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COVID-19 anticoagulation trials ‘paused’ for futility, safety
Parts of three linked studies investigating increased levels of anticoagulation in hospitalized COVID-19 patients have been “paused” because of futility and safety concerns, a statement from the U.S. National Heart, Lung, and Blood Institute (NHLBI) confirms.
The trials involved are the REMAP-CAP, ACTIV-4, and ATTACC studies.
The statement also says that a potential for harm in this subgroup could not be excluded, noting that increased bleeding is a known complication of full-dose anticoagulation. The trials are working urgently to undertake additional analyses, which will be made available as soon as possible.
The three clinical trial platforms are working together to test the effects of full therapeutic doses of anticoagulants vs. lower prophylactic doses in COVID-19 patients.
Informed by the deliberations of the data safety monitoring boards of these trials, all of the trial sites have paused enrollment of the most critically ill hospitalized patients with COVID-19.
Enrollment continues in the trials for moderately ill hospitalized COVID-19 patients, the statement notes.
“Whether the use of full-dose compared to low-dose anticoagulants leads to better outcomes in hospitalized patients with less COVID-19 severe disease remains a very important question,” the NHLBI statement says.
Patients who require full dose anticoagulants for another medical indication are not included in these trials.
The statement explains that COVID-19 is associated with significant inflammation and clinical and pathologic evidence of widespread blood clots. These trials were launched because clinicians have observed that many patients ill with COVID-19, including those who have died from the disease, formed blood clots throughout their bodies, even in their smallest blood vessels. This unusual clotting can cause multiple health complications, including lung failure, myocardial infarction, and stroke.
The three trials are the result of a collaboration between major international partners. The trials include: the Randomized, Embedded, Multi-factorial Adaptive Platform Trial for Community-Acquired Pneumonia (REMAP-CAP) Therapeutic Anticoagulation; Accelerating COVID-19 Therapeutic Interventions and Vaccines-4 (ACTIV-4) Antithrombotics Inpatient; and Antithrombotic Therapy to Ameliorate Complications of COVID-19 (ATTACC).
The trials, which span four continents, have the common goal of assessing the benefit of full doses of anticoagulants to treat moderately ill or critically ill adults hospitalized for COVID-19, compared with a lower dose often used to prevent blood clots in hospitalized patients.
In the United States, the ACTIV-4 trial is being led by a collaborative effort involving a number of universities, including the University of Pittsburgh and New York University.
The trials are supported by multiple international funding organizations including the National Institutes of Health, Canadian Institutes of Health Research, the National Institute for Health Research (UK), the National Health and Medical Research Council (Australia), and the PREPARE and RECOVER consortia (European Union).
A version of this story first appeared on Medscape.com.
Parts of three linked studies investigating increased levels of anticoagulation in hospitalized COVID-19 patients have been “paused” because of futility and safety concerns, a statement from the U.S. National Heart, Lung, and Blood Institute (NHLBI) confirms.
The trials involved are the REMAP-CAP, ACTIV-4, and ATTACC studies.
The statement also says that a potential for harm in this subgroup could not be excluded, noting that increased bleeding is a known complication of full-dose anticoagulation. The trials are working urgently to undertake additional analyses, which will be made available as soon as possible.
The three clinical trial platforms are working together to test the effects of full therapeutic doses of anticoagulants vs. lower prophylactic doses in COVID-19 patients.
Informed by the deliberations of the data safety monitoring boards of these trials, all of the trial sites have paused enrollment of the most critically ill hospitalized patients with COVID-19.
Enrollment continues in the trials for moderately ill hospitalized COVID-19 patients, the statement notes.
“Whether the use of full-dose compared to low-dose anticoagulants leads to better outcomes in hospitalized patients with less COVID-19 severe disease remains a very important question,” the NHLBI statement says.
Patients who require full dose anticoagulants for another medical indication are not included in these trials.
The statement explains that COVID-19 is associated with significant inflammation and clinical and pathologic evidence of widespread blood clots. These trials were launched because clinicians have observed that many patients ill with COVID-19, including those who have died from the disease, formed blood clots throughout their bodies, even in their smallest blood vessels. This unusual clotting can cause multiple health complications, including lung failure, myocardial infarction, and stroke.
The three trials are the result of a collaboration between major international partners. The trials include: the Randomized, Embedded, Multi-factorial Adaptive Platform Trial for Community-Acquired Pneumonia (REMAP-CAP) Therapeutic Anticoagulation; Accelerating COVID-19 Therapeutic Interventions and Vaccines-4 (ACTIV-4) Antithrombotics Inpatient; and Antithrombotic Therapy to Ameliorate Complications of COVID-19 (ATTACC).
The trials, which span four continents, have the common goal of assessing the benefit of full doses of anticoagulants to treat moderately ill or critically ill adults hospitalized for COVID-19, compared with a lower dose often used to prevent blood clots in hospitalized patients.
In the United States, the ACTIV-4 trial is being led by a collaborative effort involving a number of universities, including the University of Pittsburgh and New York University.
The trials are supported by multiple international funding organizations including the National Institutes of Health, Canadian Institutes of Health Research, the National Institute for Health Research (UK), the National Health and Medical Research Council (Australia), and the PREPARE and RECOVER consortia (European Union).
A version of this story first appeared on Medscape.com.
Parts of three linked studies investigating increased levels of anticoagulation in hospitalized COVID-19 patients have been “paused” because of futility and safety concerns, a statement from the U.S. National Heart, Lung, and Blood Institute (NHLBI) confirms.
The trials involved are the REMAP-CAP, ACTIV-4, and ATTACC studies.
The statement also says that a potential for harm in this subgroup could not be excluded, noting that increased bleeding is a known complication of full-dose anticoagulation. The trials are working urgently to undertake additional analyses, which will be made available as soon as possible.
The three clinical trial platforms are working together to test the effects of full therapeutic doses of anticoagulants vs. lower prophylactic doses in COVID-19 patients.
Informed by the deliberations of the data safety monitoring boards of these trials, all of the trial sites have paused enrollment of the most critically ill hospitalized patients with COVID-19.
Enrollment continues in the trials for moderately ill hospitalized COVID-19 patients, the statement notes.
“Whether the use of full-dose compared to low-dose anticoagulants leads to better outcomes in hospitalized patients with less COVID-19 severe disease remains a very important question,” the NHLBI statement says.
Patients who require full dose anticoagulants for another medical indication are not included in these trials.
The statement explains that COVID-19 is associated with significant inflammation and clinical and pathologic evidence of widespread blood clots. These trials were launched because clinicians have observed that many patients ill with COVID-19, including those who have died from the disease, formed blood clots throughout their bodies, even in their smallest blood vessels. This unusual clotting can cause multiple health complications, including lung failure, myocardial infarction, and stroke.
The three trials are the result of a collaboration between major international partners. The trials include: the Randomized, Embedded, Multi-factorial Adaptive Platform Trial for Community-Acquired Pneumonia (REMAP-CAP) Therapeutic Anticoagulation; Accelerating COVID-19 Therapeutic Interventions and Vaccines-4 (ACTIV-4) Antithrombotics Inpatient; and Antithrombotic Therapy to Ameliorate Complications of COVID-19 (ATTACC).
The trials, which span four continents, have the common goal of assessing the benefit of full doses of anticoagulants to treat moderately ill or critically ill adults hospitalized for COVID-19, compared with a lower dose often used to prevent blood clots in hospitalized patients.
In the United States, the ACTIV-4 trial is being led by a collaborative effort involving a number of universities, including the University of Pittsburgh and New York University.
The trials are supported by multiple international funding organizations including the National Institutes of Health, Canadian Institutes of Health Research, the National Institute for Health Research (UK), the National Health and Medical Research Council (Australia), and the PREPARE and RECOVER consortia (European Union).
A version of this story first appeared on Medscape.com.
COVID-19–induced drop in first measles vaccinations sparks resurgence concerns
Widespread use of the MMR vaccine is not only crucial for protecting the community against infectious outbreaks, but also serves as the overall pacesetter for preventive services, said Sara M. Bode, MD and colleagues at Nationwide Children’s Hospital in Columbus.
As part of a bivariate logistic regression analysis, Dr. Bode and colleagues sought to evaluate changes in measles vaccination rates across 12 clinic sites of the Nationwide Children’s Hospital pediatric primary care network in Columbus among 23,534 children aged 16 months. The study period targeted the time between April and May 2020, when clinic access and appointment attendance declined following the start of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic, until the June-to-August 2020 time period, when clinical care was allowed to return.
The need for the study was prompted by Centers for Disease Control and Prevention reporting on a state-specific precipitous decline in MMR vaccination rates shortly after the onset of COVID-19 in May 2020. Citing the results of one study, such reductions in vaccination have raised concerns over the possibility of a measles resurgence, noted Dr. Bode and associates.
MMR vaccination rates begin to drop with onset of COVID-19 pandemic.
From March 2017 to March 2020, the average rate of MMR vaccination in 16-month-olds was 72%. It subsequently decreased to 67% from April to May 2020, and then dropped further to 62% during the period June to August, 2020 (P = .001). Those without insurance were less likely to be vaccinated than were those carrying private insurance or Medicaid.
Among patients who had not attended a preventive care visit after 12 months of age, the proportion who received vaccines declined during the same time periods, from 10% before the pandemic to 6% at the start of the pandemic and 3% during the summer months of 2020.
“Given the baseline low vaccination rates even before the pandemic and the subsequent decline, we face a critical need to improve timely vaccination and provide catch-up opportunities” in areas with the highest incidence of COVID-19, observed Dr. Bode and colleagues.
Innovative approaches are needed to encourage families to seek preventive care.
In response, the researchers announced the implementation of new community-based vaccination approaches in Ohio, including pop-up vaccine clinics, mobile clinics, and school-based clinics to provide families, who are reluctant to visit health care facilities over COVID-19 related concerns, with safe alternatives. “We believe that it is critical to develop innovative approaches to have families return for preventive care,” they added.
In a separate interview, Herschel Lessin, MD, a private practice pediatrician in Poughkeepsie, N.Y., noted: “This study confirms the anecdotal experience of pediatricians around the country, and our greatest fear that the pandemic will interfere with herd immunity of children for vaccine-preventable illness. Although the study was of urban offices with a primarily Medicaid population, I believe the results to be very worrisome should they prove to be generalizable to the country, as a whole. The significant reduction of well-child visits due to COVID-19 (and fear of COVID-19) seriously impaired the vaccination status of a standard required vaccine in a large population. What is even more worrisome is that the rates continued to fall even after the initial closure of many offices and well into their reopening, despite concerted efforts to try to catch up these missed visits and immunizations.”
Measles is an intensely contagious illness that has not been eradicated, as evidenced by the enormous measles outbreak stemming from Disneyland in 2014-2015, and again with the possible exposure of hundreds to an infected Disneyland visitor last fall, where coverage rates were even higher than in this study, added Dr. Lessin. “This phenomenon, unless forcefully remedied, could easily result in large outbreaks of other vaccine-preventable illness besides COVID-19,” he cautioned.
Dr. Bode and colleagues as well as Dr. Lessin had no conflicts of interest and no relevant financial disclosures.
SOURCE: Bode SM et al. Pediatrics. 2021. doi: 10.1542/peds.2020-035576.
Widespread use of the MMR vaccine is not only crucial for protecting the community against infectious outbreaks, but also serves as the overall pacesetter for preventive services, said Sara M. Bode, MD and colleagues at Nationwide Children’s Hospital in Columbus.
As part of a bivariate logistic regression analysis, Dr. Bode and colleagues sought to evaluate changes in measles vaccination rates across 12 clinic sites of the Nationwide Children’s Hospital pediatric primary care network in Columbus among 23,534 children aged 16 months. The study period targeted the time between April and May 2020, when clinic access and appointment attendance declined following the start of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic, until the June-to-August 2020 time period, when clinical care was allowed to return.
The need for the study was prompted by Centers for Disease Control and Prevention reporting on a state-specific precipitous decline in MMR vaccination rates shortly after the onset of COVID-19 in May 2020. Citing the results of one study, such reductions in vaccination have raised concerns over the possibility of a measles resurgence, noted Dr. Bode and associates.
MMR vaccination rates begin to drop with onset of COVID-19 pandemic.
From March 2017 to March 2020, the average rate of MMR vaccination in 16-month-olds was 72%. It subsequently decreased to 67% from April to May 2020, and then dropped further to 62% during the period June to August, 2020 (P = .001). Those without insurance were less likely to be vaccinated than were those carrying private insurance or Medicaid.
Among patients who had not attended a preventive care visit after 12 months of age, the proportion who received vaccines declined during the same time periods, from 10% before the pandemic to 6% at the start of the pandemic and 3% during the summer months of 2020.
“Given the baseline low vaccination rates even before the pandemic and the subsequent decline, we face a critical need to improve timely vaccination and provide catch-up opportunities” in areas with the highest incidence of COVID-19, observed Dr. Bode and colleagues.
Innovative approaches are needed to encourage families to seek preventive care.
In response, the researchers announced the implementation of new community-based vaccination approaches in Ohio, including pop-up vaccine clinics, mobile clinics, and school-based clinics to provide families, who are reluctant to visit health care facilities over COVID-19 related concerns, with safe alternatives. “We believe that it is critical to develop innovative approaches to have families return for preventive care,” they added.
In a separate interview, Herschel Lessin, MD, a private practice pediatrician in Poughkeepsie, N.Y., noted: “This study confirms the anecdotal experience of pediatricians around the country, and our greatest fear that the pandemic will interfere with herd immunity of children for vaccine-preventable illness. Although the study was of urban offices with a primarily Medicaid population, I believe the results to be very worrisome should they prove to be generalizable to the country, as a whole. The significant reduction of well-child visits due to COVID-19 (and fear of COVID-19) seriously impaired the vaccination status of a standard required vaccine in a large population. What is even more worrisome is that the rates continued to fall even after the initial closure of many offices and well into their reopening, despite concerted efforts to try to catch up these missed visits and immunizations.”
Measles is an intensely contagious illness that has not been eradicated, as evidenced by the enormous measles outbreak stemming from Disneyland in 2014-2015, and again with the possible exposure of hundreds to an infected Disneyland visitor last fall, where coverage rates were even higher than in this study, added Dr. Lessin. “This phenomenon, unless forcefully remedied, could easily result in large outbreaks of other vaccine-preventable illness besides COVID-19,” he cautioned.
Dr. Bode and colleagues as well as Dr. Lessin had no conflicts of interest and no relevant financial disclosures.
SOURCE: Bode SM et al. Pediatrics. 2021. doi: 10.1542/peds.2020-035576.
Widespread use of the MMR vaccine is not only crucial for protecting the community against infectious outbreaks, but also serves as the overall pacesetter for preventive services, said Sara M. Bode, MD and colleagues at Nationwide Children’s Hospital in Columbus.
As part of a bivariate logistic regression analysis, Dr. Bode and colleagues sought to evaluate changes in measles vaccination rates across 12 clinic sites of the Nationwide Children’s Hospital pediatric primary care network in Columbus among 23,534 children aged 16 months. The study period targeted the time between April and May 2020, when clinic access and appointment attendance declined following the start of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic, until the June-to-August 2020 time period, when clinical care was allowed to return.
The need for the study was prompted by Centers for Disease Control and Prevention reporting on a state-specific precipitous decline in MMR vaccination rates shortly after the onset of COVID-19 in May 2020. Citing the results of one study, such reductions in vaccination have raised concerns over the possibility of a measles resurgence, noted Dr. Bode and associates.
MMR vaccination rates begin to drop with onset of COVID-19 pandemic.
From March 2017 to March 2020, the average rate of MMR vaccination in 16-month-olds was 72%. It subsequently decreased to 67% from April to May 2020, and then dropped further to 62% during the period June to August, 2020 (P = .001). Those without insurance were less likely to be vaccinated than were those carrying private insurance or Medicaid.
Among patients who had not attended a preventive care visit after 12 months of age, the proportion who received vaccines declined during the same time periods, from 10% before the pandemic to 6% at the start of the pandemic and 3% during the summer months of 2020.
“Given the baseline low vaccination rates even before the pandemic and the subsequent decline, we face a critical need to improve timely vaccination and provide catch-up opportunities” in areas with the highest incidence of COVID-19, observed Dr. Bode and colleagues.
Innovative approaches are needed to encourage families to seek preventive care.
In response, the researchers announced the implementation of new community-based vaccination approaches in Ohio, including pop-up vaccine clinics, mobile clinics, and school-based clinics to provide families, who are reluctant to visit health care facilities over COVID-19 related concerns, with safe alternatives. “We believe that it is critical to develop innovative approaches to have families return for preventive care,” they added.
In a separate interview, Herschel Lessin, MD, a private practice pediatrician in Poughkeepsie, N.Y., noted: “This study confirms the anecdotal experience of pediatricians around the country, and our greatest fear that the pandemic will interfere with herd immunity of children for vaccine-preventable illness. Although the study was of urban offices with a primarily Medicaid population, I believe the results to be very worrisome should they prove to be generalizable to the country, as a whole. The significant reduction of well-child visits due to COVID-19 (and fear of COVID-19) seriously impaired the vaccination status of a standard required vaccine in a large population. What is even more worrisome is that the rates continued to fall even after the initial closure of many offices and well into their reopening, despite concerted efforts to try to catch up these missed visits and immunizations.”
Measles is an intensely contagious illness that has not been eradicated, as evidenced by the enormous measles outbreak stemming from Disneyland in 2014-2015, and again with the possible exposure of hundreds to an infected Disneyland visitor last fall, where coverage rates were even higher than in this study, added Dr. Lessin. “This phenomenon, unless forcefully remedied, could easily result in large outbreaks of other vaccine-preventable illness besides COVID-19,” he cautioned.
Dr. Bode and colleagues as well as Dr. Lessin had no conflicts of interest and no relevant financial disclosures.
SOURCE: Bode SM et al. Pediatrics. 2021. doi: 10.1542/peds.2020-035576.
FROM PEDIATRICS
Latest rise in child COVID-19 cases is relatively small
For the seventh week out of the last eight, more new cases of COVID-19 in children were reported in the United States than any week before, according to a report from the American Academy of Pediatrics and the Children’s Hospital Association.
There were just over 182,000 new cases of COVID-19 in children during the week ending Dec. 17, topping the previous high of almost 179,000 set the previous week. – a stretch of 11 weeks that has produced only one decline, based on data from the latest AAP/CHA weekly report.
As of Dec. 17, there had been over 1.8 million cases of COVID-19 in children, which represents 12.3% of all U.S. cases. For the week, 14% of all cases occurred in children, which was up slightly from 13.8% the week before (Dec. 10). The overall rate of coronavirus infection is now 2,420 cases per 100,000 children in the population, the AAP and CHA said.
A total of 30 states are above that national rate, with North Dakota the highest at 7,515 cases per 100,000 children, followed by South Dakota (5,618), Wyoming (5,157), Wisconsin (5,106), and Tennessee (4,994). Wyoming has the highest proportion of cases occurring in children at 20.8%, but that is down from 23.4% in mid-November, based on data collected by the AAP and CHA from the health department websites of 49 states (New York does not provide age distributions), the District of Columbia, New York City, Puerto Rico, and Guam.
In the last 2 weeks, however, the largest percent increases in new cases came in states with low-to-average rates of cumulative child infection. California, Connecticut, Delaware, Maine, Maryland, New Hampshire, and Vermont all saw increases of over 35% from Dec. 3 to Dec. 17, while the smallest increases occurred in Hawaii, North Dakota, and Wyoming, the AAP and CHA reported.
For the seventh week out of the last eight, more new cases of COVID-19 in children were reported in the United States than any week before, according to a report from the American Academy of Pediatrics and the Children’s Hospital Association.
There were just over 182,000 new cases of COVID-19 in children during the week ending Dec. 17, topping the previous high of almost 179,000 set the previous week. – a stretch of 11 weeks that has produced only one decline, based on data from the latest AAP/CHA weekly report.
As of Dec. 17, there had been over 1.8 million cases of COVID-19 in children, which represents 12.3% of all U.S. cases. For the week, 14% of all cases occurred in children, which was up slightly from 13.8% the week before (Dec. 10). The overall rate of coronavirus infection is now 2,420 cases per 100,000 children in the population, the AAP and CHA said.
A total of 30 states are above that national rate, with North Dakota the highest at 7,515 cases per 100,000 children, followed by South Dakota (5,618), Wyoming (5,157), Wisconsin (5,106), and Tennessee (4,994). Wyoming has the highest proportion of cases occurring in children at 20.8%, but that is down from 23.4% in mid-November, based on data collected by the AAP and CHA from the health department websites of 49 states (New York does not provide age distributions), the District of Columbia, New York City, Puerto Rico, and Guam.
In the last 2 weeks, however, the largest percent increases in new cases came in states with low-to-average rates of cumulative child infection. California, Connecticut, Delaware, Maine, Maryland, New Hampshire, and Vermont all saw increases of over 35% from Dec. 3 to Dec. 17, while the smallest increases occurred in Hawaii, North Dakota, and Wyoming, the AAP and CHA reported.
For the seventh week out of the last eight, more new cases of COVID-19 in children were reported in the United States than any week before, according to a report from the American Academy of Pediatrics and the Children’s Hospital Association.
There were just over 182,000 new cases of COVID-19 in children during the week ending Dec. 17, topping the previous high of almost 179,000 set the previous week. – a stretch of 11 weeks that has produced only one decline, based on data from the latest AAP/CHA weekly report.
As of Dec. 17, there had been over 1.8 million cases of COVID-19 in children, which represents 12.3% of all U.S. cases. For the week, 14% of all cases occurred in children, which was up slightly from 13.8% the week before (Dec. 10). The overall rate of coronavirus infection is now 2,420 cases per 100,000 children in the population, the AAP and CHA said.
A total of 30 states are above that national rate, with North Dakota the highest at 7,515 cases per 100,000 children, followed by South Dakota (5,618), Wyoming (5,157), Wisconsin (5,106), and Tennessee (4,994). Wyoming has the highest proportion of cases occurring in children at 20.8%, but that is down from 23.4% in mid-November, based on data collected by the AAP and CHA from the health department websites of 49 states (New York does not provide age distributions), the District of Columbia, New York City, Puerto Rico, and Guam.
In the last 2 weeks, however, the largest percent increases in new cases came in states with low-to-average rates of cumulative child infection. California, Connecticut, Delaware, Maine, Maryland, New Hampshire, and Vermont all saw increases of over 35% from Dec. 3 to Dec. 17, while the smallest increases occurred in Hawaii, North Dakota, and Wyoming, the AAP and CHA reported.
Shortcomings identified in study of acne videos on TikTok
, according to an analysis of the top 100 videos using a consumer health validation tool.
The popularity of TikTok among adolescents in particular has implications for the dissemination of acne information, as some teens become “skinfluencers” and receive sponsorship from skin care brands in exchange for social media promotion, wrote David X. Zheng, BA, of the department of dermatology, Case Western Reserve University, Cleveland, and colleagues.
“However, the quality of dermatologic information found on TikTok is largely unknown,” they said.
In a brief report published in Pediatric Dermatology, the researchers identified the top 100 videos on TikTok on May 1, 2020, that were tagged with “#acne.” The information on each video included date of upload, type and gender of the individual uploading the video, physician specialty if applicable, and video category. These top 100 videos had 13,470,501 likes and 64,775 comments over a 7.6-month time period.
The researchers used the DISCERN criteria, a validated 1-5 scale designed to assess consumer health information, to evaluate the video content, with 1 (having “serious” or “extensive shortcomings”) and 5 (having “minimal shortcomings.”)
Overall, the average quality rating of the TikTok acne videos was 2.03. A total of 9 videos were produced by board-certified physicians in the United States, with an average DISCERN score of 2.41.
“Analysis of the DISCERN criteria dimensions suggested that major shortcomings common to both physician and nonphysician uploaders included failure to cite information sources, discuss treatment risks, and provide support for shared decision-making,” the researchers said.
Approximately one-third (34%) of the videos fell into the treatment-product advertisement category, while 26% were personal anecdotes, 20% presented information related to acne, 13% featured home remedy treatments, and 7% were classified as “other.” The researchers also identified the top 200 “#acne” videos on TikTok once a week from May 8, 2020 to June 5, 2020, to determine the evolution of acne content on the app and found a turnover rate of 10.9% per week.
Based on the high turnover and low quality based on DISCERN ratings, the authors suggested that patients seeking acne information should “view acne-related TikTok videos with caution and consult evidence-based resources whenever possible.”
The study findings were limited by several factors including the small sample size of physicians uploading videos, lack of information about the number of nonphysician medical professionals who uploaded videos, and lack of information about the number of video views and country of origin, the researchers noted. However, the results highlight the need for dermatologists to be aware that patients, especially teens, may be using TikTok for acne information that may be of poor quality, they said.
“Conversely, we understand that social media can be a powerful tool for advancing health literacy,” the researchers noted. “Therefore, we also recommend that health care professionals engaging on TikTok create thorough and perhaps standardized educational videos regarding acne, as well as correct any acne-related misinformation that may be present,” they concluded.
The other authors of the study were from the departments of dermatology at Case Western Reserve, University Hospitals Cleveland, and Johns Hopkins University, Baltimore.
The study received no outside funding. The researchers had no financial conflicts to disclose.
SOURCE: Zheng DX et al. Pediatr Dermatol. 2020 Nov 28. doi: 10.1111/pde.14471.
, according to an analysis of the top 100 videos using a consumer health validation tool.
The popularity of TikTok among adolescents in particular has implications for the dissemination of acne information, as some teens become “skinfluencers” and receive sponsorship from skin care brands in exchange for social media promotion, wrote David X. Zheng, BA, of the department of dermatology, Case Western Reserve University, Cleveland, and colleagues.
“However, the quality of dermatologic information found on TikTok is largely unknown,” they said.
In a brief report published in Pediatric Dermatology, the researchers identified the top 100 videos on TikTok on May 1, 2020, that were tagged with “#acne.” The information on each video included date of upload, type and gender of the individual uploading the video, physician specialty if applicable, and video category. These top 100 videos had 13,470,501 likes and 64,775 comments over a 7.6-month time period.
The researchers used the DISCERN criteria, a validated 1-5 scale designed to assess consumer health information, to evaluate the video content, with 1 (having “serious” or “extensive shortcomings”) and 5 (having “minimal shortcomings.”)
Overall, the average quality rating of the TikTok acne videos was 2.03. A total of 9 videos were produced by board-certified physicians in the United States, with an average DISCERN score of 2.41.
“Analysis of the DISCERN criteria dimensions suggested that major shortcomings common to both physician and nonphysician uploaders included failure to cite information sources, discuss treatment risks, and provide support for shared decision-making,” the researchers said.
Approximately one-third (34%) of the videos fell into the treatment-product advertisement category, while 26% were personal anecdotes, 20% presented information related to acne, 13% featured home remedy treatments, and 7% were classified as “other.” The researchers also identified the top 200 “#acne” videos on TikTok once a week from May 8, 2020 to June 5, 2020, to determine the evolution of acne content on the app and found a turnover rate of 10.9% per week.
Based on the high turnover and low quality based on DISCERN ratings, the authors suggested that patients seeking acne information should “view acne-related TikTok videos with caution and consult evidence-based resources whenever possible.”
The study findings were limited by several factors including the small sample size of physicians uploading videos, lack of information about the number of nonphysician medical professionals who uploaded videos, and lack of information about the number of video views and country of origin, the researchers noted. However, the results highlight the need for dermatologists to be aware that patients, especially teens, may be using TikTok for acne information that may be of poor quality, they said.
“Conversely, we understand that social media can be a powerful tool for advancing health literacy,” the researchers noted. “Therefore, we also recommend that health care professionals engaging on TikTok create thorough and perhaps standardized educational videos regarding acne, as well as correct any acne-related misinformation that may be present,” they concluded.
The other authors of the study were from the departments of dermatology at Case Western Reserve, University Hospitals Cleveland, and Johns Hopkins University, Baltimore.
The study received no outside funding. The researchers had no financial conflicts to disclose.
SOURCE: Zheng DX et al. Pediatr Dermatol. 2020 Nov 28. doi: 10.1111/pde.14471.
, according to an analysis of the top 100 videos using a consumer health validation tool.
The popularity of TikTok among adolescents in particular has implications for the dissemination of acne information, as some teens become “skinfluencers” and receive sponsorship from skin care brands in exchange for social media promotion, wrote David X. Zheng, BA, of the department of dermatology, Case Western Reserve University, Cleveland, and colleagues.
“However, the quality of dermatologic information found on TikTok is largely unknown,” they said.
In a brief report published in Pediatric Dermatology, the researchers identified the top 100 videos on TikTok on May 1, 2020, that were tagged with “#acne.” The information on each video included date of upload, type and gender of the individual uploading the video, physician specialty if applicable, and video category. These top 100 videos had 13,470,501 likes and 64,775 comments over a 7.6-month time period.
The researchers used the DISCERN criteria, a validated 1-5 scale designed to assess consumer health information, to evaluate the video content, with 1 (having “serious” or “extensive shortcomings”) and 5 (having “minimal shortcomings.”)
Overall, the average quality rating of the TikTok acne videos was 2.03. A total of 9 videos were produced by board-certified physicians in the United States, with an average DISCERN score of 2.41.
“Analysis of the DISCERN criteria dimensions suggested that major shortcomings common to both physician and nonphysician uploaders included failure to cite information sources, discuss treatment risks, and provide support for shared decision-making,” the researchers said.
Approximately one-third (34%) of the videos fell into the treatment-product advertisement category, while 26% were personal anecdotes, 20% presented information related to acne, 13% featured home remedy treatments, and 7% were classified as “other.” The researchers also identified the top 200 “#acne” videos on TikTok once a week from May 8, 2020 to June 5, 2020, to determine the evolution of acne content on the app and found a turnover rate of 10.9% per week.
Based on the high turnover and low quality based on DISCERN ratings, the authors suggested that patients seeking acne information should “view acne-related TikTok videos with caution and consult evidence-based resources whenever possible.”
The study findings were limited by several factors including the small sample size of physicians uploading videos, lack of information about the number of nonphysician medical professionals who uploaded videos, and lack of information about the number of video views and country of origin, the researchers noted. However, the results highlight the need for dermatologists to be aware that patients, especially teens, may be using TikTok for acne information that may be of poor quality, they said.
“Conversely, we understand that social media can be a powerful tool for advancing health literacy,” the researchers noted. “Therefore, we also recommend that health care professionals engaging on TikTok create thorough and perhaps standardized educational videos regarding acne, as well as correct any acne-related misinformation that may be present,” they concluded.
The other authors of the study were from the departments of dermatology at Case Western Reserve, University Hospitals Cleveland, and Johns Hopkins University, Baltimore.
The study received no outside funding. The researchers had no financial conflicts to disclose.
SOURCE: Zheng DX et al. Pediatr Dermatol. 2020 Nov 28. doi: 10.1111/pde.14471.
FROM PEDIATRIC DERMATOLOGY
ASH guidelines for venous thromboembolism: What family physicians need to know
Each year in the United States, approximately one to two out of every thousand people suffer from venous thromboembolism (VTE), including deep vein thrombosis and pulmonary embolism. .
These guidelines, which were recently published in Blood Advances (Ortel T L et al. Blood Adv 2020 doi: 10.1182/bloodadvances.2020001830), include 28 recommendations.
How to treat uncomplicated patients
For uncomplicated deep vein thrombosis (DVT) and/or pulmonary embolism (PE), the guidelines suggest treating patients at home rather than in the hospital. This is especially important for family physicians to note as many of these patients will now be the responsibility of the primary care doctor to treat and follow. Patients treated at home can avoid the risk of nosocomial infections, especially in the days of COVID-19. Evidence also suggests that being treated at home was shown to reduce the risk of PE versus being treated in the hospital. It is, therefore, crucial that family physicians know which patients are low versus high risk.
Further, the guidelines suggest that these patients with low risk of complications are better treated with direct oral anticoagulants (DOACs) instead of vitamin K antagonists, such as Coumadin.
Medication-related suggestions
The guidelines also suggest that no DOAC is preferred over another. Since DOACs are relatively newer agents, family doctors need to become comfortable with their use. For proximal DVTs, anticoagulation alone can be used without thrombolytics.
Family physicians are often tasked with the decision on when to stop anticoagulation. The authors recommend against using diagnostic tests such as D-Dimer or ultrasound to decide when to stop these medications in low-risk patients. In patients at risk of recurrent VTE due to chronic medical conditions, it is suggested to continue anti-coagulants indefinitely. While anticoagulant therapy effectively reduces risk of VTE, it does increase the risk of bleeding events.
The guidelines are quite extensive and specific in their recommendations and family physicians need to understand them. We are often the first ones in the medical system to diagnose VTE, and it is quite possible to keep these patients home, thereby eliminating risks they may encounter by being hospitalized. In addition, the recommendation regarding the use of DOACs may ease some of the burden of monitoring patients on long-term Coumadin. These medications do not come without risks, and we must be comfortable evaluating for any complications. In our current health care system, different insurance companies have different formularies making it necessary for us to know all these medications.
In the past, the diagnosis of PE and even a DVT would mean a hospital stay. We now know, and these guidelines reaffirm, that this is not necessary in uncomplicated cases.
In addition to diagnosing VTE, family physicians are also tasked with following up with patients who were hospitalized or started on treatment by other physicians. We need to know the plan on when to stop the medication or when to reevaluate its use. Patients often bring this question to us, and these guidelines will help us answer that question.
Many patients who have more complicated medical conditions often see multiple specialists. The ASH recommendations help standardize the care of these patients across specialties.
What the recommendations are missing
As family doctors, we often treat patients with multiple comorbidities. These guidelines do not make recommendations for patients with cancer, who are at high risk of VTE events. Some patients also have conditions that increase their risk of bleeding or have contraindications to the use of anticoagulants. It would be helpful to have more recommendations for both of these types of patients in addition to the use of inferior vena cava filter in patients with proximal DVT. The document is also missing recommendations for pregnant patients, which would be useful.
Overall, these guidelines include much of what we already do in our practices while doing a great job of incorporating the newer DOACs. These guidelines are easy for family physicians to put into practice.
Dr. Girgis practices family medicine in South River, N.J., and is a clinical assistant professor of family medicine at Robert Wood Johnson Medical School, New Brunswick, N.J. You can contact her at fpnews@mdedge.com.
Each year in the United States, approximately one to two out of every thousand people suffer from venous thromboembolism (VTE), including deep vein thrombosis and pulmonary embolism. .
These guidelines, which were recently published in Blood Advances (Ortel T L et al. Blood Adv 2020 doi: 10.1182/bloodadvances.2020001830), include 28 recommendations.
How to treat uncomplicated patients
For uncomplicated deep vein thrombosis (DVT) and/or pulmonary embolism (PE), the guidelines suggest treating patients at home rather than in the hospital. This is especially important for family physicians to note as many of these patients will now be the responsibility of the primary care doctor to treat and follow. Patients treated at home can avoid the risk of nosocomial infections, especially in the days of COVID-19. Evidence also suggests that being treated at home was shown to reduce the risk of PE versus being treated in the hospital. It is, therefore, crucial that family physicians know which patients are low versus high risk.
Further, the guidelines suggest that these patients with low risk of complications are better treated with direct oral anticoagulants (DOACs) instead of vitamin K antagonists, such as Coumadin.
Medication-related suggestions
The guidelines also suggest that no DOAC is preferred over another. Since DOACs are relatively newer agents, family doctors need to become comfortable with their use. For proximal DVTs, anticoagulation alone can be used without thrombolytics.
Family physicians are often tasked with the decision on when to stop anticoagulation. The authors recommend against using diagnostic tests such as D-Dimer or ultrasound to decide when to stop these medications in low-risk patients. In patients at risk of recurrent VTE due to chronic medical conditions, it is suggested to continue anti-coagulants indefinitely. While anticoagulant therapy effectively reduces risk of VTE, it does increase the risk of bleeding events.
The guidelines are quite extensive and specific in their recommendations and family physicians need to understand them. We are often the first ones in the medical system to diagnose VTE, and it is quite possible to keep these patients home, thereby eliminating risks they may encounter by being hospitalized. In addition, the recommendation regarding the use of DOACs may ease some of the burden of monitoring patients on long-term Coumadin. These medications do not come without risks, and we must be comfortable evaluating for any complications. In our current health care system, different insurance companies have different formularies making it necessary for us to know all these medications.
In the past, the diagnosis of PE and even a DVT would mean a hospital stay. We now know, and these guidelines reaffirm, that this is not necessary in uncomplicated cases.
In addition to diagnosing VTE, family physicians are also tasked with following up with patients who were hospitalized or started on treatment by other physicians. We need to know the plan on when to stop the medication or when to reevaluate its use. Patients often bring this question to us, and these guidelines will help us answer that question.
Many patients who have more complicated medical conditions often see multiple specialists. The ASH recommendations help standardize the care of these patients across specialties.
What the recommendations are missing
As family doctors, we often treat patients with multiple comorbidities. These guidelines do not make recommendations for patients with cancer, who are at high risk of VTE events. Some patients also have conditions that increase their risk of bleeding or have contraindications to the use of anticoagulants. It would be helpful to have more recommendations for both of these types of patients in addition to the use of inferior vena cava filter in patients with proximal DVT. The document is also missing recommendations for pregnant patients, which would be useful.
Overall, these guidelines include much of what we already do in our practices while doing a great job of incorporating the newer DOACs. These guidelines are easy for family physicians to put into practice.
Dr. Girgis practices family medicine in South River, N.J., and is a clinical assistant professor of family medicine at Robert Wood Johnson Medical School, New Brunswick, N.J. You can contact her at fpnews@mdedge.com.
Each year in the United States, approximately one to two out of every thousand people suffer from venous thromboembolism (VTE), including deep vein thrombosis and pulmonary embolism. .
These guidelines, which were recently published in Blood Advances (Ortel T L et al. Blood Adv 2020 doi: 10.1182/bloodadvances.2020001830), include 28 recommendations.
How to treat uncomplicated patients
For uncomplicated deep vein thrombosis (DVT) and/or pulmonary embolism (PE), the guidelines suggest treating patients at home rather than in the hospital. This is especially important for family physicians to note as many of these patients will now be the responsibility of the primary care doctor to treat and follow. Patients treated at home can avoid the risk of nosocomial infections, especially in the days of COVID-19. Evidence also suggests that being treated at home was shown to reduce the risk of PE versus being treated in the hospital. It is, therefore, crucial that family physicians know which patients are low versus high risk.
Further, the guidelines suggest that these patients with low risk of complications are better treated with direct oral anticoagulants (DOACs) instead of vitamin K antagonists, such as Coumadin.
Medication-related suggestions
The guidelines also suggest that no DOAC is preferred over another. Since DOACs are relatively newer agents, family doctors need to become comfortable with their use. For proximal DVTs, anticoagulation alone can be used without thrombolytics.
Family physicians are often tasked with the decision on when to stop anticoagulation. The authors recommend against using diagnostic tests such as D-Dimer or ultrasound to decide when to stop these medications in low-risk patients. In patients at risk of recurrent VTE due to chronic medical conditions, it is suggested to continue anti-coagulants indefinitely. While anticoagulant therapy effectively reduces risk of VTE, it does increase the risk of bleeding events.
The guidelines are quite extensive and specific in their recommendations and family physicians need to understand them. We are often the first ones in the medical system to diagnose VTE, and it is quite possible to keep these patients home, thereby eliminating risks they may encounter by being hospitalized. In addition, the recommendation regarding the use of DOACs may ease some of the burden of monitoring patients on long-term Coumadin. These medications do not come without risks, and we must be comfortable evaluating for any complications. In our current health care system, different insurance companies have different formularies making it necessary for us to know all these medications.
In the past, the diagnosis of PE and even a DVT would mean a hospital stay. We now know, and these guidelines reaffirm, that this is not necessary in uncomplicated cases.
In addition to diagnosing VTE, family physicians are also tasked with following up with patients who were hospitalized or started on treatment by other physicians. We need to know the plan on when to stop the medication or when to reevaluate its use. Patients often bring this question to us, and these guidelines will help us answer that question.
Many patients who have more complicated medical conditions often see multiple specialists. The ASH recommendations help standardize the care of these patients across specialties.
What the recommendations are missing
As family doctors, we often treat patients with multiple comorbidities. These guidelines do not make recommendations for patients with cancer, who are at high risk of VTE events. Some patients also have conditions that increase their risk of bleeding or have contraindications to the use of anticoagulants. It would be helpful to have more recommendations for both of these types of patients in addition to the use of inferior vena cava filter in patients with proximal DVT. The document is also missing recommendations for pregnant patients, which would be useful.
Overall, these guidelines include much of what we already do in our practices while doing a great job of incorporating the newer DOACs. These guidelines are easy for family physicians to put into practice.
Dr. Girgis practices family medicine in South River, N.J., and is a clinical assistant professor of family medicine at Robert Wood Johnson Medical School, New Brunswick, N.J. You can contact her at fpnews@mdedge.com.
Tackling screen time from birth
In this day and age, a new question should make its way to the top of the list for new parents and their pediatricians: How will the family approach the issue of household technology use – for their children as well as themselves?
Even the most vigilant among them will find much available guidance conflicting – and a good deal of it may feel oblivious to their day-to-day realities. This is especially true now, as many families face the daunting demands of pandemic parenting – juggling full-time jobs with childcare and distance learning.
While the American Academy of Pediatrics still specifies daily time limits by age (difficult for many families to achieve even in “normal” times), pediatricians and other child development experts now recognize that a host of factors should inform decisions about healthy screen use. There’s no one “magic number” for acceptable daily use, as not all screen time is the same (particularly during the pandemic) – and different children will experience the effects of technology usage differently.
The quality of content the child engages with; the degree of parental involvement; and the individual cognitive and behavioral considerations of a child are just some of the factors that should be considered. Given the complexities, it’s unfortunate that many parents will not have discussed screen use with their pediatrician or even their partner before their child first reaches for that glowing screen – and certainly not before they are using technology to multitask work, social connections, and day-to-day child rearing. Screen habits form early for both children and families.
An early well-visit priority
Pediatricians have an important role to play in helping families develop a more purposeful approach to household technology by providing them with trusted, evidence-based information on screens and the potential impact on children’s development. This is not information parents should receive when a child is 2 or 3 years of age. By then, toddlers are often already avid tablet users and parents may have come to rely on technology as a parenting aid.
Parents also need to know that, from birth, they can influence their child’s brain and communication development through undistracted time for talking, reading, singing, and interacting with their baby. Though the way children develop speech and language skills has not changed, the level of distraction posed by technology has grown immensely. It is much more difficult for parents to notice a baby’s subtle communication attempts – a coo or a smile, for instance, and respond accordingly – with a smartphone in hand. Rather than admonish parents for overusing their devices, we can focus them on what supports healthy child development instead.
By talking to parents earlier, pediatricians can help prevent premature or excessive exposure to technology – as well as encourage parents to dedicate “unplugged” times of day with their baby, such as during feeding time or before bedtime. By accenting the positive – educating parents about how they can encourage development and growth, how they can bond with their baby, and how they can establish a loving and nurturing relationship – pediatricians can motivate them towards simple steps that limit technology’s disruption of daily developmental opportunities. They can also help them lay a solid foundation for healthy screen time habits in the long term for their family.
The critical period for speech and language development is early
The impact of screen use on a child’s communication development is a significant concern. The critical time window for the development of speech, language, and social skills is between birth and 3 years. What happens then is the precursor for later reading and writing skills that are key to academic and vocational success.
A meta-analysis published in JAMA Pediatrics in July 2020 found that greater quantity of screen use was associated with poorer language skills – while screen-use onset at later ages was also associated with stronger child language skills. A November 2019 JAMA Pediatrics study using brain imaging in pre–school age children found an association between increased screen-based media use, compared with the AAP guidelines, and lower integrity of white matter tracts supporting language and emergent literacy skills. That study also used several language and literacy tests, finding that children with higher screen exposure had poorer expressive language and worse language processing speed. A 2017 study of 900 children between 18 and 24 months found that every 30-minute increase in daily screen time was linked to a 49% increased risk of expressive speech delay. And on the parental side, numerous studies have documented decreased verbal and nonverbal interactions initiated by parents when they are using a device.
Be tech wise with baby
AAP offers many resources in its Media and Children Communication Toolkit that serve as helpful starting points for conversations, including its family media use plan templates. However, more resources tailored to parents of newborns and very young children are needed.
One new option recently developed by the American Speech-Language-Hearing Association (ASHA) and the Children’s Screen Time Action Network is Be Tech Wise With Baby! Aimed at prospective and new parents, this simple handout, available for free in English and Spanish, is an easy takeaway from early well-child visits that pediatricians and pediatric nurses can distribute.
Pediatricians have a vital role to play championing healthy, balanced screen time use for children and adults – starting from baby’s first moments of life. By guiding new parents towards simple steps, such as carving out tech-free times of day and delaying introduction of screens, they can positively influence the screen-time habits of the next generation of connected kids.
Mark Bertin, MD, is a developmental pediatrician and author of numerous parenting books, including “How Children Thrive: The Practical Science of Raising Independent, Resilient, and Happy Kids” and “Mindful Parenting for ADHD.” Diane Paul, PhD, CCC-SLP, is the director of clinical issues in speech-language pathology for the American Speech-Language-Hearing Association (ASHA) and author of numerous books, including “Talking on the Go: Everyday Activities to Enhance Speech and Language Development.” Email them at pdnews@mdedge.com.
In this day and age, a new question should make its way to the top of the list for new parents and their pediatricians: How will the family approach the issue of household technology use – for their children as well as themselves?
Even the most vigilant among them will find much available guidance conflicting – and a good deal of it may feel oblivious to their day-to-day realities. This is especially true now, as many families face the daunting demands of pandemic parenting – juggling full-time jobs with childcare and distance learning.
While the American Academy of Pediatrics still specifies daily time limits by age (difficult for many families to achieve even in “normal” times), pediatricians and other child development experts now recognize that a host of factors should inform decisions about healthy screen use. There’s no one “magic number” for acceptable daily use, as not all screen time is the same (particularly during the pandemic) – and different children will experience the effects of technology usage differently.
The quality of content the child engages with; the degree of parental involvement; and the individual cognitive and behavioral considerations of a child are just some of the factors that should be considered. Given the complexities, it’s unfortunate that many parents will not have discussed screen use with their pediatrician or even their partner before their child first reaches for that glowing screen – and certainly not before they are using technology to multitask work, social connections, and day-to-day child rearing. Screen habits form early for both children and families.
An early well-visit priority
Pediatricians have an important role to play in helping families develop a more purposeful approach to household technology by providing them with trusted, evidence-based information on screens and the potential impact on children’s development. This is not information parents should receive when a child is 2 or 3 years of age. By then, toddlers are often already avid tablet users and parents may have come to rely on technology as a parenting aid.
Parents also need to know that, from birth, they can influence their child’s brain and communication development through undistracted time for talking, reading, singing, and interacting with their baby. Though the way children develop speech and language skills has not changed, the level of distraction posed by technology has grown immensely. It is much more difficult for parents to notice a baby’s subtle communication attempts – a coo or a smile, for instance, and respond accordingly – with a smartphone in hand. Rather than admonish parents for overusing their devices, we can focus them on what supports healthy child development instead.
By talking to parents earlier, pediatricians can help prevent premature or excessive exposure to technology – as well as encourage parents to dedicate “unplugged” times of day with their baby, such as during feeding time or before bedtime. By accenting the positive – educating parents about how they can encourage development and growth, how they can bond with their baby, and how they can establish a loving and nurturing relationship – pediatricians can motivate them towards simple steps that limit technology’s disruption of daily developmental opportunities. They can also help them lay a solid foundation for healthy screen time habits in the long term for their family.
The critical period for speech and language development is early
The impact of screen use on a child’s communication development is a significant concern. The critical time window for the development of speech, language, and social skills is between birth and 3 years. What happens then is the precursor for later reading and writing skills that are key to academic and vocational success.
A meta-analysis published in JAMA Pediatrics in July 2020 found that greater quantity of screen use was associated with poorer language skills – while screen-use onset at later ages was also associated with stronger child language skills. A November 2019 JAMA Pediatrics study using brain imaging in pre–school age children found an association between increased screen-based media use, compared with the AAP guidelines, and lower integrity of white matter tracts supporting language and emergent literacy skills. That study also used several language and literacy tests, finding that children with higher screen exposure had poorer expressive language and worse language processing speed. A 2017 study of 900 children between 18 and 24 months found that every 30-minute increase in daily screen time was linked to a 49% increased risk of expressive speech delay. And on the parental side, numerous studies have documented decreased verbal and nonverbal interactions initiated by parents when they are using a device.
Be tech wise with baby
AAP offers many resources in its Media and Children Communication Toolkit that serve as helpful starting points for conversations, including its family media use plan templates. However, more resources tailored to parents of newborns and very young children are needed.
One new option recently developed by the American Speech-Language-Hearing Association (ASHA) and the Children’s Screen Time Action Network is Be Tech Wise With Baby! Aimed at prospective and new parents, this simple handout, available for free in English and Spanish, is an easy takeaway from early well-child visits that pediatricians and pediatric nurses can distribute.
Pediatricians have a vital role to play championing healthy, balanced screen time use for children and adults – starting from baby’s first moments of life. By guiding new parents towards simple steps, such as carving out tech-free times of day and delaying introduction of screens, they can positively influence the screen-time habits of the next generation of connected kids.
Mark Bertin, MD, is a developmental pediatrician and author of numerous parenting books, including “How Children Thrive: The Practical Science of Raising Independent, Resilient, and Happy Kids” and “Mindful Parenting for ADHD.” Diane Paul, PhD, CCC-SLP, is the director of clinical issues in speech-language pathology for the American Speech-Language-Hearing Association (ASHA) and author of numerous books, including “Talking on the Go: Everyday Activities to Enhance Speech and Language Development.” Email them at pdnews@mdedge.com.
In this day and age, a new question should make its way to the top of the list for new parents and their pediatricians: How will the family approach the issue of household technology use – for their children as well as themselves?
Even the most vigilant among them will find much available guidance conflicting – and a good deal of it may feel oblivious to their day-to-day realities. This is especially true now, as many families face the daunting demands of pandemic parenting – juggling full-time jobs with childcare and distance learning.
While the American Academy of Pediatrics still specifies daily time limits by age (difficult for many families to achieve even in “normal” times), pediatricians and other child development experts now recognize that a host of factors should inform decisions about healthy screen use. There’s no one “magic number” for acceptable daily use, as not all screen time is the same (particularly during the pandemic) – and different children will experience the effects of technology usage differently.
The quality of content the child engages with; the degree of parental involvement; and the individual cognitive and behavioral considerations of a child are just some of the factors that should be considered. Given the complexities, it’s unfortunate that many parents will not have discussed screen use with their pediatrician or even their partner before their child first reaches for that glowing screen – and certainly not before they are using technology to multitask work, social connections, and day-to-day child rearing. Screen habits form early for both children and families.
An early well-visit priority
Pediatricians have an important role to play in helping families develop a more purposeful approach to household technology by providing them with trusted, evidence-based information on screens and the potential impact on children’s development. This is not information parents should receive when a child is 2 or 3 years of age. By then, toddlers are often already avid tablet users and parents may have come to rely on technology as a parenting aid.
Parents also need to know that, from birth, they can influence their child’s brain and communication development through undistracted time for talking, reading, singing, and interacting with their baby. Though the way children develop speech and language skills has not changed, the level of distraction posed by technology has grown immensely. It is much more difficult for parents to notice a baby’s subtle communication attempts – a coo or a smile, for instance, and respond accordingly – with a smartphone in hand. Rather than admonish parents for overusing their devices, we can focus them on what supports healthy child development instead.
By talking to parents earlier, pediatricians can help prevent premature or excessive exposure to technology – as well as encourage parents to dedicate “unplugged” times of day with their baby, such as during feeding time or before bedtime. By accenting the positive – educating parents about how they can encourage development and growth, how they can bond with their baby, and how they can establish a loving and nurturing relationship – pediatricians can motivate them towards simple steps that limit technology’s disruption of daily developmental opportunities. They can also help them lay a solid foundation for healthy screen time habits in the long term for their family.
The critical period for speech and language development is early
The impact of screen use on a child’s communication development is a significant concern. The critical time window for the development of speech, language, and social skills is between birth and 3 years. What happens then is the precursor for later reading and writing skills that are key to academic and vocational success.
A meta-analysis published in JAMA Pediatrics in July 2020 found that greater quantity of screen use was associated with poorer language skills – while screen-use onset at later ages was also associated with stronger child language skills. A November 2019 JAMA Pediatrics study using brain imaging in pre–school age children found an association between increased screen-based media use, compared with the AAP guidelines, and lower integrity of white matter tracts supporting language and emergent literacy skills. That study also used several language and literacy tests, finding that children with higher screen exposure had poorer expressive language and worse language processing speed. A 2017 study of 900 children between 18 and 24 months found that every 30-minute increase in daily screen time was linked to a 49% increased risk of expressive speech delay. And on the parental side, numerous studies have documented decreased verbal and nonverbal interactions initiated by parents when they are using a device.
Be tech wise with baby
AAP offers many resources in its Media and Children Communication Toolkit that serve as helpful starting points for conversations, including its family media use plan templates. However, more resources tailored to parents of newborns and very young children are needed.
One new option recently developed by the American Speech-Language-Hearing Association (ASHA) and the Children’s Screen Time Action Network is Be Tech Wise With Baby! Aimed at prospective and new parents, this simple handout, available for free in English and Spanish, is an easy takeaway from early well-child visits that pediatricians and pediatric nurses can distribute.
Pediatricians have a vital role to play championing healthy, balanced screen time use for children and adults – starting from baby’s first moments of life. By guiding new parents towards simple steps, such as carving out tech-free times of day and delaying introduction of screens, they can positively influence the screen-time habits of the next generation of connected kids.
Mark Bertin, MD, is a developmental pediatrician and author of numerous parenting books, including “How Children Thrive: The Practical Science of Raising Independent, Resilient, and Happy Kids” and “Mindful Parenting for ADHD.” Diane Paul, PhD, CCC-SLP, is the director of clinical issues in speech-language pathology for the American Speech-Language-Hearing Association (ASHA) and author of numerous books, including “Talking on the Go: Everyday Activities to Enhance Speech and Language Development.” Email them at pdnews@mdedge.com.
On being an elite
Regardless of who received the most electoral votes it is pretty clear that each candidate has millions of supporters, and that they are separated by only a few percentage points. I guess one could argue that so many people being able to express their opinions is healthy. However, from my side of the divide I have difficulty understanding how so many of my fellow citizens could arrive at an opinion so diametrically opposed to my own.
Since the 2016 election I have tried to read as many articles as I could find in search of an explanation for that outcome and continuing partisan support. I have never had much interest in political science because it always sounded like an oxymoron. But I am willing to listen to anyone who claims to understand how so many other citizens can see the world so differently from the way I do. It simply may be that for whatever reason one person, in this case one man, has such charismatic power that his supporters willingly abandon the moral skeleton on which their lives had been draped. Or is this us versus them primarily a chasm between the elites and the nonelites?
I don’t know much about you but the fact that you are reading this column means that, like me, you are an elite. Even if you are a woman of color and the daughter of immigrants you have taken advantage of what opportunities you have been offered, stayed in school long enough to adopt a reverence for the scientific method, and have a job that pays well because you have acquired some expertise.
Tom Nichols, a political scientist teaching at Harvard Extension School, says that “expertise is a very exclusionary idea because it’s supposed to be: Not everybody gets a vote on how to fly the plane” (Why isn’t the right more afraid of COVID-19? by Christina Pazzanese, Harvard Gazette, Oct 30, 2020) This exclusivity may in part explain the cultural trend that has eroded faith in experts in general, but particularly around issues such as climate change. Ironically, although science continues to be held in esteem in our culture, many scientists have become targets for those citizens who wish to attack authority figures.
How is it that you and I as pediatricians have avoided those attacks and the derogatory label as “so-called experts”?
You may live and practice in a community where many of your patients’ families don’t share your political views. But you have probably been successful at maintaining a trusting relationship with them in large part because you have cast yourself in the role of an adviser and not a dictator. And, although at times it has been difficult, you have been careful to avoid sharing your advice in a manner that sounds condescending. You have succeeded in functioning as an expert while carefully disguising yourself as a nonelite.
However, you are skating on thin ice if you venture into topics that run counter to your patients’ religious beliefs. Theda Skocpol, professor of government and psychology at Harvard University, Cambridge, Mass., has observed that studies have shown that while religious conservatives are aware of the science and don’t reject the finding, “they resent the use of experts as political authorities.” This may explain why all across this diverse country, our patients are eager for and accepting of our advice on all manners of health-related issues until we step into a swampy area that threatens their political views – such as vaccination or gun control.
With one misstep in the wrong direction, you can go from being a compassionate adviser to an elitist “so-called expert.”
Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Other than a Littman stethoscope he accepted as a first-year medical student in 1966, Dr. Wilkoff reports having nothing to disclose. Email him at pdnews@mdedge.com.
Regardless of who received the most electoral votes it is pretty clear that each candidate has millions of supporters, and that they are separated by only a few percentage points. I guess one could argue that so many people being able to express their opinions is healthy. However, from my side of the divide I have difficulty understanding how so many of my fellow citizens could arrive at an opinion so diametrically opposed to my own.
Since the 2016 election I have tried to read as many articles as I could find in search of an explanation for that outcome and continuing partisan support. I have never had much interest in political science because it always sounded like an oxymoron. But I am willing to listen to anyone who claims to understand how so many other citizens can see the world so differently from the way I do. It simply may be that for whatever reason one person, in this case one man, has such charismatic power that his supporters willingly abandon the moral skeleton on which their lives had been draped. Or is this us versus them primarily a chasm between the elites and the nonelites?
I don’t know much about you but the fact that you are reading this column means that, like me, you are an elite. Even if you are a woman of color and the daughter of immigrants you have taken advantage of what opportunities you have been offered, stayed in school long enough to adopt a reverence for the scientific method, and have a job that pays well because you have acquired some expertise.
Tom Nichols, a political scientist teaching at Harvard Extension School, says that “expertise is a very exclusionary idea because it’s supposed to be: Not everybody gets a vote on how to fly the plane” (Why isn’t the right more afraid of COVID-19? by Christina Pazzanese, Harvard Gazette, Oct 30, 2020) This exclusivity may in part explain the cultural trend that has eroded faith in experts in general, but particularly around issues such as climate change. Ironically, although science continues to be held in esteem in our culture, many scientists have become targets for those citizens who wish to attack authority figures.
How is it that you and I as pediatricians have avoided those attacks and the derogatory label as “so-called experts”?
You may live and practice in a community where many of your patients’ families don’t share your political views. But you have probably been successful at maintaining a trusting relationship with them in large part because you have cast yourself in the role of an adviser and not a dictator. And, although at times it has been difficult, you have been careful to avoid sharing your advice in a manner that sounds condescending. You have succeeded in functioning as an expert while carefully disguising yourself as a nonelite.
However, you are skating on thin ice if you venture into topics that run counter to your patients’ religious beliefs. Theda Skocpol, professor of government and psychology at Harvard University, Cambridge, Mass., has observed that studies have shown that while religious conservatives are aware of the science and don’t reject the finding, “they resent the use of experts as political authorities.” This may explain why all across this diverse country, our patients are eager for and accepting of our advice on all manners of health-related issues until we step into a swampy area that threatens their political views – such as vaccination or gun control.
With one misstep in the wrong direction, you can go from being a compassionate adviser to an elitist “so-called expert.”
Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Other than a Littman stethoscope he accepted as a first-year medical student in 1966, Dr. Wilkoff reports having nothing to disclose. Email him at pdnews@mdedge.com.
Regardless of who received the most electoral votes it is pretty clear that each candidate has millions of supporters, and that they are separated by only a few percentage points. I guess one could argue that so many people being able to express their opinions is healthy. However, from my side of the divide I have difficulty understanding how so many of my fellow citizens could arrive at an opinion so diametrically opposed to my own.
Since the 2016 election I have tried to read as many articles as I could find in search of an explanation for that outcome and continuing partisan support. I have never had much interest in political science because it always sounded like an oxymoron. But I am willing to listen to anyone who claims to understand how so many other citizens can see the world so differently from the way I do. It simply may be that for whatever reason one person, in this case one man, has such charismatic power that his supporters willingly abandon the moral skeleton on which their lives had been draped. Or is this us versus them primarily a chasm between the elites and the nonelites?
I don’t know much about you but the fact that you are reading this column means that, like me, you are an elite. Even if you are a woman of color and the daughter of immigrants you have taken advantage of what opportunities you have been offered, stayed in school long enough to adopt a reverence for the scientific method, and have a job that pays well because you have acquired some expertise.
Tom Nichols, a political scientist teaching at Harvard Extension School, says that “expertise is a very exclusionary idea because it’s supposed to be: Not everybody gets a vote on how to fly the plane” (Why isn’t the right more afraid of COVID-19? by Christina Pazzanese, Harvard Gazette, Oct 30, 2020) This exclusivity may in part explain the cultural trend that has eroded faith in experts in general, but particularly around issues such as climate change. Ironically, although science continues to be held in esteem in our culture, many scientists have become targets for those citizens who wish to attack authority figures.
How is it that you and I as pediatricians have avoided those attacks and the derogatory label as “so-called experts”?
You may live and practice in a community where many of your patients’ families don’t share your political views. But you have probably been successful at maintaining a trusting relationship with them in large part because you have cast yourself in the role of an adviser and not a dictator. And, although at times it has been difficult, you have been careful to avoid sharing your advice in a manner that sounds condescending. You have succeeded in functioning as an expert while carefully disguising yourself as a nonelite.
However, you are skating on thin ice if you venture into topics that run counter to your patients’ religious beliefs. Theda Skocpol, professor of government and psychology at Harvard University, Cambridge, Mass., has observed that studies have shown that while religious conservatives are aware of the science and don’t reject the finding, “they resent the use of experts as political authorities.” This may explain why all across this diverse country, our patients are eager for and accepting of our advice on all manners of health-related issues until we step into a swampy area that threatens their political views – such as vaccination or gun control.
With one misstep in the wrong direction, you can go from being a compassionate adviser to an elitist “so-called expert.”
Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Other than a Littman stethoscope he accepted as a first-year medical student in 1966, Dr. Wilkoff reports having nothing to disclose. Email him at pdnews@mdedge.com.
Doctors publish paper on COVID-19 protocol; Experts unconvinced
Physicians who developed a protocol for treating hospitalized patients with COVID-19 they call MATH+ have now published a literature review with observational mortality rates in the Journal of Intensive Care Medicine (JICM) that they say supports the protocol’s use.
The physicians have been promoting their MATH+ protocol as a way to improve survival from severe COVID-19 since the spring, and this is the first time their protocol and any results have been published in a peer-reviewed journal. But because the paper contains only hospital-level mortality rates compared with previously published observational data and clinical trials (not data from a randomized controlled trial testing the protocol), experts remain unconvinced the protocol benefits patients.
“This is not a study by any stretch of the imagination,” Hugh Cassiere, MD, director of critical care medicine at North Shore University Hospital in Manhasset, New York, told Medscape Medical News via email. “It is comparative data which should never be used to make conclusions of one therapy over another.”
“It’s food for thought for those clinicians [treating COVID-19] and it gives them some options,” said Pierre Kory, MD, MPA, a pulmonary critical care specialist in Wisconsin and one of the protocol developers. “What we really emphasize for this disease is it has to be a combination therapy protocol.”
As Medscape previously reported, MATH+ stands for methylprednisolone, ascorbic acid, thiamine, and heparin. The “+” includes additional therapies like vitamin D, zinc, melatonin, statins, and famotidine. The protocol originated as a variation of the “HAT therapy,” a combination of hydrocortisone, ascorbic acid, and thiamine, which critical care specialist Paul Marik, MD, created for treating critically ill patients with sepsis.
The protocol evolved over a few weeks this spring as Marik, chief of the division of pulmonary and critical care medicine at Eastern Virginia Medical School in Norfolk, emailed with a small group of colleagues about treatments and their observations of SARS-CoV-2 in action. In March, when Marik and his colleagues formalized the MATH+ protocol, healthcare organizations like the World Health Organization (WHO) were advising against steroids for COVID-19 patients.
Determined to spread a different message, the MATH+ physicians began publicizing the protocol with a website and a small communications team. They tried to get their protocol in front of leading healthcare organizations, like the WHO, and Kory testified remotely in front of the Senate Homeland Security Committee in early May. (Kory testified in front of the committee again earlier this month about the use of ivermectin as a COVID-19 treatment. He told Medscape the MATH+ protocol has been updated to include ivermectin since the submission to JICM.)
The physicians have continued promoting the protocol in the summer and fall, even after the RECOVERY trial showed dexamethasone treatment decreased mortality in hospitalized patients with severe COVID-19 and the WHO and other organizations started recommending the drug.
In the newly published JICM article, the researchers describe a mix of randomized controlled trials, observational studies, and basic science research that inform each of the individual pieces of the MATH+ protocol. Some of the cited research pertains specifically to the treatment of COVID-19.
Other studies the authors use to support the protocol are based on data from other viral outbreaks, like H1N1 and SARS-CoV, as well as other medical conditions, like nonviral acute respiratory distress syndrome and sepsis. The researchers did not conduct a randomized controlled trial of MATH+ for patients with COVID-19 because, as they write in the article, they did not believe they had the clinical equipoise required for such a study.
“With respect to each of the individual ‘core’ therapies of MATH+, all authors felt the therapies either superior to any placebo or possessed evidence of minimal risk and cost compared to potential benefit,” they wrote in the paper.
“With a new disease, it is totally reasonable to take your best guess at a therapy,” wrote F. Perry Wilson, MD, MSCE, director of the Clinical and Translational Research Accelerator at Yale University School of Medicine, in an email to Medscape. “When there is limited information, you go with what you have. What I take issue with here is the authors’ implication that that’s where the scientific process stops. In my mind, it’s actually just the beginning.” Every investigator believes his or her intervention is beneficial but is not sure — that’s why they conduct a randomized controlled trial, Wilson said.
“Without robust trials, we are left with too many options on the table and no way to know what helps — leading to this ‘throw the book at them’ approach, where you just pick your favorite molecule and give it,” said Wilson.
Sam Parnia, MD, PhD, associate professor of medicine and director of critical care and resuscitation research at NYU Langone, echoed this sentiment: “Many of the individual components could be expected to provide benefit and combining therapies is something physicians often do,” Parnia said in an email to Medscape. “I think this is a promising approach; however, this ultimately needs to be studied.”
: United Memorial Hospital in Houston, Texas and Norfolk General Hospital in Norfolk, Virginia. At United Memorial, MATH+ was “systematically” followed for patients admitted to the hospital, and at Norfolk General it was followed for patients admitted to the ICU. The two hospitals treated 140 and 191 COVID-19 patients with MATH+, respectively, as of July 20.
The average observed hospital or 28-day mortality rate at United Memorial was 4.4% and at Norfolk General was 6.1%, for a combined mortality rate of 5.1%. The researchers compared this rate with reported outcomes from 10 studies of more than 400 hospitals in the United States (72 hospitals), the United Kingdom (386), and China (3). The mortality rate for COVID-19 patients at these hospitals ranged from 15.6% to 32%, for an average mortality rate of 22.9%.
The difference in average mortality rates represents a “more than 75% absolute risk reduction in mortality” with MATH+, according to the authors. The data from other hospitals were reported from January to early June, representative of death rates early in the pandemic and before the announcement of the RECOVERY trial results spurred increased use of dexamethasone.
The new numbers may not be convincing to other physicians.
“The comparison of the outcomes in the two hospitals where this protocol is implemented vs mortality rates in other published studies is quite a stretch,” Wilson told Medscape. “Hospitals with robust research programs that publish large cohorts tend to be tertiary care centers where sick patients get referred. Without data on the baseline characteristics of the patients in these studies, it’s really not appropriate to draw apples-to-apples comparisons.”
“There are many factors that lead to different mortality rates [between hospitals] and it often reflects the quality of general ICU care,” said Parnia. For example, many ICUs were overwhelmed and stretched during the pandemic, while others were not.
“This protocol remains a hypothesis in need of a prospective clinical trial,” said Daniel Kaul, MD, professor of infectious diseases at the University of Michigan, Ann Arbor. “Comparing gross mortality rates from different centers at different times with different case mixes is at most hypothesis generating.”
“The use of comparative data is useless information…not based on true comparison of groups,” said Cassiere of the average mortality rates. Only a randomized, placebo-controlled trial can prove if a treatment is effective. “This protocol should be abandoned.”
“The MATH+ is based on negative evidence,” Cassiere told Medscape, pointing to trials that showed no effect for vitamin C (ascorbic acid) and thiamine in critical illnesses. And, given the “overwhelming positive data’’ for dexamethasone to treat patients with severe COVID-19, its exclusion from MATH+ in favor of a steroid that has not been extensively studied for COVID-19 is “reckless and irresponsible,” he said.
Kory pushed back strongly against this assertion, pointing to the decades of research on methylprednisolone as a treatment for lung disease and ARDS outlined in the article. “It has far more evidence than dexamethasone,” he told Medscape over the phone.
“Our recommendation is based on a clear understanding of the pharmacological principle to guide prolonged glucocorticoid administration in ARDS and COVID-19,” wrote G. Umberto Meduri, MD, a MATH+ coauthor and professor in the Division of Pulmonary, Critical Care, and Sleep Medicine at the University of Tennessee Health Science Center in Memphis.
A version of this article first appeared on Medscape.com.
Physicians who developed a protocol for treating hospitalized patients with COVID-19 they call MATH+ have now published a literature review with observational mortality rates in the Journal of Intensive Care Medicine (JICM) that they say supports the protocol’s use.
The physicians have been promoting their MATH+ protocol as a way to improve survival from severe COVID-19 since the spring, and this is the first time their protocol and any results have been published in a peer-reviewed journal. But because the paper contains only hospital-level mortality rates compared with previously published observational data and clinical trials (not data from a randomized controlled trial testing the protocol), experts remain unconvinced the protocol benefits patients.
“This is not a study by any stretch of the imagination,” Hugh Cassiere, MD, director of critical care medicine at North Shore University Hospital in Manhasset, New York, told Medscape Medical News via email. “It is comparative data which should never be used to make conclusions of one therapy over another.”
“It’s food for thought for those clinicians [treating COVID-19] and it gives them some options,” said Pierre Kory, MD, MPA, a pulmonary critical care specialist in Wisconsin and one of the protocol developers. “What we really emphasize for this disease is it has to be a combination therapy protocol.”
As Medscape previously reported, MATH+ stands for methylprednisolone, ascorbic acid, thiamine, and heparin. The “+” includes additional therapies like vitamin D, zinc, melatonin, statins, and famotidine. The protocol originated as a variation of the “HAT therapy,” a combination of hydrocortisone, ascorbic acid, and thiamine, which critical care specialist Paul Marik, MD, created for treating critically ill patients with sepsis.
The protocol evolved over a few weeks this spring as Marik, chief of the division of pulmonary and critical care medicine at Eastern Virginia Medical School in Norfolk, emailed with a small group of colleagues about treatments and their observations of SARS-CoV-2 in action. In March, when Marik and his colleagues formalized the MATH+ protocol, healthcare organizations like the World Health Organization (WHO) were advising against steroids for COVID-19 patients.
Determined to spread a different message, the MATH+ physicians began publicizing the protocol with a website and a small communications team. They tried to get their protocol in front of leading healthcare organizations, like the WHO, and Kory testified remotely in front of the Senate Homeland Security Committee in early May. (Kory testified in front of the committee again earlier this month about the use of ivermectin as a COVID-19 treatment. He told Medscape the MATH+ protocol has been updated to include ivermectin since the submission to JICM.)
The physicians have continued promoting the protocol in the summer and fall, even after the RECOVERY trial showed dexamethasone treatment decreased mortality in hospitalized patients with severe COVID-19 and the WHO and other organizations started recommending the drug.
In the newly published JICM article, the researchers describe a mix of randomized controlled trials, observational studies, and basic science research that inform each of the individual pieces of the MATH+ protocol. Some of the cited research pertains specifically to the treatment of COVID-19.
Other studies the authors use to support the protocol are based on data from other viral outbreaks, like H1N1 and SARS-CoV, as well as other medical conditions, like nonviral acute respiratory distress syndrome and sepsis. The researchers did not conduct a randomized controlled trial of MATH+ for patients with COVID-19 because, as they write in the article, they did not believe they had the clinical equipoise required for such a study.
“With respect to each of the individual ‘core’ therapies of MATH+, all authors felt the therapies either superior to any placebo or possessed evidence of minimal risk and cost compared to potential benefit,” they wrote in the paper.
“With a new disease, it is totally reasonable to take your best guess at a therapy,” wrote F. Perry Wilson, MD, MSCE, director of the Clinical and Translational Research Accelerator at Yale University School of Medicine, in an email to Medscape. “When there is limited information, you go with what you have. What I take issue with here is the authors’ implication that that’s where the scientific process stops. In my mind, it’s actually just the beginning.” Every investigator believes his or her intervention is beneficial but is not sure — that’s why they conduct a randomized controlled trial, Wilson said.
“Without robust trials, we are left with too many options on the table and no way to know what helps — leading to this ‘throw the book at them’ approach, where you just pick your favorite molecule and give it,” said Wilson.
Sam Parnia, MD, PhD, associate professor of medicine and director of critical care and resuscitation research at NYU Langone, echoed this sentiment: “Many of the individual components could be expected to provide benefit and combining therapies is something physicians often do,” Parnia said in an email to Medscape. “I think this is a promising approach; however, this ultimately needs to be studied.”
: United Memorial Hospital in Houston, Texas and Norfolk General Hospital in Norfolk, Virginia. At United Memorial, MATH+ was “systematically” followed for patients admitted to the hospital, and at Norfolk General it was followed for patients admitted to the ICU. The two hospitals treated 140 and 191 COVID-19 patients with MATH+, respectively, as of July 20.
The average observed hospital or 28-day mortality rate at United Memorial was 4.4% and at Norfolk General was 6.1%, for a combined mortality rate of 5.1%. The researchers compared this rate with reported outcomes from 10 studies of more than 400 hospitals in the United States (72 hospitals), the United Kingdom (386), and China (3). The mortality rate for COVID-19 patients at these hospitals ranged from 15.6% to 32%, for an average mortality rate of 22.9%.
The difference in average mortality rates represents a “more than 75% absolute risk reduction in mortality” with MATH+, according to the authors. The data from other hospitals were reported from January to early June, representative of death rates early in the pandemic and before the announcement of the RECOVERY trial results spurred increased use of dexamethasone.
The new numbers may not be convincing to other physicians.
“The comparison of the outcomes in the two hospitals where this protocol is implemented vs mortality rates in other published studies is quite a stretch,” Wilson told Medscape. “Hospitals with robust research programs that publish large cohorts tend to be tertiary care centers where sick patients get referred. Without data on the baseline characteristics of the patients in these studies, it’s really not appropriate to draw apples-to-apples comparisons.”
“There are many factors that lead to different mortality rates [between hospitals] and it often reflects the quality of general ICU care,” said Parnia. For example, many ICUs were overwhelmed and stretched during the pandemic, while others were not.
“This protocol remains a hypothesis in need of a prospective clinical trial,” said Daniel Kaul, MD, professor of infectious diseases at the University of Michigan, Ann Arbor. “Comparing gross mortality rates from different centers at different times with different case mixes is at most hypothesis generating.”
“The use of comparative data is useless information…not based on true comparison of groups,” said Cassiere of the average mortality rates. Only a randomized, placebo-controlled trial can prove if a treatment is effective. “This protocol should be abandoned.”
“The MATH+ is based on negative evidence,” Cassiere told Medscape, pointing to trials that showed no effect for vitamin C (ascorbic acid) and thiamine in critical illnesses. And, given the “overwhelming positive data’’ for dexamethasone to treat patients with severe COVID-19, its exclusion from MATH+ in favor of a steroid that has not been extensively studied for COVID-19 is “reckless and irresponsible,” he said.
Kory pushed back strongly against this assertion, pointing to the decades of research on methylprednisolone as a treatment for lung disease and ARDS outlined in the article. “It has far more evidence than dexamethasone,” he told Medscape over the phone.
“Our recommendation is based on a clear understanding of the pharmacological principle to guide prolonged glucocorticoid administration in ARDS and COVID-19,” wrote G. Umberto Meduri, MD, a MATH+ coauthor and professor in the Division of Pulmonary, Critical Care, and Sleep Medicine at the University of Tennessee Health Science Center in Memphis.
A version of this article first appeared on Medscape.com.
Physicians who developed a protocol for treating hospitalized patients with COVID-19 they call MATH+ have now published a literature review with observational mortality rates in the Journal of Intensive Care Medicine (JICM) that they say supports the protocol’s use.
The physicians have been promoting their MATH+ protocol as a way to improve survival from severe COVID-19 since the spring, and this is the first time their protocol and any results have been published in a peer-reviewed journal. But because the paper contains only hospital-level mortality rates compared with previously published observational data and clinical trials (not data from a randomized controlled trial testing the protocol), experts remain unconvinced the protocol benefits patients.
“This is not a study by any stretch of the imagination,” Hugh Cassiere, MD, director of critical care medicine at North Shore University Hospital in Manhasset, New York, told Medscape Medical News via email. “It is comparative data which should never be used to make conclusions of one therapy over another.”
“It’s food for thought for those clinicians [treating COVID-19] and it gives them some options,” said Pierre Kory, MD, MPA, a pulmonary critical care specialist in Wisconsin and one of the protocol developers. “What we really emphasize for this disease is it has to be a combination therapy protocol.”
As Medscape previously reported, MATH+ stands for methylprednisolone, ascorbic acid, thiamine, and heparin. The “+” includes additional therapies like vitamin D, zinc, melatonin, statins, and famotidine. The protocol originated as a variation of the “HAT therapy,” a combination of hydrocortisone, ascorbic acid, and thiamine, which critical care specialist Paul Marik, MD, created for treating critically ill patients with sepsis.
The protocol evolved over a few weeks this spring as Marik, chief of the division of pulmonary and critical care medicine at Eastern Virginia Medical School in Norfolk, emailed with a small group of colleagues about treatments and their observations of SARS-CoV-2 in action. In March, when Marik and his colleagues formalized the MATH+ protocol, healthcare organizations like the World Health Organization (WHO) were advising against steroids for COVID-19 patients.
Determined to spread a different message, the MATH+ physicians began publicizing the protocol with a website and a small communications team. They tried to get their protocol in front of leading healthcare organizations, like the WHO, and Kory testified remotely in front of the Senate Homeland Security Committee in early May. (Kory testified in front of the committee again earlier this month about the use of ivermectin as a COVID-19 treatment. He told Medscape the MATH+ protocol has been updated to include ivermectin since the submission to JICM.)
The physicians have continued promoting the protocol in the summer and fall, even after the RECOVERY trial showed dexamethasone treatment decreased mortality in hospitalized patients with severe COVID-19 and the WHO and other organizations started recommending the drug.
In the newly published JICM article, the researchers describe a mix of randomized controlled trials, observational studies, and basic science research that inform each of the individual pieces of the MATH+ protocol. Some of the cited research pertains specifically to the treatment of COVID-19.
Other studies the authors use to support the protocol are based on data from other viral outbreaks, like H1N1 and SARS-CoV, as well as other medical conditions, like nonviral acute respiratory distress syndrome and sepsis. The researchers did not conduct a randomized controlled trial of MATH+ for patients with COVID-19 because, as they write in the article, they did not believe they had the clinical equipoise required for such a study.
“With respect to each of the individual ‘core’ therapies of MATH+, all authors felt the therapies either superior to any placebo or possessed evidence of minimal risk and cost compared to potential benefit,” they wrote in the paper.
“With a new disease, it is totally reasonable to take your best guess at a therapy,” wrote F. Perry Wilson, MD, MSCE, director of the Clinical and Translational Research Accelerator at Yale University School of Medicine, in an email to Medscape. “When there is limited information, you go with what you have. What I take issue with here is the authors’ implication that that’s where the scientific process stops. In my mind, it’s actually just the beginning.” Every investigator believes his or her intervention is beneficial but is not sure — that’s why they conduct a randomized controlled trial, Wilson said.
“Without robust trials, we are left with too many options on the table and no way to know what helps — leading to this ‘throw the book at them’ approach, where you just pick your favorite molecule and give it,” said Wilson.
Sam Parnia, MD, PhD, associate professor of medicine and director of critical care and resuscitation research at NYU Langone, echoed this sentiment: “Many of the individual components could be expected to provide benefit and combining therapies is something physicians often do,” Parnia said in an email to Medscape. “I think this is a promising approach; however, this ultimately needs to be studied.”
: United Memorial Hospital in Houston, Texas and Norfolk General Hospital in Norfolk, Virginia. At United Memorial, MATH+ was “systematically” followed for patients admitted to the hospital, and at Norfolk General it was followed for patients admitted to the ICU. The two hospitals treated 140 and 191 COVID-19 patients with MATH+, respectively, as of July 20.
The average observed hospital or 28-day mortality rate at United Memorial was 4.4% and at Norfolk General was 6.1%, for a combined mortality rate of 5.1%. The researchers compared this rate with reported outcomes from 10 studies of more than 400 hospitals in the United States (72 hospitals), the United Kingdom (386), and China (3). The mortality rate for COVID-19 patients at these hospitals ranged from 15.6% to 32%, for an average mortality rate of 22.9%.
The difference in average mortality rates represents a “more than 75% absolute risk reduction in mortality” with MATH+, according to the authors. The data from other hospitals were reported from January to early June, representative of death rates early in the pandemic and before the announcement of the RECOVERY trial results spurred increased use of dexamethasone.
The new numbers may not be convincing to other physicians.
“The comparison of the outcomes in the two hospitals where this protocol is implemented vs mortality rates in other published studies is quite a stretch,” Wilson told Medscape. “Hospitals with robust research programs that publish large cohorts tend to be tertiary care centers where sick patients get referred. Without data on the baseline characteristics of the patients in these studies, it’s really not appropriate to draw apples-to-apples comparisons.”
“There are many factors that lead to different mortality rates [between hospitals] and it often reflects the quality of general ICU care,” said Parnia. For example, many ICUs were overwhelmed and stretched during the pandemic, while others were not.
“This protocol remains a hypothesis in need of a prospective clinical trial,” said Daniel Kaul, MD, professor of infectious diseases at the University of Michigan, Ann Arbor. “Comparing gross mortality rates from different centers at different times with different case mixes is at most hypothesis generating.”
“The use of comparative data is useless information…not based on true comparison of groups,” said Cassiere of the average mortality rates. Only a randomized, placebo-controlled trial can prove if a treatment is effective. “This protocol should be abandoned.”
“The MATH+ is based on negative evidence,” Cassiere told Medscape, pointing to trials that showed no effect for vitamin C (ascorbic acid) and thiamine in critical illnesses. And, given the “overwhelming positive data’’ for dexamethasone to treat patients with severe COVID-19, its exclusion from MATH+ in favor of a steroid that has not been extensively studied for COVID-19 is “reckless and irresponsible,” he said.
Kory pushed back strongly against this assertion, pointing to the decades of research on methylprednisolone as a treatment for lung disease and ARDS outlined in the article. “It has far more evidence than dexamethasone,” he told Medscape over the phone.
“Our recommendation is based on a clear understanding of the pharmacological principle to guide prolonged glucocorticoid administration in ARDS and COVID-19,” wrote G. Umberto Meduri, MD, a MATH+ coauthor and professor in the Division of Pulmonary, Critical Care, and Sleep Medicine at the University of Tennessee Health Science Center in Memphis.
A version of this article first appeared on Medscape.com.
The top pediatric articles of 2019
Updates in pediatric hospital medicine
The expansion of the field of pediatric hospital medicine in the past 30 years has resulted in improved health care outcomes for hospitalized children1,2 and has been accompanied by a robust increase in the amount of scholarly work related to the field.3 We performed a review of the literature published in 2019 to identify the 10 articles that had the most impact on pediatric hospital medicine, and presented the findings at HM20 Virtual, the 2020 annual conference of the Society of Hospital Medicine. Five of the selected articles are highlighted here.
STUDY 1
Wechsler ME et al. Step-up therapy in black children and adults with poorly controlled asthma. N Engl J Med. 2019 Sep 26;381(13):1227-39.
Background
Current pediatric asthma guidelines suggest adding a long-acting beta-agonist (LABA) to inhaled corticosteroid (ICS) therapy, rather than increasing the ICS dose, for children with poorly controlled asthma. However, these data are based on trials with disproportionately few Black subjects. This study aimed to determine the best step-up therapy for Black patients whose asthma was poorly controlled on ICS monotherapy.
Study overview and results
The authors reported two parallel double-blind, randomized, controlled trials, one in children and one in adolescents and adults. The study of children included 280 subjects ranging in age from 5 to 11, with at least one Black grandparent, and with poorly controlled asthma on low-dose ICS therapy. It used a four-way crossover design in which each subject was treated with four different 14-week treatment regimens: either double (medium-dose) or quintuple (high-dose) their baseline ICS dose, with or without the addition of a LABA. A superior response was defined by the composite outcome of at least one fewer asthma exacerbation, more asthma-control days, or a 5–percentage point difference in predicted FEV1. Forty-six percent of children had improved asthma outcomes when the ICS dose was increased rather than with the addition of a LABA. In contrast, Black adolescents and Black adults had superior responses to the addition of a LABA. There was no significant interaction between the percentage of African ancestry as determined by DNA genotyping and the primary composite outcome. High-dose ICS was associated with a decrease in the ratio of urinary cortisol to creatinine in children younger than 8 years.
Limitations
Approximately 25% of children dropped out of the study, with disproportionately more children dropping out while on a high-dose ICS regimen. Additionally, the difference in the composite outcome was primarily driven by differences in FEV1, with few subjects demonstrating a difference in asthma exacerbations or asthma-control days. Although a decrease in urinary cortisol to creatinine ratio was noted in children under 8 on high-dose ICS, the study period was not long enough to determine the clinical implications of this finding.
Important findings and implications
While studies with a majority of white children have suggested a superior response from adding a LABA compared to increasing the dose of an ICS, almost half of Black children showed a superior response when the dose of an ICS was increased rather than adding a LABA. It is important to note that current guidelines are based on studies with a disproportionate majority of white subjects and may not accurately reflect optimal care for patients in other racial groups. This study underscores the need to include a diverse patient population in research studies.
STUDY 2
Chang PW, Newman TB. A simpler prediction rule for rebound hyperbilirubinemia. Pediatrics. 2019 Jul;144(1):e20183712.
Background
Hyperbilirubinemia (jaundice) is estimated to affect 50%-60% of all newborns. Rebound hyperbilirubinemia – a rise in bilirubin after cessation of phototherapy – is common and can lead to recently discharged infants being readmitted for additional therapy. Lack of clear guidelines regarding when to discharge infants with hyperbilirubinemia has likely contributed to practice variation and some trepidation regarding whether a bilirubin level is “low enough” to discontinue therapy.
Study overview and results
The authors had previously proposed a three-factor hyperbilirubinemia risk model and sought to simplify their rule further.4 They examined a retrospective cohort of 7,048 infants greater than or equal to 35 weeks’ gestation using a random split sample. The authors derived a two-factor model using the same methods and compared its performance to the three-factor model. The two-factor formula was shown to be a good fit as a logistic regression model (Hosmer-Lemeshow test 9.21; P = .33), and the AUROC (area under the receiver operating characteristic) curves for the derivation and validation cohorts were similar between the two-factor (0.877 and 0.876, respectively) and three-factor risk models (0.887 and 0.881, respectively).
Limitations
These data are limited to infants receiving their first treatment of phototherapy and have not been externally validated. An important variable, serum bilirubin at phototherapy termination, was estimated in most subjects, which may have affected the accuracy of the prediction rule. Whether infants received home phototherapy was based only on equipment orders, and some infants may have received phototherapy unbeknownst to investigators. Last, infants with rebound hyperbilirubinemia at less than 72 hours after phototherapy discontinuation may have been missed.
Important findings and implications
This prediction model provides evidence-based, concrete data that can be used in making joint decisions with families regarding discharge timing of infants with hyperbilirubinemia. It also could be beneficial when deciding appropriate follow-up time after discharge.
STUDY 3
Ramgopal S et al. Risk of serious bacterial infection in infants aged ≤60 days presenting to emergency departments with a history of fever only. J Pediatr. 2019 Jan;204:191-195. doi: 10.1016/j.jpeds.2018.08.043.
Background
Febrile infants aged 60 days and younger are at risk for serious bacterial infections (SBI) including urinary tract infections (UTI), bacteremia, and meningitis. As physical exam is a poor discriminator of SBI in this age group, providers frequently rely on laboratory values and risk factors to guide management. Infants presenting with documented fevers by caregivers but found to have no fever in the emergency department are a challenge, and there are limited data regarding SBI frequency in this population.
Study overview and results
The authors performed a secondary analysis of a prospectively gathered cohort of infants aged 60 days and younger within the Pediatric Emergency Care Applied Research Network (PECARN) who had blood, urine, and CSF data available. Notable exclusions included infants who were premature, had a focal infection, were clinically ill, had recent antibiotic use, did not have blood, urine, and CSF data available, or were lost to telephone follow-up at 7 days to ensure wellness. The study cohort included 6,014 infants, 1,233 (32%) who were febrile by history alone. Rates of overall SBI were lower in the afebrile group (8.8% vs. 12.8%). For infants 0-28 days, rates of UTI were lower for the afebrile group (9.5% vs. 14.5%), but there was no difference in the rates of bacteremia or meningitis. For infants 29-60 days, rates of UTI (6.6% vs. 9.3%) and bacteremia (.5% vs. 1.7%) were lower in the afebrile group.
Limitations
Neither the use of home antipyretics nor the method of temperature taking at home were studied. Also, as this was a secondary analysis, it is possible that not all infants who presented with history of fever only were captured, as work-up was dictated by individual treating providers who may have chosen not to work up certain afebrile infants.
Important findings and implications
Nearly one-third of infants presenting for fever evaluation are afebrile on arrival. Although overall rates of SBI were lower in the group with fever by history only, this difference is largely accounted for by differing rates of UTI. Rates of bacteremia and meningitis remained substantial between groups, particularly for infants aged 0-28 days. Because of the significant morbidity associated with these infections, it is reasonable to suggest that absence of fever on presentation alone should not alter clinical or laboratory work-up, particularly in infants 0-28 days.
STUDY 4
Humphrey-Murto S et al. The influence of prior performance information on ratings of current performance and implications for learner handover: A scoping review. Acad Med. 2019 Jul;94(7):1050-7.
Background
Learner Handover (LH) or “forward feeding” occurs when information about trainees is shared between faculty supervisors. Although this can be helpful to tailor educational experiences and build upon previous assessments, it risks stigmatizing trainees and adding bias to future feedback and assessments as the trainee never really has a “clean slate.” In this study, the authors sought to uncover the key concepts of how prior performance information (PPI) influences assessments and any implications for medical education.
Study overview and results
The authors performed a cross-disciplinary scoping review looking at over 17,000 articles published between 1980 and 2017 across the domains of psychology, sports, business, and education. Seven themes were identified with the following notable findings. Raters exposed to positive PPI scored a learner’s performance higher, and vice versa. There was a dose-response relationship with more positive and more negative PPI resulting in higher and lower assessments, respectively. General standards, such as a direction to complete all work in a timely manner, caused an assimilation effect, while specific standards, such as a direction to complete a certain task by a certain day, did not. More motivated and more experienced raters are less affected by PPI, and those who believe that people can change (incremental theorists) are less affected by PPI while those who believe personal attributes are fixed (entity theorists) are more affected.
Limitations
The heterogeneity of the studies and the fact that they were largely conducted in experimental settings may limit generalizability to medical education. Slightly less than half of the studies included a control arm. Last, most of the studies looked at the ratings of only one target performance, not multiple performances over time.
Important findings and implications
Ratings of current performance displace toward PPI direction, with negative PPI more influential than positive PPI. In a formative setting, PPI may help the assessor focus on areas of possible weakness. In contrast, for a summative assessment, PPI may be prejudicial and have an impact on the rating given to the student. Clinicians should be mindful of the information they share with future raters about learners and the potential bias on future assessments that can manifest as a result.
STUDY 5
McCann ME et al. Neurodevelopmental outcome at 5 years of age after general anaesthesia or awake-regional anaesthesia in infancy (GAS): An international, multicentre, randomised, controlled equivalence trial. The Lancet. 2019 Feb;393:664-77.
Background
Animal models and observational studies have suggested a link between early anesthesia exposure and adverse neurocognitive outcomes; however, findings have been mixed and studies are prone to confounding. This study is the first randomized controlled trial to compare neurocognitive outcomes for infants exposed to general anesthesia versus awake-regional anesthesia.
Study overview and results
In this international, multicenter, assessor-masked trial, 722 infants undergoing inguinal hernia repair were randomized to awake-regional anesthesia or single-agent sevoflurane-based general anesthesia. Infants born at greater than 26 weeks’ gestational age were eligible, while those with prior anesthesia exposure or risks for neurocognitive delay were excluded. The primary outcome was full-scale intelligence quotient (FSIQ) testing at 5 years of age on the Wechsler Preschool and Primary Scale of Intelligence, third edition (WPPSI-III). Seven additional neurodevelopmental assessments and parental questionnaires regarding behavior were administered as secondary outcomes. Average anesthesia exposure was 54 minutes and no infant had exposure greater than 120 minutes. There was no significant difference in mean scores on WPPSI-III FSIQ testing, and no difference in the additional neurocognitive assessments or parent-reported outcomes used as secondary outcomes.
Limitations
This study was limited to single, short periods of single-agent anesthesia exposure in children with no additional neurologic risk factors, so caution should be used in extrapolating these data to children with medical complexity and children undergoing multiple procedures, longer surgeries, or multidrug anesthetic regimens. The study population was majority male because of the surgical pathology selected and included only children in the narrow range of postmenstrual age 60 weeks or less. While this population represents a suspected a period of high cerebral vulnerability based on animal models, the implications of anesthesia exposure at other ages are unclear.
Important findings and implications
An estimated 10% of children from developed countries are exposed to general anesthesia during the first 3 years of life. While hospitalists do not typically select the route of anesthesia, they frequently care for patients undergoing procedures and must address parental concerns regarding the safety of anesthesia exposure. Given the rigorous study methods and long-term follow up in the current study, these data should provide reassurance that, for healthy infants undergoing short, single-agent anesthetic exposure, there is no evidence of future adverse neurologic outcomes.
Dr. Russo is director of pediatrics, medical director for quality and innovation, at WellSpan Health, York, Pa. Dr. Money is a pediatric hospitalist at Primary Children’s Hospital, University of Utah School of Medicine, Salt Lake City. Dr. Steed is instructor of hospital medicine, Northwestern Memorial Hospital and Ann and Robert H. Lurie Children’s Hospital of Chicago, Northwestern University School of Medicine, Chicago. The authors would like to thank Dr. Klint M. Schwenk and the Society for Hospital Medicine Pediatric Special Interest Group Executive Council.
References
1. Roberts KB, Fisher ER, and Rauch DA. The history of pediatric hospital medicine in the United States, 1996-2019. J Hosp Med. 2020 Jul;15(7):424-7.
2. Mussman GM and Conway PH. Pediatric hospitalist systems versus traditional models of care: Effect on quality and cost outcomes. J Hosp Med. 2012 Apr;7(4):350-7.
3. Wang ME, Shaughnessy EE, and Leyenaar JK. The future of pediatric hospital medicine: Challenges and opportunities. J Hosp Med. 2020 Jul;15(7):428-30.
4. Chang PW et al. A clinical prediction rule for rebound hyperbilirubinemia following inpatient phototherapy. Pediatrics. 2017;139 Mar;139(3):e20162896.
Updates in pediatric hospital medicine
Updates in pediatric hospital medicine
The expansion of the field of pediatric hospital medicine in the past 30 years has resulted in improved health care outcomes for hospitalized children1,2 and has been accompanied by a robust increase in the amount of scholarly work related to the field.3 We performed a review of the literature published in 2019 to identify the 10 articles that had the most impact on pediatric hospital medicine, and presented the findings at HM20 Virtual, the 2020 annual conference of the Society of Hospital Medicine. Five of the selected articles are highlighted here.
STUDY 1
Wechsler ME et al. Step-up therapy in black children and adults with poorly controlled asthma. N Engl J Med. 2019 Sep 26;381(13):1227-39.
Background
Current pediatric asthma guidelines suggest adding a long-acting beta-agonist (LABA) to inhaled corticosteroid (ICS) therapy, rather than increasing the ICS dose, for children with poorly controlled asthma. However, these data are based on trials with disproportionately few Black subjects. This study aimed to determine the best step-up therapy for Black patients whose asthma was poorly controlled on ICS monotherapy.
Study overview and results
The authors reported two parallel double-blind, randomized, controlled trials, one in children and one in adolescents and adults. The study of children included 280 subjects ranging in age from 5 to 11, with at least one Black grandparent, and with poorly controlled asthma on low-dose ICS therapy. It used a four-way crossover design in which each subject was treated with four different 14-week treatment regimens: either double (medium-dose) or quintuple (high-dose) their baseline ICS dose, with or without the addition of a LABA. A superior response was defined by the composite outcome of at least one fewer asthma exacerbation, more asthma-control days, or a 5–percentage point difference in predicted FEV1. Forty-six percent of children had improved asthma outcomes when the ICS dose was increased rather than with the addition of a LABA. In contrast, Black adolescents and Black adults had superior responses to the addition of a LABA. There was no significant interaction between the percentage of African ancestry as determined by DNA genotyping and the primary composite outcome. High-dose ICS was associated with a decrease in the ratio of urinary cortisol to creatinine in children younger than 8 years.
Limitations
Approximately 25% of children dropped out of the study, with disproportionately more children dropping out while on a high-dose ICS regimen. Additionally, the difference in the composite outcome was primarily driven by differences in FEV1, with few subjects demonstrating a difference in asthma exacerbations or asthma-control days. Although a decrease in urinary cortisol to creatinine ratio was noted in children under 8 on high-dose ICS, the study period was not long enough to determine the clinical implications of this finding.
Important findings and implications
While studies with a majority of white children have suggested a superior response from adding a LABA compared to increasing the dose of an ICS, almost half of Black children showed a superior response when the dose of an ICS was increased rather than adding a LABA. It is important to note that current guidelines are based on studies with a disproportionate majority of white subjects and may not accurately reflect optimal care for patients in other racial groups. This study underscores the need to include a diverse patient population in research studies.
STUDY 2
Chang PW, Newman TB. A simpler prediction rule for rebound hyperbilirubinemia. Pediatrics. 2019 Jul;144(1):e20183712.
Background
Hyperbilirubinemia (jaundice) is estimated to affect 50%-60% of all newborns. Rebound hyperbilirubinemia – a rise in bilirubin after cessation of phototherapy – is common and can lead to recently discharged infants being readmitted for additional therapy. Lack of clear guidelines regarding when to discharge infants with hyperbilirubinemia has likely contributed to practice variation and some trepidation regarding whether a bilirubin level is “low enough” to discontinue therapy.
Study overview and results
The authors had previously proposed a three-factor hyperbilirubinemia risk model and sought to simplify their rule further.4 They examined a retrospective cohort of 7,048 infants greater than or equal to 35 weeks’ gestation using a random split sample. The authors derived a two-factor model using the same methods and compared its performance to the three-factor model. The two-factor formula was shown to be a good fit as a logistic regression model (Hosmer-Lemeshow test 9.21; P = .33), and the AUROC (area under the receiver operating characteristic) curves for the derivation and validation cohorts were similar between the two-factor (0.877 and 0.876, respectively) and three-factor risk models (0.887 and 0.881, respectively).
Limitations
These data are limited to infants receiving their first treatment of phototherapy and have not been externally validated. An important variable, serum bilirubin at phototherapy termination, was estimated in most subjects, which may have affected the accuracy of the prediction rule. Whether infants received home phototherapy was based only on equipment orders, and some infants may have received phototherapy unbeknownst to investigators. Last, infants with rebound hyperbilirubinemia at less than 72 hours after phototherapy discontinuation may have been missed.
Important findings and implications
This prediction model provides evidence-based, concrete data that can be used in making joint decisions with families regarding discharge timing of infants with hyperbilirubinemia. It also could be beneficial when deciding appropriate follow-up time after discharge.
STUDY 3
Ramgopal S et al. Risk of serious bacterial infection in infants aged ≤60 days presenting to emergency departments with a history of fever only. J Pediatr. 2019 Jan;204:191-195. doi: 10.1016/j.jpeds.2018.08.043.
Background
Febrile infants aged 60 days and younger are at risk for serious bacterial infections (SBI) including urinary tract infections (UTI), bacteremia, and meningitis. As physical exam is a poor discriminator of SBI in this age group, providers frequently rely on laboratory values and risk factors to guide management. Infants presenting with documented fevers by caregivers but found to have no fever in the emergency department are a challenge, and there are limited data regarding SBI frequency in this population.
Study overview and results
The authors performed a secondary analysis of a prospectively gathered cohort of infants aged 60 days and younger within the Pediatric Emergency Care Applied Research Network (PECARN) who had blood, urine, and CSF data available. Notable exclusions included infants who were premature, had a focal infection, were clinically ill, had recent antibiotic use, did not have blood, urine, and CSF data available, or were lost to telephone follow-up at 7 days to ensure wellness. The study cohort included 6,014 infants, 1,233 (32%) who were febrile by history alone. Rates of overall SBI were lower in the afebrile group (8.8% vs. 12.8%). For infants 0-28 days, rates of UTI were lower for the afebrile group (9.5% vs. 14.5%), but there was no difference in the rates of bacteremia or meningitis. For infants 29-60 days, rates of UTI (6.6% vs. 9.3%) and bacteremia (.5% vs. 1.7%) were lower in the afebrile group.
Limitations
Neither the use of home antipyretics nor the method of temperature taking at home were studied. Also, as this was a secondary analysis, it is possible that not all infants who presented with history of fever only were captured, as work-up was dictated by individual treating providers who may have chosen not to work up certain afebrile infants.
Important findings and implications
Nearly one-third of infants presenting for fever evaluation are afebrile on arrival. Although overall rates of SBI were lower in the group with fever by history only, this difference is largely accounted for by differing rates of UTI. Rates of bacteremia and meningitis remained substantial between groups, particularly for infants aged 0-28 days. Because of the significant morbidity associated with these infections, it is reasonable to suggest that absence of fever on presentation alone should not alter clinical or laboratory work-up, particularly in infants 0-28 days.
STUDY 4
Humphrey-Murto S et al. The influence of prior performance information on ratings of current performance and implications for learner handover: A scoping review. Acad Med. 2019 Jul;94(7):1050-7.
Background
Learner Handover (LH) or “forward feeding” occurs when information about trainees is shared between faculty supervisors. Although this can be helpful to tailor educational experiences and build upon previous assessments, it risks stigmatizing trainees and adding bias to future feedback and assessments as the trainee never really has a “clean slate.” In this study, the authors sought to uncover the key concepts of how prior performance information (PPI) influences assessments and any implications for medical education.
Study overview and results
The authors performed a cross-disciplinary scoping review looking at over 17,000 articles published between 1980 and 2017 across the domains of psychology, sports, business, and education. Seven themes were identified with the following notable findings. Raters exposed to positive PPI scored a learner’s performance higher, and vice versa. There was a dose-response relationship with more positive and more negative PPI resulting in higher and lower assessments, respectively. General standards, such as a direction to complete all work in a timely manner, caused an assimilation effect, while specific standards, such as a direction to complete a certain task by a certain day, did not. More motivated and more experienced raters are less affected by PPI, and those who believe that people can change (incremental theorists) are less affected by PPI while those who believe personal attributes are fixed (entity theorists) are more affected.
Limitations
The heterogeneity of the studies and the fact that they were largely conducted in experimental settings may limit generalizability to medical education. Slightly less than half of the studies included a control arm. Last, most of the studies looked at the ratings of only one target performance, not multiple performances over time.
Important findings and implications
Ratings of current performance displace toward PPI direction, with negative PPI more influential than positive PPI. In a formative setting, PPI may help the assessor focus on areas of possible weakness. In contrast, for a summative assessment, PPI may be prejudicial and have an impact on the rating given to the student. Clinicians should be mindful of the information they share with future raters about learners and the potential bias on future assessments that can manifest as a result.
STUDY 5
McCann ME et al. Neurodevelopmental outcome at 5 years of age after general anaesthesia or awake-regional anaesthesia in infancy (GAS): An international, multicentre, randomised, controlled equivalence trial. The Lancet. 2019 Feb;393:664-77.
Background
Animal models and observational studies have suggested a link between early anesthesia exposure and adverse neurocognitive outcomes; however, findings have been mixed and studies are prone to confounding. This study is the first randomized controlled trial to compare neurocognitive outcomes for infants exposed to general anesthesia versus awake-regional anesthesia.
Study overview and results
In this international, multicenter, assessor-masked trial, 722 infants undergoing inguinal hernia repair were randomized to awake-regional anesthesia or single-agent sevoflurane-based general anesthesia. Infants born at greater than 26 weeks’ gestational age were eligible, while those with prior anesthesia exposure or risks for neurocognitive delay were excluded. The primary outcome was full-scale intelligence quotient (FSIQ) testing at 5 years of age on the Wechsler Preschool and Primary Scale of Intelligence, third edition (WPPSI-III). Seven additional neurodevelopmental assessments and parental questionnaires regarding behavior were administered as secondary outcomes. Average anesthesia exposure was 54 minutes and no infant had exposure greater than 120 minutes. There was no significant difference in mean scores on WPPSI-III FSIQ testing, and no difference in the additional neurocognitive assessments or parent-reported outcomes used as secondary outcomes.
Limitations
This study was limited to single, short periods of single-agent anesthesia exposure in children with no additional neurologic risk factors, so caution should be used in extrapolating these data to children with medical complexity and children undergoing multiple procedures, longer surgeries, or multidrug anesthetic regimens. The study population was majority male because of the surgical pathology selected and included only children in the narrow range of postmenstrual age 60 weeks or less. While this population represents a suspected a period of high cerebral vulnerability based on animal models, the implications of anesthesia exposure at other ages are unclear.
Important findings and implications
An estimated 10% of children from developed countries are exposed to general anesthesia during the first 3 years of life. While hospitalists do not typically select the route of anesthesia, they frequently care for patients undergoing procedures and must address parental concerns regarding the safety of anesthesia exposure. Given the rigorous study methods and long-term follow up in the current study, these data should provide reassurance that, for healthy infants undergoing short, single-agent anesthetic exposure, there is no evidence of future adverse neurologic outcomes.
Dr. Russo is director of pediatrics, medical director for quality and innovation, at WellSpan Health, York, Pa. Dr. Money is a pediatric hospitalist at Primary Children’s Hospital, University of Utah School of Medicine, Salt Lake City. Dr. Steed is instructor of hospital medicine, Northwestern Memorial Hospital and Ann and Robert H. Lurie Children’s Hospital of Chicago, Northwestern University School of Medicine, Chicago. The authors would like to thank Dr. Klint M. Schwenk and the Society for Hospital Medicine Pediatric Special Interest Group Executive Council.
References
1. Roberts KB, Fisher ER, and Rauch DA. The history of pediatric hospital medicine in the United States, 1996-2019. J Hosp Med. 2020 Jul;15(7):424-7.
2. Mussman GM and Conway PH. Pediatric hospitalist systems versus traditional models of care: Effect on quality and cost outcomes. J Hosp Med. 2012 Apr;7(4):350-7.
3. Wang ME, Shaughnessy EE, and Leyenaar JK. The future of pediatric hospital medicine: Challenges and opportunities. J Hosp Med. 2020 Jul;15(7):428-30.
4. Chang PW et al. A clinical prediction rule for rebound hyperbilirubinemia following inpatient phototherapy. Pediatrics. 2017;139 Mar;139(3):e20162896.
The expansion of the field of pediatric hospital medicine in the past 30 years has resulted in improved health care outcomes for hospitalized children1,2 and has been accompanied by a robust increase in the amount of scholarly work related to the field.3 We performed a review of the literature published in 2019 to identify the 10 articles that had the most impact on pediatric hospital medicine, and presented the findings at HM20 Virtual, the 2020 annual conference of the Society of Hospital Medicine. Five of the selected articles are highlighted here.
STUDY 1
Wechsler ME et al. Step-up therapy in black children and adults with poorly controlled asthma. N Engl J Med. 2019 Sep 26;381(13):1227-39.
Background
Current pediatric asthma guidelines suggest adding a long-acting beta-agonist (LABA) to inhaled corticosteroid (ICS) therapy, rather than increasing the ICS dose, for children with poorly controlled asthma. However, these data are based on trials with disproportionately few Black subjects. This study aimed to determine the best step-up therapy for Black patients whose asthma was poorly controlled on ICS monotherapy.
Study overview and results
The authors reported two parallel double-blind, randomized, controlled trials, one in children and one in adolescents and adults. The study of children included 280 subjects ranging in age from 5 to 11, with at least one Black grandparent, and with poorly controlled asthma on low-dose ICS therapy. It used a four-way crossover design in which each subject was treated with four different 14-week treatment regimens: either double (medium-dose) or quintuple (high-dose) their baseline ICS dose, with or without the addition of a LABA. A superior response was defined by the composite outcome of at least one fewer asthma exacerbation, more asthma-control days, or a 5–percentage point difference in predicted FEV1. Forty-six percent of children had improved asthma outcomes when the ICS dose was increased rather than with the addition of a LABA. In contrast, Black adolescents and Black adults had superior responses to the addition of a LABA. There was no significant interaction between the percentage of African ancestry as determined by DNA genotyping and the primary composite outcome. High-dose ICS was associated with a decrease in the ratio of urinary cortisol to creatinine in children younger than 8 years.
Limitations
Approximately 25% of children dropped out of the study, with disproportionately more children dropping out while on a high-dose ICS regimen. Additionally, the difference in the composite outcome was primarily driven by differences in FEV1, with few subjects demonstrating a difference in asthma exacerbations or asthma-control days. Although a decrease in urinary cortisol to creatinine ratio was noted in children under 8 on high-dose ICS, the study period was not long enough to determine the clinical implications of this finding.
Important findings and implications
While studies with a majority of white children have suggested a superior response from adding a LABA compared to increasing the dose of an ICS, almost half of Black children showed a superior response when the dose of an ICS was increased rather than adding a LABA. It is important to note that current guidelines are based on studies with a disproportionate majority of white subjects and may not accurately reflect optimal care for patients in other racial groups. This study underscores the need to include a diverse patient population in research studies.
STUDY 2
Chang PW, Newman TB. A simpler prediction rule for rebound hyperbilirubinemia. Pediatrics. 2019 Jul;144(1):e20183712.
Background
Hyperbilirubinemia (jaundice) is estimated to affect 50%-60% of all newborns. Rebound hyperbilirubinemia – a rise in bilirubin after cessation of phototherapy – is common and can lead to recently discharged infants being readmitted for additional therapy. Lack of clear guidelines regarding when to discharge infants with hyperbilirubinemia has likely contributed to practice variation and some trepidation regarding whether a bilirubin level is “low enough” to discontinue therapy.
Study overview and results
The authors had previously proposed a three-factor hyperbilirubinemia risk model and sought to simplify their rule further.4 They examined a retrospective cohort of 7,048 infants greater than or equal to 35 weeks’ gestation using a random split sample. The authors derived a two-factor model using the same methods and compared its performance to the three-factor model. The two-factor formula was shown to be a good fit as a logistic regression model (Hosmer-Lemeshow test 9.21; P = .33), and the AUROC (area under the receiver operating characteristic) curves for the derivation and validation cohorts were similar between the two-factor (0.877 and 0.876, respectively) and three-factor risk models (0.887 and 0.881, respectively).
Limitations
These data are limited to infants receiving their first treatment of phototherapy and have not been externally validated. An important variable, serum bilirubin at phototherapy termination, was estimated in most subjects, which may have affected the accuracy of the prediction rule. Whether infants received home phototherapy was based only on equipment orders, and some infants may have received phototherapy unbeknownst to investigators. Last, infants with rebound hyperbilirubinemia at less than 72 hours after phototherapy discontinuation may have been missed.
Important findings and implications
This prediction model provides evidence-based, concrete data that can be used in making joint decisions with families regarding discharge timing of infants with hyperbilirubinemia. It also could be beneficial when deciding appropriate follow-up time after discharge.
STUDY 3
Ramgopal S et al. Risk of serious bacterial infection in infants aged ≤60 days presenting to emergency departments with a history of fever only. J Pediatr. 2019 Jan;204:191-195. doi: 10.1016/j.jpeds.2018.08.043.
Background
Febrile infants aged 60 days and younger are at risk for serious bacterial infections (SBI) including urinary tract infections (UTI), bacteremia, and meningitis. As physical exam is a poor discriminator of SBI in this age group, providers frequently rely on laboratory values and risk factors to guide management. Infants presenting with documented fevers by caregivers but found to have no fever in the emergency department are a challenge, and there are limited data regarding SBI frequency in this population.
Study overview and results
The authors performed a secondary analysis of a prospectively gathered cohort of infants aged 60 days and younger within the Pediatric Emergency Care Applied Research Network (PECARN) who had blood, urine, and CSF data available. Notable exclusions included infants who were premature, had a focal infection, were clinically ill, had recent antibiotic use, did not have blood, urine, and CSF data available, or were lost to telephone follow-up at 7 days to ensure wellness. The study cohort included 6,014 infants, 1,233 (32%) who were febrile by history alone. Rates of overall SBI were lower in the afebrile group (8.8% vs. 12.8%). For infants 0-28 days, rates of UTI were lower for the afebrile group (9.5% vs. 14.5%), but there was no difference in the rates of bacteremia or meningitis. For infants 29-60 days, rates of UTI (6.6% vs. 9.3%) and bacteremia (.5% vs. 1.7%) were lower in the afebrile group.
Limitations
Neither the use of home antipyretics nor the method of temperature taking at home were studied. Also, as this was a secondary analysis, it is possible that not all infants who presented with history of fever only were captured, as work-up was dictated by individual treating providers who may have chosen not to work up certain afebrile infants.
Important findings and implications
Nearly one-third of infants presenting for fever evaluation are afebrile on arrival. Although overall rates of SBI were lower in the group with fever by history only, this difference is largely accounted for by differing rates of UTI. Rates of bacteremia and meningitis remained substantial between groups, particularly for infants aged 0-28 days. Because of the significant morbidity associated with these infections, it is reasonable to suggest that absence of fever on presentation alone should not alter clinical or laboratory work-up, particularly in infants 0-28 days.
STUDY 4
Humphrey-Murto S et al. The influence of prior performance information on ratings of current performance and implications for learner handover: A scoping review. Acad Med. 2019 Jul;94(7):1050-7.
Background
Learner Handover (LH) or “forward feeding” occurs when information about trainees is shared between faculty supervisors. Although this can be helpful to tailor educational experiences and build upon previous assessments, it risks stigmatizing trainees and adding bias to future feedback and assessments as the trainee never really has a “clean slate.” In this study, the authors sought to uncover the key concepts of how prior performance information (PPI) influences assessments and any implications for medical education.
Study overview and results
The authors performed a cross-disciplinary scoping review looking at over 17,000 articles published between 1980 and 2017 across the domains of psychology, sports, business, and education. Seven themes were identified with the following notable findings. Raters exposed to positive PPI scored a learner’s performance higher, and vice versa. There was a dose-response relationship with more positive and more negative PPI resulting in higher and lower assessments, respectively. General standards, such as a direction to complete all work in a timely manner, caused an assimilation effect, while specific standards, such as a direction to complete a certain task by a certain day, did not. More motivated and more experienced raters are less affected by PPI, and those who believe that people can change (incremental theorists) are less affected by PPI while those who believe personal attributes are fixed (entity theorists) are more affected.
Limitations
The heterogeneity of the studies and the fact that they were largely conducted in experimental settings may limit generalizability to medical education. Slightly less than half of the studies included a control arm. Last, most of the studies looked at the ratings of only one target performance, not multiple performances over time.
Important findings and implications
Ratings of current performance displace toward PPI direction, with negative PPI more influential than positive PPI. In a formative setting, PPI may help the assessor focus on areas of possible weakness. In contrast, for a summative assessment, PPI may be prejudicial and have an impact on the rating given to the student. Clinicians should be mindful of the information they share with future raters about learners and the potential bias on future assessments that can manifest as a result.
STUDY 5
McCann ME et al. Neurodevelopmental outcome at 5 years of age after general anaesthesia or awake-regional anaesthesia in infancy (GAS): An international, multicentre, randomised, controlled equivalence trial. The Lancet. 2019 Feb;393:664-77.
Background
Animal models and observational studies have suggested a link between early anesthesia exposure and adverse neurocognitive outcomes; however, findings have been mixed and studies are prone to confounding. This study is the first randomized controlled trial to compare neurocognitive outcomes for infants exposed to general anesthesia versus awake-regional anesthesia.
Study overview and results
In this international, multicenter, assessor-masked trial, 722 infants undergoing inguinal hernia repair were randomized to awake-regional anesthesia or single-agent sevoflurane-based general anesthesia. Infants born at greater than 26 weeks’ gestational age were eligible, while those with prior anesthesia exposure or risks for neurocognitive delay were excluded. The primary outcome was full-scale intelligence quotient (FSIQ) testing at 5 years of age on the Wechsler Preschool and Primary Scale of Intelligence, third edition (WPPSI-III). Seven additional neurodevelopmental assessments and parental questionnaires regarding behavior were administered as secondary outcomes. Average anesthesia exposure was 54 minutes and no infant had exposure greater than 120 minutes. There was no significant difference in mean scores on WPPSI-III FSIQ testing, and no difference in the additional neurocognitive assessments or parent-reported outcomes used as secondary outcomes.
Limitations
This study was limited to single, short periods of single-agent anesthesia exposure in children with no additional neurologic risk factors, so caution should be used in extrapolating these data to children with medical complexity and children undergoing multiple procedures, longer surgeries, or multidrug anesthetic regimens. The study population was majority male because of the surgical pathology selected and included only children in the narrow range of postmenstrual age 60 weeks or less. While this population represents a suspected a period of high cerebral vulnerability based on animal models, the implications of anesthesia exposure at other ages are unclear.
Important findings and implications
An estimated 10% of children from developed countries are exposed to general anesthesia during the first 3 years of life. While hospitalists do not typically select the route of anesthesia, they frequently care for patients undergoing procedures and must address parental concerns regarding the safety of anesthesia exposure. Given the rigorous study methods and long-term follow up in the current study, these data should provide reassurance that, for healthy infants undergoing short, single-agent anesthetic exposure, there is no evidence of future adverse neurologic outcomes.
Dr. Russo is director of pediatrics, medical director for quality and innovation, at WellSpan Health, York, Pa. Dr. Money is a pediatric hospitalist at Primary Children’s Hospital, University of Utah School of Medicine, Salt Lake City. Dr. Steed is instructor of hospital medicine, Northwestern Memorial Hospital and Ann and Robert H. Lurie Children’s Hospital of Chicago, Northwestern University School of Medicine, Chicago. The authors would like to thank Dr. Klint M. Schwenk and the Society for Hospital Medicine Pediatric Special Interest Group Executive Council.
References
1. Roberts KB, Fisher ER, and Rauch DA. The history of pediatric hospital medicine in the United States, 1996-2019. J Hosp Med. 2020 Jul;15(7):424-7.
2. Mussman GM and Conway PH. Pediatric hospitalist systems versus traditional models of care: Effect on quality and cost outcomes. J Hosp Med. 2012 Apr;7(4):350-7.
3. Wang ME, Shaughnessy EE, and Leyenaar JK. The future of pediatric hospital medicine: Challenges and opportunities. J Hosp Med. 2020 Jul;15(7):428-30.
4. Chang PW et al. A clinical prediction rule for rebound hyperbilirubinemia following inpatient phototherapy. Pediatrics. 2017;139 Mar;139(3):e20162896.
Gender surgical outcomes differ following puberty suppression
Puberty suppression (PS) not only successfully reduces the physical development of sex characteristics, giving transgender youth the opportunity to qualify “for different gender-affirming surgical techniques, it also gives adolescents the time needed to explore their gender identity prior to beginning irreversible cross-sex hormone (CSH) treatment,” Tim C. van de Grift, MD, PhD, of the Vrije Universiteit Medical Center, Amsterdam, and colleagues reported in a retrospective single-center cohort study published in Pediatrics.
Dr. van de Grift and his colleagues evaluated the development of sex characteristics in 184 (61%) transgender men and 116 (39%) transgender women aged an average of 23 years at follow-up; a total of 50 men and 50 women served as controls within the total patient pool. The patients, identified from local registries, were adolescents at the time who had applied for gender-affirming medical interventions between 2006 and 2013.
In order to be included in the analysis, patients were required to 1) have a confirmed gender dysphoria diagnosis, 2) be at least 18 years of age at the point of data collection, 3) be less than 18 years of age when PS was initiated, 4) have initiated and continued PS treatment, and 5) not be lost to follow-up.
Clinical controls were identified by random sample using hospital records. Unlike patients in the PS cohort, the controls received CSH instead of PS, but they otherwise applied for gender-affirming surgery during the same years and met all other non-PS inclusion criteria.
PS offers more favorable, less invasive outcomes for transgender men than women
The researchers found no statistically significant impact of PS on height, weight, and body mass index preoperatively in either transgender men or women.
In transgender men, breast development differed the most, with the least development in the Tanner 2/3 puberty scale group, intermediate development in Tanner 4/5 patients, and the most development in controls who did not have PS. As a result, fewer mastectomies were required after PS, and those that were performed were less invasive, compared with controls. Dr. van de Grift and colleagues noted that these findings were in line with surgical guidelines that advise which mastectomy technique is appropriate based on breast size, elasticity, and ptosis grade. They cautioned that, while PS improves the odds of not needing a mastectomy, it is not a guaranteed outcome.
In transgender women, PS had a significant effect on penile development, which was less in Tanner 2/3 patients, compared with the other groups and less in Tanner 4/5 patients, compared with controls. As the researchers explained, penile length is key to vaginoplasty surgery since the penile skin is what is used to create the vaginal lining. For patients lacking sufficient skin, an alternative vaginoplasty technique using intestinal tissue or full-thickness graft is necessary. In this group, surgical options depended upon the onset of PS. In the control group, standard penile-inversion vaginoplasty was more probable, but it was less so in the Tanner 4/5 patients and only infrequently probable in Tanner 2/3 patients. Most transgender women who started PS in Tanner 2/3 underwent intestinal vaginoplasty.
Before PS is initiated much dialog and planning is warranted
“Clinicians should counsel transgender youth and their parents in making informed decisions when starting PS. Counseling consists of informing about the possible surgical consequences when puberty is suppressed and that these techniques may not be available in general transgender care facilities,” advised Dr. van de Grift and his colleagues. Specifically, when pediatricians prescribe PS, they need to be cognizant of the consequences down the line regarding the demand for “technically complex gender-affirming surgery,” performed by, for example, plastic surgeons, who will need to be “skilled in minimally invasive mastectomy techniques and more extensive vaginoplasty approaches.” Therefore, it is key for referring physicians to be sensitive to the need for early referral to specialized care in order to maximize positive outcomes, they added.
The study was limited by the sample size of some subgroups. Only two-thirds of eligible candidates were included in the sample size because follow-up data were not available for the remaining patients. Future studies should include multicenter standardized prospective data collection that provides patient-reported outcomes to enhance the perspective of the clinical findings, the researchers observed.
In a separate interview with Pediatric News, M. Brett Cooper, MD, of the department of pediatrics at University of Texas, Dallas, and an adolescent medicine physician at Children’s Medical Center in Dallas, noted that “Initiation of puberty suppression can be lifesaving for many gender-diverse youth, preventing the development of secondary sex characteristics. However, this can have effects later if these youth choose to pursue gender-affirming surgeries. This study is important for helping to frame the conversation for youth and their parents when doing consent to start puberty-blocking medications, as well as around optimal timing for each individual.”
Dr. Cooper is a paid MDedge consultant for the LGBTQ Youth Consult in Pediatric News. He had no other disclosures to report.
SOURCE: van de Grift T et al. Pediatrics. 2020;146(5):e20193653.
Puberty suppression (PS) not only successfully reduces the physical development of sex characteristics, giving transgender youth the opportunity to qualify “for different gender-affirming surgical techniques, it also gives adolescents the time needed to explore their gender identity prior to beginning irreversible cross-sex hormone (CSH) treatment,” Tim C. van de Grift, MD, PhD, of the Vrije Universiteit Medical Center, Amsterdam, and colleagues reported in a retrospective single-center cohort study published in Pediatrics.
Dr. van de Grift and his colleagues evaluated the development of sex characteristics in 184 (61%) transgender men and 116 (39%) transgender women aged an average of 23 years at follow-up; a total of 50 men and 50 women served as controls within the total patient pool. The patients, identified from local registries, were adolescents at the time who had applied for gender-affirming medical interventions between 2006 and 2013.
In order to be included in the analysis, patients were required to 1) have a confirmed gender dysphoria diagnosis, 2) be at least 18 years of age at the point of data collection, 3) be less than 18 years of age when PS was initiated, 4) have initiated and continued PS treatment, and 5) not be lost to follow-up.
Clinical controls were identified by random sample using hospital records. Unlike patients in the PS cohort, the controls received CSH instead of PS, but they otherwise applied for gender-affirming surgery during the same years and met all other non-PS inclusion criteria.
PS offers more favorable, less invasive outcomes for transgender men than women
The researchers found no statistically significant impact of PS on height, weight, and body mass index preoperatively in either transgender men or women.
In transgender men, breast development differed the most, with the least development in the Tanner 2/3 puberty scale group, intermediate development in Tanner 4/5 patients, and the most development in controls who did not have PS. As a result, fewer mastectomies were required after PS, and those that were performed were less invasive, compared with controls. Dr. van de Grift and colleagues noted that these findings were in line with surgical guidelines that advise which mastectomy technique is appropriate based on breast size, elasticity, and ptosis grade. They cautioned that, while PS improves the odds of not needing a mastectomy, it is not a guaranteed outcome.
In transgender women, PS had a significant effect on penile development, which was less in Tanner 2/3 patients, compared with the other groups and less in Tanner 4/5 patients, compared with controls. As the researchers explained, penile length is key to vaginoplasty surgery since the penile skin is what is used to create the vaginal lining. For patients lacking sufficient skin, an alternative vaginoplasty technique using intestinal tissue or full-thickness graft is necessary. In this group, surgical options depended upon the onset of PS. In the control group, standard penile-inversion vaginoplasty was more probable, but it was less so in the Tanner 4/5 patients and only infrequently probable in Tanner 2/3 patients. Most transgender women who started PS in Tanner 2/3 underwent intestinal vaginoplasty.
Before PS is initiated much dialog and planning is warranted
“Clinicians should counsel transgender youth and their parents in making informed decisions when starting PS. Counseling consists of informing about the possible surgical consequences when puberty is suppressed and that these techniques may not be available in general transgender care facilities,” advised Dr. van de Grift and his colleagues. Specifically, when pediatricians prescribe PS, they need to be cognizant of the consequences down the line regarding the demand for “technically complex gender-affirming surgery,” performed by, for example, plastic surgeons, who will need to be “skilled in minimally invasive mastectomy techniques and more extensive vaginoplasty approaches.” Therefore, it is key for referring physicians to be sensitive to the need for early referral to specialized care in order to maximize positive outcomes, they added.
The study was limited by the sample size of some subgroups. Only two-thirds of eligible candidates were included in the sample size because follow-up data were not available for the remaining patients. Future studies should include multicenter standardized prospective data collection that provides patient-reported outcomes to enhance the perspective of the clinical findings, the researchers observed.
In a separate interview with Pediatric News, M. Brett Cooper, MD, of the department of pediatrics at University of Texas, Dallas, and an adolescent medicine physician at Children’s Medical Center in Dallas, noted that “Initiation of puberty suppression can be lifesaving for many gender-diverse youth, preventing the development of secondary sex characteristics. However, this can have effects later if these youth choose to pursue gender-affirming surgeries. This study is important for helping to frame the conversation for youth and their parents when doing consent to start puberty-blocking medications, as well as around optimal timing for each individual.”
Dr. Cooper is a paid MDedge consultant for the LGBTQ Youth Consult in Pediatric News. He had no other disclosures to report.
SOURCE: van de Grift T et al. Pediatrics. 2020;146(5):e20193653.
Puberty suppression (PS) not only successfully reduces the physical development of sex characteristics, giving transgender youth the opportunity to qualify “for different gender-affirming surgical techniques, it also gives adolescents the time needed to explore their gender identity prior to beginning irreversible cross-sex hormone (CSH) treatment,” Tim C. van de Grift, MD, PhD, of the Vrije Universiteit Medical Center, Amsterdam, and colleagues reported in a retrospective single-center cohort study published in Pediatrics.
Dr. van de Grift and his colleagues evaluated the development of sex characteristics in 184 (61%) transgender men and 116 (39%) transgender women aged an average of 23 years at follow-up; a total of 50 men and 50 women served as controls within the total patient pool. The patients, identified from local registries, were adolescents at the time who had applied for gender-affirming medical interventions between 2006 and 2013.
In order to be included in the analysis, patients were required to 1) have a confirmed gender dysphoria diagnosis, 2) be at least 18 years of age at the point of data collection, 3) be less than 18 years of age when PS was initiated, 4) have initiated and continued PS treatment, and 5) not be lost to follow-up.
Clinical controls were identified by random sample using hospital records. Unlike patients in the PS cohort, the controls received CSH instead of PS, but they otherwise applied for gender-affirming surgery during the same years and met all other non-PS inclusion criteria.
PS offers more favorable, less invasive outcomes for transgender men than women
The researchers found no statistically significant impact of PS on height, weight, and body mass index preoperatively in either transgender men or women.
In transgender men, breast development differed the most, with the least development in the Tanner 2/3 puberty scale group, intermediate development in Tanner 4/5 patients, and the most development in controls who did not have PS. As a result, fewer mastectomies were required after PS, and those that were performed were less invasive, compared with controls. Dr. van de Grift and colleagues noted that these findings were in line with surgical guidelines that advise which mastectomy technique is appropriate based on breast size, elasticity, and ptosis grade. They cautioned that, while PS improves the odds of not needing a mastectomy, it is not a guaranteed outcome.
In transgender women, PS had a significant effect on penile development, which was less in Tanner 2/3 patients, compared with the other groups and less in Tanner 4/5 patients, compared with controls. As the researchers explained, penile length is key to vaginoplasty surgery since the penile skin is what is used to create the vaginal lining. For patients lacking sufficient skin, an alternative vaginoplasty technique using intestinal tissue or full-thickness graft is necessary. In this group, surgical options depended upon the onset of PS. In the control group, standard penile-inversion vaginoplasty was more probable, but it was less so in the Tanner 4/5 patients and only infrequently probable in Tanner 2/3 patients. Most transgender women who started PS in Tanner 2/3 underwent intestinal vaginoplasty.
Before PS is initiated much dialog and planning is warranted
“Clinicians should counsel transgender youth and their parents in making informed decisions when starting PS. Counseling consists of informing about the possible surgical consequences when puberty is suppressed and that these techniques may not be available in general transgender care facilities,” advised Dr. van de Grift and his colleagues. Specifically, when pediatricians prescribe PS, they need to be cognizant of the consequences down the line regarding the demand for “technically complex gender-affirming surgery,” performed by, for example, plastic surgeons, who will need to be “skilled in minimally invasive mastectomy techniques and more extensive vaginoplasty approaches.” Therefore, it is key for referring physicians to be sensitive to the need for early referral to specialized care in order to maximize positive outcomes, they added.
The study was limited by the sample size of some subgroups. Only two-thirds of eligible candidates were included in the sample size because follow-up data were not available for the remaining patients. Future studies should include multicenter standardized prospective data collection that provides patient-reported outcomes to enhance the perspective of the clinical findings, the researchers observed.
In a separate interview with Pediatric News, M. Brett Cooper, MD, of the department of pediatrics at University of Texas, Dallas, and an adolescent medicine physician at Children’s Medical Center in Dallas, noted that “Initiation of puberty suppression can be lifesaving for many gender-diverse youth, preventing the development of secondary sex characteristics. However, this can have effects later if these youth choose to pursue gender-affirming surgeries. This study is important for helping to frame the conversation for youth and their parents when doing consent to start puberty-blocking medications, as well as around optimal timing for each individual.”
Dr. Cooper is a paid MDedge consultant for the LGBTQ Youth Consult in Pediatric News. He had no other disclosures to report.
SOURCE: van de Grift T et al. Pediatrics. 2020;146(5):e20193653.
FROM PEDIATRICS