An alpha-synuclein seed amplification assay (αSyn-SAA) accurately identifies people with Parkinson’s disease, as well as those at risk for Parkinson’s disease and those with early, prodromal symptoms, and provides information on molecular subtypes, new research indicates.

“Identifying an effective biomarker for Parkinson’s disease pathology could have profound implications for the way we treat the condition, potentially making it possible to diagnose people earlier, identify the best treatments for different subsets of patients, and speed up clinical trials,” the study’s co-lead author Andrew Siderowf, MD, of the University of Pennsylvania, Philadelphia, said in a news release.

“Our findings suggest that the αSyn-SAA technique is highly accurate at detecting the biomarker for Parkinson’s disease regardless of the clinical features, making it possible to accurately diagnose the disease in patients at early stages,” added co-lead author Luis Concha-Marambio, PhD, director of research and development at Amprion, San Diego, Calif.

The study was published online in The Lancet Neurology.
 

‘New era’ in Parkinson’s disease

The researchers assessed the usefulness of αSyn-SAA in a cross-sectional analysis of 1,123 participants in the Parkinson’s Progression Markers Initiative (PPMI) cohort from 33 participating academic neurology outpatient practices in 12 countries.

The cohort included individuals with sporadic Parkinson’s disease from LRRK2 or GBA variants, healthy controls, individuals with clinical syndromes prodromal to Parkinson’s disease (rapid eye movement sleep behavior disorder [RBD] or hyposmia), and nonmanifesting carriers of LRRK2 and GBA variants. Cerebrospinal fluid (CSF) samples from each participant were analyzed using αSyn-SAA.

Overall, αSyn-SAA differentiated Parkinson’s disease from healthy controls with 87.7% sensitivity and 96.3% specificity.

Sensitivity of the assay varied across subgroups based on genetic and clinical features. Among genetic Parkinson’s disease subgroups, sensitivity was highest for GBA Parkinson’s disease (95.9%), followed by sporadic Parkinson’s disease (93.3%), and lowest for LRRK2 Parkinson’s disease (67.5%). Among clinical features, hyposmia was the most robust predictor of a positive assay result.

Among all Parkinson’s disease cases with hyposmia, the sensitivity of the assay was 97.2%, compared with 63.0% for Parkinson’s disease without olfactory dysfunction. Combining genetic and clinical features, the sensitivity of positive αSyn-SAA in sporadic Parkinson’s disease with olfactory deficit was 98.6%, compared with 78.3% in sporadic Parkinson’s disease without hyposmia. Most prodromal participants (86%) with RBD and hyposmia had positive αSyn-SAA results, indicating they had α-synuclein aggregates despite not yet being diagnosed with Parkinson’s disease.

Among those recruited based on their loss of smell, 89% (16 of 18 participants) had positive αSyn-SAA results. Similarly, in those with RBD, positive αSyn-SAA results were present in 85% of cases (28 of 33). No other clinical features were associated with a positive αSyn-SAA result.

In participants who carried LRRK2 or GBA variants but had no Parkinson’s disease diagnosis or prodromal symptoms (nonmanifesting carriers), 9% (14 of 159) and 7% (11 of 151), respectively, had positive αSyn-SAA results.

To date, this is the largest analysis of α-Syn-SAA for the biochemical diagnosis of Parkinson’s disease, the researchers said.

The results show that the assay classifies people with Parkinson’s disease with “high sensitivity and specificity, provides information about molecular heterogeneity, and detects prodromal individuals before diagnosis,” they wrote.

“These findings suggest a crucial role for the α-synuclein SAA in therapeutic development, both to identify pathologically defined subgroups of people with Parkinson’s disease and to establish biomarker-defined at-risk cohorts,” they added.

Amprion has commercialized the assay (SYNTap test), which can be ordered online.
 

‘Seminal development’

The authors of an accompanying editorial noted the study “lays the foundation for a biological diagnosis” of Parkinson’s disease. “We have entered a new era of biomarker and treatment development for Parkinson’s disease. The possibility of detecting a misfolded α-synuclein, the pathological hallmark of Parkinson’s disease, by employing an SSA, is a seminal development,” wrote Daniela Berg, MD, PhD, and Christine Klein, MD, with University Hospital Schleswig-Holstein, Germany.

“However, to fully leverage the enormous potential of the α-synuclein seed amplification, the test would have to be performed in blood rather than the CSF, a less invasive approach that has proven to be viable,” they added.

“Although the blood-based method needs to be further elaborated for scalability, α-synuclein SAA is a game changer in Parkinson’s disease diagnostics, research, and treatment trials,” they concluded.

The study was funded by The Michael J. Fox Foundation for Parkinson’s Research and a consortium of more than 40 private and philanthropic partners. Dr. Siderowf has declared consulting for Merck and Parkinson Study Group, and receiving honoraria from Bial. A full list of author disclosures is available with the original article. Dr. Berg and Dr. Klein have reported no relevant financial relationships.
 

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

An alpha-synuclein seed amplification assay (αSyn-SAA) accurately identifies people with Parkinson’s disease, as well as those at risk for Parkinson’s disease and those with early, prodromal symptoms, and provides information on molecular subtypes, new research indicates.

“Identifying an effective biomarker for Parkinson’s disease pathology could have profound implications for the way we treat the condition, potentially making it possible to diagnose people earlier, identify the best treatments for different subsets of patients, and speed up clinical trials,” the study’s co-lead author Andrew Siderowf, MD, of the University of Pennsylvania, Philadelphia, said in a news release.

“Our findings suggest that the αSyn-SAA technique is highly accurate at detecting the biomarker for Parkinson’s disease regardless of the clinical features, making it possible to accurately diagnose the disease in patients at early stages,” added co-lead author Luis Concha-Marambio, PhD, director of research and development at Amprion, San Diego, Calif.

The study was published online in The Lancet Neurology.
 

‘New era’ in Parkinson’s disease

The researchers assessed the usefulness of αSyn-SAA in a cross-sectional analysis of 1,123 participants in the Parkinson’s Progression Markers Initiative (PPMI) cohort from 33 participating academic neurology outpatient practices in 12 countries.

The cohort included individuals with sporadic Parkinson’s disease from LRRK2 or GBA variants, healthy controls, individuals with clinical syndromes prodromal to Parkinson’s disease (rapid eye movement sleep behavior disorder [RBD] or hyposmia), and nonmanifesting carriers of LRRK2 and GBA variants. Cerebrospinal fluid (CSF) samples from each participant were analyzed using αSyn-SAA.

Overall, αSyn-SAA differentiated Parkinson’s disease from healthy controls with 87.7% sensitivity and 96.3% specificity.

Sensitivity of the assay varied across subgroups based on genetic and clinical features. Among genetic Parkinson’s disease subgroups, sensitivity was highest for GBA Parkinson’s disease (95.9%), followed by sporadic Parkinson’s disease (93.3%), and lowest for LRRK2 Parkinson’s disease (67.5%). Among clinical features, hyposmia was the most robust predictor of a positive assay result.

Among all Parkinson’s disease cases with hyposmia, the sensitivity of the assay was 97.2%, compared with 63.0% for Parkinson’s disease without olfactory dysfunction. Combining genetic and clinical features, the sensitivity of positive αSyn-SAA in sporadic Parkinson’s disease with olfactory deficit was 98.6%, compared with 78.3% in sporadic Parkinson’s disease without hyposmia. Most prodromal participants (86%) with RBD and hyposmia had positive αSyn-SAA results, indicating they had α-synuclein aggregates despite not yet being diagnosed with Parkinson’s disease.

Among those recruited based on their loss of smell, 89% (16 of 18 participants) had positive αSyn-SAA results. Similarly, in those with RBD, positive αSyn-SAA results were present in 85% of cases (28 of 33). No other clinical features were associated with a positive αSyn-SAA result.

In participants who carried LRRK2 or GBA variants but had no Parkinson’s disease diagnosis or prodromal symptoms (nonmanifesting carriers), 9% (14 of 159) and 7% (11 of 151), respectively, had positive αSyn-SAA results.

To date, this is the largest analysis of α-Syn-SAA for the biochemical diagnosis of Parkinson’s disease, the researchers said.

The results show that the assay classifies people with Parkinson’s disease with “high sensitivity and specificity, provides information about molecular heterogeneity, and detects prodromal individuals before diagnosis,” they wrote.

“These findings suggest a crucial role for the α-synuclein SAA in therapeutic development, both to identify pathologically defined subgroups of people with Parkinson’s disease and to establish biomarker-defined at-risk cohorts,” they added.

Amprion has commercialized the assay (SYNTap test), which can be ordered online.
 

‘Seminal development’

The authors of an accompanying editorial noted the study “lays the foundation for a biological diagnosis” of Parkinson’s disease. “We have entered a new era of biomarker and treatment development for Parkinson’s disease. The possibility of detecting a misfolded α-synuclein, the pathological hallmark of Parkinson’s disease, by employing an SSA, is a seminal development,” wrote Daniela Berg, MD, PhD, and Christine Klein, MD, with University Hospital Schleswig-Holstein, Germany.

“However, to fully leverage the enormous potential of the α-synuclein seed amplification, the test would have to be performed in blood rather than the CSF, a less invasive approach that has proven to be viable,” they added.

“Although the blood-based method needs to be further elaborated for scalability, α-synuclein SAA is a game changer in Parkinson’s disease diagnostics, research, and treatment trials,” they concluded.

The study was funded by The Michael J. Fox Foundation for Parkinson’s Research and a consortium of more than 40 private and philanthropic partners. Dr. Siderowf has declared consulting for Merck and Parkinson Study Group, and receiving honoraria from Bial. A full list of author disclosures is available with the original article. Dr. Berg and Dr. Klein have reported no relevant financial relationships.
 

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

An alpha-synuclein seed amplification assay (αSyn-SAA) accurately identifies people with Parkinson’s disease, as well as those at risk for Parkinson’s disease and those with early, prodromal symptoms, and provides information on molecular subtypes, new research indicates.

“Identifying an effective biomarker for Parkinson’s disease pathology could have profound implications for the way we treat the condition, potentially making it possible to diagnose people earlier, identify the best treatments for different subsets of patients, and speed up clinical trials,” the study’s co-lead author Andrew Siderowf, MD, of the University of Pennsylvania, Philadelphia, said in a news release.

“Our findings suggest that the αSyn-SAA technique is highly accurate at detecting the biomarker for Parkinson’s disease regardless of the clinical features, making it possible to accurately diagnose the disease in patients at early stages,” added co-lead author Luis Concha-Marambio, PhD, director of research and development at Amprion, San Diego, Calif.

The study was published online in The Lancet Neurology.
 

‘New era’ in Parkinson’s disease

The researchers assessed the usefulness of αSyn-SAA in a cross-sectional analysis of 1,123 participants in the Parkinson’s Progression Markers Initiative (PPMI) cohort from 33 participating academic neurology outpatient practices in 12 countries.

The cohort included individuals with sporadic Parkinson’s disease from LRRK2 or GBA variants, healthy controls, individuals with clinical syndromes prodromal to Parkinson’s disease (rapid eye movement sleep behavior disorder [RBD] or hyposmia), and nonmanifesting carriers of LRRK2 and GBA variants. Cerebrospinal fluid (CSF) samples from each participant were analyzed using αSyn-SAA.

Overall, αSyn-SAA differentiated Parkinson’s disease from healthy controls with 87.7% sensitivity and 96.3% specificity.

Sensitivity of the assay varied across subgroups based on genetic and clinical features. Among genetic Parkinson’s disease subgroups, sensitivity was highest for GBA Parkinson’s disease (95.9%), followed by sporadic Parkinson’s disease (93.3%), and lowest for LRRK2 Parkinson’s disease (67.5%). Among clinical features, hyposmia was the most robust predictor of a positive assay result.

Among all Parkinson’s disease cases with hyposmia, the sensitivity of the assay was 97.2%, compared with 63.0% for Parkinson’s disease without olfactory dysfunction. Combining genetic and clinical features, the sensitivity of positive αSyn-SAA in sporadic Parkinson’s disease with olfactory deficit was 98.6%, compared with 78.3% in sporadic Parkinson’s disease without hyposmia. Most prodromal participants (86%) with RBD and hyposmia had positive αSyn-SAA results, indicating they had α-synuclein aggregates despite not yet being diagnosed with Parkinson’s disease.

Among those recruited based on their loss of smell, 89% (16 of 18 participants) had positive αSyn-SAA results. Similarly, in those with RBD, positive αSyn-SAA results were present in 85% of cases (28 of 33). No other clinical features were associated with a positive αSyn-SAA result.

In participants who carried LRRK2 or GBA variants but had no Parkinson’s disease diagnosis or prodromal symptoms (nonmanifesting carriers), 9% (14 of 159) and 7% (11 of 151), respectively, had positive αSyn-SAA results.

To date, this is the largest analysis of α-Syn-SAA for the biochemical diagnosis of Parkinson’s disease, the researchers said.

The results show that the assay classifies people with Parkinson’s disease with “high sensitivity and specificity, provides information about molecular heterogeneity, and detects prodromal individuals before diagnosis,” they wrote.

“These findings suggest a crucial role for the α-synuclein SAA in therapeutic development, both to identify pathologically defined subgroups of people with Parkinson’s disease and to establish biomarker-defined at-risk cohorts,” they added.

Amprion has commercialized the assay (SYNTap test), which can be ordered online.
 

‘Seminal development’

The authors of an accompanying editorial noted the study “lays the foundation for a biological diagnosis” of Parkinson’s disease. “We have entered a new era of biomarker and treatment development for Parkinson’s disease. The possibility of detecting a misfolded α-synuclein, the pathological hallmark of Parkinson’s disease, by employing an SSA, is a seminal development,” wrote Daniela Berg, MD, PhD, and Christine Klein, MD, with University Hospital Schleswig-Holstein, Germany.

“However, to fully leverage the enormous potential of the α-synuclein seed amplification, the test would have to be performed in blood rather than the CSF, a less invasive approach that has proven to be viable,” they added.

“Although the blood-based method needs to be further elaborated for scalability, α-synuclein SAA is a game changer in Parkinson’s disease diagnostics, research, and treatment trials,” they concluded.

The study was funded by The Michael J. Fox Foundation for Parkinson’s Research and a consortium of more than 40 private and philanthropic partners. Dr. Siderowf has declared consulting for Merck and Parkinson Study Group, and receiving honoraria from Bial. A full list of author disclosures is available with the original article. Dr. Berg and Dr. Klein have reported no relevant financial relationships.
 

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

Food insecurity is linked to a more rapid decline in executive function in older adults, a new study shows.

The findings were reported just weeks after a pandemic-era expansion in Supplemental Nutrition Assistance Program benefits ended, leading to less food assistance for about 5 million people over age 60 who participate in the program.

“Even though we found only a very small association between food insecurity and executive function, it’s still meaningful, because food insecurity is something we can prevent,” lead investigator Boeun Kim, PhD, MPH, RN, postdoctoral fellow at Johns Hopkins University School of Nursing, Baltimore, told this news organization.

The findings were published online  in JAMA Network Open.
 

National data

The number of Americans over 60 with food insecurity has more than doubled since 2007, with an estimated 5.2 million older adults reporting food insecurity in 2020.

Prior studies have linked malnutrition and food insecurity to a decline in cognitive function. Participating in food assistance programs such as SNAP is associated with slower memory decline in older adults.

However, to date, there has been no longitudinal study that has used data from a nationally representative sample of older Americans, which, Dr. Kim said, could limit generalizability of the findings.

To address that issue, investigators analyzed data from 3,037 participants in the National Health and Aging Trends Study, which includes community dwellers age 65 and older who receive Medicare.

Participants reported food insecurity over 7 years, from 2012 to 2019. Data on immediate memory, delayed memory, and executive function were from 2013 to 2020.

Food insecurity was defined as going without groceries due to limited ability or social support; a lack of hot meals related to functional limitation or no help; going without eating because of the inability to feed oneself or no available support; skipping meals due to insufficient food or money; or skipping meals for 5 days or more.

Immediate and delayed recall were assessed using a 10-item word-list memory task, and executive function was measured using a clock drawing test. Each year’s cognitive functions were linked to the prior year’s food insecurity data.

Over 7 years, 417 people, or 12.1%, experienced food insecurity at least once.

Those with food insecurity were more likely to be older, female, part of racial and ethnic minority groups, living alone, obese, and have a lower income and educational attainment, depressive symptoms, social isolation and disability, compared with those without food insecurity.

After adjusting for age, sex, race/ethnicity, educational level, income, marital status, body mass index, functional disability, social isolation, and other potential confounders, researchers found that food insecurity was associated with a more rapid decline in executive function (mean difference in annual change in executive function score, −0.04; 95% confidence interval, −0.09 to −0.003).

Food insecurity was not associated with baseline cognitive function scores or changes in immediate or delayed recall.

“Clinicians should be aware of the experience of food insecurity and the higher risk of cognitive decline so maybe they could do universal screening and refer people with food insecurity to programs that can help them access nutritious meals,” Dr. Kim said.
 

A sign of other problems?

Thomas Vidic, MD, said food insecurity often goes hand-in-hand with lack of medication adherence, lack of regular medical care, and a host of other issues. Dr. Vidic is a neurologist at the Elkhart Clinic, Ind., and an adjunct clinical professor of neurology at Indiana University.

“When a person has food insecurity, they likely have other problems, and they’re going to degenerate faster,” said Dr. Vidic, who was not part of the study. “This is one important component, and it’s one more way of getting a handle on people who are failing.”

Dr. Vidic, who has dealt with the issue of food insecurity with his own patients, said he suspects the self-report nature of the study may hide the true scale of the problem.

“I suspect the numbers might actually be higher,” he said, adding that the study fills a gap in the literature with a large, nationally representative sample.

“We’re looking for issues to help with the elderly as far as what can we do to keep dementia from progressing,” he said. “There are some things that make sense, but we’ve never had this kind of data before.”

The study was funded by the National Institute on Aging. Dr. Kim and Dr. Vidic have reported no relevant financial relationships.

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

Food insecurity is linked to a more rapid decline in executive function in older adults, a new study shows.

The findings were reported just weeks after a pandemic-era expansion in Supplemental Nutrition Assistance Program benefits ended, leading to less food assistance for about 5 million people over age 60 who participate in the program.

“Even though we found only a very small association between food insecurity and executive function, it’s still meaningful, because food insecurity is something we can prevent,” lead investigator Boeun Kim, PhD, MPH, RN, postdoctoral fellow at Johns Hopkins University School of Nursing, Baltimore, told this news organization.

The findings were published online  in JAMA Network Open.
 

National data

The number of Americans over 60 with food insecurity has more than doubled since 2007, with an estimated 5.2 million older adults reporting food insecurity in 2020.

Prior studies have linked malnutrition and food insecurity to a decline in cognitive function. Participating in food assistance programs such as SNAP is associated with slower memory decline in older adults.

However, to date, there has been no longitudinal study that has used data from a nationally representative sample of older Americans, which, Dr. Kim said, could limit generalizability of the findings.

To address that issue, investigators analyzed data from 3,037 participants in the National Health and Aging Trends Study, which includes community dwellers age 65 and older who receive Medicare.

Participants reported food insecurity over 7 years, from 2012 to 2019. Data on immediate memory, delayed memory, and executive function were from 2013 to 2020.

Food insecurity was defined as going without groceries due to limited ability or social support; a lack of hot meals related to functional limitation or no help; going without eating because of the inability to feed oneself or no available support; skipping meals due to insufficient food or money; or skipping meals for 5 days or more.

Immediate and delayed recall were assessed using a 10-item word-list memory task, and executive function was measured using a clock drawing test. Each year’s cognitive functions were linked to the prior year’s food insecurity data.

Over 7 years, 417 people, or 12.1%, experienced food insecurity at least once.

Those with food insecurity were more likely to be older, female, part of racial and ethnic minority groups, living alone, obese, and have a lower income and educational attainment, depressive symptoms, social isolation and disability, compared with those without food insecurity.

After adjusting for age, sex, race/ethnicity, educational level, income, marital status, body mass index, functional disability, social isolation, and other potential confounders, researchers found that food insecurity was associated with a more rapid decline in executive function (mean difference in annual change in executive function score, −0.04; 95% confidence interval, −0.09 to −0.003).

Food insecurity was not associated with baseline cognitive function scores or changes in immediate or delayed recall.

“Clinicians should be aware of the experience of food insecurity and the higher risk of cognitive decline so maybe they could do universal screening and refer people with food insecurity to programs that can help them access nutritious meals,” Dr. Kim said.
 

A sign of other problems?

Thomas Vidic, MD, said food insecurity often goes hand-in-hand with lack of medication adherence, lack of regular medical care, and a host of other issues. Dr. Vidic is a neurologist at the Elkhart Clinic, Ind., and an adjunct clinical professor of neurology at Indiana University.

“When a person has food insecurity, they likely have other problems, and they’re going to degenerate faster,” said Dr. Vidic, who was not part of the study. “This is one important component, and it’s one more way of getting a handle on people who are failing.”

Dr. Vidic, who has dealt with the issue of food insecurity with his own patients, said he suspects the self-report nature of the study may hide the true scale of the problem.

“I suspect the numbers might actually be higher,” he said, adding that the study fills a gap in the literature with a large, nationally representative sample.

“We’re looking for issues to help with the elderly as far as what can we do to keep dementia from progressing,” he said. “There are some things that make sense, but we’ve never had this kind of data before.”

The study was funded by the National Institute on Aging. Dr. Kim and Dr. Vidic have reported no relevant financial relationships.

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

Food insecurity is linked to a more rapid decline in executive function in older adults, a new study shows.

The findings were reported just weeks after a pandemic-era expansion in Supplemental Nutrition Assistance Program benefits ended, leading to less food assistance for about 5 million people over age 60 who participate in the program.

“Even though we found only a very small association between food insecurity and executive function, it’s still meaningful, because food insecurity is something we can prevent,” lead investigator Boeun Kim, PhD, MPH, RN, postdoctoral fellow at Johns Hopkins University School of Nursing, Baltimore, told this news organization.

The findings were published online  in JAMA Network Open.
 

National data

The number of Americans over 60 with food insecurity has more than doubled since 2007, with an estimated 5.2 million older adults reporting food insecurity in 2020.

Prior studies have linked malnutrition and food insecurity to a decline in cognitive function. Participating in food assistance programs such as SNAP is associated with slower memory decline in older adults.

However, to date, there has been no longitudinal study that has used data from a nationally representative sample of older Americans, which, Dr. Kim said, could limit generalizability of the findings.

To address that issue, investigators analyzed data from 3,037 participants in the National Health and Aging Trends Study, which includes community dwellers age 65 and older who receive Medicare.

Participants reported food insecurity over 7 years, from 2012 to 2019. Data on immediate memory, delayed memory, and executive function were from 2013 to 2020.

Food insecurity was defined as going without groceries due to limited ability or social support; a lack of hot meals related to functional limitation or no help; going without eating because of the inability to feed oneself or no available support; skipping meals due to insufficient food or money; or skipping meals for 5 days or more.

Immediate and delayed recall were assessed using a 10-item word-list memory task, and executive function was measured using a clock drawing test. Each year’s cognitive functions were linked to the prior year’s food insecurity data.

Over 7 years, 417 people, or 12.1%, experienced food insecurity at least once.

Those with food insecurity were more likely to be older, female, part of racial and ethnic minority groups, living alone, obese, and have a lower income and educational attainment, depressive symptoms, social isolation and disability, compared with those without food insecurity.

After adjusting for age, sex, race/ethnicity, educational level, income, marital status, body mass index, functional disability, social isolation, and other potential confounders, researchers found that food insecurity was associated with a more rapid decline in executive function (mean difference in annual change in executive function score, −0.04; 95% confidence interval, −0.09 to −0.003).

Food insecurity was not associated with baseline cognitive function scores or changes in immediate or delayed recall.

“Clinicians should be aware of the experience of food insecurity and the higher risk of cognitive decline so maybe they could do universal screening and refer people with food insecurity to programs that can help them access nutritious meals,” Dr. Kim said.
 

A sign of other problems?

Thomas Vidic, MD, said food insecurity often goes hand-in-hand with lack of medication adherence, lack of regular medical care, and a host of other issues. Dr. Vidic is a neurologist at the Elkhart Clinic, Ind., and an adjunct clinical professor of neurology at Indiana University.

“When a person has food insecurity, they likely have other problems, and they’re going to degenerate faster,” said Dr. Vidic, who was not part of the study. “This is one important component, and it’s one more way of getting a handle on people who are failing.”

Dr. Vidic, who has dealt with the issue of food insecurity with his own patients, said he suspects the self-report nature of the study may hide the true scale of the problem.

“I suspect the numbers might actually be higher,” he said, adding that the study fills a gap in the literature with a large, nationally representative sample.

“We’re looking for issues to help with the elderly as far as what can we do to keep dementia from progressing,” he said. “There are some things that make sense, but we’ve never had this kind of data before.”

The study was funded by the National Institute on Aging. Dr. Kim and Dr. Vidic have reported no relevant financial relationships.

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

Findings from a landmark clinical trial in pediatric Crohn’s disease show a clear benefit of adding methotrexate to treatment with the tumor necrosis factor inhibitor (TNFi) adalimumab (Humira) but not to infliximab therapy.

Children initiating treatment with adalimumab plus a low dose of methotrexate experienced a twofold reduction in treatment failure, note the authors of the largest, double-blind, randomized trial to date in pediatric Crohn’s disease. However, children initiating infliximab, another TNFi, had similar outcomes with or without methotrexate.

“We believe these results are practice-changing,” said principal investigator Michael Kappelman, MD, MPH, professor of pediatrics at University of North Carolina, Chapel Hill.

All patients with pediatric Crohn’s disease starting on adalimumab and their parents should be informed that combining the drug with low-dose oral methotrexate improves treatment effectiveness, he said.

“Those without contraindications should be offered combination therapy, and shared decision-making should be incorporated into final treatment decisions. In contrast, most patients starting infliximab are not likely to experience added benefits from low-dose oral methotrexate,” Dr. Kappelman added.

The study was published online  in Gastroenterology and will be presented in early May at Digestive Disease Week® 2023.

Impactful study

“This is an important study, published in a very high-ranking journal, that will have a huge impact on how we practice,” said Jacob Kurowski, MD, department of pediatric gastroenterology, hepatology, and nutrition, Cleveland Clinic Children’s, who wasn’t involved in the study.

Treatment with a TNFi, including infliximab and adalimumab, is a mainstay of pediatric Crohn’s disease therapy. However, not all patients achieve remission, and many lose response over time.

The current trial compared the effectiveness and safety of adding a low-dose of oral methotrexate to adalimumab or infliximab versus TNFi therapy alone in 297 children with Crohn’s disease.

The mean age was 13.9 years, and about two-thirds were boys. None had a prior history of TNFi therapy.

Participants initiating infliximab or adalimumab were randomly allocated (1:1) to oral methotrexate or placebo. Of them, 110 infliximab initiators and 46 adalimumab initiators received methotrexate, while 102 infliximab initiators and 39 adalimumab initiators were given placebo. Methotrexate was administered as a weekly dose of 15 mg for children weighing 40 kg or more, 12.5 mg for children 30 to less than 40 kg, and 10 mg for children 20 to less than 30 kg. All participants received pretreatment with ondansetron 4 mg (or placebo) to prevent nausea and folic acid (1 mg per day). Participants were followed for 12-36 months.

The primary outcome was a failure to achieve or maintain steroid-free remission defined by occurrence of any of the following.

• Short Pediatric Crohn’s Disease Activity Index score of less than 15 by week 26
• Failure to complete a steroid taper by week 16
• SPCDAI score of 15 or higher as a result of active Crohn’s disease at two or more consecutive visits beyond week 26
• Hospitalization or surgery for Crohn’s disease beyond week 26
• Use of corticosteroids for Crohn’s disease for 10 or more weeks cumulatively beyond week 16
• Discontinuation of anti-TNF and/or study drug for lack of effectiveness or toxicity

Overall, 88 of 297 children (30%) experienced treatment failure, including 57 of 212 (27%) on infliximab and 31 of 85 (36%) on adalimumab. Overall, 40 of 156 children (26%) on combination therapy and 48 of 141 (34%) on monotherapy experienced treatment failure.

Kaplan Meier analysis of the overall population showed a nonsignificant trend toward lower event rates with combination therapy (hazard ratio, 0.69; 95% confidence interval, 0.45-1.05; P = .08).

After stratification by TNFi, there was no difference in time to treatment failure among infliximab initiators between combination and monotherapy (HR, 0.93; 95% CI, 0.55-1.56; P = .78). In contrast, among adalimumab initiators, combination therapy was significantly associated with a longer time to treatment failure (HR, 0.40; 95% CI, 0.19-0.81; P = .01).

There was a nonsignificant trend toward lower development of anti-drug antibodies with combination therapy (risk ratio, 0.72 with infliximab and 0.71 with adalimumab). This trend is in line with adult studies and adds substantially to the pediatric literature on this topic, the researchers noted.

No differences in patient-reported outcomes were observed. There were slightly more adverse events with combination therapy, as expected, but fewer serious adverse events.
 

Shared decision-making

Dr. Kappelman noted that the study was not designed to answer the question of which is better – adalimumab plus methotrexate or infliximab alone. “This is an area for future research. At this point, we believe it is an individualized decision, and appropriate counseling is needed to support shared decision-making,” he said.

Nor was the trial designed to evaluate the role of proactive therapeutic drug monitoring. However, proactive TDM is endorsed in the ImproveCareNow Model IBD Care guidelines and was considered standard of care at the 35 study sites.

The findings “suggest strong consideration of using combination therapy for pediatric Crohn’s disease patients initiating adalimumab but not infliximab,” Dr. Kappelman and colleagues said.

“Dissemination and implementation of these findings should lead to improved outcomes in this patient population, including consideration of de-implementation of combination therapy in infliximab treated patients,” they added.

The decision about which approach to use is still very dependent on patients and their providers, Dr. Kurowski said.

“The study shows that you can safely use infliximab as monotherapy, with low risk of antibody formation, while utilizing proactive therapeutic drug monitoring and dose optimization. The study also shows that adalimumab in combination with low-dose methotrexate can be strongly considered when needed.”

The researchers’ standardization of methotrexate doses by weight “is another significant contribution and provides a guide for clinicians,” Dr. Kurowski added.

The study was funded by grants from the Patient-Centered Outcomes Research Institute, the Helmsley Charitable Trust, and National Institute of Arthritis and Musculoskeletal and Skin Diseases. Dr. Kappelman has consulted for AbbVie, Janssen, Pfizer, Takeda, and Lilly; holds shares in Johnson & Johnson; and has received research support from Pfizer, Takeda, Janssen, AbbVie, Lilly, Genentech, Boehringer Ingelheim, Bristol-Myers Squibb, Celtrion, and Arena Pharmaceuticals. Dr. Kurowski reports no relevant financial relationships.

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

Findings from a landmark clinical trial in pediatric Crohn’s disease show a clear benefit of adding methotrexate to treatment with the tumor necrosis factor inhibitor (TNFi) adalimumab (Humira) but not to infliximab therapy.

Children initiating treatment with adalimumab plus a low dose of methotrexate experienced a twofold reduction in treatment failure, note the authors of the largest, double-blind, randomized trial to date in pediatric Crohn’s disease. However, children initiating infliximab, another TNFi, had similar outcomes with or without methotrexate.

“We believe these results are practice-changing,” said principal investigator Michael Kappelman, MD, MPH, professor of pediatrics at University of North Carolina, Chapel Hill.

All patients with pediatric Crohn’s disease starting on adalimumab and their parents should be informed that combining the drug with low-dose oral methotrexate improves treatment effectiveness, he said.

“Those without contraindications should be offered combination therapy, and shared decision-making should be incorporated into final treatment decisions. In contrast, most patients starting infliximab are not likely to experience added benefits from low-dose oral methotrexate,” Dr. Kappelman added.

The study was published online  in Gastroenterology and will be presented in early May at Digestive Disease Week® 2023.

Impactful study

“This is an important study, published in a very high-ranking journal, that will have a huge impact on how we practice,” said Jacob Kurowski, MD, department of pediatric gastroenterology, hepatology, and nutrition, Cleveland Clinic Children’s, who wasn’t involved in the study.

Treatment with a TNFi, including infliximab and adalimumab, is a mainstay of pediatric Crohn’s disease therapy. However, not all patients achieve remission, and many lose response over time.

The current trial compared the effectiveness and safety of adding a low-dose of oral methotrexate to adalimumab or infliximab versus TNFi therapy alone in 297 children with Crohn’s disease.

The mean age was 13.9 years, and about two-thirds were boys. None had a prior history of TNFi therapy.

Participants initiating infliximab or adalimumab were randomly allocated (1:1) to oral methotrexate or placebo. Of them, 110 infliximab initiators and 46 adalimumab initiators received methotrexate, while 102 infliximab initiators and 39 adalimumab initiators were given placebo. Methotrexate was administered as a weekly dose of 15 mg for children weighing 40 kg or more, 12.5 mg for children 30 to less than 40 kg, and 10 mg for children 20 to less than 30 kg. All participants received pretreatment with ondansetron 4 mg (or placebo) to prevent nausea and folic acid (1 mg per day). Participants were followed for 12-36 months.

The primary outcome was a failure to achieve or maintain steroid-free remission defined by occurrence of any of the following.

• Short Pediatric Crohn’s Disease Activity Index score of less than 15 by week 26
• Failure to complete a steroid taper by week 16
• SPCDAI score of 15 or higher as a result of active Crohn’s disease at two or more consecutive visits beyond week 26
• Hospitalization or surgery for Crohn’s disease beyond week 26
• Use of corticosteroids for Crohn’s disease for 10 or more weeks cumulatively beyond week 16
• Discontinuation of anti-TNF and/or study drug for lack of effectiveness or toxicity

Overall, 88 of 297 children (30%) experienced treatment failure, including 57 of 212 (27%) on infliximab and 31 of 85 (36%) on adalimumab. Overall, 40 of 156 children (26%) on combination therapy and 48 of 141 (34%) on monotherapy experienced treatment failure.

Kaplan Meier analysis of the overall population showed a nonsignificant trend toward lower event rates with combination therapy (hazard ratio, 0.69; 95% confidence interval, 0.45-1.05; P = .08).

After stratification by TNFi, there was no difference in time to treatment failure among infliximab initiators between combination and monotherapy (HR, 0.93; 95% CI, 0.55-1.56; P = .78). In contrast, among adalimumab initiators, combination therapy was significantly associated with a longer time to treatment failure (HR, 0.40; 95% CI, 0.19-0.81; P = .01).

There was a nonsignificant trend toward lower development of anti-drug antibodies with combination therapy (risk ratio, 0.72 with infliximab and 0.71 with adalimumab). This trend is in line with adult studies and adds substantially to the pediatric literature on this topic, the researchers noted.

No differences in patient-reported outcomes were observed. There were slightly more adverse events with combination therapy, as expected, but fewer serious adverse events.
 

Shared decision-making

Dr. Kappelman noted that the study was not designed to answer the question of which is better – adalimumab plus methotrexate or infliximab alone. “This is an area for future research. At this point, we believe it is an individualized decision, and appropriate counseling is needed to support shared decision-making,” he said.

Nor was the trial designed to evaluate the role of proactive therapeutic drug monitoring. However, proactive TDM is endorsed in the ImproveCareNow Model IBD Care guidelines and was considered standard of care at the 35 study sites.

The findings “suggest strong consideration of using combination therapy for pediatric Crohn’s disease patients initiating adalimumab but not infliximab,” Dr. Kappelman and colleagues said.

“Dissemination and implementation of these findings should lead to improved outcomes in this patient population, including consideration of de-implementation of combination therapy in infliximab treated patients,” they added.

The decision about which approach to use is still very dependent on patients and their providers, Dr. Kurowski said.

“The study shows that you can safely use infliximab as monotherapy, with low risk of antibody formation, while utilizing proactive therapeutic drug monitoring and dose optimization. The study also shows that adalimumab in combination with low-dose methotrexate can be strongly considered when needed.”

The researchers’ standardization of methotrexate doses by weight “is another significant contribution and provides a guide for clinicians,” Dr. Kurowski added.

The study was funded by grants from the Patient-Centered Outcomes Research Institute, the Helmsley Charitable Trust, and National Institute of Arthritis and Musculoskeletal and Skin Diseases. Dr. Kappelman has consulted for AbbVie, Janssen, Pfizer, Takeda, and Lilly; holds shares in Johnson & Johnson; and has received research support from Pfizer, Takeda, Janssen, AbbVie, Lilly, Genentech, Boehringer Ingelheim, Bristol-Myers Squibb, Celtrion, and Arena Pharmaceuticals. Dr. Kurowski reports no relevant financial relationships.

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

Findings from a landmark clinical trial in pediatric Crohn’s disease show a clear benefit of adding methotrexate to treatment with the tumor necrosis factor inhibitor (TNFi) adalimumab (Humira) but not to infliximab therapy.

Children initiating treatment with adalimumab plus a low dose of methotrexate experienced a twofold reduction in treatment failure, note the authors of the largest, double-blind, randomized trial to date in pediatric Crohn’s disease. However, children initiating infliximab, another TNFi, had similar outcomes with or without methotrexate.

“We believe these results are practice-changing,” said principal investigator Michael Kappelman, MD, MPH, professor of pediatrics at University of North Carolina, Chapel Hill.

All patients with pediatric Crohn’s disease starting on adalimumab and their parents should be informed that combining the drug with low-dose oral methotrexate improves treatment effectiveness, he said.

“Those without contraindications should be offered combination therapy, and shared decision-making should be incorporated into final treatment decisions. In contrast, most patients starting infliximab are not likely to experience added benefits from low-dose oral methotrexate,” Dr. Kappelman added.

The study was published online  in Gastroenterology and will be presented in early May at Digestive Disease Week® 2023.

Impactful study

“This is an important study, published in a very high-ranking journal, that will have a huge impact on how we practice,” said Jacob Kurowski, MD, department of pediatric gastroenterology, hepatology, and nutrition, Cleveland Clinic Children’s, who wasn’t involved in the study.

Treatment with a TNFi, including infliximab and adalimumab, is a mainstay of pediatric Crohn’s disease therapy. However, not all patients achieve remission, and many lose response over time.

The current trial compared the effectiveness and safety of adding a low-dose of oral methotrexate to adalimumab or infliximab versus TNFi therapy alone in 297 children with Crohn’s disease.

The mean age was 13.9 years, and about two-thirds were boys. None had a prior history of TNFi therapy.

Participants initiating infliximab or adalimumab were randomly allocated (1:1) to oral methotrexate or placebo. Of them, 110 infliximab initiators and 46 adalimumab initiators received methotrexate, while 102 infliximab initiators and 39 adalimumab initiators were given placebo. Methotrexate was administered as a weekly dose of 15 mg for children weighing 40 kg or more, 12.5 mg for children 30 to less than 40 kg, and 10 mg for children 20 to less than 30 kg. All participants received pretreatment with ondansetron 4 mg (or placebo) to prevent nausea and folic acid (1 mg per day). Participants were followed for 12-36 months.

The primary outcome was a failure to achieve or maintain steroid-free remission defined by occurrence of any of the following.

• Short Pediatric Crohn’s Disease Activity Index score of less than 15 by week 26
• Failure to complete a steroid taper by week 16
• SPCDAI score of 15 or higher as a result of active Crohn’s disease at two or more consecutive visits beyond week 26
• Hospitalization or surgery for Crohn’s disease beyond week 26
• Use of corticosteroids for Crohn’s disease for 10 or more weeks cumulatively beyond week 16
• Discontinuation of anti-TNF and/or study drug for lack of effectiveness or toxicity

Overall, 88 of 297 children (30%) experienced treatment failure, including 57 of 212 (27%) on infliximab and 31 of 85 (36%) on adalimumab. Overall, 40 of 156 children (26%) on combination therapy and 48 of 141 (34%) on monotherapy experienced treatment failure.

Kaplan Meier analysis of the overall population showed a nonsignificant trend toward lower event rates with combination therapy (hazard ratio, 0.69; 95% confidence interval, 0.45-1.05; P = .08).

After stratification by TNFi, there was no difference in time to treatment failure among infliximab initiators between combination and monotherapy (HR, 0.93; 95% CI, 0.55-1.56; P = .78). In contrast, among adalimumab initiators, combination therapy was significantly associated with a longer time to treatment failure (HR, 0.40; 95% CI, 0.19-0.81; P = .01).

There was a nonsignificant trend toward lower development of anti-drug antibodies with combination therapy (risk ratio, 0.72 with infliximab and 0.71 with adalimumab). This trend is in line with adult studies and adds substantially to the pediatric literature on this topic, the researchers noted.

No differences in patient-reported outcomes were observed. There were slightly more adverse events with combination therapy, as expected, but fewer serious adverse events.
 

Shared decision-making

Dr. Kappelman noted that the study was not designed to answer the question of which is better – adalimumab plus methotrexate or infliximab alone. “This is an area for future research. At this point, we believe it is an individualized decision, and appropriate counseling is needed to support shared decision-making,” he said.

Nor was the trial designed to evaluate the role of proactive therapeutic drug monitoring. However, proactive TDM is endorsed in the ImproveCareNow Model IBD Care guidelines and was considered standard of care at the 35 study sites.

The findings “suggest strong consideration of using combination therapy for pediatric Crohn’s disease patients initiating adalimumab but not infliximab,” Dr. Kappelman and colleagues said.

“Dissemination and implementation of these findings should lead to improved outcomes in this patient population, including consideration of de-implementation of combination therapy in infliximab treated patients,” they added.

The decision about which approach to use is still very dependent on patients and their providers, Dr. Kurowski said.

“The study shows that you can safely use infliximab as monotherapy, with low risk of antibody formation, while utilizing proactive therapeutic drug monitoring and dose optimization. The study also shows that adalimumab in combination with low-dose methotrexate can be strongly considered when needed.”

The researchers’ standardization of methotrexate doses by weight “is another significant contribution and provides a guide for clinicians,” Dr. Kurowski added.

The study was funded by grants from the Patient-Centered Outcomes Research Institute, the Helmsley Charitable Trust, and National Institute of Arthritis and Musculoskeletal and Skin Diseases. Dr. Kappelman has consulted for AbbVie, Janssen, Pfizer, Takeda, and Lilly; holds shares in Johnson & Johnson; and has received research support from Pfizer, Takeda, Janssen, AbbVie, Lilly, Genentech, Boehringer Ingelheim, Bristol-Myers Squibb, Celtrion, and Arena Pharmaceuticals. Dr. Kurowski reports no relevant financial relationships.

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

Early parathyroidectomy within 1 year of diagnosis of primary hyperparathyroidism (PHPT) did not reduce the risk of a sustained decline in kidney function, measured by a decline in estimated glomerular filtration rate (eGFR) of at least 50%, compared with observation (no surgery) in adults aged 60 and older.

Early parathyroidectomy was, however, associated with a reduced adjusted risk of this decline in kidney function in patients with newly diagnosed PHPT who were younger than age 60.

The findings, based on data from close to 43,000 veterans, were published online in Annals of Internal Medicine.

“The important takeaway from our study is that for older adults [age 60 or older] with primary hyperparathyroidism, preservation of kidney function should not be a primary consideration when making decisions about whether to undergo parathyroidectomy,” lead author Carolyn D. Seib, MD, told this news organization.

“It is important that physicians also discuss with their patients the potential long-term benefits of parathyroidectomy related to a reduced risk of fractures, kidney stones, and cardiovascular disease, and improved quality of life, in addition to the need for lifelong surveillance if surgery is declined, weighing these against an individual patient’s risk of surgery,” said Dr. Seib, a surgeon at Palo Alto (Calif.) VA Medical Center.

“However, in patients younger than 60, early parathyroidectomy may prevent progression to chronic kidney disease (CKD) and should be more strongly considered,” she noted.

Parathyroidectomy, she observed, is a low-risk outpatient surgery for most adults.

“Potential complications of surgery include temporary or permanent hoarseness, hypoparathyroidism (low postoperative parathyroid function), bleeding requiring return to the operating room, and complications related to general anesthesia, all of which are rare,” said Dr. Seib.

“Surgery by a high-volume surgeon is associated with a reduced risk of complications, so patients should seek out an experienced parathyroid surgeon,” she emphasized.  

Moreover, parathyroidectomy is the only treatment for primary hyperparathyroidism.
 

Does parathyroidectomy slow loss of kidney function?

Multidisciplinary guidelines recommend parathyroidectomy, at least in part to mitigate the risk for, and effects related to, the progression of CKD in patients with PHPT and an eGFR below 60 mL/min per 1.73 m², the researchers wrote.

However, whether parathyroidectomy slows the loss of kidney function in adults with PHPT is not clear.

Guidelines also state that “observation for PHPT disease progression can be considered when patients have no obvious end organ damage (i.e., eGFR > 60 mL/min per 1.73 m², normal bone mineral density, and no history of kidney stones or fractures),” Dr. Seib noted.  

To address the evidence gap, the researchers emulated a randomized target trial using observational data.

In this type of study, Dr. Seib explained, “although patients aren’t randomly assigned to a treatment, complex statistical methods are used to adjust for baseline confounders in an attempt to emulate random treatment assignment and account for bias that may affect the timing of when patients receive treatment.”

Using national Veterans Health Administration data, researchers identified 43,697 veterans with a new biochemical diagnosis of PHPT, defined as elevated parathyroid hormone (> 65 ng/mL) within 6 months of an elevated serum calcium level (> 32.55 mmol/L or >10.2 mg/dL), from 2000 to 2019.

Of these patients, 3,804 underwent parathyroidectomy within 1 year of diagnosis of PHPT, and 39,893 did not, and instead, a watchful waiting approach was adopted.

To be included in the analysis, patients had to have an eGFR above 30 mL/min per 1.73 m² for 12 months before PHPT diagnosis to exclude secondary or tertiary hyperparathyroidism.

The primary outcome was a sustained decline in eGFR of at least 50% from baseline.

In the overall cohort, patients had a mean pretreatment eGFR of 71.8 mL/min per 1.73 m². The mean age of patients was 67, 88% were men, and 68% were White.

After a median follow-up of 4.9 years, 6.7% of the patients had a decline in eGFR of at least 50%.

The cumulative incidence of this decline in eGFR was 5.1% at 5 years and 10.8% at 10 years in patients who had had early parathyroidectomy compared with 5.1% and 12.0%, respectively, in patients who did not undergo surgery.

In the overall population, the risk of at least a 50% decline in eGFR was similar in the early parathyroidectomy group versus the observation group (adjusted hazard ratio [HR], 0.98, 95% confidence interval [CI], 0.82-1.16).

However, diving deeper showed that parathyroidectomy was associated with a reduced risk of the primary outcome among patients younger than 60 years (adjusted HR, 0.75, 95% CI, 0.59-0.93) but not among those aged 60 or older (adjusted HR, 1.08, 95% CI, 0.87-1.34).

“When participating in shared decision-making for older adults [age 60 and older] with PHPT, clinicians should not consider parathyroidectomy for potential benefits of preservation of kidney function,” the researchers reiterated.

“For younger patients, clinicians should discuss the potential benefit of parathyroidectomy to reduce the risk for CKD and associated complications in adults with PHPT,” they concluded.

The study was funded by the National Institute on Aging. The authors reported no relevant financial relationships.

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

Early parathyroidectomy within 1 year of diagnosis of primary hyperparathyroidism (PHPT) did not reduce the risk of a sustained decline in kidney function, measured by a decline in estimated glomerular filtration rate (eGFR) of at least 50%, compared with observation (no surgery) in adults aged 60 and older.

Early parathyroidectomy was, however, associated with a reduced adjusted risk of this decline in kidney function in patients with newly diagnosed PHPT who were younger than age 60.

The findings, based on data from close to 43,000 veterans, were published online in Annals of Internal Medicine.

“The important takeaway from our study is that for older adults [age 60 or older] with primary hyperparathyroidism, preservation of kidney function should not be a primary consideration when making decisions about whether to undergo parathyroidectomy,” lead author Carolyn D. Seib, MD, told this news organization.

“It is important that physicians also discuss with their patients the potential long-term benefits of parathyroidectomy related to a reduced risk of fractures, kidney stones, and cardiovascular disease, and improved quality of life, in addition to the need for lifelong surveillance if surgery is declined, weighing these against an individual patient’s risk of surgery,” said Dr. Seib, a surgeon at Palo Alto (Calif.) VA Medical Center.

“However, in patients younger than 60, early parathyroidectomy may prevent progression to chronic kidney disease (CKD) and should be more strongly considered,” she noted.

Parathyroidectomy, she observed, is a low-risk outpatient surgery for most adults.

“Potential complications of surgery include temporary or permanent hoarseness, hypoparathyroidism (low postoperative parathyroid function), bleeding requiring return to the operating room, and complications related to general anesthesia, all of which are rare,” said Dr. Seib.

“Surgery by a high-volume surgeon is associated with a reduced risk of complications, so patients should seek out an experienced parathyroid surgeon,” she emphasized.  

Moreover, parathyroidectomy is the only treatment for primary hyperparathyroidism.
 

Does parathyroidectomy slow loss of kidney function?

Multidisciplinary guidelines recommend parathyroidectomy, at least in part to mitigate the risk for, and effects related to, the progression of CKD in patients with PHPT and an eGFR below 60 mL/min per 1.73 m², the researchers wrote.

However, whether parathyroidectomy slows the loss of kidney function in adults with PHPT is not clear.

Guidelines also state that “observation for PHPT disease progression can be considered when patients have no obvious end organ damage (i.e., eGFR > 60 mL/min per 1.73 m², normal bone mineral density, and no history of kidney stones or fractures),” Dr. Seib noted.  

To address the evidence gap, the researchers emulated a randomized target trial using observational data.

In this type of study, Dr. Seib explained, “although patients aren’t randomly assigned to a treatment, complex statistical methods are used to adjust for baseline confounders in an attempt to emulate random treatment assignment and account for bias that may affect the timing of when patients receive treatment.”

Using national Veterans Health Administration data, researchers identified 43,697 veterans with a new biochemical diagnosis of PHPT, defined as elevated parathyroid hormone (> 65 ng/mL) within 6 months of an elevated serum calcium level (> 32.55 mmol/L or >10.2 mg/dL), from 2000 to 2019.

Of these patients, 3,804 underwent parathyroidectomy within 1 year of diagnosis of PHPT, and 39,893 did not, and instead, a watchful waiting approach was adopted.

To be included in the analysis, patients had to have an eGFR above 30 mL/min per 1.73 m² for 12 months before PHPT diagnosis to exclude secondary or tertiary hyperparathyroidism.

The primary outcome was a sustained decline in eGFR of at least 50% from baseline.

In the overall cohort, patients had a mean pretreatment eGFR of 71.8 mL/min per 1.73 m². The mean age of patients was 67, 88% were men, and 68% were White.

After a median follow-up of 4.9 years, 6.7% of the patients had a decline in eGFR of at least 50%.

The cumulative incidence of this decline in eGFR was 5.1% at 5 years and 10.8% at 10 years in patients who had had early parathyroidectomy compared with 5.1% and 12.0%, respectively, in patients who did not undergo surgery.

In the overall population, the risk of at least a 50% decline in eGFR was similar in the early parathyroidectomy group versus the observation group (adjusted hazard ratio [HR], 0.98, 95% confidence interval [CI], 0.82-1.16).

However, diving deeper showed that parathyroidectomy was associated with a reduced risk of the primary outcome among patients younger than 60 years (adjusted HR, 0.75, 95% CI, 0.59-0.93) but not among those aged 60 or older (adjusted HR, 1.08, 95% CI, 0.87-1.34).

“When participating in shared decision-making for older adults [age 60 and older] with PHPT, clinicians should not consider parathyroidectomy for potential benefits of preservation of kidney function,” the researchers reiterated.

“For younger patients, clinicians should discuss the potential benefit of parathyroidectomy to reduce the risk for CKD and associated complications in adults with PHPT,” they concluded.

The study was funded by the National Institute on Aging. The authors reported no relevant financial relationships.

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

Early parathyroidectomy within 1 year of diagnosis of primary hyperparathyroidism (PHPT) did not reduce the risk of a sustained decline in kidney function, measured by a decline in estimated glomerular filtration rate (eGFR) of at least 50%, compared with observation (no surgery) in adults aged 60 and older.

Early parathyroidectomy was, however, associated with a reduced adjusted risk of this decline in kidney function in patients with newly diagnosed PHPT who were younger than age 60.

The findings, based on data from close to 43,000 veterans, were published online in Annals of Internal Medicine.

“The important takeaway from our study is that for older adults [age 60 or older] with primary hyperparathyroidism, preservation of kidney function should not be a primary consideration when making decisions about whether to undergo parathyroidectomy,” lead author Carolyn D. Seib, MD, told this news organization.

“It is important that physicians also discuss with their patients the potential long-term benefits of parathyroidectomy related to a reduced risk of fractures, kidney stones, and cardiovascular disease, and improved quality of life, in addition to the need for lifelong surveillance if surgery is declined, weighing these against an individual patient’s risk of surgery,” said Dr. Seib, a surgeon at Palo Alto (Calif.) VA Medical Center.

“However, in patients younger than 60, early parathyroidectomy may prevent progression to chronic kidney disease (CKD) and should be more strongly considered,” she noted.

Parathyroidectomy, she observed, is a low-risk outpatient surgery for most adults.

“Potential complications of surgery include temporary or permanent hoarseness, hypoparathyroidism (low postoperative parathyroid function), bleeding requiring return to the operating room, and complications related to general anesthesia, all of which are rare,” said Dr. Seib.

“Surgery by a high-volume surgeon is associated with a reduced risk of complications, so patients should seek out an experienced parathyroid surgeon,” she emphasized.  

Moreover, parathyroidectomy is the only treatment for primary hyperparathyroidism.
 

Does parathyroidectomy slow loss of kidney function?

Multidisciplinary guidelines recommend parathyroidectomy, at least in part to mitigate the risk for, and effects related to, the progression of CKD in patients with PHPT and an eGFR below 60 mL/min per 1.73 m², the researchers wrote.

However, whether parathyroidectomy slows the loss of kidney function in adults with PHPT is not clear.

Guidelines also state that “observation for PHPT disease progression can be considered when patients have no obvious end organ damage (i.e., eGFR > 60 mL/min per 1.73 m², normal bone mineral density, and no history of kidney stones or fractures),” Dr. Seib noted.  

To address the evidence gap, the researchers emulated a randomized target trial using observational data.

In this type of study, Dr. Seib explained, “although patients aren’t randomly assigned to a treatment, complex statistical methods are used to adjust for baseline confounders in an attempt to emulate random treatment assignment and account for bias that may affect the timing of when patients receive treatment.”

Using national Veterans Health Administration data, researchers identified 43,697 veterans with a new biochemical diagnosis of PHPT, defined as elevated parathyroid hormone (> 65 ng/mL) within 6 months of an elevated serum calcium level (> 32.55 mmol/L or >10.2 mg/dL), from 2000 to 2019.

Of these patients, 3,804 underwent parathyroidectomy within 1 year of diagnosis of PHPT, and 39,893 did not, and instead, a watchful waiting approach was adopted.

To be included in the analysis, patients had to have an eGFR above 30 mL/min per 1.73 m² for 12 months before PHPT diagnosis to exclude secondary or tertiary hyperparathyroidism.

The primary outcome was a sustained decline in eGFR of at least 50% from baseline.

In the overall cohort, patients had a mean pretreatment eGFR of 71.8 mL/min per 1.73 m². The mean age of patients was 67, 88% were men, and 68% were White.

After a median follow-up of 4.9 years, 6.7% of the patients had a decline in eGFR of at least 50%.

The cumulative incidence of this decline in eGFR was 5.1% at 5 years and 10.8% at 10 years in patients who had had early parathyroidectomy compared with 5.1% and 12.0%, respectively, in patients who did not undergo surgery.

In the overall population, the risk of at least a 50% decline in eGFR was similar in the early parathyroidectomy group versus the observation group (adjusted hazard ratio [HR], 0.98, 95% confidence interval [CI], 0.82-1.16).

However, diving deeper showed that parathyroidectomy was associated with a reduced risk of the primary outcome among patients younger than 60 years (adjusted HR, 0.75, 95% CI, 0.59-0.93) but not among those aged 60 or older (adjusted HR, 1.08, 95% CI, 0.87-1.34).

“When participating in shared decision-making for older adults [age 60 and older] with PHPT, clinicians should not consider parathyroidectomy for potential benefits of preservation of kidney function,” the researchers reiterated.

“For younger patients, clinicians should discuss the potential benefit of parathyroidectomy to reduce the risk for CKD and associated complications in adults with PHPT,” they concluded.

The study was funded by the National Institute on Aging. The authors reported no relevant financial relationships.

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

Case: “Where’s my mommy?”

A 13-year-old girl “D” appeared lifeless in her hospital bed, swallowed by tubes, gauze, and crisp white sheets. She seemed fragile next to the giant machines beeping all around her, as they churned and groaned to keep her alive. She was in the pediatric intensive care unit, a place she had only seen once or twice on TV. Her sleeping mother lay next to her in an uncomfortable-looking recliner chair, curled up in a ball. She abruptly woke up when I walked into the room, doing her best to wipe away 5 days’ worth of worry and sadness from her exhausted face. She saw “Child Psychiatrist” written on my hospital badge, desperately searching my face for answers or a sign of hope.

Her daughter – a straight-A middle school student who loved Taylor Swift and soccer – had overdosed on Tylenol after discovering that she did not make the cheerleading team. I reported that her daughter’s liver enzymes were finally trending down and that she would likely not require a liver transplant. She would survive. As tears welled up in this mother’s eyes, I heard a faint whisper from across the room. “Where’s my mommy?” D was awake and frantically searching the room for her mother, someone who could soothe her in this living nightmare. As the two embraced, I felt tears well up in my eyes as I couldn’t help but think of my own 3-year-old daughter at home. How could I protect her from the sadness and despair that this little girl was feeling? How can we collectively protect every little girl from wanting to end their life?

CDC data: Teen girls need help now

The latest biennial Centers for Disease Control and Prevention Youth Risk Behavior Survey, administered in the fall of 2021, resulted in alarming data showing that mental health has worsened for all adolescents, but especially for girls. The survey was administered to more than 17,000 students in 152 public and private schools throughout the United States, showing that “America’s teen girls are engulfed in a growing wave of sadness, violence, and trauma.”¹ In particular, rates of sadness, suicidal ideation, suicide attempts, and mental health crisis ED visits among girls are the highest reported in a decade. Nearly 60% of girls felt persistent sadness or hopelessness during the past year, double the rate of boys. More than 25% of girls made a suicide plan; this percentage increased 60% over the past 10 years. Alarmingly, ED visits for suicide attempts for girls increased more than 50% in the past 2 years alone.

Even before the COVID-19 pandemic, experts were sounding the alarm on the growing rates of anxiety and depression in U.S. youth. The pandemic-driven isolation, lack of social connection, and missing of major milestones did not help the situation and only deepened the cracks in a faulty mental health care system. Further, civil unrest and social upheaval in the United States felt – and continues to feel – chaotic and unpredictable. For teens, the current cultural climate represents their not-too-distant future as adults, causing worry and anxiety.

In addition to securing their futures through performance in school and extracurricular activities, teenagers are forming their identities. Establishing a personal identity is a difficult task for all teens, though teenage girls face uniquely difficult challenges in our current society. In particular, teenage girls are expected to conform their behaviors to fit societal expectations that may clash with their desires and self-conceptualization. This conflict is further complicated by heightened beauty standards, online hate and competition, academic pressure, and self-doubt. CDC data show that girls experience sexual harassment and cyberbullying at roughly twice the rate of their male counterparts. Girls also experience higher levels of sexual violence and bullying. Alarmingly, 14% of girls reported being forced to have sex at some point in their lives. The sad truth is that, for every 10 teenage girls you know, at least one of them, and probably more, has likely been raped.
 

A call to action for providers

As providers, what can we do about these alarming statistics? It’s easy to become overwhelmed by data on a national level. However, regardless of our current clinical practice situation, we cannot lose sight of the humanity behind these numbers. Five extra minutes of truly listening to our patients, normalizing conversations about mental health, and looking for mental health warning signs (that is, increased isolation, declining function in school, maladaptive coping skills such as self-injurious behavior or substance use) can mean the difference between life and death.

As pediatric providers, formally screening for suicide risk is critical. Specifically, the American Academy of Pediatrics recommends that all youth aged 12 years or older be screened for suicide risk.² In addition to asking families to reduce access to lethal means, it is important to utilize suicide-specific screeners to prevent suicide attempts and deaths in the pediatric community. Pediatric providers must feel prepared to counsel patients and families on suicide prevention and, if this skill set is underdeveloped, appropriate referrals and support must be provided.

At the same time, it is important to note the larger context. This national tragedy has been long-standing and further accelerated by the social isolation and stress of the pandemic. Madigan and colleagues recently showed that the lack of a social outlet resulting from COVID-19 caused an increase in screen time among all children.³ As a result, many teen girls turned to social media to recreate these social connections online.⁴ This dependence on social media for validation has contributed to increased rates of depression by intensifying unrealistic body standards, comparisons, and competition among peers.⁵ However, recent pediatric partnership programs have improved mental health access, reduced ED visits, and increased primary care physician’s comfort with managing mental health concerns.⁶ These programs are called Child Psychiatry Access Programs (CPAPs) and utilize a collaborative care model through which primary care clinicians consult with child and adolescent psychiatrists. CPAPs, while not the entire solution, offer a major step in the right direction toward tackling this mental health crisis in a sustainable, collaborative, and effective way.

As students return to in-person learning, connectedness at school is a powerful protective factor against depression and anxiety. We must infuse resources and support into our schools and teachers, as they stand on the front lines for our children. Specifically, bolstering schools with school counselors and appropriate mental health support staff will help rescue teachers from burnout while also explicitly identifying mental health care as a priority. Finally, modeling positive behavior for families and identifying safe adults at school can help at-risk youth feel more connected. To achieve meaningful improvement in children’s mental health, it is crucial to collaboratively remodel broken systems to ensure that all children are supported early, effectively, and equitably.

Dr. Richards is assistant clinical professor in the department of psychiatry and biobehavioral sciences, program director of the child and adolescent psychiatry fellowship, and associate medical director of the perinatal program at the UCLA Semel Institute for Neuroscience and Human Behavior in Los Angeles.
 

References

1. Centers for Disease Control and Prevention. YRBSS Data Summary & Trends. 2023 Feb 13. https://www.cdc.gov/healthyyouth/data/yrbs/yrbs_data_summary_and_trends.htm

2. American Academy of Pediatrics. Screening for Suicide Risk in Clinical Practice. 2023 Feb 22. https://www.aap.org/en/patient-care/blueprint-for-youth-suicide-prevention/strategies-for-clinical-settings-for-youth-suicide-prevention/screening-for-suicide-risk-in-clinical-practice/

3. Madigan S et al. JAMA Pediatr. 2022;176(12):1188-98. doi: 10.1001/JAMAPEDIATRICS.2022.4116

4. Pew Research Center. Teens, Social Media and Technology 2022. 2022 Aug 10. https://www.pewresearch.org/internet/2022/08/10/teens-social-media-and-technology-2022/

5. Hunt MG et al. J Social Clin Psychology. 2018;37(10):751-68. doi: 10.1521/JSCP.2018.37.10.751

6. Godoy L et al. J Pediatr Health Care. 2022 Dec 16. doi: 10.1016/j.pedhc.2022.11.009.

Case: “Where’s my mommy?”

A 13-year-old girl “D” appeared lifeless in her hospital bed, swallowed by tubes, gauze, and crisp white sheets. She seemed fragile next to the giant machines beeping all around her, as they churned and groaned to keep her alive. She was in the pediatric intensive care unit, a place she had only seen once or twice on TV. Her sleeping mother lay next to her in an uncomfortable-looking recliner chair, curled up in a ball. She abruptly woke up when I walked into the room, doing her best to wipe away 5 days’ worth of worry and sadness from her exhausted face. She saw “Child Psychiatrist” written on my hospital badge, desperately searching my face for answers or a sign of hope.

Her daughter – a straight-A middle school student who loved Taylor Swift and soccer – had overdosed on Tylenol after discovering that she did not make the cheerleading team. I reported that her daughter’s liver enzymes were finally trending down and that she would likely not require a liver transplant. She would survive. As tears welled up in this mother’s eyes, I heard a faint whisper from across the room. “Where’s my mommy?” D was awake and frantically searching the room for her mother, someone who could soothe her in this living nightmare. As the two embraced, I felt tears well up in my eyes as I couldn’t help but think of my own 3-year-old daughter at home. How could I protect her from the sadness and despair that this little girl was feeling? How can we collectively protect every little girl from wanting to end their life?

CDC data: Teen girls need help now

The latest biennial Centers for Disease Control and Prevention Youth Risk Behavior Survey, administered in the fall of 2021, resulted in alarming data showing that mental health has worsened for all adolescents, but especially for girls. The survey was administered to more than 17,000 students in 152 public and private schools throughout the United States, showing that “America’s teen girls are engulfed in a growing wave of sadness, violence, and trauma.”¹ In particular, rates of sadness, suicidal ideation, suicide attempts, and mental health crisis ED visits among girls are the highest reported in a decade. Nearly 60% of girls felt persistent sadness or hopelessness during the past year, double the rate of boys. More than 25% of girls made a suicide plan; this percentage increased 60% over the past 10 years. Alarmingly, ED visits for suicide attempts for girls increased more than 50% in the past 2 years alone.

Even before the COVID-19 pandemic, experts were sounding the alarm on the growing rates of anxiety and depression in U.S. youth. The pandemic-driven isolation, lack of social connection, and missing of major milestones did not help the situation and only deepened the cracks in a faulty mental health care system. Further, civil unrest and social upheaval in the United States felt – and continues to feel – chaotic and unpredictable. For teens, the current cultural climate represents their not-too-distant future as adults, causing worry and anxiety.

In addition to securing their futures through performance in school and extracurricular activities, teenagers are forming their identities. Establishing a personal identity is a difficult task for all teens, though teenage girls face uniquely difficult challenges in our current society. In particular, teenage girls are expected to conform their behaviors to fit societal expectations that may clash with their desires and self-conceptualization. This conflict is further complicated by heightened beauty standards, online hate and competition, academic pressure, and self-doubt. CDC data show that girls experience sexual harassment and cyberbullying at roughly twice the rate of their male counterparts. Girls also experience higher levels of sexual violence and bullying. Alarmingly, 14% of girls reported being forced to have sex at some point in their lives. The sad truth is that, for every 10 teenage girls you know, at least one of them, and probably more, has likely been raped.
 

A call to action for providers

As providers, what can we do about these alarming statistics? It’s easy to become overwhelmed by data on a national level. However, regardless of our current clinical practice situation, we cannot lose sight of the humanity behind these numbers. Five extra minutes of truly listening to our patients, normalizing conversations about mental health, and looking for mental health warning signs (that is, increased isolation, declining function in school, maladaptive coping skills such as self-injurious behavior or substance use) can mean the difference between life and death.

As pediatric providers, formally screening for suicide risk is critical. Specifically, the American Academy of Pediatrics recommends that all youth aged 12 years or older be screened for suicide risk.² In addition to asking families to reduce access to lethal means, it is important to utilize suicide-specific screeners to prevent suicide attempts and deaths in the pediatric community. Pediatric providers must feel prepared to counsel patients and families on suicide prevention and, if this skill set is underdeveloped, appropriate referrals and support must be provided.

At the same time, it is important to note the larger context. This national tragedy has been long-standing and further accelerated by the social isolation and stress of the pandemic. Madigan and colleagues recently showed that the lack of a social outlet resulting from COVID-19 caused an increase in screen time among all children.³ As a result, many teen girls turned to social media to recreate these social connections online.⁴ This dependence on social media for validation has contributed to increased rates of depression by intensifying unrealistic body standards, comparisons, and competition among peers.⁵ However, recent pediatric partnership programs have improved mental health access, reduced ED visits, and increased primary care physician’s comfort with managing mental health concerns.⁶ These programs are called Child Psychiatry Access Programs (CPAPs) and utilize a collaborative care model through which primary care clinicians consult with child and adolescent psychiatrists. CPAPs, while not the entire solution, offer a major step in the right direction toward tackling this mental health crisis in a sustainable, collaborative, and effective way.

As students return to in-person learning, connectedness at school is a powerful protective factor against depression and anxiety. We must infuse resources and support into our schools and teachers, as they stand on the front lines for our children. Specifically, bolstering schools with school counselors and appropriate mental health support staff will help rescue teachers from burnout while also explicitly identifying mental health care as a priority. Finally, modeling positive behavior for families and identifying safe adults at school can help at-risk youth feel more connected. To achieve meaningful improvement in children’s mental health, it is crucial to collaboratively remodel broken systems to ensure that all children are supported early, effectively, and equitably.

Dr. Richards is assistant clinical professor in the department of psychiatry and biobehavioral sciences, program director of the child and adolescent psychiatry fellowship, and associate medical director of the perinatal program at the UCLA Semel Institute for Neuroscience and Human Behavior in Los Angeles.
 

References

1. Centers for Disease Control and Prevention. YRBSS Data Summary & Trends. 2023 Feb 13. https://www.cdc.gov/healthyyouth/data/yrbs/yrbs_data_summary_and_trends.htm

2. American Academy of Pediatrics. Screening for Suicide Risk in Clinical Practice. 2023 Feb 22. https://www.aap.org/en/patient-care/blueprint-for-youth-suicide-prevention/strategies-for-clinical-settings-for-youth-suicide-prevention/screening-for-suicide-risk-in-clinical-practice/

3. Madigan S et al. JAMA Pediatr. 2022;176(12):1188-98. doi: 10.1001/JAMAPEDIATRICS.2022.4116

4. Pew Research Center. Teens, Social Media and Technology 2022. 2022 Aug 10. https://www.pewresearch.org/internet/2022/08/10/teens-social-media-and-technology-2022/

5. Hunt MG et al. J Social Clin Psychology. 2018;37(10):751-68. doi: 10.1521/JSCP.2018.37.10.751

6. Godoy L et al. J Pediatr Health Care. 2022 Dec 16. doi: 10.1016/j.pedhc.2022.11.009.

Case: “Where’s my mommy?”

A 13-year-old girl “D” appeared lifeless in her hospital bed, swallowed by tubes, gauze, and crisp white sheets. She seemed fragile next to the giant machines beeping all around her, as they churned and groaned to keep her alive. She was in the pediatric intensive care unit, a place she had only seen once or twice on TV. Her sleeping mother lay next to her in an uncomfortable-looking recliner chair, curled up in a ball. She abruptly woke up when I walked into the room, doing her best to wipe away 5 days’ worth of worry and sadness from her exhausted face. She saw “Child Psychiatrist” written on my hospital badge, desperately searching my face for answers or a sign of hope.

Her daughter – a straight-A middle school student who loved Taylor Swift and soccer – had overdosed on Tylenol after discovering that she did not make the cheerleading team. I reported that her daughter’s liver enzymes were finally trending down and that she would likely not require a liver transplant. She would survive. As tears welled up in this mother’s eyes, I heard a faint whisper from across the room. “Where’s my mommy?” D was awake and frantically searching the room for her mother, someone who could soothe her in this living nightmare. As the two embraced, I felt tears well up in my eyes as I couldn’t help but think of my own 3-year-old daughter at home. How could I protect her from the sadness and despair that this little girl was feeling? How can we collectively protect every little girl from wanting to end their life?

CDC data: Teen girls need help now

The latest biennial Centers for Disease Control and Prevention Youth Risk Behavior Survey, administered in the fall of 2021, resulted in alarming data showing that mental health has worsened for all adolescents, but especially for girls. The survey was administered to more than 17,000 students in 152 public and private schools throughout the United States, showing that “America’s teen girls are engulfed in a growing wave of sadness, violence, and trauma.”¹ In particular, rates of sadness, suicidal ideation, suicide attempts, and mental health crisis ED visits among girls are the highest reported in a decade. Nearly 60% of girls felt persistent sadness or hopelessness during the past year, double the rate of boys. More than 25% of girls made a suicide plan; this percentage increased 60% over the past 10 years. Alarmingly, ED visits for suicide attempts for girls increased more than 50% in the past 2 years alone.

Even before the COVID-19 pandemic, experts were sounding the alarm on the growing rates of anxiety and depression in U.S. youth. The pandemic-driven isolation, lack of social connection, and missing of major milestones did not help the situation and only deepened the cracks in a faulty mental health care system. Further, civil unrest and social upheaval in the United States felt – and continues to feel – chaotic and unpredictable. For teens, the current cultural climate represents their not-too-distant future as adults, causing worry and anxiety.

In addition to securing their futures through performance in school and extracurricular activities, teenagers are forming their identities. Establishing a personal identity is a difficult task for all teens, though teenage girls face uniquely difficult challenges in our current society. In particular, teenage girls are expected to conform their behaviors to fit societal expectations that may clash with their desires and self-conceptualization. This conflict is further complicated by heightened beauty standards, online hate and competition, academic pressure, and self-doubt. CDC data show that girls experience sexual harassment and cyberbullying at roughly twice the rate of their male counterparts. Girls also experience higher levels of sexual violence and bullying. Alarmingly, 14% of girls reported being forced to have sex at some point in their lives. The sad truth is that, for every 10 teenage girls you know, at least one of them, and probably more, has likely been raped.
 

A call to action for providers

As providers, what can we do about these alarming statistics? It’s easy to become overwhelmed by data on a national level. However, regardless of our current clinical practice situation, we cannot lose sight of the humanity behind these numbers. Five extra minutes of truly listening to our patients, normalizing conversations about mental health, and looking for mental health warning signs (that is, increased isolation, declining function in school, maladaptive coping skills such as self-injurious behavior or substance use) can mean the difference between life and death.

As pediatric providers, formally screening for suicide risk is critical. Specifically, the American Academy of Pediatrics recommends that all youth aged 12 years or older be screened for suicide risk.² In addition to asking families to reduce access to lethal means, it is important to utilize suicide-specific screeners to prevent suicide attempts and deaths in the pediatric community. Pediatric providers must feel prepared to counsel patients and families on suicide prevention and, if this skill set is underdeveloped, appropriate referrals and support must be provided.

At the same time, it is important to note the larger context. This national tragedy has been long-standing and further accelerated by the social isolation and stress of the pandemic. Madigan and colleagues recently showed that the lack of a social outlet resulting from COVID-19 caused an increase in screen time among all children.³ As a result, many teen girls turned to social media to recreate these social connections online.⁴ This dependence on social media for validation has contributed to increased rates of depression by intensifying unrealistic body standards, comparisons, and competition among peers.⁵ However, recent pediatric partnership programs have improved mental health access, reduced ED visits, and increased primary care physician’s comfort with managing mental health concerns.⁶ These programs are called Child Psychiatry Access Programs (CPAPs) and utilize a collaborative care model through which primary care clinicians consult with child and adolescent psychiatrists. CPAPs, while not the entire solution, offer a major step in the right direction toward tackling this mental health crisis in a sustainable, collaborative, and effective way.

As students return to in-person learning, connectedness at school is a powerful protective factor against depression and anxiety. We must infuse resources and support into our schools and teachers, as they stand on the front lines for our children. Specifically, bolstering schools with school counselors and appropriate mental health support staff will help rescue teachers from burnout while also explicitly identifying mental health care as a priority. Finally, modeling positive behavior for families and identifying safe adults at school can help at-risk youth feel more connected. To achieve meaningful improvement in children’s mental health, it is crucial to collaboratively remodel broken systems to ensure that all children are supported early, effectively, and equitably.

Dr. Richards is assistant clinical professor in the department of psychiatry and biobehavioral sciences, program director of the child and adolescent psychiatry fellowship, and associate medical director of the perinatal program at the UCLA Semel Institute for Neuroscience and Human Behavior in Los Angeles.
 

References

1. Centers for Disease Control and Prevention. YRBSS Data Summary & Trends. 2023 Feb 13. https://www.cdc.gov/healthyyouth/data/yrbs/yrbs_data_summary_and_trends.htm

2. American Academy of Pediatrics. Screening for Suicide Risk in Clinical Practice. 2023 Feb 22. https://www.aap.org/en/patient-care/blueprint-for-youth-suicide-prevention/strategies-for-clinical-settings-for-youth-suicide-prevention/screening-for-suicide-risk-in-clinical-practice/

3. Madigan S et al. JAMA Pediatr. 2022;176(12):1188-98. doi: 10.1001/JAMAPEDIATRICS.2022.4116

4. Pew Research Center. Teens, Social Media and Technology 2022. 2022 Aug 10. https://www.pewresearch.org/internet/2022/08/10/teens-social-media-and-technology-2022/

5. Hunt MG et al. J Social Clin Psychology. 2018;37(10):751-68. doi: 10.1521/JSCP.2018.37.10.751

6. Godoy L et al. J Pediatr Health Care. 2022 Dec 16. doi: 10.1016/j.pedhc.2022.11.009.

The number of sentinel events in hospitals in the United States increased by 19% from 2021 to 2022, on the basis of new data from The Joint Commission.

Reporting sentinel events to The Joint Commission began in 1996 as a way to help health care organizations improve safety. The annual review is based on an aggregate database of reports analyzed each year, according to the review authors.

The Joint Commission defines a sentinel event as a patient safety event (not primarily related to the natural course of the patient’s illness or underlying condition) that reaches a patient and results in death, permanent harm (regardless of severity), or severe harm (regardless of duration).

Some of the specific events deemed sentinel include patient suicide while under care in a health care setting, unanticipated death of a full-term infant, homicide of any patient or staff member while on site at a health care organization, any intrapartum maternal death, severe maternal morbidity, sexual abuse or assault of any patient undergoing care in the health care setting, sexual abuse or assault of any staff member providing care, and physical assault of any patient or staff member in the health care setting.

Additional events considered sentinel are related to treatments and procedures. These include surgery in the wrong site; wrong patient or wrong procedure for a given patient; administration of blood or blood products incompatible with the patient that results in death, permanent harm, or severe harm; severe neonatal hyperbilirubinemia; and patient falls.

A total of 1,441 sentinel events were reported in 2022. Patient falls accounted for the majority (42%) of these events, continuing a trend in increasing rates of patient falls from previous years. Falls considered sentinel events were those resulting in any fracture, surgery, casting or traction, consultation or comfort care for neurologic or internal injury, the need for blood products, or death or permanent harm as a result of injuries sustained in the fall. The leading sentinel event types after falls included delay in treatment, unintended retention of a foreign object, and wrong surgery (6% for each). Other sentinel event types in the top 10 accounted for 5% or less of reports: suicide (5%), assault/rape/sexual assault/homicide (4%), fire/burns (3%), perinatal events (2%), self-harm (2%), and medication management (2%).

Overall, 20% of the 2022 events resulted in patient death, 6% in permanent harm or loss of function, 44% in severe temporary harm, and 13% in a need for additional care or an extended hospital stay.

The most common events that led to patient death were suicide (24%), treatment delays (21%), and patient falls (11%). Patient falls also accounted for nearly two-thirds of the events resulting in severe temporary harm (62%).

Most of the events (88%) occurred in hospital settings; of these, the most common were falls (45%), followed by the retention of foreign objects and incorrect surgeries (7% and 6%, respectively). Overall, 90% of sentinel events were reported by the health care organizations; the remaining 10% were reported by patients, families, or employees (current or former).

“Failures in communication, teamwork, and consistently following policies were leading causes for reported sentinel events,” the authors wrote. However, reporting sentinel events is voluntary; therefore “no conclusions should be drawn about the actual relative frequency of events or trends in events over time,” they noted.
 

Increased reporting may not reflect increased occurrence

“It is important to clarify that The Joint Commission saw an increase in reporting of sentinel events; whether this is indicative of an actual increase in occurrence of sentinel events across the country or not is difficult to say, as the reporting is voluntary,” said Haytham Kaafarani, MD, MPH, chief patient safety officer and medical director for The Joint Commission, in an interview.

“However, this is the highest number reported to The Joint Commission since the inception of the sentinel event policy: there were 547 health care organizations that reported sentinel events in 2022, compared to 500 in 2021 and 423 in 2020,” Dr. Kaafarani said. “Having said that, based on published literature, the COVID-19 pandemic stressed our health care systems in many ways including but not limited to staff shortage in times of increased needs, worsening of mental health conditions, and delay in presentation of non–COVID-related medical conditions during the pandemic,” he noted.

Dr. Kaafarani said that The Joint Commission was not surprised by the type of sentinel events reported, which has remained consistent with previous years.

However, The Joint Commission was surprised by the significant increase in the number of reported events, he said. “Since reporting is voluntarily, we welcome the increase in reporting of sentinel events, as it helps The Joint Commission better understand the patient safety landscape across the country, and better helps health care organizations during their difficult times.”

Based on the latest information, “The Joint Commission encourages health care organizations to create research that is focused on preventing patient falls in hospitals,” said Dr. Kaafarani. “With staff shortages reported within many health care organizations, it is now more essential than ever to establish systematic interventions to prevent patient falls and resultant harm.”

The review authors report no relevant financial relationships.

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

The number of sentinel events in hospitals in the United States increased by 19% from 2021 to 2022, on the basis of new data from The Joint Commission.

Reporting sentinel events to The Joint Commission began in 1996 as a way to help health care organizations improve safety. The annual review is based on an aggregate database of reports analyzed each year, according to the review authors.

The Joint Commission defines a sentinel event as a patient safety event (not primarily related to the natural course of the patient’s illness or underlying condition) that reaches a patient and results in death, permanent harm (regardless of severity), or severe harm (regardless of duration).

Some of the specific events deemed sentinel include patient suicide while under care in a health care setting, unanticipated death of a full-term infant, homicide of any patient or staff member while on site at a health care organization, any intrapartum maternal death, severe maternal morbidity, sexual abuse or assault of any patient undergoing care in the health care setting, sexual abuse or assault of any staff member providing care, and physical assault of any patient or staff member in the health care setting.

Additional events considered sentinel are related to treatments and procedures. These include surgery in the wrong site; wrong patient or wrong procedure for a given patient; administration of blood or blood products incompatible with the patient that results in death, permanent harm, or severe harm; severe neonatal hyperbilirubinemia; and patient falls.

A total of 1,441 sentinel events were reported in 2022. Patient falls accounted for the majority (42%) of these events, continuing a trend in increasing rates of patient falls from previous years. Falls considered sentinel events were those resulting in any fracture, surgery, casting or traction, consultation or comfort care for neurologic or internal injury, the need for blood products, or death or permanent harm as a result of injuries sustained in the fall. The leading sentinel event types after falls included delay in treatment, unintended retention of a foreign object, and wrong surgery (6% for each). Other sentinel event types in the top 10 accounted for 5% or less of reports: suicide (5%), assault/rape/sexual assault/homicide (4%), fire/burns (3%), perinatal events (2%), self-harm (2%), and medication management (2%).

Overall, 20% of the 2022 events resulted in patient death, 6% in permanent harm or loss of function, 44% in severe temporary harm, and 13% in a need for additional care or an extended hospital stay.

The most common events that led to patient death were suicide (24%), treatment delays (21%), and patient falls (11%). Patient falls also accounted for nearly two-thirds of the events resulting in severe temporary harm (62%).

Most of the events (88%) occurred in hospital settings; of these, the most common were falls (45%), followed by the retention of foreign objects and incorrect surgeries (7% and 6%, respectively). Overall, 90% of sentinel events were reported by the health care organizations; the remaining 10% were reported by patients, families, or employees (current or former).

“Failures in communication, teamwork, and consistently following policies were leading causes for reported sentinel events,” the authors wrote. However, reporting sentinel events is voluntary; therefore “no conclusions should be drawn about the actual relative frequency of events or trends in events over time,” they noted.
 

Increased reporting may not reflect increased occurrence

“It is important to clarify that The Joint Commission saw an increase in reporting of sentinel events; whether this is indicative of an actual increase in occurrence of sentinel events across the country or not is difficult to say, as the reporting is voluntary,” said Haytham Kaafarani, MD, MPH, chief patient safety officer and medical director for The Joint Commission, in an interview.

“However, this is the highest number reported to The Joint Commission since the inception of the sentinel event policy: there were 547 health care organizations that reported sentinel events in 2022, compared to 500 in 2021 and 423 in 2020,” Dr. Kaafarani said. “Having said that, based on published literature, the COVID-19 pandemic stressed our health care systems in many ways including but not limited to staff shortage in times of increased needs, worsening of mental health conditions, and delay in presentation of non–COVID-related medical conditions during the pandemic,” he noted.

Dr. Kaafarani said that The Joint Commission was not surprised by the type of sentinel events reported, which has remained consistent with previous years.

However, The Joint Commission was surprised by the significant increase in the number of reported events, he said. “Since reporting is voluntarily, we welcome the increase in reporting of sentinel events, as it helps The Joint Commission better understand the patient safety landscape across the country, and better helps health care organizations during their difficult times.”

Based on the latest information, “The Joint Commission encourages health care organizations to create research that is focused on preventing patient falls in hospitals,” said Dr. Kaafarani. “With staff shortages reported within many health care organizations, it is now more essential than ever to establish systematic interventions to prevent patient falls and resultant harm.”

The review authors report no relevant financial relationships.

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

The number of sentinel events in hospitals in the United States increased by 19% from 2021 to 2022, on the basis of new data from The Joint Commission.

Reporting sentinel events to The Joint Commission began in 1996 as a way to help health care organizations improve safety. The annual review is based on an aggregate database of reports analyzed each year, according to the review authors.

The Joint Commission defines a sentinel event as a patient safety event (not primarily related to the natural course of the patient’s illness or underlying condition) that reaches a patient and results in death, permanent harm (regardless of severity), or severe harm (regardless of duration).

Some of the specific events deemed sentinel include patient suicide while under care in a health care setting, unanticipated death of a full-term infant, homicide of any patient or staff member while on site at a health care organization, any intrapartum maternal death, severe maternal morbidity, sexual abuse or assault of any patient undergoing care in the health care setting, sexual abuse or assault of any staff member providing care, and physical assault of any patient or staff member in the health care setting.

Additional events considered sentinel are related to treatments and procedures. These include surgery in the wrong site; wrong patient or wrong procedure for a given patient; administration of blood or blood products incompatible with the patient that results in death, permanent harm, or severe harm; severe neonatal hyperbilirubinemia; and patient falls.

A total of 1,441 sentinel events were reported in 2022. Patient falls accounted for the majority (42%) of these events, continuing a trend in increasing rates of patient falls from previous years. Falls considered sentinel events were those resulting in any fracture, surgery, casting or traction, consultation or comfort care for neurologic or internal injury, the need for blood products, or death or permanent harm as a result of injuries sustained in the fall. The leading sentinel event types after falls included delay in treatment, unintended retention of a foreign object, and wrong surgery (6% for each). Other sentinel event types in the top 10 accounted for 5% or less of reports: suicide (5%), assault/rape/sexual assault/homicide (4%), fire/burns (3%), perinatal events (2%), self-harm (2%), and medication management (2%).

Overall, 20% of the 2022 events resulted in patient death, 6% in permanent harm or loss of function, 44% in severe temporary harm, and 13% in a need for additional care or an extended hospital stay.

The most common events that led to patient death were suicide (24%), treatment delays (21%), and patient falls (11%). Patient falls also accounted for nearly two-thirds of the events resulting in severe temporary harm (62%).

Most of the events (88%) occurred in hospital settings; of these, the most common were falls (45%), followed by the retention of foreign objects and incorrect surgeries (7% and 6%, respectively). Overall, 90% of sentinel events were reported by the health care organizations; the remaining 10% were reported by patients, families, or employees (current or former).

“Failures in communication, teamwork, and consistently following policies were leading causes for reported sentinel events,” the authors wrote. However, reporting sentinel events is voluntary; therefore “no conclusions should be drawn about the actual relative frequency of events or trends in events over time,” they noted.
 

Increased reporting may not reflect increased occurrence

“It is important to clarify that The Joint Commission saw an increase in reporting of sentinel events; whether this is indicative of an actual increase in occurrence of sentinel events across the country or not is difficult to say, as the reporting is voluntary,” said Haytham Kaafarani, MD, MPH, chief patient safety officer and medical director for The Joint Commission, in an interview.

“However, this is the highest number reported to The Joint Commission since the inception of the sentinel event policy: there were 547 health care organizations that reported sentinel events in 2022, compared to 500 in 2021 and 423 in 2020,” Dr. Kaafarani said. “Having said that, based on published literature, the COVID-19 pandemic stressed our health care systems in many ways including but not limited to staff shortage in times of increased needs, worsening of mental health conditions, and delay in presentation of non–COVID-related medical conditions during the pandemic,” he noted.

Dr. Kaafarani said that The Joint Commission was not surprised by the type of sentinel events reported, which has remained consistent with previous years.

However, The Joint Commission was surprised by the significant increase in the number of reported events, he said. “Since reporting is voluntarily, we welcome the increase in reporting of sentinel events, as it helps The Joint Commission better understand the patient safety landscape across the country, and better helps health care organizations during their difficult times.”

Based on the latest information, “The Joint Commission encourages health care organizations to create research that is focused on preventing patient falls in hospitals,” said Dr. Kaafarani. “With staff shortages reported within many health care organizations, it is now more essential than ever to establish systematic interventions to prevent patient falls and resultant harm.”

The review authors report no relevant financial relationships.

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

I imagine I am not alone when I tell you that my blood pressure rises every time I receive an email from CoverMyMeds, or worse, a phone call from a patient to tell me the pharmacist says I need to call their insurance company to get a medication authorized. Prior authorizations (PAs) are the bane of every physician’s existence.

Pharmacy benefit managers (PBMs) and insurers determine what treatment patients may have without regulation, accountability, liability, or transparency. They ask providers to jump through hoops, and no one oversees the placement of these hoops. The process puts patients at risk and sucks the joy from the practice of medicine.

In fall 2021, the legislative committee of the Maryland Psychiatric Society, with the help of Kathy Orellana and Tim Clement from the American Psychiatric Association, drafted a bill to modify the use of PAs. Unfortunately, the bill died in committee during the 2022 Maryland General Assembly legislative session.

Robert Herman, MD, who helped draft the initial legislation, was delighted when he learned that MedChi, the Maryland State Medical Society, had taken the proposed legislation and expanded it. “It was everything we wished for and more,” Dr. Herman said.

During this year’s legislative session, House Bill 305/Senate Bill 308, Health Insurance – Utilization Review – Revisions, was sponsored by 19 delegates and two senators. Fifty medical associations, including dentists and physical therapists, endorsed the bill. Many people, including Dr. Herman, testified before the Health and Government Operations Committee on Feb. 16.

Delegate Kenneth Kerr introduced the legislation to the committee.

“Before I begin, let me make two points. First, the bill does not do away with prior authorization or other utilization review techniques; rather, it tries to make a more balanced approach for both patients and physicians by attempting to reduce the volume that’s subject to prior authorization, by increasing transparency and communication, and by studying how the process can be improved overall. Second, we have over 50 organizations representing health care providers and patient advocacy organizations supporting this legislation. This is a systemic issue across the entire spectrum of healthcare,” said Mr. Kerr.

Mr. Kerr went on to say there were 81,143 denials for treatment in 2021. The three areas with the highest rate of denials were pharmacy, dental, and the combination of labs and radiology.

He further noted that, when consumers filed a complaint with the Maryland Insurance Administration, 72.4% of denials were reversed in 2022.

“This resulted in more benefits that could have, and should have, been given to the patient at the first request. These reversals indicate there is a problem,” Mr. Kerr said. He discussed increased administrative costs, the enormous workload burden this incurs, and the problem of burnout among medical providers.

The proposed legislation includes a ban on PA requirements for generic medications, for dose changes of previously authorized medication, and ends the requirement for yearly authorizations. It requires that a physician of the same specialty be on the panel that denies care and shortens the time periods allowed for responses and appeals.

Testimony began with those supporting the legislation. Doctors highlighted the harm inflicted on their patients by the PA process. An oncologist spoke of how it took weeks to get approval for chemotherapy for a patient with an aggressive cancer, a gastroenterologist discussed a patient who became ill and lost her job when successful treatment for inflammatory bowel disease was stopped while she waited for the yearly medication reapproval, and another physician told of a patient who died of an exacerbation of obstructive lung disease, also while awaiting a yearly reapproval for an effective medication.

A dentist spoke about how he was not authorized to place a crown on a patient’s tooth. Instead, he was instructed to try a filling first, and when the filling failed, he was told he would not be authorized to work on the same tooth twice in one year.

A physical therapist testified that PA was required every two to four sessions, and each request took up half of a session – a significant portion of time that was not used for treatment.

Three people testified in opposition to the bill. Matthew Celantano, executive director of the League of Life and Health Insurers of Maryland, called the legislation “drastic” and testified that the cost would be prohibitive.

“From our end, it’s important for you to hear that prior authorization is care coordination. It’s protection that keeps [patients] safe, but helps control skyrocketing health care costs,” said Mr. Celantano.

Deb Rivkin, vice president of government affairs for CareFirst Blue Cross Blue Shield, testified in favor of using better technology. She cited legislation under consideration in Virginia that would give clinicians more information about the specific medications that require PAs, price information, and real-time authorizations.

Finally, representing the Pharmaceutical Care Management Association, Heather Cascone testified about PAs for generic medications. Her testimony focused on prior authorization for generic medications. She claimed that “... by allowing unrestricted dispensing of generic drugs, or an override based on the subjective opinion of the prescriber, prior authorization can protect patients from drugs with a safety risk; they can catch things like drug-disease contraindications, dosage errors, pregnancy-related contraindications, and a variety of cost-savings protections.”

I found this testimony particularly difficult because the “protector” is generally not a physician and has neither seen, nor examined, the patient. The implication that patients need protection from their doctors who would be unaware aware that they are pregnant, or are ill, was offensive. It also implies that PBMs are lax by not requiring PA on all medications, ignoring the fact that patients often bypass such denials by paying out of pocket for treatment.

If this had been a high school debate, there would be no doubt the enthusiasm for the bill for HB305 was strong, the committee chair was eager, and the arguments in favor of the legislation robust. There are no public minutes for the subsequent meetings with stakeholders, and I was somewhat heartbroken to learn that once again, the bill died in committee.

Annette Hanson, MD, chair of the MPS legislative committee, remains optimistic for the future. “Since then, the APA [American Psychiatric Association] has taken our bill and used it as model legislation now being offered to other district branches. MPS has created something that is going to spread across the country. Change may be slow, but it is not inevitable. And when it happens, I want you to remember that it started here,” she said.

However, the pressure is on. A recent ProPublica article documented how Cigna rejects claims by the batch without ever reviewing them. Soon after that piece was published, it was announced that several of the large insurers, including Cigna, would be cutting back on PA demands. It remains to be seen whether this is a token move to placate legislators, and whether it will provide meaningful relief to physicians and patients. I remain skeptical.

In the meantime, physicians’ ability to help their patients remains compromised and administrative tasks consume valuable time. I have started to wonder whether there may be some other way to push this issue to action. PA is about cost containment, but perhaps there are other ways to economize.

Why do medications cost less in other countries? Why does a medication cost hundreds of dollars more at one pharmacy versus another? Why do medicines sometimes have a copay that is two or three times higher than the cash price? Why do some covered medications have copays of thousands of dollars a year? I wonder if physicians shouldn’t come together and collectively agree not to comply and refuse to complete PAs in organized rebellion.

The fear, of course, is that such an endeavor would hurt patients, but if we all agreed in concert, then for better or for worse, something would have to give. The existing system is already hurting everyone, and physicians, by agreeing to play this awful game, are complicit in letting insurers dictate the care our patients receive.

Dinah Miller, MD, is a coauthor of Committed: The Battle Over Involuntary Psychiatric Care (Johns Hopkins University Press, 2016) and has a private practice and is an assistant professor of psychiatry and behavioral sciences at Johns Hopkins in Baltimore.

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

I imagine I am not alone when I tell you that my blood pressure rises every time I receive an email from CoverMyMeds, or worse, a phone call from a patient to tell me the pharmacist says I need to call their insurance company to get a medication authorized. Prior authorizations (PAs) are the bane of every physician’s existence.

Pharmacy benefit managers (PBMs) and insurers determine what treatment patients may have without regulation, accountability, liability, or transparency. They ask providers to jump through hoops, and no one oversees the placement of these hoops. The process puts patients at risk and sucks the joy from the practice of medicine.

In fall 2021, the legislative committee of the Maryland Psychiatric Society, with the help of Kathy Orellana and Tim Clement from the American Psychiatric Association, drafted a bill to modify the use of PAs. Unfortunately, the bill died in committee during the 2022 Maryland General Assembly legislative session.

Robert Herman, MD, who helped draft the initial legislation, was delighted when he learned that MedChi, the Maryland State Medical Society, had taken the proposed legislation and expanded it. “It was everything we wished for and more,” Dr. Herman said.

During this year’s legislative session, House Bill 305/Senate Bill 308, Health Insurance – Utilization Review – Revisions, was sponsored by 19 delegates and two senators. Fifty medical associations, including dentists and physical therapists, endorsed the bill. Many people, including Dr. Herman, testified before the Health and Government Operations Committee on Feb. 16.

Delegate Kenneth Kerr introduced the legislation to the committee.

“Before I begin, let me make two points. First, the bill does not do away with prior authorization or other utilization review techniques; rather, it tries to make a more balanced approach for both patients and physicians by attempting to reduce the volume that’s subject to prior authorization, by increasing transparency and communication, and by studying how the process can be improved overall. Second, we have over 50 organizations representing health care providers and patient advocacy organizations supporting this legislation. This is a systemic issue across the entire spectrum of healthcare,” said Mr. Kerr.

Mr. Kerr went on to say there were 81,143 denials for treatment in 2021. The three areas with the highest rate of denials were pharmacy, dental, and the combination of labs and radiology.

He further noted that, when consumers filed a complaint with the Maryland Insurance Administration, 72.4% of denials were reversed in 2022.

“This resulted in more benefits that could have, and should have, been given to the patient at the first request. These reversals indicate there is a problem,” Mr. Kerr said. He discussed increased administrative costs, the enormous workload burden this incurs, and the problem of burnout among medical providers.

The proposed legislation includes a ban on PA requirements for generic medications, for dose changes of previously authorized medication, and ends the requirement for yearly authorizations. It requires that a physician of the same specialty be on the panel that denies care and shortens the time periods allowed for responses and appeals.

Testimony began with those supporting the legislation. Doctors highlighted the harm inflicted on their patients by the PA process. An oncologist spoke of how it took weeks to get approval for chemotherapy for a patient with an aggressive cancer, a gastroenterologist discussed a patient who became ill and lost her job when successful treatment for inflammatory bowel disease was stopped while she waited for the yearly medication reapproval, and another physician told of a patient who died of an exacerbation of obstructive lung disease, also while awaiting a yearly reapproval for an effective medication.

A dentist spoke about how he was not authorized to place a crown on a patient’s tooth. Instead, he was instructed to try a filling first, and when the filling failed, he was told he would not be authorized to work on the same tooth twice in one year.

A physical therapist testified that PA was required every two to four sessions, and each request took up half of a session – a significant portion of time that was not used for treatment.

Three people testified in opposition to the bill. Matthew Celantano, executive director of the League of Life and Health Insurers of Maryland, called the legislation “drastic” and testified that the cost would be prohibitive.

“From our end, it’s important for you to hear that prior authorization is care coordination. It’s protection that keeps [patients] safe, but helps control skyrocketing health care costs,” said Mr. Celantano.

Deb Rivkin, vice president of government affairs for CareFirst Blue Cross Blue Shield, testified in favor of using better technology. She cited legislation under consideration in Virginia that would give clinicians more information about the specific medications that require PAs, price information, and real-time authorizations.

Finally, representing the Pharmaceutical Care Management Association, Heather Cascone testified about PAs for generic medications. Her testimony focused on prior authorization for generic medications. She claimed that “... by allowing unrestricted dispensing of generic drugs, or an override based on the subjective opinion of the prescriber, prior authorization can protect patients from drugs with a safety risk; they can catch things like drug-disease contraindications, dosage errors, pregnancy-related contraindications, and a variety of cost-savings protections.”

I found this testimony particularly difficult because the “protector” is generally not a physician and has neither seen, nor examined, the patient. The implication that patients need protection from their doctors who would be unaware aware that they are pregnant, or are ill, was offensive. It also implies that PBMs are lax by not requiring PA on all medications, ignoring the fact that patients often bypass such denials by paying out of pocket for treatment.

If this had been a high school debate, there would be no doubt the enthusiasm for the bill for HB305 was strong, the committee chair was eager, and the arguments in favor of the legislation robust. There are no public minutes for the subsequent meetings with stakeholders, and I was somewhat heartbroken to learn that once again, the bill died in committee.

Annette Hanson, MD, chair of the MPS legislative committee, remains optimistic for the future. “Since then, the APA [American Psychiatric Association] has taken our bill and used it as model legislation now being offered to other district branches. MPS has created something that is going to spread across the country. Change may be slow, but it is not inevitable. And when it happens, I want you to remember that it started here,” she said.

However, the pressure is on. A recent ProPublica article documented how Cigna rejects claims by the batch without ever reviewing them. Soon after that piece was published, it was announced that several of the large insurers, including Cigna, would be cutting back on PA demands. It remains to be seen whether this is a token move to placate legislators, and whether it will provide meaningful relief to physicians and patients. I remain skeptical.

In the meantime, physicians’ ability to help their patients remains compromised and administrative tasks consume valuable time. I have started to wonder whether there may be some other way to push this issue to action. PA is about cost containment, but perhaps there are other ways to economize.

Why do medications cost less in other countries? Why does a medication cost hundreds of dollars more at one pharmacy versus another? Why do medicines sometimes have a copay that is two or three times higher than the cash price? Why do some covered medications have copays of thousands of dollars a year? I wonder if physicians shouldn’t come together and collectively agree not to comply and refuse to complete PAs in organized rebellion.

The fear, of course, is that such an endeavor would hurt patients, but if we all agreed in concert, then for better or for worse, something would have to give. The existing system is already hurting everyone, and physicians, by agreeing to play this awful game, are complicit in letting insurers dictate the care our patients receive.

Dinah Miller, MD, is a coauthor of Committed: The Battle Over Involuntary Psychiatric Care (Johns Hopkins University Press, 2016) and has a private practice and is an assistant professor of psychiatry and behavioral sciences at Johns Hopkins in Baltimore.

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

I imagine I am not alone when I tell you that my blood pressure rises every time I receive an email from CoverMyMeds, or worse, a phone call from a patient to tell me the pharmacist says I need to call their insurance company to get a medication authorized. Prior authorizations (PAs) are the bane of every physician’s existence.

Pharmacy benefit managers (PBMs) and insurers determine what treatment patients may have without regulation, accountability, liability, or transparency. They ask providers to jump through hoops, and no one oversees the placement of these hoops. The process puts patients at risk and sucks the joy from the practice of medicine.

In fall 2021, the legislative committee of the Maryland Psychiatric Society, with the help of Kathy Orellana and Tim Clement from the American Psychiatric Association, drafted a bill to modify the use of PAs. Unfortunately, the bill died in committee during the 2022 Maryland General Assembly legislative session.

Robert Herman, MD, who helped draft the initial legislation, was delighted when he learned that MedChi, the Maryland State Medical Society, had taken the proposed legislation and expanded it. “It was everything we wished for and more,” Dr. Herman said.

During this year’s legislative session, House Bill 305/Senate Bill 308, Health Insurance – Utilization Review – Revisions, was sponsored by 19 delegates and two senators. Fifty medical associations, including dentists and physical therapists, endorsed the bill. Many people, including Dr. Herman, testified before the Health and Government Operations Committee on Feb. 16.

Delegate Kenneth Kerr introduced the legislation to the committee.

“Before I begin, let me make two points. First, the bill does not do away with prior authorization or other utilization review techniques; rather, it tries to make a more balanced approach for both patients and physicians by attempting to reduce the volume that’s subject to prior authorization, by increasing transparency and communication, and by studying how the process can be improved overall. Second, we have over 50 organizations representing health care providers and patient advocacy organizations supporting this legislation. This is a systemic issue across the entire spectrum of healthcare,” said Mr. Kerr.

Mr. Kerr went on to say there were 81,143 denials for treatment in 2021. The three areas with the highest rate of denials were pharmacy, dental, and the combination of labs and radiology.

He further noted that, when consumers filed a complaint with the Maryland Insurance Administration, 72.4% of denials were reversed in 2022.

“This resulted in more benefits that could have, and should have, been given to the patient at the first request. These reversals indicate there is a problem,” Mr. Kerr said. He discussed increased administrative costs, the enormous workload burden this incurs, and the problem of burnout among medical providers.

The proposed legislation includes a ban on PA requirements for generic medications, for dose changes of previously authorized medication, and ends the requirement for yearly authorizations. It requires that a physician of the same specialty be on the panel that denies care and shortens the time periods allowed for responses and appeals.

Testimony began with those supporting the legislation. Doctors highlighted the harm inflicted on their patients by the PA process. An oncologist spoke of how it took weeks to get approval for chemotherapy for a patient with an aggressive cancer, a gastroenterologist discussed a patient who became ill and lost her job when successful treatment for inflammatory bowel disease was stopped while she waited for the yearly medication reapproval, and another physician told of a patient who died of an exacerbation of obstructive lung disease, also while awaiting a yearly reapproval for an effective medication.

A dentist spoke about how he was not authorized to place a crown on a patient’s tooth. Instead, he was instructed to try a filling first, and when the filling failed, he was told he would not be authorized to work on the same tooth twice in one year.

A physical therapist testified that PA was required every two to four sessions, and each request took up half of a session – a significant portion of time that was not used for treatment.

Three people testified in opposition to the bill. Matthew Celantano, executive director of the League of Life and Health Insurers of Maryland, called the legislation “drastic” and testified that the cost would be prohibitive.

“From our end, it’s important for you to hear that prior authorization is care coordination. It’s protection that keeps [patients] safe, but helps control skyrocketing health care costs,” said Mr. Celantano.

Deb Rivkin, vice president of government affairs for CareFirst Blue Cross Blue Shield, testified in favor of using better technology. She cited legislation under consideration in Virginia that would give clinicians more information about the specific medications that require PAs, price information, and real-time authorizations.

Finally, representing the Pharmaceutical Care Management Association, Heather Cascone testified about PAs for generic medications. Her testimony focused on prior authorization for generic medications. She claimed that “... by allowing unrestricted dispensing of generic drugs, or an override based on the subjective opinion of the prescriber, prior authorization can protect patients from drugs with a safety risk; they can catch things like drug-disease contraindications, dosage errors, pregnancy-related contraindications, and a variety of cost-savings protections.”

I found this testimony particularly difficult because the “protector” is generally not a physician and has neither seen, nor examined, the patient. The implication that patients need protection from their doctors who would be unaware aware that they are pregnant, or are ill, was offensive. It also implies that PBMs are lax by not requiring PA on all medications, ignoring the fact that patients often bypass such denials by paying out of pocket for treatment.

If this had been a high school debate, there would be no doubt the enthusiasm for the bill for HB305 was strong, the committee chair was eager, and the arguments in favor of the legislation robust. There are no public minutes for the subsequent meetings with stakeholders, and I was somewhat heartbroken to learn that once again, the bill died in committee.

Annette Hanson, MD, chair of the MPS legislative committee, remains optimistic for the future. “Since then, the APA [American Psychiatric Association] has taken our bill and used it as model legislation now being offered to other district branches. MPS has created something that is going to spread across the country. Change may be slow, but it is not inevitable. And when it happens, I want you to remember that it started here,” she said.

However, the pressure is on. A recent ProPublica article documented how Cigna rejects claims by the batch without ever reviewing them. Soon after that piece was published, it was announced that several of the large insurers, including Cigna, would be cutting back on PA demands. It remains to be seen whether this is a token move to placate legislators, and whether it will provide meaningful relief to physicians and patients. I remain skeptical.

In the meantime, physicians’ ability to help their patients remains compromised and administrative tasks consume valuable time. I have started to wonder whether there may be some other way to push this issue to action. PA is about cost containment, but perhaps there are other ways to economize.

Why do medications cost less in other countries? Why does a medication cost hundreds of dollars more at one pharmacy versus another? Why do medicines sometimes have a copay that is two or three times higher than the cash price? Why do some covered medications have copays of thousands of dollars a year? I wonder if physicians shouldn’t come together and collectively agree not to comply and refuse to complete PAs in organized rebellion.

The fear, of course, is that such an endeavor would hurt patients, but if we all agreed in concert, then for better or for worse, something would have to give. The existing system is already hurting everyone, and physicians, by agreeing to play this awful game, are complicit in letting insurers dictate the care our patients receive.

Dinah Miller, MD, is a coauthor of Committed: The Battle Over Involuntary Psychiatric Care (Johns Hopkins University Press, 2016) and has a private practice and is an assistant professor of psychiatry and behavioral sciences at Johns Hopkins in Baltimore.

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

Current U.S., European, and Australian guidelines recommend 10-mm safety margins for radical excision of primary melanomas, but for patients with early-stage cutaneous melanoma in critical areas of the body, excision with 5-mm margins may not significantly increase risk for recurrence or melanoma-specific mortality (MSM), results of a retrospective study suggest.

Among 1,179 patients with stage T1a melanomas near the face, scalp, external genitalia, or other critical areas, the weighted 10-year local recurrence rate for patients who underwent resection with 10-mm margins was 5.7%, compared with 6.7% for those who had resections with 5-mm margins, a nonsignificant difference.

Weighted 10-year melanoma-specific mortality was 1.8% for patients treated with wide margins, vs. 4.2% for those treated with narrow margins, also a nonsignificant difference. Patients treated with narrow margins did have significantly fewer reconstructive surgeries than patients treated with wide margins, reported Andrea Maurichi, MD, and colleagues at the National Cancer Institute of Italy in Milan.

“Because this association was found in melanomas of the head and neck, acral, and genital sites, there is no plausible reason why it could not be extrapolated to other locations. The findings also support the need for prospective randomized clinical trials to definitively answer the important question about appropriate excision margins for T1a melanoma,” they wrote in the study, published online in JAMA Dermatology.

The authors also found, however, that Breslow thickness greater than 0.4 mm and mitotic rate greater than 1/mm­­² were associated with worse MSM, and that acral lentiginous melanoma, lentigo maligna melanoma, and increasing Breslow thickness were associated with a higher incidence of local recurrence.

A melanoma expert who was not involved in the study said that despite these findings, wider margins are always preferable.

“There is always a conversation around these general [critical] areas, but as a rule we try to get larger margins,” said Ryan J. Sullivan, MD, of Mass General Cancer Center in Boston.

In an interview, Dr. Sullivan said that the finding about lower frequency of reconstructive procedures in the narrow margins groups may be more of a concern for younger patients than for the elderly.

Study design

The investigators conducted a retrospective cohort study of consecutive patients aged 18 or older at the National Cancer Institute of Milan who were diagnosed with T1a cutaneous melanoma close to critical areas from 2001 through 2020.

Patients with primary cutaneous melanoma of the head and face areas with functional or cosmetic considerations, acral areas (plantar, palmar, digital and interdigital areas), external genitalia, or periumbilical and perineal areas were eligible for inclusion.

The cohort comprised 1,179 patients with a median age of 50 and equal sex distribution. Of these patients, 626 (53%) had a wide excision, of whom 434 had a linear repair, and 192 had a flap of graft reconstruction. The remaining 553 patients had narrow excisions, 491 with linear repair, and 62 with flap or graft reconstruction.

Analyses were adjusted to account for imbalances between the surgical groups.

The study was supported by the nonprofit foundation Emme Rouge. The authors and Dr. Sullivan reported having no relevant conflicts of interest to disclose.

Current U.S., European, and Australian guidelines recommend 10-mm safety margins for radical excision of primary melanomas, but for patients with early-stage cutaneous melanoma in critical areas of the body, excision with 5-mm margins may not significantly increase risk for recurrence or melanoma-specific mortality (MSM), results of a retrospective study suggest.

Among 1,179 patients with stage T1a melanomas near the face, scalp, external genitalia, or other critical areas, the weighted 10-year local recurrence rate for patients who underwent resection with 10-mm margins was 5.7%, compared with 6.7% for those who had resections with 5-mm margins, a nonsignificant difference.

Weighted 10-year melanoma-specific mortality was 1.8% for patients treated with wide margins, vs. 4.2% for those treated with narrow margins, also a nonsignificant difference. Patients treated with narrow margins did have significantly fewer reconstructive surgeries than patients treated with wide margins, reported Andrea Maurichi, MD, and colleagues at the National Cancer Institute of Italy in Milan.

“Because this association was found in melanomas of the head and neck, acral, and genital sites, there is no plausible reason why it could not be extrapolated to other locations. The findings also support the need for prospective randomized clinical trials to definitively answer the important question about appropriate excision margins for T1a melanoma,” they wrote in the study, published online in JAMA Dermatology.

The authors also found, however, that Breslow thickness greater than 0.4 mm and mitotic rate greater than 1/mm­­² were associated with worse MSM, and that acral lentiginous melanoma, lentigo maligna melanoma, and increasing Breslow thickness were associated with a higher incidence of local recurrence.

A melanoma expert who was not involved in the study said that despite these findings, wider margins are always preferable.

“There is always a conversation around these general [critical] areas, but as a rule we try to get larger margins,” said Ryan J. Sullivan, MD, of Mass General Cancer Center in Boston.

In an interview, Dr. Sullivan said that the finding about lower frequency of reconstructive procedures in the narrow margins groups may be more of a concern for younger patients than for the elderly.

Study design

The investigators conducted a retrospective cohort study of consecutive patients aged 18 or older at the National Cancer Institute of Milan who were diagnosed with T1a cutaneous melanoma close to critical areas from 2001 through 2020.

Patients with primary cutaneous melanoma of the head and face areas with functional or cosmetic considerations, acral areas (plantar, palmar, digital and interdigital areas), external genitalia, or periumbilical and perineal areas were eligible for inclusion.

The cohort comprised 1,179 patients with a median age of 50 and equal sex distribution. Of these patients, 626 (53%) had a wide excision, of whom 434 had a linear repair, and 192 had a flap of graft reconstruction. The remaining 553 patients had narrow excisions, 491 with linear repair, and 62 with flap or graft reconstruction.

Analyses were adjusted to account for imbalances between the surgical groups.

The study was supported by the nonprofit foundation Emme Rouge. The authors and Dr. Sullivan reported having no relevant conflicts of interest to disclose.

Current U.S., European, and Australian guidelines recommend 10-mm safety margins for radical excision of primary melanomas, but for patients with early-stage cutaneous melanoma in critical areas of the body, excision with 5-mm margins may not significantly increase risk for recurrence or melanoma-specific mortality (MSM), results of a retrospective study suggest.

Among 1,179 patients with stage T1a melanomas near the face, scalp, external genitalia, or other critical areas, the weighted 10-year local recurrence rate for patients who underwent resection with 10-mm margins was 5.7%, compared with 6.7% for those who had resections with 5-mm margins, a nonsignificant difference.

Weighted 10-year melanoma-specific mortality was 1.8% for patients treated with wide margins, vs. 4.2% for those treated with narrow margins, also a nonsignificant difference. Patients treated with narrow margins did have significantly fewer reconstructive surgeries than patients treated with wide margins, reported Andrea Maurichi, MD, and colleagues at the National Cancer Institute of Italy in Milan.

“Because this association was found in melanomas of the head and neck, acral, and genital sites, there is no plausible reason why it could not be extrapolated to other locations. The findings also support the need for prospective randomized clinical trials to definitively answer the important question about appropriate excision margins for T1a melanoma,” they wrote in the study, published online in JAMA Dermatology.

The authors also found, however, that Breslow thickness greater than 0.4 mm and mitotic rate greater than 1/mm­­² were associated with worse MSM, and that acral lentiginous melanoma, lentigo maligna melanoma, and increasing Breslow thickness were associated with a higher incidence of local recurrence.

A melanoma expert who was not involved in the study said that despite these findings, wider margins are always preferable.

“There is always a conversation around these general [critical] areas, but as a rule we try to get larger margins,” said Ryan J. Sullivan, MD, of Mass General Cancer Center in Boston.

In an interview, Dr. Sullivan said that the finding about lower frequency of reconstructive procedures in the narrow margins groups may be more of a concern for younger patients than for the elderly.

Study design

The investigators conducted a retrospective cohort study of consecutive patients aged 18 or older at the National Cancer Institute of Milan who were diagnosed with T1a cutaneous melanoma close to critical areas from 2001 through 2020.

Patients with primary cutaneous melanoma of the head and face areas with functional or cosmetic considerations, acral areas (plantar, palmar, digital and interdigital areas), external genitalia, or periumbilical and perineal areas were eligible for inclusion.

The cohort comprised 1,179 patients with a median age of 50 and equal sex distribution. Of these patients, 626 (53%) had a wide excision, of whom 434 had a linear repair, and 192 had a flap of graft reconstruction. The remaining 553 patients had narrow excisions, 491 with linear repair, and 62 with flap or graft reconstruction.

Analyses were adjusted to account for imbalances between the surgical groups.

The study was supported by the nonprofit foundation Emme Rouge. The authors and Dr. Sullivan reported having no relevant conflicts of interest to disclose.

With a federal judge’s recent ruling clouding the future availability of mifepristone for terminating pregnancies, attention has shifted to the efficacy of another abortion drug, misoprostol.

Experts said a misoprostol-only regimen for medical abortions is as safe as but not as effective as the combination of mifepristone and misoprostol. A misoprostol-only approach also comes with more pronounced side effects.

“Misoprostol only is a good alternative; it’s not the best alternative,” Beverly Gray, MD, associate professor in the department of obstetrics and Gynecology at Duke University, Durham, N.C., said during a video conference on April 12. “The best medication would be to use mifepristone and misoprostol together because they’re efficacious with fewer side effects.”

To medically terminate a pregnancy using the two-drug regimen, patients first take the progesterone blocker mifepristone, which ends the pregnancy. That is followed 24-48 hours later with misoprostol, which causes the uterus to expel the pregnancy tissue. Used in combination, the two drugs have an efficacy rate of 98% in terminating a pregnancy.

An alternative approach is a misoprostol-only regimen. Patients take multiple doses of the drug over the course of hours until the pregnancy passes. This method is considered effective and safe, although patients may experience more nausea, vomiting, diarrhea, bleeding, and cramping.

“It’s effective, but not as effective as the combination treatment,” said Mitchell D. Creinin, MD, professor in the department of obstetrics and gynecology at University of California, Davis. “It also requires much higher doses. To get misoprostol by itself to have relatively high efficacy, you have to use multiple doses. It causes significantly more side effects, and it’s less effective.”

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

With a federal judge’s recent ruling clouding the future availability of mifepristone for terminating pregnancies, attention has shifted to the efficacy of another abortion drug, misoprostol.

Experts said a misoprostol-only regimen for medical abortions is as safe as but not as effective as the combination of mifepristone and misoprostol. A misoprostol-only approach also comes with more pronounced side effects.

“Misoprostol only is a good alternative; it’s not the best alternative,” Beverly Gray, MD, associate professor in the department of obstetrics and Gynecology at Duke University, Durham, N.C., said during a video conference on April 12. “The best medication would be to use mifepristone and misoprostol together because they’re efficacious with fewer side effects.”

To medically terminate a pregnancy using the two-drug regimen, patients first take the progesterone blocker mifepristone, which ends the pregnancy. That is followed 24-48 hours later with misoprostol, which causes the uterus to expel the pregnancy tissue. Used in combination, the two drugs have an efficacy rate of 98% in terminating a pregnancy.

An alternative approach is a misoprostol-only regimen. Patients take multiple doses of the drug over the course of hours until the pregnancy passes. This method is considered effective and safe, although patients may experience more nausea, vomiting, diarrhea, bleeding, and cramping.

“It’s effective, but not as effective as the combination treatment,” said Mitchell D. Creinin, MD, professor in the department of obstetrics and gynecology at University of California, Davis. “It also requires much higher doses. To get misoprostol by itself to have relatively high efficacy, you have to use multiple doses. It causes significantly more side effects, and it’s less effective.”

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

With a federal judge’s recent ruling clouding the future availability of mifepristone for terminating pregnancies, attention has shifted to the efficacy of another abortion drug, misoprostol.

Experts said a misoprostol-only regimen for medical abortions is as safe as but not as effective as the combination of mifepristone and misoprostol. A misoprostol-only approach also comes with more pronounced side effects.

“Misoprostol only is a good alternative; it’s not the best alternative,” Beverly Gray, MD, associate professor in the department of obstetrics and Gynecology at Duke University, Durham, N.C., said during a video conference on April 12. “The best medication would be to use mifepristone and misoprostol together because they’re efficacious with fewer side effects.”

To medically terminate a pregnancy using the two-drug regimen, patients first take the progesterone blocker mifepristone, which ends the pregnancy. That is followed 24-48 hours later with misoprostol, which causes the uterus to expel the pregnancy tissue. Used in combination, the two drugs have an efficacy rate of 98% in terminating a pregnancy.

An alternative approach is a misoprostol-only regimen. Patients take multiple doses of the drug over the course of hours until the pregnancy passes. This method is considered effective and safe, although patients may experience more nausea, vomiting, diarrhea, bleeding, and cramping.

“It’s effective, but not as effective as the combination treatment,” said Mitchell D. Creinin, MD, professor in the department of obstetrics and gynecology at University of California, Davis. “It also requires much higher doses. To get misoprostol by itself to have relatively high efficacy, you have to use multiple doses. It causes significantly more side effects, and it’s less effective.”

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

NEW ORLEANS – Pediatric patients with rheumatologic diseases experience a particularly high prevalence of psychological distress and depression and anxiety symptoms, according to research presented at the Pediatric Rheumatology Symposium. Although this finding is not necessarily surprising, the extent to which depression and psychological distress impacts these young patients’ quality of life has led to greater research and innovation in seeking ways to identify, address, and treat depression and anxiety in children and adolescents with diseases such as juvenile idiopathic arthritis (JIA) or systemic lupus erythematosus (SLE).

Accordingly, other studies presented at the conference examined more efficient ways to screen adolescent patients for depression and assessed programs designed to improve symptoms. In fact, the American College of Rheumatology award for the top Quality, Health Services, and Education Research abstract at this year’s symposium went to Lauren Harper, MD, a pediatric rheumatology fellow at Nationwide Children’s Hospital, Columbus, whose research examined the effects of automating depression screening during check-in for adolescent patients with SLE. Her findings revealed that automation of screening increased detection of depression and suicidality, thereby increasing interventions and ultimately resulting in a reduction in depression prevalence.

Tara Haelle/MDedge News

“The key clinical takeaway is that mental health screening is really important – it affects our patients in so many different ways – and it’s very doable in your rheumatology clinic,” Dr. Harper said in an interview. “It’s also important because they’re coming to us very frequently, but they don’t see their PCP [primary care provider] very often, so we can’t leave screening to the PCPs.”

Two other studies assessed the effectiveness of a 6-week cognitive-behavioral intervention for youth called Treatment and Education Approach for Childhood-Onset Lupus (TEACH). One study found that remote delivery of TEACH resulted in improved mood symptoms and reduced fatigue, and another found the program particularly effective in improving mood for patients deemed “high risk” because of greater depression and fatigue symptoms.

The impact of growing mental health problems has been enormous both in the pediatric rheumatology population and society at large, Daria Sosna, MSc, a research coordinator at the University of Calgary (Alta.), said in an interview as she visited the research posters related to psychological stress and depression.

“We need to do something,” said Ms. Sosna, whose department is currently applying for funding to develop a research project to improve mental health outcomes in adolescents with lupus. “This population, specifically, has higher numbers than anyone else does because they have chronic illness” – and those issues need to be addressed.
 

High psychological stress levels

The study looking at psychological stress in pediatric rheumatology patients, led by Natalie Rosenwasser, MD, of Seattle Children’s Hospital, relied on cross-sectional data from patients enrolled in two Childhood Arthritis and Rheumatology Research Alliance sites, one in Utah and one in Seattle. The average age of the 71 patients who completed the surveys was 13, and the researchers reported the findings in two separate age groups: those aged 13-17, who completed the surveys themselves, and those aged 8-12, whose parents completed the surveys. Nearly all the patients (94.4%) had JIA, but one had lupus and three had juvenile dermatomyositis.

E+/Getty Images

The participants completed the Patient-Reported Outcomes Measurement Information System (PROMIS) for psychological stress, physical stress, and depressive symptoms. They also filled out the National Institutes of Health–Toolbox Perceived Stress survey, the 9-item Patient Health Questionnaire (PHQ-9), the Screen for Child Anxiety Related Disorders (SCARED), a visual analog scale for COVID-related distress, and a questionnaire asking about how receptive they were to mental health screening. The researchers determined that a score 1 standard deviation above the mean on the PROMIS and NIH-Toolbox assessments qualified as a high level of psychological stress.

“There are data that suggest that psychological stress can be a precursor to depression and anxiety, which raises the concern that not every patient who’s experiencing mental health symptoms is going to be picked up on traditional measures that meet that clinical threshold, but they may really need interventions to protect their mental health,” presenter Erin Treemarcki, DO, an assistant professor of pediatric rheumatology at the University of Utah, Salt Lake City, said in an interview. “Not every patient may necessarily need referral to a mental health specialist, but there are still potential interventions that we can do in the clinical setting to address mental health, which in turn can improve outcomes, including medication compliance and knowing how patients are feeling.”

More than one-third of the patients (39%) reported a high level of psychological stress, and 43% had elevated physical stress. Broken down by age, 26% of the teens and 15% of the younger patients reported high levels of perceived stress. The PROMIS only identified increased depressive symptoms in 26% of the participants, whereas more than half (54%) had a positive PHQ-9 depression screen. Furthermore, half the patients had SCARED scores (50%) that likely indicated anxiety disorder. Only 6% of patients reported severe stress specifically related to the pandemic, but most reported mild distress from the pandemic.

“Psychological stress was highly correlated with physical stress, perceived stress, depressive symptoms [PROMIS and PHQ-9], and anxiety,” the authors reported (P < .05). The authors next plan to expand their assessment to a third CARRA site and then explore the interaction between psychological distress and sociodemographic factors.

“There’s such an increase in mental health disorders right now, and we’re overwhelmed in general,” Ms. Sosna said in an interview. “There have to be interventions that approach this. We can use pharmacological approaches, we can use CBT, we can use a lot of these things that are very well established, and they’re absolutely fantastic, but we don’t necessarily have the resources or capabilities to do that all the time.”
 

Benefits of automated depression screening

To reduce the likelihood of depression screenings falling through the cracks during visits, Dr. Harper’s study assessed the impact of automating screens in an adolescent population. In her presentation, she noted previous research finding that nearly half of youth with lupus (47%) had depression, compared with 24% of adults with lupus. Pediatric patients have nearly three times the odds of depression and more than five times the odds of suicidal ideation, she told attendees. These mood disorders are correlated with greater physical disability, higher cardiovascular risk, more disease activity, higher risk of premature death, and decreased educational attainment, medication compliance, and quality of life.

Despite recommendations for depression screening from the U.S. Preventive Services Task Force and the American Academy of Pediatrics, only 2% of pediatric rheumatology patients are routinely screened for depression with a validated instrument, and only 7% of those with depressive symptoms are screened, according to a 2016 study that Dr. Harper cited. Yet the same study found that nearly all pediatric rheumatologists (95%) supported routine depression screening every 6-12 months. Hence her team’s decision to test whether automating screening improved their screening rates.

Their population included lupus patients aged 12 and older seen at Nationwide Children’s Hospital between 2014 and 2022. Initially, patients completed the PHQ-9 on paper, which was then transcribed into the electronic health record. The process became automated and administered on an iPad at every visit in 2022. Positive screens – those endorsing suicidality or with a score of at least 10 – caused an alert to pop up for clinicians during their workflow so that they would talk to the mental health team about the patient’s needs.

A total of 149 patients completed 529 screenings during the study’s 8 years. Only 1 patient completed a PHQ-9 in 2014, which increased to just 17 patients in 2017. Automation resulted in 225 screens (P < .01). Subsequently, positive screens increased from 0% in 2014 to 25%-30% in 2018-2021, but then fell to 12% in 2022 (P < .01). The median PHQ-9 score was 3; overall scores decreased as screening increased.

The overall incidence of positive screens during the study period was 20% and prevalence was 38%, the authors reported. Of the 10 automated alerts triggered by positive screens, 90% resulted in a meeting with a psychologist or social worker, and 90% completed a suicide risk assessment. The intrusive alert for clinicians requires them to acknowledge the alert, agreeing to initiate a risk assessment, before they can enter data into the patient’s chart.

The study findings reveal “that you can successfully screen a high-risk population using an automated, seamless process, and you can alert providers without too much disruption to their typical clinic flow,” Dr. Harper told attendees. “And all of these processes have led to sustainability for routine depression screening in our lupus clinic.”

Dr. Harper’s team next plans to expand the automated screenings to populations with other diseases, to add an automated screening for anxiety, and to explore how PHQ-9 scores correlate with disease activity.
 

Treating patients’ mental health

Another two other abstracts at the symposium looked at another option, the 6-week cognitive-behavioral TEACH program. Deborah Levy, MD, MS, an associate professor of pediatrics at the University of Toronto and the clinical director of rheumatology at The Hospital for Sick Children, and colleagues assessed the program’s success when delivered remotely to adolescent patients with lupus. Pilot testing with TEACH had already shown improvements in fatigue and mood, Dr. Levy told attendees, but barriers to in-person delivery limited its utility even before the pandemic, so this study aimed to determine a remote version’s feasibility and effects, compared with treatment as usual.

The randomized, controlled trial, led by Natoshia Cunningham, PhD, from Michigan State University, Grand Rapids, included 57 participants, aged 12-22, from seven U.S. and Canadian rheumatology sites. All had been diagnosed with childhood-onset SLE by age 18 and had elevated symptoms in fatigue, pain, or depression. A PROMIS Fatigue T score of 60 or greater indicated elevated fatigue scores, whereas a high pain score was at least a 3/10 on a visual analog scale, and a high depression T score was at least a 60 but not higher than 80 on the Children’s Depression Inventory–2 or the Beck Depression Inventory–II (depending on the patient’s age).

Patients with other chronic medical conditions, developmental delays, or untreated major psychiatric illness were excluded from the study, as were patients who were receiving overlapping treatment, such as cognitive-behavioral therapy for pain or mood. Thirty patients were randomly assigned to receive treatment as usual while 27 patients were assigned to participate in the remote TEACH program.

Nearly all the patients (94%) were female, but they were racially diverse, with 42% White, 28% Asian, 19% Black, 19% Hispanic, and 4% multiracial. The patients were an average 16 years old and had been diagnosed for a median 5 years. Three of the intervention’s six modules involved the caregivers or, for older patients, their partners if desired. The communication strategies taught in the program were also tailored to patients’ ages.

“All of these strategies are educational, cognitive, behavioral, mindfulness strategies that target fatigue [and] pain, and they also developed web content for participants to use on their own,” Dr. Levy told attendees.

The researchers had complete postassessment data from 88% of participants, but they also reported some of the statements made during qualitative interviews about the program’s feasibility.

“I think it makes people more aware of themselves to become a better version of themselves, whether that’s in their normal life or in handling a lupus kind of life,” one participant said about the program’s benefits. Another appreciated the “alternative ways of thinking,” including “being more mindful of my thoughts and how those kind of aggravate my stress.”

The quantitative findings revealed a statistically significant reduction in depressive symptoms and fatigue for TEACH participants, compared with treatment as usual. Mood scores fell by an average 13.7 points in the TEACH group, compared with a drop of 2.4 points in the treatment as usual group (P < .001). Scores for fatigue fell 9.16 points in the TEACH group and 2.93 in the control group (P = .003). No statistically significant difference showed up in pain scores between the groups, although pain, medication adherence, and disease activity did improve slightly more in the TEACH group.

In addition to the significant improvements in mood and fatigue, therefore, “completion of TEACH may be associated with improved medication adherence and disease activity versus treatment as usual,” Dr. Levy said.

A much smaller study authored by some of the same researchers also assessed TEACH’s impact not in remote form but in terms of its value specifically for adolescent patients with SLE and elevated depression and fatigue scores. Comparison of 6 high-risk patients with 10 low-risk patients who underwent TEACH suggested that the program was especially effective for improving depression in high-risk patients since these patients had a statistically significantly greater improvement in mood. Fatigue, pain, anxiety, quality of life, and disease activity scores did not statistically differ between the groups.

Authors of the automated depression screening study reported no disclosures or outside funding. The study assessing psychological distress was funded by a CARRA–Arthritis Foundation grant, and the authors reported no disclosures. The remote TEACH study was funded by a CARRA–Arthritis Foundation grant, and all but one author reported no disclosures. One author had disclosures with Janssen, Roche, and Sobi. The high-risk TEACH study was also funded by a CARRA grant, and the authors had no disclosures.

NEW ORLEANS – Pediatric patients with rheumatologic diseases experience a particularly high prevalence of psychological distress and depression and anxiety symptoms, according to research presented at the Pediatric Rheumatology Symposium. Although this finding is not necessarily surprising, the extent to which depression and psychological distress impacts these young patients’ quality of life has led to greater research and innovation in seeking ways to identify, address, and treat depression and anxiety in children and adolescents with diseases such as juvenile idiopathic arthritis (JIA) or systemic lupus erythematosus (SLE).

Accordingly, other studies presented at the conference examined more efficient ways to screen adolescent patients for depression and assessed programs designed to improve symptoms. In fact, the American College of Rheumatology award for the top Quality, Health Services, and Education Research abstract at this year’s symposium went to Lauren Harper, MD, a pediatric rheumatology fellow at Nationwide Children’s Hospital, Columbus, whose research examined the effects of automating depression screening during check-in for adolescent patients with SLE. Her findings revealed that automation of screening increased detection of depression and suicidality, thereby increasing interventions and ultimately resulting in a reduction in depression prevalence.

Tara Haelle/MDedge News

“The key clinical takeaway is that mental health screening is really important – it affects our patients in so many different ways – and it’s very doable in your rheumatology clinic,” Dr. Harper said in an interview. “It’s also important because they’re coming to us very frequently, but they don’t see their PCP [primary care provider] very often, so we can’t leave screening to the PCPs.”

Two other studies assessed the effectiveness of a 6-week cognitive-behavioral intervention for youth called Treatment and Education Approach for Childhood-Onset Lupus (TEACH). One study found that remote delivery of TEACH resulted in improved mood symptoms and reduced fatigue, and another found the program particularly effective in improving mood for patients deemed “high risk” because of greater depression and fatigue symptoms.

The impact of growing mental health problems has been enormous both in the pediatric rheumatology population and society at large, Daria Sosna, MSc, a research coordinator at the University of Calgary (Alta.), said in an interview as she visited the research posters related to psychological stress and depression.

“We need to do something,” said Ms. Sosna, whose department is currently applying for funding to develop a research project to improve mental health outcomes in adolescents with lupus. “This population, specifically, has higher numbers than anyone else does because they have chronic illness” – and those issues need to be addressed.
 

High psychological stress levels

The study looking at psychological stress in pediatric rheumatology patients, led by Natalie Rosenwasser, MD, of Seattle Children’s Hospital, relied on cross-sectional data from patients enrolled in two Childhood Arthritis and Rheumatology Research Alliance sites, one in Utah and one in Seattle. The average age of the 71 patients who completed the surveys was 13, and the researchers reported the findings in two separate age groups: those aged 13-17, who completed the surveys themselves, and those aged 8-12, whose parents completed the surveys. Nearly all the patients (94.4%) had JIA, but one had lupus and three had juvenile dermatomyositis.

E+/Getty Images

The participants completed the Patient-Reported Outcomes Measurement Information System (PROMIS) for psychological stress, physical stress, and depressive symptoms. They also filled out the National Institutes of Health–Toolbox Perceived Stress survey, the 9-item Patient Health Questionnaire (PHQ-9), the Screen for Child Anxiety Related Disorders (SCARED), a visual analog scale for COVID-related distress, and a questionnaire asking about how receptive they were to mental health screening. The researchers determined that a score 1 standard deviation above the mean on the PROMIS and NIH-Toolbox assessments qualified as a high level of psychological stress.

“There are data that suggest that psychological stress can be a precursor to depression and anxiety, which raises the concern that not every patient who’s experiencing mental health symptoms is going to be picked up on traditional measures that meet that clinical threshold, but they may really need interventions to protect their mental health,” presenter Erin Treemarcki, DO, an assistant professor of pediatric rheumatology at the University of Utah, Salt Lake City, said in an interview. “Not every patient may necessarily need referral to a mental health specialist, but there are still potential interventions that we can do in the clinical setting to address mental health, which in turn can improve outcomes, including medication compliance and knowing how patients are feeling.”

More than one-third of the patients (39%) reported a high level of psychological stress, and 43% had elevated physical stress. Broken down by age, 26% of the teens and 15% of the younger patients reported high levels of perceived stress. The PROMIS only identified increased depressive symptoms in 26% of the participants, whereas more than half (54%) had a positive PHQ-9 depression screen. Furthermore, half the patients had SCARED scores (50%) that likely indicated anxiety disorder. Only 6% of patients reported severe stress specifically related to the pandemic, but most reported mild distress from the pandemic.

“Psychological stress was highly correlated with physical stress, perceived stress, depressive symptoms [PROMIS and PHQ-9], and anxiety,” the authors reported (P < .05). The authors next plan to expand their assessment to a third CARRA site and then explore the interaction between psychological distress and sociodemographic factors.

“There’s such an increase in mental health disorders right now, and we’re overwhelmed in general,” Ms. Sosna said in an interview. “There have to be interventions that approach this. We can use pharmacological approaches, we can use CBT, we can use a lot of these things that are very well established, and they’re absolutely fantastic, but we don’t necessarily have the resources or capabilities to do that all the time.”
 

Benefits of automated depression screening

To reduce the likelihood of depression screenings falling through the cracks during visits, Dr. Harper’s study assessed the impact of automating screens in an adolescent population. In her presentation, she noted previous research finding that nearly half of youth with lupus (47%) had depression, compared with 24% of adults with lupus. Pediatric patients have nearly three times the odds of depression and more than five times the odds of suicidal ideation, she told attendees. These mood disorders are correlated with greater physical disability, higher cardiovascular risk, more disease activity, higher risk of premature death, and decreased educational attainment, medication compliance, and quality of life.

Despite recommendations for depression screening from the U.S. Preventive Services Task Force and the American Academy of Pediatrics, only 2% of pediatric rheumatology patients are routinely screened for depression with a validated instrument, and only 7% of those with depressive symptoms are screened, according to a 2016 study that Dr. Harper cited. Yet the same study found that nearly all pediatric rheumatologists (95%) supported routine depression screening every 6-12 months. Hence her team’s decision to test whether automating screening improved their screening rates.

Their population included lupus patients aged 12 and older seen at Nationwide Children’s Hospital between 2014 and 2022. Initially, patients completed the PHQ-9 on paper, which was then transcribed into the electronic health record. The process became automated and administered on an iPad at every visit in 2022. Positive screens – those endorsing suicidality or with a score of at least 10 – caused an alert to pop up for clinicians during their workflow so that they would talk to the mental health team about the patient’s needs.

A total of 149 patients completed 529 screenings during the study’s 8 years. Only 1 patient completed a PHQ-9 in 2014, which increased to just 17 patients in 2017. Automation resulted in 225 screens (P < .01). Subsequently, positive screens increased from 0% in 2014 to 25%-30% in 2018-2021, but then fell to 12% in 2022 (P < .01). The median PHQ-9 score was 3; overall scores decreased as screening increased.

The overall incidence of positive screens during the study period was 20% and prevalence was 38%, the authors reported. Of the 10 automated alerts triggered by positive screens, 90% resulted in a meeting with a psychologist or social worker, and 90% completed a suicide risk assessment. The intrusive alert for clinicians requires them to acknowledge the alert, agreeing to initiate a risk assessment, before they can enter data into the patient’s chart.

The study findings reveal “that you can successfully screen a high-risk population using an automated, seamless process, and you can alert providers without too much disruption to their typical clinic flow,” Dr. Harper told attendees. “And all of these processes have led to sustainability for routine depression screening in our lupus clinic.”

Dr. Harper’s team next plans to expand the automated screenings to populations with other diseases, to add an automated screening for anxiety, and to explore how PHQ-9 scores correlate with disease activity.
 

Treating patients’ mental health

Another two other abstracts at the symposium looked at another option, the 6-week cognitive-behavioral TEACH program. Deborah Levy, MD, MS, an associate professor of pediatrics at the University of Toronto and the clinical director of rheumatology at The Hospital for Sick Children, and colleagues assessed the program’s success when delivered remotely to adolescent patients with lupus. Pilot testing with TEACH had already shown improvements in fatigue and mood, Dr. Levy told attendees, but barriers to in-person delivery limited its utility even before the pandemic, so this study aimed to determine a remote version’s feasibility and effects, compared with treatment as usual.

The randomized, controlled trial, led by Natoshia Cunningham, PhD, from Michigan State University, Grand Rapids, included 57 participants, aged 12-22, from seven U.S. and Canadian rheumatology sites. All had been diagnosed with childhood-onset SLE by age 18 and had elevated symptoms in fatigue, pain, or depression. A PROMIS Fatigue T score of 60 or greater indicated elevated fatigue scores, whereas a high pain score was at least a 3/10 on a visual analog scale, and a high depression T score was at least a 60 but not higher than 80 on the Children’s Depression Inventory–2 or the Beck Depression Inventory–II (depending on the patient’s age).

Patients with other chronic medical conditions, developmental delays, or untreated major psychiatric illness were excluded from the study, as were patients who were receiving overlapping treatment, such as cognitive-behavioral therapy for pain or mood. Thirty patients were randomly assigned to receive treatment as usual while 27 patients were assigned to participate in the remote TEACH program.

Nearly all the patients (94%) were female, but they were racially diverse, with 42% White, 28% Asian, 19% Black, 19% Hispanic, and 4% multiracial. The patients were an average 16 years old and had been diagnosed for a median 5 years. Three of the intervention’s six modules involved the caregivers or, for older patients, their partners if desired. The communication strategies taught in the program were also tailored to patients’ ages.

“All of these strategies are educational, cognitive, behavioral, mindfulness strategies that target fatigue [and] pain, and they also developed web content for participants to use on their own,” Dr. Levy told attendees.

The researchers had complete postassessment data from 88% of participants, but they also reported some of the statements made during qualitative interviews about the program’s feasibility.

“I think it makes people more aware of themselves to become a better version of themselves, whether that’s in their normal life or in handling a lupus kind of life,” one participant said about the program’s benefits. Another appreciated the “alternative ways of thinking,” including “being more mindful of my thoughts and how those kind of aggravate my stress.”

The quantitative findings revealed a statistically significant reduction in depressive symptoms and fatigue for TEACH participants, compared with treatment as usual. Mood scores fell by an average 13.7 points in the TEACH group, compared with a drop of 2.4 points in the treatment as usual group (P < .001). Scores for fatigue fell 9.16 points in the TEACH group and 2.93 in the control group (P = .003). No statistically significant difference showed up in pain scores between the groups, although pain, medication adherence, and disease activity did improve slightly more in the TEACH group.

In addition to the significant improvements in mood and fatigue, therefore, “completion of TEACH may be associated with improved medication adherence and disease activity versus treatment as usual,” Dr. Levy said.

A much smaller study authored by some of the same researchers also assessed TEACH’s impact not in remote form but in terms of its value specifically for adolescent patients with SLE and elevated depression and fatigue scores. Comparison of 6 high-risk patients with 10 low-risk patients who underwent TEACH suggested that the program was especially effective for improving depression in high-risk patients since these patients had a statistically significantly greater improvement in mood. Fatigue, pain, anxiety, quality of life, and disease activity scores did not statistically differ between the groups.

Authors of the automated depression screening study reported no disclosures or outside funding. The study assessing psychological distress was funded by a CARRA–Arthritis Foundation grant, and the authors reported no disclosures. The remote TEACH study was funded by a CARRA–Arthritis Foundation grant, and all but one author reported no disclosures. One author had disclosures with Janssen, Roche, and Sobi. The high-risk TEACH study was also funded by a CARRA grant, and the authors had no disclosures.

NEW ORLEANS – Pediatric patients with rheumatologic diseases experience a particularly high prevalence of psychological distress and depression and anxiety symptoms, according to research presented at the Pediatric Rheumatology Symposium. Although this finding is not necessarily surprising, the extent to which depression and psychological distress impacts these young patients’ quality of life has led to greater research and innovation in seeking ways to identify, address, and treat depression and anxiety in children and adolescents with diseases such as juvenile idiopathic arthritis (JIA) or systemic lupus erythematosus (SLE).

Accordingly, other studies presented at the conference examined more efficient ways to screen adolescent patients for depression and assessed programs designed to improve symptoms. In fact, the American College of Rheumatology award for the top Quality, Health Services, and Education Research abstract at this year’s symposium went to Lauren Harper, MD, a pediatric rheumatology fellow at Nationwide Children’s Hospital, Columbus, whose research examined the effects of automating depression screening during check-in for adolescent patients with SLE. Her findings revealed that automation of screening increased detection of depression and suicidality, thereby increasing interventions and ultimately resulting in a reduction in depression prevalence.

Tara Haelle/MDedge News

“The key clinical takeaway is that mental health screening is really important – it affects our patients in so many different ways – and it’s very doable in your rheumatology clinic,” Dr. Harper said in an interview. “It’s also important because they’re coming to us very frequently, but they don’t see their PCP [primary care provider] very often, so we can’t leave screening to the PCPs.”

Two other studies assessed the effectiveness of a 6-week cognitive-behavioral intervention for youth called Treatment and Education Approach for Childhood-Onset Lupus (TEACH). One study found that remote delivery of TEACH resulted in improved mood symptoms and reduced fatigue, and another found the program particularly effective in improving mood for patients deemed “high risk” because of greater depression and fatigue symptoms.

The impact of growing mental health problems has been enormous both in the pediatric rheumatology population and society at large, Daria Sosna, MSc, a research coordinator at the University of Calgary (Alta.), said in an interview as she visited the research posters related to psychological stress and depression.

“We need to do something,” said Ms. Sosna, whose department is currently applying for funding to develop a research project to improve mental health outcomes in adolescents with lupus. “This population, specifically, has higher numbers than anyone else does because they have chronic illness” – and those issues need to be addressed.
 

High psychological stress levels

The study looking at psychological stress in pediatric rheumatology patients, led by Natalie Rosenwasser, MD, of Seattle Children’s Hospital, relied on cross-sectional data from patients enrolled in two Childhood Arthritis and Rheumatology Research Alliance sites, one in Utah and one in Seattle. The average age of the 71 patients who completed the surveys was 13, and the researchers reported the findings in two separate age groups: those aged 13-17, who completed the surveys themselves, and those aged 8-12, whose parents completed the surveys. Nearly all the patients (94.4%) had JIA, but one had lupus and three had juvenile dermatomyositis.

E+/Getty Images

The participants completed the Patient-Reported Outcomes Measurement Information System (PROMIS) for psychological stress, physical stress, and depressive symptoms. They also filled out the National Institutes of Health–Toolbox Perceived Stress survey, the 9-item Patient Health Questionnaire (PHQ-9), the Screen for Child Anxiety Related Disorders (SCARED), a visual analog scale for COVID-related distress, and a questionnaire asking about how receptive they were to mental health screening. The researchers determined that a score 1 standard deviation above the mean on the PROMIS and NIH-Toolbox assessments qualified as a high level of psychological stress.

“There are data that suggest that psychological stress can be a precursor to depression and anxiety, which raises the concern that not every patient who’s experiencing mental health symptoms is going to be picked up on traditional measures that meet that clinical threshold, but they may really need interventions to protect their mental health,” presenter Erin Treemarcki, DO, an assistant professor of pediatric rheumatology at the University of Utah, Salt Lake City, said in an interview. “Not every patient may necessarily need referral to a mental health specialist, but there are still potential interventions that we can do in the clinical setting to address mental health, which in turn can improve outcomes, including medication compliance and knowing how patients are feeling.”

More than one-third of the patients (39%) reported a high level of psychological stress, and 43% had elevated physical stress. Broken down by age, 26% of the teens and 15% of the younger patients reported high levels of perceived stress. The PROMIS only identified increased depressive symptoms in 26% of the participants, whereas more than half (54%) had a positive PHQ-9 depression screen. Furthermore, half the patients had SCARED scores (50%) that likely indicated anxiety disorder. Only 6% of patients reported severe stress specifically related to the pandemic, but most reported mild distress from the pandemic.

“Psychological stress was highly correlated with physical stress, perceived stress, depressive symptoms [PROMIS and PHQ-9], and anxiety,” the authors reported (P < .05). The authors next plan to expand their assessment to a third CARRA site and then explore the interaction between psychological distress and sociodemographic factors.

“There’s such an increase in mental health disorders right now, and we’re overwhelmed in general,” Ms. Sosna said in an interview. “There have to be interventions that approach this. We can use pharmacological approaches, we can use CBT, we can use a lot of these things that are very well established, and they’re absolutely fantastic, but we don’t necessarily have the resources or capabilities to do that all the time.”
 

Benefits of automated depression screening

To reduce the likelihood of depression screenings falling through the cracks during visits, Dr. Harper’s study assessed the impact of automating screens in an adolescent population. In her presentation, she noted previous research finding that nearly half of youth with lupus (47%) had depression, compared with 24% of adults with lupus. Pediatric patients have nearly three times the odds of depression and more than five times the odds of suicidal ideation, she told attendees. These mood disorders are correlated with greater physical disability, higher cardiovascular risk, more disease activity, higher risk of premature death, and decreased educational attainment, medication compliance, and quality of life.

Despite recommendations for depression screening from the U.S. Preventive Services Task Force and the American Academy of Pediatrics, only 2% of pediatric rheumatology patients are routinely screened for depression with a validated instrument, and only 7% of those with depressive symptoms are screened, according to a 2016 study that Dr. Harper cited. Yet the same study found that nearly all pediatric rheumatologists (95%) supported routine depression screening every 6-12 months. Hence her team’s decision to test whether automating screening improved their screening rates.

Their population included lupus patients aged 12 and older seen at Nationwide Children’s Hospital between 2014 and 2022. Initially, patients completed the PHQ-9 on paper, which was then transcribed into the electronic health record. The process became automated and administered on an iPad at every visit in 2022. Positive screens – those endorsing suicidality or with a score of at least 10 – caused an alert to pop up for clinicians during their workflow so that they would talk to the mental health team about the patient’s needs.

A total of 149 patients completed 529 screenings during the study’s 8 years. Only 1 patient completed a PHQ-9 in 2014, which increased to just 17 patients in 2017. Automation resulted in 225 screens (P < .01). Subsequently, positive screens increased from 0% in 2014 to 25%-30% in 2018-2021, but then fell to 12% in 2022 (P < .01). The median PHQ-9 score was 3; overall scores decreased as screening increased.

The overall incidence of positive screens during the study period was 20% and prevalence was 38%, the authors reported. Of the 10 automated alerts triggered by positive screens, 90% resulted in a meeting with a psychologist or social worker, and 90% completed a suicide risk assessment. The intrusive alert for clinicians requires them to acknowledge the alert, agreeing to initiate a risk assessment, before they can enter data into the patient’s chart.

The study findings reveal “that you can successfully screen a high-risk population using an automated, seamless process, and you can alert providers without too much disruption to their typical clinic flow,” Dr. Harper told attendees. “And all of these processes have led to sustainability for routine depression screening in our lupus clinic.”

Dr. Harper’s team next plans to expand the automated screenings to populations with other diseases, to add an automated screening for anxiety, and to explore how PHQ-9 scores correlate with disease activity.
 

Treating patients’ mental health

Another two other abstracts at the symposium looked at another option, the 6-week cognitive-behavioral TEACH program. Deborah Levy, MD, MS, an associate professor of pediatrics at the University of Toronto and the clinical director of rheumatology at The Hospital for Sick Children, and colleagues assessed the program’s success when delivered remotely to adolescent patients with lupus. Pilot testing with TEACH had already shown improvements in fatigue and mood, Dr. Levy told attendees, but barriers to in-person delivery limited its utility even before the pandemic, so this study aimed to determine a remote version’s feasibility and effects, compared with treatment as usual.

The randomized, controlled trial, led by Natoshia Cunningham, PhD, from Michigan State University, Grand Rapids, included 57 participants, aged 12-22, from seven U.S. and Canadian rheumatology sites. All had been diagnosed with childhood-onset SLE by age 18 and had elevated symptoms in fatigue, pain, or depression. A PROMIS Fatigue T score of 60 or greater indicated elevated fatigue scores, whereas a high pain score was at least a 3/10 on a visual analog scale, and a high depression T score was at least a 60 but not higher than 80 on the Children’s Depression Inventory–2 or the Beck Depression Inventory–II (depending on the patient’s age).

Patients with other chronic medical conditions, developmental delays, or untreated major psychiatric illness were excluded from the study, as were patients who were receiving overlapping treatment, such as cognitive-behavioral therapy for pain or mood. Thirty patients were randomly assigned to receive treatment as usual while 27 patients were assigned to participate in the remote TEACH program.

Nearly all the patients (94%) were female, but they were racially diverse, with 42% White, 28% Asian, 19% Black, 19% Hispanic, and 4% multiracial. The patients were an average 16 years old and had been diagnosed for a median 5 years. Three of the intervention’s six modules involved the caregivers or, for older patients, their partners if desired. The communication strategies taught in the program were also tailored to patients’ ages.

“All of these strategies are educational, cognitive, behavioral, mindfulness strategies that target fatigue [and] pain, and they also developed web content for participants to use on their own,” Dr. Levy told attendees.

The researchers had complete postassessment data from 88% of participants, but they also reported some of the statements made during qualitative interviews about the program’s feasibility.

“I think it makes people more aware of themselves to become a better version of themselves, whether that’s in their normal life or in handling a lupus kind of life,” one participant said about the program’s benefits. Another appreciated the “alternative ways of thinking,” including “being more mindful of my thoughts and how those kind of aggravate my stress.”

The quantitative findings revealed a statistically significant reduction in depressive symptoms and fatigue for TEACH participants, compared with treatment as usual. Mood scores fell by an average 13.7 points in the TEACH group, compared with a drop of 2.4 points in the treatment as usual group (P < .001). Scores for fatigue fell 9.16 points in the TEACH group and 2.93 in the control group (P = .003). No statistically significant difference showed up in pain scores between the groups, although pain, medication adherence, and disease activity did improve slightly more in the TEACH group.

In addition to the significant improvements in mood and fatigue, therefore, “completion of TEACH may be associated with improved medication adherence and disease activity versus treatment as usual,” Dr. Levy said.

A much smaller study authored by some of the same researchers also assessed TEACH’s impact not in remote form but in terms of its value specifically for adolescent patients with SLE and elevated depression and fatigue scores. Comparison of 6 high-risk patients with 10 low-risk patients who underwent TEACH suggested that the program was especially effective for improving depression in high-risk patients since these patients had a statistically significantly greater improvement in mood. Fatigue, pain, anxiety, quality of life, and disease activity scores did not statistically differ between the groups.

Authors of the automated depression screening study reported no disclosures or outside funding. The study assessing psychological distress was funded by a CARRA–Arthritis Foundation grant, and the authors reported no disclosures. The remote TEACH study was funded by a CARRA–Arthritis Foundation grant, and all but one author reported no disclosures. One author had disclosures with Janssen, Roche, and Sobi. The high-risk TEACH study was also funded by a CARRA grant, and the authors had no disclosures.