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New hypertension performance measures boost 130/80 mm Hg target
PHILADELPHIA – The American Heart Association and American College of Cardiology took a big step toward facilitating widespread U.S. application of the hypertension management guideline that the societies issued in 2017 by releasing a set of performance and quality measures for adults with high blood pressure based on the 2017 guideline.
This guideline notably set a treatment target for patients diagnosed with hypertension of less than 130/80 mg/dL, and also lowered the threshold for diagnosing stage 1 hypertension to a blood pressure at or above 130/80 mm Hg, adding in a stroke about 31 million adults with hypertension to the U.S. total.
Having performance and quality measures based on the guideline is “critical, because how else would you know whether you’re having an effect on accurately diagnosing and properly controlling hypertension?” said Donald E. Casey Jr., MD, chair of the performance measures writing committee. The next step is field testing of the measures “to show they are reliable and effective,” as well as other steps to encourage widespread U.S. uptake of the performance and quality measures and the specifics of the 2017 guideline, Dr. Casey said during a presentation of the revised measures at the American Heart Association scientific sessions.
He especially highlighted the important role of Target: BP, an education, recognition, and quality improvement program run by the AHA and American Medical Association, as a tool that medical practices, health systems, and even payers and employers can use to begin to apply the new performance and quality measures (J Am Coll Cardiol. 2019 Nov 26;74[21]:2661-706) and better align with the recommendations of the 2017 high blood pressure guideline (J Am Coll Cardiol. 2018 May;71[19]:e127-248).
“We’re trying now to promote Target: BP; it’s something you can take off the shelf and get going if it’s embedded in a real-life delivery model. I think Target: BP is the secret sauce. It will be the way we’ll convince people to adopt this,” said Dr. Casey, principal and founder of IPO 4 Health, a Chicago-based health care consulting firm.
He also advised practices and health systems not to feel compelled to introduce all of the specific performance and quality measures at once. “We don’t believe everyone has the resources to do all of it at once; the point is to move toward this system of care. We understand that people don’t have the resources to get it all done” immediately, Dr. Casey said in an interview.
A report during another session at the meeting documented the potential impact that Target: BP can have on blood pressure control within a health system. The Trinity Health of New England medical group based in Springfield, Mass., a system with about 140,000 patients – including 20,000 adults diagnosed with hypertension – and served by 230 health care providers in 13 offices in western Massachusetts, began using Target: BP’s MAP improvement program in its practices in November 2018. (MAP stands for measure accurately, act rapidly, and partner with patients.) Just before the MAP program began, 72% of patients diagnosed with hypertension in the medical group were at their goal blood pressure. Less than a year later, in September 2019, the hypertension control rate had jumped to 84%, a 12 percentage point improvement in control in practices that already had been doing a relatively good job, said Daniel W. Weiswasser, MD, director of quality and clinical informatics at Trinity Health of New England. Based on this success, Trinity Health plans to next involve the remaining regions of Trinity Health of New England in Target: BP, followed by the other regions of Trinity’s national organization, which operates in 21 states with nearly 4,000 staff physicians and about half a million patients diagnosed with hypertension, Dr. Weiswasser said.
“If clinicians do the three steps of the MAP then we will see substantial drops in blood pressures. It will occur,” declared Brent M. Egan, MD, vice president for cardiovascular disease prevention of the AMA in Greenville, S.C.
The new report includes six performance measures based on the strongest guideline recommendations and designed to document adherence levels for the purposes of public reporting and pay-for-performance programs. It also includes 16 quality measures designed for local quality review purposes, with 6 process quality measures and 10 structural quality measures. The report spells out that the authors designed the performance measures for use by major national organizations such as the Centers for Medicare & Medicaid Services and the National Committee for Quality Assurance (NCQA), while the quality measures are designed to support quality improvement efforts in any care-delivery setting.
The authors said that the writing committee is sensitive to the fact that the 2019 performance measures for controlling high blood pressure developed by the NCQA for the Healthcare Effectiveness Data and Information Set and currently in use in 2019 by CMS also does not incorporate the 2017 Hypertension Clinical Practice Guidelines classification scheme. “It is well understood that these measures are already in widespread use, especially for quality-related payment programs promulgated by CMS, such as the Medicare Advantage ‘Stars’ ratings, the Medicare Shared Savings Program, and the Physician Quality Payment Program, as well as many other programs promoted by commercial health insurers. In particular, the widespread use of the 2017 Hypertension Clinical Practice Guidelines classification scheme will also help to guide decision making about when to prescribe antihypertensive medications in accordance with its current recommendations for the ACC/AHA “stages” of stage 1 and stage 2 hypertension and elevated blood pressure,” they added.
The report also says that “the writing committee was sensitive to the fact that there is currently not complete consensus among other guidelines from the American College of Physicians and the American Academy of Family Physicians, and also the European Society of Cardiology and the European Society of Hypertension. Nonetheless, despite this ongoing debate, the writing committee felt strongly that it is now time to move the U.S. health care system ahead to reflect these differing points of view and expects that widespread use of this new measure set will help to achieve this goal.” The new report revises hypertension performance measures developed by the ACC and AHA in 2011 (J Am Coll Cardiol. 2011 Jul 12;58[3]: 316-36).
In short, the performance and quality measures give all the diverse components of the U.S. health care delivery system a road map for implementing the 2017 High Blood Pressure Guideline in a format that depends on those components electing to adopt and adhere to the 2017 guideline. (Although one of the new performance measures, 1a, harmonizes with an existing and widely applied performance measure.)
“Who is the audience for this, and how will they respond? These performance measures need to be appropriated” by health systems and by performance-assessment groups. “I hope the NCQA will adopt it,” said William C. Cushman, MD, professor of preventive medicine at the University of Tennessee Health Science Center in Memphis, and chief of preventive medicine at the Memphis Veterans Affairs Medical Center. “There are some negatives to performance measures, but on balance they have done good things and led to better care.” Dr. Cushman also approved of several specific performance and quality measures included in the report. “Most of what they emphasized is good,” particularly the importance of accurate pressure measurement, he said in an interview.
“Process drives outcomes” in hypertension management, and the new performance and quality measures “have some very good process metrics,” commented Dr. Egan. “I’d encourage health systems to select two or three measures that are key to what they do and make sense in their setting rather than try to implement it all at once,” he advised, echoing what Dr. Casey had suggested. “It’s ideal to do everything, but we know that if you give physicians a long list of performance measures they just get overwhelmed. The nice thing about hypertension is that we know that process drives outcomes. In the past, we’ve had some process metrics that did not drive outcomes. Getting these processes implemented will lead to better patient outcomes and save a ton of money.”
“We have introduced the 2017 guideline recommendations throughout Target: BP, but like any quality improvement program there is a question of how does it spread,” said Gregory Wozniak, PhD, director of outcomes analytics for the AMA in Chicago. “Our goal for Target: BP is to be impacting 20 million patients by 2021.”
Dr. Casey, Dr. Weiswasser, and Dr. Wozniak had no disclosures. Dr. Cushman has received honoraria as a speaker from Arbor and Sanofi-Aventis, and travel and research support from Eli Lilly. Dr. Egan has been a consultant to and speaker on behalf of Merck and a speaker for Emcure.
SOURCE: Casey DE et al. J Am Coll Cardiol. 2019 Nov 26;74[21]: 2661-706.
PHILADELPHIA – The American Heart Association and American College of Cardiology took a big step toward facilitating widespread U.S. application of the hypertension management guideline that the societies issued in 2017 by releasing a set of performance and quality measures for adults with high blood pressure based on the 2017 guideline.
This guideline notably set a treatment target for patients diagnosed with hypertension of less than 130/80 mg/dL, and also lowered the threshold for diagnosing stage 1 hypertension to a blood pressure at or above 130/80 mm Hg, adding in a stroke about 31 million adults with hypertension to the U.S. total.
Having performance and quality measures based on the guideline is “critical, because how else would you know whether you’re having an effect on accurately diagnosing and properly controlling hypertension?” said Donald E. Casey Jr., MD, chair of the performance measures writing committee. The next step is field testing of the measures “to show they are reliable and effective,” as well as other steps to encourage widespread U.S. uptake of the performance and quality measures and the specifics of the 2017 guideline, Dr. Casey said during a presentation of the revised measures at the American Heart Association scientific sessions.
He especially highlighted the important role of Target: BP, an education, recognition, and quality improvement program run by the AHA and American Medical Association, as a tool that medical practices, health systems, and even payers and employers can use to begin to apply the new performance and quality measures (J Am Coll Cardiol. 2019 Nov 26;74[21]:2661-706) and better align with the recommendations of the 2017 high blood pressure guideline (J Am Coll Cardiol. 2018 May;71[19]:e127-248).
“We’re trying now to promote Target: BP; it’s something you can take off the shelf and get going if it’s embedded in a real-life delivery model. I think Target: BP is the secret sauce. It will be the way we’ll convince people to adopt this,” said Dr. Casey, principal and founder of IPO 4 Health, a Chicago-based health care consulting firm.
He also advised practices and health systems not to feel compelled to introduce all of the specific performance and quality measures at once. “We don’t believe everyone has the resources to do all of it at once; the point is to move toward this system of care. We understand that people don’t have the resources to get it all done” immediately, Dr. Casey said in an interview.
A report during another session at the meeting documented the potential impact that Target: BP can have on blood pressure control within a health system. The Trinity Health of New England medical group based in Springfield, Mass., a system with about 140,000 patients – including 20,000 adults diagnosed with hypertension – and served by 230 health care providers in 13 offices in western Massachusetts, began using Target: BP’s MAP improvement program in its practices in November 2018. (MAP stands for measure accurately, act rapidly, and partner with patients.) Just before the MAP program began, 72% of patients diagnosed with hypertension in the medical group were at their goal blood pressure. Less than a year later, in September 2019, the hypertension control rate had jumped to 84%, a 12 percentage point improvement in control in practices that already had been doing a relatively good job, said Daniel W. Weiswasser, MD, director of quality and clinical informatics at Trinity Health of New England. Based on this success, Trinity Health plans to next involve the remaining regions of Trinity Health of New England in Target: BP, followed by the other regions of Trinity’s national organization, which operates in 21 states with nearly 4,000 staff physicians and about half a million patients diagnosed with hypertension, Dr. Weiswasser said.
“If clinicians do the three steps of the MAP then we will see substantial drops in blood pressures. It will occur,” declared Brent M. Egan, MD, vice president for cardiovascular disease prevention of the AMA in Greenville, S.C.
The new report includes six performance measures based on the strongest guideline recommendations and designed to document adherence levels for the purposes of public reporting and pay-for-performance programs. It also includes 16 quality measures designed for local quality review purposes, with 6 process quality measures and 10 structural quality measures. The report spells out that the authors designed the performance measures for use by major national organizations such as the Centers for Medicare & Medicaid Services and the National Committee for Quality Assurance (NCQA), while the quality measures are designed to support quality improvement efforts in any care-delivery setting.
The authors said that the writing committee is sensitive to the fact that the 2019 performance measures for controlling high blood pressure developed by the NCQA for the Healthcare Effectiveness Data and Information Set and currently in use in 2019 by CMS also does not incorporate the 2017 Hypertension Clinical Practice Guidelines classification scheme. “It is well understood that these measures are already in widespread use, especially for quality-related payment programs promulgated by CMS, such as the Medicare Advantage ‘Stars’ ratings, the Medicare Shared Savings Program, and the Physician Quality Payment Program, as well as many other programs promoted by commercial health insurers. In particular, the widespread use of the 2017 Hypertension Clinical Practice Guidelines classification scheme will also help to guide decision making about when to prescribe antihypertensive medications in accordance with its current recommendations for the ACC/AHA “stages” of stage 1 and stage 2 hypertension and elevated blood pressure,” they added.
The report also says that “the writing committee was sensitive to the fact that there is currently not complete consensus among other guidelines from the American College of Physicians and the American Academy of Family Physicians, and also the European Society of Cardiology and the European Society of Hypertension. Nonetheless, despite this ongoing debate, the writing committee felt strongly that it is now time to move the U.S. health care system ahead to reflect these differing points of view and expects that widespread use of this new measure set will help to achieve this goal.” The new report revises hypertension performance measures developed by the ACC and AHA in 2011 (J Am Coll Cardiol. 2011 Jul 12;58[3]: 316-36).
In short, the performance and quality measures give all the diverse components of the U.S. health care delivery system a road map for implementing the 2017 High Blood Pressure Guideline in a format that depends on those components electing to adopt and adhere to the 2017 guideline. (Although one of the new performance measures, 1a, harmonizes with an existing and widely applied performance measure.)
“Who is the audience for this, and how will they respond? These performance measures need to be appropriated” by health systems and by performance-assessment groups. “I hope the NCQA will adopt it,” said William C. Cushman, MD, professor of preventive medicine at the University of Tennessee Health Science Center in Memphis, and chief of preventive medicine at the Memphis Veterans Affairs Medical Center. “There are some negatives to performance measures, but on balance they have done good things and led to better care.” Dr. Cushman also approved of several specific performance and quality measures included in the report. “Most of what they emphasized is good,” particularly the importance of accurate pressure measurement, he said in an interview.
“Process drives outcomes” in hypertension management, and the new performance and quality measures “have some very good process metrics,” commented Dr. Egan. “I’d encourage health systems to select two or three measures that are key to what they do and make sense in their setting rather than try to implement it all at once,” he advised, echoing what Dr. Casey had suggested. “It’s ideal to do everything, but we know that if you give physicians a long list of performance measures they just get overwhelmed. The nice thing about hypertension is that we know that process drives outcomes. In the past, we’ve had some process metrics that did not drive outcomes. Getting these processes implemented will lead to better patient outcomes and save a ton of money.”
“We have introduced the 2017 guideline recommendations throughout Target: BP, but like any quality improvement program there is a question of how does it spread,” said Gregory Wozniak, PhD, director of outcomes analytics for the AMA in Chicago. “Our goal for Target: BP is to be impacting 20 million patients by 2021.”
Dr. Casey, Dr. Weiswasser, and Dr. Wozniak had no disclosures. Dr. Cushman has received honoraria as a speaker from Arbor and Sanofi-Aventis, and travel and research support from Eli Lilly. Dr. Egan has been a consultant to and speaker on behalf of Merck and a speaker for Emcure.
SOURCE: Casey DE et al. J Am Coll Cardiol. 2019 Nov 26;74[21]: 2661-706.
PHILADELPHIA – The American Heart Association and American College of Cardiology took a big step toward facilitating widespread U.S. application of the hypertension management guideline that the societies issued in 2017 by releasing a set of performance and quality measures for adults with high blood pressure based on the 2017 guideline.
This guideline notably set a treatment target for patients diagnosed with hypertension of less than 130/80 mg/dL, and also lowered the threshold for diagnosing stage 1 hypertension to a blood pressure at or above 130/80 mm Hg, adding in a stroke about 31 million adults with hypertension to the U.S. total.
Having performance and quality measures based on the guideline is “critical, because how else would you know whether you’re having an effect on accurately diagnosing and properly controlling hypertension?” said Donald E. Casey Jr., MD, chair of the performance measures writing committee. The next step is field testing of the measures “to show they are reliable and effective,” as well as other steps to encourage widespread U.S. uptake of the performance and quality measures and the specifics of the 2017 guideline, Dr. Casey said during a presentation of the revised measures at the American Heart Association scientific sessions.
He especially highlighted the important role of Target: BP, an education, recognition, and quality improvement program run by the AHA and American Medical Association, as a tool that medical practices, health systems, and even payers and employers can use to begin to apply the new performance and quality measures (J Am Coll Cardiol. 2019 Nov 26;74[21]:2661-706) and better align with the recommendations of the 2017 high blood pressure guideline (J Am Coll Cardiol. 2018 May;71[19]:e127-248).
“We’re trying now to promote Target: BP; it’s something you can take off the shelf and get going if it’s embedded in a real-life delivery model. I think Target: BP is the secret sauce. It will be the way we’ll convince people to adopt this,” said Dr. Casey, principal and founder of IPO 4 Health, a Chicago-based health care consulting firm.
He also advised practices and health systems not to feel compelled to introduce all of the specific performance and quality measures at once. “We don’t believe everyone has the resources to do all of it at once; the point is to move toward this system of care. We understand that people don’t have the resources to get it all done” immediately, Dr. Casey said in an interview.
A report during another session at the meeting documented the potential impact that Target: BP can have on blood pressure control within a health system. The Trinity Health of New England medical group based in Springfield, Mass., a system with about 140,000 patients – including 20,000 adults diagnosed with hypertension – and served by 230 health care providers in 13 offices in western Massachusetts, began using Target: BP’s MAP improvement program in its practices in November 2018. (MAP stands for measure accurately, act rapidly, and partner with patients.) Just before the MAP program began, 72% of patients diagnosed with hypertension in the medical group were at their goal blood pressure. Less than a year later, in September 2019, the hypertension control rate had jumped to 84%, a 12 percentage point improvement in control in practices that already had been doing a relatively good job, said Daniel W. Weiswasser, MD, director of quality and clinical informatics at Trinity Health of New England. Based on this success, Trinity Health plans to next involve the remaining regions of Trinity Health of New England in Target: BP, followed by the other regions of Trinity’s national organization, which operates in 21 states with nearly 4,000 staff physicians and about half a million patients diagnosed with hypertension, Dr. Weiswasser said.
“If clinicians do the three steps of the MAP then we will see substantial drops in blood pressures. It will occur,” declared Brent M. Egan, MD, vice president for cardiovascular disease prevention of the AMA in Greenville, S.C.
The new report includes six performance measures based on the strongest guideline recommendations and designed to document adherence levels for the purposes of public reporting and pay-for-performance programs. It also includes 16 quality measures designed for local quality review purposes, with 6 process quality measures and 10 structural quality measures. The report spells out that the authors designed the performance measures for use by major national organizations such as the Centers for Medicare & Medicaid Services and the National Committee for Quality Assurance (NCQA), while the quality measures are designed to support quality improvement efforts in any care-delivery setting.
The authors said that the writing committee is sensitive to the fact that the 2019 performance measures for controlling high blood pressure developed by the NCQA for the Healthcare Effectiveness Data and Information Set and currently in use in 2019 by CMS also does not incorporate the 2017 Hypertension Clinical Practice Guidelines classification scheme. “It is well understood that these measures are already in widespread use, especially for quality-related payment programs promulgated by CMS, such as the Medicare Advantage ‘Stars’ ratings, the Medicare Shared Savings Program, and the Physician Quality Payment Program, as well as many other programs promoted by commercial health insurers. In particular, the widespread use of the 2017 Hypertension Clinical Practice Guidelines classification scheme will also help to guide decision making about when to prescribe antihypertensive medications in accordance with its current recommendations for the ACC/AHA “stages” of stage 1 and stage 2 hypertension and elevated blood pressure,” they added.
The report also says that “the writing committee was sensitive to the fact that there is currently not complete consensus among other guidelines from the American College of Physicians and the American Academy of Family Physicians, and also the European Society of Cardiology and the European Society of Hypertension. Nonetheless, despite this ongoing debate, the writing committee felt strongly that it is now time to move the U.S. health care system ahead to reflect these differing points of view and expects that widespread use of this new measure set will help to achieve this goal.” The new report revises hypertension performance measures developed by the ACC and AHA in 2011 (J Am Coll Cardiol. 2011 Jul 12;58[3]: 316-36).
In short, the performance and quality measures give all the diverse components of the U.S. health care delivery system a road map for implementing the 2017 High Blood Pressure Guideline in a format that depends on those components electing to adopt and adhere to the 2017 guideline. (Although one of the new performance measures, 1a, harmonizes with an existing and widely applied performance measure.)
“Who is the audience for this, and how will they respond? These performance measures need to be appropriated” by health systems and by performance-assessment groups. “I hope the NCQA will adopt it,” said William C. Cushman, MD, professor of preventive medicine at the University of Tennessee Health Science Center in Memphis, and chief of preventive medicine at the Memphis Veterans Affairs Medical Center. “There are some negatives to performance measures, but on balance they have done good things and led to better care.” Dr. Cushman also approved of several specific performance and quality measures included in the report. “Most of what they emphasized is good,” particularly the importance of accurate pressure measurement, he said in an interview.
“Process drives outcomes” in hypertension management, and the new performance and quality measures “have some very good process metrics,” commented Dr. Egan. “I’d encourage health systems to select two or three measures that are key to what they do and make sense in their setting rather than try to implement it all at once,” he advised, echoing what Dr. Casey had suggested. “It’s ideal to do everything, but we know that if you give physicians a long list of performance measures they just get overwhelmed. The nice thing about hypertension is that we know that process drives outcomes. In the past, we’ve had some process metrics that did not drive outcomes. Getting these processes implemented will lead to better patient outcomes and save a ton of money.”
“We have introduced the 2017 guideline recommendations throughout Target: BP, but like any quality improvement program there is a question of how does it spread,” said Gregory Wozniak, PhD, director of outcomes analytics for the AMA in Chicago. “Our goal for Target: BP is to be impacting 20 million patients by 2021.”
Dr. Casey, Dr. Weiswasser, and Dr. Wozniak had no disclosures. Dr. Cushman has received honoraria as a speaker from Arbor and Sanofi-Aventis, and travel and research support from Eli Lilly. Dr. Egan has been a consultant to and speaker on behalf of Merck and a speaker for Emcure.
SOURCE: Casey DE et al. J Am Coll Cardiol. 2019 Nov 26;74[21]: 2661-706.
REPORTING FROM AHA 2019
Dupilumab-induced head and neck erythema described in atopic dermatitis patients
MADRID – A growing recognition that from their background skin disease emerged as a hot topic of discussion at a meeting of the European Task Force on Atopic Dermatitis held in conjunction with the annual congress of the European Academy of Dermatology and Venereology.
“During treatment with dupilumab, we saw something that is really different from the classic eczema that patients experienced prior to dupilumab, with no or minimal scaling, itch, or burning sensation. We do not believe this is a delayed effect of dupilumab on that specific region. We think this is a dupilumab-induced entity that we’re looking at. You should take home, in my opinion, that this is a common side effect that’s underreported in daily practice at this moment, and it’s not reported in clinical trials at all,” said Linde de Wijs, MD, of the department of dermatology, Erasmus University Medical Center in Rotterdam, the Netherlands.
She presented a detailed case series of seven affected patients which included histologic examination of lesional skin biopsies. The biopsies were characterized by a perivascular lymphohistiocytic infiltrate, an increase in ectatic capillaries in the papillary dermis, and a notable dearth of spongiosis, eosinophils, and neutrophils. Four patients had bulbous elongated rete ridges evocative of a psoriasiform dermatitis. The overall histologic picture was suggestive of a drug-induced skin reaction.
A striking finding was that, even though AD patients typically place high importance on achieving total clearing of disease on the head and neck, these seven closely studied patients nonetheless rated their treatment satisfaction as 9 out of a possible 10 points. Dr. de Wijs interpreted this as testimony to dupilumab’s potent efficacy and comparatively acceptable safety profile, especially the apparent side effect’s absence of scaling and itch.
“Remember, these are patients with really severe atopic dermatitis who’ve been treated with a lot of immunosuppressants prior to dupilumab,” she said.
Once the investigators began to suspect the existence of a novel dupilumab-induced skin reaction, they conducted a retrospective chart review of more than 150 patients treated with dupilumab (Dupixent) and determined that roughly 30% had developed this distinctive sharply demarcated patchy erythema on the head and neck characterized by absence of itch. The sequence involved clearance of the AD in response to dupilumab, followed by gradual development of the head and neck erythema 10-39 weeks after the start of treatment.
The erythema proved treatment refractory. Dr. de Wijs and her colleagues tried topical corticosteroids, including potent ones, as well as topical tacrolimus, antifungals, antibiotics, emollients, oral steroids, and antihistamines, to no avail. Patch testing to investigate allergic contact dermatitis as a possible etiology was unremarkable.
She hypothesized that, since dupilumab blocks the key signaling pathways for Th2 T-cell differentiation by targeting the interleukin-4 receptor alpha, it’s possible that the biologic promotes a shift towards activation of the Th17 pathway, which might explain the observed histologic findings.
The fact that this erythema wasn’t reported in the major randomized clinical trials of dupilumab underscores the enormous value of clinical practice registries, she said.
“We are not the only ones observing this phenomenon,” noted Dr. de Wijs, citing recently published reports by other investigators (J Am Acad Dermatol. 2020 Jan;82[1]:230-2; JAMA Dermatol. 2019 Jul 1;155[7]:850-2).
Indeed, her talk was immediately followed by a presentation by Sebastien Barbarot, MD, PhD, who reported on a French national retrospective study of head and neck dermatitis arising in patients on dupilumab that was conducted by the French Atopic Dermatitis Network using the organization’s GREAT database. Among 1,000 adult patients with AD treated with the biologic at 29 French centers, 10 developed a de novo head and neck dermatitis, and 32 others experienced more than 50% worsening of eczema signs on the head and neck from baseline beginning about 2 months after starting on dupilumab.
This 4.2% incidence is probably an underestimate, since dermatologists weren’t aware of the phenomenon and didn’t specifically ask patients about it, observed Dr. Barbarot, a dermatologist at the University of Nantes (France).
Among the key findings: No differences in clinical characteristics were found between the de novo and exacerbation groups, nearly half of affected patients had concomitant conjunctivitis, and seven patients discontinued dupilumab because of an intolerable burning sensation on the head/neck.
“I think this condition is quite different from rosacea,” Dr. Barbarot emphasized.
French dermatologists generally turned to topical corticosteroids or topical tacrolimus to treat the face and neck dermatitis, with mixed results; 22 of the 42 patients showed improvement and 8 worsened.
Marjolein de Bruin-Weller, MD, PhD, a dermatologist at Utrecht (the Netherlands) University and head of the Dutch National Eczema Expertise Center, said she and her colleagues have also encountered this dupilumab-related head and neck erythema and are convinced that a subset of affected patients have Malassezia-induced dermatitis with neutrophils present on lesional biopsies. “It responds very well to treatment. I think it’s very important to try itraconazole because sometimes it works,” she said.
Dr. de Wijs replied that she and her coworkers tried 2 weeks of itraconazole in several patients, with no effect. And none of their seven biopsied patients had an increase in neutrophils.
“It might be a very heterogenous polyform entity that we’re now observing,” she commented. Dr. de Bruin-Weller concurred.
Dr. Barbarot said he’d be interested in a formal study of antifungal therapy in patients with dupilumab-related head and neck dermatitis. Mechanistically, it seems plausible that dupilumab-induced activation of the TH17 pathway might lead to proliferation of Malassezia fungus.
Dr. de Wijs and Dr. Barbarot reported having no financial conflicts regarding their respective studies, which were conducted free of commercial sponsorship.
MADRID – A growing recognition that from their background skin disease emerged as a hot topic of discussion at a meeting of the European Task Force on Atopic Dermatitis held in conjunction with the annual congress of the European Academy of Dermatology and Venereology.
“During treatment with dupilumab, we saw something that is really different from the classic eczema that patients experienced prior to dupilumab, with no or minimal scaling, itch, or burning sensation. We do not believe this is a delayed effect of dupilumab on that specific region. We think this is a dupilumab-induced entity that we’re looking at. You should take home, in my opinion, that this is a common side effect that’s underreported in daily practice at this moment, and it’s not reported in clinical trials at all,” said Linde de Wijs, MD, of the department of dermatology, Erasmus University Medical Center in Rotterdam, the Netherlands.
She presented a detailed case series of seven affected patients which included histologic examination of lesional skin biopsies. The biopsies were characterized by a perivascular lymphohistiocytic infiltrate, an increase in ectatic capillaries in the papillary dermis, and a notable dearth of spongiosis, eosinophils, and neutrophils. Four patients had bulbous elongated rete ridges evocative of a psoriasiform dermatitis. The overall histologic picture was suggestive of a drug-induced skin reaction.
A striking finding was that, even though AD patients typically place high importance on achieving total clearing of disease on the head and neck, these seven closely studied patients nonetheless rated their treatment satisfaction as 9 out of a possible 10 points. Dr. de Wijs interpreted this as testimony to dupilumab’s potent efficacy and comparatively acceptable safety profile, especially the apparent side effect’s absence of scaling and itch.
“Remember, these are patients with really severe atopic dermatitis who’ve been treated with a lot of immunosuppressants prior to dupilumab,” she said.
Once the investigators began to suspect the existence of a novel dupilumab-induced skin reaction, they conducted a retrospective chart review of more than 150 patients treated with dupilumab (Dupixent) and determined that roughly 30% had developed this distinctive sharply demarcated patchy erythema on the head and neck characterized by absence of itch. The sequence involved clearance of the AD in response to dupilumab, followed by gradual development of the head and neck erythema 10-39 weeks after the start of treatment.
The erythema proved treatment refractory. Dr. de Wijs and her colleagues tried topical corticosteroids, including potent ones, as well as topical tacrolimus, antifungals, antibiotics, emollients, oral steroids, and antihistamines, to no avail. Patch testing to investigate allergic contact dermatitis as a possible etiology was unremarkable.
She hypothesized that, since dupilumab blocks the key signaling pathways for Th2 T-cell differentiation by targeting the interleukin-4 receptor alpha, it’s possible that the biologic promotes a shift towards activation of the Th17 pathway, which might explain the observed histologic findings.
The fact that this erythema wasn’t reported in the major randomized clinical trials of dupilumab underscores the enormous value of clinical practice registries, she said.
“We are not the only ones observing this phenomenon,” noted Dr. de Wijs, citing recently published reports by other investigators (J Am Acad Dermatol. 2020 Jan;82[1]:230-2; JAMA Dermatol. 2019 Jul 1;155[7]:850-2).
Indeed, her talk was immediately followed by a presentation by Sebastien Barbarot, MD, PhD, who reported on a French national retrospective study of head and neck dermatitis arising in patients on dupilumab that was conducted by the French Atopic Dermatitis Network using the organization’s GREAT database. Among 1,000 adult patients with AD treated with the biologic at 29 French centers, 10 developed a de novo head and neck dermatitis, and 32 others experienced more than 50% worsening of eczema signs on the head and neck from baseline beginning about 2 months after starting on dupilumab.
This 4.2% incidence is probably an underestimate, since dermatologists weren’t aware of the phenomenon and didn’t specifically ask patients about it, observed Dr. Barbarot, a dermatologist at the University of Nantes (France).
Among the key findings: No differences in clinical characteristics were found between the de novo and exacerbation groups, nearly half of affected patients had concomitant conjunctivitis, and seven patients discontinued dupilumab because of an intolerable burning sensation on the head/neck.
“I think this condition is quite different from rosacea,” Dr. Barbarot emphasized.
French dermatologists generally turned to topical corticosteroids or topical tacrolimus to treat the face and neck dermatitis, with mixed results; 22 of the 42 patients showed improvement and 8 worsened.
Marjolein de Bruin-Weller, MD, PhD, a dermatologist at Utrecht (the Netherlands) University and head of the Dutch National Eczema Expertise Center, said she and her colleagues have also encountered this dupilumab-related head and neck erythema and are convinced that a subset of affected patients have Malassezia-induced dermatitis with neutrophils present on lesional biopsies. “It responds very well to treatment. I think it’s very important to try itraconazole because sometimes it works,” she said.
Dr. de Wijs replied that she and her coworkers tried 2 weeks of itraconazole in several patients, with no effect. And none of their seven biopsied patients had an increase in neutrophils.
“It might be a very heterogenous polyform entity that we’re now observing,” she commented. Dr. de Bruin-Weller concurred.
Dr. Barbarot said he’d be interested in a formal study of antifungal therapy in patients with dupilumab-related head and neck dermatitis. Mechanistically, it seems plausible that dupilumab-induced activation of the TH17 pathway might lead to proliferation of Malassezia fungus.
Dr. de Wijs and Dr. Barbarot reported having no financial conflicts regarding their respective studies, which were conducted free of commercial sponsorship.
MADRID – A growing recognition that from their background skin disease emerged as a hot topic of discussion at a meeting of the European Task Force on Atopic Dermatitis held in conjunction with the annual congress of the European Academy of Dermatology and Venereology.
“During treatment with dupilumab, we saw something that is really different from the classic eczema that patients experienced prior to dupilumab, with no or minimal scaling, itch, or burning sensation. We do not believe this is a delayed effect of dupilumab on that specific region. We think this is a dupilumab-induced entity that we’re looking at. You should take home, in my opinion, that this is a common side effect that’s underreported in daily practice at this moment, and it’s not reported in clinical trials at all,” said Linde de Wijs, MD, of the department of dermatology, Erasmus University Medical Center in Rotterdam, the Netherlands.
She presented a detailed case series of seven affected patients which included histologic examination of lesional skin biopsies. The biopsies were characterized by a perivascular lymphohistiocytic infiltrate, an increase in ectatic capillaries in the papillary dermis, and a notable dearth of spongiosis, eosinophils, and neutrophils. Four patients had bulbous elongated rete ridges evocative of a psoriasiform dermatitis. The overall histologic picture was suggestive of a drug-induced skin reaction.
A striking finding was that, even though AD patients typically place high importance on achieving total clearing of disease on the head and neck, these seven closely studied patients nonetheless rated their treatment satisfaction as 9 out of a possible 10 points. Dr. de Wijs interpreted this as testimony to dupilumab’s potent efficacy and comparatively acceptable safety profile, especially the apparent side effect’s absence of scaling and itch.
“Remember, these are patients with really severe atopic dermatitis who’ve been treated with a lot of immunosuppressants prior to dupilumab,” she said.
Once the investigators began to suspect the existence of a novel dupilumab-induced skin reaction, they conducted a retrospective chart review of more than 150 patients treated with dupilumab (Dupixent) and determined that roughly 30% had developed this distinctive sharply demarcated patchy erythema on the head and neck characterized by absence of itch. The sequence involved clearance of the AD in response to dupilumab, followed by gradual development of the head and neck erythema 10-39 weeks after the start of treatment.
The erythema proved treatment refractory. Dr. de Wijs and her colleagues tried topical corticosteroids, including potent ones, as well as topical tacrolimus, antifungals, antibiotics, emollients, oral steroids, and antihistamines, to no avail. Patch testing to investigate allergic contact dermatitis as a possible etiology was unremarkable.
She hypothesized that, since dupilumab blocks the key signaling pathways for Th2 T-cell differentiation by targeting the interleukin-4 receptor alpha, it’s possible that the biologic promotes a shift towards activation of the Th17 pathway, which might explain the observed histologic findings.
The fact that this erythema wasn’t reported in the major randomized clinical trials of dupilumab underscores the enormous value of clinical practice registries, she said.
“We are not the only ones observing this phenomenon,” noted Dr. de Wijs, citing recently published reports by other investigators (J Am Acad Dermatol. 2020 Jan;82[1]:230-2; JAMA Dermatol. 2019 Jul 1;155[7]:850-2).
Indeed, her talk was immediately followed by a presentation by Sebastien Barbarot, MD, PhD, who reported on a French national retrospective study of head and neck dermatitis arising in patients on dupilumab that was conducted by the French Atopic Dermatitis Network using the organization’s GREAT database. Among 1,000 adult patients with AD treated with the biologic at 29 French centers, 10 developed a de novo head and neck dermatitis, and 32 others experienced more than 50% worsening of eczema signs on the head and neck from baseline beginning about 2 months after starting on dupilumab.
This 4.2% incidence is probably an underestimate, since dermatologists weren’t aware of the phenomenon and didn’t specifically ask patients about it, observed Dr. Barbarot, a dermatologist at the University of Nantes (France).
Among the key findings: No differences in clinical characteristics were found between the de novo and exacerbation groups, nearly half of affected patients had concomitant conjunctivitis, and seven patients discontinued dupilumab because of an intolerable burning sensation on the head/neck.
“I think this condition is quite different from rosacea,” Dr. Barbarot emphasized.
French dermatologists generally turned to topical corticosteroids or topical tacrolimus to treat the face and neck dermatitis, with mixed results; 22 of the 42 patients showed improvement and 8 worsened.
Marjolein de Bruin-Weller, MD, PhD, a dermatologist at Utrecht (the Netherlands) University and head of the Dutch National Eczema Expertise Center, said she and her colleagues have also encountered this dupilumab-related head and neck erythema and are convinced that a subset of affected patients have Malassezia-induced dermatitis with neutrophils present on lesional biopsies. “It responds very well to treatment. I think it’s very important to try itraconazole because sometimes it works,” she said.
Dr. de Wijs replied that she and her coworkers tried 2 weeks of itraconazole in several patients, with no effect. And none of their seven biopsied patients had an increase in neutrophils.
“It might be a very heterogenous polyform entity that we’re now observing,” she commented. Dr. de Bruin-Weller concurred.
Dr. Barbarot said he’d be interested in a formal study of antifungal therapy in patients with dupilumab-related head and neck dermatitis. Mechanistically, it seems plausible that dupilumab-induced activation of the TH17 pathway might lead to proliferation of Malassezia fungus.
Dr. de Wijs and Dr. Barbarot reported having no financial conflicts regarding their respective studies, which were conducted free of commercial sponsorship.
REPORTING FROM THE EADV CONGRESS
Shining a Light to Reduce Hospital Falls
Fall prevention strategies for hospitalized older adults include environmental factors such as adequate room lighting and patient-specific factors such as medications. In 2008, the Centers for Medicare & Medicaid Services (CMS) implemented a regulatory “shining of the light” on hospital-acquired falls by eliminating hospital payment for fall-related injuries. Shorr et al. found that implementation of the CMS Hospital-Acquired Conditions Initiative was associated with only a modest decline in falls and injurious falls over the first seven years, with the greatest reduction occurring in urban, teaching hospitals.1 These disappointing findings were mitigated only by the finding that the prevalence of physical restraints decreased over the seven years of observation from 1.6% to 0.6%, suggesting that the modest reductions in falls did not occur at the expense of further restricting the mobility of hospitalized older adults. Shorr et al. concluded that falls may be largely attributable to individual patient risk and may not be prevented through health system quality and safety programs such as those that have achieved successes in never-events, including wrong-side surgery and catheter-associated blood stream infections.2 The authors expressed concern that hospital leaders remain in the dark regarding proven fall prevention strategies. They question whether hospital-acquired falls are preventable without restricting the mobility of older adults most at risk for falls.
Hoff et al. found in their 2011 literature review of the first three years following implementation of the 2008 CMS hospital payment polices limited evidence-based approaches to address falls as a spotlighted avoidable hospital-acquired condition.3 Swartzell et al. reported that at some level, every patient admitted to an acute care hospital is at risk for falls. “Patients sick enough to be in the hospital have underlying disease, are receiving physiologically altering medications and treatments, and are likely experiencing pain, fatigue, anxiety, sleep disturbance, and other symptoms that interfere with cognitive and physical functioning. The key to preventing falls among hospitalized patients may lie in addressing how the hospital environment creates risk.”4
In 2017, Avanecean et al. published a systematic review of randomized control trials on fall prevention in hospitals.5 Three of five studies demonstrated 20%-30% reductions in fall rates, whereas two studies showed no difference in fall rates among control and intervention groups. In the three studies that demonstrated reduced fall rates, standardized fall risk assessments were used to identify patient-specific risks for falls. Individualized care plans addressed gait and balance disorders, delirium and cognitive deficits, vision and hearing impairments, and toileting needs. For example, physical therapists provided instruction on the safe use of walkers for those with gait and balance disorders. Patients with delirium and cognitive deficits received some form of staff alert of unsupervised transfers out of bed, ranging from bed alarms to customized rubber socks that contained pressure alarms. All three successful intervention studies included patient-centered care plans for toileting.
None of the three studies that measured the secondary outcome of fall-related injuries demonstrated impact of interventions, although the rates of injurious falls were low in both the control and intervention groups (2%-5%).3-5
Since the 2008 CMS policies eliminated hospital payments for complications of falls, patient-centered models of fall risk reduction were widely implemented. The Systems Addressing Frail Elder (SAFE) Care, designed by Ansryan et al. includes nursing, social work, pharmacist, and medical provider assessments.6 Team huddles occur daily to establish individualized care plans, although as Shorr et al. highlight, without report of outcomes.2 Nurses Improving Care for Healthsystem Elders (NICHE) is an New York University-based nursing education and consultation program that has extended to 566 healthcare organizations.7 Factors that promote the adoption of organizational interventions such as NICHE have been identified.8 The findings that NICHE is adopted more in larger, urban healthcare systems are consistent with the findings reported by Shorr et al. that fall rate reductions were greater in such hospital settings. Patient-centered care, although time-consuming, may promote staff satisfaction and is associated with reductions in other hospital-acquired conditions such as delirium.9
Patient-engaged video surveillance systems are recent technological solutions to reduce falls. One staff monitors multiple patients for behaviors that risk falls such as unsupervised transfers out of bed. Staff can speak to a patient through the monitoring system to request the patient to wait for assistance, while the unit staff are alerted to the fall risk. Bedside caregivers can activate virtual privacy screens during personal patient care.
Shorr et al. appropriately call for studies to further illuminate strategies to reduce hospital-acquired falls. A multihospital report of fall rates before and after the implementation of SAFE Care and NICHE would have sufficient scale to address the impact of these patient-centered interventions on injurious falls. Similarly, patient-engaged video surveillance systems need validation from clinical trials.
1. Shorr RI, Staggs VS, Waters TM, et al. Impact of the hospital-acquired conditions initiative on falls and physical restraints: a longitudinal study. J Hosp Med. 2019;14:E31-E36. https://doi.org/10.12788/jhm.3295.
2. Austin JM, Demski R, Callender T, et al. From board to bedside: how the application of financial structures to safety and quality can drive accountability in a large health care system. Jt Comm J Qual Patient Saf. 2017;43(4):166-175. https://doi.org/10.1016/j.jcjq.2017.01.001.
3. Hoff TJ, Soerensen C. No payment for preventable complications: reviewing the early literature for content, guidance, and impressions. Qual Manag Health Care. 2011;20(1):62-75. https://doi.org/10.1097/QMH.0b013e31820311d2.
4. Swartzell KL, Fulton JS, Friesth BM. Relationship between occurrence of falls and fall-risk scores in an acute care setting using the Hendrich II fall risk model. Medsurg Nurs. 2013;22(3):180-187.
5. Avanecean D, Calliste D, Contreras T, Lim Y, Fitzpatrick A. Effectiveness of patient-centered interventions on falls in the acute care setting compared to usual care: a systematic review. JBI Database System Rev Implement Rep. 2017;15(12): 3006-3048. https://doi.org/10.11124/JBISRIR-2016-003331.
6. Ansryan LZ1, Aronow HU, Borenstein JE, et al. Systems addressing frail elder care: description of a successful model. J Nurs Adm. 2018;48(1):11-17. https://doi.org/10.1097/NNA.0000000000000564.
7. Boltz M1, Capezuti E, Bowar-Ferres S, et al. Changes in the geriatric care environment associated with NICHE (Nurses Improving Care for HealthSystem Elders). Geriatr Nurs. 2008;29(3):176-185. https://doi.org/10.1016/j.gerinurse.2008.02.002.
8. Stimpfel AW1, Gilmartin MJ. Factors predicting adoption of the nurses improving care of healthsystem elders program. Nurs Res. 2019;68(1):13-21. https://doi.org/10.1097/NNR.0000000000000327.
9.
Fall prevention strategies for hospitalized older adults include environmental factors such as adequate room lighting and patient-specific factors such as medications. In 2008, the Centers for Medicare & Medicaid Services (CMS) implemented a regulatory “shining of the light” on hospital-acquired falls by eliminating hospital payment for fall-related injuries. Shorr et al. found that implementation of the CMS Hospital-Acquired Conditions Initiative was associated with only a modest decline in falls and injurious falls over the first seven years, with the greatest reduction occurring in urban, teaching hospitals.1 These disappointing findings were mitigated only by the finding that the prevalence of physical restraints decreased over the seven years of observation from 1.6% to 0.6%, suggesting that the modest reductions in falls did not occur at the expense of further restricting the mobility of hospitalized older adults. Shorr et al. concluded that falls may be largely attributable to individual patient risk and may not be prevented through health system quality and safety programs such as those that have achieved successes in never-events, including wrong-side surgery and catheter-associated blood stream infections.2 The authors expressed concern that hospital leaders remain in the dark regarding proven fall prevention strategies. They question whether hospital-acquired falls are preventable without restricting the mobility of older adults most at risk for falls.
Hoff et al. found in their 2011 literature review of the first three years following implementation of the 2008 CMS hospital payment polices limited evidence-based approaches to address falls as a spotlighted avoidable hospital-acquired condition.3 Swartzell et al. reported that at some level, every patient admitted to an acute care hospital is at risk for falls. “Patients sick enough to be in the hospital have underlying disease, are receiving physiologically altering medications and treatments, and are likely experiencing pain, fatigue, anxiety, sleep disturbance, and other symptoms that interfere with cognitive and physical functioning. The key to preventing falls among hospitalized patients may lie in addressing how the hospital environment creates risk.”4
In 2017, Avanecean et al. published a systematic review of randomized control trials on fall prevention in hospitals.5 Three of five studies demonstrated 20%-30% reductions in fall rates, whereas two studies showed no difference in fall rates among control and intervention groups. In the three studies that demonstrated reduced fall rates, standardized fall risk assessments were used to identify patient-specific risks for falls. Individualized care plans addressed gait and balance disorders, delirium and cognitive deficits, vision and hearing impairments, and toileting needs. For example, physical therapists provided instruction on the safe use of walkers for those with gait and balance disorders. Patients with delirium and cognitive deficits received some form of staff alert of unsupervised transfers out of bed, ranging from bed alarms to customized rubber socks that contained pressure alarms. All three successful intervention studies included patient-centered care plans for toileting.
None of the three studies that measured the secondary outcome of fall-related injuries demonstrated impact of interventions, although the rates of injurious falls were low in both the control and intervention groups (2%-5%).3-5
Since the 2008 CMS policies eliminated hospital payments for complications of falls, patient-centered models of fall risk reduction were widely implemented. The Systems Addressing Frail Elder (SAFE) Care, designed by Ansryan et al. includes nursing, social work, pharmacist, and medical provider assessments.6 Team huddles occur daily to establish individualized care plans, although as Shorr et al. highlight, without report of outcomes.2 Nurses Improving Care for Healthsystem Elders (NICHE) is an New York University-based nursing education and consultation program that has extended to 566 healthcare organizations.7 Factors that promote the adoption of organizational interventions such as NICHE have been identified.8 The findings that NICHE is adopted more in larger, urban healthcare systems are consistent with the findings reported by Shorr et al. that fall rate reductions were greater in such hospital settings. Patient-centered care, although time-consuming, may promote staff satisfaction and is associated with reductions in other hospital-acquired conditions such as delirium.9
Patient-engaged video surveillance systems are recent technological solutions to reduce falls. One staff monitors multiple patients for behaviors that risk falls such as unsupervised transfers out of bed. Staff can speak to a patient through the monitoring system to request the patient to wait for assistance, while the unit staff are alerted to the fall risk. Bedside caregivers can activate virtual privacy screens during personal patient care.
Shorr et al. appropriately call for studies to further illuminate strategies to reduce hospital-acquired falls. A multihospital report of fall rates before and after the implementation of SAFE Care and NICHE would have sufficient scale to address the impact of these patient-centered interventions on injurious falls. Similarly, patient-engaged video surveillance systems need validation from clinical trials.
Fall prevention strategies for hospitalized older adults include environmental factors such as adequate room lighting and patient-specific factors such as medications. In 2008, the Centers for Medicare & Medicaid Services (CMS) implemented a regulatory “shining of the light” on hospital-acquired falls by eliminating hospital payment for fall-related injuries. Shorr et al. found that implementation of the CMS Hospital-Acquired Conditions Initiative was associated with only a modest decline in falls and injurious falls over the first seven years, with the greatest reduction occurring in urban, teaching hospitals.1 These disappointing findings were mitigated only by the finding that the prevalence of physical restraints decreased over the seven years of observation from 1.6% to 0.6%, suggesting that the modest reductions in falls did not occur at the expense of further restricting the mobility of hospitalized older adults. Shorr et al. concluded that falls may be largely attributable to individual patient risk and may not be prevented through health system quality and safety programs such as those that have achieved successes in never-events, including wrong-side surgery and catheter-associated blood stream infections.2 The authors expressed concern that hospital leaders remain in the dark regarding proven fall prevention strategies. They question whether hospital-acquired falls are preventable without restricting the mobility of older adults most at risk for falls.
Hoff et al. found in their 2011 literature review of the first three years following implementation of the 2008 CMS hospital payment polices limited evidence-based approaches to address falls as a spotlighted avoidable hospital-acquired condition.3 Swartzell et al. reported that at some level, every patient admitted to an acute care hospital is at risk for falls. “Patients sick enough to be in the hospital have underlying disease, are receiving physiologically altering medications and treatments, and are likely experiencing pain, fatigue, anxiety, sleep disturbance, and other symptoms that interfere with cognitive and physical functioning. The key to preventing falls among hospitalized patients may lie in addressing how the hospital environment creates risk.”4
In 2017, Avanecean et al. published a systematic review of randomized control trials on fall prevention in hospitals.5 Three of five studies demonstrated 20%-30% reductions in fall rates, whereas two studies showed no difference in fall rates among control and intervention groups. In the three studies that demonstrated reduced fall rates, standardized fall risk assessments were used to identify patient-specific risks for falls. Individualized care plans addressed gait and balance disorders, delirium and cognitive deficits, vision and hearing impairments, and toileting needs. For example, physical therapists provided instruction on the safe use of walkers for those with gait and balance disorders. Patients with delirium and cognitive deficits received some form of staff alert of unsupervised transfers out of bed, ranging from bed alarms to customized rubber socks that contained pressure alarms. All three successful intervention studies included patient-centered care plans for toileting.
None of the three studies that measured the secondary outcome of fall-related injuries demonstrated impact of interventions, although the rates of injurious falls were low in both the control and intervention groups (2%-5%).3-5
Since the 2008 CMS policies eliminated hospital payments for complications of falls, patient-centered models of fall risk reduction were widely implemented. The Systems Addressing Frail Elder (SAFE) Care, designed by Ansryan et al. includes nursing, social work, pharmacist, and medical provider assessments.6 Team huddles occur daily to establish individualized care plans, although as Shorr et al. highlight, without report of outcomes.2 Nurses Improving Care for Healthsystem Elders (NICHE) is an New York University-based nursing education and consultation program that has extended to 566 healthcare organizations.7 Factors that promote the adoption of organizational interventions such as NICHE have been identified.8 The findings that NICHE is adopted more in larger, urban healthcare systems are consistent with the findings reported by Shorr et al. that fall rate reductions were greater in such hospital settings. Patient-centered care, although time-consuming, may promote staff satisfaction and is associated with reductions in other hospital-acquired conditions such as delirium.9
Patient-engaged video surveillance systems are recent technological solutions to reduce falls. One staff monitors multiple patients for behaviors that risk falls such as unsupervised transfers out of bed. Staff can speak to a patient through the monitoring system to request the patient to wait for assistance, while the unit staff are alerted to the fall risk. Bedside caregivers can activate virtual privacy screens during personal patient care.
Shorr et al. appropriately call for studies to further illuminate strategies to reduce hospital-acquired falls. A multihospital report of fall rates before and after the implementation of SAFE Care and NICHE would have sufficient scale to address the impact of these patient-centered interventions on injurious falls. Similarly, patient-engaged video surveillance systems need validation from clinical trials.
1. Shorr RI, Staggs VS, Waters TM, et al. Impact of the hospital-acquired conditions initiative on falls and physical restraints: a longitudinal study. J Hosp Med. 2019;14:E31-E36. https://doi.org/10.12788/jhm.3295.
2. Austin JM, Demski R, Callender T, et al. From board to bedside: how the application of financial structures to safety and quality can drive accountability in a large health care system. Jt Comm J Qual Patient Saf. 2017;43(4):166-175. https://doi.org/10.1016/j.jcjq.2017.01.001.
3. Hoff TJ, Soerensen C. No payment for preventable complications: reviewing the early literature for content, guidance, and impressions. Qual Manag Health Care. 2011;20(1):62-75. https://doi.org/10.1097/QMH.0b013e31820311d2.
4. Swartzell KL, Fulton JS, Friesth BM. Relationship between occurrence of falls and fall-risk scores in an acute care setting using the Hendrich II fall risk model. Medsurg Nurs. 2013;22(3):180-187.
5. Avanecean D, Calliste D, Contreras T, Lim Y, Fitzpatrick A. Effectiveness of patient-centered interventions on falls in the acute care setting compared to usual care: a systematic review. JBI Database System Rev Implement Rep. 2017;15(12): 3006-3048. https://doi.org/10.11124/JBISRIR-2016-003331.
6. Ansryan LZ1, Aronow HU, Borenstein JE, et al. Systems addressing frail elder care: description of a successful model. J Nurs Adm. 2018;48(1):11-17. https://doi.org/10.1097/NNA.0000000000000564.
7. Boltz M1, Capezuti E, Bowar-Ferres S, et al. Changes in the geriatric care environment associated with NICHE (Nurses Improving Care for HealthSystem Elders). Geriatr Nurs. 2008;29(3):176-185. https://doi.org/10.1016/j.gerinurse.2008.02.002.
8. Stimpfel AW1, Gilmartin MJ. Factors predicting adoption of the nurses improving care of healthsystem elders program. Nurs Res. 2019;68(1):13-21. https://doi.org/10.1097/NNR.0000000000000327.
9.
1. Shorr RI, Staggs VS, Waters TM, et al. Impact of the hospital-acquired conditions initiative on falls and physical restraints: a longitudinal study. J Hosp Med. 2019;14:E31-E36. https://doi.org/10.12788/jhm.3295.
2. Austin JM, Demski R, Callender T, et al. From board to bedside: how the application of financial structures to safety and quality can drive accountability in a large health care system. Jt Comm J Qual Patient Saf. 2017;43(4):166-175. https://doi.org/10.1016/j.jcjq.2017.01.001.
3. Hoff TJ, Soerensen C. No payment for preventable complications: reviewing the early literature for content, guidance, and impressions. Qual Manag Health Care. 2011;20(1):62-75. https://doi.org/10.1097/QMH.0b013e31820311d2.
4. Swartzell KL, Fulton JS, Friesth BM. Relationship between occurrence of falls and fall-risk scores in an acute care setting using the Hendrich II fall risk model. Medsurg Nurs. 2013;22(3):180-187.
5. Avanecean D, Calliste D, Contreras T, Lim Y, Fitzpatrick A. Effectiveness of patient-centered interventions on falls in the acute care setting compared to usual care: a systematic review. JBI Database System Rev Implement Rep. 2017;15(12): 3006-3048. https://doi.org/10.11124/JBISRIR-2016-003331.
6. Ansryan LZ1, Aronow HU, Borenstein JE, et al. Systems addressing frail elder care: description of a successful model. J Nurs Adm. 2018;48(1):11-17. https://doi.org/10.1097/NNA.0000000000000564.
7. Boltz M1, Capezuti E, Bowar-Ferres S, et al. Changes in the geriatric care environment associated with NICHE (Nurses Improving Care for HealthSystem Elders). Geriatr Nurs. 2008;29(3):176-185. https://doi.org/10.1016/j.gerinurse.2008.02.002.
8. Stimpfel AW1, Gilmartin MJ. Factors predicting adoption of the nurses improving care of healthsystem elders program. Nurs Res. 2019;68(1):13-21. https://doi.org/10.1097/NNR.0000000000000327.
9.
© 2020 Society of Hospital Medicine DOI 10.12788/jhm.3345
AGA releases update for endoscopic treatment of Barrett’s esophagus
The American Gastroenterological Association recently released a clinical practice update for endoscopic treatment of Barrett’s esophagus with dysplasia and/or early esophageal adenocarcinoma.
The update offers best practice advice for a range of clinical scenarios based on published evidence, including guidelines and recent systematic reviews, reported lead author Prateek Sharma, MD, of the University of Kansas, Kansas City. Dr. Sharma was accompanied on the authoring review team by three other expert gastroenterologists from the United States and the Netherlands.
Beyond practice advice, the investigators highlighted a research focus for the future.
“Given the expense and time required for careful and continual surveillance after Barrett’s endoscopic therapy, the future must define improved means of risk-stratifying patients for therapy who are at highest risk for cancer development and for risk of recurrence after complete eradication of intestinal metaplasia,” they wrote in Gastroenterology. “Potentially, we may use a panel of patient characteristics (such as the [Progression in Barrett’s] score), preablation tissue characteristics (e.g., baseline grade of dysplasia) and the posttherapy molecular makeup of the epithelium to help risk stratify our patients.”
For now, many of the treatment principles in the update depend upon histologic features.
For instance, either endoscopic therapy or continued surveillance are reasonable options for patients with Barrett’s esophagus who have confirmed and persistent low-grade dysplasia. In contrast, the update recommends that all patients with high-grade dysplasia or esophageal adenocarcinoma (T1a) undergo endoscopic therapy, highlighting that this method is preferred over esophagectomy for patients with T1a cancer. Along the same lines, the investigators noted that endoscopic therapy is a “reasonable alternative” to esophagectomy in cases of T1b esophageal adenocarcinoma in the presence of minimal invasion and good to moderate differentiation, particularly in patients who are poor candidates for surgery.
During the decision-making process, patients with dysplasia should be advised that not undergoing endoscopic therapy may increase cancer risk, the investigators wrote, adding that patients should also be informed about endoscopic therapy–related risks of bleeding and perforation, which occur in less than 1% of patients, and the risk of postprocedural stricture formation, which occurs in approximately 6% of patients.
If endoscopic therapy is elected, the update suggests that the procedure be done by experts who perform at least 10 new cases per year.
Concerning specifics of therapy, the investigators advised that mucosal ablation be applied to all visible esophageal columnar mucosa, 5-10 mm proximal to the squamocolumnar junction, and 5-10 mm distal to the gastroesophageal junction. Ablation should only be performed in cases of flat Barrett’s esophagus in which no visible abnormalities or signs of inflammation are present, the review team wrote.
The investigators went on to lay out some “practical ground rules” for endoscopic therapy, including a potential pitfall.
“Ablation therapy may consist of multiple 2-3 monthly ablation sessions that may extend over a period of more than a year,” the investigators wrote. “The worst adverse outcome during the treatment period is failing to recognize and treat an invasive cancer while continuing the ablation sessions. This occurrence may place the patient outside of the window of opportunity for curative endoscopic treatment. Therefore, every ablation session starts with careful endoscopic inspection using [high-definition white-light endoscopy] and preferably optical chromoendoscopy to exclude the presence of visible abnormalities that require an endoscopic resection instead of the scheduled ablation. Routine biopsies of flat Barrett’s esophagus are not necessary or recommended prior to ablation at these sessions, as the blood may inhibit optimal energy transfer to the tissue.”
Following successfully achieved complete endoscopic and histologic eradication of intestinal metaplasia, the update calls for surveillance endoscopy with biopsies at intervals of 1 and 3 years for cases of low-grade dysplasia and at intervals of 3, 6, and 12 months for high-grade dysplasia or esophageal adenocarcinoma, followed by annual checks thereafter.
The investigators disclosed relationships with Olympus, Ironwood, Erbe, and others.
SOURCE: Sharma P et al. Gastroenterology. 2019 Nov 12. doi: 10.1053/j.gastro.2019.09.051.
The American Gastroenterological Association recently released a clinical practice update for endoscopic treatment of Barrett’s esophagus with dysplasia and/or early esophageal adenocarcinoma.
The update offers best practice advice for a range of clinical scenarios based on published evidence, including guidelines and recent systematic reviews, reported lead author Prateek Sharma, MD, of the University of Kansas, Kansas City. Dr. Sharma was accompanied on the authoring review team by three other expert gastroenterologists from the United States and the Netherlands.
Beyond practice advice, the investigators highlighted a research focus for the future.
“Given the expense and time required for careful and continual surveillance after Barrett’s endoscopic therapy, the future must define improved means of risk-stratifying patients for therapy who are at highest risk for cancer development and for risk of recurrence after complete eradication of intestinal metaplasia,” they wrote in Gastroenterology. “Potentially, we may use a panel of patient characteristics (such as the [Progression in Barrett’s] score), preablation tissue characteristics (e.g., baseline grade of dysplasia) and the posttherapy molecular makeup of the epithelium to help risk stratify our patients.”
For now, many of the treatment principles in the update depend upon histologic features.
For instance, either endoscopic therapy or continued surveillance are reasonable options for patients with Barrett’s esophagus who have confirmed and persistent low-grade dysplasia. In contrast, the update recommends that all patients with high-grade dysplasia or esophageal adenocarcinoma (T1a) undergo endoscopic therapy, highlighting that this method is preferred over esophagectomy for patients with T1a cancer. Along the same lines, the investigators noted that endoscopic therapy is a “reasonable alternative” to esophagectomy in cases of T1b esophageal adenocarcinoma in the presence of minimal invasion and good to moderate differentiation, particularly in patients who are poor candidates for surgery.
During the decision-making process, patients with dysplasia should be advised that not undergoing endoscopic therapy may increase cancer risk, the investigators wrote, adding that patients should also be informed about endoscopic therapy–related risks of bleeding and perforation, which occur in less than 1% of patients, and the risk of postprocedural stricture formation, which occurs in approximately 6% of patients.
If endoscopic therapy is elected, the update suggests that the procedure be done by experts who perform at least 10 new cases per year.
Concerning specifics of therapy, the investigators advised that mucosal ablation be applied to all visible esophageal columnar mucosa, 5-10 mm proximal to the squamocolumnar junction, and 5-10 mm distal to the gastroesophageal junction. Ablation should only be performed in cases of flat Barrett’s esophagus in which no visible abnormalities or signs of inflammation are present, the review team wrote.
The investigators went on to lay out some “practical ground rules” for endoscopic therapy, including a potential pitfall.
“Ablation therapy may consist of multiple 2-3 monthly ablation sessions that may extend over a period of more than a year,” the investigators wrote. “The worst adverse outcome during the treatment period is failing to recognize and treat an invasive cancer while continuing the ablation sessions. This occurrence may place the patient outside of the window of opportunity for curative endoscopic treatment. Therefore, every ablation session starts with careful endoscopic inspection using [high-definition white-light endoscopy] and preferably optical chromoendoscopy to exclude the presence of visible abnormalities that require an endoscopic resection instead of the scheduled ablation. Routine biopsies of flat Barrett’s esophagus are not necessary or recommended prior to ablation at these sessions, as the blood may inhibit optimal energy transfer to the tissue.”
Following successfully achieved complete endoscopic and histologic eradication of intestinal metaplasia, the update calls for surveillance endoscopy with biopsies at intervals of 1 and 3 years for cases of low-grade dysplasia and at intervals of 3, 6, and 12 months for high-grade dysplasia or esophageal adenocarcinoma, followed by annual checks thereafter.
The investigators disclosed relationships with Olympus, Ironwood, Erbe, and others.
SOURCE: Sharma P et al. Gastroenterology. 2019 Nov 12. doi: 10.1053/j.gastro.2019.09.051.
The American Gastroenterological Association recently released a clinical practice update for endoscopic treatment of Barrett’s esophagus with dysplasia and/or early esophageal adenocarcinoma.
The update offers best practice advice for a range of clinical scenarios based on published evidence, including guidelines and recent systematic reviews, reported lead author Prateek Sharma, MD, of the University of Kansas, Kansas City. Dr. Sharma was accompanied on the authoring review team by three other expert gastroenterologists from the United States and the Netherlands.
Beyond practice advice, the investigators highlighted a research focus for the future.
“Given the expense and time required for careful and continual surveillance after Barrett’s endoscopic therapy, the future must define improved means of risk-stratifying patients for therapy who are at highest risk for cancer development and for risk of recurrence after complete eradication of intestinal metaplasia,” they wrote in Gastroenterology. “Potentially, we may use a panel of patient characteristics (such as the [Progression in Barrett’s] score), preablation tissue characteristics (e.g., baseline grade of dysplasia) and the posttherapy molecular makeup of the epithelium to help risk stratify our patients.”
For now, many of the treatment principles in the update depend upon histologic features.
For instance, either endoscopic therapy or continued surveillance are reasonable options for patients with Barrett’s esophagus who have confirmed and persistent low-grade dysplasia. In contrast, the update recommends that all patients with high-grade dysplasia or esophageal adenocarcinoma (T1a) undergo endoscopic therapy, highlighting that this method is preferred over esophagectomy for patients with T1a cancer. Along the same lines, the investigators noted that endoscopic therapy is a “reasonable alternative” to esophagectomy in cases of T1b esophageal adenocarcinoma in the presence of minimal invasion and good to moderate differentiation, particularly in patients who are poor candidates for surgery.
During the decision-making process, patients with dysplasia should be advised that not undergoing endoscopic therapy may increase cancer risk, the investigators wrote, adding that patients should also be informed about endoscopic therapy–related risks of bleeding and perforation, which occur in less than 1% of patients, and the risk of postprocedural stricture formation, which occurs in approximately 6% of patients.
If endoscopic therapy is elected, the update suggests that the procedure be done by experts who perform at least 10 new cases per year.
Concerning specifics of therapy, the investigators advised that mucosal ablation be applied to all visible esophageal columnar mucosa, 5-10 mm proximal to the squamocolumnar junction, and 5-10 mm distal to the gastroesophageal junction. Ablation should only be performed in cases of flat Barrett’s esophagus in which no visible abnormalities or signs of inflammation are present, the review team wrote.
The investigators went on to lay out some “practical ground rules” for endoscopic therapy, including a potential pitfall.
“Ablation therapy may consist of multiple 2-3 monthly ablation sessions that may extend over a period of more than a year,” the investigators wrote. “The worst adverse outcome during the treatment period is failing to recognize and treat an invasive cancer while continuing the ablation sessions. This occurrence may place the patient outside of the window of opportunity for curative endoscopic treatment. Therefore, every ablation session starts with careful endoscopic inspection using [high-definition white-light endoscopy] and preferably optical chromoendoscopy to exclude the presence of visible abnormalities that require an endoscopic resection instead of the scheduled ablation. Routine biopsies of flat Barrett’s esophagus are not necessary or recommended prior to ablation at these sessions, as the blood may inhibit optimal energy transfer to the tissue.”
Following successfully achieved complete endoscopic and histologic eradication of intestinal metaplasia, the update calls for surveillance endoscopy with biopsies at intervals of 1 and 3 years for cases of low-grade dysplasia and at intervals of 3, 6, and 12 months for high-grade dysplasia or esophageal adenocarcinoma, followed by annual checks thereafter.
The investigators disclosed relationships with Olympus, Ironwood, Erbe, and others.
SOURCE: Sharma P et al. Gastroenterology. 2019 Nov 12. doi: 10.1053/j.gastro.2019.09.051.
FROM GASTROENTEROLOGY
Farxiga granted Priority Review for treatment of adults with HFrEF
The Food and Drug Administration has accepted a supplemental New Drug Application and granted Priority Review for dapagliflozin (Farxiga) for the reduction of risk of cardiovascular death or worsening of heart failure in adult patients with heart failure with reduced ejection fraction (HFrEF).
The application was based on results from the landmark, phase 3 DAPA-HF trial, published in September 2019 in the New England Journal of Medicine. The study showed that dapagliflozin plus standard care reduced the incidence of cardiovascular death and worsening of heart failure versus placebo in patients with HFrEF.
Dapagliflozin was granted Fast Track designation for heart failure by the FDA in September 2019. In August 2019, the FDA also granted Fast Track designation to dapagliflozin for the delayed progression of renal failure and prevention of cardiovascular and renal death in patients with chronic kidney disease.
The drug is currently indicated for the improvement of glycemic control in adults with type 2 diabetes as either monotherapy or in combination. The FDA approved dapagliflozin in October 2019 for the reduction of heart failure hospitalization risk in patients with type 2 diabetes and cardiovascular risk factors.
“Farxiga is well established in the treatment of type 2 diabetes and this Priority Review shows its potential to also impact millions of patients with heart failure. If approved, Farxiga will be the first and only medicine of its kind indicated to treat patients with heart failure,” said Mene Pangalos, executive vice president of biopharmaceutical research and development at AstraZeneca.
Find the full press release on the AstraZeneca website.
The Food and Drug Administration has accepted a supplemental New Drug Application and granted Priority Review for dapagliflozin (Farxiga) for the reduction of risk of cardiovascular death or worsening of heart failure in adult patients with heart failure with reduced ejection fraction (HFrEF).
The application was based on results from the landmark, phase 3 DAPA-HF trial, published in September 2019 in the New England Journal of Medicine. The study showed that dapagliflozin plus standard care reduced the incidence of cardiovascular death and worsening of heart failure versus placebo in patients with HFrEF.
Dapagliflozin was granted Fast Track designation for heart failure by the FDA in September 2019. In August 2019, the FDA also granted Fast Track designation to dapagliflozin for the delayed progression of renal failure and prevention of cardiovascular and renal death in patients with chronic kidney disease.
The drug is currently indicated for the improvement of glycemic control in adults with type 2 diabetes as either monotherapy or in combination. The FDA approved dapagliflozin in October 2019 for the reduction of heart failure hospitalization risk in patients with type 2 diabetes and cardiovascular risk factors.
“Farxiga is well established in the treatment of type 2 diabetes and this Priority Review shows its potential to also impact millions of patients with heart failure. If approved, Farxiga will be the first and only medicine of its kind indicated to treat patients with heart failure,” said Mene Pangalos, executive vice president of biopharmaceutical research and development at AstraZeneca.
Find the full press release on the AstraZeneca website.
The Food and Drug Administration has accepted a supplemental New Drug Application and granted Priority Review for dapagliflozin (Farxiga) for the reduction of risk of cardiovascular death or worsening of heart failure in adult patients with heart failure with reduced ejection fraction (HFrEF).
The application was based on results from the landmark, phase 3 DAPA-HF trial, published in September 2019 in the New England Journal of Medicine. The study showed that dapagliflozin plus standard care reduced the incidence of cardiovascular death and worsening of heart failure versus placebo in patients with HFrEF.
Dapagliflozin was granted Fast Track designation for heart failure by the FDA in September 2019. In August 2019, the FDA also granted Fast Track designation to dapagliflozin for the delayed progression of renal failure and prevention of cardiovascular and renal death in patients with chronic kidney disease.
The drug is currently indicated for the improvement of glycemic control in adults with type 2 diabetes as either monotherapy or in combination. The FDA approved dapagliflozin in October 2019 for the reduction of heart failure hospitalization risk in patients with type 2 diabetes and cardiovascular risk factors.
“Farxiga is well established in the treatment of type 2 diabetes and this Priority Review shows its potential to also impact millions of patients with heart failure. If approved, Farxiga will be the first and only medicine of its kind indicated to treat patients with heart failure,” said Mene Pangalos, executive vice president of biopharmaceutical research and development at AstraZeneca.
Find the full press release on the AstraZeneca website.
Armed conflict disproportionately affects children
I was asked recently about the trauma of 9/11 by a teen patient who was too young to remember the terrorist attacks. I was surprised that even today I become teary eyed thinking about it. My son was in his first week of college at Georgetown, and in the early confusion about what was going on I was panicked at reports of bombings in Washington. Fortunately, for me and my family at least, none of us were physically harmed. But the mental trauma still is with us. It was a momentary panic for me, but it’s not so fleeting for many families around the world today.
I can’t imagine what it is like today to be a parent in an armed conflict zone, or even in an area with very high levels of criminal violence. At a meeting of the International Society for Social Pediatrics (ISSOP), I learned that an estimated 1.5 billion residents of Earth, or about one in five inhabitants, lived in war zones or in areas of tremendous violence, according to the World Bank’s 2011 World Development Report. And I learned that children are disproportionately affected – physically, mentally, and developmentally – from Stella Tsitoura, MD, of the Network for Children’s Rights, Athens, and others at the ISSOP meeting in Beirut, Lebanon, where pediatricians from around the world gathered in Oct. 2019 to consider what we as a profession should be doing in the context of armed conflict’s impact on so many children. The meeting was held in the Middle East because it is an especially hot conflict area, but children in South Asia, central Africa, South America, Central America, even rough inner-city areas in the United States are also affected.
Child soldiers in some parts of the world particularly are affected, sometimes being forced to commit violence on neighbors and kin. One country that I worked in years ago, Yemen, is a horrifying example of the complex impact of war on children and families. In 2017, over 2,100 children had been recruited as soldiers during the 3-year conflict in Yemen, a UNICEF representative reported. The death toll in Yemen was over 17,500 by Nov. 2018, according to a Human Rights Watch report.
Samuel Perlo-Freeman, PhD, an expert on the economics of arms trade, noted at the ISSOP meeting that two-thirds of civilian casualties in Yemen are caused by Coalition air strikes, whose members include Bahrain, Egypt, Jordan, Kuwait, Saudi Arabia, Sudan, and United Arab Emirates. He also said rebel groups in Yemen and elsewhere acquire their arms by capture, by smuggling, or through the aid of foreign backers. Six countries – the United States, Russia, and several western European countries – account for the majority of war tools used in armed conflict zones. In June 2019, courts in Great Britain ruled that British arms sales to the parties involved in Yemen were illegal without an assessment as to whether any violation of internal humanitarian law had taken place.
Many of us feel impotent when facing the magnitude of this problem, and the lives of despair that affected children lead are sometimes too heart breaking to dwell on. ISSOP, the American Academy of Pediatrics, and the International Pediatric Association (IPA) are teaching us differently: Standing up for the human rights of children living in areas of conflict or refugees from those areas is our responsibility, both as individuals and as members of our pediatric associations. At a basic level we need to witness – we need to share what we see with our patients who have immigrated legally or illegally in our practices, our hospitals, and our communities. It’s important to be knowledgeable of current standards of clinical care outlined by both ISSOP and the AAP to ensure our patients affected by conflict and violence get appropriate treatment.
Some of the most lasting health impacts for children in conflict are their mental health needs; the World Health Organization prevalence estimates of mental disorders in conflict settings is 22%, according to a 2019 report in the Lancet (2019 Jun;394[10194]:240-8). Not only do mental health conditions last throughout a lifetime, the impact of war can affect generations through epigenetic forces.
Arms manufacturers should be held accountable as the courts are doing in Great Britain. Too often American-made armaments are falling into the wrong hands. More can be done to limit the sale of weapons that go into conflict zones. Chemical weapons, cluster bombs, and biologic weapons are banned by international agreement; shouldn’t we do the same with nuclear weapons?
Some pediatric health care facilities are impacted by the needs of traumatized children more than others. Countries at the front line of conflict – like Lebanon, Jordon, Turkey, Greece, Italy, and Mexico – should be supported in their efforts on behalf of child refugees. We need to share the burden and support entities such as Doctors Without Borders, Save the Children, and the Red Cross/Crescent as they present themselves in crisis zones. We recognize that the fundamental human rights of children are being ignored by warring parties. especially Goal 16, which asks the world community to make real progress in promoting peace and justice by 2030. Pediatricians may not be experts in armed conflict, but we are experts in what warfare does to the health and well-being of young children. It’s time to speak out and act.
I was asked recently about the trauma of 9/11 by a teen patient who was too young to remember the terrorist attacks. I was surprised that even today I become teary eyed thinking about it. My son was in his first week of college at Georgetown, and in the early confusion about what was going on I was panicked at reports of bombings in Washington. Fortunately, for me and my family at least, none of us were physically harmed. But the mental trauma still is with us. It was a momentary panic for me, but it’s not so fleeting for many families around the world today.
I can’t imagine what it is like today to be a parent in an armed conflict zone, or even in an area with very high levels of criminal violence. At a meeting of the International Society for Social Pediatrics (ISSOP), I learned that an estimated 1.5 billion residents of Earth, or about one in five inhabitants, lived in war zones or in areas of tremendous violence, according to the World Bank’s 2011 World Development Report. And I learned that children are disproportionately affected – physically, mentally, and developmentally – from Stella Tsitoura, MD, of the Network for Children’s Rights, Athens, and others at the ISSOP meeting in Beirut, Lebanon, where pediatricians from around the world gathered in Oct. 2019 to consider what we as a profession should be doing in the context of armed conflict’s impact on so many children. The meeting was held in the Middle East because it is an especially hot conflict area, but children in South Asia, central Africa, South America, Central America, even rough inner-city areas in the United States are also affected.
Child soldiers in some parts of the world particularly are affected, sometimes being forced to commit violence on neighbors and kin. One country that I worked in years ago, Yemen, is a horrifying example of the complex impact of war on children and families. In 2017, over 2,100 children had been recruited as soldiers during the 3-year conflict in Yemen, a UNICEF representative reported. The death toll in Yemen was over 17,500 by Nov. 2018, according to a Human Rights Watch report.
Samuel Perlo-Freeman, PhD, an expert on the economics of arms trade, noted at the ISSOP meeting that two-thirds of civilian casualties in Yemen are caused by Coalition air strikes, whose members include Bahrain, Egypt, Jordan, Kuwait, Saudi Arabia, Sudan, and United Arab Emirates. He also said rebel groups in Yemen and elsewhere acquire their arms by capture, by smuggling, or through the aid of foreign backers. Six countries – the United States, Russia, and several western European countries – account for the majority of war tools used in armed conflict zones. In June 2019, courts in Great Britain ruled that British arms sales to the parties involved in Yemen were illegal without an assessment as to whether any violation of internal humanitarian law had taken place.
Many of us feel impotent when facing the magnitude of this problem, and the lives of despair that affected children lead are sometimes too heart breaking to dwell on. ISSOP, the American Academy of Pediatrics, and the International Pediatric Association (IPA) are teaching us differently: Standing up for the human rights of children living in areas of conflict or refugees from those areas is our responsibility, both as individuals and as members of our pediatric associations. At a basic level we need to witness – we need to share what we see with our patients who have immigrated legally or illegally in our practices, our hospitals, and our communities. It’s important to be knowledgeable of current standards of clinical care outlined by both ISSOP and the AAP to ensure our patients affected by conflict and violence get appropriate treatment.
Some of the most lasting health impacts for children in conflict are their mental health needs; the World Health Organization prevalence estimates of mental disorders in conflict settings is 22%, according to a 2019 report in the Lancet (2019 Jun;394[10194]:240-8). Not only do mental health conditions last throughout a lifetime, the impact of war can affect generations through epigenetic forces.
Arms manufacturers should be held accountable as the courts are doing in Great Britain. Too often American-made armaments are falling into the wrong hands. More can be done to limit the sale of weapons that go into conflict zones. Chemical weapons, cluster bombs, and biologic weapons are banned by international agreement; shouldn’t we do the same with nuclear weapons?
Some pediatric health care facilities are impacted by the needs of traumatized children more than others. Countries at the front line of conflict – like Lebanon, Jordon, Turkey, Greece, Italy, and Mexico – should be supported in their efforts on behalf of child refugees. We need to share the burden and support entities such as Doctors Without Borders, Save the Children, and the Red Cross/Crescent as they present themselves in crisis zones. We recognize that the fundamental human rights of children are being ignored by warring parties. especially Goal 16, which asks the world community to make real progress in promoting peace and justice by 2030. Pediatricians may not be experts in armed conflict, but we are experts in what warfare does to the health and well-being of young children. It’s time to speak out and act.
I was asked recently about the trauma of 9/11 by a teen patient who was too young to remember the terrorist attacks. I was surprised that even today I become teary eyed thinking about it. My son was in his first week of college at Georgetown, and in the early confusion about what was going on I was panicked at reports of bombings in Washington. Fortunately, for me and my family at least, none of us were physically harmed. But the mental trauma still is with us. It was a momentary panic for me, but it’s not so fleeting for many families around the world today.
I can’t imagine what it is like today to be a parent in an armed conflict zone, or even in an area with very high levels of criminal violence. At a meeting of the International Society for Social Pediatrics (ISSOP), I learned that an estimated 1.5 billion residents of Earth, or about one in five inhabitants, lived in war zones or in areas of tremendous violence, according to the World Bank’s 2011 World Development Report. And I learned that children are disproportionately affected – physically, mentally, and developmentally – from Stella Tsitoura, MD, of the Network for Children’s Rights, Athens, and others at the ISSOP meeting in Beirut, Lebanon, where pediatricians from around the world gathered in Oct. 2019 to consider what we as a profession should be doing in the context of armed conflict’s impact on so many children. The meeting was held in the Middle East because it is an especially hot conflict area, but children in South Asia, central Africa, South America, Central America, even rough inner-city areas in the United States are also affected.
Child soldiers in some parts of the world particularly are affected, sometimes being forced to commit violence on neighbors and kin. One country that I worked in years ago, Yemen, is a horrifying example of the complex impact of war on children and families. In 2017, over 2,100 children had been recruited as soldiers during the 3-year conflict in Yemen, a UNICEF representative reported. The death toll in Yemen was over 17,500 by Nov. 2018, according to a Human Rights Watch report.
Samuel Perlo-Freeman, PhD, an expert on the economics of arms trade, noted at the ISSOP meeting that two-thirds of civilian casualties in Yemen are caused by Coalition air strikes, whose members include Bahrain, Egypt, Jordan, Kuwait, Saudi Arabia, Sudan, and United Arab Emirates. He also said rebel groups in Yemen and elsewhere acquire their arms by capture, by smuggling, or through the aid of foreign backers. Six countries – the United States, Russia, and several western European countries – account for the majority of war tools used in armed conflict zones. In June 2019, courts in Great Britain ruled that British arms sales to the parties involved in Yemen were illegal without an assessment as to whether any violation of internal humanitarian law had taken place.
Many of us feel impotent when facing the magnitude of this problem, and the lives of despair that affected children lead are sometimes too heart breaking to dwell on. ISSOP, the American Academy of Pediatrics, and the International Pediatric Association (IPA) are teaching us differently: Standing up for the human rights of children living in areas of conflict or refugees from those areas is our responsibility, both as individuals and as members of our pediatric associations. At a basic level we need to witness – we need to share what we see with our patients who have immigrated legally or illegally in our practices, our hospitals, and our communities. It’s important to be knowledgeable of current standards of clinical care outlined by both ISSOP and the AAP to ensure our patients affected by conflict and violence get appropriate treatment.
Some of the most lasting health impacts for children in conflict are their mental health needs; the World Health Organization prevalence estimates of mental disorders in conflict settings is 22%, according to a 2019 report in the Lancet (2019 Jun;394[10194]:240-8). Not only do mental health conditions last throughout a lifetime, the impact of war can affect generations through epigenetic forces.
Arms manufacturers should be held accountable as the courts are doing in Great Britain. Too often American-made armaments are falling into the wrong hands. More can be done to limit the sale of weapons that go into conflict zones. Chemical weapons, cluster bombs, and biologic weapons are banned by international agreement; shouldn’t we do the same with nuclear weapons?
Some pediatric health care facilities are impacted by the needs of traumatized children more than others. Countries at the front line of conflict – like Lebanon, Jordon, Turkey, Greece, Italy, and Mexico – should be supported in their efforts on behalf of child refugees. We need to share the burden and support entities such as Doctors Without Borders, Save the Children, and the Red Cross/Crescent as they present themselves in crisis zones. We recognize that the fundamental human rights of children are being ignored by warring parties. especially Goal 16, which asks the world community to make real progress in promoting peace and justice by 2030. Pediatricians may not be experts in armed conflict, but we are experts in what warfare does to the health and well-being of young children. It’s time to speak out and act.
Delayed clinical care after concussion may prolong recovery
, according to a study published Jan. 6 in JAMA Neurology.
In addition, more severe visual motion sensitivity symptoms are associated with longer recovery times, said lead author Anthony P. Kontos, PhD, and colleagues. Dr. Kontos is associate professor of orthopedic surgery at the University of Pittsburgh and the research director of the University of Pittsburgh Medical Center Sports Medicine Concussion Program.
“Without clinical guidance and behavioral management recommendations post injury, athletes may have been engaging in counterproductive recovery strategies, such as a strict rest or excessive physical activity,” the authors said. “This explanation is supported by the fact that athletes recovered in a similar amount of time after that first evaluation.”
Various factors may influence recovery after a concussion, including age, sex, and comorbidities. To examine the relationship between time since injury at the start of clinical care and recovery time, the investigators conducted a retrospective, cross-sectional study. They analyzed data from patients seen in a sports medicine clinic between August 2016 and March 2018. Eligible patients were aged 12-22 years and had a diagnosed, symptomatic, sport-related concussion. The researchers excluded patients with incomplete recovery data.
The investigators included 162 patients in their analyses; 98 of these patients were seen within 7 days of the injury, and 64 were seen 8-20 days after a concussion. Both groups had a mean age of 15 years and similar proportions of female patients (52% in the early-care group vs. 62.5% in the late-care group). At the first clinical visit, symptom severity and cognitive, ocular, and vestibular test results were similar in both groups.
The researchers defined recovery time as the number of days from injury until the date of clearance for a full return to play. Physicians cleared patients to return to play when they returned to preinjury levels of symptoms and preinjury performance on cognitive, ocular, and vestibular tests with no increase in symptoms after exertion.
Patients’ recovery times ranged from 9 to 299 days; the average recovery time was 57 days. Fifty-two percent of patients in the early-care group recovered in 30 days or fewer, compared with 19% of patients in late-care group. Patients in the early-care group had a mean recovery of 51.1 days, whereas patients in the late-care group had a mean recovery of 66 days.
In a logistic regression model, late care “was associated with a 5.8-times increased likelihood of a recovery longer than 30 days,” the researchers reported. Visual motion sensitivity symptoms also were associated with increased odds of protracted recovery (adjusted odds ratio, 4.5).
“Once care was established, time to recovery did not differ for athletes evaluated within the first week of injury compared with those evaluated 2-3 weeks post injury,” Dr. Kontos and colleagues concluded. “Education on injury and behavioral recommendations to optimize concussion recovery and earlier initiation of active rehabilitation strategies, including exertion and vestibular therapy, are plausible explanations for the association of a shorter recovery time with earlier care. However, future research should focus on the specific mechanisms by which earlier health care postconcussion promotes faster recovery and determine if these findings apply to other subpopulations, including military personnel.”
The researchers noted that they excluded from their analysis 254 patients who had incomplete recovery data but otherwise met inclusion criteria, which may have led to selection bias.
Dr. Kontos disclosed grants from the National Football League and personal fees from APA Books and University of Pittsburgh projects outside the scope of this study.
SOURCE: Kontos AP et al. JAMA Neurol. 2020 Jan 6. doi: 10.1001/jamaneurol.2019.4552.
, according to a study published Jan. 6 in JAMA Neurology.
In addition, more severe visual motion sensitivity symptoms are associated with longer recovery times, said lead author Anthony P. Kontos, PhD, and colleagues. Dr. Kontos is associate professor of orthopedic surgery at the University of Pittsburgh and the research director of the University of Pittsburgh Medical Center Sports Medicine Concussion Program.
“Without clinical guidance and behavioral management recommendations post injury, athletes may have been engaging in counterproductive recovery strategies, such as a strict rest or excessive physical activity,” the authors said. “This explanation is supported by the fact that athletes recovered in a similar amount of time after that first evaluation.”
Various factors may influence recovery after a concussion, including age, sex, and comorbidities. To examine the relationship between time since injury at the start of clinical care and recovery time, the investigators conducted a retrospective, cross-sectional study. They analyzed data from patients seen in a sports medicine clinic between August 2016 and March 2018. Eligible patients were aged 12-22 years and had a diagnosed, symptomatic, sport-related concussion. The researchers excluded patients with incomplete recovery data.
The investigators included 162 patients in their analyses; 98 of these patients were seen within 7 days of the injury, and 64 were seen 8-20 days after a concussion. Both groups had a mean age of 15 years and similar proportions of female patients (52% in the early-care group vs. 62.5% in the late-care group). At the first clinical visit, symptom severity and cognitive, ocular, and vestibular test results were similar in both groups.
The researchers defined recovery time as the number of days from injury until the date of clearance for a full return to play. Physicians cleared patients to return to play when they returned to preinjury levels of symptoms and preinjury performance on cognitive, ocular, and vestibular tests with no increase in symptoms after exertion.
Patients’ recovery times ranged from 9 to 299 days; the average recovery time was 57 days. Fifty-two percent of patients in the early-care group recovered in 30 days or fewer, compared with 19% of patients in late-care group. Patients in the early-care group had a mean recovery of 51.1 days, whereas patients in the late-care group had a mean recovery of 66 days.
In a logistic regression model, late care “was associated with a 5.8-times increased likelihood of a recovery longer than 30 days,” the researchers reported. Visual motion sensitivity symptoms also were associated with increased odds of protracted recovery (adjusted odds ratio, 4.5).
“Once care was established, time to recovery did not differ for athletes evaluated within the first week of injury compared with those evaluated 2-3 weeks post injury,” Dr. Kontos and colleagues concluded. “Education on injury and behavioral recommendations to optimize concussion recovery and earlier initiation of active rehabilitation strategies, including exertion and vestibular therapy, are plausible explanations for the association of a shorter recovery time with earlier care. However, future research should focus on the specific mechanisms by which earlier health care postconcussion promotes faster recovery and determine if these findings apply to other subpopulations, including military personnel.”
The researchers noted that they excluded from their analysis 254 patients who had incomplete recovery data but otherwise met inclusion criteria, which may have led to selection bias.
Dr. Kontos disclosed grants from the National Football League and personal fees from APA Books and University of Pittsburgh projects outside the scope of this study.
SOURCE: Kontos AP et al. JAMA Neurol. 2020 Jan 6. doi: 10.1001/jamaneurol.2019.4552.
, according to a study published Jan. 6 in JAMA Neurology.
In addition, more severe visual motion sensitivity symptoms are associated with longer recovery times, said lead author Anthony P. Kontos, PhD, and colleagues. Dr. Kontos is associate professor of orthopedic surgery at the University of Pittsburgh and the research director of the University of Pittsburgh Medical Center Sports Medicine Concussion Program.
“Without clinical guidance and behavioral management recommendations post injury, athletes may have been engaging in counterproductive recovery strategies, such as a strict rest or excessive physical activity,” the authors said. “This explanation is supported by the fact that athletes recovered in a similar amount of time after that first evaluation.”
Various factors may influence recovery after a concussion, including age, sex, and comorbidities. To examine the relationship between time since injury at the start of clinical care and recovery time, the investigators conducted a retrospective, cross-sectional study. They analyzed data from patients seen in a sports medicine clinic between August 2016 and March 2018. Eligible patients were aged 12-22 years and had a diagnosed, symptomatic, sport-related concussion. The researchers excluded patients with incomplete recovery data.
The investigators included 162 patients in their analyses; 98 of these patients were seen within 7 days of the injury, and 64 were seen 8-20 days after a concussion. Both groups had a mean age of 15 years and similar proportions of female patients (52% in the early-care group vs. 62.5% in the late-care group). At the first clinical visit, symptom severity and cognitive, ocular, and vestibular test results were similar in both groups.
The researchers defined recovery time as the number of days from injury until the date of clearance for a full return to play. Physicians cleared patients to return to play when they returned to preinjury levels of symptoms and preinjury performance on cognitive, ocular, and vestibular tests with no increase in symptoms after exertion.
Patients’ recovery times ranged from 9 to 299 days; the average recovery time was 57 days. Fifty-two percent of patients in the early-care group recovered in 30 days or fewer, compared with 19% of patients in late-care group. Patients in the early-care group had a mean recovery of 51.1 days, whereas patients in the late-care group had a mean recovery of 66 days.
In a logistic regression model, late care “was associated with a 5.8-times increased likelihood of a recovery longer than 30 days,” the researchers reported. Visual motion sensitivity symptoms also were associated with increased odds of protracted recovery (adjusted odds ratio, 4.5).
“Once care was established, time to recovery did not differ for athletes evaluated within the first week of injury compared with those evaluated 2-3 weeks post injury,” Dr. Kontos and colleagues concluded. “Education on injury and behavioral recommendations to optimize concussion recovery and earlier initiation of active rehabilitation strategies, including exertion and vestibular therapy, are plausible explanations for the association of a shorter recovery time with earlier care. However, future research should focus on the specific mechanisms by which earlier health care postconcussion promotes faster recovery and determine if these findings apply to other subpopulations, including military personnel.”
The researchers noted that they excluded from their analysis 254 patients who had incomplete recovery data but otherwise met inclusion criteria, which may have led to selection bias.
Dr. Kontos disclosed grants from the National Football League and personal fees from APA Books and University of Pittsburgh projects outside the scope of this study.
SOURCE: Kontos AP et al. JAMA Neurol. 2020 Jan 6. doi: 10.1001/jamaneurol.2019.4552.
FROM JAMA NEUROLOGY
High-Dose Biotin Shows No Clear Disability Improvement in Progressive MS
Key clinical point: In patients with progressive MS, high-dose biotin was not found to offer clear improvement in disability.
Major finding: At 12 months, Expanded Disability Status Scale (EDSS) scores increased from 5.8 ± 1.3 before high-dose biotin initiation to 6.0 ± 1.3 at baseline. EDSS scores increased significantly under high-dose biotin (6.3 ± 1.3 at 12 months vs. 6.1 ± 1.3 at baseline; P less than .0001).
Study details: The data were obtained from a prospective study of 178 patients in routine clinical practice; 26 patients stopped treatment before 12 months and 152 continued for at least 12 months.
Disclosures: The study was supported by MedDay Pharma and by the ANTARES association. The corresponding author received honoraria from Biogen, Sanofi Genzyme, Teva, Roche, Merck, and MSD.
Citation: Couloume L et al. Mult Scler. 2019 Dec 17. doi: 10.1177/1352458519894713.
Key clinical point: In patients with progressive MS, high-dose biotin was not found to offer clear improvement in disability.
Major finding: At 12 months, Expanded Disability Status Scale (EDSS) scores increased from 5.8 ± 1.3 before high-dose biotin initiation to 6.0 ± 1.3 at baseline. EDSS scores increased significantly under high-dose biotin (6.3 ± 1.3 at 12 months vs. 6.1 ± 1.3 at baseline; P less than .0001).
Study details: The data were obtained from a prospective study of 178 patients in routine clinical practice; 26 patients stopped treatment before 12 months and 152 continued for at least 12 months.
Disclosures: The study was supported by MedDay Pharma and by the ANTARES association. The corresponding author received honoraria from Biogen, Sanofi Genzyme, Teva, Roche, Merck, and MSD.
Citation: Couloume L et al. Mult Scler. 2019 Dec 17. doi: 10.1177/1352458519894713.
Key clinical point: In patients with progressive MS, high-dose biotin was not found to offer clear improvement in disability.
Major finding: At 12 months, Expanded Disability Status Scale (EDSS) scores increased from 5.8 ± 1.3 before high-dose biotin initiation to 6.0 ± 1.3 at baseline. EDSS scores increased significantly under high-dose biotin (6.3 ± 1.3 at 12 months vs. 6.1 ± 1.3 at baseline; P less than .0001).
Study details: The data were obtained from a prospective study of 178 patients in routine clinical practice; 26 patients stopped treatment before 12 months and 152 continued for at least 12 months.
Disclosures: The study was supported by MedDay Pharma and by the ANTARES association. The corresponding author received honoraria from Biogen, Sanofi Genzyme, Teva, Roche, Merck, and MSD.
Citation: Couloume L et al. Mult Scler. 2019 Dec 17. doi: 10.1177/1352458519894713.
Higher Vitamin D Levels Linked to Lower MS Risk
Key clinical point: Higher serum concentrations of 25-hydroxyvitamin D (25(OH)D) are associated with a reduced risk for multiple sclerosis (MS).
Major finding: Being in the top 25(OH)D quintile was significantly associated with a reduced risk of multiple sclerosis (odds ratio, 0.68; 95% confidence interval, 0.50-0.93).
Study details: A nested case-control study using data from 6 Swedish biobanks (665 cases and an equal number of matched controls).
Disclosures: This study was supported by the Swedish Research Council and through a regional agreement between Umea University and the Vasterbotten County Council. One author received speaking fees from Merck-Serono and served on advisory boards for Merck-Serono and Biogen and another received honoraria for lectures from Genzyme and for advisory board roles from Roche and Novartis.
Citation: Biström M et al. Mult Scler J Exp Transl Clin. 2019 Dec 6. doi: 10.1177/2055217319892291.
Key clinical point: Higher serum concentrations of 25-hydroxyvitamin D (25(OH)D) are associated with a reduced risk for multiple sclerosis (MS).
Major finding: Being in the top 25(OH)D quintile was significantly associated with a reduced risk of multiple sclerosis (odds ratio, 0.68; 95% confidence interval, 0.50-0.93).
Study details: A nested case-control study using data from 6 Swedish biobanks (665 cases and an equal number of matched controls).
Disclosures: This study was supported by the Swedish Research Council and through a regional agreement between Umea University and the Vasterbotten County Council. One author received speaking fees from Merck-Serono and served on advisory boards for Merck-Serono and Biogen and another received honoraria for lectures from Genzyme and for advisory board roles from Roche and Novartis.
Citation: Biström M et al. Mult Scler J Exp Transl Clin. 2019 Dec 6. doi: 10.1177/2055217319892291.
Key clinical point: Higher serum concentrations of 25-hydroxyvitamin D (25(OH)D) are associated with a reduced risk for multiple sclerosis (MS).
Major finding: Being in the top 25(OH)D quintile was significantly associated with a reduced risk of multiple sclerosis (odds ratio, 0.68; 95% confidence interval, 0.50-0.93).
Study details: A nested case-control study using data from 6 Swedish biobanks (665 cases and an equal number of matched controls).
Disclosures: This study was supported by the Swedish Research Council and through a regional agreement between Umea University and the Vasterbotten County Council. One author received speaking fees from Merck-Serono and served on advisory boards for Merck-Serono and Biogen and another received honoraria for lectures from Genzyme and for advisory board roles from Roche and Novartis.
Citation: Biström M et al. Mult Scler J Exp Transl Clin. 2019 Dec 6. doi: 10.1177/2055217319892291.
Fingolimod may offer benefits in relapsing multiple sclerosis
Key clinical point: In patients with relapsing multiple sclerosis, fingolimod has a superior effect on clinical and magnetic resonance imaging (MRI) outcomes than placebo and presents an acceptable safety profile.
Major finding: Compared with placebo, fingolimod (0.5, 1.25, and 5 mg/day doses) had a significant reduction in annualized relapse rate. Fingolimod demonstrated beneficial effects on MRI outcomes, including the number of gadolinium-enhancing T1 lesions, and improved patient quality of life. No significant difference was found between the groups in terms of adverse events.
Study details: This was a systematic review and meta-analysis of 10 studies, including 6,547 participants.
Disclosures: The authors reported having no conflicts of interest.
Citation: Yang T et al. Br J Clin Pharmacol. 2019 Dec 23. doi: 10.1111/bcp.14198.
Key clinical point: In patients with relapsing multiple sclerosis, fingolimod has a superior effect on clinical and magnetic resonance imaging (MRI) outcomes than placebo and presents an acceptable safety profile.
Major finding: Compared with placebo, fingolimod (0.5, 1.25, and 5 mg/day doses) had a significant reduction in annualized relapse rate. Fingolimod demonstrated beneficial effects on MRI outcomes, including the number of gadolinium-enhancing T1 lesions, and improved patient quality of life. No significant difference was found between the groups in terms of adverse events.
Study details: This was a systematic review and meta-analysis of 10 studies, including 6,547 participants.
Disclosures: The authors reported having no conflicts of interest.
Citation: Yang T et al. Br J Clin Pharmacol. 2019 Dec 23. doi: 10.1111/bcp.14198.
Key clinical point: In patients with relapsing multiple sclerosis, fingolimod has a superior effect on clinical and magnetic resonance imaging (MRI) outcomes than placebo and presents an acceptable safety profile.
Major finding: Compared with placebo, fingolimod (0.5, 1.25, and 5 mg/day doses) had a significant reduction in annualized relapse rate. Fingolimod demonstrated beneficial effects on MRI outcomes, including the number of gadolinium-enhancing T1 lesions, and improved patient quality of life. No significant difference was found between the groups in terms of adverse events.
Study details: This was a systematic review and meta-analysis of 10 studies, including 6,547 participants.
Disclosures: The authors reported having no conflicts of interest.
Citation: Yang T et al. Br J Clin Pharmacol. 2019 Dec 23. doi: 10.1111/bcp.14198.