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FDA approves Reyvow for acute migraine treatment
The Food and Drug Administration has approved lasmiditan (Reyvow) for acute treatment of migraines with and without auras in adults.
The agency’s Oct. 11 announcement said the approval is based on results from a pair of randomized, double-blind, placebo-controlled trials that included 3,177 adult patients with a history of migraine with and without aura. The percentage of patients whose pain and most bothersome migraine symptom (nausea, light sensitivity, or sound sensitivity) resolved after 2 hours was higher in patients receiving lasmiditan than in patients receiving placebo.
Lasmiditan is a serotonin 5-hydroxytryptamine1F–receptor agonist, giving it a unique mechanism of action as compared with other migraine treatments.
The most common adverse events associated with lasmiditan include dizziness, fatigue, paresthesia, and sedation. There is a risk of driving impairment while taking the medication, and patients are advised not to operate or drive machinery for 8 hours after taking lasmiditan.
“Reyvow is a new option for the acute treatment of migraine, a painful condition that affects one in seven Americans. We know that the migraine community is keenly interested in additional treatment options, and we remain committed to continuing to work with stakeholders to promote the development of new therapies for the acute and preventive treatment of migraine,” said Nick Kozauer, MD, acting deputy director of the division of neurology products in the FDA’s Center for Drug Evaluation and Research.
Eli Lilly, the drug’s manufacturer, said in a news release that “the recommended controlled substance classification for Reyvow is currently under review by the Drug Enforcement Administration and is expected within 90 days of today’s FDA approval, after which Reyvow will be available to patients in retail pharmacies” in oral doses of 50 mg, 100 mg, and 200 mg.
The Food and Drug Administration has approved lasmiditan (Reyvow) for acute treatment of migraines with and without auras in adults.
The agency’s Oct. 11 announcement said the approval is based on results from a pair of randomized, double-blind, placebo-controlled trials that included 3,177 adult patients with a history of migraine with and without aura. The percentage of patients whose pain and most bothersome migraine symptom (nausea, light sensitivity, or sound sensitivity) resolved after 2 hours was higher in patients receiving lasmiditan than in patients receiving placebo.
Lasmiditan is a serotonin 5-hydroxytryptamine1F–receptor agonist, giving it a unique mechanism of action as compared with other migraine treatments.
The most common adverse events associated with lasmiditan include dizziness, fatigue, paresthesia, and sedation. There is a risk of driving impairment while taking the medication, and patients are advised not to operate or drive machinery for 8 hours after taking lasmiditan.
“Reyvow is a new option for the acute treatment of migraine, a painful condition that affects one in seven Americans. We know that the migraine community is keenly interested in additional treatment options, and we remain committed to continuing to work with stakeholders to promote the development of new therapies for the acute and preventive treatment of migraine,” said Nick Kozauer, MD, acting deputy director of the division of neurology products in the FDA’s Center for Drug Evaluation and Research.
Eli Lilly, the drug’s manufacturer, said in a news release that “the recommended controlled substance classification for Reyvow is currently under review by the Drug Enforcement Administration and is expected within 90 days of today’s FDA approval, after which Reyvow will be available to patients in retail pharmacies” in oral doses of 50 mg, 100 mg, and 200 mg.
The Food and Drug Administration has approved lasmiditan (Reyvow) for acute treatment of migraines with and without auras in adults.
The agency’s Oct. 11 announcement said the approval is based on results from a pair of randomized, double-blind, placebo-controlled trials that included 3,177 adult patients with a history of migraine with and without aura. The percentage of patients whose pain and most bothersome migraine symptom (nausea, light sensitivity, or sound sensitivity) resolved after 2 hours was higher in patients receiving lasmiditan than in patients receiving placebo.
Lasmiditan is a serotonin 5-hydroxytryptamine1F–receptor agonist, giving it a unique mechanism of action as compared with other migraine treatments.
The most common adverse events associated with lasmiditan include dizziness, fatigue, paresthesia, and sedation. There is a risk of driving impairment while taking the medication, and patients are advised not to operate or drive machinery for 8 hours after taking lasmiditan.
“Reyvow is a new option for the acute treatment of migraine, a painful condition that affects one in seven Americans. We know that the migraine community is keenly interested in additional treatment options, and we remain committed to continuing to work with stakeholders to promote the development of new therapies for the acute and preventive treatment of migraine,” said Nick Kozauer, MD, acting deputy director of the division of neurology products in the FDA’s Center for Drug Evaluation and Research.
Eli Lilly, the drug’s manufacturer, said in a news release that “the recommended controlled substance classification for Reyvow is currently under review by the Drug Enforcement Administration and is expected within 90 days of today’s FDA approval, after which Reyvow will be available to patients in retail pharmacies” in oral doses of 50 mg, 100 mg, and 200 mg.
Gender bias and pediatric hospital medicine
Where do we go from here?
Autumn is a busy time for pediatric hospitalists, with this autumn being particularly eventful as the first American Board of Pediatrics (ABP) certifying exam for Pediatric Hospital Medicine (PHM) will be offered on Nov. 12, 2019.
More than 1,600 med/peds and pediatric hospitalists applied to be eligible for the 2019 exam, 71% of whom were women. At least 3.9% of those applicants were denied eligibility for the 2019 exam.1 These denials resulted in discussions on the American Academy of Pediatrics Section on Hospital Medicine (AAP SOHM) email listserv related to unintentional gender bias.
PHM was first recognized as a subspecialty by the American Board of Medical Specialties in December 2015.2 Since that time, the ABP’s PHM sub-board developed eligibility criteria for practicing pediatric and med/peds hospitalists to apply for the exam. The sub-board identified three paths: a training pathway for applicants who had completed a 2-year PHM fellowship, a practice pathway for those satisfying ABP criteria for clinical activity in PHM, and a combined pathway for applicants who had completed PHM fellowships lasting less than 2 years.
Based on these pathways, 1,627 applicants applied for eligibility for the first PHM board certification exam.1 However, many concerns arose with the practice pathway eligibility criteria.
The PHM practice pathway initially included the following eligibility criteria:
• General pediatrics board certification.
• PHM practice “look back” period ends on or before June 30 of the exam year and starts 4 years earlier.
• More than 0.5 FTE professional PHM-related activities (patient-care, research, administration), defined as more than 900 hours/year every year for the preceding 4 years.
• More than 0.25 FTE direct patient care of hospitalized children, defined as more than 450 hours/year every year for the preceding 4 years.
• Practice covers the full range of hospitalized children with regard to age, diagnoses, and complexity.
• Practice interruptions cannot exceed 3 months in the preceding 4 years, or 6 months in the preceding 5 years.
• Practice experience and hours were acquired in the United States and Canada.1,3
The start date and practice interruptions criteria in the practice pathway posed hurdles for many female applicants. Many women voiced concerns about feeling disadvantaged when applying for the PHM certifying exam and some of these women shared their concerns on the AAP SOHM email listserv. In response to these concerns, the PHM community called for increased transparency from the ABP related to denials, specifically related to unintentional gender bias against women applying for the exam.
David Skey, MD, and Jamee Walters, MD, pediatric hospitalists at Arnold Palmer Medical Center in Orlando, heard these concerns and decided to draft a petition with the help of legal counsel. The petition “demand[ed] immediate action,” and “request[ed] a formal response from the ABP regarding the practice pathway criteria.” The petition also stated that there was insufficient data to determine if the practice pathway “disadvantages women.” The petition asked the ABP to “facilitate a timely analysis to determine if gender bias” was present, or to perform an internal analysis and “release the findings publicly.”4
The petition was shared with the PHM community via the AAP SOHM listserv on July 29, 2019. Dr. Walters stated she was pleased by the response she and Dr. Skey received from the PHM community, on and off the AAP SOHM listserv. The petition was submitted to the ABP on Aug. 6, 2019, with 1,479 signatures.
On Aug. 29, 2019, the ABP’s response was shared on the AAP SOHM email listserv1 and was later published in the Journal of Hospital Medicine as a Special Announcement.5 In its response, the ABP stated that the gender bias allegation was “not supported by the facts” as there was “no significant difference between the percentage of women and men who were denied” eligibility.”5 In addressing the gender bias allegations and clarifying the practice pathway eligibility, the ABP removed the practice interruption criteria and modified the practice pathway criteria as follows:
• General pediatrics board certification.
• PHM practice started on or before July 2015 (for board eligibility in 2019).
• Professional PHM-related activities (patient-care, research, administration), defined as more than 900-1000 hours/year every year for the preceding 4 years.
• Direct patient care of hospitalized children, defined as more than 450-500 hours/year every year for the preceding 4 years.
• Practice covers the full range of hospitalized children with regard to age, diagnoses, and complexity.
• Practice experience and hours were acquired in the United States and Canada.1
Following the release of the ABP’s response, many members of the PHM community remain concerned about the ABP’s revised criteria. Arti Desai, MD, pediatric hospitalist at Seattle Children’s and senior author on a “Perspectives in Hospital Medicine” in the Journal of Hospital Medicine,6 was appreciative that the ABP chose to remove the practice interruptions criterion. However, she and her colleagues remain concerned about lingering gender bias in the ABP’s practice pathway eligibility criteria surrounding the “start date” criterion. The authors state that this criterion differentially affects women, as women may take time off during or after residency for maternity or family leave. Dr. Desai states that this criterion alone can affect a woman’s chance for being eligible for the practice pathway.
Other members of the PHM community also expressed concerns about the ABP’s response to the PHM petition. Beth C. Natt, MD, pediatric hospitalist and director of pediatric hospital medicine regional programs at Connecticut Children’s in Hartford, felt that the population may have been self-selected, as the ABP’s data were limited to individuals who applied for exam eligibility. She was concerned that the data excluded pediatric hospitalists who chose not to apply because of uncertainty about meeting eligibility criteria. Klint Schwenk, MD, pediatric hospitalist at Norton Children’s Hospital in Louisville, Ky., stated that he wished the ABP had addressed the number of pediatric hospitalists who elected not to apply based on fear of ineligibility before concluding that there was no bias. He likened the ABP’s response to that of study authors omitting selection bias when discussing the limitations of their study.
Courtney Edgar-Zarate, MD, med/peds hospitalist and associate program director of the internal medicine/pediatrics residency at the University of Arkansas, expressed concerns that the ABP’s stringent clinical patient care hours criterion may unintentionally result in ineligibility for many mid-career or senior med/peds hospitalists. Dr. Edgar-Zarate also voiced concerns that graduating med/peds residents were electing not to pursue careers in hospital medicine because they would be required to complete a PHM fellowship to become a pediatric hospitalist, when a similar fellowship is not required to practice adult hospital medicine.
The Society of Hospital Medicine shared its position in regard to the ABP’s response in a Special Announcement in the Journal of Hospital Medicine.7 In it, SHM’s pediatric leaders recognized physicians for the excellent care they provide to hospitalized children. They stated that SHM would continue to support all hospitalists, independent of board eligibility status, and would continue to offer these hospitalists the merit-based Fellow designation. SHM’s pediatric leaders also proposed future directions for the ABP, including a Focused Practice Pathway in Hospital Medicine (FPHM), such as what the American Board of Internal Medicine and the American Board of Family Medicine have adopted for board recertification in internal medicine and family medicine. This maintenance of certification program that allows physicians primarily practicing in inpatient settings to focus their continuing education on inpatient practice, and is not a subspecialty.7
Dr. Edgar-Zarate fully supports the future directions for pediatric hospitalists outlined in SHM’s Special Announcement. She hopes that the ABP will support the FPHM. She feels the FPHM will encourage more med/peds physicians to practice med/peds hospital medicine. L. Nell Hodo, MD, a family medicine–trained pediatric hospitalist at Icahn School of Medicine at Mount Sinai in New York, joins Dr. Edgar-Zarate in supporting an FPHM for PHM, and feels that it will open the door for hospitalists who are ineligible for the practice pathway to be able to focus their recertification on the inpatient setting.
Dr. Hodo and Dr. Desai hope that rather than excluding those who are not PHM board eligible/certified, institutions and professional organizations will consider all qualifications when hiring, mentoring, and promoting physicians who care for hospitalized children. Dr. Natt, Dr. Schwenk, Dr. Edgar-Zarate, and Dr. Hodo appreciate that SHM is leading the way, and will continue to allow all hospitalists who care for children to receive Fellow designation.
Dr. Kumar is clinical assistant professor of pediatrics at the Cleveland Clinic Lerner College of Medicine at Case Western Reserve University and a pediatric hospitalist at Cleveland Clinic Children’s. She is the pediatric editor of The Hospitalist.
References
1. The American Board of Pediatrics. The American Board of Pediatrics response to the Pediatric Hospital Medicine petition. https://www.abp.org/sites/abp/files/phm-petition-response.pdf. Published 2019.
2. Barrett DJ, McGuinness GA, Cunha CA, et al. Pediatric hospital medicine: A proposed new subspecialty. Pediatrics. 2017;139(3). doi: 10.1542/peds.2016-1823.
3. The American Board of Pediatrics. Pediatric Hospital Medicine Certification. https://www.abp.org/content/pediatric-hospital-medicine-certification. Published 2019.
4. Skey D. Pediatric Hospitalists, It’s time to take a stand on the PHM Boards Application Process! Five Dog Development, LLC.
5. Nichols DG, Woods SZ. The American Board of Pediatrics response to the Pediatric Hospital Medicine petition. J Hosp Med. 2019 Oct;14(10):586-8. doi: 10.12788/jhm.3322.
6. Gold JM et al. Collective action and effective dialogue to address gender bias in medicine. J Hosp Med. 2019 Oct;14(10):630-2. doi: 10.12788/jhm.3331.
7. Chang WW et al. Society of Hospital Medicine position on the American Board of Pediatrics response to the Pediatric Hospital Medicine petition. J Hosp Med. 2019 Oct;14(10):589-90. doi: 10.12788/jhm.3326.
Where do we go from here?
Where do we go from here?
Autumn is a busy time for pediatric hospitalists, with this autumn being particularly eventful as the first American Board of Pediatrics (ABP) certifying exam for Pediatric Hospital Medicine (PHM) will be offered on Nov. 12, 2019.
More than 1,600 med/peds and pediatric hospitalists applied to be eligible for the 2019 exam, 71% of whom were women. At least 3.9% of those applicants were denied eligibility for the 2019 exam.1 These denials resulted in discussions on the American Academy of Pediatrics Section on Hospital Medicine (AAP SOHM) email listserv related to unintentional gender bias.
PHM was first recognized as a subspecialty by the American Board of Medical Specialties in December 2015.2 Since that time, the ABP’s PHM sub-board developed eligibility criteria for practicing pediatric and med/peds hospitalists to apply for the exam. The sub-board identified three paths: a training pathway for applicants who had completed a 2-year PHM fellowship, a practice pathway for those satisfying ABP criteria for clinical activity in PHM, and a combined pathway for applicants who had completed PHM fellowships lasting less than 2 years.
Based on these pathways, 1,627 applicants applied for eligibility for the first PHM board certification exam.1 However, many concerns arose with the practice pathway eligibility criteria.
The PHM practice pathway initially included the following eligibility criteria:
• General pediatrics board certification.
• PHM practice “look back” period ends on or before June 30 of the exam year and starts 4 years earlier.
• More than 0.5 FTE professional PHM-related activities (patient-care, research, administration), defined as more than 900 hours/year every year for the preceding 4 years.
• More than 0.25 FTE direct patient care of hospitalized children, defined as more than 450 hours/year every year for the preceding 4 years.
• Practice covers the full range of hospitalized children with regard to age, diagnoses, and complexity.
• Practice interruptions cannot exceed 3 months in the preceding 4 years, or 6 months in the preceding 5 years.
• Practice experience and hours were acquired in the United States and Canada.1,3
The start date and practice interruptions criteria in the practice pathway posed hurdles for many female applicants. Many women voiced concerns about feeling disadvantaged when applying for the PHM certifying exam and some of these women shared their concerns on the AAP SOHM email listserv. In response to these concerns, the PHM community called for increased transparency from the ABP related to denials, specifically related to unintentional gender bias against women applying for the exam.
David Skey, MD, and Jamee Walters, MD, pediatric hospitalists at Arnold Palmer Medical Center in Orlando, heard these concerns and decided to draft a petition with the help of legal counsel. The petition “demand[ed] immediate action,” and “request[ed] a formal response from the ABP regarding the practice pathway criteria.” The petition also stated that there was insufficient data to determine if the practice pathway “disadvantages women.” The petition asked the ABP to “facilitate a timely analysis to determine if gender bias” was present, or to perform an internal analysis and “release the findings publicly.”4
The petition was shared with the PHM community via the AAP SOHM listserv on July 29, 2019. Dr. Walters stated she was pleased by the response she and Dr. Skey received from the PHM community, on and off the AAP SOHM listserv. The petition was submitted to the ABP on Aug. 6, 2019, with 1,479 signatures.
On Aug. 29, 2019, the ABP’s response was shared on the AAP SOHM email listserv1 and was later published in the Journal of Hospital Medicine as a Special Announcement.5 In its response, the ABP stated that the gender bias allegation was “not supported by the facts” as there was “no significant difference between the percentage of women and men who were denied” eligibility.”5 In addressing the gender bias allegations and clarifying the practice pathway eligibility, the ABP removed the practice interruption criteria and modified the practice pathway criteria as follows:
• General pediatrics board certification.
• PHM practice started on or before July 2015 (for board eligibility in 2019).
• Professional PHM-related activities (patient-care, research, administration), defined as more than 900-1000 hours/year every year for the preceding 4 years.
• Direct patient care of hospitalized children, defined as more than 450-500 hours/year every year for the preceding 4 years.
• Practice covers the full range of hospitalized children with regard to age, diagnoses, and complexity.
• Practice experience and hours were acquired in the United States and Canada.1
Following the release of the ABP’s response, many members of the PHM community remain concerned about the ABP’s revised criteria. Arti Desai, MD, pediatric hospitalist at Seattle Children’s and senior author on a “Perspectives in Hospital Medicine” in the Journal of Hospital Medicine,6 was appreciative that the ABP chose to remove the practice interruptions criterion. However, she and her colleagues remain concerned about lingering gender bias in the ABP’s practice pathway eligibility criteria surrounding the “start date” criterion. The authors state that this criterion differentially affects women, as women may take time off during or after residency for maternity or family leave. Dr. Desai states that this criterion alone can affect a woman’s chance for being eligible for the practice pathway.
Other members of the PHM community also expressed concerns about the ABP’s response to the PHM petition. Beth C. Natt, MD, pediatric hospitalist and director of pediatric hospital medicine regional programs at Connecticut Children’s in Hartford, felt that the population may have been self-selected, as the ABP’s data were limited to individuals who applied for exam eligibility. She was concerned that the data excluded pediatric hospitalists who chose not to apply because of uncertainty about meeting eligibility criteria. Klint Schwenk, MD, pediatric hospitalist at Norton Children’s Hospital in Louisville, Ky., stated that he wished the ABP had addressed the number of pediatric hospitalists who elected not to apply based on fear of ineligibility before concluding that there was no bias. He likened the ABP’s response to that of study authors omitting selection bias when discussing the limitations of their study.
Courtney Edgar-Zarate, MD, med/peds hospitalist and associate program director of the internal medicine/pediatrics residency at the University of Arkansas, expressed concerns that the ABP’s stringent clinical patient care hours criterion may unintentionally result in ineligibility for many mid-career or senior med/peds hospitalists. Dr. Edgar-Zarate also voiced concerns that graduating med/peds residents were electing not to pursue careers in hospital medicine because they would be required to complete a PHM fellowship to become a pediatric hospitalist, when a similar fellowship is not required to practice adult hospital medicine.
The Society of Hospital Medicine shared its position in regard to the ABP’s response in a Special Announcement in the Journal of Hospital Medicine.7 In it, SHM’s pediatric leaders recognized physicians for the excellent care they provide to hospitalized children. They stated that SHM would continue to support all hospitalists, independent of board eligibility status, and would continue to offer these hospitalists the merit-based Fellow designation. SHM’s pediatric leaders also proposed future directions for the ABP, including a Focused Practice Pathway in Hospital Medicine (FPHM), such as what the American Board of Internal Medicine and the American Board of Family Medicine have adopted for board recertification in internal medicine and family medicine. This maintenance of certification program that allows physicians primarily practicing in inpatient settings to focus their continuing education on inpatient practice, and is not a subspecialty.7
Dr. Edgar-Zarate fully supports the future directions for pediatric hospitalists outlined in SHM’s Special Announcement. She hopes that the ABP will support the FPHM. She feels the FPHM will encourage more med/peds physicians to practice med/peds hospital medicine. L. Nell Hodo, MD, a family medicine–trained pediatric hospitalist at Icahn School of Medicine at Mount Sinai in New York, joins Dr. Edgar-Zarate in supporting an FPHM for PHM, and feels that it will open the door for hospitalists who are ineligible for the practice pathway to be able to focus their recertification on the inpatient setting.
Dr. Hodo and Dr. Desai hope that rather than excluding those who are not PHM board eligible/certified, institutions and professional organizations will consider all qualifications when hiring, mentoring, and promoting physicians who care for hospitalized children. Dr. Natt, Dr. Schwenk, Dr. Edgar-Zarate, and Dr. Hodo appreciate that SHM is leading the way, and will continue to allow all hospitalists who care for children to receive Fellow designation.
Dr. Kumar is clinical assistant professor of pediatrics at the Cleveland Clinic Lerner College of Medicine at Case Western Reserve University and a pediatric hospitalist at Cleveland Clinic Children’s. She is the pediatric editor of The Hospitalist.
References
1. The American Board of Pediatrics. The American Board of Pediatrics response to the Pediatric Hospital Medicine petition. https://www.abp.org/sites/abp/files/phm-petition-response.pdf. Published 2019.
2. Barrett DJ, McGuinness GA, Cunha CA, et al. Pediatric hospital medicine: A proposed new subspecialty. Pediatrics. 2017;139(3). doi: 10.1542/peds.2016-1823.
3. The American Board of Pediatrics. Pediatric Hospital Medicine Certification. https://www.abp.org/content/pediatric-hospital-medicine-certification. Published 2019.
4. Skey D. Pediatric Hospitalists, It’s time to take a stand on the PHM Boards Application Process! Five Dog Development, LLC.
5. Nichols DG, Woods SZ. The American Board of Pediatrics response to the Pediatric Hospital Medicine petition. J Hosp Med. 2019 Oct;14(10):586-8. doi: 10.12788/jhm.3322.
6. Gold JM et al. Collective action and effective dialogue to address gender bias in medicine. J Hosp Med. 2019 Oct;14(10):630-2. doi: 10.12788/jhm.3331.
7. Chang WW et al. Society of Hospital Medicine position on the American Board of Pediatrics response to the Pediatric Hospital Medicine petition. J Hosp Med. 2019 Oct;14(10):589-90. doi: 10.12788/jhm.3326.
Autumn is a busy time for pediatric hospitalists, with this autumn being particularly eventful as the first American Board of Pediatrics (ABP) certifying exam for Pediatric Hospital Medicine (PHM) will be offered on Nov. 12, 2019.
More than 1,600 med/peds and pediatric hospitalists applied to be eligible for the 2019 exam, 71% of whom were women. At least 3.9% of those applicants were denied eligibility for the 2019 exam.1 These denials resulted in discussions on the American Academy of Pediatrics Section on Hospital Medicine (AAP SOHM) email listserv related to unintentional gender bias.
PHM was first recognized as a subspecialty by the American Board of Medical Specialties in December 2015.2 Since that time, the ABP’s PHM sub-board developed eligibility criteria for practicing pediatric and med/peds hospitalists to apply for the exam. The sub-board identified three paths: a training pathway for applicants who had completed a 2-year PHM fellowship, a practice pathway for those satisfying ABP criteria for clinical activity in PHM, and a combined pathway for applicants who had completed PHM fellowships lasting less than 2 years.
Based on these pathways, 1,627 applicants applied for eligibility for the first PHM board certification exam.1 However, many concerns arose with the practice pathway eligibility criteria.
The PHM practice pathway initially included the following eligibility criteria:
• General pediatrics board certification.
• PHM practice “look back” period ends on or before June 30 of the exam year and starts 4 years earlier.
• More than 0.5 FTE professional PHM-related activities (patient-care, research, administration), defined as more than 900 hours/year every year for the preceding 4 years.
• More than 0.25 FTE direct patient care of hospitalized children, defined as more than 450 hours/year every year for the preceding 4 years.
• Practice covers the full range of hospitalized children with regard to age, diagnoses, and complexity.
• Practice interruptions cannot exceed 3 months in the preceding 4 years, or 6 months in the preceding 5 years.
• Practice experience and hours were acquired in the United States and Canada.1,3
The start date and practice interruptions criteria in the practice pathway posed hurdles for many female applicants. Many women voiced concerns about feeling disadvantaged when applying for the PHM certifying exam and some of these women shared their concerns on the AAP SOHM email listserv. In response to these concerns, the PHM community called for increased transparency from the ABP related to denials, specifically related to unintentional gender bias against women applying for the exam.
David Skey, MD, and Jamee Walters, MD, pediatric hospitalists at Arnold Palmer Medical Center in Orlando, heard these concerns and decided to draft a petition with the help of legal counsel. The petition “demand[ed] immediate action,” and “request[ed] a formal response from the ABP regarding the practice pathway criteria.” The petition also stated that there was insufficient data to determine if the practice pathway “disadvantages women.” The petition asked the ABP to “facilitate a timely analysis to determine if gender bias” was present, or to perform an internal analysis and “release the findings publicly.”4
The petition was shared with the PHM community via the AAP SOHM listserv on July 29, 2019. Dr. Walters stated she was pleased by the response she and Dr. Skey received from the PHM community, on and off the AAP SOHM listserv. The petition was submitted to the ABP on Aug. 6, 2019, with 1,479 signatures.
On Aug. 29, 2019, the ABP’s response was shared on the AAP SOHM email listserv1 and was later published in the Journal of Hospital Medicine as a Special Announcement.5 In its response, the ABP stated that the gender bias allegation was “not supported by the facts” as there was “no significant difference between the percentage of women and men who were denied” eligibility.”5 In addressing the gender bias allegations and clarifying the practice pathway eligibility, the ABP removed the practice interruption criteria and modified the practice pathway criteria as follows:
• General pediatrics board certification.
• PHM practice started on or before July 2015 (for board eligibility in 2019).
• Professional PHM-related activities (patient-care, research, administration), defined as more than 900-1000 hours/year every year for the preceding 4 years.
• Direct patient care of hospitalized children, defined as more than 450-500 hours/year every year for the preceding 4 years.
• Practice covers the full range of hospitalized children with regard to age, diagnoses, and complexity.
• Practice experience and hours were acquired in the United States and Canada.1
Following the release of the ABP’s response, many members of the PHM community remain concerned about the ABP’s revised criteria. Arti Desai, MD, pediatric hospitalist at Seattle Children’s and senior author on a “Perspectives in Hospital Medicine” in the Journal of Hospital Medicine,6 was appreciative that the ABP chose to remove the practice interruptions criterion. However, she and her colleagues remain concerned about lingering gender bias in the ABP’s practice pathway eligibility criteria surrounding the “start date” criterion. The authors state that this criterion differentially affects women, as women may take time off during or after residency for maternity or family leave. Dr. Desai states that this criterion alone can affect a woman’s chance for being eligible for the practice pathway.
Other members of the PHM community also expressed concerns about the ABP’s response to the PHM petition. Beth C. Natt, MD, pediatric hospitalist and director of pediatric hospital medicine regional programs at Connecticut Children’s in Hartford, felt that the population may have been self-selected, as the ABP’s data were limited to individuals who applied for exam eligibility. She was concerned that the data excluded pediatric hospitalists who chose not to apply because of uncertainty about meeting eligibility criteria. Klint Schwenk, MD, pediatric hospitalist at Norton Children’s Hospital in Louisville, Ky., stated that he wished the ABP had addressed the number of pediatric hospitalists who elected not to apply based on fear of ineligibility before concluding that there was no bias. He likened the ABP’s response to that of study authors omitting selection bias when discussing the limitations of their study.
Courtney Edgar-Zarate, MD, med/peds hospitalist and associate program director of the internal medicine/pediatrics residency at the University of Arkansas, expressed concerns that the ABP’s stringent clinical patient care hours criterion may unintentionally result in ineligibility for many mid-career or senior med/peds hospitalists. Dr. Edgar-Zarate also voiced concerns that graduating med/peds residents were electing not to pursue careers in hospital medicine because they would be required to complete a PHM fellowship to become a pediatric hospitalist, when a similar fellowship is not required to practice adult hospital medicine.
The Society of Hospital Medicine shared its position in regard to the ABP’s response in a Special Announcement in the Journal of Hospital Medicine.7 In it, SHM’s pediatric leaders recognized physicians for the excellent care they provide to hospitalized children. They stated that SHM would continue to support all hospitalists, independent of board eligibility status, and would continue to offer these hospitalists the merit-based Fellow designation. SHM’s pediatric leaders also proposed future directions for the ABP, including a Focused Practice Pathway in Hospital Medicine (FPHM), such as what the American Board of Internal Medicine and the American Board of Family Medicine have adopted for board recertification in internal medicine and family medicine. This maintenance of certification program that allows physicians primarily practicing in inpatient settings to focus their continuing education on inpatient practice, and is not a subspecialty.7
Dr. Edgar-Zarate fully supports the future directions for pediatric hospitalists outlined in SHM’s Special Announcement. She hopes that the ABP will support the FPHM. She feels the FPHM will encourage more med/peds physicians to practice med/peds hospital medicine. L. Nell Hodo, MD, a family medicine–trained pediatric hospitalist at Icahn School of Medicine at Mount Sinai in New York, joins Dr. Edgar-Zarate in supporting an FPHM for PHM, and feels that it will open the door for hospitalists who are ineligible for the practice pathway to be able to focus their recertification on the inpatient setting.
Dr. Hodo and Dr. Desai hope that rather than excluding those who are not PHM board eligible/certified, institutions and professional organizations will consider all qualifications when hiring, mentoring, and promoting physicians who care for hospitalized children. Dr. Natt, Dr. Schwenk, Dr. Edgar-Zarate, and Dr. Hodo appreciate that SHM is leading the way, and will continue to allow all hospitalists who care for children to receive Fellow designation.
Dr. Kumar is clinical assistant professor of pediatrics at the Cleveland Clinic Lerner College of Medicine at Case Western Reserve University and a pediatric hospitalist at Cleveland Clinic Children’s. She is the pediatric editor of The Hospitalist.
References
1. The American Board of Pediatrics. The American Board of Pediatrics response to the Pediatric Hospital Medicine petition. https://www.abp.org/sites/abp/files/phm-petition-response.pdf. Published 2019.
2. Barrett DJ, McGuinness GA, Cunha CA, et al. Pediatric hospital medicine: A proposed new subspecialty. Pediatrics. 2017;139(3). doi: 10.1542/peds.2016-1823.
3. The American Board of Pediatrics. Pediatric Hospital Medicine Certification. https://www.abp.org/content/pediatric-hospital-medicine-certification. Published 2019.
4. Skey D. Pediatric Hospitalists, It’s time to take a stand on the PHM Boards Application Process! Five Dog Development, LLC.
5. Nichols DG, Woods SZ. The American Board of Pediatrics response to the Pediatric Hospital Medicine petition. J Hosp Med. 2019 Oct;14(10):586-8. doi: 10.12788/jhm.3322.
6. Gold JM et al. Collective action and effective dialogue to address gender bias in medicine. J Hosp Med. 2019 Oct;14(10):630-2. doi: 10.12788/jhm.3331.
7. Chang WW et al. Society of Hospital Medicine position on the American Board of Pediatrics response to the Pediatric Hospital Medicine petition. J Hosp Med. 2019 Oct;14(10):589-90. doi: 10.12788/jhm.3326.
Pediatric stroke thrombectomy study sheds light on off-label procedure
based on data from a retrospective, multicenter study of 73 patients.
Children with high scores on the Pediatric National Institutes of Health Stroke Scale (PedNIHSS) or large-vessel occlusion in the anterior or posterior circulation are at increased risk for morbidity and mortality, but the safety of thrombectomy in children has not been well studied. Several randomized trials have showed its safety and efficacy in adults, wrote Peter Sporns, MD, of the Institute of Clinical Radiology at Universitätsklinikum Muenster (Germany), and colleagues.
In a study published in JAMA Neurology, Dr. Sporns and coauthors reviewed data from pediatric patients aged younger than 18 years who underwent endovascular recanalization between Jan. 1, 2000, and Dec. 31, 2018, at 25 stroke centers in Europe and 2 in the United States.
The primary outcome was change in the PedNIHSS scores and the endovascular recanalization involved “a combination of techniques using distal thrombaspiration and/or clot retrievers,” the researchers wrote.
Neurologic outcomes improved from a median PedNIHSS score of 14.0 at hospital admission to 4.0 at day 7. The average time from stroke onset to hospital admission was 3 hours, and the median time from stroke onset to recanalization was 4 hours.
“The rapidity of recanalization across the large number of centers in the Save ChildS study is a commendable achievement, establishing feasibility for acute pediatric stroke treatment within the short window of time for embolectomy at centers prepared for this event,” wrote Christine Fox, MD, of the University of California, San Francisco, and Nomazulu Dlamini, MBBS, PhD, of the Hospital for Sick Children, Toronto, in an accompanying editorial.
In addition, the median modified Rankin Scale score was 1.0 at discharge and at 6 and 24 months, and the median Pediatric Stroke Outcome Measure score was 1.0 at discharge and 0.5 at 6 and 24 months.
The median age of the patients was 11 years, and approximately half were boys (51%). A total of 63 children (86%) were treated for anterior circulation occlusion, and 10 (14%) were treated for posterior circulation occlusion; (22%) received concomitant intravenous thrombolysis.
Transient vasospasm was the only observed periprocedural complication, seen in four patients, and all cases resolved without clinical sequelae. One patient with a history of a heart anomaly died of cardiac arrest after recanalization. No vascular complications were reported, and the proportion of symptomatic intracerebral hemorrhage events was 1.37 per 100 observations, compared with 2.79 in a meta-analysis of adult studies.
The main limitation of the study was its retrospective design, as well as the absence of a control group, the researchers noted. However, the results “may support clinicians’ practice of off-label thrombectomy in childhood stroke in the absence of high-level evidence.”
The editorial authors emphasized that safety concerns remain despite the relatively low level of complications observed in the current study. “The safety of thrombectomy in children with suspected focal cerebral arteriopathy or bilateral arteriopathies is a particular concern because of the potential to further injure an acutely inflamed or chronically diseased vessel,” they wrote.
“We should be cautious about the interpretation of long-term outcome measures in the Save ChildS study,” Dr. Fox and Dr. Dlamini added, noting that additional multicenter studies are needed “to advance our knowledge of pediatric stroke and inform best practices.”
Dr. Sporns had no financial conflicts to disclose; several coauthors disclosed relationships with multiple pharmaceutical companies. Dr. Fox and Dr. Dlamini had no financial conflicts to disclose.
SOURCES: Sporns P et al. JAMA Neurol. 2019 Oct 14. doi: 10.1001/jamaneurol.2019.3403; Fox C, Dlamini N. JAMA Neurol. 2019 Oct 14. doi: 10.1001/jamaneurol.2019.3412.
based on data from a retrospective, multicenter study of 73 patients.
Children with high scores on the Pediatric National Institutes of Health Stroke Scale (PedNIHSS) or large-vessel occlusion in the anterior or posterior circulation are at increased risk for morbidity and mortality, but the safety of thrombectomy in children has not been well studied. Several randomized trials have showed its safety and efficacy in adults, wrote Peter Sporns, MD, of the Institute of Clinical Radiology at Universitätsklinikum Muenster (Germany), and colleagues.
In a study published in JAMA Neurology, Dr. Sporns and coauthors reviewed data from pediatric patients aged younger than 18 years who underwent endovascular recanalization between Jan. 1, 2000, and Dec. 31, 2018, at 25 stroke centers in Europe and 2 in the United States.
The primary outcome was change in the PedNIHSS scores and the endovascular recanalization involved “a combination of techniques using distal thrombaspiration and/or clot retrievers,” the researchers wrote.
Neurologic outcomes improved from a median PedNIHSS score of 14.0 at hospital admission to 4.0 at day 7. The average time from stroke onset to hospital admission was 3 hours, and the median time from stroke onset to recanalization was 4 hours.
“The rapidity of recanalization across the large number of centers in the Save ChildS study is a commendable achievement, establishing feasibility for acute pediatric stroke treatment within the short window of time for embolectomy at centers prepared for this event,” wrote Christine Fox, MD, of the University of California, San Francisco, and Nomazulu Dlamini, MBBS, PhD, of the Hospital for Sick Children, Toronto, in an accompanying editorial.
In addition, the median modified Rankin Scale score was 1.0 at discharge and at 6 and 24 months, and the median Pediatric Stroke Outcome Measure score was 1.0 at discharge and 0.5 at 6 and 24 months.
The median age of the patients was 11 years, and approximately half were boys (51%). A total of 63 children (86%) were treated for anterior circulation occlusion, and 10 (14%) were treated for posterior circulation occlusion; (22%) received concomitant intravenous thrombolysis.
Transient vasospasm was the only observed periprocedural complication, seen in four patients, and all cases resolved without clinical sequelae. One patient with a history of a heart anomaly died of cardiac arrest after recanalization. No vascular complications were reported, and the proportion of symptomatic intracerebral hemorrhage events was 1.37 per 100 observations, compared with 2.79 in a meta-analysis of adult studies.
The main limitation of the study was its retrospective design, as well as the absence of a control group, the researchers noted. However, the results “may support clinicians’ practice of off-label thrombectomy in childhood stroke in the absence of high-level evidence.”
The editorial authors emphasized that safety concerns remain despite the relatively low level of complications observed in the current study. “The safety of thrombectomy in children with suspected focal cerebral arteriopathy or bilateral arteriopathies is a particular concern because of the potential to further injure an acutely inflamed or chronically diseased vessel,” they wrote.
“We should be cautious about the interpretation of long-term outcome measures in the Save ChildS study,” Dr. Fox and Dr. Dlamini added, noting that additional multicenter studies are needed “to advance our knowledge of pediatric stroke and inform best practices.”
Dr. Sporns had no financial conflicts to disclose; several coauthors disclosed relationships with multiple pharmaceutical companies. Dr. Fox and Dr. Dlamini had no financial conflicts to disclose.
SOURCES: Sporns P et al. JAMA Neurol. 2019 Oct 14. doi: 10.1001/jamaneurol.2019.3403; Fox C, Dlamini N. JAMA Neurol. 2019 Oct 14. doi: 10.1001/jamaneurol.2019.3412.
based on data from a retrospective, multicenter study of 73 patients.
Children with high scores on the Pediatric National Institutes of Health Stroke Scale (PedNIHSS) or large-vessel occlusion in the anterior or posterior circulation are at increased risk for morbidity and mortality, but the safety of thrombectomy in children has not been well studied. Several randomized trials have showed its safety and efficacy in adults, wrote Peter Sporns, MD, of the Institute of Clinical Radiology at Universitätsklinikum Muenster (Germany), and colleagues.
In a study published in JAMA Neurology, Dr. Sporns and coauthors reviewed data from pediatric patients aged younger than 18 years who underwent endovascular recanalization between Jan. 1, 2000, and Dec. 31, 2018, at 25 stroke centers in Europe and 2 in the United States.
The primary outcome was change in the PedNIHSS scores and the endovascular recanalization involved “a combination of techniques using distal thrombaspiration and/or clot retrievers,” the researchers wrote.
Neurologic outcomes improved from a median PedNIHSS score of 14.0 at hospital admission to 4.0 at day 7. The average time from stroke onset to hospital admission was 3 hours, and the median time from stroke onset to recanalization was 4 hours.
“The rapidity of recanalization across the large number of centers in the Save ChildS study is a commendable achievement, establishing feasibility for acute pediatric stroke treatment within the short window of time for embolectomy at centers prepared for this event,” wrote Christine Fox, MD, of the University of California, San Francisco, and Nomazulu Dlamini, MBBS, PhD, of the Hospital for Sick Children, Toronto, in an accompanying editorial.
In addition, the median modified Rankin Scale score was 1.0 at discharge and at 6 and 24 months, and the median Pediatric Stroke Outcome Measure score was 1.0 at discharge and 0.5 at 6 and 24 months.
The median age of the patients was 11 years, and approximately half were boys (51%). A total of 63 children (86%) were treated for anterior circulation occlusion, and 10 (14%) were treated for posterior circulation occlusion; (22%) received concomitant intravenous thrombolysis.
Transient vasospasm was the only observed periprocedural complication, seen in four patients, and all cases resolved without clinical sequelae. One patient with a history of a heart anomaly died of cardiac arrest after recanalization. No vascular complications were reported, and the proportion of symptomatic intracerebral hemorrhage events was 1.37 per 100 observations, compared with 2.79 in a meta-analysis of adult studies.
The main limitation of the study was its retrospective design, as well as the absence of a control group, the researchers noted. However, the results “may support clinicians’ practice of off-label thrombectomy in childhood stroke in the absence of high-level evidence.”
The editorial authors emphasized that safety concerns remain despite the relatively low level of complications observed in the current study. “The safety of thrombectomy in children with suspected focal cerebral arteriopathy or bilateral arteriopathies is a particular concern because of the potential to further injure an acutely inflamed or chronically diseased vessel,” they wrote.
“We should be cautious about the interpretation of long-term outcome measures in the Save ChildS study,” Dr. Fox and Dr. Dlamini added, noting that additional multicenter studies are needed “to advance our knowledge of pediatric stroke and inform best practices.”
Dr. Sporns had no financial conflicts to disclose; several coauthors disclosed relationships with multiple pharmaceutical companies. Dr. Fox and Dr. Dlamini had no financial conflicts to disclose.
SOURCES: Sporns P et al. JAMA Neurol. 2019 Oct 14. doi: 10.1001/jamaneurol.2019.3403; Fox C, Dlamini N. JAMA Neurol. 2019 Oct 14. doi: 10.1001/jamaneurol.2019.3412.
FROM JAMA NEUROLOGY
Increased Parkinson’s disease risk seen with bipolar disorder
Patients with bipolar disorder may be at increased risk of Parkinson’s disease in later life, according to a systematic review and meta-analysis published in JAMA Neurology.
Patrícia R. Faustino, MD, from the faculty of medicine at the University of Lisboa (Portgual), and coauthors reviewed and analyzed seven articles – four cohort studies and three cross-sectional studies – that reported data on idiopathic Parkinson’s disease in patients with bipolar disorder, compared with those without. The meta-analysis found that individuals with a previous diagnosis of bipolar disorder had a 235% higher risk of being later diagnosed with Parkinson’s disease. Even after removing studies with a high risk of bias, the risk was still 3.21 times higher in those with bipolar disorder, compared with those without.
“The pathophysiological rationale between bipolar disorder and Parkinson’s disease might be explained by the dopamine dysregulation hypothesis, which states that the cyclical process of bipolar disorder in manic states leads to a down-regulation of dopamine receptor sensitivity (depression phase), which is later compensated by up-regulation (manic state),” the authors wrote. “Over time, this phenomenon may lead to an overall reduction of dopaminergic activity, the prototypical Parkinson’s disease state.”
Subgroup analysis revealed that subgroups with shorter follow-up periods – less than 9 years – had a greater increase in the risk of a later Parkinson’s disease diagnosis. The authors noted that this could represent misdiagnosis of parkinsonism – possibly drug induced – as Parkinson’s disease. The researchers also raised the possibility that the increased risk of Parkinson’s disease in patients with bipolar disorder could relate to long-term lithium use, rather than being a causal relationship. “However, treatment with lithium is foundational in bipolar disorder, and so to separate the causal effect from a potential confounder would be particularly difficult,” they wrote.
One of the studies included did explore the use of lithium, and found that lithium monotherapy was associated with a significant increase in the risk of being diagnosed with Parkinson’s disease or taking antiparkinsonism medication, compared with antidepressant therapy. However the authors commented that the diagnostic code may not differentiate Parkinson’s disease from other causes of parkinsonism.
Given their findings, the authors suggested that, if patients with bipolar disorder present with parkinsonism features, it may not necessarily be drug induced. In these patients, they recommended an investigation for Parkinson’s disease, perhaps using functional neuroimaging “as Parkinson’s disease classically presents with nigrostriatal degeneration while drug-induced parkinsonism does not.”
Two authors declared grants and personal fees from the pharmaceutical sector. No other conflicts of interest were reported.
SOURCE: Faustino PR et al. JAMA Neurol. 2019 Oct 14. doi: 10.1001/jamaneurol.2019.3446.
Patients with bipolar disorder may be at increased risk of Parkinson’s disease in later life, according to a systematic review and meta-analysis published in JAMA Neurology.
Patrícia R. Faustino, MD, from the faculty of medicine at the University of Lisboa (Portgual), and coauthors reviewed and analyzed seven articles – four cohort studies and three cross-sectional studies – that reported data on idiopathic Parkinson’s disease in patients with bipolar disorder, compared with those without. The meta-analysis found that individuals with a previous diagnosis of bipolar disorder had a 235% higher risk of being later diagnosed with Parkinson’s disease. Even after removing studies with a high risk of bias, the risk was still 3.21 times higher in those with bipolar disorder, compared with those without.
“The pathophysiological rationale between bipolar disorder and Parkinson’s disease might be explained by the dopamine dysregulation hypothesis, which states that the cyclical process of bipolar disorder in manic states leads to a down-regulation of dopamine receptor sensitivity (depression phase), which is later compensated by up-regulation (manic state),” the authors wrote. “Over time, this phenomenon may lead to an overall reduction of dopaminergic activity, the prototypical Parkinson’s disease state.”
Subgroup analysis revealed that subgroups with shorter follow-up periods – less than 9 years – had a greater increase in the risk of a later Parkinson’s disease diagnosis. The authors noted that this could represent misdiagnosis of parkinsonism – possibly drug induced – as Parkinson’s disease. The researchers also raised the possibility that the increased risk of Parkinson’s disease in patients with bipolar disorder could relate to long-term lithium use, rather than being a causal relationship. “However, treatment with lithium is foundational in bipolar disorder, and so to separate the causal effect from a potential confounder would be particularly difficult,” they wrote.
One of the studies included did explore the use of lithium, and found that lithium monotherapy was associated with a significant increase in the risk of being diagnosed with Parkinson’s disease or taking antiparkinsonism medication, compared with antidepressant therapy. However the authors commented that the diagnostic code may not differentiate Parkinson’s disease from other causes of parkinsonism.
Given their findings, the authors suggested that, if patients with bipolar disorder present with parkinsonism features, it may not necessarily be drug induced. In these patients, they recommended an investigation for Parkinson’s disease, perhaps using functional neuroimaging “as Parkinson’s disease classically presents with nigrostriatal degeneration while drug-induced parkinsonism does not.”
Two authors declared grants and personal fees from the pharmaceutical sector. No other conflicts of interest were reported.
SOURCE: Faustino PR et al. JAMA Neurol. 2019 Oct 14. doi: 10.1001/jamaneurol.2019.3446.
Patients with bipolar disorder may be at increased risk of Parkinson’s disease in later life, according to a systematic review and meta-analysis published in JAMA Neurology.
Patrícia R. Faustino, MD, from the faculty of medicine at the University of Lisboa (Portgual), and coauthors reviewed and analyzed seven articles – four cohort studies and three cross-sectional studies – that reported data on idiopathic Parkinson’s disease in patients with bipolar disorder, compared with those without. The meta-analysis found that individuals with a previous diagnosis of bipolar disorder had a 235% higher risk of being later diagnosed with Parkinson’s disease. Even after removing studies with a high risk of bias, the risk was still 3.21 times higher in those with bipolar disorder, compared with those without.
“The pathophysiological rationale between bipolar disorder and Parkinson’s disease might be explained by the dopamine dysregulation hypothesis, which states that the cyclical process of bipolar disorder in manic states leads to a down-regulation of dopamine receptor sensitivity (depression phase), which is later compensated by up-regulation (manic state),” the authors wrote. “Over time, this phenomenon may lead to an overall reduction of dopaminergic activity, the prototypical Parkinson’s disease state.”
Subgroup analysis revealed that subgroups with shorter follow-up periods – less than 9 years – had a greater increase in the risk of a later Parkinson’s disease diagnosis. The authors noted that this could represent misdiagnosis of parkinsonism – possibly drug induced – as Parkinson’s disease. The researchers also raised the possibility that the increased risk of Parkinson’s disease in patients with bipolar disorder could relate to long-term lithium use, rather than being a causal relationship. “However, treatment with lithium is foundational in bipolar disorder, and so to separate the causal effect from a potential confounder would be particularly difficult,” they wrote.
One of the studies included did explore the use of lithium, and found that lithium monotherapy was associated with a significant increase in the risk of being diagnosed with Parkinson’s disease or taking antiparkinsonism medication, compared with antidepressant therapy. However the authors commented that the diagnostic code may not differentiate Parkinson’s disease from other causes of parkinsonism.
Given their findings, the authors suggested that, if patients with bipolar disorder present with parkinsonism features, it may not necessarily be drug induced. In these patients, they recommended an investigation for Parkinson’s disease, perhaps using functional neuroimaging “as Parkinson’s disease classically presents with nigrostriatal degeneration while drug-induced parkinsonism does not.”
Two authors declared grants and personal fees from the pharmaceutical sector. No other conflicts of interest were reported.
SOURCE: Faustino PR et al. JAMA Neurol. 2019 Oct 14. doi: 10.1001/jamaneurol.2019.3446.
FROM JAMA NEUROLOGY
Apply for the Travel Advocacy Scholarship by Oct. 31
Oct. 31 is the deadline for the Vascular Surgery Trainee Advocacy Travel Scholarship. The primary purpose of this award is to provide the recipient with an opportunity to participate in Capitol Hill visits and learn more about the SVS’ health policy and advocacy activities. The awardee will receive $1,500 that can be used toward the cost of travel, housing and subsistence during the visits. Reports from past recipients are available on the SVS website here. For questions, email [email protected] or telephone 800-258-7188.
Oct. 31 is the deadline for the Vascular Surgery Trainee Advocacy Travel Scholarship. The primary purpose of this award is to provide the recipient with an opportunity to participate in Capitol Hill visits and learn more about the SVS’ health policy and advocacy activities. The awardee will receive $1,500 that can be used toward the cost of travel, housing and subsistence during the visits. Reports from past recipients are available on the SVS website here. For questions, email [email protected] or telephone 800-258-7188.
Oct. 31 is the deadline for the Vascular Surgery Trainee Advocacy Travel Scholarship. The primary purpose of this award is to provide the recipient with an opportunity to participate in Capitol Hill visits and learn more about the SVS’ health policy and advocacy activities. The awardee will receive $1,500 that can be used toward the cost of travel, housing and subsistence during the visits. Reports from past recipients are available on the SVS website here. For questions, email [email protected] or telephone 800-258-7188.
Register for Upcoming Webinars
Registration is now open for two webinars hosted by the SVS Community Practice Committee. Sign up for webinars focusing on “Hiring for the Right Clinical Fit” and/or “Credentialing and Privileging for New Procedures and Technologies.” These webinars are meant to help you advance your practice – register here. If you have any questions, please contact Chantel Moore at [email protected].
Registration is now open for two webinars hosted by the SVS Community Practice Committee. Sign up for webinars focusing on “Hiring for the Right Clinical Fit” and/or “Credentialing and Privileging for New Procedures and Technologies.” These webinars are meant to help you advance your practice – register here. If you have any questions, please contact Chantel Moore at [email protected].
Registration is now open for two webinars hosted by the SVS Community Practice Committee. Sign up for webinars focusing on “Hiring for the Right Clinical Fit” and/or “Credentialing and Privileging for New Procedures and Technologies.” These webinars are meant to help you advance your practice – register here. If you have any questions, please contact Chantel Moore at [email protected].
Enroll in the Mentor Match Program on SVSConnect
The SVS has officially announced its new Mentor Match program on its online community, SVSConnect. This program provides a simple way for general surgery residents and medical students to match with vascular surgeons who will, ideally, help guide them on their career path. If you are an Active SVS member you are encouraged to participate as a mentor. Medical Students and General Surgery Residents are welcome to enroll as mentees. Not a member? Visit the SVS membership page here. Questions? Reach out to [email protected].
The SVS has officially announced its new Mentor Match program on its online community, SVSConnect. This program provides a simple way for general surgery residents and medical students to match with vascular surgeons who will, ideally, help guide them on their career path. If you are an Active SVS member you are encouraged to participate as a mentor. Medical Students and General Surgery Residents are welcome to enroll as mentees. Not a member? Visit the SVS membership page here. Questions? Reach out to [email protected].
The SVS has officially announced its new Mentor Match program on its online community, SVSConnect. This program provides a simple way for general surgery residents and medical students to match with vascular surgeons who will, ideally, help guide them on their career path. If you are an Active SVS member you are encouraged to participate as a mentor. Medical Students and General Surgery Residents are welcome to enroll as mentees. Not a member? Visit the SVS membership page here. Questions? Reach out to [email protected].
Suicidality risk high in transgender youth, varies by gender identity subtype
, new research suggests.
The study, which included more than 2,000 adolescents and was published in the October 14 issue of Pediatrics, provides new insights into suicide risk in gender identity subgroups, according to the investigators.
“Limited measures of gender identity may have led to inaccurate estimates of suicidality among transgender females in previous studies,” wrote Brian C. Thoma, PhD, and his colleagues at the University of Pittsburgh. The researchers noted that transgender females and nonbinary adolescents assigned male at birth are frequently combined in studies.
“However, our results indicate transgender females have higher risk for suicidal ideation and attempt compared with cisgender adolescents, whereas nonbinary adolescents assigned male at birth do not,” they wrote. “It is possible that estimates of suicidality that aggregate all transgender adolescents assigned male at birth into one group underestimate rates of suicidality among transgender females.”
The study, which analyzed results from a cross-sectional online survey from July to October 2018, was comprised of 2,020 adolescents, including 1,134 transgender adolescents.
The researchers divided respondents into seven categories: Cisgender males, cisgender females, transgender males, transgender females, nonbinary adolescents assigned female at birth, nonbinary adolescents assigned male at birth, and questioning gender identity. They then assessed non-suicidal self-injury (NSSI) and lifetime suicidality.
Compared to cisgender youth, transgender adolescents overall were more likely to report all outcomes: passive death wish (odds ratio [OR]=2.60), suicidal ideation (OR=2.20), suicide plan (OR=1.82), suicide attempt (OR=1.65), attempt requiring medical care (OR=2.01), and NSSI (OR=2.88).
Using cisgender males as reference after adjustment for all demographics, “cisgender females, transgender males, and nonbinary adolescents assigned female at birth had higher odds of each suicidality outcome” (OR= 1.49-5.85; OR=2.72-12.12; OR=1.84-8.59, respectively), the authors reported. “Transgender females had higher odds of each outcome [OR=2.73-6.30] except for suicide attempt requiring medical care. Nonbinary adolescents assigned male at birth had higher odds of suicide attempt requiring medical care [OR=10.13] and NSSI [OR=3.79]. Adolescents questioning their gender identity had higher odds of all outcomes [OR=3.23-7.59] except for suicide attempt.”
When compared to cisgender females as reference, however, only transgender males and transgender females had higher odds of suicidal ideation and attempts.
The overall findings were unsurprising since the higher rates of suicidality among transgender youth have already been documented, but the classification of participants was interesting, Gerald Montano, DO, an assistant professor of pediatrics at the University of Pittsburgh School of Medicine, said in an interview. Dr Montano was not involved in the study.
“It’s always been a challenge because, in the past, they always lumped transgender youth along with lesbian, gay, and bisexual youth,” Dr Montano said. This study is one of the few to go into more detail in considering participants’ gender identity, which was wise given that suicidal risk may differ accordingly.
The biggest take-home message of this study is the importance of screening for suicidality after informing adolescent patients of the limits of confidentiality, Dr Montano said.
“I think it’s very important for the physician to be aware of the reasons for those thoughts of suicide,” he continued. “A lot of it has to do with their gender identity and from discrimination and stigma from the general population.”
The research was funded by the University of Pittsburgh Central Research Development Fund and the National Institutes of Health. The authors reported no conflicts of interest.
SOURCE: Thoma BC et al, Pediatrics, October 14, 2019. DOI: 10.1542/peds.2019-1183
, new research suggests.
The study, which included more than 2,000 adolescents and was published in the October 14 issue of Pediatrics, provides new insights into suicide risk in gender identity subgroups, according to the investigators.
“Limited measures of gender identity may have led to inaccurate estimates of suicidality among transgender females in previous studies,” wrote Brian C. Thoma, PhD, and his colleagues at the University of Pittsburgh. The researchers noted that transgender females and nonbinary adolescents assigned male at birth are frequently combined in studies.
“However, our results indicate transgender females have higher risk for suicidal ideation and attempt compared with cisgender adolescents, whereas nonbinary adolescents assigned male at birth do not,” they wrote. “It is possible that estimates of suicidality that aggregate all transgender adolescents assigned male at birth into one group underestimate rates of suicidality among transgender females.”
The study, which analyzed results from a cross-sectional online survey from July to October 2018, was comprised of 2,020 adolescents, including 1,134 transgender adolescents.
The researchers divided respondents into seven categories: Cisgender males, cisgender females, transgender males, transgender females, nonbinary adolescents assigned female at birth, nonbinary adolescents assigned male at birth, and questioning gender identity. They then assessed non-suicidal self-injury (NSSI) and lifetime suicidality.
Compared to cisgender youth, transgender adolescents overall were more likely to report all outcomes: passive death wish (odds ratio [OR]=2.60), suicidal ideation (OR=2.20), suicide plan (OR=1.82), suicide attempt (OR=1.65), attempt requiring medical care (OR=2.01), and NSSI (OR=2.88).
Using cisgender males as reference after adjustment for all demographics, “cisgender females, transgender males, and nonbinary adolescents assigned female at birth had higher odds of each suicidality outcome” (OR= 1.49-5.85; OR=2.72-12.12; OR=1.84-8.59, respectively), the authors reported. “Transgender females had higher odds of each outcome [OR=2.73-6.30] except for suicide attempt requiring medical care. Nonbinary adolescents assigned male at birth had higher odds of suicide attempt requiring medical care [OR=10.13] and NSSI [OR=3.79]. Adolescents questioning their gender identity had higher odds of all outcomes [OR=3.23-7.59] except for suicide attempt.”
When compared to cisgender females as reference, however, only transgender males and transgender females had higher odds of suicidal ideation and attempts.
The overall findings were unsurprising since the higher rates of suicidality among transgender youth have already been documented, but the classification of participants was interesting, Gerald Montano, DO, an assistant professor of pediatrics at the University of Pittsburgh School of Medicine, said in an interview. Dr Montano was not involved in the study.
“It’s always been a challenge because, in the past, they always lumped transgender youth along with lesbian, gay, and bisexual youth,” Dr Montano said. This study is one of the few to go into more detail in considering participants’ gender identity, which was wise given that suicidal risk may differ accordingly.
The biggest take-home message of this study is the importance of screening for suicidality after informing adolescent patients of the limits of confidentiality, Dr Montano said.
“I think it’s very important for the physician to be aware of the reasons for those thoughts of suicide,” he continued. “A lot of it has to do with their gender identity and from discrimination and stigma from the general population.”
The research was funded by the University of Pittsburgh Central Research Development Fund and the National Institutes of Health. The authors reported no conflicts of interest.
SOURCE: Thoma BC et al, Pediatrics, October 14, 2019. DOI: 10.1542/peds.2019-1183
, new research suggests.
The study, which included more than 2,000 adolescents and was published in the October 14 issue of Pediatrics, provides new insights into suicide risk in gender identity subgroups, according to the investigators.
“Limited measures of gender identity may have led to inaccurate estimates of suicidality among transgender females in previous studies,” wrote Brian C. Thoma, PhD, and his colleagues at the University of Pittsburgh. The researchers noted that transgender females and nonbinary adolescents assigned male at birth are frequently combined in studies.
“However, our results indicate transgender females have higher risk for suicidal ideation and attempt compared with cisgender adolescents, whereas nonbinary adolescents assigned male at birth do not,” they wrote. “It is possible that estimates of suicidality that aggregate all transgender adolescents assigned male at birth into one group underestimate rates of suicidality among transgender females.”
The study, which analyzed results from a cross-sectional online survey from July to October 2018, was comprised of 2,020 adolescents, including 1,134 transgender adolescents.
The researchers divided respondents into seven categories: Cisgender males, cisgender females, transgender males, transgender females, nonbinary adolescents assigned female at birth, nonbinary adolescents assigned male at birth, and questioning gender identity. They then assessed non-suicidal self-injury (NSSI) and lifetime suicidality.
Compared to cisgender youth, transgender adolescents overall were more likely to report all outcomes: passive death wish (odds ratio [OR]=2.60), suicidal ideation (OR=2.20), suicide plan (OR=1.82), suicide attempt (OR=1.65), attempt requiring medical care (OR=2.01), and NSSI (OR=2.88).
Using cisgender males as reference after adjustment for all demographics, “cisgender females, transgender males, and nonbinary adolescents assigned female at birth had higher odds of each suicidality outcome” (OR= 1.49-5.85; OR=2.72-12.12; OR=1.84-8.59, respectively), the authors reported. “Transgender females had higher odds of each outcome [OR=2.73-6.30] except for suicide attempt requiring medical care. Nonbinary adolescents assigned male at birth had higher odds of suicide attempt requiring medical care [OR=10.13] and NSSI [OR=3.79]. Adolescents questioning their gender identity had higher odds of all outcomes [OR=3.23-7.59] except for suicide attempt.”
When compared to cisgender females as reference, however, only transgender males and transgender females had higher odds of suicidal ideation and attempts.
The overall findings were unsurprising since the higher rates of suicidality among transgender youth have already been documented, but the classification of participants was interesting, Gerald Montano, DO, an assistant professor of pediatrics at the University of Pittsburgh School of Medicine, said in an interview. Dr Montano was not involved in the study.
“It’s always been a challenge because, in the past, they always lumped transgender youth along with lesbian, gay, and bisexual youth,” Dr Montano said. This study is one of the few to go into more detail in considering participants’ gender identity, which was wise given that suicidal risk may differ accordingly.
The biggest take-home message of this study is the importance of screening for suicidality after informing adolescent patients of the limits of confidentiality, Dr Montano said.
“I think it’s very important for the physician to be aware of the reasons for those thoughts of suicide,” he continued. “A lot of it has to do with their gender identity and from discrimination and stigma from the general population.”
The research was funded by the University of Pittsburgh Central Research Development Fund and the National Institutes of Health. The authors reported no conflicts of interest.
SOURCE: Thoma BC et al, Pediatrics, October 14, 2019. DOI: 10.1542/peds.2019-1183
FROM PEDIATRICS
Key clinical point: Transgender adolescents should be screened for suicidality.
Major finding: Transgender youth as well as nonbinary adolescents assigned female at birth are at markedly high risk for suicidal ideation and attempt.
Study details: The findings are based on a cross-sectional survey of 2,020 U.S. adolescents, including 1,134 transgender or gender-diverse adolescents.
Disclosures: The research was funded by the University of Pittsburgh Central Research Development Fund and the National Institutes of Health. The authors reported no conflicts of interest.
Source: Thoma BC et al. Pediatrics. October 14, 2019. DOI: 10.1542/peds.2019-1183
Suicide attempts up in black U.S. teens
New research presents a complex picture of self-reported suicidal behavior in U.S. teenagers over the last few decades. Rates of suicidal ideation and plans dipped overall from 1991 to 2017, but the rate of suicide attempts grew slightly in black adolescents.
White young people “have historically had higher rates of suicide attempts...compared with their black counterparts; however, this study provides some evidence to the contrary,” wrote the authors of the report, which appears in the November issue of Pediatrics.
The investigators, led by Michael A. Lindsey, PhD, executive director of the McSilver Institute for Poverty Policy and Research at New York University, New York, note that suicide is the second leading cause of death in the United States in those aged 12-17. (Accidents rank first.) According to recent research, black children younger than 12 are at higher risk for death by suicide, compared with whites.
For the new study, researchers analyzed data from the Youth Risk Behavior Survey, which is conducted every 2 years among high school students in all 50 states and the District of Columbia. They examined data from 198,540 teens (mean age=16, 51% male; 49% female).
During the study period, the weighted overall prevalences rates of suicidal ideation, planning, attempt, and injury due to attempt were 19%, 15%, 8%, and 3%, respectively. “Our findings reveal that over that span of time, almost 1 in 5 adolescents are thinking about suicide... and > 1 in 10 has a suicide plan,” the researchers wrote.
Rates of suicidal ideation and planning fell overall, and among females, the rate of suicide attempts fell significantly (odds ratio [OR]=0.98). But self-reported suicide attempts grew significantly among black teens (OR=1.02), and injuries due to suicide attempts grew among black males (OR=1.04).
The findings are “troubling because attempts are the most prominent risk factor associated with suicide death,” the study authors wrote. “Findings regarding the rising rates of suicide attempts in black youth may be related to the documented disparities in mental health treatment and common social etiologic factors disproportionately experienced by black youth.”
In an accompanying commentary, psychiatrist Benjamin N. Shain, MD, PhD, of the University of Chicago, noted a seemingly “counterintuitive” fact: Black teens still have lower rates of suicide than whites teens “despite the greater, long-standing difficulties encountered by black adolescents, including disparities in mental health treatment and disproportionately higher stressors, racial discrimination, and childhood abuse and neglect, as well as other adverse experiences, such as poverty.”
It’s not clear why the reported suicide rate is lower in black adolescents than their white counterparts, Dr. Shain wrote, but misclassification and “undercount as a result of violence with suicidal intent, for example, ‘suicide by cop’” may play a role. Additionally, protective factors may have kept suicide rates down. “External attributional orientation (eg, blaming others or ‘the system’ for difficulties) among blacks may have buffered this group from internalizing blame related to psychological stressors,” he wrote.
Among black adolescents, the growing rate of suicidal behavior is concerning and may be due to a weakening of the hypothesized protective mechanism. Perhaps, Dr. Shain wrote, they now are blaming themselves more for difficulties encountered, “thus leading to an increase in suicide risk factors, particularly depression.” He stressed that, regardless of the reasons for the increase in suicide and suicide attempts, prevention and intervention efforts remain critical.
No study funding is reported, and authors report no relevant disclosures. Dr. Shain reports no relevant disclosures.
SOURCE: Lindsey MA et al, Pediatrics. 2019;144(5): e20191187, DOI:10.1542/peds.2019-1187.
New research presents a complex picture of self-reported suicidal behavior in U.S. teenagers over the last few decades. Rates of suicidal ideation and plans dipped overall from 1991 to 2017, but the rate of suicide attempts grew slightly in black adolescents.
White young people “have historically had higher rates of suicide attempts...compared with their black counterparts; however, this study provides some evidence to the contrary,” wrote the authors of the report, which appears in the November issue of Pediatrics.
The investigators, led by Michael A. Lindsey, PhD, executive director of the McSilver Institute for Poverty Policy and Research at New York University, New York, note that suicide is the second leading cause of death in the United States in those aged 12-17. (Accidents rank first.) According to recent research, black children younger than 12 are at higher risk for death by suicide, compared with whites.
For the new study, researchers analyzed data from the Youth Risk Behavior Survey, which is conducted every 2 years among high school students in all 50 states and the District of Columbia. They examined data from 198,540 teens (mean age=16, 51% male; 49% female).
During the study period, the weighted overall prevalences rates of suicidal ideation, planning, attempt, and injury due to attempt were 19%, 15%, 8%, and 3%, respectively. “Our findings reveal that over that span of time, almost 1 in 5 adolescents are thinking about suicide... and > 1 in 10 has a suicide plan,” the researchers wrote.
Rates of suicidal ideation and planning fell overall, and among females, the rate of suicide attempts fell significantly (odds ratio [OR]=0.98). But self-reported suicide attempts grew significantly among black teens (OR=1.02), and injuries due to suicide attempts grew among black males (OR=1.04).
The findings are “troubling because attempts are the most prominent risk factor associated with suicide death,” the study authors wrote. “Findings regarding the rising rates of suicide attempts in black youth may be related to the documented disparities in mental health treatment and common social etiologic factors disproportionately experienced by black youth.”
In an accompanying commentary, psychiatrist Benjamin N. Shain, MD, PhD, of the University of Chicago, noted a seemingly “counterintuitive” fact: Black teens still have lower rates of suicide than whites teens “despite the greater, long-standing difficulties encountered by black adolescents, including disparities in mental health treatment and disproportionately higher stressors, racial discrimination, and childhood abuse and neglect, as well as other adverse experiences, such as poverty.”
It’s not clear why the reported suicide rate is lower in black adolescents than their white counterparts, Dr. Shain wrote, but misclassification and “undercount as a result of violence with suicidal intent, for example, ‘suicide by cop’” may play a role. Additionally, protective factors may have kept suicide rates down. “External attributional orientation (eg, blaming others or ‘the system’ for difficulties) among blacks may have buffered this group from internalizing blame related to psychological stressors,” he wrote.
Among black adolescents, the growing rate of suicidal behavior is concerning and may be due to a weakening of the hypothesized protective mechanism. Perhaps, Dr. Shain wrote, they now are blaming themselves more for difficulties encountered, “thus leading to an increase in suicide risk factors, particularly depression.” He stressed that, regardless of the reasons for the increase in suicide and suicide attempts, prevention and intervention efforts remain critical.
No study funding is reported, and authors report no relevant disclosures. Dr. Shain reports no relevant disclosures.
SOURCE: Lindsey MA et al, Pediatrics. 2019;144(5): e20191187, DOI:10.1542/peds.2019-1187.
New research presents a complex picture of self-reported suicidal behavior in U.S. teenagers over the last few decades. Rates of suicidal ideation and plans dipped overall from 1991 to 2017, but the rate of suicide attempts grew slightly in black adolescents.
White young people “have historically had higher rates of suicide attempts...compared with their black counterparts; however, this study provides some evidence to the contrary,” wrote the authors of the report, which appears in the November issue of Pediatrics.
The investigators, led by Michael A. Lindsey, PhD, executive director of the McSilver Institute for Poverty Policy and Research at New York University, New York, note that suicide is the second leading cause of death in the United States in those aged 12-17. (Accidents rank first.) According to recent research, black children younger than 12 are at higher risk for death by suicide, compared with whites.
For the new study, researchers analyzed data from the Youth Risk Behavior Survey, which is conducted every 2 years among high school students in all 50 states and the District of Columbia. They examined data from 198,540 teens (mean age=16, 51% male; 49% female).
During the study period, the weighted overall prevalences rates of suicidal ideation, planning, attempt, and injury due to attempt were 19%, 15%, 8%, and 3%, respectively. “Our findings reveal that over that span of time, almost 1 in 5 adolescents are thinking about suicide... and > 1 in 10 has a suicide plan,” the researchers wrote.
Rates of suicidal ideation and planning fell overall, and among females, the rate of suicide attempts fell significantly (odds ratio [OR]=0.98). But self-reported suicide attempts grew significantly among black teens (OR=1.02), and injuries due to suicide attempts grew among black males (OR=1.04).
The findings are “troubling because attempts are the most prominent risk factor associated with suicide death,” the study authors wrote. “Findings regarding the rising rates of suicide attempts in black youth may be related to the documented disparities in mental health treatment and common social etiologic factors disproportionately experienced by black youth.”
In an accompanying commentary, psychiatrist Benjamin N. Shain, MD, PhD, of the University of Chicago, noted a seemingly “counterintuitive” fact: Black teens still have lower rates of suicide than whites teens “despite the greater, long-standing difficulties encountered by black adolescents, including disparities in mental health treatment and disproportionately higher stressors, racial discrimination, and childhood abuse and neglect, as well as other adverse experiences, such as poverty.”
It’s not clear why the reported suicide rate is lower in black adolescents than their white counterparts, Dr. Shain wrote, but misclassification and “undercount as a result of violence with suicidal intent, for example, ‘suicide by cop’” may play a role. Additionally, protective factors may have kept suicide rates down. “External attributional orientation (eg, blaming others or ‘the system’ for difficulties) among blacks may have buffered this group from internalizing blame related to psychological stressors,” he wrote.
Among black adolescents, the growing rate of suicidal behavior is concerning and may be due to a weakening of the hypothesized protective mechanism. Perhaps, Dr. Shain wrote, they now are blaming themselves more for difficulties encountered, “thus leading to an increase in suicide risk factors, particularly depression.” He stressed that, regardless of the reasons for the increase in suicide and suicide attempts, prevention and intervention efforts remain critical.
No study funding is reported, and authors report no relevant disclosures. Dr. Shain reports no relevant disclosures.
SOURCE: Lindsey MA et al, Pediatrics. 2019;144(5): e20191187, DOI:10.1542/peds.2019-1187.
FROM PEDIATRICS
Key clinical point: Overall self-reported suicidal behavior is down in U.S. teens, but attempts are up in black adolescents.
Major finding: Self-reported suicide attempts grew significantly among black teens (OR=1.02).
Study details: Retrospective analysis of 1991-2017 surveys of 198,540 U.S. teens (mean age=16, 51% male; 49% female).
Disclosures: No study funding is reported, and the study authors report no relevant disclosures.
Source: Lindsey MA et al, Pediatrics. 2019;144(5): e20191187,https://doi.org/10.1542/peds.2019-1187.
Automated ventilation outperformed nurses in post-op cardiac care
MADRID – In patients managed on mechanical ventilation in an intensive care unit following cardiac surgery, a fully automated system provides more reliable ventilatory support than highly experienced ICU nurses, suggest results of a randomized trial.
The study’s control group received usual care, which means that nurses adjusted mechanical ventilation manually in response to respiratory rate, tidal volume, positive end-respiratory pressure (PEEP), and other factors to maintain ventilation within parameters associated with safe respiration. The experimental group was managed with a fully automated closed-loop system to make these adjustments without any nurse intervention.
For those in the experimental group “the proportion of time in the optimal zone was increased and the proportion of time in the unsafe zone was decreased” relative to those randomized to conventional nursing care, Marcus J. Schultz, MD, reported at the annual congress of the European Respiratory Society.
Conducted at a hospital with an experienced ICU staff, the study had a control arm that was managed by “dedicated nurses who, I can tell you, are very eager to provide the best level of care possible,” said Dr. Schultz, professor of experimental intensive care, University of Amsterdam, the Netherlands..
The investigator-initiated POSITiVE trial randomized 220 cardiac surgery patients scheduled to receive postoperative mechanical ventilation in the ICU. Exclusions included those with class III or higher chronic obstructive pulmonary disease (COPD), a requirement for extracorporeal membrane oxygenation (ECMO), or a history of lung surgery.
The primary endpoint was the proportion of time spent in an optimal zone, an acceptable zone, or a dangerous zone of ventilation based on predefined values for tidal volume, maximum airway pressure, end-tidal CO2, and oxygen saturation (SpO2).
The greatest between-group difference was seen in the proportion of time spent in the optimal zone. This climbed from approximately 35% in the control arm to slightly more than 70% in the experimental arm, a significant difference. The proportion of time in the dangerous zone was reduced from approximately 6% in the control arm to 3% in the automated arm. On average nurse-managed patients spent nearly 60% of the time in the acceptable zone versus less than 30% of those in the automated experimental arm.
A heat map using green, yellow, and red to represent optimal, acceptable, and dangerous zones, respectively, for individual participants in the trial provided a more stark global impression. For the control group, the heat map was primarily yellow with scattered dashes of green and red. For the experimental group, the map was primarily green with dashes of yellow and a much smaller number of red dashes relative to the control group.
In addition, the time to spontaneous breathing was 38% shorter for those randomized to automated ventilation than to conventional care, a significant difference.
There are now many devices marketed for automated ventilation, according to Dr. Schultz. The device used in this study was the proprietary INTELLiVENT-ASV system, marketed by Hamilton Medical, which was selected based on prior satisfactory experience. Although not unique, this system has sophisticated software to adjust ventilation to reach targets set by the clinician on the basis of information it is receiving from physiologic sensors for such variables as respiratory rate, tidal volume, and inspiratory pressure.
“It is frequently adjusting the PEEP levels to reach the lowest driving pressure,” said Dr. Schultz. Among its many other features, it also “gives spontaneous breathing trials automatically.”
Uncomplicated patients were selected purposefully to test this system, but Dr. Schultz said that a second trial, called POSITiVE 2, is now being planned that will enroll more complex patients. Keeping complex patients within the optimal zone as defined by tidal volume and other critical variables has the potential to reduce the lung damage that is known to occur when these are not optimized.
“Applying safe ventilatory support in clinical practice remains a serious challenge and is extremely time consuming,” Dr. Schultz said. He reported that fully automated ventilation appears to be reliable, and “it takes out the human factor” in regard to diligence in monitoring and potential for error.
Overall, these results support the potential for a fully automated system to improve optimal ventilatory support, reduce risk of lung injury, and reduce staffing required for monitoring of mechanical ventilation, according to Dr. Schultz.
Relative costs were not evaluated in this analysis, but might be another factor relevant to the value of fully automated ventilation in ICU patients.
MADRID – In patients managed on mechanical ventilation in an intensive care unit following cardiac surgery, a fully automated system provides more reliable ventilatory support than highly experienced ICU nurses, suggest results of a randomized trial.
The study’s control group received usual care, which means that nurses adjusted mechanical ventilation manually in response to respiratory rate, tidal volume, positive end-respiratory pressure (PEEP), and other factors to maintain ventilation within parameters associated with safe respiration. The experimental group was managed with a fully automated closed-loop system to make these adjustments without any nurse intervention.
For those in the experimental group “the proportion of time in the optimal zone was increased and the proportion of time in the unsafe zone was decreased” relative to those randomized to conventional nursing care, Marcus J. Schultz, MD, reported at the annual congress of the European Respiratory Society.
Conducted at a hospital with an experienced ICU staff, the study had a control arm that was managed by “dedicated nurses who, I can tell you, are very eager to provide the best level of care possible,” said Dr. Schultz, professor of experimental intensive care, University of Amsterdam, the Netherlands..
The investigator-initiated POSITiVE trial randomized 220 cardiac surgery patients scheduled to receive postoperative mechanical ventilation in the ICU. Exclusions included those with class III or higher chronic obstructive pulmonary disease (COPD), a requirement for extracorporeal membrane oxygenation (ECMO), or a history of lung surgery.
The primary endpoint was the proportion of time spent in an optimal zone, an acceptable zone, or a dangerous zone of ventilation based on predefined values for tidal volume, maximum airway pressure, end-tidal CO2, and oxygen saturation (SpO2).
The greatest between-group difference was seen in the proportion of time spent in the optimal zone. This climbed from approximately 35% in the control arm to slightly more than 70% in the experimental arm, a significant difference. The proportion of time in the dangerous zone was reduced from approximately 6% in the control arm to 3% in the automated arm. On average nurse-managed patients spent nearly 60% of the time in the acceptable zone versus less than 30% of those in the automated experimental arm.
A heat map using green, yellow, and red to represent optimal, acceptable, and dangerous zones, respectively, for individual participants in the trial provided a more stark global impression. For the control group, the heat map was primarily yellow with scattered dashes of green and red. For the experimental group, the map was primarily green with dashes of yellow and a much smaller number of red dashes relative to the control group.
In addition, the time to spontaneous breathing was 38% shorter for those randomized to automated ventilation than to conventional care, a significant difference.
There are now many devices marketed for automated ventilation, according to Dr. Schultz. The device used in this study was the proprietary INTELLiVENT-ASV system, marketed by Hamilton Medical, which was selected based on prior satisfactory experience. Although not unique, this system has sophisticated software to adjust ventilation to reach targets set by the clinician on the basis of information it is receiving from physiologic sensors for such variables as respiratory rate, tidal volume, and inspiratory pressure.
“It is frequently adjusting the PEEP levels to reach the lowest driving pressure,” said Dr. Schultz. Among its many other features, it also “gives spontaneous breathing trials automatically.”
Uncomplicated patients were selected purposefully to test this system, but Dr. Schultz said that a second trial, called POSITiVE 2, is now being planned that will enroll more complex patients. Keeping complex patients within the optimal zone as defined by tidal volume and other critical variables has the potential to reduce the lung damage that is known to occur when these are not optimized.
“Applying safe ventilatory support in clinical practice remains a serious challenge and is extremely time consuming,” Dr. Schultz said. He reported that fully automated ventilation appears to be reliable, and “it takes out the human factor” in regard to diligence in monitoring and potential for error.
Overall, these results support the potential for a fully automated system to improve optimal ventilatory support, reduce risk of lung injury, and reduce staffing required for monitoring of mechanical ventilation, according to Dr. Schultz.
Relative costs were not evaluated in this analysis, but might be another factor relevant to the value of fully automated ventilation in ICU patients.
MADRID – In patients managed on mechanical ventilation in an intensive care unit following cardiac surgery, a fully automated system provides more reliable ventilatory support than highly experienced ICU nurses, suggest results of a randomized trial.
The study’s control group received usual care, which means that nurses adjusted mechanical ventilation manually in response to respiratory rate, tidal volume, positive end-respiratory pressure (PEEP), and other factors to maintain ventilation within parameters associated with safe respiration. The experimental group was managed with a fully automated closed-loop system to make these adjustments without any nurse intervention.
For those in the experimental group “the proportion of time in the optimal zone was increased and the proportion of time in the unsafe zone was decreased” relative to those randomized to conventional nursing care, Marcus J. Schultz, MD, reported at the annual congress of the European Respiratory Society.
Conducted at a hospital with an experienced ICU staff, the study had a control arm that was managed by “dedicated nurses who, I can tell you, are very eager to provide the best level of care possible,” said Dr. Schultz, professor of experimental intensive care, University of Amsterdam, the Netherlands..
The investigator-initiated POSITiVE trial randomized 220 cardiac surgery patients scheduled to receive postoperative mechanical ventilation in the ICU. Exclusions included those with class III or higher chronic obstructive pulmonary disease (COPD), a requirement for extracorporeal membrane oxygenation (ECMO), or a history of lung surgery.
The primary endpoint was the proportion of time spent in an optimal zone, an acceptable zone, or a dangerous zone of ventilation based on predefined values for tidal volume, maximum airway pressure, end-tidal CO2, and oxygen saturation (SpO2).
The greatest between-group difference was seen in the proportion of time spent in the optimal zone. This climbed from approximately 35% in the control arm to slightly more than 70% in the experimental arm, a significant difference. The proportion of time in the dangerous zone was reduced from approximately 6% in the control arm to 3% in the automated arm. On average nurse-managed patients spent nearly 60% of the time in the acceptable zone versus less than 30% of those in the automated experimental arm.
A heat map using green, yellow, and red to represent optimal, acceptable, and dangerous zones, respectively, for individual participants in the trial provided a more stark global impression. For the control group, the heat map was primarily yellow with scattered dashes of green and red. For the experimental group, the map was primarily green with dashes of yellow and a much smaller number of red dashes relative to the control group.
In addition, the time to spontaneous breathing was 38% shorter for those randomized to automated ventilation than to conventional care, a significant difference.
There are now many devices marketed for automated ventilation, according to Dr. Schultz. The device used in this study was the proprietary INTELLiVENT-ASV system, marketed by Hamilton Medical, which was selected based on prior satisfactory experience. Although not unique, this system has sophisticated software to adjust ventilation to reach targets set by the clinician on the basis of information it is receiving from physiologic sensors for such variables as respiratory rate, tidal volume, and inspiratory pressure.
“It is frequently adjusting the PEEP levels to reach the lowest driving pressure,” said Dr. Schultz. Among its many other features, it also “gives spontaneous breathing trials automatically.”
Uncomplicated patients were selected purposefully to test this system, but Dr. Schultz said that a second trial, called POSITiVE 2, is now being planned that will enroll more complex patients. Keeping complex patients within the optimal zone as defined by tidal volume and other critical variables has the potential to reduce the lung damage that is known to occur when these are not optimized.
“Applying safe ventilatory support in clinical practice remains a serious challenge and is extremely time consuming,” Dr. Schultz said. He reported that fully automated ventilation appears to be reliable, and “it takes out the human factor” in regard to diligence in monitoring and potential for error.
Overall, these results support the potential for a fully automated system to improve optimal ventilatory support, reduce risk of lung injury, and reduce staffing required for monitoring of mechanical ventilation, according to Dr. Schultz.
Relative costs were not evaluated in this analysis, but might be another factor relevant to the value of fully automated ventilation in ICU patients.
REPORTING FROM ERS 2019