Conference Coverage

Obstetric patients and clinicians both overwhelmingly reported that telehealth was a safer way to receive ob.gyn. care and improve health care access during the COVID-19 pandemic, according to a survey at a single institution. The findings, from the Vanderbilt University Medical Center in Nashville, Tenn., were presented in a poster at the 2021 virtual meeting of the American College of Obstetricians and Gynecologists.

“The COVID-19 pandemic caused rapid and broad expansion of tele-obstetrics, warranting the need to assess patient and provider experiences and opinions about these services,” Karampreet Kaur, a 4th-year MD candidate at Vanderbilt University, and colleagues wrote in the poster. The group’s findings led them to conclude that virtual choices for prenatal care should be available independent of the pandemic.

Neel Shah, MD, assistant professor of obstetrics, gynecology, and reproductive biology at Harvard Medical School, Boston, and founding director of the Delivery Decisions Initiative at Harvard’s Ariadne Labs, agreed that the study results supported continuation of telehealth even without COVID-19. Dr. Shah was not involved with the research.

“The fact that telehealth is broadly acceptable is not surprising but the magnitudes are striking,” Dr. Shah said in an interview. “Both providers and patients overwhelmingly see telehealth as a value-added fixture of obstetrical care that should be sustained beyond the pandemic.”

The researchers conducted an online survey of both obstetrical patients who received virtual prenatal care and ob.gyn. department providers, including MDs, DOs, advanced practice providers, genetic counselors, social workers, and registered dietitians.

Just over half (53%) of the 167 patients who completed the survey between June 2020 and April 2021 were between the ages 25 and 34. The remaining patients included 13% between ages 18 and 24 and 35% between ages 35 and 44. Most of these patients (84%) were at home for their telehealth appointment, but 16% were at a clinic for the telehealth appointment.

A quarter of the patients had a telehealth visit with a genetic counselor (26%) while 44% of patients saw an ob generalist and 28% saw a maternal fetal medicine specialist. Only 1% reported a social worker visit.

The majority of patients (75%) reported that they felt personally safer using telehealth rather than an in-person visit, and 18% said they would have forgone care if telehealth were not an option. Similarly, 74% of patients said the virtual care reduced their travel time, and 46% said they saved at least $35 in transportation, child care, or missed wages. More than half the patients surveyed were satisfied with their telehealth experience and believe Tennessee should have a tele-obstetrics program.

“The fact that a significant number of patients would have forgone care, and that nearly all providers observed improvements in access, makes widespread adoption of telehealth a moral imperative,” Dr. Shah said. “Telehealth and other forms of virtual care require rethinking our standard care models,” he added. “Traditional prenatal care for example is based on a model that is nearly a century old and may not meet the needs of many people. The experimentation with new ways of providing care that the pandemic forced should be an ongoing effort to ensure every person giving birth receives the care they deserve.”

Medical doctors (MD and DO) made up 53% of the 72 providers who completed the survey between June and August 2020, and a little over a third (36%) were advanced practice providers. Nearly all the providers (more than 95%) agreed with the statement that “telehealth was safer than in-clinic appointments for themselves, colleagues, and obstetrical patients.” Similar majorities felt telehealth was an acceptable way to provide health care (94%) and that virtual care improved access to health care (96%).

Most of the providers (85%) also felt that telehealth provided an opportunity for high-quality communication with their patients. More than half the providers said they would be willing to use telehealth outside of the pandemic, and a similar proportion felt that “Vanderbilt telehealth is a positive program for the state of Tennessee.”

Though not an author of the study, another Vanderbilt ob.gyn. also believes the findings support exploring continued telehealth options for the patients and providers interested in it.

“Health care providers and patients alike can attest to the benefits of telehealth utilization, Etoi A. Garrison, MD, PhD, associate professor of maternal-fetal medicine at Vanderbilt University, said in an interview. She was particularly struck by the savings reported by patients. “These costs are difficult to quantify but can have a significant impact on patients’ day-to-day quality of life,” she said.

A limitation of the study is the lack of information on how many were invited to complete it, so it’s not possible to know if the results are representative of the majority of people who used telehealth services, Dr. Garrison added. Dr. Shah agreed but didn’t think that limitation diminished the clinical implications of the study.

“A relatively small number of patients and providers are surveyed over a long period of time in which the context of the pandemic varied significantly,” he said. “Nonetheless, the findings show strong and internally consistent beliefs among those receiving and providing care that telehealth is valuable.”

The authors and Dr. Shah reported no disclosures. Dr. Garrison reported receiving a grant from the Tennessee Maternal Mortality Review committee to create an Unconscious Bias Faculty Train-the-Trainer program.

Obstetric patients and clinicians both overwhelmingly reported that telehealth was a safer way to receive ob.gyn. care and improve health care access during the COVID-19 pandemic, according to a survey at a single institution. The findings, from the Vanderbilt University Medical Center in Nashville, Tenn., were presented in a poster at the 2021 virtual meeting of the American College of Obstetricians and Gynecologists.

“The COVID-19 pandemic caused rapid and broad expansion of tele-obstetrics, warranting the need to assess patient and provider experiences and opinions about these services,” Karampreet Kaur, a 4th-year MD candidate at Vanderbilt University, and colleagues wrote in the poster. The group’s findings led them to conclude that virtual choices for prenatal care should be available independent of the pandemic.

Neel Shah, MD, assistant professor of obstetrics, gynecology, and reproductive biology at Harvard Medical School, Boston, and founding director of the Delivery Decisions Initiative at Harvard’s Ariadne Labs, agreed that the study results supported continuation of telehealth even without COVID-19. Dr. Shah was not involved with the research.

“The fact that telehealth is broadly acceptable is not surprising but the magnitudes are striking,” Dr. Shah said in an interview. “Both providers and patients overwhelmingly see telehealth as a value-added fixture of obstetrical care that should be sustained beyond the pandemic.”

The researchers conducted an online survey of both obstetrical patients who received virtual prenatal care and ob.gyn. department providers, including MDs, DOs, advanced practice providers, genetic counselors, social workers, and registered dietitians.

Just over half (53%) of the 167 patients who completed the survey between June 2020 and April 2021 were between the ages 25 and 34. The remaining patients included 13% between ages 18 and 24 and 35% between ages 35 and 44. Most of these patients (84%) were at home for their telehealth appointment, but 16% were at a clinic for the telehealth appointment.

A quarter of the patients had a telehealth visit with a genetic counselor (26%) while 44% of patients saw an ob generalist and 28% saw a maternal fetal medicine specialist. Only 1% reported a social worker visit.

The majority of patients (75%) reported that they felt personally safer using telehealth rather than an in-person visit, and 18% said they would have forgone care if telehealth were not an option. Similarly, 74% of patients said the virtual care reduced their travel time, and 46% said they saved at least $35 in transportation, child care, or missed wages. More than half the patients surveyed were satisfied with their telehealth experience and believe Tennessee should have a tele-obstetrics program.

“The fact that a significant number of patients would have forgone care, and that nearly all providers observed improvements in access, makes widespread adoption of telehealth a moral imperative,” Dr. Shah said. “Telehealth and other forms of virtual care require rethinking our standard care models,” he added. “Traditional prenatal care for example is based on a model that is nearly a century old and may not meet the needs of many people. The experimentation with new ways of providing care that the pandemic forced should be an ongoing effort to ensure every person giving birth receives the care they deserve.”

Medical doctors (MD and DO) made up 53% of the 72 providers who completed the survey between June and August 2020, and a little over a third (36%) were advanced practice providers. Nearly all the providers (more than 95%) agreed with the statement that “telehealth was safer than in-clinic appointments for themselves, colleagues, and obstetrical patients.” Similar majorities felt telehealth was an acceptable way to provide health care (94%) and that virtual care improved access to health care (96%).

Most of the providers (85%) also felt that telehealth provided an opportunity for high-quality communication with their patients. More than half the providers said they would be willing to use telehealth outside of the pandemic, and a similar proportion felt that “Vanderbilt telehealth is a positive program for the state of Tennessee.”

Though not an author of the study, another Vanderbilt ob.gyn. also believes the findings support exploring continued telehealth options for the patients and providers interested in it.

“Health care providers and patients alike can attest to the benefits of telehealth utilization, Etoi A. Garrison, MD, PhD, associate professor of maternal-fetal medicine at Vanderbilt University, said in an interview. She was particularly struck by the savings reported by patients. “These costs are difficult to quantify but can have a significant impact on patients’ day-to-day quality of life,” she said.

A limitation of the study is the lack of information on how many were invited to complete it, so it’s not possible to know if the results are representative of the majority of people who used telehealth services, Dr. Garrison added. Dr. Shah agreed but didn’t think that limitation diminished the clinical implications of the study.

“A relatively small number of patients and providers are surveyed over a long period of time in which the context of the pandemic varied significantly,” he said. “Nonetheless, the findings show strong and internally consistent beliefs among those receiving and providing care that telehealth is valuable.”

The authors and Dr. Shah reported no disclosures. Dr. Garrison reported receiving a grant from the Tennessee Maternal Mortality Review committee to create an Unconscious Bias Faculty Train-the-Trainer program.

Obstetric patients and clinicians both overwhelmingly reported that telehealth was a safer way to receive ob.gyn. care and improve health care access during the COVID-19 pandemic, according to a survey at a single institution. The findings, from the Vanderbilt University Medical Center in Nashville, Tenn., were presented in a poster at the 2021 virtual meeting of the American College of Obstetricians and Gynecologists.

“The COVID-19 pandemic caused rapid and broad expansion of tele-obstetrics, warranting the need to assess patient and provider experiences and opinions about these services,” Karampreet Kaur, a 4th-year MD candidate at Vanderbilt University, and colleagues wrote in the poster. The group’s findings led them to conclude that virtual choices for prenatal care should be available independent of the pandemic.

Neel Shah, MD, assistant professor of obstetrics, gynecology, and reproductive biology at Harvard Medical School, Boston, and founding director of the Delivery Decisions Initiative at Harvard’s Ariadne Labs, agreed that the study results supported continuation of telehealth even without COVID-19. Dr. Shah was not involved with the research.

“The fact that telehealth is broadly acceptable is not surprising but the magnitudes are striking,” Dr. Shah said in an interview. “Both providers and patients overwhelmingly see telehealth as a value-added fixture of obstetrical care that should be sustained beyond the pandemic.”

The researchers conducted an online survey of both obstetrical patients who received virtual prenatal care and ob.gyn. department providers, including MDs, DOs, advanced practice providers, genetic counselors, social workers, and registered dietitians.

Just over half (53%) of the 167 patients who completed the survey between June 2020 and April 2021 were between the ages 25 and 34. The remaining patients included 13% between ages 18 and 24 and 35% between ages 35 and 44. Most of these patients (84%) were at home for their telehealth appointment, but 16% were at a clinic for the telehealth appointment.

A quarter of the patients had a telehealth visit with a genetic counselor (26%) while 44% of patients saw an ob generalist and 28% saw a maternal fetal medicine specialist. Only 1% reported a social worker visit.

The majority of patients (75%) reported that they felt personally safer using telehealth rather than an in-person visit, and 18% said they would have forgone care if telehealth were not an option. Similarly, 74% of patients said the virtual care reduced their travel time, and 46% said they saved at least $35 in transportation, child care, or missed wages. More than half the patients surveyed were satisfied with their telehealth experience and believe Tennessee should have a tele-obstetrics program.

“The fact that a significant number of patients would have forgone care, and that nearly all providers observed improvements in access, makes widespread adoption of telehealth a moral imperative,” Dr. Shah said. “Telehealth and other forms of virtual care require rethinking our standard care models,” he added. “Traditional prenatal care for example is based on a model that is nearly a century old and may not meet the needs of many people. The experimentation with new ways of providing care that the pandemic forced should be an ongoing effort to ensure every person giving birth receives the care they deserve.”

Medical doctors (MD and DO) made up 53% of the 72 providers who completed the survey between June and August 2020, and a little over a third (36%) were advanced practice providers. Nearly all the providers (more than 95%) agreed with the statement that “telehealth was safer than in-clinic appointments for themselves, colleagues, and obstetrical patients.” Similar majorities felt telehealth was an acceptable way to provide health care (94%) and that virtual care improved access to health care (96%).

Most of the providers (85%) also felt that telehealth provided an opportunity for high-quality communication with their patients. More than half the providers said they would be willing to use telehealth outside of the pandemic, and a similar proportion felt that “Vanderbilt telehealth is a positive program for the state of Tennessee.”

Though not an author of the study, another Vanderbilt ob.gyn. also believes the findings support exploring continued telehealth options for the patients and providers interested in it.

“Health care providers and patients alike can attest to the benefits of telehealth utilization, Etoi A. Garrison, MD, PhD, associate professor of maternal-fetal medicine at Vanderbilt University, said in an interview. She was particularly struck by the savings reported by patients. “These costs are difficult to quantify but can have a significant impact on patients’ day-to-day quality of life,” she said.

A limitation of the study is the lack of information on how many were invited to complete it, so it’s not possible to know if the results are representative of the majority of people who used telehealth services, Dr. Garrison added. Dr. Shah agreed but didn’t think that limitation diminished the clinical implications of the study.

“A relatively small number of patients and providers are surveyed over a long period of time in which the context of the pandemic varied significantly,” he said. “Nonetheless, the findings show strong and internally consistent beliefs among those receiving and providing care that telehealth is valuable.”

The authors and Dr. Shah reported no disclosures. Dr. Garrison reported receiving a grant from the Tennessee Maternal Mortality Review committee to create an Unconscious Bias Faculty Train-the-Trainer program.

Taking more steps each day, in short spurts or longer bouts, was associated with a longer life in women older than 60 years, according to data from more than 16,000 participants in the ongoing Women’s Health Study.

The American Heart Association recommends at least 150 minutes per week of moderate physical activity, 75 minutes of vigorous physical activity, or a combination of both as fitness guidelines for adults. Walking is a safe and easy way for many adults to follow these guidelines, according to Christopher C. Moore, MS, a PhD candidate at the University of North Carolina at Chapel Hill.

The popularity of step counts reflect that they are simple and objective, and “focusing on steps can help promote an active lifestyle,” he said. Data on the impact of sporadic steps accumulated outside of longer bouts of activity on health outcomes are limited; however, technology advances in the form of fitness apps and wearable devices make it possible for researchers to track and measure the benefits of short periods of activity as well as longer periods.

In a study presented at the Epidemiology and Prevention/Lifestyle and Cardiometabolic Health meeting, sponsored by the AHA, Mr. Moore and colleagues assessed data from women older than 60 years who used wearable step-counting devices to measure their daily steps and walking patterns.

The study population included 16,732 women enrolled in the Women’s Health Study, a longstanding study of heart disease, cancer, and disease prevention among women in the United States. The participants wore waist step counters 4-7 days a week during 2011-2015. The average of the women was 72 years; 96% were non-Hispanic White, and the average BMI was 26 kg/m².

The researchers divided the total number of steps for each study participant into two groups: “bouted” steps, defined as 10 minutes or longer bouts of walking with few interruptions; and “sporadic” steps, defined as short spurts of walking during regular daily activities such as housework, taking the stairs, or walking to or from a car.

A total of 804 deaths occurred during an average of 6 years of follow-up. Each initial increase of 1,000 steps including sporadic or bouted steps was associated with a 28% decrease in death, compared with no daily steps (hazard ratio, 0.72).

Each increasing quartile of sporadic steps was linked with higher total steps per day, Mr. Moore said. “Initial increase in sporadic steps corresponded to the greatest reductions in mortality,” with a HR of 0.69 per additional sporadic steps below 3,200 per day, and the impact on reduced mortality plateaued at about 4,500 sporadic steps per day.

In further analysis, the researchers also found a roughly 32% decrease in death in participants who took more than 2,000 steps daily in uninterrupted bouts (HR, 0.69).

The study findings were limited by several factors, including the relatively short follow-up period and number of events, the assessment of steps at a single time point, and the mostly homogeneous population, Mr. Moore noted. Additional research is needed to assess whether the results are generalizable to men, younger women, and diverse racial and ethnic groups.

However, the results may have implications for public health messaging, he emphasized. The message is that, to impact longevity, the total volume of steps is more important than the type of activity through which they are accumulated.

“You can accumulate your steps through longer bouts of purposeful activity or through everyday behaviors such as walking to your car, taking the stairs, and doing housework,” Mr. Moore concluded.

Find a friend, both of you benefit

On the basis of this study and other available evidence, more steps daily are recommended for everyone, Nieca Goldberg, MD, a cardiologist at New York University Langone Health, said in an interview.

“You can increase minutes of walking and frequency of walking,” she said.

Dr. Goldberg emphasized that you don’t need a fancy app or wearable device to up your steps. She offered some tips to help overcome barriers to putting one foot in front of the other. “Take the steps instead of the elevator. Park your car farther from your destination so you can walk.” Also, you can help yourself and help a friend to better health. “Get a walking buddy so you can encourage each other to walk,” Dr. Goldberg added.

Mr. Moore and Dr. Goldberg had no financial conflicts to disclose. The Women’s Health Study is funded by Brigham and Women’s Hospital; the National Heart, Lung, and Blood Institute; and the National Cancer Institute. Mr. Moore was funded by a grant from the NHLBI but had no other financial conflicts to disclose.

Taking more steps each day, in short spurts or longer bouts, was associated with a longer life in women older than 60 years, according to data from more than 16,000 participants in the ongoing Women’s Health Study.

The American Heart Association recommends at least 150 minutes per week of moderate physical activity, 75 minutes of vigorous physical activity, or a combination of both as fitness guidelines for adults. Walking is a safe and easy way for many adults to follow these guidelines, according to Christopher C. Moore, MS, a PhD candidate at the University of North Carolina at Chapel Hill.

The popularity of step counts reflect that they are simple and objective, and “focusing on steps can help promote an active lifestyle,” he said. Data on the impact of sporadic steps accumulated outside of longer bouts of activity on health outcomes are limited; however, technology advances in the form of fitness apps and wearable devices make it possible for researchers to track and measure the benefits of short periods of activity as well as longer periods.

In a study presented at the Epidemiology and Prevention/Lifestyle and Cardiometabolic Health meeting, sponsored by the AHA, Mr. Moore and colleagues assessed data from women older than 60 years who used wearable step-counting devices to measure their daily steps and walking patterns.

The study population included 16,732 women enrolled in the Women’s Health Study, a longstanding study of heart disease, cancer, and disease prevention among women in the United States. The participants wore waist step counters 4-7 days a week during 2011-2015. The average of the women was 72 years; 96% were non-Hispanic White, and the average BMI was 26 kg/m².

The researchers divided the total number of steps for each study participant into two groups: “bouted” steps, defined as 10 minutes or longer bouts of walking with few interruptions; and “sporadic” steps, defined as short spurts of walking during regular daily activities such as housework, taking the stairs, or walking to or from a car.

A total of 804 deaths occurred during an average of 6 years of follow-up. Each initial increase of 1,000 steps including sporadic or bouted steps was associated with a 28% decrease in death, compared with no daily steps (hazard ratio, 0.72).

Each increasing quartile of sporadic steps was linked with higher total steps per day, Mr. Moore said. “Initial increase in sporadic steps corresponded to the greatest reductions in mortality,” with a HR of 0.69 per additional sporadic steps below 3,200 per day, and the impact on reduced mortality plateaued at about 4,500 sporadic steps per day.

In further analysis, the researchers also found a roughly 32% decrease in death in participants who took more than 2,000 steps daily in uninterrupted bouts (HR, 0.69).

The study findings were limited by several factors, including the relatively short follow-up period and number of events, the assessment of steps at a single time point, and the mostly homogeneous population, Mr. Moore noted. Additional research is needed to assess whether the results are generalizable to men, younger women, and diverse racial and ethnic groups.

However, the results may have implications for public health messaging, he emphasized. The message is that, to impact longevity, the total volume of steps is more important than the type of activity through which they are accumulated.

“You can accumulate your steps through longer bouts of purposeful activity or through everyday behaviors such as walking to your car, taking the stairs, and doing housework,” Mr. Moore concluded.

Find a friend, both of you benefit

On the basis of this study and other available evidence, more steps daily are recommended for everyone, Nieca Goldberg, MD, a cardiologist at New York University Langone Health, said in an interview.

“You can increase minutes of walking and frequency of walking,” she said.

Dr. Goldberg emphasized that you don’t need a fancy app or wearable device to up your steps. She offered some tips to help overcome barriers to putting one foot in front of the other. “Take the steps instead of the elevator. Park your car farther from your destination so you can walk.” Also, you can help yourself and help a friend to better health. “Get a walking buddy so you can encourage each other to walk,” Dr. Goldberg added.

Mr. Moore and Dr. Goldberg had no financial conflicts to disclose. The Women’s Health Study is funded by Brigham and Women’s Hospital; the National Heart, Lung, and Blood Institute; and the National Cancer Institute. Mr. Moore was funded by a grant from the NHLBI but had no other financial conflicts to disclose.

Taking more steps each day, in short spurts or longer bouts, was associated with a longer life in women older than 60 years, according to data from more than 16,000 participants in the ongoing Women’s Health Study.

The American Heart Association recommends at least 150 minutes per week of moderate physical activity, 75 minutes of vigorous physical activity, or a combination of both as fitness guidelines for adults. Walking is a safe and easy way for many adults to follow these guidelines, according to Christopher C. Moore, MS, a PhD candidate at the University of North Carolina at Chapel Hill.

The popularity of step counts reflect that they are simple and objective, and “focusing on steps can help promote an active lifestyle,” he said. Data on the impact of sporadic steps accumulated outside of longer bouts of activity on health outcomes are limited; however, technology advances in the form of fitness apps and wearable devices make it possible for researchers to track and measure the benefits of short periods of activity as well as longer periods.

In a study presented at the Epidemiology and Prevention/Lifestyle and Cardiometabolic Health meeting, sponsored by the AHA, Mr. Moore and colleagues assessed data from women older than 60 years who used wearable step-counting devices to measure their daily steps and walking patterns.

The study population included 16,732 women enrolled in the Women’s Health Study, a longstanding study of heart disease, cancer, and disease prevention among women in the United States. The participants wore waist step counters 4-7 days a week during 2011-2015. The average of the women was 72 years; 96% were non-Hispanic White, and the average BMI was 26 kg/m².

The researchers divided the total number of steps for each study participant into two groups: “bouted” steps, defined as 10 minutes or longer bouts of walking with few interruptions; and “sporadic” steps, defined as short spurts of walking during regular daily activities such as housework, taking the stairs, or walking to or from a car.

A total of 804 deaths occurred during an average of 6 years of follow-up. Each initial increase of 1,000 steps including sporadic or bouted steps was associated with a 28% decrease in death, compared with no daily steps (hazard ratio, 0.72).

Each increasing quartile of sporadic steps was linked with higher total steps per day, Mr. Moore said. “Initial increase in sporadic steps corresponded to the greatest reductions in mortality,” with a HR of 0.69 per additional sporadic steps below 3,200 per day, and the impact on reduced mortality plateaued at about 4,500 sporadic steps per day.

In further analysis, the researchers also found a roughly 32% decrease in death in participants who took more than 2,000 steps daily in uninterrupted bouts (HR, 0.69).

The study findings were limited by several factors, including the relatively short follow-up period and number of events, the assessment of steps at a single time point, and the mostly homogeneous population, Mr. Moore noted. Additional research is needed to assess whether the results are generalizable to men, younger women, and diverse racial and ethnic groups.

However, the results may have implications for public health messaging, he emphasized. The message is that, to impact longevity, the total volume of steps is more important than the type of activity through which they are accumulated.

“You can accumulate your steps through longer bouts of purposeful activity or through everyday behaviors such as walking to your car, taking the stairs, and doing housework,” Mr. Moore concluded.

Find a friend, both of you benefit

On the basis of this study and other available evidence, more steps daily are recommended for everyone, Nieca Goldberg, MD, a cardiologist at New York University Langone Health, said in an interview.

“You can increase minutes of walking and frequency of walking,” she said.

Dr. Goldberg emphasized that you don’t need a fancy app or wearable device to up your steps. She offered some tips to help overcome barriers to putting one foot in front of the other. “Take the steps instead of the elevator. Park your car farther from your destination so you can walk.” Also, you can help yourself and help a friend to better health. “Get a walking buddy so you can encourage each other to walk,” Dr. Goldberg added.

Mr. Moore and Dr. Goldberg had no financial conflicts to disclose. The Women’s Health Study is funded by Brigham and Women’s Hospital; the National Heart, Lung, and Blood Institute; and the National Cancer Institute. Mr. Moore was funded by a grant from the NHLBI but had no other financial conflicts to disclose.

Anti–apolipoprotein A-I (apo A-I) antibodies are common in nonalcoholic fatty liver disease and may not only drive its development but also underlie the link between NAFLD and cardiovascular disease, suggests a novel analysis.

Conducting a clinical analysis and a series of experiments, Sabrina Pagano, PhD, diagnostic department, Geneva University Hospital, and colleagues looked for anti–apo A-I antibodies in patients with NAFLD and then examined their impact on hepatic cells and inflammatory markers.

They found that nearly half of 137 patients with NAFLD were seropositive, and that the antibodies were associated with increased lipid accumulation in the liver, altered triglyceride metabolism, and proinflammatory effects on liver cells.

“We hypothesize that anti–apo A-I IgG may be a potential driver in the development of NAFLD, and further studies are needed to support anti–apo A-I IgG as a possible link between NAFLD and cardiovascular disease,” Dr. Pagano said.

The research was presented at the European Atherosclerosis Society 2021 Virtual Congress.

Asked whether anti–apo A-I antibodies could represent a potential treatment target for NAFLD, Dr. Pagano said in an interview that they have “already developed a peptide that is recognized by the antibodies in order to try to reverse the anti–apo A-I deleterious effect.”

While this was successful in vitro, “unfortunately we didn’t observe ... the peptide reverse of these anti–apo A-I effects in mice, so ... for the moment it’s a little early,” to say whether it represents a promising target.

Approached for comment, Maciej Banach, MD, PhD, full professor of cardiology, Polish Mother’s Memorial Hospital Research Institute, Lodz, said that the results are “very interesting and encouraging.”

He said that his own global burden of disease analysis, which is set to be published soon, showed that the worldwide prevalence of NAFLD is 11%, “representing almost 900 million cases,” and a more than 33% increase in prevalence in the past 30 years.

Consequently, any “attempt to have effective, especially early, diagnosis and treatment,” is highly anticipated.

Dr. Banach said the findings from the experimental analyses are “very interesting and promising,” especially regarding the proinflammatory effects of anti–apo A-I antibodies.

However, he underlined that the clinical part, looking at antibody seropositivity in patients with NAFLD, was limited by the lack of a control group, and there was no indication as to what treatment the patients received, despite it being clear that many were obese.

Dr. Banach also believes that, taking into account the patient characteristics, it is likely that most of the patients had the more severe nonalcoholic steatohepatitis, and “it would be additionally useful to see the autoantibodies levels both in NASH and NAFLD.”

Nevertheless, the clinical utility of measuring anti–apo A-I antibodies is limited at this stage.

He said that the lack of “good, easy, and cheap diagnostic methods based on both laboratory and imaging data” for NAFLD means it would be difficult to determine whether assessing antibody seropositivity “might be indeed an added value.”
 

Independent predictors

Dr. Pagano explained that anti–apo A-I antibodies, which target the major protein fraction of HDL cholesterol, are independent predictors of cardiovascular events in high-risk populations.

They are also independently associated with cardiovascular disease in the general population, as well as atherosclerotic plaque vulnerability in both mice and humans.

She said that apo A-I antibodies have a metabolic role in vivo, and have been shown in vitro to disrupt cholesterol metabolism, promoting foam cell formation.

Studies have also indicated they play a role in hepatic fibrosis, predicting the development of cirrhosis in individuals with chronic hepatitis C infection.

The team therefore set out to determine the presence of anti–apo A-I antibodies in individuals with NAFLD, defined here as fatty acid levels greater than 5% of liver weight, as well as their effect on hepatic cells.

Working with colleagues at Magna Græcia University of Catanzaro (Italy), they obtained serum samples from 137 patients with NAFLD confirmed on ultrasound.

The patients had an average age of 49 years, and 48.9% were male. The median body mass index was 31.8 kg/m². Cholesterol levels were typically in the intermediate range.

They found that 46% of the participants had anti–apo A-I IgG antibodies, “which is quite high when compared with the 15%-20% positivity that we retrieved from the general population,” Dr. Pagano said.

To explore the link between high anti–apo A-I antibodies and NAFLD, the team studied hepatic cells, treating them with anti–apo A-I IgG antibodies or control IgG antibodies, or leaving them untreated, for 24 hours.

This revealed that anti–apo A-I IgG antibodies were associated with a significant increase in liquid droplet content in hepatic cells, compared with both cells treated with control IgG (P = .0008), and untreated cells (P = .0002).

Next, the team immunized apo E knockout mice with anti–apo A-I or control IgG antibodies. After 16 weeks, they found there was a significant increase in liver lipid content in mice given anti–apo A-I antibodies versus those treated with controls (P = .03).

They then asked whether anti–apo A-I antibodies could affect triglyceride metabolism. They examined the expression of the transcription factor sterol regulatory element binding protein (SREBP) and regulation of the triglyceride and cholesterol pathways.

Treating hepatic cells again for 24 hours with anti–apo A-I IgG antibodies or control IgG antibodies, or leaving them untreated, showed that anti–apo A-I antibodies were associated with “dramatic” increases in the active form of SREBP.

They also found that expression of two key enzymes in the triglyceride pathway, fatty acid synthetase and glycerol phosphate acyltransferase, was substantially decreased in the presence anti–apo A-I antibodies.

In both experiments, the untreated hepatic cells and those exposed to control IgG antibodies showed no significant changes.

“These results suggest that negative feedback ... turns off these enzymes, probably due to the lipid overload that is found in the cells after 24 hours of anti–apo A-I treatment,” Dr. Pagano said.

Finally, the researchers observed that anti–apo A-I, but not control antibodies, were associated with increases in inflammatory markers in liver cells.

Specifically, exposure to the antibodies was linked to an approximately 10-fold increase in interleukin-6 levels, as well as an approximate 25-fold increase in IL-8, and around a 7-fold increase in tumor necrosis factor–alpha.

Dr. Pagano suggested that the inflammatory effects are “probably mediated by binding anti–apo A-I antibodies to toll-like receptor 2, which has been previously described in macrophages.”

No funding was declared. The study authors disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Anti–apolipoprotein A-I (apo A-I) antibodies are common in nonalcoholic fatty liver disease and may not only drive its development but also underlie the link between NAFLD and cardiovascular disease, suggests a novel analysis.

Conducting a clinical analysis and a series of experiments, Sabrina Pagano, PhD, diagnostic department, Geneva University Hospital, and colleagues looked for anti–apo A-I antibodies in patients with NAFLD and then examined their impact on hepatic cells and inflammatory markers.

They found that nearly half of 137 patients with NAFLD were seropositive, and that the antibodies were associated with increased lipid accumulation in the liver, altered triglyceride metabolism, and proinflammatory effects on liver cells.

“We hypothesize that anti–apo A-I IgG may be a potential driver in the development of NAFLD, and further studies are needed to support anti–apo A-I IgG as a possible link between NAFLD and cardiovascular disease,” Dr. Pagano said.

The research was presented at the European Atherosclerosis Society 2021 Virtual Congress.

Asked whether anti–apo A-I antibodies could represent a potential treatment target for NAFLD, Dr. Pagano said in an interview that they have “already developed a peptide that is recognized by the antibodies in order to try to reverse the anti–apo A-I deleterious effect.”

While this was successful in vitro, “unfortunately we didn’t observe ... the peptide reverse of these anti–apo A-I effects in mice, so ... for the moment it’s a little early,” to say whether it represents a promising target.

Approached for comment, Maciej Banach, MD, PhD, full professor of cardiology, Polish Mother’s Memorial Hospital Research Institute, Lodz, said that the results are “very interesting and encouraging.”

He said that his own global burden of disease analysis, which is set to be published soon, showed that the worldwide prevalence of NAFLD is 11%, “representing almost 900 million cases,” and a more than 33% increase in prevalence in the past 30 years.

Consequently, any “attempt to have effective, especially early, diagnosis and treatment,” is highly anticipated.

Dr. Banach said the findings from the experimental analyses are “very interesting and promising,” especially regarding the proinflammatory effects of anti–apo A-I antibodies.

However, he underlined that the clinical part, looking at antibody seropositivity in patients with NAFLD, was limited by the lack of a control group, and there was no indication as to what treatment the patients received, despite it being clear that many were obese.

Dr. Banach also believes that, taking into account the patient characteristics, it is likely that most of the patients had the more severe nonalcoholic steatohepatitis, and “it would be additionally useful to see the autoantibodies levels both in NASH and NAFLD.”

Nevertheless, the clinical utility of measuring anti–apo A-I antibodies is limited at this stage.

He said that the lack of “good, easy, and cheap diagnostic methods based on both laboratory and imaging data” for NAFLD means it would be difficult to determine whether assessing antibody seropositivity “might be indeed an added value.”
 

Independent predictors

Dr. Pagano explained that anti–apo A-I antibodies, which target the major protein fraction of HDL cholesterol, are independent predictors of cardiovascular events in high-risk populations.

They are also independently associated with cardiovascular disease in the general population, as well as atherosclerotic plaque vulnerability in both mice and humans.

She said that apo A-I antibodies have a metabolic role in vivo, and have been shown in vitro to disrupt cholesterol metabolism, promoting foam cell formation.

Studies have also indicated they play a role in hepatic fibrosis, predicting the development of cirrhosis in individuals with chronic hepatitis C infection.

The team therefore set out to determine the presence of anti–apo A-I antibodies in individuals with NAFLD, defined here as fatty acid levels greater than 5% of liver weight, as well as their effect on hepatic cells.

Working with colleagues at Magna Græcia University of Catanzaro (Italy), they obtained serum samples from 137 patients with NAFLD confirmed on ultrasound.

The patients had an average age of 49 years, and 48.9% were male. The median body mass index was 31.8 kg/m². Cholesterol levels were typically in the intermediate range.

They found that 46% of the participants had anti–apo A-I IgG antibodies, “which is quite high when compared with the 15%-20% positivity that we retrieved from the general population,” Dr. Pagano said.

To explore the link between high anti–apo A-I antibodies and NAFLD, the team studied hepatic cells, treating them with anti–apo A-I IgG antibodies or control IgG antibodies, or leaving them untreated, for 24 hours.

This revealed that anti–apo A-I IgG antibodies were associated with a significant increase in liquid droplet content in hepatic cells, compared with both cells treated with control IgG (P = .0008), and untreated cells (P = .0002).

Next, the team immunized apo E knockout mice with anti–apo A-I or control IgG antibodies. After 16 weeks, they found there was a significant increase in liver lipid content in mice given anti–apo A-I antibodies versus those treated with controls (P = .03).

They then asked whether anti–apo A-I antibodies could affect triglyceride metabolism. They examined the expression of the transcription factor sterol regulatory element binding protein (SREBP) and regulation of the triglyceride and cholesterol pathways.

Treating hepatic cells again for 24 hours with anti–apo A-I IgG antibodies or control IgG antibodies, or leaving them untreated, showed that anti–apo A-I antibodies were associated with “dramatic” increases in the active form of SREBP.

They also found that expression of two key enzymes in the triglyceride pathway, fatty acid synthetase and glycerol phosphate acyltransferase, was substantially decreased in the presence anti–apo A-I antibodies.

In both experiments, the untreated hepatic cells and those exposed to control IgG antibodies showed no significant changes.

“These results suggest that negative feedback ... turns off these enzymes, probably due to the lipid overload that is found in the cells after 24 hours of anti–apo A-I treatment,” Dr. Pagano said.

Finally, the researchers observed that anti–apo A-I, but not control antibodies, were associated with increases in inflammatory markers in liver cells.

Specifically, exposure to the antibodies was linked to an approximately 10-fold increase in interleukin-6 levels, as well as an approximate 25-fold increase in IL-8, and around a 7-fold increase in tumor necrosis factor–alpha.

Dr. Pagano suggested that the inflammatory effects are “probably mediated by binding anti–apo A-I antibodies to toll-like receptor 2, which has been previously described in macrophages.”

No funding was declared. The study authors disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Anti–apolipoprotein A-I (apo A-I) antibodies are common in nonalcoholic fatty liver disease and may not only drive its development but also underlie the link between NAFLD and cardiovascular disease, suggests a novel analysis.

Conducting a clinical analysis and a series of experiments, Sabrina Pagano, PhD, diagnostic department, Geneva University Hospital, and colleagues looked for anti–apo A-I antibodies in patients with NAFLD and then examined their impact on hepatic cells and inflammatory markers.

They found that nearly half of 137 patients with NAFLD were seropositive, and that the antibodies were associated with increased lipid accumulation in the liver, altered triglyceride metabolism, and proinflammatory effects on liver cells.

“We hypothesize that anti–apo A-I IgG may be a potential driver in the development of NAFLD, and further studies are needed to support anti–apo A-I IgG as a possible link between NAFLD and cardiovascular disease,” Dr. Pagano said.

The research was presented at the European Atherosclerosis Society 2021 Virtual Congress.

Asked whether anti–apo A-I antibodies could represent a potential treatment target for NAFLD, Dr. Pagano said in an interview that they have “already developed a peptide that is recognized by the antibodies in order to try to reverse the anti–apo A-I deleterious effect.”

While this was successful in vitro, “unfortunately we didn’t observe ... the peptide reverse of these anti–apo A-I effects in mice, so ... for the moment it’s a little early,” to say whether it represents a promising target.

Approached for comment, Maciej Banach, MD, PhD, full professor of cardiology, Polish Mother’s Memorial Hospital Research Institute, Lodz, said that the results are “very interesting and encouraging.”

He said that his own global burden of disease analysis, which is set to be published soon, showed that the worldwide prevalence of NAFLD is 11%, “representing almost 900 million cases,” and a more than 33% increase in prevalence in the past 30 years.

Consequently, any “attempt to have effective, especially early, diagnosis and treatment,” is highly anticipated.

Dr. Banach said the findings from the experimental analyses are “very interesting and promising,” especially regarding the proinflammatory effects of anti–apo A-I antibodies.

However, he underlined that the clinical part, looking at antibody seropositivity in patients with NAFLD, was limited by the lack of a control group, and there was no indication as to what treatment the patients received, despite it being clear that many were obese.

Dr. Banach also believes that, taking into account the patient characteristics, it is likely that most of the patients had the more severe nonalcoholic steatohepatitis, and “it would be additionally useful to see the autoantibodies levels both in NASH and NAFLD.”

Nevertheless, the clinical utility of measuring anti–apo A-I antibodies is limited at this stage.

He said that the lack of “good, easy, and cheap diagnostic methods based on both laboratory and imaging data” for NAFLD means it would be difficult to determine whether assessing antibody seropositivity “might be indeed an added value.”
 

Independent predictors

Dr. Pagano explained that anti–apo A-I antibodies, which target the major protein fraction of HDL cholesterol, are independent predictors of cardiovascular events in high-risk populations.

They are also independently associated with cardiovascular disease in the general population, as well as atherosclerotic plaque vulnerability in both mice and humans.

She said that apo A-I antibodies have a metabolic role in vivo, and have been shown in vitro to disrupt cholesterol metabolism, promoting foam cell formation.

Studies have also indicated they play a role in hepatic fibrosis, predicting the development of cirrhosis in individuals with chronic hepatitis C infection.

The team therefore set out to determine the presence of anti–apo A-I antibodies in individuals with NAFLD, defined here as fatty acid levels greater than 5% of liver weight, as well as their effect on hepatic cells.

Working with colleagues at Magna Græcia University of Catanzaro (Italy), they obtained serum samples from 137 patients with NAFLD confirmed on ultrasound.

The patients had an average age of 49 years, and 48.9% were male. The median body mass index was 31.8 kg/m². Cholesterol levels were typically in the intermediate range.

They found that 46% of the participants had anti–apo A-I IgG antibodies, “which is quite high when compared with the 15%-20% positivity that we retrieved from the general population,” Dr. Pagano said.

To explore the link between high anti–apo A-I antibodies and NAFLD, the team studied hepatic cells, treating them with anti–apo A-I IgG antibodies or control IgG antibodies, or leaving them untreated, for 24 hours.

This revealed that anti–apo A-I IgG antibodies were associated with a significant increase in liquid droplet content in hepatic cells, compared with both cells treated with control IgG (P = .0008), and untreated cells (P = .0002).

Next, the team immunized apo E knockout mice with anti–apo A-I or control IgG antibodies. After 16 weeks, they found there was a significant increase in liver lipid content in mice given anti–apo A-I antibodies versus those treated with controls (P = .03).

They then asked whether anti–apo A-I antibodies could affect triglyceride metabolism. They examined the expression of the transcription factor sterol regulatory element binding protein (SREBP) and regulation of the triglyceride and cholesterol pathways.

Treating hepatic cells again for 24 hours with anti–apo A-I IgG antibodies or control IgG antibodies, or leaving them untreated, showed that anti–apo A-I antibodies were associated with “dramatic” increases in the active form of SREBP.

They also found that expression of two key enzymes in the triglyceride pathway, fatty acid synthetase and glycerol phosphate acyltransferase, was substantially decreased in the presence anti–apo A-I antibodies.

In both experiments, the untreated hepatic cells and those exposed to control IgG antibodies showed no significant changes.

“These results suggest that negative feedback ... turns off these enzymes, probably due to the lipid overload that is found in the cells after 24 hours of anti–apo A-I treatment,” Dr. Pagano said.

Finally, the researchers observed that anti–apo A-I, but not control antibodies, were associated with increases in inflammatory markers in liver cells.

Specifically, exposure to the antibodies was linked to an approximately 10-fold increase in interleukin-6 levels, as well as an approximate 25-fold increase in IL-8, and around a 7-fold increase in tumor necrosis factor–alpha.

Dr. Pagano suggested that the inflammatory effects are “probably mediated by binding anti–apo A-I antibodies to toll-like receptor 2, which has been previously described in macrophages.”

No funding was declared. The study authors disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Almost 14% of transected invasive melanoma biopsies at the University of Alabama at Birmingham were up-staged on final surgical pathology, in a review of cases at the university.

Had their true Breslow depths been known before definitive surgery, sentinel lymph node (SLN) biopsies and wider surgical margins would likely have been recommended.

The findings led the investigators to conclude that a second biopsy should be considered when the first one is transected to ensure surgical and other management decisions are based on an accurate Breslow depth.

A second biopsy is especially warranted for broadly transected biopsies and transected T1a tumors with gross residual tumor or pigment on preoperative exam; both scenarios significantly increased the risk of up-staging in the study, according to lead investigator James Duncan, MD, a Mohs surgery and dermatologic oncology fellow at the University of Alabama at Birmingham, who presented the findings at the annual meeting of the American College of Mohs Surgery.

“Accurate staging of malignancies, especially melanoma, is critical to determine prognosis and the best treatment approach,” said Vishal Patel, MD, director of cutaneous oncology at George Washington University, Washington, when asked for comment.

“This study identifies how transected biopsies can underestimate a melanoma’s true depth and thus impact treatment and outcomes. The authors highlight that when a biopsy is transected, or there is notable pigment at the base, attempts should be taken to sample the remaining tumor prior to surgery so the accurate tumor depth can be determined and treatment options be fully discussed with the patient,” Dr. Patel said.

The Birmingham team reviewed invasive melanoma cases at their university from 2017 to 2019.

Almost half (49.6%) of the 726 melanomas they identified were transected on biopsy, which is in line with prior reports. About 60% of the patients were men and 98% were White; the average age was 63 years.

Of the 360 transected tumors, 49 (13.6%) had up-staging at final excision that “would have prompted discussion of alternate surgical treatment such as SLN biopsy or wider surgical margins,” the team said.

Of the 89 transected pT1a melanomas identified, 47.1% with gross residual tumor or pigment on preoperative physical examination were up-staged following excision versus 6.9% with no remaining pigment or tumor prior to surgery (P < .01).

Broadly transected tumors were up-staged in 21.7% of cases versus 4.9% of focally transected tumors (P = .038). The average increase in Breslow depth for broadly transected tumors was 1.03 mm versus 0.03 mm for focally transected lesions (P = .04).

Shave biopsies, ulceration, and lack of concern for melanoma at the initial biopsy were among the factors associated with a higher risk of transection.

Superficial spreading melanoma was the most common subtype. Tumors were evenly distributed between the head, neck, and extremities. The average Breslow depth was 1.51 mm, and the majority of tumors were pT1a or pT2a.

The review excluded melanoma in situ, recurrences, metastases, noncutaneous melanomas, and biopsies where deep margin status was unknown.

There was no funding for the study, and Dr. Duncan and Dr. Patel had no relevant disclosures.

aotto@mdedge.com

Almost 14% of transected invasive melanoma biopsies at the University of Alabama at Birmingham were up-staged on final surgical pathology, in a review of cases at the university.

Had their true Breslow depths been known before definitive surgery, sentinel lymph node (SLN) biopsies and wider surgical margins would likely have been recommended.

The findings led the investigators to conclude that a second biopsy should be considered when the first one is transected to ensure surgical and other management decisions are based on an accurate Breslow depth.

A second biopsy is especially warranted for broadly transected biopsies and transected T1a tumors with gross residual tumor or pigment on preoperative exam; both scenarios significantly increased the risk of up-staging in the study, according to lead investigator James Duncan, MD, a Mohs surgery and dermatologic oncology fellow at the University of Alabama at Birmingham, who presented the findings at the annual meeting of the American College of Mohs Surgery.

“Accurate staging of malignancies, especially melanoma, is critical to determine prognosis and the best treatment approach,” said Vishal Patel, MD, director of cutaneous oncology at George Washington University, Washington, when asked for comment.

“This study identifies how transected biopsies can underestimate a melanoma’s true depth and thus impact treatment and outcomes. The authors highlight that when a biopsy is transected, or there is notable pigment at the base, attempts should be taken to sample the remaining tumor prior to surgery so the accurate tumor depth can be determined and treatment options be fully discussed with the patient,” Dr. Patel said.

The Birmingham team reviewed invasive melanoma cases at their university from 2017 to 2019.

Almost half (49.6%) of the 726 melanomas they identified were transected on biopsy, which is in line with prior reports. About 60% of the patients were men and 98% were White; the average age was 63 years.

Of the 360 transected tumors, 49 (13.6%) had up-staging at final excision that “would have prompted discussion of alternate surgical treatment such as SLN biopsy or wider surgical margins,” the team said.

Of the 89 transected pT1a melanomas identified, 47.1% with gross residual tumor or pigment on preoperative physical examination were up-staged following excision versus 6.9% with no remaining pigment or tumor prior to surgery (P < .01).

Broadly transected tumors were up-staged in 21.7% of cases versus 4.9% of focally transected tumors (P = .038). The average increase in Breslow depth for broadly transected tumors was 1.03 mm versus 0.03 mm for focally transected lesions (P = .04).

Shave biopsies, ulceration, and lack of concern for melanoma at the initial biopsy were among the factors associated with a higher risk of transection.

Superficial spreading melanoma was the most common subtype. Tumors were evenly distributed between the head, neck, and extremities. The average Breslow depth was 1.51 mm, and the majority of tumors were pT1a or pT2a.

The review excluded melanoma in situ, recurrences, metastases, noncutaneous melanomas, and biopsies where deep margin status was unknown.

There was no funding for the study, and Dr. Duncan and Dr. Patel had no relevant disclosures.

aotto@mdedge.com

Almost 14% of transected invasive melanoma biopsies at the University of Alabama at Birmingham were up-staged on final surgical pathology, in a review of cases at the university.

Had their true Breslow depths been known before definitive surgery, sentinel lymph node (SLN) biopsies and wider surgical margins would likely have been recommended.

The findings led the investigators to conclude that a second biopsy should be considered when the first one is transected to ensure surgical and other management decisions are based on an accurate Breslow depth.

A second biopsy is especially warranted for broadly transected biopsies and transected T1a tumors with gross residual tumor or pigment on preoperative exam; both scenarios significantly increased the risk of up-staging in the study, according to lead investigator James Duncan, MD, a Mohs surgery and dermatologic oncology fellow at the University of Alabama at Birmingham, who presented the findings at the annual meeting of the American College of Mohs Surgery.

“Accurate staging of malignancies, especially melanoma, is critical to determine prognosis and the best treatment approach,” said Vishal Patel, MD, director of cutaneous oncology at George Washington University, Washington, when asked for comment.

“This study identifies how transected biopsies can underestimate a melanoma’s true depth and thus impact treatment and outcomes. The authors highlight that when a biopsy is transected, or there is notable pigment at the base, attempts should be taken to sample the remaining tumor prior to surgery so the accurate tumor depth can be determined and treatment options be fully discussed with the patient,” Dr. Patel said.

The Birmingham team reviewed invasive melanoma cases at their university from 2017 to 2019.

Almost half (49.6%) of the 726 melanomas they identified were transected on biopsy, which is in line with prior reports. About 60% of the patients were men and 98% were White; the average age was 63 years.

Of the 360 transected tumors, 49 (13.6%) had up-staging at final excision that “would have prompted discussion of alternate surgical treatment such as SLN biopsy or wider surgical margins,” the team said.

Of the 89 transected pT1a melanomas identified, 47.1% with gross residual tumor or pigment on preoperative physical examination were up-staged following excision versus 6.9% with no remaining pigment or tumor prior to surgery (P < .01).

Broadly transected tumors were up-staged in 21.7% of cases versus 4.9% of focally transected tumors (P = .038). The average increase in Breslow depth for broadly transected tumors was 1.03 mm versus 0.03 mm for focally transected lesions (P = .04).

Shave biopsies, ulceration, and lack of concern for melanoma at the initial biopsy were among the factors associated with a higher risk of transection.

Superficial spreading melanoma was the most common subtype. Tumors were evenly distributed between the head, neck, and extremities. The average Breslow depth was 1.51 mm, and the majority of tumors were pT1a or pT2a.

The review excluded melanoma in situ, recurrences, metastases, noncutaneous melanomas, and biopsies where deep margin status was unknown.

There was no funding for the study, and Dr. Duncan and Dr. Patel had no relevant disclosures.

aotto@mdedge.com

The keys to effective resuscitation in the hospital setting include effective compression and early defibrillation, according to Jessica Nave Allen, MD, FHM, a hospitalist with Emory University Hospital in Atlanta. She spoke about best practices in resuscitation medicine recently at SHM Converge, the annual conference of the Society of Hospital Medicine.

“We know CPR [cardiopulmonary resuscitation] and shocking are the two biggest determinants of outcomes, so really strive to make those chest compressions really high quality,” said Dr. Allen. She urged hospitalists to consider mechanical piston compressions and even “reverse CPR” when appropriate.

Dr. Allen offered several other tips about effective in-hospital resuscitation.
 

Don’t overcrowd the hospital room

There shouldn’t be more than eight people inside the room during a code, she said. If you’re the code leader, “make sure that somebody has already started high-quality chest compressions. You want to make sure that somebody is already on the airway. It’s usually two people, one person to actually hold the mask down to make sure there’s a good seal, and the other person to deliver the breaths.”

Two to three people should be assigned to chest compressions, Dr. Allen said, “and you need one or two nurses for medication delivery and grabbing things from the runners. And then you need to have a recorder and the code leader. Everyone else who’s not in one of those formalized roles needs to be outside the room. That includes the pharmacist, who usually stands at the door if you don’t have a code pharmacist at your institution.”

A helpful mnemonic for the resuscitation process is I(CA)RAMBO, which was developed at Tufts Medical Center and published in 2020, she said. The mnemonic stands for the following:

• I: Identify yourself as code leader.
• CA: Compression, Airway.
• R: Roles (assign roles in the resuscitation).
• A: Access (intravenous access is preferred to intraosseous, per the American Heart Association’s , unless intravenous access is unavailable, Dr. Allen noted).
• M: Monitor (make sure pads are placed correctly; turn the defibrillator on).
• B: Backboard.
• O: Oxygen.

Focus on high-quality chest compressions

The number of chest compressions must be 100-120 per minute, Dr. Allen said. You can time them to the beat of a song, such as “Stayin’ Alive,” or with a metronome, she said, “but whatever it is, you need to stay in that window.”

The correct compression depth is 2-2.4 inches. “That’s very difficult to do during the middle of a code, which is why it’s important to allow full recoil,” she said. “This doesn’t mean taking your hands off of the chest: You should actually never take your hands off of the chest. But you should allow the chest wall to return to its normal state. Also, make sure you aren’t off the chest for more for 10 seconds whenever you’re doing a rhythm check.”

Audiovisual feedback devices can provide insight into the quality of chest compressions. For example, some defibrillators are equipped with sensors that urge users to push harder and faster when appropriate. “Studies have shown that the quality of chest compressions goes up when you use these devices,” she said.
 

Don’t be afraid of mechanical chest compression

Although early research raised questions about the quality of resuscitation outcomes when mechanical piston chest compression devices are used, a 2015 systematic review and meta-analysis found that “man was equal to machine,” Dr. Allen said. “The bottom line is that these devices may be a reasonable alternative to conventional CPR in specific settings.”

American Heart Association guidelines state that mechanical compressions may be appropriate in certain specific situations “where the delivery of high-quality manual compressions may be challenging or dangerous for the provider.”

According to Dr. Allen, “there are times when it’s useful,” such as for a patient with COVID-19, in the cath lab, or in a medical helicopter.
 

Move quickly to defibrillation

“Most of us know that you want to shock as early as possible in shockable rhythms,” Dr. Allen said. Support, she said, comes from a 2008 study that linked delayed defibrillation to lower survival rates. “We want to shock as soon as possible, because your chances of surviving go down for every minute you wait.”

Take special care for patients with confirmed or suspected COVID-19

“Not surprisingly, the goals here are to minimize exposure to staff,” Dr. Allen said.

Put on personal protective equipment before entering the room even if care is delayed, she advised, and reduce the number of staff members in the room below the typical maximum of eight. “In COVID, it should be a maximum of six, and some institutions have even gotten it down to four where the code leaders are outside the room with an iPad.”

Use mechanical compression devices, she advised, and place patients on ventilators as soon as possible. She added: “Use a HEPA [high-efficiency particulate air] filter for all your airway modalities.”

CPR may be challenging in some cases, such as when a large, intubated patient is prone and cannot be quickly or safely flipped over. In those cases, consider posterior chest compressions, also known as reverse CPR, at vertebral positions T7-T10. “We have done reverse CPR on several COVID patients throughout the Emory system,” she said.
 

Debrief right after codes

“You really want to debrief with the code team,” Dr. Allen said. “If you don’t already have a policy in place at your institution, you should help come up with one where you sit down with the team and talk about what could you have done better as a group. It’s not a time to place blame. It’s a time to learn.”

Dr. Allen has disclosed no relevant financial relationships.

This article was updated 7/26/21.

A version of this article first appeared on Medscape.com.

The keys to effective resuscitation in the hospital setting include effective compression and early defibrillation, according to Jessica Nave Allen, MD, FHM, a hospitalist with Emory University Hospital in Atlanta. She spoke about best practices in resuscitation medicine recently at SHM Converge, the annual conference of the Society of Hospital Medicine.

“We know CPR [cardiopulmonary resuscitation] and shocking are the two biggest determinants of outcomes, so really strive to make those chest compressions really high quality,” said Dr. Allen. She urged hospitalists to consider mechanical piston compressions and even “reverse CPR” when appropriate.

Dr. Allen offered several other tips about effective in-hospital resuscitation.
 

Don’t overcrowd the hospital room

There shouldn’t be more than eight people inside the room during a code, she said. If you’re the code leader, “make sure that somebody has already started high-quality chest compressions. You want to make sure that somebody is already on the airway. It’s usually two people, one person to actually hold the mask down to make sure there’s a good seal, and the other person to deliver the breaths.”

Two to three people should be assigned to chest compressions, Dr. Allen said, “and you need one or two nurses for medication delivery and grabbing things from the runners. And then you need to have a recorder and the code leader. Everyone else who’s not in one of those formalized roles needs to be outside the room. That includes the pharmacist, who usually stands at the door if you don’t have a code pharmacist at your institution.”

A helpful mnemonic for the resuscitation process is I(CA)RAMBO, which was developed at Tufts Medical Center and published in 2020, she said. The mnemonic stands for the following:

• I: Identify yourself as code leader.
• CA: Compression, Airway.
• R: Roles (assign roles in the resuscitation).
• A: Access (intravenous access is preferred to intraosseous, per the American Heart Association’s , unless intravenous access is unavailable, Dr. Allen noted).
• M: Monitor (make sure pads are placed correctly; turn the defibrillator on).
• B: Backboard.
• O: Oxygen.

Focus on high-quality chest compressions

The number of chest compressions must be 100-120 per minute, Dr. Allen said. You can time them to the beat of a song, such as “Stayin’ Alive,” or with a metronome, she said, “but whatever it is, you need to stay in that window.”

The correct compression depth is 2-2.4 inches. “That’s very difficult to do during the middle of a code, which is why it’s important to allow full recoil,” she said. “This doesn’t mean taking your hands off of the chest: You should actually never take your hands off of the chest. But you should allow the chest wall to return to its normal state. Also, make sure you aren’t off the chest for more for 10 seconds whenever you’re doing a rhythm check.”

Audiovisual feedback devices can provide insight into the quality of chest compressions. For example, some defibrillators are equipped with sensors that urge users to push harder and faster when appropriate. “Studies have shown that the quality of chest compressions goes up when you use these devices,” she said.
 

Don’t be afraid of mechanical chest compression

Although early research raised questions about the quality of resuscitation outcomes when mechanical piston chest compression devices are used, a 2015 systematic review and meta-analysis found that “man was equal to machine,” Dr. Allen said. “The bottom line is that these devices may be a reasonable alternative to conventional CPR in specific settings.”

American Heart Association guidelines state that mechanical compressions may be appropriate in certain specific situations “where the delivery of high-quality manual compressions may be challenging or dangerous for the provider.”

According to Dr. Allen, “there are times when it’s useful,” such as for a patient with COVID-19, in the cath lab, or in a medical helicopter.
 

Move quickly to defibrillation

“Most of us know that you want to shock as early as possible in shockable rhythms,” Dr. Allen said. Support, she said, comes from a 2008 study that linked delayed defibrillation to lower survival rates. “We want to shock as soon as possible, because your chances of surviving go down for every minute you wait.”

Take special care for patients with confirmed or suspected COVID-19

“Not surprisingly, the goals here are to minimize exposure to staff,” Dr. Allen said.

Put on personal protective equipment before entering the room even if care is delayed, she advised, and reduce the number of staff members in the room below the typical maximum of eight. “In COVID, it should be a maximum of six, and some institutions have even gotten it down to four where the code leaders are outside the room with an iPad.”

Use mechanical compression devices, she advised, and place patients on ventilators as soon as possible. She added: “Use a HEPA [high-efficiency particulate air] filter for all your airway modalities.”

CPR may be challenging in some cases, such as when a large, intubated patient is prone and cannot be quickly or safely flipped over. In those cases, consider posterior chest compressions, also known as reverse CPR, at vertebral positions T7-T10. “We have done reverse CPR on several COVID patients throughout the Emory system,” she said.
 

Debrief right after codes

“You really want to debrief with the code team,” Dr. Allen said. “If you don’t already have a policy in place at your institution, you should help come up with one where you sit down with the team and talk about what could you have done better as a group. It’s not a time to place blame. It’s a time to learn.”

Dr. Allen has disclosed no relevant financial relationships.

This article was updated 7/26/21.

A version of this article first appeared on Medscape.com.

The keys to effective resuscitation in the hospital setting include effective compression and early defibrillation, according to Jessica Nave Allen, MD, FHM, a hospitalist with Emory University Hospital in Atlanta. She spoke about best practices in resuscitation medicine recently at SHM Converge, the annual conference of the Society of Hospital Medicine.

“We know CPR [cardiopulmonary resuscitation] and shocking are the two biggest determinants of outcomes, so really strive to make those chest compressions really high quality,” said Dr. Allen. She urged hospitalists to consider mechanical piston compressions and even “reverse CPR” when appropriate.

Dr. Allen offered several other tips about effective in-hospital resuscitation.
 

Don’t overcrowd the hospital room

There shouldn’t be more than eight people inside the room during a code, she said. If you’re the code leader, “make sure that somebody has already started high-quality chest compressions. You want to make sure that somebody is already on the airway. It’s usually two people, one person to actually hold the mask down to make sure there’s a good seal, and the other person to deliver the breaths.”

Two to three people should be assigned to chest compressions, Dr. Allen said, “and you need one or two nurses for medication delivery and grabbing things from the runners. And then you need to have a recorder and the code leader. Everyone else who’s not in one of those formalized roles needs to be outside the room. That includes the pharmacist, who usually stands at the door if you don’t have a code pharmacist at your institution.”

A helpful mnemonic for the resuscitation process is I(CA)RAMBO, which was developed at Tufts Medical Center and published in 2020, she said. The mnemonic stands for the following:

• I: Identify yourself as code leader.
• CA: Compression, Airway.
• R: Roles (assign roles in the resuscitation).
• A: Access (intravenous access is preferred to intraosseous, per the American Heart Association’s , unless intravenous access is unavailable, Dr. Allen noted).
• M: Monitor (make sure pads are placed correctly; turn the defibrillator on).
• B: Backboard.
• O: Oxygen.

Focus on high-quality chest compressions

The number of chest compressions must be 100-120 per minute, Dr. Allen said. You can time them to the beat of a song, such as “Stayin’ Alive,” or with a metronome, she said, “but whatever it is, you need to stay in that window.”

The correct compression depth is 2-2.4 inches. “That’s very difficult to do during the middle of a code, which is why it’s important to allow full recoil,” she said. “This doesn’t mean taking your hands off of the chest: You should actually never take your hands off of the chest. But you should allow the chest wall to return to its normal state. Also, make sure you aren’t off the chest for more for 10 seconds whenever you’re doing a rhythm check.”

Audiovisual feedback devices can provide insight into the quality of chest compressions. For example, some defibrillators are equipped with sensors that urge users to push harder and faster when appropriate. “Studies have shown that the quality of chest compressions goes up when you use these devices,” she said.
 

Don’t be afraid of mechanical chest compression

Although early research raised questions about the quality of resuscitation outcomes when mechanical piston chest compression devices are used, a 2015 systematic review and meta-analysis found that “man was equal to machine,” Dr. Allen said. “The bottom line is that these devices may be a reasonable alternative to conventional CPR in specific settings.”

American Heart Association guidelines state that mechanical compressions may be appropriate in certain specific situations “where the delivery of high-quality manual compressions may be challenging or dangerous for the provider.”

According to Dr. Allen, “there are times when it’s useful,” such as for a patient with COVID-19, in the cath lab, or in a medical helicopter.
 

Move quickly to defibrillation

“Most of us know that you want to shock as early as possible in shockable rhythms,” Dr. Allen said. Support, she said, comes from a 2008 study that linked delayed defibrillation to lower survival rates. “We want to shock as soon as possible, because your chances of surviving go down for every minute you wait.”

Take special care for patients with confirmed or suspected COVID-19

“Not surprisingly, the goals here are to minimize exposure to staff,” Dr. Allen said.

Put on personal protective equipment before entering the room even if care is delayed, she advised, and reduce the number of staff members in the room below the typical maximum of eight. “In COVID, it should be a maximum of six, and some institutions have even gotten it down to four where the code leaders are outside the room with an iPad.”

Use mechanical compression devices, she advised, and place patients on ventilators as soon as possible. She added: “Use a HEPA [high-efficiency particulate air] filter for all your airway modalities.”

CPR may be challenging in some cases, such as when a large, intubated patient is prone and cannot be quickly or safely flipped over. In those cases, consider posterior chest compressions, also known as reverse CPR, at vertebral positions T7-T10. “We have done reverse CPR on several COVID patients throughout the Emory system,” she said.
 

Debrief right after codes

“You really want to debrief with the code team,” Dr. Allen said. “If you don’t already have a policy in place at your institution, you should help come up with one where you sit down with the team and talk about what could you have done better as a group. It’s not a time to place blame. It’s a time to learn.”

Dr. Allen has disclosed no relevant financial relationships.

This article was updated 7/26/21.

A version of this article first appeared on Medscape.com.

Among infants younger than 1 year of age, bacterial meningitis is associated with worse long-term mortality, even after recovery from the initial infection. Heightened mortality risk stretched out to 10 years, and was highest in the wake of infection from Streptococcus agalactiae, according to a retrospective analysis of children in the Netherlands.

“The adjusted hazard rates were high for the whole group of bacterial meningitis, especially within the first year after onset. (Staphylococcus agalactiae) meningitis has the highest mortality risk within one year of disease onset,” Linde Snoek said during her presentation of the study (abstract 913) at the annual meeting of the European Society for Paediatric Infectious Diseases, held virtually this year. Ms. Snoek is a PhD student at Amsterdam University Medical Center.

Over longer time periods, the mortality associations were different. “The adjusted hazard rates were highest for pneumococcal meningitis compared to the other pathogens. And this was the case for 1 year, 5 years, and 10 years after disease onset,” said Ms. Snoek.

The study appears to be the first to look at extended mortality following bacterial meningitis in this age group, according to Marie Rohr, MD, who comoderated the session where the research was presented.

“In a quick review of the literature I did not find any [equivalent] study concerning short- and long-term mortality after bacterial meningitis in under 1 year of age,” said Dr. Rohr, a fellow in pediatric infectious diseases at University Hospitals of Geneva. But the message to physicians is clear. “Children with history of bacterial meningitis have a higher long-term mortality than children without a history of bacterial meningitis,” said Dr. Rohr.

The study did have a key limitation: For matched controls, it relied on anonymous data from the Municipal Personal Records Database in Statistics Netherlands. “Important information like cause of death is lacking,” said Dr. Rohr.

Bacterial meningitis is associated with significant mortality and morbidity. Pathogens behind the infections vary with age group and geographic location, as well as immunization status.

To examine long-term mortality after bacterial meningitis, the researchers collected 1,646 records from an exposed cohort, with a date range of 1995 to 2018, from the Netherlands Reference Laboratory for Bacterial Meningitis. Included patients had a positive culture diagnosis of bacterial meningitis during the first year of life. Each exposed subject was compared to 10 controls matched by birth month, birth year, and sex, who had no exposure to bacterial meningitis.

Staphylococcus pneumoniae accounted for the most cases, at 32.0% (median age of onset, 180 days), followed by Neisseria meningitidis at 29.0% (median age of onset, 203 days). Other pathogens included S. agalactiae (19.7%, 10 days), Escherichia coli (8.8%, 13 days), and Haemophilus influenzae (5.4%, 231 days).

The mortality risk within 1 year of disease onset was higher for all pathogens (6.2% vs. 0.2% unexposed). The highest mortality risk was seen for S. agalactiae (8.7%), followed by E. coli (6.4%), N. meningitidis (4.9%), and H. influenzae (3.4%).

Hazard ratios (HR) for mortality were also higher, particularly in the first year after disease onset. For all pathogens, mortality rates were higher within 1 year (HR, 39.2), 5 years (HR, 28.7), and 10 years (HR, 24.1). The consistently highest mortality rates were associated with S. pneumoniae over 1-year, 5-year, and 10-year follow-up (HR, 42.8; HR, 45.6; HR, 40.6, respectively). Within 1 year, the highest mortality rate was associated with N. meningitidis (HR, 58.4).

Ms. Snoek and Dr. Rohr have no relevant financial disclosures.

Among infants younger than 1 year of age, bacterial meningitis is associated with worse long-term mortality, even after recovery from the initial infection. Heightened mortality risk stretched out to 10 years, and was highest in the wake of infection from Streptococcus agalactiae, according to a retrospective analysis of children in the Netherlands.

“The adjusted hazard rates were high for the whole group of bacterial meningitis, especially within the first year after onset. (Staphylococcus agalactiae) meningitis has the highest mortality risk within one year of disease onset,” Linde Snoek said during her presentation of the study (abstract 913) at the annual meeting of the European Society for Paediatric Infectious Diseases, held virtually this year. Ms. Snoek is a PhD student at Amsterdam University Medical Center.

Over longer time periods, the mortality associations were different. “The adjusted hazard rates were highest for pneumococcal meningitis compared to the other pathogens. And this was the case for 1 year, 5 years, and 10 years after disease onset,” said Ms. Snoek.

The study appears to be the first to look at extended mortality following bacterial meningitis in this age group, according to Marie Rohr, MD, who comoderated the session where the research was presented.

“In a quick review of the literature I did not find any [equivalent] study concerning short- and long-term mortality after bacterial meningitis in under 1 year of age,” said Dr. Rohr, a fellow in pediatric infectious diseases at University Hospitals of Geneva. But the message to physicians is clear. “Children with history of bacterial meningitis have a higher long-term mortality than children without a history of bacterial meningitis,” said Dr. Rohr.

The study did have a key limitation: For matched controls, it relied on anonymous data from the Municipal Personal Records Database in Statistics Netherlands. “Important information like cause of death is lacking,” said Dr. Rohr.

Bacterial meningitis is associated with significant mortality and morbidity. Pathogens behind the infections vary with age group and geographic location, as well as immunization status.

To examine long-term mortality after bacterial meningitis, the researchers collected 1,646 records from an exposed cohort, with a date range of 1995 to 2018, from the Netherlands Reference Laboratory for Bacterial Meningitis. Included patients had a positive culture diagnosis of bacterial meningitis during the first year of life. Each exposed subject was compared to 10 controls matched by birth month, birth year, and sex, who had no exposure to bacterial meningitis.

Staphylococcus pneumoniae accounted for the most cases, at 32.0% (median age of onset, 180 days), followed by Neisseria meningitidis at 29.0% (median age of onset, 203 days). Other pathogens included S. agalactiae (19.7%, 10 days), Escherichia coli (8.8%, 13 days), and Haemophilus influenzae (5.4%, 231 days).

The mortality risk within 1 year of disease onset was higher for all pathogens (6.2% vs. 0.2% unexposed). The highest mortality risk was seen for S. agalactiae (8.7%), followed by E. coli (6.4%), N. meningitidis (4.9%), and H. influenzae (3.4%).

Hazard ratios (HR) for mortality were also higher, particularly in the first year after disease onset. For all pathogens, mortality rates were higher within 1 year (HR, 39.2), 5 years (HR, 28.7), and 10 years (HR, 24.1). The consistently highest mortality rates were associated with S. pneumoniae over 1-year, 5-year, and 10-year follow-up (HR, 42.8; HR, 45.6; HR, 40.6, respectively). Within 1 year, the highest mortality rate was associated with N. meningitidis (HR, 58.4).

Ms. Snoek and Dr. Rohr have no relevant financial disclosures.

Among infants younger than 1 year of age, bacterial meningitis is associated with worse long-term mortality, even after recovery from the initial infection. Heightened mortality risk stretched out to 10 years, and was highest in the wake of infection from Streptococcus agalactiae, according to a retrospective analysis of children in the Netherlands.

“The adjusted hazard rates were high for the whole group of bacterial meningitis, especially within the first year after onset. (Staphylococcus agalactiae) meningitis has the highest mortality risk within one year of disease onset,” Linde Snoek said during her presentation of the study (abstract 913) at the annual meeting of the European Society for Paediatric Infectious Diseases, held virtually this year. Ms. Snoek is a PhD student at Amsterdam University Medical Center.

Over longer time periods, the mortality associations were different. “The adjusted hazard rates were highest for pneumococcal meningitis compared to the other pathogens. And this was the case for 1 year, 5 years, and 10 years after disease onset,” said Ms. Snoek.

The study appears to be the first to look at extended mortality following bacterial meningitis in this age group, according to Marie Rohr, MD, who comoderated the session where the research was presented.

“In a quick review of the literature I did not find any [equivalent] study concerning short- and long-term mortality after bacterial meningitis in under 1 year of age,” said Dr. Rohr, a fellow in pediatric infectious diseases at University Hospitals of Geneva. But the message to physicians is clear. “Children with history of bacterial meningitis have a higher long-term mortality than children without a history of bacterial meningitis,” said Dr. Rohr.

The study did have a key limitation: For matched controls, it relied on anonymous data from the Municipal Personal Records Database in Statistics Netherlands. “Important information like cause of death is lacking,” said Dr. Rohr.

Bacterial meningitis is associated with significant mortality and morbidity. Pathogens behind the infections vary with age group and geographic location, as well as immunization status.

To examine long-term mortality after bacterial meningitis, the researchers collected 1,646 records from an exposed cohort, with a date range of 1995 to 2018, from the Netherlands Reference Laboratory for Bacterial Meningitis. Included patients had a positive culture diagnosis of bacterial meningitis during the first year of life. Each exposed subject was compared to 10 controls matched by birth month, birth year, and sex, who had no exposure to bacterial meningitis.

Staphylococcus pneumoniae accounted for the most cases, at 32.0% (median age of onset, 180 days), followed by Neisseria meningitidis at 29.0% (median age of onset, 203 days). Other pathogens included S. agalactiae (19.7%, 10 days), Escherichia coli (8.8%, 13 days), and Haemophilus influenzae (5.4%, 231 days).

The mortality risk within 1 year of disease onset was higher for all pathogens (6.2% vs. 0.2% unexposed). The highest mortality risk was seen for S. agalactiae (8.7%), followed by E. coli (6.4%), N. meningitidis (4.9%), and H. influenzae (3.4%).

Hazard ratios (HR) for mortality were also higher, particularly in the first year after disease onset. For all pathogens, mortality rates were higher within 1 year (HR, 39.2), 5 years (HR, 28.7), and 10 years (HR, 24.1). The consistently highest mortality rates were associated with S. pneumoniae over 1-year, 5-year, and 10-year follow-up (HR, 42.8; HR, 45.6; HR, 40.6, respectively). Within 1 year, the highest mortality rate was associated with N. meningitidis (HR, 58.4).

Ms. Snoek and Dr. Rohr have no relevant financial disclosures.

Obstetric patients whose first language is not English received fewer pain assessments and fewer doses of NSAIDs and oxycodone therapeutic equivalents (OTEs) following cesarean deliveries, according to a retrospective cohort study poster presented at the 2021 annual meeting of the American College of Obstetricians and Gynecologists.

The findings “may indicate language as a barrier for equitable pain management in the postpartum period,” concluded Alison Wiles, MD, a resident at Mount Sinai South Nassau in Oceanside, N.Y., and colleagues. They recommended “scheduled pain assessment and around the clock nonopioid medication administration” as potential ways to reduce the disparities.

“Racial and ethnic disparities in pain management have been well documented in both inpatient and outpatient settings, [and] similar disparities exist within postpartum pain management,” the researchers note in their background material. They also note that non-Hispanic White communities tend to have a higher incidence of opioid misuse.

The researchers conducted a retrospective study of 327 women who had cesarean deliveries from January to June 2018 at Mount Sinai South Nassau Hospital. They excluded women who underwent cesarean hysterectomies, received general anesthesia or patient-controlled analgesia, had a history of drug use, or had allergies to opiates. They did not note incidence of uterine fibroids, endometriosis, or other gynecologic conditions aside from delivery that could cause pain.

The population included a similar number of non-Hispanic White women (n = 111) and Hispanic women (n = 125). The remaining study participants included 32 non-Hispanic Black women and 59 women who were Asian or had another race/ethnicity. The women’s average age was 31, which was statistically similar across all four race/ethnicity groups. Average body mass index of participants was also similar, ranging from 32 to 34.6 kg/m², across all four demographic groups.

About half of all the women (52%) had a previous cesarean delivery, but rates were significantly different between groups: 31% of non-Hispanic Black women and 58% of Hispanic women had a prior cesarean, compared to 50% of non-Hispanic White, Asian, and other women (P < .05).

Half the women in the study overall (50.5%) had public insurance, but the proportion of those with public insurance differed significantly by racial/ethnic demographics. Less than a quarter of Asian/other women (23%) had public insurance, compared with 78% of Hispanic women, 74% of non-Hispanic White women, and 59% of non-Hispanic Black women (P < .0001).

Most of the women (76%) spoke English as their primary language, which included nearly all the women in each demographic group except Hispanic, in which 58% of the women’s primary language was Spanish or another language (P < .0001).

Hispanic patients received an average of 10 pain assessments after their cesarean, compared with an average of 11 in each of the other demographic groups (P = .02). Similarly, English speakers received an average 11 pain assessments, but those who primarily spoke Spanish or another language received 10 (P = .01).

The differences between English and non-English speakers were reflected in who received pain medication even though pain scores were the same between the two groups. English speakers received an average two doses of NSAIDs in the first 24 hours post partum, compared with one dose for those who spoke a primary language other than English (P = .03). At 24-48 hours post partum, those who spoke English received an average three NSAID doses, compared with two among those whose primary language was Spanish or another language (P = .03).

There was no difference between language groups in doses of OTEs in the first 24 hours post partum, but differences did occur on the second day. Women who primarily spoke English received an average four OTE doses in the 24-48 hours post partum, compared with two doses given to women who spoke a non-English primary language (P = .03).

Differences were less consistent or not significant when looking solely at race/ethnicity. All four groups received an average of two NSAID doses in the first 24 hours post partum, but second-day rates varied. Non-Hispanic White women and Asian/other women received an average three doses from 24 to 48 hours post partum while non-Hispanic Black women received one and Hispanic women received two (P = .0009).

No statistically significant differences in OTE doses occurred across the groups in the first 24 hours, but from 24 to 48 hours, the average two doses received by Hispanic women and 3 doses received by Asian women differed significantly from the average four doses received by non-Hispanic White women and the average five doses received by non-Hispanic Black women (P =.01).

“Non-Hispanic Black patients had higher OTE doses and fewer NSAID doses in the 24- to 48-hour postpartum period despite no differences in severe pain scores,” the authors also reported.

“These findings are surprising given the standardized protocols in place designed to assess and treat pain post partum,” Etoi A. Garrison, MD, PhD, an associate professor of maternal-fetal medicine at Vanderbilt University Medical Center, Memphis, Tenn., said in an interview. ” Protocols should minimize bias and promote equitable delivery of care.”

Dr. Garrison said it’s important to find out why these discrepancies exist even when ready access to interpretation services exist in the hospital.

“An important component of health care disparity research is to hear directly from patients themselves about their experiences,” Dr. Garrison said. “Often the patient voice is an overlooked and underappreciated resource. I hope that future iterations of this work include patient perceptions about the adequacy of postpartum care and provide more information about how health care delivery can be tailored to the unique needs of this vulnerable population.”

The authors reported no disclosures. Dr Garrison reported receiving a grant from the State of Tennessee Maternal Mortality Review Committee to Create an Unconscious Bias Faculty Train-the-Trainer Program.

Obstetric patients whose first language is not English received fewer pain assessments and fewer doses of NSAIDs and oxycodone therapeutic equivalents (OTEs) following cesarean deliveries, according to a retrospective cohort study poster presented at the 2021 annual meeting of the American College of Obstetricians and Gynecologists.

The findings “may indicate language as a barrier for equitable pain management in the postpartum period,” concluded Alison Wiles, MD, a resident at Mount Sinai South Nassau in Oceanside, N.Y., and colleagues. They recommended “scheduled pain assessment and around the clock nonopioid medication administration” as potential ways to reduce the disparities.

“Racial and ethnic disparities in pain management have been well documented in both inpatient and outpatient settings, [and] similar disparities exist within postpartum pain management,” the researchers note in their background material. They also note that non-Hispanic White communities tend to have a higher incidence of opioid misuse.

The researchers conducted a retrospective study of 327 women who had cesarean deliveries from January to June 2018 at Mount Sinai South Nassau Hospital. They excluded women who underwent cesarean hysterectomies, received general anesthesia or patient-controlled analgesia, had a history of drug use, or had allergies to opiates. They did not note incidence of uterine fibroids, endometriosis, or other gynecologic conditions aside from delivery that could cause pain.

The population included a similar number of non-Hispanic White women (n = 111) and Hispanic women (n = 125). The remaining study participants included 32 non-Hispanic Black women and 59 women who were Asian or had another race/ethnicity. The women’s average age was 31, which was statistically similar across all four race/ethnicity groups. Average body mass index of participants was also similar, ranging from 32 to 34.6 kg/m², across all four demographic groups.

About half of all the women (52%) had a previous cesarean delivery, but rates were significantly different between groups: 31% of non-Hispanic Black women and 58% of Hispanic women had a prior cesarean, compared to 50% of non-Hispanic White, Asian, and other women (P < .05).

Half the women in the study overall (50.5%) had public insurance, but the proportion of those with public insurance differed significantly by racial/ethnic demographics. Less than a quarter of Asian/other women (23%) had public insurance, compared with 78% of Hispanic women, 74% of non-Hispanic White women, and 59% of non-Hispanic Black women (P < .0001).

Most of the women (76%) spoke English as their primary language, which included nearly all the women in each demographic group except Hispanic, in which 58% of the women’s primary language was Spanish or another language (P < .0001).

Hispanic patients received an average of 10 pain assessments after their cesarean, compared with an average of 11 in each of the other demographic groups (P = .02). Similarly, English speakers received an average 11 pain assessments, but those who primarily spoke Spanish or another language received 10 (P = .01).

The differences between English and non-English speakers were reflected in who received pain medication even though pain scores were the same between the two groups. English speakers received an average two doses of NSAIDs in the first 24 hours post partum, compared with one dose for those who spoke a primary language other than English (P = .03). At 24-48 hours post partum, those who spoke English received an average three NSAID doses, compared with two among those whose primary language was Spanish or another language (P = .03).

There was no difference between language groups in doses of OTEs in the first 24 hours post partum, but differences did occur on the second day. Women who primarily spoke English received an average four OTE doses in the 24-48 hours post partum, compared with two doses given to women who spoke a non-English primary language (P = .03).

Differences were less consistent or not significant when looking solely at race/ethnicity. All four groups received an average of two NSAID doses in the first 24 hours post partum, but second-day rates varied. Non-Hispanic White women and Asian/other women received an average three doses from 24 to 48 hours post partum while non-Hispanic Black women received one and Hispanic women received two (P = .0009).

No statistically significant differences in OTE doses occurred across the groups in the first 24 hours, but from 24 to 48 hours, the average two doses received by Hispanic women and 3 doses received by Asian women differed significantly from the average four doses received by non-Hispanic White women and the average five doses received by non-Hispanic Black women (P =.01).

“Non-Hispanic Black patients had higher OTE doses and fewer NSAID doses in the 24- to 48-hour postpartum period despite no differences in severe pain scores,” the authors also reported.

“These findings are surprising given the standardized protocols in place designed to assess and treat pain post partum,” Etoi A. Garrison, MD, PhD, an associate professor of maternal-fetal medicine at Vanderbilt University Medical Center, Memphis, Tenn., said in an interview. ” Protocols should minimize bias and promote equitable delivery of care.”

Dr. Garrison said it’s important to find out why these discrepancies exist even when ready access to interpretation services exist in the hospital.

“An important component of health care disparity research is to hear directly from patients themselves about their experiences,” Dr. Garrison said. “Often the patient voice is an overlooked and underappreciated resource. I hope that future iterations of this work include patient perceptions about the adequacy of postpartum care and provide more information about how health care delivery can be tailored to the unique needs of this vulnerable population.”

The authors reported no disclosures. Dr Garrison reported receiving a grant from the State of Tennessee Maternal Mortality Review Committee to Create an Unconscious Bias Faculty Train-the-Trainer Program.

Obstetric patients whose first language is not English received fewer pain assessments and fewer doses of NSAIDs and oxycodone therapeutic equivalents (OTEs) following cesarean deliveries, according to a retrospective cohort study poster presented at the 2021 annual meeting of the American College of Obstetricians and Gynecologists.

The findings “may indicate language as a barrier for equitable pain management in the postpartum period,” concluded Alison Wiles, MD, a resident at Mount Sinai South Nassau in Oceanside, N.Y., and colleagues. They recommended “scheduled pain assessment and around the clock nonopioid medication administration” as potential ways to reduce the disparities.

“Racial and ethnic disparities in pain management have been well documented in both inpatient and outpatient settings, [and] similar disparities exist within postpartum pain management,” the researchers note in their background material. They also note that non-Hispanic White communities tend to have a higher incidence of opioid misuse.

The researchers conducted a retrospective study of 327 women who had cesarean deliveries from January to June 2018 at Mount Sinai South Nassau Hospital. They excluded women who underwent cesarean hysterectomies, received general anesthesia or patient-controlled analgesia, had a history of drug use, or had allergies to opiates. They did not note incidence of uterine fibroids, endometriosis, or other gynecologic conditions aside from delivery that could cause pain.

The population included a similar number of non-Hispanic White women (n = 111) and Hispanic women (n = 125). The remaining study participants included 32 non-Hispanic Black women and 59 women who were Asian or had another race/ethnicity. The women’s average age was 31, which was statistically similar across all four race/ethnicity groups. Average body mass index of participants was also similar, ranging from 32 to 34.6 kg/m², across all four demographic groups.

About half of all the women (52%) had a previous cesarean delivery, but rates were significantly different between groups: 31% of non-Hispanic Black women and 58% of Hispanic women had a prior cesarean, compared to 50% of non-Hispanic White, Asian, and other women (P < .05).

Half the women in the study overall (50.5%) had public insurance, but the proportion of those with public insurance differed significantly by racial/ethnic demographics. Less than a quarter of Asian/other women (23%) had public insurance, compared with 78% of Hispanic women, 74% of non-Hispanic White women, and 59% of non-Hispanic Black women (P < .0001).

Most of the women (76%) spoke English as their primary language, which included nearly all the women in each demographic group except Hispanic, in which 58% of the women’s primary language was Spanish or another language (P < .0001).

Hispanic patients received an average of 10 pain assessments after their cesarean, compared with an average of 11 in each of the other demographic groups (P = .02). Similarly, English speakers received an average 11 pain assessments, but those who primarily spoke Spanish or another language received 10 (P = .01).

The differences between English and non-English speakers were reflected in who received pain medication even though pain scores were the same between the two groups. English speakers received an average two doses of NSAIDs in the first 24 hours post partum, compared with one dose for those who spoke a primary language other than English (P = .03). At 24-48 hours post partum, those who spoke English received an average three NSAID doses, compared with two among those whose primary language was Spanish or another language (P = .03).

There was no difference between language groups in doses of OTEs in the first 24 hours post partum, but differences did occur on the second day. Women who primarily spoke English received an average four OTE doses in the 24-48 hours post partum, compared with two doses given to women who spoke a non-English primary language (P = .03).

Differences were less consistent or not significant when looking solely at race/ethnicity. All four groups received an average of two NSAID doses in the first 24 hours post partum, but second-day rates varied. Non-Hispanic White women and Asian/other women received an average three doses from 24 to 48 hours post partum while non-Hispanic Black women received one and Hispanic women received two (P = .0009).

No statistically significant differences in OTE doses occurred across the groups in the first 24 hours, but from 24 to 48 hours, the average two doses received by Hispanic women and 3 doses received by Asian women differed significantly from the average four doses received by non-Hispanic White women and the average five doses received by non-Hispanic Black women (P =.01).

“Non-Hispanic Black patients had higher OTE doses and fewer NSAID doses in the 24- to 48-hour postpartum period despite no differences in severe pain scores,” the authors also reported.

“These findings are surprising given the standardized protocols in place designed to assess and treat pain post partum,” Etoi A. Garrison, MD, PhD, an associate professor of maternal-fetal medicine at Vanderbilt University Medical Center, Memphis, Tenn., said in an interview. ” Protocols should minimize bias and promote equitable delivery of care.”

Dr. Garrison said it’s important to find out why these discrepancies exist even when ready access to interpretation services exist in the hospital.

“An important component of health care disparity research is to hear directly from patients themselves about their experiences,” Dr. Garrison said. “Often the patient voice is an overlooked and underappreciated resource. I hope that future iterations of this work include patient perceptions about the adequacy of postpartum care and provide more information about how health care delivery can be tailored to the unique needs of this vulnerable population.”

The authors reported no disclosures. Dr Garrison reported receiving a grant from the State of Tennessee Maternal Mortality Review Committee to Create an Unconscious Bias Faculty Train-the-Trainer Program.

The European Alliance of Associations for Rheumatology has started the process of updating their recommendations on how to manage patients with rheumatic and musculoskeletal diseases (RMDs) in the context of the SARS-CoV-2 pandemic.

So far, the first part of the systematic literature review has been performed and the conclusions that have been drawn appear to back up the recommendations that have already been made. It’s “hard to say” if there will need to be changes, said Robert B.M. Landewé, MD, PhD, at the annual European Congress of Rheumatology, as the next phase will be for the task force members to meet and discuss the implications of the literature research.“I think there will only be minor modifications and a few novel recommendations, but that is personal opinion,” speculated Dr. Landewé, who is professor of rheumatology at the Amsterdam Medical Center, University of Amsterdam.

The recommendations, which were developed a little over a year ago and published in Annals of the Rheumatic Diseases, set out provisional guidance covering four themes: infection prevention, managing patients when social distancing measures are in effect, managing patients with RMDs who develop COVID-19, and the prevention of infections other than SARS-CoV-2.
 

Emphasis on quality of evidence

According to EULAR’s standard operating procedures “updates should only be done if the evolving evidence mandates to do so,” and be based on “rational arguments,” Dr. Landewé said. “The last year was a bit unprecedented in that regard as we didn’t have those rational arguments before we designed our first set of recommendations and, as you can expect, that is totally due to the character of the pandemic.”

So much has been published on COVID-19 since then it was time to reappraise the situation. The task force behind the recommendations met in January 2021 to discuss the results of the literature search that was centered around five main research questions.

• Do patients with RMDs face more risk of contracting SARS-CoV-2 than the general population?
• If patients contract the virus, do they have a worse prognosis?
• Are antirheumatic medications associated with a worse outcome in people with RMDs?
• Should patients continue their antirheumatic medications?
• What evidence informs the use of vaccination against SARS-CoV-2 in patients with RMDs?

The latter research question is pending discussion since there were no studies to review at the time as the various vaccines had only just started to be widely available.

“We put a lot of emphasis on the quality of evidence,” Dr. Landewé said. In addition to making sure that patients did indeed have COVID-19 and checking that hospitalization and death records were caused by the disease, the task force team also looked to see if there was a control group being used. An extensive risk of bias assessment was undertaken, the results of which are pending.

Of 6,665 records identified during the literature search, just 113 full-text articles were assessed for eligibility. Of those, 60% were rejected as they did not pass the quality assessment, leaving 49 articles for consideration. The majority of these looked at the incidence of COVID-19, with others focusing on risk factors or both.
 

Literature search findings on main research questions

Dr. Landewé observed that the task force concluded that “current literature provides no evidence that patients with RMDs face more risk of contracting SARS-CoV-2 than individuals without RMDs.” They also concluded that patients with RMDs who do contract COVID-19 do not have a worse prognosis either, even though there have been a few studies suggesting a higher rate of hospitalization.

Both findings are reassuring as they fit with the existing recommendation to follow the same preventive and control measures in patients with RMDs as for the general population, but the task force is yet to determine if that recommendation should be amended.

There did not appear to be any hard evidence of any unique demographic feature or comorbidity that puts people with RMDs at more risk for severe COVID-19 than the general population. Think older age, male gender, high bodyweight, cardiovascular disease, diabetes, and chronic lung disease, Dr. Landewé said.

He noted, however, that there were some single-center reports suggesting that moderate or high levels of disease activity could put people with RMDs at greater risk for COVID-related death, “which is an intriguing finding in the context of discontinuing antirheumatic medication.” That is likely something the task force will be discussing when they decide how to update their recommendations.

The type of RMD may also be important, but again only single-center evidence to show that there might be an increased hospitalization risk in patients with autoinflammatory disease or risk for severe COVID-19 in those with certain connective tissue diseases. “These associations were not consistently found in other studies,” so it’s an open question how the task force decides to incorporate this into the updated guidance.

As for antirheumatic medications, conclusions from the literature review suggest that there doesn’t appear to be an increased or decreased risk for severe COVID-19 among users of NSAIDs or antimalarials.

That’s not the case for glucocorticoids. There appears to be an increased risk for hospitalization and COVID-19–related death, notably among those using higher (>10 mg) daily doses. “This is, so to say, the elephant in the room,” Dr. Landewé said. The current recommendation states that chronic users of glucocorticoids should continue their treatment. “The reports of additional risk could be due to glucocorticoids or to biases such as confounding by indication. So, the conclusion that we draw [is] not completely clear.”

In response to a question, he clarified this a little further: “We think ‘glucocorticoid use’ is a determinant of worse health, as is the case in many RMDs. Be aware that finding a positive association between [glucocorticoid] use and bad outcome does not mean that if you reduce [glucocorticoids], your patient will have a better outcome.”

The jury is also out on rituximab, which has been reported to increase the risk of severe COVID-19 and COVID-related death in two studies. There are also equivocal data on whether not using disease-modifying antirheumatic drugs increases the risk for these worse outcomes.

Asked about the absence of a recommendation on the use of the interleukin-6 inhibitor tocilizumab, Dr. Landewé responded: “We are caught up by evolving evidence. That is a generic problem in a dynamic field of COVID-19, I am afraid. What you recommend today is sometimes ‘old history’ tomorrow.”

Dr. Landewé had no relevant disclosures to make.

The European Alliance of Associations for Rheumatology has started the process of updating their recommendations on how to manage patients with rheumatic and musculoskeletal diseases (RMDs) in the context of the SARS-CoV-2 pandemic.

So far, the first part of the systematic literature review has been performed and the conclusions that have been drawn appear to back up the recommendations that have already been made. It’s “hard to say” if there will need to be changes, said Robert B.M. Landewé, MD, PhD, at the annual European Congress of Rheumatology, as the next phase will be for the task force members to meet and discuss the implications of the literature research.“I think there will only be minor modifications and a few novel recommendations, but that is personal opinion,” speculated Dr. Landewé, who is professor of rheumatology at the Amsterdam Medical Center, University of Amsterdam.

The recommendations, which were developed a little over a year ago and published in Annals of the Rheumatic Diseases, set out provisional guidance covering four themes: infection prevention, managing patients when social distancing measures are in effect, managing patients with RMDs who develop COVID-19, and the prevention of infections other than SARS-CoV-2.
 

Emphasis on quality of evidence

According to EULAR’s standard operating procedures “updates should only be done if the evolving evidence mandates to do so,” and be based on “rational arguments,” Dr. Landewé said. “The last year was a bit unprecedented in that regard as we didn’t have those rational arguments before we designed our first set of recommendations and, as you can expect, that is totally due to the character of the pandemic.”

So much has been published on COVID-19 since then it was time to reappraise the situation. The task force behind the recommendations met in January 2021 to discuss the results of the literature search that was centered around five main research questions.

• Do patients with RMDs face more risk of contracting SARS-CoV-2 than the general population?
• If patients contract the virus, do they have a worse prognosis?
• Are antirheumatic medications associated with a worse outcome in people with RMDs?
• Should patients continue their antirheumatic medications?
• What evidence informs the use of vaccination against SARS-CoV-2 in patients with RMDs?

The latter research question is pending discussion since there were no studies to review at the time as the various vaccines had only just started to be widely available.

“We put a lot of emphasis on the quality of evidence,” Dr. Landewé said. In addition to making sure that patients did indeed have COVID-19 and checking that hospitalization and death records were caused by the disease, the task force team also looked to see if there was a control group being used. An extensive risk of bias assessment was undertaken, the results of which are pending.

Of 6,665 records identified during the literature search, just 113 full-text articles were assessed for eligibility. Of those, 60% were rejected as they did not pass the quality assessment, leaving 49 articles for consideration. The majority of these looked at the incidence of COVID-19, with others focusing on risk factors or both.
 

Literature search findings on main research questions

Dr. Landewé observed that the task force concluded that “current literature provides no evidence that patients with RMDs face more risk of contracting SARS-CoV-2 than individuals without RMDs.” They also concluded that patients with RMDs who do contract COVID-19 do not have a worse prognosis either, even though there have been a few studies suggesting a higher rate of hospitalization.

Both findings are reassuring as they fit with the existing recommendation to follow the same preventive and control measures in patients with RMDs as for the general population, but the task force is yet to determine if that recommendation should be amended.

There did not appear to be any hard evidence of any unique demographic feature or comorbidity that puts people with RMDs at more risk for severe COVID-19 than the general population. Think older age, male gender, high bodyweight, cardiovascular disease, diabetes, and chronic lung disease, Dr. Landewé said.

He noted, however, that there were some single-center reports suggesting that moderate or high levels of disease activity could put people with RMDs at greater risk for COVID-related death, “which is an intriguing finding in the context of discontinuing antirheumatic medication.” That is likely something the task force will be discussing when they decide how to update their recommendations.

The type of RMD may also be important, but again only single-center evidence to show that there might be an increased hospitalization risk in patients with autoinflammatory disease or risk for severe COVID-19 in those with certain connective tissue diseases. “These associations were not consistently found in other studies,” so it’s an open question how the task force decides to incorporate this into the updated guidance.

As for antirheumatic medications, conclusions from the literature review suggest that there doesn’t appear to be an increased or decreased risk for severe COVID-19 among users of NSAIDs or antimalarials.

That’s not the case for glucocorticoids. There appears to be an increased risk for hospitalization and COVID-19–related death, notably among those using higher (>10 mg) daily doses. “This is, so to say, the elephant in the room,” Dr. Landewé said. The current recommendation states that chronic users of glucocorticoids should continue their treatment. “The reports of additional risk could be due to glucocorticoids or to biases such as confounding by indication. So, the conclusion that we draw [is] not completely clear.”

In response to a question, he clarified this a little further: “We think ‘glucocorticoid use’ is a determinant of worse health, as is the case in many RMDs. Be aware that finding a positive association between [glucocorticoid] use and bad outcome does not mean that if you reduce [glucocorticoids], your patient will have a better outcome.”

The jury is also out on rituximab, which has been reported to increase the risk of severe COVID-19 and COVID-related death in two studies. There are also equivocal data on whether not using disease-modifying antirheumatic drugs increases the risk for these worse outcomes.

Asked about the absence of a recommendation on the use of the interleukin-6 inhibitor tocilizumab, Dr. Landewé responded: “We are caught up by evolving evidence. That is a generic problem in a dynamic field of COVID-19, I am afraid. What you recommend today is sometimes ‘old history’ tomorrow.”

Dr. Landewé had no relevant disclosures to make.

The European Alliance of Associations for Rheumatology has started the process of updating their recommendations on how to manage patients with rheumatic and musculoskeletal diseases (RMDs) in the context of the SARS-CoV-2 pandemic.

So far, the first part of the systematic literature review has been performed and the conclusions that have been drawn appear to back up the recommendations that have already been made. It’s “hard to say” if there will need to be changes, said Robert B.M. Landewé, MD, PhD, at the annual European Congress of Rheumatology, as the next phase will be for the task force members to meet and discuss the implications of the literature research.“I think there will only be minor modifications and a few novel recommendations, but that is personal opinion,” speculated Dr. Landewé, who is professor of rheumatology at the Amsterdam Medical Center, University of Amsterdam.

The recommendations, which were developed a little over a year ago and published in Annals of the Rheumatic Diseases, set out provisional guidance covering four themes: infection prevention, managing patients when social distancing measures are in effect, managing patients with RMDs who develop COVID-19, and the prevention of infections other than SARS-CoV-2.
 

Emphasis on quality of evidence

According to EULAR’s standard operating procedures “updates should only be done if the evolving evidence mandates to do so,” and be based on “rational arguments,” Dr. Landewé said. “The last year was a bit unprecedented in that regard as we didn’t have those rational arguments before we designed our first set of recommendations and, as you can expect, that is totally due to the character of the pandemic.”

So much has been published on COVID-19 since then it was time to reappraise the situation. The task force behind the recommendations met in January 2021 to discuss the results of the literature search that was centered around five main research questions.

• Do patients with RMDs face more risk of contracting SARS-CoV-2 than the general population?
• If patients contract the virus, do they have a worse prognosis?
• Are antirheumatic medications associated with a worse outcome in people with RMDs?
• Should patients continue their antirheumatic medications?
• What evidence informs the use of vaccination against SARS-CoV-2 in patients with RMDs?

The latter research question is pending discussion since there were no studies to review at the time as the various vaccines had only just started to be widely available.

“We put a lot of emphasis on the quality of evidence,” Dr. Landewé said. In addition to making sure that patients did indeed have COVID-19 and checking that hospitalization and death records were caused by the disease, the task force team also looked to see if there was a control group being used. An extensive risk of bias assessment was undertaken, the results of which are pending.

Of 6,665 records identified during the literature search, just 113 full-text articles were assessed for eligibility. Of those, 60% were rejected as they did not pass the quality assessment, leaving 49 articles for consideration. The majority of these looked at the incidence of COVID-19, with others focusing on risk factors or both.
 

Literature search findings on main research questions

Dr. Landewé observed that the task force concluded that “current literature provides no evidence that patients with RMDs face more risk of contracting SARS-CoV-2 than individuals without RMDs.” They also concluded that patients with RMDs who do contract COVID-19 do not have a worse prognosis either, even though there have been a few studies suggesting a higher rate of hospitalization.

Both findings are reassuring as they fit with the existing recommendation to follow the same preventive and control measures in patients with RMDs as for the general population, but the task force is yet to determine if that recommendation should be amended.

There did not appear to be any hard evidence of any unique demographic feature or comorbidity that puts people with RMDs at more risk for severe COVID-19 than the general population. Think older age, male gender, high bodyweight, cardiovascular disease, diabetes, and chronic lung disease, Dr. Landewé said.

He noted, however, that there were some single-center reports suggesting that moderate or high levels of disease activity could put people with RMDs at greater risk for COVID-related death, “which is an intriguing finding in the context of discontinuing antirheumatic medication.” That is likely something the task force will be discussing when they decide how to update their recommendations.

The type of RMD may also be important, but again only single-center evidence to show that there might be an increased hospitalization risk in patients with autoinflammatory disease or risk for severe COVID-19 in those with certain connective tissue diseases. “These associations were not consistently found in other studies,” so it’s an open question how the task force decides to incorporate this into the updated guidance.

As for antirheumatic medications, conclusions from the literature review suggest that there doesn’t appear to be an increased or decreased risk for severe COVID-19 among users of NSAIDs or antimalarials.

That’s not the case for glucocorticoids. There appears to be an increased risk for hospitalization and COVID-19–related death, notably among those using higher (>10 mg) daily doses. “This is, so to say, the elephant in the room,” Dr. Landewé said. The current recommendation states that chronic users of glucocorticoids should continue their treatment. “The reports of additional risk could be due to glucocorticoids or to biases such as confounding by indication. So, the conclusion that we draw [is] not completely clear.”

In response to a question, he clarified this a little further: “We think ‘glucocorticoid use’ is a determinant of worse health, as is the case in many RMDs. Be aware that finding a positive association between [glucocorticoid] use and bad outcome does not mean that if you reduce [glucocorticoids], your patient will have a better outcome.”

The jury is also out on rituximab, which has been reported to increase the risk of severe COVID-19 and COVID-related death in two studies. There are also equivocal data on whether not using disease-modifying antirheumatic drugs increases the risk for these worse outcomes.

Asked about the absence of a recommendation on the use of the interleukin-6 inhibitor tocilizumab, Dr. Landewé responded: “We are caught up by evolving evidence. That is a generic problem in a dynamic field of COVID-19, I am afraid. What you recommend today is sometimes ‘old history’ tomorrow.”

Dr. Landewé had no relevant disclosures to make.

The first multinational, phase 3, placebo-controlled trial conducted with intravenous immunoglobulin therapy (IVIg) for dermatomyositis has confirmed significant efficacy and acceptable safety, according to data presented at the opening plenary abstract session of the annual European Congress of Rheumatology.

At the week 16 evaluation of the trial, called ProDERM, the response rates were 78.7% and 43.8% (P = .0008) for active therapy and placebo, respectively, reported Rohit Aggarwal, MD, medical director of the Arthritis and Autoimmunity Center at the University of Pittsburgh.

ProDERM is a “much-awaited study,” according to session moderator Hendrik Schulze-Koops, MD, PhD, of the division of rheumatology and clinical immunology at Ludwig Maximilian University of Munich (Germany). He was not involved in the study.

“We all have been doing what we have been doing,” Dr. Schulze-Koops said, referring to the use of IVIg for the control of dermatomyositis, “but we had no evidence for support.”

This statement could apply not only to IVIg, which has long been listed among treatment options by the Myositis Association despite the absence of controlled studies, but also to most immunosuppressive therapies and other options used for this challenging disease.

The proprietary IVIg employed in this study, Octagam 10%, has been approved in the United States for the treatment of chronic immune thrombocytopenic purpura. Its manufacturer, Octagam, plans to file a supplemental new drug application with the Food and Drug Administration for the treatment of dermatomyositis. The agent is already approved for dermatomyositis by the European Medicines Agency, according to Dr. Aggarwal.

Multiple response criteria favor IVIg

In the trial, 95 patients with dermatomyositis were randomized to 2 g/kg of IVIg (Octagam 10%) or placebo administered every 4 weeks. In a subsequent open-label extension study in which patients on placebo were switched to active therapy, the same every-4-week treatment schedule was used. The patients’ mean age was 53; 75% were women, and 92% were White.

The primary endpoint was at least minimal improvement on 2016 ACR/EULAR (American College of Rheumatology/European Alliance of Associations for Rheumatology) myositis response criteria, defined as a 20-point or greater gain in the Total Improvement Score (TIS) and no clinical worsening at two consecutive visits. But IVIg also provided a large relative benefit over placebo using more rigorous definitions of improvement. For moderate improvement, defined as at least a 40-point TIS improvement, there was a 45.2% relative advantage for IVIg over placebo (68.1% vs. 22.9%; P < .0001). For major improvement, defined as at least a 60-point TIS improvement, the relative advantage was 23.6% (31.9% vs. 8.3%; P < .0062).

At 16 weeks, the mean TIS score was more than twice as high in those receiving IVIg than in those randomized to placebo (48.4 vs. 21.6). At that point, an open-label extension was initiated. Those in the IVIg group were permitted to remain on therapy for an additional 24 weeks if they had not worsened in the blinded phase.

The mean TIS score in the IVIg group continued to rise during the extension phase. By 12 weeks in this phase, it reached 54.0. Over the same period, mean TIS scores climbed steeply among the placebo-treated patients who had switched to active therapy, reaching 44.4.

At the end of 24 weeks of the extension trial, when patients initiated on IVIg had been on active therapy for 40 weeks, the mean TIS score advantage of starting on IVIg rather than placebo was relatively modest (55.4 vs. 51.1).
 

Benefit is significant for skin and muscle

Changes in the two major components of dermatomyositis were tracked individually. For skin symptoms, patients were evaluated with the Cutaneous Dermatomyositis Disease Areas and Severity Index (CDASI). For muscle involvement, symptoms were evaluated with the 8-item Manual Muscle Testing (MMT-8) tool.

“The effects of IVIg on the muscle and the skin were both highly statistically significant,” Dr. Aggarwal reported. He said the CDASI score was reduced by almost half at the end of 16 weeks among those treated with IVIg relative to those treated with placebo. Improvement in MMT-8 scores were also clinically as well as statistically significant.

The IVIg therapy was well tolerated. The most common adverse effects in this study, like those reported with IVIg when used to treat other diseases, were headache, pyrexia, and nausea, but Dr. Aggarwal reported that these were generally mild.

Serious adverse events, particularly thromboembolism, did occur over the course of the study, but the rate of events was only slightly higher in the group receiving active therapy (5.8% vs. 4.2%).

Patients who entered the study were permitted to remain on most immunosuppressive therapies, such as methotrexate, mycophenolate, tacrolimus, and glucocorticoids. Dr. Aggarwal said that the majority of patients were taking a glucocorticoid and at least one nonglucocorticoid immunosuppressant.

Effect on associated conditions is planned

The data from this trial have not yet been analyzed for the impact of IVIg on conditions that occur frequently in association with dermatomyositis, such as interstitial lung disease (ILD) and dysphagia, but Dr. Aggarwal reported that there are plans to do so. Although severe ILD was a trial exclusion, the presence of mild to moderate ILD and dysphagia were evaluated at baseline, so the impact of treatment can be assessed.

There are also plans to evaluate how the presence or absence of myositis-specific antibodies, which were also evaluated at baseline, affected response to IVIg.

Dr. Aggarwal has financial relationships with more than 15 pharmaceutical companies, including Octapharma, which provided financial support for this trial. Dr. Schulze-Koops reported no relevant potential conflicts of interest.

The first multinational, phase 3, placebo-controlled trial conducted with intravenous immunoglobulin therapy (IVIg) for dermatomyositis has confirmed significant efficacy and acceptable safety, according to data presented at the opening plenary abstract session of the annual European Congress of Rheumatology.

At the week 16 evaluation of the trial, called ProDERM, the response rates were 78.7% and 43.8% (P = .0008) for active therapy and placebo, respectively, reported Rohit Aggarwal, MD, medical director of the Arthritis and Autoimmunity Center at the University of Pittsburgh.

ProDERM is a “much-awaited study,” according to session moderator Hendrik Schulze-Koops, MD, PhD, of the division of rheumatology and clinical immunology at Ludwig Maximilian University of Munich (Germany). He was not involved in the study.

“We all have been doing what we have been doing,” Dr. Schulze-Koops said, referring to the use of IVIg for the control of dermatomyositis, “but we had no evidence for support.”

This statement could apply not only to IVIg, which has long been listed among treatment options by the Myositis Association despite the absence of controlled studies, but also to most immunosuppressive therapies and other options used for this challenging disease.

The proprietary IVIg employed in this study, Octagam 10%, has been approved in the United States for the treatment of chronic immune thrombocytopenic purpura. Its manufacturer, Octagam, plans to file a supplemental new drug application with the Food and Drug Administration for the treatment of dermatomyositis. The agent is already approved for dermatomyositis by the European Medicines Agency, according to Dr. Aggarwal.

Multiple response criteria favor IVIg

In the trial, 95 patients with dermatomyositis were randomized to 2 g/kg of IVIg (Octagam 10%) or placebo administered every 4 weeks. In a subsequent open-label extension study in which patients on placebo were switched to active therapy, the same every-4-week treatment schedule was used. The patients’ mean age was 53; 75% were women, and 92% were White.

The primary endpoint was at least minimal improvement on 2016 ACR/EULAR (American College of Rheumatology/European Alliance of Associations for Rheumatology) myositis response criteria, defined as a 20-point or greater gain in the Total Improvement Score (TIS) and no clinical worsening at two consecutive visits. But IVIg also provided a large relative benefit over placebo using more rigorous definitions of improvement. For moderate improvement, defined as at least a 40-point TIS improvement, there was a 45.2% relative advantage for IVIg over placebo (68.1% vs. 22.9%; P < .0001). For major improvement, defined as at least a 60-point TIS improvement, the relative advantage was 23.6% (31.9% vs. 8.3%; P < .0062).

At 16 weeks, the mean TIS score was more than twice as high in those receiving IVIg than in those randomized to placebo (48.4 vs. 21.6). At that point, an open-label extension was initiated. Those in the IVIg group were permitted to remain on therapy for an additional 24 weeks if they had not worsened in the blinded phase.

The mean TIS score in the IVIg group continued to rise during the extension phase. By 12 weeks in this phase, it reached 54.0. Over the same period, mean TIS scores climbed steeply among the placebo-treated patients who had switched to active therapy, reaching 44.4.

At the end of 24 weeks of the extension trial, when patients initiated on IVIg had been on active therapy for 40 weeks, the mean TIS score advantage of starting on IVIg rather than placebo was relatively modest (55.4 vs. 51.1).
 

Benefit is significant for skin and muscle

Changes in the two major components of dermatomyositis were tracked individually. For skin symptoms, patients were evaluated with the Cutaneous Dermatomyositis Disease Areas and Severity Index (CDASI). For muscle involvement, symptoms were evaluated with the 8-item Manual Muscle Testing (MMT-8) tool.

“The effects of IVIg on the muscle and the skin were both highly statistically significant,” Dr. Aggarwal reported. He said the CDASI score was reduced by almost half at the end of 16 weeks among those treated with IVIg relative to those treated with placebo. Improvement in MMT-8 scores were also clinically as well as statistically significant.

The IVIg therapy was well tolerated. The most common adverse effects in this study, like those reported with IVIg when used to treat other diseases, were headache, pyrexia, and nausea, but Dr. Aggarwal reported that these were generally mild.

Serious adverse events, particularly thromboembolism, did occur over the course of the study, but the rate of events was only slightly higher in the group receiving active therapy (5.8% vs. 4.2%).

Patients who entered the study were permitted to remain on most immunosuppressive therapies, such as methotrexate, mycophenolate, tacrolimus, and glucocorticoids. Dr. Aggarwal said that the majority of patients were taking a glucocorticoid and at least one nonglucocorticoid immunosuppressant.

Effect on associated conditions is planned

The data from this trial have not yet been analyzed for the impact of IVIg on conditions that occur frequently in association with dermatomyositis, such as interstitial lung disease (ILD) and dysphagia, but Dr. Aggarwal reported that there are plans to do so. Although severe ILD was a trial exclusion, the presence of mild to moderate ILD and dysphagia were evaluated at baseline, so the impact of treatment can be assessed.

There are also plans to evaluate how the presence or absence of myositis-specific antibodies, which were also evaluated at baseline, affected response to IVIg.

Dr. Aggarwal has financial relationships with more than 15 pharmaceutical companies, including Octapharma, which provided financial support for this trial. Dr. Schulze-Koops reported no relevant potential conflicts of interest.

The first multinational, phase 3, placebo-controlled trial conducted with intravenous immunoglobulin therapy (IVIg) for dermatomyositis has confirmed significant efficacy and acceptable safety, according to data presented at the opening plenary abstract session of the annual European Congress of Rheumatology.

At the week 16 evaluation of the trial, called ProDERM, the response rates were 78.7% and 43.8% (P = .0008) for active therapy and placebo, respectively, reported Rohit Aggarwal, MD, medical director of the Arthritis and Autoimmunity Center at the University of Pittsburgh.

ProDERM is a “much-awaited study,” according to session moderator Hendrik Schulze-Koops, MD, PhD, of the division of rheumatology and clinical immunology at Ludwig Maximilian University of Munich (Germany). He was not involved in the study.

“We all have been doing what we have been doing,” Dr. Schulze-Koops said, referring to the use of IVIg for the control of dermatomyositis, “but we had no evidence for support.”

This statement could apply not only to IVIg, which has long been listed among treatment options by the Myositis Association despite the absence of controlled studies, but also to most immunosuppressive therapies and other options used for this challenging disease.

The proprietary IVIg employed in this study, Octagam 10%, has been approved in the United States for the treatment of chronic immune thrombocytopenic purpura. Its manufacturer, Octagam, plans to file a supplemental new drug application with the Food and Drug Administration for the treatment of dermatomyositis. The agent is already approved for dermatomyositis by the European Medicines Agency, according to Dr. Aggarwal.

Multiple response criteria favor IVIg

In the trial, 95 patients with dermatomyositis were randomized to 2 g/kg of IVIg (Octagam 10%) or placebo administered every 4 weeks. In a subsequent open-label extension study in which patients on placebo were switched to active therapy, the same every-4-week treatment schedule was used. The patients’ mean age was 53; 75% were women, and 92% were White.

The primary endpoint was at least minimal improvement on 2016 ACR/EULAR (American College of Rheumatology/European Alliance of Associations for Rheumatology) myositis response criteria, defined as a 20-point or greater gain in the Total Improvement Score (TIS) and no clinical worsening at two consecutive visits. But IVIg also provided a large relative benefit over placebo using more rigorous definitions of improvement. For moderate improvement, defined as at least a 40-point TIS improvement, there was a 45.2% relative advantage for IVIg over placebo (68.1% vs. 22.9%; P < .0001). For major improvement, defined as at least a 60-point TIS improvement, the relative advantage was 23.6% (31.9% vs. 8.3%; P < .0062).

At 16 weeks, the mean TIS score was more than twice as high in those receiving IVIg than in those randomized to placebo (48.4 vs. 21.6). At that point, an open-label extension was initiated. Those in the IVIg group were permitted to remain on therapy for an additional 24 weeks if they had not worsened in the blinded phase.

The mean TIS score in the IVIg group continued to rise during the extension phase. By 12 weeks in this phase, it reached 54.0. Over the same period, mean TIS scores climbed steeply among the placebo-treated patients who had switched to active therapy, reaching 44.4.

At the end of 24 weeks of the extension trial, when patients initiated on IVIg had been on active therapy for 40 weeks, the mean TIS score advantage of starting on IVIg rather than placebo was relatively modest (55.4 vs. 51.1).
 

Benefit is significant for skin and muscle

Changes in the two major components of dermatomyositis were tracked individually. For skin symptoms, patients were evaluated with the Cutaneous Dermatomyositis Disease Areas and Severity Index (CDASI). For muscle involvement, symptoms were evaluated with the 8-item Manual Muscle Testing (MMT-8) tool.

“The effects of IVIg on the muscle and the skin were both highly statistically significant,” Dr. Aggarwal reported. He said the CDASI score was reduced by almost half at the end of 16 weeks among those treated with IVIg relative to those treated with placebo. Improvement in MMT-8 scores were also clinically as well as statistically significant.

The IVIg therapy was well tolerated. The most common adverse effects in this study, like those reported with IVIg when used to treat other diseases, were headache, pyrexia, and nausea, but Dr. Aggarwal reported that these were generally mild.

Serious adverse events, particularly thromboembolism, did occur over the course of the study, but the rate of events was only slightly higher in the group receiving active therapy (5.8% vs. 4.2%).

Patients who entered the study were permitted to remain on most immunosuppressive therapies, such as methotrexate, mycophenolate, tacrolimus, and glucocorticoids. Dr. Aggarwal said that the majority of patients were taking a glucocorticoid and at least one nonglucocorticoid immunosuppressant.

Effect on associated conditions is planned

The data from this trial have not yet been analyzed for the impact of IVIg on conditions that occur frequently in association with dermatomyositis, such as interstitial lung disease (ILD) and dysphagia, but Dr. Aggarwal reported that there are plans to do so. Although severe ILD was a trial exclusion, the presence of mild to moderate ILD and dysphagia were evaluated at baseline, so the impact of treatment can be assessed.

There are also plans to evaluate how the presence or absence of myositis-specific antibodies, which were also evaluated at baseline, affected response to IVIg.

Dr. Aggarwal has financial relationships with more than 15 pharmaceutical companies, including Octapharma, which provided financial support for this trial. Dr. Schulze-Koops reported no relevant potential conflicts of interest.

An innovative text-messaging program that reminds patients with attention-deficit/hyperactivity disorder to take their medication and warns them about the hazards of noncompliance significantly increases treatment adherence in children and adults, new research suggests.

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In a pediatric study, 85% of participants who received a text message had their prescriptions refilled in a timely manner, compared with 62% of those who received treatment as usual and no text messaging. In a second study of adults, 81% of the group that received a text message refilled their prescriptions, versus 36% of those in the usual-treatment group.

“Patients are not going to be fully compliant if they do not understand what the implications are if they do not take their pills,” lead author Joseph Biederman, MD, chief of clinical and research programs in pediatric psychopharmacology and adult ADHD at the Massachusetts General Hospital and professor of psychiatry at Harvard Medical School, Boston, told this news organization.

He noted that the text-messaging program also provides information, support, encouragement, and guidance.

“We remind them to get in touch with their prescriber as renewals come due, and if they tell us no, we tell them how important it is” to do so, Dr. Biederman said.

The findings were presented at the virtual American Society of Clinical Psychopharmacology 2021 annual meeting.
 

Poor adherence

“Adherence to medications for ADHD is extremely poor, among the worst in medicine, despite the fact that ADHD is very morbid and we have excellent treatments people can take,” Dr. Biederman noted. “That’s the first tragedy, and it is totally unappreciated.”

He added that forgetfulness is a feature of ADHD. In addition, compliance can be difficult and cumbersome when patients require multiple prescriptions, he said.

Another contributor to medication nonadherence is the ongoing prejudice or stigma associated with ADHD, said Dr. Biederman.

“There is bad press about ADHD. There are no good comments, only disaster, doom and gloom, catastrophe, and so on. All people read in the available media are bad things about ADHD, and that only adds to stigma and misinformation,” he noted.

To combat these factors, Dr. Biederman and his team conducted two studies on the effectiveness of a novel ADHD-centric intervention based on text messaging.

One study included 87 children aged 6-12 years, and the other included 117 adults aged 18-55 years. Both groups were from primary care settings and were prescribed a stimulant medication for the treatment of ADHD.

As comparators, the researchers used age- and sex-matched pediatric patients and age-, race-, and sex-matched adult patients from the same primary care settings. They had also been prescribed stimulants but had not received the text messaging intervention.
 

Timely reminders

Results showed that 85% of the children who received text messages refilled their prescriptions vs. 65% of those who did not get the intervention (odds ratio, 3.46; 95% confidence interval, 1.82-6.58; P < .001).

Among adults, 81% of the intervention group refilled their prescriptions vs. 36% of the comparator group (OR, 7.54; 95% CI, 4.46-12.77; P < .001).

“In the number-needed-to-treat analysis, for every five pediatric patients who receive text messaging, we can keep one adherent with stimulant medication. In adults, that is one in every three who receive the text-messaging intervention,” Dr. Biederman said.

Text messaging reminds patients with ADHD to take their medications as prescribed, and it also reminds them of the consequences of not taking their medications, he added.

In another study presented at the ASCP meeting, Dr. Biederman introduced a new tool to help clinicians determine whether a patient with ADHD also has deficient emotional self-regulation (DESR).

ADHD has been associated with low frustration tolerance, impatience, and quickness to anger, he noted.

Emotional dysregulation, however, “is not a mood disorder,” said Dr. Biederman. “Some people use the term ‘hot tempered.’ These are people who overreact to things, and this is associated with a wide range of difficulties.”
 

Clinical guidance

The investigators operationalized DESR using the eight-item Emotional Dysregulation (ED) subscale of the Barkley Current Behavior Scale. They then used receiver operating characteristic curves to identify the optimal cutoff on the Barkley ED Scale that would categorize patients as having high- vs. low-level DESR.

“We wanted to give some guidance to clinicians, using a very simple rating scale that was developed by Dr. Barkley. It is one we think configures this syndrome of emotional dysregulation and emotional impulsivity,” Dr. Biederman said.

The study included 441 newly referred 18- to 55-year-old men and women who met DSM-5 diagnostic criteria for ADHD.

Using a cutoff score of 8 to represent high levels of DESR, the researchers identified 191 adults as having high-level DESR and the rest as having low-level DESR.

Those with high-level DESR had significantly more severe symptoms of ADHD, executive dysfunction, autistic traits, levels of psychopathology, and worse quality of life, compared with those with low-level DESR.

The problem of emotional dysregulation in ADHD is widespread and affects many people, Dr. Biederman noted.

“If you take 5% of adults at a minimum and 10% of children with ADHD [and] if 50% of those have emotional dysregulation, we’re talking about millions of people. And it is very morbid,” he said. “Having emotional dysregulation problems will get you in hot water.”
 

Promising results

Commenting on the findings for this news organization, Ira D. Glick, MD, professor emeritus of psychiatry and behavioral sciences, Stanford (Calif.) University, said the new studies are important.

He noted that, although ADHD has become more accepted as a “disease of the brain” over the past 20 years, patients with the disorder and their families often are not accepting of the diagnosis.

“Instead, they try to downplay it. They say this is just a ploy by psychiatrists to get business or this is just normal boys’ behavior, [and] they don’t need medicines,” said Dr. Glick, who was not involved in the current research.

“Biederman is trying to make clear that ADHD is a brain disease, and DESR symptoms are cardinal signs of a brain illness,” he said.

Dr. Glick also agreed that text messaging could be very useful for these patients.

“Text messaging might be helpful, especially in this population which can often be disorganized or forgetful. The results of that study were very promising,” he said.

Dr. Biederman is in the process of commercializing the text program used in the study. Dr. Glick reports no relevant financial relationships.

A version of this article first appeared on Medscape.com.

An innovative text-messaging program that reminds patients with attention-deficit/hyperactivity disorder to take their medication and warns them about the hazards of noncompliance significantly increases treatment adherence in children and adults, new research suggests.

PxHere

In a pediatric study, 85% of participants who received a text message had their prescriptions refilled in a timely manner, compared with 62% of those who received treatment as usual and no text messaging. In a second study of adults, 81% of the group that received a text message refilled their prescriptions, versus 36% of those in the usual-treatment group.

“Patients are not going to be fully compliant if they do not understand what the implications are if they do not take their pills,” lead author Joseph Biederman, MD, chief of clinical and research programs in pediatric psychopharmacology and adult ADHD at the Massachusetts General Hospital and professor of psychiatry at Harvard Medical School, Boston, told this news organization.

He noted that the text-messaging program also provides information, support, encouragement, and guidance.

“We remind them to get in touch with their prescriber as renewals come due, and if they tell us no, we tell them how important it is” to do so, Dr. Biederman said.

The findings were presented at the virtual American Society of Clinical Psychopharmacology 2021 annual meeting.
 

Poor adherence

“Adherence to medications for ADHD is extremely poor, among the worst in medicine, despite the fact that ADHD is very morbid and we have excellent treatments people can take,” Dr. Biederman noted. “That’s the first tragedy, and it is totally unappreciated.”

He added that forgetfulness is a feature of ADHD. In addition, compliance can be difficult and cumbersome when patients require multiple prescriptions, he said.

Another contributor to medication nonadherence is the ongoing prejudice or stigma associated with ADHD, said Dr. Biederman.

“There is bad press about ADHD. There are no good comments, only disaster, doom and gloom, catastrophe, and so on. All people read in the available media are bad things about ADHD, and that only adds to stigma and misinformation,” he noted.

To combat these factors, Dr. Biederman and his team conducted two studies on the effectiveness of a novel ADHD-centric intervention based on text messaging.

One study included 87 children aged 6-12 years, and the other included 117 adults aged 18-55 years. Both groups were from primary care settings and were prescribed a stimulant medication for the treatment of ADHD.

As comparators, the researchers used age- and sex-matched pediatric patients and age-, race-, and sex-matched adult patients from the same primary care settings. They had also been prescribed stimulants but had not received the text messaging intervention.
 

Timely reminders

Results showed that 85% of the children who received text messages refilled their prescriptions vs. 65% of those who did not get the intervention (odds ratio, 3.46; 95% confidence interval, 1.82-6.58; P < .001).

Among adults, 81% of the intervention group refilled their prescriptions vs. 36% of the comparator group (OR, 7.54; 95% CI, 4.46-12.77; P < .001).

“In the number-needed-to-treat analysis, for every five pediatric patients who receive text messaging, we can keep one adherent with stimulant medication. In adults, that is one in every three who receive the text-messaging intervention,” Dr. Biederman said.

Text messaging reminds patients with ADHD to take their medications as prescribed, and it also reminds them of the consequences of not taking their medications, he added.

In another study presented at the ASCP meeting, Dr. Biederman introduced a new tool to help clinicians determine whether a patient with ADHD also has deficient emotional self-regulation (DESR).

ADHD has been associated with low frustration tolerance, impatience, and quickness to anger, he noted.

Emotional dysregulation, however, “is not a mood disorder,” said Dr. Biederman. “Some people use the term ‘hot tempered.’ These are people who overreact to things, and this is associated with a wide range of difficulties.”
 

Clinical guidance

The investigators operationalized DESR using the eight-item Emotional Dysregulation (ED) subscale of the Barkley Current Behavior Scale. They then used receiver operating characteristic curves to identify the optimal cutoff on the Barkley ED Scale that would categorize patients as having high- vs. low-level DESR.

“We wanted to give some guidance to clinicians, using a very simple rating scale that was developed by Dr. Barkley. It is one we think configures this syndrome of emotional dysregulation and emotional impulsivity,” Dr. Biederman said.

The study included 441 newly referred 18- to 55-year-old men and women who met DSM-5 diagnostic criteria for ADHD.

Using a cutoff score of 8 to represent high levels of DESR, the researchers identified 191 adults as having high-level DESR and the rest as having low-level DESR.

Those with high-level DESR had significantly more severe symptoms of ADHD, executive dysfunction, autistic traits, levels of psychopathology, and worse quality of life, compared with those with low-level DESR.

The problem of emotional dysregulation in ADHD is widespread and affects many people, Dr. Biederman noted.

“If you take 5% of adults at a minimum and 10% of children with ADHD [and] if 50% of those have emotional dysregulation, we’re talking about millions of people. And it is very morbid,” he said. “Having emotional dysregulation problems will get you in hot water.”
 

Promising results

Commenting on the findings for this news organization, Ira D. Glick, MD, professor emeritus of psychiatry and behavioral sciences, Stanford (Calif.) University, said the new studies are important.

He noted that, although ADHD has become more accepted as a “disease of the brain” over the past 20 years, patients with the disorder and their families often are not accepting of the diagnosis.

“Instead, they try to downplay it. They say this is just a ploy by psychiatrists to get business or this is just normal boys’ behavior, [and] they don’t need medicines,” said Dr. Glick, who was not involved in the current research.

“Biederman is trying to make clear that ADHD is a brain disease, and DESR symptoms are cardinal signs of a brain illness,” he said.

Dr. Glick also agreed that text messaging could be very useful for these patients.

“Text messaging might be helpful, especially in this population which can often be disorganized or forgetful. The results of that study were very promising,” he said.

Dr. Biederman is in the process of commercializing the text program used in the study. Dr. Glick reports no relevant financial relationships.

A version of this article first appeared on Medscape.com.

An innovative text-messaging program that reminds patients with attention-deficit/hyperactivity disorder to take their medication and warns them about the hazards of noncompliance significantly increases treatment adherence in children and adults, new research suggests.

PxHere

In a pediatric study, 85% of participants who received a text message had their prescriptions refilled in a timely manner, compared with 62% of those who received treatment as usual and no text messaging. In a second study of adults, 81% of the group that received a text message refilled their prescriptions, versus 36% of those in the usual-treatment group.

“Patients are not going to be fully compliant if they do not understand what the implications are if they do not take their pills,” lead author Joseph Biederman, MD, chief of clinical and research programs in pediatric psychopharmacology and adult ADHD at the Massachusetts General Hospital and professor of psychiatry at Harvard Medical School, Boston, told this news organization.

He noted that the text-messaging program also provides information, support, encouragement, and guidance.

“We remind them to get in touch with their prescriber as renewals come due, and if they tell us no, we tell them how important it is” to do so, Dr. Biederman said.

The findings were presented at the virtual American Society of Clinical Psychopharmacology 2021 annual meeting.
 

Poor adherence

“Adherence to medications for ADHD is extremely poor, among the worst in medicine, despite the fact that ADHD is very morbid and we have excellent treatments people can take,” Dr. Biederman noted. “That’s the first tragedy, and it is totally unappreciated.”

He added that forgetfulness is a feature of ADHD. In addition, compliance can be difficult and cumbersome when patients require multiple prescriptions, he said.

Another contributor to medication nonadherence is the ongoing prejudice or stigma associated with ADHD, said Dr. Biederman.

“There is bad press about ADHD. There are no good comments, only disaster, doom and gloom, catastrophe, and so on. All people read in the available media are bad things about ADHD, and that only adds to stigma and misinformation,” he noted.

To combat these factors, Dr. Biederman and his team conducted two studies on the effectiveness of a novel ADHD-centric intervention based on text messaging.

One study included 87 children aged 6-12 years, and the other included 117 adults aged 18-55 years. Both groups were from primary care settings and were prescribed a stimulant medication for the treatment of ADHD.

As comparators, the researchers used age- and sex-matched pediatric patients and age-, race-, and sex-matched adult patients from the same primary care settings. They had also been prescribed stimulants but had not received the text messaging intervention.
 

Timely reminders

Results showed that 85% of the children who received text messages refilled their prescriptions vs. 65% of those who did not get the intervention (odds ratio, 3.46; 95% confidence interval, 1.82-6.58; P < .001).

Among adults, 81% of the intervention group refilled their prescriptions vs. 36% of the comparator group (OR, 7.54; 95% CI, 4.46-12.77; P < .001).

“In the number-needed-to-treat analysis, for every five pediatric patients who receive text messaging, we can keep one adherent with stimulant medication. In adults, that is one in every three who receive the text-messaging intervention,” Dr. Biederman said.

Text messaging reminds patients with ADHD to take their medications as prescribed, and it also reminds them of the consequences of not taking their medications, he added.

In another study presented at the ASCP meeting, Dr. Biederman introduced a new tool to help clinicians determine whether a patient with ADHD also has deficient emotional self-regulation (DESR).

ADHD has been associated with low frustration tolerance, impatience, and quickness to anger, he noted.

Emotional dysregulation, however, “is not a mood disorder,” said Dr. Biederman. “Some people use the term ‘hot tempered.’ These are people who overreact to things, and this is associated with a wide range of difficulties.”
 

Clinical guidance

The investigators operationalized DESR using the eight-item Emotional Dysregulation (ED) subscale of the Barkley Current Behavior Scale. They then used receiver operating characteristic curves to identify the optimal cutoff on the Barkley ED Scale that would categorize patients as having high- vs. low-level DESR.

“We wanted to give some guidance to clinicians, using a very simple rating scale that was developed by Dr. Barkley. It is one we think configures this syndrome of emotional dysregulation and emotional impulsivity,” Dr. Biederman said.

The study included 441 newly referred 18- to 55-year-old men and women who met DSM-5 diagnostic criteria for ADHD.

Using a cutoff score of 8 to represent high levels of DESR, the researchers identified 191 adults as having high-level DESR and the rest as having low-level DESR.

Those with high-level DESR had significantly more severe symptoms of ADHD, executive dysfunction, autistic traits, levels of psychopathology, and worse quality of life, compared with those with low-level DESR.

The problem of emotional dysregulation in ADHD is widespread and affects many people, Dr. Biederman noted.

“If you take 5% of adults at a minimum and 10% of children with ADHD [and] if 50% of those have emotional dysregulation, we’re talking about millions of people. And it is very morbid,” he said. “Having emotional dysregulation problems will get you in hot water.”
 

Promising results

Commenting on the findings for this news organization, Ira D. Glick, MD, professor emeritus of psychiatry and behavioral sciences, Stanford (Calif.) University, said the new studies are important.

He noted that, although ADHD has become more accepted as a “disease of the brain” over the past 20 years, patients with the disorder and their families often are not accepting of the diagnosis.

“Instead, they try to downplay it. They say this is just a ploy by psychiatrists to get business or this is just normal boys’ behavior, [and] they don’t need medicines,” said Dr. Glick, who was not involved in the current research.

“Biederman is trying to make clear that ADHD is a brain disease, and DESR symptoms are cardinal signs of a brain illness,” he said.

Dr. Glick also agreed that text messaging could be very useful for these patients.

“Text messaging might be helpful, especially in this population which can often be disorganized or forgetful. The results of that study were very promising,” he said.

Dr. Biederman is in the process of commercializing the text program used in the study. Dr. Glick reports no relevant financial relationships.

A version of this article first appeared on Medscape.com.