Healthcare workers have been at an increased risk for SARS-CoV-2 infection and mental distress such as anxiety and depression during the pandemic, according to new research.

In an analysis of administrative health records for about 3000 healthcare workers in Alberta, Canada, the workers were as much as twice as likely to become infected with SARS-CoV-2 compared with the overall population. The risk for infection was higher among healthcare workers in the first two waves of the pandemic and again during the fifth wave.

“Previous publications, including ours, suggested that the main problem was in the early weeks and months of the pandemic, but this paper shows that it continued until the later stages,” senior author Nicola Cherry, MD, an occupational epidemiologist at the University of Alberta in Edmonton, Canada, told this news organization.

The findings were published in the Canadian Journal of Public Health.
 

Wave Upon Wave

In the current study, the investigators sought to compare the risk for SARS-CoV-2 infection and mental distress among healthcare workers and among community referents (CRs). They examined the following waves of the COVID-19 pandemic:

• Wave 1: From March to June 2020 (4 months).
• Wave 2: From July 2020 to February 2021 (8 months).
• Wave 3: From March to June 2021 (4 months).
• Wave 4: From July to October 2021 (4 months).
• Wave 5 (Omicron): From November 2021 to March 2022 (5 months).

Healthcare workers in Alberta were asked at recruitment for consent to match their individual records to the Alberta Administrative Health Database. As the pandemic progressed, participants were also asked for consent to be linked to COVID-19 immunization records maintained by the provinces, as well as for the results of all polymerase chain reaction (PCR) testing for the SARS-CoV-2 virus.

The investigators matched 2959 healthcare workers to 14,546 CRs according to their age, sex, geographic location in Alberta, and number of physician claims from April 1, 2019, to March 31, 2020.

Incident SARS-CoV-2 infection was examined using PCR testing and the first date of a physician consultation at which the code for SARS-CoV-2 infection had been recorded. Mental health disorders were identified from physician records. They included anxiety disorders, stress and adjustment reactions, and depressive disorders.

Most (79.5%) of the healthcare workers were registered nurses, followed by physicians (16.1%), healthcare aides (2.4%), and licensed practical nurses (2.0%). Most participants (87.5%) were female. The median age at recruitment was 44 years.

Healthcare workers were at a greater risk for COVID-19 overall, with the first SARS-CoV-2 infection defined from either PCR tests (odds ratio [OR], 1.96) or from physician records (OR, 1.33). They were also at an increased risk for anxiety (adjusted OR, 1.25; P < .001), stress/adjustment reaction (adjusted OR, 1.52; P < .001), and depressive condition (adjusted OR, 1.39; P < .001). Moreover, the excess risks for stress/adjustment reactions and depressive conditions increased with successive waves during the pandemic, peaking in the fourth wave and continuing in the fifth wave.

“Although the increase was less in the middle of the phases of the pandemic, it came back with a vengeance during the last phase, which was the Omicron phase,” said Dr. Cherry.

“Employers of healthcare workers can’t assume that everything is now under control, that they know what they’re doing, and that there is no risk. We are now having some increases in COVID. It’s going to go on. The pandemic is not over in that sense, and infection control continues to be major,” she added.

The finding that mental health worsened among healthcare workers was not surprising, Dr. Cherry said. Even before the pandemic, studies had shown that healthcare workers were at a greater risk for depression than the population overall.

“There is a lot of need for care in mental health support of healthcare workers, whether during a pandemic or not,” said Dr. Cherry.
 

Nurses Are Suffering

Commenting on the research for this news organization, Farinaz Havaei, PhD, RN, assistant professor of nursing at the University of British Columbia in Vancouver, Canada, said, “This is a very important and timely study that draws on objective clinical and administrative data, as opposed to healthcare workers’ subjective reports.” Dr. Havaei did not participate in the research.

Overall, the findings are consistent with previous research that drew upon healthcare workers’ reports. They speak to the chronic and cumulative impact of COVID-19 and its associated stressors on the mental health and well-being of healthcare workers, said Dr. Havaei.

“The likelihood of stress/adjustment reaction and depression showed a relatively steady increase with increasing COVID-19 waves. This increase can likely be explained by healthcare workers’ depleting emotional reserves for coping with chronic workplace stressors such as concerns about exposure to COVID-19, inadequate staffing, and work overload,” she said. Witnessing the suffering and trauma of patients and their families likely added to this risk.

Dr. Havaei also pointed out that most of the study participants were nurses. The findings are consistent with prepandemic research that showed that the suboptimal conditions that nurses increasingly faced resulted in high levels of exhaustion and burnout.

“While I agree with the authors’ call for more mental health support for healthcare workers, I think prevention efforts that address the root cause of the problem should be prioritized,” she said.
 

From Heroes to Zeros

The same phenomena have been observed in the United States, said John Q. Young, MD, MPP, PhD, professor and chair of psychiatry at the Donald and Barbara Zucker School of Medicine at Hofstra/Northwell in Hempstead, New York. In various studies, Dr. Young and his colleagues have reported a strong association between exposure to the stressors of the pandemic and subsequent development of depression, anxiety, and posttraumatic stress disorder (PTSD) among healthcare workers.

“The findings from Alberta are remarkably consistent. In the beginning of the pandemic, there was a lot of acknowledgment of the work healthcare workers were doing. The fire department clapping as you leave work at night, being called heroes, even though a lot of healthcare workers feel uncomfortable with the hero language because they don’t feel like heroes. Yes, they’re afraid, but they are going to do what they need to do and help,” he said.

But as the pandemic continued, public sentiment changed, Dr. Young said. “They’ve gone from heroes to zeros. Now we are seeing the accumulated, chronic effects over months and years, and these are significant. Our healthcare workforce is vulnerable now. The reserves are low. There are serious shortages in nursing, with more retirements and more people leaving the field,” he said.

As part of a campaign to help healthcare workers cope, psychiatrists at Northwell Health have started a program called Stress First Aid at their Center for Traumatic Stress Response Resilience, where they train nurses, physicians, and other healthcare staff to use basic tools to recognize and respond to stress and distress in themselves and in their colleagues, said Dr. Young.

“For those healthcare workers who find that they are struggling and need more support, there is resilience coaching, which is one-on-one support. For those who need more clinical attention, there is a clinical program where our healthcare workers can meet with a psychologist, psychiatrist, or a therapist, to work through depression, PTSD, and anxiety. We didn’t have this before the pandemic, but it is now a big focus for our workforce,” he said. “We are trying to build resilience. The trauma is real.”

The study was supported by the College of Physicians and Surgeons of Alberta, the Canadian Institutes of Health Research, and the Canadian Immunology Task Force. Dr. Cherry and Dr. Havaei reported no relevant financial relationships. Dr. Young reported that he is senior vice president of behavioral health at Northwell.

A version of this article appeared on Medscape.com.

Healthcare workers have been at an increased risk for SARS-CoV-2 infection and mental distress such as anxiety and depression during the pandemic, according to new research.

In an analysis of administrative health records for about 3000 healthcare workers in Alberta, Canada, the workers were as much as twice as likely to become infected with SARS-CoV-2 compared with the overall population. The risk for infection was higher among healthcare workers in the first two waves of the pandemic and again during the fifth wave.

“Previous publications, including ours, suggested that the main problem was in the early weeks and months of the pandemic, but this paper shows that it continued until the later stages,” senior author Nicola Cherry, MD, an occupational epidemiologist at the University of Alberta in Edmonton, Canada, told this news organization.

The findings were published in the Canadian Journal of Public Health.
 

Wave Upon Wave

In the current study, the investigators sought to compare the risk for SARS-CoV-2 infection and mental distress among healthcare workers and among community referents (CRs). They examined the following waves of the COVID-19 pandemic:

• Wave 1: From March to June 2020 (4 months).
• Wave 2: From July 2020 to February 2021 (8 months).
• Wave 3: From March to June 2021 (4 months).
• Wave 4: From July to October 2021 (4 months).
• Wave 5 (Omicron): From November 2021 to March 2022 (5 months).

Healthcare workers in Alberta were asked at recruitment for consent to match their individual records to the Alberta Administrative Health Database. As the pandemic progressed, participants were also asked for consent to be linked to COVID-19 immunization records maintained by the provinces, as well as for the results of all polymerase chain reaction (PCR) testing for the SARS-CoV-2 virus.

The investigators matched 2959 healthcare workers to 14,546 CRs according to their age, sex, geographic location in Alberta, and number of physician claims from April 1, 2019, to March 31, 2020.

Incident SARS-CoV-2 infection was examined using PCR testing and the first date of a physician consultation at which the code for SARS-CoV-2 infection had been recorded. Mental health disorders were identified from physician records. They included anxiety disorders, stress and adjustment reactions, and depressive disorders.

Most (79.5%) of the healthcare workers were registered nurses, followed by physicians (16.1%), healthcare aides (2.4%), and licensed practical nurses (2.0%). Most participants (87.5%) were female. The median age at recruitment was 44 years.

Healthcare workers were at a greater risk for COVID-19 overall, with the first SARS-CoV-2 infection defined from either PCR tests (odds ratio [OR], 1.96) or from physician records (OR, 1.33). They were also at an increased risk for anxiety (adjusted OR, 1.25; P < .001), stress/adjustment reaction (adjusted OR, 1.52; P < .001), and depressive condition (adjusted OR, 1.39; P < .001). Moreover, the excess risks for stress/adjustment reactions and depressive conditions increased with successive waves during the pandemic, peaking in the fourth wave and continuing in the fifth wave.

“Although the increase was less in the middle of the phases of the pandemic, it came back with a vengeance during the last phase, which was the Omicron phase,” said Dr. Cherry.

“Employers of healthcare workers can’t assume that everything is now under control, that they know what they’re doing, and that there is no risk. We are now having some increases in COVID. It’s going to go on. The pandemic is not over in that sense, and infection control continues to be major,” she added.

The finding that mental health worsened among healthcare workers was not surprising, Dr. Cherry said. Even before the pandemic, studies had shown that healthcare workers were at a greater risk for depression than the population overall.

“There is a lot of need for care in mental health support of healthcare workers, whether during a pandemic or not,” said Dr. Cherry.
 

Nurses Are Suffering

Commenting on the research for this news organization, Farinaz Havaei, PhD, RN, assistant professor of nursing at the University of British Columbia in Vancouver, Canada, said, “This is a very important and timely study that draws on objective clinical and administrative data, as opposed to healthcare workers’ subjective reports.” Dr. Havaei did not participate in the research.

Overall, the findings are consistent with previous research that drew upon healthcare workers’ reports. They speak to the chronic and cumulative impact of COVID-19 and its associated stressors on the mental health and well-being of healthcare workers, said Dr. Havaei.

“The likelihood of stress/adjustment reaction and depression showed a relatively steady increase with increasing COVID-19 waves. This increase can likely be explained by healthcare workers’ depleting emotional reserves for coping with chronic workplace stressors such as concerns about exposure to COVID-19, inadequate staffing, and work overload,” she said. Witnessing the suffering and trauma of patients and their families likely added to this risk.

Dr. Havaei also pointed out that most of the study participants were nurses. The findings are consistent with prepandemic research that showed that the suboptimal conditions that nurses increasingly faced resulted in high levels of exhaustion and burnout.

“While I agree with the authors’ call for more mental health support for healthcare workers, I think prevention efforts that address the root cause of the problem should be prioritized,” she said.
 

From Heroes to Zeros

The same phenomena have been observed in the United States, said John Q. Young, MD, MPP, PhD, professor and chair of psychiatry at the Donald and Barbara Zucker School of Medicine at Hofstra/Northwell in Hempstead, New York. In various studies, Dr. Young and his colleagues have reported a strong association between exposure to the stressors of the pandemic and subsequent development of depression, anxiety, and posttraumatic stress disorder (PTSD) among healthcare workers.

“The findings from Alberta are remarkably consistent. In the beginning of the pandemic, there was a lot of acknowledgment of the work healthcare workers were doing. The fire department clapping as you leave work at night, being called heroes, even though a lot of healthcare workers feel uncomfortable with the hero language because they don’t feel like heroes. Yes, they’re afraid, but they are going to do what they need to do and help,” he said.

But as the pandemic continued, public sentiment changed, Dr. Young said. “They’ve gone from heroes to zeros. Now we are seeing the accumulated, chronic effects over months and years, and these are significant. Our healthcare workforce is vulnerable now. The reserves are low. There are serious shortages in nursing, with more retirements and more people leaving the field,” he said.

As part of a campaign to help healthcare workers cope, psychiatrists at Northwell Health have started a program called Stress First Aid at their Center for Traumatic Stress Response Resilience, where they train nurses, physicians, and other healthcare staff to use basic tools to recognize and respond to stress and distress in themselves and in their colleagues, said Dr. Young.

“For those healthcare workers who find that they are struggling and need more support, there is resilience coaching, which is one-on-one support. For those who need more clinical attention, there is a clinical program where our healthcare workers can meet with a psychologist, psychiatrist, or a therapist, to work through depression, PTSD, and anxiety. We didn’t have this before the pandemic, but it is now a big focus for our workforce,” he said. “We are trying to build resilience. The trauma is real.”

The study was supported by the College of Physicians and Surgeons of Alberta, the Canadian Institutes of Health Research, and the Canadian Immunology Task Force. Dr. Cherry and Dr. Havaei reported no relevant financial relationships. Dr. Young reported that he is senior vice president of behavioral health at Northwell.

A version of this article appeared on Medscape.com.

Healthcare workers have been at an increased risk for SARS-CoV-2 infection and mental distress such as anxiety and depression during the pandemic, according to new research.

In an analysis of administrative health records for about 3000 healthcare workers in Alberta, Canada, the workers were as much as twice as likely to become infected with SARS-CoV-2 compared with the overall population. The risk for infection was higher among healthcare workers in the first two waves of the pandemic and again during the fifth wave.

“Previous publications, including ours, suggested that the main problem was in the early weeks and months of the pandemic, but this paper shows that it continued until the later stages,” senior author Nicola Cherry, MD, an occupational epidemiologist at the University of Alberta in Edmonton, Canada, told this news organization.

The findings were published in the Canadian Journal of Public Health.
 

Wave Upon Wave

In the current study, the investigators sought to compare the risk for SARS-CoV-2 infection and mental distress among healthcare workers and among community referents (CRs). They examined the following waves of the COVID-19 pandemic:

• Wave 1: From March to June 2020 (4 months).
• Wave 2: From July 2020 to February 2021 (8 months).
• Wave 3: From March to June 2021 (4 months).
• Wave 4: From July to October 2021 (4 months).
• Wave 5 (Omicron): From November 2021 to March 2022 (5 months).

Healthcare workers in Alberta were asked at recruitment for consent to match their individual records to the Alberta Administrative Health Database. As the pandemic progressed, participants were also asked for consent to be linked to COVID-19 immunization records maintained by the provinces, as well as for the results of all polymerase chain reaction (PCR) testing for the SARS-CoV-2 virus.

The investigators matched 2959 healthcare workers to 14,546 CRs according to their age, sex, geographic location in Alberta, and number of physician claims from April 1, 2019, to March 31, 2020.

Incident SARS-CoV-2 infection was examined using PCR testing and the first date of a physician consultation at which the code for SARS-CoV-2 infection had been recorded. Mental health disorders were identified from physician records. They included anxiety disorders, stress and adjustment reactions, and depressive disorders.

Most (79.5%) of the healthcare workers were registered nurses, followed by physicians (16.1%), healthcare aides (2.4%), and licensed practical nurses (2.0%). Most participants (87.5%) were female. The median age at recruitment was 44 years.

Healthcare workers were at a greater risk for COVID-19 overall, with the first SARS-CoV-2 infection defined from either PCR tests (odds ratio [OR], 1.96) or from physician records (OR, 1.33). They were also at an increased risk for anxiety (adjusted OR, 1.25; P < .001), stress/adjustment reaction (adjusted OR, 1.52; P < .001), and depressive condition (adjusted OR, 1.39; P < .001). Moreover, the excess risks for stress/adjustment reactions and depressive conditions increased with successive waves during the pandemic, peaking in the fourth wave and continuing in the fifth wave.

“Although the increase was less in the middle of the phases of the pandemic, it came back with a vengeance during the last phase, which was the Omicron phase,” said Dr. Cherry.

“Employers of healthcare workers can’t assume that everything is now under control, that they know what they’re doing, and that there is no risk. We are now having some increases in COVID. It’s going to go on. The pandemic is not over in that sense, and infection control continues to be major,” she added.

The finding that mental health worsened among healthcare workers was not surprising, Dr. Cherry said. Even before the pandemic, studies had shown that healthcare workers were at a greater risk for depression than the population overall.

“There is a lot of need for care in mental health support of healthcare workers, whether during a pandemic or not,” said Dr. Cherry.
 

Nurses Are Suffering

Commenting on the research for this news organization, Farinaz Havaei, PhD, RN, assistant professor of nursing at the University of British Columbia in Vancouver, Canada, said, “This is a very important and timely study that draws on objective clinical and administrative data, as opposed to healthcare workers’ subjective reports.” Dr. Havaei did not participate in the research.

Overall, the findings are consistent with previous research that drew upon healthcare workers’ reports. They speak to the chronic and cumulative impact of COVID-19 and its associated stressors on the mental health and well-being of healthcare workers, said Dr. Havaei.

“The likelihood of stress/adjustment reaction and depression showed a relatively steady increase with increasing COVID-19 waves. This increase can likely be explained by healthcare workers’ depleting emotional reserves for coping with chronic workplace stressors such as concerns about exposure to COVID-19, inadequate staffing, and work overload,” she said. Witnessing the suffering and trauma of patients and their families likely added to this risk.

Dr. Havaei also pointed out that most of the study participants were nurses. The findings are consistent with prepandemic research that showed that the suboptimal conditions that nurses increasingly faced resulted in high levels of exhaustion and burnout.

“While I agree with the authors’ call for more mental health support for healthcare workers, I think prevention efforts that address the root cause of the problem should be prioritized,” she said.
 

From Heroes to Zeros

The same phenomena have been observed in the United States, said John Q. Young, MD, MPP, PhD, professor and chair of psychiatry at the Donald and Barbara Zucker School of Medicine at Hofstra/Northwell in Hempstead, New York. In various studies, Dr. Young and his colleagues have reported a strong association between exposure to the stressors of the pandemic and subsequent development of depression, anxiety, and posttraumatic stress disorder (PTSD) among healthcare workers.

“The findings from Alberta are remarkably consistent. In the beginning of the pandemic, there was a lot of acknowledgment of the work healthcare workers were doing. The fire department clapping as you leave work at night, being called heroes, even though a lot of healthcare workers feel uncomfortable with the hero language because they don’t feel like heroes. Yes, they’re afraid, but they are going to do what they need to do and help,” he said.

But as the pandemic continued, public sentiment changed, Dr. Young said. “They’ve gone from heroes to zeros. Now we are seeing the accumulated, chronic effects over months and years, and these are significant. Our healthcare workforce is vulnerable now. The reserves are low. There are serious shortages in nursing, with more retirements and more people leaving the field,” he said.

As part of a campaign to help healthcare workers cope, psychiatrists at Northwell Health have started a program called Stress First Aid at their Center for Traumatic Stress Response Resilience, where they train nurses, physicians, and other healthcare staff to use basic tools to recognize and respond to stress and distress in themselves and in their colleagues, said Dr. Young.

“For those healthcare workers who find that they are struggling and need more support, there is resilience coaching, which is one-on-one support. For those who need more clinical attention, there is a clinical program where our healthcare workers can meet with a psychologist, psychiatrist, or a therapist, to work through depression, PTSD, and anxiety. We didn’t have this before the pandemic, but it is now a big focus for our workforce,” he said. “We are trying to build resilience. The trauma is real.”

The study was supported by the College of Physicians and Surgeons of Alberta, the Canadian Institutes of Health Research, and the Canadian Immunology Task Force. Dr. Cherry and Dr. Havaei reported no relevant financial relationships. Dr. Young reported that he is senior vice president of behavioral health at Northwell.

A version of this article appeared on Medscape.com.

“Measles should be a memory, not a present risk,” Quique Bassat, MBBS, PhD, director general of the Barcelona Institute of Global Health, told this news organization.

That is certainly not the case right now in some parts of Europe. The World Health Organization (WHO) says the European Region is experiencing an alarming rise in cases, and urgent action is needed. Healthcare professionals are trying to gain control over measles outbreaks and roll out vaccination catch-up campaigns.

“What we are seeing currently is an almost 45-fold rise in measles cases in the WHO European Region,” Siddhartha Datta, MD, European regional advisor on vaccine-preventable diseases and immunization for the WHO, told this news organization. “In 2022, there were 940 cases, and in 2023 till November, it was around 42,000 plus. Between 2020 and 2022, we have seen 1.8 million children who have missed their measles vaccine doses.”
 

Lapses in Vaccinations

The overriding reason for the resurgence of measles is a backslide in vaccination coverage during the COVID-19 pandemic.

“During the COVID pandemic, we had a 5% decrease in coverage for most of the vaccines, and we are still seeing the consequences,” explained Dr. Bassat. “Measles is the perfect example of when you have a small drop of coverage you get outbreaks, as it’s extremely infectious and complicated to control.”

Reported national coverage with the first dose of measles-containing vaccine in the European Region fell from 96% in 2019 to 93% in 2022. Second-dose coverage fell from 92% in 2019 to 91% in 2022.

“You need to have 95% of the population vaccinated if you want herd immunity,” Dr. Bassat said.
 

Variation Across Europe

The WHO European Region comprises 53 countries, including Russia and some countries in central Asia. Its figures show Kazakhstan had the most recorded cases of measles last year, at more than 13,000, followed by the Russian Federation.

Romania declared a national epidemic in December 2023. Dr. Datta said there have also been outbreaks in Austria and France.

The UK Health Security Agency declared a major incident in January 2024 because of a surge in cases. From October 2023 to January 2024, there were 347 lab-confirmed cases of measles in England, with 127 of these confirmed in January. The West Midlands is an area of particular concern.

“It was not as though everything was rosy before COVID,” said Dr. Datta. “We saw wide variation in the coverage rates before the pandemic. Some countries weren’t doing as well. More particularly between some communities or municipalities, there were wide variations, and COVID-19 exacerbated the inequities in coverage. What we are seeing now is a combination of gaps before and after the pandemic, so it’s a compound problem.”

Belgium has also seen a measles resurgence, but not as many cases as the year before the pandemic. Laura Cornelissen, MD, works at the Belgian Public Health Institute, Sciensano, where she leads a team working on vaccine-preventable diseases.

She told this news organization: “We did observe a significant rise in cases and several clusters in 2023, compared to the very low numbers that were observed during the COVID-19 years. Preliminary figures indicate 85 measles cases for Belgium in 2023, leading to at least 26 hospitalizations. This is compared with eight cases for 2022, seven in 2021, and 47 in 2020; but 480 cases in the pre-pandemic year 2019.”

Sabrina Bacci, MD, head of vaccine-preventable diseases and immunization at the European Centre of Disease Control, told this news organization: “There have been a high number of cases in Romania and smaller outbreaks in other countries. However, there are a number of European countries which haven’t seen measles. Even though we have this variation between the different European countries, the tools to respond to outbreaks are the same.”
 

Vaccine Hesitance

Vaccine hesitance or even refusal is on the rise in Europe and elsewhere in the world.

“We can see from behavioral insights that, during COVID, people’s trust on vaccines, healthcare systems, and the government in general has gone down,” said Dr. Datta. “There had been skepticism before about the MMR jab causing autism, which was proved wrong, but vaccine skepticism shown throughout COVID is now showing its head in routine vaccine systems.”

The rise of so-called anti-vaxxers and associated fake conspiracy theories, including a mistrust of Big Pharma, hasn’t been helpful for encouraging essential childhood vaccination uptake, like measles, mumps, and rubella (MMR).

But the MMR vaccine backslide does not only originate in the pandemic.

Vanessa Saliba, consultant epidemiologist at the UK Health Security Agency, said: “MMR vaccine coverage has been falling for the last decade, with 1 out of 10 children starting school in England not protected.”

It could be that some people have religious concerns about the use of pork gelatin as a stabilizer in MMR vaccines. An alternative vaccine that does not contain pork gelatin can be requested.

Doctors and others in healthcare have a pivotal role to play when it comes to getting on top of the surges and educating patients, according to Dr. Bacci. “Healthcare professionals are the most precious resource we have, as they are the ones on the frontline explaining the importance of vaccination to their patients. It’s a very important dialogue.”
 

Clinics and Catch-Up Campaigns

Intensified routine immunization clinics and catch-up campaigns have been established in countries across Europe where they are needed.

Countries with large outbreaks are carrying out case investigations, identifying and vaccinating susceptible contacts, and generally raising awareness and implementing outbreak response immunization.

“Countries are really making good efforts and are systematically catching up the children who have missed their doses in the last 2 years. But the recovery to the 2019 levels has been slow, and more efforts and energy [need] to be put into this. We understand healthcare systems are stretched out from COVID, but this is not the time to lower our guard,” Dr. Datta said.

“Some countries are more proactive than others,” added Dr. Bassat. “Measles is an example of a disease where you typically organize catch-up campaigns. Measles has one of the highest reproductive numbers, as in the absence of preventive measures one infected person infects 14-16 others.”

All countries, even if they haven’t yet experienced measles outbreaks, are being urged by European healthcare authorities to look at potential immunity gaps and address them immediately.
 

When Will It Get Back to Normal?

“Measles was a disease that was targeted for elimination, but because of these outbreaks, we are seeing it almost everywhere again. We need to be careful and get on top of this,” warned Dr. Bassat.

Dr. Datta said it’s up to member states, decision-makers, healthcare leaders, and parents to come together to raise the immunity profiles of the European population. “Vaccination is a shared responsibility. The tools are effective. We just need to be ahead of the virus, and that is the challenge.”

Dr. Bacci added, “We have to remember we are entering the spring, which is a season when, traditionally, the disease can spread more easily, and it can find its way when people are susceptible. The vaccine is the tool that can help, and we have to act now and make sure it’s offered on time.”
 

A version of this article appeared on Medscape.com.

“Measles should be a memory, not a present risk,” Quique Bassat, MBBS, PhD, director general of the Barcelona Institute of Global Health, told this news organization.

That is certainly not the case right now in some parts of Europe. The World Health Organization (WHO) says the European Region is experiencing an alarming rise in cases, and urgent action is needed. Healthcare professionals are trying to gain control over measles outbreaks and roll out vaccination catch-up campaigns.

“What we are seeing currently is an almost 45-fold rise in measles cases in the WHO European Region,” Siddhartha Datta, MD, European regional advisor on vaccine-preventable diseases and immunization for the WHO, told this news organization. “In 2022, there were 940 cases, and in 2023 till November, it was around 42,000 plus. Between 2020 and 2022, we have seen 1.8 million children who have missed their measles vaccine doses.”
 

Lapses in Vaccinations

The overriding reason for the resurgence of measles is a backslide in vaccination coverage during the COVID-19 pandemic.

“During the COVID pandemic, we had a 5% decrease in coverage for most of the vaccines, and we are still seeing the consequences,” explained Dr. Bassat. “Measles is the perfect example of when you have a small drop of coverage you get outbreaks, as it’s extremely infectious and complicated to control.”

Reported national coverage with the first dose of measles-containing vaccine in the European Region fell from 96% in 2019 to 93% in 2022. Second-dose coverage fell from 92% in 2019 to 91% in 2022.

“You need to have 95% of the population vaccinated if you want herd immunity,” Dr. Bassat said.
 

Variation Across Europe

The WHO European Region comprises 53 countries, including Russia and some countries in central Asia. Its figures show Kazakhstan had the most recorded cases of measles last year, at more than 13,000, followed by the Russian Federation.

Romania declared a national epidemic in December 2023. Dr. Datta said there have also been outbreaks in Austria and France.

The UK Health Security Agency declared a major incident in January 2024 because of a surge in cases. From October 2023 to January 2024, there were 347 lab-confirmed cases of measles in England, with 127 of these confirmed in January. The West Midlands is an area of particular concern.

“It was not as though everything was rosy before COVID,” said Dr. Datta. “We saw wide variation in the coverage rates before the pandemic. Some countries weren’t doing as well. More particularly between some communities or municipalities, there were wide variations, and COVID-19 exacerbated the inequities in coverage. What we are seeing now is a combination of gaps before and after the pandemic, so it’s a compound problem.”

Belgium has also seen a measles resurgence, but not as many cases as the year before the pandemic. Laura Cornelissen, MD, works at the Belgian Public Health Institute, Sciensano, where she leads a team working on vaccine-preventable diseases.

She told this news organization: “We did observe a significant rise in cases and several clusters in 2023, compared to the very low numbers that were observed during the COVID-19 years. Preliminary figures indicate 85 measles cases for Belgium in 2023, leading to at least 26 hospitalizations. This is compared with eight cases for 2022, seven in 2021, and 47 in 2020; but 480 cases in the pre-pandemic year 2019.”

Sabrina Bacci, MD, head of vaccine-preventable diseases and immunization at the European Centre of Disease Control, told this news organization: “There have been a high number of cases in Romania and smaller outbreaks in other countries. However, there are a number of European countries which haven’t seen measles. Even though we have this variation between the different European countries, the tools to respond to outbreaks are the same.”
 

Vaccine Hesitance

Vaccine hesitance or even refusal is on the rise in Europe and elsewhere in the world.

“We can see from behavioral insights that, during COVID, people’s trust on vaccines, healthcare systems, and the government in general has gone down,” said Dr. Datta. “There had been skepticism before about the MMR jab causing autism, which was proved wrong, but vaccine skepticism shown throughout COVID is now showing its head in routine vaccine systems.”

The rise of so-called anti-vaxxers and associated fake conspiracy theories, including a mistrust of Big Pharma, hasn’t been helpful for encouraging essential childhood vaccination uptake, like measles, mumps, and rubella (MMR).

But the MMR vaccine backslide does not only originate in the pandemic.

Vanessa Saliba, consultant epidemiologist at the UK Health Security Agency, said: “MMR vaccine coverage has been falling for the last decade, with 1 out of 10 children starting school in England not protected.”

It could be that some people have religious concerns about the use of pork gelatin as a stabilizer in MMR vaccines. An alternative vaccine that does not contain pork gelatin can be requested.

Doctors and others in healthcare have a pivotal role to play when it comes to getting on top of the surges and educating patients, according to Dr. Bacci. “Healthcare professionals are the most precious resource we have, as they are the ones on the frontline explaining the importance of vaccination to their patients. It’s a very important dialogue.”
 

Clinics and Catch-Up Campaigns

Intensified routine immunization clinics and catch-up campaigns have been established in countries across Europe where they are needed.

Countries with large outbreaks are carrying out case investigations, identifying and vaccinating susceptible contacts, and generally raising awareness and implementing outbreak response immunization.

“Countries are really making good efforts and are systematically catching up the children who have missed their doses in the last 2 years. But the recovery to the 2019 levels has been slow, and more efforts and energy [need] to be put into this. We understand healthcare systems are stretched out from COVID, but this is not the time to lower our guard,” Dr. Datta said.

“Some countries are more proactive than others,” added Dr. Bassat. “Measles is an example of a disease where you typically organize catch-up campaigns. Measles has one of the highest reproductive numbers, as in the absence of preventive measures one infected person infects 14-16 others.”

All countries, even if they haven’t yet experienced measles outbreaks, are being urged by European healthcare authorities to look at potential immunity gaps and address them immediately.
 

When Will It Get Back to Normal?

“Measles was a disease that was targeted for elimination, but because of these outbreaks, we are seeing it almost everywhere again. We need to be careful and get on top of this,” warned Dr. Bassat.

Dr. Datta said it’s up to member states, decision-makers, healthcare leaders, and parents to come together to raise the immunity profiles of the European population. “Vaccination is a shared responsibility. The tools are effective. We just need to be ahead of the virus, and that is the challenge.”

Dr. Bacci added, “We have to remember we are entering the spring, which is a season when, traditionally, the disease can spread more easily, and it can find its way when people are susceptible. The vaccine is the tool that can help, and we have to act now and make sure it’s offered on time.”
 

A version of this article appeared on Medscape.com.

“Measles should be a memory, not a present risk,” Quique Bassat, MBBS, PhD, director general of the Barcelona Institute of Global Health, told this news organization.

That is certainly not the case right now in some parts of Europe. The World Health Organization (WHO) says the European Region is experiencing an alarming rise in cases, and urgent action is needed. Healthcare professionals are trying to gain control over measles outbreaks and roll out vaccination catch-up campaigns.

“What we are seeing currently is an almost 45-fold rise in measles cases in the WHO European Region,” Siddhartha Datta, MD, European regional advisor on vaccine-preventable diseases and immunization for the WHO, told this news organization. “In 2022, there were 940 cases, and in 2023 till November, it was around 42,000 plus. Between 2020 and 2022, we have seen 1.8 million children who have missed their measles vaccine doses.”
 

Lapses in Vaccinations

The overriding reason for the resurgence of measles is a backslide in vaccination coverage during the COVID-19 pandemic.

“During the COVID pandemic, we had a 5% decrease in coverage for most of the vaccines, and we are still seeing the consequences,” explained Dr. Bassat. “Measles is the perfect example of when you have a small drop of coverage you get outbreaks, as it’s extremely infectious and complicated to control.”

Reported national coverage with the first dose of measles-containing vaccine in the European Region fell from 96% in 2019 to 93% in 2022. Second-dose coverage fell from 92% in 2019 to 91% in 2022.

“You need to have 95% of the population vaccinated if you want herd immunity,” Dr. Bassat said.
 

Variation Across Europe

The WHO European Region comprises 53 countries, including Russia and some countries in central Asia. Its figures show Kazakhstan had the most recorded cases of measles last year, at more than 13,000, followed by the Russian Federation.

Romania declared a national epidemic in December 2023. Dr. Datta said there have also been outbreaks in Austria and France.

The UK Health Security Agency declared a major incident in January 2024 because of a surge in cases. From October 2023 to January 2024, there were 347 lab-confirmed cases of measles in England, with 127 of these confirmed in January. The West Midlands is an area of particular concern.

“It was not as though everything was rosy before COVID,” said Dr. Datta. “We saw wide variation in the coverage rates before the pandemic. Some countries weren’t doing as well. More particularly between some communities or municipalities, there were wide variations, and COVID-19 exacerbated the inequities in coverage. What we are seeing now is a combination of gaps before and after the pandemic, so it’s a compound problem.”

Belgium has also seen a measles resurgence, but not as many cases as the year before the pandemic. Laura Cornelissen, MD, works at the Belgian Public Health Institute, Sciensano, where she leads a team working on vaccine-preventable diseases.

She told this news organization: “We did observe a significant rise in cases and several clusters in 2023, compared to the very low numbers that were observed during the COVID-19 years. Preliminary figures indicate 85 measles cases for Belgium in 2023, leading to at least 26 hospitalizations. This is compared with eight cases for 2022, seven in 2021, and 47 in 2020; but 480 cases in the pre-pandemic year 2019.”

Sabrina Bacci, MD, head of vaccine-preventable diseases and immunization at the European Centre of Disease Control, told this news organization: “There have been a high number of cases in Romania and smaller outbreaks in other countries. However, there are a number of European countries which haven’t seen measles. Even though we have this variation between the different European countries, the tools to respond to outbreaks are the same.”
 

Vaccine Hesitance

Vaccine hesitance or even refusal is on the rise in Europe and elsewhere in the world.

“We can see from behavioral insights that, during COVID, people’s trust on vaccines, healthcare systems, and the government in general has gone down,” said Dr. Datta. “There had been skepticism before about the MMR jab causing autism, which was proved wrong, but vaccine skepticism shown throughout COVID is now showing its head in routine vaccine systems.”

The rise of so-called anti-vaxxers and associated fake conspiracy theories, including a mistrust of Big Pharma, hasn’t been helpful for encouraging essential childhood vaccination uptake, like measles, mumps, and rubella (MMR).

But the MMR vaccine backslide does not only originate in the pandemic.

Vanessa Saliba, consultant epidemiologist at the UK Health Security Agency, said: “MMR vaccine coverage has been falling for the last decade, with 1 out of 10 children starting school in England not protected.”

It could be that some people have religious concerns about the use of pork gelatin as a stabilizer in MMR vaccines. An alternative vaccine that does not contain pork gelatin can be requested.

Doctors and others in healthcare have a pivotal role to play when it comes to getting on top of the surges and educating patients, according to Dr. Bacci. “Healthcare professionals are the most precious resource we have, as they are the ones on the frontline explaining the importance of vaccination to their patients. It’s a very important dialogue.”
 

Clinics and Catch-Up Campaigns

Intensified routine immunization clinics and catch-up campaigns have been established in countries across Europe where they are needed.

Countries with large outbreaks are carrying out case investigations, identifying and vaccinating susceptible contacts, and generally raising awareness and implementing outbreak response immunization.

“Countries are really making good efforts and are systematically catching up the children who have missed their doses in the last 2 years. But the recovery to the 2019 levels has been slow, and more efforts and energy [need] to be put into this. We understand healthcare systems are stretched out from COVID, but this is not the time to lower our guard,” Dr. Datta said.

“Some countries are more proactive than others,” added Dr. Bassat. “Measles is an example of a disease where you typically organize catch-up campaigns. Measles has one of the highest reproductive numbers, as in the absence of preventive measures one infected person infects 14-16 others.”

All countries, even if they haven’t yet experienced measles outbreaks, are being urged by European healthcare authorities to look at potential immunity gaps and address them immediately.
 

When Will It Get Back to Normal?

“Measles was a disease that was targeted for elimination, but because of these outbreaks, we are seeing it almost everywhere again. We need to be careful and get on top of this,” warned Dr. Bassat.

Dr. Datta said it’s up to member states, decision-makers, healthcare leaders, and parents to come together to raise the immunity profiles of the European population. “Vaccination is a shared responsibility. The tools are effective. We just need to be ahead of the virus, and that is the challenge.”

Dr. Bacci added, “We have to remember we are entering the spring, which is a season when, traditionally, the disease can spread more easily, and it can find its way when people are susceptible. The vaccine is the tool that can help, and we have to act now and make sure it’s offered on time.”
 

A version of this article appeared on Medscape.com.

A journal and publisher have retracted three papers about abortion, including one that has been used in court cases to support the suspension of FDA approval for mifepristone, aka an “abortion pill.”

Sage, the publisher of Health Services Research and Managerial Epidemiology, announced the retractions yesterday and posted a retraction notice covering the three articles.

For one of those articles, initially flagged by a reader, “an independent reviewer with expertise in statistical analyses evaluated the concerns and opined that the article’s presentation of the data in Figures 2 and 3 leads to an inaccurate conclusion and that the composition of the cohort studied has problems that could affect the article’s conclusions,” according to the notice.

The notice also said Sage “confirmed that all but one of the article’s authors had an affiliation with one or more of Charlotte Lozier Institute, Elliot Institute, and American Association of Pro-Life Obstetricians and Gynecologists, all pro-life advocacy organizations, despite having declared they had no conflicts of interest when they submitted the article for publication or in the article itself.” 

One of the peer reviewers, Sage learned, “was affiliated with Charlotte Lozier Institute at the time of the review,” leading the publisher and journal editor to determine “the peer review for initial publication was unreliable.” That referee also reviewed the other two now-retracted papers, according to Sage.

James Studnicki, the lead author of the three papers, told Retraction Watch the retractions were “a blatant attempt to discredit excellent research which is incongruent with a preferred abortion narrative.” He told The Daily Wire, a conservative news outlet that was first to report on the retractions, the move was “completely unjustified.” The Daily Wire notes that “The Supreme Court is set to hear arguments in March on the legality of restricting the abortion pill based on [Judge Matthew] Kacsmaryk’s ruling, proceedings that will certainly be impacted by the retractions.”

Sage had subjected one of the papers to an expression of concern in August 2023, saying they were investigating “potential issues regarding the representation of data in the article and author conflicts of interest” after being alerted by a reader. As News From The States reported then, the notice came after Chris Adkins, a professor at South University who teaches pharmaceutical sciences, raised concerns with Sage. As News From The States noted in August:

Kacsmaryk leaned hard on a 2021 study that was designed, funded and produced by the research arm of one of the most powerful anti-abortion political groups in the U.S. The judge cited this paper — which looked at Medicaid patients’ visits to the emergency room within 30 days of having an abortion — to justify that a group of anti-abortion doctors and medical groups have legal standing to force the FDA to recall mifepristone.

In a point-by-point response to Sage’s critiques of the paper sent to the publisher in November and now shared with Retraction Watch, Studnicki and colleagues pointed out they had noted their affiliations in the original manuscript and the then-proposed retractions “misrepresent ICMJE disclosure standards,” referring to the International Committee of Medical Journal Editors’ guidelines. They also call some of the post-publication peer reviewers’ critiques “factually incorrect” and “unfounded.” They conclude:

No single specific finding in any of the three papers has been explicitly challenged, let alone invalidated.

There is no evidence of a major error, miscalculation, fabrication, or falsification.

There is no breach of any of the COPE guidelines that could permit Sage to retract any of our published papers.

The retraction of any of these papers, let alone all three, is demonstrably unwarranted.

Adkins told Retraction Watch he is “pleased the journal approached my concerns with legitimate and serious consideration.” He continued:

It is reassuring that my initial concerns with the 2021 Studnicki et al. article were verified and affirmed by other experts. Despite the length of time spanning my initial communications with the journal and today’s retractions, I understand that thorough investigations and re-review processes take time. Given that these now-retracted articles have been excessively cited by parties involved in ongoing federal judicial cases, now positioned before the SCOTUS, Sage’s retractions should help our courts remain informed by the highest standards and quality in scientific and medical evidence.

Update, 2/6/24, 2100 UTC: We note that — contrary to best industry practices described by the Committee on Publication Ethics — Sage has removed the original versions of the articles. They are available at these links:

“A Longitudinal Cohort Study of Emergency Room Utilization Following Mifepristone Chemical and Surgical Abortions, 1999–2015”

“Doctors Who Perform Abortions: Their Characteristics and Patterns of Holding and Using Hospital Privileges”

“A Post Hoc Exploratory Analysis: Induced Abortion Complications Mistaken for Miscarriage in the Emergency Room are a Risk Factor for Hospitalization”

DISCLOSURE: Adam Marcus, a cofounder of Retraction Watch, is an editor at Medscape.

A version of this article appeared on Medscape.com.

A journal and publisher have retracted three papers about abortion, including one that has been used in court cases to support the suspension of FDA approval for mifepristone, aka an “abortion pill.”

Sage, the publisher of Health Services Research and Managerial Epidemiology, announced the retractions yesterday and posted a retraction notice covering the three articles.

For one of those articles, initially flagged by a reader, “an independent reviewer with expertise in statistical analyses evaluated the concerns and opined that the article’s presentation of the data in Figures 2 and 3 leads to an inaccurate conclusion and that the composition of the cohort studied has problems that could affect the article’s conclusions,” according to the notice.

The notice also said Sage “confirmed that all but one of the article’s authors had an affiliation with one or more of Charlotte Lozier Institute, Elliot Institute, and American Association of Pro-Life Obstetricians and Gynecologists, all pro-life advocacy organizations, despite having declared they had no conflicts of interest when they submitted the article for publication or in the article itself.” 

One of the peer reviewers, Sage learned, “was affiliated with Charlotte Lozier Institute at the time of the review,” leading the publisher and journal editor to determine “the peer review for initial publication was unreliable.” That referee also reviewed the other two now-retracted papers, according to Sage.

James Studnicki, the lead author of the three papers, told Retraction Watch the retractions were “a blatant attempt to discredit excellent research which is incongruent with a preferred abortion narrative.” He told The Daily Wire, a conservative news outlet that was first to report on the retractions, the move was “completely unjustified.” The Daily Wire notes that “The Supreme Court is set to hear arguments in March on the legality of restricting the abortion pill based on [Judge Matthew] Kacsmaryk’s ruling, proceedings that will certainly be impacted by the retractions.”

Sage had subjected one of the papers to an expression of concern in August 2023, saying they were investigating “potential issues regarding the representation of data in the article and author conflicts of interest” after being alerted by a reader. As News From The States reported then, the notice came after Chris Adkins, a professor at South University who teaches pharmaceutical sciences, raised concerns with Sage. As News From The States noted in August:

Kacsmaryk leaned hard on a 2021 study that was designed, funded and produced by the research arm of one of the most powerful anti-abortion political groups in the U.S. The judge cited this paper — which looked at Medicaid patients’ visits to the emergency room within 30 days of having an abortion — to justify that a group of anti-abortion doctors and medical groups have legal standing to force the FDA to recall mifepristone.

In a point-by-point response to Sage’s critiques of the paper sent to the publisher in November and now shared with Retraction Watch, Studnicki and colleagues pointed out they had noted their affiliations in the original manuscript and the then-proposed retractions “misrepresent ICMJE disclosure standards,” referring to the International Committee of Medical Journal Editors’ guidelines. They also call some of the post-publication peer reviewers’ critiques “factually incorrect” and “unfounded.” They conclude:

No single specific finding in any of the three papers has been explicitly challenged, let alone invalidated.

There is no evidence of a major error, miscalculation, fabrication, or falsification.

There is no breach of any of the COPE guidelines that could permit Sage to retract any of our published papers.

The retraction of any of these papers, let alone all three, is demonstrably unwarranted.

Adkins told Retraction Watch he is “pleased the journal approached my concerns with legitimate and serious consideration.” He continued:

It is reassuring that my initial concerns with the 2021 Studnicki et al. article were verified and affirmed by other experts. Despite the length of time spanning my initial communications with the journal and today’s retractions, I understand that thorough investigations and re-review processes take time. Given that these now-retracted articles have been excessively cited by parties involved in ongoing federal judicial cases, now positioned before the SCOTUS, Sage’s retractions should help our courts remain informed by the highest standards and quality in scientific and medical evidence.

Update, 2/6/24, 2100 UTC: We note that — contrary to best industry practices described by the Committee on Publication Ethics — Sage has removed the original versions of the articles. They are available at these links:

“A Longitudinal Cohort Study of Emergency Room Utilization Following Mifepristone Chemical and Surgical Abortions, 1999–2015”

“Doctors Who Perform Abortions: Their Characteristics and Patterns of Holding and Using Hospital Privileges”

“A Post Hoc Exploratory Analysis: Induced Abortion Complications Mistaken for Miscarriage in the Emergency Room are a Risk Factor for Hospitalization”

DISCLOSURE: Adam Marcus, a cofounder of Retraction Watch, is an editor at Medscape.

A version of this article appeared on Medscape.com.

A journal and publisher have retracted three papers about abortion, including one that has been used in court cases to support the suspension of FDA approval for mifepristone, aka an “abortion pill.”

Sage, the publisher of Health Services Research and Managerial Epidemiology, announced the retractions yesterday and posted a retraction notice covering the three articles.

For one of those articles, initially flagged by a reader, “an independent reviewer with expertise in statistical analyses evaluated the concerns and opined that the article’s presentation of the data in Figures 2 and 3 leads to an inaccurate conclusion and that the composition of the cohort studied has problems that could affect the article’s conclusions,” according to the notice.

The notice also said Sage “confirmed that all but one of the article’s authors had an affiliation with one or more of Charlotte Lozier Institute, Elliot Institute, and American Association of Pro-Life Obstetricians and Gynecologists, all pro-life advocacy organizations, despite having declared they had no conflicts of interest when they submitted the article for publication or in the article itself.” 

One of the peer reviewers, Sage learned, “was affiliated with Charlotte Lozier Institute at the time of the review,” leading the publisher and journal editor to determine “the peer review for initial publication was unreliable.” That referee also reviewed the other two now-retracted papers, according to Sage.

James Studnicki, the lead author of the three papers, told Retraction Watch the retractions were “a blatant attempt to discredit excellent research which is incongruent with a preferred abortion narrative.” He told The Daily Wire, a conservative news outlet that was first to report on the retractions, the move was “completely unjustified.” The Daily Wire notes that “The Supreme Court is set to hear arguments in March on the legality of restricting the abortion pill based on [Judge Matthew] Kacsmaryk’s ruling, proceedings that will certainly be impacted by the retractions.”

Sage had subjected one of the papers to an expression of concern in August 2023, saying they were investigating “potential issues regarding the representation of data in the article and author conflicts of interest” after being alerted by a reader. As News From The States reported then, the notice came after Chris Adkins, a professor at South University who teaches pharmaceutical sciences, raised concerns with Sage. As News From The States noted in August:

Kacsmaryk leaned hard on a 2021 study that was designed, funded and produced by the research arm of one of the most powerful anti-abortion political groups in the U.S. The judge cited this paper — which looked at Medicaid patients’ visits to the emergency room within 30 days of having an abortion — to justify that a group of anti-abortion doctors and medical groups have legal standing to force the FDA to recall mifepristone.

In a point-by-point response to Sage’s critiques of the paper sent to the publisher in November and now shared with Retraction Watch, Studnicki and colleagues pointed out they had noted their affiliations in the original manuscript and the then-proposed retractions “misrepresent ICMJE disclosure standards,” referring to the International Committee of Medical Journal Editors’ guidelines. They also call some of the post-publication peer reviewers’ critiques “factually incorrect” and “unfounded.” They conclude:

No single specific finding in any of the three papers has been explicitly challenged, let alone invalidated.

There is no evidence of a major error, miscalculation, fabrication, or falsification.

There is no breach of any of the COPE guidelines that could permit Sage to retract any of our published papers.

The retraction of any of these papers, let alone all three, is demonstrably unwarranted.

Adkins told Retraction Watch he is “pleased the journal approached my concerns with legitimate and serious consideration.” He continued:

It is reassuring that my initial concerns with the 2021 Studnicki et al. article were verified and affirmed by other experts. Despite the length of time spanning my initial communications with the journal and today’s retractions, I understand that thorough investigations and re-review processes take time. Given that these now-retracted articles have been excessively cited by parties involved in ongoing federal judicial cases, now positioned before the SCOTUS, Sage’s retractions should help our courts remain informed by the highest standards and quality in scientific and medical evidence.

Update, 2/6/24, 2100 UTC: We note that — contrary to best industry practices described by the Committee on Publication Ethics — Sage has removed the original versions of the articles. They are available at these links:

“A Longitudinal Cohort Study of Emergency Room Utilization Following Mifepristone Chemical and Surgical Abortions, 1999–2015”

“Doctors Who Perform Abortions: Their Characteristics and Patterns of Holding and Using Hospital Privileges”

“A Post Hoc Exploratory Analysis: Induced Abortion Complications Mistaken for Miscarriage in the Emergency Room are a Risk Factor for Hospitalization”

DISCLOSURE: Adam Marcus, a cofounder of Retraction Watch, is an editor at Medscape.

A version of this article appeared on Medscape.com.

Men prescribed drugs to treat newly diagnosed erectile dysfunction (ED) are 18% less likely to develop Alzheimer’s disease (AD) during a 5-year follow-up period, new research shows. 

The study is the second in recent years to suggest an association between the use of phosphodiesterase type 5 inhibitors (PDE5Is) such as sildenafil (Viagra) or tadalafil (Cialis) and AD risk. The findings contradict those in a third study, reported by this news organization, that showed no link between the two. 

Although the research is interesting, outside experts noted that there is no evidence that the drugs can treat AD and urge caution when interpreting the findings. 

Investigators agree but believe that the results offer a direction for future studies and underscore the importance of investigating whether existing approved therapies can be repurposed to treat AD. 

“The positive findings from our large study in over 250,000 men is promising and can be used to enhance research capacity and knowledge, with a potential future impact on clinical use and public health policy,” senior author Ruth Brauer, PhD, of the University College London, told this news organization.

“However, before recommending PDE5I are used to reduce the risk of AD, more work is required to validate the findings of our work, particularly in a more generalizable population that includes women and men without erectile dysfunction,” she continued.

The findings were published online February 7 in Neurology.

Strong Association

The study drew on primary healthcare data from the United Kingdom and included 269,725 men (average age, 59 years) with newly diagnosed ED, 55% of whom had received prescriptions for PDE5Is. 

Participants were free from memory or cognitive issues when the study began and were followed for a median of 5.1 years. Investigators accounted for a range of potential AD risk factors, including smoking status, alcohol use, body mass index, hypertension, diabetes, depression, anxiety, and concomitant medication use.

During the study period, 749 in the PDE5I group were diagnosed with AD, corresponding to a rate of 8.1 cases per 10,000 person-years. Among those who did not take the drugs, 370 developed AD, corresponding to a rate of 9.7 cases per 10,000 person-years.

Overall, initiation of a PDE5I was associated with an 18% lower risk for AD (adjusted hazard ration [aHR], 0.82; 95% CI, 0.72-0.93) compared with those with no prescriptions. 

The association was stronger in people aged 70 years or older and those with a history of hypertension or diabetes. The greatest risk reduction was found in people with the most prescriptions during the study period. Those with 21-50 prescriptions had a 44% lower risk for AD (aHR, 0.56; 95% CI, 0.43-0.73) and those with more than 50 were 35% less likely to be diagnosed with AD (aHR, 0.65; 95% CI, 0.49-0.87).

There was no association with AD risk in individuals who received fewer than 20 prescriptions. 

Investigators also analyzed associations after introducing a 1- and 3-year lag period after cohort entry to address the latent period between AD onset and diagnosis. The primary findings held with a 1-year lag period but lost significance with the inclusion of a 3-year lag period.

In subgroup analyses, investigators found evidence of reduced AD risk in those who received prescriptions for sildenafil (aHR, 0.81; 95% CI, 0.71-0.93), but there was no evidence for reduced risk compared with nonusers in those who received tadalafil and vardenafil.

Lower AD risk was found in patients with hypertension, diabetes, and in men aged 70 years or older, but there was no association in younger men or those with no history of hypertension or diabetes. 

Although investigators controlled for a wide range of potential risk factors, Dr. Brauer noted that unmeasured confounders such as physical and sexual activity, which were not tracked and may predict PDE5I exposure, may have affected the results. 

Interpret With Caution

Commenting on the findings, Ozama Ismail, PhD, Alzheimer’s Association director of scientific programs, noted that in addition to the limitations cited by the study authors, AD diagnoses were not made with the “gold standard” testing that typically includes imaging biomarkers and postmortem assessments. 

“While this study is interesting and adds to a potential association, there is no evidence that these drugs are able to treat Alzheimer’s disease,” said Dr. Brauer, who was not part of the current study. 

“People should not use over-the-counter phosphodiesterase type 5 inhibitors for prevention of Alzheimer’s or other dementias based on this very preliminary finding. Always consult with your physician before starting or changing your medications,” he cautioned.

However, Dr. Ismael added that the study does highlight a potential new avenue for drug repurposing. 

“Repurposing of existing, already-approved treatments can be a valuable part of drug development because, through already-completed testing, we know much about their safety and side effects,” which can decrease cost and time needed for studies, he said. 

“When considering repurposing an existing drug to an Alzheimer’s treatment, however, it is often important to conduct new studies over longer periods of time and in older people that reflect the diversity of individuals living with Alzheimer’s disease,” Dr. Ismael said.

Randomized Trials Needed

Dr. Brauer agreed, offering that such a trial should also include people with mild cognitive impairment and measure the effects of PDE5Is given in predefined doses plus an acetylcholinesterase inhibitor or placebo plus an acetylcholinesterase inhibitor. 

“The primary outcome would be the change in baseline cognitive function,” she said. “This approach would provide a comprehensive understanding of the potential therapeutic benefits of PDE5I and AD.”

Studies are also needed to better understand the mechanisms by which these drugs might influence AD risk, Sevil Yasar, MD, PhD, and Lolita Nidadavolu, MD, PhD, from the Division of Geriatric Medicine and Gerontology, Johns Hopkins University School of Medicine, Baltimore, noted in an accompanying editorial.

The strong association between PDE5I use and AD risk in people with a history of hypertension or diabetes suggests “a potential neuroprotective effect through a vascular pathway,” they wrote.

In vitro studies on the role of inflammation and clearance of beta-amyloid could strengthen findings from studies like this one, and in vivo studies could help explain the mechanisms behind PDE5I use and lower AD risk, Dr. Yasar and Dr. Nidadavolu noted. 

“In the end, however, further observational studies exploring mechanisms will not prove a causal association,” they wrote. “A well-designed randomized controlled trial is needed before PDE5I drugs can be prescribed for AD prevention.”

The study was unfunded. The study and editorial authors and Dr. Ismail report no relevant financial conflicts. 
 

A version of this article appeared on Medscape.com.

Men prescribed drugs to treat newly diagnosed erectile dysfunction (ED) are 18% less likely to develop Alzheimer’s disease (AD) during a 5-year follow-up period, new research shows. 

The study is the second in recent years to suggest an association between the use of phosphodiesterase type 5 inhibitors (PDE5Is) such as sildenafil (Viagra) or tadalafil (Cialis) and AD risk. The findings contradict those in a third study, reported by this news organization, that showed no link between the two. 

Although the research is interesting, outside experts noted that there is no evidence that the drugs can treat AD and urge caution when interpreting the findings. 

Investigators agree but believe that the results offer a direction for future studies and underscore the importance of investigating whether existing approved therapies can be repurposed to treat AD. 

“The positive findings from our large study in over 250,000 men is promising and can be used to enhance research capacity and knowledge, with a potential future impact on clinical use and public health policy,” senior author Ruth Brauer, PhD, of the University College London, told this news organization.

“However, before recommending PDE5I are used to reduce the risk of AD, more work is required to validate the findings of our work, particularly in a more generalizable population that includes women and men without erectile dysfunction,” she continued.

The findings were published online February 7 in Neurology.

Strong Association

The study drew on primary healthcare data from the United Kingdom and included 269,725 men (average age, 59 years) with newly diagnosed ED, 55% of whom had received prescriptions for PDE5Is. 

Participants were free from memory or cognitive issues when the study began and were followed for a median of 5.1 years. Investigators accounted for a range of potential AD risk factors, including smoking status, alcohol use, body mass index, hypertension, diabetes, depression, anxiety, and concomitant medication use.

During the study period, 749 in the PDE5I group were diagnosed with AD, corresponding to a rate of 8.1 cases per 10,000 person-years. Among those who did not take the drugs, 370 developed AD, corresponding to a rate of 9.7 cases per 10,000 person-years.

Overall, initiation of a PDE5I was associated with an 18% lower risk for AD (adjusted hazard ration [aHR], 0.82; 95% CI, 0.72-0.93) compared with those with no prescriptions. 

The association was stronger in people aged 70 years or older and those with a history of hypertension or diabetes. The greatest risk reduction was found in people with the most prescriptions during the study period. Those with 21-50 prescriptions had a 44% lower risk for AD (aHR, 0.56; 95% CI, 0.43-0.73) and those with more than 50 were 35% less likely to be diagnosed with AD (aHR, 0.65; 95% CI, 0.49-0.87).

There was no association with AD risk in individuals who received fewer than 20 prescriptions. 

Investigators also analyzed associations after introducing a 1- and 3-year lag period after cohort entry to address the latent period between AD onset and diagnosis. The primary findings held with a 1-year lag period but lost significance with the inclusion of a 3-year lag period.

In subgroup analyses, investigators found evidence of reduced AD risk in those who received prescriptions for sildenafil (aHR, 0.81; 95% CI, 0.71-0.93), but there was no evidence for reduced risk compared with nonusers in those who received tadalafil and vardenafil.

Lower AD risk was found in patients with hypertension, diabetes, and in men aged 70 years or older, but there was no association in younger men or those with no history of hypertension or diabetes. 

Although investigators controlled for a wide range of potential risk factors, Dr. Brauer noted that unmeasured confounders such as physical and sexual activity, which were not tracked and may predict PDE5I exposure, may have affected the results. 

Interpret With Caution

Commenting on the findings, Ozama Ismail, PhD, Alzheimer’s Association director of scientific programs, noted that in addition to the limitations cited by the study authors, AD diagnoses were not made with the “gold standard” testing that typically includes imaging biomarkers and postmortem assessments. 

“While this study is interesting and adds to a potential association, there is no evidence that these drugs are able to treat Alzheimer’s disease,” said Dr. Brauer, who was not part of the current study. 

“People should not use over-the-counter phosphodiesterase type 5 inhibitors for prevention of Alzheimer’s or other dementias based on this very preliminary finding. Always consult with your physician before starting or changing your medications,” he cautioned.

However, Dr. Ismael added that the study does highlight a potential new avenue for drug repurposing. 

“Repurposing of existing, already-approved treatments can be a valuable part of drug development because, through already-completed testing, we know much about their safety and side effects,” which can decrease cost and time needed for studies, he said. 

“When considering repurposing an existing drug to an Alzheimer’s treatment, however, it is often important to conduct new studies over longer periods of time and in older people that reflect the diversity of individuals living with Alzheimer’s disease,” Dr. Ismael said.

Randomized Trials Needed

Dr. Brauer agreed, offering that such a trial should also include people with mild cognitive impairment and measure the effects of PDE5Is given in predefined doses plus an acetylcholinesterase inhibitor or placebo plus an acetylcholinesterase inhibitor. 

“The primary outcome would be the change in baseline cognitive function,” she said. “This approach would provide a comprehensive understanding of the potential therapeutic benefits of PDE5I and AD.”

Studies are also needed to better understand the mechanisms by which these drugs might influence AD risk, Sevil Yasar, MD, PhD, and Lolita Nidadavolu, MD, PhD, from the Division of Geriatric Medicine and Gerontology, Johns Hopkins University School of Medicine, Baltimore, noted in an accompanying editorial.

The strong association between PDE5I use and AD risk in people with a history of hypertension or diabetes suggests “a potential neuroprotective effect through a vascular pathway,” they wrote.

In vitro studies on the role of inflammation and clearance of beta-amyloid could strengthen findings from studies like this one, and in vivo studies could help explain the mechanisms behind PDE5I use and lower AD risk, Dr. Yasar and Dr. Nidadavolu noted. 

“In the end, however, further observational studies exploring mechanisms will not prove a causal association,” they wrote. “A well-designed randomized controlled trial is needed before PDE5I drugs can be prescribed for AD prevention.”

The study was unfunded. The study and editorial authors and Dr. Ismail report no relevant financial conflicts. 
 

A version of this article appeared on Medscape.com.

Men prescribed drugs to treat newly diagnosed erectile dysfunction (ED) are 18% less likely to develop Alzheimer’s disease (AD) during a 5-year follow-up period, new research shows. 

The study is the second in recent years to suggest an association between the use of phosphodiesterase type 5 inhibitors (PDE5Is) such as sildenafil (Viagra) or tadalafil (Cialis) and AD risk. The findings contradict those in a third study, reported by this news organization, that showed no link between the two. 

Although the research is interesting, outside experts noted that there is no evidence that the drugs can treat AD and urge caution when interpreting the findings. 

Investigators agree but believe that the results offer a direction for future studies and underscore the importance of investigating whether existing approved therapies can be repurposed to treat AD. 

“The positive findings from our large study in over 250,000 men is promising and can be used to enhance research capacity and knowledge, with a potential future impact on clinical use and public health policy,” senior author Ruth Brauer, PhD, of the University College London, told this news organization.

“However, before recommending PDE5I are used to reduce the risk of AD, more work is required to validate the findings of our work, particularly in a more generalizable population that includes women and men without erectile dysfunction,” she continued.

The findings were published online February 7 in Neurology.

Strong Association

The study drew on primary healthcare data from the United Kingdom and included 269,725 men (average age, 59 years) with newly diagnosed ED, 55% of whom had received prescriptions for PDE5Is. 

Participants were free from memory or cognitive issues when the study began and were followed for a median of 5.1 years. Investigators accounted for a range of potential AD risk factors, including smoking status, alcohol use, body mass index, hypertension, diabetes, depression, anxiety, and concomitant medication use.

During the study period, 749 in the PDE5I group were diagnosed with AD, corresponding to a rate of 8.1 cases per 10,000 person-years. Among those who did not take the drugs, 370 developed AD, corresponding to a rate of 9.7 cases per 10,000 person-years.

Overall, initiation of a PDE5I was associated with an 18% lower risk for AD (adjusted hazard ration [aHR], 0.82; 95% CI, 0.72-0.93) compared with those with no prescriptions. 

The association was stronger in people aged 70 years or older and those with a history of hypertension or diabetes. The greatest risk reduction was found in people with the most prescriptions during the study period. Those with 21-50 prescriptions had a 44% lower risk for AD (aHR, 0.56; 95% CI, 0.43-0.73) and those with more than 50 were 35% less likely to be diagnosed with AD (aHR, 0.65; 95% CI, 0.49-0.87).

There was no association with AD risk in individuals who received fewer than 20 prescriptions. 

Investigators also analyzed associations after introducing a 1- and 3-year lag period after cohort entry to address the latent period between AD onset and diagnosis. The primary findings held with a 1-year lag period but lost significance with the inclusion of a 3-year lag period.

In subgroup analyses, investigators found evidence of reduced AD risk in those who received prescriptions for sildenafil (aHR, 0.81; 95% CI, 0.71-0.93), but there was no evidence for reduced risk compared with nonusers in those who received tadalafil and vardenafil.

Lower AD risk was found in patients with hypertension, diabetes, and in men aged 70 years or older, but there was no association in younger men or those with no history of hypertension or diabetes. 

Although investigators controlled for a wide range of potential risk factors, Dr. Brauer noted that unmeasured confounders such as physical and sexual activity, which were not tracked and may predict PDE5I exposure, may have affected the results. 

Interpret With Caution

Commenting on the findings, Ozama Ismail, PhD, Alzheimer’s Association director of scientific programs, noted that in addition to the limitations cited by the study authors, AD diagnoses were not made with the “gold standard” testing that typically includes imaging biomarkers and postmortem assessments. 

“While this study is interesting and adds to a potential association, there is no evidence that these drugs are able to treat Alzheimer’s disease,” said Dr. Brauer, who was not part of the current study. 

“People should not use over-the-counter phosphodiesterase type 5 inhibitors for prevention of Alzheimer’s or other dementias based on this very preliminary finding. Always consult with your physician before starting or changing your medications,” he cautioned.

However, Dr. Ismael added that the study does highlight a potential new avenue for drug repurposing. 

“Repurposing of existing, already-approved treatments can be a valuable part of drug development because, through already-completed testing, we know much about their safety and side effects,” which can decrease cost and time needed for studies, he said. 

“When considering repurposing an existing drug to an Alzheimer’s treatment, however, it is often important to conduct new studies over longer periods of time and in older people that reflect the diversity of individuals living with Alzheimer’s disease,” Dr. Ismael said.

Randomized Trials Needed

Dr. Brauer agreed, offering that such a trial should also include people with mild cognitive impairment and measure the effects of PDE5Is given in predefined doses plus an acetylcholinesterase inhibitor or placebo plus an acetylcholinesterase inhibitor. 

“The primary outcome would be the change in baseline cognitive function,” she said. “This approach would provide a comprehensive understanding of the potential therapeutic benefits of PDE5I and AD.”

Studies are also needed to better understand the mechanisms by which these drugs might influence AD risk, Sevil Yasar, MD, PhD, and Lolita Nidadavolu, MD, PhD, from the Division of Geriatric Medicine and Gerontology, Johns Hopkins University School of Medicine, Baltimore, noted in an accompanying editorial.

The strong association between PDE5I use and AD risk in people with a history of hypertension or diabetes suggests “a potential neuroprotective effect through a vascular pathway,” they wrote.

In vitro studies on the role of inflammation and clearance of beta-amyloid could strengthen findings from studies like this one, and in vivo studies could help explain the mechanisms behind PDE5I use and lower AD risk, Dr. Yasar and Dr. Nidadavolu noted. 

“In the end, however, further observational studies exploring mechanisms will not prove a causal association,” they wrote. “A well-designed randomized controlled trial is needed before PDE5I drugs can be prescribed for AD prevention.”

The study was unfunded. The study and editorial authors and Dr. Ismail report no relevant financial conflicts. 
 

A version of this article appeared on Medscape.com.

Dry eye and glaucoma may be the two most confounding conditions ophthalmologists face. Late last year, the US Food and Drug Administration (FDA) approved three new treatments for dry eye disease (DED) and one new procedure for glaucoma, which means ophthalmologists will soon have the opportunity to incorporate these therapies into their practices. Meanwhile, several investigative treatments for both chronic ailments will continue to move forward.

Undry Those Eyes

Based on a 2022 study in JAMA Ophthalmology, about 27 million Americans have some form of DED or meibomian gland dysfunction. Treatments aim to preserve and enhance tears and tear production to counteract the grittiness and itchiness that accompany DED.

“For decades, we only had one treatment [cyclosporine] for dry eye, then the second one a few years ago, which is lifitegrast, but nothing innovative until very recently,” Marjan Farid, MD, director of cornea, cataract and refractive surgery at the Gavin Herbert Eye Institute at the University of California-Irvine, told this news organization.

“In 2023, I feel that innovation from the pharmaceutical standpoint in this space really exploded, and it’s very exciting because dry eye disease is such a multifactorial disease that you can’t just go after one angle,” said Dr. Farid, who is also chair of the American Society of Cataract and Refractive Surgery’s cornea clinical committee. “You really need to be able to attack dry eye disease from multiple areas, when the meibomian glands are involved, or whether or not there’s blephartitis.”

The three treatments for DED the FDA approved last year are lotilaner 0.25% ophthalmic solution, which targets the Demodex mites that cause of Demodex blepharitis, a trigger for DED; perfluorohexyloctane ophthalmic solution; and cyclosporine ophthalmic solution 0.1%. The latter two agents coat the ocular surface — perfluorohexyloctane acting as a shield to prevent tear evaporation and cyclosporine 0.1% using perfluorobutylpentane to allow the immunosuppressant cyclosporine to penetrate deeper into the eye.

This year, Dr. Farid said, while ophthalmologists will be adopting those treatments, they’ll also be watching three emerging treatments poised to report results from clinical trial or take other steps toward FDA approval. They include:

• Selenium sulfide 0.5% ophthalmic ointment will move into phase 3 trials. This ointment is applied directly to the lower eyelid to open the meibomian gland (MGs), secretions from which prevent tear evaporation and tear overflow. Results last year from a phase 2 trial demonstrated improvement in MG secretions in treated patients. “It’s a very unique compound because it’s the only compound that could potentially open the meibomian gland orifices along lid margin and improve the quality of secretions,” Dr. Farid said.
• Reproxalap, a reactive aldehyde species (RASP) inhibitor, will be the subject of a new drug application (NDA) resubmission this year. RASPs have been found in elevated levels in ocular and systemic inflammatory disease. The FDA last year notified drug developer Aldeyra Therapeutics that an additional trial was needed to demonstrate efficacy in treating symptoms of DED. Aldeyra said it would resubmit the NDA and report topline trial results in the first half of the year. “That’s a really nice anti-inflammatory eye drop that works early in the inflammatory cascade,” Dr. Farid said. “It acts almost like a steroid does without having the side effects of the steroid.”
• AR-15512, a topical transient receptor potential melastatin 8 agonist, may also be the subject of an NDA this year. Topline results from two phase 3 trials last year demonstrated a clinically meaningful increase in tear production.

The Centers for Disease Control and Prevention estimates 3 million Americans have glaucoma. The use of daily eye drops to lower intraocular pressure (IOP) has been a mainstay of glaucoma therapy treatment for decades. However, a 2018 study put the rates of nonadherence as high at 67%.

In part to skirt the adherence issue, several approaches have evolved to lower IOP without relying on drops. They include laser treatments to perforate the eye’s trabecular meshwork and improve the outflow of aqueous humor, minimally invasive glaucoma surgery to create a small tunnel or even insert a shunt to enable aqueous outflow, and, more recently, implantable depots that release IOP-lowering drugs within the eye over months.

“Glaucoma is a disease that has a slow onset, so you have to diagnose it as early as possible,” Andrew Iwach, MD, a glaucoma specialist in San Francisco and clinical spokesperson for the American Academy of Ophthalmology, told this news organization. “One challenge with glaucoma is its chronic nature. There are different methods that are being looked at to achieve sustained release of drugs — ways you can implant a little bolus of this medicine,” Dr. Iwach added.

Glaucoma also requires regular monitoring of changes in IOP, Iwach noted. “During COVID, there was an increased interest in during this remotely,” he said. A remote monitoring platform, Peripherex, was registered last year with the FDA. It consists of a diagnostic online visual field test that can enable patients with glaucoma to provide data on disease changes from home.

A laser platform, the Belkin Eagle Nd:YAG laser for performing selective laser trabeculoplasty (SLT), in December 2023 received FDA clearance. Dr. Iwach said this is the first innovation in lasers in 20 years in that it eliminates the need for placing a diagnostic lens on the eye itself to direct the laser pulses, a technique called direct SLT. It uses a computer-driven tacking device.

Looking Ahead

A laser in development is ViaLase, which offers femtosecond laser image-guided high-precision trabeculotomy or FLigHT. The VIA-002 study, which began enrolling patients in September 2023, is comparing ViaLase with SLT to determine reduction in unmedicated IOP at 6 and 12 months. A small feasibility study published last year demonstrated safety of the procedure with an average reduction in IOP of 34.6% at 24 months.

Microshunts inserted into the eye also have been used to reduce IOP. An early stage study is evaluating a new-generation, minimally invasive shunt that, once implanted, allows the ophthalmologist to adjust the level of aqueous outflow in an office-based procedure.

Another December 2023 FDA approval was iDose TR, an implant loaded with the prostaglandin analog travoprost 75 mcg. The implant is scheduled for commercial release in the first quarter of 2024, with a projected wholesale acquisition cost of $13,950 per dose or implant.

Two phase 3 trials compared two iDose TR models with two different travoprost release intervals, defined as the fast- and slow-release iDose TR models, respectively, with topical timolol ophthalmic solution, 0.5% twice a day. The trials demonstrated comparable IOP reduction between all three vehicles. At 12 months, 81% of iDose TR subjects required no IOP-lowering topical medications across both trials.

Also in development is an implant that uses a cilioscleral technique to preserve the anterior chamber of the eye, reducing the risk for complications, such as endothelial cell loss or a filtration bleb, that can occur with other implant procedures. Preliminary results of a 12-month study of 57 patients fitted with a new design with the cilioscleral interpositioning device (CID) showed it lowered IOP an average of 13.9 mmHg vs 15.1 mmHg in earlier studies with the device. In the latest study, more than 85% of patients reported being medication free at 12 months. The CID procedure spares the conjunctiva, requiring only a local incision, according to its developers.

As for topical agents that reduce IOP, cannabinoids may soon find their way into the glaucoma specialist’s toolbox. A phase 2 trial evaluating SBI-100 ophthalmic emulsion started enrolling patients late last year. SBI-100 OE is a synthetic prodrug of tetrahydrocannabinol that can bind and activate cannabinoid receptor type 1 in ocular tissues. The trial is scheduled for completion later this year. A phase 1 trial last year demonstrated an average reduction in IOP of 24%.

Another area of focus is on the use of preservatives in topical drops. “One of big issues we’re dealing with is preservatives because you’re marinating these eyes over years with these drops,” Dr. Iwach said. Late last year, the first preservative-free form of latanoprost ophthalmic solution 0.005% launched in the United States. Other delivery systems that remove preservatives from topical drops and preservative-free formulations are in the investigative stage, he said.

Dr. Farid disclosed financial relationships with Alcon Laboratories, Allergan/AbbVie, Bausch + Lomb, Bio-Tissue, CorneaGen, Harrow, Kala Pharmaceuticals, and Tarsus Pharmaceuticals. Dr. Iwach disclosed a previous financial relationship with Belkin Vision as well as relationships with Alcon Laboratories and Innovia.

A version of this article appeared on Medscape.com.

Dry eye and glaucoma may be the two most confounding conditions ophthalmologists face. Late last year, the US Food and Drug Administration (FDA) approved three new treatments for dry eye disease (DED) and one new procedure for glaucoma, which means ophthalmologists will soon have the opportunity to incorporate these therapies into their practices. Meanwhile, several investigative treatments for both chronic ailments will continue to move forward.

Undry Those Eyes

Based on a 2022 study in JAMA Ophthalmology, about 27 million Americans have some form of DED or meibomian gland dysfunction. Treatments aim to preserve and enhance tears and tear production to counteract the grittiness and itchiness that accompany DED.

“For decades, we only had one treatment [cyclosporine] for dry eye, then the second one a few years ago, which is lifitegrast, but nothing innovative until very recently,” Marjan Farid, MD, director of cornea, cataract and refractive surgery at the Gavin Herbert Eye Institute at the University of California-Irvine, told this news organization.

“In 2023, I feel that innovation from the pharmaceutical standpoint in this space really exploded, and it’s very exciting because dry eye disease is such a multifactorial disease that you can’t just go after one angle,” said Dr. Farid, who is also chair of the American Society of Cataract and Refractive Surgery’s cornea clinical committee. “You really need to be able to attack dry eye disease from multiple areas, when the meibomian glands are involved, or whether or not there’s blephartitis.”

The three treatments for DED the FDA approved last year are lotilaner 0.25% ophthalmic solution, which targets the Demodex mites that cause of Demodex blepharitis, a trigger for DED; perfluorohexyloctane ophthalmic solution; and cyclosporine ophthalmic solution 0.1%. The latter two agents coat the ocular surface — perfluorohexyloctane acting as a shield to prevent tear evaporation and cyclosporine 0.1% using perfluorobutylpentane to allow the immunosuppressant cyclosporine to penetrate deeper into the eye.

This year, Dr. Farid said, while ophthalmologists will be adopting those treatments, they’ll also be watching three emerging treatments poised to report results from clinical trial or take other steps toward FDA approval. They include:

• Selenium sulfide 0.5% ophthalmic ointment will move into phase 3 trials. This ointment is applied directly to the lower eyelid to open the meibomian gland (MGs), secretions from which prevent tear evaporation and tear overflow. Results last year from a phase 2 trial demonstrated improvement in MG secretions in treated patients. “It’s a very unique compound because it’s the only compound that could potentially open the meibomian gland orifices along lid margin and improve the quality of secretions,” Dr. Farid said.
• Reproxalap, a reactive aldehyde species (RASP) inhibitor, will be the subject of a new drug application (NDA) resubmission this year. RASPs have been found in elevated levels in ocular and systemic inflammatory disease. The FDA last year notified drug developer Aldeyra Therapeutics that an additional trial was needed to demonstrate efficacy in treating symptoms of DED. Aldeyra said it would resubmit the NDA and report topline trial results in the first half of the year. “That’s a really nice anti-inflammatory eye drop that works early in the inflammatory cascade,” Dr. Farid said. “It acts almost like a steroid does without having the side effects of the steroid.”
• AR-15512, a topical transient receptor potential melastatin 8 agonist, may also be the subject of an NDA this year. Topline results from two phase 3 trials last year demonstrated a clinically meaningful increase in tear production.

The Centers for Disease Control and Prevention estimates 3 million Americans have glaucoma. The use of daily eye drops to lower intraocular pressure (IOP) has been a mainstay of glaucoma therapy treatment for decades. However, a 2018 study put the rates of nonadherence as high at 67%.

In part to skirt the adherence issue, several approaches have evolved to lower IOP without relying on drops. They include laser treatments to perforate the eye’s trabecular meshwork and improve the outflow of aqueous humor, minimally invasive glaucoma surgery to create a small tunnel or even insert a shunt to enable aqueous outflow, and, more recently, implantable depots that release IOP-lowering drugs within the eye over months.

“Glaucoma is a disease that has a slow onset, so you have to diagnose it as early as possible,” Andrew Iwach, MD, a glaucoma specialist in San Francisco and clinical spokesperson for the American Academy of Ophthalmology, told this news organization. “One challenge with glaucoma is its chronic nature. There are different methods that are being looked at to achieve sustained release of drugs — ways you can implant a little bolus of this medicine,” Dr. Iwach added.

Glaucoma also requires regular monitoring of changes in IOP, Iwach noted. “During COVID, there was an increased interest in during this remotely,” he said. A remote monitoring platform, Peripherex, was registered last year with the FDA. It consists of a diagnostic online visual field test that can enable patients with glaucoma to provide data on disease changes from home.

A laser platform, the Belkin Eagle Nd:YAG laser for performing selective laser trabeculoplasty (SLT), in December 2023 received FDA clearance. Dr. Iwach said this is the first innovation in lasers in 20 years in that it eliminates the need for placing a diagnostic lens on the eye itself to direct the laser pulses, a technique called direct SLT. It uses a computer-driven tacking device.

Looking Ahead

A laser in development is ViaLase, which offers femtosecond laser image-guided high-precision trabeculotomy or FLigHT. The VIA-002 study, which began enrolling patients in September 2023, is comparing ViaLase with SLT to determine reduction in unmedicated IOP at 6 and 12 months. A small feasibility study published last year demonstrated safety of the procedure with an average reduction in IOP of 34.6% at 24 months.

Microshunts inserted into the eye also have been used to reduce IOP. An early stage study is evaluating a new-generation, minimally invasive shunt that, once implanted, allows the ophthalmologist to adjust the level of aqueous outflow in an office-based procedure.

Another December 2023 FDA approval was iDose TR, an implant loaded with the prostaglandin analog travoprost 75 mcg. The implant is scheduled for commercial release in the first quarter of 2024, with a projected wholesale acquisition cost of $13,950 per dose or implant.

Two phase 3 trials compared two iDose TR models with two different travoprost release intervals, defined as the fast- and slow-release iDose TR models, respectively, with topical timolol ophthalmic solution, 0.5% twice a day. The trials demonstrated comparable IOP reduction between all three vehicles. At 12 months, 81% of iDose TR subjects required no IOP-lowering topical medications across both trials.

Also in development is an implant that uses a cilioscleral technique to preserve the anterior chamber of the eye, reducing the risk for complications, such as endothelial cell loss or a filtration bleb, that can occur with other implant procedures. Preliminary results of a 12-month study of 57 patients fitted with a new design with the cilioscleral interpositioning device (CID) showed it lowered IOP an average of 13.9 mmHg vs 15.1 mmHg in earlier studies with the device. In the latest study, more than 85% of patients reported being medication free at 12 months. The CID procedure spares the conjunctiva, requiring only a local incision, according to its developers.

As for topical agents that reduce IOP, cannabinoids may soon find their way into the glaucoma specialist’s toolbox. A phase 2 trial evaluating SBI-100 ophthalmic emulsion started enrolling patients late last year. SBI-100 OE is a synthetic prodrug of tetrahydrocannabinol that can bind and activate cannabinoid receptor type 1 in ocular tissues. The trial is scheduled for completion later this year. A phase 1 trial last year demonstrated an average reduction in IOP of 24%.

Another area of focus is on the use of preservatives in topical drops. “One of big issues we’re dealing with is preservatives because you’re marinating these eyes over years with these drops,” Dr. Iwach said. Late last year, the first preservative-free form of latanoprost ophthalmic solution 0.005% launched in the United States. Other delivery systems that remove preservatives from topical drops and preservative-free formulations are in the investigative stage, he said.

Dr. Farid disclosed financial relationships with Alcon Laboratories, Allergan/AbbVie, Bausch + Lomb, Bio-Tissue, CorneaGen, Harrow, Kala Pharmaceuticals, and Tarsus Pharmaceuticals. Dr. Iwach disclosed a previous financial relationship with Belkin Vision as well as relationships with Alcon Laboratories and Innovia.

A version of this article appeared on Medscape.com.

Dry eye and glaucoma may be the two most confounding conditions ophthalmologists face. Late last year, the US Food and Drug Administration (FDA) approved three new treatments for dry eye disease (DED) and one new procedure for glaucoma, which means ophthalmologists will soon have the opportunity to incorporate these therapies into their practices. Meanwhile, several investigative treatments for both chronic ailments will continue to move forward.

Undry Those Eyes

Based on a 2022 study in JAMA Ophthalmology, about 27 million Americans have some form of DED or meibomian gland dysfunction. Treatments aim to preserve and enhance tears and tear production to counteract the grittiness and itchiness that accompany DED.

“For decades, we only had one treatment [cyclosporine] for dry eye, then the second one a few years ago, which is lifitegrast, but nothing innovative until very recently,” Marjan Farid, MD, director of cornea, cataract and refractive surgery at the Gavin Herbert Eye Institute at the University of California-Irvine, told this news organization.

“In 2023, I feel that innovation from the pharmaceutical standpoint in this space really exploded, and it’s very exciting because dry eye disease is such a multifactorial disease that you can’t just go after one angle,” said Dr. Farid, who is also chair of the American Society of Cataract and Refractive Surgery’s cornea clinical committee. “You really need to be able to attack dry eye disease from multiple areas, when the meibomian glands are involved, or whether or not there’s blephartitis.”

The three treatments for DED the FDA approved last year are lotilaner 0.25% ophthalmic solution, which targets the Demodex mites that cause of Demodex blepharitis, a trigger for DED; perfluorohexyloctane ophthalmic solution; and cyclosporine ophthalmic solution 0.1%. The latter two agents coat the ocular surface — perfluorohexyloctane acting as a shield to prevent tear evaporation and cyclosporine 0.1% using perfluorobutylpentane to allow the immunosuppressant cyclosporine to penetrate deeper into the eye.

This year, Dr. Farid said, while ophthalmologists will be adopting those treatments, they’ll also be watching three emerging treatments poised to report results from clinical trial or take other steps toward FDA approval. They include:

• Selenium sulfide 0.5% ophthalmic ointment will move into phase 3 trials. This ointment is applied directly to the lower eyelid to open the meibomian gland (MGs), secretions from which prevent tear evaporation and tear overflow. Results last year from a phase 2 trial demonstrated improvement in MG secretions in treated patients. “It’s a very unique compound because it’s the only compound that could potentially open the meibomian gland orifices along lid margin and improve the quality of secretions,” Dr. Farid said.
• Reproxalap, a reactive aldehyde species (RASP) inhibitor, will be the subject of a new drug application (NDA) resubmission this year. RASPs have been found in elevated levels in ocular and systemic inflammatory disease. The FDA last year notified drug developer Aldeyra Therapeutics that an additional trial was needed to demonstrate efficacy in treating symptoms of DED. Aldeyra said it would resubmit the NDA and report topline trial results in the first half of the year. “That’s a really nice anti-inflammatory eye drop that works early in the inflammatory cascade,” Dr. Farid said. “It acts almost like a steroid does without having the side effects of the steroid.”
• AR-15512, a topical transient receptor potential melastatin 8 agonist, may also be the subject of an NDA this year. Topline results from two phase 3 trials last year demonstrated a clinically meaningful increase in tear production.

The Centers for Disease Control and Prevention estimates 3 million Americans have glaucoma. The use of daily eye drops to lower intraocular pressure (IOP) has been a mainstay of glaucoma therapy treatment for decades. However, a 2018 study put the rates of nonadherence as high at 67%.

In part to skirt the adherence issue, several approaches have evolved to lower IOP without relying on drops. They include laser treatments to perforate the eye’s trabecular meshwork and improve the outflow of aqueous humor, minimally invasive glaucoma surgery to create a small tunnel or even insert a shunt to enable aqueous outflow, and, more recently, implantable depots that release IOP-lowering drugs within the eye over months.

“Glaucoma is a disease that has a slow onset, so you have to diagnose it as early as possible,” Andrew Iwach, MD, a glaucoma specialist in San Francisco and clinical spokesperson for the American Academy of Ophthalmology, told this news organization. “One challenge with glaucoma is its chronic nature. There are different methods that are being looked at to achieve sustained release of drugs — ways you can implant a little bolus of this medicine,” Dr. Iwach added.

Glaucoma also requires regular monitoring of changes in IOP, Iwach noted. “During COVID, there was an increased interest in during this remotely,” he said. A remote monitoring platform, Peripherex, was registered last year with the FDA. It consists of a diagnostic online visual field test that can enable patients with glaucoma to provide data on disease changes from home.

A laser platform, the Belkin Eagle Nd:YAG laser for performing selective laser trabeculoplasty (SLT), in December 2023 received FDA clearance. Dr. Iwach said this is the first innovation in lasers in 20 years in that it eliminates the need for placing a diagnostic lens on the eye itself to direct the laser pulses, a technique called direct SLT. It uses a computer-driven tacking device.

Looking Ahead

A laser in development is ViaLase, which offers femtosecond laser image-guided high-precision trabeculotomy or FLigHT. The VIA-002 study, which began enrolling patients in September 2023, is comparing ViaLase with SLT to determine reduction in unmedicated IOP at 6 and 12 months. A small feasibility study published last year demonstrated safety of the procedure with an average reduction in IOP of 34.6% at 24 months.

Microshunts inserted into the eye also have been used to reduce IOP. An early stage study is evaluating a new-generation, minimally invasive shunt that, once implanted, allows the ophthalmologist to adjust the level of aqueous outflow in an office-based procedure.

Another December 2023 FDA approval was iDose TR, an implant loaded with the prostaglandin analog travoprost 75 mcg. The implant is scheduled for commercial release in the first quarter of 2024, with a projected wholesale acquisition cost of $13,950 per dose or implant.

Two phase 3 trials compared two iDose TR models with two different travoprost release intervals, defined as the fast- and slow-release iDose TR models, respectively, with topical timolol ophthalmic solution, 0.5% twice a day. The trials demonstrated comparable IOP reduction between all three vehicles. At 12 months, 81% of iDose TR subjects required no IOP-lowering topical medications across both trials.

Also in development is an implant that uses a cilioscleral technique to preserve the anterior chamber of the eye, reducing the risk for complications, such as endothelial cell loss or a filtration bleb, that can occur with other implant procedures. Preliminary results of a 12-month study of 57 patients fitted with a new design with the cilioscleral interpositioning device (CID) showed it lowered IOP an average of 13.9 mmHg vs 15.1 mmHg in earlier studies with the device. In the latest study, more than 85% of patients reported being medication free at 12 months. The CID procedure spares the conjunctiva, requiring only a local incision, according to its developers.

As for topical agents that reduce IOP, cannabinoids may soon find their way into the glaucoma specialist’s toolbox. A phase 2 trial evaluating SBI-100 ophthalmic emulsion started enrolling patients late last year. SBI-100 OE is a synthetic prodrug of tetrahydrocannabinol that can bind and activate cannabinoid receptor type 1 in ocular tissues. The trial is scheduled for completion later this year. A phase 1 trial last year demonstrated an average reduction in IOP of 24%.

Another area of focus is on the use of preservatives in topical drops. “One of big issues we’re dealing with is preservatives because you’re marinating these eyes over years with these drops,” Dr. Iwach said. Late last year, the first preservative-free form of latanoprost ophthalmic solution 0.005% launched in the United States. Other delivery systems that remove preservatives from topical drops and preservative-free formulations are in the investigative stage, he said.

Dr. Farid disclosed financial relationships with Alcon Laboratories, Allergan/AbbVie, Bausch + Lomb, Bio-Tissue, CorneaGen, Harrow, Kala Pharmaceuticals, and Tarsus Pharmaceuticals. Dr. Iwach disclosed a previous financial relationship with Belkin Vision as well as relationships with Alcon Laboratories and Innovia.

A version of this article appeared on Medscape.com.

The US Food and Drug Administration (FDA) has cleared NM-101 (Terran Biosciences), a cloud-based software platform to analyze neuromelanin-sensitive MRI scans, which could aid in the diagnosis of neurodegenerative diseases. 

Research has suggested that neuromelanin is a potential biomarker for neurologic disorders such as Parkinson’s disease.

A recent meta-analysis of 12 neuromelanin MRI studies with 403 patients with Parkinson’s disease and 298 control participants found that neuromelanin MRI had “favorable” diagnostic performance in discriminating patients with Parkinson’s disease from healthy controls.

Until now, there were no FDA-approved devices capable of providing clinicians with analysis of neuromelanin MRI due to a lack of automation and standardization. NM-101 contains algorithms that enable fully automated analysis and the cross-scanner harmonization of neuromelanin MRI scans, the company explains in a news release.

NM-101 is designed to “seamlessly” integrate into existing workflows at hospitals and imaging centers, the company says. 

The platform allows clinicians to send neuromelanin MRI images to Terran directly through the hospital picture archiving and communication system and receive results in less than 1 hour. 

When interpreted by a neuroradiologist, NM-101 could provide information that may be helpful in determining neuromelanin association as an adjunct to diagnosis.

“We believe this technology could become very important in the clinical workflow of patients with neurological and psychiatric disorders,” Terran Biosciences Founder and CEO Sam Clark, MD, PhD, said in the release. 

Neuromelanin MRI has the potential to become “part of the standard of care for the workup of all patients suspected of Parkinson’s and related diseases,” David Sulzer, PhD, professor of neurobiology at Columbia University Vagelos College of Physicians and Surgeons, New York, and co-author of multiple studies using neuromelanin MRI, commented in the news release.

“It’s great to see neuromelanin MRI become more accessible in clinical settings. We hope this opens the door for the adoption of neuromelanin MRI into the clinical workflow for patients with neuropsychiatric disorders,” added Guillermo Horga, MD, PhD, associate professor of psychiatry at Columbia University Vagelos College of Physicians and Surgeons.

Terran Biosciences has an exclusive license to the CNS biomarker software platform and related patents co-owned by Columbia University and Research Foundation for Mental Hygiene. Dr. Horga will receive a portion of the royalties paid to Columbia University for sales of the product.

A version of this article appeared on Medscape.com.

The US Food and Drug Administration (FDA) has cleared NM-101 (Terran Biosciences), a cloud-based software platform to analyze neuromelanin-sensitive MRI scans, which could aid in the diagnosis of neurodegenerative diseases. 

Research has suggested that neuromelanin is a potential biomarker for neurologic disorders such as Parkinson’s disease.

A recent meta-analysis of 12 neuromelanin MRI studies with 403 patients with Parkinson’s disease and 298 control participants found that neuromelanin MRI had “favorable” diagnostic performance in discriminating patients with Parkinson’s disease from healthy controls.

Until now, there were no FDA-approved devices capable of providing clinicians with analysis of neuromelanin MRI due to a lack of automation and standardization. NM-101 contains algorithms that enable fully automated analysis and the cross-scanner harmonization of neuromelanin MRI scans, the company explains in a news release.

NM-101 is designed to “seamlessly” integrate into existing workflows at hospitals and imaging centers, the company says. 

The platform allows clinicians to send neuromelanin MRI images to Terran directly through the hospital picture archiving and communication system and receive results in less than 1 hour. 

When interpreted by a neuroradiologist, NM-101 could provide information that may be helpful in determining neuromelanin association as an adjunct to diagnosis.

“We believe this technology could become very important in the clinical workflow of patients with neurological and psychiatric disorders,” Terran Biosciences Founder and CEO Sam Clark, MD, PhD, said in the release. 

Neuromelanin MRI has the potential to become “part of the standard of care for the workup of all patients suspected of Parkinson’s and related diseases,” David Sulzer, PhD, professor of neurobiology at Columbia University Vagelos College of Physicians and Surgeons, New York, and co-author of multiple studies using neuromelanin MRI, commented in the news release.

“It’s great to see neuromelanin MRI become more accessible in clinical settings. We hope this opens the door for the adoption of neuromelanin MRI into the clinical workflow for patients with neuropsychiatric disorders,” added Guillermo Horga, MD, PhD, associate professor of psychiatry at Columbia University Vagelos College of Physicians and Surgeons.

Terran Biosciences has an exclusive license to the CNS biomarker software platform and related patents co-owned by Columbia University and Research Foundation for Mental Hygiene. Dr. Horga will receive a portion of the royalties paid to Columbia University for sales of the product.

A version of this article appeared on Medscape.com.

The US Food and Drug Administration (FDA) has cleared NM-101 (Terran Biosciences), a cloud-based software platform to analyze neuromelanin-sensitive MRI scans, which could aid in the diagnosis of neurodegenerative diseases. 

Research has suggested that neuromelanin is a potential biomarker for neurologic disorders such as Parkinson’s disease.

A recent meta-analysis of 12 neuromelanin MRI studies with 403 patients with Parkinson’s disease and 298 control participants found that neuromelanin MRI had “favorable” diagnostic performance in discriminating patients with Parkinson’s disease from healthy controls.

Until now, there were no FDA-approved devices capable of providing clinicians with analysis of neuromelanin MRI due to a lack of automation and standardization. NM-101 contains algorithms that enable fully automated analysis and the cross-scanner harmonization of neuromelanin MRI scans, the company explains in a news release.

NM-101 is designed to “seamlessly” integrate into existing workflows at hospitals and imaging centers, the company says. 

The platform allows clinicians to send neuromelanin MRI images to Terran directly through the hospital picture archiving and communication system and receive results in less than 1 hour. 

When interpreted by a neuroradiologist, NM-101 could provide information that may be helpful in determining neuromelanin association as an adjunct to diagnosis.

“We believe this technology could become very important in the clinical workflow of patients with neurological and psychiatric disorders,” Terran Biosciences Founder and CEO Sam Clark, MD, PhD, said in the release. 

Neuromelanin MRI has the potential to become “part of the standard of care for the workup of all patients suspected of Parkinson’s and related diseases,” David Sulzer, PhD, professor of neurobiology at Columbia University Vagelos College of Physicians and Surgeons, New York, and co-author of multiple studies using neuromelanin MRI, commented in the news release.

“It’s great to see neuromelanin MRI become more accessible in clinical settings. We hope this opens the door for the adoption of neuromelanin MRI into the clinical workflow for patients with neuropsychiatric disorders,” added Guillermo Horga, MD, PhD, associate professor of psychiatry at Columbia University Vagelos College of Physicians and Surgeons.

Terran Biosciences has an exclusive license to the CNS biomarker software platform and related patents co-owned by Columbia University and Research Foundation for Mental Hygiene. Dr. Horga will receive a portion of the royalties paid to Columbia University for sales of the product.

A version of this article appeared on Medscape.com.

When clinicians in a large-scale study viewed a series of digital images that showed skin diseases across skin tones and were asked to make a diagnosis, the accuracy was 38% among dermatologists and 19% among primary care physicians (PCPs). But when decision support from a deep learning system (DLS) was introduced, diagnostic accuracy increased by 33% among dermatologists and 69% among PCPs, results from a multicenter study showed.

However, the researchers found that across all images, diseases in dark skin (Fitzpatrick skin types 5 and 6) were diagnosed less accurately than diseases in light skin (Fitzpatrick skin types 1-4).

“These results contribute to an emerging literature on diagnostic accuracy disparities across patient skin tones and present evidence that the diagnostic accuracy of medical professionals on images of dark skin is lower than on images of light skin,” researchers led by Matthew Groh, PhD, of Northwestern University’s Kellogg School of Management, wrote in their study, published online in Nature Medicine.

For the study, 389 board-certified dermatologists and 450 PCPs in 39 countries were presented with 364 images to view spanning 46 skin diseases and asked to submit up to four differential diagnoses. Nearly 80% of the images were of 8 diseases: atopic dermatitis, cutaneous T-cell lymphoma (CTCL), dermatomyositis, lichen planus, Lyme disease, pityriasis rosea, pityriasis rubra pilaris, and secondary syphilis.

Dermatologists and PCPs achieved a diagnostic accuracy of 38% and 19%, respectively, but both groups of clinicians were 4 percentage points less accurate for diagnosis of images of dark skin as compared with light skin. With assistance from DLS decision support, diagnostic accuracy increased by 33% among dermatologists and 69% among primary care physicians. Among dermatologists, DLS support generally increased diagnostic accuracy evenly across skin tones. However, among PCPs, DLS support increased their diagnostic accuracy more in light skin tones than in dark ones.

In the survey component of the study, when the participants were asked, “Do you feel you received sufficient training for diagnosing skin diseases in patients with skin of color (non-white patients)?” 67% of all PCPs and 33% of all dermatologists responded no. “Furthermore, we have found differences in how often BCDs [board-certified dermatologists] and PCPs refer patients with light and dark skin for biopsy,” the authors wrote. “Specifically, for CTCL (a life-threatening disease), we found that both BCDs and PCPs report that they would refer patients for biopsy significantly more often in light skin than dark skin. Moreover, for the common skin diseases atopic dermatitis and pityriasis rosea, we found that BCDs report they would refer patients for biopsy more often in dark skin than light skin, which creates an unnecessary overburden on patients with dark skin.”

In a press release about the study, Dr. Groh emphasized that he and other scientists who investigate human-computer interaction “have to find a way to incorporate underrepresented demographics in our research. That way we will be ready to accurately implement these models in the real world and build AI systems that serve as tools that are designed to avoid the kind of systematic errors we know humans and machines are prone to. Then you can update curricula, you can change norms in different fields and hopefully everyone gets better.”

When clinicians in a large-scale study viewed a series of digital images that showed skin diseases across skin tones and were asked to make a diagnosis, the accuracy was 38% among dermatologists and 19% among primary care physicians (PCPs). But when decision support from a deep learning system (DLS) was introduced, diagnostic accuracy increased by 33% among dermatologists and 69% among PCPs, results from a multicenter study showed.

However, the researchers found that across all images, diseases in dark skin (Fitzpatrick skin types 5 and 6) were diagnosed less accurately than diseases in light skin (Fitzpatrick skin types 1-4).

“These results contribute to an emerging literature on diagnostic accuracy disparities across patient skin tones and present evidence that the diagnostic accuracy of medical professionals on images of dark skin is lower than on images of light skin,” researchers led by Matthew Groh, PhD, of Northwestern University’s Kellogg School of Management, wrote in their study, published online in Nature Medicine.

For the study, 389 board-certified dermatologists and 450 PCPs in 39 countries were presented with 364 images to view spanning 46 skin diseases and asked to submit up to four differential diagnoses. Nearly 80% of the images were of 8 diseases: atopic dermatitis, cutaneous T-cell lymphoma (CTCL), dermatomyositis, lichen planus, Lyme disease, pityriasis rosea, pityriasis rubra pilaris, and secondary syphilis.

Dermatologists and PCPs achieved a diagnostic accuracy of 38% and 19%, respectively, but both groups of clinicians were 4 percentage points less accurate for diagnosis of images of dark skin as compared with light skin. With assistance from DLS decision support, diagnostic accuracy increased by 33% among dermatologists and 69% among primary care physicians. Among dermatologists, DLS support generally increased diagnostic accuracy evenly across skin tones. However, among PCPs, DLS support increased their diagnostic accuracy more in light skin tones than in dark ones.

In the survey component of the study, when the participants were asked, “Do you feel you received sufficient training for diagnosing skin diseases in patients with skin of color (non-white patients)?” 67% of all PCPs and 33% of all dermatologists responded no. “Furthermore, we have found differences in how often BCDs [board-certified dermatologists] and PCPs refer patients with light and dark skin for biopsy,” the authors wrote. “Specifically, for CTCL (a life-threatening disease), we found that both BCDs and PCPs report that they would refer patients for biopsy significantly more often in light skin than dark skin. Moreover, for the common skin diseases atopic dermatitis and pityriasis rosea, we found that BCDs report they would refer patients for biopsy more often in dark skin than light skin, which creates an unnecessary overburden on patients with dark skin.”

In a press release about the study, Dr. Groh emphasized that he and other scientists who investigate human-computer interaction “have to find a way to incorporate underrepresented demographics in our research. That way we will be ready to accurately implement these models in the real world and build AI systems that serve as tools that are designed to avoid the kind of systematic errors we know humans and machines are prone to. Then you can update curricula, you can change norms in different fields and hopefully everyone gets better.”

When clinicians in a large-scale study viewed a series of digital images that showed skin diseases across skin tones and were asked to make a diagnosis, the accuracy was 38% among dermatologists and 19% among primary care physicians (PCPs). But when decision support from a deep learning system (DLS) was introduced, diagnostic accuracy increased by 33% among dermatologists and 69% among PCPs, results from a multicenter study showed.

However, the researchers found that across all images, diseases in dark skin (Fitzpatrick skin types 5 and 6) were diagnosed less accurately than diseases in light skin (Fitzpatrick skin types 1-4).

“These results contribute to an emerging literature on diagnostic accuracy disparities across patient skin tones and present evidence that the diagnostic accuracy of medical professionals on images of dark skin is lower than on images of light skin,” researchers led by Matthew Groh, PhD, of Northwestern University’s Kellogg School of Management, wrote in their study, published online in Nature Medicine.

For the study, 389 board-certified dermatologists and 450 PCPs in 39 countries were presented with 364 images to view spanning 46 skin diseases and asked to submit up to four differential diagnoses. Nearly 80% of the images were of 8 diseases: atopic dermatitis, cutaneous T-cell lymphoma (CTCL), dermatomyositis, lichen planus, Lyme disease, pityriasis rosea, pityriasis rubra pilaris, and secondary syphilis.

Dermatologists and PCPs achieved a diagnostic accuracy of 38% and 19%, respectively, but both groups of clinicians were 4 percentage points less accurate for diagnosis of images of dark skin as compared with light skin. With assistance from DLS decision support, diagnostic accuracy increased by 33% among dermatologists and 69% among primary care physicians. Among dermatologists, DLS support generally increased diagnostic accuracy evenly across skin tones. However, among PCPs, DLS support increased their diagnostic accuracy more in light skin tones than in dark ones.

In the survey component of the study, when the participants were asked, “Do you feel you received sufficient training for diagnosing skin diseases in patients with skin of color (non-white patients)?” 67% of all PCPs and 33% of all dermatologists responded no. “Furthermore, we have found differences in how often BCDs [board-certified dermatologists] and PCPs refer patients with light and dark skin for biopsy,” the authors wrote. “Specifically, for CTCL (a life-threatening disease), we found that both BCDs and PCPs report that they would refer patients for biopsy significantly more often in light skin than dark skin. Moreover, for the common skin diseases atopic dermatitis and pityriasis rosea, we found that BCDs report they would refer patients for biopsy more often in dark skin than light skin, which creates an unnecessary overburden on patients with dark skin.”

In a press release about the study, Dr. Groh emphasized that he and other scientists who investigate human-computer interaction “have to find a way to incorporate underrepresented demographics in our research. That way we will be ready to accurately implement these models in the real world and build AI systems that serve as tools that are designed to avoid the kind of systematic errors we know humans and machines are prone to. Then you can update curricula, you can change norms in different fields and hopefully everyone gets better.”

Clinical efforts to get patients with a history of gout to reach specific target serum urate (SU) levels less than either 5 or 6 mg/dL could prevent the great majority of gout flares and hospitalizations for them, according to a new study that tracked patients for a mean of 8.3 years.

The findings, which appeared February 6 in JAMA, “support the value of target serum urate levels in gout flare prevention in primary care, where most gout patients are treated,” rheumatologist and study coauthor Hyon K. Choi, MD, DrPH, of Harvard Medical School and Massachusetts General Hospital, Boston, told this news organization. However, Dr. Choi noted that “the value of relying on target urate levels is not accepted in primary care practice,” and the author of an accompanying commentary said that the jury is still out about the best strategy to prevent flares.

Gout is caused by monosodium urate crystallization within the joints, which occurs when SU levels exceed the saturation point for uric acid crystallization in the body: approximately 6.8 mg/dL. “Studies have found strongly graded associations between serum urate levels above the saturation point and the risk of developing new cases of gout among individuals without gout at baseline,” Dr. Choi said. “However, associations between serum urate levels and the risk of recurrent flares among preexisting gout patients, which is relevant to clinical gout care practice, has not been established.”

Dr. Choi added that “despite the emphasis in US and European rheumatology guidelines on the use of urate-lowering therapy to treat-to-target serum urate level — eg, under 6 or 5 mg/dL — the proportions of flares associated with such target urate levels remained unknown.”
 

Study Shows Relationship Between SU Levels and Recurrent Flares

For the study, researchers tracked 3613 patients aged 40-69 with gout in the UK Biobank database from 2006-2010 to 2017 or 2020. The patients, 86% of whom were men, had a mean age of 60 years and about 96% were White.

Among the patients, 1773 new episodes of acute gout occurred in 27% of the patients (16% had one episode, 6% had two episodes, and 5% had at least three episodes). These were treated in primary care or required hospitalizations. The other 73% of patients had no new acute gout episodes.

Overall, 95% of flares occurred in those with baseline SU levels ≥ 6 mg/dL, and 98% occurred in those with levels ≥ 5 mg/dL.

Patients with baseline SU levels < 6.0 mg/dL had an acute gout flare rate of 10.6 per 1000 person-years. In comparison, relative risks for acute gout flares per 1000 person-years were 3.16 at baseline SU levels of 6.0-6.9 mg/dL, 6.20 for 7.0-7.9 mg/dL, 7.70 for 8.0-8.9 mg/dL, 9.80 for 9.0-9.9 mg/dL, and 11.26 for > 10 mg/dL after adjustment for various possible confounders (P < .001).

The researchers identified 64 hospitalizations with gout as the main discharge diagnosis, and 97% occurred in patients with baseline SU levels ≥ 6 mg/dL. All were in patients with baseline SU levels ≥ 5 mg/dL.

“An important feature of this study was that serum urate measurements were obtained from all gout patients at the study baseline, irrespective of clinical needs or flare status,” Dr. Choi said. “Prior studies failed to reveal the truly compelling nature of relations between serum urate levels and recurrent flares among preexisting gout patients.”

As for the cost of SU tests, Dr. Choi said they can run as low as $2. “Portable tests similar to home glucose measurement for diabetes patients are also being adopted by certain gout care practices,” he said.

The findings matter, Dr. Choi said, because SU is not tracked in the “vast majority of gout patients” in primary care. Instead, primary care doctors — as per the guidelines of the American College of Physicians — often adopt an approach that treats symptoms as needed instead of tracking and lowering SU levels, he said. In fact, “95% and 98% of gout flares can be potentially preventable at the population level if serum urate levels < 6 and < 5 mg/dL can be met, respectively, and 100% of hospitalizations for gout could be preventable with serum urate < 5 mg/dL,” he said.

As for limitations, the authors noted that participants in the UK Biobank “typically have a better socioeconomic status and are healthier than the UK general population,” and they added that “these data may underestimate the number of acute gout flares in the cohort.” Also, 55% of the total 502,490 patients in the UK Biobank were excluded owing to lack of primary care data.
 

Study ‘Offers the Kind of Evidence That We Need’

In an accompanying commentary, University of Alabama at Birmingham rheumatologist Angelo L. Gaffo, MD, MSPH, also noted that the study population was overwhelmingly White, had a low mean SU level (6.9 mg/dL), and had a low level of comorbidities, making the sample “poorly representative of the most commonly described gout populations.”

However, he also noted that there is “growing evidence linking serum urate levels with clinical outcomes,” with a pair of studies — one from 2021 and the other from 2022 — linking reductions in SU to < 6 md/dL to lower flare rates.

Dr. Gaffo told this news organization that although rheumatology guidelines support a treat-to-target strategy, “we haven›t generated a whole lot of important evidence to support it.”

The new study “offers the kind of evidence that we need,” he said, “but this is not going to be the ultimate answer.” That will only come from randomized clinical trials in the works that will pit the treat-to-target approach vs the primary care–favored strategy of titrating treatment until flares are controlled, he said.

Even though evidence is sparse, Dr. Gaffo said he still believes in the treat-to-target strategy: “I believe it is the best way to treat gout.”

What’s next? Researchers hope to understand how to better reach target SU goals in clinical practice, Dr. Choi said. “Involving nurses, pharmacists, or interactive online or app systems — as in other chronic treat-to-target care such as anticoagulation care, blood pressure, or lipid care — is actively being researched.”

He added that “we are trying to find the effective and safe medications and nonpharmacologic measures to reduce the urate burden, which can also simultaneously take care of gout’s frequent cardiovascular-kidney comorbidities.”

The US National Institutes of Health supported the study. Dr. Choi reports receiving grants from Horizon and serving on a board or committee for LG Chem, Shanton, and ANI Pharmaceuticals. Some other authors report an employment and stockholder relationship with Regeneron and support from the National Institute of Arthritis and Musculoskeletal and Skin Diseases, National Institutes of Health, and Rheumatology Research Foundation. Dr. Gaffo reports personal fees from PK MED, SOBI/Selecta, Atom, and UpToDate.

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

Clinical efforts to get patients with a history of gout to reach specific target serum urate (SU) levels less than either 5 or 6 mg/dL could prevent the great majority of gout flares and hospitalizations for them, according to a new study that tracked patients for a mean of 8.3 years.

The findings, which appeared February 6 in JAMA, “support the value of target serum urate levels in gout flare prevention in primary care, where most gout patients are treated,” rheumatologist and study coauthor Hyon K. Choi, MD, DrPH, of Harvard Medical School and Massachusetts General Hospital, Boston, told this news organization. However, Dr. Choi noted that “the value of relying on target urate levels is not accepted in primary care practice,” and the author of an accompanying commentary said that the jury is still out about the best strategy to prevent flares.

Gout is caused by monosodium urate crystallization within the joints, which occurs when SU levels exceed the saturation point for uric acid crystallization in the body: approximately 6.8 mg/dL. “Studies have found strongly graded associations between serum urate levels above the saturation point and the risk of developing new cases of gout among individuals without gout at baseline,” Dr. Choi said. “However, associations between serum urate levels and the risk of recurrent flares among preexisting gout patients, which is relevant to clinical gout care practice, has not been established.”

Dr. Choi added that “despite the emphasis in US and European rheumatology guidelines on the use of urate-lowering therapy to treat-to-target serum urate level — eg, under 6 or 5 mg/dL — the proportions of flares associated with such target urate levels remained unknown.”
 

Study Shows Relationship Between SU Levels and Recurrent Flares

For the study, researchers tracked 3613 patients aged 40-69 with gout in the UK Biobank database from 2006-2010 to 2017 or 2020. The patients, 86% of whom were men, had a mean age of 60 years and about 96% were White.

Among the patients, 1773 new episodes of acute gout occurred in 27% of the patients (16% had one episode, 6% had two episodes, and 5% had at least three episodes). These were treated in primary care or required hospitalizations. The other 73% of patients had no new acute gout episodes.

Overall, 95% of flares occurred in those with baseline SU levels ≥ 6 mg/dL, and 98% occurred in those with levels ≥ 5 mg/dL.

Patients with baseline SU levels < 6.0 mg/dL had an acute gout flare rate of 10.6 per 1000 person-years. In comparison, relative risks for acute gout flares per 1000 person-years were 3.16 at baseline SU levels of 6.0-6.9 mg/dL, 6.20 for 7.0-7.9 mg/dL, 7.70 for 8.0-8.9 mg/dL, 9.80 for 9.0-9.9 mg/dL, and 11.26 for > 10 mg/dL after adjustment for various possible confounders (P < .001).

The researchers identified 64 hospitalizations with gout as the main discharge diagnosis, and 97% occurred in patients with baseline SU levels ≥ 6 mg/dL. All were in patients with baseline SU levels ≥ 5 mg/dL.

“An important feature of this study was that serum urate measurements were obtained from all gout patients at the study baseline, irrespective of clinical needs or flare status,” Dr. Choi said. “Prior studies failed to reveal the truly compelling nature of relations between serum urate levels and recurrent flares among preexisting gout patients.”

As for the cost of SU tests, Dr. Choi said they can run as low as $2. “Portable tests similar to home glucose measurement for diabetes patients are also being adopted by certain gout care practices,” he said.

The findings matter, Dr. Choi said, because SU is not tracked in the “vast majority of gout patients” in primary care. Instead, primary care doctors — as per the guidelines of the American College of Physicians — often adopt an approach that treats symptoms as needed instead of tracking and lowering SU levels, he said. In fact, “95% and 98% of gout flares can be potentially preventable at the population level if serum urate levels < 6 and < 5 mg/dL can be met, respectively, and 100% of hospitalizations for gout could be preventable with serum urate < 5 mg/dL,” he said.

As for limitations, the authors noted that participants in the UK Biobank “typically have a better socioeconomic status and are healthier than the UK general population,” and they added that “these data may underestimate the number of acute gout flares in the cohort.” Also, 55% of the total 502,490 patients in the UK Biobank were excluded owing to lack of primary care data.
 

Study ‘Offers the Kind of Evidence That We Need’

In an accompanying commentary, University of Alabama at Birmingham rheumatologist Angelo L. Gaffo, MD, MSPH, also noted that the study population was overwhelmingly White, had a low mean SU level (6.9 mg/dL), and had a low level of comorbidities, making the sample “poorly representative of the most commonly described gout populations.”

However, he also noted that there is “growing evidence linking serum urate levels with clinical outcomes,” with a pair of studies — one from 2021 and the other from 2022 — linking reductions in SU to < 6 md/dL to lower flare rates.

Dr. Gaffo told this news organization that although rheumatology guidelines support a treat-to-target strategy, “we haven›t generated a whole lot of important evidence to support it.”

The new study “offers the kind of evidence that we need,” he said, “but this is not going to be the ultimate answer.” That will only come from randomized clinical trials in the works that will pit the treat-to-target approach vs the primary care–favored strategy of titrating treatment until flares are controlled, he said.

Even though evidence is sparse, Dr. Gaffo said he still believes in the treat-to-target strategy: “I believe it is the best way to treat gout.”

What’s next? Researchers hope to understand how to better reach target SU goals in clinical practice, Dr. Choi said. “Involving nurses, pharmacists, or interactive online or app systems — as in other chronic treat-to-target care such as anticoagulation care, blood pressure, or lipid care — is actively being researched.”

He added that “we are trying to find the effective and safe medications and nonpharmacologic measures to reduce the urate burden, which can also simultaneously take care of gout’s frequent cardiovascular-kidney comorbidities.”

The US National Institutes of Health supported the study. Dr. Choi reports receiving grants from Horizon and serving on a board or committee for LG Chem, Shanton, and ANI Pharmaceuticals. Some other authors report an employment and stockholder relationship with Regeneron and support from the National Institute of Arthritis and Musculoskeletal and Skin Diseases, National Institutes of Health, and Rheumatology Research Foundation. Dr. Gaffo reports personal fees from PK MED, SOBI/Selecta, Atom, and UpToDate.

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

Clinical efforts to get patients with a history of gout to reach specific target serum urate (SU) levels less than either 5 or 6 mg/dL could prevent the great majority of gout flares and hospitalizations for them, according to a new study that tracked patients for a mean of 8.3 years.

The findings, which appeared February 6 in JAMA, “support the value of target serum urate levels in gout flare prevention in primary care, where most gout patients are treated,” rheumatologist and study coauthor Hyon K. Choi, MD, DrPH, of Harvard Medical School and Massachusetts General Hospital, Boston, told this news organization. However, Dr. Choi noted that “the value of relying on target urate levels is not accepted in primary care practice,” and the author of an accompanying commentary said that the jury is still out about the best strategy to prevent flares.

Gout is caused by monosodium urate crystallization within the joints, which occurs when SU levels exceed the saturation point for uric acid crystallization in the body: approximately 6.8 mg/dL. “Studies have found strongly graded associations between serum urate levels above the saturation point and the risk of developing new cases of gout among individuals without gout at baseline,” Dr. Choi said. “However, associations between serum urate levels and the risk of recurrent flares among preexisting gout patients, which is relevant to clinical gout care practice, has not been established.”

Dr. Choi added that “despite the emphasis in US and European rheumatology guidelines on the use of urate-lowering therapy to treat-to-target serum urate level — eg, under 6 or 5 mg/dL — the proportions of flares associated with such target urate levels remained unknown.”
 

Study Shows Relationship Between SU Levels and Recurrent Flares

For the study, researchers tracked 3613 patients aged 40-69 with gout in the UK Biobank database from 2006-2010 to 2017 or 2020. The patients, 86% of whom were men, had a mean age of 60 years and about 96% were White.

Among the patients, 1773 new episodes of acute gout occurred in 27% of the patients (16% had one episode, 6% had two episodes, and 5% had at least three episodes). These were treated in primary care or required hospitalizations. The other 73% of patients had no new acute gout episodes.

Overall, 95% of flares occurred in those with baseline SU levels ≥ 6 mg/dL, and 98% occurred in those with levels ≥ 5 mg/dL.

Patients with baseline SU levels < 6.0 mg/dL had an acute gout flare rate of 10.6 per 1000 person-years. In comparison, relative risks for acute gout flares per 1000 person-years were 3.16 at baseline SU levels of 6.0-6.9 mg/dL, 6.20 for 7.0-7.9 mg/dL, 7.70 for 8.0-8.9 mg/dL, 9.80 for 9.0-9.9 mg/dL, and 11.26 for > 10 mg/dL after adjustment for various possible confounders (P < .001).

The researchers identified 64 hospitalizations with gout as the main discharge diagnosis, and 97% occurred in patients with baseline SU levels ≥ 6 mg/dL. All were in patients with baseline SU levels ≥ 5 mg/dL.

“An important feature of this study was that serum urate measurements were obtained from all gout patients at the study baseline, irrespective of clinical needs or flare status,” Dr. Choi said. “Prior studies failed to reveal the truly compelling nature of relations between serum urate levels and recurrent flares among preexisting gout patients.”

As for the cost of SU tests, Dr. Choi said they can run as low as $2. “Portable tests similar to home glucose measurement for diabetes patients are also being adopted by certain gout care practices,” he said.

The findings matter, Dr. Choi said, because SU is not tracked in the “vast majority of gout patients” in primary care. Instead, primary care doctors — as per the guidelines of the American College of Physicians — often adopt an approach that treats symptoms as needed instead of tracking and lowering SU levels, he said. In fact, “95% and 98% of gout flares can be potentially preventable at the population level if serum urate levels < 6 and < 5 mg/dL can be met, respectively, and 100% of hospitalizations for gout could be preventable with serum urate < 5 mg/dL,” he said.

As for limitations, the authors noted that participants in the UK Biobank “typically have a better socioeconomic status and are healthier than the UK general population,” and they added that “these data may underestimate the number of acute gout flares in the cohort.” Also, 55% of the total 502,490 patients in the UK Biobank were excluded owing to lack of primary care data.
 

Study ‘Offers the Kind of Evidence That We Need’

In an accompanying commentary, University of Alabama at Birmingham rheumatologist Angelo L. Gaffo, MD, MSPH, also noted that the study population was overwhelmingly White, had a low mean SU level (6.9 mg/dL), and had a low level of comorbidities, making the sample “poorly representative of the most commonly described gout populations.”

However, he also noted that there is “growing evidence linking serum urate levels with clinical outcomes,” with a pair of studies — one from 2021 and the other from 2022 — linking reductions in SU to < 6 md/dL to lower flare rates.

Dr. Gaffo told this news organization that although rheumatology guidelines support a treat-to-target strategy, “we haven›t generated a whole lot of important evidence to support it.”

The new study “offers the kind of evidence that we need,” he said, “but this is not going to be the ultimate answer.” That will only come from randomized clinical trials in the works that will pit the treat-to-target approach vs the primary care–favored strategy of titrating treatment until flares are controlled, he said.

Even though evidence is sparse, Dr. Gaffo said he still believes in the treat-to-target strategy: “I believe it is the best way to treat gout.”

What’s next? Researchers hope to understand how to better reach target SU goals in clinical practice, Dr. Choi said. “Involving nurses, pharmacists, or interactive online or app systems — as in other chronic treat-to-target care such as anticoagulation care, blood pressure, or lipid care — is actively being researched.”

He added that “we are trying to find the effective and safe medications and nonpharmacologic measures to reduce the urate burden, which can also simultaneously take care of gout’s frequent cardiovascular-kidney comorbidities.”

The US National Institutes of Health supported the study. Dr. Choi reports receiving grants from Horizon and serving on a board or committee for LG Chem, Shanton, and ANI Pharmaceuticals. Some other authors report an employment and stockholder relationship with Regeneron and support from the National Institute of Arthritis and Musculoskeletal and Skin Diseases, National Institutes of Health, and Rheumatology Research Foundation. Dr. Gaffo reports personal fees from PK MED, SOBI/Selecta, Atom, and UpToDate.

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

Comorbidities may play a large role in driving poor pregnancy outcomes in pregnant people with certain immune-mediated inflammatory diseases (IMIDs).

In a new study of 12 individual IMIDs, people with rheumatoid arthritis (RA) or inflammatory bowel disease (IBD) did not have signficantly increased risk for preterm birth (PTB) or low birth weight (LBW), compared with people who did not have an IMID, after adjusting for additional chronic conditions and other confounding factors.

The study was published online on February 1 in eClinicalMedicine.

While many studies have explored the relationships between pregnancy outcomes and IMIDs, “the impact of comorbidities on the relation between IMIDs and pregnancy course is insufficiently examined,” the authors wrote. These previous studies also tended to have a small sample size.
 

Pregnancy Outcome Risks Varied Between IMIDs

To remedy this, researchers used electronic health record data from Providence St Joseph Health — a multistate integrated healthcare system — to identify more than 365,000 pregnant people with live births between January 1, 2013, and December 31, 2022. The cohort included more than 5700 people with at least one of 12 IMIDs: Psoriasis, IBD, RA, spondyloarthritis (SpA), multiple sclerosis, systemic lupus erythematosus (SLE), psoriatic arthritis (PsA), antiphospholipid syndrome (APS), Sjögren syndrome (SjS), vasculitis, sarcoidosis, and systemic sclerosis. The study included only live births with a gestational age of 20 weeks or greater.

Researchers compared maternal-fetal health outcomes between the two groups, controlling for comorbidities including diabetes, cardiovascular disease, chronic kidney disease, obesity, and depression. They also accounted for confounding variables including race, age, smoking status, and socioeconomic status.

In total, 83% of people in the IMID group had no immunomodulatory medication prescriptions during their pregnancy. Of the 17% taking medication, 48%-70% continued taking their medication until delivery. Most patients were White, comprising 62.9% of the non-IMID group and 73.1% of the IMID group.

After adjusting for comorbidities, patients with any of the 12 IMIDs had a 10%-20% higher risk for PTB, LBW, small for gestation age (SGA), and cesarean section than did comparators.

But these risks varied between IMIDs. Patients with RA and IBD did not have an increased risk for PTB or LBW. However, when researchers did not control for comorbidities, pregnancy risks were higher and showed statistical significance in these two groups.

“This suggests that for RA and IBD, comorbidities may be a more important factor for adverse outcomes than the underlying autoimmune disease,” senior author Jennifer Hadlock, MD, an associate professor and director of medical data science at the Institute for Systems Biology in Seattle, Washington, said in a video accompanying a press release.

Overall, the analysis found that women with IMIDs were approximately two to three times more likely to have chronic comorbidities than the control group.

Like previous studies, there was a strong association between SLE and APS and poor pregnancy outcomes, even after controlling for confounding factors. Patients with SpA had a 50% increased risk for PTB, while those with SLE and APS had more than a twofold higher risk. Patients with SLE were 90% more likely than comparators to deliver babies with an SGA condition, while RA patients had a 30% higher risk. SLE was the only condition with an increased risk for LBW (relative risk, 3.5). IBD, RA, PsA, SpA, SLE, APS, and SjS were all associated with a higher likelihood of delivery via cesarean section.

“The findings of this study reveal that the associations between IMIDs and adverse pregnancy outcomes are influenced by the specific type of IMIDs and the presence of comorbidities,” the authors wrote.
 

A Large Study, But How Representative Is It?

Asked to comment on the study, Catherine Sims, MD, a rheumatologist at Duke University Medical Center in Durham, North Carolina, noted that the analysis was much larger than many reproductive rheumatology studies, and “their statistics were phenomenal.”

She agreed that “not all autoimmune diseases are created equal when it comes to pregnancy-associated risks.” However, she added that this study’s patient population may not be totally representative of pregnant people with IMIDs or autoimmune diseases.

“We’re making generalizations about autoimmune diseases based on this demographic of White women who are not taking immunosuppression,” she said.

“We know that race and ethnicity play a huge role in pregnancy outcomes, and Black women have higher maternal and fetal morbidity and mortality, which is likely related to systemic racism and biases in the medical system,” she added. “While the study did control for sociodemographic factors, the population studied is not diverse.”

Only 17% of people with IMID in the cohort were on immunosuppressive medication, which could suggest low disease activity in the study population, Dr. Sims said. If the population generally had well-controlled disease, that could have positioned them for better pregnancy outcomes.

The authors noted that their analysis did not have information on IMID disease activity or severity — one of the limitations of the study.

However, the authors argued that the observed low prescription rate during the study may have increased poor pregnancy outcomes.

“Although this reflects real-world care in the population studied, results from this study may show higher risk than might be achieved with recommended care guidelines,” they wrote.

Ultimately, the authors argued that these findings show how co-occurring health conditions can affect pregnancy outcomes in autoimmune diseases, particularly for RA and IBD.

“There is a need to take comorbidities into consideration for guidelines for patients with inflammatory bowel disease and rheumatoid arthritis and when designing future research to investigate maternal health in patients with IMIDs,” they wrote.

The study was funded by the National Institutes of Health. Dr. Sims declared no relevant financial relationships. Dr. Hadlock has received research funding (paid to the institute) from Pfizer, Novartis, Janssen, Bristol-Myers Squibb, and Gilead.

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

Comorbidities may play a large role in driving poor pregnancy outcomes in pregnant people with certain immune-mediated inflammatory diseases (IMIDs).

In a new study of 12 individual IMIDs, people with rheumatoid arthritis (RA) or inflammatory bowel disease (IBD) did not have signficantly increased risk for preterm birth (PTB) or low birth weight (LBW), compared with people who did not have an IMID, after adjusting for additional chronic conditions and other confounding factors.

The study was published online on February 1 in eClinicalMedicine.

While many studies have explored the relationships between pregnancy outcomes and IMIDs, “the impact of comorbidities on the relation between IMIDs and pregnancy course is insufficiently examined,” the authors wrote. These previous studies also tended to have a small sample size.
 

Pregnancy Outcome Risks Varied Between IMIDs

To remedy this, researchers used electronic health record data from Providence St Joseph Health — a multistate integrated healthcare system — to identify more than 365,000 pregnant people with live births between January 1, 2013, and December 31, 2022. The cohort included more than 5700 people with at least one of 12 IMIDs: Psoriasis, IBD, RA, spondyloarthritis (SpA), multiple sclerosis, systemic lupus erythematosus (SLE), psoriatic arthritis (PsA), antiphospholipid syndrome (APS), Sjögren syndrome (SjS), vasculitis, sarcoidosis, and systemic sclerosis. The study included only live births with a gestational age of 20 weeks or greater.

Researchers compared maternal-fetal health outcomes between the two groups, controlling for comorbidities including diabetes, cardiovascular disease, chronic kidney disease, obesity, and depression. They also accounted for confounding variables including race, age, smoking status, and socioeconomic status.

In total, 83% of people in the IMID group had no immunomodulatory medication prescriptions during their pregnancy. Of the 17% taking medication, 48%-70% continued taking their medication until delivery. Most patients were White, comprising 62.9% of the non-IMID group and 73.1% of the IMID group.

After adjusting for comorbidities, patients with any of the 12 IMIDs had a 10%-20% higher risk for PTB, LBW, small for gestation age (SGA), and cesarean section than did comparators.

But these risks varied between IMIDs. Patients with RA and IBD did not have an increased risk for PTB or LBW. However, when researchers did not control for comorbidities, pregnancy risks were higher and showed statistical significance in these two groups.

“This suggests that for RA and IBD, comorbidities may be a more important factor for adverse outcomes than the underlying autoimmune disease,” senior author Jennifer Hadlock, MD, an associate professor and director of medical data science at the Institute for Systems Biology in Seattle, Washington, said in a video accompanying a press release.

Overall, the analysis found that women with IMIDs were approximately two to three times more likely to have chronic comorbidities than the control group.

Like previous studies, there was a strong association between SLE and APS and poor pregnancy outcomes, even after controlling for confounding factors. Patients with SpA had a 50% increased risk for PTB, while those with SLE and APS had more than a twofold higher risk. Patients with SLE were 90% more likely than comparators to deliver babies with an SGA condition, while RA patients had a 30% higher risk. SLE was the only condition with an increased risk for LBW (relative risk, 3.5). IBD, RA, PsA, SpA, SLE, APS, and SjS were all associated with a higher likelihood of delivery via cesarean section.

“The findings of this study reveal that the associations between IMIDs and adverse pregnancy outcomes are influenced by the specific type of IMIDs and the presence of comorbidities,” the authors wrote.
 

A Large Study, But How Representative Is It?

Asked to comment on the study, Catherine Sims, MD, a rheumatologist at Duke University Medical Center in Durham, North Carolina, noted that the analysis was much larger than many reproductive rheumatology studies, and “their statistics were phenomenal.”

She agreed that “not all autoimmune diseases are created equal when it comes to pregnancy-associated risks.” However, she added that this study’s patient population may not be totally representative of pregnant people with IMIDs or autoimmune diseases.

“We’re making generalizations about autoimmune diseases based on this demographic of White women who are not taking immunosuppression,” she said.

“We know that race and ethnicity play a huge role in pregnancy outcomes, and Black women have higher maternal and fetal morbidity and mortality, which is likely related to systemic racism and biases in the medical system,” she added. “While the study did control for sociodemographic factors, the population studied is not diverse.”

Only 17% of people with IMID in the cohort were on immunosuppressive medication, which could suggest low disease activity in the study population, Dr. Sims said. If the population generally had well-controlled disease, that could have positioned them for better pregnancy outcomes.

The authors noted that their analysis did not have information on IMID disease activity or severity — one of the limitations of the study.

However, the authors argued that the observed low prescription rate during the study may have increased poor pregnancy outcomes.

“Although this reflects real-world care in the population studied, results from this study may show higher risk than might be achieved with recommended care guidelines,” they wrote.

Ultimately, the authors argued that these findings show how co-occurring health conditions can affect pregnancy outcomes in autoimmune diseases, particularly for RA and IBD.

“There is a need to take comorbidities into consideration for guidelines for patients with inflammatory bowel disease and rheumatoid arthritis and when designing future research to investigate maternal health in patients with IMIDs,” they wrote.

The study was funded by the National Institutes of Health. Dr. Sims declared no relevant financial relationships. Dr. Hadlock has received research funding (paid to the institute) from Pfizer, Novartis, Janssen, Bristol-Myers Squibb, and Gilead.

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

Comorbidities may play a large role in driving poor pregnancy outcomes in pregnant people with certain immune-mediated inflammatory diseases (IMIDs).

In a new study of 12 individual IMIDs, people with rheumatoid arthritis (RA) or inflammatory bowel disease (IBD) did not have signficantly increased risk for preterm birth (PTB) or low birth weight (LBW), compared with people who did not have an IMID, after adjusting for additional chronic conditions and other confounding factors.

The study was published online on February 1 in eClinicalMedicine.

While many studies have explored the relationships between pregnancy outcomes and IMIDs, “the impact of comorbidities on the relation between IMIDs and pregnancy course is insufficiently examined,” the authors wrote. These previous studies also tended to have a small sample size.
 

Pregnancy Outcome Risks Varied Between IMIDs

To remedy this, researchers used electronic health record data from Providence St Joseph Health — a multistate integrated healthcare system — to identify more than 365,000 pregnant people with live births between January 1, 2013, and December 31, 2022. The cohort included more than 5700 people with at least one of 12 IMIDs: Psoriasis, IBD, RA, spondyloarthritis (SpA), multiple sclerosis, systemic lupus erythematosus (SLE), psoriatic arthritis (PsA), antiphospholipid syndrome (APS), Sjögren syndrome (SjS), vasculitis, sarcoidosis, and systemic sclerosis. The study included only live births with a gestational age of 20 weeks or greater.

Researchers compared maternal-fetal health outcomes between the two groups, controlling for comorbidities including diabetes, cardiovascular disease, chronic kidney disease, obesity, and depression. They also accounted for confounding variables including race, age, smoking status, and socioeconomic status.

In total, 83% of people in the IMID group had no immunomodulatory medication prescriptions during their pregnancy. Of the 17% taking medication, 48%-70% continued taking their medication until delivery. Most patients were White, comprising 62.9% of the non-IMID group and 73.1% of the IMID group.

After adjusting for comorbidities, patients with any of the 12 IMIDs had a 10%-20% higher risk for PTB, LBW, small for gestation age (SGA), and cesarean section than did comparators.

But these risks varied between IMIDs. Patients with RA and IBD did not have an increased risk for PTB or LBW. However, when researchers did not control for comorbidities, pregnancy risks were higher and showed statistical significance in these two groups.

“This suggests that for RA and IBD, comorbidities may be a more important factor for adverse outcomes than the underlying autoimmune disease,” senior author Jennifer Hadlock, MD, an associate professor and director of medical data science at the Institute for Systems Biology in Seattle, Washington, said in a video accompanying a press release.

Overall, the analysis found that women with IMIDs were approximately two to three times more likely to have chronic comorbidities than the control group.

Like previous studies, there was a strong association between SLE and APS and poor pregnancy outcomes, even after controlling for confounding factors. Patients with SpA had a 50% increased risk for PTB, while those with SLE and APS had more than a twofold higher risk. Patients with SLE were 90% more likely than comparators to deliver babies with an SGA condition, while RA patients had a 30% higher risk. SLE was the only condition with an increased risk for LBW (relative risk, 3.5). IBD, RA, PsA, SpA, SLE, APS, and SjS were all associated with a higher likelihood of delivery via cesarean section.

“The findings of this study reveal that the associations between IMIDs and adverse pregnancy outcomes are influenced by the specific type of IMIDs and the presence of comorbidities,” the authors wrote.
 

A Large Study, But How Representative Is It?

Asked to comment on the study, Catherine Sims, MD, a rheumatologist at Duke University Medical Center in Durham, North Carolina, noted that the analysis was much larger than many reproductive rheumatology studies, and “their statistics were phenomenal.”

She agreed that “not all autoimmune diseases are created equal when it comes to pregnancy-associated risks.” However, she added that this study’s patient population may not be totally representative of pregnant people with IMIDs or autoimmune diseases.

“We’re making generalizations about autoimmune diseases based on this demographic of White women who are not taking immunosuppression,” she said.

“We know that race and ethnicity play a huge role in pregnancy outcomes, and Black women have higher maternal and fetal morbidity and mortality, which is likely related to systemic racism and biases in the medical system,” she added. “While the study did control for sociodemographic factors, the population studied is not diverse.”

Only 17% of people with IMID in the cohort were on immunosuppressive medication, which could suggest low disease activity in the study population, Dr. Sims said. If the population generally had well-controlled disease, that could have positioned them for better pregnancy outcomes.

The authors noted that their analysis did not have information on IMID disease activity or severity — one of the limitations of the study.

However, the authors argued that the observed low prescription rate during the study may have increased poor pregnancy outcomes.

“Although this reflects real-world care in the population studied, results from this study may show higher risk than might be achieved with recommended care guidelines,” they wrote.

Ultimately, the authors argued that these findings show how co-occurring health conditions can affect pregnancy outcomes in autoimmune diseases, particularly for RA and IBD.

“There is a need to take comorbidities into consideration for guidelines for patients with inflammatory bowel disease and rheumatoid arthritis and when designing future research to investigate maternal health in patients with IMIDs,” they wrote.

The study was funded by the National Institutes of Health. Dr. Sims declared no relevant financial relationships. Dr. Hadlock has received research funding (paid to the institute) from Pfizer, Novartis, Janssen, Bristol-Myers Squibb, and Gilead.

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

For years, people living and working at Camp Lejeune in Jacksonville, N.C., drank and showered in water contaminated with trichloroethylene (TCE) and other industrial solvents. Now, a Centers for Disease Control and Prevention (CDC) study has determined that the exposure markedly increased their risk for certain cancers.

In one of the largest cohort cancer incidence studies ever completed in the US, researchers compared cancer risk between 161,315 military personnel and civilian workers at Camp Lejeune and 169,281 military personnel and civilian workers at Camp Pendleton in Oceanside, Calif., where the water was not contaminated.

Data from diagnoses between 1996 and 2017 documented 12,083 cancers among Camp Lejeune Marine and Navy personnel and 1,563 among civilian workers. By comparison, 12,144 cancers were documented among Camp Pendleton personnel and 1,372 among civilian workers. However, personnel stationed at Camp Lejeune between 1975 and 1985 had at least a 20% higher risk for all myeloid cancers including polycythemia vera, acute myeloid leukemia, myelodysplastic and myeloproliferative syndromes, and cancers of the esophagus, larynx, soft tissue, and thyroid. Civilian workers had a higher risk for all myeloid cancers, squamous cell lung cancer, and female ductal breast cancer.

The water exposures included contributions to total internal body dose from 3 routes: ingestion, inhalation, and dermal. The researchers note that a Marine in training may consume as much as 6 liters a day of drinking water, but the combined dose from inhalation and dermal routes could be as high or higher than that from ingestion. For example, they note that an internal dose via inhalation to TCE during a 10-minute shower could equal the internal dose via ingestion of 2 liters of contaminated drinking water.

Health risks at Camp Lejeune have been studied before, but this study “more fully establishes the scope,” Richard Clapp, a Boston University emeritus public health professor, told the Associated Press.

For years, people living and working at Camp Lejeune in Jacksonville, N.C., drank and showered in water contaminated with trichloroethylene (TCE) and other industrial solvents. Now, a Centers for Disease Control and Prevention (CDC) study has determined that the exposure markedly increased their risk for certain cancers.

In one of the largest cohort cancer incidence studies ever completed in the US, researchers compared cancer risk between 161,315 military personnel and civilian workers at Camp Lejeune and 169,281 military personnel and civilian workers at Camp Pendleton in Oceanside, Calif., where the water was not contaminated.

Data from diagnoses between 1996 and 2017 documented 12,083 cancers among Camp Lejeune Marine and Navy personnel and 1,563 among civilian workers. By comparison, 12,144 cancers were documented among Camp Pendleton personnel and 1,372 among civilian workers. However, personnel stationed at Camp Lejeune between 1975 and 1985 had at least a 20% higher risk for all myeloid cancers including polycythemia vera, acute myeloid leukemia, myelodysplastic and myeloproliferative syndromes, and cancers of the esophagus, larynx, soft tissue, and thyroid. Civilian workers had a higher risk for all myeloid cancers, squamous cell lung cancer, and female ductal breast cancer.

The water exposures included contributions to total internal body dose from 3 routes: ingestion, inhalation, and dermal. The researchers note that a Marine in training may consume as much as 6 liters a day of drinking water, but the combined dose from inhalation and dermal routes could be as high or higher than that from ingestion. For example, they note that an internal dose via inhalation to TCE during a 10-minute shower could equal the internal dose via ingestion of 2 liters of contaminated drinking water.

Health risks at Camp Lejeune have been studied before, but this study “more fully establishes the scope,” Richard Clapp, a Boston University emeritus public health professor, told the Associated Press.

For years, people living and working at Camp Lejeune in Jacksonville, N.C., drank and showered in water contaminated with trichloroethylene (TCE) and other industrial solvents. Now, a Centers for Disease Control and Prevention (CDC) study has determined that the exposure markedly increased their risk for certain cancers.

In one of the largest cohort cancer incidence studies ever completed in the US, researchers compared cancer risk between 161,315 military personnel and civilian workers at Camp Lejeune and 169,281 military personnel and civilian workers at Camp Pendleton in Oceanside, Calif., where the water was not contaminated.

Data from diagnoses between 1996 and 2017 documented 12,083 cancers among Camp Lejeune Marine and Navy personnel and 1,563 among civilian workers. By comparison, 12,144 cancers were documented among Camp Pendleton personnel and 1,372 among civilian workers. However, personnel stationed at Camp Lejeune between 1975 and 1985 had at least a 20% higher risk for all myeloid cancers including polycythemia vera, acute myeloid leukemia, myelodysplastic and myeloproliferative syndromes, and cancers of the esophagus, larynx, soft tissue, and thyroid. Civilian workers had a higher risk for all myeloid cancers, squamous cell lung cancer, and female ductal breast cancer.

The water exposures included contributions to total internal body dose from 3 routes: ingestion, inhalation, and dermal. The researchers note that a Marine in training may consume as much as 6 liters a day of drinking water, but the combined dose from inhalation and dermal routes could be as high or higher than that from ingestion. For example, they note that an internal dose via inhalation to TCE during a 10-minute shower could equal the internal dose via ingestion of 2 liters of contaminated drinking water.

Health risks at Camp Lejeune have been studied before, but this study “more fully establishes the scope,” Richard Clapp, a Boston University emeritus public health professor, told the Associated Press.