The prescription of positive airway pressure is associated with reduced all-cause mortality, according to the results of a cohort study published in JAMA Otolaryngology–Head & Neck Surgery.

The association becomes evident several years after positive airway pressure (PAP) initiation, according to the researchers. Obstructive sleep apnea (OSA) is among the top 10 modifiable cardiovascular risk factors, and is associated with increased risks of coronary artery disease, stroke, and death. PAP is the most effective treatment for OSA, but this treatment’s effect on all-cause and cardiovascular mortality is uncertain. Randomized trials have yielded inconclusive answers to this question, and evidence from observational studies has been weak.

To investigate the association between PAP prescription and mortality in patients with obesity and severe OSA, Quentin Lisan, MD, of the Paris Cardiovascular Research Center and his colleagues conducted a multicenter, population-based cohort study. The researchers examined data for 392 participants in the Sleep Heart Health Study, in which adult men and women age 40 years or older were recruited from nine population-based studies between 1995 and 1998 and followed for a mean of 11.1 years. With each participant who had been prescribed PAP, the investigators matched as many as four participants who had not been prescribed PAP, on the basis of age, sex, and apnea-hypopnea index. Of this sample, 81 patients were prescribed PAP, and 311 were not.

All participants had a clinic visit and underwent overnight polysomnography at baseline. At 2-3 years, participants had a follow-up visit or phone call, during which they were asked whether their physicians had prescribed PAP. Participants were monitored for cardiovascular and all-cause mortality.

In all, 319 of the 392 participants were men; the population’s mean age was 63 years. Patients who had received a PAP prescription had a higher body mass index and more education, compared with patients who had not received a prescription. Mean follow-up duration was 11.6 years in the PAP-prescribed group and 10.9 years in the nonprescribed group.

A total of 96 deaths occurred during follow-up: 12 in the PAP-prescribed group and 84 in the nonprescribed PAP group. The crude incidence rate of mortality was 24.7 deaths per 1,000 person-years in the nonprescribed group and 12.8 deaths per 1,000 person-years in the PAP-prescribed group. The difference in survival between the prescribed and nonprescribed groups was evident in survival curves after 6-7 years of follow-up. After adjustments for prevalent cardiovascular disease, hypertension, diabetes, body mass index, education level, smoking status, and alcohol consumption, the hazard ratio of all-cause mortality for the prescribed group was 0.38, compared with the nonprescribed group.

Dr. Lisan and his colleagues identified 27 deaths of cardiovascular origin, one of which occurred in the prescribed group. After adjusting for prevalent cardiovascular disease, the hazard ratio of cardiovascular mortality for the prescribed group was 0.06, compared with the nonprescribed group.

One reason that the reduction in mortality associated with PAP was not found in previous randomized, controlled trials could be that their mean length of follow-up was not long enough, the researchers wrote. For example, the mean length of follow-up in the SAVE trial was 3.7 years, but the survival benefit was not apparent in the present analysis until 6-7 years after treatment initiation.

These results are exploratory and require confirmation in future research, Dr. Lisan and his colleagues wrote. No information on adherence to PAP was available, and the researchers could not account for initiation and interruption of PAP therapy. Nevertheless, “prescribing PAP in patients with OSA should be pursued and encouraged, given its potential major public health implication,” they concluded.

The Sleep Heart Health Study was supported by grants from the National Institutes of Health.

egreb@mdedge.com

SOURCE: Lisan Q et al. JAMA Otolaryngol Head Neck Surg. 2019 Apr 11. doi: 10.1001/jamaoto.2019.0281.

The prescription of positive airway pressure is associated with reduced all-cause mortality, according to the results of a cohort study published in JAMA Otolaryngology–Head & Neck Surgery.

The association becomes evident several years after positive airway pressure (PAP) initiation, according to the researchers. Obstructive sleep apnea (OSA) is among the top 10 modifiable cardiovascular risk factors, and is associated with increased risks of coronary artery disease, stroke, and death. PAP is the most effective treatment for OSA, but this treatment’s effect on all-cause and cardiovascular mortality is uncertain. Randomized trials have yielded inconclusive answers to this question, and evidence from observational studies has been weak.

To investigate the association between PAP prescription and mortality in patients with obesity and severe OSA, Quentin Lisan, MD, of the Paris Cardiovascular Research Center and his colleagues conducted a multicenter, population-based cohort study. The researchers examined data for 392 participants in the Sleep Heart Health Study, in which adult men and women age 40 years or older were recruited from nine population-based studies between 1995 and 1998 and followed for a mean of 11.1 years. With each participant who had been prescribed PAP, the investigators matched as many as four participants who had not been prescribed PAP, on the basis of age, sex, and apnea-hypopnea index. Of this sample, 81 patients were prescribed PAP, and 311 were not.

All participants had a clinic visit and underwent overnight polysomnography at baseline. At 2-3 years, participants had a follow-up visit or phone call, during which they were asked whether their physicians had prescribed PAP. Participants were monitored for cardiovascular and all-cause mortality.

In all, 319 of the 392 participants were men; the population’s mean age was 63 years. Patients who had received a PAP prescription had a higher body mass index and more education, compared with patients who had not received a prescription. Mean follow-up duration was 11.6 years in the PAP-prescribed group and 10.9 years in the nonprescribed group.

A total of 96 deaths occurred during follow-up: 12 in the PAP-prescribed group and 84 in the nonprescribed PAP group. The crude incidence rate of mortality was 24.7 deaths per 1,000 person-years in the nonprescribed group and 12.8 deaths per 1,000 person-years in the PAP-prescribed group. The difference in survival between the prescribed and nonprescribed groups was evident in survival curves after 6-7 years of follow-up. After adjustments for prevalent cardiovascular disease, hypertension, diabetes, body mass index, education level, smoking status, and alcohol consumption, the hazard ratio of all-cause mortality for the prescribed group was 0.38, compared with the nonprescribed group.

Dr. Lisan and his colleagues identified 27 deaths of cardiovascular origin, one of which occurred in the prescribed group. After adjusting for prevalent cardiovascular disease, the hazard ratio of cardiovascular mortality for the prescribed group was 0.06, compared with the nonprescribed group.

One reason that the reduction in mortality associated with PAP was not found in previous randomized, controlled trials could be that their mean length of follow-up was not long enough, the researchers wrote. For example, the mean length of follow-up in the SAVE trial was 3.7 years, but the survival benefit was not apparent in the present analysis until 6-7 years after treatment initiation.

These results are exploratory and require confirmation in future research, Dr. Lisan and his colleagues wrote. No information on adherence to PAP was available, and the researchers could not account for initiation and interruption of PAP therapy. Nevertheless, “prescribing PAP in patients with OSA should be pursued and encouraged, given its potential major public health implication,” they concluded.

The Sleep Heart Health Study was supported by grants from the National Institutes of Health.

egreb@mdedge.com

SOURCE: Lisan Q et al. JAMA Otolaryngol Head Neck Surg. 2019 Apr 11. doi: 10.1001/jamaoto.2019.0281.

The prescription of positive airway pressure is associated with reduced all-cause mortality, according to the results of a cohort study published in JAMA Otolaryngology–Head & Neck Surgery.

The association becomes evident several years after positive airway pressure (PAP) initiation, according to the researchers. Obstructive sleep apnea (OSA) is among the top 10 modifiable cardiovascular risk factors, and is associated with increased risks of coronary artery disease, stroke, and death. PAP is the most effective treatment for OSA, but this treatment’s effect on all-cause and cardiovascular mortality is uncertain. Randomized trials have yielded inconclusive answers to this question, and evidence from observational studies has been weak.

To investigate the association between PAP prescription and mortality in patients with obesity and severe OSA, Quentin Lisan, MD, of the Paris Cardiovascular Research Center and his colleagues conducted a multicenter, population-based cohort study. The researchers examined data for 392 participants in the Sleep Heart Health Study, in which adult men and women age 40 years or older were recruited from nine population-based studies between 1995 and 1998 and followed for a mean of 11.1 years. With each participant who had been prescribed PAP, the investigators matched as many as four participants who had not been prescribed PAP, on the basis of age, sex, and apnea-hypopnea index. Of this sample, 81 patients were prescribed PAP, and 311 were not.

All participants had a clinic visit and underwent overnight polysomnography at baseline. At 2-3 years, participants had a follow-up visit or phone call, during which they were asked whether their physicians had prescribed PAP. Participants were monitored for cardiovascular and all-cause mortality.

In all, 319 of the 392 participants were men; the population’s mean age was 63 years. Patients who had received a PAP prescription had a higher body mass index and more education, compared with patients who had not received a prescription. Mean follow-up duration was 11.6 years in the PAP-prescribed group and 10.9 years in the nonprescribed group.

A total of 96 deaths occurred during follow-up: 12 in the PAP-prescribed group and 84 in the nonprescribed PAP group. The crude incidence rate of mortality was 24.7 deaths per 1,000 person-years in the nonprescribed group and 12.8 deaths per 1,000 person-years in the PAP-prescribed group. The difference in survival between the prescribed and nonprescribed groups was evident in survival curves after 6-7 years of follow-up. After adjustments for prevalent cardiovascular disease, hypertension, diabetes, body mass index, education level, smoking status, and alcohol consumption, the hazard ratio of all-cause mortality for the prescribed group was 0.38, compared with the nonprescribed group.

Dr. Lisan and his colleagues identified 27 deaths of cardiovascular origin, one of which occurred in the prescribed group. After adjusting for prevalent cardiovascular disease, the hazard ratio of cardiovascular mortality for the prescribed group was 0.06, compared with the nonprescribed group.

One reason that the reduction in mortality associated with PAP was not found in previous randomized, controlled trials could be that their mean length of follow-up was not long enough, the researchers wrote. For example, the mean length of follow-up in the SAVE trial was 3.7 years, but the survival benefit was not apparent in the present analysis until 6-7 years after treatment initiation.

These results are exploratory and require confirmation in future research, Dr. Lisan and his colleagues wrote. No information on adherence to PAP was available, and the researchers could not account for initiation and interruption of PAP therapy. Nevertheless, “prescribing PAP in patients with OSA should be pursued and encouraged, given its potential major public health implication,” they concluded.

The Sleep Heart Health Study was supported by grants from the National Institutes of Health.

egreb@mdedge.com

SOURCE: Lisan Q et al. JAMA Otolaryngol Head Neck Surg. 2019 Apr 11. doi: 10.1001/jamaoto.2019.0281.

Just as conflict of interest (COI) disclosure has moved center stage in recent months, so too have certain physician-industry relationships. Some cancer centers and academic medical institutions across the country have reinvigorated or renewed discussions about the participation of leaders on outside corporate boards and about how to best navigate an increasingly complex web of individual and institutional relationships with industry.

Courtesy Cleveland Clinic

Memorial Sloan Kettering Cancer Center (MSK), which was thrust into the spotlight last fall with news coverage of a top leader’s disclosure failures and coverage of other leaders’ financial relationships with start-up companies, has decided that its senior executives may no longer serve on boards of directors of for-profit health- or science-related companies.

MSK officials also decided that its board members may not serve on the boards of MSK-affiliated start-up companies or make any direct investments in them.

Other institutions, such as the Fred Hutchinson Cancer Research Center in Seattle, were also reviewing their conflict of interest policies.

Participation of academic medical center leaders on the boards of public companies is one of the “most important topics” of discussion – along with disclosure – among those who oversee and manage COI through institutional research offices and COI committees, said Raed Dweik, MD, MBA, chair of Cleveland Clinic’s Innovation Management and COI Committee.

Discussions cover “whether [participation on outside boards] should be allowed in the first place, how relationships should be managed if they’re allowed, and whether there should be limits on compensation,” said Dr. Dweik, who also chairs the American Association of Medical Colleges’ Forum on Conflict of Interest in Academe, a group of over 600 representatives from academic health centers, medical schools, teaching hospitals, and other hospitals and centers with substantive research programs.


Institutions have been grappling with these issues for years. But “what was reported [about] MSK has brought these topics into hyperfocus in a way,” he said, along with questions concerning the magnitude of compensation and financial interest more broadly.

Institutional approaches

One of the reports on MSK’s financial ties involved a vice president and expert in technology transfer who was appointed to the board of a biotech company, Y-mAbs, in which MSK had an equity stake; the vice president had stock options that soared when the start-up went public. (He later turned over a nearly $1.4 million windfall profit to the hospital.)

In addition to barring appointments of its leaders to boards of MSK start-ups and any direct investments in them, MSK announced that going forward, “any potential equity that could be attained by employees appointed as MSK designees to outside boards will be returned to the institution and dedicated to research.”

A letter to MSK staff also said that “when profits emerge through the monetization of our research, financial payments to MSK-designated board members should be used for the benefit of the institution.”

Broadly speaking, conflict of interest deliberations within institutions center on how financial relationships with industry can potentially compromise the integrity of research (from patient selection to data analysis and the reporting of findings), the safety of research subjects and other patients, and the protection of public trust in physicians and their institutions.

Public trust is important, said Heather Pierce, JD, MPH, senior director of science policy and regulatory counsel for the Association of American Medical Colleges.

“In some cases, institutions may decide,” she said, “that they can control for any potential bias in research, but they can’t control for a perception that a person should not be engaged, or should not be compensated by a company because of appearance.”

Institutions are guided by federal regulations and institutional considerations that deal mainly with “how to evaluate and assess [potential conflicts] and the types of information needed [to do so] – not with specific delineations on what types of relationships are prohibited or not,” said Ms. Pierce. “There are some bright lines, but most things are a lot more complicated.”

Since 2001, the AAMC has recommended the use of a rebuttable presumption framework, in which individuals with a financial interest are prohibited from participating in related research unless “compelling circumstances” justify an exemption. Institutions typically use a “de minimis threshold” to define what financial interests are significant enough for application of the rebuttable presumptions framework.

Cleveland Clinic’s COI Committee considers anything above $20,000 from one company to be significant for the purposes of rebuttable presumption. Compensation between $5,000 and $20,000 (per company per year) triggers a COI management plan that typically focuses on disclosure, but can also include elements such as limits on compensation or the involvement of nonconflicted individuals in data analysis, Dr. Dweik said.

“Anything above $20,000, or equity, we more deeply scrutinize,” he said. “You have to have a really good reason to participate in research related to that company or product. There have to be compelling circumstances.”

Any amount of equity, he emphasized, “is automatically treated as high compensation, because the potential value is high. We are very keenly aware of this in our decisions about what research goes through and what doesn’t.”

Compensation of $5,000 or less is generally considered low at Cleveland Clinic and other institutions (and not in need of COI management), in keeping with U.S. Department of Health and Human Services regulations designed to promote objectivity in research. Thresholds for rebuttable presumption vary from institution to institution, with some being much higher – around $50,000 – than at the Cleveland Clinic, said Dr. Dweik, a pulmonary and critical care medicine specialist who chairs the clinic’s Respiratory Institute.

The big challenge with industry ties involving key executives and leaders – chief medical officers, deans, department chairs, and division chiefs – is that these ties involve institutional COI (not only individual COI) since an individual’s conflicts can be imputed to the institution.

Institutional COI issues generally are much “trickier” for the AAMC’s COI forum to discuss and guide because institutions have different structures and cultures, Dr. Dweik said. Institutional start-ups, moreover, have no standard structure.

“Some institutions, once a company is spun off, will build a firewall between the institution and the company,” he said. “Some institutions will keep the company embedded within the inventor’s lab, or provide infrastructure. And there’s a lot in between.”

Regarding the participation of academic medical center leaders on outside boards, it appears “that institutions are all over the map” in how they regard and evaluate such relationships, Dr. Dweik said. Some institutions address these relationships in their COI policies, while others don’t. And “some are more liberal,” he said. “Others are stricter.”

The magnitude of personal financial interest among MSK leaders (both in institutional start-ups and other companies) is “way outside the norm,” Dr. Dweik said.

Still, board participation can be quite lucrative. One study described in a research letter in JAMA ( 2014;311[13]:1353-5 ) 5 years ago reported that the mean financial compensation of pharmaceutical company board members who held academic medical center leadership positions was more than $300,000 .

Compensation aside, corporate board participation is “one of the most egregious examples of conflict of interest,” said Vinay Prasad, MD, MPH , a hematologist-oncologist and associate professor of medicine at Oregon Health & Science University, who researches COI and bias. “You have a fiduciary duty to the company’s best interest. … so there will inevitably be a tension between that oath and your other duties,” from responsibilities for institutional oversight to one’s individual research and clinical practices, he said. Physicians at academic medical centers and cancer centers “need to interact with industry,” he said. “But it’s about creating independence.”
 

A muddied field

S. Vincent Rajkumar, MD, a hematologist-oncologist and active researcher at the Mayo Clinic in Rochester, agrees. “Being on the board of directors of a pharmaceutical company, particularly by institutional leaders, is one of the genuine COIs” amid a field of COI that’s become increasingly muddied with the shift toward more comprehensive, general disclosure practices.

“It’s important that we don’t lose sight of clarity in what types of financial ties and relationships we’re really concerned about,” he said. “The ties that are really concerning – the significant conflicts of interest – are serving on boards of companies or getting large personal payments for participating in speakers’ bureaus or single, company-sponsored CME lectures, for instance, or having stocks, investments, or significant royalties or large payments to your lab or research program [outside of clinical trial funding].”

Other financial transactions such as “reasonable” payments for participation in data-monitoring committees and steering committees are financial ties that should be disclosed, but generally aren’t concerning, Dr. Rajkumar said.

Dr. Rajkumar serves as an editor-in-chief of the Blood Cancer Journal and is an author of several UptoDate chapters. Because of these roles and in keeping with his own views on COI, he has worked deliberately over the past decade to be free of industry payments.

This has become increasingly difficult given the breadth of payments attributed to individual physicians on the federal Open Payments website – some of which are “not truly personal financial ties.” He cited industry payments to support multicompany-sponsored meetings or to institutions for clinical trials.

“It’s nearly impossible to have zero dollars against your name unless you do no clinical trials,” Dr. Rajkumar said.

Still, he said, transparency and disclosure programs like Open Payments are important. “I do think bias arising from COI is very real. There are people with significant conflicts of interest who are writing influential reviews, speaking at influential meetings, and writing influential guidelines – and you can sense the bias pretty quickly,” he said, with endpoints that aren’t appropriate for the trial at hand, for instance, or with overly rosy assessments and the exclusion of negative results.
 

Collaboration benefits

But Thomas Stossel, MD, American Cancer Society Professor of Medicine Emeritus at Harvard Medical School and founder and chief science advisor at BioAegis Therapeutics, worries that the benefit of physician-industry collaboration is being drowned out with all the attention paid to COI.

His experience on a scientific advisory board in the late 1980s was a “transforming experience that opened my eyes to [the complexities] of product development. … and [later] enabled me to turn my basic research into a potentially life-saving product,” he said.

The “conflict-of-interest narrative” falsely maintains that collaboration causes corruption, he said, and the resultant “hand wringing over [assumed risks]” has slowed innovation by preventing or delaying research and development projects. “It’s like death by a thousand cuts,” said Dr. Stossel, who wrote a book, Pharmacophobia – How the Conflict-of-Interest Myth Undermines American Medical Innovation, to document his concerns.

Dr. Dweik said he has seen the “field move in a good direction” with most academic institutions now deeming physician participation in drug company speakers’ bureaus as “no longer acceptable,” unless physicians discuss drugs in balanced, “disease-specific, not drug-specific” presentations. At this point, it’s unclear exactly how the needle will move on other types of relationships.

“I wouldn’t be surprised if over the next couple of years there is more consistency, more standardization” on issues of participation on outside boards. “The [academic medical center] community is certainly trying to get a better handle on this,” Dr. Dweik said.

Future institutional changes will come, said Ms. Pierce of the AAMC, “but in more subtle ways than we’ve seen in the past, given [progress] already made” through major reports, guidance, and laws and regulations relating to COI. Today, she said, “technology transfer is incrementally more complicated, relationships are more complicated, and corporate structures are more complicated. This makes teasing apart what the issues are a little bit harder.”

Just as conflict of interest (COI) disclosure has moved center stage in recent months, so too have certain physician-industry relationships. Some cancer centers and academic medical institutions across the country have reinvigorated or renewed discussions about the participation of leaders on outside corporate boards and about how to best navigate an increasingly complex web of individual and institutional relationships with industry.

Courtesy Cleveland Clinic

Memorial Sloan Kettering Cancer Center (MSK), which was thrust into the spotlight last fall with news coverage of a top leader’s disclosure failures and coverage of other leaders’ financial relationships with start-up companies, has decided that its senior executives may no longer serve on boards of directors of for-profit health- or science-related companies.

MSK officials also decided that its board members may not serve on the boards of MSK-affiliated start-up companies or make any direct investments in them.

Other institutions, such as the Fred Hutchinson Cancer Research Center in Seattle, were also reviewing their conflict of interest policies.

Participation of academic medical center leaders on the boards of public companies is one of the “most important topics” of discussion – along with disclosure – among those who oversee and manage COI through institutional research offices and COI committees, said Raed Dweik, MD, MBA, chair of Cleveland Clinic’s Innovation Management and COI Committee.

Discussions cover “whether [participation on outside boards] should be allowed in the first place, how relationships should be managed if they’re allowed, and whether there should be limits on compensation,” said Dr. Dweik, who also chairs the American Association of Medical Colleges’ Forum on Conflict of Interest in Academe, a group of over 600 representatives from academic health centers, medical schools, teaching hospitals, and other hospitals and centers with substantive research programs.


Institutions have been grappling with these issues for years. But “what was reported [about] MSK has brought these topics into hyperfocus in a way,” he said, along with questions concerning the magnitude of compensation and financial interest more broadly.

Institutional approaches

One of the reports on MSK’s financial ties involved a vice president and expert in technology transfer who was appointed to the board of a biotech company, Y-mAbs, in which MSK had an equity stake; the vice president had stock options that soared when the start-up went public. (He later turned over a nearly $1.4 million windfall profit to the hospital.)

In addition to barring appointments of its leaders to boards of MSK start-ups and any direct investments in them, MSK announced that going forward, “any potential equity that could be attained by employees appointed as MSK designees to outside boards will be returned to the institution and dedicated to research.”

A letter to MSK staff also said that “when profits emerge through the monetization of our research, financial payments to MSK-designated board members should be used for the benefit of the institution.”

Broadly speaking, conflict of interest deliberations within institutions center on how financial relationships with industry can potentially compromise the integrity of research (from patient selection to data analysis and the reporting of findings), the safety of research subjects and other patients, and the protection of public trust in physicians and their institutions.

Public trust is important, said Heather Pierce, JD, MPH, senior director of science policy and regulatory counsel for the Association of American Medical Colleges.

“In some cases, institutions may decide,” she said, “that they can control for any potential bias in research, but they can’t control for a perception that a person should not be engaged, or should not be compensated by a company because of appearance.”

Institutions are guided by federal regulations and institutional considerations that deal mainly with “how to evaluate and assess [potential conflicts] and the types of information needed [to do so] – not with specific delineations on what types of relationships are prohibited or not,” said Ms. Pierce. “There are some bright lines, but most things are a lot more complicated.”

Since 2001, the AAMC has recommended the use of a rebuttable presumption framework, in which individuals with a financial interest are prohibited from participating in related research unless “compelling circumstances” justify an exemption. Institutions typically use a “de minimis threshold” to define what financial interests are significant enough for application of the rebuttable presumptions framework.

Cleveland Clinic’s COI Committee considers anything above $20,000 from one company to be significant for the purposes of rebuttable presumption. Compensation between $5,000 and $20,000 (per company per year) triggers a COI management plan that typically focuses on disclosure, but can also include elements such as limits on compensation or the involvement of nonconflicted individuals in data analysis, Dr. Dweik said.

“Anything above $20,000, or equity, we more deeply scrutinize,” he said. “You have to have a really good reason to participate in research related to that company or product. There have to be compelling circumstances.”

Any amount of equity, he emphasized, “is automatically treated as high compensation, because the potential value is high. We are very keenly aware of this in our decisions about what research goes through and what doesn’t.”

Compensation of $5,000 or less is generally considered low at Cleveland Clinic and other institutions (and not in need of COI management), in keeping with U.S. Department of Health and Human Services regulations designed to promote objectivity in research. Thresholds for rebuttable presumption vary from institution to institution, with some being much higher – around $50,000 – than at the Cleveland Clinic, said Dr. Dweik, a pulmonary and critical care medicine specialist who chairs the clinic’s Respiratory Institute.

The big challenge with industry ties involving key executives and leaders – chief medical officers, deans, department chairs, and division chiefs – is that these ties involve institutional COI (not only individual COI) since an individual’s conflicts can be imputed to the institution.

Institutional COI issues generally are much “trickier” for the AAMC’s COI forum to discuss and guide because institutions have different structures and cultures, Dr. Dweik said. Institutional start-ups, moreover, have no standard structure.

“Some institutions, once a company is spun off, will build a firewall between the institution and the company,” he said. “Some institutions will keep the company embedded within the inventor’s lab, or provide infrastructure. And there’s a lot in between.”

Regarding the participation of academic medical center leaders on outside boards, it appears “that institutions are all over the map” in how they regard and evaluate such relationships, Dr. Dweik said. Some institutions address these relationships in their COI policies, while others don’t. And “some are more liberal,” he said. “Others are stricter.”

The magnitude of personal financial interest among MSK leaders (both in institutional start-ups and other companies) is “way outside the norm,” Dr. Dweik said.

Still, board participation can be quite lucrative. One study described in a research letter in JAMA ( 2014;311[13]:1353-5 ) 5 years ago reported that the mean financial compensation of pharmaceutical company board members who held academic medical center leadership positions was more than $300,000 .

Compensation aside, corporate board participation is “one of the most egregious examples of conflict of interest,” said Vinay Prasad, MD, MPH , a hematologist-oncologist and associate professor of medicine at Oregon Health & Science University, who researches COI and bias. “You have a fiduciary duty to the company’s best interest. … so there will inevitably be a tension between that oath and your other duties,” from responsibilities for institutional oversight to one’s individual research and clinical practices, he said. Physicians at academic medical centers and cancer centers “need to interact with industry,” he said. “But it’s about creating independence.”
 

A muddied field

S. Vincent Rajkumar, MD, a hematologist-oncologist and active researcher at the Mayo Clinic in Rochester, agrees. “Being on the board of directors of a pharmaceutical company, particularly by institutional leaders, is one of the genuine COIs” amid a field of COI that’s become increasingly muddied with the shift toward more comprehensive, general disclosure practices.

“It’s important that we don’t lose sight of clarity in what types of financial ties and relationships we’re really concerned about,” he said. “The ties that are really concerning – the significant conflicts of interest – are serving on boards of companies or getting large personal payments for participating in speakers’ bureaus or single, company-sponsored CME lectures, for instance, or having stocks, investments, or significant royalties or large payments to your lab or research program [outside of clinical trial funding].”

Other financial transactions such as “reasonable” payments for participation in data-monitoring committees and steering committees are financial ties that should be disclosed, but generally aren’t concerning, Dr. Rajkumar said.

Dr. Rajkumar serves as an editor-in-chief of the Blood Cancer Journal and is an author of several UptoDate chapters. Because of these roles and in keeping with his own views on COI, he has worked deliberately over the past decade to be free of industry payments.

This has become increasingly difficult given the breadth of payments attributed to individual physicians on the federal Open Payments website – some of which are “not truly personal financial ties.” He cited industry payments to support multicompany-sponsored meetings or to institutions for clinical trials.

“It’s nearly impossible to have zero dollars against your name unless you do no clinical trials,” Dr. Rajkumar said.

Still, he said, transparency and disclosure programs like Open Payments are important. “I do think bias arising from COI is very real. There are people with significant conflicts of interest who are writing influential reviews, speaking at influential meetings, and writing influential guidelines – and you can sense the bias pretty quickly,” he said, with endpoints that aren’t appropriate for the trial at hand, for instance, or with overly rosy assessments and the exclusion of negative results.
 

Collaboration benefits

But Thomas Stossel, MD, American Cancer Society Professor of Medicine Emeritus at Harvard Medical School and founder and chief science advisor at BioAegis Therapeutics, worries that the benefit of physician-industry collaboration is being drowned out with all the attention paid to COI.

His experience on a scientific advisory board in the late 1980s was a “transforming experience that opened my eyes to [the complexities] of product development. … and [later] enabled me to turn my basic research into a potentially life-saving product,” he said.

The “conflict-of-interest narrative” falsely maintains that collaboration causes corruption, he said, and the resultant “hand wringing over [assumed risks]” has slowed innovation by preventing or delaying research and development projects. “It’s like death by a thousand cuts,” said Dr. Stossel, who wrote a book, Pharmacophobia – How the Conflict-of-Interest Myth Undermines American Medical Innovation, to document his concerns.

Dr. Dweik said he has seen the “field move in a good direction” with most academic institutions now deeming physician participation in drug company speakers’ bureaus as “no longer acceptable,” unless physicians discuss drugs in balanced, “disease-specific, not drug-specific” presentations. At this point, it’s unclear exactly how the needle will move on other types of relationships.

“I wouldn’t be surprised if over the next couple of years there is more consistency, more standardization” on issues of participation on outside boards. “The [academic medical center] community is certainly trying to get a better handle on this,” Dr. Dweik said.

Future institutional changes will come, said Ms. Pierce of the AAMC, “but in more subtle ways than we’ve seen in the past, given [progress] already made” through major reports, guidance, and laws and regulations relating to COI. Today, she said, “technology transfer is incrementally more complicated, relationships are more complicated, and corporate structures are more complicated. This makes teasing apart what the issues are a little bit harder.”

Just as conflict of interest (COI) disclosure has moved center stage in recent months, so too have certain physician-industry relationships. Some cancer centers and academic medical institutions across the country have reinvigorated or renewed discussions about the participation of leaders on outside corporate boards and about how to best navigate an increasingly complex web of individual and institutional relationships with industry.

Courtesy Cleveland Clinic

Memorial Sloan Kettering Cancer Center (MSK), which was thrust into the spotlight last fall with news coverage of a top leader’s disclosure failures and coverage of other leaders’ financial relationships with start-up companies, has decided that its senior executives may no longer serve on boards of directors of for-profit health- or science-related companies.

MSK officials also decided that its board members may not serve on the boards of MSK-affiliated start-up companies or make any direct investments in them.

Other institutions, such as the Fred Hutchinson Cancer Research Center in Seattle, were also reviewing their conflict of interest policies.

Participation of academic medical center leaders on the boards of public companies is one of the “most important topics” of discussion – along with disclosure – among those who oversee and manage COI through institutional research offices and COI committees, said Raed Dweik, MD, MBA, chair of Cleveland Clinic’s Innovation Management and COI Committee.

Discussions cover “whether [participation on outside boards] should be allowed in the first place, how relationships should be managed if they’re allowed, and whether there should be limits on compensation,” said Dr. Dweik, who also chairs the American Association of Medical Colleges’ Forum on Conflict of Interest in Academe, a group of over 600 representatives from academic health centers, medical schools, teaching hospitals, and other hospitals and centers with substantive research programs.


Institutions have been grappling with these issues for years. But “what was reported [about] MSK has brought these topics into hyperfocus in a way,” he said, along with questions concerning the magnitude of compensation and financial interest more broadly.

Institutional approaches

One of the reports on MSK’s financial ties involved a vice president and expert in technology transfer who was appointed to the board of a biotech company, Y-mAbs, in which MSK had an equity stake; the vice president had stock options that soared when the start-up went public. (He later turned over a nearly $1.4 million windfall profit to the hospital.)

In addition to barring appointments of its leaders to boards of MSK start-ups and any direct investments in them, MSK announced that going forward, “any potential equity that could be attained by employees appointed as MSK designees to outside boards will be returned to the institution and dedicated to research.”

A letter to MSK staff also said that “when profits emerge through the monetization of our research, financial payments to MSK-designated board members should be used for the benefit of the institution.”

Broadly speaking, conflict of interest deliberations within institutions center on how financial relationships with industry can potentially compromise the integrity of research (from patient selection to data analysis and the reporting of findings), the safety of research subjects and other patients, and the protection of public trust in physicians and their institutions.

Public trust is important, said Heather Pierce, JD, MPH, senior director of science policy and regulatory counsel for the Association of American Medical Colleges.

“In some cases, institutions may decide,” she said, “that they can control for any potential bias in research, but they can’t control for a perception that a person should not be engaged, or should not be compensated by a company because of appearance.”

Institutions are guided by federal regulations and institutional considerations that deal mainly with “how to evaluate and assess [potential conflicts] and the types of information needed [to do so] – not with specific delineations on what types of relationships are prohibited or not,” said Ms. Pierce. “There are some bright lines, but most things are a lot more complicated.”

Since 2001, the AAMC has recommended the use of a rebuttable presumption framework, in which individuals with a financial interest are prohibited from participating in related research unless “compelling circumstances” justify an exemption. Institutions typically use a “de minimis threshold” to define what financial interests are significant enough for application of the rebuttable presumptions framework.

Cleveland Clinic’s COI Committee considers anything above $20,000 from one company to be significant for the purposes of rebuttable presumption. Compensation between $5,000 and $20,000 (per company per year) triggers a COI management plan that typically focuses on disclosure, but can also include elements such as limits on compensation or the involvement of nonconflicted individuals in data analysis, Dr. Dweik said.

“Anything above $20,000, or equity, we more deeply scrutinize,” he said. “You have to have a really good reason to participate in research related to that company or product. There have to be compelling circumstances.”

Any amount of equity, he emphasized, “is automatically treated as high compensation, because the potential value is high. We are very keenly aware of this in our decisions about what research goes through and what doesn’t.”

Compensation of $5,000 or less is generally considered low at Cleveland Clinic and other institutions (and not in need of COI management), in keeping with U.S. Department of Health and Human Services regulations designed to promote objectivity in research. Thresholds for rebuttable presumption vary from institution to institution, with some being much higher – around $50,000 – than at the Cleveland Clinic, said Dr. Dweik, a pulmonary and critical care medicine specialist who chairs the clinic’s Respiratory Institute.

The big challenge with industry ties involving key executives and leaders – chief medical officers, deans, department chairs, and division chiefs – is that these ties involve institutional COI (not only individual COI) since an individual’s conflicts can be imputed to the institution.

Institutional COI issues generally are much “trickier” for the AAMC’s COI forum to discuss and guide because institutions have different structures and cultures, Dr. Dweik said. Institutional start-ups, moreover, have no standard structure.

“Some institutions, once a company is spun off, will build a firewall between the institution and the company,” he said. “Some institutions will keep the company embedded within the inventor’s lab, or provide infrastructure. And there’s a lot in between.”

Regarding the participation of academic medical center leaders on outside boards, it appears “that institutions are all over the map” in how they regard and evaluate such relationships, Dr. Dweik said. Some institutions address these relationships in their COI policies, while others don’t. And “some are more liberal,” he said. “Others are stricter.”

The magnitude of personal financial interest among MSK leaders (both in institutional start-ups and other companies) is “way outside the norm,” Dr. Dweik said.

Still, board participation can be quite lucrative. One study described in a research letter in JAMA ( 2014;311[13]:1353-5 ) 5 years ago reported that the mean financial compensation of pharmaceutical company board members who held academic medical center leadership positions was more than $300,000 .

Compensation aside, corporate board participation is “one of the most egregious examples of conflict of interest,” said Vinay Prasad, MD, MPH , a hematologist-oncologist and associate professor of medicine at Oregon Health & Science University, who researches COI and bias. “You have a fiduciary duty to the company’s best interest. … so there will inevitably be a tension between that oath and your other duties,” from responsibilities for institutional oversight to one’s individual research and clinical practices, he said. Physicians at academic medical centers and cancer centers “need to interact with industry,” he said. “But it’s about creating independence.”
 

A muddied field

S. Vincent Rajkumar, MD, a hematologist-oncologist and active researcher at the Mayo Clinic in Rochester, agrees. “Being on the board of directors of a pharmaceutical company, particularly by institutional leaders, is one of the genuine COIs” amid a field of COI that’s become increasingly muddied with the shift toward more comprehensive, general disclosure practices.

“It’s important that we don’t lose sight of clarity in what types of financial ties and relationships we’re really concerned about,” he said. “The ties that are really concerning – the significant conflicts of interest – are serving on boards of companies or getting large personal payments for participating in speakers’ bureaus or single, company-sponsored CME lectures, for instance, or having stocks, investments, or significant royalties or large payments to your lab or research program [outside of clinical trial funding].”

Other financial transactions such as “reasonable” payments for participation in data-monitoring committees and steering committees are financial ties that should be disclosed, but generally aren’t concerning, Dr. Rajkumar said.

Dr. Rajkumar serves as an editor-in-chief of the Blood Cancer Journal and is an author of several UptoDate chapters. Because of these roles and in keeping with his own views on COI, he has worked deliberately over the past decade to be free of industry payments.

This has become increasingly difficult given the breadth of payments attributed to individual physicians on the federal Open Payments website – some of which are “not truly personal financial ties.” He cited industry payments to support multicompany-sponsored meetings or to institutions for clinical trials.

“It’s nearly impossible to have zero dollars against your name unless you do no clinical trials,” Dr. Rajkumar said.

Still, he said, transparency and disclosure programs like Open Payments are important. “I do think bias arising from COI is very real. There are people with significant conflicts of interest who are writing influential reviews, speaking at influential meetings, and writing influential guidelines – and you can sense the bias pretty quickly,” he said, with endpoints that aren’t appropriate for the trial at hand, for instance, or with overly rosy assessments and the exclusion of negative results.
 

Collaboration benefits

But Thomas Stossel, MD, American Cancer Society Professor of Medicine Emeritus at Harvard Medical School and founder and chief science advisor at BioAegis Therapeutics, worries that the benefit of physician-industry collaboration is being drowned out with all the attention paid to COI.

His experience on a scientific advisory board in the late 1980s was a “transforming experience that opened my eyes to [the complexities] of product development. … and [later] enabled me to turn my basic research into a potentially life-saving product,” he said.

The “conflict-of-interest narrative” falsely maintains that collaboration causes corruption, he said, and the resultant “hand wringing over [assumed risks]” has slowed innovation by preventing or delaying research and development projects. “It’s like death by a thousand cuts,” said Dr. Stossel, who wrote a book, Pharmacophobia – How the Conflict-of-Interest Myth Undermines American Medical Innovation, to document his concerns.

Dr. Dweik said he has seen the “field move in a good direction” with most academic institutions now deeming physician participation in drug company speakers’ bureaus as “no longer acceptable,” unless physicians discuss drugs in balanced, “disease-specific, not drug-specific” presentations. At this point, it’s unclear exactly how the needle will move on other types of relationships.

“I wouldn’t be surprised if over the next couple of years there is more consistency, more standardization” on issues of participation on outside boards. “The [academic medical center] community is certainly trying to get a better handle on this,” Dr. Dweik said.

Future institutional changes will come, said Ms. Pierce of the AAMC, “but in more subtle ways than we’ve seen in the past, given [progress] already made” through major reports, guidance, and laws and regulations relating to COI. Today, she said, “technology transfer is incrementally more complicated, relationships are more complicated, and corporate structures are more complicated. This makes teasing apart what the issues are a little bit harder.”

The severity of traumatic brain injury (TBI) is typically defined at the time of the initial injury, but a diagnosis may not come for months or even years later. Given the complexities of diagnosing what might be a slowly revealed condition, with signs and symptoms that may manifest over time; the need for self-report of symptoms; and the time that might have elapsed since the original injury, a diagnostician needs not only to have experience with TBI but to stay abreast of the state of the science.

As of now, only health care professionals in 4 specialties—neurologist, neurosurgeon, physiatrist, or psychiatrist—are allowed to diagnose TBI in the VA’s disability compensation process. A new congressionally mandated report by the National Academies of Sciences, Engineering, and Medicine, though, is advising that it’s training and experience that count, not necessarily the specialty.

In Evaluation of the Disability Determination Process for Traumatic Brain Injury in Veterans, a committee of experts in emergency medicine, neurology, neurosurgery, psychiatry, psychology, physical medicine and rehabilitation, and epidemiology and biostatistics review the process and current literature on TBI. The committee advises that any health care professional with “pertinent and ongoing brain injury training and experience” and up-to-date knowledge about TBI should be included in the diagnostic process.

The disability compensation is a tax-free benefit paid to veterans with disabilities resulting from disease or injury incurred or aggravated during active military service. The amount is determined in a 6-step process beginning when the veteran (or a proxy) files a claim. An approved clinician typically must diagnose and evaluate the degree of impairment, functional limitation, and disability.

Between 2000 and 2018, an estimated 384,000 incidents of TBI occurred in the military. That increasing prevalence means more medical specialties now include TBI training in their curriculum. The committee notes that at least 18 brain injury programs are accredited by the Accreditation Council for Graduate Medical Education to train physicians in many specialties to diagnose, treat, and rehabilitate patients with brain injury. 

Among other recommendations, the committee advised that the VA take specific actions to increase transparency at both individual and systemwide levels, such as providing veterans full access to the details of their examinations, allowing veterans to rate the quality of their evaluations, and providing public access to detailed systemwide data on the outcomes of evaluations and outcome quality. Those changes will represent a “fundamental enhancement” in the quality of disability evaluations, the committee says, which added that shifting from a focus on the consistency of the process and practitioner qualifications to a focus on the accuracy of the outcome of the evaluation will help identify steps or components in the process that warrant improvement.

It also suggested regularly updating the Veteran Affairs Schedule for Rating Disabilities and the Disability Benefits Questionnaires (DBQs) for residuals of TBI to “better reflect the current state of medical knowledge.” The committee found that 3 important residuals of TBI are not adequately covered by any of the existing DBQs: insomnia, vestibular dysfunction, and near-vision dysfunction. Although 4 DBQs (mental disorder, chronic fatigue syndrome, PTSD, and sleep apnea) contain isolated questions related to insomnia and sleep disruption, no single DBQ, the committee says, combines them all “in a way that captures the full extent of disability associated with post-TBI sleep disruption.” Similarly, no single DBQ captures the full extent of disability associated with post-TBI vestibular dysfunction or the disability associated with near-vision dysfunction.

The committee sums up: “[B]y adopting an explicit learning structure in which the reliability and validity of disability determinations are directly assessed, the VA will be able to devote its resources to those modifications and enhancements … that will have the greatest impact in improving the service provided to injured veterans.”

The severity of traumatic brain injury (TBI) is typically defined at the time of the initial injury, but a diagnosis may not come for months or even years later. Given the complexities of diagnosing what might be a slowly revealed condition, with signs and symptoms that may manifest over time; the need for self-report of symptoms; and the time that might have elapsed since the original injury, a diagnostician needs not only to have experience with TBI but to stay abreast of the state of the science.

As of now, only health care professionals in 4 specialties—neurologist, neurosurgeon, physiatrist, or psychiatrist—are allowed to diagnose TBI in the VA’s disability compensation process. A new congressionally mandated report by the National Academies of Sciences, Engineering, and Medicine, though, is advising that it’s training and experience that count, not necessarily the specialty.

In Evaluation of the Disability Determination Process for Traumatic Brain Injury in Veterans, a committee of experts in emergency medicine, neurology, neurosurgery, psychiatry, psychology, physical medicine and rehabilitation, and epidemiology and biostatistics review the process and current literature on TBI. The committee advises that any health care professional with “pertinent and ongoing brain injury training and experience” and up-to-date knowledge about TBI should be included in the diagnostic process.

The disability compensation is a tax-free benefit paid to veterans with disabilities resulting from disease or injury incurred or aggravated during active military service. The amount is determined in a 6-step process beginning when the veteran (or a proxy) files a claim. An approved clinician typically must diagnose and evaluate the degree of impairment, functional limitation, and disability.

Between 2000 and 2018, an estimated 384,000 incidents of TBI occurred in the military. That increasing prevalence means more medical specialties now include TBI training in their curriculum. The committee notes that at least 18 brain injury programs are accredited by the Accreditation Council for Graduate Medical Education to train physicians in many specialties to diagnose, treat, and rehabilitate patients with brain injury. 

Among other recommendations, the committee advised that the VA take specific actions to increase transparency at both individual and systemwide levels, such as providing veterans full access to the details of their examinations, allowing veterans to rate the quality of their evaluations, and providing public access to detailed systemwide data on the outcomes of evaluations and outcome quality. Those changes will represent a “fundamental enhancement” in the quality of disability evaluations, the committee says, which added that shifting from a focus on the consistency of the process and practitioner qualifications to a focus on the accuracy of the outcome of the evaluation will help identify steps or components in the process that warrant improvement.

It also suggested regularly updating the Veteran Affairs Schedule for Rating Disabilities and the Disability Benefits Questionnaires (DBQs) for residuals of TBI to “better reflect the current state of medical knowledge.” The committee found that 3 important residuals of TBI are not adequately covered by any of the existing DBQs: insomnia, vestibular dysfunction, and near-vision dysfunction. Although 4 DBQs (mental disorder, chronic fatigue syndrome, PTSD, and sleep apnea) contain isolated questions related to insomnia and sleep disruption, no single DBQ, the committee says, combines them all “in a way that captures the full extent of disability associated with post-TBI sleep disruption.” Similarly, no single DBQ captures the full extent of disability associated with post-TBI vestibular dysfunction or the disability associated with near-vision dysfunction.

The committee sums up: “[B]y adopting an explicit learning structure in which the reliability and validity of disability determinations are directly assessed, the VA will be able to devote its resources to those modifications and enhancements … that will have the greatest impact in improving the service provided to injured veterans.”

The severity of traumatic brain injury (TBI) is typically defined at the time of the initial injury, but a diagnosis may not come for months or even years later. Given the complexities of diagnosing what might be a slowly revealed condition, with signs and symptoms that may manifest over time; the need for self-report of symptoms; and the time that might have elapsed since the original injury, a diagnostician needs not only to have experience with TBI but to stay abreast of the state of the science.

As of now, only health care professionals in 4 specialties—neurologist, neurosurgeon, physiatrist, or psychiatrist—are allowed to diagnose TBI in the VA’s disability compensation process. A new congressionally mandated report by the National Academies of Sciences, Engineering, and Medicine, though, is advising that it’s training and experience that count, not necessarily the specialty.

In Evaluation of the Disability Determination Process for Traumatic Brain Injury in Veterans, a committee of experts in emergency medicine, neurology, neurosurgery, psychiatry, psychology, physical medicine and rehabilitation, and epidemiology and biostatistics review the process and current literature on TBI. The committee advises that any health care professional with “pertinent and ongoing brain injury training and experience” and up-to-date knowledge about TBI should be included in the diagnostic process.

The disability compensation is a tax-free benefit paid to veterans with disabilities resulting from disease or injury incurred or aggravated during active military service. The amount is determined in a 6-step process beginning when the veteran (or a proxy) files a claim. An approved clinician typically must diagnose and evaluate the degree of impairment, functional limitation, and disability.

Between 2000 and 2018, an estimated 384,000 incidents of TBI occurred in the military. That increasing prevalence means more medical specialties now include TBI training in their curriculum. The committee notes that at least 18 brain injury programs are accredited by the Accreditation Council for Graduate Medical Education to train physicians in many specialties to diagnose, treat, and rehabilitate patients with brain injury. 

Among other recommendations, the committee advised that the VA take specific actions to increase transparency at both individual and systemwide levels, such as providing veterans full access to the details of their examinations, allowing veterans to rate the quality of their evaluations, and providing public access to detailed systemwide data on the outcomes of evaluations and outcome quality. Those changes will represent a “fundamental enhancement” in the quality of disability evaluations, the committee says, which added that shifting from a focus on the consistency of the process and practitioner qualifications to a focus on the accuracy of the outcome of the evaluation will help identify steps or components in the process that warrant improvement.

It also suggested regularly updating the Veteran Affairs Schedule for Rating Disabilities and the Disability Benefits Questionnaires (DBQs) for residuals of TBI to “better reflect the current state of medical knowledge.” The committee found that 3 important residuals of TBI are not adequately covered by any of the existing DBQs: insomnia, vestibular dysfunction, and near-vision dysfunction. Although 4 DBQs (mental disorder, chronic fatigue syndrome, PTSD, and sleep apnea) contain isolated questions related to insomnia and sleep disruption, no single DBQ, the committee says, combines them all “in a way that captures the full extent of disability associated with post-TBI sleep disruption.” Similarly, no single DBQ captures the full extent of disability associated with post-TBI vestibular dysfunction or the disability associated with near-vision dysfunction.

The committee sums up: “[B]y adopting an explicit learning structure in which the reliability and validity of disability determinations are directly assessed, the VA will be able to devote its resources to those modifications and enhancements … that will have the greatest impact in improving the service provided to injured veterans.”

Sending health information videos via text or email to mothers successfully promoted safe sleep behaviors among mothers by changing their attitudes and perceived social norms related to these practices, according to a new study.

monkeybusinessimages/Thinkstock

In the past, the American Academy of Pediatrics has made safe sleep recommendations regarding infant sleep position and location. According to the new study’s authors, Rachel Y. Moon, MD, and her colleagues, parents had poorly adhered to these recommendations in several studies. However, some improvements with adherence were seen when a mobile health intervention was used in the Social Media and Risk Reduction Training Study (JAMA. 2017;318[4]:351-9). The new study, published in Pediatrics, used the same intervention described in that JAMA paper.

The more recent mobile health project sought to identify which factors, as outlined by a theory of planned behavior, were affected by a mobile health intervention through analysis of survey responses. Of the 1,600 women who provided written consent, 1,263 (78.9%) completed the survey.

According to the results, the intervention did more to affect attitudes (adjusted odds ratio, 2.35; 95% confidence interval, 1.72-3.20) than it did to affect perceived norms (aOR, 1.75; 95% CI, 1.27-2.36) regarding supine sleeping position. It had similar effects on attitudes (aOR, 1.91; 95% CI, 1.54-2.36) versus perceived norms (aOR, 1.37; 95% CI, 1.13-1.66) regarding sleep location as well. The intervention had no significant effect on perceived maternal control regarding either sleeping position or location.

While levels of safe sleep adherence were lower in African Americans and subgroups of low economic status at baseline, the intervention improved the rates of adherence in these groups to levels comparable with other groups included in the study.

“Recognition that these attitudes and social norms may be the main drivers of mothers’ choices regarding infant-sleep practices should inform health messaging strategies, including the use of [mobile heath], to promote [safe sleep],” the researchers concluded.

The study was funded by grants from the Eunice Kennedy Shriver National Institute of Child Health and Human Development and the CJ foundation for sudden infant death syndrome. The National Institutes of Health also provided funding.

cpalmer@mdedge.com

SOURCE: Moon RY et al. Pediatrics. 2019. doi: 10.1542/peds.2018-2799.

Sending health information videos via text or email to mothers successfully promoted safe sleep behaviors among mothers by changing their attitudes and perceived social norms related to these practices, according to a new study.

monkeybusinessimages/Thinkstock

In the past, the American Academy of Pediatrics has made safe sleep recommendations regarding infant sleep position and location. According to the new study’s authors, Rachel Y. Moon, MD, and her colleagues, parents had poorly adhered to these recommendations in several studies. However, some improvements with adherence were seen when a mobile health intervention was used in the Social Media and Risk Reduction Training Study (JAMA. 2017;318[4]:351-9). The new study, published in Pediatrics, used the same intervention described in that JAMA paper.

The more recent mobile health project sought to identify which factors, as outlined by a theory of planned behavior, were affected by a mobile health intervention through analysis of survey responses. Of the 1,600 women who provided written consent, 1,263 (78.9%) completed the survey.

According to the results, the intervention did more to affect attitudes (adjusted odds ratio, 2.35; 95% confidence interval, 1.72-3.20) than it did to affect perceived norms (aOR, 1.75; 95% CI, 1.27-2.36) regarding supine sleeping position. It had similar effects on attitudes (aOR, 1.91; 95% CI, 1.54-2.36) versus perceived norms (aOR, 1.37; 95% CI, 1.13-1.66) regarding sleep location as well. The intervention had no significant effect on perceived maternal control regarding either sleeping position or location.

While levels of safe sleep adherence were lower in African Americans and subgroups of low economic status at baseline, the intervention improved the rates of adherence in these groups to levels comparable with other groups included in the study.

“Recognition that these attitudes and social norms may be the main drivers of mothers’ choices regarding infant-sleep practices should inform health messaging strategies, including the use of [mobile heath], to promote [safe sleep],” the researchers concluded.

The study was funded by grants from the Eunice Kennedy Shriver National Institute of Child Health and Human Development and the CJ foundation for sudden infant death syndrome. The National Institutes of Health also provided funding.

cpalmer@mdedge.com

SOURCE: Moon RY et al. Pediatrics. 2019. doi: 10.1542/peds.2018-2799.

Sending health information videos via text or email to mothers successfully promoted safe sleep behaviors among mothers by changing their attitudes and perceived social norms related to these practices, according to a new study.

monkeybusinessimages/Thinkstock

In the past, the American Academy of Pediatrics has made safe sleep recommendations regarding infant sleep position and location. According to the new study’s authors, Rachel Y. Moon, MD, and her colleagues, parents had poorly adhered to these recommendations in several studies. However, some improvements with adherence were seen when a mobile health intervention was used in the Social Media and Risk Reduction Training Study (JAMA. 2017;318[4]:351-9). The new study, published in Pediatrics, used the same intervention described in that JAMA paper.

The more recent mobile health project sought to identify which factors, as outlined by a theory of planned behavior, were affected by a mobile health intervention through analysis of survey responses. Of the 1,600 women who provided written consent, 1,263 (78.9%) completed the survey.

According to the results, the intervention did more to affect attitudes (adjusted odds ratio, 2.35; 95% confidence interval, 1.72-3.20) than it did to affect perceived norms (aOR, 1.75; 95% CI, 1.27-2.36) regarding supine sleeping position. It had similar effects on attitudes (aOR, 1.91; 95% CI, 1.54-2.36) versus perceived norms (aOR, 1.37; 95% CI, 1.13-1.66) regarding sleep location as well. The intervention had no significant effect on perceived maternal control regarding either sleeping position or location.

While levels of safe sleep adherence were lower in African Americans and subgroups of low economic status at baseline, the intervention improved the rates of adherence in these groups to levels comparable with other groups included in the study.

“Recognition that these attitudes and social norms may be the main drivers of mothers’ choices regarding infant-sleep practices should inform health messaging strategies, including the use of [mobile heath], to promote [safe sleep],” the researchers concluded.

The study was funded by grants from the Eunice Kennedy Shriver National Institute of Child Health and Human Development and the CJ foundation for sudden infant death syndrome. The National Institutes of Health also provided funding.

cpalmer@mdedge.com

SOURCE: Moon RY et al. Pediatrics. 2019. doi: 10.1542/peds.2018-2799.

Prescribing lower quantities of opioids after total joint arthroplasty may not increase prescription refills, patient call-ins, or adverse clinical effects, according to a study in the Journal of Arthroplasty.

©decade3d/Thinkstock

Contrary to concerns that restrictive opioid prescribing might increase the number of patient call-ins and refill requests, one academic institution had significantly fewer call-ins and refills after it implemented a strict postoperative opioid prescribing protocol on Jan. 1, 2018.

“Orthopedic surgeons might be reluctant to change practice without evidence that new, more-restrictive practice will not impede patient care,” the researchers wrote. “As the current study demonstrates, there is room to significantly decrease postoperative opioid prescriptions in total joint arthroplasty. This places patients at lower risk of opioid abuse and diversion without significantly altering the risk of postoperative complications or compromising postoperative pain control.”

Opioid overuse is a major public health concern, and orthopedic surgeons may overprescribe opioids after surgery. The University of Iowa Hospitals and Clinics in Iowa City implemented strict postoperative opioid prescription guidelines that are based on the American Academy of Orthopedic Surgeons Clinical Practice Guidelines. As part of the protocol, patients receive a preoperative education session that emphasizes risks associated with opioid use. Before initiating this protocol, postoperative drug choice and quantity had not been standardized.

To examine changes in opioid prescriptions and the number of call-ins, postoperative complications, and prescription refill requests after the implementation of the restrictive opioid prescribing protocol, investigators at the institution conducted a retrospective study.

Andrew J. Holte, a researcher in the department of orthopedics and rehabilitation, and his colleagues reviewed cases from June 2017 to February 2018. Their analysis included 399 patients who underwent total hip arthroplasty or total knee arthroplasty.

In all, 282 patients underwent surgery before the restrictive protocol (the historical cohort) and 117 after (the restrictive cohort). In the historical cohort, about 48% of the patients underwent total knee arthroplasty. In the restrictive cohort, about 44% underwent total knee arthroplasty. Patients had an average age of about 61 years, and approximately 52% were women.

According to comparisons of morphine mg equivalents (MME), the historical cohort received significantly larger mean initial opioid prescriptions (752 MME vs. 387 MME), significantly more refills per patient (0.5 vs. 0.3), and significantly more medication through refills (253 MME vs. 84 MME).

“For reference, 50 pills of 5 mg oxycodone is equivalent to 300 MMEs,” the authors noted.

A multivariable model found that younger age and total knee arthroplasty, compared with total hip arthroplasty, were associated with increased likelihood of requests for refills and patient call-ins.

“Surprisingly, there were significantly more patient call-ins and requests for refills of opioids in the historical cohort,” Mr. Holte and his colleagues said. “Although this study did not collect direct data on patient pain scores, we believe that call-ins and requests for refills are sufficient surrogate markers for inadequate pain control.”

The study does not account for prescriptions from other providers or whether patients took none, some, or all of their filled prescriptions. Future studies are needed to assess how reduced opioid prescriptions affect pain and functional outcomes in the long term, the researchers said.

One or more study authors disclosed potential conflicts of interest. The disclosures can be found in Appendix A, Supplementary Data, at the end of the journal article.

SOURCE: Holte AJ et al. J Arthroplasty. 2019 Feb 20. doi: 10.1016/j.arth.2019.02.022.

Prescribing lower quantities of opioids after total joint arthroplasty may not increase prescription refills, patient call-ins, or adverse clinical effects, according to a study in the Journal of Arthroplasty.

©decade3d/Thinkstock

Contrary to concerns that restrictive opioid prescribing might increase the number of patient call-ins and refill requests, one academic institution had significantly fewer call-ins and refills after it implemented a strict postoperative opioid prescribing protocol on Jan. 1, 2018.

“Orthopedic surgeons might be reluctant to change practice without evidence that new, more-restrictive practice will not impede patient care,” the researchers wrote. “As the current study demonstrates, there is room to significantly decrease postoperative opioid prescriptions in total joint arthroplasty. This places patients at lower risk of opioid abuse and diversion without significantly altering the risk of postoperative complications or compromising postoperative pain control.”

Opioid overuse is a major public health concern, and orthopedic surgeons may overprescribe opioids after surgery. The University of Iowa Hospitals and Clinics in Iowa City implemented strict postoperative opioid prescription guidelines that are based on the American Academy of Orthopedic Surgeons Clinical Practice Guidelines. As part of the protocol, patients receive a preoperative education session that emphasizes risks associated with opioid use. Before initiating this protocol, postoperative drug choice and quantity had not been standardized.

To examine changes in opioid prescriptions and the number of call-ins, postoperative complications, and prescription refill requests after the implementation of the restrictive opioid prescribing protocol, investigators at the institution conducted a retrospective study.

Andrew J. Holte, a researcher in the department of orthopedics and rehabilitation, and his colleagues reviewed cases from June 2017 to February 2018. Their analysis included 399 patients who underwent total hip arthroplasty or total knee arthroplasty.

In all, 282 patients underwent surgery before the restrictive protocol (the historical cohort) and 117 after (the restrictive cohort). In the historical cohort, about 48% of the patients underwent total knee arthroplasty. In the restrictive cohort, about 44% underwent total knee arthroplasty. Patients had an average age of about 61 years, and approximately 52% were women.

According to comparisons of morphine mg equivalents (MME), the historical cohort received significantly larger mean initial opioid prescriptions (752 MME vs. 387 MME), significantly more refills per patient (0.5 vs. 0.3), and significantly more medication through refills (253 MME vs. 84 MME).

“For reference, 50 pills of 5 mg oxycodone is equivalent to 300 MMEs,” the authors noted.

A multivariable model found that younger age and total knee arthroplasty, compared with total hip arthroplasty, were associated with increased likelihood of requests for refills and patient call-ins.

“Surprisingly, there were significantly more patient call-ins and requests for refills of opioids in the historical cohort,” Mr. Holte and his colleagues said. “Although this study did not collect direct data on patient pain scores, we believe that call-ins and requests for refills are sufficient surrogate markers for inadequate pain control.”

The study does not account for prescriptions from other providers or whether patients took none, some, or all of their filled prescriptions. Future studies are needed to assess how reduced opioid prescriptions affect pain and functional outcomes in the long term, the researchers said.

One or more study authors disclosed potential conflicts of interest. The disclosures can be found in Appendix A, Supplementary Data, at the end of the journal article.

SOURCE: Holte AJ et al. J Arthroplasty. 2019 Feb 20. doi: 10.1016/j.arth.2019.02.022.

Prescribing lower quantities of opioids after total joint arthroplasty may not increase prescription refills, patient call-ins, or adverse clinical effects, according to a study in the Journal of Arthroplasty.

©decade3d/Thinkstock

Contrary to concerns that restrictive opioid prescribing might increase the number of patient call-ins and refill requests, one academic institution had significantly fewer call-ins and refills after it implemented a strict postoperative opioid prescribing protocol on Jan. 1, 2018.

“Orthopedic surgeons might be reluctant to change practice without evidence that new, more-restrictive practice will not impede patient care,” the researchers wrote. “As the current study demonstrates, there is room to significantly decrease postoperative opioid prescriptions in total joint arthroplasty. This places patients at lower risk of opioid abuse and diversion without significantly altering the risk of postoperative complications or compromising postoperative pain control.”

Opioid overuse is a major public health concern, and orthopedic surgeons may overprescribe opioids after surgery. The University of Iowa Hospitals and Clinics in Iowa City implemented strict postoperative opioid prescription guidelines that are based on the American Academy of Orthopedic Surgeons Clinical Practice Guidelines. As part of the protocol, patients receive a preoperative education session that emphasizes risks associated with opioid use. Before initiating this protocol, postoperative drug choice and quantity had not been standardized.

To examine changes in opioid prescriptions and the number of call-ins, postoperative complications, and prescription refill requests after the implementation of the restrictive opioid prescribing protocol, investigators at the institution conducted a retrospective study.

Andrew J. Holte, a researcher in the department of orthopedics and rehabilitation, and his colleagues reviewed cases from June 2017 to February 2018. Their analysis included 399 patients who underwent total hip arthroplasty or total knee arthroplasty.

In all, 282 patients underwent surgery before the restrictive protocol (the historical cohort) and 117 after (the restrictive cohort). In the historical cohort, about 48% of the patients underwent total knee arthroplasty. In the restrictive cohort, about 44% underwent total knee arthroplasty. Patients had an average age of about 61 years, and approximately 52% were women.

According to comparisons of morphine mg equivalents (MME), the historical cohort received significantly larger mean initial opioid prescriptions (752 MME vs. 387 MME), significantly more refills per patient (0.5 vs. 0.3), and significantly more medication through refills (253 MME vs. 84 MME).

“For reference, 50 pills of 5 mg oxycodone is equivalent to 300 MMEs,” the authors noted.

A multivariable model found that younger age and total knee arthroplasty, compared with total hip arthroplasty, were associated with increased likelihood of requests for refills and patient call-ins.

“Surprisingly, there were significantly more patient call-ins and requests for refills of opioids in the historical cohort,” Mr. Holte and his colleagues said. “Although this study did not collect direct data on patient pain scores, we believe that call-ins and requests for refills are sufficient surrogate markers for inadequate pain control.”

The study does not account for prescriptions from other providers or whether patients took none, some, or all of their filled prescriptions. Future studies are needed to assess how reduced opioid prescriptions affect pain and functional outcomes in the long term, the researchers said.

One or more study authors disclosed potential conflicts of interest. The disclosures can be found in Appendix A, Supplementary Data, at the end of the journal article.

SOURCE: Holte AJ et al. J Arthroplasty. 2019 Feb 20. doi: 10.1016/j.arth.2019.02.022.

New consensus statements, released by a panel of 11 experts, provide 27 specific recommendations related to the use of vaccines in patients with hemophilia.

The recommendations from the Italian Haemophilia and Vaccinations (HEVA) project were authored by an 11-member committee with expertise in both hemophilia and immunization. The authors reviewed 20 relevant studies published before August 30, 2017.

“Vaccination of patients with severe congenital bleeding disorders remains a challenge, and clinicians are often uncertain about immunization recommendations for these patients,” wrote Elena Santagostino, MD, PhD, of the Centro Emofilia e Trombosi Angelo Bianchi Bonomi in Milan, Italy, and her colleagues. The report is published in Haemophilia.

The statements were also validated by separate groups of clinicians at hemophilia treatment centers across Italy.

The key issues described included vaccination schedule, route of administration, vaccination of patients with antibodies that impede coagulation factor VIII inhibitors, and risk of inhibitor formation with vaccination.

In general, committee members agreed on the majority of statements, with the exception of those related to the possible links between vaccination and inhibitor formation. There were a total of five statements on which no consensus was reached.

Vaccinations in both adults and children with hemophilia should be provided in accordance with the institutional schedule for those without bleeding disorders, according to the recommendations.

“The only difference is that vaccination of patients with haemophilia requires comprehensive planning, taking into account disease severity, type and route of vaccination, and bleeding risk,” the experts wrote.

The panel also reported that current data suggest that vaccination timing is not affected by the timing of factor VIII replacement.

The authors acknowledged that the recommendations were formed by a group of experts from Italy using a specific consensus framework. As a result, they may not be applicable to all patient populations.

The manuscript was supported by Sobi. The authors reported financial relationships with Bayer, Bioverativ, CSL Behring, Grifols, Kedrion, Novo Nordisk, Pfizer, and other companies.

SOURCE: Santagostino E et al. Haemophilia. 2019 Apr 16. doi: 10.1111/hae.13756.

New consensus statements, released by a panel of 11 experts, provide 27 specific recommendations related to the use of vaccines in patients with hemophilia.

The recommendations from the Italian Haemophilia and Vaccinations (HEVA) project were authored by an 11-member committee with expertise in both hemophilia and immunization. The authors reviewed 20 relevant studies published before August 30, 2017.

“Vaccination of patients with severe congenital bleeding disorders remains a challenge, and clinicians are often uncertain about immunization recommendations for these patients,” wrote Elena Santagostino, MD, PhD, of the Centro Emofilia e Trombosi Angelo Bianchi Bonomi in Milan, Italy, and her colleagues. The report is published in Haemophilia.

The statements were also validated by separate groups of clinicians at hemophilia treatment centers across Italy.

The key issues described included vaccination schedule, route of administration, vaccination of patients with antibodies that impede coagulation factor VIII inhibitors, and risk of inhibitor formation with vaccination.

In general, committee members agreed on the majority of statements, with the exception of those related to the possible links between vaccination and inhibitor formation. There were a total of five statements on which no consensus was reached.

Vaccinations in both adults and children with hemophilia should be provided in accordance with the institutional schedule for those without bleeding disorders, according to the recommendations.

“The only difference is that vaccination of patients with haemophilia requires comprehensive planning, taking into account disease severity, type and route of vaccination, and bleeding risk,” the experts wrote.

The panel also reported that current data suggest that vaccination timing is not affected by the timing of factor VIII replacement.

The authors acknowledged that the recommendations were formed by a group of experts from Italy using a specific consensus framework. As a result, they may not be applicable to all patient populations.

The manuscript was supported by Sobi. The authors reported financial relationships with Bayer, Bioverativ, CSL Behring, Grifols, Kedrion, Novo Nordisk, Pfizer, and other companies.

SOURCE: Santagostino E et al. Haemophilia. 2019 Apr 16. doi: 10.1111/hae.13756.

New consensus statements, released by a panel of 11 experts, provide 27 specific recommendations related to the use of vaccines in patients with hemophilia.

The recommendations from the Italian Haemophilia and Vaccinations (HEVA) project were authored by an 11-member committee with expertise in both hemophilia and immunization. The authors reviewed 20 relevant studies published before August 30, 2017.

“Vaccination of patients with severe congenital bleeding disorders remains a challenge, and clinicians are often uncertain about immunization recommendations for these patients,” wrote Elena Santagostino, MD, PhD, of the Centro Emofilia e Trombosi Angelo Bianchi Bonomi in Milan, Italy, and her colleagues. The report is published in Haemophilia.

The statements were also validated by separate groups of clinicians at hemophilia treatment centers across Italy.

The key issues described included vaccination schedule, route of administration, vaccination of patients with antibodies that impede coagulation factor VIII inhibitors, and risk of inhibitor formation with vaccination.

In general, committee members agreed on the majority of statements, with the exception of those related to the possible links between vaccination and inhibitor formation. There were a total of five statements on which no consensus was reached.

Vaccinations in both adults and children with hemophilia should be provided in accordance with the institutional schedule for those without bleeding disorders, according to the recommendations.

“The only difference is that vaccination of patients with haemophilia requires comprehensive planning, taking into account disease severity, type and route of vaccination, and bleeding risk,” the experts wrote.

The panel also reported that current data suggest that vaccination timing is not affected by the timing of factor VIII replacement.

The authors acknowledged that the recommendations were formed by a group of experts from Italy using a specific consensus framework. As a result, they may not be applicable to all patient populations.

The manuscript was supported by Sobi. The authors reported financial relationships with Bayer, Bioverativ, CSL Behring, Grifols, Kedrion, Novo Nordisk, Pfizer, and other companies.

SOURCE: Santagostino E et al. Haemophilia. 2019 Apr 16. doi: 10.1111/hae.13756.

NEW ORLEANS – A well-attended afternoon symposium on transgender medicine gave participants at the annual meeting of the Endocrine Society a solid grounding in transgender care, from prepubescence through adulthood. Here, Joshua Safer, MD, and Michael Irwig, MD, discuss highlights of the symposium, which brought together research, best practices, and clinical practice pearls.

In his presentation, Dr. Safer focused on evidence-based strategies in medical education that can increase knowledge and comfort for trainees who are caring for transgender individuals. The basics, he said, begin with presenting well-established, scientific principles supporting current standards of transgender care.

Dr. Safer, executive director of the Mount Sinai Center for Transgender Medicine and Surgery, New York, pointed out the critical role of gonadotropin-releasing hormone antagonists in delaying puberty for transgender girls. Blockade of puberty – and elevated testosterone – can forestall otherwise irreversible male secondary sex characteristics. These include laryngeal enlargement and bony changes of facial structure, for example.

Dr. Irwig, director of andrology at George Washington University, Washington, laid out the basics of transgender hormone therapy, including clinical pearls, such as avoiding ethinyl estradiol because of the heightened risk of venous thromboembolism.

Dr. Safer is a member of the editorial advisory board of Clinical Endocrinology News. He reported that he has received consulting fees from Endo Pharmaceuticals and that his spouse is an employee of Parexel. Dr. Irwig reported no relevant conflicts of interest or financial disclosures.

koakes@mdedge.com

NEW ORLEANS – A well-attended afternoon symposium on transgender medicine gave participants at the annual meeting of the Endocrine Society a solid grounding in transgender care, from prepubescence through adulthood. Here, Joshua Safer, MD, and Michael Irwig, MD, discuss highlights of the symposium, which brought together research, best practices, and clinical practice pearls.

In his presentation, Dr. Safer focused on evidence-based strategies in medical education that can increase knowledge and comfort for trainees who are caring for transgender individuals. The basics, he said, begin with presenting well-established, scientific principles supporting current standards of transgender care.

Dr. Safer, executive director of the Mount Sinai Center for Transgender Medicine and Surgery, New York, pointed out the critical role of gonadotropin-releasing hormone antagonists in delaying puberty for transgender girls. Blockade of puberty – and elevated testosterone – can forestall otherwise irreversible male secondary sex characteristics. These include laryngeal enlargement and bony changes of facial structure, for example.

Dr. Irwig, director of andrology at George Washington University, Washington, laid out the basics of transgender hormone therapy, including clinical pearls, such as avoiding ethinyl estradiol because of the heightened risk of venous thromboembolism.

Dr. Safer is a member of the editorial advisory board of Clinical Endocrinology News. He reported that he has received consulting fees from Endo Pharmaceuticals and that his spouse is an employee of Parexel. Dr. Irwig reported no relevant conflicts of interest or financial disclosures.

koakes@mdedge.com

NEW ORLEANS – A well-attended afternoon symposium on transgender medicine gave participants at the annual meeting of the Endocrine Society a solid grounding in transgender care, from prepubescence through adulthood. Here, Joshua Safer, MD, and Michael Irwig, MD, discuss highlights of the symposium, which brought together research, best practices, and clinical practice pearls.

In his presentation, Dr. Safer focused on evidence-based strategies in medical education that can increase knowledge and comfort for trainees who are caring for transgender individuals. The basics, he said, begin with presenting well-established, scientific principles supporting current standards of transgender care.

Dr. Safer, executive director of the Mount Sinai Center for Transgender Medicine and Surgery, New York, pointed out the critical role of gonadotropin-releasing hormone antagonists in delaying puberty for transgender girls. Blockade of puberty – and elevated testosterone – can forestall otherwise irreversible male secondary sex characteristics. These include laryngeal enlargement and bony changes of facial structure, for example.

Dr. Irwig, director of andrology at George Washington University, Washington, laid out the basics of transgender hormone therapy, including clinical pearls, such as avoiding ethinyl estradiol because of the heightened risk of venous thromboembolism.

Dr. Safer is a member of the editorial advisory board of Clinical Endocrinology News. He reported that he has received consulting fees from Endo Pharmaceuticals and that his spouse is an employee of Parexel. Dr. Irwig reported no relevant conflicts of interest or financial disclosures.

koakes@mdedge.com

Several hematology and oncology researchers will receive awards at the 2019 conference of the American Society of Pediatric Hematology/Oncology (ASPHO), which takes place May 1-4.

Loretta Li, MD, of Boston Children’s Hospital/Dana-Farber Cancer Institute, and Akshay Sharma, MBBS, of St. Jude Children’s Research Hospital in Memphis, will receive Young Investigator awards at the conference.

Dr. Sharma is conducting research investigating the genetic regulation of fetal hemoglobin and developing transplant and gene therapy trials for patients with sickle cell disease. Dr. Li is studying the activity of JAK2 inhibitors, as well as mechanisms of response and resistance to these drugs, in leukemias.

Elliott Vichinsky, MD, of UCSF Benioff Children’s Hospital Oakland in California, will receive ASPHO’s Distinguished Career Award. Dr. Vichinsky has helped implement newborn screening programs for blood diseases, developed techniques to make blood safer for chronically transfused patients, and conducted research that furthered the development of drugs used to treat iron overload.

Wilbur Lam, MD, PhD, of Aflac Cancer & Blood Disorders Center/Emory University in Atlanta, has won the Frank A. Oski Memorial Lectureship. He will present “Development and Clinical Translation of Engineered Microsystems for Hematologic Applications” on May 2.

Dr. Lam’s research has focused on using nanomechanical and microfluidic engineering approaches to study blood cells, endothelial cells, and thrombosis. Dr. Lam and his lab have created “microvasculature-on-a-chip” models of blood diseases and a smartphone app that can detect and monitor anemia.

Kenneth McClain, MD, PhD, of Texas Children’s Hospital/Baylor University in Houston, has won the 2019 George R. Buchanan Lectureship. Dr. McClain will present “An Oncogene-Driven Orphan Disease: A Short History of Langerhans Cell Histiocytosis” on May 2.

Dr. McClain’s research has focused on Langerhans cell histiocytosis and related disorders. He has served as a founding member and president of the Histiocyte Society, and he organizes yearly events to provide information on Langerhans cell histiocytosis to patients and their families.

Smita Bhatia, MD, of University of Alabama, Birmingham, has won the Childhood Cancer Survivorship Award for Excellence. Her research has focused on health‐related outcomes in cancer survivors and the pathogenesis of these outcomes. Dr. Bhatia has developed models that can identify high-risk cancer survivors and interventions that can reduce complications among cancer survivors.
 

Movers in Medicine highlights career moves and personal achievements by hematologists and oncologists. Did you switch jobs, take on a new role, climb a mountain? Tell us all about it at hematologynews@mdedge.com, and you could be featured in Movers in Medicine.

jensmith@mdedge.com

Several hematology and oncology researchers will receive awards at the 2019 conference of the American Society of Pediatric Hematology/Oncology (ASPHO), which takes place May 1-4.

Loretta Li, MD, of Boston Children’s Hospital/Dana-Farber Cancer Institute, and Akshay Sharma, MBBS, of St. Jude Children’s Research Hospital in Memphis, will receive Young Investigator awards at the conference.

Dr. Sharma is conducting research investigating the genetic regulation of fetal hemoglobin and developing transplant and gene therapy trials for patients with sickle cell disease. Dr. Li is studying the activity of JAK2 inhibitors, as well as mechanisms of response and resistance to these drugs, in leukemias.

Elliott Vichinsky, MD, of UCSF Benioff Children’s Hospital Oakland in California, will receive ASPHO’s Distinguished Career Award. Dr. Vichinsky has helped implement newborn screening programs for blood diseases, developed techniques to make blood safer for chronically transfused patients, and conducted research that furthered the development of drugs used to treat iron overload.

Wilbur Lam, MD, PhD, of Aflac Cancer & Blood Disorders Center/Emory University in Atlanta, has won the Frank A. Oski Memorial Lectureship. He will present “Development and Clinical Translation of Engineered Microsystems for Hematologic Applications” on May 2.

Dr. Lam’s research has focused on using nanomechanical and microfluidic engineering approaches to study blood cells, endothelial cells, and thrombosis. Dr. Lam and his lab have created “microvasculature-on-a-chip” models of blood diseases and a smartphone app that can detect and monitor anemia.

Kenneth McClain, MD, PhD, of Texas Children’s Hospital/Baylor University in Houston, has won the 2019 George R. Buchanan Lectureship. Dr. McClain will present “An Oncogene-Driven Orphan Disease: A Short History of Langerhans Cell Histiocytosis” on May 2.

Dr. McClain’s research has focused on Langerhans cell histiocytosis and related disorders. He has served as a founding member and president of the Histiocyte Society, and he organizes yearly events to provide information on Langerhans cell histiocytosis to patients and their families.

Smita Bhatia, MD, of University of Alabama, Birmingham, has won the Childhood Cancer Survivorship Award for Excellence. Her research has focused on health‐related outcomes in cancer survivors and the pathogenesis of these outcomes. Dr. Bhatia has developed models that can identify high-risk cancer survivors and interventions that can reduce complications among cancer survivors.
 

Movers in Medicine highlights career moves and personal achievements by hematologists and oncologists. Did you switch jobs, take on a new role, climb a mountain? Tell us all about it at hematologynews@mdedge.com, and you could be featured in Movers in Medicine.

jensmith@mdedge.com

Several hematology and oncology researchers will receive awards at the 2019 conference of the American Society of Pediatric Hematology/Oncology (ASPHO), which takes place May 1-4.

Loretta Li, MD, of Boston Children’s Hospital/Dana-Farber Cancer Institute, and Akshay Sharma, MBBS, of St. Jude Children’s Research Hospital in Memphis, will receive Young Investigator awards at the conference.

Dr. Sharma is conducting research investigating the genetic regulation of fetal hemoglobin and developing transplant and gene therapy trials for patients with sickle cell disease. Dr. Li is studying the activity of JAK2 inhibitors, as well as mechanisms of response and resistance to these drugs, in leukemias.

Elliott Vichinsky, MD, of UCSF Benioff Children’s Hospital Oakland in California, will receive ASPHO’s Distinguished Career Award. Dr. Vichinsky has helped implement newborn screening programs for blood diseases, developed techniques to make blood safer for chronically transfused patients, and conducted research that furthered the development of drugs used to treat iron overload.

Wilbur Lam, MD, PhD, of Aflac Cancer & Blood Disorders Center/Emory University in Atlanta, has won the Frank A. Oski Memorial Lectureship. He will present “Development and Clinical Translation of Engineered Microsystems for Hematologic Applications” on May 2.

Dr. Lam’s research has focused on using nanomechanical and microfluidic engineering approaches to study blood cells, endothelial cells, and thrombosis. Dr. Lam and his lab have created “microvasculature-on-a-chip” models of blood diseases and a smartphone app that can detect and monitor anemia.

Kenneth McClain, MD, PhD, of Texas Children’s Hospital/Baylor University in Houston, has won the 2019 George R. Buchanan Lectureship. Dr. McClain will present “An Oncogene-Driven Orphan Disease: A Short History of Langerhans Cell Histiocytosis” on May 2.

Dr. McClain’s research has focused on Langerhans cell histiocytosis and related disorders. He has served as a founding member and president of the Histiocyte Society, and he organizes yearly events to provide information on Langerhans cell histiocytosis to patients and their families.

Smita Bhatia, MD, of University of Alabama, Birmingham, has won the Childhood Cancer Survivorship Award for Excellence. Her research has focused on health‐related outcomes in cancer survivors and the pathogenesis of these outcomes. Dr. Bhatia has developed models that can identify high-risk cancer survivors and interventions that can reduce complications among cancer survivors.
 

Movers in Medicine highlights career moves and personal achievements by hematologists and oncologists. Did you switch jobs, take on a new role, climb a mountain? Tell us all about it at hematologynews@mdedge.com, and you could be featured in Movers in Medicine.

jensmith@mdedge.com

PHILADELPHIA – While many internists might think a switch to spironolactone would be warranted for a heart failure patient with inadequate response to oral furosemide (Lasix), transitioning to an alternative loop diuretic may be the preferable approach, a cardiologist said at the annual meeting of the American College of Physicians.

Andrew D. Bowser/MDedge News

“Lasix is associated with very high variability in terms of absorption, so torsemide and bumetanide should be considered in patients who have a poor response,” said Paul McKie, MD, MPH, a cardiologist and internist with Mayo Clinic, Rochester, Minn., in a session at the meeting.

When polled, only 22% of attendees at the session picked “transition to torsemide” as the best approach for restoring fluid balance with the lowest adverse potential in a 74-year-old woman with nonischemic cardiomyopathy on furosemide 80 mg twice daily who has been hospitalized for fluid overload three times in the year.

The majority of attendees (41%) said they would have added spironolactone. Dr. McKie disagreed with this approach. Instead, Dr. McKie said he would have transitioned this person to an alternative loop diuretic.

“I think spironolactone is a great medication in heart failure with reduced ejection fraction, but the doses we typically use are generally suboptimal to achieve diuresis,” he added.

The rationale for considering an alternative loop diuretic in this patient hinges on bioavailability, which is “highly variable” for oral furosemide, at 10%-100%, while by contrast, torsemide and bumetanide have a very consistent bioavailability of 80%-100%, according to Dr. McKie.

“For this reason, I think about using torsemide or bumetanide in patients who are not responding to oral Lasix,” he said.

Dr. McKie described an algorithm that he and his colleagues use in clinic to intensify outpatient therapy for patients not achieving diuresis.

The first step is to ensure adherence and ask patients whether they are following sodium and fluid restriction: “I always ask about that first,” he said. “I tell patients, ‘You can out-eat and out-drink any diuretic regimen.’ ”

The next step is to double the dose of the loop diuretic and, sometimes, triple the dose if the double dose is not effective.

“If they’re diuresing but it’s just not adequate, then I’ll move to twice-daily dosing,” he said. “A practical tip is I tell patients to take their first dose as soon as they wake up and the second dose around 1:00 PM so that they’re not urinating all night.”

If twice-daily dosing doesn’t help, then that’s the point where an alternative loop diuretic would be warranted, according to Dr. McKie’s algorithm.

“Then I add a thiazide like metolazone, but I only do that after I’ve increased the dose of the loop diuretic,” he added.

If all else fails, then outpatient IV diuretics can be considered, according to the algorithmic approach.

Dr. McKie reported no relevant disclosures.

PHILADELPHIA – While many internists might think a switch to spironolactone would be warranted for a heart failure patient with inadequate response to oral furosemide (Lasix), transitioning to an alternative loop diuretic may be the preferable approach, a cardiologist said at the annual meeting of the American College of Physicians.

Andrew D. Bowser/MDedge News

“Lasix is associated with very high variability in terms of absorption, so torsemide and bumetanide should be considered in patients who have a poor response,” said Paul McKie, MD, MPH, a cardiologist and internist with Mayo Clinic, Rochester, Minn., in a session at the meeting.

When polled, only 22% of attendees at the session picked “transition to torsemide” as the best approach for restoring fluid balance with the lowest adverse potential in a 74-year-old woman with nonischemic cardiomyopathy on furosemide 80 mg twice daily who has been hospitalized for fluid overload three times in the year.

The majority of attendees (41%) said they would have added spironolactone. Dr. McKie disagreed with this approach. Instead, Dr. McKie said he would have transitioned this person to an alternative loop diuretic.

“I think spironolactone is a great medication in heart failure with reduced ejection fraction, but the doses we typically use are generally suboptimal to achieve diuresis,” he added.

The rationale for considering an alternative loop diuretic in this patient hinges on bioavailability, which is “highly variable” for oral furosemide, at 10%-100%, while by contrast, torsemide and bumetanide have a very consistent bioavailability of 80%-100%, according to Dr. McKie.

“For this reason, I think about using torsemide or bumetanide in patients who are not responding to oral Lasix,” he said.

Dr. McKie described an algorithm that he and his colleagues use in clinic to intensify outpatient therapy for patients not achieving diuresis.

The first step is to ensure adherence and ask patients whether they are following sodium and fluid restriction: “I always ask about that first,” he said. “I tell patients, ‘You can out-eat and out-drink any diuretic regimen.’ ”

The next step is to double the dose of the loop diuretic and, sometimes, triple the dose if the double dose is not effective.

“If they’re diuresing but it’s just not adequate, then I’ll move to twice-daily dosing,” he said. “A practical tip is I tell patients to take their first dose as soon as they wake up and the second dose around 1:00 PM so that they’re not urinating all night.”

If twice-daily dosing doesn’t help, then that’s the point where an alternative loop diuretic would be warranted, according to Dr. McKie’s algorithm.

“Then I add a thiazide like metolazone, but I only do that after I’ve increased the dose of the loop diuretic,” he added.

If all else fails, then outpatient IV diuretics can be considered, according to the algorithmic approach.

Dr. McKie reported no relevant disclosures.

PHILADELPHIA – While many internists might think a switch to spironolactone would be warranted for a heart failure patient with inadequate response to oral furosemide (Lasix), transitioning to an alternative loop diuretic may be the preferable approach, a cardiologist said at the annual meeting of the American College of Physicians.

Andrew D. Bowser/MDedge News

“Lasix is associated with very high variability in terms of absorption, so torsemide and bumetanide should be considered in patients who have a poor response,” said Paul McKie, MD, MPH, a cardiologist and internist with Mayo Clinic, Rochester, Minn., in a session at the meeting.

When polled, only 22% of attendees at the session picked “transition to torsemide” as the best approach for restoring fluid balance with the lowest adverse potential in a 74-year-old woman with nonischemic cardiomyopathy on furosemide 80 mg twice daily who has been hospitalized for fluid overload three times in the year.

The majority of attendees (41%) said they would have added spironolactone. Dr. McKie disagreed with this approach. Instead, Dr. McKie said he would have transitioned this person to an alternative loop diuretic.

“I think spironolactone is a great medication in heart failure with reduced ejection fraction, but the doses we typically use are generally suboptimal to achieve diuresis,” he added.

The rationale for considering an alternative loop diuretic in this patient hinges on bioavailability, which is “highly variable” for oral furosemide, at 10%-100%, while by contrast, torsemide and bumetanide have a very consistent bioavailability of 80%-100%, according to Dr. McKie.

“For this reason, I think about using torsemide or bumetanide in patients who are not responding to oral Lasix,” he said.

Dr. McKie described an algorithm that he and his colleagues use in clinic to intensify outpatient therapy for patients not achieving diuresis.

The first step is to ensure adherence and ask patients whether they are following sodium and fluid restriction: “I always ask about that first,” he said. “I tell patients, ‘You can out-eat and out-drink any diuretic regimen.’ ”

The next step is to double the dose of the loop diuretic and, sometimes, triple the dose if the double dose is not effective.

“If they’re diuresing but it’s just not adequate, then I’ll move to twice-daily dosing,” he said. “A practical tip is I tell patients to take their first dose as soon as they wake up and the second dose around 1:00 PM so that they’re not urinating all night.”

If twice-daily dosing doesn’t help, then that’s the point where an alternative loop diuretic would be warranted, according to Dr. McKie’s algorithm.

“Then I add a thiazide like metolazone, but I only do that after I’ve increased the dose of the loop diuretic,” he added.

If all else fails, then outpatient IV diuretics can be considered, according to the algorithmic approach.

Dr. McKie reported no relevant disclosures.

Rigorous evidence is unavailable for most interventions for treating hidradenitis suppurativa (HS), so management needs to be individualized, according to the first North American guidelines from the United States and Canadian Hidradenitis Suppurativa Foundations for the management and treatment of the disorder.

Christopher Sayed, MD

Adalimumab (Humira), a tumor necrosis factor blocker, was the only therapy for which level 1A evidence is available, and this is because of its study in large-scale randomized controlled trials. (The Food and Drug Administration approved adalimumab in 2015 for treating moderate to severe HS.) Other biologic therapies such as infliximab, anakinra, and ustekinumab carry level 2B recommendations, which Dr. Sayed said will likely influence the availability of these therapies.

Similarly, Nd:YAG laser carries a level 2B recommendation, as does wide excision surgical intervention.


Many of the other treatment modalities explored in the guidelines are not well supported by the literature, according to Dr. Sayed . “The vast majority ... had category C recommendations,” he said. “Some things we tried to evaluate that, really, we can’t give any recommendation on at all because there was no evidence.” He noted that changes in lifestyle and dietary practices are issues patients with HS frequently bring up, but they carry very little evidence of benefit in the literature.

“Even things we use very commonly in HS are often supported by weak evidence because we have to rely on clinical experience. ... There’s just not funding for trials of older drugs or lifestyle interventions,” he said. Treatment mainstays such as tetracycline-class antibiotics, for example, similarly have no large-scale randomized controlled trials to support their use.

Consider comorbidity screening

Treatment is frequently complicated by patient comorbidities, including type 2 diabetes, metabolic syndrome, polycystic ovary syndrome (PCOS), and impaired sexual health, said Dr. Sayed.

“The disease leads to scarring and disfigurement, and can [have a] higher impact on quality of life than almost any other dermatologic disease if you compare them side by side using quality of life measures,” he noted. “We know these patients are more likely to have depression, there are high rates of suicide among these patients. A lot of that has to do with the fact that it’s a chronic disease where there is pain and disfigurement, and patients often grow very, very frustrated in part due to the disease.”

He advised consistent follow-up to ensure patients are not frustrated because of lack of perceived progress.
 

No one-size-fits-all approach

Dr. Sayed said individualized management is one of the most important parts of taking care of a patient with HS. For example, patients with Hurley stage 1 and Hurley stage 2 variations of the disease may present very differently, and that is the reason why the guidelines do not offer a stepwise treatment algorithm for the disease.

“[The guidelines] have many treatments that may overlap different stages of disease, where those things might need to be used together,” he said. “It takes a lot of discussion with patients about their treatment preferences and listening to whether their disease is progressing or not, whether or not it’s stable, and then trying to figure out whether things like surgery fit into the treatment strategy.”


Despite these recommendations, there may be situations where the answer is not listed in the guidelines. “The guidelines are based on evidence that’s available at the time we review the literature,” he said. “For many patients, they may fail every treatment that’s recommended within the guidelines. There will be times where you have to be creative for patients and go beyond what the guidelines can currently recommend and give patients the treatment that they need even when it seems like all options have been exhausted.”

The authors report relationships with 3M, AbbVie, Adelphi Values, Amgen, BSN, Celgene, Chemocentryx, Coloplast, Galderma, Hidramed Solutions, Hollister, the HS Foundation, Incyte, InflaRx, Integra, Janssen, KCI Inc., Lenicura, Leo, Lilly, The Microdermis Corporation, Novartis, Pfizer, UCB, Valeant, and XBiotech both inside and outside the supported work.

dermnews@mdedge.com

SOURCES: Alikhan A et al. J Am Acad Dermatol. 2019. doi: 10.1016/j.jaad.2019.02.067; Alikhan A et al. J Am Acad Dermatol. 2019. doi: 10.1016/j.jaad.2019.02.068.

Rigorous evidence is unavailable for most interventions for treating hidradenitis suppurativa (HS), so management needs to be individualized, according to the first North American guidelines from the United States and Canadian Hidradenitis Suppurativa Foundations for the management and treatment of the disorder.

Christopher Sayed, MD

Adalimumab (Humira), a tumor necrosis factor blocker, was the only therapy for which level 1A evidence is available, and this is because of its study in large-scale randomized controlled trials. (The Food and Drug Administration approved adalimumab in 2015 for treating moderate to severe HS.) Other biologic therapies such as infliximab, anakinra, and ustekinumab carry level 2B recommendations, which Dr. Sayed said will likely influence the availability of these therapies.

Similarly, Nd:YAG laser carries a level 2B recommendation, as does wide excision surgical intervention.


Many of the other treatment modalities explored in the guidelines are not well supported by the literature, according to Dr. Sayed . “The vast majority ... had category C recommendations,” he said. “Some things we tried to evaluate that, really, we can’t give any recommendation on at all because there was no evidence.” He noted that changes in lifestyle and dietary practices are issues patients with HS frequently bring up, but they carry very little evidence of benefit in the literature.

“Even things we use very commonly in HS are often supported by weak evidence because we have to rely on clinical experience. ... There’s just not funding for trials of older drugs or lifestyle interventions,” he said. Treatment mainstays such as tetracycline-class antibiotics, for example, similarly have no large-scale randomized controlled trials to support their use.

Consider comorbidity screening

Treatment is frequently complicated by patient comorbidities, including type 2 diabetes, metabolic syndrome, polycystic ovary syndrome (PCOS), and impaired sexual health, said Dr. Sayed.

“The disease leads to scarring and disfigurement, and can [have a] higher impact on quality of life than almost any other dermatologic disease if you compare them side by side using quality of life measures,” he noted. “We know these patients are more likely to have depression, there are high rates of suicide among these patients. A lot of that has to do with the fact that it’s a chronic disease where there is pain and disfigurement, and patients often grow very, very frustrated in part due to the disease.”

He advised consistent follow-up to ensure patients are not frustrated because of lack of perceived progress.
 

No one-size-fits-all approach

Dr. Sayed said individualized management is one of the most important parts of taking care of a patient with HS. For example, patients with Hurley stage 1 and Hurley stage 2 variations of the disease may present very differently, and that is the reason why the guidelines do not offer a stepwise treatment algorithm for the disease.

“[The guidelines] have many treatments that may overlap different stages of disease, where those things might need to be used together,” he said. “It takes a lot of discussion with patients about their treatment preferences and listening to whether their disease is progressing or not, whether or not it’s stable, and then trying to figure out whether things like surgery fit into the treatment strategy.”


Despite these recommendations, there may be situations where the answer is not listed in the guidelines. “The guidelines are based on evidence that’s available at the time we review the literature,” he said. “For many patients, they may fail every treatment that’s recommended within the guidelines. There will be times where you have to be creative for patients and go beyond what the guidelines can currently recommend and give patients the treatment that they need even when it seems like all options have been exhausted.”

The authors report relationships with 3M, AbbVie, Adelphi Values, Amgen, BSN, Celgene, Chemocentryx, Coloplast, Galderma, Hidramed Solutions, Hollister, the HS Foundation, Incyte, InflaRx, Integra, Janssen, KCI Inc., Lenicura, Leo, Lilly, The Microdermis Corporation, Novartis, Pfizer, UCB, Valeant, and XBiotech both inside and outside the supported work.

dermnews@mdedge.com

SOURCES: Alikhan A et al. J Am Acad Dermatol. 2019. doi: 10.1016/j.jaad.2019.02.067; Alikhan A et al. J Am Acad Dermatol. 2019. doi: 10.1016/j.jaad.2019.02.068.

Rigorous evidence is unavailable for most interventions for treating hidradenitis suppurativa (HS), so management needs to be individualized, according to the first North American guidelines from the United States and Canadian Hidradenitis Suppurativa Foundations for the management and treatment of the disorder.

Christopher Sayed, MD

Adalimumab (Humira), a tumor necrosis factor blocker, was the only therapy for which level 1A evidence is available, and this is because of its study in large-scale randomized controlled trials. (The Food and Drug Administration approved adalimumab in 2015 for treating moderate to severe HS.) Other biologic therapies such as infliximab, anakinra, and ustekinumab carry level 2B recommendations, which Dr. Sayed said will likely influence the availability of these therapies.

Similarly, Nd:YAG laser carries a level 2B recommendation, as does wide excision surgical intervention.


Many of the other treatment modalities explored in the guidelines are not well supported by the literature, according to Dr. Sayed . “The vast majority ... had category C recommendations,” he said. “Some things we tried to evaluate that, really, we can’t give any recommendation on at all because there was no evidence.” He noted that changes in lifestyle and dietary practices are issues patients with HS frequently bring up, but they carry very little evidence of benefit in the literature.

“Even things we use very commonly in HS are often supported by weak evidence because we have to rely on clinical experience. ... There’s just not funding for trials of older drugs or lifestyle interventions,” he said. Treatment mainstays such as tetracycline-class antibiotics, for example, similarly have no large-scale randomized controlled trials to support their use.

Consider comorbidity screening

Treatment is frequently complicated by patient comorbidities, including type 2 diabetes, metabolic syndrome, polycystic ovary syndrome (PCOS), and impaired sexual health, said Dr. Sayed.

“The disease leads to scarring and disfigurement, and can [have a] higher impact on quality of life than almost any other dermatologic disease if you compare them side by side using quality of life measures,” he noted. “We know these patients are more likely to have depression, there are high rates of suicide among these patients. A lot of that has to do with the fact that it’s a chronic disease where there is pain and disfigurement, and patients often grow very, very frustrated in part due to the disease.”

He advised consistent follow-up to ensure patients are not frustrated because of lack of perceived progress.
 

No one-size-fits-all approach

Dr. Sayed said individualized management is one of the most important parts of taking care of a patient with HS. For example, patients with Hurley stage 1 and Hurley stage 2 variations of the disease may present very differently, and that is the reason why the guidelines do not offer a stepwise treatment algorithm for the disease.

“[The guidelines] have many treatments that may overlap different stages of disease, where those things might need to be used together,” he said. “It takes a lot of discussion with patients about their treatment preferences and listening to whether their disease is progressing or not, whether or not it’s stable, and then trying to figure out whether things like surgery fit into the treatment strategy.”


Despite these recommendations, there may be situations where the answer is not listed in the guidelines. “The guidelines are based on evidence that’s available at the time we review the literature,” he said. “For many patients, they may fail every treatment that’s recommended within the guidelines. There will be times where you have to be creative for patients and go beyond what the guidelines can currently recommend and give patients the treatment that they need even when it seems like all options have been exhausted.”

The authors report relationships with 3M, AbbVie, Adelphi Values, Amgen, BSN, Celgene, Chemocentryx, Coloplast, Galderma, Hidramed Solutions, Hollister, the HS Foundation, Incyte, InflaRx, Integra, Janssen, KCI Inc., Lenicura, Leo, Lilly, The Microdermis Corporation, Novartis, Pfizer, UCB, Valeant, and XBiotech both inside and outside the supported work.

dermnews@mdedge.com

SOURCES: Alikhan A et al. J Am Acad Dermatol. 2019. doi: 10.1016/j.jaad.2019.02.067; Alikhan A et al. J Am Acad Dermatol. 2019. doi: 10.1016/j.jaad.2019.02.068.