The U.S. Food and Drug Administration issued a warning today that the cancer drug duvelisib (Copiktra, Verastem), a PI3 kinase inhibitor, may increase the risk of death and serious side effects.

Duvelisib was approved in 2018 to treat adults with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who had received at least two prior therapies that did not work or stopped working.

However, more recent 5-year overall survival results from the randomized phase 3 DUO clinical trial found a possible increased risk of death with duvelisib, compared with another drug used to treat leukemia and lymphoma, according to an FDA Drug Safety Communication.

“The trial also found Copiktra was associated with a higher risk of serious side effects, including infections, diarrhea, inflammation of the intestines and lungs, skin reactions, and high liver enzyme levels in the blood,” states the warning, which advises prescribers to weigh the risks and benefits of continued use versus use of other treatments.

More specifically, median 5-year overall survival among 319 patients with CLL or SLL in the DUO trial was 52.3 months with duvelisib versus 63.3 months with the monoclonal antibody ofatumumab (hazard ratio, 1.09 overall and 1.06 among patients who received at least two prior lines of therapy).

Serious adverse events of grade 3 or higher were also more common in those treated with duvelisib.

Of note, in April, the FDA also announced that it was withdrawing approval of the relapsed or refractory follicular lymphoma indication for duvelisib following a voluntary request by the drug manufacturer Secura Bio.

A public meeting will be scheduled to discuss the findings of the trial and whether the drug should continue to be prescribed.

This FDA warning follows the agency’s June 1 withdrawal of approval for umbralisib (Ukoniq), another PI3 kinase inhibitor, following an investigation into a “possible increased risk of death.”

As reported by this news organization, umbralisib had received accelerated approval in February 2021 to treat adults with relapsed or refractory marginal zone lymphoma following at least one prior therapy and those with relapsed or refractory follicular lymphoma who had received at least three prior therapies.

“These safety findings were similar for other medicines in the same PI3 kinase inhibitor class, which were discussed at an advisory committee meeting of non-FDA experts in April 2022,” according to the FDA warning.

The FDA urges patients and health care professionals to report side effects involving duvelisib or other medicines to the FDA MedWatch program.

A version of this article first appeared on Medscape.com

The U.S. Food and Drug Administration issued a warning today that the cancer drug duvelisib (Copiktra, Verastem), a PI3 kinase inhibitor, may increase the risk of death and serious side effects.

Duvelisib was approved in 2018 to treat adults with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who had received at least two prior therapies that did not work or stopped working.

However, more recent 5-year overall survival results from the randomized phase 3 DUO clinical trial found a possible increased risk of death with duvelisib, compared with another drug used to treat leukemia and lymphoma, according to an FDA Drug Safety Communication.

“The trial also found Copiktra was associated with a higher risk of serious side effects, including infections, diarrhea, inflammation of the intestines and lungs, skin reactions, and high liver enzyme levels in the blood,” states the warning, which advises prescribers to weigh the risks and benefits of continued use versus use of other treatments.

More specifically, median 5-year overall survival among 319 patients with CLL or SLL in the DUO trial was 52.3 months with duvelisib versus 63.3 months with the monoclonal antibody ofatumumab (hazard ratio, 1.09 overall and 1.06 among patients who received at least two prior lines of therapy).

Serious adverse events of grade 3 or higher were also more common in those treated with duvelisib.

Of note, in April, the FDA also announced that it was withdrawing approval of the relapsed or refractory follicular lymphoma indication for duvelisib following a voluntary request by the drug manufacturer Secura Bio.

A public meeting will be scheduled to discuss the findings of the trial and whether the drug should continue to be prescribed.

This FDA warning follows the agency’s June 1 withdrawal of approval for umbralisib (Ukoniq), another PI3 kinase inhibitor, following an investigation into a “possible increased risk of death.”

As reported by this news organization, umbralisib had received accelerated approval in February 2021 to treat adults with relapsed or refractory marginal zone lymphoma following at least one prior therapy and those with relapsed or refractory follicular lymphoma who had received at least three prior therapies.

“These safety findings were similar for other medicines in the same PI3 kinase inhibitor class, which were discussed at an advisory committee meeting of non-FDA experts in April 2022,” according to the FDA warning.

The FDA urges patients and health care professionals to report side effects involving duvelisib or other medicines to the FDA MedWatch program.

A version of this article first appeared on Medscape.com

The U.S. Food and Drug Administration issued a warning today that the cancer drug duvelisib (Copiktra, Verastem), a PI3 kinase inhibitor, may increase the risk of death and serious side effects.

Duvelisib was approved in 2018 to treat adults with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who had received at least two prior therapies that did not work or stopped working.

However, more recent 5-year overall survival results from the randomized phase 3 DUO clinical trial found a possible increased risk of death with duvelisib, compared with another drug used to treat leukemia and lymphoma, according to an FDA Drug Safety Communication.

“The trial also found Copiktra was associated with a higher risk of serious side effects, including infections, diarrhea, inflammation of the intestines and lungs, skin reactions, and high liver enzyme levels in the blood,” states the warning, which advises prescribers to weigh the risks and benefits of continued use versus use of other treatments.

More specifically, median 5-year overall survival among 319 patients with CLL or SLL in the DUO trial was 52.3 months with duvelisib versus 63.3 months with the monoclonal antibody ofatumumab (hazard ratio, 1.09 overall and 1.06 among patients who received at least two prior lines of therapy).

Serious adverse events of grade 3 or higher were also more common in those treated with duvelisib.

Of note, in April, the FDA also announced that it was withdrawing approval of the relapsed or refractory follicular lymphoma indication for duvelisib following a voluntary request by the drug manufacturer Secura Bio.

A public meeting will be scheduled to discuss the findings of the trial and whether the drug should continue to be prescribed.

This FDA warning follows the agency’s June 1 withdrawal of approval for umbralisib (Ukoniq), another PI3 kinase inhibitor, following an investigation into a “possible increased risk of death.”

As reported by this news organization, umbralisib had received accelerated approval in February 2021 to treat adults with relapsed or refractory marginal zone lymphoma following at least one prior therapy and those with relapsed or refractory follicular lymphoma who had received at least three prior therapies.

“These safety findings were similar for other medicines in the same PI3 kinase inhibitor class, which were discussed at an advisory committee meeting of non-FDA experts in April 2022,” according to the FDA warning.

The FDA urges patients and health care professionals to report side effects involving duvelisib or other medicines to the FDA MedWatch program.

A version of this article first appeared on Medscape.com

Children and adolescents with migraine are about twice as likely to have an anxiety or depressive disorder as those without migraine, results from a new review and meta-analysis suggest.

“This is compelling, high-level evidence showing there’s this established comorbidity between migraine and anxiety and depressive symptoms and disorders in this age group,” co-investigator Serena L. Orr, MD, a pediatric neurologist and headache specialist at Alberta Children’s Hospital and assistant professor in the department of pediatrics, University of Calgary (Alta.), told this news organization.

The results “should compel every clinician who is seeing a child or adolescent with migraine to screen for anxiety and depression and to manage that if it’s present. That should be the standard of care with this level of evidence,” Dr. Orr said.

The findings were presented at the American Headache Society (AHS) Annual Meeting 2022.
 

Incidence divergence

Previous studies have suggested that 10%-20% of children and adolescents will experience migraine at some point before adulthood, with the prevalence increasing after puberty.

While the female-to-male ratio is about 1:1 before puberty, there is a “big divergence in incidence curves” afterward – with the female-to-male ratio reaching 2-3:1 in adulthood, Dr. Orr noted. Experts believe hormones drive this divergence, she said, noting that male adults with migraine have lower testosterone levels than male adults without migraine.

Dr. Orr and her colleagues were keen to investigate the relationship between child migraine and anxiety symptoms and disorders, as well as between child migraine and depression symptoms and disorders. They searched the literature for related case-control, cross-sectional, and cohort studies with participants of ages up to 18 years.

The researchers selected 80 studies to include in the review. Most of the studies were carried out in the past 30 to 40 years and were in English and other languages. Both community-based and clinical studies were included.

Of the total, 73 studies reported on the association between the exposures and migraine, and 51 were amenable to quantitative pooling.

Results from a meta-analysis that included 16 studies that compared children and adolescents who had migraine with their healthy peers showed a significant association between migraine and anxiety symptoms (standardized mean difference, 1.13; 95% confidence interval, 0.64-1.63; P < .0001).

Compared with children who did not have migraine, those with migraine had almost twice the odds of an anxiety disorder in 15 studies (odds ratio, 1.93; 95% CI, 1.49-2.50; P < .0001).

In addition, there was an association between migraine and depressive symptoms in 17 relevant studies (SMD, 0.67; 95% CI, 0.46-0.87; P < .0001). Participants with versus without migraine also had higher odds of depressive disorders in 18 studies (OR, 2.01; 95% CI, 1.46-2.78; P < .0001).

Effect sizes were similar between community-based and clinic studies. Dr. Orr said it is important to note that the analysis wasn’t restricted to studies with “just kids with really high disease burden who are going to naturally be more predisposed to psychiatric comorbidity.”
 

‘Shocking’ lack of research

The researchers were also interested in determining whether having migraine along with anxiety or depression symptoms or disorders could affect headache-specific outcomes and whether such patients’ conditions would be more refractory to treatment. However, these outcomes were “all over the place” in the 18 relevant studies, Dr. Orr reported.

“Some looked at headache frequency, some at disability, some at school functioning; so, we were not able to put them into a meta-analysis,” she said.

Only two studies examined whether anxiety or depression earlier in childhood predisposes to subsequent migraine, so that issue is still unresolved, Dr. Orr added.

The investigators also assessed whether outcomes with migraine are similar to those with other headache types, such as tension-type headaches. “We did not find a difference at the symptom or disorder level, but there were fewer of those studies” – and these, too, were heterogeneous, said Dr. Orr.

The researchers did not find any studies of the association between migraine and trauma, which Dr. Orr said was “shocking.”

“In the broader pediatric chronic-pain literature, there’s research showing that having a trauma or stress-related disorder is associated with more chronic pain and worse chronic pain outcomes, but we could not find a study that specifically looked at that question in migraine,” she added.

Emerging evidence suggests there may be a bidirectional relationship between migraine and anxiety/depression, at least in adults. Dr. Orr said having these symptoms appears to raise the risk for migraine, but whether that’s environmental or driven by shared genetics isn’t clear.

Experiencing chronic pain may also predispose individuals to anxiety and depression, “but we need more studies on this.”

In addition to screening children with migraine for anxiety and depression, clinicians should advocate for better access to mental health resources for patients with these comorbidities, Dr. Orr noted.

She added that a limitation of the review was that 82.5% of the studies reported unadjusted associations and that 26.3% of the studies were of low quality.
 

High-level evidence

Sara Pavitt, MD, chief of the Pediatric Headache Program and assistant professor in the department of neurology, the University of Texas at Austin, said the investigators “should be applauded” for providing “high-level evidence” to better understand the relationship between migraine and anxiety and depression in pediatric patients.

Such information has been “lacking” for this patient population, said Dr. Pavitt, who was not involved with the research.

She noted that screening kids for mood disorders is challenging, given the relatively few pediatric mental health care providers. A referral for a psychiatric follow-up can mean a 9- to 12-month wait – or even longer for children who do not have insurance or use Medicare.

“Providers need to have more incentives to care for patients with Medicare or lack of insurance – these patients are often excluded from practices because reimbursement is so poor,” Dr. Pavitt said.

Additional pediatric studies are needed to understand how other mental health disorders, such as panic disorder, phobias, and posttraumatic stress disorder, may be related to migraine, she added.

The study received no outside funding. Dr. Orr has received grants from the Canadian Institutes of Health Research and royalties from Cambridge University Press for book publication, and she is on editorial boards of Headache, Neurology, and the American Migraine Foundation. Dr. Pavitt serves on an advisory board for Theranica, which produces a neuromodulation device for acute migraine treatment, although this is not directly relevant to this review.

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

Children and adolescents with migraine are about twice as likely to have an anxiety or depressive disorder as those without migraine, results from a new review and meta-analysis suggest.

“This is compelling, high-level evidence showing there’s this established comorbidity between migraine and anxiety and depressive symptoms and disorders in this age group,” co-investigator Serena L. Orr, MD, a pediatric neurologist and headache specialist at Alberta Children’s Hospital and assistant professor in the department of pediatrics, University of Calgary (Alta.), told this news organization.

The results “should compel every clinician who is seeing a child or adolescent with migraine to screen for anxiety and depression and to manage that if it’s present. That should be the standard of care with this level of evidence,” Dr. Orr said.

The findings were presented at the American Headache Society (AHS) Annual Meeting 2022.
 

Incidence divergence

Previous studies have suggested that 10%-20% of children and adolescents will experience migraine at some point before adulthood, with the prevalence increasing after puberty.

While the female-to-male ratio is about 1:1 before puberty, there is a “big divergence in incidence curves” afterward – with the female-to-male ratio reaching 2-3:1 in adulthood, Dr. Orr noted. Experts believe hormones drive this divergence, she said, noting that male adults with migraine have lower testosterone levels than male adults without migraine.

Dr. Orr and her colleagues were keen to investigate the relationship between child migraine and anxiety symptoms and disorders, as well as between child migraine and depression symptoms and disorders. They searched the literature for related case-control, cross-sectional, and cohort studies with participants of ages up to 18 years.

The researchers selected 80 studies to include in the review. Most of the studies were carried out in the past 30 to 40 years and were in English and other languages. Both community-based and clinical studies were included.

Of the total, 73 studies reported on the association between the exposures and migraine, and 51 were amenable to quantitative pooling.

Results from a meta-analysis that included 16 studies that compared children and adolescents who had migraine with their healthy peers showed a significant association between migraine and anxiety symptoms (standardized mean difference, 1.13; 95% confidence interval, 0.64-1.63; P < .0001).

Compared with children who did not have migraine, those with migraine had almost twice the odds of an anxiety disorder in 15 studies (odds ratio, 1.93; 95% CI, 1.49-2.50; P < .0001).

In addition, there was an association between migraine and depressive symptoms in 17 relevant studies (SMD, 0.67; 95% CI, 0.46-0.87; P < .0001). Participants with versus without migraine also had higher odds of depressive disorders in 18 studies (OR, 2.01; 95% CI, 1.46-2.78; P < .0001).

Effect sizes were similar between community-based and clinic studies. Dr. Orr said it is important to note that the analysis wasn’t restricted to studies with “just kids with really high disease burden who are going to naturally be more predisposed to psychiatric comorbidity.”
 

‘Shocking’ lack of research

The researchers were also interested in determining whether having migraine along with anxiety or depression symptoms or disorders could affect headache-specific outcomes and whether such patients’ conditions would be more refractory to treatment. However, these outcomes were “all over the place” in the 18 relevant studies, Dr. Orr reported.

“Some looked at headache frequency, some at disability, some at school functioning; so, we were not able to put them into a meta-analysis,” she said.

Only two studies examined whether anxiety or depression earlier in childhood predisposes to subsequent migraine, so that issue is still unresolved, Dr. Orr added.

The investigators also assessed whether outcomes with migraine are similar to those with other headache types, such as tension-type headaches. “We did not find a difference at the symptom or disorder level, but there were fewer of those studies” – and these, too, were heterogeneous, said Dr. Orr.

The researchers did not find any studies of the association between migraine and trauma, which Dr. Orr said was “shocking.”

“In the broader pediatric chronic-pain literature, there’s research showing that having a trauma or stress-related disorder is associated with more chronic pain and worse chronic pain outcomes, but we could not find a study that specifically looked at that question in migraine,” she added.

Emerging evidence suggests there may be a bidirectional relationship between migraine and anxiety/depression, at least in adults. Dr. Orr said having these symptoms appears to raise the risk for migraine, but whether that’s environmental or driven by shared genetics isn’t clear.

Experiencing chronic pain may also predispose individuals to anxiety and depression, “but we need more studies on this.”

In addition to screening children with migraine for anxiety and depression, clinicians should advocate for better access to mental health resources for patients with these comorbidities, Dr. Orr noted.

She added that a limitation of the review was that 82.5% of the studies reported unadjusted associations and that 26.3% of the studies were of low quality.
 

High-level evidence

Sara Pavitt, MD, chief of the Pediatric Headache Program and assistant professor in the department of neurology, the University of Texas at Austin, said the investigators “should be applauded” for providing “high-level evidence” to better understand the relationship between migraine and anxiety and depression in pediatric patients.

Such information has been “lacking” for this patient population, said Dr. Pavitt, who was not involved with the research.

She noted that screening kids for mood disorders is challenging, given the relatively few pediatric mental health care providers. A referral for a psychiatric follow-up can mean a 9- to 12-month wait – or even longer for children who do not have insurance or use Medicare.

“Providers need to have more incentives to care for patients with Medicare or lack of insurance – these patients are often excluded from practices because reimbursement is so poor,” Dr. Pavitt said.

Additional pediatric studies are needed to understand how other mental health disorders, such as panic disorder, phobias, and posttraumatic stress disorder, may be related to migraine, she added.

The study received no outside funding. Dr. Orr has received grants from the Canadian Institutes of Health Research and royalties from Cambridge University Press for book publication, and she is on editorial boards of Headache, Neurology, and the American Migraine Foundation. Dr. Pavitt serves on an advisory board for Theranica, which produces a neuromodulation device for acute migraine treatment, although this is not directly relevant to this review.

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

Children and adolescents with migraine are about twice as likely to have an anxiety or depressive disorder as those without migraine, results from a new review and meta-analysis suggest.

“This is compelling, high-level evidence showing there’s this established comorbidity between migraine and anxiety and depressive symptoms and disorders in this age group,” co-investigator Serena L. Orr, MD, a pediatric neurologist and headache specialist at Alberta Children’s Hospital and assistant professor in the department of pediatrics, University of Calgary (Alta.), told this news organization.

The results “should compel every clinician who is seeing a child or adolescent with migraine to screen for anxiety and depression and to manage that if it’s present. That should be the standard of care with this level of evidence,” Dr. Orr said.

The findings were presented at the American Headache Society (AHS) Annual Meeting 2022.
 

Incidence divergence

Previous studies have suggested that 10%-20% of children and adolescents will experience migraine at some point before adulthood, with the prevalence increasing after puberty.

While the female-to-male ratio is about 1:1 before puberty, there is a “big divergence in incidence curves” afterward – with the female-to-male ratio reaching 2-3:1 in adulthood, Dr. Orr noted. Experts believe hormones drive this divergence, she said, noting that male adults with migraine have lower testosterone levels than male adults without migraine.

Dr. Orr and her colleagues were keen to investigate the relationship between child migraine and anxiety symptoms and disorders, as well as between child migraine and depression symptoms and disorders. They searched the literature for related case-control, cross-sectional, and cohort studies with participants of ages up to 18 years.

The researchers selected 80 studies to include in the review. Most of the studies were carried out in the past 30 to 40 years and were in English and other languages. Both community-based and clinical studies were included.

Of the total, 73 studies reported on the association between the exposures and migraine, and 51 were amenable to quantitative pooling.

Results from a meta-analysis that included 16 studies that compared children and adolescents who had migraine with their healthy peers showed a significant association between migraine and anxiety symptoms (standardized mean difference, 1.13; 95% confidence interval, 0.64-1.63; P < .0001).

Compared with children who did not have migraine, those with migraine had almost twice the odds of an anxiety disorder in 15 studies (odds ratio, 1.93; 95% CI, 1.49-2.50; P < .0001).

In addition, there was an association between migraine and depressive symptoms in 17 relevant studies (SMD, 0.67; 95% CI, 0.46-0.87; P < .0001). Participants with versus without migraine also had higher odds of depressive disorders in 18 studies (OR, 2.01; 95% CI, 1.46-2.78; P < .0001).

Effect sizes were similar between community-based and clinic studies. Dr. Orr said it is important to note that the analysis wasn’t restricted to studies with “just kids with really high disease burden who are going to naturally be more predisposed to psychiatric comorbidity.”
 

‘Shocking’ lack of research

The researchers were also interested in determining whether having migraine along with anxiety or depression symptoms or disorders could affect headache-specific outcomes and whether such patients’ conditions would be more refractory to treatment. However, these outcomes were “all over the place” in the 18 relevant studies, Dr. Orr reported.

“Some looked at headache frequency, some at disability, some at school functioning; so, we were not able to put them into a meta-analysis,” she said.

Only two studies examined whether anxiety or depression earlier in childhood predisposes to subsequent migraine, so that issue is still unresolved, Dr. Orr added.

The investigators also assessed whether outcomes with migraine are similar to those with other headache types, such as tension-type headaches. “We did not find a difference at the symptom or disorder level, but there were fewer of those studies” – and these, too, were heterogeneous, said Dr. Orr.

The researchers did not find any studies of the association between migraine and trauma, which Dr. Orr said was “shocking.”

“In the broader pediatric chronic-pain literature, there’s research showing that having a trauma or stress-related disorder is associated with more chronic pain and worse chronic pain outcomes, but we could not find a study that specifically looked at that question in migraine,” she added.

Emerging evidence suggests there may be a bidirectional relationship between migraine and anxiety/depression, at least in adults. Dr. Orr said having these symptoms appears to raise the risk for migraine, but whether that’s environmental or driven by shared genetics isn’t clear.

Experiencing chronic pain may also predispose individuals to anxiety and depression, “but we need more studies on this.”

In addition to screening children with migraine for anxiety and depression, clinicians should advocate for better access to mental health resources for patients with these comorbidities, Dr. Orr noted.

She added that a limitation of the review was that 82.5% of the studies reported unadjusted associations and that 26.3% of the studies were of low quality.
 

High-level evidence

Sara Pavitt, MD, chief of the Pediatric Headache Program and assistant professor in the department of neurology, the University of Texas at Austin, said the investigators “should be applauded” for providing “high-level evidence” to better understand the relationship between migraine and anxiety and depression in pediatric patients.

Such information has been “lacking” for this patient population, said Dr. Pavitt, who was not involved with the research.

She noted that screening kids for mood disorders is challenging, given the relatively few pediatric mental health care providers. A referral for a psychiatric follow-up can mean a 9- to 12-month wait – or even longer for children who do not have insurance or use Medicare.

“Providers need to have more incentives to care for patients with Medicare or lack of insurance – these patients are often excluded from practices because reimbursement is so poor,” Dr. Pavitt said.

Additional pediatric studies are needed to understand how other mental health disorders, such as panic disorder, phobias, and posttraumatic stress disorder, may be related to migraine, she added.

The study received no outside funding. Dr. Orr has received grants from the Canadian Institutes of Health Research and royalties from Cambridge University Press for book publication, and she is on editorial boards of Headache, Neurology, and the American Migraine Foundation. Dr. Pavitt serves on an advisory board for Theranica, which produces a neuromodulation device for acute migraine treatment, although this is not directly relevant to this review.

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

Key clinical point: A higher proportion of patients with psoriatic arthritis (PsA) receiving 15 mg upadacitinib achieved low disease activity (LDA) or remission after the first 6 months of treatment, with the difference being visible even after 1 year of treatment, compared to those who received a placebo.

Major finding: At week 24, a higher proportion of patients receiving 15 mg upadacitinib vs. placebo achieved Disease Activity in PsA LDA (range 35%-48% vs. 4%-16%; P < .05) and remission (range 7%-11% vs. 0%-3%; P < .05), with the responses sustained until 56 weeks.

Study details: This was a post hoc analysis of the SELECT-PsA 1 and SELECT-PsA 2 trials including 1386 adults with PsA and prior inadequate response/intolerance to ≥1 non-biologic or biologic disease-modifying antirheumatic drugs who were randomly assigned to receive upadacitinib (15 or 30 mg), adalimumab, or placebo.

Disclosures: This study was funded by AbbVie, Inc. Four authors declared being current or former employees or stockholders of AbbVie, and other authors reported ties with various sources.

Source: Mease P et al. Disease control with upadacitinib in patients with psoriatic arthritis: A post hoc analysis of the randomized, placebo-controlled SELECT-PsA 1 and 2 phase 3 trials. Rheumatol Ther. 2022 (May 23). Doi: 10.1007/s40744-022-00449-6

Key clinical point: A higher proportion of patients with psoriatic arthritis (PsA) receiving 15 mg upadacitinib achieved low disease activity (LDA) or remission after the first 6 months of treatment, with the difference being visible even after 1 year of treatment, compared to those who received a placebo.

Major finding: At week 24, a higher proportion of patients receiving 15 mg upadacitinib vs. placebo achieved Disease Activity in PsA LDA (range 35%-48% vs. 4%-16%; P < .05) and remission (range 7%-11% vs. 0%-3%; P < .05), with the responses sustained until 56 weeks.

Study details: This was a post hoc analysis of the SELECT-PsA 1 and SELECT-PsA 2 trials including 1386 adults with PsA and prior inadequate response/intolerance to ≥1 non-biologic or biologic disease-modifying antirheumatic drugs who were randomly assigned to receive upadacitinib (15 or 30 mg), adalimumab, or placebo.

Disclosures: This study was funded by AbbVie, Inc. Four authors declared being current or former employees or stockholders of AbbVie, and other authors reported ties with various sources.

Source: Mease P et al. Disease control with upadacitinib in patients with psoriatic arthritis: A post hoc analysis of the randomized, placebo-controlled SELECT-PsA 1 and 2 phase 3 trials. Rheumatol Ther. 2022 (May 23). Doi: 10.1007/s40744-022-00449-6

Key clinical point: A higher proportion of patients with psoriatic arthritis (PsA) receiving 15 mg upadacitinib achieved low disease activity (LDA) or remission after the first 6 months of treatment, with the difference being visible even after 1 year of treatment, compared to those who received a placebo.

Major finding: At week 24, a higher proportion of patients receiving 15 mg upadacitinib vs. placebo achieved Disease Activity in PsA LDA (range 35%-48% vs. 4%-16%; P < .05) and remission (range 7%-11% vs. 0%-3%; P < .05), with the responses sustained until 56 weeks.

Study details: This was a post hoc analysis of the SELECT-PsA 1 and SELECT-PsA 2 trials including 1386 adults with PsA and prior inadequate response/intolerance to ≥1 non-biologic or biologic disease-modifying antirheumatic drugs who were randomly assigned to receive upadacitinib (15 or 30 mg), adalimumab, or placebo.

Disclosures: This study was funded by AbbVie, Inc. Four authors declared being current or former employees or stockholders of AbbVie, and other authors reported ties with various sources.

Source: Mease P et al. Disease control with upadacitinib in patients with psoriatic arthritis: A post hoc analysis of the randomized, placebo-controlled SELECT-PsA 1 and 2 phase 3 trials. Rheumatol Ther. 2022 (May 23). Doi: 10.1007/s40744-022-00449-6

Key clinical point: A substantial proportion of patients with psoriatic arthritis (PsA) achieved resolution of enthesitis within a year of initiating nonsteroidal anti-inflammatory drugs (NSAID) or disease-modifying antirheumatic drugs (DMARD), although the odds were lower in patients with high joint disease activity at baseline.

Major finding: Complete resolution of enthesitis was achieved by 86.12% of patients within a mean period of 8.73 months from therapy initiation, with higher joint activity at baseline being associated with a lower chance of enthesitis resolution (odds ratio 0.97; P = .01).

Study details: Findings are from a retrospective analysis of prospectively collected data of 526 patients with PsA and enthesitis who received no treatment/only NSAID (n = 142), conventional DMARD ± NSAID but without targeted DMARD (n = 196), or targeted DMARD with or without other medications (n = 188).

Disclosures: Dr. Mathew and Dr. Chandran received funding from the National Psoriasis Foundation and University of Toronto, respectively. The authors declared no conflicts of interest.

Source: Mathew AJ et al. Effectiveness of disease modifying anti-rheumatic drugs for enthesitis in a prospective longitudinal psoriatic arthritis cohort. J Rheumatol. 2022 (Jun 1). Doi: 10.3899/jrheum.211231

Key clinical point: A substantial proportion of patients with psoriatic arthritis (PsA) achieved resolution of enthesitis within a year of initiating nonsteroidal anti-inflammatory drugs (NSAID) or disease-modifying antirheumatic drugs (DMARD), although the odds were lower in patients with high joint disease activity at baseline.

Major finding: Complete resolution of enthesitis was achieved by 86.12% of patients within a mean period of 8.73 months from therapy initiation, with higher joint activity at baseline being associated with a lower chance of enthesitis resolution (odds ratio 0.97; P = .01).

Study details: Findings are from a retrospective analysis of prospectively collected data of 526 patients with PsA and enthesitis who received no treatment/only NSAID (n = 142), conventional DMARD ± NSAID but without targeted DMARD (n = 196), or targeted DMARD with or without other medications (n = 188).

Disclosures: Dr. Mathew and Dr. Chandran received funding from the National Psoriasis Foundation and University of Toronto, respectively. The authors declared no conflicts of interest.

Source: Mathew AJ et al. Effectiveness of disease modifying anti-rheumatic drugs for enthesitis in a prospective longitudinal psoriatic arthritis cohort. J Rheumatol. 2022 (Jun 1). Doi: 10.3899/jrheum.211231

Key clinical point: A substantial proportion of patients with psoriatic arthritis (PsA) achieved resolution of enthesitis within a year of initiating nonsteroidal anti-inflammatory drugs (NSAID) or disease-modifying antirheumatic drugs (DMARD), although the odds were lower in patients with high joint disease activity at baseline.

Major finding: Complete resolution of enthesitis was achieved by 86.12% of patients within a mean period of 8.73 months from therapy initiation, with higher joint activity at baseline being associated with a lower chance of enthesitis resolution (odds ratio 0.97; P = .01).

Study details: Findings are from a retrospective analysis of prospectively collected data of 526 patients with PsA and enthesitis who received no treatment/only NSAID (n = 142), conventional DMARD ± NSAID but without targeted DMARD (n = 196), or targeted DMARD with or without other medications (n = 188).

Disclosures: Dr. Mathew and Dr. Chandran received funding from the National Psoriasis Foundation and University of Toronto, respectively. The authors declared no conflicts of interest.

Source: Mathew AJ et al. Effectiveness of disease modifying anti-rheumatic drugs for enthesitis in a prospective longitudinal psoriatic arthritis cohort. J Rheumatol. 2022 (Jun 1). Doi: 10.3899/jrheum.211231

Devices that help children control their diabetes and lead fuller lives may also give them contact dermatitis, report the authors of a new study that calls for mandatory labeling of ingredients for allergy patch testing.

“A high share of patients showed positive reactions to isobornyl acrylate adhesive (IBOA) and/or their medical devices (insulin pumps or glucose devices),” the study authors write in Contact Dermatitis. “A third of patients showed positive reactions to benzoyl peroxide (BP),” used in adhesives.

“The presence of additional unidentified allergens cannot be excluded,” they add. “Overall, our experience once more highlights the importance of having access to a full description of the chemical composition of diabetes devices and related medical devices to efficiently manage patients (including children) who experience adverse skin reactions from such devices.”

Lead study author Catarina Alves da Silva, MD, of the department of dermatology and venereology of Aarhus (Denmark) University Hospital, and her colleagues conducted a retrospective study of 15 referred patients younger than 18 years who had type 1 diabetes. The children were patch tested in the university’s dermatology clinic between 2018 and 2020 in a study of skin reactions linked with diabetes devices.
 

Contact dermatitis from device-related allergens may be common

Many children in the study reacted to chemical compounds related to their devices.

• Of the 15 patients, seven showed positive patch test reactions to IBOA, and five showed positive reactions to BP.
• Ten children had positive patch test reactions to materials from glucose sensors and insulin pumps.
• Three showed positive reactions to adhesive remover wipes.
• Five reacted to .

Marcia Hogeling, MD, a pediatric dermatologist at UCLA Health in Santa Monica, Calif., told this news organization that she expected acrylates to cause problems but was surprised that BP caused positive patch test reactions.

BP is known to be a strong irritant but a weak allergen, the authors wrote.

“It was important to identify the allergens in these devices. Hopefully, this information will be used by manufacturers to create safer products for patients,” Dr. Hogeling, who was not involved in the study, said in an email.

Dr. Hogeling acknowledged that the small sample size is a weakness of the study, although she added that the findings may help providers select devices that do not contain their patients’ contact allergens.

Ryan J. McDonough, DO, a pediatric endocrinologist and the codirector of the Diabetes Center at Children’s Mercy Kansas City (Mo.), said in an email that, despite the small sample size, the study “highlights important device-related experiences of those living with type 1 diabetes that clinicians often encounter.

“We often spend considerable time aiding patients and their families in finding ways to mitigate the reactions,” he explained. “Having a broader understanding of these chemical compositions would help clinicians choose the right devices for their patients and prevent and treat these types of reactions.”

Dr. McDonough, who was not involved in the study, noted that the patients were in Denmark, and they were able to easily transition between insulin pumps and glucose monitoring devices.

“In the U.S., it is often more challenging to switch between devices, due to insurance-related concerns.

“The true rates of reaction in the broad type 1 diabetes population are difficult to assess,” Dr. McDonough said. “The study participants were drawn from patients referred to a dermatology clinic for evaluation of reaction. Many patients either don’t develop reactions or are treated for mild symptoms locally by their endocrinologists.

“This study should serve as a call to action for continued improvements in the transparency of the components that make up the devices and adhesives, and it can provide an opportunity to develop additional interventions to prevent these reactions,” he advised.

No information regarding funding for the study was provided. The authors, Dr. Hogeling, and Dr. McDonough reported no relevant financial relationships.

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

Devices that help children control their diabetes and lead fuller lives may also give them contact dermatitis, report the authors of a new study that calls for mandatory labeling of ingredients for allergy patch testing.

“A high share of patients showed positive reactions to isobornyl acrylate adhesive (IBOA) and/or their medical devices (insulin pumps or glucose devices),” the study authors write in Contact Dermatitis. “A third of patients showed positive reactions to benzoyl peroxide (BP),” used in adhesives.

“The presence of additional unidentified allergens cannot be excluded,” they add. “Overall, our experience once more highlights the importance of having access to a full description of the chemical composition of diabetes devices and related medical devices to efficiently manage patients (including children) who experience adverse skin reactions from such devices.”

Lead study author Catarina Alves da Silva, MD, of the department of dermatology and venereology of Aarhus (Denmark) University Hospital, and her colleagues conducted a retrospective study of 15 referred patients younger than 18 years who had type 1 diabetes. The children were patch tested in the university’s dermatology clinic between 2018 and 2020 in a study of skin reactions linked with diabetes devices.
 

Contact dermatitis from device-related allergens may be common

Many children in the study reacted to chemical compounds related to their devices.

• Of the 15 patients, seven showed positive patch test reactions to IBOA, and five showed positive reactions to BP.
• Ten children had positive patch test reactions to materials from glucose sensors and insulin pumps.
• Three showed positive reactions to adhesive remover wipes.
• Five reacted to .

Marcia Hogeling, MD, a pediatric dermatologist at UCLA Health in Santa Monica, Calif., told this news organization that she expected acrylates to cause problems but was surprised that BP caused positive patch test reactions.

BP is known to be a strong irritant but a weak allergen, the authors wrote.

“It was important to identify the allergens in these devices. Hopefully, this information will be used by manufacturers to create safer products for patients,” Dr. Hogeling, who was not involved in the study, said in an email.

Dr. Hogeling acknowledged that the small sample size is a weakness of the study, although she added that the findings may help providers select devices that do not contain their patients’ contact allergens.

Ryan J. McDonough, DO, a pediatric endocrinologist and the codirector of the Diabetes Center at Children’s Mercy Kansas City (Mo.), said in an email that, despite the small sample size, the study “highlights important device-related experiences of those living with type 1 diabetes that clinicians often encounter.

“We often spend considerable time aiding patients and their families in finding ways to mitigate the reactions,” he explained. “Having a broader understanding of these chemical compositions would help clinicians choose the right devices for their patients and prevent and treat these types of reactions.”

Dr. McDonough, who was not involved in the study, noted that the patients were in Denmark, and they were able to easily transition between insulin pumps and glucose monitoring devices.

“In the U.S., it is often more challenging to switch between devices, due to insurance-related concerns.

“The true rates of reaction in the broad type 1 diabetes population are difficult to assess,” Dr. McDonough said. “The study participants were drawn from patients referred to a dermatology clinic for evaluation of reaction. Many patients either don’t develop reactions or are treated for mild symptoms locally by their endocrinologists.

“This study should serve as a call to action for continued improvements in the transparency of the components that make up the devices and adhesives, and it can provide an opportunity to develop additional interventions to prevent these reactions,” he advised.

No information regarding funding for the study was provided. The authors, Dr. Hogeling, and Dr. McDonough reported no relevant financial relationships.

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

Devices that help children control their diabetes and lead fuller lives may also give them contact dermatitis, report the authors of a new study that calls for mandatory labeling of ingredients for allergy patch testing.

“A high share of patients showed positive reactions to isobornyl acrylate adhesive (IBOA) and/or their medical devices (insulin pumps or glucose devices),” the study authors write in Contact Dermatitis. “A third of patients showed positive reactions to benzoyl peroxide (BP),” used in adhesives.

“The presence of additional unidentified allergens cannot be excluded,” they add. “Overall, our experience once more highlights the importance of having access to a full description of the chemical composition of diabetes devices and related medical devices to efficiently manage patients (including children) who experience adverse skin reactions from such devices.”

Lead study author Catarina Alves da Silva, MD, of the department of dermatology and venereology of Aarhus (Denmark) University Hospital, and her colleagues conducted a retrospective study of 15 referred patients younger than 18 years who had type 1 diabetes. The children were patch tested in the university’s dermatology clinic between 2018 and 2020 in a study of skin reactions linked with diabetes devices.
 

Contact dermatitis from device-related allergens may be common

Many children in the study reacted to chemical compounds related to their devices.

• Of the 15 patients, seven showed positive patch test reactions to IBOA, and five showed positive reactions to BP.
• Ten children had positive patch test reactions to materials from glucose sensors and insulin pumps.
• Three showed positive reactions to adhesive remover wipes.
• Five reacted to .

Marcia Hogeling, MD, a pediatric dermatologist at UCLA Health in Santa Monica, Calif., told this news organization that she expected acrylates to cause problems but was surprised that BP caused positive patch test reactions.

BP is known to be a strong irritant but a weak allergen, the authors wrote.

“It was important to identify the allergens in these devices. Hopefully, this information will be used by manufacturers to create safer products for patients,” Dr. Hogeling, who was not involved in the study, said in an email.

Dr. Hogeling acknowledged that the small sample size is a weakness of the study, although she added that the findings may help providers select devices that do not contain their patients’ contact allergens.

Ryan J. McDonough, DO, a pediatric endocrinologist and the codirector of the Diabetes Center at Children’s Mercy Kansas City (Mo.), said in an email that, despite the small sample size, the study “highlights important device-related experiences of those living with type 1 diabetes that clinicians often encounter.

“We often spend considerable time aiding patients and their families in finding ways to mitigate the reactions,” he explained. “Having a broader understanding of these chemical compositions would help clinicians choose the right devices for their patients and prevent and treat these types of reactions.”

Dr. McDonough, who was not involved in the study, noted that the patients were in Denmark, and they were able to easily transition between insulin pumps and glucose monitoring devices.

“In the U.S., it is often more challenging to switch between devices, due to insurance-related concerns.

“The true rates of reaction in the broad type 1 diabetes population are difficult to assess,” Dr. McDonough said. “The study participants were drawn from patients referred to a dermatology clinic for evaluation of reaction. Many patients either don’t develop reactions or are treated for mild symptoms locally by their endocrinologists.

“This study should serve as a call to action for continued improvements in the transparency of the components that make up the devices and adhesives, and it can provide an opportunity to develop additional interventions to prevent these reactions,” he advised.

No information regarding funding for the study was provided. The authors, Dr. Hogeling, and Dr. McDonough reported no relevant financial relationships.

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

Nordic walking was significantly better at improving functional capacity than were moderate- to vigorous-intensity continuous training and high-intensity interval training (HIIT) in a single-center randomized controlled trial.

Participants who did Nordic walking saw better improvements in functional capacity, measured via the 6-minute walk test distances, than did individuals doing either of the other exercise strategies (interaction effect, P = .010).

amriphoto/E+/Getty Images

From baseline to 26 weeks, the average changes in 6-minute walk test distance were 55.6 m and 59.9 m for moderate- to vigorous-intensity continuous training and HIIT, respectively, but 94.2 m in the Nordic walking group, reported Tasuku Terada, PhD, University of Ottawa Heart Institute, Ontario, and colleagues.

Previous research looked at these results at the end of a 12-week supervised exercise intervention and showed that although all three strategies were safe and had positive effects on physical and mental health in these patients, Nordic walking had a better effect in raising the 6-minute walk test scores than did moderate- to vigorous-intensity continuous training and HIIT, the researchers noted.

“This study is a follow-up on the previous study to show that Nordic walking had greater sustained effects even after the observation phase,” from 12 to 26 weeks, Dr. Terada said in an interview.

“Exercise is a medicine to improve the health of patients, but unfortunately, sometimes it is not as often utilized,” Dr. Terada told this news organization.

Giving patients additional exercise modalities is beneficial because not everyone likes HIIT workouts or long continuous walking, Dr. Terada said. “So, if that’s the case, we can recommend Nordic walking as another type of exercise and expect a similar or good impact in functional capacity.”

The results were published online in the Canadian Journal of Cardiology.

“I think it honestly supports the idea that, as many other studies show, physical activity and exercise improve functional capacity no matter how you measure it and have beneficial effects on mental health and quality of life and particularly depression as well,” Carl “Chip” Lavie, MD, University of Queensland, New Orleans, who coauthored an editorial accompanying the publication, said in an interview.

“Clinicians need to get patients to do the type of exercise that they are going to do. A lot of people ask what’s the best exercise, and the best exercise is one that the person is going to do,” Dr. Lavie said.

Nordic walking is an enhanced form of walking that engages the upper and lower body musculatures, noted Dr. Lavie.

“With regard to Nordic walking, I think that now adds an additional option that many people wouldn’t have thought about. For many of the patients that have issues that are musculoskeletal, issues with posture, gait, or balance, using the poles can be a way to allow them to walk much better and increase their speed, and as they do that, they become fitter,” Dr. Lavie continued.

Moreover, these findings support the use of Nordic walking in cardiac rehabilitation programs, the editorialists noted.
 

Cardiac rehabilitation

The study examined patients with coronary artery disease who underwent cardiac revascularization. They were then referred by their physicians to cardiac rehabilitation.

Participants were randomly assigned to one of the following intervention groups: Nordic walking (n = 30), moderate- to vigorous-intensity continuous training (n = 27), and HIIT (n = 29) for a 12-week period. There was then an additional 14-week observation period after the exercise program. Mean age was 60 years across the intervention groups.

The research team analyzed the extent of participants’ depression with Beck Depression Inventory–II, quality of life with Short Form–36 and HeartQoL, and functional capacity with a 6-minute walk test. They assessed functional capacity, depression, and quality of life at baseline, 12 weeks, and 26 weeks.

Using linear mixed models with extended measures, the study authors evaluated sustained effects, which were between week 12 and week 26, and prolonged effects, which were between baseline and week 26.

From baseline to 26 weeks, participants saw significantly better outcomes in quality of life, depression symptoms, and 6-minute walk test (P < .05).

Physical quality of life and 6-minute walk test distance rose significantly between weeks 12 and 26 (P < .05).

Notably, at week 26, all training groups achieved the minimal clinical threshold difference of 54 m, although participants in the Nordic walking cohort demonstrated significantly greater improvement in outcomes.

Other data indicated the following:

• From baseline to week 12, physical activity levels rose significantly, and this improvement was sustained through the observation period.
• During the observation period, mental component summary significantly declined while physical component summary outcomes improved.
• After completion of cardiac rehabilitation, functional capacity continued to increase significantly.
• Moderate- to vigorous-intensity continuous training, HIIT, and Nordic walking had positive and significant prolonged effects on depression symptoms and general and disease-specific quality of life, with no differences in the extent of improvements between exercise types.

Some limitations of the study include the fact that women comprised a small portion of the study group, which limits the generalizability of these data, the cohort was recruited from a single medical facility, and there was a short follow-up time, the researchers noted.

“Further research is warranted to investigate the efficacy and integration of Nordic walking into home-based exercise after supervised cardiac rehabilitation for maintenance of physical and mental health,” the editorialists concluded.

Dr. Terada, Dr. Lavie, and Dr. Taylor reported no relevant financial relationships.

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

Nordic walking was significantly better at improving functional capacity than were moderate- to vigorous-intensity continuous training and high-intensity interval training (HIIT) in a single-center randomized controlled trial.

Participants who did Nordic walking saw better improvements in functional capacity, measured via the 6-minute walk test distances, than did individuals doing either of the other exercise strategies (interaction effect, P = .010).

amriphoto/E+/Getty Images

From baseline to 26 weeks, the average changes in 6-minute walk test distance were 55.6 m and 59.9 m for moderate- to vigorous-intensity continuous training and HIIT, respectively, but 94.2 m in the Nordic walking group, reported Tasuku Terada, PhD, University of Ottawa Heart Institute, Ontario, and colleagues.

Previous research looked at these results at the end of a 12-week supervised exercise intervention and showed that although all three strategies were safe and had positive effects on physical and mental health in these patients, Nordic walking had a better effect in raising the 6-minute walk test scores than did moderate- to vigorous-intensity continuous training and HIIT, the researchers noted.

“This study is a follow-up on the previous study to show that Nordic walking had greater sustained effects even after the observation phase,” from 12 to 26 weeks, Dr. Terada said in an interview.

“Exercise is a medicine to improve the health of patients, but unfortunately, sometimes it is not as often utilized,” Dr. Terada told this news organization.

Giving patients additional exercise modalities is beneficial because not everyone likes HIIT workouts or long continuous walking, Dr. Terada said. “So, if that’s the case, we can recommend Nordic walking as another type of exercise and expect a similar or good impact in functional capacity.”

The results were published online in the Canadian Journal of Cardiology.

“I think it honestly supports the idea that, as many other studies show, physical activity and exercise improve functional capacity no matter how you measure it and have beneficial effects on mental health and quality of life and particularly depression as well,” Carl “Chip” Lavie, MD, University of Queensland, New Orleans, who coauthored an editorial accompanying the publication, said in an interview.

“Clinicians need to get patients to do the type of exercise that they are going to do. A lot of people ask what’s the best exercise, and the best exercise is one that the person is going to do,” Dr. Lavie said.

Nordic walking is an enhanced form of walking that engages the upper and lower body musculatures, noted Dr. Lavie.

“With regard to Nordic walking, I think that now adds an additional option that many people wouldn’t have thought about. For many of the patients that have issues that are musculoskeletal, issues with posture, gait, or balance, using the poles can be a way to allow them to walk much better and increase their speed, and as they do that, they become fitter,” Dr. Lavie continued.

Moreover, these findings support the use of Nordic walking in cardiac rehabilitation programs, the editorialists noted.
 

Cardiac rehabilitation

The study examined patients with coronary artery disease who underwent cardiac revascularization. They were then referred by their physicians to cardiac rehabilitation.

Participants were randomly assigned to one of the following intervention groups: Nordic walking (n = 30), moderate- to vigorous-intensity continuous training (n = 27), and HIIT (n = 29) for a 12-week period. There was then an additional 14-week observation period after the exercise program. Mean age was 60 years across the intervention groups.

The research team analyzed the extent of participants’ depression with Beck Depression Inventory–II, quality of life with Short Form–36 and HeartQoL, and functional capacity with a 6-minute walk test. They assessed functional capacity, depression, and quality of life at baseline, 12 weeks, and 26 weeks.

Using linear mixed models with extended measures, the study authors evaluated sustained effects, which were between week 12 and week 26, and prolonged effects, which were between baseline and week 26.

From baseline to 26 weeks, participants saw significantly better outcomes in quality of life, depression symptoms, and 6-minute walk test (P < .05).

Physical quality of life and 6-minute walk test distance rose significantly between weeks 12 and 26 (P < .05).

Notably, at week 26, all training groups achieved the minimal clinical threshold difference of 54 m, although participants in the Nordic walking cohort demonstrated significantly greater improvement in outcomes.

Other data indicated the following:

• From baseline to week 12, physical activity levels rose significantly, and this improvement was sustained through the observation period.
• During the observation period, mental component summary significantly declined while physical component summary outcomes improved.
• After completion of cardiac rehabilitation, functional capacity continued to increase significantly.
• Moderate- to vigorous-intensity continuous training, HIIT, and Nordic walking had positive and significant prolonged effects on depression symptoms and general and disease-specific quality of life, with no differences in the extent of improvements between exercise types.

Some limitations of the study include the fact that women comprised a small portion of the study group, which limits the generalizability of these data, the cohort was recruited from a single medical facility, and there was a short follow-up time, the researchers noted.

“Further research is warranted to investigate the efficacy and integration of Nordic walking into home-based exercise after supervised cardiac rehabilitation for maintenance of physical and mental health,” the editorialists concluded.

Dr. Terada, Dr. Lavie, and Dr. Taylor reported no relevant financial relationships.

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

Nordic walking was significantly better at improving functional capacity than were moderate- to vigorous-intensity continuous training and high-intensity interval training (HIIT) in a single-center randomized controlled trial.

Participants who did Nordic walking saw better improvements in functional capacity, measured via the 6-minute walk test distances, than did individuals doing either of the other exercise strategies (interaction effect, P = .010).

amriphoto/E+/Getty Images

From baseline to 26 weeks, the average changes in 6-minute walk test distance were 55.6 m and 59.9 m for moderate- to vigorous-intensity continuous training and HIIT, respectively, but 94.2 m in the Nordic walking group, reported Tasuku Terada, PhD, University of Ottawa Heart Institute, Ontario, and colleagues.

Previous research looked at these results at the end of a 12-week supervised exercise intervention and showed that although all three strategies were safe and had positive effects on physical and mental health in these patients, Nordic walking had a better effect in raising the 6-minute walk test scores than did moderate- to vigorous-intensity continuous training and HIIT, the researchers noted.

“This study is a follow-up on the previous study to show that Nordic walking had greater sustained effects even after the observation phase,” from 12 to 26 weeks, Dr. Terada said in an interview.

“Exercise is a medicine to improve the health of patients, but unfortunately, sometimes it is not as often utilized,” Dr. Terada told this news organization.

Giving patients additional exercise modalities is beneficial because not everyone likes HIIT workouts or long continuous walking, Dr. Terada said. “So, if that’s the case, we can recommend Nordic walking as another type of exercise and expect a similar or good impact in functional capacity.”

The results were published online in the Canadian Journal of Cardiology.

“I think it honestly supports the idea that, as many other studies show, physical activity and exercise improve functional capacity no matter how you measure it and have beneficial effects on mental health and quality of life and particularly depression as well,” Carl “Chip” Lavie, MD, University of Queensland, New Orleans, who coauthored an editorial accompanying the publication, said in an interview.

“Clinicians need to get patients to do the type of exercise that they are going to do. A lot of people ask what’s the best exercise, and the best exercise is one that the person is going to do,” Dr. Lavie said.

Nordic walking is an enhanced form of walking that engages the upper and lower body musculatures, noted Dr. Lavie.

“With regard to Nordic walking, I think that now adds an additional option that many people wouldn’t have thought about. For many of the patients that have issues that are musculoskeletal, issues with posture, gait, or balance, using the poles can be a way to allow them to walk much better and increase their speed, and as they do that, they become fitter,” Dr. Lavie continued.

Moreover, these findings support the use of Nordic walking in cardiac rehabilitation programs, the editorialists noted.
 

Cardiac rehabilitation

The study examined patients with coronary artery disease who underwent cardiac revascularization. They were then referred by their physicians to cardiac rehabilitation.

Participants were randomly assigned to one of the following intervention groups: Nordic walking (n = 30), moderate- to vigorous-intensity continuous training (n = 27), and HIIT (n = 29) for a 12-week period. There was then an additional 14-week observation period after the exercise program. Mean age was 60 years across the intervention groups.

The research team analyzed the extent of participants’ depression with Beck Depression Inventory–II, quality of life with Short Form–36 and HeartQoL, and functional capacity with a 6-minute walk test. They assessed functional capacity, depression, and quality of life at baseline, 12 weeks, and 26 weeks.

Using linear mixed models with extended measures, the study authors evaluated sustained effects, which were between week 12 and week 26, and prolonged effects, which were between baseline and week 26.

From baseline to 26 weeks, participants saw significantly better outcomes in quality of life, depression symptoms, and 6-minute walk test (P < .05).

Physical quality of life and 6-minute walk test distance rose significantly between weeks 12 and 26 (P < .05).

Notably, at week 26, all training groups achieved the minimal clinical threshold difference of 54 m, although participants in the Nordic walking cohort demonstrated significantly greater improvement in outcomes.

Other data indicated the following:

• From baseline to week 12, physical activity levels rose significantly, and this improvement was sustained through the observation period.
• During the observation period, mental component summary significantly declined while physical component summary outcomes improved.
• After completion of cardiac rehabilitation, functional capacity continued to increase significantly.
• Moderate- to vigorous-intensity continuous training, HIIT, and Nordic walking had positive and significant prolonged effects on depression symptoms and general and disease-specific quality of life, with no differences in the extent of improvements between exercise types.

Some limitations of the study include the fact that women comprised a small portion of the study group, which limits the generalizability of these data, the cohort was recruited from a single medical facility, and there was a short follow-up time, the researchers noted.

“Further research is warranted to investigate the efficacy and integration of Nordic walking into home-based exercise after supervised cardiac rehabilitation for maintenance of physical and mental health,” the editorialists concluded.

Dr. Terada, Dr. Lavie, and Dr. Taylor reported no relevant financial relationships.

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

Cardiac rehabilitation (CR) started 2 weeks after sternotomy for a cardiac procedure was noninferior to usual care, in which CR starts 6 weeks after the procedure, with a greater improvement in 6-minute walk test outcomes, a randomized study suggests.

There was no difference in adverse events between groups, although the researchers pointed out that the study was not powered specifically for safety outcomes.

“Cardiac surgical techniques have evolved significantly over the last 60 years, leading to improved survival and shorter hospital stays,” Gordon McGregor, PhD, University of Warwick, Coventry, England, told this news organization. “However, sternal precautions and rehabilitation guidelines have not changed accordingly. There has never been a guideline based on empirical evidence to support rehabilitation professionals working with cardiac surgery patients after median sternotomy.”

“By adopting a progressive individualized approach,” he added, “cardiac surgery sternotomy patients can start cardiac rehabilitation up to 4 weeks earlier than current guidance, and thus potentially complete their recovery sooner.”

Results of the Early Initiation of Poststernotomy Cardiac Rehabilitation Exercise Training study were published online  in JAMA Cardiology.

In the study, Dr. McGregor and colleagues randomly assigned 158 patients (mean age, 63 years; 84% men) to 8 weeks of 1-hour, twice-weekly supervised CR exercise training starting 2 weeks (early) or 6 weeks (usual care) after sternotomy.

The primary outcome was change in the 6-minute walk test distance from baseline to 10 or 14 weeks after sternotomy, respectively, and 12 months after randomization.

For usual care, training followed British standards: a warm-up with light cardiovascular and mobility exercises; continuous moderate-intensity cardiovascular exercise; a cooldown; functional exercises using resistance machines and free weights; and upper-body exercises designed to prevent sternal and leg wound pain and complications.

There are no specific outpatient CR exercise guidelines for early CR, so study participants followed an individualized exercise program for the first 2-3 weeks after surgery, starting with light mobility and moderate-intensity cardiovascular training when they could do those exercises with minimal discomfort. They then progressed to current British standards, as per usual care.

Forty patients were lost to follow-up, largely because of the pandemic; about half the participants in each group were included in the primary analysis.

Early CR was not inferior to usual care, the authors wrote. The mean change in 6-minute walk distance from baseline to completion of CR was 28 meters greater in the early group than in the usual-care group, and was achieved 4 weeks earlier in the recovery timeline.

Secondary outcomes (functional fitness and quality of life) improved in both groups and between-group differences were not statistically significant, indicating the noninferiority of early CR, the authors noted.
 

Safety not proven

There were more adverse events in the early group than in the usual-care group (58 vs. 46) and more serious adverse events (18 vs. 14), but fewer deaths (1 vs. 2).

Although there was no between-group difference in the likelihood of having an adverse or serious adverse event, Dr. McGregor acknowledged that the study was “not powered specifically for safety outcomes.” He added that “there is the potential to run a very large multination definitive superiority [randomized, controlled trial] with safety as the primary outcome; however, a very large sample would be required.”

Meanwhile, he said, “we can say with some degree of certainty that early CR was likely as safe as usual-care CR. In the United Kingdom, we work closely with the British Association for Cardiovascular Prevention and Rehabilitation and the Association of Chartered Physiotherapists in Cardiovascular Rehabilitation, who will incorporate our findings in their guidelines and training courses.”
 

Questions remain

Asked to comment on the study, John Larry, MD, medical director of cardiology and cardiac rehabilitation at the Ohio State University Wexner Medical Center East Hospital, Columbus, said: “For those under time pressure to return to work, [early CR] could be an advantage to allow more rehab time and improved stamina prior to their return-to-work date.”

That said, he noted, “we typically delay any significant upper-body training activities for 8-10 weeks to avoid impact on healing of the sternum. Thus ... starting sooner would limit the amount of time a patient would have to engage in any upper-body resistance training. Many lose upper body strength after surgery, so this is an important part of the recovery/rehab process.”

Matthew Tomey, MD, director of the cardiac intensive care unit, Mount Sinai Morningside, New York, advised “caution” when interpreting the findings, stating that “there was no evident difference in the primary outcome measure of functional capacity by 14 weeks, and the trial was not designed to directly assess impact on either social functioning or economic productivity.”

“I would be interested to [see] more comprehensive data on safety in a larger, more diverse sample of postoperative patients,” he said, “as well as evidence to indicate clear advantage of an earlier start for patient-centered outcomes specifically after cardiac surgery.

“Perhaps the greatest challenges to full realization of the benefits of CR in practice have been gaps in referral and gaps in enrollment,” he added. “It is incumbent upon us as clinicians to counsel our patients and to provide appropriate referrals.”

The study was supported by the Medical and Life Sciences Research Fund and the Jeremy Pilcher Memorial Fund. No conflicts of interest were reported.

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

Cardiac rehabilitation (CR) started 2 weeks after sternotomy for a cardiac procedure was noninferior to usual care, in which CR starts 6 weeks after the procedure, with a greater improvement in 6-minute walk test outcomes, a randomized study suggests.

There was no difference in adverse events between groups, although the researchers pointed out that the study was not powered specifically for safety outcomes.

“Cardiac surgical techniques have evolved significantly over the last 60 years, leading to improved survival and shorter hospital stays,” Gordon McGregor, PhD, University of Warwick, Coventry, England, told this news organization. “However, sternal precautions and rehabilitation guidelines have not changed accordingly. There has never been a guideline based on empirical evidence to support rehabilitation professionals working with cardiac surgery patients after median sternotomy.”

“By adopting a progressive individualized approach,” he added, “cardiac surgery sternotomy patients can start cardiac rehabilitation up to 4 weeks earlier than current guidance, and thus potentially complete their recovery sooner.”

Results of the Early Initiation of Poststernotomy Cardiac Rehabilitation Exercise Training study were published online  in JAMA Cardiology.

In the study, Dr. McGregor and colleagues randomly assigned 158 patients (mean age, 63 years; 84% men) to 8 weeks of 1-hour, twice-weekly supervised CR exercise training starting 2 weeks (early) or 6 weeks (usual care) after sternotomy.

The primary outcome was change in the 6-minute walk test distance from baseline to 10 or 14 weeks after sternotomy, respectively, and 12 months after randomization.

For usual care, training followed British standards: a warm-up with light cardiovascular and mobility exercises; continuous moderate-intensity cardiovascular exercise; a cooldown; functional exercises using resistance machines and free weights; and upper-body exercises designed to prevent sternal and leg wound pain and complications.

There are no specific outpatient CR exercise guidelines for early CR, so study participants followed an individualized exercise program for the first 2-3 weeks after surgery, starting with light mobility and moderate-intensity cardiovascular training when they could do those exercises with minimal discomfort. They then progressed to current British standards, as per usual care.

Forty patients were lost to follow-up, largely because of the pandemic; about half the participants in each group were included in the primary analysis.

Early CR was not inferior to usual care, the authors wrote. The mean change in 6-minute walk distance from baseline to completion of CR was 28 meters greater in the early group than in the usual-care group, and was achieved 4 weeks earlier in the recovery timeline.

Secondary outcomes (functional fitness and quality of life) improved in both groups and between-group differences were not statistically significant, indicating the noninferiority of early CR, the authors noted.
 

Safety not proven

There were more adverse events in the early group than in the usual-care group (58 vs. 46) and more serious adverse events (18 vs. 14), but fewer deaths (1 vs. 2).

Although there was no between-group difference in the likelihood of having an adverse or serious adverse event, Dr. McGregor acknowledged that the study was “not powered specifically for safety outcomes.” He added that “there is the potential to run a very large multination definitive superiority [randomized, controlled trial] with safety as the primary outcome; however, a very large sample would be required.”

Meanwhile, he said, “we can say with some degree of certainty that early CR was likely as safe as usual-care CR. In the United Kingdom, we work closely with the British Association for Cardiovascular Prevention and Rehabilitation and the Association of Chartered Physiotherapists in Cardiovascular Rehabilitation, who will incorporate our findings in their guidelines and training courses.”
 

Questions remain

Asked to comment on the study, John Larry, MD, medical director of cardiology and cardiac rehabilitation at the Ohio State University Wexner Medical Center East Hospital, Columbus, said: “For those under time pressure to return to work, [early CR] could be an advantage to allow more rehab time and improved stamina prior to their return-to-work date.”

That said, he noted, “we typically delay any significant upper-body training activities for 8-10 weeks to avoid impact on healing of the sternum. Thus ... starting sooner would limit the amount of time a patient would have to engage in any upper-body resistance training. Many lose upper body strength after surgery, so this is an important part of the recovery/rehab process.”

Matthew Tomey, MD, director of the cardiac intensive care unit, Mount Sinai Morningside, New York, advised “caution” when interpreting the findings, stating that “there was no evident difference in the primary outcome measure of functional capacity by 14 weeks, and the trial was not designed to directly assess impact on either social functioning or economic productivity.”

“I would be interested to [see] more comprehensive data on safety in a larger, more diverse sample of postoperative patients,” he said, “as well as evidence to indicate clear advantage of an earlier start for patient-centered outcomes specifically after cardiac surgery.

“Perhaps the greatest challenges to full realization of the benefits of CR in practice have been gaps in referral and gaps in enrollment,” he added. “It is incumbent upon us as clinicians to counsel our patients and to provide appropriate referrals.”

The study was supported by the Medical and Life Sciences Research Fund and the Jeremy Pilcher Memorial Fund. No conflicts of interest were reported.

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

Cardiac rehabilitation (CR) started 2 weeks after sternotomy for a cardiac procedure was noninferior to usual care, in which CR starts 6 weeks after the procedure, with a greater improvement in 6-minute walk test outcomes, a randomized study suggests.

There was no difference in adverse events between groups, although the researchers pointed out that the study was not powered specifically for safety outcomes.

“Cardiac surgical techniques have evolved significantly over the last 60 years, leading to improved survival and shorter hospital stays,” Gordon McGregor, PhD, University of Warwick, Coventry, England, told this news organization. “However, sternal precautions and rehabilitation guidelines have not changed accordingly. There has never been a guideline based on empirical evidence to support rehabilitation professionals working with cardiac surgery patients after median sternotomy.”

“By adopting a progressive individualized approach,” he added, “cardiac surgery sternotomy patients can start cardiac rehabilitation up to 4 weeks earlier than current guidance, and thus potentially complete their recovery sooner.”

Results of the Early Initiation of Poststernotomy Cardiac Rehabilitation Exercise Training study were published online  in JAMA Cardiology.

In the study, Dr. McGregor and colleagues randomly assigned 158 patients (mean age, 63 years; 84% men) to 8 weeks of 1-hour, twice-weekly supervised CR exercise training starting 2 weeks (early) or 6 weeks (usual care) after sternotomy.

The primary outcome was change in the 6-minute walk test distance from baseline to 10 or 14 weeks after sternotomy, respectively, and 12 months after randomization.

For usual care, training followed British standards: a warm-up with light cardiovascular and mobility exercises; continuous moderate-intensity cardiovascular exercise; a cooldown; functional exercises using resistance machines and free weights; and upper-body exercises designed to prevent sternal and leg wound pain and complications.

There are no specific outpatient CR exercise guidelines for early CR, so study participants followed an individualized exercise program for the first 2-3 weeks after surgery, starting with light mobility and moderate-intensity cardiovascular training when they could do those exercises with minimal discomfort. They then progressed to current British standards, as per usual care.

Forty patients were lost to follow-up, largely because of the pandemic; about half the participants in each group were included in the primary analysis.

Early CR was not inferior to usual care, the authors wrote. The mean change in 6-minute walk distance from baseline to completion of CR was 28 meters greater in the early group than in the usual-care group, and was achieved 4 weeks earlier in the recovery timeline.

Secondary outcomes (functional fitness and quality of life) improved in both groups and between-group differences were not statistically significant, indicating the noninferiority of early CR, the authors noted.
 

Safety not proven

There were more adverse events in the early group than in the usual-care group (58 vs. 46) and more serious adverse events (18 vs. 14), but fewer deaths (1 vs. 2).

Although there was no between-group difference in the likelihood of having an adverse or serious adverse event, Dr. McGregor acknowledged that the study was “not powered specifically for safety outcomes.” He added that “there is the potential to run a very large multination definitive superiority [randomized, controlled trial] with safety as the primary outcome; however, a very large sample would be required.”

Meanwhile, he said, “we can say with some degree of certainty that early CR was likely as safe as usual-care CR. In the United Kingdom, we work closely with the British Association for Cardiovascular Prevention and Rehabilitation and the Association of Chartered Physiotherapists in Cardiovascular Rehabilitation, who will incorporate our findings in their guidelines and training courses.”
 

Questions remain

Asked to comment on the study, John Larry, MD, medical director of cardiology and cardiac rehabilitation at the Ohio State University Wexner Medical Center East Hospital, Columbus, said: “For those under time pressure to return to work, [early CR] could be an advantage to allow more rehab time and improved stamina prior to their return-to-work date.”

That said, he noted, “we typically delay any significant upper-body training activities for 8-10 weeks to avoid impact on healing of the sternum. Thus ... starting sooner would limit the amount of time a patient would have to engage in any upper-body resistance training. Many lose upper body strength after surgery, so this is an important part of the recovery/rehab process.”

Matthew Tomey, MD, director of the cardiac intensive care unit, Mount Sinai Morningside, New York, advised “caution” when interpreting the findings, stating that “there was no evident difference in the primary outcome measure of functional capacity by 14 weeks, and the trial was not designed to directly assess impact on either social functioning or economic productivity.”

“I would be interested to [see] more comprehensive data on safety in a larger, more diverse sample of postoperative patients,” he said, “as well as evidence to indicate clear advantage of an earlier start for patient-centered outcomes specifically after cardiac surgery.

“Perhaps the greatest challenges to full realization of the benefits of CR in practice have been gaps in referral and gaps in enrollment,” he added. “It is incumbent upon us as clinicians to counsel our patients and to provide appropriate referrals.”

The study was supported by the Medical and Life Sciences Research Fund and the Jeremy Pilcher Memorial Fund. No conflicts of interest were reported.

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

Persistent abdominal pain may be caused by a whole range of different conditions, say French experts who call for more physician awareness to achieve early diagnosis and treatment so as to improve patient outcomes.

Benoit Coffin, MD, PhD, and Henri Duboc, MD, PhD, from Hôpital Louis Mourier, Colombes, France, conducted a literature review to identify rare and less well-known causes of persistent abdominal pain, identifying almost 50 across several categories.

“Some causes of persistent abdominal pain can be effectively treated using established approaches after a definitive diagnosis has been reached,” they wrote.

“Other causes are more complex and may benefit from a multidisciplinary approach involving gastroenterologists, pain specialists, allergists, immunologists, rheumatologists, psychologists, physiotherapists, dietitians, and primary care clinicians,” they wrote.

The research was published online in Alimentary Pharmacology and Therapeutics.
 

Frequent and frustrating symptoms

Although there is “no commonly accepted definition” for persistent abdominal pain, the authors said it may be defined as “continuous or intermittent abdominal discomfort that persists for at least 6 months and fails to respond to conventional therapeutic approaches.”

They highlight that it is “frequently encountered” by physicians and has a prevalence of 22.9 per 1,000 person-years, regardless of age group, ethnicity, or geographical region, with many patients experiencing pain for more than 5 years.

The cause of persistent abdominal pain can be organic with a clear cause or functional, making diagnosis and management “challenging and frustrating for patients and physicians.”

“Clinicians not only need to recognize somatic abnormalities, but they must also perceive the patient’s cognitions and emotions related to the pain,” they added, suggesting that clinicians take time to “listen to the patient and perceive psychological factors.”

Dr. Coffin and Dr. Duboc write that the most common conditions associated with persistent abdominal pain are irritable bowel syndrome and functional dyspepsia, as well as inflammatory bowel disease, chronic pancreatitis, and gallstones.

To examine the diagnosis and management of its less well-known causes, the authors conducted a literature review, beginning with the diagnosis of persistent abdominal pain.

Diagnostic workup

“Given its chronicity, many patients will have already undergone extensive and redundant medical testing,” they wrote, emphasizing that clinicians should be on the lookout for any change in the description of persistent abdominal pain or new symptoms.

“Other ‘red-flag’ symptoms include fever, vomiting, diarrhea, acute change in bowel habit, obstipation, syncope, tachycardia, hypotension, concomitant chest or back pain, unintentional weight loss, night sweats, and acute gastrointestinal bleeding,” the authors said.

They stressed the need to determine whether the origin of the pain is organic or functional, as well as the importance of identifying a “triggering event, such as an adverse life event, infection, initiating a new medication, or surgical procedure.” They also recommend discussing the patient’s diet.

There are currently no specific algorithms for diagnostic workup of persistent abdominal pain, the authors said. Patients will have undergone repeated laboratory tests, “upper and lower endoscopic examinations, abdominal ultrasounds, and computed tomography scans of the abdominal/pelvic area.”

Consequently, “in the absence of alarm features, any additional tests should be ordered in a conservative and cost-effective manner,” they advised.

They suggested that, at a tertiary center, patients should be assessed in three steps:

• In-depth questioning of the symptoms and medical history
• Summary of all previous investigations and treatments and their effectiveness
• Determination of the complementary explorations to be performed

The authors went on to list 49 rare or less well-known potential causes of persistent abdominal pain, some linked to digestive disorders, such as eosinophilic gastroenteritis, mesenteric panniculitis, and chronic mesenteric ischemia, as well as endometriosis, chronic abdominal wall pain, and referred osteoarticular pain.

Systemic causes of persistent abdominal pain may include adrenal insufficiency and mast cell activation syndrome, while acute hepatic porphyrias and Ehlers-Danlos syndrome may be genetic causes.

There are also centrally mediated disorders that lead to persistent abdominal pain, the authors noted, including postural orthostatic tachycardia syndrome and narcotic bowel syndrome caused by opioid therapy, among others.

Writing support for the manuscript was funded by Alnylam Switzerland. Dr. Coffin has served as a speaker for Kyowa Kyrin and Mayoly Spindler and as an advisory board member for Sanofi and Alnylam. Dr. Duboc reported no relevant financial relationships.

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

Persistent abdominal pain may be caused by a whole range of different conditions, say French experts who call for more physician awareness to achieve early diagnosis and treatment so as to improve patient outcomes.

Benoit Coffin, MD, PhD, and Henri Duboc, MD, PhD, from Hôpital Louis Mourier, Colombes, France, conducted a literature review to identify rare and less well-known causes of persistent abdominal pain, identifying almost 50 across several categories.

“Some causes of persistent abdominal pain can be effectively treated using established approaches after a definitive diagnosis has been reached,” they wrote.

“Other causes are more complex and may benefit from a multidisciplinary approach involving gastroenterologists, pain specialists, allergists, immunologists, rheumatologists, psychologists, physiotherapists, dietitians, and primary care clinicians,” they wrote.

The research was published online in Alimentary Pharmacology and Therapeutics.
 

Frequent and frustrating symptoms

Although there is “no commonly accepted definition” for persistent abdominal pain, the authors said it may be defined as “continuous or intermittent abdominal discomfort that persists for at least 6 months and fails to respond to conventional therapeutic approaches.”

They highlight that it is “frequently encountered” by physicians and has a prevalence of 22.9 per 1,000 person-years, regardless of age group, ethnicity, or geographical region, with many patients experiencing pain for more than 5 years.

The cause of persistent abdominal pain can be organic with a clear cause or functional, making diagnosis and management “challenging and frustrating for patients and physicians.”

“Clinicians not only need to recognize somatic abnormalities, but they must also perceive the patient’s cognitions and emotions related to the pain,” they added, suggesting that clinicians take time to “listen to the patient and perceive psychological factors.”

Dr. Coffin and Dr. Duboc write that the most common conditions associated with persistent abdominal pain are irritable bowel syndrome and functional dyspepsia, as well as inflammatory bowel disease, chronic pancreatitis, and gallstones.

To examine the diagnosis and management of its less well-known causes, the authors conducted a literature review, beginning with the diagnosis of persistent abdominal pain.

Diagnostic workup

“Given its chronicity, many patients will have already undergone extensive and redundant medical testing,” they wrote, emphasizing that clinicians should be on the lookout for any change in the description of persistent abdominal pain or new symptoms.

“Other ‘red-flag’ symptoms include fever, vomiting, diarrhea, acute change in bowel habit, obstipation, syncope, tachycardia, hypotension, concomitant chest or back pain, unintentional weight loss, night sweats, and acute gastrointestinal bleeding,” the authors said.

They stressed the need to determine whether the origin of the pain is organic or functional, as well as the importance of identifying a “triggering event, such as an adverse life event, infection, initiating a new medication, or surgical procedure.” They also recommend discussing the patient’s diet.

There are currently no specific algorithms for diagnostic workup of persistent abdominal pain, the authors said. Patients will have undergone repeated laboratory tests, “upper and lower endoscopic examinations, abdominal ultrasounds, and computed tomography scans of the abdominal/pelvic area.”

Consequently, “in the absence of alarm features, any additional tests should be ordered in a conservative and cost-effective manner,” they advised.

They suggested that, at a tertiary center, patients should be assessed in three steps:

• In-depth questioning of the symptoms and medical history
• Summary of all previous investigations and treatments and their effectiveness
• Determination of the complementary explorations to be performed

The authors went on to list 49 rare or less well-known potential causes of persistent abdominal pain, some linked to digestive disorders, such as eosinophilic gastroenteritis, mesenteric panniculitis, and chronic mesenteric ischemia, as well as endometriosis, chronic abdominal wall pain, and referred osteoarticular pain.

Systemic causes of persistent abdominal pain may include adrenal insufficiency and mast cell activation syndrome, while acute hepatic porphyrias and Ehlers-Danlos syndrome may be genetic causes.

There are also centrally mediated disorders that lead to persistent abdominal pain, the authors noted, including postural orthostatic tachycardia syndrome and narcotic bowel syndrome caused by opioid therapy, among others.

Writing support for the manuscript was funded by Alnylam Switzerland. Dr. Coffin has served as a speaker for Kyowa Kyrin and Mayoly Spindler and as an advisory board member for Sanofi and Alnylam. Dr. Duboc reported no relevant financial relationships.

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

Persistent abdominal pain may be caused by a whole range of different conditions, say French experts who call for more physician awareness to achieve early diagnosis and treatment so as to improve patient outcomes.

Benoit Coffin, MD, PhD, and Henri Duboc, MD, PhD, from Hôpital Louis Mourier, Colombes, France, conducted a literature review to identify rare and less well-known causes of persistent abdominal pain, identifying almost 50 across several categories.

“Some causes of persistent abdominal pain can be effectively treated using established approaches after a definitive diagnosis has been reached,” they wrote.

“Other causes are more complex and may benefit from a multidisciplinary approach involving gastroenterologists, pain specialists, allergists, immunologists, rheumatologists, psychologists, physiotherapists, dietitians, and primary care clinicians,” they wrote.

The research was published online in Alimentary Pharmacology and Therapeutics.
 

Frequent and frustrating symptoms

Although there is “no commonly accepted definition” for persistent abdominal pain, the authors said it may be defined as “continuous or intermittent abdominal discomfort that persists for at least 6 months and fails to respond to conventional therapeutic approaches.”

They highlight that it is “frequently encountered” by physicians and has a prevalence of 22.9 per 1,000 person-years, regardless of age group, ethnicity, or geographical region, with many patients experiencing pain for more than 5 years.

The cause of persistent abdominal pain can be organic with a clear cause or functional, making diagnosis and management “challenging and frustrating for patients and physicians.”

“Clinicians not only need to recognize somatic abnormalities, but they must also perceive the patient’s cognitions and emotions related to the pain,” they added, suggesting that clinicians take time to “listen to the patient and perceive psychological factors.”

Dr. Coffin and Dr. Duboc write that the most common conditions associated with persistent abdominal pain are irritable bowel syndrome and functional dyspepsia, as well as inflammatory bowel disease, chronic pancreatitis, and gallstones.

To examine the diagnosis and management of its less well-known causes, the authors conducted a literature review, beginning with the diagnosis of persistent abdominal pain.

Diagnostic workup

“Given its chronicity, many patients will have already undergone extensive and redundant medical testing,” they wrote, emphasizing that clinicians should be on the lookout for any change in the description of persistent abdominal pain or new symptoms.

“Other ‘red-flag’ symptoms include fever, vomiting, diarrhea, acute change in bowel habit, obstipation, syncope, tachycardia, hypotension, concomitant chest or back pain, unintentional weight loss, night sweats, and acute gastrointestinal bleeding,” the authors said.

They stressed the need to determine whether the origin of the pain is organic or functional, as well as the importance of identifying a “triggering event, such as an adverse life event, infection, initiating a new medication, or surgical procedure.” They also recommend discussing the patient’s diet.

There are currently no specific algorithms for diagnostic workup of persistent abdominal pain, the authors said. Patients will have undergone repeated laboratory tests, “upper and lower endoscopic examinations, abdominal ultrasounds, and computed tomography scans of the abdominal/pelvic area.”

Consequently, “in the absence of alarm features, any additional tests should be ordered in a conservative and cost-effective manner,” they advised.

They suggested that, at a tertiary center, patients should be assessed in three steps:

• In-depth questioning of the symptoms and medical history
• Summary of all previous investigations and treatments and their effectiveness
• Determination of the complementary explorations to be performed

The authors went on to list 49 rare or less well-known potential causes of persistent abdominal pain, some linked to digestive disorders, such as eosinophilic gastroenteritis, mesenteric panniculitis, and chronic mesenteric ischemia, as well as endometriosis, chronic abdominal wall pain, and referred osteoarticular pain.

Systemic causes of persistent abdominal pain may include adrenal insufficiency and mast cell activation syndrome, while acute hepatic porphyrias and Ehlers-Danlos syndrome may be genetic causes.

There are also centrally mediated disorders that lead to persistent abdominal pain, the authors noted, including postural orthostatic tachycardia syndrome and narcotic bowel syndrome caused by opioid therapy, among others.

Writing support for the manuscript was funded by Alnylam Switzerland. Dr. Coffin has served as a speaker for Kyowa Kyrin and Mayoly Spindler and as an advisory board member for Sanofi and Alnylam. Dr. Duboc reported no relevant financial relationships.

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

Oregon and Kentucky recently enacted policies to eliminate financial disincentives that may have deterred people from undergoing a follow-up colonoscopy after a positive result on a noninvasive screening test for colorectal cancer (CRC).

A new analysis shows that the impact has been mixed. The policies led to significantly increased overall CRC screening and use of noninvasive testing in Oregon but not Kentucky.

The study was published online in JAMA Network Open.

The Affordable Care Act mandates that several CRC screening tests be covered without cost-sharing for people at average risk for CRC. However, lingering cost barriers remain for some people who have a positive initial screening test result and who need follow-up colonoscopy.

This led Kentucky in 2016 and Oregon in 2017 to enact policies that eliminate cost-sharing. Earlier this year, federal guidance eliminated cost-sharing for colonoscopies following noninvasive CRC screening tests for commercial insurers, and a similar policy is under consideration for Medicare.

For their study, Douglas Barthold, PhD, of the University of Washington, Seattle, and colleagues used claims data to evaluate CRC screening rates in Oregon and Kentucky, compared with rates in neighboring states that do not have cost-sharing policies.

The sample included more than 1.2 million individuals aged 45-64 living in Oregon, Kentucky, and nearby states from 2012 to 2019. Overall, about 15% of the cohort underwent any CRC screening; 8% underwent colonoscopy.

After the Oregon policy that eliminated cost-sharing went into effect, Oregonians had 6% higher odds of receiving any CRC screening (odds ratio [OR], 1.06; 95% confidence interval [CI], 1.00-1.06; P = .03) and 35% higher odds of undergoing an initial noninvasive test (OR, 0.65; 95% CI, 0.58-0.73; P < .001), compared with neighboring states that did not implement a similar policy.

But there were no significant differences in total CRC screening use in Kentucky after policy implementation compared with neighboring states.

The odds of receiving a colonoscopy conditional on undergoing noninvasive CRC screening were not statistically different in Oregon or Kentucky, compared with neighboring states.

“These findings suggest that the enactment of policies that remove financial barriers is merely one of many elements (e.g., health literacy, outreach, transportation, access to care) that may help to achieve desired cancer screening outcomes,” wrote Dr. Barthold and colleagues.

The study had no commercial funding. Dr. Barthold reported no relevant financial relationships.

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

Oregon and Kentucky recently enacted policies to eliminate financial disincentives that may have deterred people from undergoing a follow-up colonoscopy after a positive result on a noninvasive screening test for colorectal cancer (CRC).

A new analysis shows that the impact has been mixed. The policies led to significantly increased overall CRC screening and use of noninvasive testing in Oregon but not Kentucky.

The study was published online in JAMA Network Open.

The Affordable Care Act mandates that several CRC screening tests be covered without cost-sharing for people at average risk for CRC. However, lingering cost barriers remain for some people who have a positive initial screening test result and who need follow-up colonoscopy.

This led Kentucky in 2016 and Oregon in 2017 to enact policies that eliminate cost-sharing. Earlier this year, federal guidance eliminated cost-sharing for colonoscopies following noninvasive CRC screening tests for commercial insurers, and a similar policy is under consideration for Medicare.

For their study, Douglas Barthold, PhD, of the University of Washington, Seattle, and colleagues used claims data to evaluate CRC screening rates in Oregon and Kentucky, compared with rates in neighboring states that do not have cost-sharing policies.

The sample included more than 1.2 million individuals aged 45-64 living in Oregon, Kentucky, and nearby states from 2012 to 2019. Overall, about 15% of the cohort underwent any CRC screening; 8% underwent colonoscopy.

After the Oregon policy that eliminated cost-sharing went into effect, Oregonians had 6% higher odds of receiving any CRC screening (odds ratio [OR], 1.06; 95% confidence interval [CI], 1.00-1.06; P = .03) and 35% higher odds of undergoing an initial noninvasive test (OR, 0.65; 95% CI, 0.58-0.73; P < .001), compared with neighboring states that did not implement a similar policy.

But there were no significant differences in total CRC screening use in Kentucky after policy implementation compared with neighboring states.

The odds of receiving a colonoscopy conditional on undergoing noninvasive CRC screening were not statistically different in Oregon or Kentucky, compared with neighboring states.

“These findings suggest that the enactment of policies that remove financial barriers is merely one of many elements (e.g., health literacy, outreach, transportation, access to care) that may help to achieve desired cancer screening outcomes,” wrote Dr. Barthold and colleagues.

The study had no commercial funding. Dr. Barthold reported no relevant financial relationships.

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

Oregon and Kentucky recently enacted policies to eliminate financial disincentives that may have deterred people from undergoing a follow-up colonoscopy after a positive result on a noninvasive screening test for colorectal cancer (CRC).

A new analysis shows that the impact has been mixed. The policies led to significantly increased overall CRC screening and use of noninvasive testing in Oregon but not Kentucky.

The study was published online in JAMA Network Open.

The Affordable Care Act mandates that several CRC screening tests be covered without cost-sharing for people at average risk for CRC. However, lingering cost barriers remain for some people who have a positive initial screening test result and who need follow-up colonoscopy.

This led Kentucky in 2016 and Oregon in 2017 to enact policies that eliminate cost-sharing. Earlier this year, federal guidance eliminated cost-sharing for colonoscopies following noninvasive CRC screening tests for commercial insurers, and a similar policy is under consideration for Medicare.

For their study, Douglas Barthold, PhD, of the University of Washington, Seattle, and colleagues used claims data to evaluate CRC screening rates in Oregon and Kentucky, compared with rates in neighboring states that do not have cost-sharing policies.

The sample included more than 1.2 million individuals aged 45-64 living in Oregon, Kentucky, and nearby states from 2012 to 2019. Overall, about 15% of the cohort underwent any CRC screening; 8% underwent colonoscopy.

After the Oregon policy that eliminated cost-sharing went into effect, Oregonians had 6% higher odds of receiving any CRC screening (odds ratio [OR], 1.06; 95% confidence interval [CI], 1.00-1.06; P = .03) and 35% higher odds of undergoing an initial noninvasive test (OR, 0.65; 95% CI, 0.58-0.73; P < .001), compared with neighboring states that did not implement a similar policy.

But there were no significant differences in total CRC screening use in Kentucky after policy implementation compared with neighboring states.

The odds of receiving a colonoscopy conditional on undergoing noninvasive CRC screening were not statistically different in Oregon or Kentucky, compared with neighboring states.

“These findings suggest that the enactment of policies that remove financial barriers is merely one of many elements (e.g., health literacy, outreach, transportation, access to care) that may help to achieve desired cancer screening outcomes,” wrote Dr. Barthold and colleagues.

The study had no commercial funding. Dr. Barthold reported no relevant financial relationships.

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

Republican and Democratic members of the House called for changes in how insurer-run Medicare plans manage the prior authorization process, following testimony from a federal watchdog organization about improper denials of payment for care.

About 18% of payment denials in a sample examined by the Office of Inspector General (OIG) of the Department of Health and Human Services (HHS) either met Medicare coverage rules or the rules of the insurance plan.

As such, they should not have been denied, according to the OIG. That was the finding of an April OIG report, based on a sample of 2019 denials from large insurer-run Medicare plans.

Erin Bliss, an assistant inspector general with the OIG, appeared as a witness at a June 28 Energy and Commerce Subcommittee on Oversight and Investigations hearing to discuss this investigation and other issues with prior authorization and insurer-run Medicare, also known as the Advantage plans.

Most of these payment denials of appropriate services were due to human error during manual claims-processing reviews, Ms. Bliss told the subcommittee, such as overlooking a document, and to system processing errors, such as a Medicare insurance plan failing to program or update a system correctly.

In many cases, these denials were reversed, but patient care was still disrupted and clinicians lost time chasing clearances for services that plans already had covered, Ms. Bliss said in her testimony.

The April report was not the OIG’s first look into concerns about insurer-run plans inappropriately denying care through prior authorizations. The OIG in 2018 reported that insurer-run Medicare plans overturned 75% of their own denials during 2014-2016 when patients and clinicians appealed these decisions, overturning approximately 216,000 denials each year.

‘Numerous hoops’ unnecessary for doctors, patients

Lawmakers at the hearing supported the idea of the need for prior authorization as a screening tool to prevent unneeded care.

But they chided insurance companies for their execution of this process, with clinicians and patients often frustrated by complex steps needed. Medicare Advantage plans sometimes require prior authorization for “relatively standard medical services,” said Subcommittee on Oversight and Investigations Chair Diana DeGette (D-Colo.).

“Our seniors and their doctors should not be required to jump through numerous hoops to ensure coverage for straightforward and medically necessary procedures,” Rep. DeGette said.

Several lawmakers spoke at the hearing about the need for changes to prior authorization, including calling for action on a pending bill intended to compel insurers to streamline the review process. The Improving Seniors’ Timely Access to Care Act of 2021 already has attracted more than 300 bipartisan sponsors. A companion Senate bill has more than 30 sponsors.

The bill’s aim is to shift this process away from faxes and phone calls while also encouraging plans to adhere to evidence-based medical guidelines in consultation with physicians. The bill calls for the establishment of an electronic prior authorization program that could issue real-time decisions.

“The result will be less administrative burden for providers and more information in the hands of patients. It will allow more patients to receive care when they need it, reducing the likelihood of additional, often more severe complications,” said Rep. Larry Bucshon, MD, (R-Ind.) who is among the active sponsors of the bill.

“In the long term, I believe it would also result in cost savings for the health care system at large by identifying problems earlier and getting them treated before their patients have more complications,” Rep. Bucshon added.
 

Finding ‘room for improvement’ for prior authorizations

There’s strong bipartisan support in Congress for insurer-run Medicare, which has grown by 10% per year over the last several years and has doubled since 2010, according to the Medicare Payment Advisory Commission (MedPAC). About 27 million people are now enrolled in these plans.

But for that reason, insurer-run Medicare may also need more careful watching, lawmakers made clear at the hearing.

“We’ve heard quite a bit of evidence today that there is room for improvement,” said Rep. Bucshon, a strong supporter of insurer-run Medicare, which can offer patients added benefits such as dental coverage.

Rep. Ann Kuster (D-N.H.) said simplifying prior authorization would reduce stress on clinicians already dealing with burnout.

“They’re just so tired of all this paperwork and red tape,” Rep. Kuster said. “In 2022 can’t we at least consider electronic prior authorization?”

At the hearing, Rep. Michael C. Burgess, MD, (R-Tex.) noted that his home state already has taken a step toward reducing the burden of prior authorization with its “gold card” program.

In 2021, a new Texas law called on the state department of insurance to develop rules to require health plans to provide an exemption from preauthorization requirements for a particular health care service if the issuer has approved, or would have approved, at least 90% of the preauthorization requests submitted by the physician or provider for that service. The law also mandates that a physician participating in a peer-to-peer review on behalf of a health benefit plan issuer must be a Texas-licensed physician who has the same or similar specialty as the physician or clinician requesting the service, according to the state insurance department.

Separately, Rep. Suzan DelBene (D-Wash.), the sponsor of the Improving Seniors’ Timely Access to Care Act, told the American Medical Association in a recent interview that she expects the House Ways and Means Committee, on which she serves, to mark up her bill in July. (A mark-up is the process by which a House or Senate committee considers and often amends a bill and then sends it to the chamber’s leadership for a floor vote.)

In a statement issued about the hearing, America’s Health Insurance Plans (AHIP) noted that there has been work in recent years toward streamlining prior authorization. AHIP said it launched the Fast Prior Authorization Technology Highway (Fast PATH) initiative in 2020 to study electronic procedures for handling these reviews.

“The findings of this study showed that ePA delivered improvements with a strong majority of experienced providers reporting faster time to patient care, fewer phone calls and faxes, better understanding of [prior authorization] requirements, and faster time to decisions,” AHIP said.

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

Republican and Democratic members of the House called for changes in how insurer-run Medicare plans manage the prior authorization process, following testimony from a federal watchdog organization about improper denials of payment for care.

About 18% of payment denials in a sample examined by the Office of Inspector General (OIG) of the Department of Health and Human Services (HHS) either met Medicare coverage rules or the rules of the insurance plan.

As such, they should not have been denied, according to the OIG. That was the finding of an April OIG report, based on a sample of 2019 denials from large insurer-run Medicare plans.

Erin Bliss, an assistant inspector general with the OIG, appeared as a witness at a June 28 Energy and Commerce Subcommittee on Oversight and Investigations hearing to discuss this investigation and other issues with prior authorization and insurer-run Medicare, also known as the Advantage plans.

Most of these payment denials of appropriate services were due to human error during manual claims-processing reviews, Ms. Bliss told the subcommittee, such as overlooking a document, and to system processing errors, such as a Medicare insurance plan failing to program or update a system correctly.

In many cases, these denials were reversed, but patient care was still disrupted and clinicians lost time chasing clearances for services that plans already had covered, Ms. Bliss said in her testimony.

The April report was not the OIG’s first look into concerns about insurer-run plans inappropriately denying care through prior authorizations. The OIG in 2018 reported that insurer-run Medicare plans overturned 75% of their own denials during 2014-2016 when patients and clinicians appealed these decisions, overturning approximately 216,000 denials each year.

‘Numerous hoops’ unnecessary for doctors, patients

Lawmakers at the hearing supported the idea of the need for prior authorization as a screening tool to prevent unneeded care.

But they chided insurance companies for their execution of this process, with clinicians and patients often frustrated by complex steps needed. Medicare Advantage plans sometimes require prior authorization for “relatively standard medical services,” said Subcommittee on Oversight and Investigations Chair Diana DeGette (D-Colo.).

“Our seniors and their doctors should not be required to jump through numerous hoops to ensure coverage for straightforward and medically necessary procedures,” Rep. DeGette said.

Several lawmakers spoke at the hearing about the need for changes to prior authorization, including calling for action on a pending bill intended to compel insurers to streamline the review process. The Improving Seniors’ Timely Access to Care Act of 2021 already has attracted more than 300 bipartisan sponsors. A companion Senate bill has more than 30 sponsors.

The bill’s aim is to shift this process away from faxes and phone calls while also encouraging plans to adhere to evidence-based medical guidelines in consultation with physicians. The bill calls for the establishment of an electronic prior authorization program that could issue real-time decisions.

“The result will be less administrative burden for providers and more information in the hands of patients. It will allow more patients to receive care when they need it, reducing the likelihood of additional, often more severe complications,” said Rep. Larry Bucshon, MD, (R-Ind.) who is among the active sponsors of the bill.

“In the long term, I believe it would also result in cost savings for the health care system at large by identifying problems earlier and getting them treated before their patients have more complications,” Rep. Bucshon added.
 

Finding ‘room for improvement’ for prior authorizations

There’s strong bipartisan support in Congress for insurer-run Medicare, which has grown by 10% per year over the last several years and has doubled since 2010, according to the Medicare Payment Advisory Commission (MedPAC). About 27 million people are now enrolled in these plans.

But for that reason, insurer-run Medicare may also need more careful watching, lawmakers made clear at the hearing.

“We’ve heard quite a bit of evidence today that there is room for improvement,” said Rep. Bucshon, a strong supporter of insurer-run Medicare, which can offer patients added benefits such as dental coverage.

Rep. Ann Kuster (D-N.H.) said simplifying prior authorization would reduce stress on clinicians already dealing with burnout.

“They’re just so tired of all this paperwork and red tape,” Rep. Kuster said. “In 2022 can’t we at least consider electronic prior authorization?”

At the hearing, Rep. Michael C. Burgess, MD, (R-Tex.) noted that his home state already has taken a step toward reducing the burden of prior authorization with its “gold card” program.

In 2021, a new Texas law called on the state department of insurance to develop rules to require health plans to provide an exemption from preauthorization requirements for a particular health care service if the issuer has approved, or would have approved, at least 90% of the preauthorization requests submitted by the physician or provider for that service. The law also mandates that a physician participating in a peer-to-peer review on behalf of a health benefit plan issuer must be a Texas-licensed physician who has the same or similar specialty as the physician or clinician requesting the service, according to the state insurance department.

Separately, Rep. Suzan DelBene (D-Wash.), the sponsor of the Improving Seniors’ Timely Access to Care Act, told the American Medical Association in a recent interview that she expects the House Ways and Means Committee, on which she serves, to mark up her bill in July. (A mark-up is the process by which a House or Senate committee considers and often amends a bill and then sends it to the chamber’s leadership for a floor vote.)

In a statement issued about the hearing, America’s Health Insurance Plans (AHIP) noted that there has been work in recent years toward streamlining prior authorization. AHIP said it launched the Fast Prior Authorization Technology Highway (Fast PATH) initiative in 2020 to study electronic procedures for handling these reviews.

“The findings of this study showed that ePA delivered improvements with a strong majority of experienced providers reporting faster time to patient care, fewer phone calls and faxes, better understanding of [prior authorization] requirements, and faster time to decisions,” AHIP said.

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

Republican and Democratic members of the House called for changes in how insurer-run Medicare plans manage the prior authorization process, following testimony from a federal watchdog organization about improper denials of payment for care.

About 18% of payment denials in a sample examined by the Office of Inspector General (OIG) of the Department of Health and Human Services (HHS) either met Medicare coverage rules or the rules of the insurance plan.

As such, they should not have been denied, according to the OIG. That was the finding of an April OIG report, based on a sample of 2019 denials from large insurer-run Medicare plans.

Erin Bliss, an assistant inspector general with the OIG, appeared as a witness at a June 28 Energy and Commerce Subcommittee on Oversight and Investigations hearing to discuss this investigation and other issues with prior authorization and insurer-run Medicare, also known as the Advantage plans.

Most of these payment denials of appropriate services were due to human error during manual claims-processing reviews, Ms. Bliss told the subcommittee, such as overlooking a document, and to system processing errors, such as a Medicare insurance plan failing to program or update a system correctly.

In many cases, these denials were reversed, but patient care was still disrupted and clinicians lost time chasing clearances for services that plans already had covered, Ms. Bliss said in her testimony.

The April report was not the OIG’s first look into concerns about insurer-run plans inappropriately denying care through prior authorizations. The OIG in 2018 reported that insurer-run Medicare plans overturned 75% of their own denials during 2014-2016 when patients and clinicians appealed these decisions, overturning approximately 216,000 denials each year.

‘Numerous hoops’ unnecessary for doctors, patients

Lawmakers at the hearing supported the idea of the need for prior authorization as a screening tool to prevent unneeded care.

But they chided insurance companies for their execution of this process, with clinicians and patients often frustrated by complex steps needed. Medicare Advantage plans sometimes require prior authorization for “relatively standard medical services,” said Subcommittee on Oversight and Investigations Chair Diana DeGette (D-Colo.).

“Our seniors and their doctors should not be required to jump through numerous hoops to ensure coverage for straightforward and medically necessary procedures,” Rep. DeGette said.

Several lawmakers spoke at the hearing about the need for changes to prior authorization, including calling for action on a pending bill intended to compel insurers to streamline the review process. The Improving Seniors’ Timely Access to Care Act of 2021 already has attracted more than 300 bipartisan sponsors. A companion Senate bill has more than 30 sponsors.

The bill’s aim is to shift this process away from faxes and phone calls while also encouraging plans to adhere to evidence-based medical guidelines in consultation with physicians. The bill calls for the establishment of an electronic prior authorization program that could issue real-time decisions.

“The result will be less administrative burden for providers and more information in the hands of patients. It will allow more patients to receive care when they need it, reducing the likelihood of additional, often more severe complications,” said Rep. Larry Bucshon, MD, (R-Ind.) who is among the active sponsors of the bill.

“In the long term, I believe it would also result in cost savings for the health care system at large by identifying problems earlier and getting them treated before their patients have more complications,” Rep. Bucshon added.
 

Finding ‘room for improvement’ for prior authorizations

There’s strong bipartisan support in Congress for insurer-run Medicare, which has grown by 10% per year over the last several years and has doubled since 2010, according to the Medicare Payment Advisory Commission (MedPAC). About 27 million people are now enrolled in these plans.

But for that reason, insurer-run Medicare may also need more careful watching, lawmakers made clear at the hearing.

“We’ve heard quite a bit of evidence today that there is room for improvement,” said Rep. Bucshon, a strong supporter of insurer-run Medicare, which can offer patients added benefits such as dental coverage.

Rep. Ann Kuster (D-N.H.) said simplifying prior authorization would reduce stress on clinicians already dealing with burnout.

“They’re just so tired of all this paperwork and red tape,” Rep. Kuster said. “In 2022 can’t we at least consider electronic prior authorization?”

At the hearing, Rep. Michael C. Burgess, MD, (R-Tex.) noted that his home state already has taken a step toward reducing the burden of prior authorization with its “gold card” program.

In 2021, a new Texas law called on the state department of insurance to develop rules to require health plans to provide an exemption from preauthorization requirements for a particular health care service if the issuer has approved, or would have approved, at least 90% of the preauthorization requests submitted by the physician or provider for that service. The law also mandates that a physician participating in a peer-to-peer review on behalf of a health benefit plan issuer must be a Texas-licensed physician who has the same or similar specialty as the physician or clinician requesting the service, according to the state insurance department.

Separately, Rep. Suzan DelBene (D-Wash.), the sponsor of the Improving Seniors’ Timely Access to Care Act, told the American Medical Association in a recent interview that she expects the House Ways and Means Committee, on which she serves, to mark up her bill in July. (A mark-up is the process by which a House or Senate committee considers and often amends a bill and then sends it to the chamber’s leadership for a floor vote.)

In a statement issued about the hearing, America’s Health Insurance Plans (AHIP) noted that there has been work in recent years toward streamlining prior authorization. AHIP said it launched the Fast Prior Authorization Technology Highway (Fast PATH) initiative in 2020 to study electronic procedures for handling these reviews.

“The findings of this study showed that ePA delivered improvements with a strong majority of experienced providers reporting faster time to patient care, fewer phone calls and faxes, better understanding of [prior authorization] requirements, and faster time to decisions,” AHIP said.

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