion over a period of 24 months. The findings were released ahead of the study’s scheduled presentation at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists. ACOG canceled the meeting and released abstracts for press coverage.
In the ongoing 3-year trial, which also was published in Obstetrics & Gynecology, 1,092 women were randomized to one of two copper IUDs. Dr. Long, project officer for the Contraceptive Clinical Trials Network, a project of the Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, Md. and colleagues conducted follow-up visits at 6 weeks after insertion in the first year, and then 3, 6, and 12 months after insertion. At the 9-month mark, the study counseling was amended to advise patients against concurrent use of the menstrual cup because of a higher risk of IUD expulsions noted in women using the cup.
Among the 1,092 women studied, 266 (24%) reported menstrual cup use. At 24 months after initiating enrollment, 43 cup users (17%) and 43 nonusers (5%) experienced expulsion (odds ratio, 3.81). Fourteen menstrual cup users with expulsion (30%) reported that the event occurred during menstrual cup removal. Dr. Long and colleagues found that, at year 1 of the study, expulsion rates among menstrual cup users and nonusers were 14% and 5%, respectively (P < .001). At the end of year 2, these rates rose to 23% and 7% (P < .001). The study won second place among abstracts in the category of current clinical and basic investigation.
“This outstanding abstract reflects an important study with results that should lead to changes in the way providers counsel patients about IUDs, namely that the risk of IUD expulsion is significantly higher in women who use menstrual cups than in those who use other menstrual hygiene products,” Eve Espey, MD, MPH, who was not affiliated with the study, said in an interview.
According to Dr. Espey, who chairs the department of obstetrics and gynecology at the University of New Mexico, Albuquerque, key strengths of the study include its prospective methodology and the relatively large number of patients with concurrent IUD and menstrual cup use.
“A limitation is the nonrandomized design for the current study’s aim, which would require randomizing women using the IUD to menstrual cup use versus nonuse,” said Dr. Espey, who is a member of the Ob.Gyn News editorial advisory board.* “Another limitation is that only copper IUDs were used, but it is plausible that this result would apply to other IUDs as well. The study is innovative and important in being the first prospective study to evaluate the association between menstrual cup use and IUD expulsion.”
Dr. Long and two coauthors reported having no financial disclosures, but the remaining three authors reported having numerous potential conflicts of interest. Dr. Espey reported having no financial disclosures.
SOURCE: Long J et al. Obstet Gynecol. 2020 May;135.1S. doi: 10.1097/01.AOG.0000662872.89062.83.
*The article was updated on 4/28/2020.
Citing menstrual cup use for menstrual hygiene as “increasingly popular,” researchers led by Jill Long, MD, MPH, studied women participating in a prospective contraceptive efficacy trial of two copper IUDs to evaluate the relationship between menstrual cup use and IUD expulsion over a period of 24 months. The findings were released ahead of the study’s scheduled presentation at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists. ACOG canceled the meeting and released abstracts for press coverage.
In the ongoing 3-year trial, which also was published in Obstetrics & Gynecology, 1,092 women were randomized to one of two copper IUDs. Dr. Long, project officer for the Contraceptive Clinical Trials Network, a project of the Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, Md. and colleagues conducted follow-up visits at 6 weeks after insertion in the first year, and then 3, 6, and 12 months after insertion. At the 9-month mark, the study counseling was amended to advise patients against concurrent use of the menstrual cup because of a higher risk of IUD expulsions noted in women using the cup.
Among the 1,092 women studied, 266 (24%) reported menstrual cup use. At 24 months after initiating enrollment, 43 cup users (17%) and 43 nonusers (5%) experienced expulsion (odds ratio, 3.81). Fourteen menstrual cup users with expulsion (30%) reported that the event occurred during menstrual cup removal. Dr. Long and colleagues found that, at year 1 of the study, expulsion rates among menstrual cup users and nonusers were 14% and 5%, respectively (P < .001). At the end of year 2, these rates rose to 23% and 7% (P < .001). The study won second place among abstracts in the category of current clinical and basic investigation.
“This outstanding abstract reflects an important study with results that should lead to changes in the way providers counsel patients about IUDs, namely that the risk of IUD expulsion is significantly higher in women who use menstrual cups than in those who use other menstrual hygiene products,” Eve Espey, MD, MPH, who was not affiliated with the study, said in an interview.
According to Dr. Espey, who chairs the department of obstetrics and gynecology at the University of New Mexico, Albuquerque, key strengths of the study include its prospective methodology and the relatively large number of patients with concurrent IUD and menstrual cup use.
“A limitation is the nonrandomized design for the current study’s aim, which would require randomizing women using the IUD to menstrual cup use versus nonuse,” said Dr. Espey, who is a member of the Ob.Gyn News editorial advisory board.* “Another limitation is that only copper IUDs were used, but it is plausible that this result would apply to other IUDs as well. The study is innovative and important in being the first prospective study to evaluate the association between menstrual cup use and IUD expulsion.”
Dr. Long and two coauthors reported having no financial disclosures, but the remaining three authors reported having numerous potential conflicts of interest. Dr. Espey reported having no financial disclosures.
SOURCE: Long J et al. Obstet Gynecol. 2020 May;135.1S. doi: 10.1097/01.AOG.0000662872.89062.83.
*The article was updated on 4/28/2020.
Citing menstrual cup use for menstrual hygiene as “increasingly popular,” researchers led by Jill Long, MD, MPH, studied women participating in a prospective contraceptive efficacy trial of two copper IUDs to evaluate the relationship between menstrual cup use and IUD expulsion over a period of 24 months. The findings were released ahead of the study’s scheduled presentation at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists. ACOG canceled the meeting and released abstracts for press coverage.
In the ongoing 3-year trial, which also was published in Obstetrics & Gynecology, 1,092 women were randomized to one of two copper IUDs. Dr. Long, project officer for the Contraceptive Clinical Trials Network, a project of the Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, Md. and colleagues conducted follow-up visits at 6 weeks after insertion in the first year, and then 3, 6, and 12 months after insertion. At the 9-month mark, the study counseling was amended to advise patients against concurrent use of the menstrual cup because of a higher risk of IUD expulsions noted in women using the cup.
Among the 1,092 women studied, 266 (24%) reported menstrual cup use. At 24 months after initiating enrollment, 43 cup users (17%) and 43 nonusers (5%) experienced expulsion (odds ratio, 3.81). Fourteen menstrual cup users with expulsion (30%) reported that the event occurred during menstrual cup removal. Dr. Long and colleagues found that, at year 1 of the study, expulsion rates among menstrual cup users and nonusers were 14% and 5%, respectively (P < .001). At the end of year 2, these rates rose to 23% and 7% (P < .001). The study won second place among abstracts in the category of current clinical and basic investigation.
“This outstanding abstract reflects an important study with results that should lead to changes in the way providers counsel patients about IUDs, namely that the risk of IUD expulsion is significantly higher in women who use menstrual cups than in those who use other menstrual hygiene products,” Eve Espey, MD, MPH, who was not affiliated with the study, said in an interview.
According to Dr. Espey, who chairs the department of obstetrics and gynecology at the University of New Mexico, Albuquerque, key strengths of the study include its prospective methodology and the relatively large number of patients with concurrent IUD and menstrual cup use.
“A limitation is the nonrandomized design for the current study’s aim, which would require randomizing women using the IUD to menstrual cup use versus nonuse,” said Dr. Espey, who is a member of the Ob.Gyn News editorial advisory board.* “Another limitation is that only copper IUDs were used, but it is plausible that this result would apply to other IUDs as well. The study is innovative and important in being the first prospective study to evaluate the association between menstrual cup use and IUD expulsion.”
Dr. Long and two coauthors reported having no financial disclosures, but the remaining three authors reported having numerous potential conflicts of interest. Dr. Espey reported having no financial disclosures.
SOURCE: Long J et al. Obstet Gynecol. 2020 May;135.1S. doi: 10.1097/01.AOG.0000662872.89062.83.
*The article was updated on 4/28/2020.
FROM ACOG 2020
Making something ordinary out of the extraordinary
These are tough times for families, children, and practices. In this case, the entire world is going through it at the same time, leaving no escape. There are so many new things each of us needs to do, and for some of the challenges, we are completely thwarted by safety restrictions from doing anything. Adults and children alike are trying to work or learn at home in new ways. This also means that old daily routines have been broken. The sense of disorientation is pervasive. Although it is only one part of what is needed, reestablishing routines can go a long way toward restoring a sense of control and meaning that you can institute for yourself and recommend to your patients.
Examples of such change include natural disasters such as COVID-19, deaths, or separations from loved ones, but also moving, job loss, or new financial instability. Many families and many doctors and staff are experiencing several of these at once these days.
Evidence from studies of times of major disruption such as divorce, a death, war, and natural disasters show that parenting tends to shift to being less organized, with less overall discipline or more arbitrary punishment, and, in some cases, less parent-child connection. Children, on their part, also tend to act differently under these conditions. They are more irritable, upset, anxious, clingy, and aggressive, and also tend to regress in recent developmental achievements such as maintaining toileting and sleep patterns. Parents often do not see the connection to the stress and react to these behaviors in ways that may make things worse by scolding or punishing.
I was really surprised to hear Daniel Kahneman, PhD, Nobel laureate in economics, talk about how even he has trouble judging risk based on mathematical probability. Instead, he recognizes that adults decide about risk based on the behavior of the people around them – when others act worried or agitated, the person does too. Children, even more than adults, must decide if they are safe based on the behavior of the adults around them. When parents maintain routines as closely as possible after a major disruption, children feel reassured that they can expect continuity of their relationship – their most important lifeboat. If their parents keep doing the things they are used to, children basically feel safe.
Simple aspects of sameness important to children are very familiar to pediatricians: always wanting the same spoon, the sandwich cut the same way, only chicken nuggets from a certain store. This tends to be true in typically developing toddlers, preschool, and some school-aged children. The desire to have the same story read to them multiple times – until parents are ready to scream! – is another sign of the importance of predictable routines to children. All of these are best accommodated during times of stress rather than trying to “avoid making a bad habit.” All disruptions of routine are even more disorienting for children with intellectual disabilities or those on the autism spectrum who are generally less able to understand or control their world. Children and adults with preexisting anxiety disorders also are more likely to have more severe reactions to major disruptions and need extra understanding.
Routines for eating at least something at regular times – even if the food is not as interesting as prior fare – provide a sense of security, as well as stabilizing blood sugar and bowel patterns. Keeping patterns of washing hands, sitting together as a family, and interacting in conversation, rather than watching TV news, allow an oasis of respite from ongoing stresses. Family meals are also known to promote learning, vocabulary growth, and better behavior.
Setting a schedule for schooling, play, hygiene, and exercise may seem silly when parents and children are home all day, but it instills a sense of meaning to the day. Making a visual schedule for younger children or a written or online one for older children can be a shared activity in itself. I remember hearing about how important changing clothes and cleaning teeth were to prisoners of war during World War II in maintaining a sense of normalcy in that time of chaos.
Exercise is particularly important to set as a routine as it directly reduces stress – even if it may need to take new forms. While there are lots of online exercise programs for adults, it is better for everyone to go outside if they can manage adequate personal spacing. There they can experience the orderly changing of the seasons and the weather, as well as soak up some sunshine. Interactive parent-child play serves multiple purposes of stress relief, seeing each other more relaxed, interacting, and having fun!
Routines for sleep are especially important. To fall asleep under normal circumstances requires a sense of safety, perhaps for evolutionary reasons because of the vulnerability of the paralysis that is part of REM sleep stages. Fear at bedtime is common in young children, as is disorientation in the elderly. Both respond to reassuring bedtime routines done the same way every night, such as brushing teeth, changing clothes, washing up, reading or being read to, and praying – if these were the previous habit. When there has been a major disruption, these routines take on added importance, even if some modifications need to be made in sleep location, privacy, etc. Keeping schedules for naps, bedtime, and wake time as stable as possible makes sleep onset easier and sleep maintenance more likely. It also increases the chances of adequate sleep duration. Getting enough sleep stabilizes mood, reduces irritability, and improves daytime concentration and problem-solving skills. These all are especially needed by adults as well as children when there are major disruptions.
Maintaining chores at times of disruption can be extra difficult, plus this may seem to parents like an added stress for their already-stressed child. But in fact, children are reassured by adults’ continuing these requirements. Not only is an expectation that chores be done a signal that life can be expected to proceed normally, but having children do things to help – such as cleaning up, restocking soap and towels, or emptying trash – gives them an active role and hence some sense of control.
Discipline is, in essence, also a routine. Maintaining standards for kindness to others and following rules can be especially difficult when life has been disrupted because emotional lability is more likely in both adults and children when severely stressed. It is important for parents to consider the source of the misbehavior as possibly stress related and to interrupt it in a gentle and understanding way. A parent might say: “I know you are upset by all the changes. It is even more important now than ever to be kind to your brother.” Under stressful conditions, it is especially important to ask how the child was feeling when acting up, but also to “speak for them” about possible stress-related reasons for their behavior. While parents may correctly say that their child will “take advantage of this excuse,” it is still a teaching opportunity. Children have little insight into these connections to their feelings and actions, but they can learn.
Times when old patterns are disrupted also are times for making new habits. The main new habit I recommend for stress relief and overall mental health are the practices of mindfulness or meditation. Mindfulness may be easier to teach children as it involves paying close attention to one’s thoughts, feelings, and sensations, but doing this without judgment. Children often are naturally better at this than adults, who have layered on more experiences to their thoughts. We pediatricians, as well as the parents we serve, can benefit – especially in stressful times – from sharing in the simple ways children experience the world.
Dr. Howard is assistant professor of pediatrics at Johns Hopkins University, Baltimore, and creator of CHADIS (www.CHADIS.com). She had no other relevant disclosures. Dr. Howard’s contribution to this publication was as a paid expert to MDedge News. Email her at [email protected].
These are tough times for families, children, and practices. In this case, the entire world is going through it at the same time, leaving no escape. There are so many new things each of us needs to do, and for some of the challenges, we are completely thwarted by safety restrictions from doing anything. Adults and children alike are trying to work or learn at home in new ways. This also means that old daily routines have been broken. The sense of disorientation is pervasive. Although it is only one part of what is needed, reestablishing routines can go a long way toward restoring a sense of control and meaning that you can institute for yourself and recommend to your patients.
Examples of such change include natural disasters such as COVID-19, deaths, or separations from loved ones, but also moving, job loss, or new financial instability. Many families and many doctors and staff are experiencing several of these at once these days.
Evidence from studies of times of major disruption such as divorce, a death, war, and natural disasters show that parenting tends to shift to being less organized, with less overall discipline or more arbitrary punishment, and, in some cases, less parent-child connection. Children, on their part, also tend to act differently under these conditions. They are more irritable, upset, anxious, clingy, and aggressive, and also tend to regress in recent developmental achievements such as maintaining toileting and sleep patterns. Parents often do not see the connection to the stress and react to these behaviors in ways that may make things worse by scolding or punishing.
I was really surprised to hear Daniel Kahneman, PhD, Nobel laureate in economics, talk about how even he has trouble judging risk based on mathematical probability. Instead, he recognizes that adults decide about risk based on the behavior of the people around them – when others act worried or agitated, the person does too. Children, even more than adults, must decide if they are safe based on the behavior of the adults around them. When parents maintain routines as closely as possible after a major disruption, children feel reassured that they can expect continuity of their relationship – their most important lifeboat. If their parents keep doing the things they are used to, children basically feel safe.
Simple aspects of sameness important to children are very familiar to pediatricians: always wanting the same spoon, the sandwich cut the same way, only chicken nuggets from a certain store. This tends to be true in typically developing toddlers, preschool, and some school-aged children. The desire to have the same story read to them multiple times – until parents are ready to scream! – is another sign of the importance of predictable routines to children. All of these are best accommodated during times of stress rather than trying to “avoid making a bad habit.” All disruptions of routine are even more disorienting for children with intellectual disabilities or those on the autism spectrum who are generally less able to understand or control their world. Children and adults with preexisting anxiety disorders also are more likely to have more severe reactions to major disruptions and need extra understanding.
Routines for eating at least something at regular times – even if the food is not as interesting as prior fare – provide a sense of security, as well as stabilizing blood sugar and bowel patterns. Keeping patterns of washing hands, sitting together as a family, and interacting in conversation, rather than watching TV news, allow an oasis of respite from ongoing stresses. Family meals are also known to promote learning, vocabulary growth, and better behavior.
Setting a schedule for schooling, play, hygiene, and exercise may seem silly when parents and children are home all day, but it instills a sense of meaning to the day. Making a visual schedule for younger children or a written or online one for older children can be a shared activity in itself. I remember hearing about how important changing clothes and cleaning teeth were to prisoners of war during World War II in maintaining a sense of normalcy in that time of chaos.
Exercise is particularly important to set as a routine as it directly reduces stress – even if it may need to take new forms. While there are lots of online exercise programs for adults, it is better for everyone to go outside if they can manage adequate personal spacing. There they can experience the orderly changing of the seasons and the weather, as well as soak up some sunshine. Interactive parent-child play serves multiple purposes of stress relief, seeing each other more relaxed, interacting, and having fun!
Routines for sleep are especially important. To fall asleep under normal circumstances requires a sense of safety, perhaps for evolutionary reasons because of the vulnerability of the paralysis that is part of REM sleep stages. Fear at bedtime is common in young children, as is disorientation in the elderly. Both respond to reassuring bedtime routines done the same way every night, such as brushing teeth, changing clothes, washing up, reading or being read to, and praying – if these were the previous habit. When there has been a major disruption, these routines take on added importance, even if some modifications need to be made in sleep location, privacy, etc. Keeping schedules for naps, bedtime, and wake time as stable as possible makes sleep onset easier and sleep maintenance more likely. It also increases the chances of adequate sleep duration. Getting enough sleep stabilizes mood, reduces irritability, and improves daytime concentration and problem-solving skills. These all are especially needed by adults as well as children when there are major disruptions.
Maintaining chores at times of disruption can be extra difficult, plus this may seem to parents like an added stress for their already-stressed child. But in fact, children are reassured by adults’ continuing these requirements. Not only is an expectation that chores be done a signal that life can be expected to proceed normally, but having children do things to help – such as cleaning up, restocking soap and towels, or emptying trash – gives them an active role and hence some sense of control.
Discipline is, in essence, also a routine. Maintaining standards for kindness to others and following rules can be especially difficult when life has been disrupted because emotional lability is more likely in both adults and children when severely stressed. It is important for parents to consider the source of the misbehavior as possibly stress related and to interrupt it in a gentle and understanding way. A parent might say: “I know you are upset by all the changes. It is even more important now than ever to be kind to your brother.” Under stressful conditions, it is especially important to ask how the child was feeling when acting up, but also to “speak for them” about possible stress-related reasons for their behavior. While parents may correctly say that their child will “take advantage of this excuse,” it is still a teaching opportunity. Children have little insight into these connections to their feelings and actions, but they can learn.
Times when old patterns are disrupted also are times for making new habits. The main new habit I recommend for stress relief and overall mental health are the practices of mindfulness or meditation. Mindfulness may be easier to teach children as it involves paying close attention to one’s thoughts, feelings, and sensations, but doing this without judgment. Children often are naturally better at this than adults, who have layered on more experiences to their thoughts. We pediatricians, as well as the parents we serve, can benefit – especially in stressful times – from sharing in the simple ways children experience the world.
Dr. Howard is assistant professor of pediatrics at Johns Hopkins University, Baltimore, and creator of CHADIS (www.CHADIS.com). She had no other relevant disclosures. Dr. Howard’s contribution to this publication was as a paid expert to MDedge News. Email her at [email protected].
These are tough times for families, children, and practices. In this case, the entire world is going through it at the same time, leaving no escape. There are so many new things each of us needs to do, and for some of the challenges, we are completely thwarted by safety restrictions from doing anything. Adults and children alike are trying to work or learn at home in new ways. This also means that old daily routines have been broken. The sense of disorientation is pervasive. Although it is only one part of what is needed, reestablishing routines can go a long way toward restoring a sense of control and meaning that you can institute for yourself and recommend to your patients.
Examples of such change include natural disasters such as COVID-19, deaths, or separations from loved ones, but also moving, job loss, or new financial instability. Many families and many doctors and staff are experiencing several of these at once these days.
Evidence from studies of times of major disruption such as divorce, a death, war, and natural disasters show that parenting tends to shift to being less organized, with less overall discipline or more arbitrary punishment, and, in some cases, less parent-child connection. Children, on their part, also tend to act differently under these conditions. They are more irritable, upset, anxious, clingy, and aggressive, and also tend to regress in recent developmental achievements such as maintaining toileting and sleep patterns. Parents often do not see the connection to the stress and react to these behaviors in ways that may make things worse by scolding or punishing.
I was really surprised to hear Daniel Kahneman, PhD, Nobel laureate in economics, talk about how even he has trouble judging risk based on mathematical probability. Instead, he recognizes that adults decide about risk based on the behavior of the people around them – when others act worried or agitated, the person does too. Children, even more than adults, must decide if they are safe based on the behavior of the adults around them. When parents maintain routines as closely as possible after a major disruption, children feel reassured that they can expect continuity of their relationship – their most important lifeboat. If their parents keep doing the things they are used to, children basically feel safe.
Simple aspects of sameness important to children are very familiar to pediatricians: always wanting the same spoon, the sandwich cut the same way, only chicken nuggets from a certain store. This tends to be true in typically developing toddlers, preschool, and some school-aged children. The desire to have the same story read to them multiple times – until parents are ready to scream! – is another sign of the importance of predictable routines to children. All of these are best accommodated during times of stress rather than trying to “avoid making a bad habit.” All disruptions of routine are even more disorienting for children with intellectual disabilities or those on the autism spectrum who are generally less able to understand or control their world. Children and adults with preexisting anxiety disorders also are more likely to have more severe reactions to major disruptions and need extra understanding.
Routines for eating at least something at regular times – even if the food is not as interesting as prior fare – provide a sense of security, as well as stabilizing blood sugar and bowel patterns. Keeping patterns of washing hands, sitting together as a family, and interacting in conversation, rather than watching TV news, allow an oasis of respite from ongoing stresses. Family meals are also known to promote learning, vocabulary growth, and better behavior.
Setting a schedule for schooling, play, hygiene, and exercise may seem silly when parents and children are home all day, but it instills a sense of meaning to the day. Making a visual schedule for younger children or a written or online one for older children can be a shared activity in itself. I remember hearing about how important changing clothes and cleaning teeth were to prisoners of war during World War II in maintaining a sense of normalcy in that time of chaos.
Exercise is particularly important to set as a routine as it directly reduces stress – even if it may need to take new forms. While there are lots of online exercise programs for adults, it is better for everyone to go outside if they can manage adequate personal spacing. There they can experience the orderly changing of the seasons and the weather, as well as soak up some sunshine. Interactive parent-child play serves multiple purposes of stress relief, seeing each other more relaxed, interacting, and having fun!
Routines for sleep are especially important. To fall asleep under normal circumstances requires a sense of safety, perhaps for evolutionary reasons because of the vulnerability of the paralysis that is part of REM sleep stages. Fear at bedtime is common in young children, as is disorientation in the elderly. Both respond to reassuring bedtime routines done the same way every night, such as brushing teeth, changing clothes, washing up, reading or being read to, and praying – if these were the previous habit. When there has been a major disruption, these routines take on added importance, even if some modifications need to be made in sleep location, privacy, etc. Keeping schedules for naps, bedtime, and wake time as stable as possible makes sleep onset easier and sleep maintenance more likely. It also increases the chances of adequate sleep duration. Getting enough sleep stabilizes mood, reduces irritability, and improves daytime concentration and problem-solving skills. These all are especially needed by adults as well as children when there are major disruptions.
Maintaining chores at times of disruption can be extra difficult, plus this may seem to parents like an added stress for their already-stressed child. But in fact, children are reassured by adults’ continuing these requirements. Not only is an expectation that chores be done a signal that life can be expected to proceed normally, but having children do things to help – such as cleaning up, restocking soap and towels, or emptying trash – gives them an active role and hence some sense of control.
Discipline is, in essence, also a routine. Maintaining standards for kindness to others and following rules can be especially difficult when life has been disrupted because emotional lability is more likely in both adults and children when severely stressed. It is important for parents to consider the source of the misbehavior as possibly stress related and to interrupt it in a gentle and understanding way. A parent might say: “I know you are upset by all the changes. It is even more important now than ever to be kind to your brother.” Under stressful conditions, it is especially important to ask how the child was feeling when acting up, but also to “speak for them” about possible stress-related reasons for their behavior. While parents may correctly say that their child will “take advantage of this excuse,” it is still a teaching opportunity. Children have little insight into these connections to their feelings and actions, but they can learn.
Times when old patterns are disrupted also are times for making new habits. The main new habit I recommend for stress relief and overall mental health are the practices of mindfulness or meditation. Mindfulness may be easier to teach children as it involves paying close attention to one’s thoughts, feelings, and sensations, but doing this without judgment. Children often are naturally better at this than adults, who have layered on more experiences to their thoughts. We pediatricians, as well as the parents we serve, can benefit – especially in stressful times – from sharing in the simple ways children experience the world.
Dr. Howard is assistant professor of pediatrics at Johns Hopkins University, Baltimore, and creator of CHADIS (www.CHADIS.com). She had no other relevant disclosures. Dr. Howard’s contribution to this publication was as a paid expert to MDedge News. Email her at [email protected].
Adolescents at risk of nutritional deficiencies after bariatric surgery
In a 5-year prospective study, more than a quarter of the participants who underwent vertical sleeve gastrectomy (VSG) developed two or more nutritional deficiencies, reported lead author Stavra A. Xanthakos, MD, of the Cincinnati Children’s Hospital Medical Center, and colleagues.
“Although prevalence of nutritional deficiencies has been estimated largely from adult cohorts, bariatric surgery is an increasingly accepted treatment for severe obesity in youth,” the investigators wrote in Clinical Gastroenterology and Hepatology. “Yet, lower adherence to supplementation and anticipated longer lifespan with altered gastrointestinal physiology may increase risk of adverse nutritional outcomes in these youth.”
Previous research has suggested that teens may be at higher risk for nutritional deficiencies, but these studies were largely retrospective, or when prospective, lacked sufficient long-term follow-up, analysis of comprehensive patient factors, or inclusion of VSG, which is now the predominant technique in the field, the investigators noted.
“Our study is the first to assess comparative nutritional outcomes in adolescents after both VSG and gastric bypass,” they wrote.
The study involved 226 participants aged 13-19 years who underwent either Roux-en-Y gastric bypass (n = 161) or VSG (n = 67) at five tertiary-care centers in the United States during 2007-2012.
Six months after surgery, at 12 months, and on an annual basis thereafter, the investigators gathered clinical data and measured participant serum levels of ferritin; transferrin; albumin; parathyroid hormone; C-reactive protein; and vitamins A, D, B1, B12, and folate. Analyses also included sex, age, ethnicity, race, household demographics, weight, height, comorbidities, and body mass index (BMI).
The majority of participants were female (75%) and white (72%). At baseline, mean BMI and age were 52.7 kg/m2 and 16.5 years, respectively. After 5 years, mean body mass index decreased 23% without a significant difference between procedures.
Generally, nutritional deficiencies occurred earlier and were more common after gastric bypass, although both procedures were ultimately associated with increased risks.
In the gastric bypass group, 59% of participants had two or more nutritional deficiencies at 5 years, and 19% had three more deficiencies, which represented increased rates of fivefold and sixfold, respectively, which the investigators described as “striking.” In the VSG group, 27% of patients had two or more nutritional deficiencies at 5 years; while this fourfold increase was not statistically significant, the investigators suggested that it indicated “a lower, but not negligible, nutritional risk.”
Hypoferritinemia was particularly common in both groups, with rates at year 5 of 71% and 45% among patients who underwent gastric bypass and VSG, respectively.
“Our results now provide critical evidence that VSG does in fact carry significantly lower nutritional risk than Roux-en-Y gastric bypass, but can still worsen iron status,” the investigators wrote.
The investigators also highlighted a nonsignificant increase in the incidence of vitamin B12 deficiency among patients who underwent gastric bypass, with rates increasing from 0.6% at baseline to 11.5% at 5 years.
“Vitamin B12 status likewise worsened disproportionately after [gastric bypass], despite similar trajectories of weight loss after VSG,” the investigators wrote. “This suggests that the differential risk is caused by anatomic and physiological differences between procedures, rather than weight loss alone.”
Beyond surgery type, risk factors for nutritional deficiency included inadequate supplement intake, pregnancy, weight regain, and black race.
“Our findings underscore the importance of long-term nutritional monitoring in adolescents after bariatric surgery and the need to examine impact on health outcomes and quality of life as these youth advance into adulthood, including systematic assessment of anemia and bone health,” the investigators concluded.
The study was funded by the National Institute of Diabetes and Digestive and Kidney Diseases and the National Center for Advancing Translational Sciences of the National Institutes of Health. Dr. Courcoulas reported grant support from Allurion.
SOURCE: Xanthakos SA et al. Clin Gastro Hepatol. 2019 Nov 6. doi: 10.1016/j.cgh.2019.10.048.
The prevalence of obesity in adolescents has ballooned to about 20% of children aged 12-19 years. Prevention with diet and exercise remains the cornerstone of obesity policy in the pediatric population. Once patients develop obesity, however, bariatric surgery increasingly is being recommended as a treatment to achieve durable weight loss. Multiple large studies in adults have shown strong evidence of the efficacy of bariatric surgery; comparable data in pediatric patients has been sparse.
The current study by Xanthakos et al. reports on 5-year prospective data from Teen-LABS specifically addressing the nutritional status of adolescents after Roux-en-Y gastric bypass and sleeve gastrectomy. Their data show deficiency only in iron and vitamin B12 levels after gastric bypass. More importantly, vertical sleeve gastrectomy, now the most common procedure, results in decreased risk of nutritional deficiencies compared with gastric bypass. These data add to the reassurance that surgical treatment in the adolescent population is overall safe and should be considered strongly after appropriate counseling.
Wasif M. Abidi, MD, PhD, is an assistant professor of medicine, section of gastroenterology and hepatology, Baylor College of Medicine, Houston. He has received research support from GI Dynamics.
The prevalence of obesity in adolescents has ballooned to about 20% of children aged 12-19 years. Prevention with diet and exercise remains the cornerstone of obesity policy in the pediatric population. Once patients develop obesity, however, bariatric surgery increasingly is being recommended as a treatment to achieve durable weight loss. Multiple large studies in adults have shown strong evidence of the efficacy of bariatric surgery; comparable data in pediatric patients has been sparse.
The current study by Xanthakos et al. reports on 5-year prospective data from Teen-LABS specifically addressing the nutritional status of adolescents after Roux-en-Y gastric bypass and sleeve gastrectomy. Their data show deficiency only in iron and vitamin B12 levels after gastric bypass. More importantly, vertical sleeve gastrectomy, now the most common procedure, results in decreased risk of nutritional deficiencies compared with gastric bypass. These data add to the reassurance that surgical treatment in the adolescent population is overall safe and should be considered strongly after appropriate counseling.
Wasif M. Abidi, MD, PhD, is an assistant professor of medicine, section of gastroenterology and hepatology, Baylor College of Medicine, Houston. He has received research support from GI Dynamics.
The prevalence of obesity in adolescents has ballooned to about 20% of children aged 12-19 years. Prevention with diet and exercise remains the cornerstone of obesity policy in the pediatric population. Once patients develop obesity, however, bariatric surgery increasingly is being recommended as a treatment to achieve durable weight loss. Multiple large studies in adults have shown strong evidence of the efficacy of bariatric surgery; comparable data in pediatric patients has been sparse.
The current study by Xanthakos et al. reports on 5-year prospective data from Teen-LABS specifically addressing the nutritional status of adolescents after Roux-en-Y gastric bypass and sleeve gastrectomy. Their data show deficiency only in iron and vitamin B12 levels after gastric bypass. More importantly, vertical sleeve gastrectomy, now the most common procedure, results in decreased risk of nutritional deficiencies compared with gastric bypass. These data add to the reassurance that surgical treatment in the adolescent population is overall safe and should be considered strongly after appropriate counseling.
Wasif M. Abidi, MD, PhD, is an assistant professor of medicine, section of gastroenterology and hepatology, Baylor College of Medicine, Houston. He has received research support from GI Dynamics.
In a 5-year prospective study, more than a quarter of the participants who underwent vertical sleeve gastrectomy (VSG) developed two or more nutritional deficiencies, reported lead author Stavra A. Xanthakos, MD, of the Cincinnati Children’s Hospital Medical Center, and colleagues.
“Although prevalence of nutritional deficiencies has been estimated largely from adult cohorts, bariatric surgery is an increasingly accepted treatment for severe obesity in youth,” the investigators wrote in Clinical Gastroenterology and Hepatology. “Yet, lower adherence to supplementation and anticipated longer lifespan with altered gastrointestinal physiology may increase risk of adverse nutritional outcomes in these youth.”
Previous research has suggested that teens may be at higher risk for nutritional deficiencies, but these studies were largely retrospective, or when prospective, lacked sufficient long-term follow-up, analysis of comprehensive patient factors, or inclusion of VSG, which is now the predominant technique in the field, the investigators noted.
“Our study is the first to assess comparative nutritional outcomes in adolescents after both VSG and gastric bypass,” they wrote.
The study involved 226 participants aged 13-19 years who underwent either Roux-en-Y gastric bypass (n = 161) or VSG (n = 67) at five tertiary-care centers in the United States during 2007-2012.
Six months after surgery, at 12 months, and on an annual basis thereafter, the investigators gathered clinical data and measured participant serum levels of ferritin; transferrin; albumin; parathyroid hormone; C-reactive protein; and vitamins A, D, B1, B12, and folate. Analyses also included sex, age, ethnicity, race, household demographics, weight, height, comorbidities, and body mass index (BMI).
The majority of participants were female (75%) and white (72%). At baseline, mean BMI and age were 52.7 kg/m2 and 16.5 years, respectively. After 5 years, mean body mass index decreased 23% without a significant difference between procedures.
Generally, nutritional deficiencies occurred earlier and were more common after gastric bypass, although both procedures were ultimately associated with increased risks.
In the gastric bypass group, 59% of participants had two or more nutritional deficiencies at 5 years, and 19% had three more deficiencies, which represented increased rates of fivefold and sixfold, respectively, which the investigators described as “striking.” In the VSG group, 27% of patients had two or more nutritional deficiencies at 5 years; while this fourfold increase was not statistically significant, the investigators suggested that it indicated “a lower, but not negligible, nutritional risk.”
Hypoferritinemia was particularly common in both groups, with rates at year 5 of 71% and 45% among patients who underwent gastric bypass and VSG, respectively.
“Our results now provide critical evidence that VSG does in fact carry significantly lower nutritional risk than Roux-en-Y gastric bypass, but can still worsen iron status,” the investigators wrote.
The investigators also highlighted a nonsignificant increase in the incidence of vitamin B12 deficiency among patients who underwent gastric bypass, with rates increasing from 0.6% at baseline to 11.5% at 5 years.
“Vitamin B12 status likewise worsened disproportionately after [gastric bypass], despite similar trajectories of weight loss after VSG,” the investigators wrote. “This suggests that the differential risk is caused by anatomic and physiological differences between procedures, rather than weight loss alone.”
Beyond surgery type, risk factors for nutritional deficiency included inadequate supplement intake, pregnancy, weight regain, and black race.
“Our findings underscore the importance of long-term nutritional monitoring in adolescents after bariatric surgery and the need to examine impact on health outcomes and quality of life as these youth advance into adulthood, including systematic assessment of anemia and bone health,” the investigators concluded.
The study was funded by the National Institute of Diabetes and Digestive and Kidney Diseases and the National Center for Advancing Translational Sciences of the National Institutes of Health. Dr. Courcoulas reported grant support from Allurion.
SOURCE: Xanthakos SA et al. Clin Gastro Hepatol. 2019 Nov 6. doi: 10.1016/j.cgh.2019.10.048.
In a 5-year prospective study, more than a quarter of the participants who underwent vertical sleeve gastrectomy (VSG) developed two or more nutritional deficiencies, reported lead author Stavra A. Xanthakos, MD, of the Cincinnati Children’s Hospital Medical Center, and colleagues.
“Although prevalence of nutritional deficiencies has been estimated largely from adult cohorts, bariatric surgery is an increasingly accepted treatment for severe obesity in youth,” the investigators wrote in Clinical Gastroenterology and Hepatology. “Yet, lower adherence to supplementation and anticipated longer lifespan with altered gastrointestinal physiology may increase risk of adverse nutritional outcomes in these youth.”
Previous research has suggested that teens may be at higher risk for nutritional deficiencies, but these studies were largely retrospective, or when prospective, lacked sufficient long-term follow-up, analysis of comprehensive patient factors, or inclusion of VSG, which is now the predominant technique in the field, the investigators noted.
“Our study is the first to assess comparative nutritional outcomes in adolescents after both VSG and gastric bypass,” they wrote.
The study involved 226 participants aged 13-19 years who underwent either Roux-en-Y gastric bypass (n = 161) or VSG (n = 67) at five tertiary-care centers in the United States during 2007-2012.
Six months after surgery, at 12 months, and on an annual basis thereafter, the investigators gathered clinical data and measured participant serum levels of ferritin; transferrin; albumin; parathyroid hormone; C-reactive protein; and vitamins A, D, B1, B12, and folate. Analyses also included sex, age, ethnicity, race, household demographics, weight, height, comorbidities, and body mass index (BMI).
The majority of participants were female (75%) and white (72%). At baseline, mean BMI and age were 52.7 kg/m2 and 16.5 years, respectively. After 5 years, mean body mass index decreased 23% without a significant difference between procedures.
Generally, nutritional deficiencies occurred earlier and were more common after gastric bypass, although both procedures were ultimately associated with increased risks.
In the gastric bypass group, 59% of participants had two or more nutritional deficiencies at 5 years, and 19% had three more deficiencies, which represented increased rates of fivefold and sixfold, respectively, which the investigators described as “striking.” In the VSG group, 27% of patients had two or more nutritional deficiencies at 5 years; while this fourfold increase was not statistically significant, the investigators suggested that it indicated “a lower, but not negligible, nutritional risk.”
Hypoferritinemia was particularly common in both groups, with rates at year 5 of 71% and 45% among patients who underwent gastric bypass and VSG, respectively.
“Our results now provide critical evidence that VSG does in fact carry significantly lower nutritional risk than Roux-en-Y gastric bypass, but can still worsen iron status,” the investigators wrote.
The investigators also highlighted a nonsignificant increase in the incidence of vitamin B12 deficiency among patients who underwent gastric bypass, with rates increasing from 0.6% at baseline to 11.5% at 5 years.
“Vitamin B12 status likewise worsened disproportionately after [gastric bypass], despite similar trajectories of weight loss after VSG,” the investigators wrote. “This suggests that the differential risk is caused by anatomic and physiological differences between procedures, rather than weight loss alone.”
Beyond surgery type, risk factors for nutritional deficiency included inadequate supplement intake, pregnancy, weight regain, and black race.
“Our findings underscore the importance of long-term nutritional monitoring in adolescents after bariatric surgery and the need to examine impact on health outcomes and quality of life as these youth advance into adulthood, including systematic assessment of anemia and bone health,” the investigators concluded.
The study was funded by the National Institute of Diabetes and Digestive and Kidney Diseases and the National Center for Advancing Translational Sciences of the National Institutes of Health. Dr. Courcoulas reported grant support from Allurion.
SOURCE: Xanthakos SA et al. Clin Gastro Hepatol. 2019 Nov 6. doi: 10.1016/j.cgh.2019.10.048.
FROM CLINICAL GASTROENTEROLOGY AND HEPATOLOGY
Novel acne drug now under review at the FDA
LAHAINA, HAWAII – by the Food and Drug Administration, is already generating considerable buzz in the patient-advocacy community even though the agency won’t issue its decision until August.
“I’ve actually had a lot of interest in this already from parents, especially regarding girls who have very hormonal acne but the parents are really not interested in starting them on a systemic hormonal therapy at their age,” Jessica Sprague, MD, said at the SDEF Hawaii Dermatology Seminar provided by the Global Academy for Medical Education/Skin Disease Education Foundation.
Clascoterone targets androgen receptors in the skin in order to reduce cutaneous 5-alpha dihydrotestosterone.
“It’s being developed for use in both males and females, which is great because at this point there’s no hormonal treatment for males,” noted Dr. Sprague, a pediatric dermatologist at Rady Children’s Hospital and the University of California, both in San Diego.
The manufacturer’s application for marketing approval of clascoterone cream 1% under FDA review includes evidence from two identical phase-3, double-blind, vehicle-controlled, 12-week, randomized trials. The two studies included a total of 1,440 patients aged 9 years through adulthood with moderate to severe facial acne vulgaris who were randomized to twice-daily application of clascoterone or its vehicle.
The primary outcome was the reduction in inflammatory lesions at week 12: a 46.2% decline from baseline with clascoterone 1% cream, which was a significantly greater improvement than the 32.7% reduction for vehicle. The secondary outcome – change in noninflammatory lesion counts at week 12 – was also positive for the topical androgen receptor inhibitor, which achieved a 29.8% reduction, compared with 18.9% for vehicle. Clascoterone exhibited a favorable safety and tolerability profile, with numerically fewer treatment-emergent adverse events than in the vehicle control group. A stronger formulation of the topical agent is in advanced clinical trials for the treatment of androgenetic alopecia in both males and females.
Dr. Sprague reported having no financial conflicts regarding her presentation.
The SDEF/Global Academy for Medical Education and this news organization are owned by the same parent company.
LAHAINA, HAWAII – by the Food and Drug Administration, is already generating considerable buzz in the patient-advocacy community even though the agency won’t issue its decision until August.
“I’ve actually had a lot of interest in this already from parents, especially regarding girls who have very hormonal acne but the parents are really not interested in starting them on a systemic hormonal therapy at their age,” Jessica Sprague, MD, said at the SDEF Hawaii Dermatology Seminar provided by the Global Academy for Medical Education/Skin Disease Education Foundation.
Clascoterone targets androgen receptors in the skin in order to reduce cutaneous 5-alpha dihydrotestosterone.
“It’s being developed for use in both males and females, which is great because at this point there’s no hormonal treatment for males,” noted Dr. Sprague, a pediatric dermatologist at Rady Children’s Hospital and the University of California, both in San Diego.
The manufacturer’s application for marketing approval of clascoterone cream 1% under FDA review includes evidence from two identical phase-3, double-blind, vehicle-controlled, 12-week, randomized trials. The two studies included a total of 1,440 patients aged 9 years through adulthood with moderate to severe facial acne vulgaris who were randomized to twice-daily application of clascoterone or its vehicle.
The primary outcome was the reduction in inflammatory lesions at week 12: a 46.2% decline from baseline with clascoterone 1% cream, which was a significantly greater improvement than the 32.7% reduction for vehicle. The secondary outcome – change in noninflammatory lesion counts at week 12 – was also positive for the topical androgen receptor inhibitor, which achieved a 29.8% reduction, compared with 18.9% for vehicle. Clascoterone exhibited a favorable safety and tolerability profile, with numerically fewer treatment-emergent adverse events than in the vehicle control group. A stronger formulation of the topical agent is in advanced clinical trials for the treatment of androgenetic alopecia in both males and females.
Dr. Sprague reported having no financial conflicts regarding her presentation.
The SDEF/Global Academy for Medical Education and this news organization are owned by the same parent company.
LAHAINA, HAWAII – by the Food and Drug Administration, is already generating considerable buzz in the patient-advocacy community even though the agency won’t issue its decision until August.
“I’ve actually had a lot of interest in this already from parents, especially regarding girls who have very hormonal acne but the parents are really not interested in starting them on a systemic hormonal therapy at their age,” Jessica Sprague, MD, said at the SDEF Hawaii Dermatology Seminar provided by the Global Academy for Medical Education/Skin Disease Education Foundation.
Clascoterone targets androgen receptors in the skin in order to reduce cutaneous 5-alpha dihydrotestosterone.
“It’s being developed for use in both males and females, which is great because at this point there’s no hormonal treatment for males,” noted Dr. Sprague, a pediatric dermatologist at Rady Children’s Hospital and the University of California, both in San Diego.
The manufacturer’s application for marketing approval of clascoterone cream 1% under FDA review includes evidence from two identical phase-3, double-blind, vehicle-controlled, 12-week, randomized trials. The two studies included a total of 1,440 patients aged 9 years through adulthood with moderate to severe facial acne vulgaris who were randomized to twice-daily application of clascoterone or its vehicle.
The primary outcome was the reduction in inflammatory lesions at week 12: a 46.2% decline from baseline with clascoterone 1% cream, which was a significantly greater improvement than the 32.7% reduction for vehicle. The secondary outcome – change in noninflammatory lesion counts at week 12 – was also positive for the topical androgen receptor inhibitor, which achieved a 29.8% reduction, compared with 18.9% for vehicle. Clascoterone exhibited a favorable safety and tolerability profile, with numerically fewer treatment-emergent adverse events than in the vehicle control group. A stronger formulation of the topical agent is in advanced clinical trials for the treatment of androgenetic alopecia in both males and females.
Dr. Sprague reported having no financial conflicts regarding her presentation.
The SDEF/Global Academy for Medical Education and this news organization are owned by the same parent company.
REPORTING FROM THE SDEF HAWAII DERMATOLOGY SEMINAR
iPLEDGE allows at-home pregnancy tests during pandemic
tests to comply with the requirements of the iPLEDGE program during the COVID-19 pandemic, according to an update program posted on the iPLEDGE website.
The program’s other requirements – the prescription window and two forms of birth control – remain unchanged.
The change follows recent guidance from the Department of Health & Human Services and the Food and Drug Administration regarding accommodations for medical care and drugs subject to Risk Evaluation and Mitigation Strategies (REMS) in the midst of a public health emergency that requires most people to remain in their homes except for essential services.
Allowing females to take at-home pregnancy tests and communicate the results to physician according to their preference is “a game changer for the middle of a pandemic, obviously,” Neil Goldberg, MD, a dermatologist in Westchester County, New York, said in an interview. “These are patients who don’t need to spend time outside just to get pregnancy tests done. It makes it a lot easier.”
Dr. Goldberg is frustrated, however, that the accommodations have not been more widely publicized; he discovered the change incidentally when speaking to an iPLEDGE program representative to request a waiver for a patient who had taken her pregnancy test too early. The program had denied a similar request for a 15-year-old patient of his the previous week, despite the patient being abstinent and having been in shelter-in-place for several weeks.
“The size of your notice [on the website] should be proportionate to how important it is,” Dr. Goldberg said, and the small red box on the site is easy to miss. By contrast, asking anyone to leave their homes to go to a lab for a pregnancy test in the midst of a global pandemic so they can continue their medication would be putting patients at risk, he added.
The iPLEDGE program is designed in part to ensure unplanned pregnancies do not occur in females while taking the teratogenic acne drug. But the rules are onerous and difficult even during normal times, pointed out Hilary Baldwin, MD, medical director of the Acne Treatment and Research Center in New York City and past president of the American Acne and Rosacea Society.
Male patients taking isotretinoin must visit their physician every month to get a new no-refills prescription, but females must get a pregnancy test at a Clinical Laboratory Improvement Amendments–certified lab, which must then provide physical results to the prescribing physician. The doctor enters the negative pregnancy test and the two forms of birth control the patient is taking in the iPLEDGE program site.
Then the patient must take an online test at home to acknowledge they understand what it means to not get pregnant and enter the two forms of birth control they are using – which must match what the doctor enters – before the pharmacy can dispense the drug. The entire process must occur within 7 days or else the patient has to wait 19 days before starting the process over.
“We run a very tight schedule for girls. And every month, we would worry that something would interfere, a snow storm or something else, and that they wouldn’t be able to complete their objectives within the 7-day period,” Dr Baldwin said in an interview. “It was always difficult, and now with us not being able to see the patient and the patient not wanting to go to the lab, this became completely impossible.”
Until this change, some patients may not have been able to get their prescription for severe nodulocystic acne, which can cause physical and psychological scarring, and “postponing treatment increases the likelihood of scarring,” Dr. Baldwin pointed out.
Dr. Goldberg’s patients now take a pregnancy test at home and send him a photo of the negative test that he then inserts into their EMR.
According to a March 17 statement from HHS, potential penalties for HIPAA violations are waived for good-faith use of “everyday communication technologies,” such as Skype or FaceTime, for telehealth treatment or diagnostics. The change was intended to allow telehealth services to continue healthcare for practices that had not previously had secure telehealth technology established.
Despite the changes for at-home pregnancy tests for females and in-person visits for all patients, the program has not altered the 7-day prescription window or the requirement to have two forms of birth control.
With reports of a global condom shortage, Dr Baldwin said she has more concerns about her adult patients being able to find a required barrier method of birth control than about her adolescent patients.
“This is a unique opportunity for us to trust our teenage patients because they can’t leave the house,” Dr. Baldwin said. “I’m actually more worried about my adult women on the drug who are bored and cooped up in a house with their significant other.”
Dr. Baldwin and Dr. Goldberg had no relevant disclosures. Dr. Goldberg is a Dermatology News board member.
tests to comply with the requirements of the iPLEDGE program during the COVID-19 pandemic, according to an update program posted on the iPLEDGE website.
The program’s other requirements – the prescription window and two forms of birth control – remain unchanged.
The change follows recent guidance from the Department of Health & Human Services and the Food and Drug Administration regarding accommodations for medical care and drugs subject to Risk Evaluation and Mitigation Strategies (REMS) in the midst of a public health emergency that requires most people to remain in their homes except for essential services.
Allowing females to take at-home pregnancy tests and communicate the results to physician according to their preference is “a game changer for the middle of a pandemic, obviously,” Neil Goldberg, MD, a dermatologist in Westchester County, New York, said in an interview. “These are patients who don’t need to spend time outside just to get pregnancy tests done. It makes it a lot easier.”
Dr. Goldberg is frustrated, however, that the accommodations have not been more widely publicized; he discovered the change incidentally when speaking to an iPLEDGE program representative to request a waiver for a patient who had taken her pregnancy test too early. The program had denied a similar request for a 15-year-old patient of his the previous week, despite the patient being abstinent and having been in shelter-in-place for several weeks.
“The size of your notice [on the website] should be proportionate to how important it is,” Dr. Goldberg said, and the small red box on the site is easy to miss. By contrast, asking anyone to leave their homes to go to a lab for a pregnancy test in the midst of a global pandemic so they can continue their medication would be putting patients at risk, he added.
The iPLEDGE program is designed in part to ensure unplanned pregnancies do not occur in females while taking the teratogenic acne drug. But the rules are onerous and difficult even during normal times, pointed out Hilary Baldwin, MD, medical director of the Acne Treatment and Research Center in New York City and past president of the American Acne and Rosacea Society.
Male patients taking isotretinoin must visit their physician every month to get a new no-refills prescription, but females must get a pregnancy test at a Clinical Laboratory Improvement Amendments–certified lab, which must then provide physical results to the prescribing physician. The doctor enters the negative pregnancy test and the two forms of birth control the patient is taking in the iPLEDGE program site.
Then the patient must take an online test at home to acknowledge they understand what it means to not get pregnant and enter the two forms of birth control they are using – which must match what the doctor enters – before the pharmacy can dispense the drug. The entire process must occur within 7 days or else the patient has to wait 19 days before starting the process over.
“We run a very tight schedule for girls. And every month, we would worry that something would interfere, a snow storm or something else, and that they wouldn’t be able to complete their objectives within the 7-day period,” Dr Baldwin said in an interview. “It was always difficult, and now with us not being able to see the patient and the patient not wanting to go to the lab, this became completely impossible.”
Until this change, some patients may not have been able to get their prescription for severe nodulocystic acne, which can cause physical and psychological scarring, and “postponing treatment increases the likelihood of scarring,” Dr. Baldwin pointed out.
Dr. Goldberg’s patients now take a pregnancy test at home and send him a photo of the negative test that he then inserts into their EMR.
According to a March 17 statement from HHS, potential penalties for HIPAA violations are waived for good-faith use of “everyday communication technologies,” such as Skype or FaceTime, for telehealth treatment or diagnostics. The change was intended to allow telehealth services to continue healthcare for practices that had not previously had secure telehealth technology established.
Despite the changes for at-home pregnancy tests for females and in-person visits for all patients, the program has not altered the 7-day prescription window or the requirement to have two forms of birth control.
With reports of a global condom shortage, Dr Baldwin said she has more concerns about her adult patients being able to find a required barrier method of birth control than about her adolescent patients.
“This is a unique opportunity for us to trust our teenage patients because they can’t leave the house,” Dr. Baldwin said. “I’m actually more worried about my adult women on the drug who are bored and cooped up in a house with their significant other.”
Dr. Baldwin and Dr. Goldberg had no relevant disclosures. Dr. Goldberg is a Dermatology News board member.
tests to comply with the requirements of the iPLEDGE program during the COVID-19 pandemic, according to an update program posted on the iPLEDGE website.
The program’s other requirements – the prescription window and two forms of birth control – remain unchanged.
The change follows recent guidance from the Department of Health & Human Services and the Food and Drug Administration regarding accommodations for medical care and drugs subject to Risk Evaluation and Mitigation Strategies (REMS) in the midst of a public health emergency that requires most people to remain in their homes except for essential services.
Allowing females to take at-home pregnancy tests and communicate the results to physician according to their preference is “a game changer for the middle of a pandemic, obviously,” Neil Goldberg, MD, a dermatologist in Westchester County, New York, said in an interview. “These are patients who don’t need to spend time outside just to get pregnancy tests done. It makes it a lot easier.”
Dr. Goldberg is frustrated, however, that the accommodations have not been more widely publicized; he discovered the change incidentally when speaking to an iPLEDGE program representative to request a waiver for a patient who had taken her pregnancy test too early. The program had denied a similar request for a 15-year-old patient of his the previous week, despite the patient being abstinent and having been in shelter-in-place for several weeks.
“The size of your notice [on the website] should be proportionate to how important it is,” Dr. Goldberg said, and the small red box on the site is easy to miss. By contrast, asking anyone to leave their homes to go to a lab for a pregnancy test in the midst of a global pandemic so they can continue their medication would be putting patients at risk, he added.
The iPLEDGE program is designed in part to ensure unplanned pregnancies do not occur in females while taking the teratogenic acne drug. But the rules are onerous and difficult even during normal times, pointed out Hilary Baldwin, MD, medical director of the Acne Treatment and Research Center in New York City and past president of the American Acne and Rosacea Society.
Male patients taking isotretinoin must visit their physician every month to get a new no-refills prescription, but females must get a pregnancy test at a Clinical Laboratory Improvement Amendments–certified lab, which must then provide physical results to the prescribing physician. The doctor enters the negative pregnancy test and the two forms of birth control the patient is taking in the iPLEDGE program site.
Then the patient must take an online test at home to acknowledge they understand what it means to not get pregnant and enter the two forms of birth control they are using – which must match what the doctor enters – before the pharmacy can dispense the drug. The entire process must occur within 7 days or else the patient has to wait 19 days before starting the process over.
“We run a very tight schedule for girls. And every month, we would worry that something would interfere, a snow storm or something else, and that they wouldn’t be able to complete their objectives within the 7-day period,” Dr Baldwin said in an interview. “It was always difficult, and now with us not being able to see the patient and the patient not wanting to go to the lab, this became completely impossible.”
Until this change, some patients may not have been able to get their prescription for severe nodulocystic acne, which can cause physical and psychological scarring, and “postponing treatment increases the likelihood of scarring,” Dr. Baldwin pointed out.
Dr. Goldberg’s patients now take a pregnancy test at home and send him a photo of the negative test that he then inserts into their EMR.
According to a March 17 statement from HHS, potential penalties for HIPAA violations are waived for good-faith use of “everyday communication technologies,” such as Skype or FaceTime, for telehealth treatment or diagnostics. The change was intended to allow telehealth services to continue healthcare for practices that had not previously had secure telehealth technology established.
Despite the changes for at-home pregnancy tests for females and in-person visits for all patients, the program has not altered the 7-day prescription window or the requirement to have two forms of birth control.
With reports of a global condom shortage, Dr Baldwin said she has more concerns about her adult patients being able to find a required barrier method of birth control than about her adolescent patients.
“This is a unique opportunity for us to trust our teenage patients because they can’t leave the house,” Dr. Baldwin said. “I’m actually more worried about my adult women on the drug who are bored and cooped up in a house with their significant other.”
Dr. Baldwin and Dr. Goldberg had no relevant disclosures. Dr. Goldberg is a Dermatology News board member.
Do we need another vital sign?
If you haven’t already found out that activity is a critical component in the physical and mental health of your patients, or if you’re trying to convince an influential person or group it deserves their attention and investment, I suggest you chase down this clinical report from the American Academy of Pediatrics. Representing the AAP’s Council on Sports Medicine and Fitness and Section on Obesity, the authors quite thoroughly make the case that anyone concerned about the health of this nation and its children should make promotion of physical activity a top priority.
I suspect that, like many of the position papers that come from the AAP, this clinical report is another example of preaching to the choir. However, I understand that the academy also hopes to convince a broader audience of nonphysician decision makers by laying out all of the evidence they can muster.
With their voluminous supporting evidence on the table, the authors move on to getting those of us in clinical practice to make our approach to this more systematic – including the addition of a Physical Activity Vital Sign (PAVS) in our patients’ health records. And here is where the authors begin to drift into the hazy dream world of unreality. They admit that “pediatricians will need efficient workflows to incorporate physical activity assessment, counseling and referral in the clinical visit.” Although there is no pediatrician more convinced of the importance of physical activity, I would find it very difficult to include a detailed assessment of my patients’ daily activity in their charts in the manner that the council members envision. Clunky EHRs, limited support staff, and a crowd of advocates already clamoring for my attention on their favorite health issue (nutrition, gun safety, parental depression, dental health to name just a few) all make creating an “efficient workflow” difficult on a good day and impossible on many days.
But, as I have said, I am a strong advocate of physical activity. So here’s a more nuanced suggestion based on a combination of my practical experience and the council’s recommendations.
If you provide good continuity of care to the families in your practice and have been asking good “getting to know you” questions at each visit, you probably already know which of your patients are sufficiently active. You don’t need to ask them how many hours a week they are doing something active. You should be able to just check a box that says “active.”
For patients that you haven’t seen before or suspect are too sedentary from looking at their biometrics and listening to their complaints you need only ask “What do you and your family like to do for fun?” The simple follow-up question of how many hours are spent watching TV, looking at smart phones or tablets, and playing video games in each day completes the survey. You don’t need to chart the depressing details because, as we know, relying on patient or parental recall is unlikely to provide the actual numbers. Just simply check the box that says “not active enough.” What you do with this crude assessment activity is another story and will be the topic for the next Letters from Maine.
This clinical report from the AAP is an excellent and exhaustive discussion of the importance of physical activity, but I hope that it doesn’t spark further cluttering of our already challenged EHR systems. Most of us don’t have the time to be data collectors and quantifiers. Let’s leave that to the clinical researchers. We already know activity is important and that most of our sedentary families aren’t going to be impressed by more science. Our challenge is to get them moving.
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.” Email him at [email protected].
If you haven’t already found out that activity is a critical component in the physical and mental health of your patients, or if you’re trying to convince an influential person or group it deserves their attention and investment, I suggest you chase down this clinical report from the American Academy of Pediatrics. Representing the AAP’s Council on Sports Medicine and Fitness and Section on Obesity, the authors quite thoroughly make the case that anyone concerned about the health of this nation and its children should make promotion of physical activity a top priority.
I suspect that, like many of the position papers that come from the AAP, this clinical report is another example of preaching to the choir. However, I understand that the academy also hopes to convince a broader audience of nonphysician decision makers by laying out all of the evidence they can muster.
With their voluminous supporting evidence on the table, the authors move on to getting those of us in clinical practice to make our approach to this more systematic – including the addition of a Physical Activity Vital Sign (PAVS) in our patients’ health records. And here is where the authors begin to drift into the hazy dream world of unreality. They admit that “pediatricians will need efficient workflows to incorporate physical activity assessment, counseling and referral in the clinical visit.” Although there is no pediatrician more convinced of the importance of physical activity, I would find it very difficult to include a detailed assessment of my patients’ daily activity in their charts in the manner that the council members envision. Clunky EHRs, limited support staff, and a crowd of advocates already clamoring for my attention on their favorite health issue (nutrition, gun safety, parental depression, dental health to name just a few) all make creating an “efficient workflow” difficult on a good day and impossible on many days.
But, as I have said, I am a strong advocate of physical activity. So here’s a more nuanced suggestion based on a combination of my practical experience and the council’s recommendations.
If you provide good continuity of care to the families in your practice and have been asking good “getting to know you” questions at each visit, you probably already know which of your patients are sufficiently active. You don’t need to ask them how many hours a week they are doing something active. You should be able to just check a box that says “active.”
For patients that you haven’t seen before or suspect are too sedentary from looking at their biometrics and listening to their complaints you need only ask “What do you and your family like to do for fun?” The simple follow-up question of how many hours are spent watching TV, looking at smart phones or tablets, and playing video games in each day completes the survey. You don’t need to chart the depressing details because, as we know, relying on patient or parental recall is unlikely to provide the actual numbers. Just simply check the box that says “not active enough.” What you do with this crude assessment activity is another story and will be the topic for the next Letters from Maine.
This clinical report from the AAP is an excellent and exhaustive discussion of the importance of physical activity, but I hope that it doesn’t spark further cluttering of our already challenged EHR systems. Most of us don’t have the time to be data collectors and quantifiers. Let’s leave that to the clinical researchers. We already know activity is important and that most of our sedentary families aren’t going to be impressed by more science. Our challenge is to get them moving.
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.” Email him at [email protected].
If you haven’t already found out that activity is a critical component in the physical and mental health of your patients, or if you’re trying to convince an influential person or group it deserves their attention and investment, I suggest you chase down this clinical report from the American Academy of Pediatrics. Representing the AAP’s Council on Sports Medicine and Fitness and Section on Obesity, the authors quite thoroughly make the case that anyone concerned about the health of this nation and its children should make promotion of physical activity a top priority.
I suspect that, like many of the position papers that come from the AAP, this clinical report is another example of preaching to the choir. However, I understand that the academy also hopes to convince a broader audience of nonphysician decision makers by laying out all of the evidence they can muster.
With their voluminous supporting evidence on the table, the authors move on to getting those of us in clinical practice to make our approach to this more systematic – including the addition of a Physical Activity Vital Sign (PAVS) in our patients’ health records. And here is where the authors begin to drift into the hazy dream world of unreality. They admit that “pediatricians will need efficient workflows to incorporate physical activity assessment, counseling and referral in the clinical visit.” Although there is no pediatrician more convinced of the importance of physical activity, I would find it very difficult to include a detailed assessment of my patients’ daily activity in their charts in the manner that the council members envision. Clunky EHRs, limited support staff, and a crowd of advocates already clamoring for my attention on their favorite health issue (nutrition, gun safety, parental depression, dental health to name just a few) all make creating an “efficient workflow” difficult on a good day and impossible on many days.
But, as I have said, I am a strong advocate of physical activity. So here’s a more nuanced suggestion based on a combination of my practical experience and the council’s recommendations.
If you provide good continuity of care to the families in your practice and have been asking good “getting to know you” questions at each visit, you probably already know which of your patients are sufficiently active. You don’t need to ask them how many hours a week they are doing something active. You should be able to just check a box that says “active.”
For patients that you haven’t seen before or suspect are too sedentary from looking at their biometrics and listening to their complaints you need only ask “What do you and your family like to do for fun?” The simple follow-up question of how many hours are spent watching TV, looking at smart phones or tablets, and playing video games in each day completes the survey. You don’t need to chart the depressing details because, as we know, relying on patient or parental recall is unlikely to provide the actual numbers. Just simply check the box that says “not active enough.” What you do with this crude assessment activity is another story and will be the topic for the next Letters from Maine.
This clinical report from the AAP is an excellent and exhaustive discussion of the importance of physical activity, but I hope that it doesn’t spark further cluttering of our already challenged EHR systems. Most of us don’t have the time to be data collectors and quantifiers. Let’s leave that to the clinical researchers. We already know activity is important and that most of our sedentary families aren’t going to be impressed by more science. Our challenge is to get them moving.
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.” Email him at [email protected].
Hormone therapy boosts body image in transgender youth
based on data from 148 individuals.
“Understanding the impact of gender-affirming hormone therapy on the mental health of transgender youth is critical given the health disparities documented in this population,” wrote Laura E. Kuper, PhD, of Children’s Health Systems of Texas, Dallas, and colleagues.
In a study published in Pediatrics, the researchers reviewed data from 148 youth aged 9-18 years who underwent gender-affirming hormone therapy in a multidisciplinary program. The average age of the patients was 15 years; 25 were receiving puberty suppression hormones only, 93 were receiving just feminizing or masculinizing hormones, and 30 were receiving both treatments.
At baseline and at approximately 1 year follow-up, all patients completed the Body Image Scale, Quick Inventory of Depressive Symptoms, and Screen for Child Anxiety Related Emotional Disorders. In addition, clinicians collected information on patients’ suicidal ideation, suicide attempts, and nonsuicidal self-injury.
Overall, the average scores on the Body Image Scale on body dissatisfaction decreased from 70 to 52, and average scores on the Quick Inventory of Depressive Symptoms decreased from 9 to 7; both were statistically significant (P less than .001), as were changes from baseline on the anxiety subscale of the Screen for Child Anxiety Related Emotional Disorders, which decreased from 32 to 29 (P less than .01). No change occurred in the average overall clinician-reported depressive symptoms.
During the follow-up period, the rates of suicidal ideation, suicide attempts, and nonsuicidal self-injury were 38%, 5%, and 17%, respectively. Of patients who reported these experiences, the lifetime histories of suicidal ideation, suicide attempts, and nonsuicidal self-injury were 81%, 15%, and 52%, respectively.
The findings were limited by several factors including some missing data and the relatively small sample size, the researchers noted.
Nonetheless, the results suggest “that youth receiving gender-affirming hormone therapy experience meaningful short-term improvements in body dissatisfaction, and no participants discontinued feminizing or masculinizing hormone therapy.” These results support the use of such therapy, Dr. Kuper and associates wrote.
The study is important because of the need for evidence that hormones actually improve patient outcomes, said Shauna M. Lawlis, MD, of the University of Oklahoma Medical Center, Oklahoma City.
“Especially given the rash of legislation across the country aimed at blocking care for transgender youth, it is helpful to show that these treatments really do decrease patients’ anxiety and depressive symptoms,” she said in an interview. “In addition, previous research has been focused on those who have undergone puberty suppression followed by gender-affirming hormone therapy, but many patients are too far along in puberty for puberty suppression to be effective and providers often go straight to gender-affirming hormones in those cases.”
Dr. Lawlis said she was not at all surprised by the study findings. “In my own practice, I have seen patients improve greatly on gender-affirming hormones with overall improvement in anxiety and depression. As a patient’s outward appearance more closely matches their gender identity, they feel more comfortable in their own bodies and their interactions with the world around them, thus improving these symptoms.”
Dr. Lawlis added that the message for pediatricians who treat transgender youth is simple: Gender-affirming hormones improve patient outcomes. “They are essential for the mental health of this vulnerable population.”
She noted that long-term follow-up studies would be useful. “There is still a lot of concern about regret and detransitioning among health care providers and the general population – showing that patients maintain satisfaction in the long-term would be helpful.
“In addition, long-term studies about other health outcomes (cardiovascular disease, cancer risk, etc.) would also be helpful,” said Dr. Lawlis, who was asked to comment on this study, with which she had no involvement.
The study was supported in part by Children’s Health. The researchers had no financial conflicts to disclose. Dr. Lawlis had no relevant financial disclosures.
SOURCE: Kuper LE et al. Pediatrics. 2020 Mar 27. doi: 10.1542/peds.2019-3006.
based on data from 148 individuals.
“Understanding the impact of gender-affirming hormone therapy on the mental health of transgender youth is critical given the health disparities documented in this population,” wrote Laura E. Kuper, PhD, of Children’s Health Systems of Texas, Dallas, and colleagues.
In a study published in Pediatrics, the researchers reviewed data from 148 youth aged 9-18 years who underwent gender-affirming hormone therapy in a multidisciplinary program. The average age of the patients was 15 years; 25 were receiving puberty suppression hormones only, 93 were receiving just feminizing or masculinizing hormones, and 30 were receiving both treatments.
At baseline and at approximately 1 year follow-up, all patients completed the Body Image Scale, Quick Inventory of Depressive Symptoms, and Screen for Child Anxiety Related Emotional Disorders. In addition, clinicians collected information on patients’ suicidal ideation, suicide attempts, and nonsuicidal self-injury.
Overall, the average scores on the Body Image Scale on body dissatisfaction decreased from 70 to 52, and average scores on the Quick Inventory of Depressive Symptoms decreased from 9 to 7; both were statistically significant (P less than .001), as were changes from baseline on the anxiety subscale of the Screen for Child Anxiety Related Emotional Disorders, which decreased from 32 to 29 (P less than .01). No change occurred in the average overall clinician-reported depressive symptoms.
During the follow-up period, the rates of suicidal ideation, suicide attempts, and nonsuicidal self-injury were 38%, 5%, and 17%, respectively. Of patients who reported these experiences, the lifetime histories of suicidal ideation, suicide attempts, and nonsuicidal self-injury were 81%, 15%, and 52%, respectively.
The findings were limited by several factors including some missing data and the relatively small sample size, the researchers noted.
Nonetheless, the results suggest “that youth receiving gender-affirming hormone therapy experience meaningful short-term improvements in body dissatisfaction, and no participants discontinued feminizing or masculinizing hormone therapy.” These results support the use of such therapy, Dr. Kuper and associates wrote.
The study is important because of the need for evidence that hormones actually improve patient outcomes, said Shauna M. Lawlis, MD, of the University of Oklahoma Medical Center, Oklahoma City.
“Especially given the rash of legislation across the country aimed at blocking care for transgender youth, it is helpful to show that these treatments really do decrease patients’ anxiety and depressive symptoms,” she said in an interview. “In addition, previous research has been focused on those who have undergone puberty suppression followed by gender-affirming hormone therapy, but many patients are too far along in puberty for puberty suppression to be effective and providers often go straight to gender-affirming hormones in those cases.”
Dr. Lawlis said she was not at all surprised by the study findings. “In my own practice, I have seen patients improve greatly on gender-affirming hormones with overall improvement in anxiety and depression. As a patient’s outward appearance more closely matches their gender identity, they feel more comfortable in their own bodies and their interactions with the world around them, thus improving these symptoms.”
Dr. Lawlis added that the message for pediatricians who treat transgender youth is simple: Gender-affirming hormones improve patient outcomes. “They are essential for the mental health of this vulnerable population.”
She noted that long-term follow-up studies would be useful. “There is still a lot of concern about regret and detransitioning among health care providers and the general population – showing that patients maintain satisfaction in the long-term would be helpful.
“In addition, long-term studies about other health outcomes (cardiovascular disease, cancer risk, etc.) would also be helpful,” said Dr. Lawlis, who was asked to comment on this study, with which she had no involvement.
The study was supported in part by Children’s Health. The researchers had no financial conflicts to disclose. Dr. Lawlis had no relevant financial disclosures.
SOURCE: Kuper LE et al. Pediatrics. 2020 Mar 27. doi: 10.1542/peds.2019-3006.
based on data from 148 individuals.
“Understanding the impact of gender-affirming hormone therapy on the mental health of transgender youth is critical given the health disparities documented in this population,” wrote Laura E. Kuper, PhD, of Children’s Health Systems of Texas, Dallas, and colleagues.
In a study published in Pediatrics, the researchers reviewed data from 148 youth aged 9-18 years who underwent gender-affirming hormone therapy in a multidisciplinary program. The average age of the patients was 15 years; 25 were receiving puberty suppression hormones only, 93 were receiving just feminizing or masculinizing hormones, and 30 were receiving both treatments.
At baseline and at approximately 1 year follow-up, all patients completed the Body Image Scale, Quick Inventory of Depressive Symptoms, and Screen for Child Anxiety Related Emotional Disorders. In addition, clinicians collected information on patients’ suicidal ideation, suicide attempts, and nonsuicidal self-injury.
Overall, the average scores on the Body Image Scale on body dissatisfaction decreased from 70 to 52, and average scores on the Quick Inventory of Depressive Symptoms decreased from 9 to 7; both were statistically significant (P less than .001), as were changes from baseline on the anxiety subscale of the Screen for Child Anxiety Related Emotional Disorders, which decreased from 32 to 29 (P less than .01). No change occurred in the average overall clinician-reported depressive symptoms.
During the follow-up period, the rates of suicidal ideation, suicide attempts, and nonsuicidal self-injury were 38%, 5%, and 17%, respectively. Of patients who reported these experiences, the lifetime histories of suicidal ideation, suicide attempts, and nonsuicidal self-injury were 81%, 15%, and 52%, respectively.
The findings were limited by several factors including some missing data and the relatively small sample size, the researchers noted.
Nonetheless, the results suggest “that youth receiving gender-affirming hormone therapy experience meaningful short-term improvements in body dissatisfaction, and no participants discontinued feminizing or masculinizing hormone therapy.” These results support the use of such therapy, Dr. Kuper and associates wrote.
The study is important because of the need for evidence that hormones actually improve patient outcomes, said Shauna M. Lawlis, MD, of the University of Oklahoma Medical Center, Oklahoma City.
“Especially given the rash of legislation across the country aimed at blocking care for transgender youth, it is helpful to show that these treatments really do decrease patients’ anxiety and depressive symptoms,” she said in an interview. “In addition, previous research has been focused on those who have undergone puberty suppression followed by gender-affirming hormone therapy, but many patients are too far along in puberty for puberty suppression to be effective and providers often go straight to gender-affirming hormones in those cases.”
Dr. Lawlis said she was not at all surprised by the study findings. “In my own practice, I have seen patients improve greatly on gender-affirming hormones with overall improvement in anxiety and depression. As a patient’s outward appearance more closely matches their gender identity, they feel more comfortable in their own bodies and their interactions with the world around them, thus improving these symptoms.”
Dr. Lawlis added that the message for pediatricians who treat transgender youth is simple: Gender-affirming hormones improve patient outcomes. “They are essential for the mental health of this vulnerable population.”
She noted that long-term follow-up studies would be useful. “There is still a lot of concern about regret and detransitioning among health care providers and the general population – showing that patients maintain satisfaction in the long-term would be helpful.
“In addition, long-term studies about other health outcomes (cardiovascular disease, cancer risk, etc.) would also be helpful,” said Dr. Lawlis, who was asked to comment on this study, with which she had no involvement.
The study was supported in part by Children’s Health. The researchers had no financial conflicts to disclose. Dr. Lawlis had no relevant financial disclosures.
SOURCE: Kuper LE et al. Pediatrics. 2020 Mar 27. doi: 10.1542/peds.2019-3006.
FROM PEDIATRICS