MDedge Dermatology

Pediatric patients with atopic dermatitis (AD) are more likely to experience symptoms at classical sites such as the knees and have more associated and severe signs of AD, while older adults tend to present with less flexural eczema and the fewest associated signs.

Those are key findings from a study conducted at a single academic medical center, which aimed to identify the age-related clinical phenotypes of AD.

LucaLorenzelli/Thinkstock

“Previous studies have found differences in the clinical characteristics of AD depending on age of AD onset, ethnic background, and AD severity,” senior author Jonathan I. Silverberg, MD, PhD, MPH, director of clinical research in the department of dermatology at George Washington University, Washington, and his coauthor wrote in the study, which was published online in JAAD International. “However, none have prospectively compared the clinical characteristics and associated signs by age group. Improved understanding of the clinical phenotypes of AD may help guide choice of treatment and improve health outcomes,” they added.

Along with coauthor Sheena Chatrath, a dermatology research fellow in the department, Dr. Silverberg prospectively reviewed self-reported questionnaires that were completed by 380 patients prior to their visit at GWU’s eczema clinic between 2013 and 2019. Questions included age of AD onset, sociodemographics, Visual Analog Scale (VAS) itch and sleep for Scoring AD, and Numeric Rating Scale (NRS) for skin pain and itch. The researchers used the Eczema Area Severity Index to assess AD severity and a dermatologist conducted full body skin exams, noting the distribution of AD involvement as well as associated signs.

Of the 380 patients, 6.1% were younger than aged 18 years, 46.3% were young adults aged 18-39 years, and 47.6% were older adults 40 years of age and older.

Compared with pediatric patients, both young and older adults were less likely to experience AD on the ankles (adjusted odds ratio [aOR], 0.41 and 0.43, respectively), moderate to severe AD lesions on flexures (aOR, 0.47 and 0.30), pityriasis alba (aOR, 0.24 and 0.07), oozing lesions (aOR, 0.44 and 0.35), and moderate to severe excoriations (aOR, 0.49 and 0.44).

In children, severe itch was more common, reported in 47.1%, compared with 43.4% of the young adults and 38.6% of the older adults, and itch was less severe among the young and older adults. “Interestingly, despite increased itch in pediatric patients, we found no difference in the severity of skin pain across all age groups,” the researchers wrote. “Moreover, pediatric patients reported skin pain less often than adult patients. This may be due to age-related differences of pain perception.”

In other findings, compared with pediatric patients, young adults were more likely to experience AD around the eyes (aOR, 2.92), while older adults were less likely to experience AD on elbows (aOR, 0.34), nipples (aOR, 0.40), knees (aOR, 0.27), and less likely to have keratosis pilaris (aOR, 0.38), and lichenification (aOR, 0.47).

Dr. Silverberg and Ms. Chatrath used latent class analysis to identify four classes for distribution of AD lesions. In this model, class 1 had low probabilities of AD involvement at all sites examined and class 2 had low probabilities of scalp, face, and foot involvement, and intermediate probability of all other AD sites. Class 3 had low probabilities of hand and foot involvement, high probability of facial erythema, and intermediate probability of all other AD signs, while class 4 had intermediate probability of postauricular and foot involvement, and high probability of all other AD sites examined.

“Pediatric patients were most commonly in class 4 (33.3%), followed by class 1 and 2 (26.7%), and least commonly in class 3 (13.3%),” the authors wrote. “In young adults, class 4 and 1 were most common (32.4% and 29.4%), followed by class 2 (27.9%), and least commonly class 3 (10.3%). In older adults, class 1 was most common (40.3%), followed by class 4 (23.6%), and least commonly classes 2 and 3 (18.1%).”

The researchers also used latent class analysis to identify four classes for the signs and symptoms of AD. In this model, class 1 had zero-low probability of all AD signs and class 2 had low probability of all AD signs. Class 3 had high probability of oozing lesions and low probability of all other signs, while class 4 had high probability of xerosis, intermediate probability of ichthyosis and palmar hyperlinearity, and low probability of all other AD signs.

In all three groups, the most common class was class 1 (85.6% of older adults, 81.8% of younger adults, and 82.6% of pediatric patients). Among the pediatric patients, they wrote, “class 3 was the second most common (8.7%), followed by class 2 and 4 (4.4%).” Among the young adults, 9.7% were in class 2, 5.7% were in class 4, and 2.8% were in class 3; and among the older adults, 8.3% were in class 4, 4.4% were in class 2, and 1.67% were in class 3.

Zelma Chiesa Fuxench, MD, of the department of dermatology at the University of Pennsylvania, Philadelphia, who was asked to comment on the study, said that while AD is traditionally largely thought of as a disease of children primarily involving the flexural areas, “this study provides additional evidence to support that AD is more than just a disease of childhood with a fixed clinical presentation, but is a heterogeneous disease whose clinical presentation varies across different population groups.”

Pediatric patients with atopic dermatitis (AD) are more likely to experience symptoms at classical sites such as the knees and have more associated and severe signs of AD, while older adults tend to present with less flexural eczema and the fewest associated signs.

Those are key findings from a study conducted at a single academic medical center, which aimed to identify the age-related clinical phenotypes of AD.

LucaLorenzelli/Thinkstock

“Previous studies have found differences in the clinical characteristics of AD depending on age of AD onset, ethnic background, and AD severity,” senior author Jonathan I. Silverberg, MD, PhD, MPH, director of clinical research in the department of dermatology at George Washington University, Washington, and his coauthor wrote in the study, which was published online in JAAD International. “However, none have prospectively compared the clinical characteristics and associated signs by age group. Improved understanding of the clinical phenotypes of AD may help guide choice of treatment and improve health outcomes,” they added.

Along with coauthor Sheena Chatrath, a dermatology research fellow in the department, Dr. Silverberg prospectively reviewed self-reported questionnaires that were completed by 380 patients prior to their visit at GWU’s eczema clinic between 2013 and 2019. Questions included age of AD onset, sociodemographics, Visual Analog Scale (VAS) itch and sleep for Scoring AD, and Numeric Rating Scale (NRS) for skin pain and itch. The researchers used the Eczema Area Severity Index to assess AD severity and a dermatologist conducted full body skin exams, noting the distribution of AD involvement as well as associated signs.

Of the 380 patients, 6.1% were younger than aged 18 years, 46.3% were young adults aged 18-39 years, and 47.6% were older adults 40 years of age and older.

Compared with pediatric patients, both young and older adults were less likely to experience AD on the ankles (adjusted odds ratio [aOR], 0.41 and 0.43, respectively), moderate to severe AD lesions on flexures (aOR, 0.47 and 0.30), pityriasis alba (aOR, 0.24 and 0.07), oozing lesions (aOR, 0.44 and 0.35), and moderate to severe excoriations (aOR, 0.49 and 0.44).

In children, severe itch was more common, reported in 47.1%, compared with 43.4% of the young adults and 38.6% of the older adults, and itch was less severe among the young and older adults. “Interestingly, despite increased itch in pediatric patients, we found no difference in the severity of skin pain across all age groups,” the researchers wrote. “Moreover, pediatric patients reported skin pain less often than adult patients. This may be due to age-related differences of pain perception.”

In other findings, compared with pediatric patients, young adults were more likely to experience AD around the eyes (aOR, 2.92), while older adults were less likely to experience AD on elbows (aOR, 0.34), nipples (aOR, 0.40), knees (aOR, 0.27), and less likely to have keratosis pilaris (aOR, 0.38), and lichenification (aOR, 0.47).

Dr. Silverberg and Ms. Chatrath used latent class analysis to identify four classes for distribution of AD lesions. In this model, class 1 had low probabilities of AD involvement at all sites examined and class 2 had low probabilities of scalp, face, and foot involvement, and intermediate probability of all other AD sites. Class 3 had low probabilities of hand and foot involvement, high probability of facial erythema, and intermediate probability of all other AD signs, while class 4 had intermediate probability of postauricular and foot involvement, and high probability of all other AD sites examined.

“Pediatric patients were most commonly in class 4 (33.3%), followed by class 1 and 2 (26.7%), and least commonly in class 3 (13.3%),” the authors wrote. “In young adults, class 4 and 1 were most common (32.4% and 29.4%), followed by class 2 (27.9%), and least commonly class 3 (10.3%). In older adults, class 1 was most common (40.3%), followed by class 4 (23.6%), and least commonly classes 2 and 3 (18.1%).”

The researchers also used latent class analysis to identify four classes for the signs and symptoms of AD. In this model, class 1 had zero-low probability of all AD signs and class 2 had low probability of all AD signs. Class 3 had high probability of oozing lesions and low probability of all other signs, while class 4 had high probability of xerosis, intermediate probability of ichthyosis and palmar hyperlinearity, and low probability of all other AD signs.

In all three groups, the most common class was class 1 (85.6% of older adults, 81.8% of younger adults, and 82.6% of pediatric patients). Among the pediatric patients, they wrote, “class 3 was the second most common (8.7%), followed by class 2 and 4 (4.4%).” Among the young adults, 9.7% were in class 2, 5.7% were in class 4, and 2.8% were in class 3; and among the older adults, 8.3% were in class 4, 4.4% were in class 2, and 1.67% were in class 3.

Zelma Chiesa Fuxench, MD, of the department of dermatology at the University of Pennsylvania, Philadelphia, who was asked to comment on the study, said that while AD is traditionally largely thought of as a disease of children primarily involving the flexural areas, “this study provides additional evidence to support that AD is more than just a disease of childhood with a fixed clinical presentation, but is a heterogeneous disease whose clinical presentation varies across different population groups.”

Pediatric patients with atopic dermatitis (AD) are more likely to experience symptoms at classical sites such as the knees and have more associated and severe signs of AD, while older adults tend to present with less flexural eczema and the fewest associated signs.

Those are key findings from a study conducted at a single academic medical center, which aimed to identify the age-related clinical phenotypes of AD.

LucaLorenzelli/Thinkstock

“Previous studies have found differences in the clinical characteristics of AD depending on age of AD onset, ethnic background, and AD severity,” senior author Jonathan I. Silverberg, MD, PhD, MPH, director of clinical research in the department of dermatology at George Washington University, Washington, and his coauthor wrote in the study, which was published online in JAAD International. “However, none have prospectively compared the clinical characteristics and associated signs by age group. Improved understanding of the clinical phenotypes of AD may help guide choice of treatment and improve health outcomes,” they added.

Along with coauthor Sheena Chatrath, a dermatology research fellow in the department, Dr. Silverberg prospectively reviewed self-reported questionnaires that were completed by 380 patients prior to their visit at GWU’s eczema clinic between 2013 and 2019. Questions included age of AD onset, sociodemographics, Visual Analog Scale (VAS) itch and sleep for Scoring AD, and Numeric Rating Scale (NRS) for skin pain and itch. The researchers used the Eczema Area Severity Index to assess AD severity and a dermatologist conducted full body skin exams, noting the distribution of AD involvement as well as associated signs.

Of the 380 patients, 6.1% were younger than aged 18 years, 46.3% were young adults aged 18-39 years, and 47.6% were older adults 40 years of age and older.

Compared with pediatric patients, both young and older adults were less likely to experience AD on the ankles (adjusted odds ratio [aOR], 0.41 and 0.43, respectively), moderate to severe AD lesions on flexures (aOR, 0.47 and 0.30), pityriasis alba (aOR, 0.24 and 0.07), oozing lesions (aOR, 0.44 and 0.35), and moderate to severe excoriations (aOR, 0.49 and 0.44).

In children, severe itch was more common, reported in 47.1%, compared with 43.4% of the young adults and 38.6% of the older adults, and itch was less severe among the young and older adults. “Interestingly, despite increased itch in pediatric patients, we found no difference in the severity of skin pain across all age groups,” the researchers wrote. “Moreover, pediatric patients reported skin pain less often than adult patients. This may be due to age-related differences of pain perception.”

In other findings, compared with pediatric patients, young adults were more likely to experience AD around the eyes (aOR, 2.92), while older adults were less likely to experience AD on elbows (aOR, 0.34), nipples (aOR, 0.40), knees (aOR, 0.27), and less likely to have keratosis pilaris (aOR, 0.38), and lichenification (aOR, 0.47).

Dr. Silverberg and Ms. Chatrath used latent class analysis to identify four classes for distribution of AD lesions. In this model, class 1 had low probabilities of AD involvement at all sites examined and class 2 had low probabilities of scalp, face, and foot involvement, and intermediate probability of all other AD sites. Class 3 had low probabilities of hand and foot involvement, high probability of facial erythema, and intermediate probability of all other AD signs, while class 4 had intermediate probability of postauricular and foot involvement, and high probability of all other AD sites examined.

“Pediatric patients were most commonly in class 4 (33.3%), followed by class 1 and 2 (26.7%), and least commonly in class 3 (13.3%),” the authors wrote. “In young adults, class 4 and 1 were most common (32.4% and 29.4%), followed by class 2 (27.9%), and least commonly class 3 (10.3%). In older adults, class 1 was most common (40.3%), followed by class 4 (23.6%), and least commonly classes 2 and 3 (18.1%).”

The researchers also used latent class analysis to identify four classes for the signs and symptoms of AD. In this model, class 1 had zero-low probability of all AD signs and class 2 had low probability of all AD signs. Class 3 had high probability of oozing lesions and low probability of all other signs, while class 4 had high probability of xerosis, intermediate probability of ichthyosis and palmar hyperlinearity, and low probability of all other AD signs.

In all three groups, the most common class was class 1 (85.6% of older adults, 81.8% of younger adults, and 82.6% of pediatric patients). Among the pediatric patients, they wrote, “class 3 was the second most common (8.7%), followed by class 2 and 4 (4.4%).” Among the young adults, 9.7% were in class 2, 5.7% were in class 4, and 2.8% were in class 3; and among the older adults, 8.3% were in class 4, 4.4% were in class 2, and 1.67% were in class 3.

Zelma Chiesa Fuxench, MD, of the department of dermatology at the University of Pennsylvania, Philadelphia, who was asked to comment on the study, said that while AD is traditionally largely thought of as a disease of children primarily involving the flexural areas, “this study provides additional evidence to support that AD is more than just a disease of childhood with a fixed clinical presentation, but is a heterogeneous disease whose clinical presentation varies across different population groups.”

If Willarda Edwards, MD, MBA, had won her 2022 campaign for president-elect of the American Medical Association (AMA), she would have been the second Black woman to head the group.

The AMA, however, accused her of vote trading. Now, the Baltimore internist and AMA trustee has sued the organization for defamation and conspiracy.

The lawsuit sheds light on the power dynamics of a politically potent organization that has more than 271,000 members and holds assets of $1.2 billion. The AMA president is one of the most visible figures in American medicine.

“The AMA impugned Dr. Edwards with these false charges, which destroyed her candidacy and irreparably damaged her reputation,” according to the complaint, which was filed Nov. 9, 2022, in Baltimore County Circuit Court. The case was later moved to federal court.

The AMA “previously rejected our attempt to resolve this matter without litigation,” Dr. Edwards’ attorney, Timothy Maloney, told this news organization. An AMA spokesman said the organization had no comment on Dr. Edwards’ suit.

Dr. Edwards is a past president of the National Medical Association, MedChi, the Baltimore City Medical Society, the Monumental City Medical Society, and the Sickle Cell Disease Association of America. She joined the AMA in 1994 and has served as a trustee since 2016.

As chair of the AMA Task Force on Health Equity, “she helped lead the way in consensus building and driving action that in 2019 resulted in the AMA House of Delegates establishing the AMA Center on Health Equity,” according to her AMA bio page.
 

‘Quid pro quo’ alleged

In June 2022, Dr. Edwards was one of three individuals running to be AMA president-elect.

According to Dr. Edwards’ complaint, she was “incorrectly advised by colleagues” that Virginia urologist William Reha, MD, had decided not to seek the AMA vice-speakership in 2023. This was important because both Dr. Edwards and Dr. Reha were in the Southeastern delegation. It could be in Dr. Edwards’ favor if Dr. Reha was not running, as it would mean one less leadership candidate from the same region.

Dr. Edwards called Dr. Reha on June 6 to discuss the matter. When they talked, Dr. Reha allegedly recorded the call without Dr. Edwards’ knowledge or permission – a felony in Maryland – and also steered her toward discussions about how his decision could benefit her campaign, according to the complaint.

The suit alleges that Dr. Reha’s questions were “clearly calculated to draw some statements by Dr. Edwards that he could use later to thwart her candidacy and to benefit her opponent.”

On June 10, at the AMA’s House of Delegates meeting in Chicago, Dr. Edwards was taken aside and questioned by members of the AMA’s Election Campaign Committee, according to the complaint. They accused her of “vote trading” but did not provide any evidence or a copy of a complaint they said had been filed against her, the suit said.

Dr. Edwards was given no opportunity to produce her own evidence or rebut the accusations, the suit alleges.

Just before the delegates started formal business on June 13, House Speaker Bruce Scott, MD, read a statement to the assembly saying that a complaint of a possible campaign violation had been filed against Dr. Edwards.

Dr. Scott told the delegates that “committee members interviewed the complainant and multiple other individuals said to have knowledge of the circumstances. In addition to conducting multiple interviews, the committee reviewed evidence that was deemed credible and corroborated that a campaign violation did in fact occur,” according to the complaint.

The supposed violation: A “quid pro quo” in which an unnamed delegation would support Dr. Edwards’ current candidacy, and the Southeastern delegation would support a future candidate from that other unnamed delegation.

Dr. Edwards was given a short opportunity to speak, in which she denied any violations.

According to a news report, Dr. Edwards said, “I’ve been in the House of Delegates for 30 years, and you know me as a process person – a person who truly believes in the process and trying to follow the complexities of our election campaign.”

The lawsuit alleges that “this defamatory conduct was repeated the next day to more than 600 delegates just minutes prior to the casting of votes, when Dr Scott repeated these allegations.”

Dr. Edwards lost the election.
 

AMA: Nothing more to add

The suit alleges that neither the Election Campaign Committee nor the AMA itself has made any accusers or complaints available to Dr. Edwards and that it has not provided any audio or written evidence of her alleged violation.

In July, the AMA’s Southeastern delegation told its membership, “We continue to maintain that Willarda was ‘set up’ ... The whole affair lacked any reasonable semblance of due process.”

The delegation has filed a counter claim against the AMA seeking “to address this lack of due process as well as the reputational harm” to the delegation.

The AMA said that it has nothing it can produce. “The Speaker of the House presented a verbal report to the attending delegates,” said a spokesman. “The Speaker’s report remains the only remarks from an AMA officer, and no additional remarks can be expected at this time.”

He added that there “is no official transcript of the Speaker’s report.”

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

If Willarda Edwards, MD, MBA, had won her 2022 campaign for president-elect of the American Medical Association (AMA), she would have been the second Black woman to head the group.

The AMA, however, accused her of vote trading. Now, the Baltimore internist and AMA trustee has sued the organization for defamation and conspiracy.

The lawsuit sheds light on the power dynamics of a politically potent organization that has more than 271,000 members and holds assets of $1.2 billion. The AMA president is one of the most visible figures in American medicine.

“The AMA impugned Dr. Edwards with these false charges, which destroyed her candidacy and irreparably damaged her reputation,” according to the complaint, which was filed Nov. 9, 2022, in Baltimore County Circuit Court. The case was later moved to federal court.

The AMA “previously rejected our attempt to resolve this matter without litigation,” Dr. Edwards’ attorney, Timothy Maloney, told this news organization. An AMA spokesman said the organization had no comment on Dr. Edwards’ suit.

Dr. Edwards is a past president of the National Medical Association, MedChi, the Baltimore City Medical Society, the Monumental City Medical Society, and the Sickle Cell Disease Association of America. She joined the AMA in 1994 and has served as a trustee since 2016.

As chair of the AMA Task Force on Health Equity, “she helped lead the way in consensus building and driving action that in 2019 resulted in the AMA House of Delegates establishing the AMA Center on Health Equity,” according to her AMA bio page.
 

‘Quid pro quo’ alleged

In June 2022, Dr. Edwards was one of three individuals running to be AMA president-elect.

According to Dr. Edwards’ complaint, she was “incorrectly advised by colleagues” that Virginia urologist William Reha, MD, had decided not to seek the AMA vice-speakership in 2023. This was important because both Dr. Edwards and Dr. Reha were in the Southeastern delegation. It could be in Dr. Edwards’ favor if Dr. Reha was not running, as it would mean one less leadership candidate from the same region.

Dr. Edwards called Dr. Reha on June 6 to discuss the matter. When they talked, Dr. Reha allegedly recorded the call without Dr. Edwards’ knowledge or permission – a felony in Maryland – and also steered her toward discussions about how his decision could benefit her campaign, according to the complaint.

The suit alleges that Dr. Reha’s questions were “clearly calculated to draw some statements by Dr. Edwards that he could use later to thwart her candidacy and to benefit her opponent.”

On June 10, at the AMA’s House of Delegates meeting in Chicago, Dr. Edwards was taken aside and questioned by members of the AMA’s Election Campaign Committee, according to the complaint. They accused her of “vote trading” but did not provide any evidence or a copy of a complaint they said had been filed against her, the suit said.

Dr. Edwards was given no opportunity to produce her own evidence or rebut the accusations, the suit alleges.

Just before the delegates started formal business on June 13, House Speaker Bruce Scott, MD, read a statement to the assembly saying that a complaint of a possible campaign violation had been filed against Dr. Edwards.

Dr. Scott told the delegates that “committee members interviewed the complainant and multiple other individuals said to have knowledge of the circumstances. In addition to conducting multiple interviews, the committee reviewed evidence that was deemed credible and corroborated that a campaign violation did in fact occur,” according to the complaint.

The supposed violation: A “quid pro quo” in which an unnamed delegation would support Dr. Edwards’ current candidacy, and the Southeastern delegation would support a future candidate from that other unnamed delegation.

Dr. Edwards was given a short opportunity to speak, in which she denied any violations.

According to a news report, Dr. Edwards said, “I’ve been in the House of Delegates for 30 years, and you know me as a process person – a person who truly believes in the process and trying to follow the complexities of our election campaign.”

The lawsuit alleges that “this defamatory conduct was repeated the next day to more than 600 delegates just minutes prior to the casting of votes, when Dr Scott repeated these allegations.”

Dr. Edwards lost the election.
 

AMA: Nothing more to add

The suit alleges that neither the Election Campaign Committee nor the AMA itself has made any accusers or complaints available to Dr. Edwards and that it has not provided any audio or written evidence of her alleged violation.

In July, the AMA’s Southeastern delegation told its membership, “We continue to maintain that Willarda was ‘set up’ ... The whole affair lacked any reasonable semblance of due process.”

The delegation has filed a counter claim against the AMA seeking “to address this lack of due process as well as the reputational harm” to the delegation.

The AMA said that it has nothing it can produce. “The Speaker of the House presented a verbal report to the attending delegates,” said a spokesman. “The Speaker’s report remains the only remarks from an AMA officer, and no additional remarks can be expected at this time.”

He added that there “is no official transcript of the Speaker’s report.”

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

If Willarda Edwards, MD, MBA, had won her 2022 campaign for president-elect of the American Medical Association (AMA), she would have been the second Black woman to head the group.

The AMA, however, accused her of vote trading. Now, the Baltimore internist and AMA trustee has sued the organization for defamation and conspiracy.

The lawsuit sheds light on the power dynamics of a politically potent organization that has more than 271,000 members and holds assets of $1.2 billion. The AMA president is one of the most visible figures in American medicine.

“The AMA impugned Dr. Edwards with these false charges, which destroyed her candidacy and irreparably damaged her reputation,” according to the complaint, which was filed Nov. 9, 2022, in Baltimore County Circuit Court. The case was later moved to federal court.

The AMA “previously rejected our attempt to resolve this matter without litigation,” Dr. Edwards’ attorney, Timothy Maloney, told this news organization. An AMA spokesman said the organization had no comment on Dr. Edwards’ suit.

Dr. Edwards is a past president of the National Medical Association, MedChi, the Baltimore City Medical Society, the Monumental City Medical Society, and the Sickle Cell Disease Association of America. She joined the AMA in 1994 and has served as a trustee since 2016.

As chair of the AMA Task Force on Health Equity, “she helped lead the way in consensus building and driving action that in 2019 resulted in the AMA House of Delegates establishing the AMA Center on Health Equity,” according to her AMA bio page.
 

‘Quid pro quo’ alleged

In June 2022, Dr. Edwards was one of three individuals running to be AMA president-elect.

According to Dr. Edwards’ complaint, she was “incorrectly advised by colleagues” that Virginia urologist William Reha, MD, had decided not to seek the AMA vice-speakership in 2023. This was important because both Dr. Edwards and Dr. Reha were in the Southeastern delegation. It could be in Dr. Edwards’ favor if Dr. Reha was not running, as it would mean one less leadership candidate from the same region.

Dr. Edwards called Dr. Reha on June 6 to discuss the matter. When they talked, Dr. Reha allegedly recorded the call without Dr. Edwards’ knowledge or permission – a felony in Maryland – and also steered her toward discussions about how his decision could benefit her campaign, according to the complaint.

The suit alleges that Dr. Reha’s questions were “clearly calculated to draw some statements by Dr. Edwards that he could use later to thwart her candidacy and to benefit her opponent.”

On June 10, at the AMA’s House of Delegates meeting in Chicago, Dr. Edwards was taken aside and questioned by members of the AMA’s Election Campaign Committee, according to the complaint. They accused her of “vote trading” but did not provide any evidence or a copy of a complaint they said had been filed against her, the suit said.

Dr. Edwards was given no opportunity to produce her own evidence or rebut the accusations, the suit alleges.

Just before the delegates started formal business on June 13, House Speaker Bruce Scott, MD, read a statement to the assembly saying that a complaint of a possible campaign violation had been filed against Dr. Edwards.

Dr. Scott told the delegates that “committee members interviewed the complainant and multiple other individuals said to have knowledge of the circumstances. In addition to conducting multiple interviews, the committee reviewed evidence that was deemed credible and corroborated that a campaign violation did in fact occur,” according to the complaint.

The supposed violation: A “quid pro quo” in which an unnamed delegation would support Dr. Edwards’ current candidacy, and the Southeastern delegation would support a future candidate from that other unnamed delegation.

Dr. Edwards was given a short opportunity to speak, in which she denied any violations.

According to a news report, Dr. Edwards said, “I’ve been in the House of Delegates for 30 years, and you know me as a process person – a person who truly believes in the process and trying to follow the complexities of our election campaign.”

The lawsuit alleges that “this defamatory conduct was repeated the next day to more than 600 delegates just minutes prior to the casting of votes, when Dr Scott repeated these allegations.”

Dr. Edwards lost the election.
 

AMA: Nothing more to add

The suit alleges that neither the Election Campaign Committee nor the AMA itself has made any accusers or complaints available to Dr. Edwards and that it has not provided any audio or written evidence of her alleged violation.

In July, the AMA’s Southeastern delegation told its membership, “We continue to maintain that Willarda was ‘set up’ ... The whole affair lacked any reasonable semblance of due process.”

The delegation has filed a counter claim against the AMA seeking “to address this lack of due process as well as the reputational harm” to the delegation.

The AMA said that it has nothing it can produce. “The Speaker of the House presented a verbal report to the attending delegates,” said a spokesman. “The Speaker’s report remains the only remarks from an AMA officer, and no additional remarks can be expected at this time.”

He added that there “is no official transcript of the Speaker’s report.”

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

The same devices used to take selfies and type out tweets are being repurposed and commercialized for quick access to information needed for monitoring a patient’s health. A fingertip pressed against a phone’s camera lens can measure a heart rate. The microphone, kept by the bedside, can screen for sleep apnea. Even the speaker is being tapped, to monitor breathing using sonar technology.

In the best of this new world, the data is conveyed remotely to a medical professional for the convenience and comfort of the patient or, in some cases, to support a clinician without the need for costly hardware.

But using smartphones as diagnostic tools is a work in progress, experts say. Although doctors and their patients have found some real-world success in deploying the phone as a medical device, the overall potential remains unfulfilled and uncertain.

Smartphones come packed with sensors capable of monitoring a patient’s vital signs. They can help assess people for concussions, watch for atrial fibrillation, and conduct mental health wellness checks, to name the uses of a few nascent applications.

Companies and researchers eager to find medical applications for smartphone technology are tapping into modern phones’ built-in cameras and light sensors; microphones; accelerometers, which detect body movements; gyroscopes; and even speakers. The apps then use artificial intelligence software to analyze the collected sights and sounds to create an easy connection between patients and physicians. Earning potential and marketability are evidenced by the more than 350,000 digital health products available in app stores, according to a Grand View Research report.

“It’s very hard to put devices into the patient home or in the hospital, but everybody is just walking around with a cellphone that has a network connection,” said Dr. Andrew Gostine, CEO of the sensor network company Artisight. Most Americans own a smartphone, including more than 60% of people 65 and over, an increase from just 13% a decade ago, according the Pew Research Center. The COVID-19 pandemic has also pushed people to become more comfortable with virtual care.

Some of these products have sought FDA clearance to be marketed as a medical device. That way, if patients must pay to use the software, health insurers are more likely to cover at least part of the cost. Other products are designated as exempt from this regulatory process, placed in the same clinical classification as a Band-Aid. But how the agency handles AI and machine learning–based medical devices is still being adjusted to reflect software’s adaptive nature.

Ensuring accuracy and clinical validation is crucial to securing buy-in from health care providers. And many tools still need fine-tuning, said Eugene Yang, MD, a professor of medicine at the University of Washington, Seattle. Currently, Dr. Yang is testing contactless measurement of blood pressure, heart rate, and oxygen saturation gleaned remotely via Zoom camera footage of a patient’s face.

Judging these new technologies is difficult because they rely on algorithms built by machine learning and artificial intelligence to collect data, rather than the physical tools typically used in hospitals. So researchers cannot “compare apples to apples” with medical industry standards, Dr. Yang said. Failure to build in such assurances undermines the technology’s ultimate goals of easing costs and access because a doctor still must verify results.

“False positives and false negatives lead to more testing and more cost to the health care system,” he said.

Big tech companies like Google have heavily invested in researching this kind of technology, catering to clinicians and in-home caregivers, as well as consumers. Currently, in the Google Fit app, users can check their heart rate by placing their finger on the rear-facing camera lens or track their breathing rate using the front-facing camera.

“If you took the sensor out of the phone and out of a clinical device, they are probably the same thing,” said Shwetak Patel, director of health technologies at Google and a professor of electrical and computer engineering at the University of Washington.

Google’s research uses machine learning and computer vision, a field within AI based on information from visual inputs like videos or images. So instead of using a blood pressure cuff, for example, the algorithm can interpret slight visual changes to the body that serve as proxies and biosignals for a patient’s blood pressure, Mr. Patel said.

Google is also investigating the effectiveness of the built-in microphone for detecting heartbeats and murmurs and using the camera to preserve eyesight by screening for diabetic eye disease, according to information the company published last year.

The tech giant recently purchased Sound Life Sciences, a Seattle startup with an FDA-cleared sonar technology app. It uses a smart device’s speaker to bounce inaudible pulses off a patient’s body to identify movement and monitor breathing.

Binah.ai, based in Israel, is another company using the smartphone camera to calculate vital signs. Its software looks at the region around the eyes, where the skin is a bit thinner, and analyzes the light reflecting off blood vessels back to the lens. The company is wrapping up a U.S. clinical trial and marketing its wellness app directly to insurers and other health companies, said company spokesperson Mona Popilian-Yona.

The applications even reach into disciplines such as optometry and mental health:

• With the microphone, Canary Speech uses the same underlying technology as Amazon’s Alexa to analyze patients’ voices for mental health conditions. The software can integrate with telemedicine appointments and allow clinicians to screen for anxiety and depression using a library of vocal biomarkers and predictive analytics, said Henry O’Connell, the company’s CEO.
• Australia-based ResApp Health last year for its iPhone app that screens for moderate to severe obstructive sleep apnea by listening to breathing and snoring. SleepCheckRx, which will require a prescription, is minimally invasive compared with sleep studies currently used to diagnose sleep apnea. Those can cost thousands of dollars and require an array of tests.
• Brightlamp’s Reflex app is a clinical decision support tool for helping manage concussions and vision rehabilitation, among other things. Using an iPad’s or iPhone’s camera, the mobile app measures how a person’s pupils react to changes in light. Through machine learning analysis, the imagery gives practitioners data points for evaluating patients. Brightlamp sells directly to health care providers and is being used in more than 230 clinics. Clinicians pay a $400 standard annual fee per account, which is currently not covered by insurance. The Department of Defense has an ongoing clinical trial using Reflex.

In some cases, such as with the Reflex app, the data is processed directly on the phone – rather than in the cloud, Brightlamp CEO Kurtis Sluss said. By processing everything on the device, the app avoids running into privacy issues, as streaming data elsewhere requires patient consent.

But algorithms need to be trained and tested by collecting reams of data, and that is an ongoing process.

Researchers, for example, have found that some computer vision applications, like heart rate or blood pressure monitoring, can be less accurate for darker skin. Studies are underway to find better solutions.

Small algorithm glitches can also produce false alarms and frighten patients enough to keep widespread adoption out of reach. For example, Apple’s new car-crash detection feature, available on both the latest iPhone and Apple Watch, was set off when people were riding roller coasters and automatically dialed 911.

“We’re not there yet,” Dr. Yang said. “That’s the bottom line.”
 

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

The same devices used to take selfies and type out tweets are being repurposed and commercialized for quick access to information needed for monitoring a patient’s health. A fingertip pressed against a phone’s camera lens can measure a heart rate. The microphone, kept by the bedside, can screen for sleep apnea. Even the speaker is being tapped, to monitor breathing using sonar technology.

In the best of this new world, the data is conveyed remotely to a medical professional for the convenience and comfort of the patient or, in some cases, to support a clinician without the need for costly hardware.

But using smartphones as diagnostic tools is a work in progress, experts say. Although doctors and their patients have found some real-world success in deploying the phone as a medical device, the overall potential remains unfulfilled and uncertain.

Smartphones come packed with sensors capable of monitoring a patient’s vital signs. They can help assess people for concussions, watch for atrial fibrillation, and conduct mental health wellness checks, to name the uses of a few nascent applications.

Companies and researchers eager to find medical applications for smartphone technology are tapping into modern phones’ built-in cameras and light sensors; microphones; accelerometers, which detect body movements; gyroscopes; and even speakers. The apps then use artificial intelligence software to analyze the collected sights and sounds to create an easy connection between patients and physicians. Earning potential and marketability are evidenced by the more than 350,000 digital health products available in app stores, according to a Grand View Research report.

“It’s very hard to put devices into the patient home or in the hospital, but everybody is just walking around with a cellphone that has a network connection,” said Dr. Andrew Gostine, CEO of the sensor network company Artisight. Most Americans own a smartphone, including more than 60% of people 65 and over, an increase from just 13% a decade ago, according the Pew Research Center. The COVID-19 pandemic has also pushed people to become more comfortable with virtual care.

Some of these products have sought FDA clearance to be marketed as a medical device. That way, if patients must pay to use the software, health insurers are more likely to cover at least part of the cost. Other products are designated as exempt from this regulatory process, placed in the same clinical classification as a Band-Aid. But how the agency handles AI and machine learning–based medical devices is still being adjusted to reflect software’s adaptive nature.

Ensuring accuracy and clinical validation is crucial to securing buy-in from health care providers. And many tools still need fine-tuning, said Eugene Yang, MD, a professor of medicine at the University of Washington, Seattle. Currently, Dr. Yang is testing contactless measurement of blood pressure, heart rate, and oxygen saturation gleaned remotely via Zoom camera footage of a patient’s face.

Judging these new technologies is difficult because they rely on algorithms built by machine learning and artificial intelligence to collect data, rather than the physical tools typically used in hospitals. So researchers cannot “compare apples to apples” with medical industry standards, Dr. Yang said. Failure to build in such assurances undermines the technology’s ultimate goals of easing costs and access because a doctor still must verify results.

“False positives and false negatives lead to more testing and more cost to the health care system,” he said.

Big tech companies like Google have heavily invested in researching this kind of technology, catering to clinicians and in-home caregivers, as well as consumers. Currently, in the Google Fit app, users can check their heart rate by placing their finger on the rear-facing camera lens or track their breathing rate using the front-facing camera.

“If you took the sensor out of the phone and out of a clinical device, they are probably the same thing,” said Shwetak Patel, director of health technologies at Google and a professor of electrical and computer engineering at the University of Washington.

Google’s research uses machine learning and computer vision, a field within AI based on information from visual inputs like videos or images. So instead of using a blood pressure cuff, for example, the algorithm can interpret slight visual changes to the body that serve as proxies and biosignals for a patient’s blood pressure, Mr. Patel said.

Google is also investigating the effectiveness of the built-in microphone for detecting heartbeats and murmurs and using the camera to preserve eyesight by screening for diabetic eye disease, according to information the company published last year.

The tech giant recently purchased Sound Life Sciences, a Seattle startup with an FDA-cleared sonar technology app. It uses a smart device’s speaker to bounce inaudible pulses off a patient’s body to identify movement and monitor breathing.

Binah.ai, based in Israel, is another company using the smartphone camera to calculate vital signs. Its software looks at the region around the eyes, where the skin is a bit thinner, and analyzes the light reflecting off blood vessels back to the lens. The company is wrapping up a U.S. clinical trial and marketing its wellness app directly to insurers and other health companies, said company spokesperson Mona Popilian-Yona.

The applications even reach into disciplines such as optometry and mental health:

• With the microphone, Canary Speech uses the same underlying technology as Amazon’s Alexa to analyze patients’ voices for mental health conditions. The software can integrate with telemedicine appointments and allow clinicians to screen for anxiety and depression using a library of vocal biomarkers and predictive analytics, said Henry O’Connell, the company’s CEO.
• Australia-based ResApp Health last year for its iPhone app that screens for moderate to severe obstructive sleep apnea by listening to breathing and snoring. SleepCheckRx, which will require a prescription, is minimally invasive compared with sleep studies currently used to diagnose sleep apnea. Those can cost thousands of dollars and require an array of tests.
• Brightlamp’s Reflex app is a clinical decision support tool for helping manage concussions and vision rehabilitation, among other things. Using an iPad’s or iPhone’s camera, the mobile app measures how a person’s pupils react to changes in light. Through machine learning analysis, the imagery gives practitioners data points for evaluating patients. Brightlamp sells directly to health care providers and is being used in more than 230 clinics. Clinicians pay a $400 standard annual fee per account, which is currently not covered by insurance. The Department of Defense has an ongoing clinical trial using Reflex.

In some cases, such as with the Reflex app, the data is processed directly on the phone – rather than in the cloud, Brightlamp CEO Kurtis Sluss said. By processing everything on the device, the app avoids running into privacy issues, as streaming data elsewhere requires patient consent.

But algorithms need to be trained and tested by collecting reams of data, and that is an ongoing process.

Researchers, for example, have found that some computer vision applications, like heart rate or blood pressure monitoring, can be less accurate for darker skin. Studies are underway to find better solutions.

Small algorithm glitches can also produce false alarms and frighten patients enough to keep widespread adoption out of reach. For example, Apple’s new car-crash detection feature, available on both the latest iPhone and Apple Watch, was set off when people were riding roller coasters and automatically dialed 911.

“We’re not there yet,” Dr. Yang said. “That’s the bottom line.”
 

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

The same devices used to take selfies and type out tweets are being repurposed and commercialized for quick access to information needed for monitoring a patient’s health. A fingertip pressed against a phone’s camera lens can measure a heart rate. The microphone, kept by the bedside, can screen for sleep apnea. Even the speaker is being tapped, to monitor breathing using sonar technology.

In the best of this new world, the data is conveyed remotely to a medical professional for the convenience and comfort of the patient or, in some cases, to support a clinician without the need for costly hardware.

But using smartphones as diagnostic tools is a work in progress, experts say. Although doctors and their patients have found some real-world success in deploying the phone as a medical device, the overall potential remains unfulfilled and uncertain.

Smartphones come packed with sensors capable of monitoring a patient’s vital signs. They can help assess people for concussions, watch for atrial fibrillation, and conduct mental health wellness checks, to name the uses of a few nascent applications.

Companies and researchers eager to find medical applications for smartphone technology are tapping into modern phones’ built-in cameras and light sensors; microphones; accelerometers, which detect body movements; gyroscopes; and even speakers. The apps then use artificial intelligence software to analyze the collected sights and sounds to create an easy connection between patients and physicians. Earning potential and marketability are evidenced by the more than 350,000 digital health products available in app stores, according to a Grand View Research report.

“It’s very hard to put devices into the patient home or in the hospital, but everybody is just walking around with a cellphone that has a network connection,” said Dr. Andrew Gostine, CEO of the sensor network company Artisight. Most Americans own a smartphone, including more than 60% of people 65 and over, an increase from just 13% a decade ago, according the Pew Research Center. The COVID-19 pandemic has also pushed people to become more comfortable with virtual care.

Some of these products have sought FDA clearance to be marketed as a medical device. That way, if patients must pay to use the software, health insurers are more likely to cover at least part of the cost. Other products are designated as exempt from this regulatory process, placed in the same clinical classification as a Band-Aid. But how the agency handles AI and machine learning–based medical devices is still being adjusted to reflect software’s adaptive nature.

Ensuring accuracy and clinical validation is crucial to securing buy-in from health care providers. And many tools still need fine-tuning, said Eugene Yang, MD, a professor of medicine at the University of Washington, Seattle. Currently, Dr. Yang is testing contactless measurement of blood pressure, heart rate, and oxygen saturation gleaned remotely via Zoom camera footage of a patient’s face.

Judging these new technologies is difficult because they rely on algorithms built by machine learning and artificial intelligence to collect data, rather than the physical tools typically used in hospitals. So researchers cannot “compare apples to apples” with medical industry standards, Dr. Yang said. Failure to build in such assurances undermines the technology’s ultimate goals of easing costs and access because a doctor still must verify results.

“False positives and false negatives lead to more testing and more cost to the health care system,” he said.

Big tech companies like Google have heavily invested in researching this kind of technology, catering to clinicians and in-home caregivers, as well as consumers. Currently, in the Google Fit app, users can check their heart rate by placing their finger on the rear-facing camera lens or track their breathing rate using the front-facing camera.

“If you took the sensor out of the phone and out of a clinical device, they are probably the same thing,” said Shwetak Patel, director of health technologies at Google and a professor of electrical and computer engineering at the University of Washington.

Google’s research uses machine learning and computer vision, a field within AI based on information from visual inputs like videos or images. So instead of using a blood pressure cuff, for example, the algorithm can interpret slight visual changes to the body that serve as proxies and biosignals for a patient’s blood pressure, Mr. Patel said.

Google is also investigating the effectiveness of the built-in microphone for detecting heartbeats and murmurs and using the camera to preserve eyesight by screening for diabetic eye disease, according to information the company published last year.

The tech giant recently purchased Sound Life Sciences, a Seattle startup with an FDA-cleared sonar technology app. It uses a smart device’s speaker to bounce inaudible pulses off a patient’s body to identify movement and monitor breathing.

Binah.ai, based in Israel, is another company using the smartphone camera to calculate vital signs. Its software looks at the region around the eyes, where the skin is a bit thinner, and analyzes the light reflecting off blood vessels back to the lens. The company is wrapping up a U.S. clinical trial and marketing its wellness app directly to insurers and other health companies, said company spokesperson Mona Popilian-Yona.

The applications even reach into disciplines such as optometry and mental health:

• With the microphone, Canary Speech uses the same underlying technology as Amazon’s Alexa to analyze patients’ voices for mental health conditions. The software can integrate with telemedicine appointments and allow clinicians to screen for anxiety and depression using a library of vocal biomarkers and predictive analytics, said Henry O’Connell, the company’s CEO.
• Australia-based ResApp Health last year for its iPhone app that screens for moderate to severe obstructive sleep apnea by listening to breathing and snoring. SleepCheckRx, which will require a prescription, is minimally invasive compared with sleep studies currently used to diagnose sleep apnea. Those can cost thousands of dollars and require an array of tests.
• Brightlamp’s Reflex app is a clinical decision support tool for helping manage concussions and vision rehabilitation, among other things. Using an iPad’s or iPhone’s camera, the mobile app measures how a person’s pupils react to changes in light. Through machine learning analysis, the imagery gives practitioners data points for evaluating patients. Brightlamp sells directly to health care providers and is being used in more than 230 clinics. Clinicians pay a $400 standard annual fee per account, which is currently not covered by insurance. The Department of Defense has an ongoing clinical trial using Reflex.

In some cases, such as with the Reflex app, the data is processed directly on the phone – rather than in the cloud, Brightlamp CEO Kurtis Sluss said. By processing everything on the device, the app avoids running into privacy issues, as streaming data elsewhere requires patient consent.

But algorithms need to be trained and tested by collecting reams of data, and that is an ongoing process.

Researchers, for example, have found that some computer vision applications, like heart rate or blood pressure monitoring, can be less accurate for darker skin. Studies are underway to find better solutions.

Small algorithm glitches can also produce false alarms and frighten patients enough to keep widespread adoption out of reach. For example, Apple’s new car-crash detection feature, available on both the latest iPhone and Apple Watch, was set off when people were riding roller coasters and automatically dialed 911.

“We’re not there yet,” Dr. Yang said. “That’s the bottom line.”
 

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

My desk looks nothing like my grandfather’s. It stands about mid-abdomen high and has a small surface, perhaps just enough for the monitor and a mug. Yes, I can move it up and down (thank you 21st century), but it has no drawers. It is lean and immaculate, but it has no soul.

My grandfather sat at a large oak desk with three drawers on each side. Each was so heavy you had to be at least 6 years old to pull one open for exploring the contents inside. The desk surface was vast and although immobile, it had a greenish leather blotter for writing. Alongside his pile of correspondences was a treasure for those of us tall enough to get it: A heavy brass letter opener. It came, I believe, with a secretary who would open his letters and stack them neatly before placing this sometimes-pirate’s-sword far enough away from the edge for us to not reach it.

Kind Regards, 

Pat

I sat down, my desk nearly at eye level now, and felt the paper in my hand. It was white, college ruled paper and a blue ink pen. She carefully looped her “y’s” and crossed her “t’s.” Not one cross out. She thought about each sentence before transcribing it. The paper once sat on her desk, touched her fingers and the envelope sealed with her saliva. It was not filled with trifling requests or complaints. It was not efficient, but it was more than just communication. She took the time to choose the words to capture her emotion and express her gratitude. It was respectful, dignified, decidedly nondigital. For a brief moment I thought I might write back, but quickly realized that was impractical. I knew I wouldn’t make the time to do so. I wish I had. 

Having no drawers to save it, I held it up with just a corner of the page resting on my desk and scribbled in black ink “Reviewed. Please scan to media file. 12/8/22. JAB”

Dr. Benabio is director of Healthcare Transformation and chief of dermatology at Kaiser Permanente San Diego. The opinions expressed in this column are his own and do not represent those of Kaiser Permanente. Dr. Benabio is @Dermdoc on Twitter. Write to him at [email protected].

My desk looks nothing like my grandfather’s. It stands about mid-abdomen high and has a small surface, perhaps just enough for the monitor and a mug. Yes, I can move it up and down (thank you 21st century), but it has no drawers. It is lean and immaculate, but it has no soul.

My grandfather sat at a large oak desk with three drawers on each side. Each was so heavy you had to be at least 6 years old to pull one open for exploring the contents inside. The desk surface was vast and although immobile, it had a greenish leather blotter for writing. Alongside his pile of correspondences was a treasure for those of us tall enough to get it: A heavy brass letter opener. It came, I believe, with a secretary who would open his letters and stack them neatly before placing this sometimes-pirate’s-sword far enough away from the edge for us to not reach it.

Kind Regards, 

Pat

I sat down, my desk nearly at eye level now, and felt the paper in my hand. It was white, college ruled paper and a blue ink pen. She carefully looped her “y’s” and crossed her “t’s.” Not one cross out. She thought about each sentence before transcribing it. The paper once sat on her desk, touched her fingers and the envelope sealed with her saliva. It was not filled with trifling requests or complaints. It was not efficient, but it was more than just communication. She took the time to choose the words to capture her emotion and express her gratitude. It was respectful, dignified, decidedly nondigital. For a brief moment I thought I might write back, but quickly realized that was impractical. I knew I wouldn’t make the time to do so. I wish I had. 

Having no drawers to save it, I held it up with just a corner of the page resting on my desk and scribbled in black ink “Reviewed. Please scan to media file. 12/8/22. JAB”

Dr. Benabio is director of Healthcare Transformation and chief of dermatology at Kaiser Permanente San Diego. The opinions expressed in this column are his own and do not represent those of Kaiser Permanente. Dr. Benabio is @Dermdoc on Twitter. Write to him at [email protected].

My desk looks nothing like my grandfather’s. It stands about mid-abdomen high and has a small surface, perhaps just enough for the monitor and a mug. Yes, I can move it up and down (thank you 21st century), but it has no drawers. It is lean and immaculate, but it has no soul.

My grandfather sat at a large oak desk with three drawers on each side. Each was so heavy you had to be at least 6 years old to pull one open for exploring the contents inside. The desk surface was vast and although immobile, it had a greenish leather blotter for writing. Alongside his pile of correspondences was a treasure for those of us tall enough to get it: A heavy brass letter opener. It came, I believe, with a secretary who would open his letters and stack them neatly before placing this sometimes-pirate’s-sword far enough away from the edge for us to not reach it.

Kind Regards, 

Pat

I sat down, my desk nearly at eye level now, and felt the paper in my hand. It was white, college ruled paper and a blue ink pen. She carefully looped her “y’s” and crossed her “t’s.” Not one cross out. She thought about each sentence before transcribing it. The paper once sat on her desk, touched her fingers and the envelope sealed with her saliva. It was not filled with trifling requests or complaints. It was not efficient, but it was more than just communication. She took the time to choose the words to capture her emotion and express her gratitude. It was respectful, dignified, decidedly nondigital. For a brief moment I thought I might write back, but quickly realized that was impractical. I knew I wouldn’t make the time to do so. I wish I had. 

Having no drawers to save it, I held it up with just a corner of the page resting on my desk and scribbled in black ink “Reviewed. Please scan to media file. 12/8/22. JAB”

Dr. Benabio is director of Healthcare Transformation and chief of dermatology at Kaiser Permanente San Diego. The opinions expressed in this column are his own and do not represent those of Kaiser Permanente. Dr. Benabio is @Dermdoc on Twitter. Write to him at [email protected].

Guilt reduction, now in deceptive and open-secret forms

Guilt plagues a lot of us, sometimes regularly. Maybe you felt bad about eating the leftovers that your partner was looking forward to eating at the end of the day. Or for not saving a seat for your friend who was running late to the movies. Maybe even hiding a secret that you know would hurt a person’s feelings. We’ve all felt it, and it doesn’t feel good.

Annie Spratt/Unsplash

But what if there was a pill that would make those feelings seem to hurt less? There’s already a pill for almost everything, right?

Well, researchers from the University of Basel are on the case and have conducted a study suggesting that a placebo might work. They asked participants to write down a time they felt super guilty about something, just to stir up those feelings again, then they were divided into three groups. One group was told they would receive real medication that was actually a placebo, one was told they would get a placebo, and one got nothing. The subjects’ guilty feelings were reduced in both the medication-that-was-really-a-placebo group and placebo-that-was-a-placebo group.

“Our study therefore supports the intriguing finding that placebos work even when they are administered openly, and that explanation of the treatment is key to its effectiveness,” lead author Dilan Sezer said in a written statement.

More research is needed, but the human mind is a very interesting place. It seems like we can convince ourselves of just about anything. Especially to feel less guilty.
 

It’s a mad, mad, mad, mad scientist’s world

Mad scientists. Life’s just more interesting with a few of them running around, but they’re mostly relegated to works of fiction. Real life is boring; we don’t actually have neurosurgeons going around claiming human brain transplant is technically feasible.

Oh, wait a minute.

Best of all, this isn’t even Dr. Sergio Canavero’s first rodeo with mad science: In 2015 he claimed human head transplants were technically feasible, and in the past few years has claimed to have rehearsed head transplants on cadavers and successfully repaired spinal cord injuries in animals. Lots of claims in there, but precious little evidence. And contrary to what everyone at the head enhancement clinic says, people will notice if you start going around with a new head.

But let’s get back to brains. Ignoring the fact that brain transplant sounds like a zombie with a PhD nibbling on your skull, the article does appear in a peer-reviewed journal. So surely there’s some level of legitimacy. After all, it’s not like Dr. Canavero is an editor for this journal. [Editor’s note: By that we mean he is an editor for the journal.]

Man, he’s taking all the fun out of this.

Anyway, now that we’ve prefaced this with the mother of all caveats, what exactly is Dr. Canavero proposing with his brain transplant? It’s pretty simple: Just have a robot scoop out the first brain and place it into a fresh body, either a donated but moribund younger body or a cloned body. Reconnect all the nerves and vasculature and you’re good to go. Enjoy your wine and laugh in the face of death.

Naturally, such a … bold proposal is lacking in the details, but who cares about details, anyway? This is mad science, not respectable science. Professionals have standards. And if we hear that a human brain transplant was successfully completed on a non–dark and stormy night and the doctor didn’t cackle madly “It’s alive! It’s alive!” then honestly, what even was the point?

Ambivalence rules!

As the office’s unofficial Sith lord/Star Wars nerd, LOTME takes notice when science extols the benefits of unhappiness: “It’s good to be grumpy: Bad moods make us more detail-oriented, study shows.”

Ryan Franco/Unsplash

The investigators manipulated the emotions of participants by having them watch a clip from “Sophie’s Choice” or one from “Friends.” Then the subjects listened to short, emotionally neutral stories, some of which contained inconsistencies, with the text displayed on a computer screen. Sorry to say, gang at Central Perk, but round one went to the sad movie.

“When people are in a negative mood, they are more careful and analytical. They scrutinize what’s actually stated in a text, and they don’t just fall back on their default world knowledge,” lead author Vicky Lai, PhD, of the University of Arizona said in a statement from the school.

Negative mood. Careful and analytical. Grumpy is good.

You’ve fallen into Darth Science’s little trap, and we have you now.

A study conducted at the University of Geneva offers a slightly different conclusion. And by slightly different, we mean completely different. People over age 65 who watched a series of short TV clips depicting people in a state of emotional suffering experienced excessive modification of their neuronal connections, compared with those who watched emotionally neutral videos.

The brains of these subjects remained “frozen in a negative state by relating the suffering of others to their own emotional memories,” lead author Sebastian Baez Lugo said in a written release from the university.

Emotional suffering. Frozen brains. Grumpy is … not good?

So there you have it. Darth Science’s lesson for the day: A negative mood makes you careful and analytical, but negative thoughts are bad for your brain.

Guilt reduction, now in deceptive and open-secret forms

Guilt plagues a lot of us, sometimes regularly. Maybe you felt bad about eating the leftovers that your partner was looking forward to eating at the end of the day. Or for not saving a seat for your friend who was running late to the movies. Maybe even hiding a secret that you know would hurt a person’s feelings. We’ve all felt it, and it doesn’t feel good.

Annie Spratt/Unsplash

But what if there was a pill that would make those feelings seem to hurt less? There’s already a pill for almost everything, right?

Well, researchers from the University of Basel are on the case and have conducted a study suggesting that a placebo might work. They asked participants to write down a time they felt super guilty about something, just to stir up those feelings again, then they were divided into three groups. One group was told they would receive real medication that was actually a placebo, one was told they would get a placebo, and one got nothing. The subjects’ guilty feelings were reduced in both the medication-that-was-really-a-placebo group and placebo-that-was-a-placebo group.

“Our study therefore supports the intriguing finding that placebos work even when they are administered openly, and that explanation of the treatment is key to its effectiveness,” lead author Dilan Sezer said in a written statement.

More research is needed, but the human mind is a very interesting place. It seems like we can convince ourselves of just about anything. Especially to feel less guilty.
 

It’s a mad, mad, mad, mad scientist’s world

Mad scientists. Life’s just more interesting with a few of them running around, but they’re mostly relegated to works of fiction. Real life is boring; we don’t actually have neurosurgeons going around claiming human brain transplant is technically feasible.

Oh, wait a minute.

Best of all, this isn’t even Dr. Sergio Canavero’s first rodeo with mad science: In 2015 he claimed human head transplants were technically feasible, and in the past few years has claimed to have rehearsed head transplants on cadavers and successfully repaired spinal cord injuries in animals. Lots of claims in there, but precious little evidence. And contrary to what everyone at the head enhancement clinic says, people will notice if you start going around with a new head.

But let’s get back to brains. Ignoring the fact that brain transplant sounds like a zombie with a PhD nibbling on your skull, the article does appear in a peer-reviewed journal. So surely there’s some level of legitimacy. After all, it’s not like Dr. Canavero is an editor for this journal. [Editor’s note: By that we mean he is an editor for the journal.]

Man, he’s taking all the fun out of this.

Anyway, now that we’ve prefaced this with the mother of all caveats, what exactly is Dr. Canavero proposing with his brain transplant? It’s pretty simple: Just have a robot scoop out the first brain and place it into a fresh body, either a donated but moribund younger body or a cloned body. Reconnect all the nerves and vasculature and you’re good to go. Enjoy your wine and laugh in the face of death.

Naturally, such a … bold proposal is lacking in the details, but who cares about details, anyway? This is mad science, not respectable science. Professionals have standards. And if we hear that a human brain transplant was successfully completed on a non–dark and stormy night and the doctor didn’t cackle madly “It’s alive! It’s alive!” then honestly, what even was the point?

Ambivalence rules!

As the office’s unofficial Sith lord/Star Wars nerd, LOTME takes notice when science extols the benefits of unhappiness: “It’s good to be grumpy: Bad moods make us more detail-oriented, study shows.”

Ryan Franco/Unsplash

The investigators manipulated the emotions of participants by having them watch a clip from “Sophie’s Choice” or one from “Friends.” Then the subjects listened to short, emotionally neutral stories, some of which contained inconsistencies, with the text displayed on a computer screen. Sorry to say, gang at Central Perk, but round one went to the sad movie.

“When people are in a negative mood, they are more careful and analytical. They scrutinize what’s actually stated in a text, and they don’t just fall back on their default world knowledge,” lead author Vicky Lai, PhD, of the University of Arizona said in a statement from the school.

Negative mood. Careful and analytical. Grumpy is good.

You’ve fallen into Darth Science’s little trap, and we have you now.

A study conducted at the University of Geneva offers a slightly different conclusion. And by slightly different, we mean completely different. People over age 65 who watched a series of short TV clips depicting people in a state of emotional suffering experienced excessive modification of their neuronal connections, compared with those who watched emotionally neutral videos.

The brains of these subjects remained “frozen in a negative state by relating the suffering of others to their own emotional memories,” lead author Sebastian Baez Lugo said in a written release from the university.

Emotional suffering. Frozen brains. Grumpy is … not good?

So there you have it. Darth Science’s lesson for the day: A negative mood makes you careful and analytical, but negative thoughts are bad for your brain.

Guilt reduction, now in deceptive and open-secret forms

Guilt plagues a lot of us, sometimes regularly. Maybe you felt bad about eating the leftovers that your partner was looking forward to eating at the end of the day. Or for not saving a seat for your friend who was running late to the movies. Maybe even hiding a secret that you know would hurt a person’s feelings. We’ve all felt it, and it doesn’t feel good.

Annie Spratt/Unsplash

But what if there was a pill that would make those feelings seem to hurt less? There’s already a pill for almost everything, right?

Well, researchers from the University of Basel are on the case and have conducted a study suggesting that a placebo might work. They asked participants to write down a time they felt super guilty about something, just to stir up those feelings again, then they were divided into three groups. One group was told they would receive real medication that was actually a placebo, one was told they would get a placebo, and one got nothing. The subjects’ guilty feelings were reduced in both the medication-that-was-really-a-placebo group and placebo-that-was-a-placebo group.

“Our study therefore supports the intriguing finding that placebos work even when they are administered openly, and that explanation of the treatment is key to its effectiveness,” lead author Dilan Sezer said in a written statement.

More research is needed, but the human mind is a very interesting place. It seems like we can convince ourselves of just about anything. Especially to feel less guilty.
 

It’s a mad, mad, mad, mad scientist’s world

Mad scientists. Life’s just more interesting with a few of them running around, but they’re mostly relegated to works of fiction. Real life is boring; we don’t actually have neurosurgeons going around claiming human brain transplant is technically feasible.

Oh, wait a minute.

Best of all, this isn’t even Dr. Sergio Canavero’s first rodeo with mad science: In 2015 he claimed human head transplants were technically feasible, and in the past few years has claimed to have rehearsed head transplants on cadavers and successfully repaired spinal cord injuries in animals. Lots of claims in there, but precious little evidence. And contrary to what everyone at the head enhancement clinic says, people will notice if you start going around with a new head.

But let’s get back to brains. Ignoring the fact that brain transplant sounds like a zombie with a PhD nibbling on your skull, the article does appear in a peer-reviewed journal. So surely there’s some level of legitimacy. After all, it’s not like Dr. Canavero is an editor for this journal. [Editor’s note: By that we mean he is an editor for the journal.]

Man, he’s taking all the fun out of this.

Anyway, now that we’ve prefaced this with the mother of all caveats, what exactly is Dr. Canavero proposing with his brain transplant? It’s pretty simple: Just have a robot scoop out the first brain and place it into a fresh body, either a donated but moribund younger body or a cloned body. Reconnect all the nerves and vasculature and you’re good to go. Enjoy your wine and laugh in the face of death.

Naturally, such a … bold proposal is lacking in the details, but who cares about details, anyway? This is mad science, not respectable science. Professionals have standards. And if we hear that a human brain transplant was successfully completed on a non–dark and stormy night and the doctor didn’t cackle madly “It’s alive! It’s alive!” then honestly, what even was the point?

Ambivalence rules!

As the office’s unofficial Sith lord/Star Wars nerd, LOTME takes notice when science extols the benefits of unhappiness: “It’s good to be grumpy: Bad moods make us more detail-oriented, study shows.”

Ryan Franco/Unsplash

The investigators manipulated the emotions of participants by having them watch a clip from “Sophie’s Choice” or one from “Friends.” Then the subjects listened to short, emotionally neutral stories, some of which contained inconsistencies, with the text displayed on a computer screen. Sorry to say, gang at Central Perk, but round one went to the sad movie.

“When people are in a negative mood, they are more careful and analytical. They scrutinize what’s actually stated in a text, and they don’t just fall back on their default world knowledge,” lead author Vicky Lai, PhD, of the University of Arizona said in a statement from the school.

Negative mood. Careful and analytical. Grumpy is good.

You’ve fallen into Darth Science’s little trap, and we have you now.

A study conducted at the University of Geneva offers a slightly different conclusion. And by slightly different, we mean completely different. People over age 65 who watched a series of short TV clips depicting people in a state of emotional suffering experienced excessive modification of their neuronal connections, compared with those who watched emotionally neutral videos.

The brains of these subjects remained “frozen in a negative state by relating the suffering of others to their own emotional memories,” lead author Sebastian Baez Lugo said in a written release from the university.

Emotional suffering. Frozen brains. Grumpy is … not good?

So there you have it. Darth Science’s lesson for the day: A negative mood makes you careful and analytical, but negative thoughts are bad for your brain.

A common sentiment shared by patients who are happy with their health care professionals is, “I feel heard and understood.” How do we become those professionals and make sure that we are doing a good job connecting and communicating with our patients?

Here are a few suggestions on how to do this.
 

Practice intent listening

When a patient shares their symptoms with you, show genuine curiosity and concern. Ask clarifying questions. Ask how the symptom or problem is affecting their day-to-day life. Avoid quick, rapid-fire questions back at the patient. Do not accept a patient self-diagnosis.

When a patient with a first-time headache says they are having a migraine headache, for example, ask many clarifying questions to make sure you can make a diagnosis of headache type, then use all the information you have gathered to educate the patient on what you believe they have.

It is easy to jump to treatment, but we always want to make sure we have the diagnosis correct first. By intently listening, it also makes it much easier to tell a patient you do not know what is causing their symptoms, but that you and the patient will be vigilant for any future clues that may lead to a diagnosis.
 

Use terminology that patients understand

Rachael Gotlieb, MD, and colleagues published an excellent study with eye-opening results on common phrases we use as health care providers and how often patients do not understand them.

Only 9% of patients understood what was meant when they were asked if they have been febrile. Only 2% understood what was meant by “I am concerned the patient has an occult infection.” Only 21% understood that “your xray findings were quite impressive” was bad news.

It is easy to avoid these medical language traps, we just have to check our doctor speak. Ask, “Do you have a fever?” Say, “I am concerned you may have an infection that is hard to find.”

Several other terms we use all the time in explaining things to patients that I have found most patients do not understand are the terms bilateral, systemic, and significant. Think carefully as you explain things to patients and check back to have them repeat to you what they think you said.
 

Be comfortable saying you don’t know

Many symptoms in medicine end up not being diagnosable. When a patient shares symptoms that do not fit a pattern of a disease, it is important to share with them why you think it is okay to wait and watch, even if you do not have a diagnosis.

Patients find it comforting that you are so honest with them. Doing this also has the benefit of gaining patients’ trust when you are sure about something, because it tells them you don’t have an answer for everything.
 

Ask your patients what they think is causing their symptoms

This way, you know what their big fear is. You can address what they are worried about, even if it isn’t something you are considering.

Patients are often fearful of a disease a close friend or relative has, so when they get new symptoms, they fear diseases that we might not think of. By knowing what they are fearful of, you can reassure when appropriate.

Dr. Paauw is professor of medicine in the division of general internal medicine at the University of Washington, Seattle, and he serves as third-year medical student clerkship director at the University of Washington. Contact Dr. Paauw at [email protected].

A common sentiment shared by patients who are happy with their health care professionals is, “I feel heard and understood.” How do we become those professionals and make sure that we are doing a good job connecting and communicating with our patients?

Here are a few suggestions on how to do this.
 

Practice intent listening

When a patient shares their symptoms with you, show genuine curiosity and concern. Ask clarifying questions. Ask how the symptom or problem is affecting their day-to-day life. Avoid quick, rapid-fire questions back at the patient. Do not accept a patient self-diagnosis.

When a patient with a first-time headache says they are having a migraine headache, for example, ask many clarifying questions to make sure you can make a diagnosis of headache type, then use all the information you have gathered to educate the patient on what you believe they have.

It is easy to jump to treatment, but we always want to make sure we have the diagnosis correct first. By intently listening, it also makes it much easier to tell a patient you do not know what is causing their symptoms, but that you and the patient will be vigilant for any future clues that may lead to a diagnosis.
 

Use terminology that patients understand

Rachael Gotlieb, MD, and colleagues published an excellent study with eye-opening results on common phrases we use as health care providers and how often patients do not understand them.

Only 9% of patients understood what was meant when they were asked if they have been febrile. Only 2% understood what was meant by “I am concerned the patient has an occult infection.” Only 21% understood that “your xray findings were quite impressive” was bad news.

It is easy to avoid these medical language traps, we just have to check our doctor speak. Ask, “Do you have a fever?” Say, “I am concerned you may have an infection that is hard to find.”

Several other terms we use all the time in explaining things to patients that I have found most patients do not understand are the terms bilateral, systemic, and significant. Think carefully as you explain things to patients and check back to have them repeat to you what they think you said.
 

Be comfortable saying you don’t know

Many symptoms in medicine end up not being diagnosable. When a patient shares symptoms that do not fit a pattern of a disease, it is important to share with them why you think it is okay to wait and watch, even if you do not have a diagnosis.

Patients find it comforting that you are so honest with them. Doing this also has the benefit of gaining patients’ trust when you are sure about something, because it tells them you don’t have an answer for everything.
 

Ask your patients what they think is causing their symptoms

This way, you know what their big fear is. You can address what they are worried about, even if it isn’t something you are considering.

Patients are often fearful of a disease a close friend or relative has, so when they get new symptoms, they fear diseases that we might not think of. By knowing what they are fearful of, you can reassure when appropriate.

Dr. Paauw is professor of medicine in the division of general internal medicine at the University of Washington, Seattle, and he serves as third-year medical student clerkship director at the University of Washington. Contact Dr. Paauw at [email protected].

A common sentiment shared by patients who are happy with their health care professionals is, “I feel heard and understood.” How do we become those professionals and make sure that we are doing a good job connecting and communicating with our patients?

Here are a few suggestions on how to do this.
 

Practice intent listening

When a patient shares their symptoms with you, show genuine curiosity and concern. Ask clarifying questions. Ask how the symptom or problem is affecting their day-to-day life. Avoid quick, rapid-fire questions back at the patient. Do not accept a patient self-diagnosis.

When a patient with a first-time headache says they are having a migraine headache, for example, ask many clarifying questions to make sure you can make a diagnosis of headache type, then use all the information you have gathered to educate the patient on what you believe they have.

It is easy to jump to treatment, but we always want to make sure we have the diagnosis correct first. By intently listening, it also makes it much easier to tell a patient you do not know what is causing their symptoms, but that you and the patient will be vigilant for any future clues that may lead to a diagnosis.
 

Use terminology that patients understand

Rachael Gotlieb, MD, and colleagues published an excellent study with eye-opening results on common phrases we use as health care providers and how often patients do not understand them.

Only 9% of patients understood what was meant when they were asked if they have been febrile. Only 2% understood what was meant by “I am concerned the patient has an occult infection.” Only 21% understood that “your xray findings were quite impressive” was bad news.

It is easy to avoid these medical language traps, we just have to check our doctor speak. Ask, “Do you have a fever?” Say, “I am concerned you may have an infection that is hard to find.”

Several other terms we use all the time in explaining things to patients that I have found most patients do not understand are the terms bilateral, systemic, and significant. Think carefully as you explain things to patients and check back to have them repeat to you what they think you said.
 

Be comfortable saying you don’t know

Many symptoms in medicine end up not being diagnosable. When a patient shares symptoms that do not fit a pattern of a disease, it is important to share with them why you think it is okay to wait and watch, even if you do not have a diagnosis.

Patients find it comforting that you are so honest with them. Doing this also has the benefit of gaining patients’ trust when you are sure about something, because it tells them you don’t have an answer for everything.
 

Ask your patients what they think is causing their symptoms

This way, you know what their big fear is. You can address what they are worried about, even if it isn’t something you are considering.

Patients are often fearful of a disease a close friend or relative has, so when they get new symptoms, they fear diseases that we might not think of. By knowing what they are fearful of, you can reassure when appropriate.

Dr. Paauw is professor of medicine in the division of general internal medicine at the University of Washington, Seattle, and he serves as third-year medical student clerkship director at the University of Washington. Contact Dr. Paauw at [email protected].

Nearly 25% of hospital admissions included at least one adverse event, as indicated from data from 2,809 admissions at 11 hospitals.

The 1991 Harvard Medical Practice Study, which focused on medical injury and litigation, documented an adverse event rate of 3.7 events per 100 admissions; 28% of those events were attributed to negligence, write David W. Bates, MD, of Brigham and Women’s Hospital, Boston, and colleagues.

Although patient safety has changed significantly since 1991, documenting improvements has been challenging, the researchers say. Several reports have shown a decrease in health care–associated infections. However, other aspects of safety – notably, adverse drug events, defined as injuries resulting from drugs taken – are not easily measured and tracked, the researchers say.

“We have not had good estimates of how much harm is being caused by care in hospitals in an ongoing way that looked across all types of adverse events,” and the current review is therefore important, Dr. Bates said in an interview.

In a study recently published in the New England Journal of Medicine, the researchers analyzed a random sample of 2,809 hospital admissions from 11 hospitals in Massachusetts during the 2018 calendar year. The hospitals ranged in size from fewer than 100 beds to more than 700 beds; all patients were aged 18 years and older. A panel of nine nurses reviewed the admissions records to identify potential adverse events, and eight physicians reviewed the adverse event summaries and either agreed or disagreed with the adverse event type. The severity of each event was ranked using a general severity scale into categories of significant, serious, life-threatening, or fatal.

Overall, at least one adverse event was identified in 23.6% of the hospital admissions. A total of 978 adverse events were deemed to have occurred during the index admission, and 222 of these (22.7%) were deemed preventable. Among the preventable adverse events, 19.7% were classified as serious, 3.3% as life-threatening, and 0.5% as fatal.

A total of 523 admissions (18.6%) involved at least one significant adverse event, defined as an event that caused unnecessary harm but from which recovery was rapid. A total of 211 admissions involved a serious adverse event, defined as harm resulting in substantial intervention or prolonged recovery; 34 included at least one life-threatening event; and seven admissions involved a fatal adverse event.

A total of 191 admissions involved at least one adverse event deemed preventable. Of those, 29 involved at least one preventable adverse event that was serious, life-threatening, or fatal, the researchers write. Of the seven deaths in the study population, one was deemed preventable.

The most common adverse events were adverse drug events, which accounted for 39.0% of the adverse events; surgical or other procedural events accounted for 30.4%; patient care events (including falls and pressure ulcers) accounted for 15.0%; and health care–associated infections accounted for 11.9%.
 

Overcoming barriers to better safety

“The overall level of harm, with nearly 1 in 4 patients suffering an adverse event, was higher than I expected it might be,” Dr. Bates told this news organization. However, techniques for identifying adverse events have improved, and “it is easier to find them in electronic records than in paper records,” he noted.

“Hospitals have many issues they are currently dealing with since COVID, and one issue is simply prioritization,” Dr. Bates said. “But it is now possible to measure harm for all patients using electronic tools, and if hospitals know how much harm they are having in specific areas, they can make choices about which ones to focus on.”

“We now have effective prevention strategies for most of the main kinds of harm,” he said. Generally, rates of harm are high because these strategies are not being used effectively, he said. “In addition, there are new tools that can be used – for example, to identify patients who are decompensating earlier,” he noted.

As for additional research, some specific types of harm that have been resistant to interventions, such as pressure ulcers, deserve more attention, said Dr. Bates. “In addition, diagnostic errors appear to cause a great deal of harm, but we don’t yet have good strategies for preventing these,” he said.

The study findings were limited by several factors, including the use of data from hospitals that might not represent hospitals at large and by the inclusion mainly of patients with private insurance, the researchers write. Other limitations include the likelihood that some adverse events were missed and the level of agreement on adverse events between adjudicators was only fair.

However, the findings serve as a reminder to health care professionals of the need for continued attention to improving patient safety, and measuring adverse events remains a critical part of guiding these improvements, the researchers conclude.
 

Timely reassessment and opportunities to improve

In the decades since the publication of the report, “To Err Is Human,” by the National Academies in 2000, significant attention has been paid to improving patient safety during hospitalizations, and health care systems have increased in both system and disease complexity, Said Suman Pal, MBBS, a specialist in hospital medicine at the University of New Mexico, Albuquerque, said in an interview. “Therefore, this study is important in reassessing the safety of inpatient care at the current time,” he said.

“The findings of this study showing preventable adverse events in approximately 7% of all admissions; while concerning, is not surprising, as it is consistent with other studies over time, as the authors have also noted in their discussion,” said Dr. Pal. The current findings “underscore the importance of continuous quality improvement efforts to increase the safety of patient care for hospitalized patients,” he noted.

“The increasing complexity of medical care, fragmentation of health care, structural inequities of health systems, and more recent widespread public health challenges such as the COVID-19 pandemic have been, in my opinion, barriers to improving patient safety,” Dr. Pal said. “The use of innovation and an interdisciplinary approach to patient safety and quality improvement in hospital-based care, such as the use of machine learning to monitor trends and predict the individualized risk of harm, could be a potential way out” to help reduce barriers and improve safety, he said.

“Additional research is needed to understand the key drivers of preventable harm for hospitalized patients in the United States,” said Dr. Pal. “When planning for change, keen attention must be paid to understanding how these [drivers] may differ for patients who have been historically marginalized or are otherwise underserved so as to not exacerbate health care inequities,” he added.

The study was funded by the Controlled Risk Insurance Company and the Risk Management Foundation of the Harvard Medical Institutions. Dr. Bates owns stock options with AESOP, Clew, FeelBetter, Guided Clinical Solutions, MDClone, and ValeraHealth and has grants/contracts from IBM Watson and EarlySense. He has also served as a consultant for CDI Negev. Dr. Pal has disclosed no relevant financial relationships.

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

Nearly 25% of hospital admissions included at least one adverse event, as indicated from data from 2,809 admissions at 11 hospitals.

The 1991 Harvard Medical Practice Study, which focused on medical injury and litigation, documented an adverse event rate of 3.7 events per 100 admissions; 28% of those events were attributed to negligence, write David W. Bates, MD, of Brigham and Women’s Hospital, Boston, and colleagues.

Although patient safety has changed significantly since 1991, documenting improvements has been challenging, the researchers say. Several reports have shown a decrease in health care–associated infections. However, other aspects of safety – notably, adverse drug events, defined as injuries resulting from drugs taken – are not easily measured and tracked, the researchers say.

“We have not had good estimates of how much harm is being caused by care in hospitals in an ongoing way that looked across all types of adverse events,” and the current review is therefore important, Dr. Bates said in an interview.

In a study recently published in the New England Journal of Medicine, the researchers analyzed a random sample of 2,809 hospital admissions from 11 hospitals in Massachusetts during the 2018 calendar year. The hospitals ranged in size from fewer than 100 beds to more than 700 beds; all patients were aged 18 years and older. A panel of nine nurses reviewed the admissions records to identify potential adverse events, and eight physicians reviewed the adverse event summaries and either agreed or disagreed with the adverse event type. The severity of each event was ranked using a general severity scale into categories of significant, serious, life-threatening, or fatal.

Overall, at least one adverse event was identified in 23.6% of the hospital admissions. A total of 978 adverse events were deemed to have occurred during the index admission, and 222 of these (22.7%) were deemed preventable. Among the preventable adverse events, 19.7% were classified as serious, 3.3% as life-threatening, and 0.5% as fatal.

A total of 523 admissions (18.6%) involved at least one significant adverse event, defined as an event that caused unnecessary harm but from which recovery was rapid. A total of 211 admissions involved a serious adverse event, defined as harm resulting in substantial intervention or prolonged recovery; 34 included at least one life-threatening event; and seven admissions involved a fatal adverse event.

A total of 191 admissions involved at least one adverse event deemed preventable. Of those, 29 involved at least one preventable adverse event that was serious, life-threatening, or fatal, the researchers write. Of the seven deaths in the study population, one was deemed preventable.

The most common adverse events were adverse drug events, which accounted for 39.0% of the adverse events; surgical or other procedural events accounted for 30.4%; patient care events (including falls and pressure ulcers) accounted for 15.0%; and health care–associated infections accounted for 11.9%.
 

Overcoming barriers to better safety

“The overall level of harm, with nearly 1 in 4 patients suffering an adverse event, was higher than I expected it might be,” Dr. Bates told this news organization. However, techniques for identifying adverse events have improved, and “it is easier to find them in electronic records than in paper records,” he noted.

“Hospitals have many issues they are currently dealing with since COVID, and one issue is simply prioritization,” Dr. Bates said. “But it is now possible to measure harm for all patients using electronic tools, and if hospitals know how much harm they are having in specific areas, they can make choices about which ones to focus on.”

“We now have effective prevention strategies for most of the main kinds of harm,” he said. Generally, rates of harm are high because these strategies are not being used effectively, he said. “In addition, there are new tools that can be used – for example, to identify patients who are decompensating earlier,” he noted.

As for additional research, some specific types of harm that have been resistant to interventions, such as pressure ulcers, deserve more attention, said Dr. Bates. “In addition, diagnostic errors appear to cause a great deal of harm, but we don’t yet have good strategies for preventing these,” he said.

The study findings were limited by several factors, including the use of data from hospitals that might not represent hospitals at large and by the inclusion mainly of patients with private insurance, the researchers write. Other limitations include the likelihood that some adverse events were missed and the level of agreement on adverse events between adjudicators was only fair.

However, the findings serve as a reminder to health care professionals of the need for continued attention to improving patient safety, and measuring adverse events remains a critical part of guiding these improvements, the researchers conclude.
 

Timely reassessment and opportunities to improve

In the decades since the publication of the report, “To Err Is Human,” by the National Academies in 2000, significant attention has been paid to improving patient safety during hospitalizations, and health care systems have increased in both system and disease complexity, Said Suman Pal, MBBS, a specialist in hospital medicine at the University of New Mexico, Albuquerque, said in an interview. “Therefore, this study is important in reassessing the safety of inpatient care at the current time,” he said.

“The findings of this study showing preventable adverse events in approximately 7% of all admissions; while concerning, is not surprising, as it is consistent with other studies over time, as the authors have also noted in their discussion,” said Dr. Pal. The current findings “underscore the importance of continuous quality improvement efforts to increase the safety of patient care for hospitalized patients,” he noted.

“The increasing complexity of medical care, fragmentation of health care, structural inequities of health systems, and more recent widespread public health challenges such as the COVID-19 pandemic have been, in my opinion, barriers to improving patient safety,” Dr. Pal said. “The use of innovation and an interdisciplinary approach to patient safety and quality improvement in hospital-based care, such as the use of machine learning to monitor trends and predict the individualized risk of harm, could be a potential way out” to help reduce barriers and improve safety, he said.

“Additional research is needed to understand the key drivers of preventable harm for hospitalized patients in the United States,” said Dr. Pal. “When planning for change, keen attention must be paid to understanding how these [drivers] may differ for patients who have been historically marginalized or are otherwise underserved so as to not exacerbate health care inequities,” he added.

The study was funded by the Controlled Risk Insurance Company and the Risk Management Foundation of the Harvard Medical Institutions. Dr. Bates owns stock options with AESOP, Clew, FeelBetter, Guided Clinical Solutions, MDClone, and ValeraHealth and has grants/contracts from IBM Watson and EarlySense. He has also served as a consultant for CDI Negev. Dr. Pal has disclosed no relevant financial relationships.

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

Nearly 25% of hospital admissions included at least one adverse event, as indicated from data from 2,809 admissions at 11 hospitals.

The 1991 Harvard Medical Practice Study, which focused on medical injury and litigation, documented an adverse event rate of 3.7 events per 100 admissions; 28% of those events were attributed to negligence, write David W. Bates, MD, of Brigham and Women’s Hospital, Boston, and colleagues.

Although patient safety has changed significantly since 1991, documenting improvements has been challenging, the researchers say. Several reports have shown a decrease in health care–associated infections. However, other aspects of safety – notably, adverse drug events, defined as injuries resulting from drugs taken – are not easily measured and tracked, the researchers say.

“We have not had good estimates of how much harm is being caused by care in hospitals in an ongoing way that looked across all types of adverse events,” and the current review is therefore important, Dr. Bates said in an interview.

In a study recently published in the New England Journal of Medicine, the researchers analyzed a random sample of 2,809 hospital admissions from 11 hospitals in Massachusetts during the 2018 calendar year. The hospitals ranged in size from fewer than 100 beds to more than 700 beds; all patients were aged 18 years and older. A panel of nine nurses reviewed the admissions records to identify potential adverse events, and eight physicians reviewed the adverse event summaries and either agreed or disagreed with the adverse event type. The severity of each event was ranked using a general severity scale into categories of significant, serious, life-threatening, or fatal.

Overall, at least one adverse event was identified in 23.6% of the hospital admissions. A total of 978 adverse events were deemed to have occurred during the index admission, and 222 of these (22.7%) were deemed preventable. Among the preventable adverse events, 19.7% were classified as serious, 3.3% as life-threatening, and 0.5% as fatal.

A total of 523 admissions (18.6%) involved at least one significant adverse event, defined as an event that caused unnecessary harm but from which recovery was rapid. A total of 211 admissions involved a serious adverse event, defined as harm resulting in substantial intervention or prolonged recovery; 34 included at least one life-threatening event; and seven admissions involved a fatal adverse event.

A total of 191 admissions involved at least one adverse event deemed preventable. Of those, 29 involved at least one preventable adverse event that was serious, life-threatening, or fatal, the researchers write. Of the seven deaths in the study population, one was deemed preventable.

The most common adverse events were adverse drug events, which accounted for 39.0% of the adverse events; surgical or other procedural events accounted for 30.4%; patient care events (including falls and pressure ulcers) accounted for 15.0%; and health care–associated infections accounted for 11.9%.
 

Overcoming barriers to better safety

“The overall level of harm, with nearly 1 in 4 patients suffering an adverse event, was higher than I expected it might be,” Dr. Bates told this news organization. However, techniques for identifying adverse events have improved, and “it is easier to find them in electronic records than in paper records,” he noted.

“Hospitals have many issues they are currently dealing with since COVID, and one issue is simply prioritization,” Dr. Bates said. “But it is now possible to measure harm for all patients using electronic tools, and if hospitals know how much harm they are having in specific areas, they can make choices about which ones to focus on.”

“We now have effective prevention strategies for most of the main kinds of harm,” he said. Generally, rates of harm are high because these strategies are not being used effectively, he said. “In addition, there are new tools that can be used – for example, to identify patients who are decompensating earlier,” he noted.

As for additional research, some specific types of harm that have been resistant to interventions, such as pressure ulcers, deserve more attention, said Dr. Bates. “In addition, diagnostic errors appear to cause a great deal of harm, but we don’t yet have good strategies for preventing these,” he said.

The study findings were limited by several factors, including the use of data from hospitals that might not represent hospitals at large and by the inclusion mainly of patients with private insurance, the researchers write. Other limitations include the likelihood that some adverse events were missed and the level of agreement on adverse events between adjudicators was only fair.

However, the findings serve as a reminder to health care professionals of the need for continued attention to improving patient safety, and measuring adverse events remains a critical part of guiding these improvements, the researchers conclude.
 

Timely reassessment and opportunities to improve

In the decades since the publication of the report, “To Err Is Human,” by the National Academies in 2000, significant attention has been paid to improving patient safety during hospitalizations, and health care systems have increased in both system and disease complexity, Said Suman Pal, MBBS, a specialist in hospital medicine at the University of New Mexico, Albuquerque, said in an interview. “Therefore, this study is important in reassessing the safety of inpatient care at the current time,” he said.

“The findings of this study showing preventable adverse events in approximately 7% of all admissions; while concerning, is not surprising, as it is consistent with other studies over time, as the authors have also noted in their discussion,” said Dr. Pal. The current findings “underscore the importance of continuous quality improvement efforts to increase the safety of patient care for hospitalized patients,” he noted.

“The increasing complexity of medical care, fragmentation of health care, structural inequities of health systems, and more recent widespread public health challenges such as the COVID-19 pandemic have been, in my opinion, barriers to improving patient safety,” Dr. Pal said. “The use of innovation and an interdisciplinary approach to patient safety and quality improvement in hospital-based care, such as the use of machine learning to monitor trends and predict the individualized risk of harm, could be a potential way out” to help reduce barriers and improve safety, he said.

“Additional research is needed to understand the key drivers of preventable harm for hospitalized patients in the United States,” said Dr. Pal. “When planning for change, keen attention must be paid to understanding how these [drivers] may differ for patients who have been historically marginalized or are otherwise underserved so as to not exacerbate health care inequities,” he added.

The study was funded by the Controlled Risk Insurance Company and the Risk Management Foundation of the Harvard Medical Institutions. Dr. Bates owns stock options with AESOP, Clew, FeelBetter, Guided Clinical Solutions, MDClone, and ValeraHealth and has grants/contracts from IBM Watson and EarlySense. He has also served as a consultant for CDI Negev. Dr. Pal has disclosed no relevant financial relationships.

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

A new study likely makes the best estimate yet of the degree of retinopathy risk that patients who take the antimalarial drug hydroxychloroquine (HCQ) can expect, deriving mainly from the cumulative dose taken during the first 5 years of use, according to a study published in Annals of Internal Medicine.

HCQ works to decrease activity in a patient’s immune system, which is effective in many cases of systemic lupus erythematosus, one of the most common indications for the drug. However, an adverse outcome of treatment can be HCQ retinopathy, a progressive form of vision loss in patients taking HCQ over an extended period (mostly for longer than 5 years). The disease is often asymptomatic, although some patients do present a paracentral scotoma and a decrease in color vision. Patients may also notice flashing shapes in their vision and find that they have difficulty reading. Eventually, HCQ retinopathy can lead to loss of visual acuity, loss of peripheral vision, and loss of night vision.

Researchers from Kaiser Permanente Northern California and Harvard Medical School analyzed 3,325 persons who received HCQ for 5 or more years between 2004 and 2020. Their goal was to both characterize the long-term risk for incident HCQ retinopathy and examine the degree to which average HCQ dose within the first 5 years of treatment serves as a prediction of the risk.

The researchers then estimated the risk for developing retinopathy after 15 years, according to patients’ average dosing levels during the first 5 years of therapy. Overall, 81 participants developed HCQ retinopathy with overall cumulative incidences of 2.5% after 10 years and 8.6% after 15 years; the risk was greater for those given a higher dose during the first 5 years of treatment.

The mechanism of how HCQ toxicity may occur is still not completely known. There is evidence that toxicity happens because HCQ binds to melanin in both the retinal pigment epithelium and uvea in high concentrations. HCQ can interfere with lysosomal function, leading to oxidation and accumulation of lysosomes, which can cause dysfunction of the retinal pigment epithelium.

Progressive retinopathy can continue even after the drug is stopped. “It’s thought to be a very mild but important risk,” said Nilanjana Bose, MD, MBA, a rheumatologist with Memorial Hermann Health System in Houston. “Patients taking HCQ must be screened for retinal issues, most certainly elderly patients and patients with any kind of comorbidities.”

“Examination alone is not sufficient to evaluate early changes, and specialized testing must be done. These include color photos, visual field tests, optical coherence tomography, fundus autofluorescence and in some cases, multifocal electroretinogram. Also, the AAO [American Academy of Ophthalmology] has specific recommendations related to Asian patients as they may have a different pattern of retinopathy that must also be considered.”
 

More accurate risk measurements

This news organization asked study coauthor April Jorge, MD, assistant professor of medicine in the division of rheumatology, allergy, and immunology at Massachusetts General Hospital and Harvard Medical School, Boston, to discuss the study, how it correlates to past research, and what it adds that’s new and useful to rheumatologists and ophthalmologists:

Question: Your research found that a higher dose of HCQ in the first 5 years of treatment led to a greater risk of retinopathy. Is there any indication that a lower dose given more frequently, either within that 5-year period or longer, would pose a similar risk?

Answer: In our study, we assessed the HCQ dose in the first 5 years of use but followed patients who continued the medication longer than 5 years, through up to 15 years of use. Therefore, we compared the risk of HCQ retinopathy associated with different HCQ dosages but for the same duration of use. We found that for any dose of HCQ, the risk of retinopathy increases the longer the medication is used. However, patients who used a higher dose of HCQ had a higher risk of developing retinopathy over time.

Also unique to our study, we graded the severity of HCQ retinopathy outcomes. This was important, as we found that the majority of retinopathy cases detected through routine screening are mild and presumed to be asymptomatic. This will likely be reassuring news for patients that we can screen for this adverse event to detect it early and prevent vision loss.

Another important difference was that we assessed the risk of retinopathy associated with using over 6 mg/kg per day, between 5 and 6 mg/kg per day, and less than 5 mg/kg per day, whereas the highest dosing group assessed in the 2014 study included all patients using over 5 mg/kg per day. The risk was considerably higher in the > 6 mg/kg per day group than in the 5-6 mg/kg per day group.

Q: How can rheumatologists and ophthalmologists use this new information specifically to better treat their patients?

A: Our study provides more accurate estimates of the risk of HCQ retinopathy than in prior studies. These risk estimates can be used when rheumatologists (and other clinicians who prescribe HCQ) consider the risks and benefits of this otherwise important and well-tolerated medication. The risk associated with different dose ranges could also inform dosing decisions, since dosing over 6 mg/kg per day may be more of a concern than using doses in the 5-6 mg/kg range. Ophthalmologists can also use these new risk estimates to counsel patients of the importance of HCQ retinopathy screening and can also hopefully provide some reassurance to patients that the risk of severe retinopathy is low as long as they are being monitored.

The study authors were supported by grants from the National Institute of Arthritis and Musculoskeletal and Skin Diseases and the Rheumatology Research Foundation. The authors report no relevant financial relationships. Dr. Bose and Dr. Mirza had no relevant disclosures.

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

A new study likely makes the best estimate yet of the degree of retinopathy risk that patients who take the antimalarial drug hydroxychloroquine (HCQ) can expect, deriving mainly from the cumulative dose taken during the first 5 years of use, according to a study published in Annals of Internal Medicine.

HCQ works to decrease activity in a patient’s immune system, which is effective in many cases of systemic lupus erythematosus, one of the most common indications for the drug. However, an adverse outcome of treatment can be HCQ retinopathy, a progressive form of vision loss in patients taking HCQ over an extended period (mostly for longer than 5 years). The disease is often asymptomatic, although some patients do present a paracentral scotoma and a decrease in color vision. Patients may also notice flashing shapes in their vision and find that they have difficulty reading. Eventually, HCQ retinopathy can lead to loss of visual acuity, loss of peripheral vision, and loss of night vision.

Researchers from Kaiser Permanente Northern California and Harvard Medical School analyzed 3,325 persons who received HCQ for 5 or more years between 2004 and 2020. Their goal was to both characterize the long-term risk for incident HCQ retinopathy and examine the degree to which average HCQ dose within the first 5 years of treatment serves as a prediction of the risk.

The researchers then estimated the risk for developing retinopathy after 15 years, according to patients’ average dosing levels during the first 5 years of therapy. Overall, 81 participants developed HCQ retinopathy with overall cumulative incidences of 2.5% after 10 years and 8.6% after 15 years; the risk was greater for those given a higher dose during the first 5 years of treatment.

The mechanism of how HCQ toxicity may occur is still not completely known. There is evidence that toxicity happens because HCQ binds to melanin in both the retinal pigment epithelium and uvea in high concentrations. HCQ can interfere with lysosomal function, leading to oxidation and accumulation of lysosomes, which can cause dysfunction of the retinal pigment epithelium.

Progressive retinopathy can continue even after the drug is stopped. “It’s thought to be a very mild but important risk,” said Nilanjana Bose, MD, MBA, a rheumatologist with Memorial Hermann Health System in Houston. “Patients taking HCQ must be screened for retinal issues, most certainly elderly patients and patients with any kind of comorbidities.”

“Examination alone is not sufficient to evaluate early changes, and specialized testing must be done. These include color photos, visual field tests, optical coherence tomography, fundus autofluorescence and in some cases, multifocal electroretinogram. Also, the AAO [American Academy of Ophthalmology] has specific recommendations related to Asian patients as they may have a different pattern of retinopathy that must also be considered.”
 

More accurate risk measurements

This news organization asked study coauthor April Jorge, MD, assistant professor of medicine in the division of rheumatology, allergy, and immunology at Massachusetts General Hospital and Harvard Medical School, Boston, to discuss the study, how it correlates to past research, and what it adds that’s new and useful to rheumatologists and ophthalmologists:

Question: Your research found that a higher dose of HCQ in the first 5 years of treatment led to a greater risk of retinopathy. Is there any indication that a lower dose given more frequently, either within that 5-year period or longer, would pose a similar risk?

Answer: In our study, we assessed the HCQ dose in the first 5 years of use but followed patients who continued the medication longer than 5 years, through up to 15 years of use. Therefore, we compared the risk of HCQ retinopathy associated with different HCQ dosages but for the same duration of use. We found that for any dose of HCQ, the risk of retinopathy increases the longer the medication is used. However, patients who used a higher dose of HCQ had a higher risk of developing retinopathy over time.

Also unique to our study, we graded the severity of HCQ retinopathy outcomes. This was important, as we found that the majority of retinopathy cases detected through routine screening are mild and presumed to be asymptomatic. This will likely be reassuring news for patients that we can screen for this adverse event to detect it early and prevent vision loss.

Another important difference was that we assessed the risk of retinopathy associated with using over 6 mg/kg per day, between 5 and 6 mg/kg per day, and less than 5 mg/kg per day, whereas the highest dosing group assessed in the 2014 study included all patients using over 5 mg/kg per day. The risk was considerably higher in the > 6 mg/kg per day group than in the 5-6 mg/kg per day group.

Q: How can rheumatologists and ophthalmologists use this new information specifically to better treat their patients?

A: Our study provides more accurate estimates of the risk of HCQ retinopathy than in prior studies. These risk estimates can be used when rheumatologists (and other clinicians who prescribe HCQ) consider the risks and benefits of this otherwise important and well-tolerated medication. The risk associated with different dose ranges could also inform dosing decisions, since dosing over 6 mg/kg per day may be more of a concern than using doses in the 5-6 mg/kg range. Ophthalmologists can also use these new risk estimates to counsel patients of the importance of HCQ retinopathy screening and can also hopefully provide some reassurance to patients that the risk of severe retinopathy is low as long as they are being monitored.

The study authors were supported by grants from the National Institute of Arthritis and Musculoskeletal and Skin Diseases and the Rheumatology Research Foundation. The authors report no relevant financial relationships. Dr. Bose and Dr. Mirza had no relevant disclosures.

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

A new study likely makes the best estimate yet of the degree of retinopathy risk that patients who take the antimalarial drug hydroxychloroquine (HCQ) can expect, deriving mainly from the cumulative dose taken during the first 5 years of use, according to a study published in Annals of Internal Medicine.

HCQ works to decrease activity in a patient’s immune system, which is effective in many cases of systemic lupus erythematosus, one of the most common indications for the drug. However, an adverse outcome of treatment can be HCQ retinopathy, a progressive form of vision loss in patients taking HCQ over an extended period (mostly for longer than 5 years). The disease is often asymptomatic, although some patients do present a paracentral scotoma and a decrease in color vision. Patients may also notice flashing shapes in their vision and find that they have difficulty reading. Eventually, HCQ retinopathy can lead to loss of visual acuity, loss of peripheral vision, and loss of night vision.

Researchers from Kaiser Permanente Northern California and Harvard Medical School analyzed 3,325 persons who received HCQ for 5 or more years between 2004 and 2020. Their goal was to both characterize the long-term risk for incident HCQ retinopathy and examine the degree to which average HCQ dose within the first 5 years of treatment serves as a prediction of the risk.

The researchers then estimated the risk for developing retinopathy after 15 years, according to patients’ average dosing levels during the first 5 years of therapy. Overall, 81 participants developed HCQ retinopathy with overall cumulative incidences of 2.5% after 10 years and 8.6% after 15 years; the risk was greater for those given a higher dose during the first 5 years of treatment.

The mechanism of how HCQ toxicity may occur is still not completely known. There is evidence that toxicity happens because HCQ binds to melanin in both the retinal pigment epithelium and uvea in high concentrations. HCQ can interfere with lysosomal function, leading to oxidation and accumulation of lysosomes, which can cause dysfunction of the retinal pigment epithelium.

Progressive retinopathy can continue even after the drug is stopped. “It’s thought to be a very mild but important risk,” said Nilanjana Bose, MD, MBA, a rheumatologist with Memorial Hermann Health System in Houston. “Patients taking HCQ must be screened for retinal issues, most certainly elderly patients and patients with any kind of comorbidities.”

“Examination alone is not sufficient to evaluate early changes, and specialized testing must be done. These include color photos, visual field tests, optical coherence tomography, fundus autofluorescence and in some cases, multifocal electroretinogram. Also, the AAO [American Academy of Ophthalmology] has specific recommendations related to Asian patients as they may have a different pattern of retinopathy that must also be considered.”
 

More accurate risk measurements

This news organization asked study coauthor April Jorge, MD, assistant professor of medicine in the division of rheumatology, allergy, and immunology at Massachusetts General Hospital and Harvard Medical School, Boston, to discuss the study, how it correlates to past research, and what it adds that’s new and useful to rheumatologists and ophthalmologists:

Question: Your research found that a higher dose of HCQ in the first 5 years of treatment led to a greater risk of retinopathy. Is there any indication that a lower dose given more frequently, either within that 5-year period or longer, would pose a similar risk?

Answer: In our study, we assessed the HCQ dose in the first 5 years of use but followed patients who continued the medication longer than 5 years, through up to 15 years of use. Therefore, we compared the risk of HCQ retinopathy associated with different HCQ dosages but for the same duration of use. We found that for any dose of HCQ, the risk of retinopathy increases the longer the medication is used. However, patients who used a higher dose of HCQ had a higher risk of developing retinopathy over time.

Also unique to our study, we graded the severity of HCQ retinopathy outcomes. This was important, as we found that the majority of retinopathy cases detected through routine screening are mild and presumed to be asymptomatic. This will likely be reassuring news for patients that we can screen for this adverse event to detect it early and prevent vision loss.

Another important difference was that we assessed the risk of retinopathy associated with using over 6 mg/kg per day, between 5 and 6 mg/kg per day, and less than 5 mg/kg per day, whereas the highest dosing group assessed in the 2014 study included all patients using over 5 mg/kg per day. The risk was considerably higher in the > 6 mg/kg per day group than in the 5-6 mg/kg per day group.

Q: How can rheumatologists and ophthalmologists use this new information specifically to better treat their patients?

A: Our study provides more accurate estimates of the risk of HCQ retinopathy than in prior studies. These risk estimates can be used when rheumatologists (and other clinicians who prescribe HCQ) consider the risks and benefits of this otherwise important and well-tolerated medication. The risk associated with different dose ranges could also inform dosing decisions, since dosing over 6 mg/kg per day may be more of a concern than using doses in the 5-6 mg/kg range. Ophthalmologists can also use these new risk estimates to counsel patients of the importance of HCQ retinopathy screening and can also hopefully provide some reassurance to patients that the risk of severe retinopathy is low as long as they are being monitored.

The study authors were supported by grants from the National Institute of Arthritis and Musculoskeletal and Skin Diseases and the Rheumatology Research Foundation. The authors report no relevant financial relationships. Dr. Bose and Dr. Mirza had no relevant disclosures.

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

Given the over 1-year history of an unchanging longitudinal band of pigment without extension to the proximal or lateral nailfolds or any other nail findings, the most likely diagnosis is benign longitudinal melanonychia.

Longitudinal melanonychia, also known as melanonychia striata, describes a brown to black streak of pigment extending from the nail matrix to the free edge of the nail.^1,2

This disorder can occur secondary to a wide variety of benign and pathologic causes including lentigines, nevi, melanoma, chronic trauma, inflammatory skin diseases, systemic diseases, iatrogenic causes, and genetic syndromes.³ In melanocytic causes of longitudinal melanonychia, either melanocytic activation or hyperplasia drive pigmentary development leading to the brown to black band seen in the nail.⁴ Benign causes of longitudinal melanonychia include benign melanocyte activation, lentigo, and benign nevus.¹

What’s the differential diagnosis?

The differential diagnosis for longitudinal melanonychia can include a wide variety of local and systemic causes. For our discussion, we will limit our differential to other locally involved disorders of the nail including subungual melanoma, subungual hematoma, onychomycosis, and glomus tumor.

Subungual melanoma is a rare subtype of acral lentiginous melanoma that most often presents as longitudinal melanonychia. Subungual melanoma is more common in those aged 50-70 years, individuals with personal or family history of melanoma or dysplastic nevus syndrome, and persons with African American, Native American, and Asian descent. Longitudinal melanonychia features that can be concerning for subungual melanoma include the presence of multiple colors, width greater than or equal to 3 mm, blurry borders, rapid increase in size, and extension to the proximal or lateral nailfolds (Hutchinson’s sign). Biopsy is required to make the diagnosis of subungual melanoma but is not necessary for melanonychia without atypical features.

Dr. Haft is an inflammatory skin disease fellow in the division of pediatric and adolescent dermatology; Ms. Sui is a research associate in the department of dermatology, division of pediatric and adolescent dermatology; and Dr. Eichenfield is vice chair of the department of dermatology and professor of dermatology and pediatrics, all at the University of California and Rady Children’s Hospital, San Diego. They have no relevant disclosures.

References

1. Mannava KA et al. Hand Surg. 2013;18(1):133-9.

2. Leung AKC et al. Int J Dermatol. 2019;58(11):1239-45.

3. Andre J and Lateur N. Dermatol Clin. 2006;24(3):329-39.

4. Lee DK and Lipner SR. Ann Med. 2022;54(1):694-712.

5. Smith RJ and Rubin AI. Curr Opin Pediatr. 2020;32(4):506-15. .

6. Matsui Y et al. J Am Acad Dermatol. 2022;86(4):946-8.

7. Lee JS et al. J Am Acad Dermatol. 2022;87(2):366-72.

Given the over 1-year history of an unchanging longitudinal band of pigment without extension to the proximal or lateral nailfolds or any other nail findings, the most likely diagnosis is benign longitudinal melanonychia.

Longitudinal melanonychia, also known as melanonychia striata, describes a brown to black streak of pigment extending from the nail matrix to the free edge of the nail.^1,2

This disorder can occur secondary to a wide variety of benign and pathologic causes including lentigines, nevi, melanoma, chronic trauma, inflammatory skin diseases, systemic diseases, iatrogenic causes, and genetic syndromes.³ In melanocytic causes of longitudinal melanonychia, either melanocytic activation or hyperplasia drive pigmentary development leading to the brown to black band seen in the nail.⁴ Benign causes of longitudinal melanonychia include benign melanocyte activation, lentigo, and benign nevus.¹

What’s the differential diagnosis?

The differential diagnosis for longitudinal melanonychia can include a wide variety of local and systemic causes. For our discussion, we will limit our differential to other locally involved disorders of the nail including subungual melanoma, subungual hematoma, onychomycosis, and glomus tumor.

Subungual melanoma is a rare subtype of acral lentiginous melanoma that most often presents as longitudinal melanonychia. Subungual melanoma is more common in those aged 50-70 years, individuals with personal or family history of melanoma or dysplastic nevus syndrome, and persons with African American, Native American, and Asian descent. Longitudinal melanonychia features that can be concerning for subungual melanoma include the presence of multiple colors, width greater than or equal to 3 mm, blurry borders, rapid increase in size, and extension to the proximal or lateral nailfolds (Hutchinson’s sign). Biopsy is required to make the diagnosis of subungual melanoma but is not necessary for melanonychia without atypical features.

Dr. Haft is an inflammatory skin disease fellow in the division of pediatric and adolescent dermatology; Ms. Sui is a research associate in the department of dermatology, division of pediatric and adolescent dermatology; and Dr. Eichenfield is vice chair of the department of dermatology and professor of dermatology and pediatrics, all at the University of California and Rady Children’s Hospital, San Diego. They have no relevant disclosures.

References

1. Mannava KA et al. Hand Surg. 2013;18(1):133-9.

2. Leung AKC et al. Int J Dermatol. 2019;58(11):1239-45.

3. Andre J and Lateur N. Dermatol Clin. 2006;24(3):329-39.

4. Lee DK and Lipner SR. Ann Med. 2022;54(1):694-712.

5. Smith RJ and Rubin AI. Curr Opin Pediatr. 2020;32(4):506-15. .

6. Matsui Y et al. J Am Acad Dermatol. 2022;86(4):946-8.

7. Lee JS et al. J Am Acad Dermatol. 2022;87(2):366-72.

Given the over 1-year history of an unchanging longitudinal band of pigment without extension to the proximal or lateral nailfolds or any other nail findings, the most likely diagnosis is benign longitudinal melanonychia.

Longitudinal melanonychia, also known as melanonychia striata, describes a brown to black streak of pigment extending from the nail matrix to the free edge of the nail.^1,2

This disorder can occur secondary to a wide variety of benign and pathologic causes including lentigines, nevi, melanoma, chronic trauma, inflammatory skin diseases, systemic diseases, iatrogenic causes, and genetic syndromes.³ In melanocytic causes of longitudinal melanonychia, either melanocytic activation or hyperplasia drive pigmentary development leading to the brown to black band seen in the nail.⁴ Benign causes of longitudinal melanonychia include benign melanocyte activation, lentigo, and benign nevus.¹

What’s the differential diagnosis?

The differential diagnosis for longitudinal melanonychia can include a wide variety of local and systemic causes. For our discussion, we will limit our differential to other locally involved disorders of the nail including subungual melanoma, subungual hematoma, onychomycosis, and glomus tumor.

Subungual melanoma is a rare subtype of acral lentiginous melanoma that most often presents as longitudinal melanonychia. Subungual melanoma is more common in those aged 50-70 years, individuals with personal or family history of melanoma or dysplastic nevus syndrome, and persons with African American, Native American, and Asian descent. Longitudinal melanonychia features that can be concerning for subungual melanoma include the presence of multiple colors, width greater than or equal to 3 mm, blurry borders, rapid increase in size, and extension to the proximal or lateral nailfolds (Hutchinson’s sign). Biopsy is required to make the diagnosis of subungual melanoma but is not necessary for melanonychia without atypical features.

Dr. Haft is an inflammatory skin disease fellow in the division of pediatric and adolescent dermatology; Ms. Sui is a research associate in the department of dermatology, division of pediatric and adolescent dermatology; and Dr. Eichenfield is vice chair of the department of dermatology and professor of dermatology and pediatrics, all at the University of California and Rady Children’s Hospital, San Diego. They have no relevant disclosures.

References

1. Mannava KA et al. Hand Surg. 2013;18(1):133-9.

2. Leung AKC et al. Int J Dermatol. 2019;58(11):1239-45.

3. Andre J and Lateur N. Dermatol Clin. 2006;24(3):329-39.

4. Lee DK and Lipner SR. Ann Med. 2022;54(1):694-712.

5. Smith RJ and Rubin AI. Curr Opin Pediatr. 2020;32(4):506-15. .

6. Matsui Y et al. J Am Acad Dermatol. 2022;86(4):946-8.

7. Lee JS et al. J Am Acad Dermatol. 2022;87(2):366-72.

Adult and adolescent patients with moderate to severe atopic dermatitis (AD) showed significant improvements with the addition of lebrikizumab to topical corticosteroid (TCS) therapy, compared with TCS plus placebo, according to results of the 16-week phase 3 ADhere trial.

“Lebrikizumab, a monoclonal antibody inhibiting interleukin-13, combined with TCS was associated with reduced overall disease severity of moderate to severe AD in adolescents and adults, and had a safety profile consistent with previous lebrikizumab AD studies,” noted lead author Eric L. Simpson, MD, professor of dermatology at Oregon Health & Science University, Portland, and coauthors in their article on the study, which was published in JAMA Dermatology.

The double-blind trial, conducted at 54 sites across Germany, Poland, Canada, and the United States, included 211 patients, mean age 37.2 years, of whom 48.8% were female and roughly 22% were adolescents. Almost 15% were Asian, and about 13% were Black.

At baseline, participants had a score of 16 or higher on the Eczema Area and Severity Index (EASI), a score of 3 or higher on the Investigator’s Global Assessment (IGA) scale, AD covering a body surface area of 10% or greater, and a history of inadequate response to treatment with topical medications.

After a minimum 1-week washout period from topical and systemic therapy, participants were randomized in a 2:1 ratio to receive lebrikizumab plus TCS (n = 145) or placebo plus TCS (n = 66) for 16 weeks.

Lebrikizumab or placebo was administered by subcutaneous injection every 2 weeks; the loading and week-2 doses of lebrikizumab were 500 mg, followed by 250 mg thereafter. All patients were instructed to use low- to mid-potency TCS at their own discretion. Study sites provided a mid-potency TCS (triamcinolone acetonide 0.1% cream) and a low-potency TCS (hydrocortisone 1% cream), with topical calcineurin inhibitors permitted for sensitive skin areas.

Primary outcomes at 16 weeks included a 2-point or more reduction in IGA score from baseline and EASI-75 response. Patients in the lebrikizumab arm had superior responses on both of these outcomes, with statistical significance achieved as early as week 8 and week 4, respectively, and maintained through week 16. Specifically, 41.2% of those treated with lebrikizumab had an IGA reduction of 2 points or more, compared with 22.1% of those receiving placebo plus TCS (P = .01), and the proportion of patients achieving EASI-75 responses was 69.5% vs. 42.2%, respectively (P < .001).

Patients treated with lebrikizumab also showed statistically significant improvements, compared with TCS alone in all key secondary endpoints, “including skin clearance, improvement in itch, itch interference on sleep, and enhanced QoL [quality of life],” noted the authors. “This study captured the clinical benefit of lebrikizumab through the combined end point of physician-assessed clinical sign of skin clearance (EASI-75) and patient-reported outcome of improvement in itch (Pruritus NRS).”

The percentage of patients who achieved the combined endpoint was more than double for the lebrikizumab plus TCS group vs. the group on TCS alone, indicating that patients treated with lebrikizumab plus TCS “were more likely to experience improvement in skin symptoms and itch,” the investigators added.

The authors noted that most treatment-emergent adverse events “were nonserious, mild, or moderate in severity, and did not lead to study discontinuation.” These included conjunctivitis (4.8%), headache (4.8%), hypertension (2.8%), injection-site reactions (2.8%), and herpes infection (3.4%) – all of which occurred in 1.5% or less of patients in the placebo group.

“The higher incidence of conjunctivitis has also been reported in other biologics inhibiting IL [interleukin]–13 and/or IL-4 signaling, as well as lebrikizumab monotherapy studies,” they noted. The 4.8% rate of conjunctivitis reported in the combination study, they added, is “compared with 7.5% frequency in 16-week data from the lebrikizumab monotherapy studies. Although the mechanism remains unclear, it has been reported that conjunctival goblet cell scarcity due to IL-13 and IL-4 inhibition, and subsequent effects on the homeostasis of the conjunctival mucosal surface, results in ocular AEs [adverse events].”

“This truly is a time of great hope and promise for our patients with AD,” commented Zelma Chiesa Fuxench, MD, who was not involved in the study. “The advent of newer, targeted therapeutic agents for AD continues to revolutionize the treatment experience for our patients, offering the possibility of greater AD disease control with a favorable risk profile and less need for blood work monitoring compared to traditional systemic agents.”

On the basis of the study results, Dr. Chiesa Fuxench, of the department of dermatology at the University of Pennsylvania, Philadelphia, said in an interview that “lebrikizumab represents an additional option in the treatment armamentarium for providers who care for patients with AD.” She added that, “while head-to-head trials comparing lebrikizumab to dupilumab, the first FDA-approved biologic for AD, would be beneficial, to the best of my knowledge this data is currently lacking. However, based on the results of this study, we would expect lebrikizumab to work at least similarly to dupilumab, based on the reported improvements in IGA and EASI score.”

Additionally, lebrikizumab showed a favorable safety profile, “with most treatment-emergent adverse effects reported as nonserious and not leading to drug discontinuation,” she said. “Of interest to clinicians may be the reported rates of conjunctivitis in this study. Rates of conjunctivitis for lebrikizumab appear to be lower than those reported in the LIBERTY AD CHRONOS study for dupilumab – a finding that merits further scrutiny in my opinion, as this one of the most frequent treatment-emergent adverse events that I encounter in my clinical practice.”

The study was funded by Dermira, a subsidiary of Eli Lilly. Dr. Simpson reported personal fees and grants from multiple sources, including Dermira and Eli Lilly, the companies developing lebrikizumab. Several authors were employees of Eli Lilly. Dr. Fuxench disclosed serving as a consultant for the Asthma and Allergy Foundation of America, National Eczema Association, Pfizer, AbbVie, and Incyte, for which she has received honoraria for AD-related work. She is the recipient of research grants through Regeneron, Sanofi, Tioga, Vanda, Menlo Therapeutics, Leo Pharma, and Eli Lilly for work related to AD as well as honoraria for continuing medical education work related to AD sponsored through educational grants from Regeneron/Sanofi and Pfizer.

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

Adult and adolescent patients with moderate to severe atopic dermatitis (AD) showed significant improvements with the addition of lebrikizumab to topical corticosteroid (TCS) therapy, compared with TCS plus placebo, according to results of the 16-week phase 3 ADhere trial.

“Lebrikizumab, a monoclonal antibody inhibiting interleukin-13, combined with TCS was associated with reduced overall disease severity of moderate to severe AD in adolescents and adults, and had a safety profile consistent with previous lebrikizumab AD studies,” noted lead author Eric L. Simpson, MD, professor of dermatology at Oregon Health & Science University, Portland, and coauthors in their article on the study, which was published in JAMA Dermatology.

The double-blind trial, conducted at 54 sites across Germany, Poland, Canada, and the United States, included 211 patients, mean age 37.2 years, of whom 48.8% were female and roughly 22% were adolescents. Almost 15% were Asian, and about 13% were Black.

At baseline, participants had a score of 16 or higher on the Eczema Area and Severity Index (EASI), a score of 3 or higher on the Investigator’s Global Assessment (IGA) scale, AD covering a body surface area of 10% or greater, and a history of inadequate response to treatment with topical medications.

After a minimum 1-week washout period from topical and systemic therapy, participants were randomized in a 2:1 ratio to receive lebrikizumab plus TCS (n = 145) or placebo plus TCS (n = 66) for 16 weeks.

Lebrikizumab or placebo was administered by subcutaneous injection every 2 weeks; the loading and week-2 doses of lebrikizumab were 500 mg, followed by 250 mg thereafter. All patients were instructed to use low- to mid-potency TCS at their own discretion. Study sites provided a mid-potency TCS (triamcinolone acetonide 0.1% cream) and a low-potency TCS (hydrocortisone 1% cream), with topical calcineurin inhibitors permitted for sensitive skin areas.

Primary outcomes at 16 weeks included a 2-point or more reduction in IGA score from baseline and EASI-75 response. Patients in the lebrikizumab arm had superior responses on both of these outcomes, with statistical significance achieved as early as week 8 and week 4, respectively, and maintained through week 16. Specifically, 41.2% of those treated with lebrikizumab had an IGA reduction of 2 points or more, compared with 22.1% of those receiving placebo plus TCS (P = .01), and the proportion of patients achieving EASI-75 responses was 69.5% vs. 42.2%, respectively (P < .001).

Patients treated with lebrikizumab also showed statistically significant improvements, compared with TCS alone in all key secondary endpoints, “including skin clearance, improvement in itch, itch interference on sleep, and enhanced QoL [quality of life],” noted the authors. “This study captured the clinical benefit of lebrikizumab through the combined end point of physician-assessed clinical sign of skin clearance (EASI-75) and patient-reported outcome of improvement in itch (Pruritus NRS).”

The percentage of patients who achieved the combined endpoint was more than double for the lebrikizumab plus TCS group vs. the group on TCS alone, indicating that patients treated with lebrikizumab plus TCS “were more likely to experience improvement in skin symptoms and itch,” the investigators added.

The authors noted that most treatment-emergent adverse events “were nonserious, mild, or moderate in severity, and did not lead to study discontinuation.” These included conjunctivitis (4.8%), headache (4.8%), hypertension (2.8%), injection-site reactions (2.8%), and herpes infection (3.4%) – all of which occurred in 1.5% or less of patients in the placebo group.

“The higher incidence of conjunctivitis has also been reported in other biologics inhibiting IL [interleukin]–13 and/or IL-4 signaling, as well as lebrikizumab monotherapy studies,” they noted. The 4.8% rate of conjunctivitis reported in the combination study, they added, is “compared with 7.5% frequency in 16-week data from the lebrikizumab monotherapy studies. Although the mechanism remains unclear, it has been reported that conjunctival goblet cell scarcity due to IL-13 and IL-4 inhibition, and subsequent effects on the homeostasis of the conjunctival mucosal surface, results in ocular AEs [adverse events].”

“This truly is a time of great hope and promise for our patients with AD,” commented Zelma Chiesa Fuxench, MD, who was not involved in the study. “The advent of newer, targeted therapeutic agents for AD continues to revolutionize the treatment experience for our patients, offering the possibility of greater AD disease control with a favorable risk profile and less need for blood work monitoring compared to traditional systemic agents.”

On the basis of the study results, Dr. Chiesa Fuxench, of the department of dermatology at the University of Pennsylvania, Philadelphia, said in an interview that “lebrikizumab represents an additional option in the treatment armamentarium for providers who care for patients with AD.” She added that, “while head-to-head trials comparing lebrikizumab to dupilumab, the first FDA-approved biologic for AD, would be beneficial, to the best of my knowledge this data is currently lacking. However, based on the results of this study, we would expect lebrikizumab to work at least similarly to dupilumab, based on the reported improvements in IGA and EASI score.”

Additionally, lebrikizumab showed a favorable safety profile, “with most treatment-emergent adverse effects reported as nonserious and not leading to drug discontinuation,” she said. “Of interest to clinicians may be the reported rates of conjunctivitis in this study. Rates of conjunctivitis for lebrikizumab appear to be lower than those reported in the LIBERTY AD CHRONOS study for dupilumab – a finding that merits further scrutiny in my opinion, as this one of the most frequent treatment-emergent adverse events that I encounter in my clinical practice.”

The study was funded by Dermira, a subsidiary of Eli Lilly. Dr. Simpson reported personal fees and grants from multiple sources, including Dermira and Eli Lilly, the companies developing lebrikizumab. Several authors were employees of Eli Lilly. Dr. Fuxench disclosed serving as a consultant for the Asthma and Allergy Foundation of America, National Eczema Association, Pfizer, AbbVie, and Incyte, for which she has received honoraria for AD-related work. She is the recipient of research grants through Regeneron, Sanofi, Tioga, Vanda, Menlo Therapeutics, Leo Pharma, and Eli Lilly for work related to AD as well as honoraria for continuing medical education work related to AD sponsored through educational grants from Regeneron/Sanofi and Pfizer.

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

Adult and adolescent patients with moderate to severe atopic dermatitis (AD) showed significant improvements with the addition of lebrikizumab to topical corticosteroid (TCS) therapy, compared with TCS plus placebo, according to results of the 16-week phase 3 ADhere trial.

“Lebrikizumab, a monoclonal antibody inhibiting interleukin-13, combined with TCS was associated with reduced overall disease severity of moderate to severe AD in adolescents and adults, and had a safety profile consistent with previous lebrikizumab AD studies,” noted lead author Eric L. Simpson, MD, professor of dermatology at Oregon Health & Science University, Portland, and coauthors in their article on the study, which was published in JAMA Dermatology.

The double-blind trial, conducted at 54 sites across Germany, Poland, Canada, and the United States, included 211 patients, mean age 37.2 years, of whom 48.8% were female and roughly 22% were adolescents. Almost 15% were Asian, and about 13% were Black.

At baseline, participants had a score of 16 or higher on the Eczema Area and Severity Index (EASI), a score of 3 or higher on the Investigator’s Global Assessment (IGA) scale, AD covering a body surface area of 10% or greater, and a history of inadequate response to treatment with topical medications.

After a minimum 1-week washout period from topical and systemic therapy, participants were randomized in a 2:1 ratio to receive lebrikizumab plus TCS (n = 145) or placebo plus TCS (n = 66) for 16 weeks.

Lebrikizumab or placebo was administered by subcutaneous injection every 2 weeks; the loading and week-2 doses of lebrikizumab were 500 mg, followed by 250 mg thereafter. All patients were instructed to use low- to mid-potency TCS at their own discretion. Study sites provided a mid-potency TCS (triamcinolone acetonide 0.1% cream) and a low-potency TCS (hydrocortisone 1% cream), with topical calcineurin inhibitors permitted for sensitive skin areas.

Primary outcomes at 16 weeks included a 2-point or more reduction in IGA score from baseline and EASI-75 response. Patients in the lebrikizumab arm had superior responses on both of these outcomes, with statistical significance achieved as early as week 8 and week 4, respectively, and maintained through week 16. Specifically, 41.2% of those treated with lebrikizumab had an IGA reduction of 2 points or more, compared with 22.1% of those receiving placebo plus TCS (P = .01), and the proportion of patients achieving EASI-75 responses was 69.5% vs. 42.2%, respectively (P < .001).

Patients treated with lebrikizumab also showed statistically significant improvements, compared with TCS alone in all key secondary endpoints, “including skin clearance, improvement in itch, itch interference on sleep, and enhanced QoL [quality of life],” noted the authors. “This study captured the clinical benefit of lebrikizumab through the combined end point of physician-assessed clinical sign of skin clearance (EASI-75) and patient-reported outcome of improvement in itch (Pruritus NRS).”

The percentage of patients who achieved the combined endpoint was more than double for the lebrikizumab plus TCS group vs. the group on TCS alone, indicating that patients treated with lebrikizumab plus TCS “were more likely to experience improvement in skin symptoms and itch,” the investigators added.

The authors noted that most treatment-emergent adverse events “were nonserious, mild, or moderate in severity, and did not lead to study discontinuation.” These included conjunctivitis (4.8%), headache (4.8%), hypertension (2.8%), injection-site reactions (2.8%), and herpes infection (3.4%) – all of which occurred in 1.5% or less of patients in the placebo group.

“The higher incidence of conjunctivitis has also been reported in other biologics inhibiting IL [interleukin]–13 and/or IL-4 signaling, as well as lebrikizumab monotherapy studies,” they noted. The 4.8% rate of conjunctivitis reported in the combination study, they added, is “compared with 7.5% frequency in 16-week data from the lebrikizumab monotherapy studies. Although the mechanism remains unclear, it has been reported that conjunctival goblet cell scarcity due to IL-13 and IL-4 inhibition, and subsequent effects on the homeostasis of the conjunctival mucosal surface, results in ocular AEs [adverse events].”

“This truly is a time of great hope and promise for our patients with AD,” commented Zelma Chiesa Fuxench, MD, who was not involved in the study. “The advent of newer, targeted therapeutic agents for AD continues to revolutionize the treatment experience for our patients, offering the possibility of greater AD disease control with a favorable risk profile and less need for blood work monitoring compared to traditional systemic agents.”

On the basis of the study results, Dr. Chiesa Fuxench, of the department of dermatology at the University of Pennsylvania, Philadelphia, said in an interview that “lebrikizumab represents an additional option in the treatment armamentarium for providers who care for patients with AD.” She added that, “while head-to-head trials comparing lebrikizumab to dupilumab, the first FDA-approved biologic for AD, would be beneficial, to the best of my knowledge this data is currently lacking. However, based on the results of this study, we would expect lebrikizumab to work at least similarly to dupilumab, based on the reported improvements in IGA and EASI score.”

Additionally, lebrikizumab showed a favorable safety profile, “with most treatment-emergent adverse effects reported as nonserious and not leading to drug discontinuation,” she said. “Of interest to clinicians may be the reported rates of conjunctivitis in this study. Rates of conjunctivitis for lebrikizumab appear to be lower than those reported in the LIBERTY AD CHRONOS study for dupilumab – a finding that merits further scrutiny in my opinion, as this one of the most frequent treatment-emergent adverse events that I encounter in my clinical practice.”

The study was funded by Dermira, a subsidiary of Eli Lilly. Dr. Simpson reported personal fees and grants from multiple sources, including Dermira and Eli Lilly, the companies developing lebrikizumab. Several authors were employees of Eli Lilly. Dr. Fuxench disclosed serving as a consultant for the Asthma and Allergy Foundation of America, National Eczema Association, Pfizer, AbbVie, and Incyte, for which she has received honoraria for AD-related work. She is the recipient of research grants through Regeneron, Sanofi, Tioga, Vanda, Menlo Therapeutics, Leo Pharma, and Eli Lilly for work related to AD as well as honoraria for continuing medical education work related to AD sponsored through educational grants from Regeneron/Sanofi and Pfizer.

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