Results from a randomized controlled trial conducted in China found low-dose benzbromarone to be more effective in lowering serum urate levels than low-dose febuxostat (Uloric), with a similar safety profile, in gout with renal uric acid underexcretion.

Benzbromarone is not approved in the United States because of concerns of acute liver injury but is approved in several other countries, including China, Brazil, and New Zealand.

“The results suggest that low dosing of benzbromarone may warrant stronger consideration as a safe and effective therapy to achieve serum urate target in gout without moderate chronic kidney disease,” the study team writes.

“Benzbromarone is severely hepatotoxic in some individuals and unlikely to ever gain approval in the United States,” one of the study’s investigators, Robert Terkeltaub, MD, professor of medicine, University of California, San Diego, told this news organization.

However, this study “illustrates the value and impact of uricosuric therapy in general in gout, including potentially as an initial urate-lowering monotherapy strategy, and the sheer number of subjects reaching urate target with low-dose uricosuric monotherapy was impressive,” Dr. Terkeltaub said.

The study was published online  in Arthritis & Rheumatology.

“Renal uric acid underexcretion is the chief mechanism driving hyperuricemia in gout, yet the standard urate-lowering therapy recommendation is first-line xanthine oxidase inhibition irrespective of the cause of hyperuricemia,” the study team explains in their article.

Their prospective, randomized, single-center, open-labeled trial was conducted at the Gout Clinic of the Affiliated Hospital of Qingdao University, China.

A total of 196 relatively young healthy men with gout and uric acid underexcretion were randomly assigned to receive low-dose benzbromarone (25 mg/d) or low-dose febuxostat (20 mg/d) for 12 weeks.

Renal uric acid underexcretion was defined as fractional excretion of urate less than 5.5% and uric acid excretion less than or equal to 600 mg/d/1.73 m2.

A “major aspect” of this comparative effectiveness trial was its specific focus on gout-associated renal uric acid underexcretion, where the uricosuric targeted the dominant abnormality promoting the hyperuricemia, Dr. Terkeltaub told this news organization.

In addition, all participants received daily urine alkalinization with oral sodium bicarbonate. “This is not always done in clinical practice, nor in clinical trials of uricosuric agents,” Dr. Terkeltaub said.

The results showed that more participants in the benzbromarone group achieved the serum urate target of less than 6 mg/dL, compared with those in the febuxostat group (primary endpoint, 61% vs. 32%, P < .001).

Adverse events, including gout flares and urolithiasis, did not differ significantly between the two groups, with the exception of more transaminase elevation in the febuxostat group (15% vs. 4%; P = .008).

“We did not find severe hepatotoxicity with low-dose benzbromarone, but ethnic background may affect drug responses, and severe hepatotoxicity of benzbromarone has rarely been reported in Asia,” the authors write.

The incidence of urolithiasis was numerically, but not significantly, higher in the benzbromarone group (5% vs. 2%).

This study found no significant changes in participants’ triglyceride levels, though a previous study suggested febuxostat could increase serum triglycerides.

The investigators caution that the study only included patients who had baseline serum urate levels ranging from 8.0 to 10 mg/dL, who were relatively young and with few comorbidities.

The authors further noted that the “... results may not be generalizable to patients with higher serum urate levels or impaired kidney function, as well [as] patients from other geographical regions, age, and ethnicity groups. The study only included men, and the findings may not be generalizable to women with gout.”

‘Very useful’ in select cases

Weighing in on the results, Valderilio Feijó Azevedo, MD, PhD, adjunct professor of rheumatology, Federal University of Paraná, Brazil, noted that in some specific clinical circumstances, benzbromarone has been “a very useful medication, alone or combined, to treat gout patients.”

“We have great experience with the drug in Brazil. However, it is not used to treat all patients. Patients must be very well-selected in our clinical practice,” Dr. Azevedo said in an interview.

“For most patients, benzbromarone is effective for those who have failed to achieve serum uric acid goals with allopurinol treatment. We do not use it to treat patients with asymptomatic hyperuricemia. In general, we avoid patients with hepatic dysfunction due to previous hepatotoxicity reports. In every patient, we do active monitoring of enzymes,” Dr. Azevedo explained.

“We also avoid using it in patients with severe kidney disease. However, we have used it in some patients with estimated glomerular filtration rate less than 30. We also avoid dosage over 200 mg per day. On average, we use 100 mg per day combined with allopurinol or alone,” said Dr. Azevedo, who was not involved with the study.

Also weighing in, Michael Pillinger, MD, rheumatologist at NYU Langone Health, noted that while benzbromarone is not used in the United States, “in many parts of the world, it is used and is felt to be effective.” Dr. Pillinger was not associated with this current research.

This study, Dr. Pillinger said, “does underline the fact that an alternative drug that lowers urate by promoting urate excretion, if it could gain [U.S. Food and Drug Association] approval and if it were safe, could present a viable new option for therapy.”

He added, “If one conclusion to the study is that determining the basis of hyperuricemia is helpful in guiding benzbromarone use, that implies an additional layer of effort for physicians and patients in a disease that is already notoriously known for patient noncompliance – and in a case where febuxostat and allopurinol will work for both overproducers and underexcreters and would not need this additional assessment.”

The study was sponsored by Shandong Provincial Key Research and Development Plan, the National Natural Science Foundation of China, and Shandong Provincial Science Foundation for Outstanding Youth Scholarship. Dr. Terkeltaub was supported by the National Institutes of Health and the VA Research Service. Dr. Terkeltaub has received research funding from AstraZeneca, and has consulted with Horizon, Selecta, SOBI, Dyve BioSciences, Fortress, AstraZeneca, Allena, Fortress Biotech, and LG Life Sciences. Dr. Azevedo and Dr. Pillinger have no reported no relevant financial relationships.

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

Results from a randomized controlled trial conducted in China found low-dose benzbromarone to be more effective in lowering serum urate levels than low-dose febuxostat (Uloric), with a similar safety profile, in gout with renal uric acid underexcretion.

Benzbromarone is not approved in the United States because of concerns of acute liver injury but is approved in several other countries, including China, Brazil, and New Zealand.

“The results suggest that low dosing of benzbromarone may warrant stronger consideration as a safe and effective therapy to achieve serum urate target in gout without moderate chronic kidney disease,” the study team writes.

“Benzbromarone is severely hepatotoxic in some individuals and unlikely to ever gain approval in the United States,” one of the study’s investigators, Robert Terkeltaub, MD, professor of medicine, University of California, San Diego, told this news organization.

However, this study “illustrates the value and impact of uricosuric therapy in general in gout, including potentially as an initial urate-lowering monotherapy strategy, and the sheer number of subjects reaching urate target with low-dose uricosuric monotherapy was impressive,” Dr. Terkeltaub said.

The study was published online  in Arthritis & Rheumatology.

“Renal uric acid underexcretion is the chief mechanism driving hyperuricemia in gout, yet the standard urate-lowering therapy recommendation is first-line xanthine oxidase inhibition irrespective of the cause of hyperuricemia,” the study team explains in their article.

Their prospective, randomized, single-center, open-labeled trial was conducted at the Gout Clinic of the Affiliated Hospital of Qingdao University, China.

A total of 196 relatively young healthy men with gout and uric acid underexcretion were randomly assigned to receive low-dose benzbromarone (25 mg/d) or low-dose febuxostat (20 mg/d) for 12 weeks.

Renal uric acid underexcretion was defined as fractional excretion of urate less than 5.5% and uric acid excretion less than or equal to 600 mg/d/1.73 m2.

A “major aspect” of this comparative effectiveness trial was its specific focus on gout-associated renal uric acid underexcretion, where the uricosuric targeted the dominant abnormality promoting the hyperuricemia, Dr. Terkeltaub told this news organization.

In addition, all participants received daily urine alkalinization with oral sodium bicarbonate. “This is not always done in clinical practice, nor in clinical trials of uricosuric agents,” Dr. Terkeltaub said.

The results showed that more participants in the benzbromarone group achieved the serum urate target of less than 6 mg/dL, compared with those in the febuxostat group (primary endpoint, 61% vs. 32%, P < .001).

Adverse events, including gout flares and urolithiasis, did not differ significantly between the two groups, with the exception of more transaminase elevation in the febuxostat group (15% vs. 4%; P = .008).

“We did not find severe hepatotoxicity with low-dose benzbromarone, but ethnic background may affect drug responses, and severe hepatotoxicity of benzbromarone has rarely been reported in Asia,” the authors write.

The incidence of urolithiasis was numerically, but not significantly, higher in the benzbromarone group (5% vs. 2%).

This study found no significant changes in participants’ triglyceride levels, though a previous study suggested febuxostat could increase serum triglycerides.

The investigators caution that the study only included patients who had baseline serum urate levels ranging from 8.0 to 10 mg/dL, who were relatively young and with few comorbidities.

The authors further noted that the “... results may not be generalizable to patients with higher serum urate levels or impaired kidney function, as well [as] patients from other geographical regions, age, and ethnicity groups. The study only included men, and the findings may not be generalizable to women with gout.”

‘Very useful’ in select cases

Weighing in on the results, Valderilio Feijó Azevedo, MD, PhD, adjunct professor of rheumatology, Federal University of Paraná, Brazil, noted that in some specific clinical circumstances, benzbromarone has been “a very useful medication, alone or combined, to treat gout patients.”

“We have great experience with the drug in Brazil. However, it is not used to treat all patients. Patients must be very well-selected in our clinical practice,” Dr. Azevedo said in an interview.

“For most patients, benzbromarone is effective for those who have failed to achieve serum uric acid goals with allopurinol treatment. We do not use it to treat patients with asymptomatic hyperuricemia. In general, we avoid patients with hepatic dysfunction due to previous hepatotoxicity reports. In every patient, we do active monitoring of enzymes,” Dr. Azevedo explained.

“We also avoid using it in patients with severe kidney disease. However, we have used it in some patients with estimated glomerular filtration rate less than 30. We also avoid dosage over 200 mg per day. On average, we use 100 mg per day combined with allopurinol or alone,” said Dr. Azevedo, who was not involved with the study.

Also weighing in, Michael Pillinger, MD, rheumatologist at NYU Langone Health, noted that while benzbromarone is not used in the United States, “in many parts of the world, it is used and is felt to be effective.” Dr. Pillinger was not associated with this current research.

This study, Dr. Pillinger said, “does underline the fact that an alternative drug that lowers urate by promoting urate excretion, if it could gain [U.S. Food and Drug Association] approval and if it were safe, could present a viable new option for therapy.”

He added, “If one conclusion to the study is that determining the basis of hyperuricemia is helpful in guiding benzbromarone use, that implies an additional layer of effort for physicians and patients in a disease that is already notoriously known for patient noncompliance – and in a case where febuxostat and allopurinol will work for both overproducers and underexcreters and would not need this additional assessment.”

The study was sponsored by Shandong Provincial Key Research and Development Plan, the National Natural Science Foundation of China, and Shandong Provincial Science Foundation for Outstanding Youth Scholarship. Dr. Terkeltaub was supported by the National Institutes of Health and the VA Research Service. Dr. Terkeltaub has received research funding from AstraZeneca, and has consulted with Horizon, Selecta, SOBI, Dyve BioSciences, Fortress, AstraZeneca, Allena, Fortress Biotech, and LG Life Sciences. Dr. Azevedo and Dr. Pillinger have no reported no relevant financial relationships.

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

Results from a randomized controlled trial conducted in China found low-dose benzbromarone to be more effective in lowering serum urate levels than low-dose febuxostat (Uloric), with a similar safety profile, in gout with renal uric acid underexcretion.

Benzbromarone is not approved in the United States because of concerns of acute liver injury but is approved in several other countries, including China, Brazil, and New Zealand.

“The results suggest that low dosing of benzbromarone may warrant stronger consideration as a safe and effective therapy to achieve serum urate target in gout without moderate chronic kidney disease,” the study team writes.

“Benzbromarone is severely hepatotoxic in some individuals and unlikely to ever gain approval in the United States,” one of the study’s investigators, Robert Terkeltaub, MD, professor of medicine, University of California, San Diego, told this news organization.

However, this study “illustrates the value and impact of uricosuric therapy in general in gout, including potentially as an initial urate-lowering monotherapy strategy, and the sheer number of subjects reaching urate target with low-dose uricosuric monotherapy was impressive,” Dr. Terkeltaub said.

The study was published online  in Arthritis & Rheumatology.

“Renal uric acid underexcretion is the chief mechanism driving hyperuricemia in gout, yet the standard urate-lowering therapy recommendation is first-line xanthine oxidase inhibition irrespective of the cause of hyperuricemia,” the study team explains in their article.

Their prospective, randomized, single-center, open-labeled trial was conducted at the Gout Clinic of the Affiliated Hospital of Qingdao University, China.

A total of 196 relatively young healthy men with gout and uric acid underexcretion were randomly assigned to receive low-dose benzbromarone (25 mg/d) or low-dose febuxostat (20 mg/d) for 12 weeks.

Renal uric acid underexcretion was defined as fractional excretion of urate less than 5.5% and uric acid excretion less than or equal to 600 mg/d/1.73 m2.

A “major aspect” of this comparative effectiveness trial was its specific focus on gout-associated renal uric acid underexcretion, where the uricosuric targeted the dominant abnormality promoting the hyperuricemia, Dr. Terkeltaub told this news organization.

In addition, all participants received daily urine alkalinization with oral sodium bicarbonate. “This is not always done in clinical practice, nor in clinical trials of uricosuric agents,” Dr. Terkeltaub said.

The results showed that more participants in the benzbromarone group achieved the serum urate target of less than 6 mg/dL, compared with those in the febuxostat group (primary endpoint, 61% vs. 32%, P < .001).

Adverse events, including gout flares and urolithiasis, did not differ significantly between the two groups, with the exception of more transaminase elevation in the febuxostat group (15% vs. 4%; P = .008).

“We did not find severe hepatotoxicity with low-dose benzbromarone, but ethnic background may affect drug responses, and severe hepatotoxicity of benzbromarone has rarely been reported in Asia,” the authors write.

The incidence of urolithiasis was numerically, but not significantly, higher in the benzbromarone group (5% vs. 2%).

This study found no significant changes in participants’ triglyceride levels, though a previous study suggested febuxostat could increase serum triglycerides.

The investigators caution that the study only included patients who had baseline serum urate levels ranging from 8.0 to 10 mg/dL, who were relatively young and with few comorbidities.

The authors further noted that the “... results may not be generalizable to patients with higher serum urate levels or impaired kidney function, as well [as] patients from other geographical regions, age, and ethnicity groups. The study only included men, and the findings may not be generalizable to women with gout.”

‘Very useful’ in select cases

Weighing in on the results, Valderilio Feijó Azevedo, MD, PhD, adjunct professor of rheumatology, Federal University of Paraná, Brazil, noted that in some specific clinical circumstances, benzbromarone has been “a very useful medication, alone or combined, to treat gout patients.”

“We have great experience with the drug in Brazil. However, it is not used to treat all patients. Patients must be very well-selected in our clinical practice,” Dr. Azevedo said in an interview.

“For most patients, benzbromarone is effective for those who have failed to achieve serum uric acid goals with allopurinol treatment. We do not use it to treat patients with asymptomatic hyperuricemia. In general, we avoid patients with hepatic dysfunction due to previous hepatotoxicity reports. In every patient, we do active monitoring of enzymes,” Dr. Azevedo explained.

“We also avoid using it in patients with severe kidney disease. However, we have used it in some patients with estimated glomerular filtration rate less than 30. We also avoid dosage over 200 mg per day. On average, we use 100 mg per day combined with allopurinol or alone,” said Dr. Azevedo, who was not involved with the study.

Also weighing in, Michael Pillinger, MD, rheumatologist at NYU Langone Health, noted that while benzbromarone is not used in the United States, “in many parts of the world, it is used and is felt to be effective.” Dr. Pillinger was not associated with this current research.

This study, Dr. Pillinger said, “does underline the fact that an alternative drug that lowers urate by promoting urate excretion, if it could gain [U.S. Food and Drug Association] approval and if it were safe, could present a viable new option for therapy.”

He added, “If one conclusion to the study is that determining the basis of hyperuricemia is helpful in guiding benzbromarone use, that implies an additional layer of effort for physicians and patients in a disease that is already notoriously known for patient noncompliance – and in a case where febuxostat and allopurinol will work for both overproducers and underexcreters and would not need this additional assessment.”

The study was sponsored by Shandong Provincial Key Research and Development Plan, the National Natural Science Foundation of China, and Shandong Provincial Science Foundation for Outstanding Youth Scholarship. Dr. Terkeltaub was supported by the National Institutes of Health and the VA Research Service. Dr. Terkeltaub has received research funding from AstraZeneca, and has consulted with Horizon, Selecta, SOBI, Dyve BioSciences, Fortress, AstraZeneca, Allena, Fortress Biotech, and LG Life Sciences. Dr. Azevedo and Dr. Pillinger have no reported no relevant financial relationships.

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

Sitting at his desk in Sea Girt, N.J., John Schwind is eager to demonstrate his ReadiMask 365. He holds up what looks like a white sheet of memo paper, peels off a protective liner, and sticks the mask first to his nose. He glides his fingers down his face, over his cheeks, and to his chin, sealing the mask and then demonstrating how easy it is to talk with it in place.

The mask’s medical adhesive sticks directly to the face, without causing breakouts, he said. It doesn’t let air leak and won’t fog his glasses. It’s strapless, so it won’t hurt his ears or make them stick out.

This fall, Mr. Schwind, the CEO of Global Safety First, is hoping to take home $150,000 as one of the two top winners of the federal Mask Innovation Challenge. He has made it to the top 10 but realizes he still has a ton of competition.

After the challenge launched in late 2021, nearly 1,500 submissions were received, says Kumiko Lippold, PhD, a health scientist and manager of the Mask Innovation Challenge. The challenge is run by Dr. Lippold and others at the Division of Research, Innovation, and Ventures (DRIVe), which is part of the Biomedical Advanced Research and Development Authority (BARDA) at the U.S. Department of Health & Human Services.

Like the rest of us, Dr. Lippold knows that masks desperately need a makeover. The point of the challenge is to inspire and design masks that are comfortable, even with long wear, and that provide excellent protection. The aim is not only to get us through this pandemic but also future pandemics and other public health emergencies. “We are focused on building masks for the next pandemic, the next wildfires,” she says.

The project is a partnership among BARDA’s DRIVe, the National Institute for Occupational Safety and Health (NIOSH), and the National Institute of Standards and Technology (NIST).

While NIOSH is a partner in the challenge, giving feedback to mask developers, “the mask challenge is entirely separate from the NIOSH approval process,” Dr. Lippold says. Companies can then pursue NIOSH approval on their own, later, if they wish. The agency certifies only masks and respirators.
 

Preview of masks to come

“We’ve seen some really amazing things,” Dr. Lippold said of the new designs. She didn’t want to play favorites, so she gave an overview of innovations. Some designs have transparent materials, or partially see-through materials, so facial expressions can be read. “We’ve also seen really unique bio-based materials that are derived from natural products. We’ve seen sensors in some.”

One mask model has origami folds, which increase overall surface and breathing area. Some 3D-printed masks promise a custom fit and take into account whether a person’s nose bridge is low or high.
 

And the finalists are ...

ReadiMask 365: “I can wear this all day long,” Mr. Schwind said of his new design. It has a nano fiber filter and is flexible. Besides the one in the BARDA challenge, the company has other ReadiMasks on the market. “The most important thing is comfort,” he says. “Second is protection. If they don’t feel they have a good seal, users don’t have confidence in the mask.”

He offers various sizes of ReadiMasks, from small sizes designed for women with smaller faces to extra-large, “for NFL linemen.”

ClearMask: “We are the original clear mask,” says Aaron Hsu, CEO and co-founder of ClearMask in Baltimore. The company began in 2017, and the clear design was inspired by a company co-founder who is deaf. She was scheduled to have surgery, and her sign language interpreter did not show up, leaving her to try to communicate in the operating room with masked health care providers. There were no transparent masks available then, Mr. Hsu says.

“Being able to work with BARDA and getting their wisdom is invaluable,” he says.

The makers of ClearMask think masks are here to stay, at least for some. “I think a certain percentage of the population will continue to wear them, regardless,” said Mr. Hsu. He predicts health care settings will become stricter about wearing masks.

“Even now, when you even walk in to a hospital, you might be required to wear a mask,” he says, even as a visitor. His company’s masks are easy to adjust and are secured around the head, so your ears don’t get sore, he says.

4C Air: The BreSafe transparent mask is semi-transparent and is made of a nanomaterial that provides high levels of filtration and breathability with some transparency.

Air99: Based on origami principles, the Airgami mask is meant to improve fit, breathability, and aesthetics over existing masks. “Airgami fits better, works better and looks better,” says Min Xiao, a company spokesperson. “It won’t fall off the nose or collapse onto the mouth, and eyeglasses fog less, she says. Voices are less muffled.” It’s also reusable, rinseable and can be heat disinfected, she says. It went on the market in November 2020.

Air Flo Labs: Flo Mask Pro, like the company’s other designs, conducted over 100 3D facial scans across many ethnicities to produce a better fit, says Kevin Ngo, its creator. For the adult masks, two nose bridge sizes are offered. And users can choose a Pro Filter, with 99% filtration, or an Everyday, which is meant to be much more breathable than other masks. “Our silicone gasket is incredibly soft and gentle on the skin,” Mr. Ngo says. “In addition,we offer indents for glasses, which prevent any fogging.” The company began shipping in May; several thousand masks are in use now, Mr. Ngo said.

Georgetown University: This team’s smart mask is made of metallic foams that can be cleaned and reused.

Levi Strauss: The form of the mask can be made by any basic garment factory. It aims to activate the apparel supply chain as another source of low-cost, high-performance masks.

Matregenix: This mask, made of a transparent nanofiber, allows for easier communication while having high filtration.

SEAL Lab: The SINEW mask stands for Smart, Individualized, Near-Face, Extended Wear. The mask used technology to overcome flaws of traditional respirators, with the same degree of protection. It doesn’t make contact with the skin of the wearer’s face.

StaySafeNow: A team from Harvard University developed Crystal Guard, a reusable, cost-effective clear mask. Its developers say it’s meant to be especially useful for essential workers, teachers, and others who have to communicate to do their work.
 

Bye-bye N95?

“From our perspective, our goal with the mask challenge was not to replace the N95 respirator,” Dr. Lippold says. N95 masks, which NIOSH certifies, are valuable and protect people in high-risk settings. “With the mask challenge, our goal was really to provide the public with a comparable alternative that really meets their specific level of risk.” Working in a health care setting carries a different risk, she says, than going to the grocery store.

“A common complaint with the N95 is that they are very uncomfortable.” It’s a major barrier to compliance, “and we wanted to address that gap. We didn’t directly compare [the entries] to an N95,” she says, although their testing was similar to NIOSH’s. A number of finalists say they will pursue NIOSH approval, she says.

Meanwhile, some of the finalists’ masks are for sale. Air Flo Labs, for instance, has its Flo Mask Pro for sale online, noting that BARDA allowed it to release the test results from NIOSH and NIST.
 

Getting from 1,500 to 10

In the first phase of the challenge, Dr. Lippold says, “the goal was to engage as wide an audience as possible.” With the second phase, the bar was set a bit higher. Instead of just submitting ideas on paper, companies had to submit prototypes for lab testing. “We got about 80 submissions,” she says.

Those 80 were whittled down to 10 finalists. Teams had sent prototypes, and experts, including those from NIOSH and NIST, rated them, sometimes looking at multiple copies of the masks. Experts looked at how well the masks filtered the air, how breathable they were, and other data. Once the feedback was given to the mask companies, they entered a redesign period. “Scientists can take this data and basically make these prototypes better,” Dr. Lippold says.

The final round of testing will be in September, and the winners will be announced in the fall. The opportunity allowed companies to have their products go through testing they might not otherwise have been able to get, she says.

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

Sitting at his desk in Sea Girt, N.J., John Schwind is eager to demonstrate his ReadiMask 365. He holds up what looks like a white sheet of memo paper, peels off a protective liner, and sticks the mask first to his nose. He glides his fingers down his face, over his cheeks, and to his chin, sealing the mask and then demonstrating how easy it is to talk with it in place.

The mask’s medical adhesive sticks directly to the face, without causing breakouts, he said. It doesn’t let air leak and won’t fog his glasses. It’s strapless, so it won’t hurt his ears or make them stick out.

This fall, Mr. Schwind, the CEO of Global Safety First, is hoping to take home $150,000 as one of the two top winners of the federal Mask Innovation Challenge. He has made it to the top 10 but realizes he still has a ton of competition.

After the challenge launched in late 2021, nearly 1,500 submissions were received, says Kumiko Lippold, PhD, a health scientist and manager of the Mask Innovation Challenge. The challenge is run by Dr. Lippold and others at the Division of Research, Innovation, and Ventures (DRIVe), which is part of the Biomedical Advanced Research and Development Authority (BARDA) at the U.S. Department of Health & Human Services.

Like the rest of us, Dr. Lippold knows that masks desperately need a makeover. The point of the challenge is to inspire and design masks that are comfortable, even with long wear, and that provide excellent protection. The aim is not only to get us through this pandemic but also future pandemics and other public health emergencies. “We are focused on building masks for the next pandemic, the next wildfires,” she says.

The project is a partnership among BARDA’s DRIVe, the National Institute for Occupational Safety and Health (NIOSH), and the National Institute of Standards and Technology (NIST).

While NIOSH is a partner in the challenge, giving feedback to mask developers, “the mask challenge is entirely separate from the NIOSH approval process,” Dr. Lippold says. Companies can then pursue NIOSH approval on their own, later, if they wish. The agency certifies only masks and respirators.
 

Preview of masks to come

“We’ve seen some really amazing things,” Dr. Lippold said of the new designs. She didn’t want to play favorites, so she gave an overview of innovations. Some designs have transparent materials, or partially see-through materials, so facial expressions can be read. “We’ve also seen really unique bio-based materials that are derived from natural products. We’ve seen sensors in some.”

One mask model has origami folds, which increase overall surface and breathing area. Some 3D-printed masks promise a custom fit and take into account whether a person’s nose bridge is low or high.
 

And the finalists are ...

ReadiMask 365: “I can wear this all day long,” Mr. Schwind said of his new design. It has a nano fiber filter and is flexible. Besides the one in the BARDA challenge, the company has other ReadiMasks on the market. “The most important thing is comfort,” he says. “Second is protection. If they don’t feel they have a good seal, users don’t have confidence in the mask.”

He offers various sizes of ReadiMasks, from small sizes designed for women with smaller faces to extra-large, “for NFL linemen.”

ClearMask: “We are the original clear mask,” says Aaron Hsu, CEO and co-founder of ClearMask in Baltimore. The company began in 2017, and the clear design was inspired by a company co-founder who is deaf. She was scheduled to have surgery, and her sign language interpreter did not show up, leaving her to try to communicate in the operating room with masked health care providers. There were no transparent masks available then, Mr. Hsu says.

“Being able to work with BARDA and getting their wisdom is invaluable,” he says.

The makers of ClearMask think masks are here to stay, at least for some. “I think a certain percentage of the population will continue to wear them, regardless,” said Mr. Hsu. He predicts health care settings will become stricter about wearing masks.

“Even now, when you even walk in to a hospital, you might be required to wear a mask,” he says, even as a visitor. His company’s masks are easy to adjust and are secured around the head, so your ears don’t get sore, he says.

4C Air: The BreSafe transparent mask is semi-transparent and is made of a nanomaterial that provides high levels of filtration and breathability with some transparency.

Air99: Based on origami principles, the Airgami mask is meant to improve fit, breathability, and aesthetics over existing masks. “Airgami fits better, works better and looks better,” says Min Xiao, a company spokesperson. “It won’t fall off the nose or collapse onto the mouth, and eyeglasses fog less, she says. Voices are less muffled.” It’s also reusable, rinseable and can be heat disinfected, she says. It went on the market in November 2020.

Air Flo Labs: Flo Mask Pro, like the company’s other designs, conducted over 100 3D facial scans across many ethnicities to produce a better fit, says Kevin Ngo, its creator. For the adult masks, two nose bridge sizes are offered. And users can choose a Pro Filter, with 99% filtration, or an Everyday, which is meant to be much more breathable than other masks. “Our silicone gasket is incredibly soft and gentle on the skin,” Mr. Ngo says. “In addition,we offer indents for glasses, which prevent any fogging.” The company began shipping in May; several thousand masks are in use now, Mr. Ngo said.

Georgetown University: This team’s smart mask is made of metallic foams that can be cleaned and reused.

Levi Strauss: The form of the mask can be made by any basic garment factory. It aims to activate the apparel supply chain as another source of low-cost, high-performance masks.

Matregenix: This mask, made of a transparent nanofiber, allows for easier communication while having high filtration.

SEAL Lab: The SINEW mask stands for Smart, Individualized, Near-Face, Extended Wear. The mask used technology to overcome flaws of traditional respirators, with the same degree of protection. It doesn’t make contact with the skin of the wearer’s face.

StaySafeNow: A team from Harvard University developed Crystal Guard, a reusable, cost-effective clear mask. Its developers say it’s meant to be especially useful for essential workers, teachers, and others who have to communicate to do their work.
 

Bye-bye N95?

“From our perspective, our goal with the mask challenge was not to replace the N95 respirator,” Dr. Lippold says. N95 masks, which NIOSH certifies, are valuable and protect people in high-risk settings. “With the mask challenge, our goal was really to provide the public with a comparable alternative that really meets their specific level of risk.” Working in a health care setting carries a different risk, she says, than going to the grocery store.

“A common complaint with the N95 is that they are very uncomfortable.” It’s a major barrier to compliance, “and we wanted to address that gap. We didn’t directly compare [the entries] to an N95,” she says, although their testing was similar to NIOSH’s. A number of finalists say they will pursue NIOSH approval, she says.

Meanwhile, some of the finalists’ masks are for sale. Air Flo Labs, for instance, has its Flo Mask Pro for sale online, noting that BARDA allowed it to release the test results from NIOSH and NIST.
 

Getting from 1,500 to 10

In the first phase of the challenge, Dr. Lippold says, “the goal was to engage as wide an audience as possible.” With the second phase, the bar was set a bit higher. Instead of just submitting ideas on paper, companies had to submit prototypes for lab testing. “We got about 80 submissions,” she says.

Those 80 were whittled down to 10 finalists. Teams had sent prototypes, and experts, including those from NIOSH and NIST, rated them, sometimes looking at multiple copies of the masks. Experts looked at how well the masks filtered the air, how breathable they were, and other data. Once the feedback was given to the mask companies, they entered a redesign period. “Scientists can take this data and basically make these prototypes better,” Dr. Lippold says.

The final round of testing will be in September, and the winners will be announced in the fall. The opportunity allowed companies to have their products go through testing they might not otherwise have been able to get, she says.

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

Sitting at his desk in Sea Girt, N.J., John Schwind is eager to demonstrate his ReadiMask 365. He holds up what looks like a white sheet of memo paper, peels off a protective liner, and sticks the mask first to his nose. He glides his fingers down his face, over his cheeks, and to his chin, sealing the mask and then demonstrating how easy it is to talk with it in place.

The mask’s medical adhesive sticks directly to the face, without causing breakouts, he said. It doesn’t let air leak and won’t fog his glasses. It’s strapless, so it won’t hurt his ears or make them stick out.

This fall, Mr. Schwind, the CEO of Global Safety First, is hoping to take home $150,000 as one of the two top winners of the federal Mask Innovation Challenge. He has made it to the top 10 but realizes he still has a ton of competition.

After the challenge launched in late 2021, nearly 1,500 submissions were received, says Kumiko Lippold, PhD, a health scientist and manager of the Mask Innovation Challenge. The challenge is run by Dr. Lippold and others at the Division of Research, Innovation, and Ventures (DRIVe), which is part of the Biomedical Advanced Research and Development Authority (BARDA) at the U.S. Department of Health & Human Services.

Like the rest of us, Dr. Lippold knows that masks desperately need a makeover. The point of the challenge is to inspire and design masks that are comfortable, even with long wear, and that provide excellent protection. The aim is not only to get us through this pandemic but also future pandemics and other public health emergencies. “We are focused on building masks for the next pandemic, the next wildfires,” she says.

The project is a partnership among BARDA’s DRIVe, the National Institute for Occupational Safety and Health (NIOSH), and the National Institute of Standards and Technology (NIST).

While NIOSH is a partner in the challenge, giving feedback to mask developers, “the mask challenge is entirely separate from the NIOSH approval process,” Dr. Lippold says. Companies can then pursue NIOSH approval on their own, later, if they wish. The agency certifies only masks and respirators.
 

Preview of masks to come

“We’ve seen some really amazing things,” Dr. Lippold said of the new designs. She didn’t want to play favorites, so she gave an overview of innovations. Some designs have transparent materials, or partially see-through materials, so facial expressions can be read. “We’ve also seen really unique bio-based materials that are derived from natural products. We’ve seen sensors in some.”

One mask model has origami folds, which increase overall surface and breathing area. Some 3D-printed masks promise a custom fit and take into account whether a person’s nose bridge is low or high.
 

And the finalists are ...

ReadiMask 365: “I can wear this all day long,” Mr. Schwind said of his new design. It has a nano fiber filter and is flexible. Besides the one in the BARDA challenge, the company has other ReadiMasks on the market. “The most important thing is comfort,” he says. “Second is protection. If they don’t feel they have a good seal, users don’t have confidence in the mask.”

He offers various sizes of ReadiMasks, from small sizes designed for women with smaller faces to extra-large, “for NFL linemen.”

ClearMask: “We are the original clear mask,” says Aaron Hsu, CEO and co-founder of ClearMask in Baltimore. The company began in 2017, and the clear design was inspired by a company co-founder who is deaf. She was scheduled to have surgery, and her sign language interpreter did not show up, leaving her to try to communicate in the operating room with masked health care providers. There were no transparent masks available then, Mr. Hsu says.

“Being able to work with BARDA and getting their wisdom is invaluable,” he says.

The makers of ClearMask think masks are here to stay, at least for some. “I think a certain percentage of the population will continue to wear them, regardless,” said Mr. Hsu. He predicts health care settings will become stricter about wearing masks.

“Even now, when you even walk in to a hospital, you might be required to wear a mask,” he says, even as a visitor. His company’s masks are easy to adjust and are secured around the head, so your ears don’t get sore, he says.

4C Air: The BreSafe transparent mask is semi-transparent and is made of a nanomaterial that provides high levels of filtration and breathability with some transparency.

Air99: Based on origami principles, the Airgami mask is meant to improve fit, breathability, and aesthetics over existing masks. “Airgami fits better, works better and looks better,” says Min Xiao, a company spokesperson. “It won’t fall off the nose or collapse onto the mouth, and eyeglasses fog less, she says. Voices are less muffled.” It’s also reusable, rinseable and can be heat disinfected, she says. It went on the market in November 2020.

Air Flo Labs: Flo Mask Pro, like the company’s other designs, conducted over 100 3D facial scans across many ethnicities to produce a better fit, says Kevin Ngo, its creator. For the adult masks, two nose bridge sizes are offered. And users can choose a Pro Filter, with 99% filtration, or an Everyday, which is meant to be much more breathable than other masks. “Our silicone gasket is incredibly soft and gentle on the skin,” Mr. Ngo says. “In addition,we offer indents for glasses, which prevent any fogging.” The company began shipping in May; several thousand masks are in use now, Mr. Ngo said.

Georgetown University: This team’s smart mask is made of metallic foams that can be cleaned and reused.

Levi Strauss: The form of the mask can be made by any basic garment factory. It aims to activate the apparel supply chain as another source of low-cost, high-performance masks.

Matregenix: This mask, made of a transparent nanofiber, allows for easier communication while having high filtration.

SEAL Lab: The SINEW mask stands for Smart, Individualized, Near-Face, Extended Wear. The mask used technology to overcome flaws of traditional respirators, with the same degree of protection. It doesn’t make contact with the skin of the wearer’s face.

StaySafeNow: A team from Harvard University developed Crystal Guard, a reusable, cost-effective clear mask. Its developers say it’s meant to be especially useful for essential workers, teachers, and others who have to communicate to do their work.
 

Bye-bye N95?

“From our perspective, our goal with the mask challenge was not to replace the N95 respirator,” Dr. Lippold says. N95 masks, which NIOSH certifies, are valuable and protect people in high-risk settings. “With the mask challenge, our goal was really to provide the public with a comparable alternative that really meets their specific level of risk.” Working in a health care setting carries a different risk, she says, than going to the grocery store.

“A common complaint with the N95 is that they are very uncomfortable.” It’s a major barrier to compliance, “and we wanted to address that gap. We didn’t directly compare [the entries] to an N95,” she says, although their testing was similar to NIOSH’s. A number of finalists say they will pursue NIOSH approval, she says.

Meanwhile, some of the finalists’ masks are for sale. Air Flo Labs, for instance, has its Flo Mask Pro for sale online, noting that BARDA allowed it to release the test results from NIOSH and NIST.
 

Getting from 1,500 to 10

In the first phase of the challenge, Dr. Lippold says, “the goal was to engage as wide an audience as possible.” With the second phase, the bar was set a bit higher. Instead of just submitting ideas on paper, companies had to submit prototypes for lab testing. “We got about 80 submissions,” she says.

Those 80 were whittled down to 10 finalists. Teams had sent prototypes, and experts, including those from NIOSH and NIST, rated them, sometimes looking at multiple copies of the masks. Experts looked at how well the masks filtered the air, how breathable they were, and other data. Once the feedback was given to the mask companies, they entered a redesign period. “Scientists can take this data and basically make these prototypes better,” Dr. Lippold says.

The final round of testing will be in September, and the winners will be announced in the fall. The opportunity allowed companies to have their products go through testing they might not otherwise have been able to get, she says.

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

The stress of losing a family member can hasten the death of patients with heart failure, suggests a large Swedish study that points to the need for greater integration of psychosocial risk factors in the treatment of HF.

The adjusted relative risk of dying was nearly 30% higher among bereaved patients with HF (1.29; 95% confidence interval, 1.27-1.30) and slightly higher for those grieving the loss of more than one family member (RR, 1.35).

The highest risk was in the first week after the loss (RR, 1.78) but persisted after 5 years of follow-up (RR, 1.30).

“Heart failure is a very difficult condition and has a very poor prognosis comparable to many, many cancers,” senior author Krisztina László, PhD, Karolinska Institutet, Stockholm, said in an interview. “So it’s important for us to be aware of these increased risks and to understand them better.”

The early risk for death could be related to stress-induced cardiomyopathy, or Takotsubo syndrome, as well as activation of the hypothalamic-pituitary-adrenal axis, the renin-angiotensin-aldosterone system, and sympathetic nervous system, she explained. Higher long-term risks may reflect chronic stress, leading to poorly managed disease and an unhealthy lifestyle.

“If we understand better the underlying mechanisms maybe we can give more specific advice,” Dr. László said. “At this stage, I think having an awareness of the risk and trying to follow patients or at least not let them fall out of usual care, asking questions, trying to understand what their needs are, maybe that is what we can do well.”

A recent position paper by the European Association of Preventive Cardiology pointed out that psychosocial risk factors, like depression and social isolation, can exacerbate heart failure and calls for better integration of psychosocial factors in the treatment of patients with chronic HF.

“We don’t do a very good job of it, but I think they are very important,” observed Stuart D. Russell, MD, a professor of medicine who specializes in advanced HF at Duke University, Durham, N.C., and was not involved in the study.

“When we hear about a spouse dying, we might call and give condolences, but it’s probably a group of patients that for the next 6 months or so we need to watch more closely and see if there are things we can impact both medically as well as socially to perhaps prevent some of this increase in mortality,” he told this news organization.

Although several studies have linked bereavement with adverse health outcomes, this is just one of two studies to look specifically at its role in HF prognosis, Dr. László noted. A 2013 study of 66,000 male veterans reported that widowers had nearly a 38% higher all-cause mortality risk than did married veterans.

The present study extends those findings to 490,527 patients in the Swedish Heart Failure Registry between 2000 and 2018 and/or in the Swedish Patient Register with a primary diagnosis of HF between 1987 and 2018. During a mean follow-up of 3.7 years, 12% of participants had a family member die, and 383,674 participants died.

Results showed the HF mortality risk increased 10% after the death of a child, 20% with the death of a spouse/partner, 13% with a sibling’s death, and 5% with the death of a grandchild.

No increased risk was seen after the death of a parent, which is likely owed to a median patient age of about 75 years and “is in line with our expectations of the life cycle,” Dr. László said.

An association between bereavement and mortality risk was observed in cases of loss caused by cardiovascular disease (RR, 1.34) and other natural causes (RR, 1.27) but also in cases of unnatural deaths, such as suicide (RR, 1.13).

The overall findings were similar regardless of left ventricular ejection fraction and New York Heart Association functional class and were not affected by sex or country of birth.

Dr. Russell agreed that the death of a parent would be expected among these older patients with HF but said that “if the mechanism of this truly is kind of this increased stress hormones and Takotsubo-type mechanism, you’d think it would be worse if it was your kid that died. That shocked me a bit.”

The strong association between mortality and the loss of a spouse or partner was not surprising, given that they’re an important source of mutual social support, he added.

“If it’s a 75-year-old whose spouse dies, we need to make sure that we have the children’s phone number or other people that we can reach out to and say: ‘Can you check on them?’ ” he said. “And we need to make sure that somebody else is coming in with them because I would guess that probably at least half of what patients hear in a clinic visit goes in one ear and out the other and it’s going to make that much better. So we need to find who that new support person is for the patient.”

Asked whether there are efforts underway to incorporate psychosocial factors into current U.S. guidelines, Dr. Russell replied, “certainly within heart failure, I don’t think we’re really discussing it and, that may be the best part of this paper. It really makes us think about a different way of approaching these older patients.”

Dr. László said that future studies are needed to investigate whether less severe sources of stress may also contribute to poor HF prognosis.

“In our population, 12% of patients were affected, which is quite high, but there are patients with heart failure who experience on a daily basis other sources of stress, which are less severe but chronic and affect large numbers,” she said. “This may also have important public health implications and will be an important next step.”

The authors noted that they were unable to eliminate residual confounding by genetic factors or unmeasured socioeconomic-, lifestyle-, or health-related factors shared by family members. Other limitations are limited power to detect a modest effect in some of the subanalyses and that the findings may be generalizable only to countries with social and cultural contexts and health-related factors similar to those of Sweden.

The study was supported by grants from the Swedish Council for Working Life and Social Research, the Karolinska Institutet’s Research Foundation, and the China Scholarship Council. Dr. László is also supported by a grant from the Heart and Lung Foundation. All other authors and Dr. Russell reported no relevant financial relationships.

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

The stress of losing a family member can hasten the death of patients with heart failure, suggests a large Swedish study that points to the need for greater integration of psychosocial risk factors in the treatment of HF.

The adjusted relative risk of dying was nearly 30% higher among bereaved patients with HF (1.29; 95% confidence interval, 1.27-1.30) and slightly higher for those grieving the loss of more than one family member (RR, 1.35).

The highest risk was in the first week after the loss (RR, 1.78) but persisted after 5 years of follow-up (RR, 1.30).

“Heart failure is a very difficult condition and has a very poor prognosis comparable to many, many cancers,” senior author Krisztina László, PhD, Karolinska Institutet, Stockholm, said in an interview. “So it’s important for us to be aware of these increased risks and to understand them better.”

The early risk for death could be related to stress-induced cardiomyopathy, or Takotsubo syndrome, as well as activation of the hypothalamic-pituitary-adrenal axis, the renin-angiotensin-aldosterone system, and sympathetic nervous system, she explained. Higher long-term risks may reflect chronic stress, leading to poorly managed disease and an unhealthy lifestyle.

“If we understand better the underlying mechanisms maybe we can give more specific advice,” Dr. László said. “At this stage, I think having an awareness of the risk and trying to follow patients or at least not let them fall out of usual care, asking questions, trying to understand what their needs are, maybe that is what we can do well.”

A recent position paper by the European Association of Preventive Cardiology pointed out that psychosocial risk factors, like depression and social isolation, can exacerbate heart failure and calls for better integration of psychosocial factors in the treatment of patients with chronic HF.

“We don’t do a very good job of it, but I think they are very important,” observed Stuart D. Russell, MD, a professor of medicine who specializes in advanced HF at Duke University, Durham, N.C., and was not involved in the study.

“When we hear about a spouse dying, we might call and give condolences, but it’s probably a group of patients that for the next 6 months or so we need to watch more closely and see if there are things we can impact both medically as well as socially to perhaps prevent some of this increase in mortality,” he told this news organization.

Although several studies have linked bereavement with adverse health outcomes, this is just one of two studies to look specifically at its role in HF prognosis, Dr. László noted. A 2013 study of 66,000 male veterans reported that widowers had nearly a 38% higher all-cause mortality risk than did married veterans.

The present study extends those findings to 490,527 patients in the Swedish Heart Failure Registry between 2000 and 2018 and/or in the Swedish Patient Register with a primary diagnosis of HF between 1987 and 2018. During a mean follow-up of 3.7 years, 12% of participants had a family member die, and 383,674 participants died.

Results showed the HF mortality risk increased 10% after the death of a child, 20% with the death of a spouse/partner, 13% with a sibling’s death, and 5% with the death of a grandchild.

No increased risk was seen after the death of a parent, which is likely owed to a median patient age of about 75 years and “is in line with our expectations of the life cycle,” Dr. László said.

An association between bereavement and mortality risk was observed in cases of loss caused by cardiovascular disease (RR, 1.34) and other natural causes (RR, 1.27) but also in cases of unnatural deaths, such as suicide (RR, 1.13).

The overall findings were similar regardless of left ventricular ejection fraction and New York Heart Association functional class and were not affected by sex or country of birth.

Dr. Russell agreed that the death of a parent would be expected among these older patients with HF but said that “if the mechanism of this truly is kind of this increased stress hormones and Takotsubo-type mechanism, you’d think it would be worse if it was your kid that died. That shocked me a bit.”

The strong association between mortality and the loss of a spouse or partner was not surprising, given that they’re an important source of mutual social support, he added.

“If it’s a 75-year-old whose spouse dies, we need to make sure that we have the children’s phone number or other people that we can reach out to and say: ‘Can you check on them?’ ” he said. “And we need to make sure that somebody else is coming in with them because I would guess that probably at least half of what patients hear in a clinic visit goes in one ear and out the other and it’s going to make that much better. So we need to find who that new support person is for the patient.”

Asked whether there are efforts underway to incorporate psychosocial factors into current U.S. guidelines, Dr. Russell replied, “certainly within heart failure, I don’t think we’re really discussing it and, that may be the best part of this paper. It really makes us think about a different way of approaching these older patients.”

Dr. László said that future studies are needed to investigate whether less severe sources of stress may also contribute to poor HF prognosis.

“In our population, 12% of patients were affected, which is quite high, but there are patients with heart failure who experience on a daily basis other sources of stress, which are less severe but chronic and affect large numbers,” she said. “This may also have important public health implications and will be an important next step.”

The authors noted that they were unable to eliminate residual confounding by genetic factors or unmeasured socioeconomic-, lifestyle-, or health-related factors shared by family members. Other limitations are limited power to detect a modest effect in some of the subanalyses and that the findings may be generalizable only to countries with social and cultural contexts and health-related factors similar to those of Sweden.

The study was supported by grants from the Swedish Council for Working Life and Social Research, the Karolinska Institutet’s Research Foundation, and the China Scholarship Council. Dr. László is also supported by a grant from the Heart and Lung Foundation. All other authors and Dr. Russell reported no relevant financial relationships.

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

The stress of losing a family member can hasten the death of patients with heart failure, suggests a large Swedish study that points to the need for greater integration of psychosocial risk factors in the treatment of HF.

The adjusted relative risk of dying was nearly 30% higher among bereaved patients with HF (1.29; 95% confidence interval, 1.27-1.30) and slightly higher for those grieving the loss of more than one family member (RR, 1.35).

The highest risk was in the first week after the loss (RR, 1.78) but persisted after 5 years of follow-up (RR, 1.30).

“Heart failure is a very difficult condition and has a very poor prognosis comparable to many, many cancers,” senior author Krisztina László, PhD, Karolinska Institutet, Stockholm, said in an interview. “So it’s important for us to be aware of these increased risks and to understand them better.”

The early risk for death could be related to stress-induced cardiomyopathy, or Takotsubo syndrome, as well as activation of the hypothalamic-pituitary-adrenal axis, the renin-angiotensin-aldosterone system, and sympathetic nervous system, she explained. Higher long-term risks may reflect chronic stress, leading to poorly managed disease and an unhealthy lifestyle.

“If we understand better the underlying mechanisms maybe we can give more specific advice,” Dr. László said. “At this stage, I think having an awareness of the risk and trying to follow patients or at least not let them fall out of usual care, asking questions, trying to understand what their needs are, maybe that is what we can do well.”

A recent position paper by the European Association of Preventive Cardiology pointed out that psychosocial risk factors, like depression and social isolation, can exacerbate heart failure and calls for better integration of psychosocial factors in the treatment of patients with chronic HF.

“We don’t do a very good job of it, but I think they are very important,” observed Stuart D. Russell, MD, a professor of medicine who specializes in advanced HF at Duke University, Durham, N.C., and was not involved in the study.

“When we hear about a spouse dying, we might call and give condolences, but it’s probably a group of patients that for the next 6 months or so we need to watch more closely and see if there are things we can impact both medically as well as socially to perhaps prevent some of this increase in mortality,” he told this news organization.

Although several studies have linked bereavement with adverse health outcomes, this is just one of two studies to look specifically at its role in HF prognosis, Dr. László noted. A 2013 study of 66,000 male veterans reported that widowers had nearly a 38% higher all-cause mortality risk than did married veterans.

The present study extends those findings to 490,527 patients in the Swedish Heart Failure Registry between 2000 and 2018 and/or in the Swedish Patient Register with a primary diagnosis of HF between 1987 and 2018. During a mean follow-up of 3.7 years, 12% of participants had a family member die, and 383,674 participants died.

Results showed the HF mortality risk increased 10% after the death of a child, 20% with the death of a spouse/partner, 13% with a sibling’s death, and 5% with the death of a grandchild.

No increased risk was seen after the death of a parent, which is likely owed to a median patient age of about 75 years and “is in line with our expectations of the life cycle,” Dr. László said.

An association between bereavement and mortality risk was observed in cases of loss caused by cardiovascular disease (RR, 1.34) and other natural causes (RR, 1.27) but also in cases of unnatural deaths, such as suicide (RR, 1.13).

The overall findings were similar regardless of left ventricular ejection fraction and New York Heart Association functional class and were not affected by sex or country of birth.

Dr. Russell agreed that the death of a parent would be expected among these older patients with HF but said that “if the mechanism of this truly is kind of this increased stress hormones and Takotsubo-type mechanism, you’d think it would be worse if it was your kid that died. That shocked me a bit.”

The strong association between mortality and the loss of a spouse or partner was not surprising, given that they’re an important source of mutual social support, he added.

“If it’s a 75-year-old whose spouse dies, we need to make sure that we have the children’s phone number or other people that we can reach out to and say: ‘Can you check on them?’ ” he said. “And we need to make sure that somebody else is coming in with them because I would guess that probably at least half of what patients hear in a clinic visit goes in one ear and out the other and it’s going to make that much better. So we need to find who that new support person is for the patient.”

Asked whether there are efforts underway to incorporate psychosocial factors into current U.S. guidelines, Dr. Russell replied, “certainly within heart failure, I don’t think we’re really discussing it and, that may be the best part of this paper. It really makes us think about a different way of approaching these older patients.”

Dr. László said that future studies are needed to investigate whether less severe sources of stress may also contribute to poor HF prognosis.

“In our population, 12% of patients were affected, which is quite high, but there are patients with heart failure who experience on a daily basis other sources of stress, which are less severe but chronic and affect large numbers,” she said. “This may also have important public health implications and will be an important next step.”

The authors noted that they were unable to eliminate residual confounding by genetic factors or unmeasured socioeconomic-, lifestyle-, or health-related factors shared by family members. Other limitations are limited power to detect a modest effect in some of the subanalyses and that the findings may be generalizable only to countries with social and cultural contexts and health-related factors similar to those of Sweden.

The study was supported by grants from the Swedish Council for Working Life and Social Research, the Karolinska Institutet’s Research Foundation, and the China Scholarship Council. Dr. László is also supported by a grant from the Heart and Lung Foundation. All other authors and Dr. Russell reported no relevant financial relationships.

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

Four years ago, when Dr. Karen Giuliano went to a Boston hospital for hip replacement surgery, she was given a pale-pink bucket of toiletries issued to patients in many hospitals. Inside were tissues, bar soap, deodorant, toothpaste, and, without a doubt, the worst toothbrush she’d ever seen.

“I couldn’t believe it. I got a toothbrush with no bristles,” she said. “It must have not gone through the bristle machine. It was just a stick.”

To most patients, a useless hospital toothbrush would be a mild inconvenience. But to Dr. Giuliano, a nursing professor at the University of Massachusetts, Amherst, it was a reminder of a pervasive “blind spot” in U.S. hospitals: the stunning consequences of unbrushed teeth.

Hospital patients not getting their teeth brushed, or not brushing their teeth themselves, is believed to be a leading cause of hundreds of thousands of cases of pneumonia a year in patients who have not been put on a ventilator. Pneumonia is among the most common infections that occur in health care facilities, and a majority of cases are nonventilator hospital-acquired pneumonia, or NVHAP, which kills up to 30% of those infected, Dr. Giuliano and other experts said.

But unlike many infections that strike within hospitals, the federal government doesn’t require hospitals to report cases of NVHAP. As a result, few hospitals understand the origin of the illness, track its occurrence, or actively work to prevent it, the experts said.

Many cases of NVHAP could be avoided if hospital staffers more dutifully brushed the teeth of bedridden patients, according to a growing body of peer-reviewed research papers. Instead, many hospitals often skip teeth brushing to prioritize other tasks and provide only cheap, ineffective toothbrushes, often unaware of the consequences, said Dr. Dian Baker, a Sacramento (Calif.) State nursing professor who has spent more than a decade studying NVHAP.

“I’ll tell you that today the vast majority of the tens of thousands of nurses in hospitals have no idea that pneumonia comes from germs in the mouth,” Dr. Baker said.

Pneumonia occurs when germs trigger an infection in the lungs. Although NVHAP accounts for most of the cases that occur in hospitals, it historically has not received the same attention as pneumonia tied to ventilators, which is easier to identify and study because it occurs among a narrow subset of patients.

NVHAP, a risk for virtually all hospital patients, is often caused by bacteria from the mouth that gathers in the scummy biofilm on unbrushed teeth and is aspirated into the lungs. Patients face a higher risk if they lie flat or remain immobile for long periods, so NVHAP can also be prevented by elevating their heads and getting them out of bed more often.

According to the National Organization for NV-HAP Prevention, which was founded in 2020, this pneumonia infects about 1 in every 100 hospital patients and kills 15%-30% of them. For those who survive, the illness often extends their hospital stay by up to 15 days and makes it much more likely they will be readmitted within a month or transferred to an intensive care unit.

John McCleary, 83, of Millinocket, Maine, contracted a likely case of NVHAP in 2008 after he fractured his ankle in a fall and spent 12 days in rehabilitation at a hospital, said his daughter, Kathy Day, a retired nurse and advocate with the Patient Safety Action Network.

Mr. McCleary recovered from the fracture but not from pneumonia. Two days after he returned home, the infection in his lungs caused him to be rushed back to the hospital, where he went into sepsis and spent weeks in treatment before moving to an isolation unit in a nursing home.

He died weeks later, emaciated, largely deaf, unable to eat, and often “too weak to get water through a straw,” his daughter said. After contracting pneumonia, he never walked again.

“It was an astounding assault on his body, from him being here visiting me the week before his fall, to his death just a few months later,” Ms. Day said. “And the whole thing was avoidable.”

While experts describe NVHAP as a largely ignored threat, that appears to be changing.

Last year, a group of researchers – including Dr. Giuliano and Dr. Baker, plus officials from the Centers for Disease Control and Prevention, the Veterans Health Administration, and the Joint Commission – published a “call-to-action” research paper hoping to launch “a national health care conversation about NVHAP prevention.”

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

Four years ago, when Dr. Karen Giuliano went to a Boston hospital for hip replacement surgery, she was given a pale-pink bucket of toiletries issued to patients in many hospitals. Inside were tissues, bar soap, deodorant, toothpaste, and, without a doubt, the worst toothbrush she’d ever seen.

“I couldn’t believe it. I got a toothbrush with no bristles,” she said. “It must have not gone through the bristle machine. It was just a stick.”

To most patients, a useless hospital toothbrush would be a mild inconvenience. But to Dr. Giuliano, a nursing professor at the University of Massachusetts, Amherst, it was a reminder of a pervasive “blind spot” in U.S. hospitals: the stunning consequences of unbrushed teeth.

Hospital patients not getting their teeth brushed, or not brushing their teeth themselves, is believed to be a leading cause of hundreds of thousands of cases of pneumonia a year in patients who have not been put on a ventilator. Pneumonia is among the most common infections that occur in health care facilities, and a majority of cases are nonventilator hospital-acquired pneumonia, or NVHAP, which kills up to 30% of those infected, Dr. Giuliano and other experts said.

But unlike many infections that strike within hospitals, the federal government doesn’t require hospitals to report cases of NVHAP. As a result, few hospitals understand the origin of the illness, track its occurrence, or actively work to prevent it, the experts said.

Many cases of NVHAP could be avoided if hospital staffers more dutifully brushed the teeth of bedridden patients, according to a growing body of peer-reviewed research papers. Instead, many hospitals often skip teeth brushing to prioritize other tasks and provide only cheap, ineffective toothbrushes, often unaware of the consequences, said Dr. Dian Baker, a Sacramento (Calif.) State nursing professor who has spent more than a decade studying NVHAP.

“I’ll tell you that today the vast majority of the tens of thousands of nurses in hospitals have no idea that pneumonia comes from germs in the mouth,” Dr. Baker said.

Pneumonia occurs when germs trigger an infection in the lungs. Although NVHAP accounts for most of the cases that occur in hospitals, it historically has not received the same attention as pneumonia tied to ventilators, which is easier to identify and study because it occurs among a narrow subset of patients.

NVHAP, a risk for virtually all hospital patients, is often caused by bacteria from the mouth that gathers in the scummy biofilm on unbrushed teeth and is aspirated into the lungs. Patients face a higher risk if they lie flat or remain immobile for long periods, so NVHAP can also be prevented by elevating their heads and getting them out of bed more often.

According to the National Organization for NV-HAP Prevention, which was founded in 2020, this pneumonia infects about 1 in every 100 hospital patients and kills 15%-30% of them. For those who survive, the illness often extends their hospital stay by up to 15 days and makes it much more likely they will be readmitted within a month or transferred to an intensive care unit.

John McCleary, 83, of Millinocket, Maine, contracted a likely case of NVHAP in 2008 after he fractured his ankle in a fall and spent 12 days in rehabilitation at a hospital, said his daughter, Kathy Day, a retired nurse and advocate with the Patient Safety Action Network.

Mr. McCleary recovered from the fracture but not from pneumonia. Two days after he returned home, the infection in his lungs caused him to be rushed back to the hospital, where he went into sepsis and spent weeks in treatment before moving to an isolation unit in a nursing home.

He died weeks later, emaciated, largely deaf, unable to eat, and often “too weak to get water through a straw,” his daughter said. After contracting pneumonia, he never walked again.

“It was an astounding assault on his body, from him being here visiting me the week before his fall, to his death just a few months later,” Ms. Day said. “And the whole thing was avoidable.”

While experts describe NVHAP as a largely ignored threat, that appears to be changing.

Last year, a group of researchers – including Dr. Giuliano and Dr. Baker, plus officials from the Centers for Disease Control and Prevention, the Veterans Health Administration, and the Joint Commission – published a “call-to-action” research paper hoping to launch “a national health care conversation about NVHAP prevention.”

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

Four years ago, when Dr. Karen Giuliano went to a Boston hospital for hip replacement surgery, she was given a pale-pink bucket of toiletries issued to patients in many hospitals. Inside were tissues, bar soap, deodorant, toothpaste, and, without a doubt, the worst toothbrush she’d ever seen.

“I couldn’t believe it. I got a toothbrush with no bristles,” she said. “It must have not gone through the bristle machine. It was just a stick.”

To most patients, a useless hospital toothbrush would be a mild inconvenience. But to Dr. Giuliano, a nursing professor at the University of Massachusetts, Amherst, it was a reminder of a pervasive “blind spot” in U.S. hospitals: the stunning consequences of unbrushed teeth.

Hospital patients not getting their teeth brushed, or not brushing their teeth themselves, is believed to be a leading cause of hundreds of thousands of cases of pneumonia a year in patients who have not been put on a ventilator. Pneumonia is among the most common infections that occur in health care facilities, and a majority of cases are nonventilator hospital-acquired pneumonia, or NVHAP, which kills up to 30% of those infected, Dr. Giuliano and other experts said.

But unlike many infections that strike within hospitals, the federal government doesn’t require hospitals to report cases of NVHAP. As a result, few hospitals understand the origin of the illness, track its occurrence, or actively work to prevent it, the experts said.

Many cases of NVHAP could be avoided if hospital staffers more dutifully brushed the teeth of bedridden patients, according to a growing body of peer-reviewed research papers. Instead, many hospitals often skip teeth brushing to prioritize other tasks and provide only cheap, ineffective toothbrushes, often unaware of the consequences, said Dr. Dian Baker, a Sacramento (Calif.) State nursing professor who has spent more than a decade studying NVHAP.

“I’ll tell you that today the vast majority of the tens of thousands of nurses in hospitals have no idea that pneumonia comes from germs in the mouth,” Dr. Baker said.

Pneumonia occurs when germs trigger an infection in the lungs. Although NVHAP accounts for most of the cases that occur in hospitals, it historically has not received the same attention as pneumonia tied to ventilators, which is easier to identify and study because it occurs among a narrow subset of patients.

NVHAP, a risk for virtually all hospital patients, is often caused by bacteria from the mouth that gathers in the scummy biofilm on unbrushed teeth and is aspirated into the lungs. Patients face a higher risk if they lie flat or remain immobile for long periods, so NVHAP can also be prevented by elevating their heads and getting them out of bed more often.

According to the National Organization for NV-HAP Prevention, which was founded in 2020, this pneumonia infects about 1 in every 100 hospital patients and kills 15%-30% of them. For those who survive, the illness often extends their hospital stay by up to 15 days and makes it much more likely they will be readmitted within a month or transferred to an intensive care unit.

John McCleary, 83, of Millinocket, Maine, contracted a likely case of NVHAP in 2008 after he fractured his ankle in a fall and spent 12 days in rehabilitation at a hospital, said his daughter, Kathy Day, a retired nurse and advocate with the Patient Safety Action Network.

Mr. McCleary recovered from the fracture but not from pneumonia. Two days after he returned home, the infection in his lungs caused him to be rushed back to the hospital, where he went into sepsis and spent weeks in treatment before moving to an isolation unit in a nursing home.

He died weeks later, emaciated, largely deaf, unable to eat, and often “too weak to get water through a straw,” his daughter said. After contracting pneumonia, he never walked again.

“It was an astounding assault on his body, from him being here visiting me the week before his fall, to his death just a few months later,” Ms. Day said. “And the whole thing was avoidable.”

While experts describe NVHAP as a largely ignored threat, that appears to be changing.

Last year, a group of researchers – including Dr. Giuliano and Dr. Baker, plus officials from the Centers for Disease Control and Prevention, the Veterans Health Administration, and the Joint Commission – published a “call-to-action” research paper hoping to launch “a national health care conversation about NVHAP prevention.”

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

Active uveitis remained in 43.4% of juvenile idiopathic arthritis (JIA) patients up to 40 years after a diagnosis, based on data from 30 individuals.

Uveitis occurs in approximately 10%-20% of patients with JIA, but data on the long-term activity and prevalence are limited, although previous studies suggest that uveitis can persist into adulthood, wrote Dr. Angelika Skarin of Skåne University in Lund, Sweden, and colleagues.

In a study published in Pediatric Rheumatology, the researchers reviewed ophthalmic records from 30 JIA patients at a mean of 40.7 years after uveitis onset. They compared these records to data collected from the same patient population at a mean of 7.2 and 24.0 years after onset. In the previous follow-up studies, 49% of the patients had active uveitis at 24 years, and the prevalence of cataracts and glaucoma increased between the 7-year and 24-year assessments.

In the current study, 43.4% of the population had active uveitis at the 40-year follow-up, which corresponded to 23.6% of the original study cohort. The mean age of the participants overall was 46.9 years, the mean duration of joint disease was 42.99 years, and the mean time from onset of uveitis was 40.7 years.

In addition, 66.6% of the patients in the current study had cataracts or had undergone cataract surgery in one or both eyes, and 40.0% had glaucoma.

By the time of the current study, of the original cohort of 55 individuals, 11 were deceased; rheumatic disease was declared the main cause in four patients and a contributing factor in three others.

Potential drivers of the earliest cases of glaucoma and ocular hypertension (G/OH) include increased intraocular pressure as a result of topical corticosteroid treatment, the researchers noted in their discussion. However, G/OH occurring later than the 7-year follow-up was “more likely to be the type observed in many patients with long-standing chronic uveitis, where a gradual increase in intraocular pressure is assumed to be caused by impaired aqueous outflow,” they said.

Only 4 of the 30 patients did not have regular ophthalmology visits, which suggests a study population with ocular symptoms or concerns about their eyesight, the researchers wrote. “The fact that 13% of our original cohort were reported to have severe visual impairment or worse in both eyes at any of the three follow-ups is noteworthy,” compared to reports of visual impairment of less than 0.5% in a German study in the general population for similar ages.

The findings were limited by several factors, including the retrospective design, small study population, and lack of data on 25 of the original 55-member study cohort, which may reduce the reliability of the current study, the researchers noted. However, the results reflect data from previous studies and support the need for JIA patients to continue regular ophthalmic checkups throughout life, they concluded.

The study was supported by Stiftelsen för Synskadade i f.d. Malmöhus län, Sweden, Skånes Universitetssjukhus Stiftelser och Donationer, Ögonfonden, and the Swedish Society of Medicine. The researchers had no financial conflicts to disclose.

Active uveitis remained in 43.4% of juvenile idiopathic arthritis (JIA) patients up to 40 years after a diagnosis, based on data from 30 individuals.

Uveitis occurs in approximately 10%-20% of patients with JIA, but data on the long-term activity and prevalence are limited, although previous studies suggest that uveitis can persist into adulthood, wrote Dr. Angelika Skarin of Skåne University in Lund, Sweden, and colleagues.

In a study published in Pediatric Rheumatology, the researchers reviewed ophthalmic records from 30 JIA patients at a mean of 40.7 years after uveitis onset. They compared these records to data collected from the same patient population at a mean of 7.2 and 24.0 years after onset. In the previous follow-up studies, 49% of the patients had active uveitis at 24 years, and the prevalence of cataracts and glaucoma increased between the 7-year and 24-year assessments.

In the current study, 43.4% of the population had active uveitis at the 40-year follow-up, which corresponded to 23.6% of the original study cohort. The mean age of the participants overall was 46.9 years, the mean duration of joint disease was 42.99 years, and the mean time from onset of uveitis was 40.7 years.

In addition, 66.6% of the patients in the current study had cataracts or had undergone cataract surgery in one or both eyes, and 40.0% had glaucoma.

By the time of the current study, of the original cohort of 55 individuals, 11 were deceased; rheumatic disease was declared the main cause in four patients and a contributing factor in three others.

Potential drivers of the earliest cases of glaucoma and ocular hypertension (G/OH) include increased intraocular pressure as a result of topical corticosteroid treatment, the researchers noted in their discussion. However, G/OH occurring later than the 7-year follow-up was “more likely to be the type observed in many patients with long-standing chronic uveitis, where a gradual increase in intraocular pressure is assumed to be caused by impaired aqueous outflow,” they said.

Only 4 of the 30 patients did not have regular ophthalmology visits, which suggests a study population with ocular symptoms or concerns about their eyesight, the researchers wrote. “The fact that 13% of our original cohort were reported to have severe visual impairment or worse in both eyes at any of the three follow-ups is noteworthy,” compared to reports of visual impairment of less than 0.5% in a German study in the general population for similar ages.

The findings were limited by several factors, including the retrospective design, small study population, and lack of data on 25 of the original 55-member study cohort, which may reduce the reliability of the current study, the researchers noted. However, the results reflect data from previous studies and support the need for JIA patients to continue regular ophthalmic checkups throughout life, they concluded.

The study was supported by Stiftelsen för Synskadade i f.d. Malmöhus län, Sweden, Skånes Universitetssjukhus Stiftelser och Donationer, Ögonfonden, and the Swedish Society of Medicine. The researchers had no financial conflicts to disclose.

Active uveitis remained in 43.4% of juvenile idiopathic arthritis (JIA) patients up to 40 years after a diagnosis, based on data from 30 individuals.

Uveitis occurs in approximately 10%-20% of patients with JIA, but data on the long-term activity and prevalence are limited, although previous studies suggest that uveitis can persist into adulthood, wrote Dr. Angelika Skarin of Skåne University in Lund, Sweden, and colleagues.

In a study published in Pediatric Rheumatology, the researchers reviewed ophthalmic records from 30 JIA patients at a mean of 40.7 years after uveitis onset. They compared these records to data collected from the same patient population at a mean of 7.2 and 24.0 years after onset. In the previous follow-up studies, 49% of the patients had active uveitis at 24 years, and the prevalence of cataracts and glaucoma increased between the 7-year and 24-year assessments.

In the current study, 43.4% of the population had active uveitis at the 40-year follow-up, which corresponded to 23.6% of the original study cohort. The mean age of the participants overall was 46.9 years, the mean duration of joint disease was 42.99 years, and the mean time from onset of uveitis was 40.7 years.

In addition, 66.6% of the patients in the current study had cataracts or had undergone cataract surgery in one or both eyes, and 40.0% had glaucoma.

By the time of the current study, of the original cohort of 55 individuals, 11 were deceased; rheumatic disease was declared the main cause in four patients and a contributing factor in three others.

Potential drivers of the earliest cases of glaucoma and ocular hypertension (G/OH) include increased intraocular pressure as a result of topical corticosteroid treatment, the researchers noted in their discussion. However, G/OH occurring later than the 7-year follow-up was “more likely to be the type observed in many patients with long-standing chronic uveitis, where a gradual increase in intraocular pressure is assumed to be caused by impaired aqueous outflow,” they said.

Only 4 of the 30 patients did not have regular ophthalmology visits, which suggests a study population with ocular symptoms or concerns about their eyesight, the researchers wrote. “The fact that 13% of our original cohort were reported to have severe visual impairment or worse in both eyes at any of the three follow-ups is noteworthy,” compared to reports of visual impairment of less than 0.5% in a German study in the general population for similar ages.

The findings were limited by several factors, including the retrospective design, small study population, and lack of data on 25 of the original 55-member study cohort, which may reduce the reliability of the current study, the researchers noted. However, the results reflect data from previous studies and support the need for JIA patients to continue regular ophthalmic checkups throughout life, they concluded.

The study was supported by Stiftelsen för Synskadade i f.d. Malmöhus län, Sweden, Skånes Universitetssjukhus Stiftelser och Donationer, Ögonfonden, and the Swedish Society of Medicine. The researchers had no financial conflicts to disclose.

Falsely elevated pulse oximeter readings are leading to less oxygen supplementation for people of color, a recent study finds.

The new research suggests that skin color–related differences in pulse oximeter readings are in fact impacting clinical decision-making, lead author Eric R. Gottlieb, MD, of Brigham and Women’s Hospital and Massachusetts Institute of Technology, both in Boston, and colleagues wrote. This suggests that technology needs to updated to improve health equity, they continued, in their paper published in JAMA Internal Medicine.

“It has been known for decades that these readings are affected by various surface pigmentations, including nail polish and skin melanin, which may affect light absorption and scattering,” the investigators wrote. “This increases the risk of hidden hypoxemia [among patients with darker skin], in which patients have falsely elevated SpO₂ readings, usually defined as 92% or greater, with a blood hemoglobin oxygen saturation less than 88%.”

Although published reports on this phenomenon date back to the 1980s, clinical significance has been largely discounted, they said, citing a 2008 paper on the topic, which stated that “oximetry need not have exact accuracy” to determine if a patient needs oxygen supplementation.
 

‘We’re not providing equal care’

Questioning the validity of this statement, Dr. Gottlieb and colleagues conducted a retrospective cohort study involving 3,069 patients admitted to intensive care at the Beth Israel Deaconess Medical Center in Boston between 2008 and 2019, thereby excluding patients treated during the COVID-19 pandemic. The population consisted of four races/ethnicities: White (87%), Black (7%), Hispanic (4%), and Asian (3%).

Aligning with previous studies, multivariable linear regression analyses showed that Asian, Black, and Hispanic patients had significantly higher SpO₂ readings than White patients in relation to hemoglobin oxygen saturation values, suggesting falsely elevated readings.

Further modeling showed that these same patient groups also received lower oxygen delivery rates, which were not explained directly by race/ethnicity, but instead were mediated by the discrepancy between SpO₂ and hemoglobin oxygen saturation values. In other words, physicians were responding consistently to pulse oximetry readings, rather than exhibiting a direct racial/ethnic bias in their clinical decision-making.

“We’re not providing equal care,” Dr. Gottlieb said in an interview. “It’s not that the patients are sicker, or have other socioeconomic explanations for why this happens to them. It’s us. It’s our technology. And that’s something that really has to be fixed.”

The investigators offered a cautionary view of corrective algorithms, as these “have exacerbated disparities and are subject to ethical concerns;” for example, with glomerular filtration rate estimations in Black patients.

Dr. Gottlieb also cautioned against action by individual physicians, who may now be inclined to change how they interpret pulse oximeter readings based on a patient’s race or ethnicity.

“I don’t think that we can expect physicians, every time they see a patient, to be second guessing whether the number basically reflects the truth,” he said.

Instead, Dr. Gottlieb suggested that the burden of change rests upon the shoulders of institutions, including hospitals and device manufacturers, both of which “really need to take the responsibility” for making sure that pulse oximeters are “equitable and have similar performance across races.”

While Dr. Gottlieb said that skin color likely plays the greatest role in measurement discrepancies, he encouraged stakeholders “to think broadly about this, and not just assume that it’s entirely skin color,” noting a small amount of evidence indicating that blood chemistry may also play a role. Still, he predicted that colorimetry – the direct measurement of skin color – will probably be incorporated into pulse oximeters of the future.
 

Black patients 3X more likely to have hidden hypoxia than White patients

Michael Sjoding, MD, of the University of Michigan, Ann Arbor, was one of the first to raise awareness of skin color–related issues with pulse oximeters during the throes of the COVID-19 pandemic. His study, which involved more than 10,000 patients, showed that Black patients were threefold more likely to have hidden hypoxia than White patients.

The present study shows that such discrepancies are indeed clinically significant, Dr. Sjoding said in an interview. And these data are needed, he added, to bring about change.

“What is being asked is potentially a big deal,” Dr. Sjoding said. “Pulse oximeters are everywhere, and it would be a big undertaking to redesign pulse oximeters and purchase new pulse oximeters. You need a compelling body of evidence to do that. I think it’s there now, clearly. So I’m hopeful that we’re going to finally move forward, towards having devices that we are confident work accurately in everyone.”

Why it has taken so long to gather this evidence, however, is a thornier topic, considering race-related discrepancies in pulse oximeter readings were first documented more than 3 decades ago.

“We sort of rediscovered something that had been known and had been described in the past,” Dr. Sjoding said. He explained how he and many of his colleagues had completed pulmonary fellowships, yet none of them knew of these potential issues with pulse oximeters until they began to observe differences in their own patients during the pandemic.

“I’ll give previous generations of researchers the benefit of the doubt,” Dr. Sjoding said, pointing out that techniques in data gathering and analysis have advanced considerably over the years. “The types of studies that were done before were very different than what we did.”

Yet Dr. Sjoding entertained the possibility that other factors may have been at play.

“I think definitely there’s a social commentary on prioritization of research,” he said.

The study was supported by grants from the National Institutes of Health. The investigators and Dr. Sjoding reported no conflicts of interest.

Falsely elevated pulse oximeter readings are leading to less oxygen supplementation for people of color, a recent study finds.

The new research suggests that skin color–related differences in pulse oximeter readings are in fact impacting clinical decision-making, lead author Eric R. Gottlieb, MD, of Brigham and Women’s Hospital and Massachusetts Institute of Technology, both in Boston, and colleagues wrote. This suggests that technology needs to updated to improve health equity, they continued, in their paper published in JAMA Internal Medicine.

“It has been known for decades that these readings are affected by various surface pigmentations, including nail polish and skin melanin, which may affect light absorption and scattering,” the investigators wrote. “This increases the risk of hidden hypoxemia [among patients with darker skin], in which patients have falsely elevated SpO₂ readings, usually defined as 92% or greater, with a blood hemoglobin oxygen saturation less than 88%.”

Although published reports on this phenomenon date back to the 1980s, clinical significance has been largely discounted, they said, citing a 2008 paper on the topic, which stated that “oximetry need not have exact accuracy” to determine if a patient needs oxygen supplementation.
 

‘We’re not providing equal care’

Questioning the validity of this statement, Dr. Gottlieb and colleagues conducted a retrospective cohort study involving 3,069 patients admitted to intensive care at the Beth Israel Deaconess Medical Center in Boston between 2008 and 2019, thereby excluding patients treated during the COVID-19 pandemic. The population consisted of four races/ethnicities: White (87%), Black (7%), Hispanic (4%), and Asian (3%).

Aligning with previous studies, multivariable linear regression analyses showed that Asian, Black, and Hispanic patients had significantly higher SpO₂ readings than White patients in relation to hemoglobin oxygen saturation values, suggesting falsely elevated readings.

Further modeling showed that these same patient groups also received lower oxygen delivery rates, which were not explained directly by race/ethnicity, but instead were mediated by the discrepancy between SpO₂ and hemoglobin oxygen saturation values. In other words, physicians were responding consistently to pulse oximetry readings, rather than exhibiting a direct racial/ethnic bias in their clinical decision-making.

“We’re not providing equal care,” Dr. Gottlieb said in an interview. “It’s not that the patients are sicker, or have other socioeconomic explanations for why this happens to them. It’s us. It’s our technology. And that’s something that really has to be fixed.”

The investigators offered a cautionary view of corrective algorithms, as these “have exacerbated disparities and are subject to ethical concerns;” for example, with glomerular filtration rate estimations in Black patients.

Dr. Gottlieb also cautioned against action by individual physicians, who may now be inclined to change how they interpret pulse oximeter readings based on a patient’s race or ethnicity.

“I don’t think that we can expect physicians, every time they see a patient, to be second guessing whether the number basically reflects the truth,” he said.

Instead, Dr. Gottlieb suggested that the burden of change rests upon the shoulders of institutions, including hospitals and device manufacturers, both of which “really need to take the responsibility” for making sure that pulse oximeters are “equitable and have similar performance across races.”

While Dr. Gottlieb said that skin color likely plays the greatest role in measurement discrepancies, he encouraged stakeholders “to think broadly about this, and not just assume that it’s entirely skin color,” noting a small amount of evidence indicating that blood chemistry may also play a role. Still, he predicted that colorimetry – the direct measurement of skin color – will probably be incorporated into pulse oximeters of the future.
 

Black patients 3X more likely to have hidden hypoxia than White patients

Michael Sjoding, MD, of the University of Michigan, Ann Arbor, was one of the first to raise awareness of skin color–related issues with pulse oximeters during the throes of the COVID-19 pandemic. His study, which involved more than 10,000 patients, showed that Black patients were threefold more likely to have hidden hypoxia than White patients.

The present study shows that such discrepancies are indeed clinically significant, Dr. Sjoding said in an interview. And these data are needed, he added, to bring about change.

“What is being asked is potentially a big deal,” Dr. Sjoding said. “Pulse oximeters are everywhere, and it would be a big undertaking to redesign pulse oximeters and purchase new pulse oximeters. You need a compelling body of evidence to do that. I think it’s there now, clearly. So I’m hopeful that we’re going to finally move forward, towards having devices that we are confident work accurately in everyone.”

Why it has taken so long to gather this evidence, however, is a thornier topic, considering race-related discrepancies in pulse oximeter readings were first documented more than 3 decades ago.

“We sort of rediscovered something that had been known and had been described in the past,” Dr. Sjoding said. He explained how he and many of his colleagues had completed pulmonary fellowships, yet none of them knew of these potential issues with pulse oximeters until they began to observe differences in their own patients during the pandemic.

“I’ll give previous generations of researchers the benefit of the doubt,” Dr. Sjoding said, pointing out that techniques in data gathering and analysis have advanced considerably over the years. “The types of studies that were done before were very different than what we did.”

Yet Dr. Sjoding entertained the possibility that other factors may have been at play.

“I think definitely there’s a social commentary on prioritization of research,” he said.

The study was supported by grants from the National Institutes of Health. The investigators and Dr. Sjoding reported no conflicts of interest.

Falsely elevated pulse oximeter readings are leading to less oxygen supplementation for people of color, a recent study finds.

The new research suggests that skin color–related differences in pulse oximeter readings are in fact impacting clinical decision-making, lead author Eric R. Gottlieb, MD, of Brigham and Women’s Hospital and Massachusetts Institute of Technology, both in Boston, and colleagues wrote. This suggests that technology needs to updated to improve health equity, they continued, in their paper published in JAMA Internal Medicine.

“It has been known for decades that these readings are affected by various surface pigmentations, including nail polish and skin melanin, which may affect light absorption and scattering,” the investigators wrote. “This increases the risk of hidden hypoxemia [among patients with darker skin], in which patients have falsely elevated SpO₂ readings, usually defined as 92% or greater, with a blood hemoglobin oxygen saturation less than 88%.”

Although published reports on this phenomenon date back to the 1980s, clinical significance has been largely discounted, they said, citing a 2008 paper on the topic, which stated that “oximetry need not have exact accuracy” to determine if a patient needs oxygen supplementation.
 

‘We’re not providing equal care’

Questioning the validity of this statement, Dr. Gottlieb and colleagues conducted a retrospective cohort study involving 3,069 patients admitted to intensive care at the Beth Israel Deaconess Medical Center in Boston between 2008 and 2019, thereby excluding patients treated during the COVID-19 pandemic. The population consisted of four races/ethnicities: White (87%), Black (7%), Hispanic (4%), and Asian (3%).

Aligning with previous studies, multivariable linear regression analyses showed that Asian, Black, and Hispanic patients had significantly higher SpO₂ readings than White patients in relation to hemoglobin oxygen saturation values, suggesting falsely elevated readings.

Further modeling showed that these same patient groups also received lower oxygen delivery rates, which were not explained directly by race/ethnicity, but instead were mediated by the discrepancy between SpO₂ and hemoglobin oxygen saturation values. In other words, physicians were responding consistently to pulse oximetry readings, rather than exhibiting a direct racial/ethnic bias in their clinical decision-making.

“We’re not providing equal care,” Dr. Gottlieb said in an interview. “It’s not that the patients are sicker, or have other socioeconomic explanations for why this happens to them. It’s us. It’s our technology. And that’s something that really has to be fixed.”

The investigators offered a cautionary view of corrective algorithms, as these “have exacerbated disparities and are subject to ethical concerns;” for example, with glomerular filtration rate estimations in Black patients.

Dr. Gottlieb also cautioned against action by individual physicians, who may now be inclined to change how they interpret pulse oximeter readings based on a patient’s race or ethnicity.

“I don’t think that we can expect physicians, every time they see a patient, to be second guessing whether the number basically reflects the truth,” he said.

Instead, Dr. Gottlieb suggested that the burden of change rests upon the shoulders of institutions, including hospitals and device manufacturers, both of which “really need to take the responsibility” for making sure that pulse oximeters are “equitable and have similar performance across races.”

While Dr. Gottlieb said that skin color likely plays the greatest role in measurement discrepancies, he encouraged stakeholders “to think broadly about this, and not just assume that it’s entirely skin color,” noting a small amount of evidence indicating that blood chemistry may also play a role. Still, he predicted that colorimetry – the direct measurement of skin color – will probably be incorporated into pulse oximeters of the future.
 

Black patients 3X more likely to have hidden hypoxia than White patients

Michael Sjoding, MD, of the University of Michigan, Ann Arbor, was one of the first to raise awareness of skin color–related issues with pulse oximeters during the throes of the COVID-19 pandemic. His study, which involved more than 10,000 patients, showed that Black patients were threefold more likely to have hidden hypoxia than White patients.

The present study shows that such discrepancies are indeed clinically significant, Dr. Sjoding said in an interview. And these data are needed, he added, to bring about change.

“What is being asked is potentially a big deal,” Dr. Sjoding said. “Pulse oximeters are everywhere, and it would be a big undertaking to redesign pulse oximeters and purchase new pulse oximeters. You need a compelling body of evidence to do that. I think it’s there now, clearly. So I’m hopeful that we’re going to finally move forward, towards having devices that we are confident work accurately in everyone.”

Why it has taken so long to gather this evidence, however, is a thornier topic, considering race-related discrepancies in pulse oximeter readings were first documented more than 3 decades ago.

“We sort of rediscovered something that had been known and had been described in the past,” Dr. Sjoding said. He explained how he and many of his colleagues had completed pulmonary fellowships, yet none of them knew of these potential issues with pulse oximeters until they began to observe differences in their own patients during the pandemic.

“I’ll give previous generations of researchers the benefit of the doubt,” Dr. Sjoding said, pointing out that techniques in data gathering and analysis have advanced considerably over the years. “The types of studies that were done before were very different than what we did.”

Yet Dr. Sjoding entertained the possibility that other factors may have been at play.

“I think definitely there’s a social commentary on prioritization of research,” he said.

The study was supported by grants from the National Institutes of Health. The investigators and Dr. Sjoding reported no conflicts of interest.

A commonly prescribed cancer and arthritis drug that is sometimes used as an oral abortifacient is facing prescription roadblocks in the wake of the Supreme Court’s overturning of Roe v. Wade.

The Court’s 5-4 decision in Dobbs v. Jackson Women’s Health Organization, which halted abortion procedures across the country, also appears to be affecting certain drug regimens. Reports have emerged that pharmacies are denying access to methotrexate (MTX), a drug often used in patients with arthritis or cancer, as well as psoriasis and other skin diseases. In very high doses, MTX it is used to terminate an ectopic pregnancy after miscarriage. The drug can also lead to birth defects.

“It’s happening all over,” Donald Miller, PharmD, professor of pharmacy practice at North Dakota State University, Fargo, said in an interview. “Pharmacists are reluctant to dispense it, and rheumatologists are reluctant to prescribe it because they’re afraid of going to jail.”

Becky Schwartz, a patient who takes MTX for lupus, recently tweeted that her physician’s office stopped prescribing the drug because it is considered an abortifacient. “I had care that made my disabled life easier, and [the Supreme Court] took that from me,” Ms. Schwartz wrote.

Prior to the Supreme Court’s ruling, physicians were concerned about the impact an overturning of the 1973 law would have on patient access to MTX and other prescription medications with abortifacient properties. Doctors in general are becoming afraid of prescribing anything that’s a teratogen, said Dr. Miller.

MTX is used far more often for autoimmune disease than as an abortifacient, said rheumatologist Kristen Young, MD, clinical assistant professor at the University of Arizona College of Medicine, Phoenix. It’s a slippery slope if states reacting to the Supreme Court ruling start regulating oral abortifacients, she added. Specifically, this will have a significant impact on patients with rheumatic disease.
 

Texas pharmacies target two drugs

MTX denials have caught the attention of health care organizations. “Uncertainty in financial and criminal liability for health care professionals in certain state laws and regulations are possibly compromising continuity of care and access [to] medications proven to be safe and effective by the Food and Drug Administration for these indications,” warned the American Pharmacists Association (APhA) in a statement to this news organization.

The APhA said that it was monitoring this situation to assess the effect on patients and pharmacists.

The Arthritis Foundation was made aware of challenges from patients in accessing their MTX prescription for managing their arthritis and shared a statement on the Foundation’s website.

In Texas, pharmacists can refuse to fill scripts for misoprostol and MTX, a combination used for medical abortions. According to the foundation, “Already there are reports that people in Texas who miscarry or take methotrexate for arthritis [are] having trouble getting their prescriptions filled.”

MTX, approved by the FDA in 1985, “is the absolute cornerstone of rheumatoid arthritis. We cannot deny our patients this incredibly valuable drug,” said John Reveille, MD, vice-chair for the department of medicine at the University of Texas McGovern School of Medicine and a member of the Arthritis Foundation expert panel, in an interview.

“While it’s true that methotrexate can be lethal to the fetus, misoprostol is much more likely to cause a spontaneous abortion, and the combination is especially effective,” he said.

“If you look at Cochrane clinical studies, the dose of misoprostol contained in certain combinations with NSAIDs [nonsteroidal anti-inflammatory drugs] can induce spontaneous abortions. It’s surprising that pharmacists are targeting methotrexate, an essential drug in arthritis treatment, when there are medications available that do not have this benefit that can by themselves cause loss of the fetus, such as mifepristone,” added Dr. Reveille.

The Dobbs ruling could also affect the ability of oncologists to provide lifesaving cancer care, according to Jason Westin, MD, an oncologist at the University of Texas MD Anderson Cancer Center in the department of lymphoma and myeloma.

“We have heard of medications with multiple indications, such as methotrexate, not being dispensed by pharmacies due to confusion regarding the intended use and potential consequences for the health care team,” he said in an interview.
 

Conflicting laws pose challenges for physicians

In North Dakota, inconsistencies in several laws are making it difficult for physicians and pharmacists to make decisions. “Lots of confusion can result when people pass laws against abortion. There’s sometimes no insight into the ramifications of those laws,” said Dr. Miller.

North Dakota approved a trigger law several years ago that makes abortion illegal 30 days after an overturning of Roe. However, another law that regulates abortion conflicts with the trigger law. “Some of the language will need clarification in the next legislative session,” he said.

APhA and other pharmacy associations strongly favor not interfering with the doctor- or pharmacist-patient relationship. The law needs to defer to appropriate care between doctor and patient, said Dr. Miller. State pharmacy associations in North Dakota are working with legislatures to clarify any exceptions in the law, he added.

Arizona lawmakers are trying to reconcile two abortion laws on the books. One, based on an 1864 territorial law, deems abortion illegal. In addition, a newly approved law bans abortions after 15 weeks. The latter will go into effect in September 2022. In both laws, a risk to the mother’s life is the only exception for abortion, said Dr. Young.
 

Denials aren’t widespread

Not all doctors are seeing MTX denials, but they’re worried about the future. “To date, we have not encountered difficulty in obtaining methotrexate based upon state abortion restrictions but are concerned that this could occur and result in dangerous delays in care,” said Dr. Westin.

Dr. Reveille, who practices rheumatology in Houston, has not yet received any complaints from patients. Things may be different in more rural parts of Texas, where pharmacists could be denying prescriptions based on religious issues, he offered.

It’s a little soon to see what repercussions may result from the Supreme Court ruling and state actions, said Dr. Reveille. “In Texas, we’re a bit ahead of the tidal wave.”

Access problems also haven’t shown up at the university clinic where Dr. Young practices. “In Arizona, it’s unclear if there would be a legal basis to refuse a person methotrexate on the basis that it can be used as an abortifacient,” she said.

Specificity is key in writing Rx scripts

Physicians can make things easier for patients by writing the indication and dose for the drug on the prescription slip. For example, a 10-mg script for MTX is not going to be used for an abortion, said Dr. Miller.

Rheumatologists in Texas have been doing this for some time, even before the Supreme Court ruling, said Fehmida Zahabi, MD, FACR, president of the Society of Texas Association of Rheumatology. For MTX prescriptions in premenopausal women, “patients are told their doctor needs to call the pharmacist. In the small print, we are asked to give a diagnosis to make sure we aren’t using it to terminate pregnancies,” said Dr. Zahabi.

She further noted that if the diagnosis is already indicated on the script, pharmacies generally won’t give patients a hard time.

Patients can also ask their physicians for a letter of medical necessity that confirms a drug’s use for a specific medical condition.

Mail order is another option if a local pharmacy won’t fill a prescription, said Dr. Miller. “This is legal unless a state makes it illegal to send an abortifacient across state lines,” he added.

Many medications used in rheumatic diseases are harmful in pregnancy, and it’s important to routinely discuss pregnancy risk and planning in the rheumatology clinic, said Dr. Young. This should include a thorough discussion and referral for long-acting reversible contraception in most cases, she suggested.
 

Actions at the federal, state level 

President Joe Biden recently signed an executive order prompting federal regulators to protect access to medication abortions, among other steps to safeguard access to reproductive services.

In a statement on Twitter, the American College of Rheumatology (ACR) said that it was “ ... following this issue closely to determine if rheumatology providers and patients are experiencing any widespread difficulty accessing methotrexate or if any initial disruptions are potentially temporary and due to the independent actions of pharmacists trying to figure out what is and isn’t allowed where they practice.”

ACR has assembled a task force of medical and policy experts to determine the best course of action for patients.

The Arthritis Foundation also continues to monitor the situation, encouraging patients to call its hotline, said Steven Schultz, director of state legislative affairs, in an interview.

“We are analyzing how medication abortion could cause confusion on the part of providers or pharmacists dispensing the medication and what this means for specific patients,” said Mr. Schultz. Through a survey, the foundation hopes to get a better idea of what’s going on in the states at a macro level.

This may take some time, as states go through a process of lawsuits, injunctions, or coming into session to do something that may affect access to MTX, said Mr. Schultz.

Being involved in local advocacy is more important than ever, stressed Dr. Young. “Additionally, being plugged into what the ACR and other advocacy groups are doing on the national level is helpful as well to know the status of these medication access issues.”

Rheumatologists have a unique voice in this discussion, she added. “We guide our patients to stability for a safe pregnancy, and even with careful planning, we see patients who become critically ill during pregnancy and require lifesaving treatment, which at times can mean an abortion is necessary.”

Oncologists also advocate for their patients on a regular basis to make sure they have access to the care they need, said Dr. Westin. This situation with Roe is no different, he added. “We will continue to use our unique expertise to advocate for policies that assure access to high-quality, evidence-based care – and to help our patients overcome barriers that may interfere.”

Dr. Reveille participated on an advisory board with Eli Lilly in October 2021.

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

A commonly prescribed cancer and arthritis drug that is sometimes used as an oral abortifacient is facing prescription roadblocks in the wake of the Supreme Court’s overturning of Roe v. Wade.

The Court’s 5-4 decision in Dobbs v. Jackson Women’s Health Organization, which halted abortion procedures across the country, also appears to be affecting certain drug regimens. Reports have emerged that pharmacies are denying access to methotrexate (MTX), a drug often used in patients with arthritis or cancer, as well as psoriasis and other skin diseases. In very high doses, MTX it is used to terminate an ectopic pregnancy after miscarriage. The drug can also lead to birth defects.

“It’s happening all over,” Donald Miller, PharmD, professor of pharmacy practice at North Dakota State University, Fargo, said in an interview. “Pharmacists are reluctant to dispense it, and rheumatologists are reluctant to prescribe it because they’re afraid of going to jail.”

Becky Schwartz, a patient who takes MTX for lupus, recently tweeted that her physician’s office stopped prescribing the drug because it is considered an abortifacient. “I had care that made my disabled life easier, and [the Supreme Court] took that from me,” Ms. Schwartz wrote.

Prior to the Supreme Court’s ruling, physicians were concerned about the impact an overturning of the 1973 law would have on patient access to MTX and other prescription medications with abortifacient properties. Doctors in general are becoming afraid of prescribing anything that’s a teratogen, said Dr. Miller.

MTX is used far more often for autoimmune disease than as an abortifacient, said rheumatologist Kristen Young, MD, clinical assistant professor at the University of Arizona College of Medicine, Phoenix. It’s a slippery slope if states reacting to the Supreme Court ruling start regulating oral abortifacients, she added. Specifically, this will have a significant impact on patients with rheumatic disease.
 

Texas pharmacies target two drugs

MTX denials have caught the attention of health care organizations. “Uncertainty in financial and criminal liability for health care professionals in certain state laws and regulations are possibly compromising continuity of care and access [to] medications proven to be safe and effective by the Food and Drug Administration for these indications,” warned the American Pharmacists Association (APhA) in a statement to this news organization.

The APhA said that it was monitoring this situation to assess the effect on patients and pharmacists.

The Arthritis Foundation was made aware of challenges from patients in accessing their MTX prescription for managing their arthritis and shared a statement on the Foundation’s website.

In Texas, pharmacists can refuse to fill scripts for misoprostol and MTX, a combination used for medical abortions. According to the foundation, “Already there are reports that people in Texas who miscarry or take methotrexate for arthritis [are] having trouble getting their prescriptions filled.”

MTX, approved by the FDA in 1985, “is the absolute cornerstone of rheumatoid arthritis. We cannot deny our patients this incredibly valuable drug,” said John Reveille, MD, vice-chair for the department of medicine at the University of Texas McGovern School of Medicine and a member of the Arthritis Foundation expert panel, in an interview.

“While it’s true that methotrexate can be lethal to the fetus, misoprostol is much more likely to cause a spontaneous abortion, and the combination is especially effective,” he said.

“If you look at Cochrane clinical studies, the dose of misoprostol contained in certain combinations with NSAIDs [nonsteroidal anti-inflammatory drugs] can induce spontaneous abortions. It’s surprising that pharmacists are targeting methotrexate, an essential drug in arthritis treatment, when there are medications available that do not have this benefit that can by themselves cause loss of the fetus, such as mifepristone,” added Dr. Reveille.

The Dobbs ruling could also affect the ability of oncologists to provide lifesaving cancer care, according to Jason Westin, MD, an oncologist at the University of Texas MD Anderson Cancer Center in the department of lymphoma and myeloma.

“We have heard of medications with multiple indications, such as methotrexate, not being dispensed by pharmacies due to confusion regarding the intended use and potential consequences for the health care team,” he said in an interview.
 

Conflicting laws pose challenges for physicians

In North Dakota, inconsistencies in several laws are making it difficult for physicians and pharmacists to make decisions. “Lots of confusion can result when people pass laws against abortion. There’s sometimes no insight into the ramifications of those laws,” said Dr. Miller.

North Dakota approved a trigger law several years ago that makes abortion illegal 30 days after an overturning of Roe. However, another law that regulates abortion conflicts with the trigger law. “Some of the language will need clarification in the next legislative session,” he said.

APhA and other pharmacy associations strongly favor not interfering with the doctor- or pharmacist-patient relationship. The law needs to defer to appropriate care between doctor and patient, said Dr. Miller. State pharmacy associations in North Dakota are working with legislatures to clarify any exceptions in the law, he added.

Arizona lawmakers are trying to reconcile two abortion laws on the books. One, based on an 1864 territorial law, deems abortion illegal. In addition, a newly approved law bans abortions after 15 weeks. The latter will go into effect in September 2022. In both laws, a risk to the mother’s life is the only exception for abortion, said Dr. Young.
 

Denials aren’t widespread

Not all doctors are seeing MTX denials, but they’re worried about the future. “To date, we have not encountered difficulty in obtaining methotrexate based upon state abortion restrictions but are concerned that this could occur and result in dangerous delays in care,” said Dr. Westin.

Dr. Reveille, who practices rheumatology in Houston, has not yet received any complaints from patients. Things may be different in more rural parts of Texas, where pharmacists could be denying prescriptions based on religious issues, he offered.

It’s a little soon to see what repercussions may result from the Supreme Court ruling and state actions, said Dr. Reveille. “In Texas, we’re a bit ahead of the tidal wave.”

Access problems also haven’t shown up at the university clinic where Dr. Young practices. “In Arizona, it’s unclear if there would be a legal basis to refuse a person methotrexate on the basis that it can be used as an abortifacient,” she said.

Specificity is key in writing Rx scripts

Physicians can make things easier for patients by writing the indication and dose for the drug on the prescription slip. For example, a 10-mg script for MTX is not going to be used for an abortion, said Dr. Miller.

Rheumatologists in Texas have been doing this for some time, even before the Supreme Court ruling, said Fehmida Zahabi, MD, FACR, president of the Society of Texas Association of Rheumatology. For MTX prescriptions in premenopausal women, “patients are told their doctor needs to call the pharmacist. In the small print, we are asked to give a diagnosis to make sure we aren’t using it to terminate pregnancies,” said Dr. Zahabi.

She further noted that if the diagnosis is already indicated on the script, pharmacies generally won’t give patients a hard time.

Patients can also ask their physicians for a letter of medical necessity that confirms a drug’s use for a specific medical condition.

Mail order is another option if a local pharmacy won’t fill a prescription, said Dr. Miller. “This is legal unless a state makes it illegal to send an abortifacient across state lines,” he added.

Many medications used in rheumatic diseases are harmful in pregnancy, and it’s important to routinely discuss pregnancy risk and planning in the rheumatology clinic, said Dr. Young. This should include a thorough discussion and referral for long-acting reversible contraception in most cases, she suggested.
 

Actions at the federal, state level 

President Joe Biden recently signed an executive order prompting federal regulators to protect access to medication abortions, among other steps to safeguard access to reproductive services.

In a statement on Twitter, the American College of Rheumatology (ACR) said that it was “ ... following this issue closely to determine if rheumatology providers and patients are experiencing any widespread difficulty accessing methotrexate or if any initial disruptions are potentially temporary and due to the independent actions of pharmacists trying to figure out what is and isn’t allowed where they practice.”

ACR has assembled a task force of medical and policy experts to determine the best course of action for patients.

The Arthritis Foundation also continues to monitor the situation, encouraging patients to call its hotline, said Steven Schultz, director of state legislative affairs, in an interview.

“We are analyzing how medication abortion could cause confusion on the part of providers or pharmacists dispensing the medication and what this means for specific patients,” said Mr. Schultz. Through a survey, the foundation hopes to get a better idea of what’s going on in the states at a macro level.

This may take some time, as states go through a process of lawsuits, injunctions, or coming into session to do something that may affect access to MTX, said Mr. Schultz.

Being involved in local advocacy is more important than ever, stressed Dr. Young. “Additionally, being plugged into what the ACR and other advocacy groups are doing on the national level is helpful as well to know the status of these medication access issues.”

Rheumatologists have a unique voice in this discussion, she added. “We guide our patients to stability for a safe pregnancy, and even with careful planning, we see patients who become critically ill during pregnancy and require lifesaving treatment, which at times can mean an abortion is necessary.”

Oncologists also advocate for their patients on a regular basis to make sure they have access to the care they need, said Dr. Westin. This situation with Roe is no different, he added. “We will continue to use our unique expertise to advocate for policies that assure access to high-quality, evidence-based care – and to help our patients overcome barriers that may interfere.”

Dr. Reveille participated on an advisory board with Eli Lilly in October 2021.

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

A commonly prescribed cancer and arthritis drug that is sometimes used as an oral abortifacient is facing prescription roadblocks in the wake of the Supreme Court’s overturning of Roe v. Wade.

The Court’s 5-4 decision in Dobbs v. Jackson Women’s Health Organization, which halted abortion procedures across the country, also appears to be affecting certain drug regimens. Reports have emerged that pharmacies are denying access to methotrexate (MTX), a drug often used in patients with arthritis or cancer, as well as psoriasis and other skin diseases. In very high doses, MTX it is used to terminate an ectopic pregnancy after miscarriage. The drug can also lead to birth defects.

“It’s happening all over,” Donald Miller, PharmD, professor of pharmacy practice at North Dakota State University, Fargo, said in an interview. “Pharmacists are reluctant to dispense it, and rheumatologists are reluctant to prescribe it because they’re afraid of going to jail.”

Becky Schwartz, a patient who takes MTX for lupus, recently tweeted that her physician’s office stopped prescribing the drug because it is considered an abortifacient. “I had care that made my disabled life easier, and [the Supreme Court] took that from me,” Ms. Schwartz wrote.

Prior to the Supreme Court’s ruling, physicians were concerned about the impact an overturning of the 1973 law would have on patient access to MTX and other prescription medications with abortifacient properties. Doctors in general are becoming afraid of prescribing anything that’s a teratogen, said Dr. Miller.

MTX is used far more often for autoimmune disease than as an abortifacient, said rheumatologist Kristen Young, MD, clinical assistant professor at the University of Arizona College of Medicine, Phoenix. It’s a slippery slope if states reacting to the Supreme Court ruling start regulating oral abortifacients, she added. Specifically, this will have a significant impact on patients with rheumatic disease.
 

Texas pharmacies target two drugs

MTX denials have caught the attention of health care organizations. “Uncertainty in financial and criminal liability for health care professionals in certain state laws and regulations are possibly compromising continuity of care and access [to] medications proven to be safe and effective by the Food and Drug Administration for these indications,” warned the American Pharmacists Association (APhA) in a statement to this news organization.

The APhA said that it was monitoring this situation to assess the effect on patients and pharmacists.

The Arthritis Foundation was made aware of challenges from patients in accessing their MTX prescription for managing their arthritis and shared a statement on the Foundation’s website.

In Texas, pharmacists can refuse to fill scripts for misoprostol and MTX, a combination used for medical abortions. According to the foundation, “Already there are reports that people in Texas who miscarry or take methotrexate for arthritis [are] having trouble getting their prescriptions filled.”

MTX, approved by the FDA in 1985, “is the absolute cornerstone of rheumatoid arthritis. We cannot deny our patients this incredibly valuable drug,” said John Reveille, MD, vice-chair for the department of medicine at the University of Texas McGovern School of Medicine and a member of the Arthritis Foundation expert panel, in an interview.

“While it’s true that methotrexate can be lethal to the fetus, misoprostol is much more likely to cause a spontaneous abortion, and the combination is especially effective,” he said.

“If you look at Cochrane clinical studies, the dose of misoprostol contained in certain combinations with NSAIDs [nonsteroidal anti-inflammatory drugs] can induce spontaneous abortions. It’s surprising that pharmacists are targeting methotrexate, an essential drug in arthritis treatment, when there are medications available that do not have this benefit that can by themselves cause loss of the fetus, such as mifepristone,” added Dr. Reveille.

The Dobbs ruling could also affect the ability of oncologists to provide lifesaving cancer care, according to Jason Westin, MD, an oncologist at the University of Texas MD Anderson Cancer Center in the department of lymphoma and myeloma.

“We have heard of medications with multiple indications, such as methotrexate, not being dispensed by pharmacies due to confusion regarding the intended use and potential consequences for the health care team,” he said in an interview.
 

Conflicting laws pose challenges for physicians

In North Dakota, inconsistencies in several laws are making it difficult for physicians and pharmacists to make decisions. “Lots of confusion can result when people pass laws against abortion. There’s sometimes no insight into the ramifications of those laws,” said Dr. Miller.

North Dakota approved a trigger law several years ago that makes abortion illegal 30 days after an overturning of Roe. However, another law that regulates abortion conflicts with the trigger law. “Some of the language will need clarification in the next legislative session,” he said.

APhA and other pharmacy associations strongly favor not interfering with the doctor- or pharmacist-patient relationship. The law needs to defer to appropriate care between doctor and patient, said Dr. Miller. State pharmacy associations in North Dakota are working with legislatures to clarify any exceptions in the law, he added.

Arizona lawmakers are trying to reconcile two abortion laws on the books. One, based on an 1864 territorial law, deems abortion illegal. In addition, a newly approved law bans abortions after 15 weeks. The latter will go into effect in September 2022. In both laws, a risk to the mother’s life is the only exception for abortion, said Dr. Young.
 

Denials aren’t widespread

Not all doctors are seeing MTX denials, but they’re worried about the future. “To date, we have not encountered difficulty in obtaining methotrexate based upon state abortion restrictions but are concerned that this could occur and result in dangerous delays in care,” said Dr. Westin.

Dr. Reveille, who practices rheumatology in Houston, has not yet received any complaints from patients. Things may be different in more rural parts of Texas, where pharmacists could be denying prescriptions based on religious issues, he offered.

It’s a little soon to see what repercussions may result from the Supreme Court ruling and state actions, said Dr. Reveille. “In Texas, we’re a bit ahead of the tidal wave.”

Access problems also haven’t shown up at the university clinic where Dr. Young practices. “In Arizona, it’s unclear if there would be a legal basis to refuse a person methotrexate on the basis that it can be used as an abortifacient,” she said.

Specificity is key in writing Rx scripts

Physicians can make things easier for patients by writing the indication and dose for the drug on the prescription slip. For example, a 10-mg script for MTX is not going to be used for an abortion, said Dr. Miller.

Rheumatologists in Texas have been doing this for some time, even before the Supreme Court ruling, said Fehmida Zahabi, MD, FACR, president of the Society of Texas Association of Rheumatology. For MTX prescriptions in premenopausal women, “patients are told their doctor needs to call the pharmacist. In the small print, we are asked to give a diagnosis to make sure we aren’t using it to terminate pregnancies,” said Dr. Zahabi.

She further noted that if the diagnosis is already indicated on the script, pharmacies generally won’t give patients a hard time.

Patients can also ask their physicians for a letter of medical necessity that confirms a drug’s use for a specific medical condition.

Mail order is another option if a local pharmacy won’t fill a prescription, said Dr. Miller. “This is legal unless a state makes it illegal to send an abortifacient across state lines,” he added.

Many medications used in rheumatic diseases are harmful in pregnancy, and it’s important to routinely discuss pregnancy risk and planning in the rheumatology clinic, said Dr. Young. This should include a thorough discussion and referral for long-acting reversible contraception in most cases, she suggested.
 

Actions at the federal, state level 

President Joe Biden recently signed an executive order prompting federal regulators to protect access to medication abortions, among other steps to safeguard access to reproductive services.

In a statement on Twitter, the American College of Rheumatology (ACR) said that it was “ ... following this issue closely to determine if rheumatology providers and patients are experiencing any widespread difficulty accessing methotrexate or if any initial disruptions are potentially temporary and due to the independent actions of pharmacists trying to figure out what is and isn’t allowed where they practice.”

ACR has assembled a task force of medical and policy experts to determine the best course of action for patients.

The Arthritis Foundation also continues to monitor the situation, encouraging patients to call its hotline, said Steven Schultz, director of state legislative affairs, in an interview.

“We are analyzing how medication abortion could cause confusion on the part of providers or pharmacists dispensing the medication and what this means for specific patients,” said Mr. Schultz. Through a survey, the foundation hopes to get a better idea of what’s going on in the states at a macro level.

This may take some time, as states go through a process of lawsuits, injunctions, or coming into session to do something that may affect access to MTX, said Mr. Schultz.

Being involved in local advocacy is more important than ever, stressed Dr. Young. “Additionally, being plugged into what the ACR and other advocacy groups are doing on the national level is helpful as well to know the status of these medication access issues.”

Rheumatologists have a unique voice in this discussion, she added. “We guide our patients to stability for a safe pregnancy, and even with careful planning, we see patients who become critically ill during pregnancy and require lifesaving treatment, which at times can mean an abortion is necessary.”

Oncologists also advocate for their patients on a regular basis to make sure they have access to the care they need, said Dr. Westin. This situation with Roe is no different, he added. “We will continue to use our unique expertise to advocate for policies that assure access to high-quality, evidence-based care – and to help our patients overcome barriers that may interfere.”

Dr. Reveille participated on an advisory board with Eli Lilly in October 2021.

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

Estrogen exposure helps protect against colorectal cancer (CRC), and in some instances, the protection is site specific, a new analysis finds.

In a 17-year study involving almost 5,000 women, researchers from Germany found that hormone replacement therapy, oral contraceptive use, pregnancy, breastfeeding, and menopause at age 50 or older were all significantly associated with reductions in CRC risk.

Interestingly, the reduced risk of CRC observed for pregnancy and breastfeeding only applied to proximal colon cancer, while the association with oral contraceptive use was confined to the distal colon and rectum.

The results were published online in JNCI Cancer Spectrum.

CRC is the second most common cause of cancer death. It is responsible for more than one million deaths globally, according to the latest figures from the Global Burden of Disease 2019 Cancer Collaboration.

And sex seems to make a difference. The Global Burden analysis, echoing previous data, found that CRC is less common among women and that fewer women die from the disease.

Little, however, is known about the mechanisms of estrogen signaling in CRC or the impact of reproductive factors on CRC, despite a large amount of literature linking CRC risk to exogenous estrogens, such as hormone replacement therapy and oral contraceptives.

In the current analysis, the team recruited 2,650 patients with CRC from 20 German cancer centers between 2003 and 2020. Researchers used standardized questionnaires to garner the women’s reproductive histories.

A matched control group of 2,175 participants who did not have a history of CRC was randomly selected from population registries. All analyses were adjusted for known CRC risk factors, such as age; body mass index; education level; family history; having previously undergone large-bowel endoscopy; diabetes; and smoking status.

The researchers found that each pregnancy was associated with a small but significant 9% reduction in CRC risk (odds ratio, 0.91), specifically in the proximal colon (OR, 0.86).

Overall, breastfeeding for a year or longer was associated with a significantly lower CRC risk, compared with never breastfeeding (OR, 0.74), but the results were only significant for the proximal colon (OR, 0.58).

Oral contraceptive use for 9 years or longer was associated with a lower CRC risk (OR, 0.75) but was only significant for the distal colon (OR, 0.63). Hormone replacement therapy was associated with a lower risk of CRC irrespective of tumor location (OR, 0.76). And using both was linked to a 42% CRC risk reduction (OR, 0.58).

Although age at menarche was not associated with CRC risk, menopause at age 50 or older was associated with a significant 17% lower risk of CRC.

In an email interview, lead author Tobias Niedermaier, PhD, expressed surprise at two of the findings. The first was the small association between pregnancies and CRC risk, “despite the strong increase in estrogen levels during pregnancy,” he said. He speculated that pregnancy-related increases in insulin levels may have “largely offset the protection effects of estrogen exposure during pregnancy.”

The second surprise was that the age at menarche did not have a bearing on CRC risk, which could be because “exposure to estrogen levels in younger ages [is] less relevant with respect to CRC risk, because CRC typically develops at comparably old age.”

John Marshall, MD, who was not involved in the research, commented that such studies “put a lot of pressure on people to perform in a certain way to modify their personal risk of something.” However, “we would not recommend people alter their life choices for reproduction for this,” said Dr. Marshall, chief of the Division of Hematology/Oncology at Georgetown University, Washington, D.C.

Dr. Niedermaier agreed that “while this knowledge will certainly not change a woman’s decision on family planning,” he noted that the findings “could influence current CRC screening strategies, for example, by risk-adapted screening intervals [and] start and stop ages of screening.”

Dr. Niedermaier and colleagues’ work was funded by the German Research Council, the German Federal Ministry of Education and Research, and the Interdisciplinary Research Program of the National Center for Tumor Diseases. Dr. Niedermaier has disclosed no relevant financial relationships. Dr. Marshall writes a column that appears regularly on Medscape: Marshall on Oncology. He has served as speaker or member of a speakers’ bureau for Genentech, Amgen, Bayer, Celgene Corporation, and Caris Life Sciences.

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

Estrogen exposure helps protect against colorectal cancer (CRC), and in some instances, the protection is site specific, a new analysis finds.

In a 17-year study involving almost 5,000 women, researchers from Germany found that hormone replacement therapy, oral contraceptive use, pregnancy, breastfeeding, and menopause at age 50 or older were all significantly associated with reductions in CRC risk.

Interestingly, the reduced risk of CRC observed for pregnancy and breastfeeding only applied to proximal colon cancer, while the association with oral contraceptive use was confined to the distal colon and rectum.

The results were published online in JNCI Cancer Spectrum.

CRC is the second most common cause of cancer death. It is responsible for more than one million deaths globally, according to the latest figures from the Global Burden of Disease 2019 Cancer Collaboration.

And sex seems to make a difference. The Global Burden analysis, echoing previous data, found that CRC is less common among women and that fewer women die from the disease.

Little, however, is known about the mechanisms of estrogen signaling in CRC or the impact of reproductive factors on CRC, despite a large amount of literature linking CRC risk to exogenous estrogens, such as hormone replacement therapy and oral contraceptives.

In the current analysis, the team recruited 2,650 patients with CRC from 20 German cancer centers between 2003 and 2020. Researchers used standardized questionnaires to garner the women’s reproductive histories.

A matched control group of 2,175 participants who did not have a history of CRC was randomly selected from population registries. All analyses were adjusted for known CRC risk factors, such as age; body mass index; education level; family history; having previously undergone large-bowel endoscopy; diabetes; and smoking status.

The researchers found that each pregnancy was associated with a small but significant 9% reduction in CRC risk (odds ratio, 0.91), specifically in the proximal colon (OR, 0.86).

Overall, breastfeeding for a year or longer was associated with a significantly lower CRC risk, compared with never breastfeeding (OR, 0.74), but the results were only significant for the proximal colon (OR, 0.58).

Oral contraceptive use for 9 years or longer was associated with a lower CRC risk (OR, 0.75) but was only significant for the distal colon (OR, 0.63). Hormone replacement therapy was associated with a lower risk of CRC irrespective of tumor location (OR, 0.76). And using both was linked to a 42% CRC risk reduction (OR, 0.58).

Although age at menarche was not associated with CRC risk, menopause at age 50 or older was associated with a significant 17% lower risk of CRC.

In an email interview, lead author Tobias Niedermaier, PhD, expressed surprise at two of the findings. The first was the small association between pregnancies and CRC risk, “despite the strong increase in estrogen levels during pregnancy,” he said. He speculated that pregnancy-related increases in insulin levels may have “largely offset the protection effects of estrogen exposure during pregnancy.”

The second surprise was that the age at menarche did not have a bearing on CRC risk, which could be because “exposure to estrogen levels in younger ages [is] less relevant with respect to CRC risk, because CRC typically develops at comparably old age.”

John Marshall, MD, who was not involved in the research, commented that such studies “put a lot of pressure on people to perform in a certain way to modify their personal risk of something.” However, “we would not recommend people alter their life choices for reproduction for this,” said Dr. Marshall, chief of the Division of Hematology/Oncology at Georgetown University, Washington, D.C.

Dr. Niedermaier agreed that “while this knowledge will certainly not change a woman’s decision on family planning,” he noted that the findings “could influence current CRC screening strategies, for example, by risk-adapted screening intervals [and] start and stop ages of screening.”

Dr. Niedermaier and colleagues’ work was funded by the German Research Council, the German Federal Ministry of Education and Research, and the Interdisciplinary Research Program of the National Center for Tumor Diseases. Dr. Niedermaier has disclosed no relevant financial relationships. Dr. Marshall writes a column that appears regularly on Medscape: Marshall on Oncology. He has served as speaker or member of a speakers’ bureau for Genentech, Amgen, Bayer, Celgene Corporation, and Caris Life Sciences.

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

Estrogen exposure helps protect against colorectal cancer (CRC), and in some instances, the protection is site specific, a new analysis finds.

In a 17-year study involving almost 5,000 women, researchers from Germany found that hormone replacement therapy, oral contraceptive use, pregnancy, breastfeeding, and menopause at age 50 or older were all significantly associated with reductions in CRC risk.

Interestingly, the reduced risk of CRC observed for pregnancy and breastfeeding only applied to proximal colon cancer, while the association with oral contraceptive use was confined to the distal colon and rectum.

The results were published online in JNCI Cancer Spectrum.

CRC is the second most common cause of cancer death. It is responsible for more than one million deaths globally, according to the latest figures from the Global Burden of Disease 2019 Cancer Collaboration.

And sex seems to make a difference. The Global Burden analysis, echoing previous data, found that CRC is less common among women and that fewer women die from the disease.

Little, however, is known about the mechanisms of estrogen signaling in CRC or the impact of reproductive factors on CRC, despite a large amount of literature linking CRC risk to exogenous estrogens, such as hormone replacement therapy and oral contraceptives.

In the current analysis, the team recruited 2,650 patients with CRC from 20 German cancer centers between 2003 and 2020. Researchers used standardized questionnaires to garner the women’s reproductive histories.

A matched control group of 2,175 participants who did not have a history of CRC was randomly selected from population registries. All analyses were adjusted for known CRC risk factors, such as age; body mass index; education level; family history; having previously undergone large-bowel endoscopy; diabetes; and smoking status.

The researchers found that each pregnancy was associated with a small but significant 9% reduction in CRC risk (odds ratio, 0.91), specifically in the proximal colon (OR, 0.86).

Overall, breastfeeding for a year or longer was associated with a significantly lower CRC risk, compared with never breastfeeding (OR, 0.74), but the results were only significant for the proximal colon (OR, 0.58).

Oral contraceptive use for 9 years or longer was associated with a lower CRC risk (OR, 0.75) but was only significant for the distal colon (OR, 0.63). Hormone replacement therapy was associated with a lower risk of CRC irrespective of tumor location (OR, 0.76). And using both was linked to a 42% CRC risk reduction (OR, 0.58).

Although age at menarche was not associated with CRC risk, menopause at age 50 or older was associated with a significant 17% lower risk of CRC.

In an email interview, lead author Tobias Niedermaier, PhD, expressed surprise at two of the findings. The first was the small association between pregnancies and CRC risk, “despite the strong increase in estrogen levels during pregnancy,” he said. He speculated that pregnancy-related increases in insulin levels may have “largely offset the protection effects of estrogen exposure during pregnancy.”

The second surprise was that the age at menarche did not have a bearing on CRC risk, which could be because “exposure to estrogen levels in younger ages [is] less relevant with respect to CRC risk, because CRC typically develops at comparably old age.”

John Marshall, MD, who was not involved in the research, commented that such studies “put a lot of pressure on people to perform in a certain way to modify their personal risk of something.” However, “we would not recommend people alter their life choices for reproduction for this,” said Dr. Marshall, chief of the Division of Hematology/Oncology at Georgetown University, Washington, D.C.

Dr. Niedermaier agreed that “while this knowledge will certainly not change a woman’s decision on family planning,” he noted that the findings “could influence current CRC screening strategies, for example, by risk-adapted screening intervals [and] start and stop ages of screening.”

Dr. Niedermaier and colleagues’ work was funded by the German Research Council, the German Federal Ministry of Education and Research, and the Interdisciplinary Research Program of the National Center for Tumor Diseases. Dr. Niedermaier has disclosed no relevant financial relationships. Dr. Marshall writes a column that appears regularly on Medscape: Marshall on Oncology. He has served as speaker or member of a speakers’ bureau for Genentech, Amgen, Bayer, Celgene Corporation, and Caris Life Sciences.

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

Luke is a 12-year-old who presents for a well-child visit accompanied by his foster mother. He appears ^more solemn and taciturn than at previous visits. He is not interested in talking about any topics, including things he enjoys. His foster mother states that he has been more irritable, oppositional, and behaviorally dysregulated over the past 2 months. She also notes that his sleep has been poor. He reports this is because of nightmares and trouble falling asleep. Luke states that he will at times remember seeing his mother being struck by his father and – even when he does not want to – will have thoughts about hiding from his dad after being hit. You learn from the foster mother that he has been residing with her for the past 2 months and that he is now in state custody following significant parental home substance use, witnessing domestic violence, and being physically abused by his father.

The above narrative may sound all too familiar to those in pediatric primary care. You may wonder if there is a potential posttraumatic response to the witnessed trauma, but does the patient meet criteria for a trauma-related disorder? If so, what are the best next steps?
 

Prevalence of posttraumatic stress disorder in the general pediatric population

According to the 2020 National Survey of Children’s Health, approximately 40% of children age 17 and under report experiencing at least one adverse childhood experience. Within the 12-17 age range, it rises to over 50%.¹ Adverse childhood experiences (ACEs) are potentially traumatic events and include items such as experiencing violence/abuse/neglect, witnessing violence in the home or community, having a family member attempt or die by suicide, and other adverse household and environmental situations. The accumulation of these ACEs can lead to long-term adverse emotional, physical, and behavioral outcomes.²

However, adverse childhood experiences do not always translate into PTSD. According to one national survey of 13- to 18-year-olds, the lifetime prevalence of PTSD is notably lower than exposure rates to ACEs and is estimated at 5% of adolescents, with higher rates among females (8%) versus males (2.3%).³

There are various risk factors for the development of PTSD that may play a role including genetic vulnerability, length of the trauma (for example, a one-time event versus repeated trauma for years), characteristics specific to the trauma, and the aftermath of the trauma. Again, it is important to note that not all youth exposed to a traumatic event will develop PTSD. Those who do make up a small percentage of at-risk children.⁴
 

Diagnosing PTSD in a child or adolescent

For a pediatric patient to be diagnosed with PTSD according to the DSM-5 criteria, they must experience a potentially traumatic event and meet criteria from four categories of symptoms. Trauma is defined as direct or indirect exposure to actual or threatened death, serious injury, or sexual violence. The four symptom categories are re-experiencing, avoidance, hyperarousal, and negative alteration in cognition and mood. The number of symptoms needed from each category varies based on the child’s age, with differing cutoffs based on whether the child is younger or older than 6 years old. Moreover, symptoms must be present for at least 1 month.⁵

Trauma can be assessed in the office by using a focused interview that includes the full DSM diagnostic criteria. There are additional trauma rating screeners and assessment tools that can be used including the Child PTSD Symptom Scale, Child Trauma Screening Questionnaire, UCLA Posttraumatic Stress Disorder Reaction Index, and the Trauma Symptom Checklist for Children, to name a few. Many of these allow for multiple informants, including the child/adolescent, thereby allowing for varying perspectives regarding trauma reactions.
 

Treatment options

Familiarity with evidence-based treatment for trauma may be useful to ensure that referral is targeted for the patient/family. There are no Food and Drug Administrations–approved medications for children with PTSD, though medications can be used to target specific PTSD symptoms (e.g. prazosin for trauma-related nightmares) as well as commonly comorbid conditions such as depression. Becoming familiar with the available therapeutic modalities offered in your area is recommended.

Highlighting trauma-focused cognitive behavioral therapy (TF-CBT)

The treatment with the most research evidence for traumatized children is trauma-focused cognitive behavioral therapy (TF-CBT), which is a 12- to 25-session therapeutic intervention for patients 3-18 years old (with some evidence for young adults as well) with PTSD and/or trauma-related behaviors. TF-CBT uses a components-based treatment model encompassed by the PRACTICE acronym/mnemonic.^6,7

• P – Psychoeducation and parenting skills.
• R – Relaxation techniques: Focused breathing, progressive muscle relaxation, and teaching the child to control their thoughts (thought stopping).
• A – Affective expression and regulation (feeling identification): To help the child and parent learn to control their emotional reaction to reminders by expanding their emotional vocabulary, enhancing their skills in identification and expression of emotions, and encouraging self-soothing activities
• C – Cognitive coping and processing: Through this component, the child learns to understand the relationships between thoughts, feelings, and behaviors and think in new and healthier ways.
• T – Trauma narrative and processing: Gradual exposure exercises including verbal, written, and/or symbolic recounting of traumatic event(s) so the child learns to be able to discuss the events when they choose to in ways that do not produce overwhelming emotions. Following the completion of the narrative, clients are supported in identifying, challenging, and correcting cognitive distortions and dysfunctional beliefs.
• I – In vivo exposure: Encourage the gradual exposure to innocuous trauma reminders in the child’s environment so the child learns they can control their emotional reactions to things that remind them of the trauma, starting with nonthreatening examples of reminders.
• C – Conjoint parent/child sessions: Sessions generally deal with psycho-education, sharing the trauma narrative, anxiety management, and correction of cognitive distortions. The family works to enhance communication and create opportunities for therapeutic discussion regarding the trauma.
• E – Enhancing personal safety and future growth: Provide training and education with respect to personal safety skills and healthy sexuality and interpersonal relationships; encourage the utilization of skills learned in managing future stressors and/or trauma reminders.

Of note, some elements of this therapy that could possibly be easily incorporated into a primary care office visit include relaxation techniques and focus on coping skills/strategies.
 

Summary

Children and adolescents often present with trauma-related symptoms to the primary care office. Having increasing familiarity with PTSD diagnostic criteria and treatment modalities will likely lead to increased confidence and comfort recognizing symptoms and when placing a referral. This may also lead to shorter wait times for receiving targeted treatment and ultimately should lead to better outcomes for affected children and families.

Dr. Abdul-Kareem is at the University of Vermont, Burlington.

References

1. National Survey of Children’s Health (2016 - present). https://nschdata.org/browse/survey.

2. Adverse Childhood Experiences (ACEs). Centers for Disease Control and Prevention. https://www.cdc.gov/violenceprevention/aces/index.html].

3. Post-Traumatic Stress Disorder (PTSD). National Institute of Mental Health. https://www.nimh.nih.gov/health/statistics/post-traumatic-stress-disorder-ptsd,

4. Martin A et al. Lewis’s Child and Adolescent Psychiatry (5th edition). Lippincott Williams & Wilkins: Philadelphia, 2017.

5. American Psychiatric Association. Neurodevelopmental disorders. In: DSM-5.  2013.

6. Trauma-Focused Cognitive Behavioral Therapy. The National Child Traumatic Stress Network. https://www.nctsn.org/interventions/trauma-focused-cognitive-behavioral-therapy.

7. Trauma-Focused Cognitive-Behavioral Therapy (TF-CBT). California Evidence-Based Clearinghouse for Child Welfare. https://www.cebc4cw.org/program/trauma-focused-cognitive-behavioral-therapy/.

Luke is a 12-year-old who presents for a well-child visit accompanied by his foster mother. He appears ^more solemn and taciturn than at previous visits. He is not interested in talking about any topics, including things he enjoys. His foster mother states that he has been more irritable, oppositional, and behaviorally dysregulated over the past 2 months. She also notes that his sleep has been poor. He reports this is because of nightmares and trouble falling asleep. Luke states that he will at times remember seeing his mother being struck by his father and – even when he does not want to – will have thoughts about hiding from his dad after being hit. You learn from the foster mother that he has been residing with her for the past 2 months and that he is now in state custody following significant parental home substance use, witnessing domestic violence, and being physically abused by his father.

The above narrative may sound all too familiar to those in pediatric primary care. You may wonder if there is a potential posttraumatic response to the witnessed trauma, but does the patient meet criteria for a trauma-related disorder? If so, what are the best next steps?
 

Prevalence of posttraumatic stress disorder in the general pediatric population

According to the 2020 National Survey of Children’s Health, approximately 40% of children age 17 and under report experiencing at least one adverse childhood experience. Within the 12-17 age range, it rises to over 50%.¹ Adverse childhood experiences (ACEs) are potentially traumatic events and include items such as experiencing violence/abuse/neglect, witnessing violence in the home or community, having a family member attempt or die by suicide, and other adverse household and environmental situations. The accumulation of these ACEs can lead to long-term adverse emotional, physical, and behavioral outcomes.²

However, adverse childhood experiences do not always translate into PTSD. According to one national survey of 13- to 18-year-olds, the lifetime prevalence of PTSD is notably lower than exposure rates to ACEs and is estimated at 5% of adolescents, with higher rates among females (8%) versus males (2.3%).³

There are various risk factors for the development of PTSD that may play a role including genetic vulnerability, length of the trauma (for example, a one-time event versus repeated trauma for years), characteristics specific to the trauma, and the aftermath of the trauma. Again, it is important to note that not all youth exposed to a traumatic event will develop PTSD. Those who do make up a small percentage of at-risk children.⁴
 

Diagnosing PTSD in a child or adolescent

For a pediatric patient to be diagnosed with PTSD according to the DSM-5 criteria, they must experience a potentially traumatic event and meet criteria from four categories of symptoms. Trauma is defined as direct or indirect exposure to actual or threatened death, serious injury, or sexual violence. The four symptom categories are re-experiencing, avoidance, hyperarousal, and negative alteration in cognition and mood. The number of symptoms needed from each category varies based on the child’s age, with differing cutoffs based on whether the child is younger or older than 6 years old. Moreover, symptoms must be present for at least 1 month.⁵

Trauma can be assessed in the office by using a focused interview that includes the full DSM diagnostic criteria. There are additional trauma rating screeners and assessment tools that can be used including the Child PTSD Symptom Scale, Child Trauma Screening Questionnaire, UCLA Posttraumatic Stress Disorder Reaction Index, and the Trauma Symptom Checklist for Children, to name a few. Many of these allow for multiple informants, including the child/adolescent, thereby allowing for varying perspectives regarding trauma reactions.
 

Treatment options

Familiarity with evidence-based treatment for trauma may be useful to ensure that referral is targeted for the patient/family. There are no Food and Drug Administrations–approved medications for children with PTSD, though medications can be used to target specific PTSD symptoms (e.g. prazosin for trauma-related nightmares) as well as commonly comorbid conditions such as depression. Becoming familiar with the available therapeutic modalities offered in your area is recommended.

Highlighting trauma-focused cognitive behavioral therapy (TF-CBT)

The treatment with the most research evidence for traumatized children is trauma-focused cognitive behavioral therapy (TF-CBT), which is a 12- to 25-session therapeutic intervention for patients 3-18 years old (with some evidence for young adults as well) with PTSD and/or trauma-related behaviors. TF-CBT uses a components-based treatment model encompassed by the PRACTICE acronym/mnemonic.^6,7

• P – Psychoeducation and parenting skills.
• R – Relaxation techniques: Focused breathing, progressive muscle relaxation, and teaching the child to control their thoughts (thought stopping).
• A – Affective expression and regulation (feeling identification): To help the child and parent learn to control their emotional reaction to reminders by expanding their emotional vocabulary, enhancing their skills in identification and expression of emotions, and encouraging self-soothing activities
• C – Cognitive coping and processing: Through this component, the child learns to understand the relationships between thoughts, feelings, and behaviors and think in new and healthier ways.
• T – Trauma narrative and processing: Gradual exposure exercises including verbal, written, and/or symbolic recounting of traumatic event(s) so the child learns to be able to discuss the events when they choose to in ways that do not produce overwhelming emotions. Following the completion of the narrative, clients are supported in identifying, challenging, and correcting cognitive distortions and dysfunctional beliefs.
• I – In vivo exposure: Encourage the gradual exposure to innocuous trauma reminders in the child’s environment so the child learns they can control their emotional reactions to things that remind them of the trauma, starting with nonthreatening examples of reminders.
• C – Conjoint parent/child sessions: Sessions generally deal with psycho-education, sharing the trauma narrative, anxiety management, and correction of cognitive distortions. The family works to enhance communication and create opportunities for therapeutic discussion regarding the trauma.
• E – Enhancing personal safety and future growth: Provide training and education with respect to personal safety skills and healthy sexuality and interpersonal relationships; encourage the utilization of skills learned in managing future stressors and/or trauma reminders.

Of note, some elements of this therapy that could possibly be easily incorporated into a primary care office visit include relaxation techniques and focus on coping skills/strategies.
 

Summary

Children and adolescents often present with trauma-related symptoms to the primary care office. Having increasing familiarity with PTSD diagnostic criteria and treatment modalities will likely lead to increased confidence and comfort recognizing symptoms and when placing a referral. This may also lead to shorter wait times for receiving targeted treatment and ultimately should lead to better outcomes for affected children and families.

Dr. Abdul-Kareem is at the University of Vermont, Burlington.

References

1. National Survey of Children’s Health (2016 - present). https://nschdata.org/browse/survey.

2. Adverse Childhood Experiences (ACEs). Centers for Disease Control and Prevention. https://www.cdc.gov/violenceprevention/aces/index.html].

3. Post-Traumatic Stress Disorder (PTSD). National Institute of Mental Health. https://www.nimh.nih.gov/health/statistics/post-traumatic-stress-disorder-ptsd,

4. Martin A et al. Lewis’s Child and Adolescent Psychiatry (5th edition). Lippincott Williams & Wilkins: Philadelphia, 2017.

5. American Psychiatric Association. Neurodevelopmental disorders. In: DSM-5.  2013.

6. Trauma-Focused Cognitive Behavioral Therapy. The National Child Traumatic Stress Network. https://www.nctsn.org/interventions/trauma-focused-cognitive-behavioral-therapy.

7. Trauma-Focused Cognitive-Behavioral Therapy (TF-CBT). California Evidence-Based Clearinghouse for Child Welfare. https://www.cebc4cw.org/program/trauma-focused-cognitive-behavioral-therapy/.

Luke is a 12-year-old who presents for a well-child visit accompanied by his foster mother. He appears ^more solemn and taciturn than at previous visits. He is not interested in talking about any topics, including things he enjoys. His foster mother states that he has been more irritable, oppositional, and behaviorally dysregulated over the past 2 months. She also notes that his sleep has been poor. He reports this is because of nightmares and trouble falling asleep. Luke states that he will at times remember seeing his mother being struck by his father and – even when he does not want to – will have thoughts about hiding from his dad after being hit. You learn from the foster mother that he has been residing with her for the past 2 months and that he is now in state custody following significant parental home substance use, witnessing domestic violence, and being physically abused by his father.

The above narrative may sound all too familiar to those in pediatric primary care. You may wonder if there is a potential posttraumatic response to the witnessed trauma, but does the patient meet criteria for a trauma-related disorder? If so, what are the best next steps?
 

Prevalence of posttraumatic stress disorder in the general pediatric population

According to the 2020 National Survey of Children’s Health, approximately 40% of children age 17 and under report experiencing at least one adverse childhood experience. Within the 12-17 age range, it rises to over 50%.¹ Adverse childhood experiences (ACEs) are potentially traumatic events and include items such as experiencing violence/abuse/neglect, witnessing violence in the home or community, having a family member attempt or die by suicide, and other adverse household and environmental situations. The accumulation of these ACEs can lead to long-term adverse emotional, physical, and behavioral outcomes.²

However, adverse childhood experiences do not always translate into PTSD. According to one national survey of 13- to 18-year-olds, the lifetime prevalence of PTSD is notably lower than exposure rates to ACEs and is estimated at 5% of adolescents, with higher rates among females (8%) versus males (2.3%).³

There are various risk factors for the development of PTSD that may play a role including genetic vulnerability, length of the trauma (for example, a one-time event versus repeated trauma for years), characteristics specific to the trauma, and the aftermath of the trauma. Again, it is important to note that not all youth exposed to a traumatic event will develop PTSD. Those who do make up a small percentage of at-risk children.⁴
 

Diagnosing PTSD in a child or adolescent

For a pediatric patient to be diagnosed with PTSD according to the DSM-5 criteria, they must experience a potentially traumatic event and meet criteria from four categories of symptoms. Trauma is defined as direct or indirect exposure to actual or threatened death, serious injury, or sexual violence. The four symptom categories are re-experiencing, avoidance, hyperarousal, and negative alteration in cognition and mood. The number of symptoms needed from each category varies based on the child’s age, with differing cutoffs based on whether the child is younger or older than 6 years old. Moreover, symptoms must be present for at least 1 month.⁵

Trauma can be assessed in the office by using a focused interview that includes the full DSM diagnostic criteria. There are additional trauma rating screeners and assessment tools that can be used including the Child PTSD Symptom Scale, Child Trauma Screening Questionnaire, UCLA Posttraumatic Stress Disorder Reaction Index, and the Trauma Symptom Checklist for Children, to name a few. Many of these allow for multiple informants, including the child/adolescent, thereby allowing for varying perspectives regarding trauma reactions.
 

Treatment options

Familiarity with evidence-based treatment for trauma may be useful to ensure that referral is targeted for the patient/family. There are no Food and Drug Administrations–approved medications for children with PTSD, though medications can be used to target specific PTSD symptoms (e.g. prazosin for trauma-related nightmares) as well as commonly comorbid conditions such as depression. Becoming familiar with the available therapeutic modalities offered in your area is recommended.

Highlighting trauma-focused cognitive behavioral therapy (TF-CBT)

The treatment with the most research evidence for traumatized children is trauma-focused cognitive behavioral therapy (TF-CBT), which is a 12- to 25-session therapeutic intervention for patients 3-18 years old (with some evidence for young adults as well) with PTSD and/or trauma-related behaviors. TF-CBT uses a components-based treatment model encompassed by the PRACTICE acronym/mnemonic.^6,7

• P – Psychoeducation and parenting skills.
• R – Relaxation techniques: Focused breathing, progressive muscle relaxation, and teaching the child to control their thoughts (thought stopping).
• A – Affective expression and regulation (feeling identification): To help the child and parent learn to control their emotional reaction to reminders by expanding their emotional vocabulary, enhancing their skills in identification and expression of emotions, and encouraging self-soothing activities
• C – Cognitive coping and processing: Through this component, the child learns to understand the relationships between thoughts, feelings, and behaviors and think in new and healthier ways.
• T – Trauma narrative and processing: Gradual exposure exercises including verbal, written, and/or symbolic recounting of traumatic event(s) so the child learns to be able to discuss the events when they choose to in ways that do not produce overwhelming emotions. Following the completion of the narrative, clients are supported in identifying, challenging, and correcting cognitive distortions and dysfunctional beliefs.
• I – In vivo exposure: Encourage the gradual exposure to innocuous trauma reminders in the child’s environment so the child learns they can control their emotional reactions to things that remind them of the trauma, starting with nonthreatening examples of reminders.
• C – Conjoint parent/child sessions: Sessions generally deal with psycho-education, sharing the trauma narrative, anxiety management, and correction of cognitive distortions. The family works to enhance communication and create opportunities for therapeutic discussion regarding the trauma.
• E – Enhancing personal safety and future growth: Provide training and education with respect to personal safety skills and healthy sexuality and interpersonal relationships; encourage the utilization of skills learned in managing future stressors and/or trauma reminders.

Of note, some elements of this therapy that could possibly be easily incorporated into a primary care office visit include relaxation techniques and focus on coping skills/strategies.
 

Summary

Children and adolescents often present with trauma-related symptoms to the primary care office. Having increasing familiarity with PTSD diagnostic criteria and treatment modalities will likely lead to increased confidence and comfort recognizing symptoms and when placing a referral. This may also lead to shorter wait times for receiving targeted treatment and ultimately should lead to better outcomes for affected children and families.

Dr. Abdul-Kareem is at the University of Vermont, Burlington.

References

1. National Survey of Children’s Health (2016 - present). https://nschdata.org/browse/survey.

2. Adverse Childhood Experiences (ACEs). Centers for Disease Control and Prevention. https://www.cdc.gov/violenceprevention/aces/index.html].

3. Post-Traumatic Stress Disorder (PTSD). National Institute of Mental Health. https://www.nimh.nih.gov/health/statistics/post-traumatic-stress-disorder-ptsd,

4. Martin A et al. Lewis’s Child and Adolescent Psychiatry (5th edition). Lippincott Williams & Wilkins: Philadelphia, 2017.

5. American Psychiatric Association. Neurodevelopmental disorders. In: DSM-5.  2013.

6. Trauma-Focused Cognitive Behavioral Therapy. The National Child Traumatic Stress Network. https://www.nctsn.org/interventions/trauma-focused-cognitive-behavioral-therapy.

7. Trauma-Focused Cognitive-Behavioral Therapy (TF-CBT). California Evidence-Based Clearinghouse for Child Welfare. https://www.cebc4cw.org/program/trauma-focused-cognitive-behavioral-therapy/.

In oncology, delayed care may result in a failed opportunity to achieve remission. Delays in diagnosis can result in patients having to undergo more extensive surgery, radiation exposure, or more intensive drug therapy than if their disease had been detected at an early stage.

Now, researchers at Harvard Medical School, Boston, report that patients with high-deductible health insurance plans are significantly more likely to have a delay in diagnosis of metastatic cancer, compared with patients with low-deductible plans.

Using national insurance claims data, the authors conducted an observational study to examine what happened when some workers with employer-based insurance were switched from low-deductible to high-deductible plans, compared with a control group of workers who remained on low-deductible plans.

After the switch, workers shunted into high-deductible plans had a longer time to first diagnosis of a metastatic cancer, indicating delayed detection of advanced disease, compared with controls. The difference translated into a delay in diagnosis of metastatic disease of nearly 5 months, reported Nico Trad, BA, a fourth-year medical student at Dana-Farber Cancer Institute, Boston.

“The takeaway here is that these plans were associated with delayed detection of metastatic cancer. We did not assess the mechanism, but it’s a reasonable assumption to make that increased cost-sharing is having some adverse impacts on people’s willingness to seek care. And although we didn’t study potential impacts, we might anticipate that a delayed diagnosis might also lead to delayed engagement with palliative care,” he said in an oral abstract presentation at the annual meeting of the American Society of Clinical Oncology.

“A delay in initiation of symptom-relieving therapies and a delayed presentation might also lead to greater dissemination of disease throughout the body, which also has the potential to limit therapeutic options,” he added.
 

‘Deductible relief day’

Mr. Trad said that in 2022 more than half of employees are covered by high-deductible health plans, compared with only about 10% in 2006.

This major shift in cost burden coincided with President Joseph Biden’s announcement in early 2022 of the “Cancer Moonshot,” program with the goal of reducing cancer mortality by 50% over the next 25 years.

“Part of that is cancer prevention and control, which involves timely detection of cancer so that we can treat it early and have better outcomes,” he said.

High-deductible health plans ostensibly provide motivation for patients to shop for lower-priced care and avoid unnecessary or low-quality care, but making patients shell out more upfront before their insurance kicks in, while it reduced health care utilization, can also reduce the quality of care, he said.

In 2022, “Deductible Relief Day,” the day in which the average patient has satisfied the deductible and insurance starts to pick up more of the tab, occurred in mid-May, compared with late February in 2006.
 

Insurance claims data

Mr. Trad and colleagues used health insurance claims data from a nationally representative cohort of privately insured patients in a national commercial and Medicare Advantage database. They excluded patients 65 and older who were eligible for Medicare because it does not have high-deductible options.

The study cohort included 345,401 adults from the ages of 18 to 64 whose employers mandated a switch from a low-deductible plan which was defined as $500 or less, to a high-deductible plan defined as $1,000 or more. Controls were 1,654,775 contemporaneous adults whose employers offered only low-deductible plans. Both groups had a 1-year baseline period when all members were enrolled in low deductible plans.

To minimize the possibility of confounding, the investigators matched the participants by age, gender, race/ethnicity, morbidity according to Adjusted Clinical Group score, poverty level, geographic region, employer size, baseline primary cancer, baseline medical and pharmacy costs, and follow-up duration.

During the baseline period, the hazard ratio for time to a first observed metastatic cancer diagnosis in the main cohort, compared with controls, was 0.96 with a nonsignificant P value, indicating no difference in the time to diagnosis between the groups.

During a maximum 13.5 years of follow-up, however, the participants who had been switched after a year to a high-deductible plan had a significantly longer time to first metastatic diagnosis (HR, 0.88; P = .01), indicating delayed diagnosis relative to controls. This difference translated to a delay of 4.6 months associated with the higher out-of-pocket costs plans.

According to a systematic review and meta-analysis published online in 2020, a 1-month delay in treatment for many types of cancer can translate into a 6% to 13% higher risk for death, a risk that continues to increase with further delays.

The investigators acknowledged that the study was limited by the use of retrospective claims-based data, which not contain information on how the patients fared after diagnosis.

“I would say in terms of policy relevance that this really points to the need for new and innovative insurance models that, No. 1, reduce the cost-sharing burden for patients so that they’re not deterred from seeking care, and No. 2, that align rather than contradict the goal of improving population-level survival from cancer,” Mr. Trad said.
 

Further evidence of a flawed system

The study adds to an already strong body of evidence showing that high-deductible plans can have a negative impact on health, said Sara R. Collins, vice president for health care coverage and access at the Commonwealth Fund, a New York–based private foundation dedicated to improving health care.

“This is really the latest evidence on top of years of research that shows that high-deductible health plans lead people to make decisions that are not in the best interest of their health,” said Ms. Collins, who is not affiliated with the study presented at ASCO.

“We have a health care cost problem in the United States that far exceeds that of other high-income countries. Insurers try to solve it by shifting the costs to consumers and using other measures to restrict people’s use of health care, and often needed health care like this. The result is less access to needed care, and long-term adverse health consequences and their associated costs to patients and the health system generally,” she said.

The real driver of health care costs is not utilization, but the prices that insurers and providers negotiate in their service contracts, she explained.

“Prices are the central problem, insurers have control over those prices in their negotiations with providers. So unless we can gain control of that driver, patients are going to continue to suffer unnecessarily from both the short- and long-term effects of insurers who use tools to reduce their access to care,” she said.

In oncology, delayed care may result in a failed opportunity to achieve remission. Delays in diagnosis can result in patients having to undergo more extensive surgery, radiation exposure, or more intensive drug therapy than if their disease had been detected at an early stage.

Now, researchers at Harvard Medical School, Boston, report that patients with high-deductible health insurance plans are significantly more likely to have a delay in diagnosis of metastatic cancer, compared with patients with low-deductible plans.

Using national insurance claims data, the authors conducted an observational study to examine what happened when some workers with employer-based insurance were switched from low-deductible to high-deductible plans, compared with a control group of workers who remained on low-deductible plans.

After the switch, workers shunted into high-deductible plans had a longer time to first diagnosis of a metastatic cancer, indicating delayed detection of advanced disease, compared with controls. The difference translated into a delay in diagnosis of metastatic disease of nearly 5 months, reported Nico Trad, BA, a fourth-year medical student at Dana-Farber Cancer Institute, Boston.

“The takeaway here is that these plans were associated with delayed detection of metastatic cancer. We did not assess the mechanism, but it’s a reasonable assumption to make that increased cost-sharing is having some adverse impacts on people’s willingness to seek care. And although we didn’t study potential impacts, we might anticipate that a delayed diagnosis might also lead to delayed engagement with palliative care,” he said in an oral abstract presentation at the annual meeting of the American Society of Clinical Oncology.

“A delay in initiation of symptom-relieving therapies and a delayed presentation might also lead to greater dissemination of disease throughout the body, which also has the potential to limit therapeutic options,” he added.
 

‘Deductible relief day’

Mr. Trad said that in 2022 more than half of employees are covered by high-deductible health plans, compared with only about 10% in 2006.

This major shift in cost burden coincided with President Joseph Biden’s announcement in early 2022 of the “Cancer Moonshot,” program with the goal of reducing cancer mortality by 50% over the next 25 years.

“Part of that is cancer prevention and control, which involves timely detection of cancer so that we can treat it early and have better outcomes,” he said.

High-deductible health plans ostensibly provide motivation for patients to shop for lower-priced care and avoid unnecessary or low-quality care, but making patients shell out more upfront before their insurance kicks in, while it reduced health care utilization, can also reduce the quality of care, he said.

In 2022, “Deductible Relief Day,” the day in which the average patient has satisfied the deductible and insurance starts to pick up more of the tab, occurred in mid-May, compared with late February in 2006.
 

Insurance claims data

Mr. Trad and colleagues used health insurance claims data from a nationally representative cohort of privately insured patients in a national commercial and Medicare Advantage database. They excluded patients 65 and older who were eligible for Medicare because it does not have high-deductible options.

The study cohort included 345,401 adults from the ages of 18 to 64 whose employers mandated a switch from a low-deductible plan which was defined as $500 or less, to a high-deductible plan defined as $1,000 or more. Controls were 1,654,775 contemporaneous adults whose employers offered only low-deductible plans. Both groups had a 1-year baseline period when all members were enrolled in low deductible plans.

To minimize the possibility of confounding, the investigators matched the participants by age, gender, race/ethnicity, morbidity according to Adjusted Clinical Group score, poverty level, geographic region, employer size, baseline primary cancer, baseline medical and pharmacy costs, and follow-up duration.

During the baseline period, the hazard ratio for time to a first observed metastatic cancer diagnosis in the main cohort, compared with controls, was 0.96 with a nonsignificant P value, indicating no difference in the time to diagnosis between the groups.

During a maximum 13.5 years of follow-up, however, the participants who had been switched after a year to a high-deductible plan had a significantly longer time to first metastatic diagnosis (HR, 0.88; P = .01), indicating delayed diagnosis relative to controls. This difference translated to a delay of 4.6 months associated with the higher out-of-pocket costs plans.

According to a systematic review and meta-analysis published online in 2020, a 1-month delay in treatment for many types of cancer can translate into a 6% to 13% higher risk for death, a risk that continues to increase with further delays.

The investigators acknowledged that the study was limited by the use of retrospective claims-based data, which not contain information on how the patients fared after diagnosis.

“I would say in terms of policy relevance that this really points to the need for new and innovative insurance models that, No. 1, reduce the cost-sharing burden for patients so that they’re not deterred from seeking care, and No. 2, that align rather than contradict the goal of improving population-level survival from cancer,” Mr. Trad said.
 

Further evidence of a flawed system

The study adds to an already strong body of evidence showing that high-deductible plans can have a negative impact on health, said Sara R. Collins, vice president for health care coverage and access at the Commonwealth Fund, a New York–based private foundation dedicated to improving health care.

“This is really the latest evidence on top of years of research that shows that high-deductible health plans lead people to make decisions that are not in the best interest of their health,” said Ms. Collins, who is not affiliated with the study presented at ASCO.

“We have a health care cost problem in the United States that far exceeds that of other high-income countries. Insurers try to solve it by shifting the costs to consumers and using other measures to restrict people’s use of health care, and often needed health care like this. The result is less access to needed care, and long-term adverse health consequences and their associated costs to patients and the health system generally,” she said.

The real driver of health care costs is not utilization, but the prices that insurers and providers negotiate in their service contracts, she explained.

“Prices are the central problem, insurers have control over those prices in their negotiations with providers. So unless we can gain control of that driver, patients are going to continue to suffer unnecessarily from both the short- and long-term effects of insurers who use tools to reduce their access to care,” she said.

In oncology, delayed care may result in a failed opportunity to achieve remission. Delays in diagnosis can result in patients having to undergo more extensive surgery, radiation exposure, or more intensive drug therapy than if their disease had been detected at an early stage.

Now, researchers at Harvard Medical School, Boston, report that patients with high-deductible health insurance plans are significantly more likely to have a delay in diagnosis of metastatic cancer, compared with patients with low-deductible plans.

Using national insurance claims data, the authors conducted an observational study to examine what happened when some workers with employer-based insurance were switched from low-deductible to high-deductible plans, compared with a control group of workers who remained on low-deductible plans.

After the switch, workers shunted into high-deductible plans had a longer time to first diagnosis of a metastatic cancer, indicating delayed detection of advanced disease, compared with controls. The difference translated into a delay in diagnosis of metastatic disease of nearly 5 months, reported Nico Trad, BA, a fourth-year medical student at Dana-Farber Cancer Institute, Boston.

“The takeaway here is that these plans were associated with delayed detection of metastatic cancer. We did not assess the mechanism, but it’s a reasonable assumption to make that increased cost-sharing is having some adverse impacts on people’s willingness to seek care. And although we didn’t study potential impacts, we might anticipate that a delayed diagnosis might also lead to delayed engagement with palliative care,” he said in an oral abstract presentation at the annual meeting of the American Society of Clinical Oncology.

“A delay in initiation of symptom-relieving therapies and a delayed presentation might also lead to greater dissemination of disease throughout the body, which also has the potential to limit therapeutic options,” he added.
 

‘Deductible relief day’

Mr. Trad said that in 2022 more than half of employees are covered by high-deductible health plans, compared with only about 10% in 2006.

This major shift in cost burden coincided with President Joseph Biden’s announcement in early 2022 of the “Cancer Moonshot,” program with the goal of reducing cancer mortality by 50% over the next 25 years.

“Part of that is cancer prevention and control, which involves timely detection of cancer so that we can treat it early and have better outcomes,” he said.

High-deductible health plans ostensibly provide motivation for patients to shop for lower-priced care and avoid unnecessary or low-quality care, but making patients shell out more upfront before their insurance kicks in, while it reduced health care utilization, can also reduce the quality of care, he said.

In 2022, “Deductible Relief Day,” the day in which the average patient has satisfied the deductible and insurance starts to pick up more of the tab, occurred in mid-May, compared with late February in 2006.
 

Insurance claims data

Mr. Trad and colleagues used health insurance claims data from a nationally representative cohort of privately insured patients in a national commercial and Medicare Advantage database. They excluded patients 65 and older who were eligible for Medicare because it does not have high-deductible options.

The study cohort included 345,401 adults from the ages of 18 to 64 whose employers mandated a switch from a low-deductible plan which was defined as $500 or less, to a high-deductible plan defined as $1,000 or more. Controls were 1,654,775 contemporaneous adults whose employers offered only low-deductible plans. Both groups had a 1-year baseline period when all members were enrolled in low deductible plans.

To minimize the possibility of confounding, the investigators matched the participants by age, gender, race/ethnicity, morbidity according to Adjusted Clinical Group score, poverty level, geographic region, employer size, baseline primary cancer, baseline medical and pharmacy costs, and follow-up duration.

During the baseline period, the hazard ratio for time to a first observed metastatic cancer diagnosis in the main cohort, compared with controls, was 0.96 with a nonsignificant P value, indicating no difference in the time to diagnosis between the groups.

During a maximum 13.5 years of follow-up, however, the participants who had been switched after a year to a high-deductible plan had a significantly longer time to first metastatic diagnosis (HR, 0.88; P = .01), indicating delayed diagnosis relative to controls. This difference translated to a delay of 4.6 months associated with the higher out-of-pocket costs plans.

According to a systematic review and meta-analysis published online in 2020, a 1-month delay in treatment for many types of cancer can translate into a 6% to 13% higher risk for death, a risk that continues to increase with further delays.

The investigators acknowledged that the study was limited by the use of retrospective claims-based data, which not contain information on how the patients fared after diagnosis.

“I would say in terms of policy relevance that this really points to the need for new and innovative insurance models that, No. 1, reduce the cost-sharing burden for patients so that they’re not deterred from seeking care, and No. 2, that align rather than contradict the goal of improving population-level survival from cancer,” Mr. Trad said.
 

Further evidence of a flawed system

The study adds to an already strong body of evidence showing that high-deductible plans can have a negative impact on health, said Sara R. Collins, vice president for health care coverage and access at the Commonwealth Fund, a New York–based private foundation dedicated to improving health care.

“This is really the latest evidence on top of years of research that shows that high-deductible health plans lead people to make decisions that are not in the best interest of their health,” said Ms. Collins, who is not affiliated with the study presented at ASCO.

“We have a health care cost problem in the United States that far exceeds that of other high-income countries. Insurers try to solve it by shifting the costs to consumers and using other measures to restrict people’s use of health care, and often needed health care like this. The result is less access to needed care, and long-term adverse health consequences and their associated costs to patients and the health system generally,” she said.

The real driver of health care costs is not utilization, but the prices that insurers and providers negotiate in their service contracts, she explained.

“Prices are the central problem, insurers have control over those prices in their negotiations with providers. So unless we can gain control of that driver, patients are going to continue to suffer unnecessarily from both the short- and long-term effects of insurers who use tools to reduce their access to care,” she said.