Kari Oakes

NEW YORK – Is there an association between sunscreen use and frontal fibrosing alopecia? Perhaps, but causation is far from well established, according to Henry Lim, MD.

“Frontal fibrosing alopecia is becoming more common – definitely,” said Dr. Lim, speaking in an exclusive interview at the American Academy of Dermatology summer meeting. “Those of us who see patients would see, on average, probably a few patients a week with new-onset frontal fibrosing alopecia.”

Dr. Lim, program director of dermatology research and the photomedicine fellowship at Henry Ford Hospital, Detroit, said in a presentation at the meeting that, in the medical literature, just four surveys have been identified that examined the potential association of UV filters in sunscreen preparations with the risk for frontal fibrosing alopecia (FFA).

The first survey-based study questioned 205 women – 105 of whom had FFA – about sunscreen use, finding increased risk for FFA when sunscreen use was reported at least twice a week (Br J Dermatol. 2016 Oct;175:762-7). The second study, by contrast, looked at men only, examining 17 patients with FFA and 73 control participants. This study found increased frequency of FFA in patients who reported use of sunscreen or sunscreen-containing moisturizers (Br J Dermatol. 2011 Jul;177:260-1).

The final two survey-based studies each also found increased FFA frequency in patients using sunscreens, said Dr. Lim. The first of these was the largest among the FFA studies, surveying 308 patients, 19 of whom were men, with FFA and 347 control participants (Clin Exp Dermatol. 2019 Jun;44:404-10). The other study, involving women only, compared 130 patients with FFA and 130 control participants (Br J Dermatol. 2019 Apr;180:943-4).

Several factors need to be taken into consideration when evaluating the available data, said Dr. Lim. “With any type of retrospective study, there are some limitations, recall bias being one. No. 2, the studies were not designed to look at which sunscreens’ ingredient is causing the frontal fibrosing alopecia, so all we can say is that there is an association of sunscreen with frontal fibrosing alopecia without knowing which active ingredient is involved.”

Also, “there is no conclusion that we can draw in terms of causation,” he said. Data are insufficient for this kind of inference.

Titanium dioxide, a mineral filter used in some sunscreen preparations, has also been implicated in FFA. Elemental titanium has been detected in the hair shafts of some patients with alopecia, said Dr. Lim, noting a case report and another small study. In the smaller study, 20 patients were included. Of them, 16 were FFA-affected women, 4 were unaffected women, and 1 was an unaffected man. Here, however, titanium was found in the hair shaft of all participants save the one unaffected man (Br J Dermatol. 2019 Jul;181:216-7).

However, he warned, “the studies are still early. The numbers are still relatively small that have been examined.” Furthermore, the controls, meaning individuals who did not have FFA in the study, also had titanium element in their hair shaft. All of this means that it’s too early to draw firm conclusions about whether there’s a causal relationship between titanium-containing preparations and FFA.

In questioning after the session, an audience member pointed out that sunscreens are not the sole source of titanium among topical preparations; many cosmetics and hair products also use titanium.

Dr. Lim reported financial relationships with Eli Lilly, Estee Lauder, Ferndale Laboratories, Incyte Corporation, ISDIN, Pierre Fabre Dermatologie, and Unigen.

[email protected]

NEW YORK – Is there an association between sunscreen use and frontal fibrosing alopecia? Perhaps, but causation is far from well established, according to Henry Lim, MD.

“Frontal fibrosing alopecia is becoming more common – definitely,” said Dr. Lim, speaking in an exclusive interview at the American Academy of Dermatology summer meeting. “Those of us who see patients would see, on average, probably a few patients a week with new-onset frontal fibrosing alopecia.”

Dr. Lim, program director of dermatology research and the photomedicine fellowship at Henry Ford Hospital, Detroit, said in a presentation at the meeting that, in the medical literature, just four surveys have been identified that examined the potential association of UV filters in sunscreen preparations with the risk for frontal fibrosing alopecia (FFA).

The first survey-based study questioned 205 women – 105 of whom had FFA – about sunscreen use, finding increased risk for FFA when sunscreen use was reported at least twice a week (Br J Dermatol. 2016 Oct;175:762-7). The second study, by contrast, looked at men only, examining 17 patients with FFA and 73 control participants. This study found increased frequency of FFA in patients who reported use of sunscreen or sunscreen-containing moisturizers (Br J Dermatol. 2011 Jul;177:260-1).

The final two survey-based studies each also found increased FFA frequency in patients using sunscreens, said Dr. Lim. The first of these was the largest among the FFA studies, surveying 308 patients, 19 of whom were men, with FFA and 347 control participants (Clin Exp Dermatol. 2019 Jun;44:404-10). The other study, involving women only, compared 130 patients with FFA and 130 control participants (Br J Dermatol. 2019 Apr;180:943-4).

Several factors need to be taken into consideration when evaluating the available data, said Dr. Lim. “With any type of retrospective study, there are some limitations, recall bias being one. No. 2, the studies were not designed to look at which sunscreens’ ingredient is causing the frontal fibrosing alopecia, so all we can say is that there is an association of sunscreen with frontal fibrosing alopecia without knowing which active ingredient is involved.”

Also, “there is no conclusion that we can draw in terms of causation,” he said. Data are insufficient for this kind of inference.

Titanium dioxide, a mineral filter used in some sunscreen preparations, has also been implicated in FFA. Elemental titanium has been detected in the hair shafts of some patients with alopecia, said Dr. Lim, noting a case report and another small study. In the smaller study, 20 patients were included. Of them, 16 were FFA-affected women, 4 were unaffected women, and 1 was an unaffected man. Here, however, titanium was found in the hair shaft of all participants save the one unaffected man (Br J Dermatol. 2019 Jul;181:216-7).

However, he warned, “the studies are still early. The numbers are still relatively small that have been examined.” Furthermore, the controls, meaning individuals who did not have FFA in the study, also had titanium element in their hair shaft. All of this means that it’s too early to draw firm conclusions about whether there’s a causal relationship between titanium-containing preparations and FFA.

In questioning after the session, an audience member pointed out that sunscreens are not the sole source of titanium among topical preparations; many cosmetics and hair products also use titanium.

Dr. Lim reported financial relationships with Eli Lilly, Estee Lauder, Ferndale Laboratories, Incyte Corporation, ISDIN, Pierre Fabre Dermatologie, and Unigen.

[email protected]

NEW YORK – Is there an association between sunscreen use and frontal fibrosing alopecia? Perhaps, but causation is far from well established, according to Henry Lim, MD.

“Frontal fibrosing alopecia is becoming more common – definitely,” said Dr. Lim, speaking in an exclusive interview at the American Academy of Dermatology summer meeting. “Those of us who see patients would see, on average, probably a few patients a week with new-onset frontal fibrosing alopecia.”

Dr. Lim, program director of dermatology research and the photomedicine fellowship at Henry Ford Hospital, Detroit, said in a presentation at the meeting that, in the medical literature, just four surveys have been identified that examined the potential association of UV filters in sunscreen preparations with the risk for frontal fibrosing alopecia (FFA).

The first survey-based study questioned 205 women – 105 of whom had FFA – about sunscreen use, finding increased risk for FFA when sunscreen use was reported at least twice a week (Br J Dermatol. 2016 Oct;175:762-7). The second study, by contrast, looked at men only, examining 17 patients with FFA and 73 control participants. This study found increased frequency of FFA in patients who reported use of sunscreen or sunscreen-containing moisturizers (Br J Dermatol. 2011 Jul;177:260-1).

The final two survey-based studies each also found increased FFA frequency in patients using sunscreens, said Dr. Lim. The first of these was the largest among the FFA studies, surveying 308 patients, 19 of whom were men, with FFA and 347 control participants (Clin Exp Dermatol. 2019 Jun;44:404-10). The other study, involving women only, compared 130 patients with FFA and 130 control participants (Br J Dermatol. 2019 Apr;180:943-4).

Several factors need to be taken into consideration when evaluating the available data, said Dr. Lim. “With any type of retrospective study, there are some limitations, recall bias being one. No. 2, the studies were not designed to look at which sunscreens’ ingredient is causing the frontal fibrosing alopecia, so all we can say is that there is an association of sunscreen with frontal fibrosing alopecia without knowing which active ingredient is involved.”

Also, “there is no conclusion that we can draw in terms of causation,” he said. Data are insufficient for this kind of inference.

Titanium dioxide, a mineral filter used in some sunscreen preparations, has also been implicated in FFA. Elemental titanium has been detected in the hair shafts of some patients with alopecia, said Dr. Lim, noting a case report and another small study. In the smaller study, 20 patients were included. Of them, 16 were FFA-affected women, 4 were unaffected women, and 1 was an unaffected man. Here, however, titanium was found in the hair shaft of all participants save the one unaffected man (Br J Dermatol. 2019 Jul;181:216-7).

However, he warned, “the studies are still early. The numbers are still relatively small that have been examined.” Furthermore, the controls, meaning individuals who did not have FFA in the study, also had titanium element in their hair shaft. All of this means that it’s too early to draw firm conclusions about whether there’s a causal relationship between titanium-containing preparations and FFA.

In questioning after the session, an audience member pointed out that sunscreens are not the sole source of titanium among topical preparations; many cosmetics and hair products also use titanium.

Dr. Lim reported financial relationships with Eli Lilly, Estee Lauder, Ferndale Laboratories, Incyte Corporation, ISDIN, Pierre Fabre Dermatologie, and Unigen.

[email protected]

Having a first-degree relative with amyotrophic lateral sclerosis (ALS) increases the lifetime risk of developing the condition, even in the absence of a known ALS-associated genetic mutation, according to a recent Irish population–based study.

designer491/Thinkstock

Among first-degree relatives of individuals with ALS whose genetic status was unknown, the lifetime risk of developing ALS was 1.4%, compared with 0.3% in the general population (P less than .001).

Overall, lifetime heritability for the 1,117 patients in the heritability study cohort was 52.3% (95% confidence interval, 42.9%-61.7%). The highest heritability was seen in mother-daughter dyads; here, the concordance rate for ALS was 2.6% and the heritability estimate was 66.2% (95% CI, 58.5%-73.9%), “pointing to a previously unrecognized sex-mediated association with disease heritability,” Marie Ryan, MD, and coauthors at Trinity College Dublin wrote in JAMA Neurology.

For the purposes of this study, heritability was defined as “the proportion of variance in liability that is attributable to additive genetic factors,” explained the investigators. Their model was applied to 1,123 Irish patients with incident ALS over a 10-year study period, drawing on a national database. Complete medical histories were available for both parents of every individual in the cohort, and the investigators identified 32 parent-offspring dyads with ALS.

In their assessment of “liability” for ALS, Dr. Ryan and colleagues accounted for age-specific and sex-specific ALS incidence rates, using a well-delineated United States reference population. They also took into account competing mortality risks that might intervene before an individual developed ALS.

Although mother-daughter dyads yielded the highest heritability estimates, heritability was also elevated among father-son dyads, at 50.1% (95% CI, 42.0%-59.4%). Opposite-sex dyads (mother-son and father-daughter) yielded similar, and lower, heritability estimates of 34%-38%. Dr. Ryan and coinvestigators acknowledged that female sex hormones might play a role in mediating risk for ALS, but the contribution and mechanism are currently unknown.

The investigators identified 674 patients in the cohort who had been tested for C9orf72; large repeat expansions in the GGGGCC segment of this gene are known to cause ALS. In all, 69 patients were C9orf72 positive, and 14 of these individuals (20.3%) reported that one parent had ALS. Among the entire cohort, 23 of the 32 patients with parents who also had ALS had C9orf72 testing, and 14 of 23 (60.9%) were positive. This discrepancy, wrote Dr. Ryan and coauthors, suggests that “genetic anticipation or pleiotropic effects may have masked the clinical phenotype in their parents.”


Parents were a mean 69.6 years old at the time of diagnosis, and offspring were a mean 52.0 years old; 56% of patients in the study cohort were male.

“[I]n our study, ALS heritability was assessed for the first time in a population in whom genetic mutations have been excluded,” wrote Dr. Ryan and coinvestigators. “We have found that, in the absence of known ALS-associated genetic mutations in the proband, first-degree relatives of individuals with ALS remain at increased risk of developing ALS compared with the general population.”

Dr. Ryan and one coauthor reported receiving funding from Science Foundation Ireland, and one coauthor reported receiving book royalties from Taylor & Francis, and fees from Cytokinetics and Wave Pharmaceuticals. The study was funded by Science Foundation Ireland and the Motor Neurone Disease Association.

[email protected]

SOURCE: Ryan M et al. JAMA Neurol. 2019 Jul 22. doi: 10.1001/jamaneurol.2019.2044.

Having a first-degree relative with amyotrophic lateral sclerosis (ALS) increases the lifetime risk of developing the condition, even in the absence of a known ALS-associated genetic mutation, according to a recent Irish population–based study.

designer491/Thinkstock

Among first-degree relatives of individuals with ALS whose genetic status was unknown, the lifetime risk of developing ALS was 1.4%, compared with 0.3% in the general population (P less than .001).

Overall, lifetime heritability for the 1,117 patients in the heritability study cohort was 52.3% (95% confidence interval, 42.9%-61.7%). The highest heritability was seen in mother-daughter dyads; here, the concordance rate for ALS was 2.6% and the heritability estimate was 66.2% (95% CI, 58.5%-73.9%), “pointing to a previously unrecognized sex-mediated association with disease heritability,” Marie Ryan, MD, and coauthors at Trinity College Dublin wrote in JAMA Neurology.

For the purposes of this study, heritability was defined as “the proportion of variance in liability that is attributable to additive genetic factors,” explained the investigators. Their model was applied to 1,123 Irish patients with incident ALS over a 10-year study period, drawing on a national database. Complete medical histories were available for both parents of every individual in the cohort, and the investigators identified 32 parent-offspring dyads with ALS.

In their assessment of “liability” for ALS, Dr. Ryan and colleagues accounted for age-specific and sex-specific ALS incidence rates, using a well-delineated United States reference population. They also took into account competing mortality risks that might intervene before an individual developed ALS.

Although mother-daughter dyads yielded the highest heritability estimates, heritability was also elevated among father-son dyads, at 50.1% (95% CI, 42.0%-59.4%). Opposite-sex dyads (mother-son and father-daughter) yielded similar, and lower, heritability estimates of 34%-38%. Dr. Ryan and coinvestigators acknowledged that female sex hormones might play a role in mediating risk for ALS, but the contribution and mechanism are currently unknown.

The investigators identified 674 patients in the cohort who had been tested for C9orf72; large repeat expansions in the GGGGCC segment of this gene are known to cause ALS. In all, 69 patients were C9orf72 positive, and 14 of these individuals (20.3%) reported that one parent had ALS. Among the entire cohort, 23 of the 32 patients with parents who also had ALS had C9orf72 testing, and 14 of 23 (60.9%) were positive. This discrepancy, wrote Dr. Ryan and coauthors, suggests that “genetic anticipation or pleiotropic effects may have masked the clinical phenotype in their parents.”


Parents were a mean 69.6 years old at the time of diagnosis, and offspring were a mean 52.0 years old; 56% of patients in the study cohort were male.

“[I]n our study, ALS heritability was assessed for the first time in a population in whom genetic mutations have been excluded,” wrote Dr. Ryan and coinvestigators. “We have found that, in the absence of known ALS-associated genetic mutations in the proband, first-degree relatives of individuals with ALS remain at increased risk of developing ALS compared with the general population.”

Dr. Ryan and one coauthor reported receiving funding from Science Foundation Ireland, and one coauthor reported receiving book royalties from Taylor & Francis, and fees from Cytokinetics and Wave Pharmaceuticals. The study was funded by Science Foundation Ireland and the Motor Neurone Disease Association.

[email protected]

SOURCE: Ryan M et al. JAMA Neurol. 2019 Jul 22. doi: 10.1001/jamaneurol.2019.2044.

Having a first-degree relative with amyotrophic lateral sclerosis (ALS) increases the lifetime risk of developing the condition, even in the absence of a known ALS-associated genetic mutation, according to a recent Irish population–based study.

designer491/Thinkstock

Among first-degree relatives of individuals with ALS whose genetic status was unknown, the lifetime risk of developing ALS was 1.4%, compared with 0.3% in the general population (P less than .001).

Overall, lifetime heritability for the 1,117 patients in the heritability study cohort was 52.3% (95% confidence interval, 42.9%-61.7%). The highest heritability was seen in mother-daughter dyads; here, the concordance rate for ALS was 2.6% and the heritability estimate was 66.2% (95% CI, 58.5%-73.9%), “pointing to a previously unrecognized sex-mediated association with disease heritability,” Marie Ryan, MD, and coauthors at Trinity College Dublin wrote in JAMA Neurology.

For the purposes of this study, heritability was defined as “the proportion of variance in liability that is attributable to additive genetic factors,” explained the investigators. Their model was applied to 1,123 Irish patients with incident ALS over a 10-year study period, drawing on a national database. Complete medical histories were available for both parents of every individual in the cohort, and the investigators identified 32 parent-offspring dyads with ALS.

In their assessment of “liability” for ALS, Dr. Ryan and colleagues accounted for age-specific and sex-specific ALS incidence rates, using a well-delineated United States reference population. They also took into account competing mortality risks that might intervene before an individual developed ALS.

Although mother-daughter dyads yielded the highest heritability estimates, heritability was also elevated among father-son dyads, at 50.1% (95% CI, 42.0%-59.4%). Opposite-sex dyads (mother-son and father-daughter) yielded similar, and lower, heritability estimates of 34%-38%. Dr. Ryan and coinvestigators acknowledged that female sex hormones might play a role in mediating risk for ALS, but the contribution and mechanism are currently unknown.

The investigators identified 674 patients in the cohort who had been tested for C9orf72; large repeat expansions in the GGGGCC segment of this gene are known to cause ALS. In all, 69 patients were C9orf72 positive, and 14 of these individuals (20.3%) reported that one parent had ALS. Among the entire cohort, 23 of the 32 patients with parents who also had ALS had C9orf72 testing, and 14 of 23 (60.9%) were positive. This discrepancy, wrote Dr. Ryan and coauthors, suggests that “genetic anticipation or pleiotropic effects may have masked the clinical phenotype in their parents.”


Parents were a mean 69.6 years old at the time of diagnosis, and offspring were a mean 52.0 years old; 56% of patients in the study cohort were male.

“[I]n our study, ALS heritability was assessed for the first time in a population in whom genetic mutations have been excluded,” wrote Dr. Ryan and coinvestigators. “We have found that, in the absence of known ALS-associated genetic mutations in the proband, first-degree relatives of individuals with ALS remain at increased risk of developing ALS compared with the general population.”

Dr. Ryan and one coauthor reported receiving funding from Science Foundation Ireland, and one coauthor reported receiving book royalties from Taylor & Francis, and fees from Cytokinetics and Wave Pharmaceuticals. The study was funded by Science Foundation Ireland and the Motor Neurone Disease Association.

[email protected]

SOURCE: Ryan M et al. JAMA Neurol. 2019 Jul 22. doi: 10.1001/jamaneurol.2019.2044.

SAN DIEGO – Authors of endoscopy clinical practice guidelines (CPGs) received many more payments from industry than they disclosed, according to a new review of publicly available data.

Additionally, many of the payments came from pharmaceutical companies or medical device manufacturers whose products were directly related to the practice guideline topic at hand, said Amir Rumann, MD, and coauthors, who presented their findings in a poster session at the annual Digestive Disease Week^®.

The researchers found that, of 581 authors listed in 38 CPGs, 127 had initially disclosed payments when the guidelines were published. A search of the federal Open Payments database, however, found that 452 of these authors had payments that they did not disclose in the CPG publication process.

For authors with undisclosed payments, the median value of the total undisclosed amounts was $2,445, from a median of 2.5 unique companies, according to records maintained by the Centers for Medicare & Medicaid Services. The interquartile range for payments was $167-$10,380.

“There is a high burden of undisclosed payments by pharmaceutical and medical device manufacturers to authors of endoscopy guidelines in the United States,” wrote Dr. Rumman and coauthors at the University of Toronto, where Dr. Rumann is a gastroenterology resident.

Of the authors who disclosed payments, 20 (16%) disclosed payments from sources directly related to the CPG in the publication. But the Open Payments database search yielded 314 (54%) disclosed payments that were judged directly related to the CPG topic at hand.

Of the 38 CPGs included in the analysis, 24 were from the American Society for Gastrointestinal Endoscopy (ASGE), and 4 were from the American Gastroenterological Association (AGA). According to the analysis performed by Dr. Rumman and his coauthors, 23 of these guidelines adhered to standards proposed by the National Academy of Medicine for development of “trustworthy” CPGs.

“The prevalence of conflicts of interest in the form of industry payments among physicians is well described in academic literature. A number of studies, including several from our group, have found there is a high burden of these payments among authors and chairs of CPGs in various therapeutic areas,” commented senior author Samir Grover, MD, a gastroenterologist at the University of Toronto. “Additionally, the existing literature has shown that many of these payments go undisclosed in the CPG themselves. This is concerning. Although the presence of these payments doesn’t necessarily indicate any obvious wrongdoing on the part of the recipients, it can undermine public and professional trust in guidelines.”

In its 2011 report, the National Academy of Medicine outlined three criteria for trustworthy guidelines. These include ensuring that committee chairs do not have financial conflicts of interest (COIs), limiting authors who do have financial COIs to less than half of the guideline drafting panel, and disclosing financially motivated relationships between individual health care providers and members of industry. “To our surprise, our findings demonstrated that none of the CPGs we identified met all of these criteria,” noted Dr. Grover, adding that “this finding highlights the importance of accountability at both the contributor level (to ensure conflicts are appropriately declared) and at the level of the sponsoring society (to ensure that guideline committee members and chairs are selected a priori for reasons that include impact of conflicts).”

Dr. Rumann and his colleagues conducted a cross-sectional study, including all endoscopy-related CPGs from AGA and ASGE published from 2014 through 2017. They performed a manual reconciliation between financial COIs disclosed in CPG documents and those reported in the Open Payments database maintained by CMS, which includes data from August 2013 to December 2017. “We decided to focus on CPGs of relevance to endoscopy, as the majority of the work to date has revolved around pharma and not devices, a potentially significant other source for industry payments to physicians,” explained Dr. Grover.

In the Open Payments database, payment types are recorded as general payments, research payments, or ownerships or investments. For each payment transaction, the type, amount, and date of payment are recorded, as is the payer.

In all, 91 individuals appeared as authors 581 times. The median number of CPGs per author was 2 with a range of 1-26.

About 80% of authors had payments reported in the Open Payments database. Though Dr. Grover acknowledged that reporting errors may exist in the Open Payments database, this fact, he said, “highlights the need for greater involvement of physicians in correct declaration of their payments.”

Among the guideline authors, 119 (20.5%) had originally disclosed general payments. However, more than three times that many authors had undisclosed records of general payments that showed up in the Open Payments database query. In all, 399 authors (68.6%) had received general payments, according to the database.

Though all 12 of the ownership or investment payments seen on Open Payments were disclosed, just 40 of 74 research payments were disclosed, said Dr. Rumann and coauthors.

“Given the potential impact of these undisclosed payments on CPGs, stricter policies on conflict of interest disclosures are needed,” they wrote.

When asked whether he would expect change to come from the findings, Dr. Grover replied, “First and foremost, we want to increase the awareness of the issue, among both the health professions and the public. While we believe that more research into COI in general is required, our study, along with similar papers in the field, show that CPGs authors need to be more cognizant of declaration of potential conflicts. In addition to being hopeful that readers of the article will be prompted to exert more diligence in tracking and declaring any payments they have received, we are hopeful that sponsoring societies self-regulate the membership of CPG committees and the choice of chairs in accordance with established criteria to mitigate conflicts.”

Dr. Rumann and other coauthors reported no conflicts of interest. Senior author Samir Grover, MD, reported financial relationships with several pharmaceutical companies.

[email protected]

SOURCE: Rumann A et al. DDW 2019, poster Sa1004.

SAN DIEGO – Authors of endoscopy clinical practice guidelines (CPGs) received many more payments from industry than they disclosed, according to a new review of publicly available data.

Additionally, many of the payments came from pharmaceutical companies or medical device manufacturers whose products were directly related to the practice guideline topic at hand, said Amir Rumann, MD, and coauthors, who presented their findings in a poster session at the annual Digestive Disease Week^®.

The researchers found that, of 581 authors listed in 38 CPGs, 127 had initially disclosed payments when the guidelines were published. A search of the federal Open Payments database, however, found that 452 of these authors had payments that they did not disclose in the CPG publication process.

For authors with undisclosed payments, the median value of the total undisclosed amounts was $2,445, from a median of 2.5 unique companies, according to records maintained by the Centers for Medicare & Medicaid Services. The interquartile range for payments was $167-$10,380.

“There is a high burden of undisclosed payments by pharmaceutical and medical device manufacturers to authors of endoscopy guidelines in the United States,” wrote Dr. Rumman and coauthors at the University of Toronto, where Dr. Rumann is a gastroenterology resident.

Of the authors who disclosed payments, 20 (16%) disclosed payments from sources directly related to the CPG in the publication. But the Open Payments database search yielded 314 (54%) disclosed payments that were judged directly related to the CPG topic at hand.

Of the 38 CPGs included in the analysis, 24 were from the American Society for Gastrointestinal Endoscopy (ASGE), and 4 were from the American Gastroenterological Association (AGA). According to the analysis performed by Dr. Rumman and his coauthors, 23 of these guidelines adhered to standards proposed by the National Academy of Medicine for development of “trustworthy” CPGs.

“The prevalence of conflicts of interest in the form of industry payments among physicians is well described in academic literature. A number of studies, including several from our group, have found there is a high burden of these payments among authors and chairs of CPGs in various therapeutic areas,” commented senior author Samir Grover, MD, a gastroenterologist at the University of Toronto. “Additionally, the existing literature has shown that many of these payments go undisclosed in the CPG themselves. This is concerning. Although the presence of these payments doesn’t necessarily indicate any obvious wrongdoing on the part of the recipients, it can undermine public and professional trust in guidelines.”

In its 2011 report, the National Academy of Medicine outlined three criteria for trustworthy guidelines. These include ensuring that committee chairs do not have financial conflicts of interest (COIs), limiting authors who do have financial COIs to less than half of the guideline drafting panel, and disclosing financially motivated relationships between individual health care providers and members of industry. “To our surprise, our findings demonstrated that none of the CPGs we identified met all of these criteria,” noted Dr. Grover, adding that “this finding highlights the importance of accountability at both the contributor level (to ensure conflicts are appropriately declared) and at the level of the sponsoring society (to ensure that guideline committee members and chairs are selected a priori for reasons that include impact of conflicts).”

Dr. Rumann and his colleagues conducted a cross-sectional study, including all endoscopy-related CPGs from AGA and ASGE published from 2014 through 2017. They performed a manual reconciliation between financial COIs disclosed in CPG documents and those reported in the Open Payments database maintained by CMS, which includes data from August 2013 to December 2017. “We decided to focus on CPGs of relevance to endoscopy, as the majority of the work to date has revolved around pharma and not devices, a potentially significant other source for industry payments to physicians,” explained Dr. Grover.

In the Open Payments database, payment types are recorded as general payments, research payments, or ownerships or investments. For each payment transaction, the type, amount, and date of payment are recorded, as is the payer.

In all, 91 individuals appeared as authors 581 times. The median number of CPGs per author was 2 with a range of 1-26.

About 80% of authors had payments reported in the Open Payments database. Though Dr. Grover acknowledged that reporting errors may exist in the Open Payments database, this fact, he said, “highlights the need for greater involvement of physicians in correct declaration of their payments.”

Among the guideline authors, 119 (20.5%) had originally disclosed general payments. However, more than three times that many authors had undisclosed records of general payments that showed up in the Open Payments database query. In all, 399 authors (68.6%) had received general payments, according to the database.

Though all 12 of the ownership or investment payments seen on Open Payments were disclosed, just 40 of 74 research payments were disclosed, said Dr. Rumann and coauthors.

“Given the potential impact of these undisclosed payments on CPGs, stricter policies on conflict of interest disclosures are needed,” they wrote.

When asked whether he would expect change to come from the findings, Dr. Grover replied, “First and foremost, we want to increase the awareness of the issue, among both the health professions and the public. While we believe that more research into COI in general is required, our study, along with similar papers in the field, show that CPGs authors need to be more cognizant of declaration of potential conflicts. In addition to being hopeful that readers of the article will be prompted to exert more diligence in tracking and declaring any payments they have received, we are hopeful that sponsoring societies self-regulate the membership of CPG committees and the choice of chairs in accordance with established criteria to mitigate conflicts.”

Dr. Rumann and other coauthors reported no conflicts of interest. Senior author Samir Grover, MD, reported financial relationships with several pharmaceutical companies.

[email protected]

SOURCE: Rumann A et al. DDW 2019, poster Sa1004.

SAN DIEGO – Authors of endoscopy clinical practice guidelines (CPGs) received many more payments from industry than they disclosed, according to a new review of publicly available data.

Additionally, many of the payments came from pharmaceutical companies or medical device manufacturers whose products were directly related to the practice guideline topic at hand, said Amir Rumann, MD, and coauthors, who presented their findings in a poster session at the annual Digestive Disease Week^®.

The researchers found that, of 581 authors listed in 38 CPGs, 127 had initially disclosed payments when the guidelines were published. A search of the federal Open Payments database, however, found that 452 of these authors had payments that they did not disclose in the CPG publication process.

For authors with undisclosed payments, the median value of the total undisclosed amounts was $2,445, from a median of 2.5 unique companies, according to records maintained by the Centers for Medicare & Medicaid Services. The interquartile range for payments was $167-$10,380.

“There is a high burden of undisclosed payments by pharmaceutical and medical device manufacturers to authors of endoscopy guidelines in the United States,” wrote Dr. Rumman and coauthors at the University of Toronto, where Dr. Rumann is a gastroenterology resident.

Of the authors who disclosed payments, 20 (16%) disclosed payments from sources directly related to the CPG in the publication. But the Open Payments database search yielded 314 (54%) disclosed payments that were judged directly related to the CPG topic at hand.

Of the 38 CPGs included in the analysis, 24 were from the American Society for Gastrointestinal Endoscopy (ASGE), and 4 were from the American Gastroenterological Association (AGA). According to the analysis performed by Dr. Rumman and his coauthors, 23 of these guidelines adhered to standards proposed by the National Academy of Medicine for development of “trustworthy” CPGs.

“The prevalence of conflicts of interest in the form of industry payments among physicians is well described in academic literature. A number of studies, including several from our group, have found there is a high burden of these payments among authors and chairs of CPGs in various therapeutic areas,” commented senior author Samir Grover, MD, a gastroenterologist at the University of Toronto. “Additionally, the existing literature has shown that many of these payments go undisclosed in the CPG themselves. This is concerning. Although the presence of these payments doesn’t necessarily indicate any obvious wrongdoing on the part of the recipients, it can undermine public and professional trust in guidelines.”

In its 2011 report, the National Academy of Medicine outlined three criteria for trustworthy guidelines. These include ensuring that committee chairs do not have financial conflicts of interest (COIs), limiting authors who do have financial COIs to less than half of the guideline drafting panel, and disclosing financially motivated relationships between individual health care providers and members of industry. “To our surprise, our findings demonstrated that none of the CPGs we identified met all of these criteria,” noted Dr. Grover, adding that “this finding highlights the importance of accountability at both the contributor level (to ensure conflicts are appropriately declared) and at the level of the sponsoring society (to ensure that guideline committee members and chairs are selected a priori for reasons that include impact of conflicts).”

Dr. Rumann and his colleagues conducted a cross-sectional study, including all endoscopy-related CPGs from AGA and ASGE published from 2014 through 2017. They performed a manual reconciliation between financial COIs disclosed in CPG documents and those reported in the Open Payments database maintained by CMS, which includes data from August 2013 to December 2017. “We decided to focus on CPGs of relevance to endoscopy, as the majority of the work to date has revolved around pharma and not devices, a potentially significant other source for industry payments to physicians,” explained Dr. Grover.

In the Open Payments database, payment types are recorded as general payments, research payments, or ownerships or investments. For each payment transaction, the type, amount, and date of payment are recorded, as is the payer.

In all, 91 individuals appeared as authors 581 times. The median number of CPGs per author was 2 with a range of 1-26.

About 80% of authors had payments reported in the Open Payments database. Though Dr. Grover acknowledged that reporting errors may exist in the Open Payments database, this fact, he said, “highlights the need for greater involvement of physicians in correct declaration of their payments.”

Among the guideline authors, 119 (20.5%) had originally disclosed general payments. However, more than three times that many authors had undisclosed records of general payments that showed up in the Open Payments database query. In all, 399 authors (68.6%) had received general payments, according to the database.

Though all 12 of the ownership or investment payments seen on Open Payments were disclosed, just 40 of 74 research payments were disclosed, said Dr. Rumann and coauthors.

“Given the potential impact of these undisclosed payments on CPGs, stricter policies on conflict of interest disclosures are needed,” they wrote.

When asked whether he would expect change to come from the findings, Dr. Grover replied, “First and foremost, we want to increase the awareness of the issue, among both the health professions and the public. While we believe that more research into COI in general is required, our study, along with similar papers in the field, show that CPGs authors need to be more cognizant of declaration of potential conflicts. In addition to being hopeful that readers of the article will be prompted to exert more diligence in tracking and declaring any payments they have received, we are hopeful that sponsoring societies self-regulate the membership of CPG committees and the choice of chairs in accordance with established criteria to mitigate conflicts.”

Dr. Rumann and other coauthors reported no conflicts of interest. Senior author Samir Grover, MD, reported financial relationships with several pharmaceutical companies.

[email protected]

SOURCE: Rumann A et al. DDW 2019, poster Sa1004.

[UPDATED 5:12 PM]

Effective immediately, recipients of federal family planning dollars under the Title X program can no longer provide referrals for abortion services.

The Health and Human Services department issued the email notification to Title X recipients late in the day on July 15, a day before a planned national Title X grantee meeting in Washington.

The HHS statement cited recent federal appellate court decisions that have declined to stay the ban on abortion referrals for Title X recipients contained in a March 2019 final rule. “Consistent with those rulings, HHS shall now require compliance with the Final Rule,” HHS said in the emailed statement.

Currently, no federal funds can be used to provide abortion services, but Title X recipients have been able to provide referrals for abortions or to perform non–federally funded abortions on the same premises where Title X–funded family planning services are provided. The implementation of the final rule would change this by barring referrals and by imposing physical separation requirements for health centers that offer abortions.

In an email accompanying the notification to Title X grantees, Diane Foley, MD, deputy assistant secretary of the HHS Office of Population Affairs, noted that, “We are aware that many of you have been frustrated with the lack of guidance given to you regarding the 2019 Title X Final Rule that was posted earlier this year.” She added that “The timing of the national grantee meeting will allow us to provide direction to you as well as hopefully answer your questions face to face.”

Providers of family planning and abortion services objected to what they are calling the Title X “gag rule.”

“As we have said all along, the Trump-Pence administration’s Title X gag rule is devastating for the millions of people who rely on this program for cancer screenings, HIV tests, affordable birth control and other critical primary and preventive care,” Leana Wen, MD, president and CEO of the Planned Parenthood Federation of America (PPFA), said in a statement. She went on to say that, “While we are incredibly concerned by this harmful rule, our doors are still open.”

Shortly after that statement was issued, Dr. Wen was removed from her position. 

"We thank Dr. Leana Wen for her service to Planned Parenthood in such a pivotal time and extend our best wishes for her continued success," PPFA Board Chair Aimee Cunningham and Planned Parenthood Action Fund Board Chair Jennie Rosenthal said in a joint statement. Alexis McGill Johnson, a PPFA board member and former board chair, was named acting president. 

"I am leaving the organization sooner than I'd hoped because of philosophical differences about the direction and future of Planned Parenthood," Dr. Wen said in a post on Twitter. "I came to Planned Parenthood to run a national health care organization and to advocate for the broad range of public health policies that affect our patients' health.... New board leadership has determined that the priorit for Planned Parenthood moving forward is to double down on abortion rights advocacy. Witht he landscape changing dramatically in the last several months and the right to safe, legal abortion care under attack as never before, I understand the shift in the board's prioritization."

The National Family Planning & Reproductive Health Association’s president and CEO Clare Coleman said that, “this rule will shatter the long-standing provider network – leaving hundreds of thousands of vulnerable patients without essential care. Last night’s notice will prompt grantees and other participating entities to withdraw from Title X, and we anticipate withdrawals beginning this week.”

An HHS spokeswoman said additional guidance will be provided to grantees during the meeting.

“While the final rule prohibits referral for abortion as a method of family planning, nondirective counseling on abortion is permitted,” the HHS spokeswoman said. “The final rule protects Title X health care providers so that they are not required to choose between participating in the program and violating their own consciences by providing abortion counseling and referral.”

The American Association of Pro-Life Obstetricians and Gynecologists applauded the implementation of the final rule and the “separation of Title X funds from the provision of abortion.”

Most recently, the federal Ninth Circuit Court of Appeals, in an en banc ruling, denied requests for an administrative stay of the final rule. Previous rulings by the Fourth Circuit, as well as a federal district court in Maine, also have denied requests for injunctions against the final rule.

An additional requirement for physical separation of abortion facilities from other Title X–funded family planning facilities will go into effect on March 4, 2020, according to the HHS communication.

[email protected]

[UPDATED 5:12 PM]

Effective immediately, recipients of federal family planning dollars under the Title X program can no longer provide referrals for abortion services.

The Health and Human Services department issued the email notification to Title X recipients late in the day on July 15, a day before a planned national Title X grantee meeting in Washington.

The HHS statement cited recent federal appellate court decisions that have declined to stay the ban on abortion referrals for Title X recipients contained in a March 2019 final rule. “Consistent with those rulings, HHS shall now require compliance with the Final Rule,” HHS said in the emailed statement.

Currently, no federal funds can be used to provide abortion services, but Title X recipients have been able to provide referrals for abortions or to perform non–federally funded abortions on the same premises where Title X–funded family planning services are provided. The implementation of the final rule would change this by barring referrals and by imposing physical separation requirements for health centers that offer abortions.

In an email accompanying the notification to Title X grantees, Diane Foley, MD, deputy assistant secretary of the HHS Office of Population Affairs, noted that, “We are aware that many of you have been frustrated with the lack of guidance given to you regarding the 2019 Title X Final Rule that was posted earlier this year.” She added that “The timing of the national grantee meeting will allow us to provide direction to you as well as hopefully answer your questions face to face.”

Providers of family planning and abortion services objected to what they are calling the Title X “gag rule.”

“As we have said all along, the Trump-Pence administration’s Title X gag rule is devastating for the millions of people who rely on this program for cancer screenings, HIV tests, affordable birth control and other critical primary and preventive care,” Leana Wen, MD, president and CEO of the Planned Parenthood Federation of America (PPFA), said in a statement. She went on to say that, “While we are incredibly concerned by this harmful rule, our doors are still open.”

Shortly after that statement was issued, Dr. Wen was removed from her position. 

"We thank Dr. Leana Wen for her service to Planned Parenthood in such a pivotal time and extend our best wishes for her continued success," PPFA Board Chair Aimee Cunningham and Planned Parenthood Action Fund Board Chair Jennie Rosenthal said in a joint statement. Alexis McGill Johnson, a PPFA board member and former board chair, was named acting president. 

"I am leaving the organization sooner than I'd hoped because of philosophical differences about the direction and future of Planned Parenthood," Dr. Wen said in a post on Twitter. "I came to Planned Parenthood to run a national health care organization and to advocate for the broad range of public health policies that affect our patients' health.... New board leadership has determined that the priorit for Planned Parenthood moving forward is to double down on abortion rights advocacy. Witht he landscape changing dramatically in the last several months and the right to safe, legal abortion care under attack as never before, I understand the shift in the board's prioritization."

The National Family Planning & Reproductive Health Association’s president and CEO Clare Coleman said that, “this rule will shatter the long-standing provider network – leaving hundreds of thousands of vulnerable patients without essential care. Last night’s notice will prompt grantees and other participating entities to withdraw from Title X, and we anticipate withdrawals beginning this week.”

An HHS spokeswoman said additional guidance will be provided to grantees during the meeting.

“While the final rule prohibits referral for abortion as a method of family planning, nondirective counseling on abortion is permitted,” the HHS spokeswoman said. “The final rule protects Title X health care providers so that they are not required to choose between participating in the program and violating their own consciences by providing abortion counseling and referral.”

The American Association of Pro-Life Obstetricians and Gynecologists applauded the implementation of the final rule and the “separation of Title X funds from the provision of abortion.”

Most recently, the federal Ninth Circuit Court of Appeals, in an en banc ruling, denied requests for an administrative stay of the final rule. Previous rulings by the Fourth Circuit, as well as a federal district court in Maine, also have denied requests for injunctions against the final rule.

An additional requirement for physical separation of abortion facilities from other Title X–funded family planning facilities will go into effect on March 4, 2020, according to the HHS communication.

[email protected]

[UPDATED 5:12 PM]

Effective immediately, recipients of federal family planning dollars under the Title X program can no longer provide referrals for abortion services.

The Health and Human Services department issued the email notification to Title X recipients late in the day on July 15, a day before a planned national Title X grantee meeting in Washington.

The HHS statement cited recent federal appellate court decisions that have declined to stay the ban on abortion referrals for Title X recipients contained in a March 2019 final rule. “Consistent with those rulings, HHS shall now require compliance with the Final Rule,” HHS said in the emailed statement.

Currently, no federal funds can be used to provide abortion services, but Title X recipients have been able to provide referrals for abortions or to perform non–federally funded abortions on the same premises where Title X–funded family planning services are provided. The implementation of the final rule would change this by barring referrals and by imposing physical separation requirements for health centers that offer abortions.

In an email accompanying the notification to Title X grantees, Diane Foley, MD, deputy assistant secretary of the HHS Office of Population Affairs, noted that, “We are aware that many of you have been frustrated with the lack of guidance given to you regarding the 2019 Title X Final Rule that was posted earlier this year.” She added that “The timing of the national grantee meeting will allow us to provide direction to you as well as hopefully answer your questions face to face.”

Providers of family planning and abortion services objected to what they are calling the Title X “gag rule.”

“As we have said all along, the Trump-Pence administration’s Title X gag rule is devastating for the millions of people who rely on this program for cancer screenings, HIV tests, affordable birth control and other critical primary and preventive care,” Leana Wen, MD, president and CEO of the Planned Parenthood Federation of America (PPFA), said in a statement. She went on to say that, “While we are incredibly concerned by this harmful rule, our doors are still open.”

Shortly after that statement was issued, Dr. Wen was removed from her position. 

"We thank Dr. Leana Wen for her service to Planned Parenthood in such a pivotal time and extend our best wishes for her continued success," PPFA Board Chair Aimee Cunningham and Planned Parenthood Action Fund Board Chair Jennie Rosenthal said in a joint statement. Alexis McGill Johnson, a PPFA board member and former board chair, was named acting president. 

"I am leaving the organization sooner than I'd hoped because of philosophical differences about the direction and future of Planned Parenthood," Dr. Wen said in a post on Twitter. "I came to Planned Parenthood to run a national health care organization and to advocate for the broad range of public health policies that affect our patients' health.... New board leadership has determined that the priorit for Planned Parenthood moving forward is to double down on abortion rights advocacy. Witht he landscape changing dramatically in the last several months and the right to safe, legal abortion care under attack as never before, I understand the shift in the board's prioritization."

The National Family Planning & Reproductive Health Association’s president and CEO Clare Coleman said that, “this rule will shatter the long-standing provider network – leaving hundreds of thousands of vulnerable patients without essential care. Last night’s notice will prompt grantees and other participating entities to withdraw from Title X, and we anticipate withdrawals beginning this week.”

An HHS spokeswoman said additional guidance will be provided to grantees during the meeting.

“While the final rule prohibits referral for abortion as a method of family planning, nondirective counseling on abortion is permitted,” the HHS spokeswoman said. “The final rule protects Title X health care providers so that they are not required to choose between participating in the program and violating their own consciences by providing abortion counseling and referral.”

The American Association of Pro-Life Obstetricians and Gynecologists applauded the implementation of the final rule and the “separation of Title X funds from the provision of abortion.”

Most recently, the federal Ninth Circuit Court of Appeals, in an en banc ruling, denied requests for an administrative stay of the final rule. Previous rulings by the Fourth Circuit, as well as a federal district court in Maine, also have denied requests for injunctions against the final rule.

An additional requirement for physical separation of abortion facilities from other Title X–funded family planning facilities will go into effect on March 4, 2020, according to the HHS communication.

[email protected]

Severe maternal morbidity is almost five times more common in women who have stillbirth deliveries than in women who have live births, according to research in Obstetrics & Gynecology.

JazzIRT/Getty Images

Citing major increases in risk for a host of serious complications, the authors of the large population-based study urge those caring for women experiencing stillbirth to be vigilant for trouble.

Severe maternal morbidity among mothers experiencing stillbirth occurred in 578 cases per 10,000 deliveries, compared with 99 cases per 10,000 live deliveries, wrote Elizabeth Wall-Wieler, PhD, and coauthors. After statistical adjustment, the relative risk (RR) for severe maternal morbidity in a stillbirth compared with a live delivery was 4.77 (95% confidence interval, 4.53-5.02).

“Our findings indicate that nearly 1 in 17 women who deliver a stillbirth in California experience severe maternal morbidity. Furthermore, the risk of severe maternal morbidity was more than fourfold higher for women undergoing stillbirth delivery than live birth delivery,” the investigators wrote.

Major maternal organ dysfunction or failure – including acute renal failure, adult respiratory distress syndrome, disseminated intravascular coagulation, sepsis, or shock – all were more common in stillbirth deliveries, noted Dr. Wall-Wieler and colleagues. Hysterectomy, likely performed to control major loss of blood, also was more likely in stillbirth deliveries.

“Minimal attention has been given to maternal outcomes and acute complications experienced by women who have a stillbirth,” wrote Dr. Wall-Wieler, a postdoctoral research fellow in developmental and neonatal medicine, and colleagues at Stanford (Calif.) University. This is so because many analyses of maternal morbidity exclude stillbirth deliveries, or lump them with term deliveries, she and coauthors explained.

Using data from the Office of Statewide Health Planning and Development in California, Dr. Wall-Wieler and colleagues examined a total of 6,459,842 deliveries occurring in the state during 1999-2011; of these, 25,997 (0.4%) were stillbirths. For the cross-sectional study, the investigators included only deliveries for which fetal or neonatal vital records could be linked with the maternal hospital record.

Stillbirth was defined in the study as a fetal death delivered at or after 20 weeks’ gestation, so deliveries at less than 20 weeks’ gestation were excluded, as were any deliveries recorded as being at or after 45 weeks’ gestation, because the latter set were considered likely to be data entry errors.

Deliveries were considered to have severe maternal morbidity if any of the 18 indicators identified by the Centers for Disease Control and Prevention were coded in the medical record. The most common severe morbidities seen in stillbirth were blood transfusion, disseminated intravascular coagulation, and acute renal failure (adjusted RRs 5.38, 8.78, and 13.22, respectively). Although absolute occurrences were less frequent, relative risk for sepsis and shock were more than 14 times higher for stillbirths than for live birth deliveries.

“Taken together, these findings suggest the morbidity associated with obstetric hemorrhage and preeclampsia among women hospitalized for stillbirth delivery is a serious concern,” wrote Dr. Wall-Wieler and coauthors. They called for prospective studies to clarify cause and effect between stillbirth and these morbidities and to look into whether women carrying a nonviable fetus or with known fetal demise are managed differently than those with a viable fetus.

Overall, stillbirth deliveries were more likely for women who were older, for non-Hispanic black women, for those who did not have a college education, and those who did not have private insurance. Preexisting diabetes and hypertension, as well as a vaginal delivery, also upped the risk for stillbirth.

For reasons that are not completely clear, the risk for severe maternal morbidity with stillbirth climbed after 30 weeks’ gestation. Dr. Wall-Wieler and collaborators conducted an exploratory analysis that dichotomized deliveries for both stillbirth and live births into those occurring at fewer than 30 weeks’ gestation, or at or after 30 weeks’. They found no increased risk for severe maternal morbidity earlier than 30 weeks, but an RR of 5.4 for stillbirth at or after 30 weeks.

A reported cause of fetal demise was available for 71% of deliveries, with umbilical cord anomalies, obstetric complications, and placental conditions collectively accounting for almost half (46%) of the identified causes of demise. Severe maternal morbidity was most common in deaths related to hypertensive disorders, at 24/100, and least common in deaths from major fetal structural or genetic problems, at 1/100.

The size of the study strengthens the findings, said the investigators, but the large amount of missing data in recording fetal deaths does introduce some limitations. These include the inability to distinguish between intrapartum and antepartum fetal death, as well as the fact that cause of fetal death was not recorded for over one in four stillbirths.

“Given the recent calls to reduce the national rate of severe maternal morbidity, new public health initiatives and practice guidelines are needed to highlight and address the morbidity risk associated with stillbirth identified in this study,” wrote Dr. Wall-Wieler and colleagues.

The study was funded by the National Institutes of Health and by Stanford University. Ronald S. Gibbs, MD, reported receiving money from Novavax/ACI. Alexander J. Butwick, MD, reported receiving money from Cerus Corp. and Instrumentation Laboratory. The other coauthors reported no relevant financial conflicts of interest.

[email protected]

SOURCE: Wall-Wieler E et al. Obstet Gynecol. 2019 Aug. 134:2;310-7.

Severe maternal morbidity is almost five times more common in women who have stillbirth deliveries than in women who have live births, according to research in Obstetrics & Gynecology.

JazzIRT/Getty Images

Citing major increases in risk for a host of serious complications, the authors of the large population-based study urge those caring for women experiencing stillbirth to be vigilant for trouble.

Severe maternal morbidity among mothers experiencing stillbirth occurred in 578 cases per 10,000 deliveries, compared with 99 cases per 10,000 live deliveries, wrote Elizabeth Wall-Wieler, PhD, and coauthors. After statistical adjustment, the relative risk (RR) for severe maternal morbidity in a stillbirth compared with a live delivery was 4.77 (95% confidence interval, 4.53-5.02).

“Our findings indicate that nearly 1 in 17 women who deliver a stillbirth in California experience severe maternal morbidity. Furthermore, the risk of severe maternal morbidity was more than fourfold higher for women undergoing stillbirth delivery than live birth delivery,” the investigators wrote.

Major maternal organ dysfunction or failure – including acute renal failure, adult respiratory distress syndrome, disseminated intravascular coagulation, sepsis, or shock – all were more common in stillbirth deliveries, noted Dr. Wall-Wieler and colleagues. Hysterectomy, likely performed to control major loss of blood, also was more likely in stillbirth deliveries.

“Minimal attention has been given to maternal outcomes and acute complications experienced by women who have a stillbirth,” wrote Dr. Wall-Wieler, a postdoctoral research fellow in developmental and neonatal medicine, and colleagues at Stanford (Calif.) University. This is so because many analyses of maternal morbidity exclude stillbirth deliveries, or lump them with term deliveries, she and coauthors explained.

Using data from the Office of Statewide Health Planning and Development in California, Dr. Wall-Wieler and colleagues examined a total of 6,459,842 deliveries occurring in the state during 1999-2011; of these, 25,997 (0.4%) were stillbirths. For the cross-sectional study, the investigators included only deliveries for which fetal or neonatal vital records could be linked with the maternal hospital record.

Stillbirth was defined in the study as a fetal death delivered at or after 20 weeks’ gestation, so deliveries at less than 20 weeks’ gestation were excluded, as were any deliveries recorded as being at or after 45 weeks’ gestation, because the latter set were considered likely to be data entry errors.

Deliveries were considered to have severe maternal morbidity if any of the 18 indicators identified by the Centers for Disease Control and Prevention were coded in the medical record. The most common severe morbidities seen in stillbirth were blood transfusion, disseminated intravascular coagulation, and acute renal failure (adjusted RRs 5.38, 8.78, and 13.22, respectively). Although absolute occurrences were less frequent, relative risk for sepsis and shock were more than 14 times higher for stillbirths than for live birth deliveries.

“Taken together, these findings suggest the morbidity associated with obstetric hemorrhage and preeclampsia among women hospitalized for stillbirth delivery is a serious concern,” wrote Dr. Wall-Wieler and coauthors. They called for prospective studies to clarify cause and effect between stillbirth and these morbidities and to look into whether women carrying a nonviable fetus or with known fetal demise are managed differently than those with a viable fetus.

Overall, stillbirth deliveries were more likely for women who were older, for non-Hispanic black women, for those who did not have a college education, and those who did not have private insurance. Preexisting diabetes and hypertension, as well as a vaginal delivery, also upped the risk for stillbirth.

For reasons that are not completely clear, the risk for severe maternal morbidity with stillbirth climbed after 30 weeks’ gestation. Dr. Wall-Wieler and collaborators conducted an exploratory analysis that dichotomized deliveries for both stillbirth and live births into those occurring at fewer than 30 weeks’ gestation, or at or after 30 weeks’. They found no increased risk for severe maternal morbidity earlier than 30 weeks, but an RR of 5.4 for stillbirth at or after 30 weeks.

A reported cause of fetal demise was available for 71% of deliveries, with umbilical cord anomalies, obstetric complications, and placental conditions collectively accounting for almost half (46%) of the identified causes of demise. Severe maternal morbidity was most common in deaths related to hypertensive disorders, at 24/100, and least common in deaths from major fetal structural or genetic problems, at 1/100.

The size of the study strengthens the findings, said the investigators, but the large amount of missing data in recording fetal deaths does introduce some limitations. These include the inability to distinguish between intrapartum and antepartum fetal death, as well as the fact that cause of fetal death was not recorded for over one in four stillbirths.

“Given the recent calls to reduce the national rate of severe maternal morbidity, new public health initiatives and practice guidelines are needed to highlight and address the morbidity risk associated with stillbirth identified in this study,” wrote Dr. Wall-Wieler and colleagues.

The study was funded by the National Institutes of Health and by Stanford University. Ronald S. Gibbs, MD, reported receiving money from Novavax/ACI. Alexander J. Butwick, MD, reported receiving money from Cerus Corp. and Instrumentation Laboratory. The other coauthors reported no relevant financial conflicts of interest.

[email protected]

SOURCE: Wall-Wieler E et al. Obstet Gynecol. 2019 Aug. 134:2;310-7.

Severe maternal morbidity is almost five times more common in women who have stillbirth deliveries than in women who have live births, according to research in Obstetrics & Gynecology.

JazzIRT/Getty Images

Citing major increases in risk for a host of serious complications, the authors of the large population-based study urge those caring for women experiencing stillbirth to be vigilant for trouble.

Severe maternal morbidity among mothers experiencing stillbirth occurred in 578 cases per 10,000 deliveries, compared with 99 cases per 10,000 live deliveries, wrote Elizabeth Wall-Wieler, PhD, and coauthors. After statistical adjustment, the relative risk (RR) for severe maternal morbidity in a stillbirth compared with a live delivery was 4.77 (95% confidence interval, 4.53-5.02).

“Our findings indicate that nearly 1 in 17 women who deliver a stillbirth in California experience severe maternal morbidity. Furthermore, the risk of severe maternal morbidity was more than fourfold higher for women undergoing stillbirth delivery than live birth delivery,” the investigators wrote.

Major maternal organ dysfunction or failure – including acute renal failure, adult respiratory distress syndrome, disseminated intravascular coagulation, sepsis, or shock – all were more common in stillbirth deliveries, noted Dr. Wall-Wieler and colleagues. Hysterectomy, likely performed to control major loss of blood, also was more likely in stillbirth deliveries.

“Minimal attention has been given to maternal outcomes and acute complications experienced by women who have a stillbirth,” wrote Dr. Wall-Wieler, a postdoctoral research fellow in developmental and neonatal medicine, and colleagues at Stanford (Calif.) University. This is so because many analyses of maternal morbidity exclude stillbirth deliveries, or lump them with term deliveries, she and coauthors explained.

Using data from the Office of Statewide Health Planning and Development in California, Dr. Wall-Wieler and colleagues examined a total of 6,459,842 deliveries occurring in the state during 1999-2011; of these, 25,997 (0.4%) were stillbirths. For the cross-sectional study, the investigators included only deliveries for which fetal or neonatal vital records could be linked with the maternal hospital record.

Stillbirth was defined in the study as a fetal death delivered at or after 20 weeks’ gestation, so deliveries at less than 20 weeks’ gestation were excluded, as were any deliveries recorded as being at or after 45 weeks’ gestation, because the latter set were considered likely to be data entry errors.

Deliveries were considered to have severe maternal morbidity if any of the 18 indicators identified by the Centers for Disease Control and Prevention were coded in the medical record. The most common severe morbidities seen in stillbirth were blood transfusion, disseminated intravascular coagulation, and acute renal failure (adjusted RRs 5.38, 8.78, and 13.22, respectively). Although absolute occurrences were less frequent, relative risk for sepsis and shock were more than 14 times higher for stillbirths than for live birth deliveries.

“Taken together, these findings suggest the morbidity associated with obstetric hemorrhage and preeclampsia among women hospitalized for stillbirth delivery is a serious concern,” wrote Dr. Wall-Wieler and coauthors. They called for prospective studies to clarify cause and effect between stillbirth and these morbidities and to look into whether women carrying a nonviable fetus or with known fetal demise are managed differently than those with a viable fetus.

Overall, stillbirth deliveries were more likely for women who were older, for non-Hispanic black women, for those who did not have a college education, and those who did not have private insurance. Preexisting diabetes and hypertension, as well as a vaginal delivery, also upped the risk for stillbirth.

For reasons that are not completely clear, the risk for severe maternal morbidity with stillbirth climbed after 30 weeks’ gestation. Dr. Wall-Wieler and collaborators conducted an exploratory analysis that dichotomized deliveries for both stillbirth and live births into those occurring at fewer than 30 weeks’ gestation, or at or after 30 weeks’. They found no increased risk for severe maternal morbidity earlier than 30 weeks, but an RR of 5.4 for stillbirth at or after 30 weeks.

A reported cause of fetal demise was available for 71% of deliveries, with umbilical cord anomalies, obstetric complications, and placental conditions collectively accounting for almost half (46%) of the identified causes of demise. Severe maternal morbidity was most common in deaths related to hypertensive disorders, at 24/100, and least common in deaths from major fetal structural or genetic problems, at 1/100.

The size of the study strengthens the findings, said the investigators, but the large amount of missing data in recording fetal deaths does introduce some limitations. These include the inability to distinguish between intrapartum and antepartum fetal death, as well as the fact that cause of fetal death was not recorded for over one in four stillbirths.

“Given the recent calls to reduce the national rate of severe maternal morbidity, new public health initiatives and practice guidelines are needed to highlight and address the morbidity risk associated with stillbirth identified in this study,” wrote Dr. Wall-Wieler and colleagues.

The study was funded by the National Institutes of Health and by Stanford University. Ronald S. Gibbs, MD, reported receiving money from Novavax/ACI. Alexander J. Butwick, MD, reported receiving money from Cerus Corp. and Instrumentation Laboratory. The other coauthors reported no relevant financial conflicts of interest.

[email protected]

SOURCE: Wall-Wieler E et al. Obstet Gynecol. 2019 Aug. 134:2;310-7.

MILAN – A novel topical nonsteroidal treatment for psoriasis showed sufficient efficacy in phase 2b clinical trials to proceed to phase 3 studies, with improvements in severity, pain, and burning in adults with mild to moderate psoriasis.

At the end of 12 weeks of treatment, 29% of patients receiving the medication – which targets nerve pathways – experienced a decrease of at least 2 grades on the 5-point Investigator’s Global Assessment (IGA) scale, compared with 13% of those receiving the topical vehicle only (P = .036). A similar proportion of patients achieved 75% improvement on the Psoriasis Area and Severity Index (PASI-75)compared with those on vehicle alone (27% versus 13%; P = .045).

These findings were seen only with the less concentrated formulation of pegcantratinib, known as SNA-120 in the clinical trial program, said Paul F. Lizzul, MD, PhD, presenting the findings during a late-breaking abstract session at the World Congress of Dermatology.

Pruritus severity also dropped by about 60%, but the decrease did not differ significantly from the change seen with vehicle alone, said Dr. Lizzul, chief medical officer for Sienna Biopharmaceuticals, Westlake Village, Calif., which funded the study. He and his coinvestigators found this “interesting, surprising, and different from what we had seen previously,” he said. “We think a few things happened here,” including intensive querying on itch by means of daily diaries, a different approach than had been taken in the investigator’s earlier SNA-120 trials. “We think in this way we probably biased patients’ expectations, altering reporting on this subjective measure,” he added.

“There’s been really a lack of innovation in the topical world in developing nonsteroidal therapies for the majority of patients who are treated with topicals, said Dr. Lizzul. Keratinocytes within psoriatic plaques are known to have elevated levels of nerve growth factor (NGF), he explained. Together with tropomyosin receptor kinase A (TrkA), NGF is implicated in the pathogenesis of psoriasis; it stimulates keratinocyte hyperproliferation, is a factor in neurogenic inflammation, and contributes to pruritus. Upregulation of TrkA expression is seen in nerve fibers within pruritic psoriasis plaques as well, said Dr. Lizzul, senior author of the study. (The first author was Kristina Callis Duffin, MD, cochair of the dermatology department at the University of Utah, Salt Lake City.)

In fact, the pruritus that plagues many psoriasis patients, said Dr. Lizzul, may “serve as a clinical biomarker for elevated NGF/TrkA expression.” And certain clinical phenomena observed in psoriasis, such as the Koebner phenomenon and plaque resolution along the path of damaged nerves, provide other clues. “Clearly, astute clinicians going back many, many years have recognized the very important role that nerves and neuropeptides play in psoriasis,” he added.

SNA-120 targets NGF TrKA activity, and “achieves high local drug concentration in the skin, with low systemic availability,” he said.

The randomized, double-blind, vehicle-controlled study enrolled 208 adults with mild to moderate psoriasis (scores of 2 or 3 on the IGA), with pruritus of at least moderate intensity (5 or higher on a 10-point itch numeric rating scale, or I-NRS). The mean age of the patients was 50 years, and about half were male. Most (84%-90% across study arms) were white. At baseline, the mean I-NRS was 7.3-7.4, and the mean PASI score at baseline ranged from 5.9 to 6.5.


Patients were randomized to receive SNA-120 twice daily at either 0.05% (70 patients) or 0.5% (69 patients) in an ointment formulation, or vehicle alone twice daily (69 patients). Efficacy was tracked by measuring decrease in IGA by one or two grades, the number of patients achieving PASI-50 and PASI-75, reduction in itch, and a composite of a decrease of at least 2 grades on the IGA and having clear or almost clear skin.

The investigators also tracked reduction in burning and pain as measured on a 10-point numeric rating scale. Though itch scores didn’t differ significantly from reductions seen with the topical vehicle alone, pain and burning were both reduced significantly compared with vehicle by week 12 of the study (P = .033 for pain; P = .043 for burning).

All improvements were seen only with the lower dose, not the 0.5% dose of SNA-120, noted Dr. Lizzul, adding: “This is not necessarily surprising in the world of kinase inhibitors, where you can see these J-shaped or inverse dose-response curves.”

In addition to recording adverse events, the researchers assessed safety by obtaining laboratory values and electrocardiograms. Plasma SNA-120 levels at study weeks 2, 4, and 8 were obtained for pharmacokinetic analysis. Systemic uptake was virtually nil, and the safety profile overall was good, said Dr. Lizzul.

Next steps are phase 3 clinical trials that will evaluate global improvement as well as pain, burning, and itch in psoriasis, he noted.

Dr. Lizzul is an employee of Sienna Biopharmaceuticals, which is developing SNA-120.

[email protected]

MILAN – A novel topical nonsteroidal treatment for psoriasis showed sufficient efficacy in phase 2b clinical trials to proceed to phase 3 studies, with improvements in severity, pain, and burning in adults with mild to moderate psoriasis.

At the end of 12 weeks of treatment, 29% of patients receiving the medication – which targets nerve pathways – experienced a decrease of at least 2 grades on the 5-point Investigator’s Global Assessment (IGA) scale, compared with 13% of those receiving the topical vehicle only (P = .036). A similar proportion of patients achieved 75% improvement on the Psoriasis Area and Severity Index (PASI-75)compared with those on vehicle alone (27% versus 13%; P = .045).

These findings were seen only with the less concentrated formulation of pegcantratinib, known as SNA-120 in the clinical trial program, said Paul F. Lizzul, MD, PhD, presenting the findings during a late-breaking abstract session at the World Congress of Dermatology.

Pruritus severity also dropped by about 60%, but the decrease did not differ significantly from the change seen with vehicle alone, said Dr. Lizzul, chief medical officer for Sienna Biopharmaceuticals, Westlake Village, Calif., which funded the study. He and his coinvestigators found this “interesting, surprising, and different from what we had seen previously,” he said. “We think a few things happened here,” including intensive querying on itch by means of daily diaries, a different approach than had been taken in the investigator’s earlier SNA-120 trials. “We think in this way we probably biased patients’ expectations, altering reporting on this subjective measure,” he added.

“There’s been really a lack of innovation in the topical world in developing nonsteroidal therapies for the majority of patients who are treated with topicals, said Dr. Lizzul. Keratinocytes within psoriatic plaques are known to have elevated levels of nerve growth factor (NGF), he explained. Together with tropomyosin receptor kinase A (TrkA), NGF is implicated in the pathogenesis of psoriasis; it stimulates keratinocyte hyperproliferation, is a factor in neurogenic inflammation, and contributes to pruritus. Upregulation of TrkA expression is seen in nerve fibers within pruritic psoriasis plaques as well, said Dr. Lizzul, senior author of the study. (The first author was Kristina Callis Duffin, MD, cochair of the dermatology department at the University of Utah, Salt Lake City.)

In fact, the pruritus that plagues many psoriasis patients, said Dr. Lizzul, may “serve as a clinical biomarker for elevated NGF/TrkA expression.” And certain clinical phenomena observed in psoriasis, such as the Koebner phenomenon and plaque resolution along the path of damaged nerves, provide other clues. “Clearly, astute clinicians going back many, many years have recognized the very important role that nerves and neuropeptides play in psoriasis,” he added.

SNA-120 targets NGF TrKA activity, and “achieves high local drug concentration in the skin, with low systemic availability,” he said.

The randomized, double-blind, vehicle-controlled study enrolled 208 adults with mild to moderate psoriasis (scores of 2 or 3 on the IGA), with pruritus of at least moderate intensity (5 or higher on a 10-point itch numeric rating scale, or I-NRS). The mean age of the patients was 50 years, and about half were male. Most (84%-90% across study arms) were white. At baseline, the mean I-NRS was 7.3-7.4, and the mean PASI score at baseline ranged from 5.9 to 6.5.


Patients were randomized to receive SNA-120 twice daily at either 0.05% (70 patients) or 0.5% (69 patients) in an ointment formulation, or vehicle alone twice daily (69 patients). Efficacy was tracked by measuring decrease in IGA by one or two grades, the number of patients achieving PASI-50 and PASI-75, reduction in itch, and a composite of a decrease of at least 2 grades on the IGA and having clear or almost clear skin.

The investigators also tracked reduction in burning and pain as measured on a 10-point numeric rating scale. Though itch scores didn’t differ significantly from reductions seen with the topical vehicle alone, pain and burning were both reduced significantly compared with vehicle by week 12 of the study (P = .033 for pain; P = .043 for burning).

All improvements were seen only with the lower dose, not the 0.5% dose of SNA-120, noted Dr. Lizzul, adding: “This is not necessarily surprising in the world of kinase inhibitors, where you can see these J-shaped or inverse dose-response curves.”

In addition to recording adverse events, the researchers assessed safety by obtaining laboratory values and electrocardiograms. Plasma SNA-120 levels at study weeks 2, 4, and 8 were obtained for pharmacokinetic analysis. Systemic uptake was virtually nil, and the safety profile overall was good, said Dr. Lizzul.

Next steps are phase 3 clinical trials that will evaluate global improvement as well as pain, burning, and itch in psoriasis, he noted.

Dr. Lizzul is an employee of Sienna Biopharmaceuticals, which is developing SNA-120.

[email protected]

MILAN – A novel topical nonsteroidal treatment for psoriasis showed sufficient efficacy in phase 2b clinical trials to proceed to phase 3 studies, with improvements in severity, pain, and burning in adults with mild to moderate psoriasis.

At the end of 12 weeks of treatment, 29% of patients receiving the medication – which targets nerve pathways – experienced a decrease of at least 2 grades on the 5-point Investigator’s Global Assessment (IGA) scale, compared with 13% of those receiving the topical vehicle only (P = .036). A similar proportion of patients achieved 75% improvement on the Psoriasis Area and Severity Index (PASI-75)compared with those on vehicle alone (27% versus 13%; P = .045).

These findings were seen only with the less concentrated formulation of pegcantratinib, known as SNA-120 in the clinical trial program, said Paul F. Lizzul, MD, PhD, presenting the findings during a late-breaking abstract session at the World Congress of Dermatology.

Pruritus severity also dropped by about 60%, but the decrease did not differ significantly from the change seen with vehicle alone, said Dr. Lizzul, chief medical officer for Sienna Biopharmaceuticals, Westlake Village, Calif., which funded the study. He and his coinvestigators found this “interesting, surprising, and different from what we had seen previously,” he said. “We think a few things happened here,” including intensive querying on itch by means of daily diaries, a different approach than had been taken in the investigator’s earlier SNA-120 trials. “We think in this way we probably biased patients’ expectations, altering reporting on this subjective measure,” he added.

“There’s been really a lack of innovation in the topical world in developing nonsteroidal therapies for the majority of patients who are treated with topicals, said Dr. Lizzul. Keratinocytes within psoriatic plaques are known to have elevated levels of nerve growth factor (NGF), he explained. Together with tropomyosin receptor kinase A (TrkA), NGF is implicated in the pathogenesis of psoriasis; it stimulates keratinocyte hyperproliferation, is a factor in neurogenic inflammation, and contributes to pruritus. Upregulation of TrkA expression is seen in nerve fibers within pruritic psoriasis plaques as well, said Dr. Lizzul, senior author of the study. (The first author was Kristina Callis Duffin, MD, cochair of the dermatology department at the University of Utah, Salt Lake City.)

In fact, the pruritus that plagues many psoriasis patients, said Dr. Lizzul, may “serve as a clinical biomarker for elevated NGF/TrkA expression.” And certain clinical phenomena observed in psoriasis, such as the Koebner phenomenon and plaque resolution along the path of damaged nerves, provide other clues. “Clearly, astute clinicians going back many, many years have recognized the very important role that nerves and neuropeptides play in psoriasis,” he added.

SNA-120 targets NGF TrKA activity, and “achieves high local drug concentration in the skin, with low systemic availability,” he said.

The randomized, double-blind, vehicle-controlled study enrolled 208 adults with mild to moderate psoriasis (scores of 2 or 3 on the IGA), with pruritus of at least moderate intensity (5 or higher on a 10-point itch numeric rating scale, or I-NRS). The mean age of the patients was 50 years, and about half were male. Most (84%-90% across study arms) were white. At baseline, the mean I-NRS was 7.3-7.4, and the mean PASI score at baseline ranged from 5.9 to 6.5.


Patients were randomized to receive SNA-120 twice daily at either 0.05% (70 patients) or 0.5% (69 patients) in an ointment formulation, or vehicle alone twice daily (69 patients). Efficacy was tracked by measuring decrease in IGA by one or two grades, the number of patients achieving PASI-50 and PASI-75, reduction in itch, and a composite of a decrease of at least 2 grades on the IGA and having clear or almost clear skin.

The investigators also tracked reduction in burning and pain as measured on a 10-point numeric rating scale. Though itch scores didn’t differ significantly from reductions seen with the topical vehicle alone, pain and burning were both reduced significantly compared with vehicle by week 12 of the study (P = .033 for pain; P = .043 for burning).

All improvements were seen only with the lower dose, not the 0.5% dose of SNA-120, noted Dr. Lizzul, adding: “This is not necessarily surprising in the world of kinase inhibitors, where you can see these J-shaped or inverse dose-response curves.”

In addition to recording adverse events, the researchers assessed safety by obtaining laboratory values and electrocardiograms. Plasma SNA-120 levels at study weeks 2, 4, and 8 were obtained for pharmacokinetic analysis. Systemic uptake was virtually nil, and the safety profile overall was good, said Dr. Lizzul.

Next steps are phase 3 clinical trials that will evaluate global improvement as well as pain, burning, and itch in psoriasis, he noted.

Dr. Lizzul is an employee of Sienna Biopharmaceuticals, which is developing SNA-120.

[email protected]

MILAN – Health-related quality of life improved for patients with moderate to severe genital psoriasis while they received ixekizumab, according to data presented at the World Congress of Dermatology.

After 12 weeks of ixekizumab administration, nearly half of patients who received ixekizumab in the randomized, double-blind, placebo-controlled trial achieved a Dermatology Life Quality Index (DLQI) score of 0 or 1, compared with fewer than 5% of those receiving placebo. At the end of one year, 46.7% of the original ixekizumab group and 50.8% of those who transitioned to ixekizumab from placebo via an open-label extension arm achieved a DLQI of 0 or 1. A DLQI score of 0 or 1 on a 30-point scale indicated that psoriasis had no effect on health-related quality of life.

Among patients with plaque psoriasis, genital involvement is common – present in over 60% at some point during the disease course, Lyn Guenther, MD, of Guenther Dermatology Research Centre, London, Ont., and her colleagues wrote in the poster accompanying the presentation. Sexual health and overall quality of life can be negatively affected by genital psoriasis, they added.

In the study, adult patients were included if they had chronic plaque psoriasis present in genital and nongenital areas. For overall psoriasis and genital involvement, the Static Physician’s Global Assessment (sPGA) was 3 or greater, and total body surface area involvement was at least 1%. Also, patients had to have failed or been intolerant to at least one topical therapy for genital psoriasis.

Patients were excluded if they had genital pustules or vesicles, significant uncontrolled medical or psychiatric comorbidities, recent infection, or prior interleukin-17 antagonist treatment.

In all, patients received ixekizumab 160 mg (75 patients) or placebo (74) subcutaneously every 2 weeks during the initial 12-week study period. For the open-label extension arm, 74 patients in the active arm and 65 patients in the placebo arm went on to receive 80 mg of ixekizumab every 4 weeks, with a step-up option to every other week dosing depending on clinical response.

Patients were given the Short Form Health Survey (SF-36) at baseline and at week 12 and week 52; investigators recorded the mean change for baseline for both the physical and mental component.

Participants also completed the DLQI, which was administered nine times over the 52-week study period.

From baseline, SF-36 scores climbed in both the physical and mental domains for those on ixekizumab, wrote Dr. Guenther and her coinvestigators, with “improvements in all SF-36 domains” for those on ixekizumab at 12 weeks, which continued through week 52. For patients who transitioned to ixekizumab from placebo, “improvements in all SF-36 domains were achieved at week 52,” they wrote.

The mean change from baseline on the SF-36 for the ixekizumab population was 3.5 on the physical domain and 4.8 on the mental component. For the placebo-ixekizumab group, scores improved by a mean 4.5 on the physical domain and 4.9 on the mental domain. Those who stayed on ixekizumab saw some decline in SF-36 scores, with a physical component improvement of 2.5 and mental component improvement of 3.6 at 52 weeks.

Ixekizumab (Taltz), a monoclonal antibody targeting interleukin-17A, is approved for moderate to severe plaque psoriasis, and active psoriatic arthritis..

“Ixekizumab provided clinically meaningful and persistent improvements in HRQoL in patients with moderate to severe genital psoriasis,” wrote Dr. Guenther and her colleagues.

Dr. Guenther and two coauthors reported receiving remuneration from several pharmaceutical companies, including Eli Lilly, which funded the study. Four coauthors are employees and shareholders of Eli Lilly.

[email protected]

MILAN – Health-related quality of life improved for patients with moderate to severe genital psoriasis while they received ixekizumab, according to data presented at the World Congress of Dermatology.

After 12 weeks of ixekizumab administration, nearly half of patients who received ixekizumab in the randomized, double-blind, placebo-controlled trial achieved a Dermatology Life Quality Index (DLQI) score of 0 or 1, compared with fewer than 5% of those receiving placebo. At the end of one year, 46.7% of the original ixekizumab group and 50.8% of those who transitioned to ixekizumab from placebo via an open-label extension arm achieved a DLQI of 0 or 1. A DLQI score of 0 or 1 on a 30-point scale indicated that psoriasis had no effect on health-related quality of life.

Among patients with plaque psoriasis, genital involvement is common – present in over 60% at some point during the disease course, Lyn Guenther, MD, of Guenther Dermatology Research Centre, London, Ont., and her colleagues wrote in the poster accompanying the presentation. Sexual health and overall quality of life can be negatively affected by genital psoriasis, they added.

In the study, adult patients were included if they had chronic plaque psoriasis present in genital and nongenital areas. For overall psoriasis and genital involvement, the Static Physician’s Global Assessment (sPGA) was 3 or greater, and total body surface area involvement was at least 1%. Also, patients had to have failed or been intolerant to at least one topical therapy for genital psoriasis.

Patients were excluded if they had genital pustules or vesicles, significant uncontrolled medical or psychiatric comorbidities, recent infection, or prior interleukin-17 antagonist treatment.

In all, patients received ixekizumab 160 mg (75 patients) or placebo (74) subcutaneously every 2 weeks during the initial 12-week study period. For the open-label extension arm, 74 patients in the active arm and 65 patients in the placebo arm went on to receive 80 mg of ixekizumab every 4 weeks, with a step-up option to every other week dosing depending on clinical response.

Patients were given the Short Form Health Survey (SF-36) at baseline and at week 12 and week 52; investigators recorded the mean change for baseline for both the physical and mental component.

Participants also completed the DLQI, which was administered nine times over the 52-week study period.

From baseline, SF-36 scores climbed in both the physical and mental domains for those on ixekizumab, wrote Dr. Guenther and her coinvestigators, with “improvements in all SF-36 domains” for those on ixekizumab at 12 weeks, which continued through week 52. For patients who transitioned to ixekizumab from placebo, “improvements in all SF-36 domains were achieved at week 52,” they wrote.

The mean change from baseline on the SF-36 for the ixekizumab population was 3.5 on the physical domain and 4.8 on the mental component. For the placebo-ixekizumab group, scores improved by a mean 4.5 on the physical domain and 4.9 on the mental domain. Those who stayed on ixekizumab saw some decline in SF-36 scores, with a physical component improvement of 2.5 and mental component improvement of 3.6 at 52 weeks.

Ixekizumab (Taltz), a monoclonal antibody targeting interleukin-17A, is approved for moderate to severe plaque psoriasis, and active psoriatic arthritis..

“Ixekizumab provided clinically meaningful and persistent improvements in HRQoL in patients with moderate to severe genital psoriasis,” wrote Dr. Guenther and her colleagues.

Dr. Guenther and two coauthors reported receiving remuneration from several pharmaceutical companies, including Eli Lilly, which funded the study. Four coauthors are employees and shareholders of Eli Lilly.

[email protected]

MILAN – Health-related quality of life improved for patients with moderate to severe genital psoriasis while they received ixekizumab, according to data presented at the World Congress of Dermatology.

After 12 weeks of ixekizumab administration, nearly half of patients who received ixekizumab in the randomized, double-blind, placebo-controlled trial achieved a Dermatology Life Quality Index (DLQI) score of 0 or 1, compared with fewer than 5% of those receiving placebo. At the end of one year, 46.7% of the original ixekizumab group and 50.8% of those who transitioned to ixekizumab from placebo via an open-label extension arm achieved a DLQI of 0 or 1. A DLQI score of 0 or 1 on a 30-point scale indicated that psoriasis had no effect on health-related quality of life.

Among patients with plaque psoriasis, genital involvement is common – present in over 60% at some point during the disease course, Lyn Guenther, MD, of Guenther Dermatology Research Centre, London, Ont., and her colleagues wrote in the poster accompanying the presentation. Sexual health and overall quality of life can be negatively affected by genital psoriasis, they added.

In the study, adult patients were included if they had chronic plaque psoriasis present in genital and nongenital areas. For overall psoriasis and genital involvement, the Static Physician’s Global Assessment (sPGA) was 3 or greater, and total body surface area involvement was at least 1%. Also, patients had to have failed or been intolerant to at least one topical therapy for genital psoriasis.

Patients were excluded if they had genital pustules or vesicles, significant uncontrolled medical or psychiatric comorbidities, recent infection, or prior interleukin-17 antagonist treatment.

In all, patients received ixekizumab 160 mg (75 patients) or placebo (74) subcutaneously every 2 weeks during the initial 12-week study period. For the open-label extension arm, 74 patients in the active arm and 65 patients in the placebo arm went on to receive 80 mg of ixekizumab every 4 weeks, with a step-up option to every other week dosing depending on clinical response.

Patients were given the Short Form Health Survey (SF-36) at baseline and at week 12 and week 52; investigators recorded the mean change for baseline for both the physical and mental component.

Participants also completed the DLQI, which was administered nine times over the 52-week study period.

From baseline, SF-36 scores climbed in both the physical and mental domains for those on ixekizumab, wrote Dr. Guenther and her coinvestigators, with “improvements in all SF-36 domains” for those on ixekizumab at 12 weeks, which continued through week 52. For patients who transitioned to ixekizumab from placebo, “improvements in all SF-36 domains were achieved at week 52,” they wrote.

The mean change from baseline on the SF-36 for the ixekizumab population was 3.5 on the physical domain and 4.8 on the mental component. For the placebo-ixekizumab group, scores improved by a mean 4.5 on the physical domain and 4.9 on the mental domain. Those who stayed on ixekizumab saw some decline in SF-36 scores, with a physical component improvement of 2.5 and mental component improvement of 3.6 at 52 weeks.

Ixekizumab (Taltz), a monoclonal antibody targeting interleukin-17A, is approved for moderate to severe plaque psoriasis, and active psoriatic arthritis..

“Ixekizumab provided clinically meaningful and persistent improvements in HRQoL in patients with moderate to severe genital psoriasis,” wrote Dr. Guenther and her colleagues.

Dr. Guenther and two coauthors reported receiving remuneration from several pharmaceutical companies, including Eli Lilly, which funded the study. Four coauthors are employees and shareholders of Eli Lilly.

[email protected]

SAN DIEGO – Eat a healthy lunch. Get more sleep. Move your body. How many times in the course of a week do you give patients gentle reminders to practice these most basic steps of self-care? And how many times in the course of a week do you allow these basics to go by the wayside for yourself?

Self-care is one of the elements that can defend against physician burnout, Carol Burke, MD, said at a session on physician burnout held during the annual Digestive Disease Week^®. Personal self-care can make a real difference, and shouldn’t be ignored as the profession works to reel back some of the institutional changes that challenge physicians today.

In the workplace, unhealthy stress levels can contribute to burnout, disruptive behavior, decreased productivity, and disengagement. Burnout – a response to chronic stress characterized by a diminished sense of personal accomplishment and emotional exhaustion – can result in cynicism, a lack of compassion, and feelings of depersonalization, said Dr. Burke.

Contributors to physician stress have been well documented, said Dr. Burke, a professor of gastroenterology at the Cleveland Clinic. These range from personal debt and the struggle for work-life balance to an increased focus on metrics and documentation at the expense of authentic patient engagement. All of these factors are measurable by means of the validated Maslach Burnout Inventory, said Dr. Burke. A recent survey that used this measure indicated that nearly half of physician respondents report experiencing burnout.

In 2017, Dr. Burke led a survey of American College of Gastroenterology members that showed 49.3% of respondents reported feeling emotional exhaustion and/or depersonalization. Some key themes emerged from the survey, she said. Women and younger physicians were more likely to experience burnout. Having children in the middle years (11-15 years old) and spending more time on domestic duties and child care increased the risk of burnout.

And doing patient-related work at home or having a spouse or partner bring work home also upped burnout risk. Skipping breakfast and lunch during the workweek was another risk factor, which highlights the importance of basic self-care as armor against the administrative onslaught, said Dr. Burke.

Measured by volume alone, physician work can be overwhelming: 45% of physicians in the United States work more than 60 hours weekly, compared with fewer than 10% of the general workforce, said Dr. Burke.

What factors within the control of an individual practitioner can reduce the risk of debilitating burnout and improve quality of life? Physicians who do report a high quality of life, said Dr. Burke, are more likely to have a positive outlook. They also practice basic self-care like taking vacations, exercising regularly, and engaging in hobbies outside of work.

For exhausted, overworked clinicians, getting a good night’s sleep is a critical form of self-care. But erratic schedules, stress, and family demands can all sabotage plans for better sleep hygiene. Still, attending to sleep is important, said Dr. Burke. Individuals with disturbed sleep are less mindful and have less self-compassion. Sleep disturbance is also strongly correlated with perceived stress.

She also reported that the odds ratio for burnout was 14.7 for physicians who reported insomnia when compared with those without sleep disturbance, and it was 9.9 for those who reported nonrestorative sleep.

Physical activity can help sleep and also help other markers of burnout. Dr. Burke pointed to a recent study of 4,402 medical students. Participants were able to reduce burnout risk when they met the Centers for Disease Control and Prevention recommendations of achieving at least 150 minutes/week of moderate exercise or 75 minutes/week of vigorous exercise, plus at least 2 days/week of strength training (P less than .001; Acad Med. 2017;92:1006).

These physician-targeted programs can work, she said: “Faciliated interventions improve well-being, attitudes associated with patient-centered care, meaning and engagement in work, and reduce burnout.”

Practice-focused interventions to reclaim a semblance of control over one’s time are varied, and some are easier to implement than others. Virtual visits and group visits are surprisingly well received by patients, and each can be huge time-savers for physicians, said Dr. Burke. There are billing and workflow pitfalls to avoid, but group visits, in particular, can be practice changing for those who have heavy backlogs and see many patients with the same condition.

Medical scribes can improve productivity and reduce physician time spent on documentation. Also, said Dr. Burke, visits can appropriately be billed at a higher level of complexity when contemporaneous documentation is thorough. Clinicians overall feel that they can engage more fully with patients, and also feel more effective, when well-trained scribes are integrated into a practice, she said.

Female physicians have repeatedly been shown to have patient panels that are more demanding, and male and female patients alike expect more empathy and social support from their physicians, said Dr. Burke. When psychosocial complexities are interwoven with patient care, as they are more frequently for female providers, a 15-minute visit can easily run twice that – or more. Dr. Burke is among the physicians advocating for recognition of this invisible burden on female clinicians, either through adaptive scheduling or differential productivity expectations. This approach is not without controversy, she acknowledged; still, practices should acknowledge that clinic flow can be very different for male and female gastroenterologists, she said.

Dr. Burke reported no relevant conflicts of interest.

Read tips for how to balance family and personal lives with a professional career in order to avoid burnout at https://www.ddwnews.org/news/aga-symposium-provides-practical-tips-to-avoid-physician-burnout/.

[email protected]

SAN DIEGO – Eat a healthy lunch. Get more sleep. Move your body. How many times in the course of a week do you give patients gentle reminders to practice these most basic steps of self-care? And how many times in the course of a week do you allow these basics to go by the wayside for yourself?

Self-care is one of the elements that can defend against physician burnout, Carol Burke, MD, said at a session on physician burnout held during the annual Digestive Disease Week^®. Personal self-care can make a real difference, and shouldn’t be ignored as the profession works to reel back some of the institutional changes that challenge physicians today.

In the workplace, unhealthy stress levels can contribute to burnout, disruptive behavior, decreased productivity, and disengagement. Burnout – a response to chronic stress characterized by a diminished sense of personal accomplishment and emotional exhaustion – can result in cynicism, a lack of compassion, and feelings of depersonalization, said Dr. Burke.

Contributors to physician stress have been well documented, said Dr. Burke, a professor of gastroenterology at the Cleveland Clinic. These range from personal debt and the struggle for work-life balance to an increased focus on metrics and documentation at the expense of authentic patient engagement. All of these factors are measurable by means of the validated Maslach Burnout Inventory, said Dr. Burke. A recent survey that used this measure indicated that nearly half of physician respondents report experiencing burnout.

In 2017, Dr. Burke led a survey of American College of Gastroenterology members that showed 49.3% of respondents reported feeling emotional exhaustion and/or depersonalization. Some key themes emerged from the survey, she said. Women and younger physicians were more likely to experience burnout. Having children in the middle years (11-15 years old) and spending more time on domestic duties and child care increased the risk of burnout.

And doing patient-related work at home or having a spouse or partner bring work home also upped burnout risk. Skipping breakfast and lunch during the workweek was another risk factor, which highlights the importance of basic self-care as armor against the administrative onslaught, said Dr. Burke.

Measured by volume alone, physician work can be overwhelming: 45% of physicians in the United States work more than 60 hours weekly, compared with fewer than 10% of the general workforce, said Dr. Burke.

What factors within the control of an individual practitioner can reduce the risk of debilitating burnout and improve quality of life? Physicians who do report a high quality of life, said Dr. Burke, are more likely to have a positive outlook. They also practice basic self-care like taking vacations, exercising regularly, and engaging in hobbies outside of work.

For exhausted, overworked clinicians, getting a good night’s sleep is a critical form of self-care. But erratic schedules, stress, and family demands can all sabotage plans for better sleep hygiene. Still, attending to sleep is important, said Dr. Burke. Individuals with disturbed sleep are less mindful and have less self-compassion. Sleep disturbance is also strongly correlated with perceived stress.

She also reported that the odds ratio for burnout was 14.7 for physicians who reported insomnia when compared with those without sleep disturbance, and it was 9.9 for those who reported nonrestorative sleep.

Physical activity can help sleep and also help other markers of burnout. Dr. Burke pointed to a recent study of 4,402 medical students. Participants were able to reduce burnout risk when they met the Centers for Disease Control and Prevention recommendations of achieving at least 150 minutes/week of moderate exercise or 75 minutes/week of vigorous exercise, plus at least 2 days/week of strength training (P less than .001; Acad Med. 2017;92:1006).

These physician-targeted programs can work, she said: “Faciliated interventions improve well-being, attitudes associated with patient-centered care, meaning and engagement in work, and reduce burnout.”

Practice-focused interventions to reclaim a semblance of control over one’s time are varied, and some are easier to implement than others. Virtual visits and group visits are surprisingly well received by patients, and each can be huge time-savers for physicians, said Dr. Burke. There are billing and workflow pitfalls to avoid, but group visits, in particular, can be practice changing for those who have heavy backlogs and see many patients with the same condition.

Medical scribes can improve productivity and reduce physician time spent on documentation. Also, said Dr. Burke, visits can appropriately be billed at a higher level of complexity when contemporaneous documentation is thorough. Clinicians overall feel that they can engage more fully with patients, and also feel more effective, when well-trained scribes are integrated into a practice, she said.

Female physicians have repeatedly been shown to have patient panels that are more demanding, and male and female patients alike expect more empathy and social support from their physicians, said Dr. Burke. When psychosocial complexities are interwoven with patient care, as they are more frequently for female providers, a 15-minute visit can easily run twice that – or more. Dr. Burke is among the physicians advocating for recognition of this invisible burden on female clinicians, either through adaptive scheduling or differential productivity expectations. This approach is not without controversy, she acknowledged; still, practices should acknowledge that clinic flow can be very different for male and female gastroenterologists, she said.

Dr. Burke reported no relevant conflicts of interest.

Read tips for how to balance family and personal lives with a professional career in order to avoid burnout at https://www.ddwnews.org/news/aga-symposium-provides-practical-tips-to-avoid-physician-burnout/.

[email protected]

SAN DIEGO – Eat a healthy lunch. Get more sleep. Move your body. How many times in the course of a week do you give patients gentle reminders to practice these most basic steps of self-care? And how many times in the course of a week do you allow these basics to go by the wayside for yourself?

Self-care is one of the elements that can defend against physician burnout, Carol Burke, MD, said at a session on physician burnout held during the annual Digestive Disease Week^®. Personal self-care can make a real difference, and shouldn’t be ignored as the profession works to reel back some of the institutional changes that challenge physicians today.

In the workplace, unhealthy stress levels can contribute to burnout, disruptive behavior, decreased productivity, and disengagement. Burnout – a response to chronic stress characterized by a diminished sense of personal accomplishment and emotional exhaustion – can result in cynicism, a lack of compassion, and feelings of depersonalization, said Dr. Burke.

Contributors to physician stress have been well documented, said Dr. Burke, a professor of gastroenterology at the Cleveland Clinic. These range from personal debt and the struggle for work-life balance to an increased focus on metrics and documentation at the expense of authentic patient engagement. All of these factors are measurable by means of the validated Maslach Burnout Inventory, said Dr. Burke. A recent survey that used this measure indicated that nearly half of physician respondents report experiencing burnout.

In 2017, Dr. Burke led a survey of American College of Gastroenterology members that showed 49.3% of respondents reported feeling emotional exhaustion and/or depersonalization. Some key themes emerged from the survey, she said. Women and younger physicians were more likely to experience burnout. Having children in the middle years (11-15 years old) and spending more time on domestic duties and child care increased the risk of burnout.

And doing patient-related work at home or having a spouse or partner bring work home also upped burnout risk. Skipping breakfast and lunch during the workweek was another risk factor, which highlights the importance of basic self-care as armor against the administrative onslaught, said Dr. Burke.

Measured by volume alone, physician work can be overwhelming: 45% of physicians in the United States work more than 60 hours weekly, compared with fewer than 10% of the general workforce, said Dr. Burke.

What factors within the control of an individual practitioner can reduce the risk of debilitating burnout and improve quality of life? Physicians who do report a high quality of life, said Dr. Burke, are more likely to have a positive outlook. They also practice basic self-care like taking vacations, exercising regularly, and engaging in hobbies outside of work.

For exhausted, overworked clinicians, getting a good night’s sleep is a critical form of self-care. But erratic schedules, stress, and family demands can all sabotage plans for better sleep hygiene. Still, attending to sleep is important, said Dr. Burke. Individuals with disturbed sleep are less mindful and have less self-compassion. Sleep disturbance is also strongly correlated with perceived stress.

She also reported that the odds ratio for burnout was 14.7 for physicians who reported insomnia when compared with those without sleep disturbance, and it was 9.9 for those who reported nonrestorative sleep.

Physical activity can help sleep and also help other markers of burnout. Dr. Burke pointed to a recent study of 4,402 medical students. Participants were able to reduce burnout risk when they met the Centers for Disease Control and Prevention recommendations of achieving at least 150 minutes/week of moderate exercise or 75 minutes/week of vigorous exercise, plus at least 2 days/week of strength training (P less than .001; Acad Med. 2017;92:1006).

These physician-targeted programs can work, she said: “Faciliated interventions improve well-being, attitudes associated with patient-centered care, meaning and engagement in work, and reduce burnout.”

Practice-focused interventions to reclaim a semblance of control over one’s time are varied, and some are easier to implement than others. Virtual visits and group visits are surprisingly well received by patients, and each can be huge time-savers for physicians, said Dr. Burke. There are billing and workflow pitfalls to avoid, but group visits, in particular, can be practice changing for those who have heavy backlogs and see many patients with the same condition.

Medical scribes can improve productivity and reduce physician time spent on documentation. Also, said Dr. Burke, visits can appropriately be billed at a higher level of complexity when contemporaneous documentation is thorough. Clinicians overall feel that they can engage more fully with patients, and also feel more effective, when well-trained scribes are integrated into a practice, she said.

Female physicians have repeatedly been shown to have patient panels that are more demanding, and male and female patients alike expect more empathy and social support from their physicians, said Dr. Burke. When psychosocial complexities are interwoven with patient care, as they are more frequently for female providers, a 15-minute visit can easily run twice that – or more. Dr. Burke is among the physicians advocating for recognition of this invisible burden on female clinicians, either through adaptive scheduling or differential productivity expectations. This approach is not without controversy, she acknowledged; still, practices should acknowledge that clinic flow can be very different for male and female gastroenterologists, she said.

Dr. Burke reported no relevant conflicts of interest.

Read tips for how to balance family and personal lives with a professional career in order to avoid burnout at https://www.ddwnews.org/news/aga-symposium-provides-practical-tips-to-avoid-physician-burnout/.

[email protected]

SAN DIEGO – Eat a healthy lunch. Get more sleep. Move your body. How many times in the course of a week do you give patients gentle reminders to practice these most basic steps of self-care? And how many times in the course of a week do you allow these basics to go by the wayside for yourself?

Self-care is one of the elements that can defend against physician burnout, Carol Burke, MD, said at a session on physician burnout held during the annual Digestive Disease Week^®. Personal self-care can make a real difference, and shouldn’t be ignored as the profession works to reel back some of the institutional changes that challenge physicians today.

In the workplace, unhealthy stress levels can contribute to burnout, disruptive behavior, decreased productivity, and disengagement. Burnout – a response to chronic stress characterized by a diminished sense of personal accomplishment and emotional exhaustion – can result in cynicism, a lack of compassion, and feelings of depersonalization, said Dr. Burke.

Contributors to physician stress have been well documented, said Dr. Burke, a professor of gastroenterology at the Cleveland Clinic. These range from personal debt and the struggle for work-life balance to an increased focus on metrics and documentation at the expense of authentic patient engagement. All of these factors are measurable by means of the validated Maslach Burnout Inventory, said Dr. Burke. A recent survey that used this measure indicated that nearly half of physician respondents report experiencing burnout.

In 2017, Dr. Burke led a survey of American College of Gastroenterology members that showed 49.3% of respondents reported feeling emotional exhaustion and/or depersonalization. Some key themes emerged from the survey, she said. Women and younger physicians were more likely to experience burnout. Having children in the middle years (11-15 years old) and spending more time on domestic duties and child care increased the risk of burnout.

And doing patient-related work at home or having a spouse or partner bring work home also upped burnout risk. Skipping breakfast and lunch during the workweek was another risk factor, which highlights the importance of basic self-care as armor against the administrative onslaught, said Dr. Burke.

Measured by volume alone, physician work can be overwhelming: 45% of physicians in the United States work more than 60 hours weekly, compared with fewer than 10% of the general workforce, said Dr. Burke.

What factors within the control of an individual practitioner can reduce the risk of debilitating burnout and improve quality of life? Physicians who do report a high quality of life, said Dr. Burke, are more likely to have a positive outlook. They also practice basic self-care like taking vacations, exercising regularly, and engaging in hobbies outside of work.

For exhausted, overworked clinicians, getting a good night’s sleep is a critical form of self-care. But erratic schedules, stress, and family demands can all sabotage plans for better sleep hygiene. Still, attending to sleep is important, said Dr. Burke. Individuals with disturbed sleep are less mindful and have less self-compassion. Sleep disturbance is also strongly correlated with perceived stress.

She also reported that the odds ratio for burnout was 14.7 for physicians who reported insomnia when compared with those without sleep disturbance, and it was 9.9 for those who reported nonrestorative sleep.

Physical activity can help sleep and also help other markers of burnout. Dr. Burke pointed to a recent study of 4,402 medical students. Participants were able to reduce burnout risk when they met the Centers for Disease Control and Prevention recommendations of achieving at least 150 minutes/week of moderate exercise or 75 minutes/week of vigorous exercise, plus at least 2 days/week of strength training (P less than .001; Acad Med. 2017;92:1006).

These physician-targeted programs can work, she said: “Faciliated interventions improve well-being, attitudes associated with patient-centered care, meaning and engagement in work, and reduce burnout.”

Practice-focused interventions to reclaim a semblance of control over one’s time are varied, and some are easier to implement than others. Virtual visits and group visits are surprisingly well received by patients, and each can be huge time-savers for physicians, said Dr. Burke. There are billing and workflow pitfalls to avoid, but group visits, in particular, can be practice changing for those who have heavy backlogs and see many patients with the same condition.

Medical scribes can improve productivity and reduce physician time spent on documentation. Also, said Dr. Burke, visits can appropriately be billed at a higher level of complexity when contemporaneous documentation is thorough. Clinicians overall feel that they can engage more fully with patients, and also feel more effective, when well-trained scribes are integrated into a practice, she said.

Female physicians have repeatedly been shown to have patient panels that are more demanding, and male and female patients alike expect more empathy and social support from their physicians, said Dr. Burke. When psychosocial complexities are interwoven with patient care, as they are more frequently for female providers, a 15-minute visit can easily run twice that – or more. Dr. Burke is among the physicians advocating for recognition of this invisible burden on female clinicians, either through adaptive scheduling or differential productivity expectations. This approach is not without controversy, she acknowledged; still, practices should acknowledge that clinic flow can be very different for male and female gastroenterologists, she said.

Dr. Burke reported no relevant conflicts of interest.

[email protected]

SAN DIEGO – Eat a healthy lunch. Get more sleep. Move your body. How many times in the course of a week do you give patients gentle reminders to practice these most basic steps of self-care? And how many times in the course of a week do you allow these basics to go by the wayside for yourself?

Self-care is one of the elements that can defend against physician burnout, Carol Burke, MD, said at a session on physician burnout held during the annual Digestive Disease Week^®. Personal self-care can make a real difference, and shouldn’t be ignored as the profession works to reel back some of the institutional changes that challenge physicians today.

In the workplace, unhealthy stress levels can contribute to burnout, disruptive behavior, decreased productivity, and disengagement. Burnout – a response to chronic stress characterized by a diminished sense of personal accomplishment and emotional exhaustion – can result in cynicism, a lack of compassion, and feelings of depersonalization, said Dr. Burke.

Contributors to physician stress have been well documented, said Dr. Burke, a professor of gastroenterology at the Cleveland Clinic. These range from personal debt and the struggle for work-life balance to an increased focus on metrics and documentation at the expense of authentic patient engagement. All of these factors are measurable by means of the validated Maslach Burnout Inventory, said Dr. Burke. A recent survey that used this measure indicated that nearly half of physician respondents report experiencing burnout.

In 2017, Dr. Burke led a survey of American College of Gastroenterology members that showed 49.3% of respondents reported feeling emotional exhaustion and/or depersonalization. Some key themes emerged from the survey, she said. Women and younger physicians were more likely to experience burnout. Having children in the middle years (11-15 years old) and spending more time on domestic duties and child care increased the risk of burnout.

And doing patient-related work at home or having a spouse or partner bring work home also upped burnout risk. Skipping breakfast and lunch during the workweek was another risk factor, which highlights the importance of basic self-care as armor against the administrative onslaught, said Dr. Burke.

Measured by volume alone, physician work can be overwhelming: 45% of physicians in the United States work more than 60 hours weekly, compared with fewer than 10% of the general workforce, said Dr. Burke.

What factors within the control of an individual practitioner can reduce the risk of debilitating burnout and improve quality of life? Physicians who do report a high quality of life, said Dr. Burke, are more likely to have a positive outlook. They also practice basic self-care like taking vacations, exercising regularly, and engaging in hobbies outside of work.

For exhausted, overworked clinicians, getting a good night’s sleep is a critical form of self-care. But erratic schedules, stress, and family demands can all sabotage plans for better sleep hygiene. Still, attending to sleep is important, said Dr. Burke. Individuals with disturbed sleep are less mindful and have less self-compassion. Sleep disturbance is also strongly correlated with perceived stress.

She also reported that the odds ratio for burnout was 14.7 for physicians who reported insomnia when compared with those without sleep disturbance, and it was 9.9 for those who reported nonrestorative sleep.

Physical activity can help sleep and also help other markers of burnout. Dr. Burke pointed to a recent study of 4,402 medical students. Participants were able to reduce burnout risk when they met the Centers for Disease Control and Prevention recommendations of achieving at least 150 minutes/week of moderate exercise or 75 minutes/week of vigorous exercise, plus at least 2 days/week of strength training (P less than .001; Acad Med. 2017;92:1006).

These physician-targeted programs can work, she said: “Faciliated interventions improve well-being, attitudes associated with patient-centered care, meaning and engagement in work, and reduce burnout.”

Practice-focused interventions to reclaim a semblance of control over one’s time are varied, and some are easier to implement than others. Virtual visits and group visits are surprisingly well received by patients, and each can be huge time-savers for physicians, said Dr. Burke. There are billing and workflow pitfalls to avoid, but group visits, in particular, can be practice changing for those who have heavy backlogs and see many patients with the same condition.

Medical scribes can improve productivity and reduce physician time spent on documentation. Also, said Dr. Burke, visits can appropriately be billed at a higher level of complexity when contemporaneous documentation is thorough. Clinicians overall feel that they can engage more fully with patients, and also feel more effective, when well-trained scribes are integrated into a practice, she said.

Female physicians have repeatedly been shown to have patient panels that are more demanding, and male and female patients alike expect more empathy and social support from their physicians, said Dr. Burke. When psychosocial complexities are interwoven with patient care, as they are more frequently for female providers, a 15-minute visit can easily run twice that – or more. Dr. Burke is among the physicians advocating for recognition of this invisible burden on female clinicians, either through adaptive scheduling or differential productivity expectations. This approach is not without controversy, she acknowledged; still, practices should acknowledge that clinic flow can be very different for male and female gastroenterologists, she said.

Dr. Burke reported no relevant conflicts of interest.

[email protected]

SAN DIEGO – Eat a healthy lunch. Get more sleep. Move your body. How many times in the course of a week do you give patients gentle reminders to practice these most basic steps of self-care? And how many times in the course of a week do you allow these basics to go by the wayside for yourself?

Self-care is one of the elements that can defend against physician burnout, Carol Burke, MD, said at a session on physician burnout held during the annual Digestive Disease Week^®. Personal self-care can make a real difference, and shouldn’t be ignored as the profession works to reel back some of the institutional changes that challenge physicians today.

In the workplace, unhealthy stress levels can contribute to burnout, disruptive behavior, decreased productivity, and disengagement. Burnout – a response to chronic stress characterized by a diminished sense of personal accomplishment and emotional exhaustion – can result in cynicism, a lack of compassion, and feelings of depersonalization, said Dr. Burke.

Contributors to physician stress have been well documented, said Dr. Burke, a professor of gastroenterology at the Cleveland Clinic. These range from personal debt and the struggle for work-life balance to an increased focus on metrics and documentation at the expense of authentic patient engagement. All of these factors are measurable by means of the validated Maslach Burnout Inventory, said Dr. Burke. A recent survey that used this measure indicated that nearly half of physician respondents report experiencing burnout.

In 2017, Dr. Burke led a survey of American College of Gastroenterology members that showed 49.3% of respondents reported feeling emotional exhaustion and/or depersonalization. Some key themes emerged from the survey, she said. Women and younger physicians were more likely to experience burnout. Having children in the middle years (11-15 years old) and spending more time on domestic duties and child care increased the risk of burnout.

And doing patient-related work at home or having a spouse or partner bring work home also upped burnout risk. Skipping breakfast and lunch during the workweek was another risk factor, which highlights the importance of basic self-care as armor against the administrative onslaught, said Dr. Burke.

Measured by volume alone, physician work can be overwhelming: 45% of physicians in the United States work more than 60 hours weekly, compared with fewer than 10% of the general workforce, said Dr. Burke.

What factors within the control of an individual practitioner can reduce the risk of debilitating burnout and improve quality of life? Physicians who do report a high quality of life, said Dr. Burke, are more likely to have a positive outlook. They also practice basic self-care like taking vacations, exercising regularly, and engaging in hobbies outside of work.

For exhausted, overworked clinicians, getting a good night’s sleep is a critical form of self-care. But erratic schedules, stress, and family demands can all sabotage plans for better sleep hygiene. Still, attending to sleep is important, said Dr. Burke. Individuals with disturbed sleep are less mindful and have less self-compassion. Sleep disturbance is also strongly correlated with perceived stress.

She also reported that the odds ratio for burnout was 14.7 for physicians who reported insomnia when compared with those without sleep disturbance, and it was 9.9 for those who reported nonrestorative sleep.

Physical activity can help sleep and also help other markers of burnout. Dr. Burke pointed to a recent study of 4,402 medical students. Participants were able to reduce burnout risk when they met the Centers for Disease Control and Prevention recommendations of achieving at least 150 minutes/week of moderate exercise or 75 minutes/week of vigorous exercise, plus at least 2 days/week of strength training (P less than .001; Acad Med. 2017;92:1006).

These physician-targeted programs can work, she said: “Faciliated interventions improve well-being, attitudes associated with patient-centered care, meaning and engagement in work, and reduce burnout.”

Practice-focused interventions to reclaim a semblance of control over one’s time are varied, and some are easier to implement than others. Virtual visits and group visits are surprisingly well received by patients, and each can be huge time-savers for physicians, said Dr. Burke. There are billing and workflow pitfalls to avoid, but group visits, in particular, can be practice changing for those who have heavy backlogs and see many patients with the same condition.

Medical scribes can improve productivity and reduce physician time spent on documentation. Also, said Dr. Burke, visits can appropriately be billed at a higher level of complexity when contemporaneous documentation is thorough. Clinicians overall feel that they can engage more fully with patients, and also feel more effective, when well-trained scribes are integrated into a practice, she said.

Female physicians have repeatedly been shown to have patient panels that are more demanding, and male and female patients alike expect more empathy and social support from their physicians, said Dr. Burke. When psychosocial complexities are interwoven with patient care, as they are more frequently for female providers, a 15-minute visit can easily run twice that – or more. Dr. Burke is among the physicians advocating for recognition of this invisible burden on female clinicians, either through adaptive scheduling or differential productivity expectations. This approach is not without controversy, she acknowledged; still, practices should acknowledge that clinic flow can be very different for male and female gastroenterologists, she said.

Dr. Burke reported no relevant conflicts of interest.

[email protected]

MILAN – A retrospective, multicenter study affirmed clinical trial results showing the beneficial clinical impact of dupilumab in adults with moderate to severe atopic dermatitis, Maria Fargnoli, MD, reported at the World Congress of Dermatology.

Kari Oakes/MDedge News

By the end of 4 weeks of treatment, participants’ mean Eczema Area and Severity Index (EASI) score had dropped from 33.3 to 15.3, a 54.2% reduction. At 16 weeks, the mean EASI score was 9.2, a reduction of 72.5% from baseline (P less than .001 for both time points, compared with baseline). At 16 weeks, 87.2% of patients achieved EASI 50, 60.6% achieved EASI 75, and 32.4% achieved EASI 90.

“In a real-life context, dupilumab significantly improved disease severity, pruritus, sleep loss, and quality of life in adult moderate to severe atopic dermatitis patients,” said Dr. Fargnoli, presenting results of the study during a late-breaking abstract session at the meeting. “All measures improved at 4 weeks, and a further decline was seen at 16 weeks. … These results confirm data from clinical trials, and from other real-life experiences with dupilumab.”

The study, conducted in Italy, tracked outcomes for 109 patients treated for moderate to severe atopic dermatitis at 39 centers from June 2018 to February 2019. Adult patients with EASI scores of at least 24 with contraindications, failure, or intolerance of corticosteroid therapy were included and followed for at least 16 weeks. Those who had concomitant systemic anti-inflammatory or immunomodulator use were excluded, as were those with missing data, said Dr. Fargnoli, chair of the department of dermatology at the University of L’Aquila (Italy).

Patients were given a loading dose of two 300-mg subcutaneous injections of dupilumab, followed by 300-mg injections at 2-week intervals.

Patients were assessed at baseline and after 4 and 16 weeks of treatment. In addition to EASI score, itch and sleep were measured via numeric rating scales; mean itch scores dropped from 8.4 at baseline to 4.1 after 4 weeks, and to 2.5 at 16 weeks (P less than .001 for both time points, compared with baseline).

Sleep scores also improved, from a mean 6.9 at baseline to 3.3 at four weeks, and 1.9 at 16 weeks (P less than .001 for both time points, compared with baseline).


Patients also completed the Dermatology Life Quality Index. At the 4-week mark, patients saw a reduction to 8.3 points from the baseline score of 17.6 points (out of a possible 30, with higher scores indicating worse quality of life); scores dropped to 5.4 by week 16 (P less than .001 for both time points, compared with baseline).

Dupilumab was generally well tolerated, with conjunctivitis – seen in 11% of patients – being the most commonly reported adverse event. This falls in line with other recently published real-world studies of dupilumab, Dr. Fargnoli noted.

Efficacy, as measured by EASI reduction and improvement in itch and sleep, were also comparable between the Italian cohort and clinical trial results, as well as other real-life studies in Denmark, France, the Netherlands, and Spain, she said.

Patients, about one-third female, had a mean body mass index of about 24 kg/m². Mean age was about 38 years (range, 19-80 years). The mean age of disease onset was about 14 years (range, 0-77 years).

Atopic dermatitis was characterized by phenotype for each patient; groupings included classic adult type (73%), nummular dermatitis (7%), prurigo (8%), and erythrodermic dermatitis (12%). About three in four patients (76.1%) had facial involvement; 61.5% had hand involvement, and 22.9% had genital involvement.

Allergic comorbidities were reported by many patients; 44.9% had rhinitis, 38.5% had asthma, 33% had conjunctivitis, and 15.6% reported food allergies. Other notable comorbidities included psychiatric or psychological conditions, present in 11% of patients, and hypertension or other cardiovascular disorders, seen in 9.1% of patients.

Most patients had tried treatment with both cyclosporine A and corticosteroids (88.9% and 88.1%, respectively). Almost half (45.8%) had tried UV-light therapy, and about a quarter had tried methotrexate.

“The results give real-life data on patterns of treatment response according to heterogeneous atopic dermatitis phenotypes, and on long-term efficacy and safety,” said Dr. Fargnoli.

The study was not funded by any company, according to Dr. Fargnoli. She has served on the advisory board for and has received honoraria for lectures and research grants from Sanofi-Genzyme.

[email protected]

MILAN – A retrospective, multicenter study affirmed clinical trial results showing the beneficial clinical impact of dupilumab in adults with moderate to severe atopic dermatitis, Maria Fargnoli, MD, reported at the World Congress of Dermatology.

Kari Oakes/MDedge News

By the end of 4 weeks of treatment, participants’ mean Eczema Area and Severity Index (EASI) score had dropped from 33.3 to 15.3, a 54.2% reduction. At 16 weeks, the mean EASI score was 9.2, a reduction of 72.5% from baseline (P less than .001 for both time points, compared with baseline). At 16 weeks, 87.2% of patients achieved EASI 50, 60.6% achieved EASI 75, and 32.4% achieved EASI 90.

“In a real-life context, dupilumab significantly improved disease severity, pruritus, sleep loss, and quality of life in adult moderate to severe atopic dermatitis patients,” said Dr. Fargnoli, presenting results of the study during a late-breaking abstract session at the meeting. “All measures improved at 4 weeks, and a further decline was seen at 16 weeks. … These results confirm data from clinical trials, and from other real-life experiences with dupilumab.”

The study, conducted in Italy, tracked outcomes for 109 patients treated for moderate to severe atopic dermatitis at 39 centers from June 2018 to February 2019. Adult patients with EASI scores of at least 24 with contraindications, failure, or intolerance of corticosteroid therapy were included and followed for at least 16 weeks. Those who had concomitant systemic anti-inflammatory or immunomodulator use were excluded, as were those with missing data, said Dr. Fargnoli, chair of the department of dermatology at the University of L’Aquila (Italy).

Patients were given a loading dose of two 300-mg subcutaneous injections of dupilumab, followed by 300-mg injections at 2-week intervals.

Patients were assessed at baseline and after 4 and 16 weeks of treatment. In addition to EASI score, itch and sleep were measured via numeric rating scales; mean itch scores dropped from 8.4 at baseline to 4.1 after 4 weeks, and to 2.5 at 16 weeks (P less than .001 for both time points, compared with baseline).

Sleep scores also improved, from a mean 6.9 at baseline to 3.3 at four weeks, and 1.9 at 16 weeks (P less than .001 for both time points, compared with baseline).


Patients also completed the Dermatology Life Quality Index. At the 4-week mark, patients saw a reduction to 8.3 points from the baseline score of 17.6 points (out of a possible 30, with higher scores indicating worse quality of life); scores dropped to 5.4 by week 16 (P less than .001 for both time points, compared with baseline).

Dupilumab was generally well tolerated, with conjunctivitis – seen in 11% of patients – being the most commonly reported adverse event. This falls in line with other recently published real-world studies of dupilumab, Dr. Fargnoli noted.

Efficacy, as measured by EASI reduction and improvement in itch and sleep, were also comparable between the Italian cohort and clinical trial results, as well as other real-life studies in Denmark, France, the Netherlands, and Spain, she said.

Patients, about one-third female, had a mean body mass index of about 24 kg/m². Mean age was about 38 years (range, 19-80 years). The mean age of disease onset was about 14 years (range, 0-77 years).

Atopic dermatitis was characterized by phenotype for each patient; groupings included classic adult type (73%), nummular dermatitis (7%), prurigo (8%), and erythrodermic dermatitis (12%). About three in four patients (76.1%) had facial involvement; 61.5% had hand involvement, and 22.9% had genital involvement.

Allergic comorbidities were reported by many patients; 44.9% had rhinitis, 38.5% had asthma, 33% had conjunctivitis, and 15.6% reported food allergies. Other notable comorbidities included psychiatric or psychological conditions, present in 11% of patients, and hypertension or other cardiovascular disorders, seen in 9.1% of patients.

Most patients had tried treatment with both cyclosporine A and corticosteroids (88.9% and 88.1%, respectively). Almost half (45.8%) had tried UV-light therapy, and about a quarter had tried methotrexate.

“The results give real-life data on patterns of treatment response according to heterogeneous atopic dermatitis phenotypes, and on long-term efficacy and safety,” said Dr. Fargnoli.

The study was not funded by any company, according to Dr. Fargnoli. She has served on the advisory board for and has received honoraria for lectures and research grants from Sanofi-Genzyme.

[email protected]

MILAN – A retrospective, multicenter study affirmed clinical trial results showing the beneficial clinical impact of dupilumab in adults with moderate to severe atopic dermatitis, Maria Fargnoli, MD, reported at the World Congress of Dermatology.

Kari Oakes/MDedge News

By the end of 4 weeks of treatment, participants’ mean Eczema Area and Severity Index (EASI) score had dropped from 33.3 to 15.3, a 54.2% reduction. At 16 weeks, the mean EASI score was 9.2, a reduction of 72.5% from baseline (P less than .001 for both time points, compared with baseline). At 16 weeks, 87.2% of patients achieved EASI 50, 60.6% achieved EASI 75, and 32.4% achieved EASI 90.

“In a real-life context, dupilumab significantly improved disease severity, pruritus, sleep loss, and quality of life in adult moderate to severe atopic dermatitis patients,” said Dr. Fargnoli, presenting results of the study during a late-breaking abstract session at the meeting. “All measures improved at 4 weeks, and a further decline was seen at 16 weeks. … These results confirm data from clinical trials, and from other real-life experiences with dupilumab.”

The study, conducted in Italy, tracked outcomes for 109 patients treated for moderate to severe atopic dermatitis at 39 centers from June 2018 to February 2019. Adult patients with EASI scores of at least 24 with contraindications, failure, or intolerance of corticosteroid therapy were included and followed for at least 16 weeks. Those who had concomitant systemic anti-inflammatory or immunomodulator use were excluded, as were those with missing data, said Dr. Fargnoli, chair of the department of dermatology at the University of L’Aquila (Italy).

Patients were given a loading dose of two 300-mg subcutaneous injections of dupilumab, followed by 300-mg injections at 2-week intervals.

Patients were assessed at baseline and after 4 and 16 weeks of treatment. In addition to EASI score, itch and sleep were measured via numeric rating scales; mean itch scores dropped from 8.4 at baseline to 4.1 after 4 weeks, and to 2.5 at 16 weeks (P less than .001 for both time points, compared with baseline).

Sleep scores also improved, from a mean 6.9 at baseline to 3.3 at four weeks, and 1.9 at 16 weeks (P less than .001 for both time points, compared with baseline).


Patients also completed the Dermatology Life Quality Index. At the 4-week mark, patients saw a reduction to 8.3 points from the baseline score of 17.6 points (out of a possible 30, with higher scores indicating worse quality of life); scores dropped to 5.4 by week 16 (P less than .001 for both time points, compared with baseline).

Dupilumab was generally well tolerated, with conjunctivitis – seen in 11% of patients – being the most commonly reported adverse event. This falls in line with other recently published real-world studies of dupilumab, Dr. Fargnoli noted.

Efficacy, as measured by EASI reduction and improvement in itch and sleep, were also comparable between the Italian cohort and clinical trial results, as well as other real-life studies in Denmark, France, the Netherlands, and Spain, she said.

Patients, about one-third female, had a mean body mass index of about 24 kg/m². Mean age was about 38 years (range, 19-80 years). The mean age of disease onset was about 14 years (range, 0-77 years).

Atopic dermatitis was characterized by phenotype for each patient; groupings included classic adult type (73%), nummular dermatitis (7%), prurigo (8%), and erythrodermic dermatitis (12%). About three in four patients (76.1%) had facial involvement; 61.5% had hand involvement, and 22.9% had genital involvement.

Allergic comorbidities were reported by many patients; 44.9% had rhinitis, 38.5% had asthma, 33% had conjunctivitis, and 15.6% reported food allergies. Other notable comorbidities included psychiatric or psychological conditions, present in 11% of patients, and hypertension or other cardiovascular disorders, seen in 9.1% of patients.

Most patients had tried treatment with both cyclosporine A and corticosteroids (88.9% and 88.1%, respectively). Almost half (45.8%) had tried UV-light therapy, and about a quarter had tried methotrexate.

“The results give real-life data on patterns of treatment response according to heterogeneous atopic dermatitis phenotypes, and on long-term efficacy and safety,” said Dr. Fargnoli.

The study was not funded by any company, according to Dr. Fargnoli. She has served on the advisory board for and has received honoraria for lectures and research grants from Sanofi-Genzyme.

[email protected]