Journal of Clinical Outcomes Management

The number of men with prostate cancer who opted for active surveillance (AS) doubled nationally between 2014 and 2021, according to experts who say the dramatic increase reflects a growing understanding among both researchers and patients that low-grade prostate tumors can be safely watched for years without requiring treatment.

Roughly 60% of men eligible for AS chose that approach in 2021, up from 27% in 2014 and less than 10% in 2010, according to panel member Matthew Cooperberg, MD, MPH, of University of California, San Francisco. He presented the data for a panel of the American Urological Association (AUA) at the group’s annual meeting in New Orleans.

Dr. Cooperberg attributed the hike in AS rates in the United States to the growing scientific literature and guidelines supportive of the approach, which calls for periodic assessments of low-risk tumors but no surgery, radiation, or other therapies. In Canada and parts of Europe, approximately 80%-90% of men who are eligible for AS choose that approach, experts said.

Earlier this month, the AUA and the American Society for Radiation Oncology released the strongest guidelines to date supporting AS for low-risk patients, and, for the first time, for select patients with favorable intermediate-risk prostate cancer.

In 2012, the U.S. Preventative Services Task Force (USPSTF) recommended against screening for prostate-specific antigen (PSA), concluding that the benefits of the test did not outweigh the risks, such as overdiagnosis and overtreatment of low-risk prostate cancer.

Urologists blamed the USPSTF policy for a decline in PSA screening and an uptick in the diagnosis of advanced prostate cancer.

Dr. Cooperberg said the shift served as “a bit of a wake-up call for at least a segment of the urology community that if we didn’t fix the overtreatment problem, we would never retake the chunks of the conversation about screening and early detection.”

In 2018, following protests by urologists and patient advocates, the USPSTF revised its statements to include shared decisionmaking for PSA testing in men aged 55-69 years, reflecting emerging evidence of longer-term benefits and widespread adoption of active surveillance after detection of low-risk disease.

Laurence Klotz, MD, the University of Toronto researcher who named and helped develop AS 30 years ago, and who was not on the AUA panel, said other factors also help to explain the growing interest in AS. These include an increasing consensus among experts on the value of the strategy, mounting public awareness of its benefits, the efforts of support and advocacy groups, and the arrival of more sophisticated imaging and biomarkers that help further refine risk.

“We’re shrinking the gray zone,” Dr. Klotz said. “Remaining resistance to AS is due to legitimate concerns about missing significant cancer and losing a patient to metastatic disease, and perhaps financial drivers, particularly with less invasive technologies like radiation and focal therapy.”

The national rate for AS increased from 26.5% in 2014, when data were first reported through the AUA’s AQUA data registry. AQUA’s data comes from electronic health records and included 27,289 patients with newly diagnosed low-risk prostate cancer.

In 2014, radical prostatectomy was the leading treatment in the low-risk population, with 29.7% of these patients overall opting for surgery, edging out external beam radiotherapy (EBRT) and AS, at 28.2% and 26.5% respectively.

In 2015, AS and EBRT overtook surgery, and by 2021, 59.6% of low-risk patients had chosen AS, followed by 20.9% for EBRT and 15.8% for prostatectomy.
 

Aiming higher

William Catalona, MD, a panel member from Northwestern University Feinberg School of Medicine, Chicago, said the AUA’s Prostate Cancer Active Surveillance Project has set a goal of 80% uptake of AS in patients with low-risk prostate cancer. Dr. Catalona, an early critic of AS, called that figure “optimal and realistic,” something that should happen “as soon as possible.”

Dr. Catalona said the 80% benchmark matches acceptance of AS within the U.S. Department of Veterans Affairs hospitals.

However, Dr. Klotz said the American culture of treatment, which is driven at least in part by financial incentives on the part of physicians, may prevent the growth of AS above 80% in this country.

Dr. Cooperberg said financial incentives are real. “I think it’s a small minority of docs that are heavily driven by the financial incentive, but it certainly exists,” he told this news organization. When you look at the extreme variation of active surveillance rates, there is no question that factors like reimbursement are going to play a role.”

Dr. Catalona, who through the first decade of the 2000s regularly debated Dr. Klotz about the concept of AS, said he today recommends AS when appropriate.

“The variability of AS adoption among practices and physicians varies from 0% to 100%. Therefore, some are too ‘tight’ in recommending AS and some are ‘too loose.’ I do not attempt to steer [patients] into treatment unless I believe that would be their best option. Nevertheless, some opt for surveillance when I believe they are making a mistake, and some opt for treatment when I believe surveillance would have been a rational choice.”

Dr. Cooperberg agreed that a personalized approach is important and that both physicians and patients should be flexible in their decisionmaking. “There will always be some men with low-grade disease who should get immediate treatment. For example, a young man with very high-volume disease, even if it’s Gleason 3+3,” he said. “If it is clearly inevitable that he’s going to need treatment, he could reasonably make a decision to get immediate treatment.”

Dr. Cooperberg, Dr. Klotz, and Dr. Catalona have disclosed no relevant financial relationships.

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

The number of men with prostate cancer who opted for active surveillance (AS) doubled nationally between 2014 and 2021, according to experts who say the dramatic increase reflects a growing understanding among both researchers and patients that low-grade prostate tumors can be safely watched for years without requiring treatment.

Roughly 60% of men eligible for AS chose that approach in 2021, up from 27% in 2014 and less than 10% in 2010, according to panel member Matthew Cooperberg, MD, MPH, of University of California, San Francisco. He presented the data for a panel of the American Urological Association (AUA) at the group’s annual meeting in New Orleans.

Dr. Cooperberg attributed the hike in AS rates in the United States to the growing scientific literature and guidelines supportive of the approach, which calls for periodic assessments of low-risk tumors but no surgery, radiation, or other therapies. In Canada and parts of Europe, approximately 80%-90% of men who are eligible for AS choose that approach, experts said.

Earlier this month, the AUA and the American Society for Radiation Oncology released the strongest guidelines to date supporting AS for low-risk patients, and, for the first time, for select patients with favorable intermediate-risk prostate cancer.

In 2012, the U.S. Preventative Services Task Force (USPSTF) recommended against screening for prostate-specific antigen (PSA), concluding that the benefits of the test did not outweigh the risks, such as overdiagnosis and overtreatment of low-risk prostate cancer.

Urologists blamed the USPSTF policy for a decline in PSA screening and an uptick in the diagnosis of advanced prostate cancer.

Dr. Cooperberg said the shift served as “a bit of a wake-up call for at least a segment of the urology community that if we didn’t fix the overtreatment problem, we would never retake the chunks of the conversation about screening and early detection.”

In 2018, following protests by urologists and patient advocates, the USPSTF revised its statements to include shared decisionmaking for PSA testing in men aged 55-69 years, reflecting emerging evidence of longer-term benefits and widespread adoption of active surveillance after detection of low-risk disease.

Laurence Klotz, MD, the University of Toronto researcher who named and helped develop AS 30 years ago, and who was not on the AUA panel, said other factors also help to explain the growing interest in AS. These include an increasing consensus among experts on the value of the strategy, mounting public awareness of its benefits, the efforts of support and advocacy groups, and the arrival of more sophisticated imaging and biomarkers that help further refine risk.

“We’re shrinking the gray zone,” Dr. Klotz said. “Remaining resistance to AS is due to legitimate concerns about missing significant cancer and losing a patient to metastatic disease, and perhaps financial drivers, particularly with less invasive technologies like radiation and focal therapy.”

The national rate for AS increased from 26.5% in 2014, when data were first reported through the AUA’s AQUA data registry. AQUA’s data comes from electronic health records and included 27,289 patients with newly diagnosed low-risk prostate cancer.

In 2014, radical prostatectomy was the leading treatment in the low-risk population, with 29.7% of these patients overall opting for surgery, edging out external beam radiotherapy (EBRT) and AS, at 28.2% and 26.5% respectively.

In 2015, AS and EBRT overtook surgery, and by 2021, 59.6% of low-risk patients had chosen AS, followed by 20.9% for EBRT and 15.8% for prostatectomy.
 

Aiming higher

William Catalona, MD, a panel member from Northwestern University Feinberg School of Medicine, Chicago, said the AUA’s Prostate Cancer Active Surveillance Project has set a goal of 80% uptake of AS in patients with low-risk prostate cancer. Dr. Catalona, an early critic of AS, called that figure “optimal and realistic,” something that should happen “as soon as possible.”

Dr. Catalona said the 80% benchmark matches acceptance of AS within the U.S. Department of Veterans Affairs hospitals.

However, Dr. Klotz said the American culture of treatment, which is driven at least in part by financial incentives on the part of physicians, may prevent the growth of AS above 80% in this country.

Dr. Cooperberg said financial incentives are real. “I think it’s a small minority of docs that are heavily driven by the financial incentive, but it certainly exists,” he told this news organization. When you look at the extreme variation of active surveillance rates, there is no question that factors like reimbursement are going to play a role.”

Dr. Catalona, who through the first decade of the 2000s regularly debated Dr. Klotz about the concept of AS, said he today recommends AS when appropriate.

“The variability of AS adoption among practices and physicians varies from 0% to 100%. Therefore, some are too ‘tight’ in recommending AS and some are ‘too loose.’ I do not attempt to steer [patients] into treatment unless I believe that would be their best option. Nevertheless, some opt for surveillance when I believe they are making a mistake, and some opt for treatment when I believe surveillance would have been a rational choice.”

Dr. Cooperberg agreed that a personalized approach is important and that both physicians and patients should be flexible in their decisionmaking. “There will always be some men with low-grade disease who should get immediate treatment. For example, a young man with very high-volume disease, even if it’s Gleason 3+3,” he said. “If it is clearly inevitable that he’s going to need treatment, he could reasonably make a decision to get immediate treatment.”

Dr. Cooperberg, Dr. Klotz, and Dr. Catalona have disclosed no relevant financial relationships.

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

The number of men with prostate cancer who opted for active surveillance (AS) doubled nationally between 2014 and 2021, according to experts who say the dramatic increase reflects a growing understanding among both researchers and patients that low-grade prostate tumors can be safely watched for years without requiring treatment.

Roughly 60% of men eligible for AS chose that approach in 2021, up from 27% in 2014 and less than 10% in 2010, according to panel member Matthew Cooperberg, MD, MPH, of University of California, San Francisco. He presented the data for a panel of the American Urological Association (AUA) at the group’s annual meeting in New Orleans.

Dr. Cooperberg attributed the hike in AS rates in the United States to the growing scientific literature and guidelines supportive of the approach, which calls for periodic assessments of low-risk tumors but no surgery, radiation, or other therapies. In Canada and parts of Europe, approximately 80%-90% of men who are eligible for AS choose that approach, experts said.

Earlier this month, the AUA and the American Society for Radiation Oncology released the strongest guidelines to date supporting AS for low-risk patients, and, for the first time, for select patients with favorable intermediate-risk prostate cancer.

In 2012, the U.S. Preventative Services Task Force (USPSTF) recommended against screening for prostate-specific antigen (PSA), concluding that the benefits of the test did not outweigh the risks, such as overdiagnosis and overtreatment of low-risk prostate cancer.

Urologists blamed the USPSTF policy for a decline in PSA screening and an uptick in the diagnosis of advanced prostate cancer.

Dr. Cooperberg said the shift served as “a bit of a wake-up call for at least a segment of the urology community that if we didn’t fix the overtreatment problem, we would never retake the chunks of the conversation about screening and early detection.”

In 2018, following protests by urologists and patient advocates, the USPSTF revised its statements to include shared decisionmaking for PSA testing in men aged 55-69 years, reflecting emerging evidence of longer-term benefits and widespread adoption of active surveillance after detection of low-risk disease.

Laurence Klotz, MD, the University of Toronto researcher who named and helped develop AS 30 years ago, and who was not on the AUA panel, said other factors also help to explain the growing interest in AS. These include an increasing consensus among experts on the value of the strategy, mounting public awareness of its benefits, the efforts of support and advocacy groups, and the arrival of more sophisticated imaging and biomarkers that help further refine risk.

“We’re shrinking the gray zone,” Dr. Klotz said. “Remaining resistance to AS is due to legitimate concerns about missing significant cancer and losing a patient to metastatic disease, and perhaps financial drivers, particularly with less invasive technologies like radiation and focal therapy.”

The national rate for AS increased from 26.5% in 2014, when data were first reported through the AUA’s AQUA data registry. AQUA’s data comes from electronic health records and included 27,289 patients with newly diagnosed low-risk prostate cancer.

In 2014, radical prostatectomy was the leading treatment in the low-risk population, with 29.7% of these patients overall opting for surgery, edging out external beam radiotherapy (EBRT) and AS, at 28.2% and 26.5% respectively.

In 2015, AS and EBRT overtook surgery, and by 2021, 59.6% of low-risk patients had chosen AS, followed by 20.9% for EBRT and 15.8% for prostatectomy.
 

Aiming higher

William Catalona, MD, a panel member from Northwestern University Feinberg School of Medicine, Chicago, said the AUA’s Prostate Cancer Active Surveillance Project has set a goal of 80% uptake of AS in patients with low-risk prostate cancer. Dr. Catalona, an early critic of AS, called that figure “optimal and realistic,” something that should happen “as soon as possible.”

Dr. Catalona said the 80% benchmark matches acceptance of AS within the U.S. Department of Veterans Affairs hospitals.

However, Dr. Klotz said the American culture of treatment, which is driven at least in part by financial incentives on the part of physicians, may prevent the growth of AS above 80% in this country.

Dr. Cooperberg said financial incentives are real. “I think it’s a small minority of docs that are heavily driven by the financial incentive, but it certainly exists,” he told this news organization. When you look at the extreme variation of active surveillance rates, there is no question that factors like reimbursement are going to play a role.”

Dr. Catalona, who through the first decade of the 2000s regularly debated Dr. Klotz about the concept of AS, said he today recommends AS when appropriate.

“The variability of AS adoption among practices and physicians varies from 0% to 100%. Therefore, some are too ‘tight’ in recommending AS and some are ‘too loose.’ I do not attempt to steer [patients] into treatment unless I believe that would be their best option. Nevertheless, some opt for surveillance when I believe they are making a mistake, and some opt for treatment when I believe surveillance would have been a rational choice.”

Dr. Cooperberg agreed that a personalized approach is important and that both physicians and patients should be flexible in their decisionmaking. “There will always be some men with low-grade disease who should get immediate treatment. For example, a young man with very high-volume disease, even if it’s Gleason 3+3,” he said. “If it is clearly inevitable that he’s going to need treatment, he could reasonably make a decision to get immediate treatment.”

Dr. Cooperberg, Dr. Klotz, and Dr. Catalona have disclosed no relevant financial relationships.

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

The Pfizer-BioNTech mRNA vaccine (Comirnaty) showed a good safety profile with minimal short-term side effects and no negative impact on disease activity in a cohort of adolescents and young adults with rheumatic diseases, according to research presented at the annual scientific meeting of the Childhood Arthritis and Rheumatology Research Alliance, held virtually this year.

Only 3% of patients experience a severe transient adverse event, according to Merav Heshin-Bekenstein, MD, of Dana-Dwek Children’s Hospital at the Tel Aviv Sourasky Medical Center in Israel. The findings were published in Rheumatology.

Courtesy Dr. Heshin-Bekenstein

“We found that the mRNA Pfizer vaccine was immunogenic and induced an adequate humoral immune response in adolescent patients,” Dr. Heshin-Bekenstein told CARRA attendees. “It was definitely comparable to healthy controls and practically all patients were seropositive following the second vaccine, except for one patient with long-standing systemic sclerosis.”

The findings were not necessarily surprising but were encouraging to Melissa S. Oliver, MD, assistant professor of clinical pediatrics in the division of pediatric rheumatology at Indiana University, Indianapolis. Dr. Oliver wasn’t part of the study team.

“We know that the COVID vaccines in healthy adolescents have shown good efficacy with minimal side effects, and it’s good to see that this study showed that in those with rheumatic diseases on immunosuppressive therapy,” Dr. Oliver told this news organization.

Until now, the data on COVID-19 vaccines in teens with rheumatic illnesses has been limited, she said, so “many pediatric rheumatologists only have the data from adult studies to go on or personal experience with their own cohort of patients.”

But the high immunogenicity seen in the study was a pleasant surprise to Beth H. Rutstein, MD, assistant professor of clinical pediatrics in the division of rheumatology at Children’s Hospital of Philadelphia and the Perelman School of Medicine at the University of Pennsylvania.

“I was both surprised and thrilled with Dr. Heshin-Bekenstein’s findings suggesting near-universal seroconversion for patients with rheumatic disease regardless of underlying diagnosis or immunomodulatory therapy regimen, as much of the adult data has suggested a poorer seroconversion rate” and lower antibody titers in adults with similar illnesses, Dr. Rutstein said in an interview.

The study “provides essential reassurance that vaccination against COVID-19 does not increase the risk of disease flare or worsen disease severity scores,” said Dr. Rutstein, who was not associated with the research. “Rather than speaking purely anecdotally with our patients and their families, we can refer to the science – which is always more reassuring for both our patients and ourselves.”
 

Study included diverse conditions and therapies

Risk factors for poor outcomes with COVID-19 in children include obesity, cardiovascular disease, chronic lung disease, diabetes, and asthma, Dr. Heshin-Bekenstein told CARRA attendees. Multisystem inflammatory syndrome in children (MIS-C) and long COVID are also potential complications of COVID-19 with less understood risk factors.

Although COVID-19 is most often mild in children, certain severe, systemic rheumatic diseases increase hospitalization risk, including systemic lupus erythematosus (SLE) and vasculitis. Evidence has also shown that COVID-19 infection increases the risk of disease flare in teens with juvenile-onset rheumatic diseases, so it’s “crucial to prevent COVID-19 disease in this population,” Dr. Heshin-Bekenstein said.

Her study therefore aimed to assess the safety and immunogenicity of the Pfizer mRNA vaccine for teens with juvenile-onset rheumatic diseases and those taking immunomodulatory medications. The international prospective multicenter study ran from April to November 2021 at three pediatric rheumatology clinics in Israel and one in Slovenia. Endpoints included short-term side effects, vaccination impact on clinical disease activity, immunogenicity at 2-9 weeks after the second dose, and, secondarily, efficacy against COVID-19 infection.

The 91 participants included adolescents aged 12-18 and young adults aged 18-21. Nearly half of the participants (46%) had juvenile idiopathic arthritis (JIA), and 14% had SLE. Other participants’ conditions included systemic vasculitis, idiopathic uveitis, inflammatory bowel disease–related arthritis, systemic or localized scleroderma, juvenile dermatomyositis, or an autoinflammatory disease. Participants’ mean disease duration was 4.8 years.  

The researchers compared the patients with a control group of 40 individuals with similar demographics but without rheumatic disease. The researchers used the LIAISON quantitative assay to assess serum IgG antibody levels against the SARS-CoV-2 spike protein in both groups.

Eight in 10 participants with rheumatic disease were taking an immunomodulatory medication, including a conventional synthetic disease-modifying antirheumatic drug (csDMARD) in 40%, a biologic DMARD in 37%, tumor necrosis factor (TNF) inhibitors in 32%, hydroxychloroquine (HCQ) in 19%, glucocorticoids in 14%, and mycophenolate in 11%. A smaller proportion were on other biologics: JAK inhibitors in 6.6%, anti-CD20 drugs in 4.4%, and an IL-6 inhibitor in 1%.
 

Side effects similar in both groups

None of the side effects reported by participants were statistically different between those with rheumatic disease and the control group. Localized pain was the most common side effect, reported by 73%-79% of participants after each dose. About twice as many participants with rheumatic disease experienced muscle aches and joint pains, compared with the control group, but the differences were not significant. Fever occurred more often in those with rheumatic disease (6%, five cases) than without (3%, one case). One-third of those with rheumatic disease felt tiredness, compared with 20% of the control group.

None of the healthy controls were hospitalized after vaccination, but three rheumatic patients were, including two after the first dose. Both were 17 years old, had systemic vasculitis with granulomatosis with polyangiitis (GPA), and were taking rituximab (Rituxan). One patient experienced acute onset of chronic renal failure, fever, dehydration, and high C-reactive protein within hours of vaccination. The other experienced new onset of pulmonary hemorrhage a week after vaccination.

In addition, a 14-year-old female with lupus, taking only HCQ, went to the emergency department with fever, headache, vomiting, and joint pain 1 day after the second vaccine dose. She had normal inflammatory markers and no change in disease activity score, and she was discharged with low-dose steroids tapered after 2 weeks.
 

Immune response high in patients with rheumatic disease

Immunogenicity was similar in both groups, with 97% seropositivity in the rheumatic disease group and 100% in the control group. Average IgG titers were 242 in the rheumatic group and 388 in the control group (P < .0001). Seropositivity was 88% in those taking mycophenolate with another drug (100% with mycophenolate monotherapy), 90% with HCQ, 94% with any csDMARDs and another drug (100% with csDMARD monotherapy), and 100% for all other drugs. During 3 months’ follow-up after vaccination, there were no COVID-19 cases among the participants.

Dr. Heshin-Bekenstein noted that their results showed better immunogenicity in teens, compared with adults, for two specific drugs. Seropositivity in teens taking methotrexate (Rheumatrex, Trexall) or rituximab was 100% in this study, compared with 84% in adults taking methotrexate and 39% in adults taking rituximab in a previous study. However, only three patients in this study were taking rituximab, and only seven were taking methotrexate.

The study’s heterogenous population was both a strength and a weakness of the study. “Due to the diversity of rheumatic diseases and medications included in this cohort, it was not possible to draw significant conclusions regarding the impact of the immunomodulatory medications and type of disease” on titers, Dr. Heshin-Bekenstein told attendees.

Still, “I think as pediatric rheumatologists, we can feel reassured in recommending the COVID-19 vaccine to our patients,” Dr. Oliver said. “I will add that every patient is different, and everyone should have a conversation with their physician about receiving the COVID-19 vaccine.” Dr. Oliver said she discusses vaccination, including COVID vaccination, with every patient, and it’s been challenging to address concerns in the midst of so much misinformation circulating about the vaccine.

These findings do raise questions about whether it’s still necessary to hold immunomodulatory medications to get the vaccine,” Dr. Rutstein said.

“Many families are nervous to pause their medications before and after the vaccine as is currently recommended for many therapies by the American College of Rheumatology, and I do share that concern for some of my patients with more clinically unstable disease, so I try to work with each family to decide on best timing and have delayed or deferred the series until some patients are on a steady dose of a new immunomodulatory medication if it has been recently started,” Dr. Rutstein said. “This is one of the reasons why Dr. Heshin-Bekenstein’s study is so important – we may be holding medications that can be safely continued and even further decrease the risk of disease flare.”

None of the physicians have disclosed any relevant financial relationships.

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

The Pfizer-BioNTech mRNA vaccine (Comirnaty) showed a good safety profile with minimal short-term side effects and no negative impact on disease activity in a cohort of adolescents and young adults with rheumatic diseases, according to research presented at the annual scientific meeting of the Childhood Arthritis and Rheumatology Research Alliance, held virtually this year.

Only 3% of patients experience a severe transient adverse event, according to Merav Heshin-Bekenstein, MD, of Dana-Dwek Children’s Hospital at the Tel Aviv Sourasky Medical Center in Israel. The findings were published in Rheumatology.

Courtesy Dr. Heshin-Bekenstein

“We found that the mRNA Pfizer vaccine was immunogenic and induced an adequate humoral immune response in adolescent patients,” Dr. Heshin-Bekenstein told CARRA attendees. “It was definitely comparable to healthy controls and practically all patients were seropositive following the second vaccine, except for one patient with long-standing systemic sclerosis.”

The findings were not necessarily surprising but were encouraging to Melissa S. Oliver, MD, assistant professor of clinical pediatrics in the division of pediatric rheumatology at Indiana University, Indianapolis. Dr. Oliver wasn’t part of the study team.

“We know that the COVID vaccines in healthy adolescents have shown good efficacy with minimal side effects, and it’s good to see that this study showed that in those with rheumatic diseases on immunosuppressive therapy,” Dr. Oliver told this news organization.

Until now, the data on COVID-19 vaccines in teens with rheumatic illnesses has been limited, she said, so “many pediatric rheumatologists only have the data from adult studies to go on or personal experience with their own cohort of patients.”

But the high immunogenicity seen in the study was a pleasant surprise to Beth H. Rutstein, MD, assistant professor of clinical pediatrics in the division of rheumatology at Children’s Hospital of Philadelphia and the Perelman School of Medicine at the University of Pennsylvania.

“I was both surprised and thrilled with Dr. Heshin-Bekenstein’s findings suggesting near-universal seroconversion for patients with rheumatic disease regardless of underlying diagnosis or immunomodulatory therapy regimen, as much of the adult data has suggested a poorer seroconversion rate” and lower antibody titers in adults with similar illnesses, Dr. Rutstein said in an interview.

The study “provides essential reassurance that vaccination against COVID-19 does not increase the risk of disease flare or worsen disease severity scores,” said Dr. Rutstein, who was not associated with the research. “Rather than speaking purely anecdotally with our patients and their families, we can refer to the science – which is always more reassuring for both our patients and ourselves.”
 

Study included diverse conditions and therapies

Risk factors for poor outcomes with COVID-19 in children include obesity, cardiovascular disease, chronic lung disease, diabetes, and asthma, Dr. Heshin-Bekenstein told CARRA attendees. Multisystem inflammatory syndrome in children (MIS-C) and long COVID are also potential complications of COVID-19 with less understood risk factors.

Although COVID-19 is most often mild in children, certain severe, systemic rheumatic diseases increase hospitalization risk, including systemic lupus erythematosus (SLE) and vasculitis. Evidence has also shown that COVID-19 infection increases the risk of disease flare in teens with juvenile-onset rheumatic diseases, so it’s “crucial to prevent COVID-19 disease in this population,” Dr. Heshin-Bekenstein said.

Her study therefore aimed to assess the safety and immunogenicity of the Pfizer mRNA vaccine for teens with juvenile-onset rheumatic diseases and those taking immunomodulatory medications. The international prospective multicenter study ran from April to November 2021 at three pediatric rheumatology clinics in Israel and one in Slovenia. Endpoints included short-term side effects, vaccination impact on clinical disease activity, immunogenicity at 2-9 weeks after the second dose, and, secondarily, efficacy against COVID-19 infection.

The 91 participants included adolescents aged 12-18 and young adults aged 18-21. Nearly half of the participants (46%) had juvenile idiopathic arthritis (JIA), and 14% had SLE. Other participants’ conditions included systemic vasculitis, idiopathic uveitis, inflammatory bowel disease–related arthritis, systemic or localized scleroderma, juvenile dermatomyositis, or an autoinflammatory disease. Participants’ mean disease duration was 4.8 years.  

The researchers compared the patients with a control group of 40 individuals with similar demographics but without rheumatic disease. The researchers used the LIAISON quantitative assay to assess serum IgG antibody levels against the SARS-CoV-2 spike protein in both groups.

Eight in 10 participants with rheumatic disease were taking an immunomodulatory medication, including a conventional synthetic disease-modifying antirheumatic drug (csDMARD) in 40%, a biologic DMARD in 37%, tumor necrosis factor (TNF) inhibitors in 32%, hydroxychloroquine (HCQ) in 19%, glucocorticoids in 14%, and mycophenolate in 11%. A smaller proportion were on other biologics: JAK inhibitors in 6.6%, anti-CD20 drugs in 4.4%, and an IL-6 inhibitor in 1%.
 

Side effects similar in both groups

None of the side effects reported by participants were statistically different between those with rheumatic disease and the control group. Localized pain was the most common side effect, reported by 73%-79% of participants after each dose. About twice as many participants with rheumatic disease experienced muscle aches and joint pains, compared with the control group, but the differences were not significant. Fever occurred more often in those with rheumatic disease (6%, five cases) than without (3%, one case). One-third of those with rheumatic disease felt tiredness, compared with 20% of the control group.

None of the healthy controls were hospitalized after vaccination, but three rheumatic patients were, including two after the first dose. Both were 17 years old, had systemic vasculitis with granulomatosis with polyangiitis (GPA), and were taking rituximab (Rituxan). One patient experienced acute onset of chronic renal failure, fever, dehydration, and high C-reactive protein within hours of vaccination. The other experienced new onset of pulmonary hemorrhage a week after vaccination.

In addition, a 14-year-old female with lupus, taking only HCQ, went to the emergency department with fever, headache, vomiting, and joint pain 1 day after the second vaccine dose. She had normal inflammatory markers and no change in disease activity score, and she was discharged with low-dose steroids tapered after 2 weeks.
 

Immune response high in patients with rheumatic disease

Immunogenicity was similar in both groups, with 97% seropositivity in the rheumatic disease group and 100% in the control group. Average IgG titers were 242 in the rheumatic group and 388 in the control group (P < .0001). Seropositivity was 88% in those taking mycophenolate with another drug (100% with mycophenolate monotherapy), 90% with HCQ, 94% with any csDMARDs and another drug (100% with csDMARD monotherapy), and 100% for all other drugs. During 3 months’ follow-up after vaccination, there were no COVID-19 cases among the participants.

Dr. Heshin-Bekenstein noted that their results showed better immunogenicity in teens, compared with adults, for two specific drugs. Seropositivity in teens taking methotrexate (Rheumatrex, Trexall) or rituximab was 100% in this study, compared with 84% in adults taking methotrexate and 39% in adults taking rituximab in a previous study. However, only three patients in this study were taking rituximab, and only seven were taking methotrexate.

The study’s heterogenous population was both a strength and a weakness of the study. “Due to the diversity of rheumatic diseases and medications included in this cohort, it was not possible to draw significant conclusions regarding the impact of the immunomodulatory medications and type of disease” on titers, Dr. Heshin-Bekenstein told attendees.

Still, “I think as pediatric rheumatologists, we can feel reassured in recommending the COVID-19 vaccine to our patients,” Dr. Oliver said. “I will add that every patient is different, and everyone should have a conversation with their physician about receiving the COVID-19 vaccine.” Dr. Oliver said she discusses vaccination, including COVID vaccination, with every patient, and it’s been challenging to address concerns in the midst of so much misinformation circulating about the vaccine.

These findings do raise questions about whether it’s still necessary to hold immunomodulatory medications to get the vaccine,” Dr. Rutstein said.

“Many families are nervous to pause their medications before and after the vaccine as is currently recommended for many therapies by the American College of Rheumatology, and I do share that concern for some of my patients with more clinically unstable disease, so I try to work with each family to decide on best timing and have delayed or deferred the series until some patients are on a steady dose of a new immunomodulatory medication if it has been recently started,” Dr. Rutstein said. “This is one of the reasons why Dr. Heshin-Bekenstein’s study is so important – we may be holding medications that can be safely continued and even further decrease the risk of disease flare.”

None of the physicians have disclosed any relevant financial relationships.

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

The Pfizer-BioNTech mRNA vaccine (Comirnaty) showed a good safety profile with minimal short-term side effects and no negative impact on disease activity in a cohort of adolescents and young adults with rheumatic diseases, according to research presented at the annual scientific meeting of the Childhood Arthritis and Rheumatology Research Alliance, held virtually this year.

Only 3% of patients experience a severe transient adverse event, according to Merav Heshin-Bekenstein, MD, of Dana-Dwek Children’s Hospital at the Tel Aviv Sourasky Medical Center in Israel. The findings were published in Rheumatology.

Courtesy Dr. Heshin-Bekenstein

“We found that the mRNA Pfizer vaccine was immunogenic and induced an adequate humoral immune response in adolescent patients,” Dr. Heshin-Bekenstein told CARRA attendees. “It was definitely comparable to healthy controls and practically all patients were seropositive following the second vaccine, except for one patient with long-standing systemic sclerosis.”

The findings were not necessarily surprising but were encouraging to Melissa S. Oliver, MD, assistant professor of clinical pediatrics in the division of pediatric rheumatology at Indiana University, Indianapolis. Dr. Oliver wasn’t part of the study team.

“We know that the COVID vaccines in healthy adolescents have shown good efficacy with minimal side effects, and it’s good to see that this study showed that in those with rheumatic diseases on immunosuppressive therapy,” Dr. Oliver told this news organization.

Until now, the data on COVID-19 vaccines in teens with rheumatic illnesses has been limited, she said, so “many pediatric rheumatologists only have the data from adult studies to go on or personal experience with their own cohort of patients.”

But the high immunogenicity seen in the study was a pleasant surprise to Beth H. Rutstein, MD, assistant professor of clinical pediatrics in the division of rheumatology at Children’s Hospital of Philadelphia and the Perelman School of Medicine at the University of Pennsylvania.

“I was both surprised and thrilled with Dr. Heshin-Bekenstein’s findings suggesting near-universal seroconversion for patients with rheumatic disease regardless of underlying diagnosis or immunomodulatory therapy regimen, as much of the adult data has suggested a poorer seroconversion rate” and lower antibody titers in adults with similar illnesses, Dr. Rutstein said in an interview.

The study “provides essential reassurance that vaccination against COVID-19 does not increase the risk of disease flare or worsen disease severity scores,” said Dr. Rutstein, who was not associated with the research. “Rather than speaking purely anecdotally with our patients and their families, we can refer to the science – which is always more reassuring for both our patients and ourselves.”
 

Study included diverse conditions and therapies

Risk factors for poor outcomes with COVID-19 in children include obesity, cardiovascular disease, chronic lung disease, diabetes, and asthma, Dr. Heshin-Bekenstein told CARRA attendees. Multisystem inflammatory syndrome in children (MIS-C) and long COVID are also potential complications of COVID-19 with less understood risk factors.

Although COVID-19 is most often mild in children, certain severe, systemic rheumatic diseases increase hospitalization risk, including systemic lupus erythematosus (SLE) and vasculitis. Evidence has also shown that COVID-19 infection increases the risk of disease flare in teens with juvenile-onset rheumatic diseases, so it’s “crucial to prevent COVID-19 disease in this population,” Dr. Heshin-Bekenstein said.

Her study therefore aimed to assess the safety and immunogenicity of the Pfizer mRNA vaccine for teens with juvenile-onset rheumatic diseases and those taking immunomodulatory medications. The international prospective multicenter study ran from April to November 2021 at three pediatric rheumatology clinics in Israel and one in Slovenia. Endpoints included short-term side effects, vaccination impact on clinical disease activity, immunogenicity at 2-9 weeks after the second dose, and, secondarily, efficacy against COVID-19 infection.

The 91 participants included adolescents aged 12-18 and young adults aged 18-21. Nearly half of the participants (46%) had juvenile idiopathic arthritis (JIA), and 14% had SLE. Other participants’ conditions included systemic vasculitis, idiopathic uveitis, inflammatory bowel disease–related arthritis, systemic or localized scleroderma, juvenile dermatomyositis, or an autoinflammatory disease. Participants’ mean disease duration was 4.8 years.  

The researchers compared the patients with a control group of 40 individuals with similar demographics but without rheumatic disease. The researchers used the LIAISON quantitative assay to assess serum IgG antibody levels against the SARS-CoV-2 spike protein in both groups.

Eight in 10 participants with rheumatic disease were taking an immunomodulatory medication, including a conventional synthetic disease-modifying antirheumatic drug (csDMARD) in 40%, a biologic DMARD in 37%, tumor necrosis factor (TNF) inhibitors in 32%, hydroxychloroquine (HCQ) in 19%, glucocorticoids in 14%, and mycophenolate in 11%. A smaller proportion were on other biologics: JAK inhibitors in 6.6%, anti-CD20 drugs in 4.4%, and an IL-6 inhibitor in 1%.
 

Side effects similar in both groups

None of the side effects reported by participants were statistically different between those with rheumatic disease and the control group. Localized pain was the most common side effect, reported by 73%-79% of participants after each dose. About twice as many participants with rheumatic disease experienced muscle aches and joint pains, compared with the control group, but the differences were not significant. Fever occurred more often in those with rheumatic disease (6%, five cases) than without (3%, one case). One-third of those with rheumatic disease felt tiredness, compared with 20% of the control group.

None of the healthy controls were hospitalized after vaccination, but three rheumatic patients were, including two after the first dose. Both were 17 years old, had systemic vasculitis with granulomatosis with polyangiitis (GPA), and were taking rituximab (Rituxan). One patient experienced acute onset of chronic renal failure, fever, dehydration, and high C-reactive protein within hours of vaccination. The other experienced new onset of pulmonary hemorrhage a week after vaccination.

In addition, a 14-year-old female with lupus, taking only HCQ, went to the emergency department with fever, headache, vomiting, and joint pain 1 day after the second vaccine dose. She had normal inflammatory markers and no change in disease activity score, and she was discharged with low-dose steroids tapered after 2 weeks.
 

Immune response high in patients with rheumatic disease

Immunogenicity was similar in both groups, with 97% seropositivity in the rheumatic disease group and 100% in the control group. Average IgG titers were 242 in the rheumatic group and 388 in the control group (P < .0001). Seropositivity was 88% in those taking mycophenolate with another drug (100% with mycophenolate monotherapy), 90% with HCQ, 94% with any csDMARDs and another drug (100% with csDMARD monotherapy), and 100% for all other drugs. During 3 months’ follow-up after vaccination, there were no COVID-19 cases among the participants.

Dr. Heshin-Bekenstein noted that their results showed better immunogenicity in teens, compared with adults, for two specific drugs. Seropositivity in teens taking methotrexate (Rheumatrex, Trexall) or rituximab was 100% in this study, compared with 84% in adults taking methotrexate and 39% in adults taking rituximab in a previous study. However, only three patients in this study were taking rituximab, and only seven were taking methotrexate.

The study’s heterogenous population was both a strength and a weakness of the study. “Due to the diversity of rheumatic diseases and medications included in this cohort, it was not possible to draw significant conclusions regarding the impact of the immunomodulatory medications and type of disease” on titers, Dr. Heshin-Bekenstein told attendees.

Still, “I think as pediatric rheumatologists, we can feel reassured in recommending the COVID-19 vaccine to our patients,” Dr. Oliver said. “I will add that every patient is different, and everyone should have a conversation with their physician about receiving the COVID-19 vaccine.” Dr. Oliver said she discusses vaccination, including COVID vaccination, with every patient, and it’s been challenging to address concerns in the midst of so much misinformation circulating about the vaccine.

These findings do raise questions about whether it’s still necessary to hold immunomodulatory medications to get the vaccine,” Dr. Rutstein said.

“Many families are nervous to pause their medications before and after the vaccine as is currently recommended for many therapies by the American College of Rheumatology, and I do share that concern for some of my patients with more clinically unstable disease, so I try to work with each family to decide on best timing and have delayed or deferred the series until some patients are on a steady dose of a new immunomodulatory medication if it has been recently started,” Dr. Rutstein said. “This is one of the reasons why Dr. Heshin-Bekenstein’s study is so important – we may be holding medications that can be safely continued and even further decrease the risk of disease flare.”

None of the physicians have disclosed any relevant financial relationships.

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

Young stroke patients have an increased risk of being diagnosed with a new cancer in the years following their stroke, a new study shows, raising the possibility that the stroke might be the first manifestation of an underlying cancer.

The data were presented by Jamie Verhoeven, MD, Radboud University Medical Centre, the Netherlands, at the recent European Stroke Organisation Conference 2022.

Dr. Verhoeven noted that 10% of all stroke cases occur in individuals younger than 50 years. During the past few decades, the incidence of stroke in the young has steadily increased, whereas the incidence of stroke in older adults has stabilized or decreased.

“Stroke in the young differs from stroke in older patients, and one of the major differences is that stroke in the young has a higher proportion of cryptogenic stroke, with no clear cause found in over one-third of patients,” she said.

Also, having an active cancer is known to be a risk factor for thrombosis. This association is strongest in venous thrombosis and has been less well investigated in arterial thrombosis, Dr. Verhoeven reported.

Her group aimed to investigate whether in some patients with cryptogenic stroke, this may be the first manifestation of an underlying cancer. “If this hypothesis is true, then it would be more obvious in young patients who have a higher incidence of cryptogenic stroke,” she said.

They performed a population-based observational cohort study using diagnostic ICD codes from the national Hospital Discharge Registry in the Netherlands and the Dutch Population Registry from 1998 to 2019.

Patients with a history of cancer before their first stroke and those with central nervous system cancers at the time of stroke or nonmelanoma skin cancers (which have been shown to have no systemic effects) were excluded.

Reference data came from the Netherlands Comprehensive Cancer Organisation, which collects data on all cancer diagnoses in the country.

The researchers identified 27,616 young stroke patients (age range, 15-49 years; median age, 45 years) and 362,782 older stroke patients (age range, 50 years and older; median age, 76 years).

The cumulative incidence of any cancer at 10 years was 3.7% in the younger group and 8.5% in the older group.

The data were compared with matched peers from the general population. The main outcome measures were cumulative incidence of first-ever cancer after stroke (stratified by stroke subtype, age and sex) and standardized incidence rates.

Results showed that the risk for cancer was higher in the younger age group than in the matched general population.

In this age group, the 1-year risk of any new cancer was 2.6 times higher (95% confidence interval, 2.2-3.1) after ischemic stroke and 5.4 times (95% CI, 3.8-7.3) after intracerebral hemorrhage than in matched peers from the general population.

In contrast, in stroke patients older than 50 years, the 1-year risk for any new cancer was 1.2 times higher than the general population after either ischemic or hemorrhagic stroke.

“The younger patients have a higher risk increase of cancer than older patients, and this risk increase is most evident in the first 1 to 2 years after stroke but remains statistically significant for up to 5 to 8 years later,” Dr. Verhoeven said.

The cancers that were most involved in this risk increase were those of the lower respiratory tract, hematologic cancers, and gastrointestinal cancers.

The main strength of this study was the use of national databases that allowed for a very large sample size, but this brings with it the danger of misclassification of events and the lack of clinical data, Dr. Verhoeven noted.

“Young stroke patients are at increased risk of developing a new cancer in the years following their stroke compared to peers from the general population, but this risk is only marginally increased in the older stroke population,” she concluded.

She pointed out that it is not possible to confirm any causal relation from this study design, but a clear association has been shown.

“We need more studies into this field. We need a large clinical dataset to examine which clinical phenotypes are associated with possible underlying cancers to identify which patients are most at risk. We are already working on this,” she said. “Then it remains to be investigated whether screening for an underlying cancer should be added to the diagnostic workup in young stroke patients.”

Commenting on the study after the presentation, William Whiteley, BM, PhD, a clinical epidemiologist at the University of Edinburgh, Scotland, and a consultant neurologist in NHS Lothian, said it was difficult to know whether the link shown between stroke and cancer was causal, but the effect size in this study was “quite large.”

He pointed out that the associations with bowel and lung cancer could be due to shared risk factors, such as smoking, but he said the finding on a link with hematologic cancers is “interesting.”

Noting that there are links between hematologic cancers and thrombotic events, he said: “People have wondered if that is because of clonal expansion, which has been shown to increase the risk of atherosclerosis, so the question is whether this is some kind of common risk factor here.”

Dr. Verhoeven said she did not believe that shared risk factors fully explained the difference in increased risks between young and older patients.

“It does not fully explain why the risk of cancer is specifically higher in the first 1 to 2 years after the stroke diagnosis. I would think if it was just shared risk factors, the risk increase should remain relatively stable, or even increase due to the build-up of exposure to risk factors over the years,” she said.

Dr. Whiteley said that data like these are “really useful in trying to estimate these associations and it gives us some hypotheses to investigate in smaller mechanistic studies.”

Asked whether these data justify screening younger cryptogenic stroke patients more systematically for cancer, Dr. Whiteley replied: “I think we need some absolute risk estimates for that; for example, what proportion of younger patients would be at risk over the next few years when that screening would make a difference.”

Dr. Verhoeven reports no disclosures.

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

Young stroke patients have an increased risk of being diagnosed with a new cancer in the years following their stroke, a new study shows, raising the possibility that the stroke might be the first manifestation of an underlying cancer.

The data were presented by Jamie Verhoeven, MD, Radboud University Medical Centre, the Netherlands, at the recent European Stroke Organisation Conference 2022.

Dr. Verhoeven noted that 10% of all stroke cases occur in individuals younger than 50 years. During the past few decades, the incidence of stroke in the young has steadily increased, whereas the incidence of stroke in older adults has stabilized or decreased.

“Stroke in the young differs from stroke in older patients, and one of the major differences is that stroke in the young has a higher proportion of cryptogenic stroke, with no clear cause found in over one-third of patients,” she said.

Also, having an active cancer is known to be a risk factor for thrombosis. This association is strongest in venous thrombosis and has been less well investigated in arterial thrombosis, Dr. Verhoeven reported.

Her group aimed to investigate whether in some patients with cryptogenic stroke, this may be the first manifestation of an underlying cancer. “If this hypothesis is true, then it would be more obvious in young patients who have a higher incidence of cryptogenic stroke,” she said.

They performed a population-based observational cohort study using diagnostic ICD codes from the national Hospital Discharge Registry in the Netherlands and the Dutch Population Registry from 1998 to 2019.

Patients with a history of cancer before their first stroke and those with central nervous system cancers at the time of stroke or nonmelanoma skin cancers (which have been shown to have no systemic effects) were excluded.

Reference data came from the Netherlands Comprehensive Cancer Organisation, which collects data on all cancer diagnoses in the country.

The researchers identified 27,616 young stroke patients (age range, 15-49 years; median age, 45 years) and 362,782 older stroke patients (age range, 50 years and older; median age, 76 years).

The cumulative incidence of any cancer at 10 years was 3.7% in the younger group and 8.5% in the older group.

The data were compared with matched peers from the general population. The main outcome measures were cumulative incidence of first-ever cancer after stroke (stratified by stroke subtype, age and sex) and standardized incidence rates.

Results showed that the risk for cancer was higher in the younger age group than in the matched general population.

In this age group, the 1-year risk of any new cancer was 2.6 times higher (95% confidence interval, 2.2-3.1) after ischemic stroke and 5.4 times (95% CI, 3.8-7.3) after intracerebral hemorrhage than in matched peers from the general population.

In contrast, in stroke patients older than 50 years, the 1-year risk for any new cancer was 1.2 times higher than the general population after either ischemic or hemorrhagic stroke.

“The younger patients have a higher risk increase of cancer than older patients, and this risk increase is most evident in the first 1 to 2 years after stroke but remains statistically significant for up to 5 to 8 years later,” Dr. Verhoeven said.

The cancers that were most involved in this risk increase were those of the lower respiratory tract, hematologic cancers, and gastrointestinal cancers.

The main strength of this study was the use of national databases that allowed for a very large sample size, but this brings with it the danger of misclassification of events and the lack of clinical data, Dr. Verhoeven noted.

“Young stroke patients are at increased risk of developing a new cancer in the years following their stroke compared to peers from the general population, but this risk is only marginally increased in the older stroke population,” she concluded.

She pointed out that it is not possible to confirm any causal relation from this study design, but a clear association has been shown.

“We need more studies into this field. We need a large clinical dataset to examine which clinical phenotypes are associated with possible underlying cancers to identify which patients are most at risk. We are already working on this,” she said. “Then it remains to be investigated whether screening for an underlying cancer should be added to the diagnostic workup in young stroke patients.”

Commenting on the study after the presentation, William Whiteley, BM, PhD, a clinical epidemiologist at the University of Edinburgh, Scotland, and a consultant neurologist in NHS Lothian, said it was difficult to know whether the link shown between stroke and cancer was causal, but the effect size in this study was “quite large.”

He pointed out that the associations with bowel and lung cancer could be due to shared risk factors, such as smoking, but he said the finding on a link with hematologic cancers is “interesting.”

Noting that there are links between hematologic cancers and thrombotic events, he said: “People have wondered if that is because of clonal expansion, which has been shown to increase the risk of atherosclerosis, so the question is whether this is some kind of common risk factor here.”

Dr. Verhoeven said she did not believe that shared risk factors fully explained the difference in increased risks between young and older patients.

“It does not fully explain why the risk of cancer is specifically higher in the first 1 to 2 years after the stroke diagnosis. I would think if it was just shared risk factors, the risk increase should remain relatively stable, or even increase due to the build-up of exposure to risk factors over the years,” she said.

Dr. Whiteley said that data like these are “really useful in trying to estimate these associations and it gives us some hypotheses to investigate in smaller mechanistic studies.”

Asked whether these data justify screening younger cryptogenic stroke patients more systematically for cancer, Dr. Whiteley replied: “I think we need some absolute risk estimates for that; for example, what proportion of younger patients would be at risk over the next few years when that screening would make a difference.”

Dr. Verhoeven reports no disclosures.

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

Young stroke patients have an increased risk of being diagnosed with a new cancer in the years following their stroke, a new study shows, raising the possibility that the stroke might be the first manifestation of an underlying cancer.

The data were presented by Jamie Verhoeven, MD, Radboud University Medical Centre, the Netherlands, at the recent European Stroke Organisation Conference 2022.

Dr. Verhoeven noted that 10% of all stroke cases occur in individuals younger than 50 years. During the past few decades, the incidence of stroke in the young has steadily increased, whereas the incidence of stroke in older adults has stabilized or decreased.

“Stroke in the young differs from stroke in older patients, and one of the major differences is that stroke in the young has a higher proportion of cryptogenic stroke, with no clear cause found in over one-third of patients,” she said.

Also, having an active cancer is known to be a risk factor for thrombosis. This association is strongest in venous thrombosis and has been less well investigated in arterial thrombosis, Dr. Verhoeven reported.

Her group aimed to investigate whether in some patients with cryptogenic stroke, this may be the first manifestation of an underlying cancer. “If this hypothesis is true, then it would be more obvious in young patients who have a higher incidence of cryptogenic stroke,” she said.

They performed a population-based observational cohort study using diagnostic ICD codes from the national Hospital Discharge Registry in the Netherlands and the Dutch Population Registry from 1998 to 2019.

Patients with a history of cancer before their first stroke and those with central nervous system cancers at the time of stroke or nonmelanoma skin cancers (which have been shown to have no systemic effects) were excluded.

Reference data came from the Netherlands Comprehensive Cancer Organisation, which collects data on all cancer diagnoses in the country.

The researchers identified 27,616 young stroke patients (age range, 15-49 years; median age, 45 years) and 362,782 older stroke patients (age range, 50 years and older; median age, 76 years).

The cumulative incidence of any cancer at 10 years was 3.7% in the younger group and 8.5% in the older group.

The data were compared with matched peers from the general population. The main outcome measures were cumulative incidence of first-ever cancer after stroke (stratified by stroke subtype, age and sex) and standardized incidence rates.

Results showed that the risk for cancer was higher in the younger age group than in the matched general population.

In this age group, the 1-year risk of any new cancer was 2.6 times higher (95% confidence interval, 2.2-3.1) after ischemic stroke and 5.4 times (95% CI, 3.8-7.3) after intracerebral hemorrhage than in matched peers from the general population.

In contrast, in stroke patients older than 50 years, the 1-year risk for any new cancer was 1.2 times higher than the general population after either ischemic or hemorrhagic stroke.

“The younger patients have a higher risk increase of cancer than older patients, and this risk increase is most evident in the first 1 to 2 years after stroke but remains statistically significant for up to 5 to 8 years later,” Dr. Verhoeven said.

The cancers that were most involved in this risk increase were those of the lower respiratory tract, hematologic cancers, and gastrointestinal cancers.

The main strength of this study was the use of national databases that allowed for a very large sample size, but this brings with it the danger of misclassification of events and the lack of clinical data, Dr. Verhoeven noted.

“Young stroke patients are at increased risk of developing a new cancer in the years following their stroke compared to peers from the general population, but this risk is only marginally increased in the older stroke population,” she concluded.

She pointed out that it is not possible to confirm any causal relation from this study design, but a clear association has been shown.

“We need more studies into this field. We need a large clinical dataset to examine which clinical phenotypes are associated with possible underlying cancers to identify which patients are most at risk. We are already working on this,” she said. “Then it remains to be investigated whether screening for an underlying cancer should be added to the diagnostic workup in young stroke patients.”

Commenting on the study after the presentation, William Whiteley, BM, PhD, a clinical epidemiologist at the University of Edinburgh, Scotland, and a consultant neurologist in NHS Lothian, said it was difficult to know whether the link shown between stroke and cancer was causal, but the effect size in this study was “quite large.”

He pointed out that the associations with bowel and lung cancer could be due to shared risk factors, such as smoking, but he said the finding on a link with hematologic cancers is “interesting.”

Noting that there are links between hematologic cancers and thrombotic events, he said: “People have wondered if that is because of clonal expansion, which has been shown to increase the risk of atherosclerosis, so the question is whether this is some kind of common risk factor here.”

Dr. Verhoeven said she did not believe that shared risk factors fully explained the difference in increased risks between young and older patients.

“It does not fully explain why the risk of cancer is specifically higher in the first 1 to 2 years after the stroke diagnosis. I would think if it was just shared risk factors, the risk increase should remain relatively stable, or even increase due to the build-up of exposure to risk factors over the years,” she said.

Dr. Whiteley said that data like these are “really useful in trying to estimate these associations and it gives us some hypotheses to investigate in smaller mechanistic studies.”

Asked whether these data justify screening younger cryptogenic stroke patients more systematically for cancer, Dr. Whiteley replied: “I think we need some absolute risk estimates for that; for example, what proportion of younger patients would be at risk over the next few years when that screening would make a difference.”

Dr. Verhoeven reports no disclosures.

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

The presence of gallstone disease may be a harbinger of pancreatic ductal adenocarcinoma (PDAC), researchers suggest after showing an association between the two in a SEER-Medicare database analysis. Patients with PDAC were six times more likely to have had gallstone disease in the year prior to diagnosis than noncancer patients, they found.

“We can’t be certain at this time as to whether gallstone disease is a precursor to PDAC or whether it is the end result of PDAC, but we do know there is an association, and we plan to explore it further,” commented study author Teviah Sachs, MD, MPH, Boston Medical Center.

“We don’t want anyone with gallstone disease to think that they have pancreatic cancer because, certainly, the overwhelming majority of patients with gallstone disease do not have pancreatic cancer,” he emphasized.

“But I would say to physicians that if you have a patient who presents with gallstone disease and they have other symptoms, you should not necessarily attribute those symptoms just to their gallstone disease,” Dr. Sachs commented.

“The diagnosis of pancreatic cancer should be on the differential in patients who present with symptoms that might not otherwise correlate with typical gallstones,” he added. 

Dr. Sachs was speaking at a press briefing ahead of the annual Digestive Disease Week® (DDW), where the study will be presented.

“PDAC is often fatal because it’s frequently not diagnosed until it is late-stage disease,” Dr. Sachs noted.  

Complicating earlier diagnosis is the fact that symptoms of PDAC often mirror those associated with gallstone disease and gallbladder infection, “both of which have been demonstrated to be risk factors for PDAC,” Dr. Sachs added.
 

Annual incidence

The purpose of the present study was to compare the incidence of cholelithiasis or cholecystitis in the year before a diagnosis of PDAC with the annual incidence in the general population.

A total of 18,700 patients with PDAC, median age 76 years, were identified in the SEER-Medicare database between 2008 and 2015. The incidence of hospital visits for gallstone disease in the year prior to PDAC diagnosis as well as the annual incidence of gallstone disease in the SEER-Medicare noncancer cohort were assessed.

An average of 99,287 patients per year were available from the noncancer cohort, 0.8% of whom had gallstone disease and 0.3% of whom had their gallbladders removed. In contrast, in the year before their diagnosis, 4.7% of PDAC patients had a diagnosis of gallstone disease and 1.6% had their gallbladders removed.

“Gallstone disease does not cause pancreatic cancer,” lead author, Marianna Papageorge, MD, research fellow, also of Boston Medical Center, said in a statement.

“But understanding its association with PDAC can help combat the high mortality rate with pancreatic cancer by providing the opportunity for earlier diagnosis and treatment,” she added.

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

The presence of gallstone disease may be a harbinger of pancreatic ductal adenocarcinoma (PDAC), researchers suggest after showing an association between the two in a SEER-Medicare database analysis. Patients with PDAC were six times more likely to have had gallstone disease in the year prior to diagnosis than noncancer patients, they found.

“We can’t be certain at this time as to whether gallstone disease is a precursor to PDAC or whether it is the end result of PDAC, but we do know there is an association, and we plan to explore it further,” commented study author Teviah Sachs, MD, MPH, Boston Medical Center.

“We don’t want anyone with gallstone disease to think that they have pancreatic cancer because, certainly, the overwhelming majority of patients with gallstone disease do not have pancreatic cancer,” he emphasized.

“But I would say to physicians that if you have a patient who presents with gallstone disease and they have other symptoms, you should not necessarily attribute those symptoms just to their gallstone disease,” Dr. Sachs commented.

“The diagnosis of pancreatic cancer should be on the differential in patients who present with symptoms that might not otherwise correlate with typical gallstones,” he added. 

Dr. Sachs was speaking at a press briefing ahead of the annual Digestive Disease Week® (DDW), where the study will be presented.

“PDAC is often fatal because it’s frequently not diagnosed until it is late-stage disease,” Dr. Sachs noted.  

Complicating earlier diagnosis is the fact that symptoms of PDAC often mirror those associated with gallstone disease and gallbladder infection, “both of which have been demonstrated to be risk factors for PDAC,” Dr. Sachs added.
 

Annual incidence

The purpose of the present study was to compare the incidence of cholelithiasis or cholecystitis in the year before a diagnosis of PDAC with the annual incidence in the general population.

A total of 18,700 patients with PDAC, median age 76 years, were identified in the SEER-Medicare database between 2008 and 2015. The incidence of hospital visits for gallstone disease in the year prior to PDAC diagnosis as well as the annual incidence of gallstone disease in the SEER-Medicare noncancer cohort were assessed.

An average of 99,287 patients per year were available from the noncancer cohort, 0.8% of whom had gallstone disease and 0.3% of whom had their gallbladders removed. In contrast, in the year before their diagnosis, 4.7% of PDAC patients had a diagnosis of gallstone disease and 1.6% had their gallbladders removed.

“Gallstone disease does not cause pancreatic cancer,” lead author, Marianna Papageorge, MD, research fellow, also of Boston Medical Center, said in a statement.

“But understanding its association with PDAC can help combat the high mortality rate with pancreatic cancer by providing the opportunity for earlier diagnosis and treatment,” she added.

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

The presence of gallstone disease may be a harbinger of pancreatic ductal adenocarcinoma (PDAC), researchers suggest after showing an association between the two in a SEER-Medicare database analysis. Patients with PDAC were six times more likely to have had gallstone disease in the year prior to diagnosis than noncancer patients, they found.

“We can’t be certain at this time as to whether gallstone disease is a precursor to PDAC or whether it is the end result of PDAC, but we do know there is an association, and we plan to explore it further,” commented study author Teviah Sachs, MD, MPH, Boston Medical Center.

“We don’t want anyone with gallstone disease to think that they have pancreatic cancer because, certainly, the overwhelming majority of patients with gallstone disease do not have pancreatic cancer,” he emphasized.

“But I would say to physicians that if you have a patient who presents with gallstone disease and they have other symptoms, you should not necessarily attribute those symptoms just to their gallstone disease,” Dr. Sachs commented.

“The diagnosis of pancreatic cancer should be on the differential in patients who present with symptoms that might not otherwise correlate with typical gallstones,” he added. 

Dr. Sachs was speaking at a press briefing ahead of the annual Digestive Disease Week® (DDW), where the study will be presented.

“PDAC is often fatal because it’s frequently not diagnosed until it is late-stage disease,” Dr. Sachs noted.  

Complicating earlier diagnosis is the fact that symptoms of PDAC often mirror those associated with gallstone disease and gallbladder infection, “both of which have been demonstrated to be risk factors for PDAC,” Dr. Sachs added.
 

Annual incidence

The purpose of the present study was to compare the incidence of cholelithiasis or cholecystitis in the year before a diagnosis of PDAC with the annual incidence in the general population.

A total of 18,700 patients with PDAC, median age 76 years, were identified in the SEER-Medicare database between 2008 and 2015. The incidence of hospital visits for gallstone disease in the year prior to PDAC diagnosis as well as the annual incidence of gallstone disease in the SEER-Medicare noncancer cohort were assessed.

An average of 99,287 patients per year were available from the noncancer cohort, 0.8% of whom had gallstone disease and 0.3% of whom had their gallbladders removed. In contrast, in the year before their diagnosis, 4.7% of PDAC patients had a diagnosis of gallstone disease and 1.6% had their gallbladders removed.

“Gallstone disease does not cause pancreatic cancer,” lead author, Marianna Papageorge, MD, research fellow, also of Boston Medical Center, said in a statement.

“But understanding its association with PDAC can help combat the high mortality rate with pancreatic cancer by providing the opportunity for earlier diagnosis and treatment,” she added.

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

Early in the COVID-19 pandemic, Trisha Pasricha, MD, a gastroenterologist and research fellow at Massachusetts General Hospital in Boston, was talking to a patient who had been hospitalized for a peptic ulcer.

Like other physicians in her institution, Dr. Pasricha was wearing scrubs instead of a white coat, out of concern that the white coat might be more prone to accumulating or transmitting COVID-19 pathogens. Her badge identified her as a physician, and she introduced herself clearly as “Dr. Pasricha.”

The patient “required an emergent procedure, which I discussed with him,” Dr. Pasricha told this news organization. “I went over what the procedure entailed, the risks and benefits, and the need for informed consent. The patient nodded and seemed to understand, but at the end of the discussion he said: ‘That all sounds fine, but I need to speak to the doctor first.’ ”

Dr. Pasricha was taken aback. She wondered: “Who did he think I was the whole time that I was reviewing medical concerns, explaining medical concepts, and describing a procedure in a way that a physician would describe it?”

She realized the reason he didn’t correctly identify her was that, clad only in scrubs, she was less easily recognizable as a physician. And while this type of misidentification happened to physicians of both genders wearing scrubs and no white coat, it was more common for female than for male physicians to be misidentified as technicians, nurses, physician assistants, or other health care professionals, according to Dr. Pasricha.

Dr. Pasricha said she has been the recipient of this “implicit bias” not only from patients but also from members of the health care team, and added that other female colleagues have told her that they’ve had similar experiences, especially when they’re not wearing a white coat.
 

Changing times, changing trends

When COVID-19 began to spread, “there was an initial concern that COVID-19 was passed through surfaces, and concerns about whether white coats could carry viral particles,” according to Jordan Steinberg, MD, PhD, surgical director of the craniofacial program at Nicklaus Children’s Pediatric Specialists/Nicklaus Children’s Health System, Miami. “Hospitals didn’t want to launder the white coats as frequently as scrubs, due to cost concerns. There was also a concern raised that a necktie might dangle in patients’ faces, coming in closer contact with pathogens, so more physicians were wearing scrubs.”

Yet even before the pandemic, physician attire in hospital and outpatient settings had started to change. Dr. Steinberg, who is also a clinical associate professor at Florida International University, Miami, told this news organization that, in his previous appointment at Johns Hopkins University, Baltimore, he and his colleagues “had noticed in our institution, as well as other facilities, an increasing trend that moved from white coats worn over professional attire toward more casual dress among medical staff – increased wearing of casual fleece or softshell jackets with the institutional logo.”

This was especially true with trainees and the “younger generation,” who were preferring “what I would almost call ‘warm-up clothes,’ gym clothes, and less shirt-tie-white-coat attire for men or white-coats-and-business attire for women.” Dr. Steinberg thinks that some physicians prefer the fleece with the institutional logo “because it’s like wearing your favorite sports team jersey. It gives a sense of belonging.”

Todd Shaffer, MD, MBA, a family physician at University Physicians Associates, Truman Medical Centers and the Lakewood Medical Pavilion, Kansas City, Mo., has been at his institution for 30 years and has seen a similar trend. “At one point, things were very formal,” he told this news organization. But attire was already becoming less formal before the pandemic, and new changes took place during the pandemic, as physicians began wearing scrubs instead of white coats because of fears of viral contamination.

Now, there is less concern about potential viral contamination with the white coat. Yet many physicians continue to wear scrubs – especially those who interact with patients with COVID – and it has become more acceptable to do so, or to wear personal protective equipment (PPE) over ordinary clothing, but it is less common in routine clinical practice, said Dr. Shaffer, a member of the board of directors of the American Academy of Family Physicians.

“The world has changed since COVID. People feel more comfortable dressing more casually during professional Zoom calls, when they have the convenience of working from home,” said Dr. Shaffer, who is also a professor of family medicine at University of Missouri–Kansas City.

Dr. Shaffer himself hasn’t worn a white coat for years. “I’m more likely to wear medium casual pants. I’ve bought some nicer shirts, so I still look professional and upbeat. I don’t always tuck in my shirt, and I don’t dress as formally.” He wears PPE and a mask and/or face shield when treating patients with COVID-19. And he wears a white coat “when someone wants a photograph taken with the doctors – with the stethoscope draped around my neck.”
 

Traditional symbol of medicine

Because of the changing mores, Dr. Steinberg and colleagues at Johns Hopkins wondered if there might still be a role for professional attire and white coats and what patients prefer. To investigate the question, they surveyed 487 U.S. adults in the spring of 2020.

Respondents were asked where and how frequently they see health care professionals wearing white coats, scrubs, and fleece or softshell jackets. They were also shown photographs depicting models wearing various types of attire commonly seen in health care settings and were asked to rank the “health care provider’s” level of experience, professionalism, and friendliness.

The majority of participants said they had seen health care practitioners in white coats “most of the time,” in scrubs “sometimes,” and in fleece or softshell jackets “rarely.” Models in white coats were regarded by respondents as more experienced and professional, although those in softshell jackets were perceived as friendlier.

There were age as well as regional differences in the responses, Dr. Steinberg said. Older respondents were significantly more likely than their younger counterparts to perceive a model wearing a white coat over business attire as being more experienced, and – in all regions of the United States except the West coast – respondents gave lower professionalism scores to providers wearing fleece jackets with scrubs underneath.

Respondents tended to prefer surgeons wearing a white coat with scrubs underneath, while a white coat over business attire was the preferred dress code for family physicians and dermatologists.

“People tended to respond as if there was a more professional element in the white coat. The age-old symbol of the white coat still marked something important,” Dr. Steinberg said. “Our data suggest that the white coat isn’t ready to die just yet. People still see an air of authority and a traditional symbol of medicine. Nevertheless, I do think it will become less common than it used to be, especially in certain regions of the country.”
 

Organic, subtle changes

Christopher Petrilli, MD, assistant professor at New York University, conducted research in 2018 regarding physician attire by surveying over 4,000 patients in 10 U.S. academic hospitals. His team found that most patients continued to prefer physicians to wear formal attire under a white coat, especially older respondents.

Dr. Petrilli and colleagues have been studying the issue of physician attire since 2015. “The big issue when we did our initial study – which might not be accurate anymore – is that few hospitals actually had a uniform dress code,” said Dr. Petrilli, the medical director of clinical documentation improvement and the clinical lead of value-based medicine at NYU Langone Hospitals. “When we looked at ‘honor roll hospitals’ during our study, we cold-called these hospitals and also looked online for their dress code policies. Except for the Mayo Clinic, hospitals that had dress code policies were more generic.”

For example, the American Medical Association guidance merely states that attire should be “clean, unsoiled, and appropriate to the setting of care” and recommends weighing research findings regarding textile transmission of health care–associated infections when individual institutions determine their dress code policies. The AMA’s last policy discussion took place in 2015 and its guidance has not changed since the pandemic.

Regardless of what institutions and patients prefer, some research suggests that many physicians would prefer to stay with wearing scrubs rather than reverting to the white coat. One study of 151 hospitalists, conducted in Ireland, found that three-quarters wanted scrubs to remain standard attire, despite the fact that close to half had experienced changes in patients› perception in the absence of their white coat and “professional attire.”

Jennifer Workman, MD, assistant professor of pediatrics, division of pediatric critical care, University of Utah, Salt Lake City, said in an interview that, as the pandemic has “waxed and waned, some trends have reverted to what they were prepandemic, but other physicians have stayed with wearing scrubs.”

Much depends on practice setting, said Dr. Workman, who is also the medical director of pediatric sepsis at Intermountain Care. In pediatrics, for example, many physicians prefer not to wear white coats when they are interacting with young children or adolescents.

Like Dr. Shaffer, Dr. Workman has seen changes in physicians’ attire during video meetings, where they often dress more casually, perhaps wearing sweatshirts. And in the hospital, more are continuing to wear scrubs. “But I don’t see it as people trying to consciously experiment or push boundaries,” she said. “I see it as a more organic, subtle shift.”

Dr. Petrilli thinks that, at this juncture, it’s “pretty heterogeneous as to who is going to return to formal attire and a white coat and who won’t.” Further research needs to be done into currently evolving trends. “We need a more thorough survey looking at changes. We need to ask [physician respondents]: ‘What is your current attire, and how has it changed?’ ”
 

Navigating the gender divide

In their study, Dr. Steinberg and colleagues found that respondents perceived a male model wearing business attire underneath any type of outerwear (white coat or fleece) to be significantly more professional than a female model wearing the same attire. Respondents also perceived males wearing scrubs to be more professional than females wearing scrubs.

Male models in white coats over business attire were also more likely to be identified as physicians, compared with female models in the same attire. Females were also more likely to be misidentified as nonphysician health care professionals.

Shikha Jain, MD, assistant professor of medicine at the University of Illinois Cancer Center in Chicago, said that Dr. Steinberg’s study confirmed experiences that she and other female physicians have had. Wearing a white coat makes it more likely that a patient will identify you as a physician, but women are less likely to be identified as physicians, regardless of what they wear.

“I think that individuals of color and especially people with intersectional identities – such as women of color – are even more frequently targeted and stereotyped. Numerous studies have shown that a person of color is less likely to be seen as an authority figure, and studies have shown that physicians of color are less likely to be identified as ‘physicians,’ compared to a Caucasian individual,” she said.

Does that mean that female physicians should revert back to prepandemic white coats rather than scrubs or more casual attire? Not necessarily, according to Dr. Jain.

“The typical dress code guidance is that physicians should dress ‘professionally,’ but what that means is a question that needs to be addressed,” Dr. Jain said. “Medicine has evolved from the days of house calls, in which one’s patient population is a very small, intimate group of people in the physician’s community. Yet now, we’ve given rebirth to the ‘house call’ when we do telemedicine with a patient in his or her home. And in the old days, doctors often had offices their homes and now, with telemedicine, patients often see the interior of their physician’s home.” As the delivery of medicine evolves, concepts of “professionalism” – what is defined as “casual” and what is defined as “formal” – is also evolving.

The more important issue, according to Dr. Jain, is to “continue the conversation” about the discrepancies between how men and women are treated in medicine. Attire is one arena in which this issue plays out, and it’s a “bigger picture” that goes beyond the white coat.

Dr. Jain has been “told by patients that a particular outfit doesn’t make me look like a doctor or that scrubs make me look younger. I don’t think my male colleagues have been subjected to these types of remarks, but my female colleagues have heard them as well.”

Even fellow health care providers have commented on Dr. Jain’s clothing. She was presenting at a major medical conference via video and was wearing a similar outfit to the one she wore for her headshot. “Thirty seconds before beginning my talk, one of the male physicians said: ‘Are you wearing the same outfit you wore for your headshot?’ I can’t imagine a man commenting that another man was wearing the same jacket or tie that he wore in the photograph. I found it odd that this was something that someone felt the need to comment on right before I was about to address a large group of people in a professional capacity.”

Addressing these systemic issues “needs to be done and amplified not only by women but also by men in medicine,” said Dr. Jain, founder and director of  Women in Medicine, an organization consisting of women physicians whose goal is to “find and implement solutions to gender inequity.”

Dr. Jain said the organization offers an Inclusive Leadership Development Lab – a course specifically for men in health care leadership positions to learn how to be more equitable, inclusive leaders.
 

A personal decision

Dr. Pasricha hopes she “handled the patient’s misidentification graciously.” She explained to him that she would be the physician conducting the procedure. The patient was initially “a little embarrassed” that he had misidentified her, but she put him at ease and “we moved forward quickly.”

At this point, although some of her colleagues have continued to wear scrubs or have returned to wearing fleeces with hospital logos, Dr. Pasricha prefers to wear a white coat in both inpatient and outpatient settings because it reduces the likelihood of misidentification.

And white coats can be more convenient – for example, Dr. Jain likes the fact that the white coat has pockets where she can put her stethoscope and other items, while some of her professional clothes don’t always have pockets.

Dr. Jain noted that there are some institutions where everyone seems to wear white coats, not only the physician – “from the chaplain to the phlebotomist to the social worker.” In those settings, the white coat no longer distinguishes physicians from nonphysicians, and so wearing a white coat may not confer additional credibility as a physician.

Nevertheless, “if you want to wear a white coat, if you feel it gives you that added level of authority, if you feel it tells people more clearly that you’re a physician, by all means go ahead and do so,” she said. “There’s no ‘one-size-fits-all’ strategy or solution. What’s more important than your clothing is your professionalism.”

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

Early in the COVID-19 pandemic, Trisha Pasricha, MD, a gastroenterologist and research fellow at Massachusetts General Hospital in Boston, was talking to a patient who had been hospitalized for a peptic ulcer.

Like other physicians in her institution, Dr. Pasricha was wearing scrubs instead of a white coat, out of concern that the white coat might be more prone to accumulating or transmitting COVID-19 pathogens. Her badge identified her as a physician, and she introduced herself clearly as “Dr. Pasricha.”

The patient “required an emergent procedure, which I discussed with him,” Dr. Pasricha told this news organization. “I went over what the procedure entailed, the risks and benefits, and the need for informed consent. The patient nodded and seemed to understand, but at the end of the discussion he said: ‘That all sounds fine, but I need to speak to the doctor first.’ ”

Dr. Pasricha was taken aback. She wondered: “Who did he think I was the whole time that I was reviewing medical concerns, explaining medical concepts, and describing a procedure in a way that a physician would describe it?”

She realized the reason he didn’t correctly identify her was that, clad only in scrubs, she was less easily recognizable as a physician. And while this type of misidentification happened to physicians of both genders wearing scrubs and no white coat, it was more common for female than for male physicians to be misidentified as technicians, nurses, physician assistants, or other health care professionals, according to Dr. Pasricha.

Dr. Pasricha said she has been the recipient of this “implicit bias” not only from patients but also from members of the health care team, and added that other female colleagues have told her that they’ve had similar experiences, especially when they’re not wearing a white coat.
 

Changing times, changing trends

When COVID-19 began to spread, “there was an initial concern that COVID-19 was passed through surfaces, and concerns about whether white coats could carry viral particles,” according to Jordan Steinberg, MD, PhD, surgical director of the craniofacial program at Nicklaus Children’s Pediatric Specialists/Nicklaus Children’s Health System, Miami. “Hospitals didn’t want to launder the white coats as frequently as scrubs, due to cost concerns. There was also a concern raised that a necktie might dangle in patients’ faces, coming in closer contact with pathogens, so more physicians were wearing scrubs.”

Yet even before the pandemic, physician attire in hospital and outpatient settings had started to change. Dr. Steinberg, who is also a clinical associate professor at Florida International University, Miami, told this news organization that, in his previous appointment at Johns Hopkins University, Baltimore, he and his colleagues “had noticed in our institution, as well as other facilities, an increasing trend that moved from white coats worn over professional attire toward more casual dress among medical staff – increased wearing of casual fleece or softshell jackets with the institutional logo.”

This was especially true with trainees and the “younger generation,” who were preferring “what I would almost call ‘warm-up clothes,’ gym clothes, and less shirt-tie-white-coat attire for men or white-coats-and-business attire for women.” Dr. Steinberg thinks that some physicians prefer the fleece with the institutional logo “because it’s like wearing your favorite sports team jersey. It gives a sense of belonging.”

Todd Shaffer, MD, MBA, a family physician at University Physicians Associates, Truman Medical Centers and the Lakewood Medical Pavilion, Kansas City, Mo., has been at his institution for 30 years and has seen a similar trend. “At one point, things were very formal,” he told this news organization. But attire was already becoming less formal before the pandemic, and new changes took place during the pandemic, as physicians began wearing scrubs instead of white coats because of fears of viral contamination.

Now, there is less concern about potential viral contamination with the white coat. Yet many physicians continue to wear scrubs – especially those who interact with patients with COVID – and it has become more acceptable to do so, or to wear personal protective equipment (PPE) over ordinary clothing, but it is less common in routine clinical practice, said Dr. Shaffer, a member of the board of directors of the American Academy of Family Physicians.

“The world has changed since COVID. People feel more comfortable dressing more casually during professional Zoom calls, when they have the convenience of working from home,” said Dr. Shaffer, who is also a professor of family medicine at University of Missouri–Kansas City.

Dr. Shaffer himself hasn’t worn a white coat for years. “I’m more likely to wear medium casual pants. I’ve bought some nicer shirts, so I still look professional and upbeat. I don’t always tuck in my shirt, and I don’t dress as formally.” He wears PPE and a mask and/or face shield when treating patients with COVID-19. And he wears a white coat “when someone wants a photograph taken with the doctors – with the stethoscope draped around my neck.”
 

Traditional symbol of medicine

Because of the changing mores, Dr. Steinberg and colleagues at Johns Hopkins wondered if there might still be a role for professional attire and white coats and what patients prefer. To investigate the question, they surveyed 487 U.S. adults in the spring of 2020.

Respondents were asked where and how frequently they see health care professionals wearing white coats, scrubs, and fleece or softshell jackets. They were also shown photographs depicting models wearing various types of attire commonly seen in health care settings and were asked to rank the “health care provider’s” level of experience, professionalism, and friendliness.

The majority of participants said they had seen health care practitioners in white coats “most of the time,” in scrubs “sometimes,” and in fleece or softshell jackets “rarely.” Models in white coats were regarded by respondents as more experienced and professional, although those in softshell jackets were perceived as friendlier.

There were age as well as regional differences in the responses, Dr. Steinberg said. Older respondents were significantly more likely than their younger counterparts to perceive a model wearing a white coat over business attire as being more experienced, and – in all regions of the United States except the West coast – respondents gave lower professionalism scores to providers wearing fleece jackets with scrubs underneath.

Respondents tended to prefer surgeons wearing a white coat with scrubs underneath, while a white coat over business attire was the preferred dress code for family physicians and dermatologists.

“People tended to respond as if there was a more professional element in the white coat. The age-old symbol of the white coat still marked something important,” Dr. Steinberg said. “Our data suggest that the white coat isn’t ready to die just yet. People still see an air of authority and a traditional symbol of medicine. Nevertheless, I do think it will become less common than it used to be, especially in certain regions of the country.”
 

Organic, subtle changes

Christopher Petrilli, MD, assistant professor at New York University, conducted research in 2018 regarding physician attire by surveying over 4,000 patients in 10 U.S. academic hospitals. His team found that most patients continued to prefer physicians to wear formal attire under a white coat, especially older respondents.

Dr. Petrilli and colleagues have been studying the issue of physician attire since 2015. “The big issue when we did our initial study – which might not be accurate anymore – is that few hospitals actually had a uniform dress code,” said Dr. Petrilli, the medical director of clinical documentation improvement and the clinical lead of value-based medicine at NYU Langone Hospitals. “When we looked at ‘honor roll hospitals’ during our study, we cold-called these hospitals and also looked online for their dress code policies. Except for the Mayo Clinic, hospitals that had dress code policies were more generic.”

For example, the American Medical Association guidance merely states that attire should be “clean, unsoiled, and appropriate to the setting of care” and recommends weighing research findings regarding textile transmission of health care–associated infections when individual institutions determine their dress code policies. The AMA’s last policy discussion took place in 2015 and its guidance has not changed since the pandemic.

Regardless of what institutions and patients prefer, some research suggests that many physicians would prefer to stay with wearing scrubs rather than reverting to the white coat. One study of 151 hospitalists, conducted in Ireland, found that three-quarters wanted scrubs to remain standard attire, despite the fact that close to half had experienced changes in patients› perception in the absence of their white coat and “professional attire.”

Jennifer Workman, MD, assistant professor of pediatrics, division of pediatric critical care, University of Utah, Salt Lake City, said in an interview that, as the pandemic has “waxed and waned, some trends have reverted to what they were prepandemic, but other physicians have stayed with wearing scrubs.”

Much depends on practice setting, said Dr. Workman, who is also the medical director of pediatric sepsis at Intermountain Care. In pediatrics, for example, many physicians prefer not to wear white coats when they are interacting with young children or adolescents.

Like Dr. Shaffer, Dr. Workman has seen changes in physicians’ attire during video meetings, where they often dress more casually, perhaps wearing sweatshirts. And in the hospital, more are continuing to wear scrubs. “But I don’t see it as people trying to consciously experiment or push boundaries,” she said. “I see it as a more organic, subtle shift.”

Dr. Petrilli thinks that, at this juncture, it’s “pretty heterogeneous as to who is going to return to formal attire and a white coat and who won’t.” Further research needs to be done into currently evolving trends. “We need a more thorough survey looking at changes. We need to ask [physician respondents]: ‘What is your current attire, and how has it changed?’ ”
 

Navigating the gender divide

In their study, Dr. Steinberg and colleagues found that respondents perceived a male model wearing business attire underneath any type of outerwear (white coat or fleece) to be significantly more professional than a female model wearing the same attire. Respondents also perceived males wearing scrubs to be more professional than females wearing scrubs.

Male models in white coats over business attire were also more likely to be identified as physicians, compared with female models in the same attire. Females were also more likely to be misidentified as nonphysician health care professionals.

Shikha Jain, MD, assistant professor of medicine at the University of Illinois Cancer Center in Chicago, said that Dr. Steinberg’s study confirmed experiences that she and other female physicians have had. Wearing a white coat makes it more likely that a patient will identify you as a physician, but women are less likely to be identified as physicians, regardless of what they wear.

“I think that individuals of color and especially people with intersectional identities – such as women of color – are even more frequently targeted and stereotyped. Numerous studies have shown that a person of color is less likely to be seen as an authority figure, and studies have shown that physicians of color are less likely to be identified as ‘physicians,’ compared to a Caucasian individual,” she said.

Does that mean that female physicians should revert back to prepandemic white coats rather than scrubs or more casual attire? Not necessarily, according to Dr. Jain.

“The typical dress code guidance is that physicians should dress ‘professionally,’ but what that means is a question that needs to be addressed,” Dr. Jain said. “Medicine has evolved from the days of house calls, in which one’s patient population is a very small, intimate group of people in the physician’s community. Yet now, we’ve given rebirth to the ‘house call’ when we do telemedicine with a patient in his or her home. And in the old days, doctors often had offices their homes and now, with telemedicine, patients often see the interior of their physician’s home.” As the delivery of medicine evolves, concepts of “professionalism” – what is defined as “casual” and what is defined as “formal” – is also evolving.

The more important issue, according to Dr. Jain, is to “continue the conversation” about the discrepancies between how men and women are treated in medicine. Attire is one arena in which this issue plays out, and it’s a “bigger picture” that goes beyond the white coat.

Dr. Jain has been “told by patients that a particular outfit doesn’t make me look like a doctor or that scrubs make me look younger. I don’t think my male colleagues have been subjected to these types of remarks, but my female colleagues have heard them as well.”

Even fellow health care providers have commented on Dr. Jain’s clothing. She was presenting at a major medical conference via video and was wearing a similar outfit to the one she wore for her headshot. “Thirty seconds before beginning my talk, one of the male physicians said: ‘Are you wearing the same outfit you wore for your headshot?’ I can’t imagine a man commenting that another man was wearing the same jacket or tie that he wore in the photograph. I found it odd that this was something that someone felt the need to comment on right before I was about to address a large group of people in a professional capacity.”

Addressing these systemic issues “needs to be done and amplified not only by women but also by men in medicine,” said Dr. Jain, founder and director of  Women in Medicine, an organization consisting of women physicians whose goal is to “find and implement solutions to gender inequity.”

Dr. Jain said the organization offers an Inclusive Leadership Development Lab – a course specifically for men in health care leadership positions to learn how to be more equitable, inclusive leaders.
 

A personal decision

Dr. Pasricha hopes she “handled the patient’s misidentification graciously.” She explained to him that she would be the physician conducting the procedure. The patient was initially “a little embarrassed” that he had misidentified her, but she put him at ease and “we moved forward quickly.”

At this point, although some of her colleagues have continued to wear scrubs or have returned to wearing fleeces with hospital logos, Dr. Pasricha prefers to wear a white coat in both inpatient and outpatient settings because it reduces the likelihood of misidentification.

And white coats can be more convenient – for example, Dr. Jain likes the fact that the white coat has pockets where she can put her stethoscope and other items, while some of her professional clothes don’t always have pockets.

Dr. Jain noted that there are some institutions where everyone seems to wear white coats, not only the physician – “from the chaplain to the phlebotomist to the social worker.” In those settings, the white coat no longer distinguishes physicians from nonphysicians, and so wearing a white coat may not confer additional credibility as a physician.

Nevertheless, “if you want to wear a white coat, if you feel it gives you that added level of authority, if you feel it tells people more clearly that you’re a physician, by all means go ahead and do so,” she said. “There’s no ‘one-size-fits-all’ strategy or solution. What’s more important than your clothing is your professionalism.”

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

Early in the COVID-19 pandemic, Trisha Pasricha, MD, a gastroenterologist and research fellow at Massachusetts General Hospital in Boston, was talking to a patient who had been hospitalized for a peptic ulcer.

Like other physicians in her institution, Dr. Pasricha was wearing scrubs instead of a white coat, out of concern that the white coat might be more prone to accumulating or transmitting COVID-19 pathogens. Her badge identified her as a physician, and she introduced herself clearly as “Dr. Pasricha.”

The patient “required an emergent procedure, which I discussed with him,” Dr. Pasricha told this news organization. “I went over what the procedure entailed, the risks and benefits, and the need for informed consent. The patient nodded and seemed to understand, but at the end of the discussion he said: ‘That all sounds fine, but I need to speak to the doctor first.’ ”

Dr. Pasricha was taken aback. She wondered: “Who did he think I was the whole time that I was reviewing medical concerns, explaining medical concepts, and describing a procedure in a way that a physician would describe it?”

She realized the reason he didn’t correctly identify her was that, clad only in scrubs, she was less easily recognizable as a physician. And while this type of misidentification happened to physicians of both genders wearing scrubs and no white coat, it was more common for female than for male physicians to be misidentified as technicians, nurses, physician assistants, or other health care professionals, according to Dr. Pasricha.

Dr. Pasricha said she has been the recipient of this “implicit bias” not only from patients but also from members of the health care team, and added that other female colleagues have told her that they’ve had similar experiences, especially when they’re not wearing a white coat.
 

Changing times, changing trends

When COVID-19 began to spread, “there was an initial concern that COVID-19 was passed through surfaces, and concerns about whether white coats could carry viral particles,” according to Jordan Steinberg, MD, PhD, surgical director of the craniofacial program at Nicklaus Children’s Pediatric Specialists/Nicklaus Children’s Health System, Miami. “Hospitals didn’t want to launder the white coats as frequently as scrubs, due to cost concerns. There was also a concern raised that a necktie might dangle in patients’ faces, coming in closer contact with pathogens, so more physicians were wearing scrubs.”

Yet even before the pandemic, physician attire in hospital and outpatient settings had started to change. Dr. Steinberg, who is also a clinical associate professor at Florida International University, Miami, told this news organization that, in his previous appointment at Johns Hopkins University, Baltimore, he and his colleagues “had noticed in our institution, as well as other facilities, an increasing trend that moved from white coats worn over professional attire toward more casual dress among medical staff – increased wearing of casual fleece or softshell jackets with the institutional logo.”

This was especially true with trainees and the “younger generation,” who were preferring “what I would almost call ‘warm-up clothes,’ gym clothes, and less shirt-tie-white-coat attire for men or white-coats-and-business attire for women.” Dr. Steinberg thinks that some physicians prefer the fleece with the institutional logo “because it’s like wearing your favorite sports team jersey. It gives a sense of belonging.”

Todd Shaffer, MD, MBA, a family physician at University Physicians Associates, Truman Medical Centers and the Lakewood Medical Pavilion, Kansas City, Mo., has been at his institution for 30 years and has seen a similar trend. “At one point, things were very formal,” he told this news organization. But attire was already becoming less formal before the pandemic, and new changes took place during the pandemic, as physicians began wearing scrubs instead of white coats because of fears of viral contamination.

Now, there is less concern about potential viral contamination with the white coat. Yet many physicians continue to wear scrubs – especially those who interact with patients with COVID – and it has become more acceptable to do so, or to wear personal protective equipment (PPE) over ordinary clothing, but it is less common in routine clinical practice, said Dr. Shaffer, a member of the board of directors of the American Academy of Family Physicians.

“The world has changed since COVID. People feel more comfortable dressing more casually during professional Zoom calls, when they have the convenience of working from home,” said Dr. Shaffer, who is also a professor of family medicine at University of Missouri–Kansas City.

Dr. Shaffer himself hasn’t worn a white coat for years. “I’m more likely to wear medium casual pants. I’ve bought some nicer shirts, so I still look professional and upbeat. I don’t always tuck in my shirt, and I don’t dress as formally.” He wears PPE and a mask and/or face shield when treating patients with COVID-19. And he wears a white coat “when someone wants a photograph taken with the doctors – with the stethoscope draped around my neck.”
 

Traditional symbol of medicine

Because of the changing mores, Dr. Steinberg and colleagues at Johns Hopkins wondered if there might still be a role for professional attire and white coats and what patients prefer. To investigate the question, they surveyed 487 U.S. adults in the spring of 2020.

Respondents were asked where and how frequently they see health care professionals wearing white coats, scrubs, and fleece or softshell jackets. They were also shown photographs depicting models wearing various types of attire commonly seen in health care settings and were asked to rank the “health care provider’s” level of experience, professionalism, and friendliness.

The majority of participants said they had seen health care practitioners in white coats “most of the time,” in scrubs “sometimes,” and in fleece or softshell jackets “rarely.” Models in white coats were regarded by respondents as more experienced and professional, although those in softshell jackets were perceived as friendlier.

There were age as well as regional differences in the responses, Dr. Steinberg said. Older respondents were significantly more likely than their younger counterparts to perceive a model wearing a white coat over business attire as being more experienced, and – in all regions of the United States except the West coast – respondents gave lower professionalism scores to providers wearing fleece jackets with scrubs underneath.

Respondents tended to prefer surgeons wearing a white coat with scrubs underneath, while a white coat over business attire was the preferred dress code for family physicians and dermatologists.

“People tended to respond as if there was a more professional element in the white coat. The age-old symbol of the white coat still marked something important,” Dr. Steinberg said. “Our data suggest that the white coat isn’t ready to die just yet. People still see an air of authority and a traditional symbol of medicine. Nevertheless, I do think it will become less common than it used to be, especially in certain regions of the country.”
 

Organic, subtle changes

Christopher Petrilli, MD, assistant professor at New York University, conducted research in 2018 regarding physician attire by surveying over 4,000 patients in 10 U.S. academic hospitals. His team found that most patients continued to prefer physicians to wear formal attire under a white coat, especially older respondents.

Dr. Petrilli and colleagues have been studying the issue of physician attire since 2015. “The big issue when we did our initial study – which might not be accurate anymore – is that few hospitals actually had a uniform dress code,” said Dr. Petrilli, the medical director of clinical documentation improvement and the clinical lead of value-based medicine at NYU Langone Hospitals. “When we looked at ‘honor roll hospitals’ during our study, we cold-called these hospitals and also looked online for their dress code policies. Except for the Mayo Clinic, hospitals that had dress code policies were more generic.”

For example, the American Medical Association guidance merely states that attire should be “clean, unsoiled, and appropriate to the setting of care” and recommends weighing research findings regarding textile transmission of health care–associated infections when individual institutions determine their dress code policies. The AMA’s last policy discussion took place in 2015 and its guidance has not changed since the pandemic.

Regardless of what institutions and patients prefer, some research suggests that many physicians would prefer to stay with wearing scrubs rather than reverting to the white coat. One study of 151 hospitalists, conducted in Ireland, found that three-quarters wanted scrubs to remain standard attire, despite the fact that close to half had experienced changes in patients› perception in the absence of their white coat and “professional attire.”

Jennifer Workman, MD, assistant professor of pediatrics, division of pediatric critical care, University of Utah, Salt Lake City, said in an interview that, as the pandemic has “waxed and waned, some trends have reverted to what they were prepandemic, but other physicians have stayed with wearing scrubs.”

Much depends on practice setting, said Dr. Workman, who is also the medical director of pediatric sepsis at Intermountain Care. In pediatrics, for example, many physicians prefer not to wear white coats when they are interacting with young children or adolescents.

Like Dr. Shaffer, Dr. Workman has seen changes in physicians’ attire during video meetings, where they often dress more casually, perhaps wearing sweatshirts. And in the hospital, more are continuing to wear scrubs. “But I don’t see it as people trying to consciously experiment or push boundaries,” she said. “I see it as a more organic, subtle shift.”

Dr. Petrilli thinks that, at this juncture, it’s “pretty heterogeneous as to who is going to return to formal attire and a white coat and who won’t.” Further research needs to be done into currently evolving trends. “We need a more thorough survey looking at changes. We need to ask [physician respondents]: ‘What is your current attire, and how has it changed?’ ”
 

Navigating the gender divide

In their study, Dr. Steinberg and colleagues found that respondents perceived a male model wearing business attire underneath any type of outerwear (white coat or fleece) to be significantly more professional than a female model wearing the same attire. Respondents also perceived males wearing scrubs to be more professional than females wearing scrubs.

Male models in white coats over business attire were also more likely to be identified as physicians, compared with female models in the same attire. Females were also more likely to be misidentified as nonphysician health care professionals.

Shikha Jain, MD, assistant professor of medicine at the University of Illinois Cancer Center in Chicago, said that Dr. Steinberg’s study confirmed experiences that she and other female physicians have had. Wearing a white coat makes it more likely that a patient will identify you as a physician, but women are less likely to be identified as physicians, regardless of what they wear.

“I think that individuals of color and especially people with intersectional identities – such as women of color – are even more frequently targeted and stereotyped. Numerous studies have shown that a person of color is less likely to be seen as an authority figure, and studies have shown that physicians of color are less likely to be identified as ‘physicians,’ compared to a Caucasian individual,” she said.

Does that mean that female physicians should revert back to prepandemic white coats rather than scrubs or more casual attire? Not necessarily, according to Dr. Jain.

“The typical dress code guidance is that physicians should dress ‘professionally,’ but what that means is a question that needs to be addressed,” Dr. Jain said. “Medicine has evolved from the days of house calls, in which one’s patient population is a very small, intimate group of people in the physician’s community. Yet now, we’ve given rebirth to the ‘house call’ when we do telemedicine with a patient in his or her home. And in the old days, doctors often had offices their homes and now, with telemedicine, patients often see the interior of their physician’s home.” As the delivery of medicine evolves, concepts of “professionalism” – what is defined as “casual” and what is defined as “formal” – is also evolving.

The more important issue, according to Dr. Jain, is to “continue the conversation” about the discrepancies between how men and women are treated in medicine. Attire is one arena in which this issue plays out, and it’s a “bigger picture” that goes beyond the white coat.

Dr. Jain has been “told by patients that a particular outfit doesn’t make me look like a doctor or that scrubs make me look younger. I don’t think my male colleagues have been subjected to these types of remarks, but my female colleagues have heard them as well.”

Even fellow health care providers have commented on Dr. Jain’s clothing. She was presenting at a major medical conference via video and was wearing a similar outfit to the one she wore for her headshot. “Thirty seconds before beginning my talk, one of the male physicians said: ‘Are you wearing the same outfit you wore for your headshot?’ I can’t imagine a man commenting that another man was wearing the same jacket or tie that he wore in the photograph. I found it odd that this was something that someone felt the need to comment on right before I was about to address a large group of people in a professional capacity.”

Addressing these systemic issues “needs to be done and amplified not only by women but also by men in medicine,” said Dr. Jain, founder and director of  Women in Medicine, an organization consisting of women physicians whose goal is to “find and implement solutions to gender inequity.”

Dr. Jain said the organization offers an Inclusive Leadership Development Lab – a course specifically for men in health care leadership positions to learn how to be more equitable, inclusive leaders.
 

A personal decision

Dr. Pasricha hopes she “handled the patient’s misidentification graciously.” She explained to him that she would be the physician conducting the procedure. The patient was initially “a little embarrassed” that he had misidentified her, but she put him at ease and “we moved forward quickly.”

At this point, although some of her colleagues have continued to wear scrubs or have returned to wearing fleeces with hospital logos, Dr. Pasricha prefers to wear a white coat in both inpatient and outpatient settings because it reduces the likelihood of misidentification.

And white coats can be more convenient – for example, Dr. Jain likes the fact that the white coat has pockets where she can put her stethoscope and other items, while some of her professional clothes don’t always have pockets.

Dr. Jain noted that there are some institutions where everyone seems to wear white coats, not only the physician – “from the chaplain to the phlebotomist to the social worker.” In those settings, the white coat no longer distinguishes physicians from nonphysicians, and so wearing a white coat may not confer additional credibility as a physician.

Nevertheless, “if you want to wear a white coat, if you feel it gives you that added level of authority, if you feel it tells people more clearly that you’re a physician, by all means go ahead and do so,” she said. “There’s no ‘one-size-fits-all’ strategy or solution. What’s more important than your clothing is your professionalism.”

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

A new study questions the conventional wisdom of using steroids and anti-inflammatory drugs like ibuprofen to treat low back pain if exercise and other nondrug therapies don’t work right away.

Those medications offer relief from acute pain but may actually increase a person’s chances of developing chronic pain, said the investigators for a study published in Science Translational Medicine. The study results indicate that inflammation is a normal part of recovering from a painful injury and that inhibiting inflammation may result in more-difficult-to-treat chronic pain.

“For many decades it’s been standard medical practice to treat pain with anti-inflammatory drugs,” Jeffrey Mogil, PhD, a psychology professor at McGill University, Montreal, said in a school news release. “But we found that this short-term fix could lead to longer-term problems.”

Researchers looked at low back pain because it’s so common, with 25% of U.S. adults saying they had low back pain in the previous 3 months, according to the Centers for Disease Control and Prevention. Acute back pain is defined as lasting less than 4 weeks while chronic back pain lasts more than 12 weeks.

By examining blood samples, researchers discovered that people whose low back pain was resolved had high inflammation driven by neutrophils, a type of white blood cell that helps the body fight infection, the study said.

“Neutrophils dominate the early stages of inflammation and set the stage for repair of tissue damage. Inflammation occurs for a reason, and it looks like it’s dangerous to interfere with it,” Dr. Mogil said in the news release.

The research team found that blocking neutrophils in mice prolonged pain in the animals up to 10-fold. Pain also was prolonged when the mice were given anti-inflammatory drugs and steroids, the news release says.

McGill University said other studies support the findings. The school cited an analysis of 500,000 people in the United Kingdom. The analysis found that those taking anti-inflammatory drugs for pain were more likely to have pain 2 to 10 years later.

While saying the study suggests it’s time to reconsider how pain is treated, the researchers called for clinical trials on humans, not just observations of people with low back pain.

Experts warned about accepting the results without further investigation.

“It’s intriguing but requires further study,” Steven J. Atlas, MD, director of the Primary Care Research & Quality Improvement Network at Massachusetts General Hospital, Boston, told The New York Times.

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

A new study questions the conventional wisdom of using steroids and anti-inflammatory drugs like ibuprofen to treat low back pain if exercise and other nondrug therapies don’t work right away.

Those medications offer relief from acute pain but may actually increase a person’s chances of developing chronic pain, said the investigators for a study published in Science Translational Medicine. The study results indicate that inflammation is a normal part of recovering from a painful injury and that inhibiting inflammation may result in more-difficult-to-treat chronic pain.

“For many decades it’s been standard medical practice to treat pain with anti-inflammatory drugs,” Jeffrey Mogil, PhD, a psychology professor at McGill University, Montreal, said in a school news release. “But we found that this short-term fix could lead to longer-term problems.”

Researchers looked at low back pain because it’s so common, with 25% of U.S. adults saying they had low back pain in the previous 3 months, according to the Centers for Disease Control and Prevention. Acute back pain is defined as lasting less than 4 weeks while chronic back pain lasts more than 12 weeks.

By examining blood samples, researchers discovered that people whose low back pain was resolved had high inflammation driven by neutrophils, a type of white blood cell that helps the body fight infection, the study said.

“Neutrophils dominate the early stages of inflammation and set the stage for repair of tissue damage. Inflammation occurs for a reason, and it looks like it’s dangerous to interfere with it,” Dr. Mogil said in the news release.

The research team found that blocking neutrophils in mice prolonged pain in the animals up to 10-fold. Pain also was prolonged when the mice were given anti-inflammatory drugs and steroids, the news release says.

McGill University said other studies support the findings. The school cited an analysis of 500,000 people in the United Kingdom. The analysis found that those taking anti-inflammatory drugs for pain were more likely to have pain 2 to 10 years later.

While saying the study suggests it’s time to reconsider how pain is treated, the researchers called for clinical trials on humans, not just observations of people with low back pain.

Experts warned about accepting the results without further investigation.

“It’s intriguing but requires further study,” Steven J. Atlas, MD, director of the Primary Care Research & Quality Improvement Network at Massachusetts General Hospital, Boston, told The New York Times.

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

A new study questions the conventional wisdom of using steroids and anti-inflammatory drugs like ibuprofen to treat low back pain if exercise and other nondrug therapies don’t work right away.

Those medications offer relief from acute pain but may actually increase a person’s chances of developing chronic pain, said the investigators for a study published in Science Translational Medicine. The study results indicate that inflammation is a normal part of recovering from a painful injury and that inhibiting inflammation may result in more-difficult-to-treat chronic pain.

“For many decades it’s been standard medical practice to treat pain with anti-inflammatory drugs,” Jeffrey Mogil, PhD, a psychology professor at McGill University, Montreal, said in a school news release. “But we found that this short-term fix could lead to longer-term problems.”

Researchers looked at low back pain because it’s so common, with 25% of U.S. adults saying they had low back pain in the previous 3 months, according to the Centers for Disease Control and Prevention. Acute back pain is defined as lasting less than 4 weeks while chronic back pain lasts more than 12 weeks.

By examining blood samples, researchers discovered that people whose low back pain was resolved had high inflammation driven by neutrophils, a type of white blood cell that helps the body fight infection, the study said.

“Neutrophils dominate the early stages of inflammation and set the stage for repair of tissue damage. Inflammation occurs for a reason, and it looks like it’s dangerous to interfere with it,” Dr. Mogil said in the news release.

The research team found that blocking neutrophils in mice prolonged pain in the animals up to 10-fold. Pain also was prolonged when the mice were given anti-inflammatory drugs and steroids, the news release says.

McGill University said other studies support the findings. The school cited an analysis of 500,000 people in the United Kingdom. The analysis found that those taking anti-inflammatory drugs for pain were more likely to have pain 2 to 10 years later.

While saying the study suggests it’s time to reconsider how pain is treated, the researchers called for clinical trials on humans, not just observations of people with low back pain.

Experts warned about accepting the results without further investigation.

“It’s intriguing but requires further study,” Steven J. Atlas, MD, director of the Primary Care Research & Quality Improvement Network at Massachusetts General Hospital, Boston, told The New York Times.

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

The annual cost of Lyme disease in the United States could be nearly $970 million, according to new research. But not all cases of Lyme disease are equally costly. Costs for patients with disseminated Lyme disease were more than twice as high as those for patients with localized disease.

CDC/ Dr. Amanda Loftis, Dr. William Nicholson, Dr. Will Reeves, Dr. Chris Paddock

“These findings emphasize the importance of early and accurate diagnosis to reduce both illness and its associated personal and societal costs,” the study’s authors write. The analysis was published  in Emerging Infectious Diseases. The authors are from the Centers for Disease Control and Prevention, the Yale School of Public Health, and the Departments of Health of Minnesota, Maryland, and New York State.

Lyme disease is the most reported vector-borne disease in the United States; an estimated 476,000 Americans are diagnosed with the infection every year. Though the highest incidences are in the Northeast and in Minnesota and Wisconsin, the CDC has recorded cases in all 50 states. Over the past 20 years, estimates of the total cost of treating Lyme disease have varied from $203 million to nearly $1.3 billion. A major limitation to these studies, however, is that they may not accurately identify patients with Lyme disease or capture many of the nonmedical costs associated with treatment, the authors write, such as costs associated with time taken off work and travel to appointments.

To better capture the comprehensive cost of Lyme disease in the United States, researchers conducted a prospective study from September 2014 to January 2016 and followed reported cases in four states with high rates of Lyme disease: Connecticut, Maryland, Minnesota, and New York. The team conducted monthly patient surveys and queried billing codes from participants’ clinicians to estimate both the personal expenses and societal costs – such as total costs to the health care system – of Lyme disease.

Participants were variously assigned to one of three categories: those with confirmed local disease (such as patients with erythema migrans); those with confirmed disseminated disease, with symptoms including arthritis, lymphocytic meningitis, and encephalomyelitis; and those with probable cases with reported symptoms.

The researchers surveyed 901 participants with clinician-diagnosed Lyme disease: 402 with localized disease, 238 with disseminated disease, and 261 with probable cases. Nearly all participants (94%) were White, 57% were men, and 71% had an annual household income above $60,000. About 28% of participants were younger than 18 years, 16% were aged 18-45 years, 36% were aged 46-65, and 19% were older than 65 years. For most participants (68%), complete medical cost data were available. Those data were used to calculate societal costs.

Costs per patient varied dramatically, from $0.46 to $30,628. On average, patients spent $1,252 during the study period on expenses related to Lyme disease treatment, including expenses associated with travel and time taken off work. The median cost to patients was notably smaller, at $244. Patients with disseminated disease had the highest median ($358) and mean ($1,692) costs, followed by participants with probable disease (median, $315; mean, $1,277). Participants with localized disease had the lowest median ($170) and mean ($1,070) costs.

Societal costs ranged from $54 to $122,766 per patient; the median was $690, and the mean was $2,032. Multiplying these numbers by the estimated cases diagnosed nationally each year, researchers determined that the total cost of Lyme disease in the United States is between $345 million and $968 million.

The study “pointed out the tremendous variability in costs” associated with Lyme disease treatment, Brian Fallon, MD, MPH, director of the Lyme and Tick-Borne Diseases Research Center at the Columbia University Irving Medical Center, New York, told this news organization. He was not involved with the research. Some patients continued having health expenses after the end of the study, which means their costs would be even higher, he noted. Though most patients fully recovered after 1 year, about 4% still reported symptoms, and 3% were still incurring costs.

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

The annual cost of Lyme disease in the United States could be nearly $970 million, according to new research. But not all cases of Lyme disease are equally costly. Costs for patients with disseminated Lyme disease were more than twice as high as those for patients with localized disease.

CDC/ Dr. Amanda Loftis, Dr. William Nicholson, Dr. Will Reeves, Dr. Chris Paddock

“These findings emphasize the importance of early and accurate diagnosis to reduce both illness and its associated personal and societal costs,” the study’s authors write. The analysis was published  in Emerging Infectious Diseases. The authors are from the Centers for Disease Control and Prevention, the Yale School of Public Health, and the Departments of Health of Minnesota, Maryland, and New York State.

Lyme disease is the most reported vector-borne disease in the United States; an estimated 476,000 Americans are diagnosed with the infection every year. Though the highest incidences are in the Northeast and in Minnesota and Wisconsin, the CDC has recorded cases in all 50 states. Over the past 20 years, estimates of the total cost of treating Lyme disease have varied from $203 million to nearly $1.3 billion. A major limitation to these studies, however, is that they may not accurately identify patients with Lyme disease or capture many of the nonmedical costs associated with treatment, the authors write, such as costs associated with time taken off work and travel to appointments.

To better capture the comprehensive cost of Lyme disease in the United States, researchers conducted a prospective study from September 2014 to January 2016 and followed reported cases in four states with high rates of Lyme disease: Connecticut, Maryland, Minnesota, and New York. The team conducted monthly patient surveys and queried billing codes from participants’ clinicians to estimate both the personal expenses and societal costs – such as total costs to the health care system – of Lyme disease.

Participants were variously assigned to one of three categories: those with confirmed local disease (such as patients with erythema migrans); those with confirmed disseminated disease, with symptoms including arthritis, lymphocytic meningitis, and encephalomyelitis; and those with probable cases with reported symptoms.

The researchers surveyed 901 participants with clinician-diagnosed Lyme disease: 402 with localized disease, 238 with disseminated disease, and 261 with probable cases. Nearly all participants (94%) were White, 57% were men, and 71% had an annual household income above $60,000. About 28% of participants were younger than 18 years, 16% were aged 18-45 years, 36% were aged 46-65, and 19% were older than 65 years. For most participants (68%), complete medical cost data were available. Those data were used to calculate societal costs.

Costs per patient varied dramatically, from $0.46 to $30,628. On average, patients spent $1,252 during the study period on expenses related to Lyme disease treatment, including expenses associated with travel and time taken off work. The median cost to patients was notably smaller, at $244. Patients with disseminated disease had the highest median ($358) and mean ($1,692) costs, followed by participants with probable disease (median, $315; mean, $1,277). Participants with localized disease had the lowest median ($170) and mean ($1,070) costs.

Societal costs ranged from $54 to $122,766 per patient; the median was $690, and the mean was $2,032. Multiplying these numbers by the estimated cases diagnosed nationally each year, researchers determined that the total cost of Lyme disease in the United States is between $345 million and $968 million.

The study “pointed out the tremendous variability in costs” associated with Lyme disease treatment, Brian Fallon, MD, MPH, director of the Lyme and Tick-Borne Diseases Research Center at the Columbia University Irving Medical Center, New York, told this news organization. He was not involved with the research. Some patients continued having health expenses after the end of the study, which means their costs would be even higher, he noted. Though most patients fully recovered after 1 year, about 4% still reported symptoms, and 3% were still incurring costs.

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

The annual cost of Lyme disease in the United States could be nearly $970 million, according to new research. But not all cases of Lyme disease are equally costly. Costs for patients with disseminated Lyme disease were more than twice as high as those for patients with localized disease.

CDC/ Dr. Amanda Loftis, Dr. William Nicholson, Dr. Will Reeves, Dr. Chris Paddock

“These findings emphasize the importance of early and accurate diagnosis to reduce both illness and its associated personal and societal costs,” the study’s authors write. The analysis was published  in Emerging Infectious Diseases. The authors are from the Centers for Disease Control and Prevention, the Yale School of Public Health, and the Departments of Health of Minnesota, Maryland, and New York State.

Lyme disease is the most reported vector-borne disease in the United States; an estimated 476,000 Americans are diagnosed with the infection every year. Though the highest incidences are in the Northeast and in Minnesota and Wisconsin, the CDC has recorded cases in all 50 states. Over the past 20 years, estimates of the total cost of treating Lyme disease have varied from $203 million to nearly $1.3 billion. A major limitation to these studies, however, is that they may not accurately identify patients with Lyme disease or capture many of the nonmedical costs associated with treatment, the authors write, such as costs associated with time taken off work and travel to appointments.

To better capture the comprehensive cost of Lyme disease in the United States, researchers conducted a prospective study from September 2014 to January 2016 and followed reported cases in four states with high rates of Lyme disease: Connecticut, Maryland, Minnesota, and New York. The team conducted monthly patient surveys and queried billing codes from participants’ clinicians to estimate both the personal expenses and societal costs – such as total costs to the health care system – of Lyme disease.

Participants were variously assigned to one of three categories: those with confirmed local disease (such as patients with erythema migrans); those with confirmed disseminated disease, with symptoms including arthritis, lymphocytic meningitis, and encephalomyelitis; and those with probable cases with reported symptoms.

The researchers surveyed 901 participants with clinician-diagnosed Lyme disease: 402 with localized disease, 238 with disseminated disease, and 261 with probable cases. Nearly all participants (94%) were White, 57% were men, and 71% had an annual household income above $60,000. About 28% of participants were younger than 18 years, 16% were aged 18-45 years, 36% were aged 46-65, and 19% were older than 65 years. For most participants (68%), complete medical cost data were available. Those data were used to calculate societal costs.

Costs per patient varied dramatically, from $0.46 to $30,628. On average, patients spent $1,252 during the study period on expenses related to Lyme disease treatment, including expenses associated with travel and time taken off work. The median cost to patients was notably smaller, at $244. Patients with disseminated disease had the highest median ($358) and mean ($1,692) costs, followed by participants with probable disease (median, $315; mean, $1,277). Participants with localized disease had the lowest median ($170) and mean ($1,070) costs.

Societal costs ranged from $54 to $122,766 per patient; the median was $690, and the mean was $2,032. Multiplying these numbers by the estimated cases diagnosed nationally each year, researchers determined that the total cost of Lyme disease in the United States is between $345 million and $968 million.

The study “pointed out the tremendous variability in costs” associated with Lyme disease treatment, Brian Fallon, MD, MPH, director of the Lyme and Tick-Borne Diseases Research Center at the Columbia University Irving Medical Center, New York, told this news organization. He was not involved with the research. Some patients continued having health expenses after the end of the study, which means their costs would be even higher, he noted. Though most patients fully recovered after 1 year, about 4% still reported symptoms, and 3% were still incurring costs.

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

The Food and Drug Administration has approved an orally administered version of edaravone (Radicava ORS, Mitsubishi Tanabe Pharma America) for adults with amyotrophic lateral sclerosis (ALS). Edaravone is a pyrazolone free-radical scavenger thought to lessen the effects of oxidative stress, which is a probable factor in ALS onset and progression. The drug was first approved in 2017 as an intravenous (IV) infusion to treat ALS.

Radicava ORS is self-administered and can be taken at home. After fasting overnight, Radicava ORS should be taken in the morning orally or through a feeding tube. The oral version has the same dosing regimen as the original IV version, with an initial treatment cycle of daily dosing for 14 days, followed by a 14-day drug-free period and subsequent treatment cycles consisting of daily dosing for 10 out of 14-day periods, followed by 14-day drug-free periods.

Compared with the IV formation of Radicava, Radicava ORS has been shown to generate comparable levels of active drug in the bloodstream, the FDA said.

The FDA determined that IV Radicava was effective based on a 6-month clinical trial in Japan involving 137 individuals who were randomly chosen to receive either the drug or a placebo. At 24 weeks, individuals receiving Radicava showed less decline on a clinical assessment of daily functioning, compared with those receiving placebo.

The most common side effects of Radicava are bruising, problems walking, and headache. Fatigue is also a possible side effect from Radicava ORS. Both formulations can have serious side effects associated with allergic reactions, including hives, rash, and shortness of breath.

Full prescribing information, including additional information on risks associated with Radicava ORS, is available online.

The FDA granted Radicava ORS orphan drug status, priority review, and Fast Track designations.

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

The Food and Drug Administration has approved an orally administered version of edaravone (Radicava ORS, Mitsubishi Tanabe Pharma America) for adults with amyotrophic lateral sclerosis (ALS). Edaravone is a pyrazolone free-radical scavenger thought to lessen the effects of oxidative stress, which is a probable factor in ALS onset and progression. The drug was first approved in 2017 as an intravenous (IV) infusion to treat ALS.

Radicava ORS is self-administered and can be taken at home. After fasting overnight, Radicava ORS should be taken in the morning orally or through a feeding tube. The oral version has the same dosing regimen as the original IV version, with an initial treatment cycle of daily dosing for 14 days, followed by a 14-day drug-free period and subsequent treatment cycles consisting of daily dosing for 10 out of 14-day periods, followed by 14-day drug-free periods.

Compared with the IV formation of Radicava, Radicava ORS has been shown to generate comparable levels of active drug in the bloodstream, the FDA said.

The FDA determined that IV Radicava was effective based on a 6-month clinical trial in Japan involving 137 individuals who were randomly chosen to receive either the drug or a placebo. At 24 weeks, individuals receiving Radicava showed less decline on a clinical assessment of daily functioning, compared with those receiving placebo.

The most common side effects of Radicava are bruising, problems walking, and headache. Fatigue is also a possible side effect from Radicava ORS. Both formulations can have serious side effects associated with allergic reactions, including hives, rash, and shortness of breath.

Full prescribing information, including additional information on risks associated with Radicava ORS, is available online.

The FDA granted Radicava ORS orphan drug status, priority review, and Fast Track designations.

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

The Food and Drug Administration has approved an orally administered version of edaravone (Radicava ORS, Mitsubishi Tanabe Pharma America) for adults with amyotrophic lateral sclerosis (ALS). Edaravone is a pyrazolone free-radical scavenger thought to lessen the effects of oxidative stress, which is a probable factor in ALS onset and progression. The drug was first approved in 2017 as an intravenous (IV) infusion to treat ALS.

Radicava ORS is self-administered and can be taken at home. After fasting overnight, Radicava ORS should be taken in the morning orally or through a feeding tube. The oral version has the same dosing regimen as the original IV version, with an initial treatment cycle of daily dosing for 14 days, followed by a 14-day drug-free period and subsequent treatment cycles consisting of daily dosing for 10 out of 14-day periods, followed by 14-day drug-free periods.

Compared with the IV formation of Radicava, Radicava ORS has been shown to generate comparable levels of active drug in the bloodstream, the FDA said.

The FDA determined that IV Radicava was effective based on a 6-month clinical trial in Japan involving 137 individuals who were randomly chosen to receive either the drug or a placebo. At 24 weeks, individuals receiving Radicava showed less decline on a clinical assessment of daily functioning, compared with those receiving placebo.

The most common side effects of Radicava are bruising, problems walking, and headache. Fatigue is also a possible side effect from Radicava ORS. Both formulations can have serious side effects associated with allergic reactions, including hives, rash, and shortness of breath.

Full prescribing information, including additional information on risks associated with Radicava ORS, is available online.

The FDA granted Radicava ORS orphan drug status, priority review, and Fast Track designations.

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

Being identified as someone that was advised to stay at home and shield, or keep away from face-to-face interactions with others, during the COVID-19 pandemic was indicative of an increased risk for dying from COVID-19 within 28 days of infection, a U.K. study of inflammatory arthritis patients versus the general population suggests.

In fact, shielding status was the highest ranked of all the risk factors identified for early mortality from COVID-19, with a hazard ratio of 1.52 (95% confidence interval, 1.40-1.64) comparing people with and without inflammatory arthritis (IA) who had tested positive.

The list of risk factors associated with higher mortality in the IA patients versus the general population also included diabetes (HR, 1.38), smoking (HR, 1.27), hypertension (HR, 1.19), glucocorticoid use (HR, 1.17), and cancer (HR, 1.10), as well as increasing age (HR, 1.08) and body mass index (HR, 1.01).

Also important was the person’s prior hospitalization history, with those needing in-hospital care in the year running up to their admission for COVID-19 associated with a 34% higher risk for death, and being hospitalized previously with a serious infection was associated with a 20% higher risk.

This has more to do people’s overall vulnerability than their IA, suggested the team behind the findings, who also found that the risk of catching COVID-19 was significantly lower among patients with IA than the general population (3.5% vs. 6%), presumably because of shielding.

Examining the risks for COVID-19 in real-life practice

“COVID-19 has caused over 10 million deaths,” Roxanne Cooksey, PhD, said at the annual meeting of the British Society for Rheumatology. “It’s greatly affected vulnerable individuals, which includes individuals with IA, this is due to their compromised immune system and increased risk of infection and the medications that they take to manage their conditions.

“Previous studies have had mixed results about whether people with IA have an increased risk of poor outcome,” added Dr. Cooksey, who is a postdoctoral researcher in the division of infection and immunity at Cardiff (Wales) University.

“So, our research question looks to investigate inflammatory arthritis – that’s rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis – to see whether the conditions themselves or indeed their medications predispose individuals to an increased risk of contracting COVID or even more adverse outcomes.”

Dr. Cooksey and colleagues looked specifically at COVID-19 infection rates and outcomes in adults living in Wales during the first year of the pandemic (March 2020 to May 2021). As such they used routinely collected, anonymized health data from the SAIL Databank and performed a retrospective, population-based cohort study. In total, there were 1,966 people with inflammatory arthritis identified as having COVID-19 and 166,602 people without IA but who had COVID-19 in the study population.

As might be expected, people with inflammatory arthritis who tested positive for COVID-19 were older than those testing positive in the general population, at a mean of 62 years versus 46 years. They were also more likely to have been advised to shield (49.4% versus 4.6%), which in the United Kingdom constituted of receiving a letter telling them about the importance of social distancing, wearing a mask when out in public, and quarantining themselves at home whenever possible.

The main outcomes were hospitalizations and mortality within 28 days of COVID-19 infection. Considering the overall inflammatory arthritis population, rates of both outcomes were higher versus the general population. And when the researchers analyzed the risks according to the type of inflammatory arthritis, the associations were not statistically significant in a multivariable analysis for people with any of the inflammatory arthritis diagnoses: rheumatoid arthritis (n = 1,283), psoriatic arthritis (n = 514), or ankylosing spondylitis (n = 246). Some patients had more than one inflammatory arthritis diagnosis.
 

What does this all mean?

Dr. Cooksey conceded that there were lots of limitations to the data collected – from misclassification bias to data possibly not have been recorded completely or missing because of the disruption to health care services during the early stages of the pandemic. Patients may have been told to shield but not actually shielded, she observed, and maybe because a lack of testing COVID-19 cases were missed or people could have been asymptomatic or unable to be tested.

“The study supports the role of shielding in inflammatory arthritis,” Dr. Cooksey said, particularly in those with RA and the risk factors associated with an increased risk in death. However, that may not mean the entire population, she suggested, saying that “refining the criteria for shielding will help mitigate the negative effects of the entire IA population.”

Senior team member Ernest Choy, MD, added his thoughts, saying that, rather than giving generic shielding recommendations to all IA patients, not everyone has the same risk, so maybe not everyone needs to shield to the same level.

“Psoriatic arthritis patients and ankylosing spondylitis patients are younger, so they really don’t have as high a risk like patients with rheumatoid arthritis,” he said.

Dr. Choy, who is professor of rheumatology at the Cardiff Institute of Infection & Immunity, commented that it was not surprising to find that a prior serious infection was a risk for COVID-19 mortality. This risk factor was examined because of the known association between biologic use and the risk for serious infection.

Moreover, he said that, “if you have a serious comorbidity that requires you to get admitted to hospital, that is a reflection of your vulnerability.”

Dr. Cooksey and Dr. Choy had no relevant conflicts of interest to disclose.

Being identified as someone that was advised to stay at home and shield, or keep away from face-to-face interactions with others, during the COVID-19 pandemic was indicative of an increased risk for dying from COVID-19 within 28 days of infection, a U.K. study of inflammatory arthritis patients versus the general population suggests.

In fact, shielding status was the highest ranked of all the risk factors identified for early mortality from COVID-19, with a hazard ratio of 1.52 (95% confidence interval, 1.40-1.64) comparing people with and without inflammatory arthritis (IA) who had tested positive.

The list of risk factors associated with higher mortality in the IA patients versus the general population also included diabetes (HR, 1.38), smoking (HR, 1.27), hypertension (HR, 1.19), glucocorticoid use (HR, 1.17), and cancer (HR, 1.10), as well as increasing age (HR, 1.08) and body mass index (HR, 1.01).

Also important was the person’s prior hospitalization history, with those needing in-hospital care in the year running up to their admission for COVID-19 associated with a 34% higher risk for death, and being hospitalized previously with a serious infection was associated with a 20% higher risk.

This has more to do people’s overall vulnerability than their IA, suggested the team behind the findings, who also found that the risk of catching COVID-19 was significantly lower among patients with IA than the general population (3.5% vs. 6%), presumably because of shielding.

Examining the risks for COVID-19 in real-life practice

“COVID-19 has caused over 10 million deaths,” Roxanne Cooksey, PhD, said at the annual meeting of the British Society for Rheumatology. “It’s greatly affected vulnerable individuals, which includes individuals with IA, this is due to their compromised immune system and increased risk of infection and the medications that they take to manage their conditions.

“Previous studies have had mixed results about whether people with IA have an increased risk of poor outcome,” added Dr. Cooksey, who is a postdoctoral researcher in the division of infection and immunity at Cardiff (Wales) University.

“So, our research question looks to investigate inflammatory arthritis – that’s rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis – to see whether the conditions themselves or indeed their medications predispose individuals to an increased risk of contracting COVID or even more adverse outcomes.”

Dr. Cooksey and colleagues looked specifically at COVID-19 infection rates and outcomes in adults living in Wales during the first year of the pandemic (March 2020 to May 2021). As such they used routinely collected, anonymized health data from the SAIL Databank and performed a retrospective, population-based cohort study. In total, there were 1,966 people with inflammatory arthritis identified as having COVID-19 and 166,602 people without IA but who had COVID-19 in the study population.

As might be expected, people with inflammatory arthritis who tested positive for COVID-19 were older than those testing positive in the general population, at a mean of 62 years versus 46 years. They were also more likely to have been advised to shield (49.4% versus 4.6%), which in the United Kingdom constituted of receiving a letter telling them about the importance of social distancing, wearing a mask when out in public, and quarantining themselves at home whenever possible.

The main outcomes were hospitalizations and mortality within 28 days of COVID-19 infection. Considering the overall inflammatory arthritis population, rates of both outcomes were higher versus the general population. And when the researchers analyzed the risks according to the type of inflammatory arthritis, the associations were not statistically significant in a multivariable analysis for people with any of the inflammatory arthritis diagnoses: rheumatoid arthritis (n = 1,283), psoriatic arthritis (n = 514), or ankylosing spondylitis (n = 246). Some patients had more than one inflammatory arthritis diagnosis.
 

What does this all mean?

Dr. Cooksey conceded that there were lots of limitations to the data collected – from misclassification bias to data possibly not have been recorded completely or missing because of the disruption to health care services during the early stages of the pandemic. Patients may have been told to shield but not actually shielded, she observed, and maybe because a lack of testing COVID-19 cases were missed or people could have been asymptomatic or unable to be tested.

“The study supports the role of shielding in inflammatory arthritis,” Dr. Cooksey said, particularly in those with RA and the risk factors associated with an increased risk in death. However, that may not mean the entire population, she suggested, saying that “refining the criteria for shielding will help mitigate the negative effects of the entire IA population.”

Senior team member Ernest Choy, MD, added his thoughts, saying that, rather than giving generic shielding recommendations to all IA patients, not everyone has the same risk, so maybe not everyone needs to shield to the same level.

“Psoriatic arthritis patients and ankylosing spondylitis patients are younger, so they really don’t have as high a risk like patients with rheumatoid arthritis,” he said.

Dr. Choy, who is professor of rheumatology at the Cardiff Institute of Infection & Immunity, commented that it was not surprising to find that a prior serious infection was a risk for COVID-19 mortality. This risk factor was examined because of the known association between biologic use and the risk for serious infection.

Moreover, he said that, “if you have a serious comorbidity that requires you to get admitted to hospital, that is a reflection of your vulnerability.”

Dr. Cooksey and Dr. Choy had no relevant conflicts of interest to disclose.

Being identified as someone that was advised to stay at home and shield, or keep away from face-to-face interactions with others, during the COVID-19 pandemic was indicative of an increased risk for dying from COVID-19 within 28 days of infection, a U.K. study of inflammatory arthritis patients versus the general population suggests.

In fact, shielding status was the highest ranked of all the risk factors identified for early mortality from COVID-19, with a hazard ratio of 1.52 (95% confidence interval, 1.40-1.64) comparing people with and without inflammatory arthritis (IA) who had tested positive.

The list of risk factors associated with higher mortality in the IA patients versus the general population also included diabetes (HR, 1.38), smoking (HR, 1.27), hypertension (HR, 1.19), glucocorticoid use (HR, 1.17), and cancer (HR, 1.10), as well as increasing age (HR, 1.08) and body mass index (HR, 1.01).

Also important was the person’s prior hospitalization history, with those needing in-hospital care in the year running up to their admission for COVID-19 associated with a 34% higher risk for death, and being hospitalized previously with a serious infection was associated with a 20% higher risk.

This has more to do people’s overall vulnerability than their IA, suggested the team behind the findings, who also found that the risk of catching COVID-19 was significantly lower among patients with IA than the general population (3.5% vs. 6%), presumably because of shielding.

Examining the risks for COVID-19 in real-life practice

“COVID-19 has caused over 10 million deaths,” Roxanne Cooksey, PhD, said at the annual meeting of the British Society for Rheumatology. “It’s greatly affected vulnerable individuals, which includes individuals with IA, this is due to their compromised immune system and increased risk of infection and the medications that they take to manage their conditions.

“Previous studies have had mixed results about whether people with IA have an increased risk of poor outcome,” added Dr. Cooksey, who is a postdoctoral researcher in the division of infection and immunity at Cardiff (Wales) University.

“So, our research question looks to investigate inflammatory arthritis – that’s rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis – to see whether the conditions themselves or indeed their medications predispose individuals to an increased risk of contracting COVID or even more adverse outcomes.”

Dr. Cooksey and colleagues looked specifically at COVID-19 infection rates and outcomes in adults living in Wales during the first year of the pandemic (March 2020 to May 2021). As such they used routinely collected, anonymized health data from the SAIL Databank and performed a retrospective, population-based cohort study. In total, there were 1,966 people with inflammatory arthritis identified as having COVID-19 and 166,602 people without IA but who had COVID-19 in the study population.

As might be expected, people with inflammatory arthritis who tested positive for COVID-19 were older than those testing positive in the general population, at a mean of 62 years versus 46 years. They were also more likely to have been advised to shield (49.4% versus 4.6%), which in the United Kingdom constituted of receiving a letter telling them about the importance of social distancing, wearing a mask when out in public, and quarantining themselves at home whenever possible.

The main outcomes were hospitalizations and mortality within 28 days of COVID-19 infection. Considering the overall inflammatory arthritis population, rates of both outcomes were higher versus the general population. And when the researchers analyzed the risks according to the type of inflammatory arthritis, the associations were not statistically significant in a multivariable analysis for people with any of the inflammatory arthritis diagnoses: rheumatoid arthritis (n = 1,283), psoriatic arthritis (n = 514), or ankylosing spondylitis (n = 246). Some patients had more than one inflammatory arthritis diagnosis.
 

What does this all mean?

Dr. Cooksey conceded that there were lots of limitations to the data collected – from misclassification bias to data possibly not have been recorded completely or missing because of the disruption to health care services during the early stages of the pandemic. Patients may have been told to shield but not actually shielded, she observed, and maybe because a lack of testing COVID-19 cases were missed or people could have been asymptomatic or unable to be tested.

“The study supports the role of shielding in inflammatory arthritis,” Dr. Cooksey said, particularly in those with RA and the risk factors associated with an increased risk in death. However, that may not mean the entire population, she suggested, saying that “refining the criteria for shielding will help mitigate the negative effects of the entire IA population.”

Senior team member Ernest Choy, MD, added his thoughts, saying that, rather than giving generic shielding recommendations to all IA patients, not everyone has the same risk, so maybe not everyone needs to shield to the same level.

“Psoriatic arthritis patients and ankylosing spondylitis patients are younger, so they really don’t have as high a risk like patients with rheumatoid arthritis,” he said.

Dr. Choy, who is professor of rheumatology at the Cardiff Institute of Infection & Immunity, commented that it was not surprising to find that a prior serious infection was a risk for COVID-19 mortality. This risk factor was examined because of the known association between biologic use and the risk for serious infection.

Moreover, he said that, “if you have a serious comorbidity that requires you to get admitted to hospital, that is a reflection of your vulnerability.”

Dr. Cooksey and Dr. Choy had no relevant conflicts of interest to disclose.

Regardless of the severity of their initial illness, 89% of people who were hospitalized with COVID-19 had returned to their original work 2 years later, a new study shows.

The burden of persistent COVID-19 symptoms appeared to improve over time, but a higher percentage of former patients reported poor health, compared with the general population. This suggests that some patients need more time to completely recover from COVID-19, wrote the authors of the new study, which was published in The Lancet Respiratory Medicine. Previous research has shown that the health effects of COVID-19 last for up to a year, but data from longer-term studies are limited, said Lixue Huang, MD, of Capital Medical University, Beijing, one of the study authors, and colleagues.

Methods and results

In the new study, the researchers reviewed data from 1,192 adult patients who were discharged from the hospital after surviving COVID-19 between Jan. 7, 2020, and May 29, 2020. The researchers measured the participants’ health outcomes at 6 months, 12 months, and 2 years after their onset of symptoms. A community-based dataset of 3,383 adults with no history of COVID-19 served as controls to measure the recovery of the COVID-19 patients. The median age of the patients at the time of hospital discharge was 57 years, and 46% were women. The median follow-up time after the onset of symptoms was 185 days, 349 days, and 685 days for the 6-month, 12-month, and 2-year visits, respectively. The researchers measured health outcomes using a 6-min walking distance (6MWD) test, laboratory tests, and questionnaires about symptoms, mental health, health-related quality of life, returning to work, and health care use since leaving the hospital.

Overall, the proportion of COVID-19 survivors with at least one symptom decreased from 68% at 6 months to 55% at 2 years (P < .0001). The most frequent symptoms were fatigue and muscle weakness, reported by approximately one-third of the patients (31%); sleep problems also were reported by 31% of the patients.

The proportion of individuals with poor results on the 6MWD decreased continuously over time, not only in COVID-19 survivors overall, but also in three subgroups of varying initial disease severity. Of the 494 survivors who reported working before becoming ill, 438 (89%) had returned to their original jobs 2 years later. The most common reasons for not returning to work were decreased physical function, unwillingness to return, and unemployment, the researchers noted.

However, at 2 years, COVID-19 survivors reported more pain and discomfort, as well as more anxiety and depression, compared with the controls (23% vs. 5% and 12% vs. 5%, respectively).

In addition, significantly more survivors who needed high levels of respiratory support while hospitalized had lung diffusion impairment (65%), reduced residual volume (62%), and total lung capacity (39%), compared with matched controls (36%, 20%, and 6%, respectively) at 2 years.

Long-COVID concerns

Approximately half of the survivors had symptoms of long COVID at 2 years. These individuals were more likely to report pain or discomfort or anxiety or depression, as well as mobility problems, compared to survivors without long COVID. Participants with long-COVID symptoms were more than twice as likely to have an outpatient clinic visit (odds ratio, 2.82), and not quite twice as likely to be rehospitalized (OR, 1.64).

“We found that [health-related quality of life], exercise capacity, and mental health continued to improve throughout the 2 years regardless of initial disease severity, but about half still had symptomatic sequelae at 2 years,” the researchers wrote in their paper.

Findings can inform doctor-patient discussions

“We are increasingly recognizing that the health effects of COVID-19 may persist beyond acute illness, therefore this is a timely study to assess the long-term impact of COVID-19 with a long follow-up period,” said Suman Pal, MD, an internal medicine physician at the University of New Mexico, Albuquerque, in an interview.

The findings are consistent with the existing literature, said Dr. Pal, who was not involved in the study.  The data from the study “can help clinicians have discussions regarding expected recovery and long-term prognosis for patients with COVID-19,” he noted.

What patients should know is that “studies such as this can help COVID-19 survivors understand and monitor persistent symptoms they may experience, and bring them to the attention of their clinicians,” said Dr. Pal.

However, “As a single-center study with high attrition of subjects during the study period, the findings may not be generalizable,” Dr. Pal emphasized. “Larger-scale studies and patient registries distributed over different geographical areas and time periods will help obtain a better understanding of the nature and prevalence of long COVID,” he said.

The study findings were limited by several factors, including the lack of formerly hospitalized controls with respiratory infections other than COVID-19 to determine which outcomes are COVID-19 specific, the researchers noted. Other limitations included the use of data from only patients at a single center, and from the early stages of the pandemic, as well as the use of self-reports for comorbidities and health outcomes, they said.

However, the results represent the longest-known published longitudinal follow-up of patients who recovered from acute COVID-19, the researchers emphasized. Study strengths included the large sample size, longitudinal design, and long-term follow-up with non-COVID controls to determine outcomes. The researchers noted their plans to conduct annual follow-ups in the current study population. They added that more research is needed to explore rehabilitation programs to promote recovery for COVID-19 survivors and to reduce the effects of long COVID.

The study was supported by the Chinese Academy of Medical Sciences, National Natural Science Foundation of China, National Key Research and Development Program of China, National Administration of Traditional Chinese Medicine, Major Projects of National Science and Technology on New Drug Creation and Development of Pulmonary Tuberculosis, China Evergrande Group, Jack Ma Foundation, Sino Biopharmaceutical, Ping An Insurance (Group), and New Sunshine Charity Foundation. The researchers and Dr. Pal had no financial conflicts to disclose.

This article was updated on 5/16/2022.

Regardless of the severity of their initial illness, 89% of people who were hospitalized with COVID-19 had returned to their original work 2 years later, a new study shows.

The burden of persistent COVID-19 symptoms appeared to improve over time, but a higher percentage of former patients reported poor health, compared with the general population. This suggests that some patients need more time to completely recover from COVID-19, wrote the authors of the new study, which was published in The Lancet Respiratory Medicine. Previous research has shown that the health effects of COVID-19 last for up to a year, but data from longer-term studies are limited, said Lixue Huang, MD, of Capital Medical University, Beijing, one of the study authors, and colleagues.

Methods and results

In the new study, the researchers reviewed data from 1,192 adult patients who were discharged from the hospital after surviving COVID-19 between Jan. 7, 2020, and May 29, 2020. The researchers measured the participants’ health outcomes at 6 months, 12 months, and 2 years after their onset of symptoms. A community-based dataset of 3,383 adults with no history of COVID-19 served as controls to measure the recovery of the COVID-19 patients. The median age of the patients at the time of hospital discharge was 57 years, and 46% were women. The median follow-up time after the onset of symptoms was 185 days, 349 days, and 685 days for the 6-month, 12-month, and 2-year visits, respectively. The researchers measured health outcomes using a 6-min walking distance (6MWD) test, laboratory tests, and questionnaires about symptoms, mental health, health-related quality of life, returning to work, and health care use since leaving the hospital.

Overall, the proportion of COVID-19 survivors with at least one symptom decreased from 68% at 6 months to 55% at 2 years (P < .0001). The most frequent symptoms were fatigue and muscle weakness, reported by approximately one-third of the patients (31%); sleep problems also were reported by 31% of the patients.

The proportion of individuals with poor results on the 6MWD decreased continuously over time, not only in COVID-19 survivors overall, but also in three subgroups of varying initial disease severity. Of the 494 survivors who reported working before becoming ill, 438 (89%) had returned to their original jobs 2 years later. The most common reasons for not returning to work were decreased physical function, unwillingness to return, and unemployment, the researchers noted.

However, at 2 years, COVID-19 survivors reported more pain and discomfort, as well as more anxiety and depression, compared with the controls (23% vs. 5% and 12% vs. 5%, respectively).

In addition, significantly more survivors who needed high levels of respiratory support while hospitalized had lung diffusion impairment (65%), reduced residual volume (62%), and total lung capacity (39%), compared with matched controls (36%, 20%, and 6%, respectively) at 2 years.

Long-COVID concerns

Approximately half of the survivors had symptoms of long COVID at 2 years. These individuals were more likely to report pain or discomfort or anxiety or depression, as well as mobility problems, compared to survivors without long COVID. Participants with long-COVID symptoms were more than twice as likely to have an outpatient clinic visit (odds ratio, 2.82), and not quite twice as likely to be rehospitalized (OR, 1.64).

“We found that [health-related quality of life], exercise capacity, and mental health continued to improve throughout the 2 years regardless of initial disease severity, but about half still had symptomatic sequelae at 2 years,” the researchers wrote in their paper.

Findings can inform doctor-patient discussions

“We are increasingly recognizing that the health effects of COVID-19 may persist beyond acute illness, therefore this is a timely study to assess the long-term impact of COVID-19 with a long follow-up period,” said Suman Pal, MD, an internal medicine physician at the University of New Mexico, Albuquerque, in an interview.

The findings are consistent with the existing literature, said Dr. Pal, who was not involved in the study.  The data from the study “can help clinicians have discussions regarding expected recovery and long-term prognosis for patients with COVID-19,” he noted.

What patients should know is that “studies such as this can help COVID-19 survivors understand and monitor persistent symptoms they may experience, and bring them to the attention of their clinicians,” said Dr. Pal.

However, “As a single-center study with high attrition of subjects during the study period, the findings may not be generalizable,” Dr. Pal emphasized. “Larger-scale studies and patient registries distributed over different geographical areas and time periods will help obtain a better understanding of the nature and prevalence of long COVID,” he said.

The study findings were limited by several factors, including the lack of formerly hospitalized controls with respiratory infections other than COVID-19 to determine which outcomes are COVID-19 specific, the researchers noted. Other limitations included the use of data from only patients at a single center, and from the early stages of the pandemic, as well as the use of self-reports for comorbidities and health outcomes, they said.

However, the results represent the longest-known published longitudinal follow-up of patients who recovered from acute COVID-19, the researchers emphasized. Study strengths included the large sample size, longitudinal design, and long-term follow-up with non-COVID controls to determine outcomes. The researchers noted their plans to conduct annual follow-ups in the current study population. They added that more research is needed to explore rehabilitation programs to promote recovery for COVID-19 survivors and to reduce the effects of long COVID.

The study was supported by the Chinese Academy of Medical Sciences, National Natural Science Foundation of China, National Key Research and Development Program of China, National Administration of Traditional Chinese Medicine, Major Projects of National Science and Technology on New Drug Creation and Development of Pulmonary Tuberculosis, China Evergrande Group, Jack Ma Foundation, Sino Biopharmaceutical, Ping An Insurance (Group), and New Sunshine Charity Foundation. The researchers and Dr. Pal had no financial conflicts to disclose.

This article was updated on 5/16/2022.

Regardless of the severity of their initial illness, 89% of people who were hospitalized with COVID-19 had returned to their original work 2 years later, a new study shows.

The burden of persistent COVID-19 symptoms appeared to improve over time, but a higher percentage of former patients reported poor health, compared with the general population. This suggests that some patients need more time to completely recover from COVID-19, wrote the authors of the new study, which was published in The Lancet Respiratory Medicine. Previous research has shown that the health effects of COVID-19 last for up to a year, but data from longer-term studies are limited, said Lixue Huang, MD, of Capital Medical University, Beijing, one of the study authors, and colleagues.

Methods and results

In the new study, the researchers reviewed data from 1,192 adult patients who were discharged from the hospital after surviving COVID-19 between Jan. 7, 2020, and May 29, 2020. The researchers measured the participants’ health outcomes at 6 months, 12 months, and 2 years after their onset of symptoms. A community-based dataset of 3,383 adults with no history of COVID-19 served as controls to measure the recovery of the COVID-19 patients. The median age of the patients at the time of hospital discharge was 57 years, and 46% were women. The median follow-up time after the onset of symptoms was 185 days, 349 days, and 685 days for the 6-month, 12-month, and 2-year visits, respectively. The researchers measured health outcomes using a 6-min walking distance (6MWD) test, laboratory tests, and questionnaires about symptoms, mental health, health-related quality of life, returning to work, and health care use since leaving the hospital.

Overall, the proportion of COVID-19 survivors with at least one symptom decreased from 68% at 6 months to 55% at 2 years (P < .0001). The most frequent symptoms were fatigue and muscle weakness, reported by approximately one-third of the patients (31%); sleep problems also were reported by 31% of the patients.

The proportion of individuals with poor results on the 6MWD decreased continuously over time, not only in COVID-19 survivors overall, but also in three subgroups of varying initial disease severity. Of the 494 survivors who reported working before becoming ill, 438 (89%) had returned to their original jobs 2 years later. The most common reasons for not returning to work were decreased physical function, unwillingness to return, and unemployment, the researchers noted.

However, at 2 years, COVID-19 survivors reported more pain and discomfort, as well as more anxiety and depression, compared with the controls (23% vs. 5% and 12% vs. 5%, respectively).

In addition, significantly more survivors who needed high levels of respiratory support while hospitalized had lung diffusion impairment (65%), reduced residual volume (62%), and total lung capacity (39%), compared with matched controls (36%, 20%, and 6%, respectively) at 2 years.

Long-COVID concerns

Approximately half of the survivors had symptoms of long COVID at 2 years. These individuals were more likely to report pain or discomfort or anxiety or depression, as well as mobility problems, compared to survivors without long COVID. Participants with long-COVID symptoms were more than twice as likely to have an outpatient clinic visit (odds ratio, 2.82), and not quite twice as likely to be rehospitalized (OR, 1.64).

“We found that [health-related quality of life], exercise capacity, and mental health continued to improve throughout the 2 years regardless of initial disease severity, but about half still had symptomatic sequelae at 2 years,” the researchers wrote in their paper.

Findings can inform doctor-patient discussions

“We are increasingly recognizing that the health effects of COVID-19 may persist beyond acute illness, therefore this is a timely study to assess the long-term impact of COVID-19 with a long follow-up period,” said Suman Pal, MD, an internal medicine physician at the University of New Mexico, Albuquerque, in an interview.

The findings are consistent with the existing literature, said Dr. Pal, who was not involved in the study.  The data from the study “can help clinicians have discussions regarding expected recovery and long-term prognosis for patients with COVID-19,” he noted.

What patients should know is that “studies such as this can help COVID-19 survivors understand and monitor persistent symptoms they may experience, and bring them to the attention of their clinicians,” said Dr. Pal.

However, “As a single-center study with high attrition of subjects during the study period, the findings may not be generalizable,” Dr. Pal emphasized. “Larger-scale studies and patient registries distributed over different geographical areas and time periods will help obtain a better understanding of the nature and prevalence of long COVID,” he said.

The study findings were limited by several factors, including the lack of formerly hospitalized controls with respiratory infections other than COVID-19 to determine which outcomes are COVID-19 specific, the researchers noted. Other limitations included the use of data from only patients at a single center, and from the early stages of the pandemic, as well as the use of self-reports for comorbidities and health outcomes, they said.

However, the results represent the longest-known published longitudinal follow-up of patients who recovered from acute COVID-19, the researchers emphasized. Study strengths included the large sample size, longitudinal design, and long-term follow-up with non-COVID controls to determine outcomes. The researchers noted their plans to conduct annual follow-ups in the current study population. They added that more research is needed to explore rehabilitation programs to promote recovery for COVID-19 survivors and to reduce the effects of long COVID.

The study was supported by the Chinese Academy of Medical Sciences, National Natural Science Foundation of China, National Key Research and Development Program of China, National Administration of Traditional Chinese Medicine, Major Projects of National Science and Technology on New Drug Creation and Development of Pulmonary Tuberculosis, China Evergrande Group, Jack Ma Foundation, Sino Biopharmaceutical, Ping An Insurance (Group), and New Sunshine Charity Foundation. The researchers and Dr. Pal had no financial conflicts to disclose.

This article was updated on 5/16/2022.