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Study examines burden of vitiligo in the U.S.

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Asian American, Hispanic/Latino, and older individuals appear to have the greatest burden of vitiligo in the United States, according to the results of a cross sectional study.

To investigate the incidence and prevalence of diagnosed vitiligo in the United States, researchers used a 15% random sample of electronic medical records from the IBM Explorys database. Two cohorts were included: 2,980,778 patients diagnosed with vitiligo between Jan. 1, 2015, and Dec. 31, 2019 (incidence analysis), and 1,057,534 patients diagnosed with vitiligo between Jan. 1 and Dec. 31, 2019 (prevalence analysis).The main outcomes were incidence (per 100,000 person-years) and prevalence of diagnosed vitiligo overall and by age, race/ethnicity, and sex. Amit Garg, MD, a dermatologist with Northwell Health, New Hyde Park, N.Y., led the study, which was published in JAMA Dermatology.

The age- and sex-adjusted overall incidence rate of diagnosed vitiligo was 22.6 per 100,000 person-years, and the prevalence was 0.16%, the authors reported. The sex-adjusted IR was highest among patients aged 60-69 years (25.3 per 100,000 person-years); prevalence was highest among patients aged 70 years or older (0.21%).

The highest age-adjusted IR was among Asian American patients (41.2 per 100,000 person-years), followed by Hispanic/Latino patients (37.3 per 100,000 PY), those reporting other or multiple races (31.1 per 100,000), Black patients (29.6 per 100,000 person-years), and White patients (18.7 per 100,000 person-years). The highest age-adjusted prevalence was among Hispanic/Latino patients (0.29%), followed by Asian American patients (0.27%), those reporting other or multiple races (0.24%), Black patients (0.22%), and White patients (0.13%).

The burden of vitiligo in the United States is poorly understood, and the findings “may support improving awareness of vitiligo disease burden in medical and public sectors, informing research agendas, improving enrollment of racial and ethnic minority populations in trials, and developing health policies,” the authors wrote.

Limitations of the study included that the analysis only captured patients who sought care in health systems included in the database, and there was the potential for underreporting, “since not all patients with vitiligo seek care,” the authors noted.

Dr. Garg reported being an adviser for and receiving honoraria from many pharmaceutical companies. He has also received research grants from AbbVie, UCB, the National Psoriasis Foundation, and the CHORD COUSIN Collaboration. No other disclosures were reported.

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

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Asian American, Hispanic/Latino, and older individuals appear to have the greatest burden of vitiligo in the United States, according to the results of a cross sectional study.

To investigate the incidence and prevalence of diagnosed vitiligo in the United States, researchers used a 15% random sample of electronic medical records from the IBM Explorys database. Two cohorts were included: 2,980,778 patients diagnosed with vitiligo between Jan. 1, 2015, and Dec. 31, 2019 (incidence analysis), and 1,057,534 patients diagnosed with vitiligo between Jan. 1 and Dec. 31, 2019 (prevalence analysis).The main outcomes were incidence (per 100,000 person-years) and prevalence of diagnosed vitiligo overall and by age, race/ethnicity, and sex. Amit Garg, MD, a dermatologist with Northwell Health, New Hyde Park, N.Y., led the study, which was published in JAMA Dermatology.

The age- and sex-adjusted overall incidence rate of diagnosed vitiligo was 22.6 per 100,000 person-years, and the prevalence was 0.16%, the authors reported. The sex-adjusted IR was highest among patients aged 60-69 years (25.3 per 100,000 person-years); prevalence was highest among patients aged 70 years or older (0.21%).

The highest age-adjusted IR was among Asian American patients (41.2 per 100,000 person-years), followed by Hispanic/Latino patients (37.3 per 100,000 PY), those reporting other or multiple races (31.1 per 100,000), Black patients (29.6 per 100,000 person-years), and White patients (18.7 per 100,000 person-years). The highest age-adjusted prevalence was among Hispanic/Latino patients (0.29%), followed by Asian American patients (0.27%), those reporting other or multiple races (0.24%), Black patients (0.22%), and White patients (0.13%).

The burden of vitiligo in the United States is poorly understood, and the findings “may support improving awareness of vitiligo disease burden in medical and public sectors, informing research agendas, improving enrollment of racial and ethnic minority populations in trials, and developing health policies,” the authors wrote.

Limitations of the study included that the analysis only captured patients who sought care in health systems included in the database, and there was the potential for underreporting, “since not all patients with vitiligo seek care,” the authors noted.

Dr. Garg reported being an adviser for and receiving honoraria from many pharmaceutical companies. He has also received research grants from AbbVie, UCB, the National Psoriasis Foundation, and the CHORD COUSIN Collaboration. No other disclosures were reported.

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

Asian American, Hispanic/Latino, and older individuals appear to have the greatest burden of vitiligo in the United States, according to the results of a cross sectional study.

To investigate the incidence and prevalence of diagnosed vitiligo in the United States, researchers used a 15% random sample of electronic medical records from the IBM Explorys database. Two cohorts were included: 2,980,778 patients diagnosed with vitiligo between Jan. 1, 2015, and Dec. 31, 2019 (incidence analysis), and 1,057,534 patients diagnosed with vitiligo between Jan. 1 and Dec. 31, 2019 (prevalence analysis).The main outcomes were incidence (per 100,000 person-years) and prevalence of diagnosed vitiligo overall and by age, race/ethnicity, and sex. Amit Garg, MD, a dermatologist with Northwell Health, New Hyde Park, N.Y., led the study, which was published in JAMA Dermatology.

The age- and sex-adjusted overall incidence rate of diagnosed vitiligo was 22.6 per 100,000 person-years, and the prevalence was 0.16%, the authors reported. The sex-adjusted IR was highest among patients aged 60-69 years (25.3 per 100,000 person-years); prevalence was highest among patients aged 70 years or older (0.21%).

The highest age-adjusted IR was among Asian American patients (41.2 per 100,000 person-years), followed by Hispanic/Latino patients (37.3 per 100,000 PY), those reporting other or multiple races (31.1 per 100,000), Black patients (29.6 per 100,000 person-years), and White patients (18.7 per 100,000 person-years). The highest age-adjusted prevalence was among Hispanic/Latino patients (0.29%), followed by Asian American patients (0.27%), those reporting other or multiple races (0.24%), Black patients (0.22%), and White patients (0.13%).

The burden of vitiligo in the United States is poorly understood, and the findings “may support improving awareness of vitiligo disease burden in medical and public sectors, informing research agendas, improving enrollment of racial and ethnic minority populations in trials, and developing health policies,” the authors wrote.

Limitations of the study included that the analysis only captured patients who sought care in health systems included in the database, and there was the potential for underreporting, “since not all patients with vitiligo seek care,” the authors noted.

Dr. Garg reported being an adviser for and receiving honoraria from many pharmaceutical companies. He has also received research grants from AbbVie, UCB, the National Psoriasis Foundation, and the CHORD COUSIN Collaboration. No other disclosures were reported.

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

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FROM JAMA DERMATOLOGY

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Rheumatology summit tackles racial disparities in lupus trials

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Clinical research in lupus has a mammoth diversity problem: Black individuals are most likely to develop the disease, but they’re the least likely to take part in studies. By the numbers, a 2018 analysis of randomized controlled trials in systemic lupus erythematosus from the years 1997 to 2017 found that 51% of trial participants were White and 14% were Black, even though an estimated 33% of patients with lupus were White and 43% were Black.

Are there ways to fix this disparity? The topic is getting plenty of attention, and speakers at a July 21 online conference touted research projects that aim to boost the numbers of non-White participants in lupus trials.

So far there doesn’t seem to be anything like a magic bullet. Still, the stakes are high. “While race is a social construct, genetic polymorphisms as well as environmental and social differences may influence drugs, safety, and efficacy,” Joy Buie, PhD, MSCR, research director for the Lupus Foundation of America, said at the “Engaging Diverse Participants in Lupus Clinical Trials: The Path Forward” summit held by the American College of Rheumatology (ACR).

As African American patients explained, minority populations often don’t trust the medical system and feel burned by their lengthy struggles to get diagnosed. In some cases, they don’t have full faith in their clinicians and feel unheard.

In a video presentation developed as part of a federal education campaign, Shanelle Gabriel, a poet and musician diagnosed with lupus, described her first reaction when her physician suggested she join a clinical trial. “My first reaction was no. I know my history,” she said, apparently referring to the infamous Tuskegee study that withheld proper treatment from Black men with syphilis for decades. “As an African American woman, I was scared. I didn’t want to be a guinea pig.”

Stacey Kennedy-Conner, a Chicago-area patient and advocate, told the summit audience about how patients can feel that clinical trial information can add “an extra layer of confusion” to their experience. “There’s also the mentality of, ‘If it’s not broke, don’t fix it’: If this medication regimen is working, I don’t want anybody to touch me.”

Monique Gore-Massy, a New York City patient and advocate, added that there can be a perception that patients with lupus “are stuck at home in bed.” In reality, she said, “we have jobs, we have families. Think about that, and consider everything that you’re asking from us: Is this taking me away from my family? Am I going to have to take off work? There may be incentives, but is that worth me taking time off work that I may not get paid for? These are some of the realities that we have to look at in terms of the whole entire clinical trial process.”

It’s also important to keep patients informed of progress being made in trials, she said. “You don’t want to say you just felt like a number and then not get any kind of follow-up.”

In the big picture, “there has to be something that builds up the confidence of individuals so that they are more mindful to participate in these clinical trials,” said Aleta McLean, an Atlanta patient who was diagnosed with lupus 14 years ago.

Several researchers highlighted ongoing projects at the summit. The ACR, for example, has launched a $500,000 initiative called Training to Increase Minority Enrollment in Lupus Clinical Trials with Community Engagement (TIMELY). The federally funded project aims to evaluate whether training of health care professionals can boost clinical trial participation among Black and Hispanic patients.

“We hope to disseminate the results of our project to the scientific community through abstracts, manuscripts, presentations at national meetings,” said rheumatologist Saira Z. Sheikh, MD, of the University of North Carolina at Chapel Hill. “Overall, our goal is to establish new partnerships to support the TIMELY model and advance the education and engagement of providers and community health workers.”

Pamela Payne-Foster, MD, MPH, preventive medicine/public health physician at the University of Alabama College of Community Health Sciences, Tuscaloosa, spoke about the federally funded Deep South Health Equity Project, which is paying patients to take part in an online education program and attend an online regional conference.

Other efforts are underway. The Lupus Research Alliance and its clinical affiliate Lupus Therapeutics have launched two initiatives. One is a program called Project Change (Community-based Health Action Network to Generate Trial Participation and Eliminate Disparities), and the Diversity in Lupus Research Program aims to fund scientists’ work.

Will any of this work boost diversity in clinical trials? As one audience member noted in a Q&A session, health care disparities – and knowledge about them – are nothing new: “Why are we not able to narrow the gap?”

Rear Admiral Richardae Araojo, PharmD, MS, director of the FDA’s Office of Minority Health and Health Equity and associate commissioner for minority health, replied that waves of interest in disparities come and go. “That contributes to why we may not see solutions. But ultimately, there are a lot of people doing a lot of work trying to solve the issues.”

The summit was sponsored by Bristol-Myers Squibb, Genentech, and RemeGen.

A version of this article appeared on Medscape.com.

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Clinical research in lupus has a mammoth diversity problem: Black individuals are most likely to develop the disease, but they’re the least likely to take part in studies. By the numbers, a 2018 analysis of randomized controlled trials in systemic lupus erythematosus from the years 1997 to 2017 found that 51% of trial participants were White and 14% were Black, even though an estimated 33% of patients with lupus were White and 43% were Black.

Are there ways to fix this disparity? The topic is getting plenty of attention, and speakers at a July 21 online conference touted research projects that aim to boost the numbers of non-White participants in lupus trials.

So far there doesn’t seem to be anything like a magic bullet. Still, the stakes are high. “While race is a social construct, genetic polymorphisms as well as environmental and social differences may influence drugs, safety, and efficacy,” Joy Buie, PhD, MSCR, research director for the Lupus Foundation of America, said at the “Engaging Diverse Participants in Lupus Clinical Trials: The Path Forward” summit held by the American College of Rheumatology (ACR).

As African American patients explained, minority populations often don’t trust the medical system and feel burned by their lengthy struggles to get diagnosed. In some cases, they don’t have full faith in their clinicians and feel unheard.

In a video presentation developed as part of a federal education campaign, Shanelle Gabriel, a poet and musician diagnosed with lupus, described her first reaction when her physician suggested she join a clinical trial. “My first reaction was no. I know my history,” she said, apparently referring to the infamous Tuskegee study that withheld proper treatment from Black men with syphilis for decades. “As an African American woman, I was scared. I didn’t want to be a guinea pig.”

Stacey Kennedy-Conner, a Chicago-area patient and advocate, told the summit audience about how patients can feel that clinical trial information can add “an extra layer of confusion” to their experience. “There’s also the mentality of, ‘If it’s not broke, don’t fix it’: If this medication regimen is working, I don’t want anybody to touch me.”

Monique Gore-Massy, a New York City patient and advocate, added that there can be a perception that patients with lupus “are stuck at home in bed.” In reality, she said, “we have jobs, we have families. Think about that, and consider everything that you’re asking from us: Is this taking me away from my family? Am I going to have to take off work? There may be incentives, but is that worth me taking time off work that I may not get paid for? These are some of the realities that we have to look at in terms of the whole entire clinical trial process.”

It’s also important to keep patients informed of progress being made in trials, she said. “You don’t want to say you just felt like a number and then not get any kind of follow-up.”

In the big picture, “there has to be something that builds up the confidence of individuals so that they are more mindful to participate in these clinical trials,” said Aleta McLean, an Atlanta patient who was diagnosed with lupus 14 years ago.

Several researchers highlighted ongoing projects at the summit. The ACR, for example, has launched a $500,000 initiative called Training to Increase Minority Enrollment in Lupus Clinical Trials with Community Engagement (TIMELY). The federally funded project aims to evaluate whether training of health care professionals can boost clinical trial participation among Black and Hispanic patients.

“We hope to disseminate the results of our project to the scientific community through abstracts, manuscripts, presentations at national meetings,” said rheumatologist Saira Z. Sheikh, MD, of the University of North Carolina at Chapel Hill. “Overall, our goal is to establish new partnerships to support the TIMELY model and advance the education and engagement of providers and community health workers.”

Pamela Payne-Foster, MD, MPH, preventive medicine/public health physician at the University of Alabama College of Community Health Sciences, Tuscaloosa, spoke about the federally funded Deep South Health Equity Project, which is paying patients to take part in an online education program and attend an online regional conference.

Other efforts are underway. The Lupus Research Alliance and its clinical affiliate Lupus Therapeutics have launched two initiatives. One is a program called Project Change (Community-based Health Action Network to Generate Trial Participation and Eliminate Disparities), and the Diversity in Lupus Research Program aims to fund scientists’ work.

Will any of this work boost diversity in clinical trials? As one audience member noted in a Q&A session, health care disparities – and knowledge about them – are nothing new: “Why are we not able to narrow the gap?”

Rear Admiral Richardae Araojo, PharmD, MS, director of the FDA’s Office of Minority Health and Health Equity and associate commissioner for minority health, replied that waves of interest in disparities come and go. “That contributes to why we may not see solutions. But ultimately, there are a lot of people doing a lot of work trying to solve the issues.”

The summit was sponsored by Bristol-Myers Squibb, Genentech, and RemeGen.

A version of this article appeared on Medscape.com.

Clinical research in lupus has a mammoth diversity problem: Black individuals are most likely to develop the disease, but they’re the least likely to take part in studies. By the numbers, a 2018 analysis of randomized controlled trials in systemic lupus erythematosus from the years 1997 to 2017 found that 51% of trial participants were White and 14% were Black, even though an estimated 33% of patients with lupus were White and 43% were Black.

Are there ways to fix this disparity? The topic is getting plenty of attention, and speakers at a July 21 online conference touted research projects that aim to boost the numbers of non-White participants in lupus trials.

So far there doesn’t seem to be anything like a magic bullet. Still, the stakes are high. “While race is a social construct, genetic polymorphisms as well as environmental and social differences may influence drugs, safety, and efficacy,” Joy Buie, PhD, MSCR, research director for the Lupus Foundation of America, said at the “Engaging Diverse Participants in Lupus Clinical Trials: The Path Forward” summit held by the American College of Rheumatology (ACR).

As African American patients explained, minority populations often don’t trust the medical system and feel burned by their lengthy struggles to get diagnosed. In some cases, they don’t have full faith in their clinicians and feel unheard.

In a video presentation developed as part of a federal education campaign, Shanelle Gabriel, a poet and musician diagnosed with lupus, described her first reaction when her physician suggested she join a clinical trial. “My first reaction was no. I know my history,” she said, apparently referring to the infamous Tuskegee study that withheld proper treatment from Black men with syphilis for decades. “As an African American woman, I was scared. I didn’t want to be a guinea pig.”

Stacey Kennedy-Conner, a Chicago-area patient and advocate, told the summit audience about how patients can feel that clinical trial information can add “an extra layer of confusion” to their experience. “There’s also the mentality of, ‘If it’s not broke, don’t fix it’: If this medication regimen is working, I don’t want anybody to touch me.”

Monique Gore-Massy, a New York City patient and advocate, added that there can be a perception that patients with lupus “are stuck at home in bed.” In reality, she said, “we have jobs, we have families. Think about that, and consider everything that you’re asking from us: Is this taking me away from my family? Am I going to have to take off work? There may be incentives, but is that worth me taking time off work that I may not get paid for? These are some of the realities that we have to look at in terms of the whole entire clinical trial process.”

It’s also important to keep patients informed of progress being made in trials, she said. “You don’t want to say you just felt like a number and then not get any kind of follow-up.”

In the big picture, “there has to be something that builds up the confidence of individuals so that they are more mindful to participate in these clinical trials,” said Aleta McLean, an Atlanta patient who was diagnosed with lupus 14 years ago.

Several researchers highlighted ongoing projects at the summit. The ACR, for example, has launched a $500,000 initiative called Training to Increase Minority Enrollment in Lupus Clinical Trials with Community Engagement (TIMELY). The federally funded project aims to evaluate whether training of health care professionals can boost clinical trial participation among Black and Hispanic patients.

“We hope to disseminate the results of our project to the scientific community through abstracts, manuscripts, presentations at national meetings,” said rheumatologist Saira Z. Sheikh, MD, of the University of North Carolina at Chapel Hill. “Overall, our goal is to establish new partnerships to support the TIMELY model and advance the education and engagement of providers and community health workers.”

Pamela Payne-Foster, MD, MPH, preventive medicine/public health physician at the University of Alabama College of Community Health Sciences, Tuscaloosa, spoke about the federally funded Deep South Health Equity Project, which is paying patients to take part in an online education program and attend an online regional conference.

Other efforts are underway. The Lupus Research Alliance and its clinical affiliate Lupus Therapeutics have launched two initiatives. One is a program called Project Change (Community-based Health Action Network to Generate Trial Participation and Eliminate Disparities), and the Diversity in Lupus Research Program aims to fund scientists’ work.

Will any of this work boost diversity in clinical trials? As one audience member noted in a Q&A session, health care disparities – and knowledge about them – are nothing new: “Why are we not able to narrow the gap?”

Rear Admiral Richardae Araojo, PharmD, MS, director of the FDA’s Office of Minority Health and Health Equity and associate commissioner for minority health, replied that waves of interest in disparities come and go. “That contributes to why we may not see solutions. But ultimately, there are a lot of people doing a lot of work trying to solve the issues.”

The summit was sponsored by Bristol-Myers Squibb, Genentech, and RemeGen.

A version of this article appeared on Medscape.com.

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FROM AN ACR CLINICAL TRIAL SUMMIT

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Kidnapping and treatment risks come with medical tourism

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Tue, 07/25/2023 - 10:30

In March 2023, four “medical tourists” from South Carolina who were seeking health care in Mexico were kidnapped by a drug cartel. Two were killed when they were trapped in a shootout. One of them was scheduled for tummy-tuck surgery, and others were seeking cheaper prescription drugs.

The news reached Bruce Hermann, MD, a plastic surgeon in Denton, Tex., who brought up the incident in a segment of his podcast, “Nip Talk,” in which he talked about the risks of medical tourism. But violence in foreign countries isn’t Dr. Hermann’s primary concern.

“Being the victim of a crime is lower down the risk strata,” Dr. Hermann said in an interview. “A bigger concern is the lack of regulations of doctors and facilities in countries like Mexico.”

The savings from medical tourism may be tempting, but the unpredictable clinical risks are daunting. Some employers pay for treatment at certain foreign clinics, and Blue Shield of California’s HMO plan, Access Baja, covers care in certain clinics in Mexico’s Baja peninsula. But U.S. health insurance generally does not cover medical tourism.

Despite its popularity, medical tourism is not siphoning off a significant number of patients from U.S. doctors, with the possible exception of plastic surgery. One study found that medical tourism accounts for less than 2% of U.S. spending on noncosmetic health care.

Still, as many as 1.2 million Americans travel to Mexico each year seeking health care at lower costs, particularly dental care, bariatric surgery, and cosmetic procedures.

Physicians such as Dr. Hermann see the results when things go awry. Dr. Hermann said when he takes calls at a nearby level II trauma center, he sees, on average, one patient a month with complications from plastic surgeries performed abroad.

Patients tell Dr. Hermann they often had little preoperative time with the surgeons, and some may not even see their surgeon. They have to fly back home just days after their procedures, so complications that typically arise later are missed, he said.
 

Who opts for medical tourism?

There are few statistics on the number of medical tourists or the clinical problems they have. Josef Woodman, CEO of Patients Beyond Borders, a medical tourism consultancy in Chapel Hill, N.C., has developed a profile of medical tourism that is based on his close contacts within the industry.

Mr. Woodman said the vast majority of U.S. medical tourists go to Mexico, which accounts for an estimated 1 million to 1.2 million medical visitors a year. He said Costa Rica is another popular destination, followed by other Latin American countries and some in the Far East, the Middle East, and Eastern Europe.

Mr. Woodman estimates that dental treatments make up 65% of all medical tourism. Cosmetic procedures come in a distant second, at 15%. Cosmetic procedures can be expensive and are rarely covered by insurance. They can be performed at half the price abroad, he said.

According to Mr. Woodman, other significant fields for medical tourism are orthopedics, which accounts for 5% of all visits, and bariatrics, with 3%-5%. Hip and knee replacements are expensive, and in the case of bariatrics, U.S. insurers often deny coverage, he said.

People also go abroad for fertility care and organ transplants, and one Jamaica company even offered dialysis vacations for U.S. tourists.

On the other hand, medical tourism does not work well for cancer treatments, because cancer care involves long periods of treatment and cannot be completed in a trip or two, Mr. Woodman said. “The media also plays up major procedures like open heart surgery, but they are in fact very rare,” he added.
 

 

 

What patients are looking for

Medical tourists typically pay 50%-70% of what they would pay in the United States for the same procedure, Mr. Woodman said. Prices are lower because patients pay in cash, foreign wages are lower, and expenses such as malpractice insurance are much lower.

“Many medical tourists don’t have a choice,” Mr. Woodman said. “They cannot afford the U.S. price for the procedure, even if they have health insurance, because they often have a high deductible.” In one study, the majority of medical tourists to Mexico reported an income of $25,000-$50,000 a year.

That same study also found that the average age of medical tourists was just under 65. These older patients often come for a vacation. “A sizable number of medical tourists are looking for surgery plus a vacation, a tummy-tuck and a stay at an all-inclusive resort,” said Steven P. Davison, MD, DDS, a plastic surgeon in Washington, who has written on the phenomenon.

Another large group of medical tourists are immigrants to the United States who want surgery in their country of origin, such as Brazil or Iran, Dr. Davison said, perhaps because they feel more comfortable or have family members who can act as caregivers. He said some go to places that have expertise in a certain procedure.

“For instance, they get their hair transplantation done in Turkey because surgeons there have the expertise and it’s cheaper than in the United States,” Dr. Davison said.
 

Arranging the trip

Patients often find foreign providers through online brokers who can arrange the flight, hotel, clinic, and physician. Brokers are not unbiased because they are usually paid by the clinic. Mr. Woodman said this arrangement works when the broker can offer a wide variety of options but not when the broker represents just a few clinics.

Mr. Woodman said patients could conceivably make their own arrangements without a broker, and some do so. “All the tools are on the Internet,” he said. “However, many people don’t trust themselves to do this work.”

Even for patients who depend on brokers, Mr. Woodman advises verifying the quality of the clinic and its doctors before signing on. Most countries have online lists of registered doctors, and patients seeking health care can research complaints against a doctor.

There is no insurance that patients can have to guard against the risks of medical tourism, Mr. Woodman said. “When you could get it, it was prohibitively expensive,” he said. “You can get travel insurance, but that just covers peripheral problems, such as flight cancellations, accidental injury, and emergency care. It has nothing to do with problems stemming from planned procedures.

“Some clinics and hospitals serving medical tourists provide warranties on their work,” he added. “However, plastic surgery clinics are less likely to offer warranties, because patients are so frequently dissatisfied.”
 

How things can go wrong

Mr. Woodman said medical tourists may often receive substandard care when they select a provider who offers unusually large savings, such as 80% off the U.S. price. “Those providers are likely cutting corners to get that kind of savings, and you should stay away from them,” he said.

Even when receiving care at an excellent clinic, patients can get infections if postoperative requirements are not followed, according to Darrick E. Antell, MD, a plastic surgeon in New York, who has treated medical tourists upon their return to the United States.

Typically, patients are told to stay in their rooms for several days after the operation, but friends may push them to go out and have fun, he said. Sometimes patients choose exotic arrangements that place them at risk for infection. As an example, Dr. Antell mentioned a broker who offered a safari in combination with plastic surgery.

Dr. Hermann said tummy tucks are riskier because they involve large incisions, and many such patients are overweight, which impairs healing. “Tummy-tuck patients need a longer recovery, and they often have more discomfort than other plastic surgery,” he said.

When things go wrong, medical tourists have few legal protections. “They usually don’t go to an accredited facility, there is no credentialing of physicians, and their ability to sue is extremely limited,” Dr. Davison said. Patients would have to return to the foreign country and hire a lawyer there, and even then, it is harder to win a case and to receive an award as high as in the United States, he added.
 

Dealing with follow-ups

An inherent flaw with medical tourism, Dr. Antell said, is that patients typically go back home before postoperative care is fully completed. “They may stay just a few days after surgery, and then fly back home,” he said.

“Patients who have complex operations abroad should stay for 8-10 days to have a proper follow-up,” he said. “But they fly back early, which can also lead to getting pulmonary embolisms on the flight.

“A checkup right after surgery doesn’t uncover many complications, because these tend to occur 7-12 days after surgery,” Dr. Hermann said.

“If they come to me within 3 months after surgery, I charge an upfront fee just to see them, because it takes an hour of my time,” Dr. Davison said. “Then I will take care of acute emergency, such as taking out an infected implant.”

Hermann said many patients wait too long to have their complications treated in the United States. “They may first try calling their doctor in Mexico, who tells them to take some antibiotics or something,” he said. “So when they finally do seek care, the infection is pretty far along.”
 

What U.S. doctors can do

Patients rarely tell their U.S. doctors that they are planning a trip to a foreign country to undergo medical treatment, even though they have to request a copy of their medical records for the foreign doctor, Mr. Woodman said.

Dr. Hermann said only one of his patients told him she was planning to go aboard for plastic surgery. “She was a young mom, and I tried to talk her out of it,” he said. “I don’t know what happened because she didn’t come back.”

Dr. Hermann said doctors should assume that they won’t be able to change their patients’ minds, and they should try to help their patients make the best of it.

“They should insist on seeing the doctor ahead of time and make sure they get along with them,” he said. “Ask for credentialing of the doctor and the facility, and stay there several weeks post op. But they’re probably not going to do all of this.”

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

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In March 2023, four “medical tourists” from South Carolina who were seeking health care in Mexico were kidnapped by a drug cartel. Two were killed when they were trapped in a shootout. One of them was scheduled for tummy-tuck surgery, and others were seeking cheaper prescription drugs.

The news reached Bruce Hermann, MD, a plastic surgeon in Denton, Tex., who brought up the incident in a segment of his podcast, “Nip Talk,” in which he talked about the risks of medical tourism. But violence in foreign countries isn’t Dr. Hermann’s primary concern.

“Being the victim of a crime is lower down the risk strata,” Dr. Hermann said in an interview. “A bigger concern is the lack of regulations of doctors and facilities in countries like Mexico.”

The savings from medical tourism may be tempting, but the unpredictable clinical risks are daunting. Some employers pay for treatment at certain foreign clinics, and Blue Shield of California’s HMO plan, Access Baja, covers care in certain clinics in Mexico’s Baja peninsula. But U.S. health insurance generally does not cover medical tourism.

Despite its popularity, medical tourism is not siphoning off a significant number of patients from U.S. doctors, with the possible exception of plastic surgery. One study found that medical tourism accounts for less than 2% of U.S. spending on noncosmetic health care.

Still, as many as 1.2 million Americans travel to Mexico each year seeking health care at lower costs, particularly dental care, bariatric surgery, and cosmetic procedures.

Physicians such as Dr. Hermann see the results when things go awry. Dr. Hermann said when he takes calls at a nearby level II trauma center, he sees, on average, one patient a month with complications from plastic surgeries performed abroad.

Patients tell Dr. Hermann they often had little preoperative time with the surgeons, and some may not even see their surgeon. They have to fly back home just days after their procedures, so complications that typically arise later are missed, he said.
 

Who opts for medical tourism?

There are few statistics on the number of medical tourists or the clinical problems they have. Josef Woodman, CEO of Patients Beyond Borders, a medical tourism consultancy in Chapel Hill, N.C., has developed a profile of medical tourism that is based on his close contacts within the industry.

Mr. Woodman said the vast majority of U.S. medical tourists go to Mexico, which accounts for an estimated 1 million to 1.2 million medical visitors a year. He said Costa Rica is another popular destination, followed by other Latin American countries and some in the Far East, the Middle East, and Eastern Europe.

Mr. Woodman estimates that dental treatments make up 65% of all medical tourism. Cosmetic procedures come in a distant second, at 15%. Cosmetic procedures can be expensive and are rarely covered by insurance. They can be performed at half the price abroad, he said.

According to Mr. Woodman, other significant fields for medical tourism are orthopedics, which accounts for 5% of all visits, and bariatrics, with 3%-5%. Hip and knee replacements are expensive, and in the case of bariatrics, U.S. insurers often deny coverage, he said.

People also go abroad for fertility care and organ transplants, and one Jamaica company even offered dialysis vacations for U.S. tourists.

On the other hand, medical tourism does not work well for cancer treatments, because cancer care involves long periods of treatment and cannot be completed in a trip or two, Mr. Woodman said. “The media also plays up major procedures like open heart surgery, but they are in fact very rare,” he added.
 

 

 

What patients are looking for

Medical tourists typically pay 50%-70% of what they would pay in the United States for the same procedure, Mr. Woodman said. Prices are lower because patients pay in cash, foreign wages are lower, and expenses such as malpractice insurance are much lower.

“Many medical tourists don’t have a choice,” Mr. Woodman said. “They cannot afford the U.S. price for the procedure, even if they have health insurance, because they often have a high deductible.” In one study, the majority of medical tourists to Mexico reported an income of $25,000-$50,000 a year.

That same study also found that the average age of medical tourists was just under 65. These older patients often come for a vacation. “A sizable number of medical tourists are looking for surgery plus a vacation, a tummy-tuck and a stay at an all-inclusive resort,” said Steven P. Davison, MD, DDS, a plastic surgeon in Washington, who has written on the phenomenon.

Another large group of medical tourists are immigrants to the United States who want surgery in their country of origin, such as Brazil or Iran, Dr. Davison said, perhaps because they feel more comfortable or have family members who can act as caregivers. He said some go to places that have expertise in a certain procedure.

“For instance, they get their hair transplantation done in Turkey because surgeons there have the expertise and it’s cheaper than in the United States,” Dr. Davison said.
 

Arranging the trip

Patients often find foreign providers through online brokers who can arrange the flight, hotel, clinic, and physician. Brokers are not unbiased because they are usually paid by the clinic. Mr. Woodman said this arrangement works when the broker can offer a wide variety of options but not when the broker represents just a few clinics.

Mr. Woodman said patients could conceivably make their own arrangements without a broker, and some do so. “All the tools are on the Internet,” he said. “However, many people don’t trust themselves to do this work.”

Even for patients who depend on brokers, Mr. Woodman advises verifying the quality of the clinic and its doctors before signing on. Most countries have online lists of registered doctors, and patients seeking health care can research complaints against a doctor.

There is no insurance that patients can have to guard against the risks of medical tourism, Mr. Woodman said. “When you could get it, it was prohibitively expensive,” he said. “You can get travel insurance, but that just covers peripheral problems, such as flight cancellations, accidental injury, and emergency care. It has nothing to do with problems stemming from planned procedures.

“Some clinics and hospitals serving medical tourists provide warranties on their work,” he added. “However, plastic surgery clinics are less likely to offer warranties, because patients are so frequently dissatisfied.”
 

How things can go wrong

Mr. Woodman said medical tourists may often receive substandard care when they select a provider who offers unusually large savings, such as 80% off the U.S. price. “Those providers are likely cutting corners to get that kind of savings, and you should stay away from them,” he said.

Even when receiving care at an excellent clinic, patients can get infections if postoperative requirements are not followed, according to Darrick E. Antell, MD, a plastic surgeon in New York, who has treated medical tourists upon their return to the United States.

Typically, patients are told to stay in their rooms for several days after the operation, but friends may push them to go out and have fun, he said. Sometimes patients choose exotic arrangements that place them at risk for infection. As an example, Dr. Antell mentioned a broker who offered a safari in combination with plastic surgery.

Dr. Hermann said tummy tucks are riskier because they involve large incisions, and many such patients are overweight, which impairs healing. “Tummy-tuck patients need a longer recovery, and they often have more discomfort than other plastic surgery,” he said.

When things go wrong, medical tourists have few legal protections. “They usually don’t go to an accredited facility, there is no credentialing of physicians, and their ability to sue is extremely limited,” Dr. Davison said. Patients would have to return to the foreign country and hire a lawyer there, and even then, it is harder to win a case and to receive an award as high as in the United States, he added.
 

Dealing with follow-ups

An inherent flaw with medical tourism, Dr. Antell said, is that patients typically go back home before postoperative care is fully completed. “They may stay just a few days after surgery, and then fly back home,” he said.

“Patients who have complex operations abroad should stay for 8-10 days to have a proper follow-up,” he said. “But they fly back early, which can also lead to getting pulmonary embolisms on the flight.

“A checkup right after surgery doesn’t uncover many complications, because these tend to occur 7-12 days after surgery,” Dr. Hermann said.

“If they come to me within 3 months after surgery, I charge an upfront fee just to see them, because it takes an hour of my time,” Dr. Davison said. “Then I will take care of acute emergency, such as taking out an infected implant.”

Hermann said many patients wait too long to have their complications treated in the United States. “They may first try calling their doctor in Mexico, who tells them to take some antibiotics or something,” he said. “So when they finally do seek care, the infection is pretty far along.”
 

What U.S. doctors can do

Patients rarely tell their U.S. doctors that they are planning a trip to a foreign country to undergo medical treatment, even though they have to request a copy of their medical records for the foreign doctor, Mr. Woodman said.

Dr. Hermann said only one of his patients told him she was planning to go aboard for plastic surgery. “She was a young mom, and I tried to talk her out of it,” he said. “I don’t know what happened because she didn’t come back.”

Dr. Hermann said doctors should assume that they won’t be able to change their patients’ minds, and they should try to help their patients make the best of it.

“They should insist on seeing the doctor ahead of time and make sure they get along with them,” he said. “Ask for credentialing of the doctor and the facility, and stay there several weeks post op. But they’re probably not going to do all of this.”

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

In March 2023, four “medical tourists” from South Carolina who were seeking health care in Mexico were kidnapped by a drug cartel. Two were killed when they were trapped in a shootout. One of them was scheduled for tummy-tuck surgery, and others were seeking cheaper prescription drugs.

The news reached Bruce Hermann, MD, a plastic surgeon in Denton, Tex., who brought up the incident in a segment of his podcast, “Nip Talk,” in which he talked about the risks of medical tourism. But violence in foreign countries isn’t Dr. Hermann’s primary concern.

“Being the victim of a crime is lower down the risk strata,” Dr. Hermann said in an interview. “A bigger concern is the lack of regulations of doctors and facilities in countries like Mexico.”

The savings from medical tourism may be tempting, but the unpredictable clinical risks are daunting. Some employers pay for treatment at certain foreign clinics, and Blue Shield of California’s HMO plan, Access Baja, covers care in certain clinics in Mexico’s Baja peninsula. But U.S. health insurance generally does not cover medical tourism.

Despite its popularity, medical tourism is not siphoning off a significant number of patients from U.S. doctors, with the possible exception of plastic surgery. One study found that medical tourism accounts for less than 2% of U.S. spending on noncosmetic health care.

Still, as many as 1.2 million Americans travel to Mexico each year seeking health care at lower costs, particularly dental care, bariatric surgery, and cosmetic procedures.

Physicians such as Dr. Hermann see the results when things go awry. Dr. Hermann said when he takes calls at a nearby level II trauma center, he sees, on average, one patient a month with complications from plastic surgeries performed abroad.

Patients tell Dr. Hermann they often had little preoperative time with the surgeons, and some may not even see their surgeon. They have to fly back home just days after their procedures, so complications that typically arise later are missed, he said.
 

Who opts for medical tourism?

There are few statistics on the number of medical tourists or the clinical problems they have. Josef Woodman, CEO of Patients Beyond Borders, a medical tourism consultancy in Chapel Hill, N.C., has developed a profile of medical tourism that is based on his close contacts within the industry.

Mr. Woodman said the vast majority of U.S. medical tourists go to Mexico, which accounts for an estimated 1 million to 1.2 million medical visitors a year. He said Costa Rica is another popular destination, followed by other Latin American countries and some in the Far East, the Middle East, and Eastern Europe.

Mr. Woodman estimates that dental treatments make up 65% of all medical tourism. Cosmetic procedures come in a distant second, at 15%. Cosmetic procedures can be expensive and are rarely covered by insurance. They can be performed at half the price abroad, he said.

According to Mr. Woodman, other significant fields for medical tourism are orthopedics, which accounts for 5% of all visits, and bariatrics, with 3%-5%. Hip and knee replacements are expensive, and in the case of bariatrics, U.S. insurers often deny coverage, he said.

People also go abroad for fertility care and organ transplants, and one Jamaica company even offered dialysis vacations for U.S. tourists.

On the other hand, medical tourism does not work well for cancer treatments, because cancer care involves long periods of treatment and cannot be completed in a trip or two, Mr. Woodman said. “The media also plays up major procedures like open heart surgery, but they are in fact very rare,” he added.
 

 

 

What patients are looking for

Medical tourists typically pay 50%-70% of what they would pay in the United States for the same procedure, Mr. Woodman said. Prices are lower because patients pay in cash, foreign wages are lower, and expenses such as malpractice insurance are much lower.

“Many medical tourists don’t have a choice,” Mr. Woodman said. “They cannot afford the U.S. price for the procedure, even if they have health insurance, because they often have a high deductible.” In one study, the majority of medical tourists to Mexico reported an income of $25,000-$50,000 a year.

That same study also found that the average age of medical tourists was just under 65. These older patients often come for a vacation. “A sizable number of medical tourists are looking for surgery plus a vacation, a tummy-tuck and a stay at an all-inclusive resort,” said Steven P. Davison, MD, DDS, a plastic surgeon in Washington, who has written on the phenomenon.

Another large group of medical tourists are immigrants to the United States who want surgery in their country of origin, such as Brazil or Iran, Dr. Davison said, perhaps because they feel more comfortable or have family members who can act as caregivers. He said some go to places that have expertise in a certain procedure.

“For instance, they get their hair transplantation done in Turkey because surgeons there have the expertise and it’s cheaper than in the United States,” Dr. Davison said.
 

Arranging the trip

Patients often find foreign providers through online brokers who can arrange the flight, hotel, clinic, and physician. Brokers are not unbiased because they are usually paid by the clinic. Mr. Woodman said this arrangement works when the broker can offer a wide variety of options but not when the broker represents just a few clinics.

Mr. Woodman said patients could conceivably make their own arrangements without a broker, and some do so. “All the tools are on the Internet,” he said. “However, many people don’t trust themselves to do this work.”

Even for patients who depend on brokers, Mr. Woodman advises verifying the quality of the clinic and its doctors before signing on. Most countries have online lists of registered doctors, and patients seeking health care can research complaints against a doctor.

There is no insurance that patients can have to guard against the risks of medical tourism, Mr. Woodman said. “When you could get it, it was prohibitively expensive,” he said. “You can get travel insurance, but that just covers peripheral problems, such as flight cancellations, accidental injury, and emergency care. It has nothing to do with problems stemming from planned procedures.

“Some clinics and hospitals serving medical tourists provide warranties on their work,” he added. “However, plastic surgery clinics are less likely to offer warranties, because patients are so frequently dissatisfied.”
 

How things can go wrong

Mr. Woodman said medical tourists may often receive substandard care when they select a provider who offers unusually large savings, such as 80% off the U.S. price. “Those providers are likely cutting corners to get that kind of savings, and you should stay away from them,” he said.

Even when receiving care at an excellent clinic, patients can get infections if postoperative requirements are not followed, according to Darrick E. Antell, MD, a plastic surgeon in New York, who has treated medical tourists upon their return to the United States.

Typically, patients are told to stay in their rooms for several days after the operation, but friends may push them to go out and have fun, he said. Sometimes patients choose exotic arrangements that place them at risk for infection. As an example, Dr. Antell mentioned a broker who offered a safari in combination with plastic surgery.

Dr. Hermann said tummy tucks are riskier because they involve large incisions, and many such patients are overweight, which impairs healing. “Tummy-tuck patients need a longer recovery, and they often have more discomfort than other plastic surgery,” he said.

When things go wrong, medical tourists have few legal protections. “They usually don’t go to an accredited facility, there is no credentialing of physicians, and their ability to sue is extremely limited,” Dr. Davison said. Patients would have to return to the foreign country and hire a lawyer there, and even then, it is harder to win a case and to receive an award as high as in the United States, he added.
 

Dealing with follow-ups

An inherent flaw with medical tourism, Dr. Antell said, is that patients typically go back home before postoperative care is fully completed. “They may stay just a few days after surgery, and then fly back home,” he said.

“Patients who have complex operations abroad should stay for 8-10 days to have a proper follow-up,” he said. “But they fly back early, which can also lead to getting pulmonary embolisms on the flight.

“A checkup right after surgery doesn’t uncover many complications, because these tend to occur 7-12 days after surgery,” Dr. Hermann said.

“If they come to me within 3 months after surgery, I charge an upfront fee just to see them, because it takes an hour of my time,” Dr. Davison said. “Then I will take care of acute emergency, such as taking out an infected implant.”

Hermann said many patients wait too long to have their complications treated in the United States. “They may first try calling their doctor in Mexico, who tells them to take some antibiotics or something,” he said. “So when they finally do seek care, the infection is pretty far along.”
 

What U.S. doctors can do

Patients rarely tell their U.S. doctors that they are planning a trip to a foreign country to undergo medical treatment, even though they have to request a copy of their medical records for the foreign doctor, Mr. Woodman said.

Dr. Hermann said only one of his patients told him she was planning to go aboard for plastic surgery. “She was a young mom, and I tried to talk her out of it,” he said. “I don’t know what happened because she didn’t come back.”

Dr. Hermann said doctors should assume that they won’t be able to change their patients’ minds, and they should try to help their patients make the best of it.

“They should insist on seeing the doctor ahead of time and make sure they get along with them,” he said. “Ask for credentialing of the doctor and the facility, and stay there several weeks post op. But they’re probably not going to do all of this.”

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

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Chaperones for physical exams? Doctors and patients weigh in

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Thu, 08/03/2023 - 15:59

News of physicians accused or convicted of sexually inappropriate behavior toward patients during medical exams has been frequent recently. And patient advocates have brought up the fact that many patients are uncomfortable during sensitive exams.

As a result, more doctors and medical organizations are using chaperones to protect the patient and the physician.

For some institutions, the movement has been toward mandating chaperones. Chaperones can be present for any examination of what are often referred to as sensitive areas, such as breasts, genitalia, and the perianal area. For example, Yale University Health requires patients to use a medical staff member as a chaperone for all sensitive exams except in emergency situations. UCLA Health, on the other hand, allows any adult or child aged 12 years or older to decline a chaperone if they wish to do so. Michigan Medicine provides a chaperone on request, although a patient can opt out.

Many physicians fully support the concept. “If a patient requests a chaperone I think we all, as practitioners, should honor that request respectfully,” said Shieva Ghofrany, MD, an ob.gyn. practicing in Stamford, Conn., and cofounder of tribecalledv, a women’s health knowledge platform. “It’s a clear sign a patient wants to ensure that they feel safe and comfortable.”

However, using a chaperone can be challenging for many primary care physicians and specialists in terms of logistics. Should a chaperone’s job be purely observational? Or should the chaperone also be a medical professional who assists during the procedure? How, specifically, should a chaperone perform their duty during an exam? Where should the chaperone stand? What about legal and ethical ramifications?
 

Who should be a chaperone?

The role of a chaperone is sometimes vaguely defined. It’s logical that a chaperone should have sufficient medical knowledge. Could it be a medical student? Should it be a nurse or another doctor? Would a patient representative suffice even if they aren’t a direct-care clinician?

There are no set standards about who can assume the role. However, the American Medical Association recommends that a patient chaperone be an authorized member of a health care team. For many patients, this is vital.

“As a survivor of sexual assault by an ob.gyn. while I was pregnant, I can assure you that the heinous crime committed against me and hundreds of other women would have been prevented had there been another medical professional in the room,” said Laurie Kanyok, founder of a dance company in New York City, whose former doctor was recently convicted of federal sex abuse charges and is scheduled to be sentenced in July 2023. “The chaperone should be a physician assistant, nurse or medical professional. Qualified professionals better understand the nature and protocols of an exam.”

For children and adolescents, allowing a parent to be a chaperone might be a logical and comforting choice. However, a new British study found that it’s not appropriate.

Study authors Rebecca Jane Moon and Justin Huw Davies looked at pubertal staging–related exams and contend that a chaperone should always be impartial, and a parent’s presence could conceivably open up a physician to false charges of misconduct.

The solution: A parent should have the option be present during any physical exam of their child, with a medical professional additionally acting as chaperone. This can also work for any patient who wishes to bring a trusted friend or family member to their medical appointments.
 

 

 

How does a chaperoned exam work?

A research team from the Medical College of Wisconsin and Louisiana State University Health conducted a recent systematic review of patient and clinician perspectives on carrying out a chaperoned urology exam. The review found that the protocol could use improvement. For example, it was reported that over one-quarter of patients didn’t feel comfortable asking for a chaperone if they were not offered one. “Patients should not have to request this,” said Diana Londoño, MD, a board-certified urologist and assistant clinical professor at City of Hope National Medical Center in Duarte, Calif.

The researchers also found that 93% of female patients preferred a chaperone of the same gender, whereas male patients were split on this issue. Key duties of a chaperone should be to ensure privacy, help interpret instructions from doctor to patient, and continually clarify that consent is being requested as a sensitive exam proceeds, the researchers report. Although clinical practice standards for chaperones aren’t uniform, keeping these important points in mind can easily be adopted by any health care provider.

Many doctors do follow their own set guidelines. “Often, we have our medical assistants be our chaperones,” explained Dr. Ghofrany. “Ideally they ‘room’ the patient – take vitals and ask the patient what specific concerns they would like to address. This helps with exam set-up.

“For example, if a patient has a breast concern versus a concern about their genital area, this would change what drapes are used. The medical assistant would then stand near me if they are helping with a Pap smear or cultures, or they may stand by the patient’s head at the bedside and offer support if needed. Some patients want to hold someone’s hand during an uncomfortable exam.”

The issue of positioning is important. A patient may feel very uneasy if it appears that the chaperone is looking at their body from the doctor’s angle, negating the point of reassurance. The key is to explain before an exam exactly how a chaperone is needed during the exam itself and whether the chaperone is a medical assistant or nurse.

“Chaperones usually stand next to me on either side or on the side of the patient facing me, depending on if they are immediately assisting me or helping the patient,” said Dr. Londoño. If a chaperone will be moving back and forth during the exam, that should be conveyed as well. For virtual visits, a chaperone can act as a third party and be present on a split screen, a process Michigan Medicine uses.

It’s also important to inform patients that a chaperone can step in and stop an exam at any point, both at the patient’s request or because of any observation of inappropriate physician behavior. Understanding this can help reluctant patients feel less worry.

When Christian Miller was diagnosed with a sleep disorder, his doctor suggested having a chaperone present during his physical exams. At first, he was apprehensive but then found the experience to be very positive. “Having someone there with me gave me an extra measure of assurance that nothing untoward would happen,” he said. “I found that having a chaperone was reassuring. The chaperone was not intrusive but stood close enough to ensure everything went smoothly and respectfully.”
 

 

 

Do chaperones help protect physicians legally?

Some states mandate that chaperones be present by patient request during sensitive exams, such as Texas and Oregon. For the most part, though, physicians have no legal obligation to offer chaperones, although it could be in their best interest to do so.

Ob.gyn. is one of the most litigated specialties, for example, so these physicians may find chaperones can play a key role in averting lawsuits. According to data from Physicians’ Insurance, having a reliable witness in an exam room can mitigate claims, and doctors should follow a clear practice policy regarding chaperones for all patients to further reduce liability.

Another advantage to having a chaperone present: protection for a doctor against a problematic patient. The risk for assault or aggression during an exam can of course go both ways. It’s important to be able to prove any patient misconduct through a witness, and a chaperone can lessen the prospect of violence in any form. “Having a chaperone in an exam room is about protecting the doctors as well as the patient,” said Ms. Kanyok.

A chaperone can also defuse ethical dilemmas. Consider a patient who refuses to allow a chaperone in an exam, but a chaperone is required by the physician’s health care organization. Asking a patient to state their reasons for wanting privacy with the chaperone present before the actual exam can help document the patient’s wish respectfully as well as protect a physician and organization from any potential liability if the patient refuses the exam altogether or if an exception for the patient is made.
 

Making a chaperone policy work best

  • Have your staff inform patients of a medical chaperone policy at the time an appointment is made. Have fact sheets available for the patient before appointments fully outlining your policy.
  • Inform the chaperone fully about the details of the exam and the patient’s case prior to the exam, in accordance with HIPAA.
  • The chaperone can introduce themselves to the patient in the waiting room or exam room before you enter the room. The chaperone can go over the policy again verbally and answer any questions the patient may have initially. You can then clarify whether the patient understands your chaperone policy when you come in.
  • Document, document, document. Write down who the chaperone was for each exam in patient notes and note the details of any interactions that are significant, such as patient questions or conflicts.
  • Practice respect, above all. “A patient’s safety and level of comfort should be prioritized,” said Ms. Kanyok.

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

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News of physicians accused or convicted of sexually inappropriate behavior toward patients during medical exams has been frequent recently. And patient advocates have brought up the fact that many patients are uncomfortable during sensitive exams.

As a result, more doctors and medical organizations are using chaperones to protect the patient and the physician.

For some institutions, the movement has been toward mandating chaperones. Chaperones can be present for any examination of what are often referred to as sensitive areas, such as breasts, genitalia, and the perianal area. For example, Yale University Health requires patients to use a medical staff member as a chaperone for all sensitive exams except in emergency situations. UCLA Health, on the other hand, allows any adult or child aged 12 years or older to decline a chaperone if they wish to do so. Michigan Medicine provides a chaperone on request, although a patient can opt out.

Many physicians fully support the concept. “If a patient requests a chaperone I think we all, as practitioners, should honor that request respectfully,” said Shieva Ghofrany, MD, an ob.gyn. practicing in Stamford, Conn., and cofounder of tribecalledv, a women’s health knowledge platform. “It’s a clear sign a patient wants to ensure that they feel safe and comfortable.”

However, using a chaperone can be challenging for many primary care physicians and specialists in terms of logistics. Should a chaperone’s job be purely observational? Or should the chaperone also be a medical professional who assists during the procedure? How, specifically, should a chaperone perform their duty during an exam? Where should the chaperone stand? What about legal and ethical ramifications?
 

Who should be a chaperone?

The role of a chaperone is sometimes vaguely defined. It’s logical that a chaperone should have sufficient medical knowledge. Could it be a medical student? Should it be a nurse or another doctor? Would a patient representative suffice even if they aren’t a direct-care clinician?

There are no set standards about who can assume the role. However, the American Medical Association recommends that a patient chaperone be an authorized member of a health care team. For many patients, this is vital.

“As a survivor of sexual assault by an ob.gyn. while I was pregnant, I can assure you that the heinous crime committed against me and hundreds of other women would have been prevented had there been another medical professional in the room,” said Laurie Kanyok, founder of a dance company in New York City, whose former doctor was recently convicted of federal sex abuse charges and is scheduled to be sentenced in July 2023. “The chaperone should be a physician assistant, nurse or medical professional. Qualified professionals better understand the nature and protocols of an exam.”

For children and adolescents, allowing a parent to be a chaperone might be a logical and comforting choice. However, a new British study found that it’s not appropriate.

Study authors Rebecca Jane Moon and Justin Huw Davies looked at pubertal staging–related exams and contend that a chaperone should always be impartial, and a parent’s presence could conceivably open up a physician to false charges of misconduct.

The solution: A parent should have the option be present during any physical exam of their child, with a medical professional additionally acting as chaperone. This can also work for any patient who wishes to bring a trusted friend or family member to their medical appointments.
 

 

 

How does a chaperoned exam work?

A research team from the Medical College of Wisconsin and Louisiana State University Health conducted a recent systematic review of patient and clinician perspectives on carrying out a chaperoned urology exam. The review found that the protocol could use improvement. For example, it was reported that over one-quarter of patients didn’t feel comfortable asking for a chaperone if they were not offered one. “Patients should not have to request this,” said Diana Londoño, MD, a board-certified urologist and assistant clinical professor at City of Hope National Medical Center in Duarte, Calif.

The researchers also found that 93% of female patients preferred a chaperone of the same gender, whereas male patients were split on this issue. Key duties of a chaperone should be to ensure privacy, help interpret instructions from doctor to patient, and continually clarify that consent is being requested as a sensitive exam proceeds, the researchers report. Although clinical practice standards for chaperones aren’t uniform, keeping these important points in mind can easily be adopted by any health care provider.

Many doctors do follow their own set guidelines. “Often, we have our medical assistants be our chaperones,” explained Dr. Ghofrany. “Ideally they ‘room’ the patient – take vitals and ask the patient what specific concerns they would like to address. This helps with exam set-up.

“For example, if a patient has a breast concern versus a concern about their genital area, this would change what drapes are used. The medical assistant would then stand near me if they are helping with a Pap smear or cultures, or they may stand by the patient’s head at the bedside and offer support if needed. Some patients want to hold someone’s hand during an uncomfortable exam.”

The issue of positioning is important. A patient may feel very uneasy if it appears that the chaperone is looking at their body from the doctor’s angle, negating the point of reassurance. The key is to explain before an exam exactly how a chaperone is needed during the exam itself and whether the chaperone is a medical assistant or nurse.

“Chaperones usually stand next to me on either side or on the side of the patient facing me, depending on if they are immediately assisting me or helping the patient,” said Dr. Londoño. If a chaperone will be moving back and forth during the exam, that should be conveyed as well. For virtual visits, a chaperone can act as a third party and be present on a split screen, a process Michigan Medicine uses.

It’s also important to inform patients that a chaperone can step in and stop an exam at any point, both at the patient’s request or because of any observation of inappropriate physician behavior. Understanding this can help reluctant patients feel less worry.

When Christian Miller was diagnosed with a sleep disorder, his doctor suggested having a chaperone present during his physical exams. At first, he was apprehensive but then found the experience to be very positive. “Having someone there with me gave me an extra measure of assurance that nothing untoward would happen,” he said. “I found that having a chaperone was reassuring. The chaperone was not intrusive but stood close enough to ensure everything went smoothly and respectfully.”
 

 

 

Do chaperones help protect physicians legally?

Some states mandate that chaperones be present by patient request during sensitive exams, such as Texas and Oregon. For the most part, though, physicians have no legal obligation to offer chaperones, although it could be in their best interest to do so.

Ob.gyn. is one of the most litigated specialties, for example, so these physicians may find chaperones can play a key role in averting lawsuits. According to data from Physicians’ Insurance, having a reliable witness in an exam room can mitigate claims, and doctors should follow a clear practice policy regarding chaperones for all patients to further reduce liability.

Another advantage to having a chaperone present: protection for a doctor against a problematic patient. The risk for assault or aggression during an exam can of course go both ways. It’s important to be able to prove any patient misconduct through a witness, and a chaperone can lessen the prospect of violence in any form. “Having a chaperone in an exam room is about protecting the doctors as well as the patient,” said Ms. Kanyok.

A chaperone can also defuse ethical dilemmas. Consider a patient who refuses to allow a chaperone in an exam, but a chaperone is required by the physician’s health care organization. Asking a patient to state their reasons for wanting privacy with the chaperone present before the actual exam can help document the patient’s wish respectfully as well as protect a physician and organization from any potential liability if the patient refuses the exam altogether or if an exception for the patient is made.
 

Making a chaperone policy work best

  • Have your staff inform patients of a medical chaperone policy at the time an appointment is made. Have fact sheets available for the patient before appointments fully outlining your policy.
  • Inform the chaperone fully about the details of the exam and the patient’s case prior to the exam, in accordance with HIPAA.
  • The chaperone can introduce themselves to the patient in the waiting room or exam room before you enter the room. The chaperone can go over the policy again verbally and answer any questions the patient may have initially. You can then clarify whether the patient understands your chaperone policy when you come in.
  • Document, document, document. Write down who the chaperone was for each exam in patient notes and note the details of any interactions that are significant, such as patient questions or conflicts.
  • Practice respect, above all. “A patient’s safety and level of comfort should be prioritized,” said Ms. Kanyok.

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

News of physicians accused or convicted of sexually inappropriate behavior toward patients during medical exams has been frequent recently. And patient advocates have brought up the fact that many patients are uncomfortable during sensitive exams.

As a result, more doctors and medical organizations are using chaperones to protect the patient and the physician.

For some institutions, the movement has been toward mandating chaperones. Chaperones can be present for any examination of what are often referred to as sensitive areas, such as breasts, genitalia, and the perianal area. For example, Yale University Health requires patients to use a medical staff member as a chaperone for all sensitive exams except in emergency situations. UCLA Health, on the other hand, allows any adult or child aged 12 years or older to decline a chaperone if they wish to do so. Michigan Medicine provides a chaperone on request, although a patient can opt out.

Many physicians fully support the concept. “If a patient requests a chaperone I think we all, as practitioners, should honor that request respectfully,” said Shieva Ghofrany, MD, an ob.gyn. practicing in Stamford, Conn., and cofounder of tribecalledv, a women’s health knowledge platform. “It’s a clear sign a patient wants to ensure that they feel safe and comfortable.”

However, using a chaperone can be challenging for many primary care physicians and specialists in terms of logistics. Should a chaperone’s job be purely observational? Or should the chaperone also be a medical professional who assists during the procedure? How, specifically, should a chaperone perform their duty during an exam? Where should the chaperone stand? What about legal and ethical ramifications?
 

Who should be a chaperone?

The role of a chaperone is sometimes vaguely defined. It’s logical that a chaperone should have sufficient medical knowledge. Could it be a medical student? Should it be a nurse or another doctor? Would a patient representative suffice even if they aren’t a direct-care clinician?

There are no set standards about who can assume the role. However, the American Medical Association recommends that a patient chaperone be an authorized member of a health care team. For many patients, this is vital.

“As a survivor of sexual assault by an ob.gyn. while I was pregnant, I can assure you that the heinous crime committed against me and hundreds of other women would have been prevented had there been another medical professional in the room,” said Laurie Kanyok, founder of a dance company in New York City, whose former doctor was recently convicted of federal sex abuse charges and is scheduled to be sentenced in July 2023. “The chaperone should be a physician assistant, nurse or medical professional. Qualified professionals better understand the nature and protocols of an exam.”

For children and adolescents, allowing a parent to be a chaperone might be a logical and comforting choice. However, a new British study found that it’s not appropriate.

Study authors Rebecca Jane Moon and Justin Huw Davies looked at pubertal staging–related exams and contend that a chaperone should always be impartial, and a parent’s presence could conceivably open up a physician to false charges of misconduct.

The solution: A parent should have the option be present during any physical exam of their child, with a medical professional additionally acting as chaperone. This can also work for any patient who wishes to bring a trusted friend or family member to their medical appointments.
 

 

 

How does a chaperoned exam work?

A research team from the Medical College of Wisconsin and Louisiana State University Health conducted a recent systematic review of patient and clinician perspectives on carrying out a chaperoned urology exam. The review found that the protocol could use improvement. For example, it was reported that over one-quarter of patients didn’t feel comfortable asking for a chaperone if they were not offered one. “Patients should not have to request this,” said Diana Londoño, MD, a board-certified urologist and assistant clinical professor at City of Hope National Medical Center in Duarte, Calif.

The researchers also found that 93% of female patients preferred a chaperone of the same gender, whereas male patients were split on this issue. Key duties of a chaperone should be to ensure privacy, help interpret instructions from doctor to patient, and continually clarify that consent is being requested as a sensitive exam proceeds, the researchers report. Although clinical practice standards for chaperones aren’t uniform, keeping these important points in mind can easily be adopted by any health care provider.

Many doctors do follow their own set guidelines. “Often, we have our medical assistants be our chaperones,” explained Dr. Ghofrany. “Ideally they ‘room’ the patient – take vitals and ask the patient what specific concerns they would like to address. This helps with exam set-up.

“For example, if a patient has a breast concern versus a concern about their genital area, this would change what drapes are used. The medical assistant would then stand near me if they are helping with a Pap smear or cultures, or they may stand by the patient’s head at the bedside and offer support if needed. Some patients want to hold someone’s hand during an uncomfortable exam.”

The issue of positioning is important. A patient may feel very uneasy if it appears that the chaperone is looking at their body from the doctor’s angle, negating the point of reassurance. The key is to explain before an exam exactly how a chaperone is needed during the exam itself and whether the chaperone is a medical assistant or nurse.

“Chaperones usually stand next to me on either side or on the side of the patient facing me, depending on if they are immediately assisting me or helping the patient,” said Dr. Londoño. If a chaperone will be moving back and forth during the exam, that should be conveyed as well. For virtual visits, a chaperone can act as a third party and be present on a split screen, a process Michigan Medicine uses.

It’s also important to inform patients that a chaperone can step in and stop an exam at any point, both at the patient’s request or because of any observation of inappropriate physician behavior. Understanding this can help reluctant patients feel less worry.

When Christian Miller was diagnosed with a sleep disorder, his doctor suggested having a chaperone present during his physical exams. At first, he was apprehensive but then found the experience to be very positive. “Having someone there with me gave me an extra measure of assurance that nothing untoward would happen,” he said. “I found that having a chaperone was reassuring. The chaperone was not intrusive but stood close enough to ensure everything went smoothly and respectfully.”
 

 

 

Do chaperones help protect physicians legally?

Some states mandate that chaperones be present by patient request during sensitive exams, such as Texas and Oregon. For the most part, though, physicians have no legal obligation to offer chaperones, although it could be in their best interest to do so.

Ob.gyn. is one of the most litigated specialties, for example, so these physicians may find chaperones can play a key role in averting lawsuits. According to data from Physicians’ Insurance, having a reliable witness in an exam room can mitigate claims, and doctors should follow a clear practice policy regarding chaperones for all patients to further reduce liability.

Another advantage to having a chaperone present: protection for a doctor against a problematic patient. The risk for assault or aggression during an exam can of course go both ways. It’s important to be able to prove any patient misconduct through a witness, and a chaperone can lessen the prospect of violence in any form. “Having a chaperone in an exam room is about protecting the doctors as well as the patient,” said Ms. Kanyok.

A chaperone can also defuse ethical dilemmas. Consider a patient who refuses to allow a chaperone in an exam, but a chaperone is required by the physician’s health care organization. Asking a patient to state their reasons for wanting privacy with the chaperone present before the actual exam can help document the patient’s wish respectfully as well as protect a physician and organization from any potential liability if the patient refuses the exam altogether or if an exception for the patient is made.
 

Making a chaperone policy work best

  • Have your staff inform patients of a medical chaperone policy at the time an appointment is made. Have fact sheets available for the patient before appointments fully outlining your policy.
  • Inform the chaperone fully about the details of the exam and the patient’s case prior to the exam, in accordance with HIPAA.
  • The chaperone can introduce themselves to the patient in the waiting room or exam room before you enter the room. The chaperone can go over the policy again verbally and answer any questions the patient may have initially. You can then clarify whether the patient understands your chaperone policy when you come in.
  • Document, document, document. Write down who the chaperone was for each exam in patient notes and note the details of any interactions that are significant, such as patient questions or conflicts.
  • Practice respect, above all. “A patient’s safety and level of comfort should be prioritized,” said Ms. Kanyok.

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

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Sibship composition and size alter the risk for atopic dermatitis

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Key clinical point: Having siblings and being born second or later is associated with a marginally reduced lifetime risk of developing atopic dermatitis (AD).

Major finding: Children born in the birth order ≥2 vs 1 had a 9% lower risk for ever AD (pooled risk ratio [RR] 0.91; 95% CI 0.84-0.98), and a sibship size ≥2 vs 1 was associated with an 8% lower risk for ever AD (RR 0.92; 95% CI 0.86-0.97) and a 10% lower risk for current AD (RR 0.90; 95% CI 0.83-0.98).

Study details: Findings are from a meta-analysis of 102 observational studies that analyzed the association between birth order or sibship size and the risk for AD.

Disclosures: This study did not disclose the source of funding. H Kankaanranta declared receiving lecture and consulting fees from various sources. The other authors declared no conflicts of interest.

Source: Lisik D et al. Birth order, sibship size, and risk of atopic dermatitis, food allergy, and atopy: A systematic review and meta‐analysis. Clin Transl Allergy. 2023;13(6):e12270 (Jun 17). Doi: 10.1002/clt2.12270

 

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Key clinical point: Having siblings and being born second or later is associated with a marginally reduced lifetime risk of developing atopic dermatitis (AD).

Major finding: Children born in the birth order ≥2 vs 1 had a 9% lower risk for ever AD (pooled risk ratio [RR] 0.91; 95% CI 0.84-0.98), and a sibship size ≥2 vs 1 was associated with an 8% lower risk for ever AD (RR 0.92; 95% CI 0.86-0.97) and a 10% lower risk for current AD (RR 0.90; 95% CI 0.83-0.98).

Study details: Findings are from a meta-analysis of 102 observational studies that analyzed the association between birth order or sibship size and the risk for AD.

Disclosures: This study did not disclose the source of funding. H Kankaanranta declared receiving lecture and consulting fees from various sources. The other authors declared no conflicts of interest.

Source: Lisik D et al. Birth order, sibship size, and risk of atopic dermatitis, food allergy, and atopy: A systematic review and meta‐analysis. Clin Transl Allergy. 2023;13(6):e12270 (Jun 17). Doi: 10.1002/clt2.12270

 

Key clinical point: Having siblings and being born second or later is associated with a marginally reduced lifetime risk of developing atopic dermatitis (AD).

Major finding: Children born in the birth order ≥2 vs 1 had a 9% lower risk for ever AD (pooled risk ratio [RR] 0.91; 95% CI 0.84-0.98), and a sibship size ≥2 vs 1 was associated with an 8% lower risk for ever AD (RR 0.92; 95% CI 0.86-0.97) and a 10% lower risk for current AD (RR 0.90; 95% CI 0.83-0.98).

Study details: Findings are from a meta-analysis of 102 observational studies that analyzed the association between birth order or sibship size and the risk for AD.

Disclosures: This study did not disclose the source of funding. H Kankaanranta declared receiving lecture and consulting fees from various sources. The other authors declared no conflicts of interest.

Source: Lisik D et al. Birth order, sibship size, and risk of atopic dermatitis, food allergy, and atopy: A systematic review and meta‐analysis. Clin Transl Allergy. 2023;13(6):e12270 (Jun 17). Doi: 10.1002/clt2.12270

 

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Probiotic intake by breastfeeding mothers halves the incidence of atopic dermatitis in children

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Key clinical point: Probiotic intake by breastfeeding mothers reduced atopic dermatitis (AD) incidence in children by half, whereas in children receiving probiotic supplementation, AD incidence decreased by 22% only.

Major finding: Probiotic intake by pregnant and breastfeeding mothers, pregnant and breastfeeding mothers and children, and pregnant mothers and children reduced the incidence of pediatric AD by 49% (relative risk [RR] 0.51; 95% CI 0.39-0.66), 39% (RR 0.61; 95% CI 0.43-0.86), and 27% (RR 0.73; 95% CI 0.63-0.86), respectively. Children receiving probiotics vs placebo had a 22% lower incidence of AD (RR 0.78; 95% CI 0.64-0.94).

Study details: Findings are from a systematic review and meta-analysis of 75 studies on the prophylactic (n = 8754 participants) or therapeutic (n = 2021 children) effects of probiotics in children age ≤ 18 years, including 17 studies involving 2844 children who received probiotics or placebo.

Disclosures: This study did not declare the source of funding. M Steinhoff declared receiving research funds from and serving as an advisor and consultant for various organizations.

Source: Husein-ElAhmed H and Steinhoff M. Meta-analysis on preventive and therapeutic effects of probiotic supplementation in infant atopic dermatitis. J Dtsch Dermatol Ges. 2023 (Jun 22). Doi: 10.1111/ddg.15120

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Key clinical point: Probiotic intake by breastfeeding mothers reduced atopic dermatitis (AD) incidence in children by half, whereas in children receiving probiotic supplementation, AD incidence decreased by 22% only.

Major finding: Probiotic intake by pregnant and breastfeeding mothers, pregnant and breastfeeding mothers and children, and pregnant mothers and children reduced the incidence of pediatric AD by 49% (relative risk [RR] 0.51; 95% CI 0.39-0.66), 39% (RR 0.61; 95% CI 0.43-0.86), and 27% (RR 0.73; 95% CI 0.63-0.86), respectively. Children receiving probiotics vs placebo had a 22% lower incidence of AD (RR 0.78; 95% CI 0.64-0.94).

Study details: Findings are from a systematic review and meta-analysis of 75 studies on the prophylactic (n = 8754 participants) or therapeutic (n = 2021 children) effects of probiotics in children age ≤ 18 years, including 17 studies involving 2844 children who received probiotics or placebo.

Disclosures: This study did not declare the source of funding. M Steinhoff declared receiving research funds from and serving as an advisor and consultant for various organizations.

Source: Husein-ElAhmed H and Steinhoff M. Meta-analysis on preventive and therapeutic effects of probiotic supplementation in infant atopic dermatitis. J Dtsch Dermatol Ges. 2023 (Jun 22). Doi: 10.1111/ddg.15120

Key clinical point: Probiotic intake by breastfeeding mothers reduced atopic dermatitis (AD) incidence in children by half, whereas in children receiving probiotic supplementation, AD incidence decreased by 22% only.

Major finding: Probiotic intake by pregnant and breastfeeding mothers, pregnant and breastfeeding mothers and children, and pregnant mothers and children reduced the incidence of pediatric AD by 49% (relative risk [RR] 0.51; 95% CI 0.39-0.66), 39% (RR 0.61; 95% CI 0.43-0.86), and 27% (RR 0.73; 95% CI 0.63-0.86), respectively. Children receiving probiotics vs placebo had a 22% lower incidence of AD (RR 0.78; 95% CI 0.64-0.94).

Study details: Findings are from a systematic review and meta-analysis of 75 studies on the prophylactic (n = 8754 participants) or therapeutic (n = 2021 children) effects of probiotics in children age ≤ 18 years, including 17 studies involving 2844 children who received probiotics or placebo.

Disclosures: This study did not declare the source of funding. M Steinhoff declared receiving research funds from and serving as an advisor and consultant for various organizations.

Source: Husein-ElAhmed H and Steinhoff M. Meta-analysis on preventive and therapeutic effects of probiotic supplementation in infant atopic dermatitis. J Dtsch Dermatol Ges. 2023 (Jun 22). Doi: 10.1111/ddg.15120

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History of herpes zoster predicts recurrence during treatment of atopic dermatitis with upadacitinib

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Key clinical point: A history of herpes zoster (HZ) infection is a predictive factor for the occurrence of HZ in patients with moderate-to-severe atopic dermatitis (AD) during upadacitinib therapy.

Major finding: The incidence of a history of HZ was significantly higher in patients with vs without the occurrence of HZ in the 15 mg upadacitinib (70% vs 3%), 30 mg upadacitinib (100% vs 10%), and overall (79% vs 5%) groups (all P < .01). HZ history was significantly associated with the occurrence of HZ during treatment in the 15 mg upadacitinib (adjusted odds ratio [aOR] 172) and overall (aOR 74.6) groups (both P < .01).

Study details: Findings are from a retrospective analysis of 112 patients aged ≥12 years with moderate-to-severe AD who received 15 mg upadacitinib (n = 78) or 30 mg upadacitinib (n = 34) daily for 3-9 months.

Disclosures: This study did not declare the funding source. All authors, except E Fujimoto, declared receiving research funding or lecture fees from AbbVie GK.

Source: Hagino T et al. Background factors predicting the occurrence of herpes zoster in atopic dermatitis patients treated with upadacitinib. J Dermatol. 2023 (Jul 3). Doi: 10.1111/1346-8138.16879

 

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Key clinical point: A history of herpes zoster (HZ) infection is a predictive factor for the occurrence of HZ in patients with moderate-to-severe atopic dermatitis (AD) during upadacitinib therapy.

Major finding: The incidence of a history of HZ was significantly higher in patients with vs without the occurrence of HZ in the 15 mg upadacitinib (70% vs 3%), 30 mg upadacitinib (100% vs 10%), and overall (79% vs 5%) groups (all P < .01). HZ history was significantly associated with the occurrence of HZ during treatment in the 15 mg upadacitinib (adjusted odds ratio [aOR] 172) and overall (aOR 74.6) groups (both P < .01).

Study details: Findings are from a retrospective analysis of 112 patients aged ≥12 years with moderate-to-severe AD who received 15 mg upadacitinib (n = 78) or 30 mg upadacitinib (n = 34) daily for 3-9 months.

Disclosures: This study did not declare the funding source. All authors, except E Fujimoto, declared receiving research funding or lecture fees from AbbVie GK.

Source: Hagino T et al. Background factors predicting the occurrence of herpes zoster in atopic dermatitis patients treated with upadacitinib. J Dermatol. 2023 (Jul 3). Doi: 10.1111/1346-8138.16879

 

Key clinical point: A history of herpes zoster (HZ) infection is a predictive factor for the occurrence of HZ in patients with moderate-to-severe atopic dermatitis (AD) during upadacitinib therapy.

Major finding: The incidence of a history of HZ was significantly higher in patients with vs without the occurrence of HZ in the 15 mg upadacitinib (70% vs 3%), 30 mg upadacitinib (100% vs 10%), and overall (79% vs 5%) groups (all P < .01). HZ history was significantly associated with the occurrence of HZ during treatment in the 15 mg upadacitinib (adjusted odds ratio [aOR] 172) and overall (aOR 74.6) groups (both P < .01).

Study details: Findings are from a retrospective analysis of 112 patients aged ≥12 years with moderate-to-severe AD who received 15 mg upadacitinib (n = 78) or 30 mg upadacitinib (n = 34) daily for 3-9 months.

Disclosures: This study did not declare the funding source. All authors, except E Fujimoto, declared receiving research funding or lecture fees from AbbVie GK.

Source: Hagino T et al. Background factors predicting the occurrence of herpes zoster in atopic dermatitis patients treated with upadacitinib. J Dermatol. 2023 (Jul 3). Doi: 10.1111/1346-8138.16879

 

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Atopic dermatitis decreases lung function in infants

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Key clinical point: Infants with atopic dermatitis (AD) experience significant bronchial obstruction regardless of disease severity, food sensitivity, and a history of recurrent wheezing.

Major finding: Tidal breath analysis revealed that the AD vs control group had significantly lower time to peak tidal expiratory flow (TPTEF; P = .001), exhaled volume to peak tidal expiratory flow (VPTEF; P = .001), TPTEF/expiratory time (P < .001), VPTEF/total expiratory volume (P < .001), expiratory flow when 25% of tidal volume remains in the lungs (P < .001), and respiratory rate (P = .007), with no differences observed within the AD group when these parameters were compared based on disease severity, food sensitivity, and a history of recurrent wheezing (all P > .05).

Study details: This prospective cross-sectional study included 150 infants aged 0-3 years with AD and 80 control infants of similar age without chronic disease, acute or chronic infection, history of prematurity, developmental delay, neurometabolic disease, or atopy.

Disclosures: This study did not receive any funding. The authors declared no conflicts of interest.

Source: Koksal ZG and Uysal P. Beyond the skin: Reduced lung function associated with atopic dermatitis in infants. J Allergy Clin Immunol Pract. 2023 (Jul 3). Doi: 10.1016/j.jaip.2023.06.055

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Key clinical point: Infants with atopic dermatitis (AD) experience significant bronchial obstruction regardless of disease severity, food sensitivity, and a history of recurrent wheezing.

Major finding: Tidal breath analysis revealed that the AD vs control group had significantly lower time to peak tidal expiratory flow (TPTEF; P = .001), exhaled volume to peak tidal expiratory flow (VPTEF; P = .001), TPTEF/expiratory time (P < .001), VPTEF/total expiratory volume (P < .001), expiratory flow when 25% of tidal volume remains in the lungs (P < .001), and respiratory rate (P = .007), with no differences observed within the AD group when these parameters were compared based on disease severity, food sensitivity, and a history of recurrent wheezing (all P > .05).

Study details: This prospective cross-sectional study included 150 infants aged 0-3 years with AD and 80 control infants of similar age without chronic disease, acute or chronic infection, history of prematurity, developmental delay, neurometabolic disease, or atopy.

Disclosures: This study did not receive any funding. The authors declared no conflicts of interest.

Source: Koksal ZG and Uysal P. Beyond the skin: Reduced lung function associated with atopic dermatitis in infants. J Allergy Clin Immunol Pract. 2023 (Jul 3). Doi: 10.1016/j.jaip.2023.06.055

Key clinical point: Infants with atopic dermatitis (AD) experience significant bronchial obstruction regardless of disease severity, food sensitivity, and a history of recurrent wheezing.

Major finding: Tidal breath analysis revealed that the AD vs control group had significantly lower time to peak tidal expiratory flow (TPTEF; P = .001), exhaled volume to peak tidal expiratory flow (VPTEF; P = .001), TPTEF/expiratory time (P < .001), VPTEF/total expiratory volume (P < .001), expiratory flow when 25% of tidal volume remains in the lungs (P < .001), and respiratory rate (P = .007), with no differences observed within the AD group when these parameters were compared based on disease severity, food sensitivity, and a history of recurrent wheezing (all P > .05).

Study details: This prospective cross-sectional study included 150 infants aged 0-3 years with AD and 80 control infants of similar age without chronic disease, acute or chronic infection, history of prematurity, developmental delay, neurometabolic disease, or atopy.

Disclosures: This study did not receive any funding. The authors declared no conflicts of interest.

Source: Koksal ZG and Uysal P. Beyond the skin: Reduced lung function associated with atopic dermatitis in infants. J Allergy Clin Immunol Pract. 2023 (Jul 3). Doi: 10.1016/j.jaip.2023.06.055

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Clinical Edge Journal Scan: Atopic Dermatitis August 2023
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Baricitinib improves outcomes in moderate-to-severe atopic dermatitis

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Mon, 07/31/2023 - 10:44

Key clinical point: In patients with moderate-to-severe atopic dermatitis (AD), baricitinib with or without topical corticosteroids (TCS) resulted in rapid achievement of the recommended absolute Eczema Area and Severity Index (EASI) and SCORing of AD (SCORAD) outcomes, which were sustained until week 16.

Major finding: An EASI score of ≤7 and a SCORAD score of <25 were achieved by significantly more patients receiving baricitinib (2 or 4 mg) vs placebo at all timepoints from week 1 (all P ≤ .01 and all P ≤ .05, respectively) and those receiving 4 mg baricitinib + TCS vs placebo + TCS at all timepoints from week 2 (all P ≤ .05 for both).

Study details: This post hoc analysis included 1316 patients with moderate-to-severe AD who received baricitinib (2 or 4 mg) or placebo in BREEZE-AD1/AD2 or baricitinib (2 or 4 mg)+TCS or placebo+TCS in BREEZE-AD7 for 16 weeks.

Disclosures: This study was funded by Eli Lilly and Company. Some authors reported ties with various organizations, including Eli Lilly. Three authors declared being current or former employees or shareholders of Eli Lilly.

Source: Thyssen JP et al. Baricitinib provides rapid and sustained improvements in absolute EASI and SCORAD outcomes in adults with moderate-to-severe atopic dermatitis. J Dermatolog Treat. 2023;34(1):2216322 (Jun 21). Doi: 10.1080/09546634.2023.2216322

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Key clinical point: In patients with moderate-to-severe atopic dermatitis (AD), baricitinib with or without topical corticosteroids (TCS) resulted in rapid achievement of the recommended absolute Eczema Area and Severity Index (EASI) and SCORing of AD (SCORAD) outcomes, which were sustained until week 16.

Major finding: An EASI score of ≤7 and a SCORAD score of <25 were achieved by significantly more patients receiving baricitinib (2 or 4 mg) vs placebo at all timepoints from week 1 (all P ≤ .01 and all P ≤ .05, respectively) and those receiving 4 mg baricitinib + TCS vs placebo + TCS at all timepoints from week 2 (all P ≤ .05 for both).

Study details: This post hoc analysis included 1316 patients with moderate-to-severe AD who received baricitinib (2 or 4 mg) or placebo in BREEZE-AD1/AD2 or baricitinib (2 or 4 mg)+TCS or placebo+TCS in BREEZE-AD7 for 16 weeks.

Disclosures: This study was funded by Eli Lilly and Company. Some authors reported ties with various organizations, including Eli Lilly. Three authors declared being current or former employees or shareholders of Eli Lilly.

Source: Thyssen JP et al. Baricitinib provides rapid and sustained improvements in absolute EASI and SCORAD outcomes in adults with moderate-to-severe atopic dermatitis. J Dermatolog Treat. 2023;34(1):2216322 (Jun 21). Doi: 10.1080/09546634.2023.2216322

Key clinical point: In patients with moderate-to-severe atopic dermatitis (AD), baricitinib with or without topical corticosteroids (TCS) resulted in rapid achievement of the recommended absolute Eczema Area and Severity Index (EASI) and SCORing of AD (SCORAD) outcomes, which were sustained until week 16.

Major finding: An EASI score of ≤7 and a SCORAD score of <25 were achieved by significantly more patients receiving baricitinib (2 or 4 mg) vs placebo at all timepoints from week 1 (all P ≤ .01 and all P ≤ .05, respectively) and those receiving 4 mg baricitinib + TCS vs placebo + TCS at all timepoints from week 2 (all P ≤ .05 for both).

Study details: This post hoc analysis included 1316 patients with moderate-to-severe AD who received baricitinib (2 or 4 mg) or placebo in BREEZE-AD1/AD2 or baricitinib (2 or 4 mg)+TCS or placebo+TCS in BREEZE-AD7 for 16 weeks.

Disclosures: This study was funded by Eli Lilly and Company. Some authors reported ties with various organizations, including Eli Lilly. Three authors declared being current or former employees or shareholders of Eli Lilly.

Source: Thyssen JP et al. Baricitinib provides rapid and sustained improvements in absolute EASI and SCORAD outcomes in adults with moderate-to-severe atopic dermatitis. J Dermatolog Treat. 2023;34(1):2216322 (Jun 21). Doi: 10.1080/09546634.2023.2216322

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Upadacitinib offers long-term benefits against treatment-resistant moderate-to-severe atopic dermatitis

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Key clinical point: Upadacitinib demonstrated an acceptable safety profile and led to significant and sustained improvements in disease signs and symptoms through 48 weeks of observation in patients with moderate-to-severe atopic dermatitis (AD) who were unresponsive to conventional treatments.

Major finding: At weeks 16 and 48, an Eczema Area and Severity Index-75 response was achieved by 78.2% and 87.6% of patients, respectively, with a significant reduction in mean sleeplessness, skin pain, and itch Numeric Rating Scale scores (all P < .001). Most adverse events were of mild-to-moderate severity.

Study details: This real-world prospective study included 146 adult patients with moderate-to-severe AD who were unresponsive, intolerant, or had contraindications to the approved therapies for moderate-to-severe AD and received 15 or 30 mg upadacitinib alone or combined with corticosteroids for 48 weeks.

Disclosures: This study did not receive any funding. Some authors, including the lead author, declared serving as investigators, speakers, advisory board members, or consultants for or receiving lecture or speaker honoraria, research grants, or personal fees from various sources.

Source: Chiricozzi A et al. Long-term effectiveness and safety of upadacitinib for atopic dermatitis in a real-world setting: An interim analysis through 48 weeks of observation. Am J Clin Dermatol. 2023 (Jun 15). Doi: 10.1007/s40257-023-00798-0

 

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Key clinical point: Upadacitinib demonstrated an acceptable safety profile and led to significant and sustained improvements in disease signs and symptoms through 48 weeks of observation in patients with moderate-to-severe atopic dermatitis (AD) who were unresponsive to conventional treatments.

Major finding: At weeks 16 and 48, an Eczema Area and Severity Index-75 response was achieved by 78.2% and 87.6% of patients, respectively, with a significant reduction in mean sleeplessness, skin pain, and itch Numeric Rating Scale scores (all P < .001). Most adverse events were of mild-to-moderate severity.

Study details: This real-world prospective study included 146 adult patients with moderate-to-severe AD who were unresponsive, intolerant, or had contraindications to the approved therapies for moderate-to-severe AD and received 15 or 30 mg upadacitinib alone or combined with corticosteroids for 48 weeks.

Disclosures: This study did not receive any funding. Some authors, including the lead author, declared serving as investigators, speakers, advisory board members, or consultants for or receiving lecture or speaker honoraria, research grants, or personal fees from various sources.

Source: Chiricozzi A et al. Long-term effectiveness and safety of upadacitinib for atopic dermatitis in a real-world setting: An interim analysis through 48 weeks of observation. Am J Clin Dermatol. 2023 (Jun 15). Doi: 10.1007/s40257-023-00798-0

 

Key clinical point: Upadacitinib demonstrated an acceptable safety profile and led to significant and sustained improvements in disease signs and symptoms through 48 weeks of observation in patients with moderate-to-severe atopic dermatitis (AD) who were unresponsive to conventional treatments.

Major finding: At weeks 16 and 48, an Eczema Area and Severity Index-75 response was achieved by 78.2% and 87.6% of patients, respectively, with a significant reduction in mean sleeplessness, skin pain, and itch Numeric Rating Scale scores (all P < .001). Most adverse events were of mild-to-moderate severity.

Study details: This real-world prospective study included 146 adult patients with moderate-to-severe AD who were unresponsive, intolerant, or had contraindications to the approved therapies for moderate-to-severe AD and received 15 or 30 mg upadacitinib alone or combined with corticosteroids for 48 weeks.

Disclosures: This study did not receive any funding. Some authors, including the lead author, declared serving as investigators, speakers, advisory board members, or consultants for or receiving lecture or speaker honoraria, research grants, or personal fees from various sources.

Source: Chiricozzi A et al. Long-term effectiveness and safety of upadacitinib for atopic dermatitis in a real-world setting: An interim analysis through 48 weeks of observation. Am J Clin Dermatol. 2023 (Jun 15). Doi: 10.1007/s40257-023-00798-0

 

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