Heidi Splete

Functional luminal imaging probe (FLIP) panometry proved superior to high-resolution manometry (HRM) for evaluation of esophageal motility, according to a new study based on data from 329 adults.

Eraxion/Thinkstock.com

HRM is generally considered the primary method for evaluating esophageal motility, but current recommendations include the use of a FLIP or timed barium esophogram (TBE) if HRM yields inconclusive results, Dustin A. Carlson, MD, of Northwestern University, Chicago, and colleagues wrote in the recent study. FLIP has several potential advantages over HRM, including that “the test is performed on a sedated patient at the time of endoscopy, as opposed to the awake transnasal catheter used for HRM”; however, comparisons of the two methods for predicting esophageal retention are lacking.

In the study published in the American Journal of Gastroenterology, the researchers reviewed data from 329 consecutive patients aged 18-89 years who completed FLIP, HRM, and TBE for evaluation of primary esophageal motility. They excluded patients with previous foregut surgery. The researchers compared the ability of FLIP and HRM to predict esophageal retention based on abnormal TBE findings, which was defined as a 1-minute column height greater than 5 cm or as impaction of a 12.5-mm barium tablet.

For HRM, the integrated relaxation pressure (IRP) was assessed in the supine and upright patient positions to predict abnormal TBE findings. For FLIP, esophagogastric junction (EGJ) opening was assessed with a 16-cm FLIP performed during sedated endoscopy, and the presence of abnormal TBE findings was determined using the EGJ–distensibility index and maximum EGJ diameter.

The area under the ROC curve for identifying abnormal TBE findings was 0.79 (95% confidence interval, 0.75-0.84) for supine, 0.79 (95% CI, 0.76-0.86) for upright IRP, 0.84 (95% CI, 0.79-0.88) for the EGJ–distensibility index, and 0.88 (95% CI, 0.85-0.92) for the maximum EGJ diameter.

In a logistic regression analysis, the odds ratios for predicting abnormal TBE findings were 1.8 (95% confidence interval, 0.84-3.7; P < .133) for consistent elevation of IRP in HRM, compared with normal IRP, and 39.7 (95% CI, 16.4-96.2; P < .001) for reduced EGJ opening on FLIP panometry, compared with normal EGJ opening.

“Both the IRP on HRM and FLIP panometry metrics of EGJ opening (EGJ–[distensibility index] and maximum EGJ diameter) demonstrated capabilities to differentiate between abnormal and normal esophageal retention, which supports confidence in both tools,” the authors explained. “However, FLIP panometry parameters did so more accurately and with greater predictive capability as reflected by ROC and regression analysis.”

A total of 40 patients (12%) showed discordance between their HRM and FLIP panometry measures, and among these, FLIP showed stronger detection of esophageal retention. FLIP panometry was consistent with TBE in 78% of cases, while HRM-IRP was consistent with TBE in 23%. “Discordant results between HRM and FLIP panometry were observed in previous studies and again in this study, a scenario with unclear clinical significance,” the authors noted, which was why they used TBE as “an objective measure of esophageal retention that was independent of both HRM and FLIP to compare the two modalities.”

The study findings were limited by several factors including ones related to the use of TBE as the primary outcome, as well as the lack of longitudinal outcomes, the researchers noted. There is also the potential for referral bias and selection bias with an overrepresentation of patients with achalasia and EGJ outflow obstruction. However, the results were strengthened by the large sample size of patients who completed evaluations with HRM, FLIP, and TBE.

The study “provides additional support for the use of FLIP panometry to evaluate esophageal motility because it accurately identifies normal and abnormal retention, but also identifies patients who should undergo further complementary diagnostic testing,” they noted. Longitudinal studies are needed to explore best practices for managing esophageal motor disorders. In the meantime, evaluation with FLIP panometry, TBE, and HRM likely remains necessary for some patients, “particularly those with equivocal findings on a single test,” to better characterize disease and guide treatment, the researchers concluded.
 

Findings support potential of FLIP

“The endoscopic FLIP is an exciting clinical tool that utilizes distension of a catheter-mounted balloon to different volumes to acquire esophageal dimensions and pressures,” Amit Patel, MD, of Duke University, Durham, N.C., said in an interview.

“Accumulating data on FLIP inspired [recently published guidelines] to suggest the use of FLIP to complement high-resolution manometry in the setting of obstructive esophageal symptoms and borderline HRM findings, for patients in whom an HRM study cannot be completed, and for intraprocedural use during interventions for achalasia,” Dr. Patel said. “However, the comparative utility of FLIP, particularly among foundational esophageal diagnostics such as HRM and TBE, is less well developed at this point.”

Dr. Patel said he was surprised by some of the findings. “The characteristics of FLIP metrics (specifically, EGJ–distensibility index <2 mm²/mm Hg and/or maximum EGJ diameter <12 mm) were numerically superior to those for traditional IRP metrics from HRM in predicting retention on TBE on AUROC, regression analyses, and discordant cases in this study,” said Dr. Patel. “Although this study also corroborated the value of IRP on HRM, these findings were somewhat surprising for HRM, given its well-earned reputation as the gold standard for the diagnosis of esophageal motor disorders, its widespread use, and the record of strong data supporting its important role in clinical practice.”

Overall, this study suggests these metrics from FLIP (namely, EGJ–distensibility index and EGJ diameter) may have “diagnostic value beyond traditional IRP metrics from HRM to identify objective retention on TBE,” said Dr. Patel, who also said these exciting findings “support the growth of the complementary role of FLIP ... particularly in cases where HRM may be inconclusive or not tolerated by patients.”

However, more research is needed. “Taking into account other HRM metrics beyond IRP, such as intrabolus pressures or evaluation of bolus transit on impedance, and provocative maneuvers on HRM, such as rapid drink challenges or solid swallows, may be appropriate for further evaluation, as will improved arbitration of ‘borderline’ metrics or less clear cases,” Dr. Patel emphasized. Future studies should also incorporate management interventions and assessments of outcomes.  

The study was supported by a grant from the Public Health service to a coinvestigator, and by the American College of Gastroenterology Junior Faculty Development Award to lead author Dr. Carlson. Dr. Carlson also disclosed speaking and consulting relationships with Medtronic, which manufactures FLIP panometry systems. Northwestern University and several coauthors also disclosed intellectual property rights and ownership surrounding FLIP panometry systems, methods, and apparatus with Medtronic. Dr. Patel had no financial conflicts to disclose.

This article was updated Oct. 13, 2021.

Functional luminal imaging probe (FLIP) panometry proved superior to high-resolution manometry (HRM) for evaluation of esophageal motility, according to a new study based on data from 329 adults.

Eraxion/Thinkstock.com

HRM is generally considered the primary method for evaluating esophageal motility, but current recommendations include the use of a FLIP or timed barium esophogram (TBE) if HRM yields inconclusive results, Dustin A. Carlson, MD, of Northwestern University, Chicago, and colleagues wrote in the recent study. FLIP has several potential advantages over HRM, including that “the test is performed on a sedated patient at the time of endoscopy, as opposed to the awake transnasal catheter used for HRM”; however, comparisons of the two methods for predicting esophageal retention are lacking.

In the study published in the American Journal of Gastroenterology, the researchers reviewed data from 329 consecutive patients aged 18-89 years who completed FLIP, HRM, and TBE for evaluation of primary esophageal motility. They excluded patients with previous foregut surgery. The researchers compared the ability of FLIP and HRM to predict esophageal retention based on abnormal TBE findings, which was defined as a 1-minute column height greater than 5 cm or as impaction of a 12.5-mm barium tablet.

For HRM, the integrated relaxation pressure (IRP) was assessed in the supine and upright patient positions to predict abnormal TBE findings. For FLIP, esophagogastric junction (EGJ) opening was assessed with a 16-cm FLIP performed during sedated endoscopy, and the presence of abnormal TBE findings was determined using the EGJ–distensibility index and maximum EGJ diameter.

The area under the ROC curve for identifying abnormal TBE findings was 0.79 (95% confidence interval, 0.75-0.84) for supine, 0.79 (95% CI, 0.76-0.86) for upright IRP, 0.84 (95% CI, 0.79-0.88) for the EGJ–distensibility index, and 0.88 (95% CI, 0.85-0.92) for the maximum EGJ diameter.

In a logistic regression analysis, the odds ratios for predicting abnormal TBE findings were 1.8 (95% confidence interval, 0.84-3.7; P < .133) for consistent elevation of IRP in HRM, compared with normal IRP, and 39.7 (95% CI, 16.4-96.2; P < .001) for reduced EGJ opening on FLIP panometry, compared with normal EGJ opening.

“Both the IRP on HRM and FLIP panometry metrics of EGJ opening (EGJ–[distensibility index] and maximum EGJ diameter) demonstrated capabilities to differentiate between abnormal and normal esophageal retention, which supports confidence in both tools,” the authors explained. “However, FLIP panometry parameters did so more accurately and with greater predictive capability as reflected by ROC and regression analysis.”

A total of 40 patients (12%) showed discordance between their HRM and FLIP panometry measures, and among these, FLIP showed stronger detection of esophageal retention. FLIP panometry was consistent with TBE in 78% of cases, while HRM-IRP was consistent with TBE in 23%. “Discordant results between HRM and FLIP panometry were observed in previous studies and again in this study, a scenario with unclear clinical significance,” the authors noted, which was why they used TBE as “an objective measure of esophageal retention that was independent of both HRM and FLIP to compare the two modalities.”

The study findings were limited by several factors including ones related to the use of TBE as the primary outcome, as well as the lack of longitudinal outcomes, the researchers noted. There is also the potential for referral bias and selection bias with an overrepresentation of patients with achalasia and EGJ outflow obstruction. However, the results were strengthened by the large sample size of patients who completed evaluations with HRM, FLIP, and TBE.

The study “provides additional support for the use of FLIP panometry to evaluate esophageal motility because it accurately identifies normal and abnormal retention, but also identifies patients who should undergo further complementary diagnostic testing,” they noted. Longitudinal studies are needed to explore best practices for managing esophageal motor disorders. In the meantime, evaluation with FLIP panometry, TBE, and HRM likely remains necessary for some patients, “particularly those with equivocal findings on a single test,” to better characterize disease and guide treatment, the researchers concluded.
 

Findings support potential of FLIP

“The endoscopic FLIP is an exciting clinical tool that utilizes distension of a catheter-mounted balloon to different volumes to acquire esophageal dimensions and pressures,” Amit Patel, MD, of Duke University, Durham, N.C., said in an interview.

“Accumulating data on FLIP inspired [recently published guidelines] to suggest the use of FLIP to complement high-resolution manometry in the setting of obstructive esophageal symptoms and borderline HRM findings, for patients in whom an HRM study cannot be completed, and for intraprocedural use during interventions for achalasia,” Dr. Patel said. “However, the comparative utility of FLIP, particularly among foundational esophageal diagnostics such as HRM and TBE, is less well developed at this point.”

Dr. Patel said he was surprised by some of the findings. “The characteristics of FLIP metrics (specifically, EGJ–distensibility index <2 mm²/mm Hg and/or maximum EGJ diameter <12 mm) were numerically superior to those for traditional IRP metrics from HRM in predicting retention on TBE on AUROC, regression analyses, and discordant cases in this study,” said Dr. Patel. “Although this study also corroborated the value of IRP on HRM, these findings were somewhat surprising for HRM, given its well-earned reputation as the gold standard for the diagnosis of esophageal motor disorders, its widespread use, and the record of strong data supporting its important role in clinical practice.”

Overall, this study suggests these metrics from FLIP (namely, EGJ–distensibility index and EGJ diameter) may have “diagnostic value beyond traditional IRP metrics from HRM to identify objective retention on TBE,” said Dr. Patel, who also said these exciting findings “support the growth of the complementary role of FLIP ... particularly in cases where HRM may be inconclusive or not tolerated by patients.”

However, more research is needed. “Taking into account other HRM metrics beyond IRP, such as intrabolus pressures or evaluation of bolus transit on impedance, and provocative maneuvers on HRM, such as rapid drink challenges or solid swallows, may be appropriate for further evaluation, as will improved arbitration of ‘borderline’ metrics or less clear cases,” Dr. Patel emphasized. Future studies should also incorporate management interventions and assessments of outcomes.  

The study was supported by a grant from the Public Health service to a coinvestigator, and by the American College of Gastroenterology Junior Faculty Development Award to lead author Dr. Carlson. Dr. Carlson also disclosed speaking and consulting relationships with Medtronic, which manufactures FLIP panometry systems. Northwestern University and several coauthors also disclosed intellectual property rights and ownership surrounding FLIP panometry systems, methods, and apparatus with Medtronic. Dr. Patel had no financial conflicts to disclose.

This article was updated Oct. 13, 2021.

Functional luminal imaging probe (FLIP) panometry proved superior to high-resolution manometry (HRM) for evaluation of esophageal motility, according to a new study based on data from 329 adults.

Eraxion/Thinkstock.com

HRM is generally considered the primary method for evaluating esophageal motility, but current recommendations include the use of a FLIP or timed barium esophogram (TBE) if HRM yields inconclusive results, Dustin A. Carlson, MD, of Northwestern University, Chicago, and colleagues wrote in the recent study. FLIP has several potential advantages over HRM, including that “the test is performed on a sedated patient at the time of endoscopy, as opposed to the awake transnasal catheter used for HRM”; however, comparisons of the two methods for predicting esophageal retention are lacking.

In the study published in the American Journal of Gastroenterology, the researchers reviewed data from 329 consecutive patients aged 18-89 years who completed FLIP, HRM, and TBE for evaluation of primary esophageal motility. They excluded patients with previous foregut surgery. The researchers compared the ability of FLIP and HRM to predict esophageal retention based on abnormal TBE findings, which was defined as a 1-minute column height greater than 5 cm or as impaction of a 12.5-mm barium tablet.

For HRM, the integrated relaxation pressure (IRP) was assessed in the supine and upright patient positions to predict abnormal TBE findings. For FLIP, esophagogastric junction (EGJ) opening was assessed with a 16-cm FLIP performed during sedated endoscopy, and the presence of abnormal TBE findings was determined using the EGJ–distensibility index and maximum EGJ diameter.

The area under the ROC curve for identifying abnormal TBE findings was 0.79 (95% confidence interval, 0.75-0.84) for supine, 0.79 (95% CI, 0.76-0.86) for upright IRP, 0.84 (95% CI, 0.79-0.88) for the EGJ–distensibility index, and 0.88 (95% CI, 0.85-0.92) for the maximum EGJ diameter.

In a logistic regression analysis, the odds ratios for predicting abnormal TBE findings were 1.8 (95% confidence interval, 0.84-3.7; P < .133) for consistent elevation of IRP in HRM, compared with normal IRP, and 39.7 (95% CI, 16.4-96.2; P < .001) for reduced EGJ opening on FLIP panometry, compared with normal EGJ opening.

“Both the IRP on HRM and FLIP panometry metrics of EGJ opening (EGJ–[distensibility index] and maximum EGJ diameter) demonstrated capabilities to differentiate between abnormal and normal esophageal retention, which supports confidence in both tools,” the authors explained. “However, FLIP panometry parameters did so more accurately and with greater predictive capability as reflected by ROC and regression analysis.”

A total of 40 patients (12%) showed discordance between their HRM and FLIP panometry measures, and among these, FLIP showed stronger detection of esophageal retention. FLIP panometry was consistent with TBE in 78% of cases, while HRM-IRP was consistent with TBE in 23%. “Discordant results between HRM and FLIP panometry were observed in previous studies and again in this study, a scenario with unclear clinical significance,” the authors noted, which was why they used TBE as “an objective measure of esophageal retention that was independent of both HRM and FLIP to compare the two modalities.”

The study findings were limited by several factors including ones related to the use of TBE as the primary outcome, as well as the lack of longitudinal outcomes, the researchers noted. There is also the potential for referral bias and selection bias with an overrepresentation of patients with achalasia and EGJ outflow obstruction. However, the results were strengthened by the large sample size of patients who completed evaluations with HRM, FLIP, and TBE.

The study “provides additional support for the use of FLIP panometry to evaluate esophageal motility because it accurately identifies normal and abnormal retention, but also identifies patients who should undergo further complementary diagnostic testing,” they noted. Longitudinal studies are needed to explore best practices for managing esophageal motor disorders. In the meantime, evaluation with FLIP panometry, TBE, and HRM likely remains necessary for some patients, “particularly those with equivocal findings on a single test,” to better characterize disease and guide treatment, the researchers concluded.
 

Findings support potential of FLIP

“The endoscopic FLIP is an exciting clinical tool that utilizes distension of a catheter-mounted balloon to different volumes to acquire esophageal dimensions and pressures,” Amit Patel, MD, of Duke University, Durham, N.C., said in an interview.

“Accumulating data on FLIP inspired [recently published guidelines] to suggest the use of FLIP to complement high-resolution manometry in the setting of obstructive esophageal symptoms and borderline HRM findings, for patients in whom an HRM study cannot be completed, and for intraprocedural use during interventions for achalasia,” Dr. Patel said. “However, the comparative utility of FLIP, particularly among foundational esophageal diagnostics such as HRM and TBE, is less well developed at this point.”

Dr. Patel said he was surprised by some of the findings. “The characteristics of FLIP metrics (specifically, EGJ–distensibility index <2 mm²/mm Hg and/or maximum EGJ diameter <12 mm) were numerically superior to those for traditional IRP metrics from HRM in predicting retention on TBE on AUROC, regression analyses, and discordant cases in this study,” said Dr. Patel. “Although this study also corroborated the value of IRP on HRM, these findings were somewhat surprising for HRM, given its well-earned reputation as the gold standard for the diagnosis of esophageal motor disorders, its widespread use, and the record of strong data supporting its important role in clinical practice.”

Overall, this study suggests these metrics from FLIP (namely, EGJ–distensibility index and EGJ diameter) may have “diagnostic value beyond traditional IRP metrics from HRM to identify objective retention on TBE,” said Dr. Patel, who also said these exciting findings “support the growth of the complementary role of FLIP ... particularly in cases where HRM may be inconclusive or not tolerated by patients.”

However, more research is needed. “Taking into account other HRM metrics beyond IRP, such as intrabolus pressures or evaluation of bolus transit on impedance, and provocative maneuvers on HRM, such as rapid drink challenges or solid swallows, may be appropriate for further evaluation, as will improved arbitration of ‘borderline’ metrics or less clear cases,” Dr. Patel emphasized. Future studies should also incorporate management interventions and assessments of outcomes.  

The study was supported by a grant from the Public Health service to a coinvestigator, and by the American College of Gastroenterology Junior Faculty Development Award to lead author Dr. Carlson. Dr. Carlson also disclosed speaking and consulting relationships with Medtronic, which manufactures FLIP panometry systems. Northwestern University and several coauthors also disclosed intellectual property rights and ownership surrounding FLIP panometry systems, methods, and apparatus with Medtronic. Dr. Patel had no financial conflicts to disclose.

This article was updated Oct. 13, 2021.

High out-of-pocket costs for medications remain a barrier for patients with psoriasis or psoriatic arthritis on Medicare, according to findings from a cross-sectional analysis of the Centers for Medicare & Medicaid Services Prescription Drug Plan Formulary Data from the fourth quarter of 2020.

Mathier/Thinkstock

Although biologics have demonstrated safety and effectiveness for psoriasis and psoriatic arthritis, their costs have risen, which has led patients to switch or discontinue biologics and consequently incur greater health care costs, wrote Sarah P. Pourali and colleagues at Vanderbilt University, Nashville, Tenn.

The authors also noted that Medicare patients in particular experience a financial burden if they have no limits on out-of-pocket spending, and while patient assistance programs may offset some out-of-pocket spending for specialty drugs, not all patients are aware of or qualify for them. Ineligibility for low-income subsidies also serves as a barrier and is associated with lower adherence to treatment.

In a study published in JAMA Dermatology, the researchers identified 5,011 formularies using the CMS data. The medications were etanercept, adalimumab, golimumab, ustekinumab, certolizumab pegol, apremilast, secukinumab, abatacept, ixekizumab, brodalumab, tofacitinib, tofacitinib XR, guselkumab, tildrakizumab, and risankizumab.

Overall, coverage for those 15 specialty medications ranged from 10.0% to 99.8% across products and Part D plans. The most commonly covered medications were adalimumab and ustekinumab (99.8% for both) and the least covered were brodalumab and tildrakizumab (10.9% and 10.0%, respectively).

Prior authorization was required by 90.5%-100% of the plans when medications were covered, and plans with limits on the quantity of medications covered ranged from 1.0% of plans (for guselkumab) to 78% of plans (for tofacitinib).

Copays were relatively rare; 2.4%-5.5% of the plans offered copays on any of the 15 medications.

The standard Medicare benefit for 2021 included a $445 deductible, 25% coinsurance for initial drug spending, and 5% coinsurance for drug spending in the catastrophic phase of coverage, the researchers noted. Overall, apremilast had the lowest estimated out-of-pocket costs for initial fills, under the catastrophic coverage phase, and annual cost, and ustekinumab had the highest. The estimated out-of-pocket costs for an initial fill ranged from $1,234 for apremilast to $3,426 for ustekinumab. Out-of-pocket costs for medications under the catastrophic phase ranged from $181 for apremilast to $1,175 for ustekinumab. Estimated out-of-pocket costs for a year of treatment ranged from $4,423 for apremilast to $6,950 for ustekinumab.

Median point-of-sale prices per fill – meaning pricing with no rebates or discounts – were lowest for apremilast ($3,620.40) and reached $23,492.93 per fill for ustekinumab, the researchers wrote. Other medications with point-of-sale prices above $10,000 were guselkumab ($11,511.52), tildrakizumab ($14,112.13), and risankizumab ($16,248.90).

The study was supported by grants from the Commonwealth Fund and the Leukemia & Lymphoma Society. One author disclosed receiving grants from Arnold Ventures, the Commonwealth Fund, and the Robert Wood Johnson Foundation for unrelated work, as well as honoraria from West Health and the Institute for Clinical and Economic Review.

High out-of-pocket costs for medications remain a barrier for patients with psoriasis or psoriatic arthritis on Medicare, according to findings from a cross-sectional analysis of the Centers for Medicare & Medicaid Services Prescription Drug Plan Formulary Data from the fourth quarter of 2020.

Mathier/Thinkstock

Although biologics have demonstrated safety and effectiveness for psoriasis and psoriatic arthritis, their costs have risen, which has led patients to switch or discontinue biologics and consequently incur greater health care costs, wrote Sarah P. Pourali and colleagues at Vanderbilt University, Nashville, Tenn.

The authors also noted that Medicare patients in particular experience a financial burden if they have no limits on out-of-pocket spending, and while patient assistance programs may offset some out-of-pocket spending for specialty drugs, not all patients are aware of or qualify for them. Ineligibility for low-income subsidies also serves as a barrier and is associated with lower adherence to treatment.

In a study published in JAMA Dermatology, the researchers identified 5,011 formularies using the CMS data. The medications were etanercept, adalimumab, golimumab, ustekinumab, certolizumab pegol, apremilast, secukinumab, abatacept, ixekizumab, brodalumab, tofacitinib, tofacitinib XR, guselkumab, tildrakizumab, and risankizumab.

Overall, coverage for those 15 specialty medications ranged from 10.0% to 99.8% across products and Part D plans. The most commonly covered medications were adalimumab and ustekinumab (99.8% for both) and the least covered were brodalumab and tildrakizumab (10.9% and 10.0%, respectively).

Prior authorization was required by 90.5%-100% of the plans when medications were covered, and plans with limits on the quantity of medications covered ranged from 1.0% of plans (for guselkumab) to 78% of plans (for tofacitinib).

Copays were relatively rare; 2.4%-5.5% of the plans offered copays on any of the 15 medications.

The standard Medicare benefit for 2021 included a $445 deductible, 25% coinsurance for initial drug spending, and 5% coinsurance for drug spending in the catastrophic phase of coverage, the researchers noted. Overall, apremilast had the lowest estimated out-of-pocket costs for initial fills, under the catastrophic coverage phase, and annual cost, and ustekinumab had the highest. The estimated out-of-pocket costs for an initial fill ranged from $1,234 for apremilast to $3,426 for ustekinumab. Out-of-pocket costs for medications under the catastrophic phase ranged from $181 for apremilast to $1,175 for ustekinumab. Estimated out-of-pocket costs for a year of treatment ranged from $4,423 for apremilast to $6,950 for ustekinumab.

Median point-of-sale prices per fill – meaning pricing with no rebates or discounts – were lowest for apremilast ($3,620.40) and reached $23,492.93 per fill for ustekinumab, the researchers wrote. Other medications with point-of-sale prices above $10,000 were guselkumab ($11,511.52), tildrakizumab ($14,112.13), and risankizumab ($16,248.90).

The study was supported by grants from the Commonwealth Fund and the Leukemia & Lymphoma Society. One author disclosed receiving grants from Arnold Ventures, the Commonwealth Fund, and the Robert Wood Johnson Foundation for unrelated work, as well as honoraria from West Health and the Institute for Clinical and Economic Review.

High out-of-pocket costs for medications remain a barrier for patients with psoriasis or psoriatic arthritis on Medicare, according to findings from a cross-sectional analysis of the Centers for Medicare & Medicaid Services Prescription Drug Plan Formulary Data from the fourth quarter of 2020.

Mathier/Thinkstock

Although biologics have demonstrated safety and effectiveness for psoriasis and psoriatic arthritis, their costs have risen, which has led patients to switch or discontinue biologics and consequently incur greater health care costs, wrote Sarah P. Pourali and colleagues at Vanderbilt University, Nashville, Tenn.

The authors also noted that Medicare patients in particular experience a financial burden if they have no limits on out-of-pocket spending, and while patient assistance programs may offset some out-of-pocket spending for specialty drugs, not all patients are aware of or qualify for them. Ineligibility for low-income subsidies also serves as a barrier and is associated with lower adherence to treatment.

In a study published in JAMA Dermatology, the researchers identified 5,011 formularies using the CMS data. The medications were etanercept, adalimumab, golimumab, ustekinumab, certolizumab pegol, apremilast, secukinumab, abatacept, ixekizumab, brodalumab, tofacitinib, tofacitinib XR, guselkumab, tildrakizumab, and risankizumab.

Overall, coverage for those 15 specialty medications ranged from 10.0% to 99.8% across products and Part D plans. The most commonly covered medications were adalimumab and ustekinumab (99.8% for both) and the least covered were brodalumab and tildrakizumab (10.9% and 10.0%, respectively).

Prior authorization was required by 90.5%-100% of the plans when medications were covered, and plans with limits on the quantity of medications covered ranged from 1.0% of plans (for guselkumab) to 78% of plans (for tofacitinib).

Copays were relatively rare; 2.4%-5.5% of the plans offered copays on any of the 15 medications.

The standard Medicare benefit for 2021 included a $445 deductible, 25% coinsurance for initial drug spending, and 5% coinsurance for drug spending in the catastrophic phase of coverage, the researchers noted. Overall, apremilast had the lowest estimated out-of-pocket costs for initial fills, under the catastrophic coverage phase, and annual cost, and ustekinumab had the highest. The estimated out-of-pocket costs for an initial fill ranged from $1,234 for apremilast to $3,426 for ustekinumab. Out-of-pocket costs for medications under the catastrophic phase ranged from $181 for apremilast to $1,175 for ustekinumab. Estimated out-of-pocket costs for a year of treatment ranged from $4,423 for apremilast to $6,950 for ustekinumab.

Median point-of-sale prices per fill – meaning pricing with no rebates or discounts – were lowest for apremilast ($3,620.40) and reached $23,492.93 per fill for ustekinumab, the researchers wrote. Other medications with point-of-sale prices above $10,000 were guselkumab ($11,511.52), tildrakizumab ($14,112.13), and risankizumab ($16,248.90).

The study was supported by grants from the Commonwealth Fund and the Leukemia & Lymphoma Society. One author disclosed receiving grants from Arnold Ventures, the Commonwealth Fund, and the Robert Wood Johnson Foundation for unrelated work, as well as honoraria from West Health and the Institute for Clinical and Economic Review.

Use of cannabidiol (CBD) as an add-on pain management technique in patients with either hand osteoarthritis (OA) or psoriatic arthritis (PsA) did not significantly decrease pain intensity when compared with a placebo in a randomized, double-blind trial described as the first of its kind to investigate the effect of pure CBD as an add-on analgesic therapy in patients with joint disease.

Anatoliy Sizov/Getty Images

Although data on the use of medical cannabis as a modulator of joint pain are limited, some studies suggest an effect from CBD without the addition of delta-9-tetrahydrocannabinol (THC), wrote Jonathan Vela, MD, of Aalborg (Denmark) University Hospital, and colleagues.

CBD is being used for pain conditions despite a lack of data on safety and effectiveness, the researchers emphasized. Notably, in a 2018 online survey, 62% of respondents reported using CBD for medical conditions, primarily for chronic pain and arthritis or joint pain, they wrote.

In a study published in the journal Pain, the researchers randomized 59 adults with PsA and 77 adults with hand OA to 20-30 mg of synthetic CBD or a placebo daily for 12 weeks in addition to conventional pain management. Patients initially received either oral CBD 10 mg or a placebo tablet once daily, increasing to 10 mg twice daily after 2 weeks, and once again up to 10 mg three times daily at 4 weeks if the patient did not experience more than 20-mm improvement on the visual analog scale (VAS).

The primary outcome in the trial was patient-reported pain intensity during the last 24 hours as assessed on a paper-based 100-mm VAS with the text, “How much pain have you experienced in the most symptomatic joint during the last 24 hours?” with 0 representing no pain and 100 representing the worst pain imaginable.

Overall, both CBD and placebo groups achieved significant reductions in pain intensity of 11-12 mm at 12 weeks. The mean between-group difference on the VAS was 0.23 mm (P = .96). Twenty-two percent of patients who received CBD and 21% who received placebo demonstrated a pain intensity reduction greater than 30 mm on the VAS. Pain reduction greater than 50% was reported by 17 patients (25%) in the CBD group and 16 (27%) in the placebo group. CBD had a similar effect in patients with either PsA or hand OA.

Four serious adverse events occurred during the 12-week study period, but none of these were deemed adverse drug reactions. Serious adverse events in the CBD patients included one case of ductal carcinoma and one case of lipotymia; serious adverse events in the placebo group included one case of acute shoulder fracture and one case of malignant hypertension. Fifty-nine patients reported adverse events during the study. The CBD group reported more ear-nose-throat adverse events, compared with the placebo group (8 vs. 0).

The researchers assessed the impact of CBD vs. placebo on sleep quality, depression, anxiety, or pain catastrophizing scores using the Pittsburgh Sleep Quality Index, Hospital Anxiety and Depression Scale, Pain Catastrophizing Scale, and Health Assessment Questionnaire but found no differences in patients taking CBD vs. placebo.

The study findings were limited by several factors, including the potentially insufficient dose level to evoke a pain relief response, and a lack of data on additional daily use of analgesics or of the study drug beyond the prescribed dosage, the researchers noted.

The results were strengthened by the randomized, double-blind trial design and its relatively large sample size, they wrote. However, the researchers also cautioned that their study focused on CBD as a single ingredient, and the results might not generalize to other CBD formulations. They also noted that more research is needed to examine both higher doses of CBD and different types of pain disorders.

The study was supported by the Danish Psoriasis Foundation Grant and the Danish Rheumatism Foundation. The researchers had no financial conflicts to disclose.

Use of cannabidiol (CBD) as an add-on pain management technique in patients with either hand osteoarthritis (OA) or psoriatic arthritis (PsA) did not significantly decrease pain intensity when compared with a placebo in a randomized, double-blind trial described as the first of its kind to investigate the effect of pure CBD as an add-on analgesic therapy in patients with joint disease.

Anatoliy Sizov/Getty Images

Although data on the use of medical cannabis as a modulator of joint pain are limited, some studies suggest an effect from CBD without the addition of delta-9-tetrahydrocannabinol (THC), wrote Jonathan Vela, MD, of Aalborg (Denmark) University Hospital, and colleagues.

CBD is being used for pain conditions despite a lack of data on safety and effectiveness, the researchers emphasized. Notably, in a 2018 online survey, 62% of respondents reported using CBD for medical conditions, primarily for chronic pain and arthritis or joint pain, they wrote.

In a study published in the journal Pain, the researchers randomized 59 adults with PsA and 77 adults with hand OA to 20-30 mg of synthetic CBD or a placebo daily for 12 weeks in addition to conventional pain management. Patients initially received either oral CBD 10 mg or a placebo tablet once daily, increasing to 10 mg twice daily after 2 weeks, and once again up to 10 mg three times daily at 4 weeks if the patient did not experience more than 20-mm improvement on the visual analog scale (VAS).

The primary outcome in the trial was patient-reported pain intensity during the last 24 hours as assessed on a paper-based 100-mm VAS with the text, “How much pain have you experienced in the most symptomatic joint during the last 24 hours?” with 0 representing no pain and 100 representing the worst pain imaginable.

Overall, both CBD and placebo groups achieved significant reductions in pain intensity of 11-12 mm at 12 weeks. The mean between-group difference on the VAS was 0.23 mm (P = .96). Twenty-two percent of patients who received CBD and 21% who received placebo demonstrated a pain intensity reduction greater than 30 mm on the VAS. Pain reduction greater than 50% was reported by 17 patients (25%) in the CBD group and 16 (27%) in the placebo group. CBD had a similar effect in patients with either PsA or hand OA.

Four serious adverse events occurred during the 12-week study period, but none of these were deemed adverse drug reactions. Serious adverse events in the CBD patients included one case of ductal carcinoma and one case of lipotymia; serious adverse events in the placebo group included one case of acute shoulder fracture and one case of malignant hypertension. Fifty-nine patients reported adverse events during the study. The CBD group reported more ear-nose-throat adverse events, compared with the placebo group (8 vs. 0).

The researchers assessed the impact of CBD vs. placebo on sleep quality, depression, anxiety, or pain catastrophizing scores using the Pittsburgh Sleep Quality Index, Hospital Anxiety and Depression Scale, Pain Catastrophizing Scale, and Health Assessment Questionnaire but found no differences in patients taking CBD vs. placebo.

The study findings were limited by several factors, including the potentially insufficient dose level to evoke a pain relief response, and a lack of data on additional daily use of analgesics or of the study drug beyond the prescribed dosage, the researchers noted.

The results were strengthened by the randomized, double-blind trial design and its relatively large sample size, they wrote. However, the researchers also cautioned that their study focused on CBD as a single ingredient, and the results might not generalize to other CBD formulations. They also noted that more research is needed to examine both higher doses of CBD and different types of pain disorders.

The study was supported by the Danish Psoriasis Foundation Grant and the Danish Rheumatism Foundation. The researchers had no financial conflicts to disclose.

Use of cannabidiol (CBD) as an add-on pain management technique in patients with either hand osteoarthritis (OA) or psoriatic arthritis (PsA) did not significantly decrease pain intensity when compared with a placebo in a randomized, double-blind trial described as the first of its kind to investigate the effect of pure CBD as an add-on analgesic therapy in patients with joint disease.

Anatoliy Sizov/Getty Images

Although data on the use of medical cannabis as a modulator of joint pain are limited, some studies suggest an effect from CBD without the addition of delta-9-tetrahydrocannabinol (THC), wrote Jonathan Vela, MD, of Aalborg (Denmark) University Hospital, and colleagues.

CBD is being used for pain conditions despite a lack of data on safety and effectiveness, the researchers emphasized. Notably, in a 2018 online survey, 62% of respondents reported using CBD for medical conditions, primarily for chronic pain and arthritis or joint pain, they wrote.

In a study published in the journal Pain, the researchers randomized 59 adults with PsA and 77 adults with hand OA to 20-30 mg of synthetic CBD or a placebo daily for 12 weeks in addition to conventional pain management. Patients initially received either oral CBD 10 mg or a placebo tablet once daily, increasing to 10 mg twice daily after 2 weeks, and once again up to 10 mg three times daily at 4 weeks if the patient did not experience more than 20-mm improvement on the visual analog scale (VAS).

The primary outcome in the trial was patient-reported pain intensity during the last 24 hours as assessed on a paper-based 100-mm VAS with the text, “How much pain have you experienced in the most symptomatic joint during the last 24 hours?” with 0 representing no pain and 100 representing the worst pain imaginable.

Overall, both CBD and placebo groups achieved significant reductions in pain intensity of 11-12 mm at 12 weeks. The mean between-group difference on the VAS was 0.23 mm (P = .96). Twenty-two percent of patients who received CBD and 21% who received placebo demonstrated a pain intensity reduction greater than 30 mm on the VAS. Pain reduction greater than 50% was reported by 17 patients (25%) in the CBD group and 16 (27%) in the placebo group. CBD had a similar effect in patients with either PsA or hand OA.

Four serious adverse events occurred during the 12-week study period, but none of these were deemed adverse drug reactions. Serious adverse events in the CBD patients included one case of ductal carcinoma and one case of lipotymia; serious adverse events in the placebo group included one case of acute shoulder fracture and one case of malignant hypertension. Fifty-nine patients reported adverse events during the study. The CBD group reported more ear-nose-throat adverse events, compared with the placebo group (8 vs. 0).

The researchers assessed the impact of CBD vs. placebo on sleep quality, depression, anxiety, or pain catastrophizing scores using the Pittsburgh Sleep Quality Index, Hospital Anxiety and Depression Scale, Pain Catastrophizing Scale, and Health Assessment Questionnaire but found no differences in patients taking CBD vs. placebo.

The study findings were limited by several factors, including the potentially insufficient dose level to evoke a pain relief response, and a lack of data on additional daily use of analgesics or of the study drug beyond the prescribed dosage, the researchers noted.

The results were strengthened by the randomized, double-blind trial design and its relatively large sample size, they wrote. However, the researchers also cautioned that their study focused on CBD as a single ingredient, and the results might not generalize to other CBD formulations. They also noted that more research is needed to examine both higher doses of CBD and different types of pain disorders.

The study was supported by the Danish Psoriasis Foundation Grant and the Danish Rheumatism Foundation. The researchers had no financial conflicts to disclose.

The 30-day mortality rate was significantly lower among hospitalized patients treated by full-time clinicians, compared with those treated by part-time clinicians, in a new study.

The number of physicians working part time in the United States has increased by nearly 11% since 1993, and as more physicians opt for part-time work, quality of care deserves further study, the investigators wrote in JAMA Internal Medicine. Most studies comparing outcomes for patients treated by full-timers and part-timers have focused on outpatient care settings, where mortality is low and the potential for confounding is high, according to the study authors Hirotaka Kato, PhD, of Keio University in Tokyo, and colleagues. The new study, in contrast, is based on data from nearly 400,000 hospitalizations.

The researchers conducted a cross-sectional analysis on a 20% random sample of Medicare patients aged 65 years and older who were treated by a hospitalist for an emergency medical condition between 2011 and 2016. They examined associations between the number of days per year worked by hospitalists and they 30-day mortality rates among the patients they treated. The researchers analyzed a total of 392,797 hospitalizations in which patients were treated by 19,170 hospitalists. The mean age of the hospitalists was 41 years; 39% were female. Clinician work days were divided into quartiles.

Overall, the 30-day mortality was significantly higher among patients treated by clinicians in the bottom quartile with the fewest number of days worked, compared with those treated by clinicians in the top quartile with the most days worked (10.5% vs. 9.6%). The rates were similar in the second and third quartiles (10.0% and 9.5%).

The average number of days worked clinically per year was 57.6 in the lowest quartile versus 163.3 in the highest quartile, a 65% difference. No significant associations were noted between days worked and patient outcomes with regard to physician age, gender, or hospital teaching status.

Hospital 30-day readmission rates were examined as a secondary outcome, but there was no association between patient readmission and the number of days worked by the clinician. The adjusted 30-day readmission rate for clinicians in the bottom quartile of days worked, compared with those in the top quartile, was 15.3% versus 15.2% (P = .61).

The researchers found no difference in patients’ severity of illness (defined by expected mortality) or reason for admission between physicians in the different quartiles of days worked. They eliminated confounding from hospital-level differences by comparing outcomes of patients between physicians in the same hospital.
 

Possible explanations for worse patient outcomes

“As the number of physicians who engage in part-time clinical work continues to increase, these findings should lead to careful consideration by health systems to reevaluate preventive measures to address potential unintended patient harm,” the researchers wrote.

The researchers proposed several reasons for the association between fewer clinical work days and worse patient outcomes. First, physicians putting in less clinical time may be less updated on the latest guidelines, their skills may decline with less frequent patient care, and they may be less familiar with the nurses, medical assistants, and support staff, which may contribute to poor teamwork. The researchers also stated that some part-time physicians may need to balance nonclinical responsibilities, such as research or administrative tasks, concurrently with inpatient care. “It is also possible that physicians with less clinical knowledge or skills select to become part-time physicians, whereas physicians with higher clinical performance decide to work full time,” they noted.

The study findings were limited by several factors including the observational design and potential for unmeasured confounding variables, and the results may not generalize to younger patients or surgical patients, the researchers noted. Also, the study did not include care by hospitalists that was not billed, days in which clinicians treated non-Medicare patients or patients not part of the Medicare sample, or information about the reasons for clinicians’ part-time work.

However, the results were strengthened by the large sample size, and suggest the need for better institutional support to maintain the clinical performance of physicians who may be balancing a range of obligations, they concluded.

Clinician work issues have renewed relevance

“The data in this paper are from 2016 and earlier, but it is possibly event more relevant today than then,” Eileen Barrett, MD, of the University of New Mexico, Albuquerque, said in an interview. “The pandemic has exacerbated stressors being experienced by physicians and other health care workers, including higher clinical workloads and burnout, and spotlighted gendered effects on women in the workforce, which is likely to drive more physicians to part-time work.

“Reporting these findings now is so important so they can contribute to a shared mental model of the challenges physicians and hospitals face as we seek solutions to deliver high-quality and high-value care with an engaged, professionally fulfilled workforce,” she emphasized.

Dr. Barrett said she was surprised that the study did not show differences in readmission rates depending on the number of shifts worked, and also that the results were not different when considering expected mortality.

“However unpopular it may be to say so, physicians and administrators should assume these results apply to their practice unless they have examined their own data and know it does not,” Dr. Barrett said. “With that in mind, hospitals, administrators, and regulatory bodies have an urgent need to examine and reduce the forces driving physicians to part-time clinical work. Some of these factors include the absence of childcare, excessive paperwork, burnout, administrative duties, and valued experiences such as teaching, leadership, and research that keep clinicians from the bedside.

“Additionally, steps should be taken to reduce the administrative complexity that makes providing the best care to patients difficult and requires hospitalists to create ‘workarounds,’ because those who work fewer clinical hours may not know how to do these, nor how to advocate for their patients,” Dr. Barrett emphasized.

“Additional research is needed to determine how mortality varies by number of clinical shifts for pediatric and obstetric patients who are infrequently covered by Medicare, also how the pandemic and increasing administrative complexity since the time the data was obtained affect patient care,” Dr. Barrett noted.

The study was supported by a grant from the Japan Society for the Promotion of Science to lead author Dr. Kato, who had no financial conflicts to disclose. Dr. Barrett, who serves on the editorial advisory board of Internal Medicine News, had no financial conflicts.

The 30-day mortality rate was significantly lower among hospitalized patients treated by full-time clinicians, compared with those treated by part-time clinicians, in a new study.

The number of physicians working part time in the United States has increased by nearly 11% since 1993, and as more physicians opt for part-time work, quality of care deserves further study, the investigators wrote in JAMA Internal Medicine. Most studies comparing outcomes for patients treated by full-timers and part-timers have focused on outpatient care settings, where mortality is low and the potential for confounding is high, according to the study authors Hirotaka Kato, PhD, of Keio University in Tokyo, and colleagues. The new study, in contrast, is based on data from nearly 400,000 hospitalizations.

The researchers conducted a cross-sectional analysis on a 20% random sample of Medicare patients aged 65 years and older who were treated by a hospitalist for an emergency medical condition between 2011 and 2016. They examined associations between the number of days per year worked by hospitalists and they 30-day mortality rates among the patients they treated. The researchers analyzed a total of 392,797 hospitalizations in which patients were treated by 19,170 hospitalists. The mean age of the hospitalists was 41 years; 39% were female. Clinician work days were divided into quartiles.

Overall, the 30-day mortality was significantly higher among patients treated by clinicians in the bottom quartile with the fewest number of days worked, compared with those treated by clinicians in the top quartile with the most days worked (10.5% vs. 9.6%). The rates were similar in the second and third quartiles (10.0% and 9.5%).

The average number of days worked clinically per year was 57.6 in the lowest quartile versus 163.3 in the highest quartile, a 65% difference. No significant associations were noted between days worked and patient outcomes with regard to physician age, gender, or hospital teaching status.

Hospital 30-day readmission rates were examined as a secondary outcome, but there was no association between patient readmission and the number of days worked by the clinician. The adjusted 30-day readmission rate for clinicians in the bottom quartile of days worked, compared with those in the top quartile, was 15.3% versus 15.2% (P = .61).

The researchers found no difference in patients’ severity of illness (defined by expected mortality) or reason for admission between physicians in the different quartiles of days worked. They eliminated confounding from hospital-level differences by comparing outcomes of patients between physicians in the same hospital.
 

Possible explanations for worse patient outcomes

“As the number of physicians who engage in part-time clinical work continues to increase, these findings should lead to careful consideration by health systems to reevaluate preventive measures to address potential unintended patient harm,” the researchers wrote.

The researchers proposed several reasons for the association between fewer clinical work days and worse patient outcomes. First, physicians putting in less clinical time may be less updated on the latest guidelines, their skills may decline with less frequent patient care, and they may be less familiar with the nurses, medical assistants, and support staff, which may contribute to poor teamwork. The researchers also stated that some part-time physicians may need to balance nonclinical responsibilities, such as research or administrative tasks, concurrently with inpatient care. “It is also possible that physicians with less clinical knowledge or skills select to become part-time physicians, whereas physicians with higher clinical performance decide to work full time,” they noted.

The study findings were limited by several factors including the observational design and potential for unmeasured confounding variables, and the results may not generalize to younger patients or surgical patients, the researchers noted. Also, the study did not include care by hospitalists that was not billed, days in which clinicians treated non-Medicare patients or patients not part of the Medicare sample, or information about the reasons for clinicians’ part-time work.

However, the results were strengthened by the large sample size, and suggest the need for better institutional support to maintain the clinical performance of physicians who may be balancing a range of obligations, they concluded.

Clinician work issues have renewed relevance

“The data in this paper are from 2016 and earlier, but it is possibly event more relevant today than then,” Eileen Barrett, MD, of the University of New Mexico, Albuquerque, said in an interview. “The pandemic has exacerbated stressors being experienced by physicians and other health care workers, including higher clinical workloads and burnout, and spotlighted gendered effects on women in the workforce, which is likely to drive more physicians to part-time work.

“Reporting these findings now is so important so they can contribute to a shared mental model of the challenges physicians and hospitals face as we seek solutions to deliver high-quality and high-value care with an engaged, professionally fulfilled workforce,” she emphasized.

Dr. Barrett said she was surprised that the study did not show differences in readmission rates depending on the number of shifts worked, and also that the results were not different when considering expected mortality.

“However unpopular it may be to say so, physicians and administrators should assume these results apply to their practice unless they have examined their own data and know it does not,” Dr. Barrett said. “With that in mind, hospitals, administrators, and regulatory bodies have an urgent need to examine and reduce the forces driving physicians to part-time clinical work. Some of these factors include the absence of childcare, excessive paperwork, burnout, administrative duties, and valued experiences such as teaching, leadership, and research that keep clinicians from the bedside.

“Additionally, steps should be taken to reduce the administrative complexity that makes providing the best care to patients difficult and requires hospitalists to create ‘workarounds,’ because those who work fewer clinical hours may not know how to do these, nor how to advocate for their patients,” Dr. Barrett emphasized.

“Additional research is needed to determine how mortality varies by number of clinical shifts for pediatric and obstetric patients who are infrequently covered by Medicare, also how the pandemic and increasing administrative complexity since the time the data was obtained affect patient care,” Dr. Barrett noted.

The study was supported by a grant from the Japan Society for the Promotion of Science to lead author Dr. Kato, who had no financial conflicts to disclose. Dr. Barrett, who serves on the editorial advisory board of Internal Medicine News, had no financial conflicts.

The 30-day mortality rate was significantly lower among hospitalized patients treated by full-time clinicians, compared with those treated by part-time clinicians, in a new study.

The number of physicians working part time in the United States has increased by nearly 11% since 1993, and as more physicians opt for part-time work, quality of care deserves further study, the investigators wrote in JAMA Internal Medicine. Most studies comparing outcomes for patients treated by full-timers and part-timers have focused on outpatient care settings, where mortality is low and the potential for confounding is high, according to the study authors Hirotaka Kato, PhD, of Keio University in Tokyo, and colleagues. The new study, in contrast, is based on data from nearly 400,000 hospitalizations.

The researchers conducted a cross-sectional analysis on a 20% random sample of Medicare patients aged 65 years and older who were treated by a hospitalist for an emergency medical condition between 2011 and 2016. They examined associations between the number of days per year worked by hospitalists and they 30-day mortality rates among the patients they treated. The researchers analyzed a total of 392,797 hospitalizations in which patients were treated by 19,170 hospitalists. The mean age of the hospitalists was 41 years; 39% were female. Clinician work days were divided into quartiles.

Overall, the 30-day mortality was significantly higher among patients treated by clinicians in the bottom quartile with the fewest number of days worked, compared with those treated by clinicians in the top quartile with the most days worked (10.5% vs. 9.6%). The rates were similar in the second and third quartiles (10.0% and 9.5%).

The average number of days worked clinically per year was 57.6 in the lowest quartile versus 163.3 in the highest quartile, a 65% difference. No significant associations were noted between days worked and patient outcomes with regard to physician age, gender, or hospital teaching status.

Hospital 30-day readmission rates were examined as a secondary outcome, but there was no association between patient readmission and the number of days worked by the clinician. The adjusted 30-day readmission rate for clinicians in the bottom quartile of days worked, compared with those in the top quartile, was 15.3% versus 15.2% (P = .61).

The researchers found no difference in patients’ severity of illness (defined by expected mortality) or reason for admission between physicians in the different quartiles of days worked. They eliminated confounding from hospital-level differences by comparing outcomes of patients between physicians in the same hospital.
 

Possible explanations for worse patient outcomes

“As the number of physicians who engage in part-time clinical work continues to increase, these findings should lead to careful consideration by health systems to reevaluate preventive measures to address potential unintended patient harm,” the researchers wrote.

The researchers proposed several reasons for the association between fewer clinical work days and worse patient outcomes. First, physicians putting in less clinical time may be less updated on the latest guidelines, their skills may decline with less frequent patient care, and they may be less familiar with the nurses, medical assistants, and support staff, which may contribute to poor teamwork. The researchers also stated that some part-time physicians may need to balance nonclinical responsibilities, such as research or administrative tasks, concurrently with inpatient care. “It is also possible that physicians with less clinical knowledge or skills select to become part-time physicians, whereas physicians with higher clinical performance decide to work full time,” they noted.

The study findings were limited by several factors including the observational design and potential for unmeasured confounding variables, and the results may not generalize to younger patients or surgical patients, the researchers noted. Also, the study did not include care by hospitalists that was not billed, days in which clinicians treated non-Medicare patients or patients not part of the Medicare sample, or information about the reasons for clinicians’ part-time work.

However, the results were strengthened by the large sample size, and suggest the need for better institutional support to maintain the clinical performance of physicians who may be balancing a range of obligations, they concluded.

Clinician work issues have renewed relevance

“The data in this paper are from 2016 and earlier, but it is possibly event more relevant today than then,” Eileen Barrett, MD, of the University of New Mexico, Albuquerque, said in an interview. “The pandemic has exacerbated stressors being experienced by physicians and other health care workers, including higher clinical workloads and burnout, and spotlighted gendered effects on women in the workforce, which is likely to drive more physicians to part-time work.

“Reporting these findings now is so important so they can contribute to a shared mental model of the challenges physicians and hospitals face as we seek solutions to deliver high-quality and high-value care with an engaged, professionally fulfilled workforce,” she emphasized.

Dr. Barrett said she was surprised that the study did not show differences in readmission rates depending on the number of shifts worked, and also that the results were not different when considering expected mortality.

“However unpopular it may be to say so, physicians and administrators should assume these results apply to their practice unless they have examined their own data and know it does not,” Dr. Barrett said. “With that in mind, hospitals, administrators, and regulatory bodies have an urgent need to examine and reduce the forces driving physicians to part-time clinical work. Some of these factors include the absence of childcare, excessive paperwork, burnout, administrative duties, and valued experiences such as teaching, leadership, and research that keep clinicians from the bedside.

“Additionally, steps should be taken to reduce the administrative complexity that makes providing the best care to patients difficult and requires hospitalists to create ‘workarounds,’ because those who work fewer clinical hours may not know how to do these, nor how to advocate for their patients,” Dr. Barrett emphasized.

“Additional research is needed to determine how mortality varies by number of clinical shifts for pediatric and obstetric patients who are infrequently covered by Medicare, also how the pandemic and increasing administrative complexity since the time the data was obtained affect patient care,” Dr. Barrett noted.

The study was supported by a grant from the Japan Society for the Promotion of Science to lead author Dr. Kato, who had no financial conflicts to disclose. Dr. Barrett, who serves on the editorial advisory board of Internal Medicine News, had no financial conflicts.

“All physicians, regardless of specialty, will work with patients with disabilities,” Corrie Harris, MD, of the University of Louisville (Ky.), said in a plenary session presentation at the 2021 virtual Pediatric Hospital Medicine conference.

Disabilities vary in their visibility, from cognitive and sensory impairments that are not immediately obvious to an obvious physical disability, she said.

One in four adults and one in six children in the United States has a disability, said Dr. Harris. The prevalence of disability increases with age, but occurs across the lifespan, and will likely increase in the future with greater improvements in health care overall.

Dr. Harris reviewed the current conceptual model that forms the basis for the World Health Organization definition of functioning disability. This “functional model” defines disability as caused by interactions between health conditions and the environment, and the response is to “prioritize function to meet patient goals,” Dr. Harris said at the meeting, sponsored by the Society of Hospital Medicine, the American Academy of Pediatrics, and the Academic Pediatric Association.

This model is based on collaboration between health care providers and their patients with disabilities, and training is important to help providers make this collaboration successful, said Dr. Harris. Without training, physicians may be ineffective in communicating with patients with disabilities by not speaking directly to the patient, not speaking in a way the patient can understand clearly, and not providing accessible patient education materials. Physicians also tend to minimize the extent of the patient’s expertise in their own condition based on their lived experiences, and tend to underestimate the abilities of patients with disabilities.

However, direct experience with disabled patients and an understanding of the health disparities they endure can help physicians look at these patients “through a more intersectional lens,” that also takes into account social determinants of health, Dr. Harris said. “I have found that people with disabilities are the best teachers about disability, because they have expertise that comes from their lived experience.”
 

Patients are the best teachers

Several initiatives are helping physicians to bridge this gap in understanding and reduce disparities in care. One such program is FRAME: Faces Redefining the Art of Medical Education. FRAME is a web-based film library designed to present medical information to health care providers in training, clinicians, families, and communities in a dignified and humanizing way. FRAME was developed in part by fashion photographer Rick Guidotti, who was inspired after meeting a young woman with albinism to create Positive Exposure, an ongoing project featuring children and adolescents with various disabilities.

FRAME films are “short films presenting all the basic hallmark characteristics of a certain genetic condition, but presented by somebody living with that condition,” said Mr. Guidotti in his presentation during the session.

The National Curriculum Initiative in Developmental Medicine (NCIDM) is designed to incorporate care for individuals with disabilities into medical education. NCIDM is a project created by the American Academy of Developmental Medicine and Dentistry (AADMD).

“The need for this program is that there is no U.S. requirement for medical schools to teach about intellectual and developmental disabilities,” Priya Chandan, MD, also of the University of Louisville, said in her presentation during the session. “Approximately 81% of graduating medical students have no training in caring for adults with disabilities,” said Dr. Chandan, who serves as director of the NCIDM.

The current NCIDM was created as a 5-year partnership between the AADMD and Special Olympics, supported in part by the Centers for Disease Control and Prevention, Dr. Chandan said. The purpose was to provide training to medical students in the field of developmental medicine, meaning the care of individuals with intellectual/developmental disabilities (IDD) across the lifespan. The AADMD has expanded to 26 medical schools in the United States and will reach approximately 4,000 medical students by the conclusion of the current initiative.

One challenge in medical education is getting past the idea that people living with disabilities need to be fixed, said Dr. Chandan. The NCIDM approach reflects Mr. Guidotti’s approach in both the FRAME initiatives and his Positive Exposure foundation, with a focus on treating people as people, and letting individuals with disabilities represent themselves.

Dr. Chandan described the NCIDM curriculum as allowing for flexible teaching methodologies and materials, as long as they meet the NCIDM-created learning goals and objectives. The curriculum also includes standardized evaluations. Each NCIDM program in a participating medical school includes a faculty champion, and the curriculum supports meeting people with IDD not only inside medical settings, but also outside in the community.

NCIDM embraces the idea of community-engaged scholarship, which Dr. Chandan defined as “a form of scholarship that directly benefits the community and is consistent with university and unit missions.” This method combined teaching and conducting research while providing a service to the community.

The next steps for the current NCIDM initiative are to complete collection of data and course evaluations from participating schools by early 2022, followed by continued dissemination and collaboration through AADMD.

Overall, the content of the curriculum explores how and where IDD fits into clinical care, Dr. Chandan said, who also emphasized the implications of communication. “How we think affects how we communicate,” she added. Be mindful of the language used to talk to and about patients with disabilities, both to colleagues and to learners.

When talking to the patient, find something in common, beyond the diagnosis, said Dr. Chandan. Remember that some disabilities are visible and some are not. “Treat people with respect, because you won’t know what their functional level is just by looking,” she concluded.

The presenters had no financial conflicts to disclose.

“All physicians, regardless of specialty, will work with patients with disabilities,” Corrie Harris, MD, of the University of Louisville (Ky.), said in a plenary session presentation at the 2021 virtual Pediatric Hospital Medicine conference.

Disabilities vary in their visibility, from cognitive and sensory impairments that are not immediately obvious to an obvious physical disability, she said.

One in four adults and one in six children in the United States has a disability, said Dr. Harris. The prevalence of disability increases with age, but occurs across the lifespan, and will likely increase in the future with greater improvements in health care overall.

Dr. Harris reviewed the current conceptual model that forms the basis for the World Health Organization definition of functioning disability. This “functional model” defines disability as caused by interactions between health conditions and the environment, and the response is to “prioritize function to meet patient goals,” Dr. Harris said at the meeting, sponsored by the Society of Hospital Medicine, the American Academy of Pediatrics, and the Academic Pediatric Association.

This model is based on collaboration between health care providers and their patients with disabilities, and training is important to help providers make this collaboration successful, said Dr. Harris. Without training, physicians may be ineffective in communicating with patients with disabilities by not speaking directly to the patient, not speaking in a way the patient can understand clearly, and not providing accessible patient education materials. Physicians also tend to minimize the extent of the patient’s expertise in their own condition based on their lived experiences, and tend to underestimate the abilities of patients with disabilities.

However, direct experience with disabled patients and an understanding of the health disparities they endure can help physicians look at these patients “through a more intersectional lens,” that also takes into account social determinants of health, Dr. Harris said. “I have found that people with disabilities are the best teachers about disability, because they have expertise that comes from their lived experience.”
 

Patients are the best teachers

Several initiatives are helping physicians to bridge this gap in understanding and reduce disparities in care. One such program is FRAME: Faces Redefining the Art of Medical Education. FRAME is a web-based film library designed to present medical information to health care providers in training, clinicians, families, and communities in a dignified and humanizing way. FRAME was developed in part by fashion photographer Rick Guidotti, who was inspired after meeting a young woman with albinism to create Positive Exposure, an ongoing project featuring children and adolescents with various disabilities.

FRAME films are “short films presenting all the basic hallmark characteristics of a certain genetic condition, but presented by somebody living with that condition,” said Mr. Guidotti in his presentation during the session.

The National Curriculum Initiative in Developmental Medicine (NCIDM) is designed to incorporate care for individuals with disabilities into medical education. NCIDM is a project created by the American Academy of Developmental Medicine and Dentistry (AADMD).

“The need for this program is that there is no U.S. requirement for medical schools to teach about intellectual and developmental disabilities,” Priya Chandan, MD, also of the University of Louisville, said in her presentation during the session. “Approximately 81% of graduating medical students have no training in caring for adults with disabilities,” said Dr. Chandan, who serves as director of the NCIDM.

The current NCIDM was created as a 5-year partnership between the AADMD and Special Olympics, supported in part by the Centers for Disease Control and Prevention, Dr. Chandan said. The purpose was to provide training to medical students in the field of developmental medicine, meaning the care of individuals with intellectual/developmental disabilities (IDD) across the lifespan. The AADMD has expanded to 26 medical schools in the United States and will reach approximately 4,000 medical students by the conclusion of the current initiative.

One challenge in medical education is getting past the idea that people living with disabilities need to be fixed, said Dr. Chandan. The NCIDM approach reflects Mr. Guidotti’s approach in both the FRAME initiatives and his Positive Exposure foundation, with a focus on treating people as people, and letting individuals with disabilities represent themselves.

Dr. Chandan described the NCIDM curriculum as allowing for flexible teaching methodologies and materials, as long as they meet the NCIDM-created learning goals and objectives. The curriculum also includes standardized evaluations. Each NCIDM program in a participating medical school includes a faculty champion, and the curriculum supports meeting people with IDD not only inside medical settings, but also outside in the community.

NCIDM embraces the idea of community-engaged scholarship, which Dr. Chandan defined as “a form of scholarship that directly benefits the community and is consistent with university and unit missions.” This method combined teaching and conducting research while providing a service to the community.

The next steps for the current NCIDM initiative are to complete collection of data and course evaluations from participating schools by early 2022, followed by continued dissemination and collaboration through AADMD.

Overall, the content of the curriculum explores how and where IDD fits into clinical care, Dr. Chandan said, who also emphasized the implications of communication. “How we think affects how we communicate,” she added. Be mindful of the language used to talk to and about patients with disabilities, both to colleagues and to learners.

When talking to the patient, find something in common, beyond the diagnosis, said Dr. Chandan. Remember that some disabilities are visible and some are not. “Treat people with respect, because you won’t know what their functional level is just by looking,” she concluded.

The presenters had no financial conflicts to disclose.

“All physicians, regardless of specialty, will work with patients with disabilities,” Corrie Harris, MD, of the University of Louisville (Ky.), said in a plenary session presentation at the 2021 virtual Pediatric Hospital Medicine conference.

Disabilities vary in their visibility, from cognitive and sensory impairments that are not immediately obvious to an obvious physical disability, she said.

One in four adults and one in six children in the United States has a disability, said Dr. Harris. The prevalence of disability increases with age, but occurs across the lifespan, and will likely increase in the future with greater improvements in health care overall.

Dr. Harris reviewed the current conceptual model that forms the basis for the World Health Organization definition of functioning disability. This “functional model” defines disability as caused by interactions between health conditions and the environment, and the response is to “prioritize function to meet patient goals,” Dr. Harris said at the meeting, sponsored by the Society of Hospital Medicine, the American Academy of Pediatrics, and the Academic Pediatric Association.

This model is based on collaboration between health care providers and their patients with disabilities, and training is important to help providers make this collaboration successful, said Dr. Harris. Without training, physicians may be ineffective in communicating with patients with disabilities by not speaking directly to the patient, not speaking in a way the patient can understand clearly, and not providing accessible patient education materials. Physicians also tend to minimize the extent of the patient’s expertise in their own condition based on their lived experiences, and tend to underestimate the abilities of patients with disabilities.

However, direct experience with disabled patients and an understanding of the health disparities they endure can help physicians look at these patients “through a more intersectional lens,” that also takes into account social determinants of health, Dr. Harris said. “I have found that people with disabilities are the best teachers about disability, because they have expertise that comes from their lived experience.”
 

Patients are the best teachers

Several initiatives are helping physicians to bridge this gap in understanding and reduce disparities in care. One such program is FRAME: Faces Redefining the Art of Medical Education. FRAME is a web-based film library designed to present medical information to health care providers in training, clinicians, families, and communities in a dignified and humanizing way. FRAME was developed in part by fashion photographer Rick Guidotti, who was inspired after meeting a young woman with albinism to create Positive Exposure, an ongoing project featuring children and adolescents with various disabilities.

FRAME films are “short films presenting all the basic hallmark characteristics of a certain genetic condition, but presented by somebody living with that condition,” said Mr. Guidotti in his presentation during the session.

The National Curriculum Initiative in Developmental Medicine (NCIDM) is designed to incorporate care for individuals with disabilities into medical education. NCIDM is a project created by the American Academy of Developmental Medicine and Dentistry (AADMD).

“The need for this program is that there is no U.S. requirement for medical schools to teach about intellectual and developmental disabilities,” Priya Chandan, MD, also of the University of Louisville, said in her presentation during the session. “Approximately 81% of graduating medical students have no training in caring for adults with disabilities,” said Dr. Chandan, who serves as director of the NCIDM.

The current NCIDM was created as a 5-year partnership between the AADMD and Special Olympics, supported in part by the Centers for Disease Control and Prevention, Dr. Chandan said. The purpose was to provide training to medical students in the field of developmental medicine, meaning the care of individuals with intellectual/developmental disabilities (IDD) across the lifespan. The AADMD has expanded to 26 medical schools in the United States and will reach approximately 4,000 medical students by the conclusion of the current initiative.

One challenge in medical education is getting past the idea that people living with disabilities need to be fixed, said Dr. Chandan. The NCIDM approach reflects Mr. Guidotti’s approach in both the FRAME initiatives and his Positive Exposure foundation, with a focus on treating people as people, and letting individuals with disabilities represent themselves.

Dr. Chandan described the NCIDM curriculum as allowing for flexible teaching methodologies and materials, as long as they meet the NCIDM-created learning goals and objectives. The curriculum also includes standardized evaluations. Each NCIDM program in a participating medical school includes a faculty champion, and the curriculum supports meeting people with IDD not only inside medical settings, but also outside in the community.

NCIDM embraces the idea of community-engaged scholarship, which Dr. Chandan defined as “a form of scholarship that directly benefits the community and is consistent with university and unit missions.” This method combined teaching and conducting research while providing a service to the community.

The next steps for the current NCIDM initiative are to complete collection of data and course evaluations from participating schools by early 2022, followed by continued dissemination and collaboration through AADMD.

Overall, the content of the curriculum explores how and where IDD fits into clinical care, Dr. Chandan said, who also emphasized the implications of communication. “How we think affects how we communicate,” she added. Be mindful of the language used to talk to and about patients with disabilities, both to colleagues and to learners.

When talking to the patient, find something in common, beyond the diagnosis, said Dr. Chandan. Remember that some disabilities are visible and some are not. “Treat people with respect, because you won’t know what their functional level is just by looking,” she concluded.

The presenters had no financial conflicts to disclose.

Most adverse events associated with the practice of microneedling are transient, and most adverse effects and allergic reactions occur in conjunction with combination therapies, according to the results of a systematic review of nearly 3,000 patients.

marcinm111/iStock/Getty Images

Microneedling involves the use of instruments including dermarollers and microneedling pens to cause controlled microtraumas at various skin depths and induce a wounding cascade that ultimately improves the visual appearance of the skin, Sherman Chu, DO, of the department of dermatology at the University of California, Irvine, and colleagues wrote.

Microneedling has increased in popularity because of its relatively low cost, effectiveness, and ease of use, and is often promoted as “a safe alternative treatment, particularly in skin of color, but the safety of microneedling and its complications are not often discussed,” the researchers noted.

In the study, published in Dermatologic Surgery, Dr. Chu and coauthors identified 85 articles for the systematic review of safety data on microneedling. The studies included 30 randomized, controlled trials; 24 prospective studies; 16 case series; 12 case reports; and 3 retrospective cohort studies, with a total of 2,805 patients treated with microneedling.

The devices used in the studies were primarily dermarollers (1,758 procedures), but 425 procedures involved dermapens, and 176 involved unidentified microneedling devices.

The most common adverse effect after microneedling with any device was any of anticipated transient procedural side effects including transient erythema or edema, pain, burning, bruising, pruritus, stinging, bleeding, crusting, and desquamation. Overall, these effects resolved within a week with little or no treatment, the researchers said.

The most commonly reported postprocedure side effects of microneedling were postinflammatory hyperpigmentation (46 incidents), followed by dry skin and exfoliation (41 incidents). Fewer than 15 incidents were reported of each the following: acne flare, pruritus, persistent erythema, herpetic infection, flushing, seborrheic dermatitis, burning, headache, stinging, milia, tram-track scarring, facial allergic granulomatous reaction and systematic hypersensitivity, and tender cervical lymphadenopathy. In addition, one incident each was reported of periorbital dermatitis, phototoxic reaction, pressure urticaria, irritant contact dermatitis, widespread facial inoculation of varicella, pustular folliculitis, and tinea corporis.

The studies suggest that microneedling is generally well tolerated, the researchers wrote. Factors that increased the risk of adverse events included the presence of active infections, darker skin types, metal allergies, and the use of combination therapies. For example, they noted, one randomized, controlled trial showed greater skin irritation in patients treated with both microneedling and tranexamic acid compared with those treated with tranexamic acid alone.

Other studies described increased risk of postinflammatory hyperpigmentation in patients treated with both microneedling and platelet-rich plasma, and with microneedling and topical 5-FU or tacrolimus. Also, in one of the studies in the review, “the development of a delayed granulomatous hypersensitivity reaction in 2 patients was attributed to a reaction to vitamin C serum, whereas another study attributes vitamin A and vitamin C oil to be the cause of a patient’s prolonged erythema and pruritus,” the researchers said.

The study findings were limited to adverse events reported by clinicians in published literature, and did not account for adverse events that occur when microneedling is performed at home or in medical spas. Although the results suggest that microneedling is relatively safe for patients of most skin types, “great caution should be taken when performing microneedling with products not approved to be used intradermally,” they emphasized.

“Further studies are needed to determine which patients are at a higher chance of developing scarring because depth of the needle and skin type do not directly correlate as initially believed,” they concluded.

Microneedling offers safe alternative to lasers

“Microneedling is a popular procedure that can be used as an alternative to laser treatments to provide low down time, and lower-cost treatments for similar indications in which lasers are used, such as rhytides and scars,” Catherine M. DiGiorgio, MD, a laser and cosmetic dermatologist at the Boston Center for Facial Rejuvenation, said in an interview.

“Many clinicians and/or providers utilize microneedling in their practice also because they may not have the ability to perform laser and energy-based device treatments,” noted Dr. DiGiorgio, who was asked to comment on the study findings. “Microneedling is safer than energy-based devices in darker skin types due to the lack of energy or heat being delivered to the epidermis. However, as shown in this study, darker skin types remain at risk for [postinflammatory hyperpigmentation], particularly in the hands of an unskilled, inexperienced operator.”

Dr. DiGiorgio said she was not surprised by the study findings. “Microneedling creates microwounds in the skin, which contributes to the risk of all of the side effects listed in the study. Further, the proper use of microneedling devices by the providers performing the procedure is variable and depths of penetration can vary based on which device or roller pen is used and the experience of the person performing the procedures. Depth, after a certain point, can be inaccurate and can superficially abrade the epidermis rather than the intended individual microneedle punctures.”

Laser and energy-based device treatments can be performed safely in patients with darker skin types in the hands of skilled and experienced laser surgeons, said Dr. DiGiorgio. However, “more studies are needed to determine the effectiveness of microneedling alone compared to other treatment modalities. Patients tend to select microneedling due to affordability and less down time; however, sometimes it may not be the best treatment option for their skin condition.

“Patient education is an important factor because one treatment that worked for one of their friends, for example, may not be the best treatment option for their skin complaints.”

Dr. DiGiorgio added that there are few randomized, controlled trials comparing microneedling to laser treatment. “More studies of this nature would benefit the scientific literature and the addition of histological analysis would help us better understand how these treatments compare on a microscopic level.”

The study received no outside funding and the author has no disclosures. Dr. DiGiorgio has served as a consultant for Allergan Aesthetics.

Most adverse events associated with the practice of microneedling are transient, and most adverse effects and allergic reactions occur in conjunction with combination therapies, according to the results of a systematic review of nearly 3,000 patients.

marcinm111/iStock/Getty Images

Microneedling involves the use of instruments including dermarollers and microneedling pens to cause controlled microtraumas at various skin depths and induce a wounding cascade that ultimately improves the visual appearance of the skin, Sherman Chu, DO, of the department of dermatology at the University of California, Irvine, and colleagues wrote.

Microneedling has increased in popularity because of its relatively low cost, effectiveness, and ease of use, and is often promoted as “a safe alternative treatment, particularly in skin of color, but the safety of microneedling and its complications are not often discussed,” the researchers noted.

In the study, published in Dermatologic Surgery, Dr. Chu and coauthors identified 85 articles for the systematic review of safety data on microneedling. The studies included 30 randomized, controlled trials; 24 prospective studies; 16 case series; 12 case reports; and 3 retrospective cohort studies, with a total of 2,805 patients treated with microneedling.

The devices used in the studies were primarily dermarollers (1,758 procedures), but 425 procedures involved dermapens, and 176 involved unidentified microneedling devices.

The most common adverse effect after microneedling with any device was any of anticipated transient procedural side effects including transient erythema or edema, pain, burning, bruising, pruritus, stinging, bleeding, crusting, and desquamation. Overall, these effects resolved within a week with little or no treatment, the researchers said.

The most commonly reported postprocedure side effects of microneedling were postinflammatory hyperpigmentation (46 incidents), followed by dry skin and exfoliation (41 incidents). Fewer than 15 incidents were reported of each the following: acne flare, pruritus, persistent erythema, herpetic infection, flushing, seborrheic dermatitis, burning, headache, stinging, milia, tram-track scarring, facial allergic granulomatous reaction and systematic hypersensitivity, and tender cervical lymphadenopathy. In addition, one incident each was reported of periorbital dermatitis, phototoxic reaction, pressure urticaria, irritant contact dermatitis, widespread facial inoculation of varicella, pustular folliculitis, and tinea corporis.

The studies suggest that microneedling is generally well tolerated, the researchers wrote. Factors that increased the risk of adverse events included the presence of active infections, darker skin types, metal allergies, and the use of combination therapies. For example, they noted, one randomized, controlled trial showed greater skin irritation in patients treated with both microneedling and tranexamic acid compared with those treated with tranexamic acid alone.

Other studies described increased risk of postinflammatory hyperpigmentation in patients treated with both microneedling and platelet-rich plasma, and with microneedling and topical 5-FU or tacrolimus. Also, in one of the studies in the review, “the development of a delayed granulomatous hypersensitivity reaction in 2 patients was attributed to a reaction to vitamin C serum, whereas another study attributes vitamin A and vitamin C oil to be the cause of a patient’s prolonged erythema and pruritus,” the researchers said.

The study findings were limited to adverse events reported by clinicians in published literature, and did not account for adverse events that occur when microneedling is performed at home or in medical spas. Although the results suggest that microneedling is relatively safe for patients of most skin types, “great caution should be taken when performing microneedling with products not approved to be used intradermally,” they emphasized.

“Further studies are needed to determine which patients are at a higher chance of developing scarring because depth of the needle and skin type do not directly correlate as initially believed,” they concluded.

Microneedling offers safe alternative to lasers

“Microneedling is a popular procedure that can be used as an alternative to laser treatments to provide low down time, and lower-cost treatments for similar indications in which lasers are used, such as rhytides and scars,” Catherine M. DiGiorgio, MD, a laser and cosmetic dermatologist at the Boston Center for Facial Rejuvenation, said in an interview.

“Many clinicians and/or providers utilize microneedling in their practice also because they may not have the ability to perform laser and energy-based device treatments,” noted Dr. DiGiorgio, who was asked to comment on the study findings. “Microneedling is safer than energy-based devices in darker skin types due to the lack of energy or heat being delivered to the epidermis. However, as shown in this study, darker skin types remain at risk for [postinflammatory hyperpigmentation], particularly in the hands of an unskilled, inexperienced operator.”

Dr. DiGiorgio said she was not surprised by the study findings. “Microneedling creates microwounds in the skin, which contributes to the risk of all of the side effects listed in the study. Further, the proper use of microneedling devices by the providers performing the procedure is variable and depths of penetration can vary based on which device or roller pen is used and the experience of the person performing the procedures. Depth, after a certain point, can be inaccurate and can superficially abrade the epidermis rather than the intended individual microneedle punctures.”

Laser and energy-based device treatments can be performed safely in patients with darker skin types in the hands of skilled and experienced laser surgeons, said Dr. DiGiorgio. However, “more studies are needed to determine the effectiveness of microneedling alone compared to other treatment modalities. Patients tend to select microneedling due to affordability and less down time; however, sometimes it may not be the best treatment option for their skin condition.

“Patient education is an important factor because one treatment that worked for one of their friends, for example, may not be the best treatment option for their skin complaints.”

Dr. DiGiorgio added that there are few randomized, controlled trials comparing microneedling to laser treatment. “More studies of this nature would benefit the scientific literature and the addition of histological analysis would help us better understand how these treatments compare on a microscopic level.”

The study received no outside funding and the author has no disclosures. Dr. DiGiorgio has served as a consultant for Allergan Aesthetics.

Most adverse events associated with the practice of microneedling are transient, and most adverse effects and allergic reactions occur in conjunction with combination therapies, according to the results of a systematic review of nearly 3,000 patients.

marcinm111/iStock/Getty Images

Microneedling involves the use of instruments including dermarollers and microneedling pens to cause controlled microtraumas at various skin depths and induce a wounding cascade that ultimately improves the visual appearance of the skin, Sherman Chu, DO, of the department of dermatology at the University of California, Irvine, and colleagues wrote.

Microneedling has increased in popularity because of its relatively low cost, effectiveness, and ease of use, and is often promoted as “a safe alternative treatment, particularly in skin of color, but the safety of microneedling and its complications are not often discussed,” the researchers noted.

In the study, published in Dermatologic Surgery, Dr. Chu and coauthors identified 85 articles for the systematic review of safety data on microneedling. The studies included 30 randomized, controlled trials; 24 prospective studies; 16 case series; 12 case reports; and 3 retrospective cohort studies, with a total of 2,805 patients treated with microneedling.

The devices used in the studies were primarily dermarollers (1,758 procedures), but 425 procedures involved dermapens, and 176 involved unidentified microneedling devices.

The most common adverse effect after microneedling with any device was any of anticipated transient procedural side effects including transient erythema or edema, pain, burning, bruising, pruritus, stinging, bleeding, crusting, and desquamation. Overall, these effects resolved within a week with little or no treatment, the researchers said.

The most commonly reported postprocedure side effects of microneedling were postinflammatory hyperpigmentation (46 incidents), followed by dry skin and exfoliation (41 incidents). Fewer than 15 incidents were reported of each the following: acne flare, pruritus, persistent erythema, herpetic infection, flushing, seborrheic dermatitis, burning, headache, stinging, milia, tram-track scarring, facial allergic granulomatous reaction and systematic hypersensitivity, and tender cervical lymphadenopathy. In addition, one incident each was reported of periorbital dermatitis, phototoxic reaction, pressure urticaria, irritant contact dermatitis, widespread facial inoculation of varicella, pustular folliculitis, and tinea corporis.

The studies suggest that microneedling is generally well tolerated, the researchers wrote. Factors that increased the risk of adverse events included the presence of active infections, darker skin types, metal allergies, and the use of combination therapies. For example, they noted, one randomized, controlled trial showed greater skin irritation in patients treated with both microneedling and tranexamic acid compared with those treated with tranexamic acid alone.

Other studies described increased risk of postinflammatory hyperpigmentation in patients treated with both microneedling and platelet-rich plasma, and with microneedling and topical 5-FU or tacrolimus. Also, in one of the studies in the review, “the development of a delayed granulomatous hypersensitivity reaction in 2 patients was attributed to a reaction to vitamin C serum, whereas another study attributes vitamin A and vitamin C oil to be the cause of a patient’s prolonged erythema and pruritus,” the researchers said.

The study findings were limited to adverse events reported by clinicians in published literature, and did not account for adverse events that occur when microneedling is performed at home or in medical spas. Although the results suggest that microneedling is relatively safe for patients of most skin types, “great caution should be taken when performing microneedling with products not approved to be used intradermally,” they emphasized.

“Further studies are needed to determine which patients are at a higher chance of developing scarring because depth of the needle and skin type do not directly correlate as initially believed,” they concluded.

Microneedling offers safe alternative to lasers

“Microneedling is a popular procedure that can be used as an alternative to laser treatments to provide low down time, and lower-cost treatments for similar indications in which lasers are used, such as rhytides and scars,” Catherine M. DiGiorgio, MD, a laser and cosmetic dermatologist at the Boston Center for Facial Rejuvenation, said in an interview.

“Many clinicians and/or providers utilize microneedling in their practice also because they may not have the ability to perform laser and energy-based device treatments,” noted Dr. DiGiorgio, who was asked to comment on the study findings. “Microneedling is safer than energy-based devices in darker skin types due to the lack of energy or heat being delivered to the epidermis. However, as shown in this study, darker skin types remain at risk for [postinflammatory hyperpigmentation], particularly in the hands of an unskilled, inexperienced operator.”

Dr. DiGiorgio said she was not surprised by the study findings. “Microneedling creates microwounds in the skin, which contributes to the risk of all of the side effects listed in the study. Further, the proper use of microneedling devices by the providers performing the procedure is variable and depths of penetration can vary based on which device or roller pen is used and the experience of the person performing the procedures. Depth, after a certain point, can be inaccurate and can superficially abrade the epidermis rather than the intended individual microneedle punctures.”

Laser and energy-based device treatments can be performed safely in patients with darker skin types in the hands of skilled and experienced laser surgeons, said Dr. DiGiorgio. However, “more studies are needed to determine the effectiveness of microneedling alone compared to other treatment modalities. Patients tend to select microneedling due to affordability and less down time; however, sometimes it may not be the best treatment option for their skin condition.

“Patient education is an important factor because one treatment that worked for one of their friends, for example, may not be the best treatment option for their skin complaints.”

Dr. DiGiorgio added that there are few randomized, controlled trials comparing microneedling to laser treatment. “More studies of this nature would benefit the scientific literature and the addition of histological analysis would help us better understand how these treatments compare on a microscopic level.”

The study received no outside funding and the author has no disclosures. Dr. DiGiorgio has served as a consultant for Allergan Aesthetics.

“Health care spending and health care waste is a huge problem in the U.S., including for children,” Vivian Lee, MD, of Children’s Hospital, Los Angeles, said in a presentation at the 2021 virtual Pediatric Hospital Medicine conference.

Data from a 2019 study suggested that approximately 25% of health care spending in the United States qualifies as “wasteful spending,” in categories such as overtesting, and unnecessary hospitalization, Dr. Lee said. “It is essential for physicians in hospitals to be stewards of high-value care,” she emphasized.

To combat wasteful spending and control health care costs, the Choosing Wisely campaign was created in 2012 as an initiative from the American Board of Internal Medicine Foundation. An ongoing goal of the campaign is to raise awareness among physicians and patients about potential areas of low-value services and overuse. The overall campaign includes clinician-driven recommendations from multiple medical organizations.

The PHM produced its first set of five recommendations in 2012, Dr. Lee said. These recommendations, titled “Five Things Physicians and Patients Should Question,” have been updated for 2021. The updated recommendations were created as a partnership among the Academic Pediatric Association, the American Academy of Pediatrics, and the Society of Hospital Medicine. A joint committee reviewed the latest evidence, and the updates were approved by the societies and published by the ABIM in January 2021.

“We think these recommendations truly reflect an exciting and evolving landscape for pediatric hospitalists,” Dr. Lee said. “There is a greater focus on opportunities to transition out of the hospital sooner, or avoid hospitalization altogether. There is an emphasis on antibiotic stewardship and a growing recognition of the impact that overuse may have on our vulnerable neonatal population,” she said. Several members of the Choosing Wisely panel presented the recommendations during the virtual presentation.
 

Revised recommendations

The new “Five Things Physicians and Patients Should Question” are as follows:

1. Do not prescribe IV antibiotics for predetermined durations for patients hospitalized with infections such as pyelonephritis, osteomyelitis, and complicated pneumonia. Consider early transition to oral antibiotics.

Many antibiotic doses used in clinical practice are preset durations that are not based on high-quality evidence, said Mike Tchou, MD, of Children’s Hospital of Colorado in Aurora. However, studies now show that earlier transition to enteral antibiotics can improve a range of outcomes including neonatal UTIs, osteomyelitis, and complicated pneumonia, he said. Considering early transition based on a patient’s response can decrease adverse events, pain, length of stay, and health care costs, he explained.

2. Do not continue hospitalization in well-appearing febrile infants once bacterial cultures (i.e., blood, cerebrospinal, and/or urine) have been confirmed negative for 24-36 hours, if adequate outpatient follow-up can be assured.

Recent data indicate that continuing hospitalization beyond 24-36 hours of confirmed negative bacterial cultures does not improve clinical outcomes for well-appearing infants admitted for concern of serious bacterial infection, said Paula Soung, MD, of Children’s Wisconsin in Milwaukee. In fact, “blood culture yield is highest in the first 12-36 hours after incubation with multiple studies demonstrating > 90% of pathogen cultures being positive by 24 hours,” Dr. Soung said. “If adequate outpatient follow-up can be assured, discharging well-appearing febrile infants at 24-36 hours after confirming cultures are negative has many positive outcomes,” she said.

3. Do not initiate phototherapy in term or late preterm well-appearing infants with neonatal hyperbilirubinemia if their bilirubin is below levels at which the AAP guidelines recommend treatment.

In making this recommendation, “we considered that the risk of kernicterus and cerebral palsy is extremely low in otherwise healthy term and late preterm newborns,” said Allison Holmes, MD, of Children’s Hospital at Dartmouth-Hitchcock, Manchester, N.H. “Subthreshold phototherapy leads to unnecessary hospitalization and its associated costs and harms,” and data show that kernicterus generally occurs close to 40 mg/dL and occurs most often in infants with hemolysis, she added.

The evidence for the recommendations included data showing that, among other factors, 8.6 of 100,000 babies have a bilirubin greater than 30 mg/dL, said Dr. Holmes. Risks of using subthreshold phototherapy include increased length of stay, increased readmissions, and increased costs, as well as decreased breastfeeding, bonding with parents, and increased parental anxiety. “Adding prolonged hospitalization for an intervention that might not be necessary can be stressful for parents,” she said.

4. Do not use broad-spectrum antibiotics such as ceftriaxone for children hospitalized with uncomplicated community-acquired pneumonia. Use narrow-spectrum antibiotics such as penicillin, ampicillin, or amoxicillin.

Michelle Lossius, MD, of the Shands Hospital for Children at the University of Florida, Gainesville, noted that the recommendations reflect IDSA guidelines from 2011 advising the use of ampicillin or penicillin for this population of children. More recent studies with large populations support the ability of narrow-spectrum antibiotics to limit the development of resistant organisms while achieving the same or better outcomes for children hospitalized with CAP, she said.

5. Do not start IV antibiotic therapy on well-appearing newborn infants with isolated risk factors for sepsis such as maternal chorioamnionitis, prolonged rupture of membranes, or untreated group-B streptococcal colonization. Use clinical tools such as an evidence-based sepsis risk calculator to guide management.

“This recommendation combines other recommendations,” said Prabi Rajbhandari, MD, of Akron (Ohio) Children’s Hospital. The evidence is ample, as the Centers for Disease Control and Prevention recommends the use of sepsis calculators to guide clinical management in sepsis patients, she said.

Data comparing periods before and after the adoption of a sepsis risk calculator showed a significant reduction in the use of blood cultures and antibiotics, she noted. Other risks of jumping to IV antibiotics include increased hospital stay, increased parental anxiety, and decreased parental bonding, Dr. Rajbhandari added.

Next steps include how to prioritize implementation, as well as deimplementation of outdated practices, said Francisco Alvarez, MD, of Lucile Packard Children’s Hospital, Palo Alto, Calif. “A lot of our practices were started without good evidence for why they should be done,” he said. Other steps include value improvement research; use of dashboards and benchmarking; involving other stakeholders including patients, families, and other health care providers; and addressing racial disparities, he concluded.

The presenters had no financial conflicts to disclose. The conference was sponsored by the Academic Pediatric Association, the American Academy of Pediatrics, and the Society of Hospital Medicine.

“Health care spending and health care waste is a huge problem in the U.S., including for children,” Vivian Lee, MD, of Children’s Hospital, Los Angeles, said in a presentation at the 2021 virtual Pediatric Hospital Medicine conference.

Data from a 2019 study suggested that approximately 25% of health care spending in the United States qualifies as “wasteful spending,” in categories such as overtesting, and unnecessary hospitalization, Dr. Lee said. “It is essential for physicians in hospitals to be stewards of high-value care,” she emphasized.

To combat wasteful spending and control health care costs, the Choosing Wisely campaign was created in 2012 as an initiative from the American Board of Internal Medicine Foundation. An ongoing goal of the campaign is to raise awareness among physicians and patients about potential areas of low-value services and overuse. The overall campaign includes clinician-driven recommendations from multiple medical organizations.

The PHM produced its first set of five recommendations in 2012, Dr. Lee said. These recommendations, titled “Five Things Physicians and Patients Should Question,” have been updated for 2021. The updated recommendations were created as a partnership among the Academic Pediatric Association, the American Academy of Pediatrics, and the Society of Hospital Medicine. A joint committee reviewed the latest evidence, and the updates were approved by the societies and published by the ABIM in January 2021.

“We think these recommendations truly reflect an exciting and evolving landscape for pediatric hospitalists,” Dr. Lee said. “There is a greater focus on opportunities to transition out of the hospital sooner, or avoid hospitalization altogether. There is an emphasis on antibiotic stewardship and a growing recognition of the impact that overuse may have on our vulnerable neonatal population,” she said. Several members of the Choosing Wisely panel presented the recommendations during the virtual presentation.
 

Revised recommendations

The new “Five Things Physicians and Patients Should Question” are as follows:

1. Do not prescribe IV antibiotics for predetermined durations for patients hospitalized with infections such as pyelonephritis, osteomyelitis, and complicated pneumonia. Consider early transition to oral antibiotics.

Many antibiotic doses used in clinical practice are preset durations that are not based on high-quality evidence, said Mike Tchou, MD, of Children’s Hospital of Colorado in Aurora. However, studies now show that earlier transition to enteral antibiotics can improve a range of outcomes including neonatal UTIs, osteomyelitis, and complicated pneumonia, he said. Considering early transition based on a patient’s response can decrease adverse events, pain, length of stay, and health care costs, he explained.

2. Do not continue hospitalization in well-appearing febrile infants once bacterial cultures (i.e., blood, cerebrospinal, and/or urine) have been confirmed negative for 24-36 hours, if adequate outpatient follow-up can be assured.

Recent data indicate that continuing hospitalization beyond 24-36 hours of confirmed negative bacterial cultures does not improve clinical outcomes for well-appearing infants admitted for concern of serious bacterial infection, said Paula Soung, MD, of Children’s Wisconsin in Milwaukee. In fact, “blood culture yield is highest in the first 12-36 hours after incubation with multiple studies demonstrating > 90% of pathogen cultures being positive by 24 hours,” Dr. Soung said. “If adequate outpatient follow-up can be assured, discharging well-appearing febrile infants at 24-36 hours after confirming cultures are negative has many positive outcomes,” she said.

3. Do not initiate phototherapy in term or late preterm well-appearing infants with neonatal hyperbilirubinemia if their bilirubin is below levels at which the AAP guidelines recommend treatment.

In making this recommendation, “we considered that the risk of kernicterus and cerebral palsy is extremely low in otherwise healthy term and late preterm newborns,” said Allison Holmes, MD, of Children’s Hospital at Dartmouth-Hitchcock, Manchester, N.H. “Subthreshold phototherapy leads to unnecessary hospitalization and its associated costs and harms,” and data show that kernicterus generally occurs close to 40 mg/dL and occurs most often in infants with hemolysis, she added.

The evidence for the recommendations included data showing that, among other factors, 8.6 of 100,000 babies have a bilirubin greater than 30 mg/dL, said Dr. Holmes. Risks of using subthreshold phototherapy include increased length of stay, increased readmissions, and increased costs, as well as decreased breastfeeding, bonding with parents, and increased parental anxiety. “Adding prolonged hospitalization for an intervention that might not be necessary can be stressful for parents,” she said.

4. Do not use broad-spectrum antibiotics such as ceftriaxone for children hospitalized with uncomplicated community-acquired pneumonia. Use narrow-spectrum antibiotics such as penicillin, ampicillin, or amoxicillin.

Michelle Lossius, MD, of the Shands Hospital for Children at the University of Florida, Gainesville, noted that the recommendations reflect IDSA guidelines from 2011 advising the use of ampicillin or penicillin for this population of children. More recent studies with large populations support the ability of narrow-spectrum antibiotics to limit the development of resistant organisms while achieving the same or better outcomes for children hospitalized with CAP, she said.

5. Do not start IV antibiotic therapy on well-appearing newborn infants with isolated risk factors for sepsis such as maternal chorioamnionitis, prolonged rupture of membranes, or untreated group-B streptococcal colonization. Use clinical tools such as an evidence-based sepsis risk calculator to guide management.

“This recommendation combines other recommendations,” said Prabi Rajbhandari, MD, of Akron (Ohio) Children’s Hospital. The evidence is ample, as the Centers for Disease Control and Prevention recommends the use of sepsis calculators to guide clinical management in sepsis patients, she said.

Data comparing periods before and after the adoption of a sepsis risk calculator showed a significant reduction in the use of blood cultures and antibiotics, she noted. Other risks of jumping to IV antibiotics include increased hospital stay, increased parental anxiety, and decreased parental bonding, Dr. Rajbhandari added.

Next steps include how to prioritize implementation, as well as deimplementation of outdated practices, said Francisco Alvarez, MD, of Lucile Packard Children’s Hospital, Palo Alto, Calif. “A lot of our practices were started without good evidence for why they should be done,” he said. Other steps include value improvement research; use of dashboards and benchmarking; involving other stakeholders including patients, families, and other health care providers; and addressing racial disparities, he concluded.

The presenters had no financial conflicts to disclose. The conference was sponsored by the Academic Pediatric Association, the American Academy of Pediatrics, and the Society of Hospital Medicine.

“Health care spending and health care waste is a huge problem in the U.S., including for children,” Vivian Lee, MD, of Children’s Hospital, Los Angeles, said in a presentation at the 2021 virtual Pediatric Hospital Medicine conference.

Data from a 2019 study suggested that approximately 25% of health care spending in the United States qualifies as “wasteful spending,” in categories such as overtesting, and unnecessary hospitalization, Dr. Lee said. “It is essential for physicians in hospitals to be stewards of high-value care,” she emphasized.

To combat wasteful spending and control health care costs, the Choosing Wisely campaign was created in 2012 as an initiative from the American Board of Internal Medicine Foundation. An ongoing goal of the campaign is to raise awareness among physicians and patients about potential areas of low-value services and overuse. The overall campaign includes clinician-driven recommendations from multiple medical organizations.

The PHM produced its first set of five recommendations in 2012, Dr. Lee said. These recommendations, titled “Five Things Physicians and Patients Should Question,” have been updated for 2021. The updated recommendations were created as a partnership among the Academic Pediatric Association, the American Academy of Pediatrics, and the Society of Hospital Medicine. A joint committee reviewed the latest evidence, and the updates were approved by the societies and published by the ABIM in January 2021.

“We think these recommendations truly reflect an exciting and evolving landscape for pediatric hospitalists,” Dr. Lee said. “There is a greater focus on opportunities to transition out of the hospital sooner, or avoid hospitalization altogether. There is an emphasis on antibiotic stewardship and a growing recognition of the impact that overuse may have on our vulnerable neonatal population,” she said. Several members of the Choosing Wisely panel presented the recommendations during the virtual presentation.
 

Revised recommendations

The new “Five Things Physicians and Patients Should Question” are as follows:

1. Do not prescribe IV antibiotics for predetermined durations for patients hospitalized with infections such as pyelonephritis, osteomyelitis, and complicated pneumonia. Consider early transition to oral antibiotics.

Many antibiotic doses used in clinical practice are preset durations that are not based on high-quality evidence, said Mike Tchou, MD, of Children’s Hospital of Colorado in Aurora. However, studies now show that earlier transition to enteral antibiotics can improve a range of outcomes including neonatal UTIs, osteomyelitis, and complicated pneumonia, he said. Considering early transition based on a patient’s response can decrease adverse events, pain, length of stay, and health care costs, he explained.

2. Do not continue hospitalization in well-appearing febrile infants once bacterial cultures (i.e., blood, cerebrospinal, and/or urine) have been confirmed negative for 24-36 hours, if adequate outpatient follow-up can be assured.

Recent data indicate that continuing hospitalization beyond 24-36 hours of confirmed negative bacterial cultures does not improve clinical outcomes for well-appearing infants admitted for concern of serious bacterial infection, said Paula Soung, MD, of Children’s Wisconsin in Milwaukee. In fact, “blood culture yield is highest in the first 12-36 hours after incubation with multiple studies demonstrating > 90% of pathogen cultures being positive by 24 hours,” Dr. Soung said. “If adequate outpatient follow-up can be assured, discharging well-appearing febrile infants at 24-36 hours after confirming cultures are negative has many positive outcomes,” she said.

3. Do not initiate phototherapy in term or late preterm well-appearing infants with neonatal hyperbilirubinemia if their bilirubin is below levels at which the AAP guidelines recommend treatment.

In making this recommendation, “we considered that the risk of kernicterus and cerebral palsy is extremely low in otherwise healthy term and late preterm newborns,” said Allison Holmes, MD, of Children’s Hospital at Dartmouth-Hitchcock, Manchester, N.H. “Subthreshold phototherapy leads to unnecessary hospitalization and its associated costs and harms,” and data show that kernicterus generally occurs close to 40 mg/dL and occurs most often in infants with hemolysis, she added.

The evidence for the recommendations included data showing that, among other factors, 8.6 of 100,000 babies have a bilirubin greater than 30 mg/dL, said Dr. Holmes. Risks of using subthreshold phototherapy include increased length of stay, increased readmissions, and increased costs, as well as decreased breastfeeding, bonding with parents, and increased parental anxiety. “Adding prolonged hospitalization for an intervention that might not be necessary can be stressful for parents,” she said.

4. Do not use broad-spectrum antibiotics such as ceftriaxone for children hospitalized with uncomplicated community-acquired pneumonia. Use narrow-spectrum antibiotics such as penicillin, ampicillin, or amoxicillin.

Michelle Lossius, MD, of the Shands Hospital for Children at the University of Florida, Gainesville, noted that the recommendations reflect IDSA guidelines from 2011 advising the use of ampicillin or penicillin for this population of children. More recent studies with large populations support the ability of narrow-spectrum antibiotics to limit the development of resistant organisms while achieving the same or better outcomes for children hospitalized with CAP, she said.

5. Do not start IV antibiotic therapy on well-appearing newborn infants with isolated risk factors for sepsis such as maternal chorioamnionitis, prolonged rupture of membranes, or untreated group-B streptococcal colonization. Use clinical tools such as an evidence-based sepsis risk calculator to guide management.

“This recommendation combines other recommendations,” said Prabi Rajbhandari, MD, of Akron (Ohio) Children’s Hospital. The evidence is ample, as the Centers for Disease Control and Prevention recommends the use of sepsis calculators to guide clinical management in sepsis patients, she said.

Data comparing periods before and after the adoption of a sepsis risk calculator showed a significant reduction in the use of blood cultures and antibiotics, she noted. Other risks of jumping to IV antibiotics include increased hospital stay, increased parental anxiety, and decreased parental bonding, Dr. Rajbhandari added.

Next steps include how to prioritize implementation, as well as deimplementation of outdated practices, said Francisco Alvarez, MD, of Lucile Packard Children’s Hospital, Palo Alto, Calif. “A lot of our practices were started without good evidence for why they should be done,” he said. Other steps include value improvement research; use of dashboards and benchmarking; involving other stakeholders including patients, families, and other health care providers; and addressing racial disparities, he concluded.

The presenters had no financial conflicts to disclose. The conference was sponsored by the Academic Pediatric Association, the American Academy of Pediatrics, and the Society of Hospital Medicine.

The COVID-19 pandemic continues to impact child and adolescent mental health, and clinicians are learning as they go to develop strategies that address the challenges of providing both medical and mental health care to young patients, including those who test positive for COVID-19, according to Hani Talebi, PhD, director of pediatric psychology, and Jorge Ganem, MD, FAAP, director of pediatric hospital medicine, both of the University of Texas at Austin and Dell Children’s Medical Center.

In a presentation at the 2021 virtual Pediatric Hospital Medicine conference, Dr. Talebi and Dr. Ganem shared their experiences in identifying the impact of the pandemic on mental health services in a freestanding hospital, and synthesizing inpatient mental health care and medical care outside of a dedicated mental health unit.

Mental health is a significant pediatric issue; approximately one in five children have a diagnosable mental or behavioral health problem, but nearly two-thirds get little or no help, Dr. Talebi said. “COVID-19 has only exacerbated these mental health challenges,” he said.

He noted that beginning in April 2020, the proportion of children’s mental health-related emergency department visits increased and remained elevated through the spring, summer, and fall of 2020, as families fearful of COVID-19 avoided regular hospital visits.

Data suggest that up to 50% of all adolescent psychiatric crises that led to inpatient admissions were related in some way to COVID-19, Dr. Talebi said. In addition, “individuals with a recent diagnosis of a mental health disorder are at increased risk for COVID-19 infection,” and the risk is even higher among women and African Americans, he said.

The past year significantly impacted the mental wellbeing of parents and children, Dr. Talebi said. He cited a June 2020 study in Pediatrics in which 27% of parents reported worsening mental health for themselves, and 14% reported worsening behavioral health for their children. Ongoing issues including food insecurity, loss of regular child care, and an overall “very disorienting experience in the day-to-day” compromised the mental health of families, Dr. Talebi emphasized. Children isolated at home were not meeting developmental milestones that organically occur when socializing with peers, parents didn’t know how to handle some of their children’s issues without support from schools, and many people were struggling with other preexisting health conditions, he said.

This confluence of factors helped drive a surge in emergency department visits, meaning longer wait times and concerns about meeting urgent medical and mental health needs while maintaining safety, he added.

Parents and children waited longer to seek care, and community hospitals such as Dell Children’s Medical Center were faced with children in the emergency department with crisis-level mental health issues, along with children already waiting in the ED to address medical emergencies. All these patients had to be tested for COVID-19 and managed accordingly, Dr. Talebi noted.

Dr. Talebi emphasized the need for clinically robust care of the children who were in isolation for 10 days on the medical unit, waiting to test negative. New protocols were created for social workers to conduct daily safety checks, and to develop regular schedules for screening, “so they are having an experience on the medical floors similar to what they would have in a mental health unit,” he said.

Dr. Ganem reflected on the logistical challenges of managing mental health care while observing COVID-19 safety protocols. “COVID-19 added a new wrinkle of isolation,” he said. As institutional guidelines on testing and isolation evolved, negative COVID-19 tests were required for admission to the mental health units both in the hospital and throughout the region. Patients who tested positive had to be quarantined for 10 days, at which time they could be admitted to a mental health unit if necessary, he said.

Dr. Ganem shared details of some strategies adopted by Dell Children’s. He explained that the COVID-19 psychiatry patient workflow started with an ED evaluation, followed by medical clearance and consideration for admission.

“There was significant coordination between the social worker in the emergency department and the psychiatry social worker,” he said.

Key elements of the treatment plan for children with positive COVID-19 tests included an “interprofessional huddle” to coordinate the plan of care, goals for admission, and goals for safety, Dr. Ganem said.

Patients who required admission were expected to have an initial length of stay of 72 hours, and those who tested positive for COVID-19 were admitted to a medical unit with COVID-19 isolation, he said.

Once a patient is admitted, an RN activates a suicide prevention pathway, and an interprofessional team meets to determine what patients need for safe and effective discharge, said Dr. Ganem. He cited the SAFE-T protocol (Suicide Assessment Five-step Evaluation and Triage) as one of the tools used to determine safe discharge criteria. Considerations on the SAFE-T list include family support, an established outpatient therapist and psychiatrist, no suicide attempts prior to the current admission, or a low lethality attempt, and access to partial hospitalization or intensive outpatient programs.

Patients who could not be discharged because of suicidality or inadequate support or concerns about safety at home were considered for inpatient admission. Patients with COVID-19–positive tests who had continued need for inpatient mental health services could be transferred to an inpatient mental health unit after a 10-day quarantine.

Overall, “this has been a continuum of lessons learned, with some things we know now that we didn’t know in April or May of 2020,” Dr. Ganem said. Early in the pandemic, the focus was on minimizing risk, securing personal protective equipment, and determining who provided services in a patient’s room. “We developed new paradigms on the fly,” he said, including the use of virtual visits, which included securing and cleaning devices, as well as learning how to use them in this setting,” he said.

More recently, the emphasis has been on providing services to patients before they need to visit the hospital, rather than automatically admitting any patients with suicidal ideation and a positive COVID-19 test, Dr. Ganem said.

Dr. Talebi and Dr. Ganem had no financial conflicts to disclose. The conference was sponsored by the Society of Hospital Medicine, the American Academy of Pediatrics, and the Academic Pediatric Association.

The COVID-19 pandemic continues to impact child and adolescent mental health, and clinicians are learning as they go to develop strategies that address the challenges of providing both medical and mental health care to young patients, including those who test positive for COVID-19, according to Hani Talebi, PhD, director of pediatric psychology, and Jorge Ganem, MD, FAAP, director of pediatric hospital medicine, both of the University of Texas at Austin and Dell Children’s Medical Center.

In a presentation at the 2021 virtual Pediatric Hospital Medicine conference, Dr. Talebi and Dr. Ganem shared their experiences in identifying the impact of the pandemic on mental health services in a freestanding hospital, and synthesizing inpatient mental health care and medical care outside of a dedicated mental health unit.

Mental health is a significant pediatric issue; approximately one in five children have a diagnosable mental or behavioral health problem, but nearly two-thirds get little or no help, Dr. Talebi said. “COVID-19 has only exacerbated these mental health challenges,” he said.

He noted that beginning in April 2020, the proportion of children’s mental health-related emergency department visits increased and remained elevated through the spring, summer, and fall of 2020, as families fearful of COVID-19 avoided regular hospital visits.

Data suggest that up to 50% of all adolescent psychiatric crises that led to inpatient admissions were related in some way to COVID-19, Dr. Talebi said. In addition, “individuals with a recent diagnosis of a mental health disorder are at increased risk for COVID-19 infection,” and the risk is even higher among women and African Americans, he said.

The past year significantly impacted the mental wellbeing of parents and children, Dr. Talebi said. He cited a June 2020 study in Pediatrics in which 27% of parents reported worsening mental health for themselves, and 14% reported worsening behavioral health for their children. Ongoing issues including food insecurity, loss of regular child care, and an overall “very disorienting experience in the day-to-day” compromised the mental health of families, Dr. Talebi emphasized. Children isolated at home were not meeting developmental milestones that organically occur when socializing with peers, parents didn’t know how to handle some of their children’s issues without support from schools, and many people were struggling with other preexisting health conditions, he said.

This confluence of factors helped drive a surge in emergency department visits, meaning longer wait times and concerns about meeting urgent medical and mental health needs while maintaining safety, he added.

Parents and children waited longer to seek care, and community hospitals such as Dell Children’s Medical Center were faced with children in the emergency department with crisis-level mental health issues, along with children already waiting in the ED to address medical emergencies. All these patients had to be tested for COVID-19 and managed accordingly, Dr. Talebi noted.

Dr. Talebi emphasized the need for clinically robust care of the children who were in isolation for 10 days on the medical unit, waiting to test negative. New protocols were created for social workers to conduct daily safety checks, and to develop regular schedules for screening, “so they are having an experience on the medical floors similar to what they would have in a mental health unit,” he said.

Dr. Ganem reflected on the logistical challenges of managing mental health care while observing COVID-19 safety protocols. “COVID-19 added a new wrinkle of isolation,” he said. As institutional guidelines on testing and isolation evolved, negative COVID-19 tests were required for admission to the mental health units both in the hospital and throughout the region. Patients who tested positive had to be quarantined for 10 days, at which time they could be admitted to a mental health unit if necessary, he said.

Dr. Ganem shared details of some strategies adopted by Dell Children’s. He explained that the COVID-19 psychiatry patient workflow started with an ED evaluation, followed by medical clearance and consideration for admission.

“There was significant coordination between the social worker in the emergency department and the psychiatry social worker,” he said.

Key elements of the treatment plan for children with positive COVID-19 tests included an “interprofessional huddle” to coordinate the plan of care, goals for admission, and goals for safety, Dr. Ganem said.

Patients who required admission were expected to have an initial length of stay of 72 hours, and those who tested positive for COVID-19 were admitted to a medical unit with COVID-19 isolation, he said.

Once a patient is admitted, an RN activates a suicide prevention pathway, and an interprofessional team meets to determine what patients need for safe and effective discharge, said Dr. Ganem. He cited the SAFE-T protocol (Suicide Assessment Five-step Evaluation and Triage) as one of the tools used to determine safe discharge criteria. Considerations on the SAFE-T list include family support, an established outpatient therapist and psychiatrist, no suicide attempts prior to the current admission, or a low lethality attempt, and access to partial hospitalization or intensive outpatient programs.

Patients who could not be discharged because of suicidality or inadequate support or concerns about safety at home were considered for inpatient admission. Patients with COVID-19–positive tests who had continued need for inpatient mental health services could be transferred to an inpatient mental health unit after a 10-day quarantine.

Overall, “this has been a continuum of lessons learned, with some things we know now that we didn’t know in April or May of 2020,” Dr. Ganem said. Early in the pandemic, the focus was on minimizing risk, securing personal protective equipment, and determining who provided services in a patient’s room. “We developed new paradigms on the fly,” he said, including the use of virtual visits, which included securing and cleaning devices, as well as learning how to use them in this setting,” he said.

More recently, the emphasis has been on providing services to patients before they need to visit the hospital, rather than automatically admitting any patients with suicidal ideation and a positive COVID-19 test, Dr. Ganem said.

Dr. Talebi and Dr. Ganem had no financial conflicts to disclose. The conference was sponsored by the Society of Hospital Medicine, the American Academy of Pediatrics, and the Academic Pediatric Association.

The COVID-19 pandemic continues to impact child and adolescent mental health, and clinicians are learning as they go to develop strategies that address the challenges of providing both medical and mental health care to young patients, including those who test positive for COVID-19, according to Hani Talebi, PhD, director of pediatric psychology, and Jorge Ganem, MD, FAAP, director of pediatric hospital medicine, both of the University of Texas at Austin and Dell Children’s Medical Center.

In a presentation at the 2021 virtual Pediatric Hospital Medicine conference, Dr. Talebi and Dr. Ganem shared their experiences in identifying the impact of the pandemic on mental health services in a freestanding hospital, and synthesizing inpatient mental health care and medical care outside of a dedicated mental health unit.

Mental health is a significant pediatric issue; approximately one in five children have a diagnosable mental or behavioral health problem, but nearly two-thirds get little or no help, Dr. Talebi said. “COVID-19 has only exacerbated these mental health challenges,” he said.

He noted that beginning in April 2020, the proportion of children’s mental health-related emergency department visits increased and remained elevated through the spring, summer, and fall of 2020, as families fearful of COVID-19 avoided regular hospital visits.

Data suggest that up to 50% of all adolescent psychiatric crises that led to inpatient admissions were related in some way to COVID-19, Dr. Talebi said. In addition, “individuals with a recent diagnosis of a mental health disorder are at increased risk for COVID-19 infection,” and the risk is even higher among women and African Americans, he said.

The past year significantly impacted the mental wellbeing of parents and children, Dr. Talebi said. He cited a June 2020 study in Pediatrics in which 27% of parents reported worsening mental health for themselves, and 14% reported worsening behavioral health for their children. Ongoing issues including food insecurity, loss of regular child care, and an overall “very disorienting experience in the day-to-day” compromised the mental health of families, Dr. Talebi emphasized. Children isolated at home were not meeting developmental milestones that organically occur when socializing with peers, parents didn’t know how to handle some of their children’s issues without support from schools, and many people were struggling with other preexisting health conditions, he said.

This confluence of factors helped drive a surge in emergency department visits, meaning longer wait times and concerns about meeting urgent medical and mental health needs while maintaining safety, he added.

Parents and children waited longer to seek care, and community hospitals such as Dell Children’s Medical Center were faced with children in the emergency department with crisis-level mental health issues, along with children already waiting in the ED to address medical emergencies. All these patients had to be tested for COVID-19 and managed accordingly, Dr. Talebi noted.

Dr. Talebi emphasized the need for clinically robust care of the children who were in isolation for 10 days on the medical unit, waiting to test negative. New protocols were created for social workers to conduct daily safety checks, and to develop regular schedules for screening, “so they are having an experience on the medical floors similar to what they would have in a mental health unit,” he said.

Dr. Ganem reflected on the logistical challenges of managing mental health care while observing COVID-19 safety protocols. “COVID-19 added a new wrinkle of isolation,” he said. As institutional guidelines on testing and isolation evolved, negative COVID-19 tests were required for admission to the mental health units both in the hospital and throughout the region. Patients who tested positive had to be quarantined for 10 days, at which time they could be admitted to a mental health unit if necessary, he said.

Dr. Ganem shared details of some strategies adopted by Dell Children’s. He explained that the COVID-19 psychiatry patient workflow started with an ED evaluation, followed by medical clearance and consideration for admission.

“There was significant coordination between the social worker in the emergency department and the psychiatry social worker,” he said.

Key elements of the treatment plan for children with positive COVID-19 tests included an “interprofessional huddle” to coordinate the plan of care, goals for admission, and goals for safety, Dr. Ganem said.

Patients who required admission were expected to have an initial length of stay of 72 hours, and those who tested positive for COVID-19 were admitted to a medical unit with COVID-19 isolation, he said.

Once a patient is admitted, an RN activates a suicide prevention pathway, and an interprofessional team meets to determine what patients need for safe and effective discharge, said Dr. Ganem. He cited the SAFE-T protocol (Suicide Assessment Five-step Evaluation and Triage) as one of the tools used to determine safe discharge criteria. Considerations on the SAFE-T list include family support, an established outpatient therapist and psychiatrist, no suicide attempts prior to the current admission, or a low lethality attempt, and access to partial hospitalization or intensive outpatient programs.

Patients who could not be discharged because of suicidality or inadequate support or concerns about safety at home were considered for inpatient admission. Patients with COVID-19–positive tests who had continued need for inpatient mental health services could be transferred to an inpatient mental health unit after a 10-day quarantine.

Overall, “this has been a continuum of lessons learned, with some things we know now that we didn’t know in April or May of 2020,” Dr. Ganem said. Early in the pandemic, the focus was on minimizing risk, securing personal protective equipment, and determining who provided services in a patient’s room. “We developed new paradigms on the fly,” he said, including the use of virtual visits, which included securing and cleaning devices, as well as learning how to use them in this setting,” he said.

More recently, the emphasis has been on providing services to patients before they need to visit the hospital, rather than automatically admitting any patients with suicidal ideation and a positive COVID-19 test, Dr. Ganem said.

Dr. Talebi and Dr. Ganem had no financial conflicts to disclose. The conference was sponsored by the Society of Hospital Medicine, the American Academy of Pediatrics, and the Academic Pediatric Association.

Hospitalized COVID-19 patients at increased risk for respiratory failure showed significant improvement after treatment with anakinra, compared with placebo, based on data from a phase 3, randomized trial of nearly 600 patients who also received standard of care treatment.

Anakinra, a recombinant interleukin (IL)-1 receptor antagonist that blocks activity for both IL-1 alpha and beta, showed a 70% decrease in the risk of progression to severe respiratory failure in a prior open-label, phase 2, proof-of-concept study, wrote Evdoxia Kyriazopoulou, MD, PhD, of National and Kapodistrian University of Athens, and colleagues.

Previous research has shown that soluble urokinase plasminogen activator receptor (suPAR) serum levels can signal increased risk of progression to severe disease and respiratory failure in COVID-19 patients, they noted.

Supported by these early findings, “the SAVE-MORE study (suPAR-guided anakinra treatment for validation of the risk and early management of severe respiratory failure by COVID-19) is a pivotal, confirmatory, phase 3, double-blind, randomized controlled trial that evaluated the efficacy and safety of early initiation of anakinra treatment in hospitalized patients with moderate or severe COVID-19,” the researchers said.

In the SAVE-MORE study published Sept. 3 in Nature Medicine, the researchers identified 594 adults with COVID-19 who were hospitalized at 37 centers in Greece and Italy and at risk of progressing to respiratory failure based on plasma suPAR levels of at least 6 ng/mL.

The primary objective was to assess the impact of early anakinra treatment on the clinical status of COVID-19 patients at risk for severe disease according to the 11-point, ordinal World Health Organization Clinical Progression Scale (WHO-CPS) at 28 days after starting treatment. All patients received standard of care, which consisted of regular monitoring of physical signs, oximetry, and anticoagulation. Patients with severe disease by the WHO definition were also received 6 mg of dexamethasone intravenously daily for 10 days. A total of 405 were randomized to anakinra and 189 to placebo. Approximately 92% of the study participants had severe pneumonia according to the WHO classification for COVID-19. The average age of the patients was 62 years, 58% were male, and the average body mass index was 29.5 kg/m².

At 28 days, 204 (50.4%) of the anakinra-treated patients had fully recovered, with no detectable viral RNA, compared with 50 (26.5%) of the placebo-treated patients (P < .0001). In addition, significantly fewer patients in the anakinra group had died by 28 days (13 patients, 3.2%), compared with patients in the placebo group (13 patients, 6.9%).

The median decrease in WHO-CPS scores from baseline to 28 days was 4 points in the anakinra group and 3 points in the placebo group, a statistically significant difference (P < .0001).

“Overall, the unadjusted proportional odds of having a worse score on the 11-point WHO-CPS at day 28 with anakinra was 0.36 versus placebo,” and this number remained the same in adjusted analysis, the researchers wrote.

All five secondary endpoints on the WHO-CPS showed significant benefits of anakinra, compared with placebo. These included an absolute decrease of WHO-CPS at day 28 and day 14 from baseline; an absolute decrease of Sequential Organ Failure Assessment scores at day 7 from baseline; and a significantly shorter mean time to both hospital and ICU discharge (1 day and 4 days, respectively) with anakinra versus placebo.

Follow-up laboratory data showed a significant increase in absolute lymphocyte count at 7 days, a significant decrease in circulating IL-6 levels at 4 and 7 days, and significantly decreased plasma C-reactive protein (CRP) levels at 7 days.

Serious treatment-emergent adverse events were reported in 16% with anakinra and in 21.7% with placebo; the most common of these events were infections (8.4% with anakinra and 15.9% with placebo). The next most common serious treatment-emergent adverse events were ventilator-associated pneumonia, septic shock and multiple organ dysfunction, bloodstream infections, and pulmonary embolism. The most common nonserious treatment-emergent adverse events were an increase of liver function tests and hyperglycemia (similar in anakinra and placebo groups) and nonserious anemia (lower in the anakinra group).

The study findings were limited by several factors, including the lack of patients with critical COVID-19 disease and the challenge of application of suPAR in all hospital settings, the researchers noted. However, “the results validate the findings of the previous SAVE open-label phase 2 trial,” they said. The results suggest “that suPAR should be measured upon admission of all patients with COVID-19 who do not need oxygen or who need nasal or mask oxygen, and that, if suPAR levels are 6 ng/mL or higher, anakinra treatment might be a suitable therapy,” they concluded.
 

Cytokine storm syndrome remains a treatment challenge

“Many who die from COVID-19 suffer hyperinflammation with features of cytokine storm syndrome (CSS) and associated acute respiratory distress syndrome,” wrote Randy Q. Cron, MD, and W. Winn Chatham, MD, of the University of Alabama at Birmingham, and Roberto Caricchio, MD, of Temple University, Philadelphia, in an accompanying editorial. They noted that the SAVE-MORE trial results contrast with another recent randomized trial of canakinumab, which failed to show notable benefits, compared with placebo, in treating hospitalized patients with COVID-19 pneumonia.

“There are some key differences between these trials, one being that anakinra blocks signaling of both IL-1 alpha and IL-1 beta, whereas canakinumab binds only IL-1 beta,” the editorialists explained. “SARS-CoV-2–infected endothelium may be a particularly important source of IL-1 alpha that is not targeted by canakinumab,” they noted.

Additional studies have examined IL-6 inhibition to treat COVID-19 patients, but data have been inconsistent, the editorialists said.

“One thing that is clearly emerging from this pandemic is that the CSS associated with COVID-19 is relatively unique, with only modestly elevated levels of IL-6, CRP, and ferritin, for example,” they noted. However, the SAVE-MORE study suggests that more targeted approaches, such as anakinra, “may allow earlier introduction of anticytokine treatment” and support the use of IL-1 blockade with anakinra for cases of severe COVID-19 pneumonia.
 

Predicting risk for severe disease

“One of the major challenges in the management of patients with COVID-19 is identifying patients at risk of severe disease who would warrant early intervention with anti-inflammatory therapy,” said Salim Hayek, MD, medical director of the University of Michigan’s Frankel Cardiovascular Center Clinics, in an interview. “We and others had found that soluble urokinase plasminogen activator receptor (suPAR) levels are the strongest predictor of severe disease amongst biomarkers of inflammation,” he said. “In this study, patients with high suPAR levels derived benefit from anakinra, compared to those with placebo. This study is a great example of how suPAR levels could be used to identify high-risk patients that would benefit from therapies targeting inflammation,” Dr. Hayek emphasized.

“The findings are in line with the hypothesis that patients with the highest degrees of inflammation would benefit the best from targeting the hyperinflammatory cascade using anakinra or other interleukin antagonists,” Dr. Hayek said. “Given suPAR levels are the best predictors of high-risk disease, it is not surprising to see that patients with high levels benefit from targeting inflammation,” he noted.

The take-home message for clinicians at this time is that anakinra effectively improves outcomes in COVID-19 patients with high suPAR levels, Dr. Hayek said. “SuPAR can be measured easily at the point of care. Thus, a targeted strategy using suPAR to identify patients who would benefit from anakinra appears to be viable,” he explained.

However, “Whether anakinra is effective in patients with lower suPAR levels (<6 ng/mL) is unclear and was not answered by this study,” he said. “We eagerly await results of other trials to make that determination. Whether suPAR levels can also help guide the use of other therapies for COVID-19 should be explored and would enhance the personalization of treatment for COVID-19 according to the underlying inflammatory state,” he added.

The SAVE-MORE study was funded by the Hellenic Institute for the Study of Sepsis and Sobi, which manufactures anakinra. Some of the study authors reported financial relationships with Sobi and other pharmaceutical companies.

Dr. Cron disclosed serving as a consultant to Sobi, Novartis, Pfizer, and Sironax. Dr. Cron and Dr. Chatham disclosed having received grant support from Sobi for investigator-initiated clinical trials, and Dr. Caricchio disclosed serving as a consultant to GlaxoSmithKline, Johnson & Johnson, Aurinia, and Bristol-Myers Squibb. Dr. Hayek had no relevant financial conflicts to disclose.

Hospitalized COVID-19 patients at increased risk for respiratory failure showed significant improvement after treatment with anakinra, compared with placebo, based on data from a phase 3, randomized trial of nearly 600 patients who also received standard of care treatment.

Anakinra, a recombinant interleukin (IL)-1 receptor antagonist that blocks activity for both IL-1 alpha and beta, showed a 70% decrease in the risk of progression to severe respiratory failure in a prior open-label, phase 2, proof-of-concept study, wrote Evdoxia Kyriazopoulou, MD, PhD, of National and Kapodistrian University of Athens, and colleagues.

Previous research has shown that soluble urokinase plasminogen activator receptor (suPAR) serum levels can signal increased risk of progression to severe disease and respiratory failure in COVID-19 patients, they noted.

Supported by these early findings, “the SAVE-MORE study (suPAR-guided anakinra treatment for validation of the risk and early management of severe respiratory failure by COVID-19) is a pivotal, confirmatory, phase 3, double-blind, randomized controlled trial that evaluated the efficacy and safety of early initiation of anakinra treatment in hospitalized patients with moderate or severe COVID-19,” the researchers said.

In the SAVE-MORE study published Sept. 3 in Nature Medicine, the researchers identified 594 adults with COVID-19 who were hospitalized at 37 centers in Greece and Italy and at risk of progressing to respiratory failure based on plasma suPAR levels of at least 6 ng/mL.

The primary objective was to assess the impact of early anakinra treatment on the clinical status of COVID-19 patients at risk for severe disease according to the 11-point, ordinal World Health Organization Clinical Progression Scale (WHO-CPS) at 28 days after starting treatment. All patients received standard of care, which consisted of regular monitoring of physical signs, oximetry, and anticoagulation. Patients with severe disease by the WHO definition were also received 6 mg of dexamethasone intravenously daily for 10 days. A total of 405 were randomized to anakinra and 189 to placebo. Approximately 92% of the study participants had severe pneumonia according to the WHO classification for COVID-19. The average age of the patients was 62 years, 58% were male, and the average body mass index was 29.5 kg/m².

At 28 days, 204 (50.4%) of the anakinra-treated patients had fully recovered, with no detectable viral RNA, compared with 50 (26.5%) of the placebo-treated patients (P < .0001). In addition, significantly fewer patients in the anakinra group had died by 28 days (13 patients, 3.2%), compared with patients in the placebo group (13 patients, 6.9%).

The median decrease in WHO-CPS scores from baseline to 28 days was 4 points in the anakinra group and 3 points in the placebo group, a statistically significant difference (P < .0001).

“Overall, the unadjusted proportional odds of having a worse score on the 11-point WHO-CPS at day 28 with anakinra was 0.36 versus placebo,” and this number remained the same in adjusted analysis, the researchers wrote.

All five secondary endpoints on the WHO-CPS showed significant benefits of anakinra, compared with placebo. These included an absolute decrease of WHO-CPS at day 28 and day 14 from baseline; an absolute decrease of Sequential Organ Failure Assessment scores at day 7 from baseline; and a significantly shorter mean time to both hospital and ICU discharge (1 day and 4 days, respectively) with anakinra versus placebo.

Follow-up laboratory data showed a significant increase in absolute lymphocyte count at 7 days, a significant decrease in circulating IL-6 levels at 4 and 7 days, and significantly decreased plasma C-reactive protein (CRP) levels at 7 days.

Serious treatment-emergent adverse events were reported in 16% with anakinra and in 21.7% with placebo; the most common of these events were infections (8.4% with anakinra and 15.9% with placebo). The next most common serious treatment-emergent adverse events were ventilator-associated pneumonia, septic shock and multiple organ dysfunction, bloodstream infections, and pulmonary embolism. The most common nonserious treatment-emergent adverse events were an increase of liver function tests and hyperglycemia (similar in anakinra and placebo groups) and nonserious anemia (lower in the anakinra group).

The study findings were limited by several factors, including the lack of patients with critical COVID-19 disease and the challenge of application of suPAR in all hospital settings, the researchers noted. However, “the results validate the findings of the previous SAVE open-label phase 2 trial,” they said. The results suggest “that suPAR should be measured upon admission of all patients with COVID-19 who do not need oxygen or who need nasal or mask oxygen, and that, if suPAR levels are 6 ng/mL or higher, anakinra treatment might be a suitable therapy,” they concluded.
 

Cytokine storm syndrome remains a treatment challenge

“Many who die from COVID-19 suffer hyperinflammation with features of cytokine storm syndrome (CSS) and associated acute respiratory distress syndrome,” wrote Randy Q. Cron, MD, and W. Winn Chatham, MD, of the University of Alabama at Birmingham, and Roberto Caricchio, MD, of Temple University, Philadelphia, in an accompanying editorial. They noted that the SAVE-MORE trial results contrast with another recent randomized trial of canakinumab, which failed to show notable benefits, compared with placebo, in treating hospitalized patients with COVID-19 pneumonia.

“There are some key differences between these trials, one being that anakinra blocks signaling of both IL-1 alpha and IL-1 beta, whereas canakinumab binds only IL-1 beta,” the editorialists explained. “SARS-CoV-2–infected endothelium may be a particularly important source of IL-1 alpha that is not targeted by canakinumab,” they noted.

Additional studies have examined IL-6 inhibition to treat COVID-19 patients, but data have been inconsistent, the editorialists said.

“One thing that is clearly emerging from this pandemic is that the CSS associated with COVID-19 is relatively unique, with only modestly elevated levels of IL-6, CRP, and ferritin, for example,” they noted. However, the SAVE-MORE study suggests that more targeted approaches, such as anakinra, “may allow earlier introduction of anticytokine treatment” and support the use of IL-1 blockade with anakinra for cases of severe COVID-19 pneumonia.
 

Predicting risk for severe disease

“One of the major challenges in the management of patients with COVID-19 is identifying patients at risk of severe disease who would warrant early intervention with anti-inflammatory therapy,” said Salim Hayek, MD, medical director of the University of Michigan’s Frankel Cardiovascular Center Clinics, in an interview. “We and others had found that soluble urokinase plasminogen activator receptor (suPAR) levels are the strongest predictor of severe disease amongst biomarkers of inflammation,” he said. “In this study, patients with high suPAR levels derived benefit from anakinra, compared to those with placebo. This study is a great example of how suPAR levels could be used to identify high-risk patients that would benefit from therapies targeting inflammation,” Dr. Hayek emphasized.

“The findings are in line with the hypothesis that patients with the highest degrees of inflammation would benefit the best from targeting the hyperinflammatory cascade using anakinra or other interleukin antagonists,” Dr. Hayek said. “Given suPAR levels are the best predictors of high-risk disease, it is not surprising to see that patients with high levels benefit from targeting inflammation,” he noted.

The take-home message for clinicians at this time is that anakinra effectively improves outcomes in COVID-19 patients with high suPAR levels, Dr. Hayek said. “SuPAR can be measured easily at the point of care. Thus, a targeted strategy using suPAR to identify patients who would benefit from anakinra appears to be viable,” he explained.

However, “Whether anakinra is effective in patients with lower suPAR levels (<6 ng/mL) is unclear and was not answered by this study,” he said. “We eagerly await results of other trials to make that determination. Whether suPAR levels can also help guide the use of other therapies for COVID-19 should be explored and would enhance the personalization of treatment for COVID-19 according to the underlying inflammatory state,” he added.

The SAVE-MORE study was funded by the Hellenic Institute for the Study of Sepsis and Sobi, which manufactures anakinra. Some of the study authors reported financial relationships with Sobi and other pharmaceutical companies.

Dr. Cron disclosed serving as a consultant to Sobi, Novartis, Pfizer, and Sironax. Dr. Cron and Dr. Chatham disclosed having received grant support from Sobi for investigator-initiated clinical trials, and Dr. Caricchio disclosed serving as a consultant to GlaxoSmithKline, Johnson & Johnson, Aurinia, and Bristol-Myers Squibb. Dr. Hayek had no relevant financial conflicts to disclose.

Hospitalized COVID-19 patients at increased risk for respiratory failure showed significant improvement after treatment with anakinra, compared with placebo, based on data from a phase 3, randomized trial of nearly 600 patients who also received standard of care treatment.

Anakinra, a recombinant interleukin (IL)-1 receptor antagonist that blocks activity for both IL-1 alpha and beta, showed a 70% decrease in the risk of progression to severe respiratory failure in a prior open-label, phase 2, proof-of-concept study, wrote Evdoxia Kyriazopoulou, MD, PhD, of National and Kapodistrian University of Athens, and colleagues.

Previous research has shown that soluble urokinase plasminogen activator receptor (suPAR) serum levels can signal increased risk of progression to severe disease and respiratory failure in COVID-19 patients, they noted.

Supported by these early findings, “the SAVE-MORE study (suPAR-guided anakinra treatment for validation of the risk and early management of severe respiratory failure by COVID-19) is a pivotal, confirmatory, phase 3, double-blind, randomized controlled trial that evaluated the efficacy and safety of early initiation of anakinra treatment in hospitalized patients with moderate or severe COVID-19,” the researchers said.

In the SAVE-MORE study published Sept. 3 in Nature Medicine, the researchers identified 594 adults with COVID-19 who were hospitalized at 37 centers in Greece and Italy and at risk of progressing to respiratory failure based on plasma suPAR levels of at least 6 ng/mL.

The primary objective was to assess the impact of early anakinra treatment on the clinical status of COVID-19 patients at risk for severe disease according to the 11-point, ordinal World Health Organization Clinical Progression Scale (WHO-CPS) at 28 days after starting treatment. All patients received standard of care, which consisted of regular monitoring of physical signs, oximetry, and anticoagulation. Patients with severe disease by the WHO definition were also received 6 mg of dexamethasone intravenously daily for 10 days. A total of 405 were randomized to anakinra and 189 to placebo. Approximately 92% of the study participants had severe pneumonia according to the WHO classification for COVID-19. The average age of the patients was 62 years, 58% were male, and the average body mass index was 29.5 kg/m².

At 28 days, 204 (50.4%) of the anakinra-treated patients had fully recovered, with no detectable viral RNA, compared with 50 (26.5%) of the placebo-treated patients (P < .0001). In addition, significantly fewer patients in the anakinra group had died by 28 days (13 patients, 3.2%), compared with patients in the placebo group (13 patients, 6.9%).

The median decrease in WHO-CPS scores from baseline to 28 days was 4 points in the anakinra group and 3 points in the placebo group, a statistically significant difference (P < .0001).

“Overall, the unadjusted proportional odds of having a worse score on the 11-point WHO-CPS at day 28 with anakinra was 0.36 versus placebo,” and this number remained the same in adjusted analysis, the researchers wrote.

All five secondary endpoints on the WHO-CPS showed significant benefits of anakinra, compared with placebo. These included an absolute decrease of WHO-CPS at day 28 and day 14 from baseline; an absolute decrease of Sequential Organ Failure Assessment scores at day 7 from baseline; and a significantly shorter mean time to both hospital and ICU discharge (1 day and 4 days, respectively) with anakinra versus placebo.

Follow-up laboratory data showed a significant increase in absolute lymphocyte count at 7 days, a significant decrease in circulating IL-6 levels at 4 and 7 days, and significantly decreased plasma C-reactive protein (CRP) levels at 7 days.

Serious treatment-emergent adverse events were reported in 16% with anakinra and in 21.7% with placebo; the most common of these events were infections (8.4% with anakinra and 15.9% with placebo). The next most common serious treatment-emergent adverse events were ventilator-associated pneumonia, septic shock and multiple organ dysfunction, bloodstream infections, and pulmonary embolism. The most common nonserious treatment-emergent adverse events were an increase of liver function tests and hyperglycemia (similar in anakinra and placebo groups) and nonserious anemia (lower in the anakinra group).

The study findings were limited by several factors, including the lack of patients with critical COVID-19 disease and the challenge of application of suPAR in all hospital settings, the researchers noted. However, “the results validate the findings of the previous SAVE open-label phase 2 trial,” they said. The results suggest “that suPAR should be measured upon admission of all patients with COVID-19 who do not need oxygen or who need nasal or mask oxygen, and that, if suPAR levels are 6 ng/mL or higher, anakinra treatment might be a suitable therapy,” they concluded.
 

Cytokine storm syndrome remains a treatment challenge

“Many who die from COVID-19 suffer hyperinflammation with features of cytokine storm syndrome (CSS) and associated acute respiratory distress syndrome,” wrote Randy Q. Cron, MD, and W. Winn Chatham, MD, of the University of Alabama at Birmingham, and Roberto Caricchio, MD, of Temple University, Philadelphia, in an accompanying editorial. They noted that the SAVE-MORE trial results contrast with another recent randomized trial of canakinumab, which failed to show notable benefits, compared with placebo, in treating hospitalized patients with COVID-19 pneumonia.

“There are some key differences between these trials, one being that anakinra blocks signaling of both IL-1 alpha and IL-1 beta, whereas canakinumab binds only IL-1 beta,” the editorialists explained. “SARS-CoV-2–infected endothelium may be a particularly important source of IL-1 alpha that is not targeted by canakinumab,” they noted.

Additional studies have examined IL-6 inhibition to treat COVID-19 patients, but data have been inconsistent, the editorialists said.

“One thing that is clearly emerging from this pandemic is that the CSS associated with COVID-19 is relatively unique, with only modestly elevated levels of IL-6, CRP, and ferritin, for example,” they noted. However, the SAVE-MORE study suggests that more targeted approaches, such as anakinra, “may allow earlier introduction of anticytokine treatment” and support the use of IL-1 blockade with anakinra for cases of severe COVID-19 pneumonia.
 

Predicting risk for severe disease

“One of the major challenges in the management of patients with COVID-19 is identifying patients at risk of severe disease who would warrant early intervention with anti-inflammatory therapy,” said Salim Hayek, MD, medical director of the University of Michigan’s Frankel Cardiovascular Center Clinics, in an interview. “We and others had found that soluble urokinase plasminogen activator receptor (suPAR) levels are the strongest predictor of severe disease amongst biomarkers of inflammation,” he said. “In this study, patients with high suPAR levels derived benefit from anakinra, compared to those with placebo. This study is a great example of how suPAR levels could be used to identify high-risk patients that would benefit from therapies targeting inflammation,” Dr. Hayek emphasized.

“The findings are in line with the hypothesis that patients with the highest degrees of inflammation would benefit the best from targeting the hyperinflammatory cascade using anakinra or other interleukin antagonists,” Dr. Hayek said. “Given suPAR levels are the best predictors of high-risk disease, it is not surprising to see that patients with high levels benefit from targeting inflammation,” he noted.

The take-home message for clinicians at this time is that anakinra effectively improves outcomes in COVID-19 patients with high suPAR levels, Dr. Hayek said. “SuPAR can be measured easily at the point of care. Thus, a targeted strategy using suPAR to identify patients who would benefit from anakinra appears to be viable,” he explained.

However, “Whether anakinra is effective in patients with lower suPAR levels (<6 ng/mL) is unclear and was not answered by this study,” he said. “We eagerly await results of other trials to make that determination. Whether suPAR levels can also help guide the use of other therapies for COVID-19 should be explored and would enhance the personalization of treatment for COVID-19 according to the underlying inflammatory state,” he added.

The SAVE-MORE study was funded by the Hellenic Institute for the Study of Sepsis and Sobi, which manufactures anakinra. Some of the study authors reported financial relationships with Sobi and other pharmaceutical companies.

Dr. Cron disclosed serving as a consultant to Sobi, Novartis, Pfizer, and Sironax. Dr. Cron and Dr. Chatham disclosed having received grant support from Sobi for investigator-initiated clinical trials, and Dr. Caricchio disclosed serving as a consultant to GlaxoSmithKline, Johnson & Johnson, Aurinia, and Bristol-Myers Squibb. Dr. Hayek had no relevant financial conflicts to disclose.

The restrictions resulting from the COVID-19 pandemic altered patterns of substance use by early adolescents to less alcohol use and greater use and misuse of nicotine and prescription drugs, based on data from more than 7,000 youth aged 10-14 years.

Substance use in early adolescence is a function of many environmental factors including substance availability, parent and peer use, and family function, as well as macroeconomic factors, William E. Pelham III, PhD, of the University of California, San Diego, and colleagues wrote. “Thus, it is critical to evaluate how substance use during early adolescence has been impacted by the coronavirus disease 2019 (COVID-19) pandemic, a source of large and sustained disruptions to adolescents’ daily lives in terms of education, contact with family/friends, and health behaviors.”

In a prospective, community-based cohort study, published in the Journal of Adolescent Health, the researchers conducted a three-wave assessment of substance use between May 2020 and August 2020, and reviewed prepandemic assessments from 2018 to 2019. The participants included 7,842 adolescents with an average age of 12 years who were initially enrolled in the Adolescent Brain Cognitive Development (ABCD) study at age 9-10 years. At the start of the study, 48% of the participants were female, 20% were Hispanic, 15% were Black, and 2% were Asian. Participants completed three online surveys between May 2020 and August 2020.

Each survey included the number of days in the past 30 days in which the adolescents drank alcohol; smoked cigarettes; used electronic nicotine delivery systems; smoked a cigar, hookah, or pipe; used smokeless tobacco products; used a cannabis product; abused prescription drugs; used inhalants; or used any other drugs. The response scale was 0 days to 10-plus days.

The overall prevalence of substance use among young adolescents was similar between prepandemic and pandemic periods; however fewer respondents reported using alcohol, but more reported using nicotine or misusing prescription medications.

Across all three survey periods, 7.4% of youth reported any substance use, 3.4% reported ever using alcohol, and 3.2% reported ever using nicotine. Of those who reported substance use, 79% reported 1-2 days of use in the past month, and 87% reported using a single substance.

In comparing prepandemic and pandemic substance use, the prevalence of alcohol use in the past 30 days decreased significantly, from 2.1% to 0.8%. However, use of nicotine increased significantly from 0% to 1.3%, and misuse of prescription drugs increased significantly from 0% to 0.6%. “Changes in the rates of use of any substance, cannabis, or inhalants were not statistically significant,” the researchers wrote.

Sex and ethnicity were not associated with substance use during the pandemic, but rates of substance use were higher among youth whose parents were unmarried or had lower levels of education, and among those with preexisting externalizing and internalizing behaviors. Youth who reported higher levels of uncertainty related to COVID-19 were significantly more likely to report substance use; additionally, stress, anxiety, and depressive symptoms were positively association with any substance use during the pandemic survey periods. Youth whose parents experienced hardship or whose parents used alcohol or drugs also were more likely to report substance use.

“Stability in the overall rate of substance use in this cohort is reassuring given that the pandemic has brought increases in teens’ unoccupied time, stress, and loneliness, reduced access to support services, and disruptions to routines and family/parenting practices, all of which might be expected to have increased youth substance use,” the researchers noted. The findings do not explain the decreased alcohol use, but the researchers cited possible reasons for reduced alcohol use including lack of contact with friends and social activities, and greater supervision by parents.

The study findings were limited by several factors including the comparison of prepandemic and pandemic substance use in younger adolescents, which may not reflect changes in substance use in older adolescents. The study also could not establish causality, and did not account for the intensity of substance use, such as number of drinks, the researchers wrote. However, the results were strengthened by the longitudinal design and large, diverse study population, and the use of prepandemic assessments that allowed evaluation of changes over time.

Overall, the results highlight the importance of preexisting and acute risk protective factors in mitigating substance use in young adolescents, and suggest the potential of economic support for families and emotional support for youth as ways to reduce risk, the researchers concluded.
 

Predicting use and identifying risk factors

“It was important to conduct research at this time so we know how trends have changed during the pandemic,” Karalyn Kinsella, MD, a pediatrician in private practice in Cheshire, Conn., said in an interview. The research helps clinicians “so we can better predict which substances our patients may be using, especially those with preexisting psychological conditions and those at socioeconomic disadvantage.

“I was surprised by the increased prescription drug use, but it make sense, as adolescents are at home more and may be illicitly using their parents medications,” Dr. Kinsella noted. “I think as they go back to school, trends will shift back to where they were as they will be spending more time with friends.” The take-home message to clinicians is the increased use of nicotine and prescription drugs during the pandemic, and future research should focus on substance use trends in 14- to 20-year-olds.

The ABCD study was supported by the National Institutes of Health, and the current study also received support from the National Science Foundation and Children and Screens: Institute of Digital Media and Child Development. The researchers had no financial conflicts to disclose. Dr. Kinsella had no financial conflicts to disclose, but serves on the editorial advisory board of Pediatric News.

The restrictions resulting from the COVID-19 pandemic altered patterns of substance use by early adolescents to less alcohol use and greater use and misuse of nicotine and prescription drugs, based on data from more than 7,000 youth aged 10-14 years.

Substance use in early adolescence is a function of many environmental factors including substance availability, parent and peer use, and family function, as well as macroeconomic factors, William E. Pelham III, PhD, of the University of California, San Diego, and colleagues wrote. “Thus, it is critical to evaluate how substance use during early adolescence has been impacted by the coronavirus disease 2019 (COVID-19) pandemic, a source of large and sustained disruptions to adolescents’ daily lives in terms of education, contact with family/friends, and health behaviors.”

In a prospective, community-based cohort study, published in the Journal of Adolescent Health, the researchers conducted a three-wave assessment of substance use between May 2020 and August 2020, and reviewed prepandemic assessments from 2018 to 2019. The participants included 7,842 adolescents with an average age of 12 years who were initially enrolled in the Adolescent Brain Cognitive Development (ABCD) study at age 9-10 years. At the start of the study, 48% of the participants were female, 20% were Hispanic, 15% were Black, and 2% were Asian. Participants completed three online surveys between May 2020 and August 2020.

Each survey included the number of days in the past 30 days in which the adolescents drank alcohol; smoked cigarettes; used electronic nicotine delivery systems; smoked a cigar, hookah, or pipe; used smokeless tobacco products; used a cannabis product; abused prescription drugs; used inhalants; or used any other drugs. The response scale was 0 days to 10-plus days.

The overall prevalence of substance use among young adolescents was similar between prepandemic and pandemic periods; however fewer respondents reported using alcohol, but more reported using nicotine or misusing prescription medications.

Across all three survey periods, 7.4% of youth reported any substance use, 3.4% reported ever using alcohol, and 3.2% reported ever using nicotine. Of those who reported substance use, 79% reported 1-2 days of use in the past month, and 87% reported using a single substance.

In comparing prepandemic and pandemic substance use, the prevalence of alcohol use in the past 30 days decreased significantly, from 2.1% to 0.8%. However, use of nicotine increased significantly from 0% to 1.3%, and misuse of prescription drugs increased significantly from 0% to 0.6%. “Changes in the rates of use of any substance, cannabis, or inhalants were not statistically significant,” the researchers wrote.

Sex and ethnicity were not associated with substance use during the pandemic, but rates of substance use were higher among youth whose parents were unmarried or had lower levels of education, and among those with preexisting externalizing and internalizing behaviors. Youth who reported higher levels of uncertainty related to COVID-19 were significantly more likely to report substance use; additionally, stress, anxiety, and depressive symptoms were positively association with any substance use during the pandemic survey periods. Youth whose parents experienced hardship or whose parents used alcohol or drugs also were more likely to report substance use.

“Stability in the overall rate of substance use in this cohort is reassuring given that the pandemic has brought increases in teens’ unoccupied time, stress, and loneliness, reduced access to support services, and disruptions to routines and family/parenting practices, all of which might be expected to have increased youth substance use,” the researchers noted. The findings do not explain the decreased alcohol use, but the researchers cited possible reasons for reduced alcohol use including lack of contact with friends and social activities, and greater supervision by parents.

The study findings were limited by several factors including the comparison of prepandemic and pandemic substance use in younger adolescents, which may not reflect changes in substance use in older adolescents. The study also could not establish causality, and did not account for the intensity of substance use, such as number of drinks, the researchers wrote. However, the results were strengthened by the longitudinal design and large, diverse study population, and the use of prepandemic assessments that allowed evaluation of changes over time.

Overall, the results highlight the importance of preexisting and acute risk protective factors in mitigating substance use in young adolescents, and suggest the potential of economic support for families and emotional support for youth as ways to reduce risk, the researchers concluded.
 

Predicting use and identifying risk factors

“It was important to conduct research at this time so we know how trends have changed during the pandemic,” Karalyn Kinsella, MD, a pediatrician in private practice in Cheshire, Conn., said in an interview. The research helps clinicians “so we can better predict which substances our patients may be using, especially those with preexisting psychological conditions and those at socioeconomic disadvantage.

“I was surprised by the increased prescription drug use, but it make sense, as adolescents are at home more and may be illicitly using their parents medications,” Dr. Kinsella noted. “I think as they go back to school, trends will shift back to where they were as they will be spending more time with friends.” The take-home message to clinicians is the increased use of nicotine and prescription drugs during the pandemic, and future research should focus on substance use trends in 14- to 20-year-olds.

The ABCD study was supported by the National Institutes of Health, and the current study also received support from the National Science Foundation and Children and Screens: Institute of Digital Media and Child Development. The researchers had no financial conflicts to disclose. Dr. Kinsella had no financial conflicts to disclose, but serves on the editorial advisory board of Pediatric News.

The restrictions resulting from the COVID-19 pandemic altered patterns of substance use by early adolescents to less alcohol use and greater use and misuse of nicotine and prescription drugs, based on data from more than 7,000 youth aged 10-14 years.

Substance use in early adolescence is a function of many environmental factors including substance availability, parent and peer use, and family function, as well as macroeconomic factors, William E. Pelham III, PhD, of the University of California, San Diego, and colleagues wrote. “Thus, it is critical to evaluate how substance use during early adolescence has been impacted by the coronavirus disease 2019 (COVID-19) pandemic, a source of large and sustained disruptions to adolescents’ daily lives in terms of education, contact with family/friends, and health behaviors.”

In a prospective, community-based cohort study, published in the Journal of Adolescent Health, the researchers conducted a three-wave assessment of substance use between May 2020 and August 2020, and reviewed prepandemic assessments from 2018 to 2019. The participants included 7,842 adolescents with an average age of 12 years who were initially enrolled in the Adolescent Brain Cognitive Development (ABCD) study at age 9-10 years. At the start of the study, 48% of the participants were female, 20% were Hispanic, 15% were Black, and 2% were Asian. Participants completed three online surveys between May 2020 and August 2020.

Each survey included the number of days in the past 30 days in which the adolescents drank alcohol; smoked cigarettes; used electronic nicotine delivery systems; smoked a cigar, hookah, or pipe; used smokeless tobacco products; used a cannabis product; abused prescription drugs; used inhalants; or used any other drugs. The response scale was 0 days to 10-plus days.

The overall prevalence of substance use among young adolescents was similar between prepandemic and pandemic periods; however fewer respondents reported using alcohol, but more reported using nicotine or misusing prescription medications.

Across all three survey periods, 7.4% of youth reported any substance use, 3.4% reported ever using alcohol, and 3.2% reported ever using nicotine. Of those who reported substance use, 79% reported 1-2 days of use in the past month, and 87% reported using a single substance.

In comparing prepandemic and pandemic substance use, the prevalence of alcohol use in the past 30 days decreased significantly, from 2.1% to 0.8%. However, use of nicotine increased significantly from 0% to 1.3%, and misuse of prescription drugs increased significantly from 0% to 0.6%. “Changes in the rates of use of any substance, cannabis, or inhalants were not statistically significant,” the researchers wrote.

Sex and ethnicity were not associated with substance use during the pandemic, but rates of substance use were higher among youth whose parents were unmarried or had lower levels of education, and among those with preexisting externalizing and internalizing behaviors. Youth who reported higher levels of uncertainty related to COVID-19 were significantly more likely to report substance use; additionally, stress, anxiety, and depressive symptoms were positively association with any substance use during the pandemic survey periods. Youth whose parents experienced hardship or whose parents used alcohol or drugs also were more likely to report substance use.

“Stability in the overall rate of substance use in this cohort is reassuring given that the pandemic has brought increases in teens’ unoccupied time, stress, and loneliness, reduced access to support services, and disruptions to routines and family/parenting practices, all of which might be expected to have increased youth substance use,” the researchers noted. The findings do not explain the decreased alcohol use, but the researchers cited possible reasons for reduced alcohol use including lack of contact with friends and social activities, and greater supervision by parents.

The study findings were limited by several factors including the comparison of prepandemic and pandemic substance use in younger adolescents, which may not reflect changes in substance use in older adolescents. The study also could not establish causality, and did not account for the intensity of substance use, such as number of drinks, the researchers wrote. However, the results were strengthened by the longitudinal design and large, diverse study population, and the use of prepandemic assessments that allowed evaluation of changes over time.

Overall, the results highlight the importance of preexisting and acute risk protective factors in mitigating substance use in young adolescents, and suggest the potential of economic support for families and emotional support for youth as ways to reduce risk, the researchers concluded.
 

Predicting use and identifying risk factors

“It was important to conduct research at this time so we know how trends have changed during the pandemic,” Karalyn Kinsella, MD, a pediatrician in private practice in Cheshire, Conn., said in an interview. The research helps clinicians “so we can better predict which substances our patients may be using, especially those with preexisting psychological conditions and those at socioeconomic disadvantage.

“I was surprised by the increased prescription drug use, but it make sense, as adolescents are at home more and may be illicitly using their parents medications,” Dr. Kinsella noted. “I think as they go back to school, trends will shift back to where they were as they will be spending more time with friends.” The take-home message to clinicians is the increased use of nicotine and prescription drugs during the pandemic, and future research should focus on substance use trends in 14- to 20-year-olds.

The ABCD study was supported by the National Institutes of Health, and the current study also received support from the National Science Foundation and Children and Screens: Institute of Digital Media and Child Development. The researchers had no financial conflicts to disclose. Dr. Kinsella had no financial conflicts to disclose, but serves on the editorial advisory board of Pediatric News.