Heidi Splete

Individuals who consumed more ultraprocessed foods had a significantly increased risk of developing inflammatory bowel disease (IBD) than those who consumed less, according to data from more than 100,000 adults.

Digital Vision/Thinkstock

“Diet alters the microbiome and modifies the intestinal immune response and so could play a role in the pathogenesis of IBD,” Neeraj Narula, MD, of McMaster University, Hamilton, Ont., and colleagues wrote. Although previous studies have investigated the impact of dietary risk factors on IBD, an association with ultraprocessed foods (defined as foods containing additives and preservatives) in particular has not been examined, they wrote.

In a study published in BMJ, the researchers examined data from 116,087 adults aged 35-70 years from 21 countries between 2003 and 2016 who were part of the large Prospective Urban Rural Epidemiology (PURE) Cohort. Participants completed baseline food frequency questionnaires and were followed at least every 3 years; the median follow-up time was 9.7 years. The primary outcome was the development of Crohn’s disease or ulcerative colitis. In this study, ultraprocessed food included all packaged and formulated foods and beverages that contained food additives, artificial flavors or colors, or other chemical ingredients.

The categories of ultraprocessed foods included processed meat, cold breakfast cereal, various sauces, soft drinks, and fruit drinks, and refined sweetened foods such as candy, chocolate, jam, jelly, and brownies.

Overall, 467 participants developed IBD, including 90 with Crohn’s disease and 377 with ulcerative colitis.

After controlling for confounding factors, the investigators found that increased consumption of ultraprocessed foods was significantly associated with an increased risk of incident IBD. Compared with individuals who consumed less than 1 serving per day of ultraprocessed foods, the hazard ratio was 1.82 for those who consumed 5 or more servings and 1.67 for those who consumed 1-4 servings daily (P = .006).

“The pattern of increased ultraprocessed food intake and higher risk of IBD persisted within each of the regions examined, and effect estimates were generally similar, with overlapping confidence intervals and no significant heterogeneity,” the researchers noted.

The risk of IBD increased among individuals who consumed 1 serving per week or more of processed meat, compared with those who consumed less than 1 serving per week, and the risk increased with the amount consumed (HR, 2.07 for 1 or more servings per day). Similarly, IBD risk was higher among individuals who consumed 100 g/day or more of refined sweetened foods compared with no intake of these foods (HR, 2.58).

Individuals who consumed at least one serving of fried foods per day had the highest risk of IBD (HR, 3.02), the researchers noted. The reason for the association is uncertain, but may occur not only because many fried foods are also processed but also because the action of frying food and the processing of oil, as well as type and quality of oil, might modify the nutrients.

In the subgroup analysis, higher consumption of salty snacks and soft drinks also was associated with higher risk for IBD. However, the researchers found no association between increased risk of IBD and consumption of white meat, unprocessed red meat, dairy, starchy foods, and fruit/vegetables/legumes.

The study findings were limited by several factors including the relatively small number of individuals with Crohn’s disease, potential lack of generalizability to those who develop IBD in childhood or young adulthood, and possible confounding from unmeasured variables. The study also did not account for dietary changes over time, the investigators reported. However, the longitudinal design allowed them “to focus on people with incident IBD and to use medical record review and central adjudication to validate a sample of the diagnoses.”

The results suggest that the way food is processed or ultraprocessed, rather than the food itself, may be what confers the risk for IBD, given the lack of association between IBD and other food categories such as unprocessed red meat and dairy, the researchers concluded.
 

Next steps: Pin down driving factors

“There is significant interest in the apparent increase in the incidence and prevalence of IBD, particularly in previously low incidence areas,” Edward L. Barnes, MD, MPH, of the University of North Carolina at Chapel Hill said in an interview.

“Many research groups and clinicians suspect that environmental exposures, including dietary exposures, may play a critical role in these trends,” said Dr. Barnes. “This study utilized a large, multinational prospective cohort design to assess the influence of diet on the risk of developing IBD,” which is particularly important considering the potential for processed foods and food additives to impact the gastrointestinal tract.

“The strong associations demonstrated by the authors were impressive, particularly given that the authors performed multiple subanalyses, including evaluations by participant age and evaluations of particular food groups/types [e.g., processed meat, soft drinks, and refined sweet foods],” he noted. Dr. Barnes also found the lack of association with intake of white meat and unprocessed red meat interesting. “In my opinion, these subanalyses strengthen the overall associations demonstrated by the authors given their prospective study design and their attention to evaluating all potential associations that may be driving the relationships present in this cohort.

“At this point, the take-home message for clinicians treating patients with Crohn’s disease and ulcerative colitis should be that this association exists,” said Dr. Barnes. “One question that remains is whether the same risk factors that are present for developing disease also influence the disease course, given that the primary outcome of this study was the development of IBD. Given that much of our data with regard to the interplay between diet and IBD are still emerging, physicians treating patients with IBD can make patients aware of these associations and the potential benefit of limiting ultraprocessed foods in their diet.”

For these important results to become actionable, “further research is likely necessary to identify the factors that are driving this association,” Dr. Barnes explained. “This would likely build on prior animal models that have demonstrated an association between food additives such as emulsifiers and changes in the gastrointestinal tract that could ultimately lead to increased inflammation and the development of IBD.” Such information about specific drivers “would then allow clinicians to determine which population would benefit most from dietary changes/recommendations.”

The overall PURE study was supported by the Population Health Research Institute, Hamilton Health Sciences Research Institute, Canadian Institutes of Health Research, Heart and Stroke Foundation of Ontario, CIHR’s Strategy for Patient Oriented Research through the Ontario SPOR Support Unit, and the Ontario Ministry of Health and Long-term Care. PURE also was supported in part by unrestricted grants from several pharmaceutical companies, notably AstraZeneca, Sanofi-Aventis, Boehringer Ingelheim, Servier, and GlaxoSmithKline. The researchers had no relevant financial conflicts to disclose. Dr. Barnes disclosed serving as a consultant for AbbVie, Gilead, Pfizer, Takeda, and Target RWE.

Individuals who consumed more ultraprocessed foods had a significantly increased risk of developing inflammatory bowel disease (IBD) than those who consumed less, according to data from more than 100,000 adults.

Digital Vision/Thinkstock

“Diet alters the microbiome and modifies the intestinal immune response and so could play a role in the pathogenesis of IBD,” Neeraj Narula, MD, of McMaster University, Hamilton, Ont., and colleagues wrote. Although previous studies have investigated the impact of dietary risk factors on IBD, an association with ultraprocessed foods (defined as foods containing additives and preservatives) in particular has not been examined, they wrote.

In a study published in BMJ, the researchers examined data from 116,087 adults aged 35-70 years from 21 countries between 2003 and 2016 who were part of the large Prospective Urban Rural Epidemiology (PURE) Cohort. Participants completed baseline food frequency questionnaires and were followed at least every 3 years; the median follow-up time was 9.7 years. The primary outcome was the development of Crohn’s disease or ulcerative colitis. In this study, ultraprocessed food included all packaged and formulated foods and beverages that contained food additives, artificial flavors or colors, or other chemical ingredients.

The categories of ultraprocessed foods included processed meat, cold breakfast cereal, various sauces, soft drinks, and fruit drinks, and refined sweetened foods such as candy, chocolate, jam, jelly, and brownies.

Overall, 467 participants developed IBD, including 90 with Crohn’s disease and 377 with ulcerative colitis.

After controlling for confounding factors, the investigators found that increased consumption of ultraprocessed foods was significantly associated with an increased risk of incident IBD. Compared with individuals who consumed less than 1 serving per day of ultraprocessed foods, the hazard ratio was 1.82 for those who consumed 5 or more servings and 1.67 for those who consumed 1-4 servings daily (P = .006).

“The pattern of increased ultraprocessed food intake and higher risk of IBD persisted within each of the regions examined, and effect estimates were generally similar, with overlapping confidence intervals and no significant heterogeneity,” the researchers noted.

The risk of IBD increased among individuals who consumed 1 serving per week or more of processed meat, compared with those who consumed less than 1 serving per week, and the risk increased with the amount consumed (HR, 2.07 for 1 or more servings per day). Similarly, IBD risk was higher among individuals who consumed 100 g/day or more of refined sweetened foods compared with no intake of these foods (HR, 2.58).

Individuals who consumed at least one serving of fried foods per day had the highest risk of IBD (HR, 3.02), the researchers noted. The reason for the association is uncertain, but may occur not only because many fried foods are also processed but also because the action of frying food and the processing of oil, as well as type and quality of oil, might modify the nutrients.

In the subgroup analysis, higher consumption of salty snacks and soft drinks also was associated with higher risk for IBD. However, the researchers found no association between increased risk of IBD and consumption of white meat, unprocessed red meat, dairy, starchy foods, and fruit/vegetables/legumes.

The study findings were limited by several factors including the relatively small number of individuals with Crohn’s disease, potential lack of generalizability to those who develop IBD in childhood or young adulthood, and possible confounding from unmeasured variables. The study also did not account for dietary changes over time, the investigators reported. However, the longitudinal design allowed them “to focus on people with incident IBD and to use medical record review and central adjudication to validate a sample of the diagnoses.”

The results suggest that the way food is processed or ultraprocessed, rather than the food itself, may be what confers the risk for IBD, given the lack of association between IBD and other food categories such as unprocessed red meat and dairy, the researchers concluded.
 

Next steps: Pin down driving factors

“There is significant interest in the apparent increase in the incidence and prevalence of IBD, particularly in previously low incidence areas,” Edward L. Barnes, MD, MPH, of the University of North Carolina at Chapel Hill said in an interview.

“Many research groups and clinicians suspect that environmental exposures, including dietary exposures, may play a critical role in these trends,” said Dr. Barnes. “This study utilized a large, multinational prospective cohort design to assess the influence of diet on the risk of developing IBD,” which is particularly important considering the potential for processed foods and food additives to impact the gastrointestinal tract.

“The strong associations demonstrated by the authors were impressive, particularly given that the authors performed multiple subanalyses, including evaluations by participant age and evaluations of particular food groups/types [e.g., processed meat, soft drinks, and refined sweet foods],” he noted. Dr. Barnes also found the lack of association with intake of white meat and unprocessed red meat interesting. “In my opinion, these subanalyses strengthen the overall associations demonstrated by the authors given their prospective study design and their attention to evaluating all potential associations that may be driving the relationships present in this cohort.

“At this point, the take-home message for clinicians treating patients with Crohn’s disease and ulcerative colitis should be that this association exists,” said Dr. Barnes. “One question that remains is whether the same risk factors that are present for developing disease also influence the disease course, given that the primary outcome of this study was the development of IBD. Given that much of our data with regard to the interplay between diet and IBD are still emerging, physicians treating patients with IBD can make patients aware of these associations and the potential benefit of limiting ultraprocessed foods in their diet.”

For these important results to become actionable, “further research is likely necessary to identify the factors that are driving this association,” Dr. Barnes explained. “This would likely build on prior animal models that have demonstrated an association between food additives such as emulsifiers and changes in the gastrointestinal tract that could ultimately lead to increased inflammation and the development of IBD.” Such information about specific drivers “would then allow clinicians to determine which population would benefit most from dietary changes/recommendations.”

The overall PURE study was supported by the Population Health Research Institute, Hamilton Health Sciences Research Institute, Canadian Institutes of Health Research, Heart and Stroke Foundation of Ontario, CIHR’s Strategy for Patient Oriented Research through the Ontario SPOR Support Unit, and the Ontario Ministry of Health and Long-term Care. PURE also was supported in part by unrestricted grants from several pharmaceutical companies, notably AstraZeneca, Sanofi-Aventis, Boehringer Ingelheim, Servier, and GlaxoSmithKline. The researchers had no relevant financial conflicts to disclose. Dr. Barnes disclosed serving as a consultant for AbbVie, Gilead, Pfizer, Takeda, and Target RWE.

Individuals who consumed more ultraprocessed foods had a significantly increased risk of developing inflammatory bowel disease (IBD) than those who consumed less, according to data from more than 100,000 adults.

Digital Vision/Thinkstock

“Diet alters the microbiome and modifies the intestinal immune response and so could play a role in the pathogenesis of IBD,” Neeraj Narula, MD, of McMaster University, Hamilton, Ont., and colleagues wrote. Although previous studies have investigated the impact of dietary risk factors on IBD, an association with ultraprocessed foods (defined as foods containing additives and preservatives) in particular has not been examined, they wrote.

In a study published in BMJ, the researchers examined data from 116,087 adults aged 35-70 years from 21 countries between 2003 and 2016 who were part of the large Prospective Urban Rural Epidemiology (PURE) Cohort. Participants completed baseline food frequency questionnaires and were followed at least every 3 years; the median follow-up time was 9.7 years. The primary outcome was the development of Crohn’s disease or ulcerative colitis. In this study, ultraprocessed food included all packaged and formulated foods and beverages that contained food additives, artificial flavors or colors, or other chemical ingredients.

The categories of ultraprocessed foods included processed meat, cold breakfast cereal, various sauces, soft drinks, and fruit drinks, and refined sweetened foods such as candy, chocolate, jam, jelly, and brownies.

Overall, 467 participants developed IBD, including 90 with Crohn’s disease and 377 with ulcerative colitis.

After controlling for confounding factors, the investigators found that increased consumption of ultraprocessed foods was significantly associated with an increased risk of incident IBD. Compared with individuals who consumed less than 1 serving per day of ultraprocessed foods, the hazard ratio was 1.82 for those who consumed 5 or more servings and 1.67 for those who consumed 1-4 servings daily (P = .006).

“The pattern of increased ultraprocessed food intake and higher risk of IBD persisted within each of the regions examined, and effect estimates were generally similar, with overlapping confidence intervals and no significant heterogeneity,” the researchers noted.

The risk of IBD increased among individuals who consumed 1 serving per week or more of processed meat, compared with those who consumed less than 1 serving per week, and the risk increased with the amount consumed (HR, 2.07 for 1 or more servings per day). Similarly, IBD risk was higher among individuals who consumed 100 g/day or more of refined sweetened foods compared with no intake of these foods (HR, 2.58).

Individuals who consumed at least one serving of fried foods per day had the highest risk of IBD (HR, 3.02), the researchers noted. The reason for the association is uncertain, but may occur not only because many fried foods are also processed but also because the action of frying food and the processing of oil, as well as type and quality of oil, might modify the nutrients.

In the subgroup analysis, higher consumption of salty snacks and soft drinks also was associated with higher risk for IBD. However, the researchers found no association between increased risk of IBD and consumption of white meat, unprocessed red meat, dairy, starchy foods, and fruit/vegetables/legumes.

The study findings were limited by several factors including the relatively small number of individuals with Crohn’s disease, potential lack of generalizability to those who develop IBD in childhood or young adulthood, and possible confounding from unmeasured variables. The study also did not account for dietary changes over time, the investigators reported. However, the longitudinal design allowed them “to focus on people with incident IBD and to use medical record review and central adjudication to validate a sample of the diagnoses.”

The results suggest that the way food is processed or ultraprocessed, rather than the food itself, may be what confers the risk for IBD, given the lack of association between IBD and other food categories such as unprocessed red meat and dairy, the researchers concluded.
 

Next steps: Pin down driving factors

“There is significant interest in the apparent increase in the incidence and prevalence of IBD, particularly in previously low incidence areas,” Edward L. Barnes, MD, MPH, of the University of North Carolina at Chapel Hill said in an interview.

“Many research groups and clinicians suspect that environmental exposures, including dietary exposures, may play a critical role in these trends,” said Dr. Barnes. “This study utilized a large, multinational prospective cohort design to assess the influence of diet on the risk of developing IBD,” which is particularly important considering the potential for processed foods and food additives to impact the gastrointestinal tract.

“The strong associations demonstrated by the authors were impressive, particularly given that the authors performed multiple subanalyses, including evaluations by participant age and evaluations of particular food groups/types [e.g., processed meat, soft drinks, and refined sweet foods],” he noted. Dr. Barnes also found the lack of association with intake of white meat and unprocessed red meat interesting. “In my opinion, these subanalyses strengthen the overall associations demonstrated by the authors given their prospective study design and their attention to evaluating all potential associations that may be driving the relationships present in this cohort.

“At this point, the take-home message for clinicians treating patients with Crohn’s disease and ulcerative colitis should be that this association exists,” said Dr. Barnes. “One question that remains is whether the same risk factors that are present for developing disease also influence the disease course, given that the primary outcome of this study was the development of IBD. Given that much of our data with regard to the interplay between diet and IBD are still emerging, physicians treating patients with IBD can make patients aware of these associations and the potential benefit of limiting ultraprocessed foods in their diet.”

For these important results to become actionable, “further research is likely necessary to identify the factors that are driving this association,” Dr. Barnes explained. “This would likely build on prior animal models that have demonstrated an association between food additives such as emulsifiers and changes in the gastrointestinal tract that could ultimately lead to increased inflammation and the development of IBD.” Such information about specific drivers “would then allow clinicians to determine which population would benefit most from dietary changes/recommendations.”

The overall PURE study was supported by the Population Health Research Institute, Hamilton Health Sciences Research Institute, Canadian Institutes of Health Research, Heart and Stroke Foundation of Ontario, CIHR’s Strategy for Patient Oriented Research through the Ontario SPOR Support Unit, and the Ontario Ministry of Health and Long-term Care. PURE also was supported in part by unrestricted grants from several pharmaceutical companies, notably AstraZeneca, Sanofi-Aventis, Boehringer Ingelheim, Servier, and GlaxoSmithKline. The researchers had no relevant financial conflicts to disclose. Dr. Barnes disclosed serving as a consultant for AbbVie, Gilead, Pfizer, Takeda, and Target RWE.

Ultrasonography screening intervals of less than 6-12 months were associated with early detection of hepatocellular carcinoma, as well as increased life expectancy and quality of life, according to data from a nationwide comparative effectiveness study of nearly 60,000 patients in Taiwan.

Many international societies, including the American Association for the Study of Liver Diseases, the Asian Pacific Association for the Study of the Liver, and the European Association for the Study of the Liver, recommend abdominal ultrasonography screening for hepatocellular carcinoma (HCC) with or without alpha-fetoprotein every 6 months for patients at increased risk for HCC, wrote Shih-Chiang Kuo, MD, of National Cheng Kung University, Tainan, Taiwan, and colleagues.

However, some studies do not support this recommendation, and data suggest that “adherence to regular screenings by high-risk patients has been inadequate, leading to reduced overall benefits of ultrasonography screening in real-world practice,” and the impact of screening schedules on quality of life has not been assessed, they said.

In a study published in JAMA Network Open, the researchers identified adults with newly diagnosed HCC from 2002 through 2015 using data from the Taiwan National Cancer Registry. Barcelona Clinic Liver Cancer (BCLC) staging information was available for 42,081 men and 17,113 women; the average age was 62 years for men and 69 years for women. The patients were divided into five cohorts based on the time between their last ultrasonography screening and an index date of 90 days before their HCC diagnosis. These groups were 6 months (0-6 months), 12 months (7-12 months), 24 months (13-24 months), 36 months (25-36 months), and longer than 36 months.

“For both sexes, the proportions of patients with HCC classified as being in earlier stages (stage 0 and A) were higher in subcohorts with shorter screening intervals since the most recent ultrasonography,” the researchers wrote.

The researchers also assessed quality of life measures using the European Quality of Life Five-Dimensions in 807 men (3,370 repeated assessments) and 252 women (1,044 repeated assessments). Among men, the loss of quality of life expectancy in terms of quality of life years (QALYs) was 10.0, 11.1, 12.1, 13.1, and 14.6 for screening intervals of 6 months, 12 months, 24 months, 36 months, and beyond 36 months, respectively. The corresponding QALYs for women at the same screening intervals were 9.0, 9.7, 10.3, 10.7, and 11.4, respectively.

In a subgroup analysis according to underlying liver disease, patients with underlying hepatitis B virus infection or cirrhosis showed the greatest benefits from shorter screening intervals. For those with hepatitis B virus infection, abdominal ultrasonography screening 6 months or less prior to diagnosis of HCC was associated with an additional 4.8 QALYs for men and 2.8 QALYs for women, compared with screening longer than 36 months prior to diagnosis. The corresponding savings in QALY for men and women with underlying cirrhosis was 4.8 QALYs and 2.4 QALYs. Patients with no underlying liver disease also benefited from shorter intervals, with potential savings of 3.2 QALYs for men and 1.6 QALYs for women in the 6-month screening groups, compared with the longer than 36 months groups.

However, less than half of the men overall underwent screening withing 6 months or 12 months before diagnosis (31.4% and 39.3%, respectively); for women, 42.2% received screening within 6 months of diagnosis and 51.9% received screening within 12 months.

The study findings were limited by several factors including the use of only the last screening before diagnosis, which allows the possibility that patients in the 6- or 12-month groups did not have regular screening, the researchers noted. In addition, the lack of data on quality of life for women with BCLC stage D might have caused an underestimation of quality of life loss, they said. However, the results were strengthened by the use of a national database and long follow-up period, they said.

The results support intervals of 6-12 months or less for regular ultrasonography screening as a way to improve early detection of HCC, “and may save lives and improve utility for patients with HCC from a lifetime perspective,” the researchers emphasized. “Because people with underlying risk factors (including hepatitis B virus or hepatitis C virus infection, cirrhosis, and alcoholic liver disease) showed only slightly more frequent ultrasonography screening than those without underlying risk factors, we recommend improving this clinical practice,” they concluded.
 

Impact of identifying risk

“This study is important because HCC remains the third leading cause of cancer deaths, and the 5-year survival rate is low,” said Atsushi Sakuraba, MD, of the University of Chicago, in an interview.

Dr. Sakuraba said that he was not surprised by any of the study findings. “Earlier diagnosis of cancer is often associated with improved outcome in many cancers,” he noted.

However, “Overutilization of resources may lead to increased health care costs, so correct identification of high-risk populations is needed,” Dr. Sakuraba said.

Additional research is warranted in several areas in order to make an impact on clinical practice, Dr. Sakuraba said, notably, “confirmation in other countries and ethnicities where the incidence of viral hepatitis varies.” Comparison to other tests, such as tumor markers, CT, and MRI, is needed as well, he concluded.

The study was supported by the Taiwan Ministry of Science and Technology. The researchers had no financial conflicts to disclose. Dr. Sakuraba had no financial conflicts to disclose.

Ultrasonography screening intervals of less than 6-12 months were associated with early detection of hepatocellular carcinoma, as well as increased life expectancy and quality of life, according to data from a nationwide comparative effectiveness study of nearly 60,000 patients in Taiwan.

Many international societies, including the American Association for the Study of Liver Diseases, the Asian Pacific Association for the Study of the Liver, and the European Association for the Study of the Liver, recommend abdominal ultrasonography screening for hepatocellular carcinoma (HCC) with or without alpha-fetoprotein every 6 months for patients at increased risk for HCC, wrote Shih-Chiang Kuo, MD, of National Cheng Kung University, Tainan, Taiwan, and colleagues.

However, some studies do not support this recommendation, and data suggest that “adherence to regular screenings by high-risk patients has been inadequate, leading to reduced overall benefits of ultrasonography screening in real-world practice,” and the impact of screening schedules on quality of life has not been assessed, they said.

In a study published in JAMA Network Open, the researchers identified adults with newly diagnosed HCC from 2002 through 2015 using data from the Taiwan National Cancer Registry. Barcelona Clinic Liver Cancer (BCLC) staging information was available for 42,081 men and 17,113 women; the average age was 62 years for men and 69 years for women. The patients were divided into five cohorts based on the time between their last ultrasonography screening and an index date of 90 days before their HCC diagnosis. These groups were 6 months (0-6 months), 12 months (7-12 months), 24 months (13-24 months), 36 months (25-36 months), and longer than 36 months.

“For both sexes, the proportions of patients with HCC classified as being in earlier stages (stage 0 and A) were higher in subcohorts with shorter screening intervals since the most recent ultrasonography,” the researchers wrote.

The researchers also assessed quality of life measures using the European Quality of Life Five-Dimensions in 807 men (3,370 repeated assessments) and 252 women (1,044 repeated assessments). Among men, the loss of quality of life expectancy in terms of quality of life years (QALYs) was 10.0, 11.1, 12.1, 13.1, and 14.6 for screening intervals of 6 months, 12 months, 24 months, 36 months, and beyond 36 months, respectively. The corresponding QALYs for women at the same screening intervals were 9.0, 9.7, 10.3, 10.7, and 11.4, respectively.

In a subgroup analysis according to underlying liver disease, patients with underlying hepatitis B virus infection or cirrhosis showed the greatest benefits from shorter screening intervals. For those with hepatitis B virus infection, abdominal ultrasonography screening 6 months or less prior to diagnosis of HCC was associated with an additional 4.8 QALYs for men and 2.8 QALYs for women, compared with screening longer than 36 months prior to diagnosis. The corresponding savings in QALY for men and women with underlying cirrhosis was 4.8 QALYs and 2.4 QALYs. Patients with no underlying liver disease also benefited from shorter intervals, with potential savings of 3.2 QALYs for men and 1.6 QALYs for women in the 6-month screening groups, compared with the longer than 36 months groups.

However, less than half of the men overall underwent screening withing 6 months or 12 months before diagnosis (31.4% and 39.3%, respectively); for women, 42.2% received screening within 6 months of diagnosis and 51.9% received screening within 12 months.

The study findings were limited by several factors including the use of only the last screening before diagnosis, which allows the possibility that patients in the 6- or 12-month groups did not have regular screening, the researchers noted. In addition, the lack of data on quality of life for women with BCLC stage D might have caused an underestimation of quality of life loss, they said. However, the results were strengthened by the use of a national database and long follow-up period, they said.

The results support intervals of 6-12 months or less for regular ultrasonography screening as a way to improve early detection of HCC, “and may save lives and improve utility for patients with HCC from a lifetime perspective,” the researchers emphasized. “Because people with underlying risk factors (including hepatitis B virus or hepatitis C virus infection, cirrhosis, and alcoholic liver disease) showed only slightly more frequent ultrasonography screening than those without underlying risk factors, we recommend improving this clinical practice,” they concluded.
 

Impact of identifying risk

“This study is important because HCC remains the third leading cause of cancer deaths, and the 5-year survival rate is low,” said Atsushi Sakuraba, MD, of the University of Chicago, in an interview.

Dr. Sakuraba said that he was not surprised by any of the study findings. “Earlier diagnosis of cancer is often associated with improved outcome in many cancers,” he noted.

However, “Overutilization of resources may lead to increased health care costs, so correct identification of high-risk populations is needed,” Dr. Sakuraba said.

Additional research is warranted in several areas in order to make an impact on clinical practice, Dr. Sakuraba said, notably, “confirmation in other countries and ethnicities where the incidence of viral hepatitis varies.” Comparison to other tests, such as tumor markers, CT, and MRI, is needed as well, he concluded.

The study was supported by the Taiwan Ministry of Science and Technology. The researchers had no financial conflicts to disclose. Dr. Sakuraba had no financial conflicts to disclose.

Ultrasonography screening intervals of less than 6-12 months were associated with early detection of hepatocellular carcinoma, as well as increased life expectancy and quality of life, according to data from a nationwide comparative effectiveness study of nearly 60,000 patients in Taiwan.

Many international societies, including the American Association for the Study of Liver Diseases, the Asian Pacific Association for the Study of the Liver, and the European Association for the Study of the Liver, recommend abdominal ultrasonography screening for hepatocellular carcinoma (HCC) with or without alpha-fetoprotein every 6 months for patients at increased risk for HCC, wrote Shih-Chiang Kuo, MD, of National Cheng Kung University, Tainan, Taiwan, and colleagues.

However, some studies do not support this recommendation, and data suggest that “adherence to regular screenings by high-risk patients has been inadequate, leading to reduced overall benefits of ultrasonography screening in real-world practice,” and the impact of screening schedules on quality of life has not been assessed, they said.

In a study published in JAMA Network Open, the researchers identified adults with newly diagnosed HCC from 2002 through 2015 using data from the Taiwan National Cancer Registry. Barcelona Clinic Liver Cancer (BCLC) staging information was available for 42,081 men and 17,113 women; the average age was 62 years for men and 69 years for women. The patients were divided into five cohorts based on the time between their last ultrasonography screening and an index date of 90 days before their HCC diagnosis. These groups were 6 months (0-6 months), 12 months (7-12 months), 24 months (13-24 months), 36 months (25-36 months), and longer than 36 months.

“For both sexes, the proportions of patients with HCC classified as being in earlier stages (stage 0 and A) were higher in subcohorts with shorter screening intervals since the most recent ultrasonography,” the researchers wrote.

The researchers also assessed quality of life measures using the European Quality of Life Five-Dimensions in 807 men (3,370 repeated assessments) and 252 women (1,044 repeated assessments). Among men, the loss of quality of life expectancy in terms of quality of life years (QALYs) was 10.0, 11.1, 12.1, 13.1, and 14.6 for screening intervals of 6 months, 12 months, 24 months, 36 months, and beyond 36 months, respectively. The corresponding QALYs for women at the same screening intervals were 9.0, 9.7, 10.3, 10.7, and 11.4, respectively.

In a subgroup analysis according to underlying liver disease, patients with underlying hepatitis B virus infection or cirrhosis showed the greatest benefits from shorter screening intervals. For those with hepatitis B virus infection, abdominal ultrasonography screening 6 months or less prior to diagnosis of HCC was associated with an additional 4.8 QALYs for men and 2.8 QALYs for women, compared with screening longer than 36 months prior to diagnosis. The corresponding savings in QALY for men and women with underlying cirrhosis was 4.8 QALYs and 2.4 QALYs. Patients with no underlying liver disease also benefited from shorter intervals, with potential savings of 3.2 QALYs for men and 1.6 QALYs for women in the 6-month screening groups, compared with the longer than 36 months groups.

However, less than half of the men overall underwent screening withing 6 months or 12 months before diagnosis (31.4% and 39.3%, respectively); for women, 42.2% received screening within 6 months of diagnosis and 51.9% received screening within 12 months.

The study findings were limited by several factors including the use of only the last screening before diagnosis, which allows the possibility that patients in the 6- or 12-month groups did not have regular screening, the researchers noted. In addition, the lack of data on quality of life for women with BCLC stage D might have caused an underestimation of quality of life loss, they said. However, the results were strengthened by the use of a national database and long follow-up period, they said.

The results support intervals of 6-12 months or less for regular ultrasonography screening as a way to improve early detection of HCC, “and may save lives and improve utility for patients with HCC from a lifetime perspective,” the researchers emphasized. “Because people with underlying risk factors (including hepatitis B virus or hepatitis C virus infection, cirrhosis, and alcoholic liver disease) showed only slightly more frequent ultrasonography screening than those without underlying risk factors, we recommend improving this clinical practice,” they concluded.
 

Impact of identifying risk

“This study is important because HCC remains the third leading cause of cancer deaths, and the 5-year survival rate is low,” said Atsushi Sakuraba, MD, of the University of Chicago, in an interview.

Dr. Sakuraba said that he was not surprised by any of the study findings. “Earlier diagnosis of cancer is often associated with improved outcome in many cancers,” he noted.

However, “Overutilization of resources may lead to increased health care costs, so correct identification of high-risk populations is needed,” Dr. Sakuraba said.

Additional research is warranted in several areas in order to make an impact on clinical practice, Dr. Sakuraba said, notably, “confirmation in other countries and ethnicities where the incidence of viral hepatitis varies.” Comparison to other tests, such as tumor markers, CT, and MRI, is needed as well, he concluded.

The study was supported by the Taiwan Ministry of Science and Technology. The researchers had no financial conflicts to disclose. Dr. Sakuraba had no financial conflicts to disclose.

Anifrolumab, an inhibitor of type 1 interferons, received approval from the Food and Drug Administration for the treatment of adults with moderate to severe systemic lupus erythematosus (SLE) who are receiving standard therapy, according to a statement released Aug. 2 from its manufacturer, AstraZeneca.

Courtesy AstraZeneca

Anifrolumab will be marketed as Saphnelo. It is a fully human monoclonal antibody against subunit 1 of the type 1 interferon receptor, and its approval represents the only new treatment approved for patients with SLE in a decade. The recommended dosage is 300 mg as an intravenous infusion over a 30-minute period every 4 weeks, according to its prescribing information, and it will be sold in a single-dose vial containing 300 mg/2 mL (150 mg/mL).

Wikimedia Commons/FitzColinGerald/ Creative Commons License

Increased type I interferon (IFN) signaling is associated with increased disease activity in patients with SLE, and the option of a type I IFN receptor antagonist may allow physicians to treat patients with fewer corticosteroids, according to the statement.

The approval was based on data from three trials. The TULIP (Treatment of Uncontrolled Lupus via the Interferon Pathway) phase 3 research included two randomized, double-blind, placebo-controlled studies, TULIP-1 and TULIP-2. The TULIP trials each enrolled seropositive patients with moderate to severe active disease despite standard-of-care therapy (SOC), which included oral corticosteroids, antimalarials, and immunosuppressants (methotrexate, azathioprine, or mycophenolate mofetil). All patients met American College of Rheumatology criteria and had an SLE Disease Activity Index (SLEDAI)-2K of 6 or greater, as well as British Isles Lupus Assessment Group (BILAG) index scoring showing one or more organ systems with grade A involvement or two or more with grade B. Both trials required stable SOC therapy throughout the study except for mandatory attempts at oral corticosteroid tapering for patients who were receiving 10 mg/day or more of prednisone or its equivalent at study entry.

TULIP-1 failed to meet its primary endpoint of SLE Responder Index (SRI) at 52 weeks, but investigators determined after the trial that some patients taking anifrolumab had been inappropriately labeled as nonresponders because the trial automatically required any patient who used a restricted drug, including NSAIDs, to be classified as a nonresponder even if they used the medication for something unrelated to SLE. When these rules were amended in a post hoc analysis, differences between the groups treated with anifrolumab and placebo widened in secondary endpoints for oral corticosteroid dose reduction, Cutaneous Lupus Erythematosus Disease Activity Severity Index response, and BILAG-Based Composite Lupus Assessment (BICLA) response.

The TULIP-2 trial included 362 patients who received a fixed dose of 300 mg anifrolumab or a placebo intravenously every 4 weeks for 48 weeks. In this study, anifrolumab patients showed significant improvement in disease activity on the BICLA scale, compared with placebo patients. The BICLA response was 47.8% in patients taking anifrolumab and 31.5% in placebo-treated patients (P = .001).

In the MUSE phase 2 trial, 305 adults with SLE were randomized to a fixed-dose intravenous infusion of 300 mg or 1,000 mg of anifrolumab or a placebo every 4 weeks, plus SOC, for 48 weeks. Patients in this study showed significant improvement on either dose, compared with placebo.

The results from the MUSE trial were published online in Arthritis & Rheumatology Nov. 7, 2016, followed by the TULIP-1 trial in The Lancet Rheumatology Nov. 11, 2019, and the TULIP-2 trial in the New England Journal of Medicine Jan. 16, 2020.

The most common treatment-related adverse events in all three studies were nasopharyngitis, upper respiratory tract infection, bronchitis, infusion-related reactions, herpes zoster, and cough. Infusion-related reactions in the trials were similar in anifrolumab and placebo patients, and included headache, nausea, vomiting, fatigue, and dizziness.

Anifrolumab has not been evaluated in patients with severe active lupus nephritis or severe active central nervous system lupus and is not recommended for these patients, according to the statement.

AstraZeneca said in its statement that anifrolumab is also under regulatory review in Japan and the European Union, and it continues to evaluate anifrolumab in patients with SLE in a long-term extension phase 3 trial and a phase 3 trial assessing subcutaneous delivery. The company said it “is exploring the potential of Saphnelo in a variety of diseases where type I IFN plays a key role, including lupus nephritis, cutaneous lupus erythematosus, and myositis.”

Anifrolumab, an inhibitor of type 1 interferons, received approval from the Food and Drug Administration for the treatment of adults with moderate to severe systemic lupus erythematosus (SLE) who are receiving standard therapy, according to a statement released Aug. 2 from its manufacturer, AstraZeneca.

Courtesy AstraZeneca

Anifrolumab will be marketed as Saphnelo. It is a fully human monoclonal antibody against subunit 1 of the type 1 interferon receptor, and its approval represents the only new treatment approved for patients with SLE in a decade. The recommended dosage is 300 mg as an intravenous infusion over a 30-minute period every 4 weeks, according to its prescribing information, and it will be sold in a single-dose vial containing 300 mg/2 mL (150 mg/mL).

Wikimedia Commons/FitzColinGerald/ Creative Commons License

Increased type I interferon (IFN) signaling is associated with increased disease activity in patients with SLE, and the option of a type I IFN receptor antagonist may allow physicians to treat patients with fewer corticosteroids, according to the statement.

The approval was based on data from three trials. The TULIP (Treatment of Uncontrolled Lupus via the Interferon Pathway) phase 3 research included two randomized, double-blind, placebo-controlled studies, TULIP-1 and TULIP-2. The TULIP trials each enrolled seropositive patients with moderate to severe active disease despite standard-of-care therapy (SOC), which included oral corticosteroids, antimalarials, and immunosuppressants (methotrexate, azathioprine, or mycophenolate mofetil). All patients met American College of Rheumatology criteria and had an SLE Disease Activity Index (SLEDAI)-2K of 6 or greater, as well as British Isles Lupus Assessment Group (BILAG) index scoring showing one or more organ systems with grade A involvement or two or more with grade B. Both trials required stable SOC therapy throughout the study except for mandatory attempts at oral corticosteroid tapering for patients who were receiving 10 mg/day or more of prednisone or its equivalent at study entry.

TULIP-1 failed to meet its primary endpoint of SLE Responder Index (SRI) at 52 weeks, but investigators determined after the trial that some patients taking anifrolumab had been inappropriately labeled as nonresponders because the trial automatically required any patient who used a restricted drug, including NSAIDs, to be classified as a nonresponder even if they used the medication for something unrelated to SLE. When these rules were amended in a post hoc analysis, differences between the groups treated with anifrolumab and placebo widened in secondary endpoints for oral corticosteroid dose reduction, Cutaneous Lupus Erythematosus Disease Activity Severity Index response, and BILAG-Based Composite Lupus Assessment (BICLA) response.

The TULIP-2 trial included 362 patients who received a fixed dose of 300 mg anifrolumab or a placebo intravenously every 4 weeks for 48 weeks. In this study, anifrolumab patients showed significant improvement in disease activity on the BICLA scale, compared with placebo patients. The BICLA response was 47.8% in patients taking anifrolumab and 31.5% in placebo-treated patients (P = .001).

In the MUSE phase 2 trial, 305 adults with SLE were randomized to a fixed-dose intravenous infusion of 300 mg or 1,000 mg of anifrolumab or a placebo every 4 weeks, plus SOC, for 48 weeks. Patients in this study showed significant improvement on either dose, compared with placebo.

The results from the MUSE trial were published online in Arthritis & Rheumatology Nov. 7, 2016, followed by the TULIP-1 trial in The Lancet Rheumatology Nov. 11, 2019, and the TULIP-2 trial in the New England Journal of Medicine Jan. 16, 2020.

The most common treatment-related adverse events in all three studies were nasopharyngitis, upper respiratory tract infection, bronchitis, infusion-related reactions, herpes zoster, and cough. Infusion-related reactions in the trials were similar in anifrolumab and placebo patients, and included headache, nausea, vomiting, fatigue, and dizziness.

Anifrolumab has not been evaluated in patients with severe active lupus nephritis or severe active central nervous system lupus and is not recommended for these patients, according to the statement.

AstraZeneca said in its statement that anifrolumab is also under regulatory review in Japan and the European Union, and it continues to evaluate anifrolumab in patients with SLE in a long-term extension phase 3 trial and a phase 3 trial assessing subcutaneous delivery. The company said it “is exploring the potential of Saphnelo in a variety of diseases where type I IFN plays a key role, including lupus nephritis, cutaneous lupus erythematosus, and myositis.”

Anifrolumab, an inhibitor of type 1 interferons, received approval from the Food and Drug Administration for the treatment of adults with moderate to severe systemic lupus erythematosus (SLE) who are receiving standard therapy, according to a statement released Aug. 2 from its manufacturer, AstraZeneca.

Courtesy AstraZeneca

Anifrolumab will be marketed as Saphnelo. It is a fully human monoclonal antibody against subunit 1 of the type 1 interferon receptor, and its approval represents the only new treatment approved for patients with SLE in a decade. The recommended dosage is 300 mg as an intravenous infusion over a 30-minute period every 4 weeks, according to its prescribing information, and it will be sold in a single-dose vial containing 300 mg/2 mL (150 mg/mL).

Wikimedia Commons/FitzColinGerald/ Creative Commons License

Increased type I interferon (IFN) signaling is associated with increased disease activity in patients with SLE, and the option of a type I IFN receptor antagonist may allow physicians to treat patients with fewer corticosteroids, according to the statement.

The approval was based on data from three trials. The TULIP (Treatment of Uncontrolled Lupus via the Interferon Pathway) phase 3 research included two randomized, double-blind, placebo-controlled studies, TULIP-1 and TULIP-2. The TULIP trials each enrolled seropositive patients with moderate to severe active disease despite standard-of-care therapy (SOC), which included oral corticosteroids, antimalarials, and immunosuppressants (methotrexate, azathioprine, or mycophenolate mofetil). All patients met American College of Rheumatology criteria and had an SLE Disease Activity Index (SLEDAI)-2K of 6 or greater, as well as British Isles Lupus Assessment Group (BILAG) index scoring showing one or more organ systems with grade A involvement or two or more with grade B. Both trials required stable SOC therapy throughout the study except for mandatory attempts at oral corticosteroid tapering for patients who were receiving 10 mg/day or more of prednisone or its equivalent at study entry.

TULIP-1 failed to meet its primary endpoint of SLE Responder Index (SRI) at 52 weeks, but investigators determined after the trial that some patients taking anifrolumab had been inappropriately labeled as nonresponders because the trial automatically required any patient who used a restricted drug, including NSAIDs, to be classified as a nonresponder even if they used the medication for something unrelated to SLE. When these rules were amended in a post hoc analysis, differences between the groups treated with anifrolumab and placebo widened in secondary endpoints for oral corticosteroid dose reduction, Cutaneous Lupus Erythematosus Disease Activity Severity Index response, and BILAG-Based Composite Lupus Assessment (BICLA) response.

The TULIP-2 trial included 362 patients who received a fixed dose of 300 mg anifrolumab or a placebo intravenously every 4 weeks for 48 weeks. In this study, anifrolumab patients showed significant improvement in disease activity on the BICLA scale, compared with placebo patients. The BICLA response was 47.8% in patients taking anifrolumab and 31.5% in placebo-treated patients (P = .001).

In the MUSE phase 2 trial, 305 adults with SLE were randomized to a fixed-dose intravenous infusion of 300 mg or 1,000 mg of anifrolumab or a placebo every 4 weeks, plus SOC, for 48 weeks. Patients in this study showed significant improvement on either dose, compared with placebo.

The results from the MUSE trial were published online in Arthritis & Rheumatology Nov. 7, 2016, followed by the TULIP-1 trial in The Lancet Rheumatology Nov. 11, 2019, and the TULIP-2 trial in the New England Journal of Medicine Jan. 16, 2020.

The most common treatment-related adverse events in all three studies were nasopharyngitis, upper respiratory tract infection, bronchitis, infusion-related reactions, herpes zoster, and cough. Infusion-related reactions in the trials were similar in anifrolumab and placebo patients, and included headache, nausea, vomiting, fatigue, and dizziness.

Anifrolumab has not been evaluated in patients with severe active lupus nephritis or severe active central nervous system lupus and is not recommended for these patients, according to the statement.

AstraZeneca said in its statement that anifrolumab is also under regulatory review in Japan and the European Union, and it continues to evaluate anifrolumab in patients with SLE in a long-term extension phase 3 trial and a phase 3 trial assessing subcutaneous delivery. The company said it “is exploring the potential of Saphnelo in a variety of diseases where type I IFN plays a key role, including lupus nephritis, cutaneous lupus erythematosus, and myositis.”

Exposure to deprivation in early life was significantly associated with impaired executive functioning in children and adolescents, based on data from a systematic review and meta-analysis of 91 studies.

Previous research has shown connections between early-life adversity (ELA) and changes in psychological, cognitive, and neurobiological development, including increased risk of anxiety, depression, attention-deficit/hyperactivity disorder, conduct disorder, suicidality, and substance use disorder; however, research focusing on the associations between different types of ELA and specific processes is limited, wrote Dylan Johnson, MSc, of the University of Toronto and colleagues.

“We directly addressed this gap in the literature by examining the association between the type of ELA and executive functioning in children and youth,” they said.

In a study published in JAMA Pediatrics, the researchers identified 91 articles including 82 unique cohorts and 31,188 unique individuals aged 1-18 years.

The articles were selected from Embase, ERIC, MEDLINE, and PsycInfo databases and published up to Dec. 31, 2020. The primary outcomes were measures of the three domains of executive functioning: cognitive flexibility, inhibitory control, and working memory. To correct for small sample sizes in some studies, the researchers standardized their measures of association into Hedges g effect sizes.

Overall, the pooled estimates of the association of any childhood adversity with the three domains of executive functioning showed significant heterogeneity, with Hedges g effects of –0.49 for cognitive flexibility, –0.39 for inhibitory control, and –0.47 for working memory.

The researchers also examined a subsample of ELA–executive functioning associations in categories of early-life exposure to threat, compared with early-life deprivation, including 56 of the original 91 articles. In this analysis, significantly lower inhibitory control was associated with deprivation compared to threat (Hedges g –0.43 vs. –0.27). Similarly, significantly lower working memory was associated with deprivation, compared with threat (Hedges g –0.54 vs. Hedges g –0.28). For both inhibitory control and working memory, the association of adversity was not moderated by the age or sex of the study participants, study design, outcome quality, or selection quality, the researchers noted.

No significant difference in affect of exposure threat vs. deprivation was noted for the association with cognitive flexibility. The reason for this discrepancy remains unclear, the researchers said. “Some evidence suggests that individuals who grow up in unpredictable environments may have reduced inhibitory control but enhanced cognitive flexibility,” they noted.

However, the overall results suggest that exposure to deprivation may be associated with neurodevelopmental changes that support the development of executive functioning, they said.

The study findings were limited by several factors, including the substantial heterogeneity in the pooled estimates and the need to consider variation in study design, the researchers noted. In addition, the cross-sectional design of many studies prevented conclusions about causality between ELA and executive functioning, they said.

“Future research should explore the differences between threat and deprivation when emotionally salient executive functioning measures are used,” the researchers emphasized. “Threat experiences are often associated with alterations in emotional processing, and different findings may be observed when investigating emotionally salient executive functioning outcomes,” they concluded.
 

Prevention and intervention plans needed

“Although numerous studies have examined associations between ELA and executive functioning, the associations of threat and deprivation with specific executive functioning domains (e.g., cognitive flexibility, inhibitory control, and working memory) have not been explored comprehensively,” wrote Beth S. Slomine, PhD, and Nikeea Copeland-Linder, PhD, of the Kennedy Krieger Institute, Johns Hopkins University School, Baltimore, in an accompanying editorial.

The study is “critical and timely” because of the impact of the COVID-19 pandemic on children’s exposure to deprivation, the authors said. “Many children have experienced the death of family members or friends, food and housing insecurity owing to the economic recession, school closures, loss of critical support services, and increased isolation because of social distancing measures,” and these effects are even greater for children already living in poverty and those with developmental disabilities, they noted.

More resources are needed to develop and implement ELA prevention policies, as well as early intervention plans, the editorialists said.

“Early intervention programs have a great potential to reduce the risk of ELA and promote executive functioning development,” they said. “These programs, such as family support and preschool services, are viable solutions for children and their families,” they added. Although the pandemic prevented the use of many support services for children at risk, the adoption of telehealth technology means that “it is now more feasible for cognitive rehabilitation experts to implement the telehealth technology to train parents and school staff on how to assist with the delivery of interventions in real-world settings and how to promote executive functioning in daily life,” they noted.

Overall, the study findings highlight the urgency of identifying ELA and implementing strategies to reduce and prevent ELA, and to provide early intervention to mitigate the impact of ELA on executive function in children, the editorialists emphasized.
 

Data bring understanding, but barriers remain

“At this point, there are data demonstrating the significant impact that adverse childhood experiences have on health outcomes – from worsened mental health to an increased risk for cancer and diabetes,” said Kelly A. Curran, MD, of the University of Oklahoma Health Sciences Center, Oklahoma City, in an interview.

“Physicians – myself included – tend to lump all these experiences together when thinking about future health outcomes,” Dr. Curran said. “However, there are evolving data that neurocognitive outcomes may be different based on the type of early-life adversity experienced. This meta-analysis examines the risk of different neurocognitive impact of threat versus deprivation types of adversity, which is important to pediatricians because it helps us to better understand the risks that our patients may experience,” she explained. 

“The results of this meta-analysis were especially intriguing because I hadn’t previously considered the impact that different types of adversity had on neurocognitive development,” said Dr. Curran. “This study caused me to think about these experiences differently, and as I reflect on the patients I have cared for over the years, I can see the difference in their outcomes,” she said.

Many barriers persist in addressing the effects of early-life deprivation on executive function, Dr. Curran said.

“First are barriers around identification of these children and adolescents, who may not have regular contact with the medical system. Additionally, it’s important to provide resources for parents and caregivers – this includes creating a strong support network and providing education about the impact of these experiences,” she noted. “There are also barriers to identifying and connecting with what resources will help children at risk of poor neurodevelopmental outcomes,” she added.

“Now that we know that children who have experienced early-life deprivation are at increased risk of worsened neurodevelopmental outcomes, it will be important to understand what interventions can help improve their outcomes,” Dr. Curran said.

The study was supported by a Connaught New Researcher Award from the University of Toronto. The researchers had no financial conflicts to disclose.

Dr. Slomine disclosed book royalties from Cambridge University Press unrelated to this study. Dr. Curran had no financial conflicts to disclose, but serves on the Pediatric News Editorial Advisory Board.

Exposure to deprivation in early life was significantly associated with impaired executive functioning in children and adolescents, based on data from a systematic review and meta-analysis of 91 studies.

Previous research has shown connections between early-life adversity (ELA) and changes in psychological, cognitive, and neurobiological development, including increased risk of anxiety, depression, attention-deficit/hyperactivity disorder, conduct disorder, suicidality, and substance use disorder; however, research focusing on the associations between different types of ELA and specific processes is limited, wrote Dylan Johnson, MSc, of the University of Toronto and colleagues.

“We directly addressed this gap in the literature by examining the association between the type of ELA and executive functioning in children and youth,” they said.

In a study published in JAMA Pediatrics, the researchers identified 91 articles including 82 unique cohorts and 31,188 unique individuals aged 1-18 years.

The articles were selected from Embase, ERIC, MEDLINE, and PsycInfo databases and published up to Dec. 31, 2020. The primary outcomes were measures of the three domains of executive functioning: cognitive flexibility, inhibitory control, and working memory. To correct for small sample sizes in some studies, the researchers standardized their measures of association into Hedges g effect sizes.

Overall, the pooled estimates of the association of any childhood adversity with the three domains of executive functioning showed significant heterogeneity, with Hedges g effects of –0.49 for cognitive flexibility, –0.39 for inhibitory control, and –0.47 for working memory.

The researchers also examined a subsample of ELA–executive functioning associations in categories of early-life exposure to threat, compared with early-life deprivation, including 56 of the original 91 articles. In this analysis, significantly lower inhibitory control was associated with deprivation compared to threat (Hedges g –0.43 vs. –0.27). Similarly, significantly lower working memory was associated with deprivation, compared with threat (Hedges g –0.54 vs. Hedges g –0.28). For both inhibitory control and working memory, the association of adversity was not moderated by the age or sex of the study participants, study design, outcome quality, or selection quality, the researchers noted.

No significant difference in affect of exposure threat vs. deprivation was noted for the association with cognitive flexibility. The reason for this discrepancy remains unclear, the researchers said. “Some evidence suggests that individuals who grow up in unpredictable environments may have reduced inhibitory control but enhanced cognitive flexibility,” they noted.

However, the overall results suggest that exposure to deprivation may be associated with neurodevelopmental changes that support the development of executive functioning, they said.

The study findings were limited by several factors, including the substantial heterogeneity in the pooled estimates and the need to consider variation in study design, the researchers noted. In addition, the cross-sectional design of many studies prevented conclusions about causality between ELA and executive functioning, they said.

“Future research should explore the differences between threat and deprivation when emotionally salient executive functioning measures are used,” the researchers emphasized. “Threat experiences are often associated with alterations in emotional processing, and different findings may be observed when investigating emotionally salient executive functioning outcomes,” they concluded.
 

Prevention and intervention plans needed

“Although numerous studies have examined associations between ELA and executive functioning, the associations of threat and deprivation with specific executive functioning domains (e.g., cognitive flexibility, inhibitory control, and working memory) have not been explored comprehensively,” wrote Beth S. Slomine, PhD, and Nikeea Copeland-Linder, PhD, of the Kennedy Krieger Institute, Johns Hopkins University School, Baltimore, in an accompanying editorial.

The study is “critical and timely” because of the impact of the COVID-19 pandemic on children’s exposure to deprivation, the authors said. “Many children have experienced the death of family members or friends, food and housing insecurity owing to the economic recession, school closures, loss of critical support services, and increased isolation because of social distancing measures,” and these effects are even greater for children already living in poverty and those with developmental disabilities, they noted.

More resources are needed to develop and implement ELA prevention policies, as well as early intervention plans, the editorialists said.

“Early intervention programs have a great potential to reduce the risk of ELA and promote executive functioning development,” they said. “These programs, such as family support and preschool services, are viable solutions for children and their families,” they added. Although the pandemic prevented the use of many support services for children at risk, the adoption of telehealth technology means that “it is now more feasible for cognitive rehabilitation experts to implement the telehealth technology to train parents and school staff on how to assist with the delivery of interventions in real-world settings and how to promote executive functioning in daily life,” they noted.

Overall, the study findings highlight the urgency of identifying ELA and implementing strategies to reduce and prevent ELA, and to provide early intervention to mitigate the impact of ELA on executive function in children, the editorialists emphasized.
 

Data bring understanding, but barriers remain

“At this point, there are data demonstrating the significant impact that adverse childhood experiences have on health outcomes – from worsened mental health to an increased risk for cancer and diabetes,” said Kelly A. Curran, MD, of the University of Oklahoma Health Sciences Center, Oklahoma City, in an interview.

“Physicians – myself included – tend to lump all these experiences together when thinking about future health outcomes,” Dr. Curran said. “However, there are evolving data that neurocognitive outcomes may be different based on the type of early-life adversity experienced. This meta-analysis examines the risk of different neurocognitive impact of threat versus deprivation types of adversity, which is important to pediatricians because it helps us to better understand the risks that our patients may experience,” she explained. 

“The results of this meta-analysis were especially intriguing because I hadn’t previously considered the impact that different types of adversity had on neurocognitive development,” said Dr. Curran. “This study caused me to think about these experiences differently, and as I reflect on the patients I have cared for over the years, I can see the difference in their outcomes,” she said.

Many barriers persist in addressing the effects of early-life deprivation on executive function, Dr. Curran said.

“First are barriers around identification of these children and adolescents, who may not have regular contact with the medical system. Additionally, it’s important to provide resources for parents and caregivers – this includes creating a strong support network and providing education about the impact of these experiences,” she noted. “There are also barriers to identifying and connecting with what resources will help children at risk of poor neurodevelopmental outcomes,” she added.

“Now that we know that children who have experienced early-life deprivation are at increased risk of worsened neurodevelopmental outcomes, it will be important to understand what interventions can help improve their outcomes,” Dr. Curran said.

The study was supported by a Connaught New Researcher Award from the University of Toronto. The researchers had no financial conflicts to disclose.

Dr. Slomine disclosed book royalties from Cambridge University Press unrelated to this study. Dr. Curran had no financial conflicts to disclose, but serves on the Pediatric News Editorial Advisory Board.

Exposure to deprivation in early life was significantly associated with impaired executive functioning in children and adolescents, based on data from a systematic review and meta-analysis of 91 studies.

Previous research has shown connections between early-life adversity (ELA) and changes in psychological, cognitive, and neurobiological development, including increased risk of anxiety, depression, attention-deficit/hyperactivity disorder, conduct disorder, suicidality, and substance use disorder; however, research focusing on the associations between different types of ELA and specific processes is limited, wrote Dylan Johnson, MSc, of the University of Toronto and colleagues.

“We directly addressed this gap in the literature by examining the association between the type of ELA and executive functioning in children and youth,” they said.

In a study published in JAMA Pediatrics, the researchers identified 91 articles including 82 unique cohorts and 31,188 unique individuals aged 1-18 years.

The articles were selected from Embase, ERIC, MEDLINE, and PsycInfo databases and published up to Dec. 31, 2020. The primary outcomes were measures of the three domains of executive functioning: cognitive flexibility, inhibitory control, and working memory. To correct for small sample sizes in some studies, the researchers standardized their measures of association into Hedges g effect sizes.

Overall, the pooled estimates of the association of any childhood adversity with the three domains of executive functioning showed significant heterogeneity, with Hedges g effects of –0.49 for cognitive flexibility, –0.39 for inhibitory control, and –0.47 for working memory.

The researchers also examined a subsample of ELA–executive functioning associations in categories of early-life exposure to threat, compared with early-life deprivation, including 56 of the original 91 articles. In this analysis, significantly lower inhibitory control was associated with deprivation compared to threat (Hedges g –0.43 vs. –0.27). Similarly, significantly lower working memory was associated with deprivation, compared with threat (Hedges g –0.54 vs. Hedges g –0.28). For both inhibitory control and working memory, the association of adversity was not moderated by the age or sex of the study participants, study design, outcome quality, or selection quality, the researchers noted.

No significant difference in affect of exposure threat vs. deprivation was noted for the association with cognitive flexibility. The reason for this discrepancy remains unclear, the researchers said. “Some evidence suggests that individuals who grow up in unpredictable environments may have reduced inhibitory control but enhanced cognitive flexibility,” they noted.

However, the overall results suggest that exposure to deprivation may be associated with neurodevelopmental changes that support the development of executive functioning, they said.

The study findings were limited by several factors, including the substantial heterogeneity in the pooled estimates and the need to consider variation in study design, the researchers noted. In addition, the cross-sectional design of many studies prevented conclusions about causality between ELA and executive functioning, they said.

“Future research should explore the differences between threat and deprivation when emotionally salient executive functioning measures are used,” the researchers emphasized. “Threat experiences are often associated with alterations in emotional processing, and different findings may be observed when investigating emotionally salient executive functioning outcomes,” they concluded.
 

Prevention and intervention plans needed

“Although numerous studies have examined associations between ELA and executive functioning, the associations of threat and deprivation with specific executive functioning domains (e.g., cognitive flexibility, inhibitory control, and working memory) have not been explored comprehensively,” wrote Beth S. Slomine, PhD, and Nikeea Copeland-Linder, PhD, of the Kennedy Krieger Institute, Johns Hopkins University School, Baltimore, in an accompanying editorial.

The study is “critical and timely” because of the impact of the COVID-19 pandemic on children’s exposure to deprivation, the authors said. “Many children have experienced the death of family members or friends, food and housing insecurity owing to the economic recession, school closures, loss of critical support services, and increased isolation because of social distancing measures,” and these effects are even greater for children already living in poverty and those with developmental disabilities, they noted.

More resources are needed to develop and implement ELA prevention policies, as well as early intervention plans, the editorialists said.

“Early intervention programs have a great potential to reduce the risk of ELA and promote executive functioning development,” they said. “These programs, such as family support and preschool services, are viable solutions for children and their families,” they added. Although the pandemic prevented the use of many support services for children at risk, the adoption of telehealth technology means that “it is now more feasible for cognitive rehabilitation experts to implement the telehealth technology to train parents and school staff on how to assist with the delivery of interventions in real-world settings and how to promote executive functioning in daily life,” they noted.

Overall, the study findings highlight the urgency of identifying ELA and implementing strategies to reduce and prevent ELA, and to provide early intervention to mitigate the impact of ELA on executive function in children, the editorialists emphasized.
 

Data bring understanding, but barriers remain

“At this point, there are data demonstrating the significant impact that adverse childhood experiences have on health outcomes – from worsened mental health to an increased risk for cancer and diabetes,” said Kelly A. Curran, MD, of the University of Oklahoma Health Sciences Center, Oklahoma City, in an interview.

“Physicians – myself included – tend to lump all these experiences together when thinking about future health outcomes,” Dr. Curran said. “However, there are evolving data that neurocognitive outcomes may be different based on the type of early-life adversity experienced. This meta-analysis examines the risk of different neurocognitive impact of threat versus deprivation types of adversity, which is important to pediatricians because it helps us to better understand the risks that our patients may experience,” she explained. 

“The results of this meta-analysis were especially intriguing because I hadn’t previously considered the impact that different types of adversity had on neurocognitive development,” said Dr. Curran. “This study caused me to think about these experiences differently, and as I reflect on the patients I have cared for over the years, I can see the difference in their outcomes,” she said.

Many barriers persist in addressing the effects of early-life deprivation on executive function, Dr. Curran said.

“First are barriers around identification of these children and adolescents, who may not have regular contact with the medical system. Additionally, it’s important to provide resources for parents and caregivers – this includes creating a strong support network and providing education about the impact of these experiences,” she noted. “There are also barriers to identifying and connecting with what resources will help children at risk of poor neurodevelopmental outcomes,” she added.

“Now that we know that children who have experienced early-life deprivation are at increased risk of worsened neurodevelopmental outcomes, it will be important to understand what interventions can help improve their outcomes,” Dr. Curran said.

The study was supported by a Connaught New Researcher Award from the University of Toronto. The researchers had no financial conflicts to disclose.

Dr. Slomine disclosed book royalties from Cambridge University Press unrelated to this study. Dr. Curran had no financial conflicts to disclose, but serves on the Pediatric News Editorial Advisory Board.

Black individuals who received mental health services through a church-based program reported high levels of satisfaction, data from a small, qualitative study show.

“This model of providing mental health services adjacent to or supported by a trusted institution, with providers who may have a more nuanced and intimate knowledge of the experiences of and perceptions held by community members, may facilitate important therapy-mediating factors, such as trust,” wrote Angela Coombs, MD, of Columbia University, New York, and colleagues.

Black Americans continue to face barriers to mental health services, and fewer than one-third of Black Americans with a mental health condition receive formal mental health care, Dr. Coombs and colleagues reported. Barriers to treatment include stigma and distrust of medical institutions, and strategies are needed to address these barriers to improve access. Consequently, “one approach includes the development of mental health programming and supports with trusted institutions, such as churches,” they said. Data are limited, however, on the perspectives of individuals who have used church-based services.

In the study, published in Psychiatric Services, Dr. Coombs and colleagues recruited 15 adults aged 27-69 years who were receiving or had received mental health services at the HOPE (Healing On Purpose and Evolving) Center, a freestanding mental health clinic affiliated with the First Corinthian Baptist Church in Harlem, New York. At the time of the study in 2019, those attending the center (referred to as “innovators” rather than patients or clients to reduce stigma) received 10 free sessions of evidence-based psychotherapy.

Treatment included cognitive-behavioral therapy (CBT), religiously integrated CBT, and interpersonal psychotherapy (IPT) to individuals, couples, and families. Group psychotherapy also was an option. Clinicians at the HOPE Center included licensed social workers with doctoral and master’s-level degrees, as well as supervised social work student interns.

Study participants took part in a 30-minute interview, in person or by phone, with a female psychiatrist who was not employed by the HOPE Center or involved in treating the patients. There were 15 participants: 13 women and 2 men, with mean ages of 48 and 51 years, respectively; 14 identified as Black, non-Hispanic. Most (13 individuals) identified as heterosexual, 11 had never married, and 14 had some college or technical school education.

Notably, 11 participants reported attending church once a week, and 13 said they considered religion or spirituality highly important. Participants “reported that services that could integrate their spiritual beliefs with their current mental health challenges enhanced the therapeutic experience,” the researchers said.

Positive messaging about mental health care from the church and senior pastor also encouraged the participants to take advantage of the HOPE Center services.

As one participant said, “I’ve always believed that I can handle my own issues ... but listening to the pastor always talking about the [HOPE] Center and not to be ashamed if you have weaknesses, that’s when I said, ‘You know what, let me just start seeking mental health services because I really need [them].’ ”

Overall, study participants said that they learned skills during their therapy that they could apply in daily life, including recognizing cycles of unproductive behavior, processing traumatic experiences and learning self-love, and embracing meditation at home.

“A common theme among participants was that the HOPE Center provided them with tools to destress, process trauma, and manage anxiety,” the researchers wrote. In particular, several participants cited group sessions on teaching and practicing mindfulness as their favorite services. They described the HOPE Center as a positive, peaceful, and welcoming environment where they felt safe.

Cost issues were important as well. Participants noted that the HOPE Center’s ability to provide services that were free made it easier for them to attend. “Although participants said that it was helpful that the HOPE Center provided referrals to external providers and agencies for additional services, some said they wished that the HOPE Center would provide long-term therapy,” the researchers noted.

Overall, “most participants said that establishing more mental health resources within faith-based spaces could accelerate normalization of seeking and receiving mental health care within religious Black communities,” they said.

The study findings were limited by the absence of clinical data – and data on participants’ frequency and location of church attendance, the researchers noted. In addition, the positive results could be tied to selection bias, Dr. Coombs and colleagues said. Another possible limitation is the overrepresentation of cisgender women among the participants. Still, “the perspectives shared by participants suggest that this model of care may address several important barriers to care faced by some Black American populations,” the researchers wrote.
 

Bridging gap between spirituality and mental health

In an interview, Atasha Jordan, MD, said Black Americans with mental illnesses have long lacked equal access to mental health services. “However, in light of the COVID-19 pandemic, published studies have shown that rates of mental illness increased concurrently with a rise in spirituality and faith. That said, we currently live in a time where mental health and spirituality are more likely to intersect,” noted Dr. Jordan, of the University of Pennsylvania, Philadelphia.

She said it is not surprising that the study participants felt more comfortable receiving mental health services at a clinic that was church affiliated.

“We have known for years that people of faith are more likely to seek comfort for psychological distress from clergy, rather than mental health professionals. Providing a more familiar entry point to mental health services through a church-affiliated mental health clinic helps to bridge the existing gap between spirituality and mental health,” Dr. Jordan said. “For many Black Americans, spirituality is a central component of culturally-informed mental health care.

“Mental health providers may find improved service utilization and outcomes for their patients by collaborating with faith-based organizations or investing time to learn spiritually-based psychotherapies.”

Recently published data, notably a study published May 1, 2021, in Psychiatric Services, continue to support the existing knowledge “that many patients with psychiatric illnesses want increased attention paid to spirituality during their mental health care,” Dr. Jordan noted. “Moreover, they showed that nonreligious clinicians may be more apt than religious clinicians to provide objective, spiritually-oriented mental health care. In this vein, further research aimed at understanding the most effective methods to address spiritual health in times of mental distress can help all mental health providers better meet their patients’ psychiatric and psychological needs.”
 

Overcoming stigma, mistrust

During the pandemic, clinicians have seen an increase in mental health distress in the form of anxiety, depression, and trauma symptoms, Lorenzo Norris, MD, of George Washington University, Washington, said in an interview.

“Historically, African Americans have faced numerous barriers to mental health care, including stigma and mistrust of medical institutions,” Dr. Norris said. “At this time, perhaps more than in recent decades, novel ways of eliminating and navigating these barriers must be explored in an evidence-based fashion that will inform future interventions.”

Dr. Norris also found that the study findings make sense.

“Historically, the Black church has been a central institution in the community,” he said. “In my personal experience, the church served in a variety of roles, including but not limited to advocacy, employment, social services, peer support, and notably a trusted source of advice pertaining to health. In addition, Black churches may be in an ideal position to serve as culturally sensitive facilitators to build trust,” he said.

The study’s message for clinicians, according to Dr. Norris, is to “carefully consider partnering with faith-based organizations and community leaders if you want to supplement your efforts at decreasing mental health care disparities in the African American community.”

He pointed out, however, that in addition to the small number of participants, the study did not examine clinical outcomes. “So we must be careful how much we take from the initial conclusions,” Dr. Norris said.

Additional research is needed on a much larger scale to add support to the study findings, he said. “This study focused on one church and its particular program,” Dr. Norris noted. “There is likely a great deal of heterogeneity with Black churches and definitely among church members they serve,” he said. “Although it may be tempting to go with an ‘of course it will work’ approach, it is best to have additional qualitative and quantitative research of a much larger scale, with clinical controls that examine the ability of Black churches to address barriers African Americans face in receiving and utilizing mental health services,” he concluded.

Dr. Jordan disclosed receiving a 2021-2022 American Psychiatric Association/Substance Abuse and Mental Health Services Administration Minority Fellowship Program grant to study mental health literacy in the Black church. Dr. Norris disclosed serving as CEO of the Cleveland Clergy Alliance, a nonprofit organization providing outreach assistance as a mechanism to help seniors and the disabled population through community programming. The study authors reported no disclosures.

Black individuals who received mental health services through a church-based program reported high levels of satisfaction, data from a small, qualitative study show.

“This model of providing mental health services adjacent to or supported by a trusted institution, with providers who may have a more nuanced and intimate knowledge of the experiences of and perceptions held by community members, may facilitate important therapy-mediating factors, such as trust,” wrote Angela Coombs, MD, of Columbia University, New York, and colleagues.

Black Americans continue to face barriers to mental health services, and fewer than one-third of Black Americans with a mental health condition receive formal mental health care, Dr. Coombs and colleagues reported. Barriers to treatment include stigma and distrust of medical institutions, and strategies are needed to address these barriers to improve access. Consequently, “one approach includes the development of mental health programming and supports with trusted institutions, such as churches,” they said. Data are limited, however, on the perspectives of individuals who have used church-based services.

In the study, published in Psychiatric Services, Dr. Coombs and colleagues recruited 15 adults aged 27-69 years who were receiving or had received mental health services at the HOPE (Healing On Purpose and Evolving) Center, a freestanding mental health clinic affiliated with the First Corinthian Baptist Church in Harlem, New York. At the time of the study in 2019, those attending the center (referred to as “innovators” rather than patients or clients to reduce stigma) received 10 free sessions of evidence-based psychotherapy.

Treatment included cognitive-behavioral therapy (CBT), religiously integrated CBT, and interpersonal psychotherapy (IPT) to individuals, couples, and families. Group psychotherapy also was an option. Clinicians at the HOPE Center included licensed social workers with doctoral and master’s-level degrees, as well as supervised social work student interns.

Study participants took part in a 30-minute interview, in person or by phone, with a female psychiatrist who was not employed by the HOPE Center or involved in treating the patients. There were 15 participants: 13 women and 2 men, with mean ages of 48 and 51 years, respectively; 14 identified as Black, non-Hispanic. Most (13 individuals) identified as heterosexual, 11 had never married, and 14 had some college or technical school education.

Notably, 11 participants reported attending church once a week, and 13 said they considered religion or spirituality highly important. Participants “reported that services that could integrate their spiritual beliefs with their current mental health challenges enhanced the therapeutic experience,” the researchers said.

Positive messaging about mental health care from the church and senior pastor also encouraged the participants to take advantage of the HOPE Center services.

As one participant said, “I’ve always believed that I can handle my own issues ... but listening to the pastor always talking about the [HOPE] Center and not to be ashamed if you have weaknesses, that’s when I said, ‘You know what, let me just start seeking mental health services because I really need [them].’ ”

Overall, study participants said that they learned skills during their therapy that they could apply in daily life, including recognizing cycles of unproductive behavior, processing traumatic experiences and learning self-love, and embracing meditation at home.

“A common theme among participants was that the HOPE Center provided them with tools to destress, process trauma, and manage anxiety,” the researchers wrote. In particular, several participants cited group sessions on teaching and practicing mindfulness as their favorite services. They described the HOPE Center as a positive, peaceful, and welcoming environment where they felt safe.

Cost issues were important as well. Participants noted that the HOPE Center’s ability to provide services that were free made it easier for them to attend. “Although participants said that it was helpful that the HOPE Center provided referrals to external providers and agencies for additional services, some said they wished that the HOPE Center would provide long-term therapy,” the researchers noted.

Overall, “most participants said that establishing more mental health resources within faith-based spaces could accelerate normalization of seeking and receiving mental health care within religious Black communities,” they said.

The study findings were limited by the absence of clinical data – and data on participants’ frequency and location of church attendance, the researchers noted. In addition, the positive results could be tied to selection bias, Dr. Coombs and colleagues said. Another possible limitation is the overrepresentation of cisgender women among the participants. Still, “the perspectives shared by participants suggest that this model of care may address several important barriers to care faced by some Black American populations,” the researchers wrote.
 

Bridging gap between spirituality and mental health

In an interview, Atasha Jordan, MD, said Black Americans with mental illnesses have long lacked equal access to mental health services. “However, in light of the COVID-19 pandemic, published studies have shown that rates of mental illness increased concurrently with a rise in spirituality and faith. That said, we currently live in a time where mental health and spirituality are more likely to intersect,” noted Dr. Jordan, of the University of Pennsylvania, Philadelphia.

She said it is not surprising that the study participants felt more comfortable receiving mental health services at a clinic that was church affiliated.

“We have known for years that people of faith are more likely to seek comfort for psychological distress from clergy, rather than mental health professionals. Providing a more familiar entry point to mental health services through a church-affiliated mental health clinic helps to bridge the existing gap between spirituality and mental health,” Dr. Jordan said. “For many Black Americans, spirituality is a central component of culturally-informed mental health care.

“Mental health providers may find improved service utilization and outcomes for their patients by collaborating with faith-based organizations or investing time to learn spiritually-based psychotherapies.”

Recently published data, notably a study published May 1, 2021, in Psychiatric Services, continue to support the existing knowledge “that many patients with psychiatric illnesses want increased attention paid to spirituality during their mental health care,” Dr. Jordan noted. “Moreover, they showed that nonreligious clinicians may be more apt than religious clinicians to provide objective, spiritually-oriented mental health care. In this vein, further research aimed at understanding the most effective methods to address spiritual health in times of mental distress can help all mental health providers better meet their patients’ psychiatric and psychological needs.”
 

Overcoming stigma, mistrust

During the pandemic, clinicians have seen an increase in mental health distress in the form of anxiety, depression, and trauma symptoms, Lorenzo Norris, MD, of George Washington University, Washington, said in an interview.

“Historically, African Americans have faced numerous barriers to mental health care, including stigma and mistrust of medical institutions,” Dr. Norris said. “At this time, perhaps more than in recent decades, novel ways of eliminating and navigating these barriers must be explored in an evidence-based fashion that will inform future interventions.”

Dr. Norris also found that the study findings make sense.

“Historically, the Black church has been a central institution in the community,” he said. “In my personal experience, the church served in a variety of roles, including but not limited to advocacy, employment, social services, peer support, and notably a trusted source of advice pertaining to health. In addition, Black churches may be in an ideal position to serve as culturally sensitive facilitators to build trust,” he said.

The study’s message for clinicians, according to Dr. Norris, is to “carefully consider partnering with faith-based organizations and community leaders if you want to supplement your efforts at decreasing mental health care disparities in the African American community.”

He pointed out, however, that in addition to the small number of participants, the study did not examine clinical outcomes. “So we must be careful how much we take from the initial conclusions,” Dr. Norris said.

Additional research is needed on a much larger scale to add support to the study findings, he said. “This study focused on one church and its particular program,” Dr. Norris noted. “There is likely a great deal of heterogeneity with Black churches and definitely among church members they serve,” he said. “Although it may be tempting to go with an ‘of course it will work’ approach, it is best to have additional qualitative and quantitative research of a much larger scale, with clinical controls that examine the ability of Black churches to address barriers African Americans face in receiving and utilizing mental health services,” he concluded.

Dr. Jordan disclosed receiving a 2021-2022 American Psychiatric Association/Substance Abuse and Mental Health Services Administration Minority Fellowship Program grant to study mental health literacy in the Black church. Dr. Norris disclosed serving as CEO of the Cleveland Clergy Alliance, a nonprofit organization providing outreach assistance as a mechanism to help seniors and the disabled population through community programming. The study authors reported no disclosures.

Black individuals who received mental health services through a church-based program reported high levels of satisfaction, data from a small, qualitative study show.

“This model of providing mental health services adjacent to or supported by a trusted institution, with providers who may have a more nuanced and intimate knowledge of the experiences of and perceptions held by community members, may facilitate important therapy-mediating factors, such as trust,” wrote Angela Coombs, MD, of Columbia University, New York, and colleagues.

Black Americans continue to face barriers to mental health services, and fewer than one-third of Black Americans with a mental health condition receive formal mental health care, Dr. Coombs and colleagues reported. Barriers to treatment include stigma and distrust of medical institutions, and strategies are needed to address these barriers to improve access. Consequently, “one approach includes the development of mental health programming and supports with trusted institutions, such as churches,” they said. Data are limited, however, on the perspectives of individuals who have used church-based services.

In the study, published in Psychiatric Services, Dr. Coombs and colleagues recruited 15 adults aged 27-69 years who were receiving or had received mental health services at the HOPE (Healing On Purpose and Evolving) Center, a freestanding mental health clinic affiliated with the First Corinthian Baptist Church in Harlem, New York. At the time of the study in 2019, those attending the center (referred to as “innovators” rather than patients or clients to reduce stigma) received 10 free sessions of evidence-based psychotherapy.

Treatment included cognitive-behavioral therapy (CBT), religiously integrated CBT, and interpersonal psychotherapy (IPT) to individuals, couples, and families. Group psychotherapy also was an option. Clinicians at the HOPE Center included licensed social workers with doctoral and master’s-level degrees, as well as supervised social work student interns.

Study participants took part in a 30-minute interview, in person or by phone, with a female psychiatrist who was not employed by the HOPE Center or involved in treating the patients. There were 15 participants: 13 women and 2 men, with mean ages of 48 and 51 years, respectively; 14 identified as Black, non-Hispanic. Most (13 individuals) identified as heterosexual, 11 had never married, and 14 had some college or technical school education.

Notably, 11 participants reported attending church once a week, and 13 said they considered religion or spirituality highly important. Participants “reported that services that could integrate their spiritual beliefs with their current mental health challenges enhanced the therapeutic experience,” the researchers said.

Positive messaging about mental health care from the church and senior pastor also encouraged the participants to take advantage of the HOPE Center services.

As one participant said, “I’ve always believed that I can handle my own issues ... but listening to the pastor always talking about the [HOPE] Center and not to be ashamed if you have weaknesses, that’s when I said, ‘You know what, let me just start seeking mental health services because I really need [them].’ ”

Overall, study participants said that they learned skills during their therapy that they could apply in daily life, including recognizing cycles of unproductive behavior, processing traumatic experiences and learning self-love, and embracing meditation at home.

“A common theme among participants was that the HOPE Center provided them with tools to destress, process trauma, and manage anxiety,” the researchers wrote. In particular, several participants cited group sessions on teaching and practicing mindfulness as their favorite services. They described the HOPE Center as a positive, peaceful, and welcoming environment where they felt safe.

Cost issues were important as well. Participants noted that the HOPE Center’s ability to provide services that were free made it easier for them to attend. “Although participants said that it was helpful that the HOPE Center provided referrals to external providers and agencies for additional services, some said they wished that the HOPE Center would provide long-term therapy,” the researchers noted.

Overall, “most participants said that establishing more mental health resources within faith-based spaces could accelerate normalization of seeking and receiving mental health care within religious Black communities,” they said.

The study findings were limited by the absence of clinical data – and data on participants’ frequency and location of church attendance, the researchers noted. In addition, the positive results could be tied to selection bias, Dr. Coombs and colleagues said. Another possible limitation is the overrepresentation of cisgender women among the participants. Still, “the perspectives shared by participants suggest that this model of care may address several important barriers to care faced by some Black American populations,” the researchers wrote.
 

Bridging gap between spirituality and mental health

In an interview, Atasha Jordan, MD, said Black Americans with mental illnesses have long lacked equal access to mental health services. “However, in light of the COVID-19 pandemic, published studies have shown that rates of mental illness increased concurrently with a rise in spirituality and faith. That said, we currently live in a time where mental health and spirituality are more likely to intersect,” noted Dr. Jordan, of the University of Pennsylvania, Philadelphia.

She said it is not surprising that the study participants felt more comfortable receiving mental health services at a clinic that was church affiliated.

“We have known for years that people of faith are more likely to seek comfort for psychological distress from clergy, rather than mental health professionals. Providing a more familiar entry point to mental health services through a church-affiliated mental health clinic helps to bridge the existing gap between spirituality and mental health,” Dr. Jordan said. “For many Black Americans, spirituality is a central component of culturally-informed mental health care.

“Mental health providers may find improved service utilization and outcomes for their patients by collaborating with faith-based organizations or investing time to learn spiritually-based psychotherapies.”

Recently published data, notably a study published May 1, 2021, in Psychiatric Services, continue to support the existing knowledge “that many patients with psychiatric illnesses want increased attention paid to spirituality during their mental health care,” Dr. Jordan noted. “Moreover, they showed that nonreligious clinicians may be more apt than religious clinicians to provide objective, spiritually-oriented mental health care. In this vein, further research aimed at understanding the most effective methods to address spiritual health in times of mental distress can help all mental health providers better meet their patients’ psychiatric and psychological needs.”
 

Overcoming stigma, mistrust

During the pandemic, clinicians have seen an increase in mental health distress in the form of anxiety, depression, and trauma symptoms, Lorenzo Norris, MD, of George Washington University, Washington, said in an interview.

“Historically, African Americans have faced numerous barriers to mental health care, including stigma and mistrust of medical institutions,” Dr. Norris said. “At this time, perhaps more than in recent decades, novel ways of eliminating and navigating these barriers must be explored in an evidence-based fashion that will inform future interventions.”

Dr. Norris also found that the study findings make sense.

“Historically, the Black church has been a central institution in the community,” he said. “In my personal experience, the church served in a variety of roles, including but not limited to advocacy, employment, social services, peer support, and notably a trusted source of advice pertaining to health. In addition, Black churches may be in an ideal position to serve as culturally sensitive facilitators to build trust,” he said.

The study’s message for clinicians, according to Dr. Norris, is to “carefully consider partnering with faith-based organizations and community leaders if you want to supplement your efforts at decreasing mental health care disparities in the African American community.”

He pointed out, however, that in addition to the small number of participants, the study did not examine clinical outcomes. “So we must be careful how much we take from the initial conclusions,” Dr. Norris said.

Additional research is needed on a much larger scale to add support to the study findings, he said. “This study focused on one church and its particular program,” Dr. Norris noted. “There is likely a great deal of heterogeneity with Black churches and definitely among church members they serve,” he said. “Although it may be tempting to go with an ‘of course it will work’ approach, it is best to have additional qualitative and quantitative research of a much larger scale, with clinical controls that examine the ability of Black churches to address barriers African Americans face in receiving and utilizing mental health services,” he concluded.

Dr. Jordan disclosed receiving a 2021-2022 American Psychiatric Association/Substance Abuse and Mental Health Services Administration Minority Fellowship Program grant to study mental health literacy in the Black church. Dr. Norris disclosed serving as CEO of the Cleveland Clergy Alliance, a nonprofit organization providing outreach assistance as a mechanism to help seniors and the disabled population through community programming. The study authors reported no disclosures.

Most adults with functional motor disorders (FMDs) report a history of psychological or physical trauma 6 months before the onset of symptoms, a retrospective study of 482 individuals suggests. Those challenges prevent more than half of those patients – most of whom are women – from working, the researchers found.

“This finding points to the huge socioeconomical burden of FMD and emphasizes the need for better diagnostic procedure and active management,” wrote Béatrice Garcin, MD, of Sorbonne Université, Paris, and associates.

FMDs are a common presentation of functional neurologic disorders, but clinical characteristics of FMDs are not well understood because large series of consecutive patients are limited, Dr. Garcin and associates said.

In the study, published in the Journal of Psychosomatic Research, the investigators reviewed data from consecutive patients with FMD who were seen at a single hospital in France between 2008 and 2016. Half of the patients had functional motor weakness (241) and half had functional movement disorders (241). All of the patients had been referred for transcranial magnetic stimulation (TMS) as treatment for FMD.

The median age of the patients was 40 years, the median age at the onset of symptoms was 35.5 years, and 74% were women. The most common clinical presentations were tremor and dystonia (83.4%), and no demographic differences were observed between patients with functional motor weakness and functional movement disorders. Symptoms were bilateral in about half of the patients (51.7%), with left- and right-sided symptoms in 28.2% and 20.1%, respectively.

More than 80% of the patients reported a history of trauma within 6 months of the onset of their symptoms, mainly psychological trauma (50.6%). Another 20.1% reported a physical trauma, and 8.7% reported trauma from surgical procedures.

In addition, about two-thirds (66.4%) had psychiatric comorbidities; 52.7% of these were mood disorders: 49.3% depression and 3.3% bipolar disorder. “However, these results about psychiatric comorbidities should be taken with caution,” the researchers emphasized. “The proportion of trauma and psychiatric comorbidities might be significantly underestimated, and psychiatric diagnosis may lack precision because of the absence of systematic psychiatric interviews and psychiatric questionnaires in the present study.”

No significant differences appeared between the motor weakness and movement disorders groups in terms of occupation, level of education, medical somatic history, symptom onset, psychiatric comorbidities, or self-reported history of trauma. Patients in the motor weakness group were significantly younger at the time of TMS treatment and had a shorter disease duration prior to that treatment. No differences were noted between the groups with regard to clinical FMD phenotypes.

The study findings were limited by several factors, including the potential selection bias because of enrollment at a neurology referral center, lack of a control group, and underrepresentation of children and older adults, the researchers noted. Also, symptom severity was not assessed and could not be compared among phenotypes or demographic groups.

However, the results contribute to the characterization of FMD patients. “Future studies are needed to clarify the characteristics of FMD patients and the consequences of their symptoms on disability and work status,” they said.

The study received no outside funding. Lead author Dr. Garcin had no disclosures.

Most adults with functional motor disorders (FMDs) report a history of psychological or physical trauma 6 months before the onset of symptoms, a retrospective study of 482 individuals suggests. Those challenges prevent more than half of those patients – most of whom are women – from working, the researchers found.

“This finding points to the huge socioeconomical burden of FMD and emphasizes the need for better diagnostic procedure and active management,” wrote Béatrice Garcin, MD, of Sorbonne Université, Paris, and associates.

FMDs are a common presentation of functional neurologic disorders, but clinical characteristics of FMDs are not well understood because large series of consecutive patients are limited, Dr. Garcin and associates said.

In the study, published in the Journal of Psychosomatic Research, the investigators reviewed data from consecutive patients with FMD who were seen at a single hospital in France between 2008 and 2016. Half of the patients had functional motor weakness (241) and half had functional movement disorders (241). All of the patients had been referred for transcranial magnetic stimulation (TMS) as treatment for FMD.

The median age of the patients was 40 years, the median age at the onset of symptoms was 35.5 years, and 74% were women. The most common clinical presentations were tremor and dystonia (83.4%), and no demographic differences were observed between patients with functional motor weakness and functional movement disorders. Symptoms were bilateral in about half of the patients (51.7%), with left- and right-sided symptoms in 28.2% and 20.1%, respectively.

More than 80% of the patients reported a history of trauma within 6 months of the onset of their symptoms, mainly psychological trauma (50.6%). Another 20.1% reported a physical trauma, and 8.7% reported trauma from surgical procedures.

In addition, about two-thirds (66.4%) had psychiatric comorbidities; 52.7% of these were mood disorders: 49.3% depression and 3.3% bipolar disorder. “However, these results about psychiatric comorbidities should be taken with caution,” the researchers emphasized. “The proportion of trauma and psychiatric comorbidities might be significantly underestimated, and psychiatric diagnosis may lack precision because of the absence of systematic psychiatric interviews and psychiatric questionnaires in the present study.”

No significant differences appeared between the motor weakness and movement disorders groups in terms of occupation, level of education, medical somatic history, symptom onset, psychiatric comorbidities, or self-reported history of trauma. Patients in the motor weakness group were significantly younger at the time of TMS treatment and had a shorter disease duration prior to that treatment. No differences were noted between the groups with regard to clinical FMD phenotypes.

The study findings were limited by several factors, including the potential selection bias because of enrollment at a neurology referral center, lack of a control group, and underrepresentation of children and older adults, the researchers noted. Also, symptom severity was not assessed and could not be compared among phenotypes or demographic groups.

However, the results contribute to the characterization of FMD patients. “Future studies are needed to clarify the characteristics of FMD patients and the consequences of their symptoms on disability and work status,” they said.

The study received no outside funding. Lead author Dr. Garcin had no disclosures.

Most adults with functional motor disorders (FMDs) report a history of psychological or physical trauma 6 months before the onset of symptoms, a retrospective study of 482 individuals suggests. Those challenges prevent more than half of those patients – most of whom are women – from working, the researchers found.

“This finding points to the huge socioeconomical burden of FMD and emphasizes the need for better diagnostic procedure and active management,” wrote Béatrice Garcin, MD, of Sorbonne Université, Paris, and associates.

FMDs are a common presentation of functional neurologic disorders, but clinical characteristics of FMDs are not well understood because large series of consecutive patients are limited, Dr. Garcin and associates said.

In the study, published in the Journal of Psychosomatic Research, the investigators reviewed data from consecutive patients with FMD who were seen at a single hospital in France between 2008 and 2016. Half of the patients had functional motor weakness (241) and half had functional movement disorders (241). All of the patients had been referred for transcranial magnetic stimulation (TMS) as treatment for FMD.

The median age of the patients was 40 years, the median age at the onset of symptoms was 35.5 years, and 74% were women. The most common clinical presentations were tremor and dystonia (83.4%), and no demographic differences were observed between patients with functional motor weakness and functional movement disorders. Symptoms were bilateral in about half of the patients (51.7%), with left- and right-sided symptoms in 28.2% and 20.1%, respectively.

More than 80% of the patients reported a history of trauma within 6 months of the onset of their symptoms, mainly psychological trauma (50.6%). Another 20.1% reported a physical trauma, and 8.7% reported trauma from surgical procedures.

In addition, about two-thirds (66.4%) had psychiatric comorbidities; 52.7% of these were mood disorders: 49.3% depression and 3.3% bipolar disorder. “However, these results about psychiatric comorbidities should be taken with caution,” the researchers emphasized. “The proportion of trauma and psychiatric comorbidities might be significantly underestimated, and psychiatric diagnosis may lack precision because of the absence of systematic psychiatric interviews and psychiatric questionnaires in the present study.”

No significant differences appeared between the motor weakness and movement disorders groups in terms of occupation, level of education, medical somatic history, symptom onset, psychiatric comorbidities, or self-reported history of trauma. Patients in the motor weakness group were significantly younger at the time of TMS treatment and had a shorter disease duration prior to that treatment. No differences were noted between the groups with regard to clinical FMD phenotypes.

The study findings were limited by several factors, including the potential selection bias because of enrollment at a neurology referral center, lack of a control group, and underrepresentation of children and older adults, the researchers noted. Also, symptom severity was not assessed and could not be compared among phenotypes or demographic groups.

However, the results contribute to the characterization of FMD patients. “Future studies are needed to clarify the characteristics of FMD patients and the consequences of their symptoms on disability and work status,” they said.

The study received no outside funding. Lead author Dr. Garcin had no disclosures.

The Pediatric Hospital Medicine annual conference, though virtual in 2021, promises to retain its role as the premier educational event for pediatric hospitalists and other clinicians involved in treating pediatric patients.

The “can’t-miss” session, on August 5, at 6:30 p.m. ET, is a one-on-one discussion between Anthony S. Fauci, MD, and Lee Savio Beers, MD, president of the American Academic of Pediatrics, according to members of the meeting planning committee.

In addition to the conversation between Dr. Beers and Dr. Fauci, this year’s meeting offers a mix of workshops with pointers and pearls to improve practice, keynote and plenary sessions to inform and inspire, and abstract presentations of new research. Three members of the PHM Planning Committee shared their insights on the hot topics, advice for new clinicians, and tips for making the most of this year’s meeting.
 

Workshops worth watching

“The keynote plenary sessions by Julie Silver, MD, on ‘Accelerating Patient Care and Healthcare Workforce Diversity and Inclusion,’ and by Ilan Alhadeff, MD, on ‘Leading through Adversity’ should inspire even the least enthusiastic among us,” Mirna Giordano, MD, FHM, of Columbia University Medical Center, New York, said in an interview. A talk by Nathan T. Chomilo, MD, “will likely prompt reflection on how George Floyd’s death changed us, and how we practice medicine forever.” In addition, “PHM Stories are not to be missed, they are voices that speak loud and move mountains.”

The PHM Stories are concise, narrative talks with minimal use of slides; each PHM Stories session includes three distinct talks and a 15-minute question and answer session. PHM Stories sessions are scheduled for each day of the conference, and topics include “Practicing Medicine While Human: The Secrets Physicians Keep,” by Uchenna Ewulonu, MD; “Finding the Power of the Imposter: How I Learned to Be Exactly the Color I Am, Everywhere I Go,” by Alexandra Coria, MD; and “Purple Butterflies: A Reflection on Why I’m a Pediatric Hospitalist,” by Joanne Mendoza, MD.

“The PHM community has been through a lot in the aftermath of the pandemic,” said Dr. Giordano. “The mini-plenary session on the mental health needs of our patients, and clinical quick-hit sessions on verbal deescalation of the agitated patients and cardiac effects of COVID-19 will likely be not only very popular, but also useful in clinical endeavors. The workshop on how to navigate the adult issues in hospitalized patients will provide the Med-Peds pearls we all wish we heard earlier.”

Although a 75-minute workshop session may seem long, “the workshop choices will offer something for everyone’s taste: education, research, clinical topics, diversity, and advocacy,” Dr. Giordano said. “I suggest that attendees check in advance which sessions will be available after the meeting, so that they prioritize highly interactive sessions like workshops, and that they experience, even if virtual, small group/room gatherings and networking.” There will be time for fun, too, she emphasized, with social sessions “that we hope will break the screen monotony and bring smiles to everyone’s faces.”

For younger clinicians relatively new to practice, Dr. Giordano recommended several workshops for a wealth of advice and guidance, including “New Kids on the Block: Thriving in your First Faculty Position,” “Channeling Your Inner Coach: Techniques to Enhance Clinical Teaching & Feedback,” “Palliative Care Pearls for the Pediatric Hospitalist,” “Perioperative Medicine for Medically Complex Children: Case Studies in Programmatic Approaches,” “The Bare Necessities: Social Determinant of Health Screening for the Hospitalist,” and “Mentorship, Autonomy, and Supervising a PHM Fellow.”
 

Classic topics and new concepts

“We are so excited to be able to offer a full spectrum of offerings at this year’s virtual meeting,” Yemisi Jones, MD, FHM, of Cincinnati Children’s Hospital, said in an interview. “We are covering some classic topics that we can’t do without at PHM, such as clinical updates in the management of sick and well newborns; workshops on best practices for educators; as well as the latest in PHM scholarship.” Sessions include “timely topics such as equity for women in medicine with one of our plenary speakers, Julie Silver, MD, and new febrile infant guidelines,” she added.

In particular, the COVID-19 and mental health session will help address clinicians’ evolving understanding of the COVID-19 pandemic and its effects on hospitalized children, said Dr. Jones. “Attendees can expect practical, timely updates on the current state of the science and ways to improve their practice to provide the best care for our patients.”

Attendees will be able to maximize the virtual conference format by accessing archived recordings, including clinical quick hits, mini-plenaries, and PHM Stories, which can be viewed during the scheduled meeting time or after, Dr. Jones said. “Workshops and abstract presentations will involve real-time interaction with presenters, so would be highest yield to attend during the live meeting. We also encourage all participants to take full advantage of the platform and the various networking opportunities to engage with others in our PHM community.”

For residents and new fellows, Dr. Jones advised making the workshop, “A Whole New World: Tips and Tools to Soar Into Your First Year of Fellowship,” a priority. “For early-career faculty, the ‘New Kids on the Block: Thriving in your First Faculty Position workshop will be a valuable resource.”
 

Make the meeting content a priority

This year’s conference has an exceptional slate of plenary speakers, Michelle Marks, DO, SFHM, of the Cleveland Clinic said in an interview. In addition to the much-anticipated session on vaccinations, school guidelines, and other topics with Dr. Fauci and Dr. Beers, the sessions on leading through adversity and workforce diversity and inclusion are “important topics to the PHM community and to our greater communities as a whole.”

Dr. Marks also highlighted the value of the COVID-19 and mental health session, as the long-term impact of COVID-19 on mental health of children and adults continues to grab headlines. “From this session specifically, I hope the attendees will gain awareness of the special mental health needs for child during a global disaster like a pandemic, which can be generalized to other situations and gain skills and resources to help meet and advocate for children’s mental health needs.”

For clinicians attending the virtual conference, “The most important strategy is to schedule time off of clinical work for the virtual meeting if you can so you can focus on the content,” said Dr. Marks. “For the longer sessions, it would be very important to block time in your day to fully attend the session, attend in a private space if possible since there will be breakouts with discussion, have your camera on, and engage with the workshop group as much as possible. The virtual format can be challenging because of all the external distractions, so intentional focus is necessary,” to get the most out of the experience.

The mini-plenary session on “The New AAP Clinical Practice Guideline on the Evaluation and Management of Febrile Infants 8-60 Days Old,” is an important session for all attendees, Dr. Marks said. She also recommended the Clinical Quick Hits sessions for anyone seeking “a diverse array of practical knowledge which can be easily applied to everyday practice.” The Clinical Quick Hits are designed as 35-minute, rapid-fire presentations focused on clinical knowledge. Each of these presentations will focus on the latest updates or evolutions in clinical practice in one area. Some key topics include counseling parents when a child has an abnormal exam finding, assessing pelvic pain in adolescent girls, and preventing venous thromboembolism in the inpatient setting.

“I would also recommend that younger clinicians take in at least one or two workshops or sessions on nonclinical topics to see the breath of content at the meeting and to develop a niche interest for themselves outside of clinical work,” Dr. Marks noted.

Nonclinical sessions at PHM 2021 include workshops on a pilot for a comprehensive LGBTQ+ curriculum, using media tools for public health messaging, and practicing health literacy.

To register for the Pediatric Hospital Medicine 2021 virtual conference, visit https://apaevents.regfox.com/phm21-virtual-conference.

Dr. Giordano, Dr. Jones, and Dr. Marks are members of the PHM conference planning committee and had no relevant financial conflicts to disclose.

The Pediatric Hospital Medicine annual conference, though virtual in 2021, promises to retain its role as the premier educational event for pediatric hospitalists and other clinicians involved in treating pediatric patients.

The “can’t-miss” session, on August 5, at 6:30 p.m. ET, is a one-on-one discussion between Anthony S. Fauci, MD, and Lee Savio Beers, MD, president of the American Academic of Pediatrics, according to members of the meeting planning committee.

In addition to the conversation between Dr. Beers and Dr. Fauci, this year’s meeting offers a mix of workshops with pointers and pearls to improve practice, keynote and plenary sessions to inform and inspire, and abstract presentations of new research. Three members of the PHM Planning Committee shared their insights on the hot topics, advice for new clinicians, and tips for making the most of this year’s meeting.
 

Workshops worth watching

“The keynote plenary sessions by Julie Silver, MD, on ‘Accelerating Patient Care and Healthcare Workforce Diversity and Inclusion,’ and by Ilan Alhadeff, MD, on ‘Leading through Adversity’ should inspire even the least enthusiastic among us,” Mirna Giordano, MD, FHM, of Columbia University Medical Center, New York, said in an interview. A talk by Nathan T. Chomilo, MD, “will likely prompt reflection on how George Floyd’s death changed us, and how we practice medicine forever.” In addition, “PHM Stories are not to be missed, they are voices that speak loud and move mountains.”

The PHM Stories are concise, narrative talks with minimal use of slides; each PHM Stories session includes three distinct talks and a 15-minute question and answer session. PHM Stories sessions are scheduled for each day of the conference, and topics include “Practicing Medicine While Human: The Secrets Physicians Keep,” by Uchenna Ewulonu, MD; “Finding the Power of the Imposter: How I Learned to Be Exactly the Color I Am, Everywhere I Go,” by Alexandra Coria, MD; and “Purple Butterflies: A Reflection on Why I’m a Pediatric Hospitalist,” by Joanne Mendoza, MD.

“The PHM community has been through a lot in the aftermath of the pandemic,” said Dr. Giordano. “The mini-plenary session on the mental health needs of our patients, and clinical quick-hit sessions on verbal deescalation of the agitated patients and cardiac effects of COVID-19 will likely be not only very popular, but also useful in clinical endeavors. The workshop on how to navigate the adult issues in hospitalized patients will provide the Med-Peds pearls we all wish we heard earlier.”

Although a 75-minute workshop session may seem long, “the workshop choices will offer something for everyone’s taste: education, research, clinical topics, diversity, and advocacy,” Dr. Giordano said. “I suggest that attendees check in advance which sessions will be available after the meeting, so that they prioritize highly interactive sessions like workshops, and that they experience, even if virtual, small group/room gatherings and networking.” There will be time for fun, too, she emphasized, with social sessions “that we hope will break the screen monotony and bring smiles to everyone’s faces.”

For younger clinicians relatively new to practice, Dr. Giordano recommended several workshops for a wealth of advice and guidance, including “New Kids on the Block: Thriving in your First Faculty Position,” “Channeling Your Inner Coach: Techniques to Enhance Clinical Teaching & Feedback,” “Palliative Care Pearls for the Pediatric Hospitalist,” “Perioperative Medicine for Medically Complex Children: Case Studies in Programmatic Approaches,” “The Bare Necessities: Social Determinant of Health Screening for the Hospitalist,” and “Mentorship, Autonomy, and Supervising a PHM Fellow.”
 

Classic topics and new concepts

“We are so excited to be able to offer a full spectrum of offerings at this year’s virtual meeting,” Yemisi Jones, MD, FHM, of Cincinnati Children’s Hospital, said in an interview. “We are covering some classic topics that we can’t do without at PHM, such as clinical updates in the management of sick and well newborns; workshops on best practices for educators; as well as the latest in PHM scholarship.” Sessions include “timely topics such as equity for women in medicine with one of our plenary speakers, Julie Silver, MD, and new febrile infant guidelines,” she added.

In particular, the COVID-19 and mental health session will help address clinicians’ evolving understanding of the COVID-19 pandemic and its effects on hospitalized children, said Dr. Jones. “Attendees can expect practical, timely updates on the current state of the science and ways to improve their practice to provide the best care for our patients.”

Attendees will be able to maximize the virtual conference format by accessing archived recordings, including clinical quick hits, mini-plenaries, and PHM Stories, which can be viewed during the scheduled meeting time or after, Dr. Jones said. “Workshops and abstract presentations will involve real-time interaction with presenters, so would be highest yield to attend during the live meeting. We also encourage all participants to take full advantage of the platform and the various networking opportunities to engage with others in our PHM community.”

For residents and new fellows, Dr. Jones advised making the workshop, “A Whole New World: Tips and Tools to Soar Into Your First Year of Fellowship,” a priority. “For early-career faculty, the ‘New Kids on the Block: Thriving in your First Faculty Position workshop will be a valuable resource.”
 

Make the meeting content a priority

This year’s conference has an exceptional slate of plenary speakers, Michelle Marks, DO, SFHM, of the Cleveland Clinic said in an interview. In addition to the much-anticipated session on vaccinations, school guidelines, and other topics with Dr. Fauci and Dr. Beers, the sessions on leading through adversity and workforce diversity and inclusion are “important topics to the PHM community and to our greater communities as a whole.”

Dr. Marks also highlighted the value of the COVID-19 and mental health session, as the long-term impact of COVID-19 on mental health of children and adults continues to grab headlines. “From this session specifically, I hope the attendees will gain awareness of the special mental health needs for child during a global disaster like a pandemic, which can be generalized to other situations and gain skills and resources to help meet and advocate for children’s mental health needs.”

For clinicians attending the virtual conference, “The most important strategy is to schedule time off of clinical work for the virtual meeting if you can so you can focus on the content,” said Dr. Marks. “For the longer sessions, it would be very important to block time in your day to fully attend the session, attend in a private space if possible since there will be breakouts with discussion, have your camera on, and engage with the workshop group as much as possible. The virtual format can be challenging because of all the external distractions, so intentional focus is necessary,” to get the most out of the experience.

The mini-plenary session on “The New AAP Clinical Practice Guideline on the Evaluation and Management of Febrile Infants 8-60 Days Old,” is an important session for all attendees, Dr. Marks said. She also recommended the Clinical Quick Hits sessions for anyone seeking “a diverse array of practical knowledge which can be easily applied to everyday practice.” The Clinical Quick Hits are designed as 35-minute, rapid-fire presentations focused on clinical knowledge. Each of these presentations will focus on the latest updates or evolutions in clinical practice in one area. Some key topics include counseling parents when a child has an abnormal exam finding, assessing pelvic pain in adolescent girls, and preventing venous thromboembolism in the inpatient setting.

“I would also recommend that younger clinicians take in at least one or two workshops or sessions on nonclinical topics to see the breath of content at the meeting and to develop a niche interest for themselves outside of clinical work,” Dr. Marks noted.

Nonclinical sessions at PHM 2021 include workshops on a pilot for a comprehensive LGBTQ+ curriculum, using media tools for public health messaging, and practicing health literacy.

To register for the Pediatric Hospital Medicine 2021 virtual conference, visit https://apaevents.regfox.com/phm21-virtual-conference.

Dr. Giordano, Dr. Jones, and Dr. Marks are members of the PHM conference planning committee and had no relevant financial conflicts to disclose.

The Pediatric Hospital Medicine annual conference, though virtual in 2021, promises to retain its role as the premier educational event for pediatric hospitalists and other clinicians involved in treating pediatric patients.

The “can’t-miss” session, on August 5, at 6:30 p.m. ET, is a one-on-one discussion between Anthony S. Fauci, MD, and Lee Savio Beers, MD, president of the American Academic of Pediatrics, according to members of the meeting planning committee.

In addition to the conversation between Dr. Beers and Dr. Fauci, this year’s meeting offers a mix of workshops with pointers and pearls to improve practice, keynote and plenary sessions to inform and inspire, and abstract presentations of new research. Three members of the PHM Planning Committee shared their insights on the hot topics, advice for new clinicians, and tips for making the most of this year’s meeting.
 

Workshops worth watching

“The keynote plenary sessions by Julie Silver, MD, on ‘Accelerating Patient Care and Healthcare Workforce Diversity and Inclusion,’ and by Ilan Alhadeff, MD, on ‘Leading through Adversity’ should inspire even the least enthusiastic among us,” Mirna Giordano, MD, FHM, of Columbia University Medical Center, New York, said in an interview. A talk by Nathan T. Chomilo, MD, “will likely prompt reflection on how George Floyd’s death changed us, and how we practice medicine forever.” In addition, “PHM Stories are not to be missed, they are voices that speak loud and move mountains.”

The PHM Stories are concise, narrative talks with minimal use of slides; each PHM Stories session includes three distinct talks and a 15-minute question and answer session. PHM Stories sessions are scheduled for each day of the conference, and topics include “Practicing Medicine While Human: The Secrets Physicians Keep,” by Uchenna Ewulonu, MD; “Finding the Power of the Imposter: How I Learned to Be Exactly the Color I Am, Everywhere I Go,” by Alexandra Coria, MD; and “Purple Butterflies: A Reflection on Why I’m a Pediatric Hospitalist,” by Joanne Mendoza, MD.

“The PHM community has been through a lot in the aftermath of the pandemic,” said Dr. Giordano. “The mini-plenary session on the mental health needs of our patients, and clinical quick-hit sessions on verbal deescalation of the agitated patients and cardiac effects of COVID-19 will likely be not only very popular, but also useful in clinical endeavors. The workshop on how to navigate the adult issues in hospitalized patients will provide the Med-Peds pearls we all wish we heard earlier.”

Although a 75-minute workshop session may seem long, “the workshop choices will offer something for everyone’s taste: education, research, clinical topics, diversity, and advocacy,” Dr. Giordano said. “I suggest that attendees check in advance which sessions will be available after the meeting, so that they prioritize highly interactive sessions like workshops, and that they experience, even if virtual, small group/room gatherings and networking.” There will be time for fun, too, she emphasized, with social sessions “that we hope will break the screen monotony and bring smiles to everyone’s faces.”

For younger clinicians relatively new to practice, Dr. Giordano recommended several workshops for a wealth of advice and guidance, including “New Kids on the Block: Thriving in your First Faculty Position,” “Channeling Your Inner Coach: Techniques to Enhance Clinical Teaching & Feedback,” “Palliative Care Pearls for the Pediatric Hospitalist,” “Perioperative Medicine for Medically Complex Children: Case Studies in Programmatic Approaches,” “The Bare Necessities: Social Determinant of Health Screening for the Hospitalist,” and “Mentorship, Autonomy, and Supervising a PHM Fellow.”
 

Classic topics and new concepts

“We are so excited to be able to offer a full spectrum of offerings at this year’s virtual meeting,” Yemisi Jones, MD, FHM, of Cincinnati Children’s Hospital, said in an interview. “We are covering some classic topics that we can’t do without at PHM, such as clinical updates in the management of sick and well newborns; workshops on best practices for educators; as well as the latest in PHM scholarship.” Sessions include “timely topics such as equity for women in medicine with one of our plenary speakers, Julie Silver, MD, and new febrile infant guidelines,” she added.

In particular, the COVID-19 and mental health session will help address clinicians’ evolving understanding of the COVID-19 pandemic and its effects on hospitalized children, said Dr. Jones. “Attendees can expect practical, timely updates on the current state of the science and ways to improve their practice to provide the best care for our patients.”

Attendees will be able to maximize the virtual conference format by accessing archived recordings, including clinical quick hits, mini-plenaries, and PHM Stories, which can be viewed during the scheduled meeting time or after, Dr. Jones said. “Workshops and abstract presentations will involve real-time interaction with presenters, so would be highest yield to attend during the live meeting. We also encourage all participants to take full advantage of the platform and the various networking opportunities to engage with others in our PHM community.”

For residents and new fellows, Dr. Jones advised making the workshop, “A Whole New World: Tips and Tools to Soar Into Your First Year of Fellowship,” a priority. “For early-career faculty, the ‘New Kids on the Block: Thriving in your First Faculty Position workshop will be a valuable resource.”
 

Make the meeting content a priority

This year’s conference has an exceptional slate of plenary speakers, Michelle Marks, DO, SFHM, of the Cleveland Clinic said in an interview. In addition to the much-anticipated session on vaccinations, school guidelines, and other topics with Dr. Fauci and Dr. Beers, the sessions on leading through adversity and workforce diversity and inclusion are “important topics to the PHM community and to our greater communities as a whole.”

Dr. Marks also highlighted the value of the COVID-19 and mental health session, as the long-term impact of COVID-19 on mental health of children and adults continues to grab headlines. “From this session specifically, I hope the attendees will gain awareness of the special mental health needs for child during a global disaster like a pandemic, which can be generalized to other situations and gain skills and resources to help meet and advocate for children’s mental health needs.”

For clinicians attending the virtual conference, “The most important strategy is to schedule time off of clinical work for the virtual meeting if you can so you can focus on the content,” said Dr. Marks. “For the longer sessions, it would be very important to block time in your day to fully attend the session, attend in a private space if possible since there will be breakouts with discussion, have your camera on, and engage with the workshop group as much as possible. The virtual format can be challenging because of all the external distractions, so intentional focus is necessary,” to get the most out of the experience.

The mini-plenary session on “The New AAP Clinical Practice Guideline on the Evaluation and Management of Febrile Infants 8-60 Days Old,” is an important session for all attendees, Dr. Marks said. She also recommended the Clinical Quick Hits sessions for anyone seeking “a diverse array of practical knowledge which can be easily applied to everyday practice.” The Clinical Quick Hits are designed as 35-minute, rapid-fire presentations focused on clinical knowledge. Each of these presentations will focus on the latest updates or evolutions in clinical practice in one area. Some key topics include counseling parents when a child has an abnormal exam finding, assessing pelvic pain in adolescent girls, and preventing venous thromboembolism in the inpatient setting.

“I would also recommend that younger clinicians take in at least one or two workshops or sessions on nonclinical topics to see the breath of content at the meeting and to develop a niche interest for themselves outside of clinical work,” Dr. Marks noted.

Nonclinical sessions at PHM 2021 include workshops on a pilot for a comprehensive LGBTQ+ curriculum, using media tools for public health messaging, and practicing health literacy.

To register for the Pediatric Hospital Medicine 2021 virtual conference, visit https://apaevents.regfox.com/phm21-virtual-conference.

Dr. Giordano, Dr. Jones, and Dr. Marks are members of the PHM conference planning committee and had no relevant financial conflicts to disclose.

The Food and Drug Administration has approved Octagam 10% as the first intravenous immunoglobulin with an indication specifically for adult dermatomyositis, according to a statement from manufacturer Octapharma USA.

Dermatomyositis is a rare, idiopathic autoimmune disorder that affects approximately 10 out of every million people in the United States, mainly adults in their late 40s to early 60s, according to the company, but children aged 5-15 years can be affected. The disease is characterized by skin rashes, chronic muscle inflammation, progressive muscle weakness, and risk for mortality that is three times higher than for the general population.

There are no previously approved treatments for dermatomyositis prior to Octagam 10%, which also is indicated for chronic immune thrombocytopenic purpura in adults.

The approval for dermatomyositis was based on the results of a phase 3 randomized, double-blind, placebo-controlled clinical trial (the ProDERM trial) that included 95 adult patients at 36 sites worldwide, with 17 sites in the United States. In the trial, 78.7% of patients with dermatomyositis who were randomized to receive 2 g/kg of Octagam 10% every 4 weeks showed response at 16 weeks, compared with 43.8% of patients who received placebo. Response was based on the 2016 American College of Rheumatology/European Alliance of Associations for Rheumatology myositis response criteria. Placebo patients who switched to intravenous immunoglobulin (IVIG) during a trial extension had response rates at week 40 similar to the original patients at week 16.

“The study gives clinicians much more confidence in the efficacy and safety of intravenous immunoglobulin and provides valuable information about what type of patient is best suited for the treatment,” Rohit Aggarwal, MD, medical director of the Arthritis and Autoimmunity Center at the University of Pittsburgh and a member of the ProDERM study Steering Committee, said in the Octapharma statement.

Safety and tolerability were similar to profiles seen with other IVIG medications, according to the statement. The medication does carry a boxed warning from its chronic ITP approval, cautioning about the potential for thrombosis, renal dysfunction, and acute renal failure.

The most common adverse reactions reported by dermatomyositis patients in the ProDERM trial were headache, fever, nausea, vomiting, increased blood pressure, chills, musculoskeletal pain, increased heart rate, dyspnea, and reactions at the infusion sites.

Read the full prescribing information here.

The Food and Drug Administration has approved Octagam 10% as the first intravenous immunoglobulin with an indication specifically for adult dermatomyositis, according to a statement from manufacturer Octapharma USA.

Dermatomyositis is a rare, idiopathic autoimmune disorder that affects approximately 10 out of every million people in the United States, mainly adults in their late 40s to early 60s, according to the company, but children aged 5-15 years can be affected. The disease is characterized by skin rashes, chronic muscle inflammation, progressive muscle weakness, and risk for mortality that is three times higher than for the general population.

There are no previously approved treatments for dermatomyositis prior to Octagam 10%, which also is indicated for chronic immune thrombocytopenic purpura in adults.

The approval for dermatomyositis was based on the results of a phase 3 randomized, double-blind, placebo-controlled clinical trial (the ProDERM trial) that included 95 adult patients at 36 sites worldwide, with 17 sites in the United States. In the trial, 78.7% of patients with dermatomyositis who were randomized to receive 2 g/kg of Octagam 10% every 4 weeks showed response at 16 weeks, compared with 43.8% of patients who received placebo. Response was based on the 2016 American College of Rheumatology/European Alliance of Associations for Rheumatology myositis response criteria. Placebo patients who switched to intravenous immunoglobulin (IVIG) during a trial extension had response rates at week 40 similar to the original patients at week 16.

“The study gives clinicians much more confidence in the efficacy and safety of intravenous immunoglobulin and provides valuable information about what type of patient is best suited for the treatment,” Rohit Aggarwal, MD, medical director of the Arthritis and Autoimmunity Center at the University of Pittsburgh and a member of the ProDERM study Steering Committee, said in the Octapharma statement.

Safety and tolerability were similar to profiles seen with other IVIG medications, according to the statement. The medication does carry a boxed warning from its chronic ITP approval, cautioning about the potential for thrombosis, renal dysfunction, and acute renal failure.

The most common adverse reactions reported by dermatomyositis patients in the ProDERM trial were headache, fever, nausea, vomiting, increased blood pressure, chills, musculoskeletal pain, increased heart rate, dyspnea, and reactions at the infusion sites.

Read the full prescribing information here.

The Food and Drug Administration has approved Octagam 10% as the first intravenous immunoglobulin with an indication specifically for adult dermatomyositis, according to a statement from manufacturer Octapharma USA.

Dermatomyositis is a rare, idiopathic autoimmune disorder that affects approximately 10 out of every million people in the United States, mainly adults in their late 40s to early 60s, according to the company, but children aged 5-15 years can be affected. The disease is characterized by skin rashes, chronic muscle inflammation, progressive muscle weakness, and risk for mortality that is three times higher than for the general population.

There are no previously approved treatments for dermatomyositis prior to Octagam 10%, which also is indicated for chronic immune thrombocytopenic purpura in adults.

The approval for dermatomyositis was based on the results of a phase 3 randomized, double-blind, placebo-controlled clinical trial (the ProDERM trial) that included 95 adult patients at 36 sites worldwide, with 17 sites in the United States. In the trial, 78.7% of patients with dermatomyositis who were randomized to receive 2 g/kg of Octagam 10% every 4 weeks showed response at 16 weeks, compared with 43.8% of patients who received placebo. Response was based on the 2016 American College of Rheumatology/European Alliance of Associations for Rheumatology myositis response criteria. Placebo patients who switched to intravenous immunoglobulin (IVIG) during a trial extension had response rates at week 40 similar to the original patients at week 16.

“The study gives clinicians much more confidence in the efficacy and safety of intravenous immunoglobulin and provides valuable information about what type of patient is best suited for the treatment,” Rohit Aggarwal, MD, medical director of the Arthritis and Autoimmunity Center at the University of Pittsburgh and a member of the ProDERM study Steering Committee, said in the Octapharma statement.

Safety and tolerability were similar to profiles seen with other IVIG medications, according to the statement. The medication does carry a boxed warning from its chronic ITP approval, cautioning about the potential for thrombosis, renal dysfunction, and acute renal failure.

The most common adverse reactions reported by dermatomyositis patients in the ProDERM trial were headache, fever, nausea, vomiting, increased blood pressure, chills, musculoskeletal pain, increased heart rate, dyspnea, and reactions at the infusion sites.

Read the full prescribing information here.

The amount of prescription drugs given to children in the United States decreased by 27.1% between April and December 2020, compared with the same period in 2019, based on data from a national database.

Overall, dispensing of prescription drugs to all patients in the United States decreased in the wake of COVID-19 but has since rebounded, wrote Kao-Ping Chua, MD, of the University of Michigan, Ann Arbor, and colleagues. “However, whether these same trends occurred for children is unknown.”

In a study published in Pediatrics, the researchers used the IQVIA National Prescription Audit, a database that contains monthly dispensing details from 92% of retail pharmacies in the United States. They compared changes in the dispensing of prescriptions with children aged 0-19 years during 2018-2020.

In the April 2020–December 2020 time period, prescriptions for children aged 1-2 years, 3-9 years, and 10-19 years decreased by 48.7%, 40.6%, and 16.8%, respectively, compared with the same time period in 2019.

The overall dispensing total for children from April 2020 to December 2020 was 160,630,406, representing a 27.1% reduction, compared with the 220,284,613 total from April 2019 to December 2019.

By drug class, prescriptions for antibiotics, ADHD medications, and antidepressants decreased by 55.6%, 11.8%, and 0.1%, respectively, in comparing the two time periods. Prescriptions for drug classes used typically for acute infections decreased by 51.3%, and those used for chronic diseases decreased by 17.4%.

From January 2018 to February 2020, a median of 25,744,758 prescriptions were dispensed to children aged 0-19 years each month. The total prescriptions decreased from 25,684,219 in March 2020 to 16,742,568 in April 2020, increased to 19,657,289 in October 2020, and decreased again to 15,821,914 during December 2020.

In a subgroup analysis, the decline in prescriptions was greater in children aged 0-9 years, compared with those aged 10-19 years. “Because young children have a higher rate of antibiotic use than older children, declines in antibiotic dispensing might affect overall dispensing totals to a greater degree in young children,” the researchers said.

The study findings were limited by several factors including the lack of information on clinical outcomes, disease severity, and details of new versus ongoing prescriptions, as well as the possible heterogeneity in indications within drug classes, and lack of data from small pharmacies, the researchers noted. However, the results were strengthened by the use of a national all-payer database that including most prescriptions dispensed in the United States, and the use of objective measurements of prescribing practices rather than self-reports.

Despite concerns for the decreased dispensing of chronic disease drugs to children during the pandemic, “declines in dispensing of infection-related drugs, such as antitussives and antibiotics, may be welcome developments,” the researchers said. “These declines reveal that substantial reductions in prescribing of these drugs are possible,” and ongoing monitoring is needed to follow whether the reductions continue long term.
 

COVID precautions contributed to prescription declines

The mask-wearing and social distancing imposed by the COVID-19 pandemic has contributed to reduced rates of other illnesses, Karalyn Kinsella, MD, a pediatrician in private practice in Cheshire, Conn., said in an interview.

“On the surface, with masks and social isolation, we have seen a drastic reduction in infectious disease,” she said. Fewer infections mean a reduced need for prescriptions to treat them. However, Dr. Kinsella expects the situation to change as more venues and activities open. “I expect that, as things continue to open, we will continue to see more infectious disease,” which will likely lead to more prescription drug use.

Part of the study data were provided through the IQVIA Institute’s Human Data Science Research Collaborative. Lead author Dr. Chua was supported by a career development award from the National Institute on Drug Abuse, but had no financial conflicts to disclose. Dr. Kinsella had no financial conflicts to disclose, but serves as a member of the Pediatric News editorial advisory board.

The amount of prescription drugs given to children in the United States decreased by 27.1% between April and December 2020, compared with the same period in 2019, based on data from a national database.

Overall, dispensing of prescription drugs to all patients in the United States decreased in the wake of COVID-19 but has since rebounded, wrote Kao-Ping Chua, MD, of the University of Michigan, Ann Arbor, and colleagues. “However, whether these same trends occurred for children is unknown.”

In a study published in Pediatrics, the researchers used the IQVIA National Prescription Audit, a database that contains monthly dispensing details from 92% of retail pharmacies in the United States. They compared changes in the dispensing of prescriptions with children aged 0-19 years during 2018-2020.

In the April 2020–December 2020 time period, prescriptions for children aged 1-2 years, 3-9 years, and 10-19 years decreased by 48.7%, 40.6%, and 16.8%, respectively, compared with the same time period in 2019.

The overall dispensing total for children from April 2020 to December 2020 was 160,630,406, representing a 27.1% reduction, compared with the 220,284,613 total from April 2019 to December 2019.

By drug class, prescriptions for antibiotics, ADHD medications, and antidepressants decreased by 55.6%, 11.8%, and 0.1%, respectively, in comparing the two time periods. Prescriptions for drug classes used typically for acute infections decreased by 51.3%, and those used for chronic diseases decreased by 17.4%.

From January 2018 to February 2020, a median of 25,744,758 prescriptions were dispensed to children aged 0-19 years each month. The total prescriptions decreased from 25,684,219 in March 2020 to 16,742,568 in April 2020, increased to 19,657,289 in October 2020, and decreased again to 15,821,914 during December 2020.

In a subgroup analysis, the decline in prescriptions was greater in children aged 0-9 years, compared with those aged 10-19 years. “Because young children have a higher rate of antibiotic use than older children, declines in antibiotic dispensing might affect overall dispensing totals to a greater degree in young children,” the researchers said.

The study findings were limited by several factors including the lack of information on clinical outcomes, disease severity, and details of new versus ongoing prescriptions, as well as the possible heterogeneity in indications within drug classes, and lack of data from small pharmacies, the researchers noted. However, the results were strengthened by the use of a national all-payer database that including most prescriptions dispensed in the United States, and the use of objective measurements of prescribing practices rather than self-reports.

Despite concerns for the decreased dispensing of chronic disease drugs to children during the pandemic, “declines in dispensing of infection-related drugs, such as antitussives and antibiotics, may be welcome developments,” the researchers said. “These declines reveal that substantial reductions in prescribing of these drugs are possible,” and ongoing monitoring is needed to follow whether the reductions continue long term.
 

COVID precautions contributed to prescription declines

The mask-wearing and social distancing imposed by the COVID-19 pandemic has contributed to reduced rates of other illnesses, Karalyn Kinsella, MD, a pediatrician in private practice in Cheshire, Conn., said in an interview.

“On the surface, with masks and social isolation, we have seen a drastic reduction in infectious disease,” she said. Fewer infections mean a reduced need for prescriptions to treat them. However, Dr. Kinsella expects the situation to change as more venues and activities open. “I expect that, as things continue to open, we will continue to see more infectious disease,” which will likely lead to more prescription drug use.

Part of the study data were provided through the IQVIA Institute’s Human Data Science Research Collaborative. Lead author Dr. Chua was supported by a career development award from the National Institute on Drug Abuse, but had no financial conflicts to disclose. Dr. Kinsella had no financial conflicts to disclose, but serves as a member of the Pediatric News editorial advisory board.

The amount of prescription drugs given to children in the United States decreased by 27.1% between April and December 2020, compared with the same period in 2019, based on data from a national database.

Overall, dispensing of prescription drugs to all patients in the United States decreased in the wake of COVID-19 but has since rebounded, wrote Kao-Ping Chua, MD, of the University of Michigan, Ann Arbor, and colleagues. “However, whether these same trends occurred for children is unknown.”

In a study published in Pediatrics, the researchers used the IQVIA National Prescription Audit, a database that contains monthly dispensing details from 92% of retail pharmacies in the United States. They compared changes in the dispensing of prescriptions with children aged 0-19 years during 2018-2020.

In the April 2020–December 2020 time period, prescriptions for children aged 1-2 years, 3-9 years, and 10-19 years decreased by 48.7%, 40.6%, and 16.8%, respectively, compared with the same time period in 2019.

The overall dispensing total for children from April 2020 to December 2020 was 160,630,406, representing a 27.1% reduction, compared with the 220,284,613 total from April 2019 to December 2019.

By drug class, prescriptions for antibiotics, ADHD medications, and antidepressants decreased by 55.6%, 11.8%, and 0.1%, respectively, in comparing the two time periods. Prescriptions for drug classes used typically for acute infections decreased by 51.3%, and those used for chronic diseases decreased by 17.4%.

From January 2018 to February 2020, a median of 25,744,758 prescriptions were dispensed to children aged 0-19 years each month. The total prescriptions decreased from 25,684,219 in March 2020 to 16,742,568 in April 2020, increased to 19,657,289 in October 2020, and decreased again to 15,821,914 during December 2020.

In a subgroup analysis, the decline in prescriptions was greater in children aged 0-9 years, compared with those aged 10-19 years. “Because young children have a higher rate of antibiotic use than older children, declines in antibiotic dispensing might affect overall dispensing totals to a greater degree in young children,” the researchers said.

The study findings were limited by several factors including the lack of information on clinical outcomes, disease severity, and details of new versus ongoing prescriptions, as well as the possible heterogeneity in indications within drug classes, and lack of data from small pharmacies, the researchers noted. However, the results were strengthened by the use of a national all-payer database that including most prescriptions dispensed in the United States, and the use of objective measurements of prescribing practices rather than self-reports.

Despite concerns for the decreased dispensing of chronic disease drugs to children during the pandemic, “declines in dispensing of infection-related drugs, such as antitussives and antibiotics, may be welcome developments,” the researchers said. “These declines reveal that substantial reductions in prescribing of these drugs are possible,” and ongoing monitoring is needed to follow whether the reductions continue long term.
 

COVID precautions contributed to prescription declines

The mask-wearing and social distancing imposed by the COVID-19 pandemic has contributed to reduced rates of other illnesses, Karalyn Kinsella, MD, a pediatrician in private practice in Cheshire, Conn., said in an interview.

“On the surface, with masks and social isolation, we have seen a drastic reduction in infectious disease,” she said. Fewer infections mean a reduced need for prescriptions to treat them. However, Dr. Kinsella expects the situation to change as more venues and activities open. “I expect that, as things continue to open, we will continue to see more infectious disease,” which will likely lead to more prescription drug use.

Part of the study data were provided through the IQVIA Institute’s Human Data Science Research Collaborative. Lead author Dr. Chua was supported by a career development award from the National Institute on Drug Abuse, but had no financial conflicts to disclose. Dr. Kinsella had no financial conflicts to disclose, but serves as a member of the Pediatric News editorial advisory board.

Black women undergoing hysterectomies were significantly more likely to be treated by low-volume surgeons than high-volume surgeons, and to experience perioperative complications as a result, based on data from more than 300,000 patients.

“Outcomes for hysterectomy, for both benign and malignant disease, are improved when the procedure is performed at high-volume hospitals and by high-volume surgeons,” Anne Knisely, MD, of Columbia University, New York, and colleagues wrote.

Historically, Black patients have been less likely to be referred to high-volume hospitals, the researchers noted. Recent efforts to regionalize surgical procedures to high-volume hospitals aim to reduce disparities and improve care for all patients, but the data on disparities in care within high-volume hospitals are limited, they said.

In a study published in Obstetrics & Gynecology, the researchers identified 300,586 women who underwent hysterectomy in New York state between 2000 and 2014. The researchers divided surgeons at these hospitals into volume groups based on average annual hysterectomy volume.

The women were treated by 5,505 surgeons at 59 hospitals. Overall, Black women comprised significantly more of the patients treated by low-volume surgeons compared with high-volume surgeons (19.4% vs. 14.3%; adjusted odds ratio, 1.26), and more women treated by low-volume surgeons had Medicare insurance compared with those treated by high-volume surgeons (20.6% vs. 14.5%; aOR, 1.22).

A majority of the patients (262,005 patients) were treated by a total of 1,377 high-volume surgeons, while 2,105 low-volume surgeons treated 2,900 patients. Abdominal hysterectomies accounted for 57.5% of the procedures, followed by laparoscopic (23.9%), vaginal (13.2%), and robotic assisted (5.3%). Approximately two-thirds (64.4%) of the patients were aged 40-59 years; 63.7% were White, 15.1% were Black, and 8.5% were Hispanic.

The overall complication rate was significantly higher in patients treated by low-volume surgeons, compared with high-volume surgeons (31.0% vs. 10.3%), including intraoperative complications, surgical-site complications, medical complications, and transfusions. The perioperative mortality rate also was significantly higher for patients of low-volume surgeons compared with high-volume surgeons (2.2% vs. 0.2%).

Low-volume surgeons were more likely to perform urgent or emergent procedures, compared with high-volume surgeons (26.1% vs 6.4%), and to perform abdominal hysterectomy versus minimally invasive hysterectomy compared with high-volume surgeons (77.8% vs. 54.7%), the researchers added.

The study findings were limited by several factors, including the observational design and possible undercoding of outcomes, inclusion only of New York state patients, lack of data on clinical characteristics such as surgical history and complexity, lack of data on surgeon characteristics, and changing practice patterns over time, the researchers noted.

However, “this study demonstrates increased perioperative morbidity and mortality for patients who underwent hysterectomy by low-volume surgeons, in comparison with high-volume surgeons, at high-volume hospitals,” and that Black patients were more likely to be treated by low-volume surgeons, they said. “Although centralization of complex surgical care to higher-volume hospitals may have benefit, there are additional surgeon-level factors that must be considered to address disparities in access to high-quality care for patients undergoing hysterectomy.”

Explore range of issues to improve access

“It is always beneficial to review morbidity and mortality statistics,” Constance Bohon, MD, a gynecologist in private practice in Washington, D.C., said in an interview. “With a heightened awareness of equity and equality, now is a good time to review the data with that focus in mind. Hospital committees review the data on a regular basis, but they may not have looked closely at demographics in the past.

“It was always my understanding that for many procedures, including surgery, volume impacts outcome, so the finding that low-volume surgeons had worse outcomes than high-volume surgeons was not particularly surprising,” said Dr. Bohon. However, the question of how hospitals might address disparities in access to high-volume surgeons “is a difficult question, because there are a variety of issues that may not be caused by disparities,” she added. “It may be that the high-volume surgeons do not take Medicare. It may be that some of the emergent/urgent surgeries come from patients seen in the ED and the high-volume surgeons may not take call or see new patients in the ED. There may be a difference in the preop testing done that may be more extensive with the high-volume surgeons as compared with the low-volume surgeons. It may be that it is easier to get an appointment with a low-volume rather than a high-volume surgeon.

“Additional research is needed to determine whether there is an algorithm that can be created to determine risk for morbidity or mortality based on factors such as the number of years in practice, the number of hysterectomies per year, and the age of the physician,” Dr. Bohon explained. “The patient data could include preexisting risk factors such as weight, preexisting medical conditions, prior surgeries, and current medications, along with demographics. It would be interesting to determine whether low-risk patients have similar outcomes with low- as compared with high-volume surgeons while high-risk patients do not. The demographics could then be evaluated to determine if disparities exist for both low- and high-risk patients.”

The study received no outside funding. One coauthor disclosed serving as a consultant for Clovis Oncology, receiving research funding from Merck, and receiving royalties from UpToDate. Lead author Dr. Knisely had no financial conflicts to disclose. Dr. Bohon had no financial conflicts to disclose, but serves on the Ob.Gyn. News editorial advisory board.

Black women undergoing hysterectomies were significantly more likely to be treated by low-volume surgeons than high-volume surgeons, and to experience perioperative complications as a result, based on data from more than 300,000 patients.

“Outcomes for hysterectomy, for both benign and malignant disease, are improved when the procedure is performed at high-volume hospitals and by high-volume surgeons,” Anne Knisely, MD, of Columbia University, New York, and colleagues wrote.

Historically, Black patients have been less likely to be referred to high-volume hospitals, the researchers noted. Recent efforts to regionalize surgical procedures to high-volume hospitals aim to reduce disparities and improve care for all patients, but the data on disparities in care within high-volume hospitals are limited, they said.

In a study published in Obstetrics & Gynecology, the researchers identified 300,586 women who underwent hysterectomy in New York state between 2000 and 2014. The researchers divided surgeons at these hospitals into volume groups based on average annual hysterectomy volume.

The women were treated by 5,505 surgeons at 59 hospitals. Overall, Black women comprised significantly more of the patients treated by low-volume surgeons compared with high-volume surgeons (19.4% vs. 14.3%; adjusted odds ratio, 1.26), and more women treated by low-volume surgeons had Medicare insurance compared with those treated by high-volume surgeons (20.6% vs. 14.5%; aOR, 1.22).

A majority of the patients (262,005 patients) were treated by a total of 1,377 high-volume surgeons, while 2,105 low-volume surgeons treated 2,900 patients. Abdominal hysterectomies accounted for 57.5% of the procedures, followed by laparoscopic (23.9%), vaginal (13.2%), and robotic assisted (5.3%). Approximately two-thirds (64.4%) of the patients were aged 40-59 years; 63.7% were White, 15.1% were Black, and 8.5% were Hispanic.

The overall complication rate was significantly higher in patients treated by low-volume surgeons, compared with high-volume surgeons (31.0% vs. 10.3%), including intraoperative complications, surgical-site complications, medical complications, and transfusions. The perioperative mortality rate also was significantly higher for patients of low-volume surgeons compared with high-volume surgeons (2.2% vs. 0.2%).

Low-volume surgeons were more likely to perform urgent or emergent procedures, compared with high-volume surgeons (26.1% vs 6.4%), and to perform abdominal hysterectomy versus minimally invasive hysterectomy compared with high-volume surgeons (77.8% vs. 54.7%), the researchers added.

The study findings were limited by several factors, including the observational design and possible undercoding of outcomes, inclusion only of New York state patients, lack of data on clinical characteristics such as surgical history and complexity, lack of data on surgeon characteristics, and changing practice patterns over time, the researchers noted.

However, “this study demonstrates increased perioperative morbidity and mortality for patients who underwent hysterectomy by low-volume surgeons, in comparison with high-volume surgeons, at high-volume hospitals,” and that Black patients were more likely to be treated by low-volume surgeons, they said. “Although centralization of complex surgical care to higher-volume hospitals may have benefit, there are additional surgeon-level factors that must be considered to address disparities in access to high-quality care for patients undergoing hysterectomy.”

Explore range of issues to improve access

“It is always beneficial to review morbidity and mortality statistics,” Constance Bohon, MD, a gynecologist in private practice in Washington, D.C., said in an interview. “With a heightened awareness of equity and equality, now is a good time to review the data with that focus in mind. Hospital committees review the data on a regular basis, but they may not have looked closely at demographics in the past.

“It was always my understanding that for many procedures, including surgery, volume impacts outcome, so the finding that low-volume surgeons had worse outcomes than high-volume surgeons was not particularly surprising,” said Dr. Bohon. However, the question of how hospitals might address disparities in access to high-volume surgeons “is a difficult question, because there are a variety of issues that may not be caused by disparities,” she added. “It may be that the high-volume surgeons do not take Medicare. It may be that some of the emergent/urgent surgeries come from patients seen in the ED and the high-volume surgeons may not take call or see new patients in the ED. There may be a difference in the preop testing done that may be more extensive with the high-volume surgeons as compared with the low-volume surgeons. It may be that it is easier to get an appointment with a low-volume rather than a high-volume surgeon.

“Additional research is needed to determine whether there is an algorithm that can be created to determine risk for morbidity or mortality based on factors such as the number of years in practice, the number of hysterectomies per year, and the age of the physician,” Dr. Bohon explained. “The patient data could include preexisting risk factors such as weight, preexisting medical conditions, prior surgeries, and current medications, along with demographics. It would be interesting to determine whether low-risk patients have similar outcomes with low- as compared with high-volume surgeons while high-risk patients do not. The demographics could then be evaluated to determine if disparities exist for both low- and high-risk patients.”

The study received no outside funding. One coauthor disclosed serving as a consultant for Clovis Oncology, receiving research funding from Merck, and receiving royalties from UpToDate. Lead author Dr. Knisely had no financial conflicts to disclose. Dr. Bohon had no financial conflicts to disclose, but serves on the Ob.Gyn. News editorial advisory board.

Black women undergoing hysterectomies were significantly more likely to be treated by low-volume surgeons than high-volume surgeons, and to experience perioperative complications as a result, based on data from more than 300,000 patients.

“Outcomes for hysterectomy, for both benign and malignant disease, are improved when the procedure is performed at high-volume hospitals and by high-volume surgeons,” Anne Knisely, MD, of Columbia University, New York, and colleagues wrote.

Historically, Black patients have been less likely to be referred to high-volume hospitals, the researchers noted. Recent efforts to regionalize surgical procedures to high-volume hospitals aim to reduce disparities and improve care for all patients, but the data on disparities in care within high-volume hospitals are limited, they said.

In a study published in Obstetrics & Gynecology, the researchers identified 300,586 women who underwent hysterectomy in New York state between 2000 and 2014. The researchers divided surgeons at these hospitals into volume groups based on average annual hysterectomy volume.

The women were treated by 5,505 surgeons at 59 hospitals. Overall, Black women comprised significantly more of the patients treated by low-volume surgeons compared with high-volume surgeons (19.4% vs. 14.3%; adjusted odds ratio, 1.26), and more women treated by low-volume surgeons had Medicare insurance compared with those treated by high-volume surgeons (20.6% vs. 14.5%; aOR, 1.22).

A majority of the patients (262,005 patients) were treated by a total of 1,377 high-volume surgeons, while 2,105 low-volume surgeons treated 2,900 patients. Abdominal hysterectomies accounted for 57.5% of the procedures, followed by laparoscopic (23.9%), vaginal (13.2%), and robotic assisted (5.3%). Approximately two-thirds (64.4%) of the patients were aged 40-59 years; 63.7% were White, 15.1% were Black, and 8.5% were Hispanic.

The overall complication rate was significantly higher in patients treated by low-volume surgeons, compared with high-volume surgeons (31.0% vs. 10.3%), including intraoperative complications, surgical-site complications, medical complications, and transfusions. The perioperative mortality rate also was significantly higher for patients of low-volume surgeons compared with high-volume surgeons (2.2% vs. 0.2%).

Low-volume surgeons were more likely to perform urgent or emergent procedures, compared with high-volume surgeons (26.1% vs 6.4%), and to perform abdominal hysterectomy versus minimally invasive hysterectomy compared with high-volume surgeons (77.8% vs. 54.7%), the researchers added.

The study findings were limited by several factors, including the observational design and possible undercoding of outcomes, inclusion only of New York state patients, lack of data on clinical characteristics such as surgical history and complexity, lack of data on surgeon characteristics, and changing practice patterns over time, the researchers noted.

However, “this study demonstrates increased perioperative morbidity and mortality for patients who underwent hysterectomy by low-volume surgeons, in comparison with high-volume surgeons, at high-volume hospitals,” and that Black patients were more likely to be treated by low-volume surgeons, they said. “Although centralization of complex surgical care to higher-volume hospitals may have benefit, there are additional surgeon-level factors that must be considered to address disparities in access to high-quality care for patients undergoing hysterectomy.”

Explore range of issues to improve access

“It is always beneficial to review morbidity and mortality statistics,” Constance Bohon, MD, a gynecologist in private practice in Washington, D.C., said in an interview. “With a heightened awareness of equity and equality, now is a good time to review the data with that focus in mind. Hospital committees review the data on a regular basis, but they may not have looked closely at demographics in the past.

“It was always my understanding that for many procedures, including surgery, volume impacts outcome, so the finding that low-volume surgeons had worse outcomes than high-volume surgeons was not particularly surprising,” said Dr. Bohon. However, the question of how hospitals might address disparities in access to high-volume surgeons “is a difficult question, because there are a variety of issues that may not be caused by disparities,” she added. “It may be that the high-volume surgeons do not take Medicare. It may be that some of the emergent/urgent surgeries come from patients seen in the ED and the high-volume surgeons may not take call or see new patients in the ED. There may be a difference in the preop testing done that may be more extensive with the high-volume surgeons as compared with the low-volume surgeons. It may be that it is easier to get an appointment with a low-volume rather than a high-volume surgeon.

“Additional research is needed to determine whether there is an algorithm that can be created to determine risk for morbidity or mortality based on factors such as the number of years in practice, the number of hysterectomies per year, and the age of the physician,” Dr. Bohon explained. “The patient data could include preexisting risk factors such as weight, preexisting medical conditions, prior surgeries, and current medications, along with demographics. It would be interesting to determine whether low-risk patients have similar outcomes with low- as compared with high-volume surgeons while high-risk patients do not. The demographics could then be evaluated to determine if disparities exist for both low- and high-risk patients.”

The study received no outside funding. One coauthor disclosed serving as a consultant for Clovis Oncology, receiving research funding from Merck, and receiving royalties from UpToDate. Lead author Dr. Knisely had no financial conflicts to disclose. Dr. Bohon had no financial conflicts to disclose, but serves on the Ob.Gyn. News editorial advisory board.