Pneumonia, COPD most common emergency care–sensitive conditions

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– Emergency care–sensitive conditions – those for which timely access to high-quality emergency care impact morbidity and mortality—account for 14% of all ED visits, results from a large analysis of national data showed.

Doug Brunk/MDedge News
Dr. Anita Vashi

In previously published work, an eight-member expert panel identified 51 condition groups as emergency care–sensitive conditions (ECSCs), including asthma, cardiac arrest, cerebral infarction, and pneumonia. The purpose of the current study, published in Annals of Emergency Medicine and presented by Anita Vashi, MD, MPH, at the annual meeting of the American College of Emergency Physicians, was to provide the first national estimates of acute care utilization and the demographic characteristics of adults experiencing ECSCs, compare ECSC and non-ECSC ED visits, and assess patient- and hospital-level characteristics predictive of an ECSC-related ED visit.

Using the Nationwide Emergency Department Sample data set, Dr. Vashi, a physician investigator at the Center for Innovation to Implementation at the VA Palo Alto Health Care System, and her colleagues retrospectively evaluated all ED visits for patients aged 18 years and older from 2009 to 2014. The researchers used summary statistics to compare population characteristics across groups and multivariable logistic regression models to assess the odds of an ECSC-related ED visit with patient- and hospital-level characteristics.

Of the 622,725,542 estimated ED visits evaluated during the study period, 86,577,041 (14%) were ECSCs. Among these ECSC visits, 58% of patients were admitted for an average length of 3.2 days and an average charge of $2,240. The most frequent ECSC-related visits were for pneumonia (9%), chronic obstructive pulmonary disease (9%), asthma (7%), heart failure (7%), and sepsis (5%), but varied by age group.

Dr. Vashi and her colleagues found that ECSCs were more common among older adults, males, those who reside in low-income areas, those who reside in the South, and among metropolitan-based hospitals and nontrauma center hospitals. ECSCs also accounted for about 45% of all inpatient admissions.



Multivariate logistic regression analysis revealed that the odds of having an ECSC-related visit was highest among patients aged 65 years and older (odds ratio, 3.84), those on Medicare (OR, 1.37), those who resided in rural counties (OR, 1.21), and those who reside in the Western portion of the United States (OR, 1.11). Significant hospital-related factors related to ECSC visits included trauma centers (OR, 1.09), nonteaching hospitals (OR, 1.04), and EDs located in the wealthiest counties (OR, 1.02).

The researchers also found that 40% of patients who made ECSC-related ED visits were treated and discharged back to the community. “There is evidence of regional variability, suggesting the need for future research,” said Dr. Vashi, who also holds a faculty position in the department of emergency medicine at Stanford (Calif.) University. “We found no consistent relationship between insurance, income, and ED use for ECSC-related conditions. This suggests that ECSCs are not significantly influenced by socioeconomic factor and can serve as a reliable marker for acuity.”

The next steps in this research area, she added, are to create condition-specific measures related to morbidity, mortality, and posthospital events, as well as to analyze regional and hospital variations including correlation across conditions, and to compare performance across conditions and hospitals.

Dr. Vashi reported having no financial disclosures.

Source: Vashi A et al. Ann Emerg Med. 2018 Oct;72;4:S38. doi. 10.1016/j.annemergmed.2018.08.091.




 

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– Emergency care–sensitive conditions – those for which timely access to high-quality emergency care impact morbidity and mortality—account for 14% of all ED visits, results from a large analysis of national data showed.

Doug Brunk/MDedge News
Dr. Anita Vashi

In previously published work, an eight-member expert panel identified 51 condition groups as emergency care–sensitive conditions (ECSCs), including asthma, cardiac arrest, cerebral infarction, and pneumonia. The purpose of the current study, published in Annals of Emergency Medicine and presented by Anita Vashi, MD, MPH, at the annual meeting of the American College of Emergency Physicians, was to provide the first national estimates of acute care utilization and the demographic characteristics of adults experiencing ECSCs, compare ECSC and non-ECSC ED visits, and assess patient- and hospital-level characteristics predictive of an ECSC-related ED visit.

Using the Nationwide Emergency Department Sample data set, Dr. Vashi, a physician investigator at the Center for Innovation to Implementation at the VA Palo Alto Health Care System, and her colleagues retrospectively evaluated all ED visits for patients aged 18 years and older from 2009 to 2014. The researchers used summary statistics to compare population characteristics across groups and multivariable logistic regression models to assess the odds of an ECSC-related ED visit with patient- and hospital-level characteristics.

Of the 622,725,542 estimated ED visits evaluated during the study period, 86,577,041 (14%) were ECSCs. Among these ECSC visits, 58% of patients were admitted for an average length of 3.2 days and an average charge of $2,240. The most frequent ECSC-related visits were for pneumonia (9%), chronic obstructive pulmonary disease (9%), asthma (7%), heart failure (7%), and sepsis (5%), but varied by age group.

Dr. Vashi and her colleagues found that ECSCs were more common among older adults, males, those who reside in low-income areas, those who reside in the South, and among metropolitan-based hospitals and nontrauma center hospitals. ECSCs also accounted for about 45% of all inpatient admissions.



Multivariate logistic regression analysis revealed that the odds of having an ECSC-related visit was highest among patients aged 65 years and older (odds ratio, 3.84), those on Medicare (OR, 1.37), those who resided in rural counties (OR, 1.21), and those who reside in the Western portion of the United States (OR, 1.11). Significant hospital-related factors related to ECSC visits included trauma centers (OR, 1.09), nonteaching hospitals (OR, 1.04), and EDs located in the wealthiest counties (OR, 1.02).

The researchers also found that 40% of patients who made ECSC-related ED visits were treated and discharged back to the community. “There is evidence of regional variability, suggesting the need for future research,” said Dr. Vashi, who also holds a faculty position in the department of emergency medicine at Stanford (Calif.) University. “We found no consistent relationship between insurance, income, and ED use for ECSC-related conditions. This suggests that ECSCs are not significantly influenced by socioeconomic factor and can serve as a reliable marker for acuity.”

The next steps in this research area, she added, are to create condition-specific measures related to morbidity, mortality, and posthospital events, as well as to analyze regional and hospital variations including correlation across conditions, and to compare performance across conditions and hospitals.

Dr. Vashi reported having no financial disclosures.

Source: Vashi A et al. Ann Emerg Med. 2018 Oct;72;4:S38. doi. 10.1016/j.annemergmed.2018.08.091.




 

 

– Emergency care–sensitive conditions – those for which timely access to high-quality emergency care impact morbidity and mortality—account for 14% of all ED visits, results from a large analysis of national data showed.

Doug Brunk/MDedge News
Dr. Anita Vashi

In previously published work, an eight-member expert panel identified 51 condition groups as emergency care–sensitive conditions (ECSCs), including asthma, cardiac arrest, cerebral infarction, and pneumonia. The purpose of the current study, published in Annals of Emergency Medicine and presented by Anita Vashi, MD, MPH, at the annual meeting of the American College of Emergency Physicians, was to provide the first national estimates of acute care utilization and the demographic characteristics of adults experiencing ECSCs, compare ECSC and non-ECSC ED visits, and assess patient- and hospital-level characteristics predictive of an ECSC-related ED visit.

Using the Nationwide Emergency Department Sample data set, Dr. Vashi, a physician investigator at the Center for Innovation to Implementation at the VA Palo Alto Health Care System, and her colleagues retrospectively evaluated all ED visits for patients aged 18 years and older from 2009 to 2014. The researchers used summary statistics to compare population characteristics across groups and multivariable logistic regression models to assess the odds of an ECSC-related ED visit with patient- and hospital-level characteristics.

Of the 622,725,542 estimated ED visits evaluated during the study period, 86,577,041 (14%) were ECSCs. Among these ECSC visits, 58% of patients were admitted for an average length of 3.2 days and an average charge of $2,240. The most frequent ECSC-related visits were for pneumonia (9%), chronic obstructive pulmonary disease (9%), asthma (7%), heart failure (7%), and sepsis (5%), but varied by age group.

Dr. Vashi and her colleagues found that ECSCs were more common among older adults, males, those who reside in low-income areas, those who reside in the South, and among metropolitan-based hospitals and nontrauma center hospitals. ECSCs also accounted for about 45% of all inpatient admissions.



Multivariate logistic regression analysis revealed that the odds of having an ECSC-related visit was highest among patients aged 65 years and older (odds ratio, 3.84), those on Medicare (OR, 1.37), those who resided in rural counties (OR, 1.21), and those who reside in the Western portion of the United States (OR, 1.11). Significant hospital-related factors related to ECSC visits included trauma centers (OR, 1.09), nonteaching hospitals (OR, 1.04), and EDs located in the wealthiest counties (OR, 1.02).

The researchers also found that 40% of patients who made ECSC-related ED visits were treated and discharged back to the community. “There is evidence of regional variability, suggesting the need for future research,” said Dr. Vashi, who also holds a faculty position in the department of emergency medicine at Stanford (Calif.) University. “We found no consistent relationship between insurance, income, and ED use for ECSC-related conditions. This suggests that ECSCs are not significantly influenced by socioeconomic factor and can serve as a reliable marker for acuity.”

The next steps in this research area, she added, are to create condition-specific measures related to morbidity, mortality, and posthospital events, as well as to analyze regional and hospital variations including correlation across conditions, and to compare performance across conditions and hospitals.

Dr. Vashi reported having no financial disclosures.

Source: Vashi A et al. Ann Emerg Med. 2018 Oct;72;4:S38. doi. 10.1016/j.annemergmed.2018.08.091.




 

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Key clinical point: Emergency care–sensitive conditions (ECSCs) make up a significant proportion of ED visits.

Major finding: The most common ECSC-related visits were for pneumonia (9%), chronic obstructive pulmonary disease (9%), and asthma (7%).

Study details: A retrospective cohort study of more than 86.5 million ECSC-related ED visits.

Disclosures: Dr. Vashi reported having no financial disclosures.

Source: Vashi A et al. Ann Emerg Med. 2018 Oct;72;4:S38. doi. 10.1016/j.annemergmed.2018.08.091.

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ED clinicians’ confidence in dealing with ICE mixed, survey finds

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– Most emergency physicians have limited comfort and knowledge about appropriate interactions with Immigration and Customs Enforcement officers in the ED, based on results from a survey conducted at two Chicago hospitals.

Doug Brunk/MDedge News
Dr. Charlotte Roy

“More robust training and education may improve provider comfort and ability to appropriately balance patients’ rights with law enforcement,” one of the study authors, Charlotte Roy, MD, said at the annual meeting of the American College of Emergency Physicians.

Immigration and Customs Enforcement (ICE) is a federal government agency responsible for the detainment and deportation of immigrants whom they deem to be in violation of federal immigration law. Typically, hospitals have fallen into the category of “sensitive locations,” meaning they are avoided by ICE for enforcement actions, said Dr. Roy, a third-year resident in the department of emergency medicine at University of Chicago Hospital. However, “we’ve seen an increase in the apprehension and removal of illegal immigrants by 30% in 2017 across all locations,” she said.

In an effort to assess provider comfort, knowledge, and previous training on the subject, Dr. Roy and her colleagues administered a 15-question multiple-choice survey to 128 emergency residents, fellows, and attendings at John H. Stroger Jr. Hospital of Cook County and University of Chicago Hospital. Most of the 128 survey participants were residents (70), followed by 54 fellows and 4 attendings. One of the two hospital ED programs offered formal training on the topic, yet only 44% of respondents from that program reported that they participated in the training.



Examples of questions included “Do you know in what circumstances you are required to give protected health information of patients to immigration officers?” “Do you feel confident in your knowledge of which areas of the emergency department ICE agents could enter?” and “Are you confident you can get real-time help to answer questions regarding interactions with immigration officers?”

Among all respondents, 52% said that they would not feel comfortable interacting with immigration officers in the ED, 12% felt confident knowing which areas of the ED immigration officers could freely enter, and 11% were familiar with the designation of “sensitive locations” within their hospital. In addition, 23% of respondents knew that immigration status is protected under the Health Insurance Portability and Accountability Act of 1996 as protected health information, 16% knew in which circumstances they were required to convey immigrant status, and 51% knew a warrant or a court order is required for an immigration office to enter a patient’s room.

“Our conclusion based on these survey results is that there is very limited comfort and knowledge amongst ED providers regarding interactions with ICE officers in the ED,” Dr. Roy said. One resource she recommended is the National Immigration Law Center, which publishes a guide, “What to Do If Immigration Comes to Your Workplace.” The study’s primary author was Joseph Palter, MD. The researchers reported having no financial disclosures.

Source: Palter J et al. Ann Emerg Med. 2018 Oct;72;4:S117. doi. 10.1016/j.annemergmed.2018.08.303.

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– Most emergency physicians have limited comfort and knowledge about appropriate interactions with Immigration and Customs Enforcement officers in the ED, based on results from a survey conducted at two Chicago hospitals.

Doug Brunk/MDedge News
Dr. Charlotte Roy

“More robust training and education may improve provider comfort and ability to appropriately balance patients’ rights with law enforcement,” one of the study authors, Charlotte Roy, MD, said at the annual meeting of the American College of Emergency Physicians.

Immigration and Customs Enforcement (ICE) is a federal government agency responsible for the detainment and deportation of immigrants whom they deem to be in violation of federal immigration law. Typically, hospitals have fallen into the category of “sensitive locations,” meaning they are avoided by ICE for enforcement actions, said Dr. Roy, a third-year resident in the department of emergency medicine at University of Chicago Hospital. However, “we’ve seen an increase in the apprehension and removal of illegal immigrants by 30% in 2017 across all locations,” she said.

In an effort to assess provider comfort, knowledge, and previous training on the subject, Dr. Roy and her colleagues administered a 15-question multiple-choice survey to 128 emergency residents, fellows, and attendings at John H. Stroger Jr. Hospital of Cook County and University of Chicago Hospital. Most of the 128 survey participants were residents (70), followed by 54 fellows and 4 attendings. One of the two hospital ED programs offered formal training on the topic, yet only 44% of respondents from that program reported that they participated in the training.



Examples of questions included “Do you know in what circumstances you are required to give protected health information of patients to immigration officers?” “Do you feel confident in your knowledge of which areas of the emergency department ICE agents could enter?” and “Are you confident you can get real-time help to answer questions regarding interactions with immigration officers?”

Among all respondents, 52% said that they would not feel comfortable interacting with immigration officers in the ED, 12% felt confident knowing which areas of the ED immigration officers could freely enter, and 11% were familiar with the designation of “sensitive locations” within their hospital. In addition, 23% of respondents knew that immigration status is protected under the Health Insurance Portability and Accountability Act of 1996 as protected health information, 16% knew in which circumstances they were required to convey immigrant status, and 51% knew a warrant or a court order is required for an immigration office to enter a patient’s room.

“Our conclusion based on these survey results is that there is very limited comfort and knowledge amongst ED providers regarding interactions with ICE officers in the ED,” Dr. Roy said. One resource she recommended is the National Immigration Law Center, which publishes a guide, “What to Do If Immigration Comes to Your Workplace.” The study’s primary author was Joseph Palter, MD. The researchers reported having no financial disclosures.

Source: Palter J et al. Ann Emerg Med. 2018 Oct;72;4:S117. doi. 10.1016/j.annemergmed.2018.08.303.

 

– Most emergency physicians have limited comfort and knowledge about appropriate interactions with Immigration and Customs Enforcement officers in the ED, based on results from a survey conducted at two Chicago hospitals.

Doug Brunk/MDedge News
Dr. Charlotte Roy

“More robust training and education may improve provider comfort and ability to appropriately balance patients’ rights with law enforcement,” one of the study authors, Charlotte Roy, MD, said at the annual meeting of the American College of Emergency Physicians.

Immigration and Customs Enforcement (ICE) is a federal government agency responsible for the detainment and deportation of immigrants whom they deem to be in violation of federal immigration law. Typically, hospitals have fallen into the category of “sensitive locations,” meaning they are avoided by ICE for enforcement actions, said Dr. Roy, a third-year resident in the department of emergency medicine at University of Chicago Hospital. However, “we’ve seen an increase in the apprehension and removal of illegal immigrants by 30% in 2017 across all locations,” she said.

In an effort to assess provider comfort, knowledge, and previous training on the subject, Dr. Roy and her colleagues administered a 15-question multiple-choice survey to 128 emergency residents, fellows, and attendings at John H. Stroger Jr. Hospital of Cook County and University of Chicago Hospital. Most of the 128 survey participants were residents (70), followed by 54 fellows and 4 attendings. One of the two hospital ED programs offered formal training on the topic, yet only 44% of respondents from that program reported that they participated in the training.



Examples of questions included “Do you know in what circumstances you are required to give protected health information of patients to immigration officers?” “Do you feel confident in your knowledge of which areas of the emergency department ICE agents could enter?” and “Are you confident you can get real-time help to answer questions regarding interactions with immigration officers?”

Among all respondents, 52% said that they would not feel comfortable interacting with immigration officers in the ED, 12% felt confident knowing which areas of the ED immigration officers could freely enter, and 11% were familiar with the designation of “sensitive locations” within their hospital. In addition, 23% of respondents knew that immigration status is protected under the Health Insurance Portability and Accountability Act of 1996 as protected health information, 16% knew in which circumstances they were required to convey immigrant status, and 51% knew a warrant or a court order is required for an immigration office to enter a patient’s room.

“Our conclusion based on these survey results is that there is very limited comfort and knowledge amongst ED providers regarding interactions with ICE officers in the ED,” Dr. Roy said. One resource she recommended is the National Immigration Law Center, which publishes a guide, “What to Do If Immigration Comes to Your Workplace.” The study’s primary author was Joseph Palter, MD. The researchers reported having no financial disclosures.

Source: Palter J et al. Ann Emerg Med. 2018 Oct;72;4:S117. doi. 10.1016/j.annemergmed.2018.08.303.

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Key clinical point: Emergency physicians’ knowledge of how to interact with immigration agencies is highly variable.

Major finding: More than half of respondents (52%) said that they would not feel comfortable interacting with immigration officers in the ED.

Study details: A survey of 128 emergency medicine physicians.

Disclosures: The researchers reported having no financial disclosures.

Source: Palter J et al. Ann Emerg Med. 2018 Oct;72;4:S117. doi. 10.1016/j.annemergmed.2018.08.303.

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BIOFLOW V: Orsiro outperforms Xience stent

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– Seemingly nuanced differences between drug-eluting stents can translate to substantial differences in clinical outcomes longer term, updated results of the BIOFLOW V randomized trial reported at the Transcatheter Cardiovascular Therapeutics annual meeting suggest.

“As we have celebrated recently the 30th year of stent implantation, coronary drug-eluting stent development has included new metal alloys, changes in stent architecture, and bioresorbable polymers,” commented lead investigator David E. Kandzari, MD, director of interventional cardiology and chief scientific officer at the Piedmont Heart Institute, Atlanta. “Yet whether these advancements improve long-term clinical safety and efficacy has been inconsistent in previous studies.”

BIOFLOW V compared the Orsiro ultrathin-strut, bioresorbable-polymer, sirolimus-eluting stent with the Xience thin-strut, durable-polymer, everolimus-eluting stent among 1,334 patients undergoing percutaneous coronary intervention.

Initial results showed that the primary outcome of 1-year target lesion failure – the composite of cardiac death, ischemia-driven target lesion revascularization, and target vessel–related myocardial infarction – was significantly lower in the Orsiro stent group (6% vs. 10%, P = .0399) (Lancet. 2017;390:1843-52). Superiority at this time point was mainly driven by a lower rate of target vessel–related MI (5% vs. 8%, P = .0155).

With the update, now at 2 years of follow-up, the significant difference in target lesion failure rate persisted, with a rate of 7.1% with Orsiro stents versus 11.9% with Xience stents (P = .015), according to results reported at the meeting and simultaneously published (J Am Coll Cardiol. 2018 Sep 19. doi: 10.1016/j.jacc.2018.09.019).

There was likewise still a significant difference in favor of the Orsiro stent in target vessel–related MI, but the rate of ischemia-driven target lesion revascularization was now significantly lower as well. In addition, this stent yielded a lower rate of definite or probable stent thrombosis occurring late or very late.

“Altogether, these results not only advance a standard of comparison for new drug-eluting stents, but they direct our attention to strut thickness and polymer composition as key features for iterative drug-eluting stent development,” Dr. Kandzari summarized. Additional BIOFLOW V follow-up, out to 5 years, is planned, he noted.

Session comoderator Fernando Alfonso, MD, PhD, an interventional cardiologist at the Cardiovascular Institute at San Carlos University Hospital in Madrid, wondered about the role of dual-antiplatelet therapy. “Was that treatment related in some way to events? Was there any kind of interaction between those who were maintained on dual-antiplatelet therapy and those having late events?” he asked.

“Through 2 years of follow-up, adherence to dual-antiplatelet therapy was numerically identical in both groups. But it was not related in any way to either target vessel MI–related events or stent thrombosis events,” Dr. Kandzari replied.
 

Trial details

The BIOFLOW V trialists recruited patients from 13 countries and enrolled those who had up to three de novo target lesions in up to two native target vessels. Patients were randomized 2:1 to receive Orsiro stents (Biotronik) or Xience stents (Abbott).

At 2 years, 45.6% of those in the former group and 45.1% of those in the latter group were adherent to dual antiplatelet therapy (P = .88), Dr. Kandzari reported at the meeting, which was sponsored by the Cardiovascular Research Foundation.

The lower 2-year rate of the primary composite outcome of target lesion failure with the Orsiro stent was driven by lower rates of both target vessel–related MI (5.3% vs. 9.5%, P = .01) and ischemia-driven target lesion revascularization (2.6% vs. 4.9%, P = .04). There was still no significant difference for cardiac death (0.6% vs. 0.5%, P = 1.0).

The edge of Orsiro stents over Xience stents for target lesion failure was similar across subgroups, with the possible exception of greater benefit of the latter in patients older than 75 (P for interaction = .039).

In landmark analyses, a significant difference in rates of target vessel–related MI favoring Orsiro stents was evident both in the first 30 days after the procedure (P = .04) and from 30 days to 2 years, presumably reflecting fewer spontaneous MIs (P = .01). Ischemia-driven target lesion revascularization did not difference in the first year of follow-up (P = .72) but it did between the first and second years (P = .01).

Most measures of stent thrombosis were similar for the two groups. However, the rate of definite or probable stent thrombosis occurring late or very late (between 30 days and 2 years) was just 0.1% for Orsiro stents, compared with 1.0% for Xience stents (P = .045).

Dr. Kandzari disclosed that he receives grant/research support from Biotronik, Boston Scientific, Medtronic CardioVascular, Medinol, and Orbus Neich, and that he receives consulting fees and honoraria from Biotronik, Boston Scientific Corporation, Cardinal Health, and Medtronic CardioVascular. The trial was sponsored by Biotronik.

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– Seemingly nuanced differences between drug-eluting stents can translate to substantial differences in clinical outcomes longer term, updated results of the BIOFLOW V randomized trial reported at the Transcatheter Cardiovascular Therapeutics annual meeting suggest.

“As we have celebrated recently the 30th year of stent implantation, coronary drug-eluting stent development has included new metal alloys, changes in stent architecture, and bioresorbable polymers,” commented lead investigator David E. Kandzari, MD, director of interventional cardiology and chief scientific officer at the Piedmont Heart Institute, Atlanta. “Yet whether these advancements improve long-term clinical safety and efficacy has been inconsistent in previous studies.”

BIOFLOW V compared the Orsiro ultrathin-strut, bioresorbable-polymer, sirolimus-eluting stent with the Xience thin-strut, durable-polymer, everolimus-eluting stent among 1,334 patients undergoing percutaneous coronary intervention.

Initial results showed that the primary outcome of 1-year target lesion failure – the composite of cardiac death, ischemia-driven target lesion revascularization, and target vessel–related myocardial infarction – was significantly lower in the Orsiro stent group (6% vs. 10%, P = .0399) (Lancet. 2017;390:1843-52). Superiority at this time point was mainly driven by a lower rate of target vessel–related MI (5% vs. 8%, P = .0155).

With the update, now at 2 years of follow-up, the significant difference in target lesion failure rate persisted, with a rate of 7.1% with Orsiro stents versus 11.9% with Xience stents (P = .015), according to results reported at the meeting and simultaneously published (J Am Coll Cardiol. 2018 Sep 19. doi: 10.1016/j.jacc.2018.09.019).

There was likewise still a significant difference in favor of the Orsiro stent in target vessel–related MI, but the rate of ischemia-driven target lesion revascularization was now significantly lower as well. In addition, this stent yielded a lower rate of definite or probable stent thrombosis occurring late or very late.

“Altogether, these results not only advance a standard of comparison for new drug-eluting stents, but they direct our attention to strut thickness and polymer composition as key features for iterative drug-eluting stent development,” Dr. Kandzari summarized. Additional BIOFLOW V follow-up, out to 5 years, is planned, he noted.

Session comoderator Fernando Alfonso, MD, PhD, an interventional cardiologist at the Cardiovascular Institute at San Carlos University Hospital in Madrid, wondered about the role of dual-antiplatelet therapy. “Was that treatment related in some way to events? Was there any kind of interaction between those who were maintained on dual-antiplatelet therapy and those having late events?” he asked.

“Through 2 years of follow-up, adherence to dual-antiplatelet therapy was numerically identical in both groups. But it was not related in any way to either target vessel MI–related events or stent thrombosis events,” Dr. Kandzari replied.
 

Trial details

The BIOFLOW V trialists recruited patients from 13 countries and enrolled those who had up to three de novo target lesions in up to two native target vessels. Patients were randomized 2:1 to receive Orsiro stents (Biotronik) or Xience stents (Abbott).

At 2 years, 45.6% of those in the former group and 45.1% of those in the latter group were adherent to dual antiplatelet therapy (P = .88), Dr. Kandzari reported at the meeting, which was sponsored by the Cardiovascular Research Foundation.

The lower 2-year rate of the primary composite outcome of target lesion failure with the Orsiro stent was driven by lower rates of both target vessel–related MI (5.3% vs. 9.5%, P = .01) and ischemia-driven target lesion revascularization (2.6% vs. 4.9%, P = .04). There was still no significant difference for cardiac death (0.6% vs. 0.5%, P = 1.0).

The edge of Orsiro stents over Xience stents for target lesion failure was similar across subgroups, with the possible exception of greater benefit of the latter in patients older than 75 (P for interaction = .039).

In landmark analyses, a significant difference in rates of target vessel–related MI favoring Orsiro stents was evident both in the first 30 days after the procedure (P = .04) and from 30 days to 2 years, presumably reflecting fewer spontaneous MIs (P = .01). Ischemia-driven target lesion revascularization did not difference in the first year of follow-up (P = .72) but it did between the first and second years (P = .01).

Most measures of stent thrombosis were similar for the two groups. However, the rate of definite or probable stent thrombosis occurring late or very late (between 30 days and 2 years) was just 0.1% for Orsiro stents, compared with 1.0% for Xience stents (P = .045).

Dr. Kandzari disclosed that he receives grant/research support from Biotronik, Boston Scientific, Medtronic CardioVascular, Medinol, and Orbus Neich, and that he receives consulting fees and honoraria from Biotronik, Boston Scientific Corporation, Cardinal Health, and Medtronic CardioVascular. The trial was sponsored by Biotronik.

 

– Seemingly nuanced differences between drug-eluting stents can translate to substantial differences in clinical outcomes longer term, updated results of the BIOFLOW V randomized trial reported at the Transcatheter Cardiovascular Therapeutics annual meeting suggest.

“As we have celebrated recently the 30th year of stent implantation, coronary drug-eluting stent development has included new metal alloys, changes in stent architecture, and bioresorbable polymers,” commented lead investigator David E. Kandzari, MD, director of interventional cardiology and chief scientific officer at the Piedmont Heart Institute, Atlanta. “Yet whether these advancements improve long-term clinical safety and efficacy has been inconsistent in previous studies.”

BIOFLOW V compared the Orsiro ultrathin-strut, bioresorbable-polymer, sirolimus-eluting stent with the Xience thin-strut, durable-polymer, everolimus-eluting stent among 1,334 patients undergoing percutaneous coronary intervention.

Initial results showed that the primary outcome of 1-year target lesion failure – the composite of cardiac death, ischemia-driven target lesion revascularization, and target vessel–related myocardial infarction – was significantly lower in the Orsiro stent group (6% vs. 10%, P = .0399) (Lancet. 2017;390:1843-52). Superiority at this time point was mainly driven by a lower rate of target vessel–related MI (5% vs. 8%, P = .0155).

With the update, now at 2 years of follow-up, the significant difference in target lesion failure rate persisted, with a rate of 7.1% with Orsiro stents versus 11.9% with Xience stents (P = .015), according to results reported at the meeting and simultaneously published (J Am Coll Cardiol. 2018 Sep 19. doi: 10.1016/j.jacc.2018.09.019).

There was likewise still a significant difference in favor of the Orsiro stent in target vessel–related MI, but the rate of ischemia-driven target lesion revascularization was now significantly lower as well. In addition, this stent yielded a lower rate of definite or probable stent thrombosis occurring late or very late.

“Altogether, these results not only advance a standard of comparison for new drug-eluting stents, but they direct our attention to strut thickness and polymer composition as key features for iterative drug-eluting stent development,” Dr. Kandzari summarized. Additional BIOFLOW V follow-up, out to 5 years, is planned, he noted.

Session comoderator Fernando Alfonso, MD, PhD, an interventional cardiologist at the Cardiovascular Institute at San Carlos University Hospital in Madrid, wondered about the role of dual-antiplatelet therapy. “Was that treatment related in some way to events? Was there any kind of interaction between those who were maintained on dual-antiplatelet therapy and those having late events?” he asked.

“Through 2 years of follow-up, adherence to dual-antiplatelet therapy was numerically identical in both groups. But it was not related in any way to either target vessel MI–related events or stent thrombosis events,” Dr. Kandzari replied.
 

Trial details

The BIOFLOW V trialists recruited patients from 13 countries and enrolled those who had up to three de novo target lesions in up to two native target vessels. Patients were randomized 2:1 to receive Orsiro stents (Biotronik) or Xience stents (Abbott).

At 2 years, 45.6% of those in the former group and 45.1% of those in the latter group were adherent to dual antiplatelet therapy (P = .88), Dr. Kandzari reported at the meeting, which was sponsored by the Cardiovascular Research Foundation.

The lower 2-year rate of the primary composite outcome of target lesion failure with the Orsiro stent was driven by lower rates of both target vessel–related MI (5.3% vs. 9.5%, P = .01) and ischemia-driven target lesion revascularization (2.6% vs. 4.9%, P = .04). There was still no significant difference for cardiac death (0.6% vs. 0.5%, P = 1.0).

The edge of Orsiro stents over Xience stents for target lesion failure was similar across subgroups, with the possible exception of greater benefit of the latter in patients older than 75 (P for interaction = .039).

In landmark analyses, a significant difference in rates of target vessel–related MI favoring Orsiro stents was evident both in the first 30 days after the procedure (P = .04) and from 30 days to 2 years, presumably reflecting fewer spontaneous MIs (P = .01). Ischemia-driven target lesion revascularization did not difference in the first year of follow-up (P = .72) but it did between the first and second years (P = .01).

Most measures of stent thrombosis were similar for the two groups. However, the rate of definite or probable stent thrombosis occurring late or very late (between 30 days and 2 years) was just 0.1% for Orsiro stents, compared with 1.0% for Xience stents (P = .045).

Dr. Kandzari disclosed that he receives grant/research support from Biotronik, Boston Scientific, Medtronic CardioVascular, Medinol, and Orbus Neich, and that he receives consulting fees and honoraria from Biotronik, Boston Scientific Corporation, Cardinal Health, and Medtronic CardioVascular. The trial was sponsored by Biotronik.

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Key clinical point: The Orsiro stent outperformed the Xience stent in patients undergoing PCI.

Major finding: The 2-year rate of target lesion failure was lower with the Orsiro stent than with the Xience stent (7.5% vs. 11.9%, P = .015).

Study details: A randomized controlled trial comparing the Orsiro ultrathin-strut, bioresorbable-polymer, sirolimus-eluting stent and the Xience thin-strut, durable-polymer, everolimus-eluting stent among 1,334 patients undergoing PCI (BIOFLOW V trial).

Disclosures: Dr. Kandzari disclosed that he receives grant/research support from Biotronik, Boston Scientific, Medtronic CardioVascular, Medinol, and Orbus Neich, and that he receives consulting fees and honoraria from Biotronik, Boston Scientific Corporation, Cardinal Health, and Medtronic CardioVascular. The trial was sponsored by Biotronik.

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AAP renews public health approach to gun injury prevention

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– The American Academy of Pediatrics created the Gun Safety and Injury Prevention Research Initiative to study and implement gun safety interventions to prevent homicide, suicide and unintentional injuries caused by firearms.

In an interview at the annual meeting of the American Academy of Pediatrics, Colleen A. Kraft, MD, FAAP, current AAP president, explained how AAP has renewed its efforts to protect children from firearm injuries. Black children are more likely to die in a homicide, while white children are more likely to die in a suicide through use of a firearm, Dr. Kraft said. The AAP seeks to find a nonpolitical way to discuss gun safety “with a lens on children and a lens on safety,” she said.

“What we are looking to do is to bring together partners who have the research expertise in gun safety and injury prevention, find out what we know, decide what we don’t know yet, and begin to bring together focus groups of parents and families and legislators and doctors, and people to talk about … gun safety in a way that resonates with everyone,” Dr. Kraft said.

Visit AAP’s website for more information on the Gun Safety and Injury Prevention Research Initiative.

Dr. Kraft reports no relevant conflicts of interest.

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– The American Academy of Pediatrics created the Gun Safety and Injury Prevention Research Initiative to study and implement gun safety interventions to prevent homicide, suicide and unintentional injuries caused by firearms.

In an interview at the annual meeting of the American Academy of Pediatrics, Colleen A. Kraft, MD, FAAP, current AAP president, explained how AAP has renewed its efforts to protect children from firearm injuries. Black children are more likely to die in a homicide, while white children are more likely to die in a suicide through use of a firearm, Dr. Kraft said. The AAP seeks to find a nonpolitical way to discuss gun safety “with a lens on children and a lens on safety,” she said.

“What we are looking to do is to bring together partners who have the research expertise in gun safety and injury prevention, find out what we know, decide what we don’t know yet, and begin to bring together focus groups of parents and families and legislators and doctors, and people to talk about … gun safety in a way that resonates with everyone,” Dr. Kraft said.

Visit AAP’s website for more information on the Gun Safety and Injury Prevention Research Initiative.

Dr. Kraft reports no relevant conflicts of interest.

– The American Academy of Pediatrics created the Gun Safety and Injury Prevention Research Initiative to study and implement gun safety interventions to prevent homicide, suicide and unintentional injuries caused by firearms.

In an interview at the annual meeting of the American Academy of Pediatrics, Colleen A. Kraft, MD, FAAP, current AAP president, explained how AAP has renewed its efforts to protect children from firearm injuries. Black children are more likely to die in a homicide, while white children are more likely to die in a suicide through use of a firearm, Dr. Kraft said. The AAP seeks to find a nonpolitical way to discuss gun safety “with a lens on children and a lens on safety,” she said.

“What we are looking to do is to bring together partners who have the research expertise in gun safety and injury prevention, find out what we know, decide what we don’t know yet, and begin to bring together focus groups of parents and families and legislators and doctors, and people to talk about … gun safety in a way that resonates with everyone,” Dr. Kraft said.

Visit AAP’s website for more information on the Gun Safety and Injury Prevention Research Initiative.

Dr. Kraft reports no relevant conflicts of interest.

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Triggers May Guide Treatment of New Daily Persistent Headache

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Aggressive initial therapy is appropriate because the disorder becomes increasingly refractory with time.

ASHEVILLE, NC—New daily persistent headache is rare and difficult to treat. Although neurologists may be tempted to try a series of treatments until the patient improves, therapeutic success is more likely if the neurologist can identify a triggering event, said Todd Rozen, MD, a neurologist at Mayo Clinic in Jacksonville, Florida. Elements of the patient’s history or clinical examination also can guide treatment, he added at the Eighth Annual Scientific Meeting of the Southern Headache Society.

Patients Remember the Onset

New daily persistent headache was first described in 1986, and few researchers have studied it. It is a persistent headache with a clearly remembered onset. “Most [patients] can name the date it began or at least the month,” said Dr. Rozen. The headache becomes unremitting within 24 hours and must be present for longer than three months, according to the current diagnostic criteria. Patients may have a remitting form, a relapsing-remitting form, or a refractory form of the headache. The age of onset “can be as early as in the mid to late teens or early 20s, especially in the female population,” said Dr. Rozen. Age of onset also depends on the triggering event.

The pain typically is bilateral and moderate to severe. Although many patients may present with a tension-type headache, more than 60% have migrainous symptoms such as nausea, photophobia, or phonophobia, said Dr. Rozen.

The disorder is more common among women than among men. Between 10% and 13% of patients who present to headache clinics have new daily persistent headache, said Dr. Rozen. “It is either becoming more prevalent in the office, or we are better at recognizing it.”

Comparing Effects on the Genders

For a study published in 2016, Dr. Rozen examined 97 patients (65 women) with new daily persistent headache. Approximately 53% of patients could not identify a triggering event for their headache, which makes treatment “much more difficult,” said Dr. Rozen. Although the mean age of onset was younger in women (32.4) than men (35.8), the age of onset was the same between genders when Dr. Rozen examined for individual triggers.

The frequency of individual triggering events also was the same between genders, and these results suggest that each trigger may be associated with a discrete pathogenesis. Triggers included infection or flulike illness (22%), stressful life event (9%), surgery (9%), and other (7%). All patients who had identified surgery as a trigger had been intubated, and Dr. Rozen hypothesized that their headaches were cervicogenic. The younger patients who had undergone surgery were hypermobile, and the older patients had neck arthritis as predisposing risk factors for neck irritation with intubation.

A Somatoform Disorder?

The stubbornly refractory nature of this disorder has aroused the suspicion that it may be somatoform. In 2017, Uniyal and colleagues found that somatization, generalized anxiety disorder, depression, and catastrophization were more common in patients with new daily persistent headache, compared with patients with chronic low back pain and healthy controls.

Interpreting these data is difficult, said Dr. Rozen. They may indicate that these psychiatric comorbidities are risk factors for new daily persistent headache. An equally plausible interpretation is that these patients have a different disorder (eg, Ehlers-Danlos syndrome) that encompasses these common traits. Finally, symptoms such as depression and catastrophization may be sequelae of, rather than risk factors for, new daily persistent headache.

Researchers have found imaging abnormalities to be rare in patients with new daily persistent headache. About two-thirds of patients in a 2002 study had normal MRI or CT results, and the rest had nonspecific findings unrelated to the headache. Dr. Rozen found that white matter lesions were uncommon in patients with this disorder, except for those with a history of migraine or cardiovascular or cerebrovascular risk factors. CSF likewise generally is normal in patients with new daily persistent headache.

 

 

Triggers Suggest Treatments

Goadsby proposed in 2011 that new daily persistent headache is a syndrome rather than a single disorder. “I’m completely in agreement,” said Dr. Rozen. “However, I do believe that individuals who have the same triggering event have the same pathogenesis.” Identifying the triggering event and understanding the temporal profile of the first headache can enable the choice of appropriate therapy, he added.

A patient whose persistent headache begins with a thunderclap onset likely has a prolonged cerebral artery vasospasm. Dr. Rozen treated a patient whose initial headache was a thunderclap; imaging ultimately revealed that she had a vasospasm. Her headache responded to nimodipine within days. Nimodipine generally provides relief within three to five days, said Dr. Rozen. If it worsens the headache, then the patient does not have vasospasm, he added.

Many patients with new daily persistent headache have a physical presentation that suggests Marfan syndrome. This observation led Dr. Rozen to hypothesize that cervical hypermobility is a risk factor for new daily persistent headache. Hypermobile patients may put significant stress on the C1, C2, and C3 joints, which are “where the trigeminal–cervical complex comes together,” said Dr. Rozen. A long plane ride or appointment with the dentist could trigger new daily persistent headache. Treatment with onabotulinumtoxinA often helps these patients. High cervical blocks also can bring relief, said Dr. Rozen.

He and his colleagues recently identified a new subset of patients with new daily persistent headache. They were older female patients with a mean age of 57 who suddenly developed the disorder. Most of them reported that the pain was worst before they got out of bed in the morning. Within seconds of assuming the Trendelenburg position, these patients had intensified pain and nausea, suggesting CSF hypertension. The patients all responded to acetazolamide or spironolactone, which lowered CSF pressure. “I think these individuals developed cerebral vein insufficiency because of estrogen withdrawal based on their age. Plus, the majority were overweight, which can also raise baseline CSF pressure.”

Examination Should Incorporate Imaging

All patients with new daily persistent headache should undergo imaging, including a brain MRI with and without gadolinium, plus an MR venogram, which can identify CSF leaks and a cerebral vein thrombosis, which are leading secondary causes of the disorder. Neurologists could examine patients’ viral titers in addition if the history suggests a post infectious trigger. A lumbar puncture and measurement of opening CSF pressure are appropriate for patients who have not responded to medication.

Evidence From the Literature

The literature possibly supports the efficacy of several treatments in new daily persistent headache, but includes no placebo-controlled trials for them. Dr. Rozen found doxycycline to be helpful for several patients with elevated CSF tumor necrosis factor alpha.

Marmura and colleagues found that mexiletine reduced the severity of pain in patients with refractory new daily persistent headache. The treatment did not reduce headache frequency, however, and side effects were common.

In a retrospective study, Prakash et al followed 63 patients with new daily persistent headache for five years. They found that patients who received IV methyl prednisolone and sodium valproate had a better response than patients who received other therapies. They called for prospective and controlled studies to confirm this observation.

In general, aggressive initial therapy is warranted, “especially if you meet an individual within one year of headache onset,” said Dr. Rozen. The likelihood of response to therapy appears to decline with the duration of the headache. “Infusion therapy or inpatient therapy with IV medications, even with standard migraine protocols, may help break the cycle,” Dr. Rozen concluded.

—Erik Greb

Suggested Reading

Goadsby PJ. New daily persistent headache: a syndrome, not a discrete disorder. Headache. 2011;51(4):650-653.

Marmura MJ, Passero FC Jr, Young WB. Mexiletine for refractory chronic daily headache: a report of nine cases. Headache. 2008;48(10):1506-1510.

Prakash S, Saini S, Rana KR, Mahato P. Refining clinical features and therapeutic options of new daily persistent headache: a retrospective study of 63 patients in India. J Headache Pain. 2012;13(6):477-485.

Rozen TD. A new subtype of chronic daily headache presenting in older women. J Womens Health (Larchmt). 2018;27(2):203-208.

Rozen TD. Triggering events and new daily persistent headache: age and gender differences and insights on pathogenesis-a clinic-based study. Headache. 2016;56(1):164-173.

Uniyal R, Paliwal VK, Tripathi A. Psychiatric comorbidity in new daily persistent headache: a cross-sectional study. Eur J Pain. 2017;21(6):1031-1038.

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Aggressive initial therapy is appropriate because the disorder becomes increasingly refractory with time.

Aggressive initial therapy is appropriate because the disorder becomes increasingly refractory with time.

ASHEVILLE, NC—New daily persistent headache is rare and difficult to treat. Although neurologists may be tempted to try a series of treatments until the patient improves, therapeutic success is more likely if the neurologist can identify a triggering event, said Todd Rozen, MD, a neurologist at Mayo Clinic in Jacksonville, Florida. Elements of the patient’s history or clinical examination also can guide treatment, he added at the Eighth Annual Scientific Meeting of the Southern Headache Society.

Patients Remember the Onset

New daily persistent headache was first described in 1986, and few researchers have studied it. It is a persistent headache with a clearly remembered onset. “Most [patients] can name the date it began or at least the month,” said Dr. Rozen. The headache becomes unremitting within 24 hours and must be present for longer than three months, according to the current diagnostic criteria. Patients may have a remitting form, a relapsing-remitting form, or a refractory form of the headache. The age of onset “can be as early as in the mid to late teens or early 20s, especially in the female population,” said Dr. Rozen. Age of onset also depends on the triggering event.

The pain typically is bilateral and moderate to severe. Although many patients may present with a tension-type headache, more than 60% have migrainous symptoms such as nausea, photophobia, or phonophobia, said Dr. Rozen.

The disorder is more common among women than among men. Between 10% and 13% of patients who present to headache clinics have new daily persistent headache, said Dr. Rozen. “It is either becoming more prevalent in the office, or we are better at recognizing it.”

Comparing Effects on the Genders

For a study published in 2016, Dr. Rozen examined 97 patients (65 women) with new daily persistent headache. Approximately 53% of patients could not identify a triggering event for their headache, which makes treatment “much more difficult,” said Dr. Rozen. Although the mean age of onset was younger in women (32.4) than men (35.8), the age of onset was the same between genders when Dr. Rozen examined for individual triggers.

The frequency of individual triggering events also was the same between genders, and these results suggest that each trigger may be associated with a discrete pathogenesis. Triggers included infection or flulike illness (22%), stressful life event (9%), surgery (9%), and other (7%). All patients who had identified surgery as a trigger had been intubated, and Dr. Rozen hypothesized that their headaches were cervicogenic. The younger patients who had undergone surgery were hypermobile, and the older patients had neck arthritis as predisposing risk factors for neck irritation with intubation.

A Somatoform Disorder?

The stubbornly refractory nature of this disorder has aroused the suspicion that it may be somatoform. In 2017, Uniyal and colleagues found that somatization, generalized anxiety disorder, depression, and catastrophization were more common in patients with new daily persistent headache, compared with patients with chronic low back pain and healthy controls.

Interpreting these data is difficult, said Dr. Rozen. They may indicate that these psychiatric comorbidities are risk factors for new daily persistent headache. An equally plausible interpretation is that these patients have a different disorder (eg, Ehlers-Danlos syndrome) that encompasses these common traits. Finally, symptoms such as depression and catastrophization may be sequelae of, rather than risk factors for, new daily persistent headache.

Researchers have found imaging abnormalities to be rare in patients with new daily persistent headache. About two-thirds of patients in a 2002 study had normal MRI or CT results, and the rest had nonspecific findings unrelated to the headache. Dr. Rozen found that white matter lesions were uncommon in patients with this disorder, except for those with a history of migraine or cardiovascular or cerebrovascular risk factors. CSF likewise generally is normal in patients with new daily persistent headache.

 

 

Triggers Suggest Treatments

Goadsby proposed in 2011 that new daily persistent headache is a syndrome rather than a single disorder. “I’m completely in agreement,” said Dr. Rozen. “However, I do believe that individuals who have the same triggering event have the same pathogenesis.” Identifying the triggering event and understanding the temporal profile of the first headache can enable the choice of appropriate therapy, he added.

A patient whose persistent headache begins with a thunderclap onset likely has a prolonged cerebral artery vasospasm. Dr. Rozen treated a patient whose initial headache was a thunderclap; imaging ultimately revealed that she had a vasospasm. Her headache responded to nimodipine within days. Nimodipine generally provides relief within three to five days, said Dr. Rozen. If it worsens the headache, then the patient does not have vasospasm, he added.

Many patients with new daily persistent headache have a physical presentation that suggests Marfan syndrome. This observation led Dr. Rozen to hypothesize that cervical hypermobility is a risk factor for new daily persistent headache. Hypermobile patients may put significant stress on the C1, C2, and C3 joints, which are “where the trigeminal–cervical complex comes together,” said Dr. Rozen. A long plane ride or appointment with the dentist could trigger new daily persistent headache. Treatment with onabotulinumtoxinA often helps these patients. High cervical blocks also can bring relief, said Dr. Rozen.

He and his colleagues recently identified a new subset of patients with new daily persistent headache. They were older female patients with a mean age of 57 who suddenly developed the disorder. Most of them reported that the pain was worst before they got out of bed in the morning. Within seconds of assuming the Trendelenburg position, these patients had intensified pain and nausea, suggesting CSF hypertension. The patients all responded to acetazolamide or spironolactone, which lowered CSF pressure. “I think these individuals developed cerebral vein insufficiency because of estrogen withdrawal based on their age. Plus, the majority were overweight, which can also raise baseline CSF pressure.”

Examination Should Incorporate Imaging

All patients with new daily persistent headache should undergo imaging, including a brain MRI with and without gadolinium, plus an MR venogram, which can identify CSF leaks and a cerebral vein thrombosis, which are leading secondary causes of the disorder. Neurologists could examine patients’ viral titers in addition if the history suggests a post infectious trigger. A lumbar puncture and measurement of opening CSF pressure are appropriate for patients who have not responded to medication.

Evidence From the Literature

The literature possibly supports the efficacy of several treatments in new daily persistent headache, but includes no placebo-controlled trials for them. Dr. Rozen found doxycycline to be helpful for several patients with elevated CSF tumor necrosis factor alpha.

Marmura and colleagues found that mexiletine reduced the severity of pain in patients with refractory new daily persistent headache. The treatment did not reduce headache frequency, however, and side effects were common.

In a retrospective study, Prakash et al followed 63 patients with new daily persistent headache for five years. They found that patients who received IV methyl prednisolone and sodium valproate had a better response than patients who received other therapies. They called for prospective and controlled studies to confirm this observation.

In general, aggressive initial therapy is warranted, “especially if you meet an individual within one year of headache onset,” said Dr. Rozen. The likelihood of response to therapy appears to decline with the duration of the headache. “Infusion therapy or inpatient therapy with IV medications, even with standard migraine protocols, may help break the cycle,” Dr. Rozen concluded.

—Erik Greb

Suggested Reading

Goadsby PJ. New daily persistent headache: a syndrome, not a discrete disorder. Headache. 2011;51(4):650-653.

Marmura MJ, Passero FC Jr, Young WB. Mexiletine for refractory chronic daily headache: a report of nine cases. Headache. 2008;48(10):1506-1510.

Prakash S, Saini S, Rana KR, Mahato P. Refining clinical features and therapeutic options of new daily persistent headache: a retrospective study of 63 patients in India. J Headache Pain. 2012;13(6):477-485.

Rozen TD. A new subtype of chronic daily headache presenting in older women. J Womens Health (Larchmt). 2018;27(2):203-208.

Rozen TD. Triggering events and new daily persistent headache: age and gender differences and insights on pathogenesis-a clinic-based study. Headache. 2016;56(1):164-173.

Uniyal R, Paliwal VK, Tripathi A. Psychiatric comorbidity in new daily persistent headache: a cross-sectional study. Eur J Pain. 2017;21(6):1031-1038.

ASHEVILLE, NC—New daily persistent headache is rare and difficult to treat. Although neurologists may be tempted to try a series of treatments until the patient improves, therapeutic success is more likely if the neurologist can identify a triggering event, said Todd Rozen, MD, a neurologist at Mayo Clinic in Jacksonville, Florida. Elements of the patient’s history or clinical examination also can guide treatment, he added at the Eighth Annual Scientific Meeting of the Southern Headache Society.

Patients Remember the Onset

New daily persistent headache was first described in 1986, and few researchers have studied it. It is a persistent headache with a clearly remembered onset. “Most [patients] can name the date it began or at least the month,” said Dr. Rozen. The headache becomes unremitting within 24 hours and must be present for longer than three months, according to the current diagnostic criteria. Patients may have a remitting form, a relapsing-remitting form, or a refractory form of the headache. The age of onset “can be as early as in the mid to late teens or early 20s, especially in the female population,” said Dr. Rozen. Age of onset also depends on the triggering event.

The pain typically is bilateral and moderate to severe. Although many patients may present with a tension-type headache, more than 60% have migrainous symptoms such as nausea, photophobia, or phonophobia, said Dr. Rozen.

The disorder is more common among women than among men. Between 10% and 13% of patients who present to headache clinics have new daily persistent headache, said Dr. Rozen. “It is either becoming more prevalent in the office, or we are better at recognizing it.”

Comparing Effects on the Genders

For a study published in 2016, Dr. Rozen examined 97 patients (65 women) with new daily persistent headache. Approximately 53% of patients could not identify a triggering event for their headache, which makes treatment “much more difficult,” said Dr. Rozen. Although the mean age of onset was younger in women (32.4) than men (35.8), the age of onset was the same between genders when Dr. Rozen examined for individual triggers.

The frequency of individual triggering events also was the same between genders, and these results suggest that each trigger may be associated with a discrete pathogenesis. Triggers included infection or flulike illness (22%), stressful life event (9%), surgery (9%), and other (7%). All patients who had identified surgery as a trigger had been intubated, and Dr. Rozen hypothesized that their headaches were cervicogenic. The younger patients who had undergone surgery were hypermobile, and the older patients had neck arthritis as predisposing risk factors for neck irritation with intubation.

A Somatoform Disorder?

The stubbornly refractory nature of this disorder has aroused the suspicion that it may be somatoform. In 2017, Uniyal and colleagues found that somatization, generalized anxiety disorder, depression, and catastrophization were more common in patients with new daily persistent headache, compared with patients with chronic low back pain and healthy controls.

Interpreting these data is difficult, said Dr. Rozen. They may indicate that these psychiatric comorbidities are risk factors for new daily persistent headache. An equally plausible interpretation is that these patients have a different disorder (eg, Ehlers-Danlos syndrome) that encompasses these common traits. Finally, symptoms such as depression and catastrophization may be sequelae of, rather than risk factors for, new daily persistent headache.

Researchers have found imaging abnormalities to be rare in patients with new daily persistent headache. About two-thirds of patients in a 2002 study had normal MRI or CT results, and the rest had nonspecific findings unrelated to the headache. Dr. Rozen found that white matter lesions were uncommon in patients with this disorder, except for those with a history of migraine or cardiovascular or cerebrovascular risk factors. CSF likewise generally is normal in patients with new daily persistent headache.

 

 

Triggers Suggest Treatments

Goadsby proposed in 2011 that new daily persistent headache is a syndrome rather than a single disorder. “I’m completely in agreement,” said Dr. Rozen. “However, I do believe that individuals who have the same triggering event have the same pathogenesis.” Identifying the triggering event and understanding the temporal profile of the first headache can enable the choice of appropriate therapy, he added.

A patient whose persistent headache begins with a thunderclap onset likely has a prolonged cerebral artery vasospasm. Dr. Rozen treated a patient whose initial headache was a thunderclap; imaging ultimately revealed that she had a vasospasm. Her headache responded to nimodipine within days. Nimodipine generally provides relief within three to five days, said Dr. Rozen. If it worsens the headache, then the patient does not have vasospasm, he added.

Many patients with new daily persistent headache have a physical presentation that suggests Marfan syndrome. This observation led Dr. Rozen to hypothesize that cervical hypermobility is a risk factor for new daily persistent headache. Hypermobile patients may put significant stress on the C1, C2, and C3 joints, which are “where the trigeminal–cervical complex comes together,” said Dr. Rozen. A long plane ride or appointment with the dentist could trigger new daily persistent headache. Treatment with onabotulinumtoxinA often helps these patients. High cervical blocks also can bring relief, said Dr. Rozen.

He and his colleagues recently identified a new subset of patients with new daily persistent headache. They were older female patients with a mean age of 57 who suddenly developed the disorder. Most of them reported that the pain was worst before they got out of bed in the morning. Within seconds of assuming the Trendelenburg position, these patients had intensified pain and nausea, suggesting CSF hypertension. The patients all responded to acetazolamide or spironolactone, which lowered CSF pressure. “I think these individuals developed cerebral vein insufficiency because of estrogen withdrawal based on their age. Plus, the majority were overweight, which can also raise baseline CSF pressure.”

Examination Should Incorporate Imaging

All patients with new daily persistent headache should undergo imaging, including a brain MRI with and without gadolinium, plus an MR venogram, which can identify CSF leaks and a cerebral vein thrombosis, which are leading secondary causes of the disorder. Neurologists could examine patients’ viral titers in addition if the history suggests a post infectious trigger. A lumbar puncture and measurement of opening CSF pressure are appropriate for patients who have not responded to medication.

Evidence From the Literature

The literature possibly supports the efficacy of several treatments in new daily persistent headache, but includes no placebo-controlled trials for them. Dr. Rozen found doxycycline to be helpful for several patients with elevated CSF tumor necrosis factor alpha.

Marmura and colleagues found that mexiletine reduced the severity of pain in patients with refractory new daily persistent headache. The treatment did not reduce headache frequency, however, and side effects were common.

In a retrospective study, Prakash et al followed 63 patients with new daily persistent headache for five years. They found that patients who received IV methyl prednisolone and sodium valproate had a better response than patients who received other therapies. They called for prospective and controlled studies to confirm this observation.

In general, aggressive initial therapy is warranted, “especially if you meet an individual within one year of headache onset,” said Dr. Rozen. The likelihood of response to therapy appears to decline with the duration of the headache. “Infusion therapy or inpatient therapy with IV medications, even with standard migraine protocols, may help break the cycle,” Dr. Rozen concluded.

—Erik Greb

Suggested Reading

Goadsby PJ. New daily persistent headache: a syndrome, not a discrete disorder. Headache. 2011;51(4):650-653.

Marmura MJ, Passero FC Jr, Young WB. Mexiletine for refractory chronic daily headache: a report of nine cases. Headache. 2008;48(10):1506-1510.

Prakash S, Saini S, Rana KR, Mahato P. Refining clinical features and therapeutic options of new daily persistent headache: a retrospective study of 63 patients in India. J Headache Pain. 2012;13(6):477-485.

Rozen TD. A new subtype of chronic daily headache presenting in older women. J Womens Health (Larchmt). 2018;27(2):203-208.

Rozen TD. Triggering events and new daily persistent headache: age and gender differences and insights on pathogenesis-a clinic-based study. Headache. 2016;56(1):164-173.

Uniyal R, Paliwal VK, Tripathi A. Psychiatric comorbidity in new daily persistent headache: a cross-sectional study. Eur J Pain. 2017;21(6):1031-1038.

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Complications cluster in inflammatory arthritis patients after total knee replacement

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– Patients with an inflammatory arthritis had significantly higher rates of infections, transfusions, and readmissions following total knee replacement than did patients without inflammatory arthritis in a study of more than 137,000 Americans who underwent this surgery.

Dr. Susan M. Goodman

A sampling of U.S. patients who underwent total knee arthroplasty (TKA) during 2007-2016 showed that among the small percentage of these patients who had an inflammatory arthritis (IA), the rate of periprosthetic joint or wound infection while hospitalized or out to 30 days after surgery was a statistically significant 64% higher relative to patients without inflammatory arthritis, after adjustment for several demographic and clinical confounders, including recent glucocorticoid treatment, Susan M. Goodman, MD, said at the annual meeting of the American College of Rheumatology. The analysis also showed a statistically significant 46% higher relative rate of hospital readmission for any cause during the 90 days after surgery, and a significant 39% relative increase in blood transfusions during the 30 days after TKA in the IA patients.

“These results have important implications for evolving bundled payment models” for TKA, said Dr. Goodman, a rheumatologist at the Hospital for Special Surgery in New York. “Hospitals should receive commensurate resources to maintain access to total TKA for patients with IA.”

For this analysis, Dr. Goodman and her associates classified IA as a patient with a recorded diagnosis of rheumatoid arthritis, spondyloarthritis, or systemic lupus erythematosus if the patient had also received treatment during the year before surgery with a disease-modifying antirheumatic drug, a biologic agent, or a drug that treats systemic lupus erythematosus.



Complications following TKA became a particular concern to hospitals starting in 2013 when the Centers for Medicare & Medicaid Services began a program that penalized hospitals for outcomes such as excessive readmissions following selected types of hospitalizations and also with recent steps to bundle TKA reimbursement with related 90-day outcomes.

“My concern is to ensure that patients with IA aren’t penalized and can maintain access” to TKA despite recent policy moves by the CMS. Faced with potential disincentives to treat patients with an IA, “hospitals might cherry pick patients,” Dr. Goodman said in an interview. The new findings “are a reason for administrators to argue for patients with IA to come out of the cost bundle.”

Dr. Goodman expressed hope that future policies will better reflect the higher levels of risk faced by patients with an IA undergoing TKA. CMS “is pretty responsive,” she said.

The study used data collected by Humana for about 25 million American health insurance beneficiaries during 2007-2016, which included 137,550 people who underwent a TKA. Of these, 3,067 (2%) met the study’s definition for IA, and 134,483 did not. Most of those who did not meet the definition likely had osteoarthritis, Dr. Goodman said. This low percentage of U.S. TKA patients with IA was consistent with numbers in prior reports.

The researchers calculated the relative risk of the IA patients, compared with all the others, for nine potential complications, including acute MI, pneumonia, sepsis, pulmonary embolism, and death. The complications with significantly higher rates among the IA patients after confounder adjustment were 30-day infections, 30-day transfusions, and 90-day readmissions.

Dr. Goodman had no relevant disclosures.

[email protected]

SOURCE: Richardson S et al. Arthritis Rheumatol. 2018;70(Suppl 10): Abstract 1932.

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– Patients with an inflammatory arthritis had significantly higher rates of infections, transfusions, and readmissions following total knee replacement than did patients without inflammatory arthritis in a study of more than 137,000 Americans who underwent this surgery.

Dr. Susan M. Goodman

A sampling of U.S. patients who underwent total knee arthroplasty (TKA) during 2007-2016 showed that among the small percentage of these patients who had an inflammatory arthritis (IA), the rate of periprosthetic joint or wound infection while hospitalized or out to 30 days after surgery was a statistically significant 64% higher relative to patients without inflammatory arthritis, after adjustment for several demographic and clinical confounders, including recent glucocorticoid treatment, Susan M. Goodman, MD, said at the annual meeting of the American College of Rheumatology. The analysis also showed a statistically significant 46% higher relative rate of hospital readmission for any cause during the 90 days after surgery, and a significant 39% relative increase in blood transfusions during the 30 days after TKA in the IA patients.

“These results have important implications for evolving bundled payment models” for TKA, said Dr. Goodman, a rheumatologist at the Hospital for Special Surgery in New York. “Hospitals should receive commensurate resources to maintain access to total TKA for patients with IA.”

For this analysis, Dr. Goodman and her associates classified IA as a patient with a recorded diagnosis of rheumatoid arthritis, spondyloarthritis, or systemic lupus erythematosus if the patient had also received treatment during the year before surgery with a disease-modifying antirheumatic drug, a biologic agent, or a drug that treats systemic lupus erythematosus.



Complications following TKA became a particular concern to hospitals starting in 2013 when the Centers for Medicare & Medicaid Services began a program that penalized hospitals for outcomes such as excessive readmissions following selected types of hospitalizations and also with recent steps to bundle TKA reimbursement with related 90-day outcomes.

“My concern is to ensure that patients with IA aren’t penalized and can maintain access” to TKA despite recent policy moves by the CMS. Faced with potential disincentives to treat patients with an IA, “hospitals might cherry pick patients,” Dr. Goodman said in an interview. The new findings “are a reason for administrators to argue for patients with IA to come out of the cost bundle.”

Dr. Goodman expressed hope that future policies will better reflect the higher levels of risk faced by patients with an IA undergoing TKA. CMS “is pretty responsive,” she said.

The study used data collected by Humana for about 25 million American health insurance beneficiaries during 2007-2016, which included 137,550 people who underwent a TKA. Of these, 3,067 (2%) met the study’s definition for IA, and 134,483 did not. Most of those who did not meet the definition likely had osteoarthritis, Dr. Goodman said. This low percentage of U.S. TKA patients with IA was consistent with numbers in prior reports.

The researchers calculated the relative risk of the IA patients, compared with all the others, for nine potential complications, including acute MI, pneumonia, sepsis, pulmonary embolism, and death. The complications with significantly higher rates among the IA patients after confounder adjustment were 30-day infections, 30-day transfusions, and 90-day readmissions.

Dr. Goodman had no relevant disclosures.

[email protected]

SOURCE: Richardson S et al. Arthritis Rheumatol. 2018;70(Suppl 10): Abstract 1932.

– Patients with an inflammatory arthritis had significantly higher rates of infections, transfusions, and readmissions following total knee replacement than did patients without inflammatory arthritis in a study of more than 137,000 Americans who underwent this surgery.

Dr. Susan M. Goodman

A sampling of U.S. patients who underwent total knee arthroplasty (TKA) during 2007-2016 showed that among the small percentage of these patients who had an inflammatory arthritis (IA), the rate of periprosthetic joint or wound infection while hospitalized or out to 30 days after surgery was a statistically significant 64% higher relative to patients without inflammatory arthritis, after adjustment for several demographic and clinical confounders, including recent glucocorticoid treatment, Susan M. Goodman, MD, said at the annual meeting of the American College of Rheumatology. The analysis also showed a statistically significant 46% higher relative rate of hospital readmission for any cause during the 90 days after surgery, and a significant 39% relative increase in blood transfusions during the 30 days after TKA in the IA patients.

“These results have important implications for evolving bundled payment models” for TKA, said Dr. Goodman, a rheumatologist at the Hospital for Special Surgery in New York. “Hospitals should receive commensurate resources to maintain access to total TKA for patients with IA.”

For this analysis, Dr. Goodman and her associates classified IA as a patient with a recorded diagnosis of rheumatoid arthritis, spondyloarthritis, or systemic lupus erythematosus if the patient had also received treatment during the year before surgery with a disease-modifying antirheumatic drug, a biologic agent, or a drug that treats systemic lupus erythematosus.



Complications following TKA became a particular concern to hospitals starting in 2013 when the Centers for Medicare & Medicaid Services began a program that penalized hospitals for outcomes such as excessive readmissions following selected types of hospitalizations and also with recent steps to bundle TKA reimbursement with related 90-day outcomes.

“My concern is to ensure that patients with IA aren’t penalized and can maintain access” to TKA despite recent policy moves by the CMS. Faced with potential disincentives to treat patients with an IA, “hospitals might cherry pick patients,” Dr. Goodman said in an interview. The new findings “are a reason for administrators to argue for patients with IA to come out of the cost bundle.”

Dr. Goodman expressed hope that future policies will better reflect the higher levels of risk faced by patients with an IA undergoing TKA. CMS “is pretty responsive,” she said.

The study used data collected by Humana for about 25 million American health insurance beneficiaries during 2007-2016, which included 137,550 people who underwent a TKA. Of these, 3,067 (2%) met the study’s definition for IA, and 134,483 did not. Most of those who did not meet the definition likely had osteoarthritis, Dr. Goodman said. This low percentage of U.S. TKA patients with IA was consistent with numbers in prior reports.

The researchers calculated the relative risk of the IA patients, compared with all the others, for nine potential complications, including acute MI, pneumonia, sepsis, pulmonary embolism, and death. The complications with significantly higher rates among the IA patients after confounder adjustment were 30-day infections, 30-day transfusions, and 90-day readmissions.

Dr. Goodman had no relevant disclosures.

[email protected]

SOURCE: Richardson S et al. Arthritis Rheumatol. 2018;70(Suppl 10): Abstract 1932.

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Key clinical point: Complications were more common after total knee arthroplasty in patients with an inflammatory arthritis.

Major finding: Inflammatory arthritis patients had a 64% higher rate of infections after total knee arthroplasty, compared with patients without inflammatory arthritis.

Study details: Data analysis for 137,550 Americans who underwent total knee arthroplasty during 2007-2016.

Disclosures: Dr. Goodman had no relevant disclosures.

Source: Richardson S et al. Arthritis Rheumatol. 2018;70(Suppl 10): Abstract 1932.

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Guideline authors inconsistently disclose conflicts

Consider conflict-free guidelines the UK way
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Financial conflicts are often underreported by authors of clinical practice guidelines (CPGs) in several specialties including oncology, rheumatology, and gastroenterology, according to a pair of research letters published in JAMA Internal Medicine. The Institute of Medicine recommends that guideline authors include no more than 50% individuals with financial conflicts.

In one research letter, Rishad Khan, BSc, of the University of Toronto in Ontario and his colleagues reviewed data on undeclared financial conflicts of interest among authors of guidelines related to high-revenue medications.

The researchers identified CPGs via the National Guideline Clearinghouse and selected 18 CPGs for 10 high-revenue medications published between 2013 and 2017. Financial conflicts of interest were based on the Centers for Medicare & Medicaid Services Open Payments.

Of the 160 authors involved in the various guidelines, 79 (49.4%) disclosed a payment in the CPG or supplemental materials, and 50 (31.3%) disclosed payments from companies marketing 1 of the 10 high-revenue medications in the related guidelines.

Another 41 authors (25.6%) received but did not disclose payments from companies marketing 1 of the 10 high-revenue medications in CPGs.

Overall, 91 authors (56.9%) were found to have financial conflicts of interest that involved 1 of the 10 high-revenue medications, and “the median value of undeclared payments from companies marketing 1 of the 10 high-revenue medications recommended in the CPGs was $522 (interquartile range, $0-$40,444) from two companies,” the researchers said.

The study findings were limited by several factors including “potential inaccuracies in CMS-OP reporting, which are rarely corrected, and lack of generalizability outside the United States” and by the limited time frame for data collection, which may have led to underestimation of conflicts for the guidelines, the researchers noted. In addition, “we did not have access to guideline voting records and thus did not know when conflicted panel members recommended against a medication or recused themselves from voting,” they said.

Mr. Khan disclosed research funding from AbbVie and Ferring Pharmaceuticals.

 

 


In a second research letter, half of the authors of gastroenterology guidelines received payments from industry, wrote Tyler Combs, BS, of Oklahoma State University, Tulsa, and his colleagues. Previous studies have reviewed the financial conflicts of interest in specialties including oncology, dermatology, and otolaryngology, but financial conflicts of interest among authors of gastroenterology guidelines have not been examined, the researchers said.

Mr. Combs and his colleagues identified 15 CPGs published by the American College of Gastroenterology between 2014 and 2016. They identified 83 authors, with an average of 4 authors for each guideline. Overall, 53% of the authors received industry payments, according to based on data from the 2014 to 2016 Centers for Medicare and Medicaid Services Open Payments database (OPD).

However, OPD information was not always consistent with information published with the guidelines, the researchers noted. They found that 16 (19%) of the 83 authors both disclosed financial conflicts of interests in the CPGs and had received payments according to OPD or had disclosed no financial conflicts of interest and had received no payments according to OPD. In addition, 49 (34%) of 146 cumulative financial conflicts of interest disclosed in the CPGs and 148 relationships identified on OPD were both disclosed as financial conflicts of interest and evidenced by OPD payment records. In this review, the median total payment was $1,000, with an interquartile range from $0 to $39,938.

The study findings were limited by a relatively short 12-month time frame, the researchers noted. However, “our finding that FCOI [financial conflicts of interest] disclosure only corroborates with OPD payment records between 19% and 34% of the time also suggests that guidance from the ACG [American College of Gastroenterology] may be needed to improve FCOI disclosure efforts in future iterations of gastroenterology CPGs,” they said.

The researchers had no financial conflicts to disclose.

 

SOURCE: Combs T et al. JAMA Intern Med. 2018 Oct 29. doi: 10.1001/jamainternmed.2018.4730. Khan R et al. JAMA Intern Med. 2018 Oct 29. doi: 10.1001/jamainternmed.2018.5106.

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None of the guidelines included in either study was fully compliant with National Academy of Medicine standards, which include written disclosure, appointing committee chairs or cochairs with no conflicts of interest, and keeping committee members with conflicts to a minority of the committee membership, wrote Colette DeJong, MD, and Robert Steinbrook, MD, in an accompanying editorial. In the study by Khan et al., “Notably, 14 of the 18 panels had chairs with industry payments, and 10 had a majority of members with payments,” they wrote.

However, the federal government has so far shown no interest in supporting a fully independent entity to develop clinical practice guidelines, as occurs in the United Kingdom via the National Institute for Health and Care Excellence. “Preparation of guidelines by an independent public body with assured funding and independence could be an effective approach, not only for eliminating issues related to financial conflicts of interest but also for assuring the use of rigorous methodologies and avoiding the wasteful duplication of efforts by multiple committees,” they wrote.

Financial conflicts in clinical practice guidelines persist in the United States in part because many professional societies have financial conflicts with industry, the editorialists wrote.

“Robust, objective, and unbiased clinical practice guidelines support improvements in patient care; the best interests of patients are the paramount consideration,” they emphasized (JAMA Intern Med. 2018 Oct 29. doi: 10.1001/jamainternmed.2018.4974).

Dr. DeJong is affiliated with the University of California, San Francisco; Dr. Steinbrook is Editor at Large for JAMA Internal Medicine. They had no financial conflicts to disclose.

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None of the guidelines included in either study was fully compliant with National Academy of Medicine standards, which include written disclosure, appointing committee chairs or cochairs with no conflicts of interest, and keeping committee members with conflicts to a minority of the committee membership, wrote Colette DeJong, MD, and Robert Steinbrook, MD, in an accompanying editorial. In the study by Khan et al., “Notably, 14 of the 18 panels had chairs with industry payments, and 10 had a majority of members with payments,” they wrote.

However, the federal government has so far shown no interest in supporting a fully independent entity to develop clinical practice guidelines, as occurs in the United Kingdom via the National Institute for Health and Care Excellence. “Preparation of guidelines by an independent public body with assured funding and independence could be an effective approach, not only for eliminating issues related to financial conflicts of interest but also for assuring the use of rigorous methodologies and avoiding the wasteful duplication of efforts by multiple committees,” they wrote.

Financial conflicts in clinical practice guidelines persist in the United States in part because many professional societies have financial conflicts with industry, the editorialists wrote.

“Robust, objective, and unbiased clinical practice guidelines support improvements in patient care; the best interests of patients are the paramount consideration,” they emphasized (JAMA Intern Med. 2018 Oct 29. doi: 10.1001/jamainternmed.2018.4974).

Dr. DeJong is affiliated with the University of California, San Francisco; Dr. Steinbrook is Editor at Large for JAMA Internal Medicine. They had no financial conflicts to disclose.

Body

 

None of the guidelines included in either study was fully compliant with National Academy of Medicine standards, which include written disclosure, appointing committee chairs or cochairs with no conflicts of interest, and keeping committee members with conflicts to a minority of the committee membership, wrote Colette DeJong, MD, and Robert Steinbrook, MD, in an accompanying editorial. In the study by Khan et al., “Notably, 14 of the 18 panels had chairs with industry payments, and 10 had a majority of members with payments,” they wrote.

However, the federal government has so far shown no interest in supporting a fully independent entity to develop clinical practice guidelines, as occurs in the United Kingdom via the National Institute for Health and Care Excellence. “Preparation of guidelines by an independent public body with assured funding and independence could be an effective approach, not only for eliminating issues related to financial conflicts of interest but also for assuring the use of rigorous methodologies and avoiding the wasteful duplication of efforts by multiple committees,” they wrote.

Financial conflicts in clinical practice guidelines persist in the United States in part because many professional societies have financial conflicts with industry, the editorialists wrote.

“Robust, objective, and unbiased clinical practice guidelines support improvements in patient care; the best interests of patients are the paramount consideration,” they emphasized (JAMA Intern Med. 2018 Oct 29. doi: 10.1001/jamainternmed.2018.4974).

Dr. DeJong is affiliated with the University of California, San Francisco; Dr. Steinbrook is Editor at Large for JAMA Internal Medicine. They had no financial conflicts to disclose.

Title
Consider conflict-free guidelines the UK way
Consider conflict-free guidelines the UK way

Financial conflicts are often underreported by authors of clinical practice guidelines (CPGs) in several specialties including oncology, rheumatology, and gastroenterology, according to a pair of research letters published in JAMA Internal Medicine. The Institute of Medicine recommends that guideline authors include no more than 50% individuals with financial conflicts.

In one research letter, Rishad Khan, BSc, of the University of Toronto in Ontario and his colleagues reviewed data on undeclared financial conflicts of interest among authors of guidelines related to high-revenue medications.

The researchers identified CPGs via the National Guideline Clearinghouse and selected 18 CPGs for 10 high-revenue medications published between 2013 and 2017. Financial conflicts of interest were based on the Centers for Medicare & Medicaid Services Open Payments.

Of the 160 authors involved in the various guidelines, 79 (49.4%) disclosed a payment in the CPG or supplemental materials, and 50 (31.3%) disclosed payments from companies marketing 1 of the 10 high-revenue medications in the related guidelines.

Another 41 authors (25.6%) received but did not disclose payments from companies marketing 1 of the 10 high-revenue medications in CPGs.

Overall, 91 authors (56.9%) were found to have financial conflicts of interest that involved 1 of the 10 high-revenue medications, and “the median value of undeclared payments from companies marketing 1 of the 10 high-revenue medications recommended in the CPGs was $522 (interquartile range, $0-$40,444) from two companies,” the researchers said.

The study findings were limited by several factors including “potential inaccuracies in CMS-OP reporting, which are rarely corrected, and lack of generalizability outside the United States” and by the limited time frame for data collection, which may have led to underestimation of conflicts for the guidelines, the researchers noted. In addition, “we did not have access to guideline voting records and thus did not know when conflicted panel members recommended against a medication or recused themselves from voting,” they said.

Mr. Khan disclosed research funding from AbbVie and Ferring Pharmaceuticals.

 

 


In a second research letter, half of the authors of gastroenterology guidelines received payments from industry, wrote Tyler Combs, BS, of Oklahoma State University, Tulsa, and his colleagues. Previous studies have reviewed the financial conflicts of interest in specialties including oncology, dermatology, and otolaryngology, but financial conflicts of interest among authors of gastroenterology guidelines have not been examined, the researchers said.

Mr. Combs and his colleagues identified 15 CPGs published by the American College of Gastroenterology between 2014 and 2016. They identified 83 authors, with an average of 4 authors for each guideline. Overall, 53% of the authors received industry payments, according to based on data from the 2014 to 2016 Centers for Medicare and Medicaid Services Open Payments database (OPD).

However, OPD information was not always consistent with information published with the guidelines, the researchers noted. They found that 16 (19%) of the 83 authors both disclosed financial conflicts of interests in the CPGs and had received payments according to OPD or had disclosed no financial conflicts of interest and had received no payments according to OPD. In addition, 49 (34%) of 146 cumulative financial conflicts of interest disclosed in the CPGs and 148 relationships identified on OPD were both disclosed as financial conflicts of interest and evidenced by OPD payment records. In this review, the median total payment was $1,000, with an interquartile range from $0 to $39,938.

The study findings were limited by a relatively short 12-month time frame, the researchers noted. However, “our finding that FCOI [financial conflicts of interest] disclosure only corroborates with OPD payment records between 19% and 34% of the time also suggests that guidance from the ACG [American College of Gastroenterology] may be needed to improve FCOI disclosure efforts in future iterations of gastroenterology CPGs,” they said.

The researchers had no financial conflicts to disclose.

 

SOURCE: Combs T et al. JAMA Intern Med. 2018 Oct 29. doi: 10.1001/jamainternmed.2018.4730. Khan R et al. JAMA Intern Med. 2018 Oct 29. doi: 10.1001/jamainternmed.2018.5106.

Financial conflicts are often underreported by authors of clinical practice guidelines (CPGs) in several specialties including oncology, rheumatology, and gastroenterology, according to a pair of research letters published in JAMA Internal Medicine. The Institute of Medicine recommends that guideline authors include no more than 50% individuals with financial conflicts.

In one research letter, Rishad Khan, BSc, of the University of Toronto in Ontario and his colleagues reviewed data on undeclared financial conflicts of interest among authors of guidelines related to high-revenue medications.

The researchers identified CPGs via the National Guideline Clearinghouse and selected 18 CPGs for 10 high-revenue medications published between 2013 and 2017. Financial conflicts of interest were based on the Centers for Medicare & Medicaid Services Open Payments.

Of the 160 authors involved in the various guidelines, 79 (49.4%) disclosed a payment in the CPG or supplemental materials, and 50 (31.3%) disclosed payments from companies marketing 1 of the 10 high-revenue medications in the related guidelines.

Another 41 authors (25.6%) received but did not disclose payments from companies marketing 1 of the 10 high-revenue medications in CPGs.

Overall, 91 authors (56.9%) were found to have financial conflicts of interest that involved 1 of the 10 high-revenue medications, and “the median value of undeclared payments from companies marketing 1 of the 10 high-revenue medications recommended in the CPGs was $522 (interquartile range, $0-$40,444) from two companies,” the researchers said.

The study findings were limited by several factors including “potential inaccuracies in CMS-OP reporting, which are rarely corrected, and lack of generalizability outside the United States” and by the limited time frame for data collection, which may have led to underestimation of conflicts for the guidelines, the researchers noted. In addition, “we did not have access to guideline voting records and thus did not know when conflicted panel members recommended against a medication or recused themselves from voting,” they said.

Mr. Khan disclosed research funding from AbbVie and Ferring Pharmaceuticals.

 

 


In a second research letter, half of the authors of gastroenterology guidelines received payments from industry, wrote Tyler Combs, BS, of Oklahoma State University, Tulsa, and his colleagues. Previous studies have reviewed the financial conflicts of interest in specialties including oncology, dermatology, and otolaryngology, but financial conflicts of interest among authors of gastroenterology guidelines have not been examined, the researchers said.

Mr. Combs and his colleagues identified 15 CPGs published by the American College of Gastroenterology between 2014 and 2016. They identified 83 authors, with an average of 4 authors for each guideline. Overall, 53% of the authors received industry payments, according to based on data from the 2014 to 2016 Centers for Medicare and Medicaid Services Open Payments database (OPD).

However, OPD information was not always consistent with information published with the guidelines, the researchers noted. They found that 16 (19%) of the 83 authors both disclosed financial conflicts of interests in the CPGs and had received payments according to OPD or had disclosed no financial conflicts of interest and had received no payments according to OPD. In addition, 49 (34%) of 146 cumulative financial conflicts of interest disclosed in the CPGs and 148 relationships identified on OPD were both disclosed as financial conflicts of interest and evidenced by OPD payment records. In this review, the median total payment was $1,000, with an interquartile range from $0 to $39,938.

The study findings were limited by a relatively short 12-month time frame, the researchers noted. However, “our finding that FCOI [financial conflicts of interest] disclosure only corroborates with OPD payment records between 19% and 34% of the time also suggests that guidance from the ACG [American College of Gastroenterology] may be needed to improve FCOI disclosure efforts in future iterations of gastroenterology CPGs,” they said.

The researchers had no financial conflicts to disclose.

 

SOURCE: Combs T et al. JAMA Intern Med. 2018 Oct 29. doi: 10.1001/jamainternmed.2018.4730. Khan R et al. JAMA Intern Med. 2018 Oct 29. doi: 10.1001/jamainternmed.2018.5106.

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Key clinical point: Financial conflicts of interest in the development of clinical guidelines persist in the United States.

Major finding: Approximately half of the committee members of guidelines in both studies had financial relationships; many were undisclosed and involved substantial payments.

Study details: The data come from two research letters, including 15 gastroenterology guidelines and 18 guidelines from multiple specialties.

Disclosures: Mr. Khan disclosed research funding from AbbVie and Ferring Pharmaceuticals. Mr. Combs had no financial conflicts to disclose.

Source: Combs T et al. JAMA Intern Med. 2018 Oct 29. doi: 10.1001/jamainternmed.2018.4730. Khan R et al. JAMA Intern Med. 2018 Oct 29. doi: 10.1001/jamainternmed.2018.5106.
 

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How Long Should Dual Antiplatelet Therapy Last After Stroke or TIA?

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A 21-day period could maximize the therapy’s benefits and minimize the risk of major hemorrhage.

MONTREAL—The optimal length for dual antiplatelet therapy (DAPT) in patients with mild stroke or transient ischemic attack (TIA) is 21 days, according to a prespecified analysis of data from the Platelet-Oriented Inhibition in New TIA and Minor Ischemic Stroke (POINT) trial that was presented at the 11th World Stroke Congress. This duration of combined treatment maximizes protection against major ischemic events while minimizing the extra risk of a major hemorrhage, the researchers said.

Clopidogrel Plus Aspirin or Aspirin Alone

The POINT trial randomized 4,881 patients with a recent mild stroke or TIA and without atrial fibrillation to treatment with either clopidogrel plus aspirin or aspirin alone for 90 days. Compared with aspirin alone, DAPT decreased the incidence of a major ischemic event by 25% and more than doubled the rate of major hemorrhage.

The new prespecified analysis looked at outcomes on a weekly basis during 90 days of treatment. During the first 21 days, the rate of major hemorrhage events was 5.6% among those patients on aspirin alone and 3.6% among those on DAPT. Thus, DAPT was associated with a statistically significant 35% decrease in these adverse outcomes, said Jordan J. Elm, PhD, Associate Professor of Biostatistics at the Medical University of South Carolina in Charleston. During the subsequent 69 days of treatment, the incidence of major ischemic events was approximately 1% in both arms of the study, showing that after three weeks, the incremental benefit of DAPT disappeared, said Dr. Elm.

Jordan J. Elm, PhD


In contrast, the doubled rate of major hemorrhages (which mostly were reversible gastrointestinal bleeds) with DAPT, compared with aspirin alone, occurred at a relatively uniform rate throughout the 90 days of treatment. This suggests that limiting DAPT to 21 days could prevent many of the excess hemorrhages, maximize benefit, and reduce risk, said Dr. Elm. The findings of the Clopidogrel in High-Risk Patients with Acute Nondisabling Cerebrovascular Events (CHANCE) trial confirmed the efficacy of 21 days of DAPT following a minor stroke or TIA.

Although the new finding from the POINT study resulted from a secondary analysis, it should be taken into account when writing treatment guidelines, said Dr. Elm. “This is an important analysis that is not just hypothesis-generating.”

Early Treatment

Another finding from the new analysis was that many major ischemic events, hence many of the events prevented by DAPT, occurred during the first two days following the index event. The POINT investigators were able to observe this finding because they enrolled patients and started treatment within 12 hours of the qualifying events.

“It is better to start treatment early,” said Dr. Elm. Major ischemic events continued to accumulate during Days 3 through 21, suggesting that patients could still benefit from DAPT if treatment did not start until 24 or 48 hours after the index event.

—Mitchel L. Zoler

Suggested Reading

Johnston SC, Easton JD, Farrant M, et al. Clopidogrel and aspirin in acute ischemic stroke and high-risk TIA. N Engl J Med. 2018;379(3):215-225.

Tsivgoulis G, Safouris A, Kim DE, Alexandrov AV. Recent advances in primary and secondary prevention of atherosclerotic stroke. J Stroke. 2018;20(2):145-166.

Wang Y, Wang Y, Zhao X, et al. Clopidogrel with aspirin in acute minor stroke or transient ischemic attack. N Engl J Med. 2013;369(1):11-19.

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A 21-day period could maximize the therapy’s benefits and minimize the risk of major hemorrhage.

A 21-day period could maximize the therapy’s benefits and minimize the risk of major hemorrhage.

MONTREAL—The optimal length for dual antiplatelet therapy (DAPT) in patients with mild stroke or transient ischemic attack (TIA) is 21 days, according to a prespecified analysis of data from the Platelet-Oriented Inhibition in New TIA and Minor Ischemic Stroke (POINT) trial that was presented at the 11th World Stroke Congress. This duration of combined treatment maximizes protection against major ischemic events while minimizing the extra risk of a major hemorrhage, the researchers said.

Clopidogrel Plus Aspirin or Aspirin Alone

The POINT trial randomized 4,881 patients with a recent mild stroke or TIA and without atrial fibrillation to treatment with either clopidogrel plus aspirin or aspirin alone for 90 days. Compared with aspirin alone, DAPT decreased the incidence of a major ischemic event by 25% and more than doubled the rate of major hemorrhage.

The new prespecified analysis looked at outcomes on a weekly basis during 90 days of treatment. During the first 21 days, the rate of major hemorrhage events was 5.6% among those patients on aspirin alone and 3.6% among those on DAPT. Thus, DAPT was associated with a statistically significant 35% decrease in these adverse outcomes, said Jordan J. Elm, PhD, Associate Professor of Biostatistics at the Medical University of South Carolina in Charleston. During the subsequent 69 days of treatment, the incidence of major ischemic events was approximately 1% in both arms of the study, showing that after three weeks, the incremental benefit of DAPT disappeared, said Dr. Elm.

Jordan J. Elm, PhD


In contrast, the doubled rate of major hemorrhages (which mostly were reversible gastrointestinal bleeds) with DAPT, compared with aspirin alone, occurred at a relatively uniform rate throughout the 90 days of treatment. This suggests that limiting DAPT to 21 days could prevent many of the excess hemorrhages, maximize benefit, and reduce risk, said Dr. Elm. The findings of the Clopidogrel in High-Risk Patients with Acute Nondisabling Cerebrovascular Events (CHANCE) trial confirmed the efficacy of 21 days of DAPT following a minor stroke or TIA.

Although the new finding from the POINT study resulted from a secondary analysis, it should be taken into account when writing treatment guidelines, said Dr. Elm. “This is an important analysis that is not just hypothesis-generating.”

Early Treatment

Another finding from the new analysis was that many major ischemic events, hence many of the events prevented by DAPT, occurred during the first two days following the index event. The POINT investigators were able to observe this finding because they enrolled patients and started treatment within 12 hours of the qualifying events.

“It is better to start treatment early,” said Dr. Elm. Major ischemic events continued to accumulate during Days 3 through 21, suggesting that patients could still benefit from DAPT if treatment did not start until 24 or 48 hours after the index event.

—Mitchel L. Zoler

Suggested Reading

Johnston SC, Easton JD, Farrant M, et al. Clopidogrel and aspirin in acute ischemic stroke and high-risk TIA. N Engl J Med. 2018;379(3):215-225.

Tsivgoulis G, Safouris A, Kim DE, Alexandrov AV. Recent advances in primary and secondary prevention of atherosclerotic stroke. J Stroke. 2018;20(2):145-166.

Wang Y, Wang Y, Zhao X, et al. Clopidogrel with aspirin in acute minor stroke or transient ischemic attack. N Engl J Med. 2013;369(1):11-19.

MONTREAL—The optimal length for dual antiplatelet therapy (DAPT) in patients with mild stroke or transient ischemic attack (TIA) is 21 days, according to a prespecified analysis of data from the Platelet-Oriented Inhibition in New TIA and Minor Ischemic Stroke (POINT) trial that was presented at the 11th World Stroke Congress. This duration of combined treatment maximizes protection against major ischemic events while minimizing the extra risk of a major hemorrhage, the researchers said.

Clopidogrel Plus Aspirin or Aspirin Alone

The POINT trial randomized 4,881 patients with a recent mild stroke or TIA and without atrial fibrillation to treatment with either clopidogrel plus aspirin or aspirin alone for 90 days. Compared with aspirin alone, DAPT decreased the incidence of a major ischemic event by 25% and more than doubled the rate of major hemorrhage.

The new prespecified analysis looked at outcomes on a weekly basis during 90 days of treatment. During the first 21 days, the rate of major hemorrhage events was 5.6% among those patients on aspirin alone and 3.6% among those on DAPT. Thus, DAPT was associated with a statistically significant 35% decrease in these adverse outcomes, said Jordan J. Elm, PhD, Associate Professor of Biostatistics at the Medical University of South Carolina in Charleston. During the subsequent 69 days of treatment, the incidence of major ischemic events was approximately 1% in both arms of the study, showing that after three weeks, the incremental benefit of DAPT disappeared, said Dr. Elm.

Jordan J. Elm, PhD


In contrast, the doubled rate of major hemorrhages (which mostly were reversible gastrointestinal bleeds) with DAPT, compared with aspirin alone, occurred at a relatively uniform rate throughout the 90 days of treatment. This suggests that limiting DAPT to 21 days could prevent many of the excess hemorrhages, maximize benefit, and reduce risk, said Dr. Elm. The findings of the Clopidogrel in High-Risk Patients with Acute Nondisabling Cerebrovascular Events (CHANCE) trial confirmed the efficacy of 21 days of DAPT following a minor stroke or TIA.

Although the new finding from the POINT study resulted from a secondary analysis, it should be taken into account when writing treatment guidelines, said Dr. Elm. “This is an important analysis that is not just hypothesis-generating.”

Early Treatment

Another finding from the new analysis was that many major ischemic events, hence many of the events prevented by DAPT, occurred during the first two days following the index event. The POINT investigators were able to observe this finding because they enrolled patients and started treatment within 12 hours of the qualifying events.

“It is better to start treatment early,” said Dr. Elm. Major ischemic events continued to accumulate during Days 3 through 21, suggesting that patients could still benefit from DAPT if treatment did not start until 24 or 48 hours after the index event.

—Mitchel L. Zoler

Suggested Reading

Johnston SC, Easton JD, Farrant M, et al. Clopidogrel and aspirin in acute ischemic stroke and high-risk TIA. N Engl J Med. 2018;379(3):215-225.

Tsivgoulis G, Safouris A, Kim DE, Alexandrov AV. Recent advances in primary and secondary prevention of atherosclerotic stroke. J Stroke. 2018;20(2):145-166.

Wang Y, Wang Y, Zhao X, et al. Clopidogrel with aspirin in acute minor stroke or transient ischemic attack. N Engl J Med. 2013;369(1):11-19.

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Rapid adoption of a key program

 

In 2015, 75% of U.S. hospitals with more than 50 beds had palliative care programs – a sharp increase from the 25% that had palliative care in 2000.

“The rapid adoption of this high-value program, which is voluntary and runs counter to the dominant culture in U.S. hospitals, was catalyzed by tens of millions of dollars in philanthropic support for innovation, dissemination, and professionalization in the palliative care field,” according to research published in Health Affairs.
 

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Cassel JB et al. Palliative care leadership centers are key to the diffusion of palliative care innovation. Health Aff. 2018 Feb. doi: 10.1377/hlthaff.2017.1122.

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Rapid adoption of a key program

Rapid adoption of a key program

 

In 2015, 75% of U.S. hospitals with more than 50 beds had palliative care programs – a sharp increase from the 25% that had palliative care in 2000.

“The rapid adoption of this high-value program, which is voluntary and runs counter to the dominant culture in U.S. hospitals, was catalyzed by tens of millions of dollars in philanthropic support for innovation, dissemination, and professionalization in the palliative care field,” according to research published in Health Affairs.
 

Reference

Cassel JB et al. Palliative care leadership centers are key to the diffusion of palliative care innovation. Health Aff. 2018 Feb. doi: 10.1377/hlthaff.2017.1122.

 

In 2015, 75% of U.S. hospitals with more than 50 beds had palliative care programs – a sharp increase from the 25% that had palliative care in 2000.

“The rapid adoption of this high-value program, which is voluntary and runs counter to the dominant culture in U.S. hospitals, was catalyzed by tens of millions of dollars in philanthropic support for innovation, dissemination, and professionalization in the palliative care field,” according to research published in Health Affairs.
 

Reference

Cassel JB et al. Palliative care leadership centers are key to the diffusion of palliative care innovation. Health Aff. 2018 Feb. doi: 10.1377/hlthaff.2017.1122.

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AAP president affirms academy’s support for transgender children

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– Many pediatricians have little support or guidance in how to address the unique issues that arise during care of transgender and gender-diverse children and adolescents, Colleen A. Kraft, MD, president of the American Academy of Pediatrics, said in an interview.

The AAP’s policy on caring and supporting these patients is evidence-based, and includes recommendations on providing appropriate health care services for transgender individuals, as well as respect and understanding for families. In the interview, Dr. Kraft, discussed the role pediatricians have in providing a safe and supportive environment for transgender and gender-diverse individuals and their families.



“[These children] need to be listened to, they need to be respected for who they are, and they need access to the appropriate health services,” Dr. Kraft said.

The AAP’s policy statement on ensuring care and support for transgender children and adolescents is available here.



Dr. Kraft reported no relevant conflicts of interest.

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– Many pediatricians have little support or guidance in how to address the unique issues that arise during care of transgender and gender-diverse children and adolescents, Colleen A. Kraft, MD, president of the American Academy of Pediatrics, said in an interview.

The AAP’s policy on caring and supporting these patients is evidence-based, and includes recommendations on providing appropriate health care services for transgender individuals, as well as respect and understanding for families. In the interview, Dr. Kraft, discussed the role pediatricians have in providing a safe and supportive environment for transgender and gender-diverse individuals and their families.



“[These children] need to be listened to, they need to be respected for who they are, and they need access to the appropriate health services,” Dr. Kraft said.

The AAP’s policy statement on ensuring care and support for transgender children and adolescents is available here.



Dr. Kraft reported no relevant conflicts of interest.

– Many pediatricians have little support or guidance in how to address the unique issues that arise during care of transgender and gender-diverse children and adolescents, Colleen A. Kraft, MD, president of the American Academy of Pediatrics, said in an interview.

The AAP’s policy on caring and supporting these patients is evidence-based, and includes recommendations on providing appropriate health care services for transgender individuals, as well as respect and understanding for families. In the interview, Dr. Kraft, discussed the role pediatricians have in providing a safe and supportive environment for transgender and gender-diverse individuals and their families.



“[These children] need to be listened to, they need to be respected for who they are, and they need access to the appropriate health services,” Dr. Kraft said.

The AAP’s policy statement on ensuring care and support for transgender children and adolescents is available here.



Dr. Kraft reported no relevant conflicts of interest.

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REPORTING FROM AAP 2018

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