A new blood test performed in the second trimester could help identify pregnancies at risk of early and very early spontaneous preterm birth (sPTB), based on a prospective cohort trial.

The cell-free RNA (cfRNA) profiling tool could guide patient and provider decision-making, while the underlying research illuminates biological pathways that may facilitate novel interventions, reported lead author Joan Camunas-Soler, PhD, of Mirvie, South San Francisco, and colleagues.

“Given the complex etiology of this heterogeneous syndrome, it would be advantageous to develop predictive tests that provide insight on the specific pathophysiology leading to preterm birth for each particular pregnancy,” Dr. Camunas-Soler and colleagues wrote in the American Journal of Obstetrics and Gynecology. “Such an approach could inform the development of preventive treatments and targeted therapeutics that are currently lacking/difficult to implement due to the heterogeneous etiology of sPTB.”

Currently, the best predictor of sPTB is previous sPTB, according to the investigators. Although a combination approach that incorporates cervical length and fetal fibronectin in cervicovaginal fluid is “of use,” they noted, “this is not standard of care in the U.S.A. nor recommended by the American College of Obstetricians and Gynecologists or the Society for Maternal-Fetal Medicine.” Existing molecular tests lack clinical data and may be inaccurate across diverse patient populations, they added.

The present study aimed to address these shortcomings by creating a second-trimester blood test for predicting sPTB. To identify relevant biomarkers, the investigators compared RNA profiles that were differentially expressed in three types of cases: term birth, early sPTB, and very early sPTB.

Among 242 women who contributed second-trimester blood samples for analysis, 194 went on to have a term birth. Of the remaining 48 women who gave birth spontaneously before 35 weeks’ gestation, 32 delivered between 25 and 35 weeks (early sPTB), while 16 delivered before 25 weeks’ gestation (very early sPTB). Slightly more than half of the patients were White, about one-third were Black, approximately 10% were Asian, and the remainder were of unknown race/ethnicity. Cases of preeclampsia were excluded.

The gene discovery and modeling process revealed 25 distinct genes that were significantly associated with early sPTB, offering a risk model with a sensitivity of 76% and a specificity of 72% (area under the curve, 0.80; 95% confidence interval, 0.72-0.87). Very early sPTB was associated with a set of 39 genes, giving a model with a sensitivity of 64% and a specificity of 80% (area under the curve = 0.76; 95% CI, 0.63-0.87).

Characterization of the two RNA profiles offered a glimpse into the underlying biological processes driving preterm birth. The genes predicting early sPTB are largely responsible for extracellular matrix degradation and remodeling, which could, “in terms of mechanism, reflect ongoing processes associated with cervical shortening, a feature often detected some weeks prior to sPTB,” the investigators wrote. In contrast, genes associated with very early sPTB are linked with insulinlike growth factor transport, which drives fetal growth and placentation. These findings could lead to development of pathway-specific interventions, Dr. Camunas-Soler and colleagues suggested.

According to coauthor Michal A. Elovitz, MD, the Hilarie L. Morgan and Mitchell L. Morgan President’s Distinguished Professor in Women’s Health at the University of Pennsylvania, Philadelphia, and chief medical advisor at Mirvie, the proprietary RNA platform moves beyond “unreliable and at times biased clinical factors such as race, BMI, and maternal age” to offer a “precision-based approach to pregnancy health.”

Excluding traditional risk factors also “promises more equitable care than the use of broad sociodemographic factors that often result in bias,” she added, noting that this may help address the higher rate of pregnancy complications among Black patients.

When asked about the potential for false-positive results, considering reported specificity rates of 72%-80%, Dr. Elovitz suggested that such concerns among pregnant women are an “unfortunate misconception.”

“It is not reflective of what women want regarding knowledge about the health of their pregnancy,” she said in a written comment. “Rather than be left in the dark, women want to be prepared for what is to come in their pregnancy journey.”

In support of this statement, Dr. Elovitz cited a recent study involving women with preeclampsia and other hypertensive disorders in pregnancy. A questionnaire showed that women appreciated pregnancy risk models when making decisions, and reported that they would have greater peace of mind if such tests were available.

*This story was updated on 4/26/2022. 

A new blood test performed in the second trimester could help identify pregnancies at risk of early and very early spontaneous preterm birth (sPTB), based on a prospective cohort trial.

The cell-free RNA (cfRNA) profiling tool could guide patient and provider decision-making, while the underlying research illuminates biological pathways that may facilitate novel interventions, reported lead author Joan Camunas-Soler, PhD, of Mirvie, South San Francisco, and colleagues.

“Given the complex etiology of this heterogeneous syndrome, it would be advantageous to develop predictive tests that provide insight on the specific pathophysiology leading to preterm birth for each particular pregnancy,” Dr. Camunas-Soler and colleagues wrote in the American Journal of Obstetrics and Gynecology. “Such an approach could inform the development of preventive treatments and targeted therapeutics that are currently lacking/difficult to implement due to the heterogeneous etiology of sPTB.”

Currently, the best predictor of sPTB is previous sPTB, according to the investigators. Although a combination approach that incorporates cervical length and fetal fibronectin in cervicovaginal fluid is “of use,” they noted, “this is not standard of care in the U.S.A. nor recommended by the American College of Obstetricians and Gynecologists or the Society for Maternal-Fetal Medicine.” Existing molecular tests lack clinical data and may be inaccurate across diverse patient populations, they added.

The present study aimed to address these shortcomings by creating a second-trimester blood test for predicting sPTB. To identify relevant biomarkers, the investigators compared RNA profiles that were differentially expressed in three types of cases: term birth, early sPTB, and very early sPTB.

Among 242 women who contributed second-trimester blood samples for analysis, 194 went on to have a term birth. Of the remaining 48 women who gave birth spontaneously before 35 weeks’ gestation, 32 delivered between 25 and 35 weeks (early sPTB), while 16 delivered before 25 weeks’ gestation (very early sPTB). Slightly more than half of the patients were White, about one-third were Black, approximately 10% were Asian, and the remainder were of unknown race/ethnicity. Cases of preeclampsia were excluded.

The gene discovery and modeling process revealed 25 distinct genes that were significantly associated with early sPTB, offering a risk model with a sensitivity of 76% and a specificity of 72% (area under the curve, 0.80; 95% confidence interval, 0.72-0.87). Very early sPTB was associated with a set of 39 genes, giving a model with a sensitivity of 64% and a specificity of 80% (area under the curve = 0.76; 95% CI, 0.63-0.87).

Characterization of the two RNA profiles offered a glimpse into the underlying biological processes driving preterm birth. The genes predicting early sPTB are largely responsible for extracellular matrix degradation and remodeling, which could, “in terms of mechanism, reflect ongoing processes associated with cervical shortening, a feature often detected some weeks prior to sPTB,” the investigators wrote. In contrast, genes associated with very early sPTB are linked with insulinlike growth factor transport, which drives fetal growth and placentation. These findings could lead to development of pathway-specific interventions, Dr. Camunas-Soler and colleagues suggested.

According to coauthor Michal A. Elovitz, MD, the Hilarie L. Morgan and Mitchell L. Morgan President’s Distinguished Professor in Women’s Health at the University of Pennsylvania, Philadelphia, and chief medical advisor at Mirvie, the proprietary RNA platform moves beyond “unreliable and at times biased clinical factors such as race, BMI, and maternal age” to offer a “precision-based approach to pregnancy health.”

Excluding traditional risk factors also “promises more equitable care than the use of broad sociodemographic factors that often result in bias,” she added, noting that this may help address the higher rate of pregnancy complications among Black patients.

When asked about the potential for false-positive results, considering reported specificity rates of 72%-80%, Dr. Elovitz suggested that such concerns among pregnant women are an “unfortunate misconception.”

“It is not reflective of what women want regarding knowledge about the health of their pregnancy,” she said in a written comment. “Rather than be left in the dark, women want to be prepared for what is to come in their pregnancy journey.”

In support of this statement, Dr. Elovitz cited a recent study involving women with preeclampsia and other hypertensive disorders in pregnancy. A questionnaire showed that women appreciated pregnancy risk models when making decisions, and reported that they would have greater peace of mind if such tests were available.

*This story was updated on 4/26/2022. 

A new blood test performed in the second trimester could help identify pregnancies at risk of early and very early spontaneous preterm birth (sPTB), based on a prospective cohort trial.

The cell-free RNA (cfRNA) profiling tool could guide patient and provider decision-making, while the underlying research illuminates biological pathways that may facilitate novel interventions, reported lead author Joan Camunas-Soler, PhD, of Mirvie, South San Francisco, and colleagues.

“Given the complex etiology of this heterogeneous syndrome, it would be advantageous to develop predictive tests that provide insight on the specific pathophysiology leading to preterm birth for each particular pregnancy,” Dr. Camunas-Soler and colleagues wrote in the American Journal of Obstetrics and Gynecology. “Such an approach could inform the development of preventive treatments and targeted therapeutics that are currently lacking/difficult to implement due to the heterogeneous etiology of sPTB.”

Currently, the best predictor of sPTB is previous sPTB, according to the investigators. Although a combination approach that incorporates cervical length and fetal fibronectin in cervicovaginal fluid is “of use,” they noted, “this is not standard of care in the U.S.A. nor recommended by the American College of Obstetricians and Gynecologists or the Society for Maternal-Fetal Medicine.” Existing molecular tests lack clinical data and may be inaccurate across diverse patient populations, they added.

The present study aimed to address these shortcomings by creating a second-trimester blood test for predicting sPTB. To identify relevant biomarkers, the investigators compared RNA profiles that were differentially expressed in three types of cases: term birth, early sPTB, and very early sPTB.

Among 242 women who contributed second-trimester blood samples for analysis, 194 went on to have a term birth. Of the remaining 48 women who gave birth spontaneously before 35 weeks’ gestation, 32 delivered between 25 and 35 weeks (early sPTB), while 16 delivered before 25 weeks’ gestation (very early sPTB). Slightly more than half of the patients were White, about one-third were Black, approximately 10% were Asian, and the remainder were of unknown race/ethnicity. Cases of preeclampsia were excluded.

The gene discovery and modeling process revealed 25 distinct genes that were significantly associated with early sPTB, offering a risk model with a sensitivity of 76% and a specificity of 72% (area under the curve, 0.80; 95% confidence interval, 0.72-0.87). Very early sPTB was associated with a set of 39 genes, giving a model with a sensitivity of 64% and a specificity of 80% (area under the curve = 0.76; 95% CI, 0.63-0.87).

Characterization of the two RNA profiles offered a glimpse into the underlying biological processes driving preterm birth. The genes predicting early sPTB are largely responsible for extracellular matrix degradation and remodeling, which could, “in terms of mechanism, reflect ongoing processes associated with cervical shortening, a feature often detected some weeks prior to sPTB,” the investigators wrote. In contrast, genes associated with very early sPTB are linked with insulinlike growth factor transport, which drives fetal growth and placentation. These findings could lead to development of pathway-specific interventions, Dr. Camunas-Soler and colleagues suggested.

According to coauthor Michal A. Elovitz, MD, the Hilarie L. Morgan and Mitchell L. Morgan President’s Distinguished Professor in Women’s Health at the University of Pennsylvania, Philadelphia, and chief medical advisor at Mirvie, the proprietary RNA platform moves beyond “unreliable and at times biased clinical factors such as race, BMI, and maternal age” to offer a “precision-based approach to pregnancy health.”

Excluding traditional risk factors also “promises more equitable care than the use of broad sociodemographic factors that often result in bias,” she added, noting that this may help address the higher rate of pregnancy complications among Black patients.

When asked about the potential for false-positive results, considering reported specificity rates of 72%-80%, Dr. Elovitz suggested that such concerns among pregnant women are an “unfortunate misconception.”

“It is not reflective of what women want regarding knowledge about the health of their pregnancy,” she said in a written comment. “Rather than be left in the dark, women want to be prepared for what is to come in their pregnancy journey.”

In support of this statement, Dr. Elovitz cited a recent study involving women with preeclampsia and other hypertensive disorders in pregnancy. A questionnaire showed that women appreciated pregnancy risk models when making decisions, and reported that they would have greater peace of mind if such tests were available.

*This story was updated on 4/26/2022. 

Treatment with deep brain stimulation improved motor function and quality of life, but depression scores increased after 1 year, based on data from 20 adults.

Subthalamic nucleus deep brain stimulation (STN-DBS) has emerged as an effective treatment for Parkinson’s disease symptoms, with evidence supporting improved motor symptoms and quality of life, wrote Francesca Mameli, PsyD, of Foundation IRCCS Ca’ Granda Ospedale Maggiore Policlinico, Milan, and colleagues.

Maggiore Policlinico Hospital of Milan

However, the effect of STN-DBS on personality in Parkinson’s disease (PD) has not been well investigated they said.

In a study published in Neuromodulation, the researchers reviewed data from 12 women and 8 men with PD who underwent bilateral STN-DBS.

Depression was assessed via the Montgomery-Asberg Depressive Rating Scale (MADRS), personality characteristics were assessed via the Minnesota Multiphasic Personality Inventory–2 (MMPI-2), and motor disabilities were assessed via UPDRS-III-Motor. The motor disabilities score was obtained in medication on and medication off conditions; the off condition followed a 12-hour overnight withdrawal of dopaminergic medication. Quality of life was assessed via the Parkinson’s Disease Questionnaire–8 (PDQ-8).

After 12 months, scores on the MMPI-2 were significantly higher on the D subscale, increased from a baseline mean of 56.05 to a 12-month mean of 61.90 (P = .015).

Other MMPI-2 scales showing significant increases included the DEP scale, LSE scale, WRK scale, and TRT scale. No differences appeared between male and female patients.

No significant changes occurred from pre-DBS baseline to the 12-month follow-up in MADRS scale assessment, with mean scores of 8.18 and 9.22, respectively.

A 40% improvement in UPDRS measures of motor function occurred among patients in the “medication-off” condition, although there was no significant change following DBS in the medication-on condition, the researchers said. Among 18 patients with PDQ-8 assessments, quality of life scores were significantly higher at 12 months’ post DBS compared to baseline pre DBS (40.15 vs. 30.73, P = .011).

The researchers also examined the relationship between the total electrical energy delivered (TEED) and the occurrence of personality trait shift. In the TEED analysis, “only the energy on the right side was inversely correlated with the changes in depression,” they wrote.

“Because of the complexity of psychiatric phenomena, it would be advisable to take a cautious approach by including psychiatric evaluation by interview for a better selection of patients who score close to the pathological cutoffs in MADRS and MMPI-2,” the researchers wrote in their discussion.

The study findings were limited by several factors including the small sample size, lack of data on the prevalence and severity of apathy, the use of scales based on self-reports, and inability to control for all factors that might affect depressive traits, the researchers noted. In addition, more research is needed to explore the correlation between TEED and personality trait changes, they said.

However, the results support the value of DBS in PD, but emphasize the need to manage expectations, they emphasized. “Expectations should never be unrealistic, and the caring team should ensure not only that patients fully understand the risks and potential benefits of the DBS but also that it will not stop the neurodegenerative progression of the disease,” they said.

The study was supported in part by the Italian Ministry of Health. The researchers had no financial conflicts to disclose.

Treatment with deep brain stimulation improved motor function and quality of life, but depression scores increased after 1 year, based on data from 20 adults.

Subthalamic nucleus deep brain stimulation (STN-DBS) has emerged as an effective treatment for Parkinson’s disease symptoms, with evidence supporting improved motor symptoms and quality of life, wrote Francesca Mameli, PsyD, of Foundation IRCCS Ca’ Granda Ospedale Maggiore Policlinico, Milan, and colleagues.

Maggiore Policlinico Hospital of Milan

However, the effect of STN-DBS on personality in Parkinson’s disease (PD) has not been well investigated they said.

In a study published in Neuromodulation, the researchers reviewed data from 12 women and 8 men with PD who underwent bilateral STN-DBS.

Depression was assessed via the Montgomery-Asberg Depressive Rating Scale (MADRS), personality characteristics were assessed via the Minnesota Multiphasic Personality Inventory–2 (MMPI-2), and motor disabilities were assessed via UPDRS-III-Motor. The motor disabilities score was obtained in medication on and medication off conditions; the off condition followed a 12-hour overnight withdrawal of dopaminergic medication. Quality of life was assessed via the Parkinson’s Disease Questionnaire–8 (PDQ-8).

After 12 months, scores on the MMPI-2 were significantly higher on the D subscale, increased from a baseline mean of 56.05 to a 12-month mean of 61.90 (P = .015).

Other MMPI-2 scales showing significant increases included the DEP scale, LSE scale, WRK scale, and TRT scale. No differences appeared between male and female patients.

No significant changes occurred from pre-DBS baseline to the 12-month follow-up in MADRS scale assessment, with mean scores of 8.18 and 9.22, respectively.

A 40% improvement in UPDRS measures of motor function occurred among patients in the “medication-off” condition, although there was no significant change following DBS in the medication-on condition, the researchers said. Among 18 patients with PDQ-8 assessments, quality of life scores were significantly higher at 12 months’ post DBS compared to baseline pre DBS (40.15 vs. 30.73, P = .011).

The researchers also examined the relationship between the total electrical energy delivered (TEED) and the occurrence of personality trait shift. In the TEED analysis, “only the energy on the right side was inversely correlated with the changes in depression,” they wrote.

“Because of the complexity of psychiatric phenomena, it would be advisable to take a cautious approach by including psychiatric evaluation by interview for a better selection of patients who score close to the pathological cutoffs in MADRS and MMPI-2,” the researchers wrote in their discussion.

The study findings were limited by several factors including the small sample size, lack of data on the prevalence and severity of apathy, the use of scales based on self-reports, and inability to control for all factors that might affect depressive traits, the researchers noted. In addition, more research is needed to explore the correlation between TEED and personality trait changes, they said.

However, the results support the value of DBS in PD, but emphasize the need to manage expectations, they emphasized. “Expectations should never be unrealistic, and the caring team should ensure not only that patients fully understand the risks and potential benefits of the DBS but also that it will not stop the neurodegenerative progression of the disease,” they said.

The study was supported in part by the Italian Ministry of Health. The researchers had no financial conflicts to disclose.

Treatment with deep brain stimulation improved motor function and quality of life, but depression scores increased after 1 year, based on data from 20 adults.

Subthalamic nucleus deep brain stimulation (STN-DBS) has emerged as an effective treatment for Parkinson’s disease symptoms, with evidence supporting improved motor symptoms and quality of life, wrote Francesca Mameli, PsyD, of Foundation IRCCS Ca’ Granda Ospedale Maggiore Policlinico, Milan, and colleagues.

Maggiore Policlinico Hospital of Milan

However, the effect of STN-DBS on personality in Parkinson’s disease (PD) has not been well investigated they said.

In a study published in Neuromodulation, the researchers reviewed data from 12 women and 8 men with PD who underwent bilateral STN-DBS.

Depression was assessed via the Montgomery-Asberg Depressive Rating Scale (MADRS), personality characteristics were assessed via the Minnesota Multiphasic Personality Inventory–2 (MMPI-2), and motor disabilities were assessed via UPDRS-III-Motor. The motor disabilities score was obtained in medication on and medication off conditions; the off condition followed a 12-hour overnight withdrawal of dopaminergic medication. Quality of life was assessed via the Parkinson’s Disease Questionnaire–8 (PDQ-8).

After 12 months, scores on the MMPI-2 were significantly higher on the D subscale, increased from a baseline mean of 56.05 to a 12-month mean of 61.90 (P = .015).

Other MMPI-2 scales showing significant increases included the DEP scale, LSE scale, WRK scale, and TRT scale. No differences appeared between male and female patients.

No significant changes occurred from pre-DBS baseline to the 12-month follow-up in MADRS scale assessment, with mean scores of 8.18 and 9.22, respectively.

A 40% improvement in UPDRS measures of motor function occurred among patients in the “medication-off” condition, although there was no significant change following DBS in the medication-on condition, the researchers said. Among 18 patients with PDQ-8 assessments, quality of life scores were significantly higher at 12 months’ post DBS compared to baseline pre DBS (40.15 vs. 30.73, P = .011).

The researchers also examined the relationship between the total electrical energy delivered (TEED) and the occurrence of personality trait shift. In the TEED analysis, “only the energy on the right side was inversely correlated with the changes in depression,” they wrote.

“Because of the complexity of psychiatric phenomena, it would be advisable to take a cautious approach by including psychiatric evaluation by interview for a better selection of patients who score close to the pathological cutoffs in MADRS and MMPI-2,” the researchers wrote in their discussion.

The study findings were limited by several factors including the small sample size, lack of data on the prevalence and severity of apathy, the use of scales based on self-reports, and inability to control for all factors that might affect depressive traits, the researchers noted. In addition, more research is needed to explore the correlation between TEED and personality trait changes, they said.

However, the results support the value of DBS in PD, but emphasize the need to manage expectations, they emphasized. “Expectations should never be unrealistic, and the caring team should ensure not only that patients fully understand the risks and potential benefits of the DBS but also that it will not stop the neurodegenerative progression of the disease,” they said.

The study was supported in part by the Italian Ministry of Health. The researchers had no financial conflicts to disclose.

Hospital admission for children with eating disorders approximately tripled during the COVID-19 pandemic, based on data from 85 patients.

Eating disorders are common among adolescents and often require hospital admission for nutritional restoration, according to May Shum of Yale University, New Haven, Conn., and colleagues

During the COVID-19 pandemic, the volume of hospital admissions for adolescents with eating disorders has increased, the researchers wrote in a poster presented at the annual meeting of the Pediatric Academic Societies. This increase may be driven both by interruptions in medical care and increased psychological distress, but data on changes in patient characteristics and hospitalization course are lacking, they said.

The researchers reviewed charts from patients with eating disorders admitted to a single center between Jan. 1, 2017, and June 30, 2021. The majority of the patients were female (90.6%), and White (78.8%), had restrictive eating behaviors (97.2%), and had private insurance (80.0%).

Overall, the number of monthly admissions increased from 1.4 before the onset of the pandemic to 3.6 during the pandemic (P < .001).

Length of stay increased significantly from before to during pandemic cases (12.8 days vs. 17.3 days, P = .04) and age younger than 13 years was significantly associated with a longer length of stay (P < .001).

The number of patients for whom psychotropic medications were initiated or changed increased significantly (12.5% vs. 28.3%, P = .04); as did the proportion of patients discharged to partial hospitalization, residential, or inpatient psychiatric treatment rather than discharged home with outpatient therapy (56.2% vs. 75.0%, P = .04).

No significant differences were noted in demographics, comorbidities, admission parameters, EKG abnormalities, electrolyte repletion, or tube feeding.

The study findings were limited by the use of data from a single center. However, the results suggest an increase in severity of hospital admissions that have implications for use of hospital resources, the researchers said.

“In addition to an increase in hospital admissions for eating disorder management during the pandemic, longer inpatient stays of younger children with higher acuity at discharge is an added strain on hospital resources and warrants attention,” they concluded.
 

Considerations for younger patients

The current study is especially important at this time, Margaret Thew, DNP, FNP-BC, medical director of the department of adolescent medicine at Children’s Wisconsin in Milwaukee, said in an interview. “There have been reports of the rising numbers in eating disorders, but until research has been conducted, we cannot quantify the volumes,” said Ms. Thew, who was not involved in the study. “There have been many reports of the rise in mental health issues during the pandemic, so it seems accurate that the rate of eating disorders would rise,” she said. “Additionally, from a clinical perspective there seemed to be many younger-age patients with eating disorders presenting to the inpatient units who seemed sicker,” she noted.

Ms. Thew said she was not surprised by the study findings. “Working with adolescents with eating disorders we saw the increased numbers of both hospitalizations and outpatient referrals during the pandemic,” said Ms. Thew. “Length of stay was higher across the nation regarding admissions for concerns of eating disorders. These patients are sicker and fewer went home after medical stabilization,” she emphasized.

“Clinicians should be more aware of the rise in patients presenting with eating disorders at younger ages to their clinics and provide early interventions to prevent severe illness and medical instability,” said Ms. Thew. Clinicians also should be more proactive in managing younger children and adolescents who express mood disorders, disordered eating, or weight loss, given the significant rise in eating disorders and mental health concerns, she said.  

Additional research is needed to continue following the rate of eating disorders into 2022, said Ms. Thew. More research is needed on early interventions and recognition of eating disorders for preteens and teens to prevent severe illness, as is research on how the younger patient with an eating disorder may present differently to the primary care doctor or emergency department, she said.

“We may need to study treatment of the younger population, as they may not do as well with admissions into behavioral health facilities,” Ms. Thew added.

The study received no outside funding. The researchers had no financial conflicts to disclose. Ms. Thew had no financial conflicts to disclose and serves on the editorial advisory board of Pediatric News.

Hospital admission for children with eating disorders approximately tripled during the COVID-19 pandemic, based on data from 85 patients.

Eating disorders are common among adolescents and often require hospital admission for nutritional restoration, according to May Shum of Yale University, New Haven, Conn., and colleagues

During the COVID-19 pandemic, the volume of hospital admissions for adolescents with eating disorders has increased, the researchers wrote in a poster presented at the annual meeting of the Pediatric Academic Societies. This increase may be driven both by interruptions in medical care and increased psychological distress, but data on changes in patient characteristics and hospitalization course are lacking, they said.

The researchers reviewed charts from patients with eating disorders admitted to a single center between Jan. 1, 2017, and June 30, 2021. The majority of the patients were female (90.6%), and White (78.8%), had restrictive eating behaviors (97.2%), and had private insurance (80.0%).

Overall, the number of monthly admissions increased from 1.4 before the onset of the pandemic to 3.6 during the pandemic (P < .001).

Length of stay increased significantly from before to during pandemic cases (12.8 days vs. 17.3 days, P = .04) and age younger than 13 years was significantly associated with a longer length of stay (P < .001).

The number of patients for whom psychotropic medications were initiated or changed increased significantly (12.5% vs. 28.3%, P = .04); as did the proportion of patients discharged to partial hospitalization, residential, or inpatient psychiatric treatment rather than discharged home with outpatient therapy (56.2% vs. 75.0%, P = .04).

No significant differences were noted in demographics, comorbidities, admission parameters, EKG abnormalities, electrolyte repletion, or tube feeding.

The study findings were limited by the use of data from a single center. However, the results suggest an increase in severity of hospital admissions that have implications for use of hospital resources, the researchers said.

“In addition to an increase in hospital admissions for eating disorder management during the pandemic, longer inpatient stays of younger children with higher acuity at discharge is an added strain on hospital resources and warrants attention,” they concluded.
 

Considerations for younger patients

The current study is especially important at this time, Margaret Thew, DNP, FNP-BC, medical director of the department of adolescent medicine at Children’s Wisconsin in Milwaukee, said in an interview. “There have been reports of the rising numbers in eating disorders, but until research has been conducted, we cannot quantify the volumes,” said Ms. Thew, who was not involved in the study. “There have been many reports of the rise in mental health issues during the pandemic, so it seems accurate that the rate of eating disorders would rise,” she said. “Additionally, from a clinical perspective there seemed to be many younger-age patients with eating disorders presenting to the inpatient units who seemed sicker,” she noted.

Ms. Thew said she was not surprised by the study findings. “Working with adolescents with eating disorders we saw the increased numbers of both hospitalizations and outpatient referrals during the pandemic,” said Ms. Thew. “Length of stay was higher across the nation regarding admissions for concerns of eating disorders. These patients are sicker and fewer went home after medical stabilization,” she emphasized.

“Clinicians should be more aware of the rise in patients presenting with eating disorders at younger ages to their clinics and provide early interventions to prevent severe illness and medical instability,” said Ms. Thew. Clinicians also should be more proactive in managing younger children and adolescents who express mood disorders, disordered eating, or weight loss, given the significant rise in eating disorders and mental health concerns, she said.  

Additional research is needed to continue following the rate of eating disorders into 2022, said Ms. Thew. More research is needed on early interventions and recognition of eating disorders for preteens and teens to prevent severe illness, as is research on how the younger patient with an eating disorder may present differently to the primary care doctor or emergency department, she said.

“We may need to study treatment of the younger population, as they may not do as well with admissions into behavioral health facilities,” Ms. Thew added.

The study received no outside funding. The researchers had no financial conflicts to disclose. Ms. Thew had no financial conflicts to disclose and serves on the editorial advisory board of Pediatric News.

Hospital admission for children with eating disorders approximately tripled during the COVID-19 pandemic, based on data from 85 patients.

Eating disorders are common among adolescents and often require hospital admission for nutritional restoration, according to May Shum of Yale University, New Haven, Conn., and colleagues

During the COVID-19 pandemic, the volume of hospital admissions for adolescents with eating disorders has increased, the researchers wrote in a poster presented at the annual meeting of the Pediatric Academic Societies. This increase may be driven both by interruptions in medical care and increased psychological distress, but data on changes in patient characteristics and hospitalization course are lacking, they said.

The researchers reviewed charts from patients with eating disorders admitted to a single center between Jan. 1, 2017, and June 30, 2021. The majority of the patients were female (90.6%), and White (78.8%), had restrictive eating behaviors (97.2%), and had private insurance (80.0%).

Overall, the number of monthly admissions increased from 1.4 before the onset of the pandemic to 3.6 during the pandemic (P < .001).

Length of stay increased significantly from before to during pandemic cases (12.8 days vs. 17.3 days, P = .04) and age younger than 13 years was significantly associated with a longer length of stay (P < .001).

The number of patients for whom psychotropic medications were initiated or changed increased significantly (12.5% vs. 28.3%, P = .04); as did the proportion of patients discharged to partial hospitalization, residential, or inpatient psychiatric treatment rather than discharged home with outpatient therapy (56.2% vs. 75.0%, P = .04).

No significant differences were noted in demographics, comorbidities, admission parameters, EKG abnormalities, electrolyte repletion, or tube feeding.

The study findings were limited by the use of data from a single center. However, the results suggest an increase in severity of hospital admissions that have implications for use of hospital resources, the researchers said.

“In addition to an increase in hospital admissions for eating disorder management during the pandemic, longer inpatient stays of younger children with higher acuity at discharge is an added strain on hospital resources and warrants attention,” they concluded.
 

Considerations for younger patients

The current study is especially important at this time, Margaret Thew, DNP, FNP-BC, medical director of the department of adolescent medicine at Children’s Wisconsin in Milwaukee, said in an interview. “There have been reports of the rising numbers in eating disorders, but until research has been conducted, we cannot quantify the volumes,” said Ms. Thew, who was not involved in the study. “There have been many reports of the rise in mental health issues during the pandemic, so it seems accurate that the rate of eating disorders would rise,” she said. “Additionally, from a clinical perspective there seemed to be many younger-age patients with eating disorders presenting to the inpatient units who seemed sicker,” she noted.

Ms. Thew said she was not surprised by the study findings. “Working with adolescents with eating disorders we saw the increased numbers of both hospitalizations and outpatient referrals during the pandemic,” said Ms. Thew. “Length of stay was higher across the nation regarding admissions for concerns of eating disorders. These patients are sicker and fewer went home after medical stabilization,” she emphasized.

“Clinicians should be more aware of the rise in patients presenting with eating disorders at younger ages to their clinics and provide early interventions to prevent severe illness and medical instability,” said Ms. Thew. Clinicians also should be more proactive in managing younger children and adolescents who express mood disorders, disordered eating, or weight loss, given the significant rise in eating disorders and mental health concerns, she said.  

Additional research is needed to continue following the rate of eating disorders into 2022, said Ms. Thew. More research is needed on early interventions and recognition of eating disorders for preteens and teens to prevent severe illness, as is research on how the younger patient with an eating disorder may present differently to the primary care doctor or emergency department, she said.

“We may need to study treatment of the younger population, as they may not do as well with admissions into behavioral health facilities,” Ms. Thew added.

The study received no outside funding. The researchers had no financial conflicts to disclose. Ms. Thew had no financial conflicts to disclose and serves on the editorial advisory board of Pediatric News.

Elementary schools that provide easy access to drinking water and education about its benefits may help their students maintain a healthy weight, a new study found.

Researchers examined the health and drinking habits of 1,249 children in 26 low-income, ethnically diverse elementary schools in the San Francisco Bay Area. In half of the schools, water stations were placed throughout, along with signs explaining why water is healthier than sugary drinks. In addition, assemblies were held explaining the advantages of water over sugary drinks.

That simple message seemed to have had an outsized effect. Schools with water stations had significantly fewer overweight students than the other schools by the end of the 15-month study, according to Anisha Patel, MD, MSPH, MSHS, associate professor of pediatrics at Stanford (Calif.) University, who will be presenting the findings at the Pediatric Academic Societies (PAS) 2022 Meeting, Denver.

“Sugar-sweetened beverages are a huge contributor to obesity,” Dr. Patel told this news organization. “This provides a key strategy for schools to adopt, and the time is right for this type of work – in the pandemic period we’ve seen significant increases in obesity. Investments like this could help stem that.”

According to the U.S. Centers for Disease Control and Prevention, 14.4 million children aged 2-19 years in the United States – about 19% of all kids in that age range – were obese in 2017-2018. The agency said the rate of increase in body mass index among this group nearly doubled during the COVID-19 pandemic.

Children with obesity are at higher risk for chronic health problems, including diabetes, heart disease, depression, and high blood pressure.

Dr. Patel’s study, funded by the National Institutes of Health, was the culmination of a decade of interest in the area, she said.

Water stations and compostable or recyclable cups were placed in high-traffic areas of the schools, including playgrounds and cafeterias. The water was tested for lead, and if needed, researchers worked with school districts to remediate, Dr. Patel said in an interview.

The intervention included a kickoff assembly about the health benefits of water intake, and students who were seen drinking water with their lunches were given small prizes.

The researchers assessed body weight, height, and dietary intake of students throughout the study, including their consumption of water, sodas, fruit juices, and flavored and unflavored milk.

Promoting water didn’t lead to magical weight loss. At the start of the study, 49.5% of students in the intervention group were overweight – a figure that nudged up to 49.8% by the end of the study. In the control group, however, 47.7% of students began the study overweight – a number that climbed to 51.4% by the end of the trial (odds ratio, 0.3; P = .01), according to the researchers, who credited the increase to the lack of emphasis on opting for water over sweetened drinks.

“We were very excited the effect sizes were nearly double previous studies, which was great news,” Dr. Patel said.

Water intake began to decline at about the 15-month mark, signaling the need for more long-term, consistent education and incentive to foster lasting habits, Dr. Patel said.

The researchers noted that they were unable to collect data from eight of the target schools because of the pandemic. In addition, the study focused on schools with heavily Latino student populations, so the results might not be generalizable to other communities, they said.

Angie Cradock, a principal research scientist at the Harvard T. H. Chan School of Public Health, Boston, said the study “offers an important and practical strategy to promote student health.”

Ms. Cradock serves as deputy director of the Harvard Prevention Research Center on Nutrition and Physical Activity, which focuses on improving population nutrition, increasing physical activity, reducing obesity and chronic disease, and improving health equity.

Dr. Patel and her colleagues’ three-pronged approach of using education, promotion, and accessibility to increase student interest in drinking water could be employed at countless other schools, said Ms. Cradock, who was not involved in the study.

“Negative perceptions of tap water and drinking fountains are common,” she said. “Not all students have access to safe and appealing drinking water while at school, and this strategy seems like a recipe for success.”

Dr. Patel reported no relevant financial relationships.

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

Elementary schools that provide easy access to drinking water and education about its benefits may help their students maintain a healthy weight, a new study found.

Researchers examined the health and drinking habits of 1,249 children in 26 low-income, ethnically diverse elementary schools in the San Francisco Bay Area. In half of the schools, water stations were placed throughout, along with signs explaining why water is healthier than sugary drinks. In addition, assemblies were held explaining the advantages of water over sugary drinks.

That simple message seemed to have had an outsized effect. Schools with water stations had significantly fewer overweight students than the other schools by the end of the 15-month study, according to Anisha Patel, MD, MSPH, MSHS, associate professor of pediatrics at Stanford (Calif.) University, who will be presenting the findings at the Pediatric Academic Societies (PAS) 2022 Meeting, Denver.

“Sugar-sweetened beverages are a huge contributor to obesity,” Dr. Patel told this news organization. “This provides a key strategy for schools to adopt, and the time is right for this type of work – in the pandemic period we’ve seen significant increases in obesity. Investments like this could help stem that.”

According to the U.S. Centers for Disease Control and Prevention, 14.4 million children aged 2-19 years in the United States – about 19% of all kids in that age range – were obese in 2017-2018. The agency said the rate of increase in body mass index among this group nearly doubled during the COVID-19 pandemic.

Children with obesity are at higher risk for chronic health problems, including diabetes, heart disease, depression, and high blood pressure.

Dr. Patel’s study, funded by the National Institutes of Health, was the culmination of a decade of interest in the area, she said.

Water stations and compostable or recyclable cups were placed in high-traffic areas of the schools, including playgrounds and cafeterias. The water was tested for lead, and if needed, researchers worked with school districts to remediate, Dr. Patel said in an interview.

The intervention included a kickoff assembly about the health benefits of water intake, and students who were seen drinking water with their lunches were given small prizes.

The researchers assessed body weight, height, and dietary intake of students throughout the study, including their consumption of water, sodas, fruit juices, and flavored and unflavored milk.

Promoting water didn’t lead to magical weight loss. At the start of the study, 49.5% of students in the intervention group were overweight – a figure that nudged up to 49.8% by the end of the study. In the control group, however, 47.7% of students began the study overweight – a number that climbed to 51.4% by the end of the trial (odds ratio, 0.3; P = .01), according to the researchers, who credited the increase to the lack of emphasis on opting for water over sweetened drinks.

“We were very excited the effect sizes were nearly double previous studies, which was great news,” Dr. Patel said.

Water intake began to decline at about the 15-month mark, signaling the need for more long-term, consistent education and incentive to foster lasting habits, Dr. Patel said.

The researchers noted that they were unable to collect data from eight of the target schools because of the pandemic. In addition, the study focused on schools with heavily Latino student populations, so the results might not be generalizable to other communities, they said.

Angie Cradock, a principal research scientist at the Harvard T. H. Chan School of Public Health, Boston, said the study “offers an important and practical strategy to promote student health.”

Ms. Cradock serves as deputy director of the Harvard Prevention Research Center on Nutrition and Physical Activity, which focuses on improving population nutrition, increasing physical activity, reducing obesity and chronic disease, and improving health equity.

Dr. Patel and her colleagues’ three-pronged approach of using education, promotion, and accessibility to increase student interest in drinking water could be employed at countless other schools, said Ms. Cradock, who was not involved in the study.

“Negative perceptions of tap water and drinking fountains are common,” she said. “Not all students have access to safe and appealing drinking water while at school, and this strategy seems like a recipe for success.”

Dr. Patel reported no relevant financial relationships.

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

Elementary schools that provide easy access to drinking water and education about its benefits may help their students maintain a healthy weight, a new study found.

Researchers examined the health and drinking habits of 1,249 children in 26 low-income, ethnically diverse elementary schools in the San Francisco Bay Area. In half of the schools, water stations were placed throughout, along with signs explaining why water is healthier than sugary drinks. In addition, assemblies were held explaining the advantages of water over sugary drinks.

That simple message seemed to have had an outsized effect. Schools with water stations had significantly fewer overweight students than the other schools by the end of the 15-month study, according to Anisha Patel, MD, MSPH, MSHS, associate professor of pediatrics at Stanford (Calif.) University, who will be presenting the findings at the Pediatric Academic Societies (PAS) 2022 Meeting, Denver.

“Sugar-sweetened beverages are a huge contributor to obesity,” Dr. Patel told this news organization. “This provides a key strategy for schools to adopt, and the time is right for this type of work – in the pandemic period we’ve seen significant increases in obesity. Investments like this could help stem that.”

According to the U.S. Centers for Disease Control and Prevention, 14.4 million children aged 2-19 years in the United States – about 19% of all kids in that age range – were obese in 2017-2018. The agency said the rate of increase in body mass index among this group nearly doubled during the COVID-19 pandemic.

Children with obesity are at higher risk for chronic health problems, including diabetes, heart disease, depression, and high blood pressure.

Dr. Patel’s study, funded by the National Institutes of Health, was the culmination of a decade of interest in the area, she said.

Water stations and compostable or recyclable cups were placed in high-traffic areas of the schools, including playgrounds and cafeterias. The water was tested for lead, and if needed, researchers worked with school districts to remediate, Dr. Patel said in an interview.

The intervention included a kickoff assembly about the health benefits of water intake, and students who were seen drinking water with their lunches were given small prizes.

The researchers assessed body weight, height, and dietary intake of students throughout the study, including their consumption of water, sodas, fruit juices, and flavored and unflavored milk.

Promoting water didn’t lead to magical weight loss. At the start of the study, 49.5% of students in the intervention group were overweight – a figure that nudged up to 49.8% by the end of the study. In the control group, however, 47.7% of students began the study overweight – a number that climbed to 51.4% by the end of the trial (odds ratio, 0.3; P = .01), according to the researchers, who credited the increase to the lack of emphasis on opting for water over sweetened drinks.

“We were very excited the effect sizes were nearly double previous studies, which was great news,” Dr. Patel said.

Water intake began to decline at about the 15-month mark, signaling the need for more long-term, consistent education and incentive to foster lasting habits, Dr. Patel said.

The researchers noted that they were unable to collect data from eight of the target schools because of the pandemic. In addition, the study focused on schools with heavily Latino student populations, so the results might not be generalizable to other communities, they said.

Angie Cradock, a principal research scientist at the Harvard T. H. Chan School of Public Health, Boston, said the study “offers an important and practical strategy to promote student health.”

Ms. Cradock serves as deputy director of the Harvard Prevention Research Center on Nutrition and Physical Activity, which focuses on improving population nutrition, increasing physical activity, reducing obesity and chronic disease, and improving health equity.

Dr. Patel and her colleagues’ three-pronged approach of using education, promotion, and accessibility to increase student interest in drinking water could be employed at countless other schools, said Ms. Cradock, who was not involved in the study.

“Negative perceptions of tap water and drinking fountains are common,” she said. “Not all students have access to safe and appealing drinking water while at school, and this strategy seems like a recipe for success.”

Dr. Patel reported no relevant financial relationships.

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

MADRID, Spain – Individuals with substance use disorders are at higher risk of being infected by and dying from COVID-19 – even if they are fully vaccinated – compared with the general population. Such are the findings of a line of research led by Mexican psychiatrist Nora Volkow, MD, director of the U.S. National Institute on Drug Abuse (NIDA).

A pioneer in the use of brain imaging to investigate how substance use affects brain functions and one of Time magazine’s “Top 100 People Who Shape Our World,” she led the Inaugural Conference at the XXXI Congress of the Spanish Society of Clinical Pharmacology “Drugs and Actions During the Pandemic.” Dr. Volkow spoke about the effects that the current health crisis has had on drug use and the social challenges that arose from lockdowns. She also presented and discussed the results of studies being conducted at NIDA that “are aimed at reviewing what we’ve learned and what the consequences of COVID-19 have been with respect to substance abuse disorder.”

As Dr. Volkow pointed out, drugs affect much more than just the brain. “In particular, the heart, the lungs, the immune system – all of these are significantly harmed by substances like tobacco, alcohol, cocaine, and methamphetamine. This is why, since the beginning of the pandemic, we’ve been worried about seeing what consequences SARS-CoV-2 was going to have on users of these substances, especially in light of the great toll this disease takes on the respiratory system and the vascular system.”
 

Pulmonary ‘predisposition’ and race

Dr. Volkow and her team launched several studies to get a more thorough understanding of the link between substance abuse disorders and poor COVID-19 prognoses. One of them was based on analyses from electronic health records in the United States. The purpose was to determine COVID-19 risk and outcomes in patients based on the type of use disorder (for example, alcohol, opioid, cannabis, cocaine).

“The results showed that regardless of the drug type, all users of these substances had both a higher risk of being infected by COVID-19 and a higher death rate in comparison with the rest of the population,” said Dr. Volkow. “This surprised us, because there’s no evidence that drugs themselves make the virus more infectious. However, what the results did clearly indicate to us was that using these substances was associated with behavior that put these individuals at a greater risk for infection,” Dr. Volkow explained.

“In addition,” she continued, “using, for example, tobacco or cannabis causes inflammation in the lungs. It seems that, as a result, they end up being more vulnerable to infection by COVID. And this has consequences, above all, in terms of mortality.”

Another finding was that, among patients with substance use disorders, race had the largest effect on COVID risk. “From the very start, we saw that, compared with White individuals, Black individuals showed a much higher risk of not only getting COVID, but also dying from it,” said Dr. Volkow. “Therefore, on the one hand, our data show that drug users are more vulnerable to COVID-19 and, on the other hand, they reflect that within this group, Black individuals are even more vulnerable.”

In her presentation, Dr. Volkow drew particular attention to the impact that social surroundings have on these patients and the decisive role they played in terms of vulnerability. “It’s a very complex issue, what with the various factors at play: family, social environment. ... A person living in an at-risk situation can more easily get drugs or even prescription medication, which can also be abused.”

The psychiatrist stressed that when it comes to addictive disorders (and related questions such as prevention, treatment, and social reintegration), one of the most crucial factors has to do with the individual’s social support structures. “The studies also brought to light the role that social interaction has as an inhibitory factor with regard to drug use,” said Dr. Volkow. “And indeed, adequate adherence to treatment requires that the necessary support systems be maintained.”

In the context of the pandemic, this social aspect was also key, especially concerning the high death rate among substance use disorder patients with COVID-19. “There are very significant social determinants, such as the stigma associated with these groups – a stigma that makes these individuals more likely to hesitate to seek out treatment for diseases that may be starting to take hold, in this case COVID-19.”

On that note, Dr. Volkow emphasized the importance of treating drug addicts as though they had a chronic disease in need of treatment. “In fact, the prevalence of pathologies such as hypertension, diabetes, cancer, and dementia is much higher in these individuals than in the general population,” she said. “However, this isn’t widely known. The data reflect that not only the prevalence of these diseases, but also the severity of the symptoms, is higher, and this has a lot to do with these individuals’ reticence when it comes to reaching out for medical care. Added to that are the effects of their economic situation and other factors, such as stress (which can trigger a relapse), lack of ready access to medications, and limited access to community support or other sources of social connection.”
 

Opioids and COVID-19

As for drug use during the pandemic, Dr. Volkow provided context by mentioning that in the United States, the experts and authorities have spent two decades fighting the epidemic of opioid-related drug overdoses, which has caused many deaths. “And on top of this epidemic – one that we still haven’t been able to get control of – there’s the situation brought about by COVID-19. So, we had to see the consequences of a pandemic crossing paths with an epidemic.”

The United States’s epidemic of overdose deaths started with the use of opioid painkillers, medications which are overprescribed. Another issue that the United States faces is that many drugs are contaminated with fentanyl. This contamination has caused an increase in deaths.

“In the United States, fentanyl is everywhere,” said Dr. Volkow. “And what’s more concerning: almost a third of this fentanyl comes in pills that are sold as benzodiazepines. With this comes a high risk for overdose. In line with this, we saw overdose deaths among adolescents nearly double in 1 year, an increase which is likely related to these contaminated pills. It’s a risk that’s just below the surface. We’ve got to be vigilant, because this phenomenon is expected to eventually spread to Europe. After all, these pills are very cheap, hence the rapid increase in their use.”

To provide figures on drug use and overdose deaths since the beginning of the pandemic, Dr. Volkow referred to COVID-19 data provided by the National Center for Health Statistics (NCHS) at the U.S. Centers for Disease Control and Prevention. The data indicate that of the 70,630 drug overdose deaths that occurred in 2019, 49,860 involved opioids (whether prescribed or illicit). “And these numbers have continued to rise, so much so that the current situation can be classified as catastrophic – because this increase has been even greater during the pandemic due to the rise in the use of all drugs,” said Dr. Volkow.

Dr. Volkow referred to an NCHS study that looked at the period between September 2020 and September 2021, finding a 15.9% increase in the number of drug overdose deaths. A breakdown of these data shows that the highest percentage corresponds to deaths from “other psychostimulants,” primarily methamphetamines (35.7%). This category is followed by deaths involving synthetic opioids, mostly illicit fentanyl (25.8%), and deaths from cocaine (13.4%).

“These figures indicate that, for the first time in history, the United States had over 100,000 overdose deaths in 1 year,” said Dr. Volkow. “This is something that has never happened. We can only infer that the pandemic had a hand in making the overdose crisis even worse than it already was.”

As Dr. Volkow explained, policies related to handling overdoses and prescribing medications have been changed in the context of COVID-19. Addiction treatment consequently has been provided through a larger number of telehealth services, and measures such as greater access to treatment for comorbid conditions, expanded access to behavioral treatments, and the establishment of mental health hotlines have been undertaken.
 

Children’s cognitive development

Dr. Volkow also spoke about another of NIDA’s current subjects of research: The role that damage or compromise from drugs has on the neural circuits involved in reinforcement systems. “It’s important that we make people aware of the significance of what’s at play there, because the greatest damage that can be inflicted on the brain comes from using any type of drug during adolescence. In these cases, the likelihood of having an addictive disorder as an adult significantly increases.”

Within this framework, her team has also investigated the impact of the pandemic on the cognitive development of infants under 1 year of age. One of these studies was a pilot program in which pregnant women participated. “We found that children born during the pandemic had lower cognitive development: n = 112 versus n = 554 of those born before January 2019.”

“None of the mothers or children in the study had been infected with SARS-CoV-2,” Dr. Volkow explained. “But the results clearly reflect the negative effect of the circumstances brought about by the pandemic, especially the high level of stress, the isolation, and the lack of stimuli. Another study, currently in preprint, is based on imaging. It analyzed the impact on myelination in children not exposed to COVID-19 but born during the pandemic, compared with pre-pandemic infants. The data showed significantly reduced areas of myelin development (P < .05) in those born after 2019. And the researchers didn’t find significant differences in gestation duration or birth weight.”

The longitudinal characteristics of these studies will let us see whether a change in these individuals’ social circumstances over time also brings to light cognitive changes, even the recovery of lost or underdeveloped cognitive processes, Dr. Volkow concluded.

Dr. Volkow has disclosed no relevant financial relationships.

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

MADRID, Spain – Individuals with substance use disorders are at higher risk of being infected by and dying from COVID-19 – even if they are fully vaccinated – compared with the general population. Such are the findings of a line of research led by Mexican psychiatrist Nora Volkow, MD, director of the U.S. National Institute on Drug Abuse (NIDA).

A pioneer in the use of brain imaging to investigate how substance use affects brain functions and one of Time magazine’s “Top 100 People Who Shape Our World,” she led the Inaugural Conference at the XXXI Congress of the Spanish Society of Clinical Pharmacology “Drugs and Actions During the Pandemic.” Dr. Volkow spoke about the effects that the current health crisis has had on drug use and the social challenges that arose from lockdowns. She also presented and discussed the results of studies being conducted at NIDA that “are aimed at reviewing what we’ve learned and what the consequences of COVID-19 have been with respect to substance abuse disorder.”

As Dr. Volkow pointed out, drugs affect much more than just the brain. “In particular, the heart, the lungs, the immune system – all of these are significantly harmed by substances like tobacco, alcohol, cocaine, and methamphetamine. This is why, since the beginning of the pandemic, we’ve been worried about seeing what consequences SARS-CoV-2 was going to have on users of these substances, especially in light of the great toll this disease takes on the respiratory system and the vascular system.”
 

Pulmonary ‘predisposition’ and race

Dr. Volkow and her team launched several studies to get a more thorough understanding of the link between substance abuse disorders and poor COVID-19 prognoses. One of them was based on analyses from electronic health records in the United States. The purpose was to determine COVID-19 risk and outcomes in patients based on the type of use disorder (for example, alcohol, opioid, cannabis, cocaine).

“The results showed that regardless of the drug type, all users of these substances had both a higher risk of being infected by COVID-19 and a higher death rate in comparison with the rest of the population,” said Dr. Volkow. “This surprised us, because there’s no evidence that drugs themselves make the virus more infectious. However, what the results did clearly indicate to us was that using these substances was associated with behavior that put these individuals at a greater risk for infection,” Dr. Volkow explained.

“In addition,” she continued, “using, for example, tobacco or cannabis causes inflammation in the lungs. It seems that, as a result, they end up being more vulnerable to infection by COVID. And this has consequences, above all, in terms of mortality.”

Another finding was that, among patients with substance use disorders, race had the largest effect on COVID risk. “From the very start, we saw that, compared with White individuals, Black individuals showed a much higher risk of not only getting COVID, but also dying from it,” said Dr. Volkow. “Therefore, on the one hand, our data show that drug users are more vulnerable to COVID-19 and, on the other hand, they reflect that within this group, Black individuals are even more vulnerable.”

In her presentation, Dr. Volkow drew particular attention to the impact that social surroundings have on these patients and the decisive role they played in terms of vulnerability. “It’s a very complex issue, what with the various factors at play: family, social environment. ... A person living in an at-risk situation can more easily get drugs or even prescription medication, which can also be abused.”

The psychiatrist stressed that when it comes to addictive disorders (and related questions such as prevention, treatment, and social reintegration), one of the most crucial factors has to do with the individual’s social support structures. “The studies also brought to light the role that social interaction has as an inhibitory factor with regard to drug use,” said Dr. Volkow. “And indeed, adequate adherence to treatment requires that the necessary support systems be maintained.”

In the context of the pandemic, this social aspect was also key, especially concerning the high death rate among substance use disorder patients with COVID-19. “There are very significant social determinants, such as the stigma associated with these groups – a stigma that makes these individuals more likely to hesitate to seek out treatment for diseases that may be starting to take hold, in this case COVID-19.”

On that note, Dr. Volkow emphasized the importance of treating drug addicts as though they had a chronic disease in need of treatment. “In fact, the prevalence of pathologies such as hypertension, diabetes, cancer, and dementia is much higher in these individuals than in the general population,” she said. “However, this isn’t widely known. The data reflect that not only the prevalence of these diseases, but also the severity of the symptoms, is higher, and this has a lot to do with these individuals’ reticence when it comes to reaching out for medical care. Added to that are the effects of their economic situation and other factors, such as stress (which can trigger a relapse), lack of ready access to medications, and limited access to community support or other sources of social connection.”
 

Opioids and COVID-19

As for drug use during the pandemic, Dr. Volkow provided context by mentioning that in the United States, the experts and authorities have spent two decades fighting the epidemic of opioid-related drug overdoses, which has caused many deaths. “And on top of this epidemic – one that we still haven’t been able to get control of – there’s the situation brought about by COVID-19. So, we had to see the consequences of a pandemic crossing paths with an epidemic.”

The United States’s epidemic of overdose deaths started with the use of opioid painkillers, medications which are overprescribed. Another issue that the United States faces is that many drugs are contaminated with fentanyl. This contamination has caused an increase in deaths.

“In the United States, fentanyl is everywhere,” said Dr. Volkow. “And what’s more concerning: almost a third of this fentanyl comes in pills that are sold as benzodiazepines. With this comes a high risk for overdose. In line with this, we saw overdose deaths among adolescents nearly double in 1 year, an increase which is likely related to these contaminated pills. It’s a risk that’s just below the surface. We’ve got to be vigilant, because this phenomenon is expected to eventually spread to Europe. After all, these pills are very cheap, hence the rapid increase in their use.”

To provide figures on drug use and overdose deaths since the beginning of the pandemic, Dr. Volkow referred to COVID-19 data provided by the National Center for Health Statistics (NCHS) at the U.S. Centers for Disease Control and Prevention. The data indicate that of the 70,630 drug overdose deaths that occurred in 2019, 49,860 involved opioids (whether prescribed or illicit). “And these numbers have continued to rise, so much so that the current situation can be classified as catastrophic – because this increase has been even greater during the pandemic due to the rise in the use of all drugs,” said Dr. Volkow.

Dr. Volkow referred to an NCHS study that looked at the period between September 2020 and September 2021, finding a 15.9% increase in the number of drug overdose deaths. A breakdown of these data shows that the highest percentage corresponds to deaths from “other psychostimulants,” primarily methamphetamines (35.7%). This category is followed by deaths involving synthetic opioids, mostly illicit fentanyl (25.8%), and deaths from cocaine (13.4%).

“These figures indicate that, for the first time in history, the United States had over 100,000 overdose deaths in 1 year,” said Dr. Volkow. “This is something that has never happened. We can only infer that the pandemic had a hand in making the overdose crisis even worse than it already was.”

As Dr. Volkow explained, policies related to handling overdoses and prescribing medications have been changed in the context of COVID-19. Addiction treatment consequently has been provided through a larger number of telehealth services, and measures such as greater access to treatment for comorbid conditions, expanded access to behavioral treatments, and the establishment of mental health hotlines have been undertaken.
 

Children’s cognitive development

Dr. Volkow also spoke about another of NIDA’s current subjects of research: The role that damage or compromise from drugs has on the neural circuits involved in reinforcement systems. “It’s important that we make people aware of the significance of what’s at play there, because the greatest damage that can be inflicted on the brain comes from using any type of drug during adolescence. In these cases, the likelihood of having an addictive disorder as an adult significantly increases.”

Within this framework, her team has also investigated the impact of the pandemic on the cognitive development of infants under 1 year of age. One of these studies was a pilot program in which pregnant women participated. “We found that children born during the pandemic had lower cognitive development: n = 112 versus n = 554 of those born before January 2019.”

“None of the mothers or children in the study had been infected with SARS-CoV-2,” Dr. Volkow explained. “But the results clearly reflect the negative effect of the circumstances brought about by the pandemic, especially the high level of stress, the isolation, and the lack of stimuli. Another study, currently in preprint, is based on imaging. It analyzed the impact on myelination in children not exposed to COVID-19 but born during the pandemic, compared with pre-pandemic infants. The data showed significantly reduced areas of myelin development (P < .05) in those born after 2019. And the researchers didn’t find significant differences in gestation duration or birth weight.”

The longitudinal characteristics of these studies will let us see whether a change in these individuals’ social circumstances over time also brings to light cognitive changes, even the recovery of lost or underdeveloped cognitive processes, Dr. Volkow concluded.

Dr. Volkow has disclosed no relevant financial relationships.

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

MADRID, Spain – Individuals with substance use disorders are at higher risk of being infected by and dying from COVID-19 – even if they are fully vaccinated – compared with the general population. Such are the findings of a line of research led by Mexican psychiatrist Nora Volkow, MD, director of the U.S. National Institute on Drug Abuse (NIDA).

A pioneer in the use of brain imaging to investigate how substance use affects brain functions and one of Time magazine’s “Top 100 People Who Shape Our World,” she led the Inaugural Conference at the XXXI Congress of the Spanish Society of Clinical Pharmacology “Drugs and Actions During the Pandemic.” Dr. Volkow spoke about the effects that the current health crisis has had on drug use and the social challenges that arose from lockdowns. She also presented and discussed the results of studies being conducted at NIDA that “are aimed at reviewing what we’ve learned and what the consequences of COVID-19 have been with respect to substance abuse disorder.”

As Dr. Volkow pointed out, drugs affect much more than just the brain. “In particular, the heart, the lungs, the immune system – all of these are significantly harmed by substances like tobacco, alcohol, cocaine, and methamphetamine. This is why, since the beginning of the pandemic, we’ve been worried about seeing what consequences SARS-CoV-2 was going to have on users of these substances, especially in light of the great toll this disease takes on the respiratory system and the vascular system.”
 

Pulmonary ‘predisposition’ and race

Dr. Volkow and her team launched several studies to get a more thorough understanding of the link between substance abuse disorders and poor COVID-19 prognoses. One of them was based on analyses from electronic health records in the United States. The purpose was to determine COVID-19 risk and outcomes in patients based on the type of use disorder (for example, alcohol, opioid, cannabis, cocaine).

“The results showed that regardless of the drug type, all users of these substances had both a higher risk of being infected by COVID-19 and a higher death rate in comparison with the rest of the population,” said Dr. Volkow. “This surprised us, because there’s no evidence that drugs themselves make the virus more infectious. However, what the results did clearly indicate to us was that using these substances was associated with behavior that put these individuals at a greater risk for infection,” Dr. Volkow explained.

“In addition,” she continued, “using, for example, tobacco or cannabis causes inflammation in the lungs. It seems that, as a result, they end up being more vulnerable to infection by COVID. And this has consequences, above all, in terms of mortality.”

Another finding was that, among patients with substance use disorders, race had the largest effect on COVID risk. “From the very start, we saw that, compared with White individuals, Black individuals showed a much higher risk of not only getting COVID, but also dying from it,” said Dr. Volkow. “Therefore, on the one hand, our data show that drug users are more vulnerable to COVID-19 and, on the other hand, they reflect that within this group, Black individuals are even more vulnerable.”

In her presentation, Dr. Volkow drew particular attention to the impact that social surroundings have on these patients and the decisive role they played in terms of vulnerability. “It’s a very complex issue, what with the various factors at play: family, social environment. ... A person living in an at-risk situation can more easily get drugs or even prescription medication, which can also be abused.”

The psychiatrist stressed that when it comes to addictive disorders (and related questions such as prevention, treatment, and social reintegration), one of the most crucial factors has to do with the individual’s social support structures. “The studies also brought to light the role that social interaction has as an inhibitory factor with regard to drug use,” said Dr. Volkow. “And indeed, adequate adherence to treatment requires that the necessary support systems be maintained.”

In the context of the pandemic, this social aspect was also key, especially concerning the high death rate among substance use disorder patients with COVID-19. “There are very significant social determinants, such as the stigma associated with these groups – a stigma that makes these individuals more likely to hesitate to seek out treatment for diseases that may be starting to take hold, in this case COVID-19.”

On that note, Dr. Volkow emphasized the importance of treating drug addicts as though they had a chronic disease in need of treatment. “In fact, the prevalence of pathologies such as hypertension, diabetes, cancer, and dementia is much higher in these individuals than in the general population,” she said. “However, this isn’t widely known. The data reflect that not only the prevalence of these diseases, but also the severity of the symptoms, is higher, and this has a lot to do with these individuals’ reticence when it comes to reaching out for medical care. Added to that are the effects of their economic situation and other factors, such as stress (which can trigger a relapse), lack of ready access to medications, and limited access to community support or other sources of social connection.”
 

Opioids and COVID-19

As for drug use during the pandemic, Dr. Volkow provided context by mentioning that in the United States, the experts and authorities have spent two decades fighting the epidemic of opioid-related drug overdoses, which has caused many deaths. “And on top of this epidemic – one that we still haven’t been able to get control of – there’s the situation brought about by COVID-19. So, we had to see the consequences of a pandemic crossing paths with an epidemic.”

The United States’s epidemic of overdose deaths started with the use of opioid painkillers, medications which are overprescribed. Another issue that the United States faces is that many drugs are contaminated with fentanyl. This contamination has caused an increase in deaths.

“In the United States, fentanyl is everywhere,” said Dr. Volkow. “And what’s more concerning: almost a third of this fentanyl comes in pills that are sold as benzodiazepines. With this comes a high risk for overdose. In line with this, we saw overdose deaths among adolescents nearly double in 1 year, an increase which is likely related to these contaminated pills. It’s a risk that’s just below the surface. We’ve got to be vigilant, because this phenomenon is expected to eventually spread to Europe. After all, these pills are very cheap, hence the rapid increase in their use.”

To provide figures on drug use and overdose deaths since the beginning of the pandemic, Dr. Volkow referred to COVID-19 data provided by the National Center for Health Statistics (NCHS) at the U.S. Centers for Disease Control and Prevention. The data indicate that of the 70,630 drug overdose deaths that occurred in 2019, 49,860 involved opioids (whether prescribed or illicit). “And these numbers have continued to rise, so much so that the current situation can be classified as catastrophic – because this increase has been even greater during the pandemic due to the rise in the use of all drugs,” said Dr. Volkow.

Dr. Volkow referred to an NCHS study that looked at the period between September 2020 and September 2021, finding a 15.9% increase in the number of drug overdose deaths. A breakdown of these data shows that the highest percentage corresponds to deaths from “other psychostimulants,” primarily methamphetamines (35.7%). This category is followed by deaths involving synthetic opioids, mostly illicit fentanyl (25.8%), and deaths from cocaine (13.4%).

“These figures indicate that, for the first time in history, the United States had over 100,000 overdose deaths in 1 year,” said Dr. Volkow. “This is something that has never happened. We can only infer that the pandemic had a hand in making the overdose crisis even worse than it already was.”

As Dr. Volkow explained, policies related to handling overdoses and prescribing medications have been changed in the context of COVID-19. Addiction treatment consequently has been provided through a larger number of telehealth services, and measures such as greater access to treatment for comorbid conditions, expanded access to behavioral treatments, and the establishment of mental health hotlines have been undertaken.
 

Children’s cognitive development

Dr. Volkow also spoke about another of NIDA’s current subjects of research: The role that damage or compromise from drugs has on the neural circuits involved in reinforcement systems. “It’s important that we make people aware of the significance of what’s at play there, because the greatest damage that can be inflicted on the brain comes from using any type of drug during adolescence. In these cases, the likelihood of having an addictive disorder as an adult significantly increases.”

Within this framework, her team has also investigated the impact of the pandemic on the cognitive development of infants under 1 year of age. One of these studies was a pilot program in which pregnant women participated. “We found that children born during the pandemic had lower cognitive development: n = 112 versus n = 554 of those born before January 2019.”

“None of the mothers or children in the study had been infected with SARS-CoV-2,” Dr. Volkow explained. “But the results clearly reflect the negative effect of the circumstances brought about by the pandemic, especially the high level of stress, the isolation, and the lack of stimuli. Another study, currently in preprint, is based on imaging. It analyzed the impact on myelination in children not exposed to COVID-19 but born during the pandemic, compared with pre-pandemic infants. The data showed significantly reduced areas of myelin development (P < .05) in those born after 2019. And the researchers didn’t find significant differences in gestation duration or birth weight.”

The longitudinal characteristics of these studies will let us see whether a change in these individuals’ social circumstances over time also brings to light cognitive changes, even the recovery of lost or underdeveloped cognitive processes, Dr. Volkow concluded.

Dr. Volkow has disclosed no relevant financial relationships.

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

COVID-19 was the third-leading cause of death in the United States in 2021 for the second straight year, with only heart disease and cancer causing more deaths, the Centers for Disease Control and Prevention said April 22.

About 693,000 people died of heart disease in 2021, with 605,000 dying of cancer and 415,000 of COVID, the CDC said, citing provisional data that might be updated later.

Unintentional injuries were the fourth-leading cause of death, increasing to 219,000 in 2021 from 201,000 in 2020. Influenza and pneumonia dropped out of the top 10 leading causes of death and suicide moved into 10th place.

Overall, about 3,458,697 deaths were reported in the United States in 2021. The age-adjusted death rate was 841.6 deaths per 100,000 people, an increase of 0.7% from 2020. The 2021 death rate was the highest since 2003, the CDC said.

The overall number of COVID deaths in 2021 increased around 20% over 2020, when around 384,000 people died from the virus, the CDC said. COVID deaths in 2021 peaked for the weeks ending Jan. 16 and Sept. 11, following holiday periods.

The demographics of COVID mortality changed slightly, the CDC said in a second report.

Blacks accounted for 13.3% of COVID deaths in 2021 and Hispanics 16.5%, down several percentage points from 2020, the CDC said. Asians made up 3.1% of COVID deaths for 2021, a drop from 3.6% in 2020. White people accounted for 65.2% of COVID deaths in 2021, an increase from 59.6% in 2020.

Non-Hispanic American Indian/Alaskan Native and non-Hispanic Black or African American had the highest overall death rates for COVID, the CDC said.

Breaking the data down by age, the number of COVID deaths among people aged 75 years and older dropped to 178,000 in 2021 from around 207,000 in 2020. The numbers went up in other age groups. Among people aged 65-75, about 101,000 died of COVID in 2021, up from around 76,000 in 2020.

“The results of both studies highlight the need for greater effort to implement effective interventions,” the CDC said in a statement. “We must work to ensure equal treatment in all communities in proportion to their need for effective interventions that can prevent excess COVID-19 deaths.”

Since the pandemic began, about 991,000 people in the United States have died from COVID-related causes, the most among all nations in the world.
 

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

COVID-19 was the third-leading cause of death in the United States in 2021 for the second straight year, with only heart disease and cancer causing more deaths, the Centers for Disease Control and Prevention said April 22.

About 693,000 people died of heart disease in 2021, with 605,000 dying of cancer and 415,000 of COVID, the CDC said, citing provisional data that might be updated later.

Unintentional injuries were the fourth-leading cause of death, increasing to 219,000 in 2021 from 201,000 in 2020. Influenza and pneumonia dropped out of the top 10 leading causes of death and suicide moved into 10th place.

Overall, about 3,458,697 deaths were reported in the United States in 2021. The age-adjusted death rate was 841.6 deaths per 100,000 people, an increase of 0.7% from 2020. The 2021 death rate was the highest since 2003, the CDC said.

The overall number of COVID deaths in 2021 increased around 20% over 2020, when around 384,000 people died from the virus, the CDC said. COVID deaths in 2021 peaked for the weeks ending Jan. 16 and Sept. 11, following holiday periods.

The demographics of COVID mortality changed slightly, the CDC said in a second report.

Blacks accounted for 13.3% of COVID deaths in 2021 and Hispanics 16.5%, down several percentage points from 2020, the CDC said. Asians made up 3.1% of COVID deaths for 2021, a drop from 3.6% in 2020. White people accounted for 65.2% of COVID deaths in 2021, an increase from 59.6% in 2020.

Non-Hispanic American Indian/Alaskan Native and non-Hispanic Black or African American had the highest overall death rates for COVID, the CDC said.

Breaking the data down by age, the number of COVID deaths among people aged 75 years and older dropped to 178,000 in 2021 from around 207,000 in 2020. The numbers went up in other age groups. Among people aged 65-75, about 101,000 died of COVID in 2021, up from around 76,000 in 2020.

“The results of both studies highlight the need for greater effort to implement effective interventions,” the CDC said in a statement. “We must work to ensure equal treatment in all communities in proportion to their need for effective interventions that can prevent excess COVID-19 deaths.”

Since the pandemic began, about 991,000 people in the United States have died from COVID-related causes, the most among all nations in the world.
 

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

COVID-19 was the third-leading cause of death in the United States in 2021 for the second straight year, with only heart disease and cancer causing more deaths, the Centers for Disease Control and Prevention said April 22.

About 693,000 people died of heart disease in 2021, with 605,000 dying of cancer and 415,000 of COVID, the CDC said, citing provisional data that might be updated later.

Unintentional injuries were the fourth-leading cause of death, increasing to 219,000 in 2021 from 201,000 in 2020. Influenza and pneumonia dropped out of the top 10 leading causes of death and suicide moved into 10th place.

Overall, about 3,458,697 deaths were reported in the United States in 2021. The age-adjusted death rate was 841.6 deaths per 100,000 people, an increase of 0.7% from 2020. The 2021 death rate was the highest since 2003, the CDC said.

The overall number of COVID deaths in 2021 increased around 20% over 2020, when around 384,000 people died from the virus, the CDC said. COVID deaths in 2021 peaked for the weeks ending Jan. 16 and Sept. 11, following holiday periods.

The demographics of COVID mortality changed slightly, the CDC said in a second report.

Blacks accounted for 13.3% of COVID deaths in 2021 and Hispanics 16.5%, down several percentage points from 2020, the CDC said. Asians made up 3.1% of COVID deaths for 2021, a drop from 3.6% in 2020. White people accounted for 65.2% of COVID deaths in 2021, an increase from 59.6% in 2020.

Non-Hispanic American Indian/Alaskan Native and non-Hispanic Black or African American had the highest overall death rates for COVID, the CDC said.

Breaking the data down by age, the number of COVID deaths among people aged 75 years and older dropped to 178,000 in 2021 from around 207,000 in 2020. The numbers went up in other age groups. Among people aged 65-75, about 101,000 died of COVID in 2021, up from around 76,000 in 2020.

“The results of both studies highlight the need for greater effort to implement effective interventions,” the CDC said in a statement. “We must work to ensure equal treatment in all communities in proportion to their need for effective interventions that can prevent excess COVID-19 deaths.”

Since the pandemic began, about 991,000 people in the United States have died from COVID-related causes, the most among all nations in the world.
 

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

The Centers for Disease Control and Prevention has long been the premier reference lab for the United States and, for some diseases, internationally. But the agency stopped testing for parasites more than 6 months ago, and public health experts say that’s putting vulnerable populations even more at risk.

In September 2021, the CDC stated on its website that it would stop testing for parasites, herpesvirus encephalitis, human herpesvirus 6 and 7, Epstein-Barr virus, and other viruses, saying, “We are working diligently to implement laboratory system improvements.”

At the time, the CDC said testing would be halted only for a few months.

In response to a query from this news organization, a CDC spokesperson replied, “While at present we are unable to share a detailed timeline, our highest priority is to resume high-quality testing operations in a phased, prioritized approach as soon as possible and to offer the same tests that were available before the pause.”

Several global health clinicians told this news organization that they were not aware of the halt and that they are now uncertain about the specific diagnosis and best treatment for some patients. Other patients have been lost to follow-up.

In response, a group of tropical disease specialists who focus on neglected tropical diseases (NTDs) wrote an editorial, “Neglected Testing for Neglected Tropical Diseases at the CDC,” which recently appeared in the American Journal of Tropical Medicine and Hygiene (AJTMH).

NTDs are caused by viruses, bacteria, and parasites. They include leprosy and worms; many such diseases are disfiguring, such as filariasis (which causes the hugely swollen extremities of elephantiasis) and onchocerciasis (river blindness). They also include some viral and bacterial diseases. Their common denominator is that they are diseases of poverty, primarily in Africa, Asia, and Latin America, so they garner little attention from “first world” countries.

The loss of testing for two devastating parasites – Chagas and Leishmania – was particularly significant. Few other labs in the United States test for these, and the tests can be expensive and of variable quality, experts said.

Norman Beatty, MD, a global health physician at the University of Florida, told this news organization, “Chagas confirmatory testing is only available at the CDC and is the most reliable testing we have access to in the United States. Leishmania species identification is also only available at the CDC and is important in determining which antiparasitic medications we will use.”

Chagas disease is caused by the parasite Trypanosoma cruzi and is transmitted by triatomine bugs, also known as kissing bugs. Chagas is a major cause of an enlarged heart and congestive heart failure, as well as a dramatically enlarged esophagus or colon.

Prior to the cuts and before COVID-19, the CDC reported that they ran 10,000 to 15,000 tests for parasitic diseases annually. Testing requests declined during COVID. In 2021, they ran 1,003 tests for Chagas.

Dr. Beatty said that he first became aware of the CDC’s testing cuts last fall when he sought care for a patient. He was first told the delay would be 2-3 weeks, then another 2-3 weeks. It’s now been 7 months, and only three tests have been resumed.

Dr. Beatty added that for Chagas disease in particular, there is urgency in testing because cardiac complications can be life-threatening. He said that “a lot of these diseases can be considered rare, but they also have a tremendous ability to cause morbidity and mortality.”

Leishmania infections are also serious. Following the bite of an infected sandfly, they can cause disfiguring skin infections, but, more importantly, they can affect the liver, spleen, and bone marrow. Dr. Beatty said that since testing was dropped at the CDC, some colleagues had to send specimens outside of the country.

Dr. Beatty emphasized that the cuts in testing at the CDC highlight disparities in our society. “There are other commercial reference laboratories who may have some of these tests available, but the vast majority of people who suffer from diseases are underserved and vulnerable. [My patients] most definitely will not have access to advanced testing commercial laboratories,” Dr. Beatty said. Those laboratories include Associated Regional University Pathologists laboratories, Quest Diagnostics, and LabCorp Diagnostics. But for some parasitic infections, there will simply be no testing, and patients will not receive appropriate therapy.

The CDC’s website says, “USAID and CDC work together on a shared agenda to advance global progress towards the control and elimination of NTDs that can be addressed with preventive chemotherapy. ... CDC has strong working relationships with WHO, regional reference laboratories/bodies, [and] national NTD programs ... working with these partners through the provision of unique laboratory, diagnostic, and epidemiological technical assistance.”

The WHO Roadmap for 2030 aims to prevent and control many NTDs, in part by “providing new interventions and effective, standardized, and affordable diagnostics.” Last year, the CDC said that they “will continue working with WHO and other global partners to meet the established goals.”

But testing for a number of NTDs is not currently available at the CDC. In response to questions from this news organization, a CDC spokesperson said the agency “supports the development of country capacity for NTD testing required ... but does not perform testing related to the WHO Roadmap.”

A group of CDC officials wrote an editorial response that was published in AJTMH, saying the agency has “three main priorities: reducing parasitic disease-related death, illness, and disability in the United States; reducing the global burden of malaria; and eliminating targeted neglected tropical diseases.”

In response to this news organization’s interview request, a CDC spokesperson wrote, “CDC is unwavering in our commitment to provide the highest quality laboratory diagnostic services for parasitic diseases. We understand the concerns expressed in the editorial and the challenges the pause in testing for parasitic diseases presents for health care providers, particularly those treating people at elevated risk for parasitic diseases.”

Michael Reich, PhD, Dr. Beatty’s co-author, is an international health policy expert at Harvard. He and the physicians had approached CDC about the elimination of services. He said in an interview, “We’re still unable to get clear responses except for something along the lines of, ‘We are working on it. It is complicated. It takes time. We’re doing our best.’”

Dr. Reich added, “For me, this raises troubling issues both of transparency and accountability – transparency about what is going on and what the problems are, and accountability in terms of who’s being held responsible for the closures and the impacts on both public health and patient treatment.”

Dr. Beatty concluded, “I think the goal of our group was to bring more awareness to the importance of having a national laboratory that can service all people, even the most underserved and vulnerable populations.” He added, “Chagas disease is a disease of inequity in Latin Americans. Without having access to an appropriate laboratory such as the CDC, we would be taking a backwards approach to tackle neglected tropical diseases in our country and worldwide.”

Dr. Beatty and Dr. Reich report no relevant financial relationships.

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

The Centers for Disease Control and Prevention has long been the premier reference lab for the United States and, for some diseases, internationally. But the agency stopped testing for parasites more than 6 months ago, and public health experts say that’s putting vulnerable populations even more at risk.

In September 2021, the CDC stated on its website that it would stop testing for parasites, herpesvirus encephalitis, human herpesvirus 6 and 7, Epstein-Barr virus, and other viruses, saying, “We are working diligently to implement laboratory system improvements.”

At the time, the CDC said testing would be halted only for a few months.

In response to a query from this news organization, a CDC spokesperson replied, “While at present we are unable to share a detailed timeline, our highest priority is to resume high-quality testing operations in a phased, prioritized approach as soon as possible and to offer the same tests that were available before the pause.”

Several global health clinicians told this news organization that they were not aware of the halt and that they are now uncertain about the specific diagnosis and best treatment for some patients. Other patients have been lost to follow-up.

In response, a group of tropical disease specialists who focus on neglected tropical diseases (NTDs) wrote an editorial, “Neglected Testing for Neglected Tropical Diseases at the CDC,” which recently appeared in the American Journal of Tropical Medicine and Hygiene (AJTMH).

NTDs are caused by viruses, bacteria, and parasites. They include leprosy and worms; many such diseases are disfiguring, such as filariasis (which causes the hugely swollen extremities of elephantiasis) and onchocerciasis (river blindness). They also include some viral and bacterial diseases. Their common denominator is that they are diseases of poverty, primarily in Africa, Asia, and Latin America, so they garner little attention from “first world” countries.

The loss of testing for two devastating parasites – Chagas and Leishmania – was particularly significant. Few other labs in the United States test for these, and the tests can be expensive and of variable quality, experts said.

Norman Beatty, MD, a global health physician at the University of Florida, told this news organization, “Chagas confirmatory testing is only available at the CDC and is the most reliable testing we have access to in the United States. Leishmania species identification is also only available at the CDC and is important in determining which antiparasitic medications we will use.”

Chagas disease is caused by the parasite Trypanosoma cruzi and is transmitted by triatomine bugs, also known as kissing bugs. Chagas is a major cause of an enlarged heart and congestive heart failure, as well as a dramatically enlarged esophagus or colon.

Prior to the cuts and before COVID-19, the CDC reported that they ran 10,000 to 15,000 tests for parasitic diseases annually. Testing requests declined during COVID. In 2021, they ran 1,003 tests for Chagas.

Dr. Beatty said that he first became aware of the CDC’s testing cuts last fall when he sought care for a patient. He was first told the delay would be 2-3 weeks, then another 2-3 weeks. It’s now been 7 months, and only three tests have been resumed.

Dr. Beatty added that for Chagas disease in particular, there is urgency in testing because cardiac complications can be life-threatening. He said that “a lot of these diseases can be considered rare, but they also have a tremendous ability to cause morbidity and mortality.”

Leishmania infections are also serious. Following the bite of an infected sandfly, they can cause disfiguring skin infections, but, more importantly, they can affect the liver, spleen, and bone marrow. Dr. Beatty said that since testing was dropped at the CDC, some colleagues had to send specimens outside of the country.

Dr. Beatty emphasized that the cuts in testing at the CDC highlight disparities in our society. “There are other commercial reference laboratories who may have some of these tests available, but the vast majority of people who suffer from diseases are underserved and vulnerable. [My patients] most definitely will not have access to advanced testing commercial laboratories,” Dr. Beatty said. Those laboratories include Associated Regional University Pathologists laboratories, Quest Diagnostics, and LabCorp Diagnostics. But for some parasitic infections, there will simply be no testing, and patients will not receive appropriate therapy.

The CDC’s website says, “USAID and CDC work together on a shared agenda to advance global progress towards the control and elimination of NTDs that can be addressed with preventive chemotherapy. ... CDC has strong working relationships with WHO, regional reference laboratories/bodies, [and] national NTD programs ... working with these partners through the provision of unique laboratory, diagnostic, and epidemiological technical assistance.”

The WHO Roadmap for 2030 aims to prevent and control many NTDs, in part by “providing new interventions and effective, standardized, and affordable diagnostics.” Last year, the CDC said that they “will continue working with WHO and other global partners to meet the established goals.”

But testing for a number of NTDs is not currently available at the CDC. In response to questions from this news organization, a CDC spokesperson said the agency “supports the development of country capacity for NTD testing required ... but does not perform testing related to the WHO Roadmap.”

A group of CDC officials wrote an editorial response that was published in AJTMH, saying the agency has “three main priorities: reducing parasitic disease-related death, illness, and disability in the United States; reducing the global burden of malaria; and eliminating targeted neglected tropical diseases.”

In response to this news organization’s interview request, a CDC spokesperson wrote, “CDC is unwavering in our commitment to provide the highest quality laboratory diagnostic services for parasitic diseases. We understand the concerns expressed in the editorial and the challenges the pause in testing for parasitic diseases presents for health care providers, particularly those treating people at elevated risk for parasitic diseases.”

Michael Reich, PhD, Dr. Beatty’s co-author, is an international health policy expert at Harvard. He and the physicians had approached CDC about the elimination of services. He said in an interview, “We’re still unable to get clear responses except for something along the lines of, ‘We are working on it. It is complicated. It takes time. We’re doing our best.’”

Dr. Reich added, “For me, this raises troubling issues both of transparency and accountability – transparency about what is going on and what the problems are, and accountability in terms of who’s being held responsible for the closures and the impacts on both public health and patient treatment.”

Dr. Beatty concluded, “I think the goal of our group was to bring more awareness to the importance of having a national laboratory that can service all people, even the most underserved and vulnerable populations.” He added, “Chagas disease is a disease of inequity in Latin Americans. Without having access to an appropriate laboratory such as the CDC, we would be taking a backwards approach to tackle neglected tropical diseases in our country and worldwide.”

Dr. Beatty and Dr. Reich report no relevant financial relationships.

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

The Centers for Disease Control and Prevention has long been the premier reference lab for the United States and, for some diseases, internationally. But the agency stopped testing for parasites more than 6 months ago, and public health experts say that’s putting vulnerable populations even more at risk.

In September 2021, the CDC stated on its website that it would stop testing for parasites, herpesvirus encephalitis, human herpesvirus 6 and 7, Epstein-Barr virus, and other viruses, saying, “We are working diligently to implement laboratory system improvements.”

At the time, the CDC said testing would be halted only for a few months.

In response to a query from this news organization, a CDC spokesperson replied, “While at present we are unable to share a detailed timeline, our highest priority is to resume high-quality testing operations in a phased, prioritized approach as soon as possible and to offer the same tests that were available before the pause.”

Several global health clinicians told this news organization that they were not aware of the halt and that they are now uncertain about the specific diagnosis and best treatment for some patients. Other patients have been lost to follow-up.

In response, a group of tropical disease specialists who focus on neglected tropical diseases (NTDs) wrote an editorial, “Neglected Testing for Neglected Tropical Diseases at the CDC,” which recently appeared in the American Journal of Tropical Medicine and Hygiene (AJTMH).

NTDs are caused by viruses, bacteria, and parasites. They include leprosy and worms; many such diseases are disfiguring, such as filariasis (which causes the hugely swollen extremities of elephantiasis) and onchocerciasis (river blindness). They also include some viral and bacterial diseases. Their common denominator is that they are diseases of poverty, primarily in Africa, Asia, and Latin America, so they garner little attention from “first world” countries.

The loss of testing for two devastating parasites – Chagas and Leishmania – was particularly significant. Few other labs in the United States test for these, and the tests can be expensive and of variable quality, experts said.

Norman Beatty, MD, a global health physician at the University of Florida, told this news organization, “Chagas confirmatory testing is only available at the CDC and is the most reliable testing we have access to in the United States. Leishmania species identification is also only available at the CDC and is important in determining which antiparasitic medications we will use.”

Chagas disease is caused by the parasite Trypanosoma cruzi and is transmitted by triatomine bugs, also known as kissing bugs. Chagas is a major cause of an enlarged heart and congestive heart failure, as well as a dramatically enlarged esophagus or colon.

Prior to the cuts and before COVID-19, the CDC reported that they ran 10,000 to 15,000 tests for parasitic diseases annually. Testing requests declined during COVID. In 2021, they ran 1,003 tests for Chagas.

Dr. Beatty said that he first became aware of the CDC’s testing cuts last fall when he sought care for a patient. He was first told the delay would be 2-3 weeks, then another 2-3 weeks. It’s now been 7 months, and only three tests have been resumed.

Dr. Beatty added that for Chagas disease in particular, there is urgency in testing because cardiac complications can be life-threatening. He said that “a lot of these diseases can be considered rare, but they also have a tremendous ability to cause morbidity and mortality.”

Leishmania infections are also serious. Following the bite of an infected sandfly, they can cause disfiguring skin infections, but, more importantly, they can affect the liver, spleen, and bone marrow. Dr. Beatty said that since testing was dropped at the CDC, some colleagues had to send specimens outside of the country.

Dr. Beatty emphasized that the cuts in testing at the CDC highlight disparities in our society. “There are other commercial reference laboratories who may have some of these tests available, but the vast majority of people who suffer from diseases are underserved and vulnerable. [My patients] most definitely will not have access to advanced testing commercial laboratories,” Dr. Beatty said. Those laboratories include Associated Regional University Pathologists laboratories, Quest Diagnostics, and LabCorp Diagnostics. But for some parasitic infections, there will simply be no testing, and patients will not receive appropriate therapy.

The CDC’s website says, “USAID and CDC work together on a shared agenda to advance global progress towards the control and elimination of NTDs that can be addressed with preventive chemotherapy. ... CDC has strong working relationships with WHO, regional reference laboratories/bodies, [and] national NTD programs ... working with these partners through the provision of unique laboratory, diagnostic, and epidemiological technical assistance.”

The WHO Roadmap for 2030 aims to prevent and control many NTDs, in part by “providing new interventions and effective, standardized, and affordable diagnostics.” Last year, the CDC said that they “will continue working with WHO and other global partners to meet the established goals.”

But testing for a number of NTDs is not currently available at the CDC. In response to questions from this news organization, a CDC spokesperson said the agency “supports the development of country capacity for NTD testing required ... but does not perform testing related to the WHO Roadmap.”

A group of CDC officials wrote an editorial response that was published in AJTMH, saying the agency has “three main priorities: reducing parasitic disease-related death, illness, and disability in the United States; reducing the global burden of malaria; and eliminating targeted neglected tropical diseases.”

In response to this news organization’s interview request, a CDC spokesperson wrote, “CDC is unwavering in our commitment to provide the highest quality laboratory diagnostic services for parasitic diseases. We understand the concerns expressed in the editorial and the challenges the pause in testing for parasitic diseases presents for health care providers, particularly those treating people at elevated risk for parasitic diseases.”

Michael Reich, PhD, Dr. Beatty’s co-author, is an international health policy expert at Harvard. He and the physicians had approached CDC about the elimination of services. He said in an interview, “We’re still unable to get clear responses except for something along the lines of, ‘We are working on it. It is complicated. It takes time. We’re doing our best.’”

Dr. Reich added, “For me, this raises troubling issues both of transparency and accountability – transparency about what is going on and what the problems are, and accountability in terms of who’s being held responsible for the closures and the impacts on both public health and patient treatment.”

Dr. Beatty concluded, “I think the goal of our group was to bring more awareness to the importance of having a national laboratory that can service all people, even the most underserved and vulnerable populations.” He added, “Chagas disease is a disease of inequity in Latin Americans. Without having access to an appropriate laboratory such as the CDC, we would be taking a backwards approach to tackle neglected tropical diseases in our country and worldwide.”

Dr. Beatty and Dr. Reich report no relevant financial relationships.

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

Marcus Welby, MD, was a fictitious hometown doctor featured in a TV drama with the same name that was shown on ABC from 1969 to 1976. Played by actor Robert Young, Dr. Welby treated his patients through their bouts with breast cancer, impotence, and Alzheimer’s disease.

Dr. Welby likely wouldn’t recognize the practice of medicine today, where nearly three quarters (73.9%) of physicians are employed by hospitals, health systems, or corporate entities, according to a recent report sponsored by the Physicians Advocacy Institute and prepared by consulting firm Avalere Health.

“COVID-19 drove physicians to leave private practice for employment at an even more rapid pace than we’ve seen in recent years, and these trends continued to accelerate in 2021,” Kelly Kenney, chief executive officer of Physicians Advocacy Institute, said in an announcement. “This study underscores the fact that physicians across the nation are facing severe burnout and strain. The pressures of the pandemic forced many independent physicians to make difficult decisions to sell their practices, health insurers, or other corporate entities.”

Corporate entities are defined in the report as health insurers, private equity firms, and umbrella corporate entities that own multiple physician practices.

“The pandemic has been just brutal ... for nurses and physicians who are caring for patients,” Ms. Kenney told this news organization. “Between the financial stress that the pandemic certainly had on practices, because they certainly had little revenue for a while, and then also we know that the stress that physicians have felt mentally, you can’t overstate that.”

More than half of physician practices owned by hospitals, corporate entities

The Physicians Advocacy Institute has tracked changes in physician employment consistently since 2012, said Ms. Kenney. In 2012, 25% of physicians were employed; that has jumped to nearly 74%, which means the past decade has brought a world of change to the nation’s physicians.

“These are essentially small-business people ... and they were primarily trained to care for patients,” said Ms. Kenney, referring to physicians in independent practice. Still, she understands why physicians would seek employment in the face of “the crushing kind of pressure of having to deal with 20 different payers, pay overhead, and keep the lights on [at the practice].”

According to the report, 108,700 physicians left independent practice to enter employment with hospitals or other corporate entities in the 3-year period that ended in 2021. Seventy-six percent of that shift to employed status among physicians has occurred since the start of the COVID-19 pandemic in March 2020.

From a regional perspective, the report found continued growth among employed physicians across all U.S. regions in the last half of 2020. Hospital- or corporate-owned physician practices increased between 28% and 44%, while the percentage of hospital- or corporate-employed physicians increased between 13% and 24%.

Eighty percent of physicians in the Midwest are employed by hospitals or corporations, which leads the rest of the country, per the report. That’s followed by the Northeast, the West, and the South. Overall, the number of physicians working for such entities increased in all regions.

The report revealed that physician employment by corporations such as health insurers and venture capital firms grew from 92,400 in January 2019 to 142,900 in January 2022.

Hospitals and corporate entities acquired 36,200 physician practices (representing 38% growth) between 2019 and 2021, and the majority of these moves occurred since the pandemic’s start, according to the report.

Value-based care, venture capital firms driving change

Ms. Kenney pointed to value-based care as driving much of this activity by hospitals. “We all embrace [value-based payment], because we need to get a handle on cost, and we want better quality [but] those trends tend to favor integrated systems and systems that can handle a lot of risk and populations of patients.”

Still, the moves by private equity firms and health insurers in this space is relatively new, said Ms. Kenney, who added that her organization started tracking this trend 3 years ago. She pointed to a “marked acceleration” in the trend toward employing physicians and the sale of practices in the 18 months following the pandemic’s start; nonhospital corporate entities drove that steep increase, she said.

Ms. Kenney calls for further study and “guardrails” to respond to “that force in the health care system,” referring to the acquisition of practices by entities such as private equity firms. “Are these big [health care] systems going to continue to see patients in underserved areas, rural areas, and Medicaid patients if it doesn’t make sense financially to do so?

“That’s what we’re teeing up with this research,” added Ms. Kenney. “We are providing information that starts some conversations around what we might want to think about in terms of policies to ensure that we don’t impact patients’ access to care.”

The Physicians Advocacy Institute represents more than 170,000 physicians and medical students. Avalere Health used the IQVIA OneKey database for the report. The researchers studied the 3-year period from Jan. 1, 2019, to Jan. 1, 2022.

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

Marcus Welby, MD, was a fictitious hometown doctor featured in a TV drama with the same name that was shown on ABC from 1969 to 1976. Played by actor Robert Young, Dr. Welby treated his patients through their bouts with breast cancer, impotence, and Alzheimer’s disease.

Dr. Welby likely wouldn’t recognize the practice of medicine today, where nearly three quarters (73.9%) of physicians are employed by hospitals, health systems, or corporate entities, according to a recent report sponsored by the Physicians Advocacy Institute and prepared by consulting firm Avalere Health.

“COVID-19 drove physicians to leave private practice for employment at an even more rapid pace than we’ve seen in recent years, and these trends continued to accelerate in 2021,” Kelly Kenney, chief executive officer of Physicians Advocacy Institute, said in an announcement. “This study underscores the fact that physicians across the nation are facing severe burnout and strain. The pressures of the pandemic forced many independent physicians to make difficult decisions to sell their practices, health insurers, or other corporate entities.”

Corporate entities are defined in the report as health insurers, private equity firms, and umbrella corporate entities that own multiple physician practices.

“The pandemic has been just brutal ... for nurses and physicians who are caring for patients,” Ms. Kenney told this news organization. “Between the financial stress that the pandemic certainly had on practices, because they certainly had little revenue for a while, and then also we know that the stress that physicians have felt mentally, you can’t overstate that.”

More than half of physician practices owned by hospitals, corporate entities

The Physicians Advocacy Institute has tracked changes in physician employment consistently since 2012, said Ms. Kenney. In 2012, 25% of physicians were employed; that has jumped to nearly 74%, which means the past decade has brought a world of change to the nation’s physicians.

“These are essentially small-business people ... and they were primarily trained to care for patients,” said Ms. Kenney, referring to physicians in independent practice. Still, she understands why physicians would seek employment in the face of “the crushing kind of pressure of having to deal with 20 different payers, pay overhead, and keep the lights on [at the practice].”

According to the report, 108,700 physicians left independent practice to enter employment with hospitals or other corporate entities in the 3-year period that ended in 2021. Seventy-six percent of that shift to employed status among physicians has occurred since the start of the COVID-19 pandemic in March 2020.

From a regional perspective, the report found continued growth among employed physicians across all U.S. regions in the last half of 2020. Hospital- or corporate-owned physician practices increased between 28% and 44%, while the percentage of hospital- or corporate-employed physicians increased between 13% and 24%.

Eighty percent of physicians in the Midwest are employed by hospitals or corporations, which leads the rest of the country, per the report. That’s followed by the Northeast, the West, and the South. Overall, the number of physicians working for such entities increased in all regions.

The report revealed that physician employment by corporations such as health insurers and venture capital firms grew from 92,400 in January 2019 to 142,900 in January 2022.

Hospitals and corporate entities acquired 36,200 physician practices (representing 38% growth) between 2019 and 2021, and the majority of these moves occurred since the pandemic’s start, according to the report.

Value-based care, venture capital firms driving change

Ms. Kenney pointed to value-based care as driving much of this activity by hospitals. “We all embrace [value-based payment], because we need to get a handle on cost, and we want better quality [but] those trends tend to favor integrated systems and systems that can handle a lot of risk and populations of patients.”

Still, the moves by private equity firms and health insurers in this space is relatively new, said Ms. Kenney, who added that her organization started tracking this trend 3 years ago. She pointed to a “marked acceleration” in the trend toward employing physicians and the sale of practices in the 18 months following the pandemic’s start; nonhospital corporate entities drove that steep increase, she said.

Ms. Kenney calls for further study and “guardrails” to respond to “that force in the health care system,” referring to the acquisition of practices by entities such as private equity firms. “Are these big [health care] systems going to continue to see patients in underserved areas, rural areas, and Medicaid patients if it doesn’t make sense financially to do so?

“That’s what we’re teeing up with this research,” added Ms. Kenney. “We are providing information that starts some conversations around what we might want to think about in terms of policies to ensure that we don’t impact patients’ access to care.”

The Physicians Advocacy Institute represents more than 170,000 physicians and medical students. Avalere Health used the IQVIA OneKey database for the report. The researchers studied the 3-year period from Jan. 1, 2019, to Jan. 1, 2022.

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

Marcus Welby, MD, was a fictitious hometown doctor featured in a TV drama with the same name that was shown on ABC from 1969 to 1976. Played by actor Robert Young, Dr. Welby treated his patients through their bouts with breast cancer, impotence, and Alzheimer’s disease.

Dr. Welby likely wouldn’t recognize the practice of medicine today, where nearly three quarters (73.9%) of physicians are employed by hospitals, health systems, or corporate entities, according to a recent report sponsored by the Physicians Advocacy Institute and prepared by consulting firm Avalere Health.

“COVID-19 drove physicians to leave private practice for employment at an even more rapid pace than we’ve seen in recent years, and these trends continued to accelerate in 2021,” Kelly Kenney, chief executive officer of Physicians Advocacy Institute, said in an announcement. “This study underscores the fact that physicians across the nation are facing severe burnout and strain. The pressures of the pandemic forced many independent physicians to make difficult decisions to sell their practices, health insurers, or other corporate entities.”

Corporate entities are defined in the report as health insurers, private equity firms, and umbrella corporate entities that own multiple physician practices.

“The pandemic has been just brutal ... for nurses and physicians who are caring for patients,” Ms. Kenney told this news organization. “Between the financial stress that the pandemic certainly had on practices, because they certainly had little revenue for a while, and then also we know that the stress that physicians have felt mentally, you can’t overstate that.”

More than half of physician practices owned by hospitals, corporate entities

The Physicians Advocacy Institute has tracked changes in physician employment consistently since 2012, said Ms. Kenney. In 2012, 25% of physicians were employed; that has jumped to nearly 74%, which means the past decade has brought a world of change to the nation’s physicians.

“These are essentially small-business people ... and they were primarily trained to care for patients,” said Ms. Kenney, referring to physicians in independent practice. Still, she understands why physicians would seek employment in the face of “the crushing kind of pressure of having to deal with 20 different payers, pay overhead, and keep the lights on [at the practice].”

According to the report, 108,700 physicians left independent practice to enter employment with hospitals or other corporate entities in the 3-year period that ended in 2021. Seventy-six percent of that shift to employed status among physicians has occurred since the start of the COVID-19 pandemic in March 2020.

From a regional perspective, the report found continued growth among employed physicians across all U.S. regions in the last half of 2020. Hospital- or corporate-owned physician practices increased between 28% and 44%, while the percentage of hospital- or corporate-employed physicians increased between 13% and 24%.

Eighty percent of physicians in the Midwest are employed by hospitals or corporations, which leads the rest of the country, per the report. That’s followed by the Northeast, the West, and the South. Overall, the number of physicians working for such entities increased in all regions.

The report revealed that physician employment by corporations such as health insurers and venture capital firms grew from 92,400 in January 2019 to 142,900 in January 2022.

Hospitals and corporate entities acquired 36,200 physician practices (representing 38% growth) between 2019 and 2021, and the majority of these moves occurred since the pandemic’s start, according to the report.

Value-based care, venture capital firms driving change

Ms. Kenney pointed to value-based care as driving much of this activity by hospitals. “We all embrace [value-based payment], because we need to get a handle on cost, and we want better quality [but] those trends tend to favor integrated systems and systems that can handle a lot of risk and populations of patients.”

Still, the moves by private equity firms and health insurers in this space is relatively new, said Ms. Kenney, who added that her organization started tracking this trend 3 years ago. She pointed to a “marked acceleration” in the trend toward employing physicians and the sale of practices in the 18 months following the pandemic’s start; nonhospital corporate entities drove that steep increase, she said.

Ms. Kenney calls for further study and “guardrails” to respond to “that force in the health care system,” referring to the acquisition of practices by entities such as private equity firms. “Are these big [health care] systems going to continue to see patients in underserved areas, rural areas, and Medicaid patients if it doesn’t make sense financially to do so?

“That’s what we’re teeing up with this research,” added Ms. Kenney. “We are providing information that starts some conversations around what we might want to think about in terms of policies to ensure that we don’t impact patients’ access to care.”

The Physicians Advocacy Institute represents more than 170,000 physicians and medical students. Avalere Health used the IQVIA OneKey database for the report. The researchers studied the 3-year period from Jan. 1, 2019, to Jan. 1, 2022.

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

In the placebo-controlled REDUCE-IT trial, icosapent ethyl (IPE) was linked to a significant reduction in major adverse cardiovascular events (MACE) when administered on top of LDL cholesterol control, but a new substudy suggests a greater relative advantage in those with a prior myocardial infarction.

In the study as a whole, IPE (Vascepa, Amarin) was tied to a 20% reduction in CV death (hazard ratio, 0.80; P = .03), but it climbed to a 30% reduction (HR, 0.70; P = .01) in the subgroup with a prior MI, reported a multinational team of investigators led by Prakriti Gaba, MD, a cardiologist at Brigham and Women’s Hospital, Boston.

On the basis of these data, “the imperative to treat patients who have a history of prior MI is even stronger,” said Deepak L. Bhatt, MD, executive director of interventional cardiovascular programs at Brigham and Women’s Hospital.

The principal investigator of REDUCE-IT and a coauthor of this subanalysis, Dr. Bhatt said in an interview, “The significant reduction in cardiovascular mortality, as well as sudden cardiac death and cardiac arrest, really should make physicians strongly consider this therapy in eligible patients.”

The main results of the REDUCE-IT trial were published more than 3 years ago. It enrolled patients with established CV disease or diabetes with additional risk factors who were on a statin and had elevated triglyceride (TG) levels.

A 25% reduction in MACE reported

In those randomized to IPE, there was about a 25% reduction in the primary composite MACE outcome of cardiovascular death, nonfatal MI, nonfatal stroke, revascularization, and unstable angina relative to placebo. About the same relative reduction was achieved in the key secondary endpoint of CV death, nonfatal MI, and nonfatal stroke.

Some guidelines have been changed on the basis of these data. The National Lipid Association, for example, conferred a class 1 recommendation for adding IPE to other appropriate lipid-reducing therapies in any individual 45 years of age or older with atherosclerotic cardiovascular disease.

This new substudy (J Am Coll Cardiol. 2022 Apr 25; doi: 10.1016/j.jacc.2022.02.035), is likely to be influential for those guidelines not yet revised. In the substudy of the prior MI patients, the relative benefit of IPE for the primary and secondary MACE endpoints were of similar magnitude to the overall study population, but events occurred more frequently in the prior-MI subgroup, greatly increasing the statistical power of the advantage.


 

More MACE in prior MI patients

For example, the primary outcome was observed in 22% of the placebo patients in the overall REDUCE-IT analysis but in 26.1% of those with prior MI, so even though the relative risk reduction remained at about 25%, the statistical strength was a hundred-fold greater (P = .00001 vs. P < .001).

For the key secondary composite MACE endpoint, the relative reduction for those with a prior MI was modestly greater than the study as a whole (HR 0.71 vs. HR. 075) but the statistical strength was again magnified in those with a prior MI (P = .00006 vs. P < .001). In those with a prior MI , the advantage of receiving IPE was similar whether or not there had been a prior revascularization.

The 20% lower rate of all-cause mortality among prior MI patients receiving IPE rather than placebo fell just short of statistical significance (HR, 0.80; P = .054). Ischemic events on IPE were reduced by 35% (P = .0000001) and recurrent MI was reduced by 34% (P = .00009).

In the substudy as well as in the REDUCE-IT trial overall, IPE was well tolerated. A slightly higher rate of atrial fibrillation was reported in both.

The REDUCE-IT substudy evaluated 3,693 patients with a history of MI, representing 45% of the 8,179 patients randomized.

IPE, an ethyl ester of the omega-3 polyunsaturated fatty acid, initially attracted attention for its ability to reduce elevated TG. It was hoped this would address reduce residual risk in patients on maximally reduced LDL cholesterol. However, it is suspected that IPE exerts benefits additive to or independent of TG lowering, according to the authors of the REDUCE-IT substudy. These include attenuation of the inflammatory response, release of nitric oxide, and effects that support stabilization of atherosclerotic plaque.

The investigators reported that the pattern of response supports this theory. In the newly reported substudy, the primary event curves that included nonthrombotic events separated at about 1 year, but even curves for CV death and sudden cardiac death were more delayed.

This delay might be explained “by the slow but steady reduction in plaque volume, mitigation of inflammation, improvements in endothelial function, and membrane stabilization,” according to the authors, who cited studies suggesting each of these effects might not be wholly dependent on TG reductions alone.
 

Prior TG-lowering studies disappointing

In fact, several studies evaluating other strategies for TG reductions have been disappointing, according to an accompanying editorial (J Am Coll Cardiol. 2022 Apr 25; doi: 10.1016/j.jacc.2022.03.001). For example, the STRENGTH trial did not show clinical benefits despite a slightly greater reduction in TGs than that shown in REDUCE-IT (19% reduction vs. 18.3%).

Overall, the REDUCE-IT trial and the prior-MI REDUCE-IT substudy show that there is targetable residual risk in high risk patients on statin therapy. One of the authors of the editorial that accompanied the prior-MI substudy of REDUCE-IT, William E. Boden, MD, professor of medicine, Boston University, emphasized this point. On the basis of REDUCE-IT, he said he believes that IPE should be considered to have broad indications as an adjunctive treatment to other lipid-lowering strategies.

“My practice centers on optimizing secondary prevention in high-risk patients who have elevated TG levels despite well-controlled LDL levels on statins, ezetimibe, or even PCSK-9 [proprotein convertase subtilisin/kexin type 9] inhibitors,” Dr. Boden said in an interview. Patients with diabetes are notorious for presenting with this profile of dyslipidemia, but he added that “even nondiabetics with prior MI, acute coronary syndrome, or revascularization will benefit from the addition of IPE to high-potency statins.”

Although the American Heart Association and the American College of Cardiology have not yet updated their guidelines to include IPE, Dr. Boden pointed out that the European Society of Cardiology, the Canadian Cardiovascular Society, and the American Diabetes Society have.

Dr. Bhatt added that there is a clear message from REDUCE-IT that IPE addresses residual risk.

Targeting the subgroup of high-risk patients with elevated TGs “is easy” because they are so readily identifiable, according to Dr. Bhatt, but he said it should be used for any patient that meet the entry criteria used for REDUCE-IT.

“The overall results of REDUCE-IT were robustly positive, so I wouldn’t just use it in patients with prior MI,” Dr. Bhatt said.

Dr. Bhatt reports financial relationships with more than 20 pharmaceutical companies, including Amarin, which provided funding for this trial. Dr. Boden reports no potential conflicts of interest.

In the placebo-controlled REDUCE-IT trial, icosapent ethyl (IPE) was linked to a significant reduction in major adverse cardiovascular events (MACE) when administered on top of LDL cholesterol control, but a new substudy suggests a greater relative advantage in those with a prior myocardial infarction.

In the study as a whole, IPE (Vascepa, Amarin) was tied to a 20% reduction in CV death (hazard ratio, 0.80; P = .03), but it climbed to a 30% reduction (HR, 0.70; P = .01) in the subgroup with a prior MI, reported a multinational team of investigators led by Prakriti Gaba, MD, a cardiologist at Brigham and Women’s Hospital, Boston.

On the basis of these data, “the imperative to treat patients who have a history of prior MI is even stronger,” said Deepak L. Bhatt, MD, executive director of interventional cardiovascular programs at Brigham and Women’s Hospital.

The principal investigator of REDUCE-IT and a coauthor of this subanalysis, Dr. Bhatt said in an interview, “The significant reduction in cardiovascular mortality, as well as sudden cardiac death and cardiac arrest, really should make physicians strongly consider this therapy in eligible patients.”

The main results of the REDUCE-IT trial were published more than 3 years ago. It enrolled patients with established CV disease or diabetes with additional risk factors who were on a statin and had elevated triglyceride (TG) levels.

A 25% reduction in MACE reported

In those randomized to IPE, there was about a 25% reduction in the primary composite MACE outcome of cardiovascular death, nonfatal MI, nonfatal stroke, revascularization, and unstable angina relative to placebo. About the same relative reduction was achieved in the key secondary endpoint of CV death, nonfatal MI, and nonfatal stroke.

Some guidelines have been changed on the basis of these data. The National Lipid Association, for example, conferred a class 1 recommendation for adding IPE to other appropriate lipid-reducing therapies in any individual 45 years of age or older with atherosclerotic cardiovascular disease.

This new substudy (J Am Coll Cardiol. 2022 Apr 25; doi: 10.1016/j.jacc.2022.02.035), is likely to be influential for those guidelines not yet revised. In the substudy of the prior MI patients, the relative benefit of IPE for the primary and secondary MACE endpoints were of similar magnitude to the overall study population, but events occurred more frequently in the prior-MI subgroup, greatly increasing the statistical power of the advantage.


 

More MACE in prior MI patients

For example, the primary outcome was observed in 22% of the placebo patients in the overall REDUCE-IT analysis but in 26.1% of those with prior MI, so even though the relative risk reduction remained at about 25%, the statistical strength was a hundred-fold greater (P = .00001 vs. P < .001).

For the key secondary composite MACE endpoint, the relative reduction for those with a prior MI was modestly greater than the study as a whole (HR 0.71 vs. HR. 075) but the statistical strength was again magnified in those with a prior MI (P = .00006 vs. P < .001). In those with a prior MI , the advantage of receiving IPE was similar whether or not there had been a prior revascularization.

The 20% lower rate of all-cause mortality among prior MI patients receiving IPE rather than placebo fell just short of statistical significance (HR, 0.80; P = .054). Ischemic events on IPE were reduced by 35% (P = .0000001) and recurrent MI was reduced by 34% (P = .00009).

In the substudy as well as in the REDUCE-IT trial overall, IPE was well tolerated. A slightly higher rate of atrial fibrillation was reported in both.

The REDUCE-IT substudy evaluated 3,693 patients with a history of MI, representing 45% of the 8,179 patients randomized.

IPE, an ethyl ester of the omega-3 polyunsaturated fatty acid, initially attracted attention for its ability to reduce elevated TG. It was hoped this would address reduce residual risk in patients on maximally reduced LDL cholesterol. However, it is suspected that IPE exerts benefits additive to or independent of TG lowering, according to the authors of the REDUCE-IT substudy. These include attenuation of the inflammatory response, release of nitric oxide, and effects that support stabilization of atherosclerotic plaque.

The investigators reported that the pattern of response supports this theory. In the newly reported substudy, the primary event curves that included nonthrombotic events separated at about 1 year, but even curves for CV death and sudden cardiac death were more delayed.

This delay might be explained “by the slow but steady reduction in plaque volume, mitigation of inflammation, improvements in endothelial function, and membrane stabilization,” according to the authors, who cited studies suggesting each of these effects might not be wholly dependent on TG reductions alone.
 

Prior TG-lowering studies disappointing

In fact, several studies evaluating other strategies for TG reductions have been disappointing, according to an accompanying editorial (J Am Coll Cardiol. 2022 Apr 25; doi: 10.1016/j.jacc.2022.03.001). For example, the STRENGTH trial did not show clinical benefits despite a slightly greater reduction in TGs than that shown in REDUCE-IT (19% reduction vs. 18.3%).

Overall, the REDUCE-IT trial and the prior-MI REDUCE-IT substudy show that there is targetable residual risk in high risk patients on statin therapy. One of the authors of the editorial that accompanied the prior-MI substudy of REDUCE-IT, William E. Boden, MD, professor of medicine, Boston University, emphasized this point. On the basis of REDUCE-IT, he said he believes that IPE should be considered to have broad indications as an adjunctive treatment to other lipid-lowering strategies.

“My practice centers on optimizing secondary prevention in high-risk patients who have elevated TG levels despite well-controlled LDL levels on statins, ezetimibe, or even PCSK-9 [proprotein convertase subtilisin/kexin type 9] inhibitors,” Dr. Boden said in an interview. Patients with diabetes are notorious for presenting with this profile of dyslipidemia, but he added that “even nondiabetics with prior MI, acute coronary syndrome, or revascularization will benefit from the addition of IPE to high-potency statins.”

Although the American Heart Association and the American College of Cardiology have not yet updated their guidelines to include IPE, Dr. Boden pointed out that the European Society of Cardiology, the Canadian Cardiovascular Society, and the American Diabetes Society have.

Dr. Bhatt added that there is a clear message from REDUCE-IT that IPE addresses residual risk.

Targeting the subgroup of high-risk patients with elevated TGs “is easy” because they are so readily identifiable, according to Dr. Bhatt, but he said it should be used for any patient that meet the entry criteria used for REDUCE-IT.

“The overall results of REDUCE-IT were robustly positive, so I wouldn’t just use it in patients with prior MI,” Dr. Bhatt said.

Dr. Bhatt reports financial relationships with more than 20 pharmaceutical companies, including Amarin, which provided funding for this trial. Dr. Boden reports no potential conflicts of interest.

In the placebo-controlled REDUCE-IT trial, icosapent ethyl (IPE) was linked to a significant reduction in major adverse cardiovascular events (MACE) when administered on top of LDL cholesterol control, but a new substudy suggests a greater relative advantage in those with a prior myocardial infarction.

In the study as a whole, IPE (Vascepa, Amarin) was tied to a 20% reduction in CV death (hazard ratio, 0.80; P = .03), but it climbed to a 30% reduction (HR, 0.70; P = .01) in the subgroup with a prior MI, reported a multinational team of investigators led by Prakriti Gaba, MD, a cardiologist at Brigham and Women’s Hospital, Boston.

On the basis of these data, “the imperative to treat patients who have a history of prior MI is even stronger,” said Deepak L. Bhatt, MD, executive director of interventional cardiovascular programs at Brigham and Women’s Hospital.

The principal investigator of REDUCE-IT and a coauthor of this subanalysis, Dr. Bhatt said in an interview, “The significant reduction in cardiovascular mortality, as well as sudden cardiac death and cardiac arrest, really should make physicians strongly consider this therapy in eligible patients.”

The main results of the REDUCE-IT trial were published more than 3 years ago. It enrolled patients with established CV disease or diabetes with additional risk factors who were on a statin and had elevated triglyceride (TG) levels.

A 25% reduction in MACE reported

In those randomized to IPE, there was about a 25% reduction in the primary composite MACE outcome of cardiovascular death, nonfatal MI, nonfatal stroke, revascularization, and unstable angina relative to placebo. About the same relative reduction was achieved in the key secondary endpoint of CV death, nonfatal MI, and nonfatal stroke.

Some guidelines have been changed on the basis of these data. The National Lipid Association, for example, conferred a class 1 recommendation for adding IPE to other appropriate lipid-reducing therapies in any individual 45 years of age or older with atherosclerotic cardiovascular disease.

This new substudy (J Am Coll Cardiol. 2022 Apr 25; doi: 10.1016/j.jacc.2022.02.035), is likely to be influential for those guidelines not yet revised. In the substudy of the prior MI patients, the relative benefit of IPE for the primary and secondary MACE endpoints were of similar magnitude to the overall study population, but events occurred more frequently in the prior-MI subgroup, greatly increasing the statistical power of the advantage.


 

More MACE in prior MI patients

For example, the primary outcome was observed in 22% of the placebo patients in the overall REDUCE-IT analysis but in 26.1% of those with prior MI, so even though the relative risk reduction remained at about 25%, the statistical strength was a hundred-fold greater (P = .00001 vs. P < .001).

For the key secondary composite MACE endpoint, the relative reduction for those with a prior MI was modestly greater than the study as a whole (HR 0.71 vs. HR. 075) but the statistical strength was again magnified in those with a prior MI (P = .00006 vs. P < .001). In those with a prior MI , the advantage of receiving IPE was similar whether or not there had been a prior revascularization.

The 20% lower rate of all-cause mortality among prior MI patients receiving IPE rather than placebo fell just short of statistical significance (HR, 0.80; P = .054). Ischemic events on IPE were reduced by 35% (P = .0000001) and recurrent MI was reduced by 34% (P = .00009).

In the substudy as well as in the REDUCE-IT trial overall, IPE was well tolerated. A slightly higher rate of atrial fibrillation was reported in both.

The REDUCE-IT substudy evaluated 3,693 patients with a history of MI, representing 45% of the 8,179 patients randomized.

IPE, an ethyl ester of the omega-3 polyunsaturated fatty acid, initially attracted attention for its ability to reduce elevated TG. It was hoped this would address reduce residual risk in patients on maximally reduced LDL cholesterol. However, it is suspected that IPE exerts benefits additive to or independent of TG lowering, according to the authors of the REDUCE-IT substudy. These include attenuation of the inflammatory response, release of nitric oxide, and effects that support stabilization of atherosclerotic plaque.

The investigators reported that the pattern of response supports this theory. In the newly reported substudy, the primary event curves that included nonthrombotic events separated at about 1 year, but even curves for CV death and sudden cardiac death were more delayed.

This delay might be explained “by the slow but steady reduction in plaque volume, mitigation of inflammation, improvements in endothelial function, and membrane stabilization,” according to the authors, who cited studies suggesting each of these effects might not be wholly dependent on TG reductions alone.
 

Prior TG-lowering studies disappointing

In fact, several studies evaluating other strategies for TG reductions have been disappointing, according to an accompanying editorial (J Am Coll Cardiol. 2022 Apr 25; doi: 10.1016/j.jacc.2022.03.001). For example, the STRENGTH trial did not show clinical benefits despite a slightly greater reduction in TGs than that shown in REDUCE-IT (19% reduction vs. 18.3%).

Overall, the REDUCE-IT trial and the prior-MI REDUCE-IT substudy show that there is targetable residual risk in high risk patients on statin therapy. One of the authors of the editorial that accompanied the prior-MI substudy of REDUCE-IT, William E. Boden, MD, professor of medicine, Boston University, emphasized this point. On the basis of REDUCE-IT, he said he believes that IPE should be considered to have broad indications as an adjunctive treatment to other lipid-lowering strategies.

“My practice centers on optimizing secondary prevention in high-risk patients who have elevated TG levels despite well-controlled LDL levels on statins, ezetimibe, or even PCSK-9 [proprotein convertase subtilisin/kexin type 9] inhibitors,” Dr. Boden said in an interview. Patients with diabetes are notorious for presenting with this profile of dyslipidemia, but he added that “even nondiabetics with prior MI, acute coronary syndrome, or revascularization will benefit from the addition of IPE to high-potency statins.”

Although the American Heart Association and the American College of Cardiology have not yet updated their guidelines to include IPE, Dr. Boden pointed out that the European Society of Cardiology, the Canadian Cardiovascular Society, and the American Diabetes Society have.

Dr. Bhatt added that there is a clear message from REDUCE-IT that IPE addresses residual risk.

Targeting the subgroup of high-risk patients with elevated TGs “is easy” because they are so readily identifiable, according to Dr. Bhatt, but he said it should be used for any patient that meet the entry criteria used for REDUCE-IT.

“The overall results of REDUCE-IT were robustly positive, so I wouldn’t just use it in patients with prior MI,” Dr. Bhatt said.

Dr. Bhatt reports financial relationships with more than 20 pharmaceutical companies, including Amarin, which provided funding for this trial. Dr. Boden reports no potential conflicts of interest.

Remote gait assessment in people with knee osteoarthritis using wearable sensors appears reliable but yields results slightly different from those achieved in the laboratory, researchers from Boston University have found.

As reported at the OARSI 2022 World Congress, there was “good to excellent reliability” in repeated measures collected by patients at home while being instructed via video teleconferencing.

Agreement was “moderate to excellent” when the findings were compared with those recorded in the lab, Michael J. Rose of Boston University reported at the congress, sponsored by the Osteoarthritis Research Society International.

“People walked faster and stood up faster in the lab,” Mr. Rose said. “Later we found that the difference in gait speed was statistically significant between the lab and home environment.”

This has been suggested previously and implies that data collected at home may have “greater ecological validity,” he observed.
 

Accelerated adoption of telehealth

Assessing how well someone walks or can stand from a seated position are well known and important assessments in knee OA, but these have but have traditionally only been done in large and expensive gait labs, Mr. Rose said.

Wearable technologies, such as the ones used in the study he presented, could help move these assessments out into the community. This is particularly timely considering the increased adoption of telehealth practices during the COVID-19 pandemic.

To look at the reliability measurements obtained via wearable sensors versus lab assessments, Mr. Rose and associates set up a substudy within a larger ongoing, single-arm trial looking at the use of digital assessments to measure the efficacy of an exercise intervention in reducing knee pain and improving knee function.

For inclusion in the main trial (n = 60), and hence the substudy (n = 20), participants had to have physician-diagnosed knee OA, be 50 years of age or older, have a body mass index of 40 kg/m² or lower, be able to walk at for a least 20 minutes, and have a score of three or higher on the Knee Injury and Osteoarthritis Outcome Score pain subscale for weight-bearing items.

Acceptance of in-lab versus home testing

The substudy participants (mean age, 70.5 years) all underwent in-person lab visits in which a wearable sensor was placed on each foot and one around the lower back and the participant asked to perform walking and chair stand tests. The latter involved standing from a seated position as quickly as possible without using the arms five times, while the former involved walking 28 meters in two laps of a 7-meter path defined by two cones. These tests were repeated twice.

Participants were then given the equipment to repeat these tests at home; this included the three sensors, a tablet computer, and chair and cones. The home assessments were conducted via video conferencing, with the researchers reminding how to place the sensors correctly. The walking and chair stand tests were then each performed four times: Twice in a row and then a 15-minute rest period before being performed twice in a row again.

The researchers collected participants’ feedback about the process on questionnaires and Likert scales that showed an overall positive experience for the remote home visit, with the median rating being “very likely” to participate in another home visit and that the time commitment required was “very manageable.”
 

Good correlation found

To determine the correlation and the test-retest reliability of the data obtained during the repeated home tasks, Mr. Rose and collaborators used Pearson’s correlation R² and the intra-class correlation coefficients (ICC).

ICCs for various gait and chair stand variables obtained with the sensors were between 0.85 and 0.96 for the test-retest reliability during the remote home visit, and R² ranged between 0.81 and 0.95. Variables include stance, cadence (steps per minute), step duration and length, speed, and chair stand duration.

With regard to the agreement between the home versus lab results, ICCs ranged between 0.63 and 0.9.

“There were some logistical and technological challenges with the approach,” Mr. Rose conceded. “Despite written and verbal instructions, 2 of the 20 participants ended up having gait data that was unusable in the home visit.”

Another limitation is that the study population, while “representative,” contained a higher number of individuals than the general population who identified as being White (95%) and female (85%), and 90% had a college degree.

“Individuals typically representative of an OA population were generally accepting and willing to participate in remote visits showing the feasibility of our approach,” Mr. Rose said.

“We need to determine the responsiveness of gait and chair stand outcomes from wearable sensors at home to change over time.”

The study was sponsored by Boston University with funding from Pfizer and Eli Lilly. The researchers used the OPAL inertial sensor (APDM Wearable Technologies) in the study. Mr. Rose made no personal disclosures. Four of his collaborators were employees of Pfizer and one is an employee of Eli Lilly & Company, all with stock or stock options.

Remote gait assessment in people with knee osteoarthritis using wearable sensors appears reliable but yields results slightly different from those achieved in the laboratory, researchers from Boston University have found.

As reported at the OARSI 2022 World Congress, there was “good to excellent reliability” in repeated measures collected by patients at home while being instructed via video teleconferencing.

Agreement was “moderate to excellent” when the findings were compared with those recorded in the lab, Michael J. Rose of Boston University reported at the congress, sponsored by the Osteoarthritis Research Society International.

“People walked faster and stood up faster in the lab,” Mr. Rose said. “Later we found that the difference in gait speed was statistically significant between the lab and home environment.”

This has been suggested previously and implies that data collected at home may have “greater ecological validity,” he observed.
 

Accelerated adoption of telehealth

Assessing how well someone walks or can stand from a seated position are well known and important assessments in knee OA, but these have but have traditionally only been done in large and expensive gait labs, Mr. Rose said.

Wearable technologies, such as the ones used in the study he presented, could help move these assessments out into the community. This is particularly timely considering the increased adoption of telehealth practices during the COVID-19 pandemic.

To look at the reliability measurements obtained via wearable sensors versus lab assessments, Mr. Rose and associates set up a substudy within a larger ongoing, single-arm trial looking at the use of digital assessments to measure the efficacy of an exercise intervention in reducing knee pain and improving knee function.

For inclusion in the main trial (n = 60), and hence the substudy (n = 20), participants had to have physician-diagnosed knee OA, be 50 years of age or older, have a body mass index of 40 kg/m² or lower, be able to walk at for a least 20 minutes, and have a score of three or higher on the Knee Injury and Osteoarthritis Outcome Score pain subscale for weight-bearing items.

Acceptance of in-lab versus home testing

The substudy participants (mean age, 70.5 years) all underwent in-person lab visits in which a wearable sensor was placed on each foot and one around the lower back and the participant asked to perform walking and chair stand tests. The latter involved standing from a seated position as quickly as possible without using the arms five times, while the former involved walking 28 meters in two laps of a 7-meter path defined by two cones. These tests were repeated twice.

Participants were then given the equipment to repeat these tests at home; this included the three sensors, a tablet computer, and chair and cones. The home assessments were conducted via video conferencing, with the researchers reminding how to place the sensors correctly. The walking and chair stand tests were then each performed four times: Twice in a row and then a 15-minute rest period before being performed twice in a row again.

The researchers collected participants’ feedback about the process on questionnaires and Likert scales that showed an overall positive experience for the remote home visit, with the median rating being “very likely” to participate in another home visit and that the time commitment required was “very manageable.”
 

Good correlation found

To determine the correlation and the test-retest reliability of the data obtained during the repeated home tasks, Mr. Rose and collaborators used Pearson’s correlation R² and the intra-class correlation coefficients (ICC).

ICCs for various gait and chair stand variables obtained with the sensors were between 0.85 and 0.96 for the test-retest reliability during the remote home visit, and R² ranged between 0.81 and 0.95. Variables include stance, cadence (steps per minute), step duration and length, speed, and chair stand duration.

With regard to the agreement between the home versus lab results, ICCs ranged between 0.63 and 0.9.

“There were some logistical and technological challenges with the approach,” Mr. Rose conceded. “Despite written and verbal instructions, 2 of the 20 participants ended up having gait data that was unusable in the home visit.”

Another limitation is that the study population, while “representative,” contained a higher number of individuals than the general population who identified as being White (95%) and female (85%), and 90% had a college degree.

“Individuals typically representative of an OA population were generally accepting and willing to participate in remote visits showing the feasibility of our approach,” Mr. Rose said.

“We need to determine the responsiveness of gait and chair stand outcomes from wearable sensors at home to change over time.”

The study was sponsored by Boston University with funding from Pfizer and Eli Lilly. The researchers used the OPAL inertial sensor (APDM Wearable Technologies) in the study. Mr. Rose made no personal disclosures. Four of his collaborators were employees of Pfizer and one is an employee of Eli Lilly & Company, all with stock or stock options.

Remote gait assessment in people with knee osteoarthritis using wearable sensors appears reliable but yields results slightly different from those achieved in the laboratory, researchers from Boston University have found.

As reported at the OARSI 2022 World Congress, there was “good to excellent reliability” in repeated measures collected by patients at home while being instructed via video teleconferencing.

Agreement was “moderate to excellent” when the findings were compared with those recorded in the lab, Michael J. Rose of Boston University reported at the congress, sponsored by the Osteoarthritis Research Society International.

“People walked faster and stood up faster in the lab,” Mr. Rose said. “Later we found that the difference in gait speed was statistically significant between the lab and home environment.”

This has been suggested previously and implies that data collected at home may have “greater ecological validity,” he observed.
 

Accelerated adoption of telehealth

Assessing how well someone walks or can stand from a seated position are well known and important assessments in knee OA, but these have but have traditionally only been done in large and expensive gait labs, Mr. Rose said.

Wearable technologies, such as the ones used in the study he presented, could help move these assessments out into the community. This is particularly timely considering the increased adoption of telehealth practices during the COVID-19 pandemic.

To look at the reliability measurements obtained via wearable sensors versus lab assessments, Mr. Rose and associates set up a substudy within a larger ongoing, single-arm trial looking at the use of digital assessments to measure the efficacy of an exercise intervention in reducing knee pain and improving knee function.

For inclusion in the main trial (n = 60), and hence the substudy (n = 20), participants had to have physician-diagnosed knee OA, be 50 years of age or older, have a body mass index of 40 kg/m² or lower, be able to walk at for a least 20 minutes, and have a score of three or higher on the Knee Injury and Osteoarthritis Outcome Score pain subscale for weight-bearing items.

Acceptance of in-lab versus home testing

The substudy participants (mean age, 70.5 years) all underwent in-person lab visits in which a wearable sensor was placed on each foot and one around the lower back and the participant asked to perform walking and chair stand tests. The latter involved standing from a seated position as quickly as possible without using the arms five times, while the former involved walking 28 meters in two laps of a 7-meter path defined by two cones. These tests were repeated twice.

Participants were then given the equipment to repeat these tests at home; this included the three sensors, a tablet computer, and chair and cones. The home assessments were conducted via video conferencing, with the researchers reminding how to place the sensors correctly. The walking and chair stand tests were then each performed four times: Twice in a row and then a 15-minute rest period before being performed twice in a row again.

The researchers collected participants’ feedback about the process on questionnaires and Likert scales that showed an overall positive experience for the remote home visit, with the median rating being “very likely” to participate in another home visit and that the time commitment required was “very manageable.”
 

Good correlation found

To determine the correlation and the test-retest reliability of the data obtained during the repeated home tasks, Mr. Rose and collaborators used Pearson’s correlation R² and the intra-class correlation coefficients (ICC).

ICCs for various gait and chair stand variables obtained with the sensors were between 0.85 and 0.96 for the test-retest reliability during the remote home visit, and R² ranged between 0.81 and 0.95. Variables include stance, cadence (steps per minute), step duration and length, speed, and chair stand duration.

With regard to the agreement between the home versus lab results, ICCs ranged between 0.63 and 0.9.

“There were some logistical and technological challenges with the approach,” Mr. Rose conceded. “Despite written and verbal instructions, 2 of the 20 participants ended up having gait data that was unusable in the home visit.”

Another limitation is that the study population, while “representative,” contained a higher number of individuals than the general population who identified as being White (95%) and female (85%), and 90% had a college degree.

“Individuals typically representative of an OA population were generally accepting and willing to participate in remote visits showing the feasibility of our approach,” Mr. Rose said.

“We need to determine the responsiveness of gait and chair stand outcomes from wearable sensors at home to change over time.”

The study was sponsored by Boston University with funding from Pfizer and Eli Lilly. The researchers used the OPAL inertial sensor (APDM Wearable Technologies) in the study. Mr. Rose made no personal disclosures. Four of his collaborators were employees of Pfizer and one is an employee of Eli Lilly & Company, all with stock or stock options.