Should frequency of prenatal visits be reduced for low-risk women?

Article Type
Changed
Wed, 11/06/2019 - 16:46

In their article, “Feasibility—and safety—of reducing the traditional 14 prenatal visits to 8 or 10” (July 2019), Erin Clark, MD, Yvonne Butler-Tobah, MD, and Lauren D. Demosthenes, MD, argued as to why a “one-size-fits all” approach to prenatal care should be redesigned for low-risk expectant mothers. They highlighted 3 institutions that developed a reduced-visit prenatal care model incorporating remote monitoring and mobile health app technology. Women who used the reduced visit option were overall satisfied with the technology employed and with their health care experience.

OBG Management polled readers with this question: “Do you agree that the number of prenatal care visits for low-risk women should be reduced?” 

 

 

Poll results

A total of 123 readers cast their vote:   

  • 40.7% (50 readers) said yes
  • 59.4% (73 readers) said no

 

 

Article PDF
Issue
OBG Management - 31(11)
Publications
Page Number
52
Sections
Article PDF
Article PDF

In their article, “Feasibility—and safety—of reducing the traditional 14 prenatal visits to 8 or 10” (July 2019), Erin Clark, MD, Yvonne Butler-Tobah, MD, and Lauren D. Demosthenes, MD, argued as to why a “one-size-fits all” approach to prenatal care should be redesigned for low-risk expectant mothers. They highlighted 3 institutions that developed a reduced-visit prenatal care model incorporating remote monitoring and mobile health app technology. Women who used the reduced visit option were overall satisfied with the technology employed and with their health care experience.

OBG Management polled readers with this question: “Do you agree that the number of prenatal care visits for low-risk women should be reduced?” 

 

 

Poll results

A total of 123 readers cast their vote:   

  • 40.7% (50 readers) said yes
  • 59.4% (73 readers) said no

 

 

In their article, “Feasibility—and safety—of reducing the traditional 14 prenatal visits to 8 or 10” (July 2019), Erin Clark, MD, Yvonne Butler-Tobah, MD, and Lauren D. Demosthenes, MD, argued as to why a “one-size-fits all” approach to prenatal care should be redesigned for low-risk expectant mothers. They highlighted 3 institutions that developed a reduced-visit prenatal care model incorporating remote monitoring and mobile health app technology. Women who used the reduced visit option were overall satisfied with the technology employed and with their health care experience.

OBG Management polled readers with this question: “Do you agree that the number of prenatal care visits for low-risk women should be reduced?” 

 

 

Poll results

A total of 123 readers cast their vote:   

  • 40.7% (50 readers) said yes
  • 59.4% (73 readers) said no

 

 

Issue
OBG Management - 31(11)
Issue
OBG Management - 31(11)
Page Number
52
Page Number
52
Publications
Publications
Article Type
Sections
Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Disqus Comments
Default
Eyebrow Default
Commentary
Gate On Date
Mon, 11/04/2019 - 15:30
Un-Gate On Date
Mon, 11/04/2019 - 15:30
Use ProPublica
CFC Schedule Remove Status
Mon, 11/04/2019 - 15:30
Hide sidebar & use full width
render the right sidebar.
Article PDF Media

Racial disparities in pregnancy-related death

Article Type
Changed
Fri, 12/04/2020 - 17:19

Article PDF
Issue
OBG Management - 31(11)
Publications
Topics
Page Number
56
Article PDF
Article PDF

Issue
OBG Management - 31(11)
Issue
OBG Management - 31(11)
Page Number
56
Page Number
56
Publications
Publications
Topics
Article Type
Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Disqus Comments
Default
Eyebrow Default
infographic
Gate On Date
Mon, 11/04/2019 - 15:15
Un-Gate On Date
Mon, 11/04/2019 - 15:15
Use ProPublica
CFC Schedule Remove Status
Mon, 11/04/2019 - 15:15
Hide sidebar & use full width
render the right sidebar.
Conference Recap Checkbox
Not Conference Recap
Clinical Edge
Display the Slideshow in this Article
Medscape Article
Article PDF Media

Product Update: Addyi alcohol ban lifted, fezolinetant trial, outcomes tracker, comfort gown

Article Type
Changed
Wed, 11/06/2019 - 13:25

FDA REMOVES ALCOHOL BAN WITH ADDYI

Sprout Pharmaceuticals announced that the US Food and Drug Administration (FDA) has removed their contraindication on alcohol use with Addyi® (flibanserin). Addyi was approved in 2015 and is an oral nonhormonal pill for acquired, generalized hypoactive sexual desire disorder (HSDD) in premenopausal women. Patients are advised to discontinue drinking alcohol at least 2 hours before taking Addyi at bedtime or skip the Addyi dose that evening.

The FDA also removed the requirement, under its Risk Evaluation and Mitigation Strategy (REMS) program, for health care practitioners or pharmacies to be certified to prescribe or dispense Addyi. Sprout says that to make all labeling elements consistent with the FDA’s findings the boxed warning will change and the medication guide will be updated and included under the REMS. 

The most commonly reported adverse events among patients taking Addyi are dizziness, sleepiness, nausea, fatigue, insomnia, and dry mouth. Addyi is contraindicated in patients taking moderate or strong cytochrome P450 3A4 (CYP3A4) inhibitors and in those with hepatic impairment.

FOR MORE INFORMATION AND THE FULL PRESCRIBING INFORMATION AND MEDICATION GUIDE, VISIT: www.addyi.com


FEZOLINETANT FOR VMS

Astellas Pharma Inc. announced that it has initiated phase 3 trials for oral, nonhormonal fezolinetant to treat moderate-to-severe vasomotor symptoms (VMS) in postmenopausal women. Fezolinetant is a selective neurokinin-3 receptor antagonist, with dosages of 30 and 45 mg once daily being evaluated for efficacy and safety of reducing VMS frequency and severity. The trials each will enroll about 450 women with moderate-to-severe VMS at approximately 200 sites within the United States, Canada, and Europe. They will be double-blinded and placebo-controlled for the first 12 weeks, followed by noncontrolled 40-week extension periods. An additional 52-week trial will investigate long-term safety.

FOR MORE INFORMATION, VISIT: http://www.clinicaltrials.gov, TRIAL IDENTIFIERS NCT04003155, NCT04003142, AND NCT04003389

 

SOLUTIONS FOR OUTCOME TRACKING

DrChrono and OutcomeMD announce a partnership to track and analyze patient outcome data and confounding factors. DrChrono is an electronic health record (EHR) system, and OutcomeMD is a software solution that uses literature-validated patient-reported outcome instruments to score and track a patient’s symptom severity and inform treatment decisions for users.

Via a HIPAA compliant process, patients answer a list of questions that are accessed through a web link on their mobile or desktop devices. OutcomeMD summarizes the symptoms into a score that displays to both the physician and patient. Patients’ answers and scores are pushed to the clinician’s DrChrono EHR medical note. As care progresses in the OutcomeMD platform, patients remotely track how their symptoms change, and notifications alert clinicians of patients who may need attention. The integration with DrChrono also allows patient data on confounding factors to be automatically pushed from the patient’s device into the clinician’s medical note. The partnership will enable physicians to visualize patients’ status, and all the factors involved in their care, on one screen, says DrChrono and OutcomeMD, strengthening documentation and saving time for both patients and clinicians. An integration demo video is available at https://youtu.be/jnh7YPII080.

FOR MORE INFORMATION, VISIT: www.outcomemd.com

Continue to: NEW MATERNITY GOWN...

 

 


NEW MATERNITY GOWN

ImageFIRST launched a new maternity gown for expecting mothers. The Comfort Care® Maternity Gown is a lightweight, premium polyester/nylon fabric that front snaps to allow for skin-to-skin access and optional breastfeeding. The gown also includes shoulder snaps and a full cut for extra coverage and to accommodate a variety of body types, says ImageFIRST.

ImageFIRST is a national linen rental provider. It developed the Comfort Care® Maternity Gown with input from labor and delivery departments to best meet the needs of expecting mothers. It also says that a portion of the proceeds from each gown rental will be donated to the National Pediatric Cancer Foundation. 

FOR MORE INFORMATION, VISIT: www.imagefirst.com

Article PDF
Issue
OBG Management - 31(11)
Publications
Topics
Page Number
53
Sections
Article PDF
Article PDF

FDA REMOVES ALCOHOL BAN WITH ADDYI

Sprout Pharmaceuticals announced that the US Food and Drug Administration (FDA) has removed their contraindication on alcohol use with Addyi® (flibanserin). Addyi was approved in 2015 and is an oral nonhormonal pill for acquired, generalized hypoactive sexual desire disorder (HSDD) in premenopausal women. Patients are advised to discontinue drinking alcohol at least 2 hours before taking Addyi at bedtime or skip the Addyi dose that evening.

The FDA also removed the requirement, under its Risk Evaluation and Mitigation Strategy (REMS) program, for health care practitioners or pharmacies to be certified to prescribe or dispense Addyi. Sprout says that to make all labeling elements consistent with the FDA’s findings the boxed warning will change and the medication guide will be updated and included under the REMS. 

The most commonly reported adverse events among patients taking Addyi are dizziness, sleepiness, nausea, fatigue, insomnia, and dry mouth. Addyi is contraindicated in patients taking moderate or strong cytochrome P450 3A4 (CYP3A4) inhibitors and in those with hepatic impairment.

FOR MORE INFORMATION AND THE FULL PRESCRIBING INFORMATION AND MEDICATION GUIDE, VISIT: www.addyi.com


FEZOLINETANT FOR VMS

Astellas Pharma Inc. announced that it has initiated phase 3 trials for oral, nonhormonal fezolinetant to treat moderate-to-severe vasomotor symptoms (VMS) in postmenopausal women. Fezolinetant is a selective neurokinin-3 receptor antagonist, with dosages of 30 and 45 mg once daily being evaluated for efficacy and safety of reducing VMS frequency and severity. The trials each will enroll about 450 women with moderate-to-severe VMS at approximately 200 sites within the United States, Canada, and Europe. They will be double-blinded and placebo-controlled for the first 12 weeks, followed by noncontrolled 40-week extension periods. An additional 52-week trial will investigate long-term safety.

FOR MORE INFORMATION, VISIT: http://www.clinicaltrials.gov, TRIAL IDENTIFIERS NCT04003155, NCT04003142, AND NCT04003389

 

SOLUTIONS FOR OUTCOME TRACKING

DrChrono and OutcomeMD announce a partnership to track and analyze patient outcome data and confounding factors. DrChrono is an electronic health record (EHR) system, and OutcomeMD is a software solution that uses literature-validated patient-reported outcome instruments to score and track a patient’s symptom severity and inform treatment decisions for users.

Via a HIPAA compliant process, patients answer a list of questions that are accessed through a web link on their mobile or desktop devices. OutcomeMD summarizes the symptoms into a score that displays to both the physician and patient. Patients’ answers and scores are pushed to the clinician’s DrChrono EHR medical note. As care progresses in the OutcomeMD platform, patients remotely track how their symptoms change, and notifications alert clinicians of patients who may need attention. The integration with DrChrono also allows patient data on confounding factors to be automatically pushed from the patient’s device into the clinician’s medical note. The partnership will enable physicians to visualize patients’ status, and all the factors involved in their care, on one screen, says DrChrono and OutcomeMD, strengthening documentation and saving time for both patients and clinicians. An integration demo video is available at https://youtu.be/jnh7YPII080.

FOR MORE INFORMATION, VISIT: www.outcomemd.com

Continue to: NEW MATERNITY GOWN...

 

 


NEW MATERNITY GOWN

ImageFIRST launched a new maternity gown for expecting mothers. The Comfort Care® Maternity Gown is a lightweight, premium polyester/nylon fabric that front snaps to allow for skin-to-skin access and optional breastfeeding. The gown also includes shoulder snaps and a full cut for extra coverage and to accommodate a variety of body types, says ImageFIRST.

ImageFIRST is a national linen rental provider. It developed the Comfort Care® Maternity Gown with input from labor and delivery departments to best meet the needs of expecting mothers. It also says that a portion of the proceeds from each gown rental will be donated to the National Pediatric Cancer Foundation. 

FOR MORE INFORMATION, VISIT: www.imagefirst.com

FDA REMOVES ALCOHOL BAN WITH ADDYI

Sprout Pharmaceuticals announced that the US Food and Drug Administration (FDA) has removed their contraindication on alcohol use with Addyi® (flibanserin). Addyi was approved in 2015 and is an oral nonhormonal pill for acquired, generalized hypoactive sexual desire disorder (HSDD) in premenopausal women. Patients are advised to discontinue drinking alcohol at least 2 hours before taking Addyi at bedtime or skip the Addyi dose that evening.

The FDA also removed the requirement, under its Risk Evaluation and Mitigation Strategy (REMS) program, for health care practitioners or pharmacies to be certified to prescribe or dispense Addyi. Sprout says that to make all labeling elements consistent with the FDA’s findings the boxed warning will change and the medication guide will be updated and included under the REMS. 

The most commonly reported adverse events among patients taking Addyi are dizziness, sleepiness, nausea, fatigue, insomnia, and dry mouth. Addyi is contraindicated in patients taking moderate or strong cytochrome P450 3A4 (CYP3A4) inhibitors and in those with hepatic impairment.

FOR MORE INFORMATION AND THE FULL PRESCRIBING INFORMATION AND MEDICATION GUIDE, VISIT: www.addyi.com


FEZOLINETANT FOR VMS

Astellas Pharma Inc. announced that it has initiated phase 3 trials for oral, nonhormonal fezolinetant to treat moderate-to-severe vasomotor symptoms (VMS) in postmenopausal women. Fezolinetant is a selective neurokinin-3 receptor antagonist, with dosages of 30 and 45 mg once daily being evaluated for efficacy and safety of reducing VMS frequency and severity. The trials each will enroll about 450 women with moderate-to-severe VMS at approximately 200 sites within the United States, Canada, and Europe. They will be double-blinded and placebo-controlled for the first 12 weeks, followed by noncontrolled 40-week extension periods. An additional 52-week trial will investigate long-term safety.

FOR MORE INFORMATION, VISIT: http://www.clinicaltrials.gov, TRIAL IDENTIFIERS NCT04003155, NCT04003142, AND NCT04003389

 

SOLUTIONS FOR OUTCOME TRACKING

DrChrono and OutcomeMD announce a partnership to track and analyze patient outcome data and confounding factors. DrChrono is an electronic health record (EHR) system, and OutcomeMD is a software solution that uses literature-validated patient-reported outcome instruments to score and track a patient’s symptom severity and inform treatment decisions for users.

Via a HIPAA compliant process, patients answer a list of questions that are accessed through a web link on their mobile or desktop devices. OutcomeMD summarizes the symptoms into a score that displays to both the physician and patient. Patients’ answers and scores are pushed to the clinician’s DrChrono EHR medical note. As care progresses in the OutcomeMD platform, patients remotely track how their symptoms change, and notifications alert clinicians of patients who may need attention. The integration with DrChrono also allows patient data on confounding factors to be automatically pushed from the patient’s device into the clinician’s medical note. The partnership will enable physicians to visualize patients’ status, and all the factors involved in their care, on one screen, says DrChrono and OutcomeMD, strengthening documentation and saving time for both patients and clinicians. An integration demo video is available at https://youtu.be/jnh7YPII080.

FOR MORE INFORMATION, VISIT: www.outcomemd.com

Continue to: NEW MATERNITY GOWN...

 

 


NEW MATERNITY GOWN

ImageFIRST launched a new maternity gown for expecting mothers. The Comfort Care® Maternity Gown is a lightweight, premium polyester/nylon fabric that front snaps to allow for skin-to-skin access and optional breastfeeding. The gown also includes shoulder snaps and a full cut for extra coverage and to accommodate a variety of body types, says ImageFIRST.

ImageFIRST is a national linen rental provider. It developed the Comfort Care® Maternity Gown with input from labor and delivery departments to best meet the needs of expecting mothers. It also says that a portion of the proceeds from each gown rental will be donated to the National Pediatric Cancer Foundation. 

FOR MORE INFORMATION, VISIT: www.imagefirst.com

Issue
OBG Management - 31(11)
Issue
OBG Management - 31(11)
Page Number
53
Page Number
53
Publications
Publications
Topics
Article Type
Sections
Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Disqus Comments
Default
Use ProPublica
Hide sidebar & use full width
render the right sidebar.
Article PDF Media

President to nominate oncologist to lead FDA

Article Type
Changed
Wed, 05/06/2020 - 12:37

 

Stephen M. Hahn, MD, a radiation oncologist and researcher, may soon take the reins of the Food and Drug Administration.

Dr. Stephen Hahn

President Trump indicated his intent to nominate Dr. Hahn as FDA Commissioner in a brief Nov.1 statement that outlined Dr. Hahn’s background. Dr. Hahn currently serves as chief medical executive at MD Anderson Cancer Center, Houston, where he heads the radiology oncology division.

Dr. Hahn specializes in treating lung cancer and sarcoma and has authored 220 peer-reviewed original research articles, according to his biography. He was previously chair of the department of radiology oncology at the University of Pennsylvania, Philadelphia, and also served as a senior investigator at the National Cancer Institute.

Dr. Hahn completed his residency in radiation oncology at NCI and his residency in internal medicine at the University of California, San Francisco.

Margaret Foti, PhD, chief executive officer for the American Association for Cancer Research called Dr. Hahn a renowned expert in radiation oncology and research, an experienced and highly effective administrator, and an innovative leader.

“I have seen firsthand Dr. Hahn’s extraordinary dedication and commitment to cancer patients, and the AACR is extremely confident that he will be an outstanding leader for the FDA,” Dr. Foti said in a statement. “Dr. Hahn, who is board certified in both radiation and medical oncology, is esteemed for the breadth and depth of his scientific knowledge and expertise, and he has consistently advocated for a drug review process at the FDA that is both science-directed and patient-focused.”

The American Society of Clinical Oncology also congratulated Dr. Hahn on the upcoming nomination, noting that he has a strong grasp of the drug development process and understands the realities of working in a complex clinical care environment.

“The role of FDA commissioner requires a strong commitment to advancing the agency’s mission to protect public health across the United States, and an understanding of how to help speed innovations to get new treatments to patients, while also ensuring the safety and efficacy of the medical products that millions of Americans rely on to manage, treat, and cure their cancer,” the society stated. “ASCO has a long and productive history of collaborating with FDA, including with current acting Commissioner Norman E. “Ned” Sharpless, MD, in support of the agency’s important role in reducing cancer incidence, advancing treatment options, and improving the lives of individuals with cancer. We look forward to continuing our close collaboration to make it possible for every American with cancer to have access to medical products that are safe and effective.”

Dr. Sharpless will return to his position as NCI director; he served as interim FDA commissioner from the April departure of then-FDA commissioner, Scott Gottlieb, MD.

“As one of the nation’s leading oncologists who has devoted his entire professional career to helping patients in the fight against cancer, Ned is returning home to NCI to continue this work and we look forward to working closely with him once again,” Francis S. Collins, MD, director of the National Institutes of Health, said in a statement. “I want to thank Dr. Doug Lowy, principal deputy director of NCI, for having stepped in, once again, to take the helm at NCI and lead the institute so skillfully while Ned was at FDA.”

At press time, neither Dr. Hahn nor MD Anderson Cancer Center had returned messages seeking comment about his nomination.

Publications
Topics
Sections

 

Stephen M. Hahn, MD, a radiation oncologist and researcher, may soon take the reins of the Food and Drug Administration.

Dr. Stephen Hahn

President Trump indicated his intent to nominate Dr. Hahn as FDA Commissioner in a brief Nov.1 statement that outlined Dr. Hahn’s background. Dr. Hahn currently serves as chief medical executive at MD Anderson Cancer Center, Houston, where he heads the radiology oncology division.

Dr. Hahn specializes in treating lung cancer and sarcoma and has authored 220 peer-reviewed original research articles, according to his biography. He was previously chair of the department of radiology oncology at the University of Pennsylvania, Philadelphia, and also served as a senior investigator at the National Cancer Institute.

Dr. Hahn completed his residency in radiation oncology at NCI and his residency in internal medicine at the University of California, San Francisco.

Margaret Foti, PhD, chief executive officer for the American Association for Cancer Research called Dr. Hahn a renowned expert in radiation oncology and research, an experienced and highly effective administrator, and an innovative leader.

“I have seen firsthand Dr. Hahn’s extraordinary dedication and commitment to cancer patients, and the AACR is extremely confident that he will be an outstanding leader for the FDA,” Dr. Foti said in a statement. “Dr. Hahn, who is board certified in both radiation and medical oncology, is esteemed for the breadth and depth of his scientific knowledge and expertise, and he has consistently advocated for a drug review process at the FDA that is both science-directed and patient-focused.”

The American Society of Clinical Oncology also congratulated Dr. Hahn on the upcoming nomination, noting that he has a strong grasp of the drug development process and understands the realities of working in a complex clinical care environment.

“The role of FDA commissioner requires a strong commitment to advancing the agency’s mission to protect public health across the United States, and an understanding of how to help speed innovations to get new treatments to patients, while also ensuring the safety and efficacy of the medical products that millions of Americans rely on to manage, treat, and cure their cancer,” the society stated. “ASCO has a long and productive history of collaborating with FDA, including with current acting Commissioner Norman E. “Ned” Sharpless, MD, in support of the agency’s important role in reducing cancer incidence, advancing treatment options, and improving the lives of individuals with cancer. We look forward to continuing our close collaboration to make it possible for every American with cancer to have access to medical products that are safe and effective.”

Dr. Sharpless will return to his position as NCI director; he served as interim FDA commissioner from the April departure of then-FDA commissioner, Scott Gottlieb, MD.

“As one of the nation’s leading oncologists who has devoted his entire professional career to helping patients in the fight against cancer, Ned is returning home to NCI to continue this work and we look forward to working closely with him once again,” Francis S. Collins, MD, director of the National Institutes of Health, said in a statement. “I want to thank Dr. Doug Lowy, principal deputy director of NCI, for having stepped in, once again, to take the helm at NCI and lead the institute so skillfully while Ned was at FDA.”

At press time, neither Dr. Hahn nor MD Anderson Cancer Center had returned messages seeking comment about his nomination.

 

Stephen M. Hahn, MD, a radiation oncologist and researcher, may soon take the reins of the Food and Drug Administration.

Dr. Stephen Hahn

President Trump indicated his intent to nominate Dr. Hahn as FDA Commissioner in a brief Nov.1 statement that outlined Dr. Hahn’s background. Dr. Hahn currently serves as chief medical executive at MD Anderson Cancer Center, Houston, where he heads the radiology oncology division.

Dr. Hahn specializes in treating lung cancer and sarcoma and has authored 220 peer-reviewed original research articles, according to his biography. He was previously chair of the department of radiology oncology at the University of Pennsylvania, Philadelphia, and also served as a senior investigator at the National Cancer Institute.

Dr. Hahn completed his residency in radiation oncology at NCI and his residency in internal medicine at the University of California, San Francisco.

Margaret Foti, PhD, chief executive officer for the American Association for Cancer Research called Dr. Hahn a renowned expert in radiation oncology and research, an experienced and highly effective administrator, and an innovative leader.

“I have seen firsthand Dr. Hahn’s extraordinary dedication and commitment to cancer patients, and the AACR is extremely confident that he will be an outstanding leader for the FDA,” Dr. Foti said in a statement. “Dr. Hahn, who is board certified in both radiation and medical oncology, is esteemed for the breadth and depth of his scientific knowledge and expertise, and he has consistently advocated for a drug review process at the FDA that is both science-directed and patient-focused.”

The American Society of Clinical Oncology also congratulated Dr. Hahn on the upcoming nomination, noting that he has a strong grasp of the drug development process and understands the realities of working in a complex clinical care environment.

“The role of FDA commissioner requires a strong commitment to advancing the agency’s mission to protect public health across the United States, and an understanding of how to help speed innovations to get new treatments to patients, while also ensuring the safety and efficacy of the medical products that millions of Americans rely on to manage, treat, and cure their cancer,” the society stated. “ASCO has a long and productive history of collaborating with FDA, including with current acting Commissioner Norman E. “Ned” Sharpless, MD, in support of the agency’s important role in reducing cancer incidence, advancing treatment options, and improving the lives of individuals with cancer. We look forward to continuing our close collaboration to make it possible for every American with cancer to have access to medical products that are safe and effective.”

Dr. Sharpless will return to his position as NCI director; he served as interim FDA commissioner from the April departure of then-FDA commissioner, Scott Gottlieb, MD.

“As one of the nation’s leading oncologists who has devoted his entire professional career to helping patients in the fight against cancer, Ned is returning home to NCI to continue this work and we look forward to working closely with him once again,” Francis S. Collins, MD, director of the National Institutes of Health, said in a statement. “I want to thank Dr. Doug Lowy, principal deputy director of NCI, for having stepped in, once again, to take the helm at NCI and lead the institute so skillfully while Ned was at FDA.”

At press time, neither Dr. Hahn nor MD Anderson Cancer Center had returned messages seeking comment about his nomination.

Publications
Publications
Topics
Article Type
Sections
Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Disqus Comments
Default
Use ProPublica
Hide sidebar & use full width
render the right sidebar.

Patient-reported complications regarding PICC lines after inpatient discharge

Article Type
Changed
Mon, 11/04/2019 - 16:52

Background: Despite the rise in utilization of PICC lines, few studies have addressed complications experienced by patients following PICC placement, especially subsequent to discharge from the inpatient setting.

Dr. Amanda Cooke

Study design: Prospective longitudinal study.

Setting: Medical inpatient wards at four U.S. hospitals in Michigan and Texas.

Synopsis: Standardized questionnaires were completed by 438 patients who underwent PICC line placement during inpatient hospitalization within 3 days of placement and at 14, 30, and 70 days. The authors found that 61.4% of patients reported at least one possible PICC-related complication or complaint. A total of 17.6% reported signs and symptoms associated with a possible bloodstream infection; however, a central line–associated bloodstream infection was documented in only 1.6% of patients in the medical record. Furthermore, 30.6% of patients reported possible symptoms associated with deep venous thrombosis (DVT), which was documented in the medical record in 7.1% of patients. These data highlight that the frequency of PICC-related complications may be underestimated when relying solely on the medical record, especially when patients receive follow-up care at different facilities. Functionally, 26% of patients reported restrictions in activities of daily living and 19.2% reported difficulty with flushing and operating the PICC.

Bottom line: More than 60% of patients with PICC lines report signs or symptoms of a PICC-related complication or an adverse impact on physical or social function.

Citation: Krein SL et al. Patient-­reported complications related to peripherally inserted central catheters: A multicenter prospective cohort study. BMJ Qual Saf. 2019 Jan 25. doi: 10.1136/bmjqs-2018-008726.

Dr. Cooke is a hospitalist at Beth Israel Deaconess Medical Center.

Publications
Topics
Sections

Background: Despite the rise in utilization of PICC lines, few studies have addressed complications experienced by patients following PICC placement, especially subsequent to discharge from the inpatient setting.

Dr. Amanda Cooke

Study design: Prospective longitudinal study.

Setting: Medical inpatient wards at four U.S. hospitals in Michigan and Texas.

Synopsis: Standardized questionnaires were completed by 438 patients who underwent PICC line placement during inpatient hospitalization within 3 days of placement and at 14, 30, and 70 days. The authors found that 61.4% of patients reported at least one possible PICC-related complication or complaint. A total of 17.6% reported signs and symptoms associated with a possible bloodstream infection; however, a central line–associated bloodstream infection was documented in only 1.6% of patients in the medical record. Furthermore, 30.6% of patients reported possible symptoms associated with deep venous thrombosis (DVT), which was documented in the medical record in 7.1% of patients. These data highlight that the frequency of PICC-related complications may be underestimated when relying solely on the medical record, especially when patients receive follow-up care at different facilities. Functionally, 26% of patients reported restrictions in activities of daily living and 19.2% reported difficulty with flushing and operating the PICC.

Bottom line: More than 60% of patients with PICC lines report signs or symptoms of a PICC-related complication or an adverse impact on physical or social function.

Citation: Krein SL et al. Patient-­reported complications related to peripherally inserted central catheters: A multicenter prospective cohort study. BMJ Qual Saf. 2019 Jan 25. doi: 10.1136/bmjqs-2018-008726.

Dr. Cooke is a hospitalist at Beth Israel Deaconess Medical Center.

Background: Despite the rise in utilization of PICC lines, few studies have addressed complications experienced by patients following PICC placement, especially subsequent to discharge from the inpatient setting.

Dr. Amanda Cooke

Study design: Prospective longitudinal study.

Setting: Medical inpatient wards at four U.S. hospitals in Michigan and Texas.

Synopsis: Standardized questionnaires were completed by 438 patients who underwent PICC line placement during inpatient hospitalization within 3 days of placement and at 14, 30, and 70 days. The authors found that 61.4% of patients reported at least one possible PICC-related complication or complaint. A total of 17.6% reported signs and symptoms associated with a possible bloodstream infection; however, a central line–associated bloodstream infection was documented in only 1.6% of patients in the medical record. Furthermore, 30.6% of patients reported possible symptoms associated with deep venous thrombosis (DVT), which was documented in the medical record in 7.1% of patients. These data highlight that the frequency of PICC-related complications may be underestimated when relying solely on the medical record, especially when patients receive follow-up care at different facilities. Functionally, 26% of patients reported restrictions in activities of daily living and 19.2% reported difficulty with flushing and operating the PICC.

Bottom line: More than 60% of patients with PICC lines report signs or symptoms of a PICC-related complication or an adverse impact on physical or social function.

Citation: Krein SL et al. Patient-­reported complications related to peripherally inserted central catheters: A multicenter prospective cohort study. BMJ Qual Saf. 2019 Jan 25. doi: 10.1136/bmjqs-2018-008726.

Dr. Cooke is a hospitalist at Beth Israel Deaconess Medical Center.

Publications
Publications
Topics
Article Type
Sections
Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Disqus Comments
Default
Use ProPublica
Hide sidebar & use full width
render the right sidebar.

Multiple Myeloma: A New Treatment Option for Newly Diagnosed, Transplant-Ineligible Patients

Article Type
Changed
Mon, 11/04/2019 - 14:03

Saad Z. Usmani, MD, FACP, discusses a new treatment option for newly diagnosed, transplant-ineligible patients with multiple myeloma.

Article includes:

  • An important option for patients with multiple myeloma
  • Details on the phase 3 trial
  • Efficacy and safety profile

 

 

 
Sponsor
This supplement is sponsored by Janssen Biotech, Inc.
Publications
Topics
Sections
Sponsor
This supplement is sponsored by Janssen Biotech, Inc.
Sponsor
This supplement is sponsored by Janssen Biotech, Inc.

Saad Z. Usmani, MD, FACP, discusses a new treatment option for newly diagnosed, transplant-ineligible patients with multiple myeloma.

Article includes:

  • An important option for patients with multiple myeloma
  • Details on the phase 3 trial
  • Efficacy and safety profile

 

 

 

Saad Z. Usmani, MD, FACP, discusses a new treatment option for newly diagnosed, transplant-ineligible patients with multiple myeloma.

Article includes:

  • An important option for patients with multiple myeloma
  • Details on the phase 3 trial
  • Efficacy and safety profile

 

 

 
Publications
Publications
Topics
Article Type
Sections
Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Disqus Comments
Default
Gate On Date
Tue, 06/18/2019 - 14:30
Un-Gate On Date
Tue, 06/18/2019 - 14:30
Use ProPublica
CFC Schedule Remove Status
Tue, 06/18/2019 - 14:30
Hide sidebar & use full width
render the right sidebar.

Hospitalists finding their role in hospital quality ratings

Article Type
Changed
Mon, 11/11/2019 - 11:47

CMS considers how to assess socioeconomic factors

Since 2005 the government website Hospital Compare has publicly reported quality data on hospitals, with periodic updates of their performance, including specific measures of quality. But how accurately do the ratings reflect a hospital’s actual quality of care, and what do the ratings mean for hospitalists?

Dr. Kate Goodrich

Hospital Compare provides searchable, comparable information to consumers on reported quality of care data submitted by more than 4,000 Medicare-certified hospitals, along with Veterans Administration and military health system hospitals. It is designed to allow consumers to select hospitals and directly compare their mortality, complication, infection, and other performance measures on conditions such as heart attacks, heart failure, pneumonia, and surgical outcomes.

The Overall Hospital Quality Star Ratings, which began in 2016, combine data from more than 50 quality measures publicly reported on Hospital Compare into an overall rating of one to five stars for each hospital. These ratings are designed to enhance and supplement existing quality measures with a more “customer-centric” measure that makes it easier for consumers to act on the information. Obviously, this would be helpful to consumers who feel overwhelmed by the volume of data on the Hospital Compare website, and by the complexity of some of the measures.

A posted call in spring 2019 by CMS for public comment on possible methodological changes to the Overall Hospital Quality Star Ratings received more than 800 comments from 150 different organizations. And this past summer, the Centers for Medicare & Medicaid Services decided to delay posting the refreshed Star Ratings in its Hospital Compare data preview reports for July 2019. The agency says it intends to release the updated information in early 2020. Meanwhile, the reported data – particularly the overall star ratings – continue to generate controversy for the hospital field.
 

Hospitalists’ critical role

Hospitalists are not rated individually on Hospital Compare, but they play important roles in the quality of care their hospital provides – and thus ultimately the hospital’s publicly reported rankings. Hospitalists typically are not specifically incentivized or penalized for their hospital’s performance, but this does happen in some cases.

“Hospital administrators absolutely take note of their hospital’s star ratings. These are the people hospitalists work for, and this is definitely top of their minds,” said Kate Goodrich, MD, MHS, director of the Center for Clinical Standards and Quality at CMS. “I recently spoke at an SHM annual conference and every question I was asked was about hospital ratings and the star system,” noted Dr. Goodrich, herself a practicing hospitalist at George Washington University Medical Center in Washington.

The government’s aim for Hospital Compare is to give consumers easy-to-understand indicators of the quality of care provided by hospitals, especially where they might have a choice of hospitals, such as for an elective surgery. Making that information public is also viewed as a motivator to help drive improvements in hospital performance, Dr. Goodrich said.

“In terms of what we measure, we try to make sure it’s important to patients and to clinicians. We have frontline practicing physicians, patients, and families advising us, along with methodologists and PhD researchers. These stakeholders tell us what is important to measure and why,” she said. “Hospitals and all health providers need more actionable and timely data to improve their quality of care, especially if they want to participate in accountable care organizations. And we need to make the information easy to understand.”

Dr. Goodrich sees two main themes in the public response to its request for comment. “People say the methodology we use to calculate star ratings is frustrating for hospitals, which have found it difficult to model their performance, predict their star ratings, or explain the discrepancies.” Hospitals taking care of sicker patients with lower socioeconomic status also say the ratings unfairly penalize them. “I work in a large urban hospital, and I understand this. They say we don’t take that sufficiently into account in the ratings,” she said.

“While our modeling shows that current ratings highly correlate with performance on individual measures, we have asked for comment on if and how we could adjust for socioeconomic factors. We are actively considering how to make changes to address these concerns,” Dr. Goodrich said.

In August 2019, CMS acknowledged that it plans to change the methodology used to calculate hospital star ratings in early 2021, but has not yet revealed specific details about the nature of the changes. The agency intends to propose the changes through the public rule-making process sometime in 2020.
 

 

 

Continuing controversy

The American Hospital Association – which has had strong concerns about the methodology and the usefulness of hospital star ratings – is pushing back on some of the changes to the system being considered by CMS. In its submitted comments, AHA supported only three of the 14 potential star ratings methodology changes being considered. AHA and the American Association of Medical Colleges, among others, have urged taking down the star ratings until major changes can be made.

“When the star ratings were first implemented, a lot of challenges became apparent right away,” said Akin Demehin, MPH, AHA’s director of quality policy. “We began to see that those hospitals that treat more complicated patients and poorer patients tended to perform more poorly on the ratings. So there was something wrong with the methodology. Then, starting in 2018, hospitals began seeing real shifts in their performance ratings when the underlying data hadn’t really changed.”

CMS uses a statistical approach called latent variable modeling. Its underlying assumption is that you can say something about a hospital’s underlying quality based on the data you already have, Mr. Demehin said, but noted “that can be a questionable assumption.” He also emphasized the need for ratings that compare hospitals that are similar in size and model to each other.

Dr. Suparna Dutta

Suparna Dutta, MD, division chief, hospital medicine, Rush University, Chicago, said analyses done at Rush showed that the statistical model CMS used in calculating the star ratings was dynamically changing the weighting of certain measures in every release. “That meant one specific performance measure could play an outsized role in determining a final rating,” she said. In particular the methodology inadvertently penalized large hospitals, academic medical centers, and institutions that provide heroic care.

“We fundamentally believe that consumers should have meaningful information about hospital quality,” said Nancy Foster, AHA’s vice president for quality and patient safety policy at AHA. “We understand the complexities of Hospital Compare and the challenges of getting simple information for consumers. To its credit, CMS is thinking about how to do that, and we support them in that effort.”
 

Getting a handle on quality

Hospitalists are responsible for ensuring that their hospitals excel in the care of patients, said Julius Yang, MD, hospitalist and director of quality at Beth Israel Deaconess Medical Center in Boston. That also requires keeping up on the primary public ways these issues are addressed through reporting of quality data and through reimbursement policy. “That should be part of our core competencies as hospitalists.”

Some of the measures on Hospital Compare don’t overlap much with the work of hospitalists, he noted. But for others, such as for pneumonia, COPD, and care of patients with stroke, or for mortality and 30-day readmissions rates, “we are involved, even if not directly, and certainly responsible for contributing to the outcomes and the opportunity to add value,” he said.

“When it comes to 30-day readmission rates, do we really understand the risk factors for readmissions and the barriers to patients remaining in the community after their hospital stay? Are our patients stable enough to be discharged, and have we worked with the care coordination team to make sure they have the resources they need? And have we communicated adequately with the outpatient doctor? All of these things are within the wheelhouse of the hospitalist,” Dr. Yang said. “Let’s accept that the readmissions rate, for example, is not a perfect measure of quality. But as an imperfect measure, it can point us in the right direction.”

Dr. Jose Figueroa

Jose Figueroa, MD, MPH, hospitalist and assistant professor at Harvard Medical School, has been studying for his health system the impact of hospital penalties such as the Hospital Readmissions Reduction Program on health equity. In general, hospitalists play an important role in dictating processes of care and serving on quality-oriented committees across multiple realms of the hospital, he said.

“What’s hard from the hospitalist’s perspective is that there don’t seem to be simple solutions to move the dial on many of these measures,” Dr. Figueroa said. “If the hospital is at three stars, can we say, okay, if we do X, Y, and Z, then our hospital will move from three to five stars? Some of these measures are so broad and not in our purview. Which ones apply to me as a hospitalist and my care processes?”

Dr. Dutta sits on the SHM Policy Committee, which has been working to bring these issues to the attention of frontline hospitalists. “Hospitalists are always going to be aligned with their hospital’s priorities. We’re in it to provide high-quality care, but there’s no magic way to do that,” she said.

Hospital Compare measures sometimes end up in hospitalist incentives plans – for example, the readmission penalty rates – even though that is a fairly arbitrary measure and hard to pin to one doctor, Dr. Dutta explained. “If you look at the evidence regarding these metrics, there are not a lot of data to show that the metrics lead to what we really want, which is better care for patients.”

A recent study in the British Medical Journal, for example, examined the association between the penalties on hospitals in the Hospital Acquired Condition Reduction Program and clinical outcome.1 The researchers concluded that the penalties were not associated with significant change or found to drive meaningful clinical improvement.
 

 

 

How can hospitalists engage with Compare?

Dr. Goodrich refers hospitalists seeking quality resources to their local quality improvement organizations (QIO) and to Hospital Improvement Innovation Networks at the regional, state, national, or hospital system level.

One helpful thing that any group of hospitalists could do, added Dr. Figueroa, is to examine the measures closely and determine which ones they think they can influence. “Then look for the hospitals that resemble ours and care for similar patients, based on the demographics. We can then say: ‘Okay, that’s a fair comparison. This can be a benchmark with our peers,’” he said. Then it’s important to ask how your hospital is doing over time on these measures, and use that to prioritize.

“You also have to appreciate that these are broad quality measures, and to impact them you have to do broad quality improvement efforts. Another piece of this is getting good at collecting and analyzing data internally in a timely fashion. You don’t want to wait 2-3 years to find out in Hospital Compare that you’re not performing well. You care about the care you provided today, not 2 or 3 years ago. Without this internal check, it’s impossible to know what to invest in – and to see if things you do are having an impact,” Dr. Figueroa said.

“As physician leaders, this is a real opportunity for us to trigger a conversation with our hospital’s administration around what we went into medicine for in the first place – to improve our patients’ care,” said Dr. Goodrich. She said Hospital Compare is one tool for sparking systemic quality improvement across the hospital – which is an important part of the hospitalist’s job. “If you want to be a bigger star within your hospital, show that level of commitment. It likely would be welcomed by your hospital.”
 

Reference

1. Sankaran R et al. Changes in hospital safety following penalties in the US Hospital Acquired Condition Reduction Program: retrospective cohort study. BMJ. 2019 Jul 3 doi: 10.1136/bmj.l4109.

Publications
Topics
Sections

CMS considers how to assess socioeconomic factors

CMS considers how to assess socioeconomic factors

Since 2005 the government website Hospital Compare has publicly reported quality data on hospitals, with periodic updates of their performance, including specific measures of quality. But how accurately do the ratings reflect a hospital’s actual quality of care, and what do the ratings mean for hospitalists?

Dr. Kate Goodrich

Hospital Compare provides searchable, comparable information to consumers on reported quality of care data submitted by more than 4,000 Medicare-certified hospitals, along with Veterans Administration and military health system hospitals. It is designed to allow consumers to select hospitals and directly compare their mortality, complication, infection, and other performance measures on conditions such as heart attacks, heart failure, pneumonia, and surgical outcomes.

The Overall Hospital Quality Star Ratings, which began in 2016, combine data from more than 50 quality measures publicly reported on Hospital Compare into an overall rating of one to five stars for each hospital. These ratings are designed to enhance and supplement existing quality measures with a more “customer-centric” measure that makes it easier for consumers to act on the information. Obviously, this would be helpful to consumers who feel overwhelmed by the volume of data on the Hospital Compare website, and by the complexity of some of the measures.

A posted call in spring 2019 by CMS for public comment on possible methodological changes to the Overall Hospital Quality Star Ratings received more than 800 comments from 150 different organizations. And this past summer, the Centers for Medicare & Medicaid Services decided to delay posting the refreshed Star Ratings in its Hospital Compare data preview reports for July 2019. The agency says it intends to release the updated information in early 2020. Meanwhile, the reported data – particularly the overall star ratings – continue to generate controversy for the hospital field.
 

Hospitalists’ critical role

Hospitalists are not rated individually on Hospital Compare, but they play important roles in the quality of care their hospital provides – and thus ultimately the hospital’s publicly reported rankings. Hospitalists typically are not specifically incentivized or penalized for their hospital’s performance, but this does happen in some cases.

“Hospital administrators absolutely take note of their hospital’s star ratings. These are the people hospitalists work for, and this is definitely top of their minds,” said Kate Goodrich, MD, MHS, director of the Center for Clinical Standards and Quality at CMS. “I recently spoke at an SHM annual conference and every question I was asked was about hospital ratings and the star system,” noted Dr. Goodrich, herself a practicing hospitalist at George Washington University Medical Center in Washington.

The government’s aim for Hospital Compare is to give consumers easy-to-understand indicators of the quality of care provided by hospitals, especially where they might have a choice of hospitals, such as for an elective surgery. Making that information public is also viewed as a motivator to help drive improvements in hospital performance, Dr. Goodrich said.

“In terms of what we measure, we try to make sure it’s important to patients and to clinicians. We have frontline practicing physicians, patients, and families advising us, along with methodologists and PhD researchers. These stakeholders tell us what is important to measure and why,” she said. “Hospitals and all health providers need more actionable and timely data to improve their quality of care, especially if they want to participate in accountable care organizations. And we need to make the information easy to understand.”

Dr. Goodrich sees two main themes in the public response to its request for comment. “People say the methodology we use to calculate star ratings is frustrating for hospitals, which have found it difficult to model their performance, predict their star ratings, or explain the discrepancies.” Hospitals taking care of sicker patients with lower socioeconomic status also say the ratings unfairly penalize them. “I work in a large urban hospital, and I understand this. They say we don’t take that sufficiently into account in the ratings,” she said.

“While our modeling shows that current ratings highly correlate with performance on individual measures, we have asked for comment on if and how we could adjust for socioeconomic factors. We are actively considering how to make changes to address these concerns,” Dr. Goodrich said.

In August 2019, CMS acknowledged that it plans to change the methodology used to calculate hospital star ratings in early 2021, but has not yet revealed specific details about the nature of the changes. The agency intends to propose the changes through the public rule-making process sometime in 2020.
 

 

 

Continuing controversy

The American Hospital Association – which has had strong concerns about the methodology and the usefulness of hospital star ratings – is pushing back on some of the changes to the system being considered by CMS. In its submitted comments, AHA supported only three of the 14 potential star ratings methodology changes being considered. AHA and the American Association of Medical Colleges, among others, have urged taking down the star ratings until major changes can be made.

“When the star ratings were first implemented, a lot of challenges became apparent right away,” said Akin Demehin, MPH, AHA’s director of quality policy. “We began to see that those hospitals that treat more complicated patients and poorer patients tended to perform more poorly on the ratings. So there was something wrong with the methodology. Then, starting in 2018, hospitals began seeing real shifts in their performance ratings when the underlying data hadn’t really changed.”

CMS uses a statistical approach called latent variable modeling. Its underlying assumption is that you can say something about a hospital’s underlying quality based on the data you already have, Mr. Demehin said, but noted “that can be a questionable assumption.” He also emphasized the need for ratings that compare hospitals that are similar in size and model to each other.

Dr. Suparna Dutta

Suparna Dutta, MD, division chief, hospital medicine, Rush University, Chicago, said analyses done at Rush showed that the statistical model CMS used in calculating the star ratings was dynamically changing the weighting of certain measures in every release. “That meant one specific performance measure could play an outsized role in determining a final rating,” she said. In particular the methodology inadvertently penalized large hospitals, academic medical centers, and institutions that provide heroic care.

“We fundamentally believe that consumers should have meaningful information about hospital quality,” said Nancy Foster, AHA’s vice president for quality and patient safety policy at AHA. “We understand the complexities of Hospital Compare and the challenges of getting simple information for consumers. To its credit, CMS is thinking about how to do that, and we support them in that effort.”
 

Getting a handle on quality

Hospitalists are responsible for ensuring that their hospitals excel in the care of patients, said Julius Yang, MD, hospitalist and director of quality at Beth Israel Deaconess Medical Center in Boston. That also requires keeping up on the primary public ways these issues are addressed through reporting of quality data and through reimbursement policy. “That should be part of our core competencies as hospitalists.”

Some of the measures on Hospital Compare don’t overlap much with the work of hospitalists, he noted. But for others, such as for pneumonia, COPD, and care of patients with stroke, or for mortality and 30-day readmissions rates, “we are involved, even if not directly, and certainly responsible for contributing to the outcomes and the opportunity to add value,” he said.

“When it comes to 30-day readmission rates, do we really understand the risk factors for readmissions and the barriers to patients remaining in the community after their hospital stay? Are our patients stable enough to be discharged, and have we worked with the care coordination team to make sure they have the resources they need? And have we communicated adequately with the outpatient doctor? All of these things are within the wheelhouse of the hospitalist,” Dr. Yang said. “Let’s accept that the readmissions rate, for example, is not a perfect measure of quality. But as an imperfect measure, it can point us in the right direction.”

Dr. Jose Figueroa

Jose Figueroa, MD, MPH, hospitalist and assistant professor at Harvard Medical School, has been studying for his health system the impact of hospital penalties such as the Hospital Readmissions Reduction Program on health equity. In general, hospitalists play an important role in dictating processes of care and serving on quality-oriented committees across multiple realms of the hospital, he said.

“What’s hard from the hospitalist’s perspective is that there don’t seem to be simple solutions to move the dial on many of these measures,” Dr. Figueroa said. “If the hospital is at three stars, can we say, okay, if we do X, Y, and Z, then our hospital will move from three to five stars? Some of these measures are so broad and not in our purview. Which ones apply to me as a hospitalist and my care processes?”

Dr. Dutta sits on the SHM Policy Committee, which has been working to bring these issues to the attention of frontline hospitalists. “Hospitalists are always going to be aligned with their hospital’s priorities. We’re in it to provide high-quality care, but there’s no magic way to do that,” she said.

Hospital Compare measures sometimes end up in hospitalist incentives plans – for example, the readmission penalty rates – even though that is a fairly arbitrary measure and hard to pin to one doctor, Dr. Dutta explained. “If you look at the evidence regarding these metrics, there are not a lot of data to show that the metrics lead to what we really want, which is better care for patients.”

A recent study in the British Medical Journal, for example, examined the association between the penalties on hospitals in the Hospital Acquired Condition Reduction Program and clinical outcome.1 The researchers concluded that the penalties were not associated with significant change or found to drive meaningful clinical improvement.
 

 

 

How can hospitalists engage with Compare?

Dr. Goodrich refers hospitalists seeking quality resources to their local quality improvement organizations (QIO) and to Hospital Improvement Innovation Networks at the regional, state, national, or hospital system level.

One helpful thing that any group of hospitalists could do, added Dr. Figueroa, is to examine the measures closely and determine which ones they think they can influence. “Then look for the hospitals that resemble ours and care for similar patients, based on the demographics. We can then say: ‘Okay, that’s a fair comparison. This can be a benchmark with our peers,’” he said. Then it’s important to ask how your hospital is doing over time on these measures, and use that to prioritize.

“You also have to appreciate that these are broad quality measures, and to impact them you have to do broad quality improvement efforts. Another piece of this is getting good at collecting and analyzing data internally in a timely fashion. You don’t want to wait 2-3 years to find out in Hospital Compare that you’re not performing well. You care about the care you provided today, not 2 or 3 years ago. Without this internal check, it’s impossible to know what to invest in – and to see if things you do are having an impact,” Dr. Figueroa said.

“As physician leaders, this is a real opportunity for us to trigger a conversation with our hospital’s administration around what we went into medicine for in the first place – to improve our patients’ care,” said Dr. Goodrich. She said Hospital Compare is one tool for sparking systemic quality improvement across the hospital – which is an important part of the hospitalist’s job. “If you want to be a bigger star within your hospital, show that level of commitment. It likely would be welcomed by your hospital.”
 

Reference

1. Sankaran R et al. Changes in hospital safety following penalties in the US Hospital Acquired Condition Reduction Program: retrospective cohort study. BMJ. 2019 Jul 3 doi: 10.1136/bmj.l4109.

Since 2005 the government website Hospital Compare has publicly reported quality data on hospitals, with periodic updates of their performance, including specific measures of quality. But how accurately do the ratings reflect a hospital’s actual quality of care, and what do the ratings mean for hospitalists?

Dr. Kate Goodrich

Hospital Compare provides searchable, comparable information to consumers on reported quality of care data submitted by more than 4,000 Medicare-certified hospitals, along with Veterans Administration and military health system hospitals. It is designed to allow consumers to select hospitals and directly compare their mortality, complication, infection, and other performance measures on conditions such as heart attacks, heart failure, pneumonia, and surgical outcomes.

The Overall Hospital Quality Star Ratings, which began in 2016, combine data from more than 50 quality measures publicly reported on Hospital Compare into an overall rating of one to five stars for each hospital. These ratings are designed to enhance and supplement existing quality measures with a more “customer-centric” measure that makes it easier for consumers to act on the information. Obviously, this would be helpful to consumers who feel overwhelmed by the volume of data on the Hospital Compare website, and by the complexity of some of the measures.

A posted call in spring 2019 by CMS for public comment on possible methodological changes to the Overall Hospital Quality Star Ratings received more than 800 comments from 150 different organizations. And this past summer, the Centers for Medicare & Medicaid Services decided to delay posting the refreshed Star Ratings in its Hospital Compare data preview reports for July 2019. The agency says it intends to release the updated information in early 2020. Meanwhile, the reported data – particularly the overall star ratings – continue to generate controversy for the hospital field.
 

Hospitalists’ critical role

Hospitalists are not rated individually on Hospital Compare, but they play important roles in the quality of care their hospital provides – and thus ultimately the hospital’s publicly reported rankings. Hospitalists typically are not specifically incentivized or penalized for their hospital’s performance, but this does happen in some cases.

“Hospital administrators absolutely take note of their hospital’s star ratings. These are the people hospitalists work for, and this is definitely top of their minds,” said Kate Goodrich, MD, MHS, director of the Center for Clinical Standards and Quality at CMS. “I recently spoke at an SHM annual conference and every question I was asked was about hospital ratings and the star system,” noted Dr. Goodrich, herself a practicing hospitalist at George Washington University Medical Center in Washington.

The government’s aim for Hospital Compare is to give consumers easy-to-understand indicators of the quality of care provided by hospitals, especially where they might have a choice of hospitals, such as for an elective surgery. Making that information public is also viewed as a motivator to help drive improvements in hospital performance, Dr. Goodrich said.

“In terms of what we measure, we try to make sure it’s important to patients and to clinicians. We have frontline practicing physicians, patients, and families advising us, along with methodologists and PhD researchers. These stakeholders tell us what is important to measure and why,” she said. “Hospitals and all health providers need more actionable and timely data to improve their quality of care, especially if they want to participate in accountable care organizations. And we need to make the information easy to understand.”

Dr. Goodrich sees two main themes in the public response to its request for comment. “People say the methodology we use to calculate star ratings is frustrating for hospitals, which have found it difficult to model their performance, predict their star ratings, or explain the discrepancies.” Hospitals taking care of sicker patients with lower socioeconomic status also say the ratings unfairly penalize them. “I work in a large urban hospital, and I understand this. They say we don’t take that sufficiently into account in the ratings,” she said.

“While our modeling shows that current ratings highly correlate with performance on individual measures, we have asked for comment on if and how we could adjust for socioeconomic factors. We are actively considering how to make changes to address these concerns,” Dr. Goodrich said.

In August 2019, CMS acknowledged that it plans to change the methodology used to calculate hospital star ratings in early 2021, but has not yet revealed specific details about the nature of the changes. The agency intends to propose the changes through the public rule-making process sometime in 2020.
 

 

 

Continuing controversy

The American Hospital Association – which has had strong concerns about the methodology and the usefulness of hospital star ratings – is pushing back on some of the changes to the system being considered by CMS. In its submitted comments, AHA supported only three of the 14 potential star ratings methodology changes being considered. AHA and the American Association of Medical Colleges, among others, have urged taking down the star ratings until major changes can be made.

“When the star ratings were first implemented, a lot of challenges became apparent right away,” said Akin Demehin, MPH, AHA’s director of quality policy. “We began to see that those hospitals that treat more complicated patients and poorer patients tended to perform more poorly on the ratings. So there was something wrong with the methodology. Then, starting in 2018, hospitals began seeing real shifts in their performance ratings when the underlying data hadn’t really changed.”

CMS uses a statistical approach called latent variable modeling. Its underlying assumption is that you can say something about a hospital’s underlying quality based on the data you already have, Mr. Demehin said, but noted “that can be a questionable assumption.” He also emphasized the need for ratings that compare hospitals that are similar in size and model to each other.

Dr. Suparna Dutta

Suparna Dutta, MD, division chief, hospital medicine, Rush University, Chicago, said analyses done at Rush showed that the statistical model CMS used in calculating the star ratings was dynamically changing the weighting of certain measures in every release. “That meant one specific performance measure could play an outsized role in determining a final rating,” she said. In particular the methodology inadvertently penalized large hospitals, academic medical centers, and institutions that provide heroic care.

“We fundamentally believe that consumers should have meaningful information about hospital quality,” said Nancy Foster, AHA’s vice president for quality and patient safety policy at AHA. “We understand the complexities of Hospital Compare and the challenges of getting simple information for consumers. To its credit, CMS is thinking about how to do that, and we support them in that effort.”
 

Getting a handle on quality

Hospitalists are responsible for ensuring that their hospitals excel in the care of patients, said Julius Yang, MD, hospitalist and director of quality at Beth Israel Deaconess Medical Center in Boston. That also requires keeping up on the primary public ways these issues are addressed through reporting of quality data and through reimbursement policy. “That should be part of our core competencies as hospitalists.”

Some of the measures on Hospital Compare don’t overlap much with the work of hospitalists, he noted. But for others, such as for pneumonia, COPD, and care of patients with stroke, or for mortality and 30-day readmissions rates, “we are involved, even if not directly, and certainly responsible for contributing to the outcomes and the opportunity to add value,” he said.

“When it comes to 30-day readmission rates, do we really understand the risk factors for readmissions and the barriers to patients remaining in the community after their hospital stay? Are our patients stable enough to be discharged, and have we worked with the care coordination team to make sure they have the resources they need? And have we communicated adequately with the outpatient doctor? All of these things are within the wheelhouse of the hospitalist,” Dr. Yang said. “Let’s accept that the readmissions rate, for example, is not a perfect measure of quality. But as an imperfect measure, it can point us in the right direction.”

Dr. Jose Figueroa

Jose Figueroa, MD, MPH, hospitalist and assistant professor at Harvard Medical School, has been studying for his health system the impact of hospital penalties such as the Hospital Readmissions Reduction Program on health equity. In general, hospitalists play an important role in dictating processes of care and serving on quality-oriented committees across multiple realms of the hospital, he said.

“What’s hard from the hospitalist’s perspective is that there don’t seem to be simple solutions to move the dial on many of these measures,” Dr. Figueroa said. “If the hospital is at three stars, can we say, okay, if we do X, Y, and Z, then our hospital will move from three to five stars? Some of these measures are so broad and not in our purview. Which ones apply to me as a hospitalist and my care processes?”

Dr. Dutta sits on the SHM Policy Committee, which has been working to bring these issues to the attention of frontline hospitalists. “Hospitalists are always going to be aligned with their hospital’s priorities. We’re in it to provide high-quality care, but there’s no magic way to do that,” she said.

Hospital Compare measures sometimes end up in hospitalist incentives plans – for example, the readmission penalty rates – even though that is a fairly arbitrary measure and hard to pin to one doctor, Dr. Dutta explained. “If you look at the evidence regarding these metrics, there are not a lot of data to show that the metrics lead to what we really want, which is better care for patients.”

A recent study in the British Medical Journal, for example, examined the association between the penalties on hospitals in the Hospital Acquired Condition Reduction Program and clinical outcome.1 The researchers concluded that the penalties were not associated with significant change or found to drive meaningful clinical improvement.
 

 

 

How can hospitalists engage with Compare?

Dr. Goodrich refers hospitalists seeking quality resources to their local quality improvement organizations (QIO) and to Hospital Improvement Innovation Networks at the regional, state, national, or hospital system level.

One helpful thing that any group of hospitalists could do, added Dr. Figueroa, is to examine the measures closely and determine which ones they think they can influence. “Then look for the hospitals that resemble ours and care for similar patients, based on the demographics. We can then say: ‘Okay, that’s a fair comparison. This can be a benchmark with our peers,’” he said. Then it’s important to ask how your hospital is doing over time on these measures, and use that to prioritize.

“You also have to appreciate that these are broad quality measures, and to impact them you have to do broad quality improvement efforts. Another piece of this is getting good at collecting and analyzing data internally in a timely fashion. You don’t want to wait 2-3 years to find out in Hospital Compare that you’re not performing well. You care about the care you provided today, not 2 or 3 years ago. Without this internal check, it’s impossible to know what to invest in – and to see if things you do are having an impact,” Dr. Figueroa said.

“As physician leaders, this is a real opportunity for us to trigger a conversation with our hospital’s administration around what we went into medicine for in the first place – to improve our patients’ care,” said Dr. Goodrich. She said Hospital Compare is one tool for sparking systemic quality improvement across the hospital – which is an important part of the hospitalist’s job. “If you want to be a bigger star within your hospital, show that level of commitment. It likely would be welcomed by your hospital.”
 

Reference

1. Sankaran R et al. Changes in hospital safety following penalties in the US Hospital Acquired Condition Reduction Program: retrospective cohort study. BMJ. 2019 Jul 3 doi: 10.1136/bmj.l4109.

Publications
Publications
Topics
Article Type
Sections
Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Disqus Comments
Default
Use ProPublica
Hide sidebar & use full width
render the right sidebar.

Levothyroxine dose for checkpoint inhibitor toxicity may be too high

Article Type
Changed
Fri, 11/22/2019 - 10:24

Current dosing recommendations for thyroid replacement during immune checkpoint inhibitor therapy may overshoot the mark, both for patients with preexisting and de novo hypothyroidism.

Kari Oakes/MDedge News
Dr. Megan Kristan

The real-world data, presented by Megan Kristan, MD, at the annual meeting of the American Thyroid Association, refine recommendations for dosing by body weight for levothyroxine in patients receiving checkpoint inhibitor therapy.

Immune checkpoint inhibitors stand a good chance of turning the tide against melanoma, some lung cancers, and other malignancies that have long been considered lethal. However, as more patients are exposed to the therapies, endocrinologists are seeing a wave of thyroid abnormalities, and must decide when, and at what doses, to treat hypothyroidism, said Dr. Kristan, a diabetes, endocrinology, and nutrition fellow at the University of Maryland, Baltimore.

Six checkpoint inhibitors are currently approved to hit a variety of molecular targets, and the prevalence of thyroid toxicity and hypothyroidism across the drug class ranges from a reported 9% to 40%, said Dr. Kristan.

The acknowledged thyroid toxicity of these drugs led the American Society for Clinical Oncology (ASCO) to issue guidelines advising that oncologists obtain baseline thyroid function tests before initiating checkpoint inhibitors, and that values be rechecked frequently – every 4-6 weeks – during therapy.

The guidelines advise dosing levothyroxine at approximately 1.6 mcg/kg per day, based on ideal patient body weight. The recommendation is limited to patients without risk factors, and approximates full levothyroxine replacement.

However, some patients enter cancer treatment with hypothyroidism, and some develop it de novo after beginning checkpoint inhibitor therapy. It is not known how best to treat each group, said Dr. Kristan.

To help answer that question, she and her collaborators at Georgetown University Hospital, McLean, Va., made use of a database drawn from five hospitals to perform a retrospective chart review. They looked at 822 patients who had received checkpoint inhibitor therapy, and from those patients, they selected 118 who had a diagnosis of hypothyroidism, or who received a prescription for levothyroxine during the 8-year study period.

The investigators assembled all available relevant data for each patient, including thyroid function tests, levothyroxine dosing, type of cancer, and type of therapy. They sorted participants into those who had received a diagnosis of hypothyroidism before or after receiving the first dose of checkpoint inhibitor therapy.

At baseline, 81 patients had preexisting hypothyroidism and were receiving a mean levothyroxine dose of 88.2 mcg. After treatment, the mean dose was 94.3 mcg, a nonsignificant difference. The median dose for this group remained at 88 mcg through treatment.

For the 37 patients who developed hypothyroidism de novo during checkpoint inhibitor therapy, the final observed levothyroxine dose was 71.2 mcg.

The mean age of the patients at baseline was 69 years. About half were women, and 91% were white. Either nivolumab or pembrolizumab was used in 72% of patients, making them the most commonly used checkpoint inhibitors, though 90% of patients received combination therapy. Taken together, melanoma and lung cancer accounted for about two-thirds of the cancers seen.

For both groups, the on-treatment levothyroxine dose was considerably lower than the ASCO-recommended, weight-based dosing, which would have been 122.9 mcg for those with preexisting hypothyroidism and 115.7 mcg for those who developed hypothyroidism on treatment (P less than .001 for both).

Dr. Kristan noted that thyroid stimulating hormone (TSH) values for patients with pretreatment hypothyroidism peaked between weeks 12 and 20, though there was no preemptive adjustment of levothyroxine dosing.

For those who developed on-treatment hypothyroidism, TSH values peaked at a series of times, at about weeks 8, 16, and 32. These waves of TSH elevation, she said, support the 4- to 6-week follow-up interval recommended in the ASCO guidelines.

However, she said, patients with de novo hypothyroidism “should not be started on the 1.6-mcg/kg-a-day weight-based dosing.” The cohort with de novo hypothyroidism in Dr. Kristan’s analysis required a daily dose of about 1 mcg/kg, she said. These real-world results support the idea that many patients on checkpoint inhibitors retain some thyroid reserve.

Dr. Kristan said that based on these findings, she and her collaborators recommend monitoring thyroid function every 4-6 weeks for patients taking immune checkpoint inhibitors. Patients with preexisting thyroid disease should not have an empiric adjustment of levothyroxine dose on checkpoint inhibitor initiation. For patients who develop thyroiditis after starting therapy, initiating a dose at 1 mcg/kg per day of ideal body weight is a good place to start, and treatment response should be monitored.

The study was limited by its retrospective nature and the small sample size, acknowledged Dr. Kristan. In addition, there were confounding variables and different frequencies of testing across institutions, and antibody status was not available and may have affected the results. Testing was performable for all participants.

Dr. Kristan said that the analysis opens up areas for further study, such as which patient populations are at risk for developing thyroid toxicity, what baseline characteristics can help predict which patients develop toxicity, and whether particular checkpoint inhibitors are more likely to cause toxicity. In addition, she said, a subset of patients will develop hyperthyroidism on checkpoint inhibitor therapy, and little is known about how to treat that complication.

Dr. Kristan reported no conflicts of interest. The research she presented was completed during her residency at Georgetown University.
 

SOURCE: Kristan M et al. ATA 2019, Oral Abstract 25.

Meeting/Event
Publications
Topics
Sections
Meeting/Event
Meeting/Event

Current dosing recommendations for thyroid replacement during immune checkpoint inhibitor therapy may overshoot the mark, both for patients with preexisting and de novo hypothyroidism.

Kari Oakes/MDedge News
Dr. Megan Kristan

The real-world data, presented by Megan Kristan, MD, at the annual meeting of the American Thyroid Association, refine recommendations for dosing by body weight for levothyroxine in patients receiving checkpoint inhibitor therapy.

Immune checkpoint inhibitors stand a good chance of turning the tide against melanoma, some lung cancers, and other malignancies that have long been considered lethal. However, as more patients are exposed to the therapies, endocrinologists are seeing a wave of thyroid abnormalities, and must decide when, and at what doses, to treat hypothyroidism, said Dr. Kristan, a diabetes, endocrinology, and nutrition fellow at the University of Maryland, Baltimore.

Six checkpoint inhibitors are currently approved to hit a variety of molecular targets, and the prevalence of thyroid toxicity and hypothyroidism across the drug class ranges from a reported 9% to 40%, said Dr. Kristan.

The acknowledged thyroid toxicity of these drugs led the American Society for Clinical Oncology (ASCO) to issue guidelines advising that oncologists obtain baseline thyroid function tests before initiating checkpoint inhibitors, and that values be rechecked frequently – every 4-6 weeks – during therapy.

The guidelines advise dosing levothyroxine at approximately 1.6 mcg/kg per day, based on ideal patient body weight. The recommendation is limited to patients without risk factors, and approximates full levothyroxine replacement.

However, some patients enter cancer treatment with hypothyroidism, and some develop it de novo after beginning checkpoint inhibitor therapy. It is not known how best to treat each group, said Dr. Kristan.

To help answer that question, she and her collaborators at Georgetown University Hospital, McLean, Va., made use of a database drawn from five hospitals to perform a retrospective chart review. They looked at 822 patients who had received checkpoint inhibitor therapy, and from those patients, they selected 118 who had a diagnosis of hypothyroidism, or who received a prescription for levothyroxine during the 8-year study period.

The investigators assembled all available relevant data for each patient, including thyroid function tests, levothyroxine dosing, type of cancer, and type of therapy. They sorted participants into those who had received a diagnosis of hypothyroidism before or after receiving the first dose of checkpoint inhibitor therapy.

At baseline, 81 patients had preexisting hypothyroidism and were receiving a mean levothyroxine dose of 88.2 mcg. After treatment, the mean dose was 94.3 mcg, a nonsignificant difference. The median dose for this group remained at 88 mcg through treatment.

For the 37 patients who developed hypothyroidism de novo during checkpoint inhibitor therapy, the final observed levothyroxine dose was 71.2 mcg.

The mean age of the patients at baseline was 69 years. About half were women, and 91% were white. Either nivolumab or pembrolizumab was used in 72% of patients, making them the most commonly used checkpoint inhibitors, though 90% of patients received combination therapy. Taken together, melanoma and lung cancer accounted for about two-thirds of the cancers seen.

For both groups, the on-treatment levothyroxine dose was considerably lower than the ASCO-recommended, weight-based dosing, which would have been 122.9 mcg for those with preexisting hypothyroidism and 115.7 mcg for those who developed hypothyroidism on treatment (P less than .001 for both).

Dr. Kristan noted that thyroid stimulating hormone (TSH) values for patients with pretreatment hypothyroidism peaked between weeks 12 and 20, though there was no preemptive adjustment of levothyroxine dosing.

For those who developed on-treatment hypothyroidism, TSH values peaked at a series of times, at about weeks 8, 16, and 32. These waves of TSH elevation, she said, support the 4- to 6-week follow-up interval recommended in the ASCO guidelines.

However, she said, patients with de novo hypothyroidism “should not be started on the 1.6-mcg/kg-a-day weight-based dosing.” The cohort with de novo hypothyroidism in Dr. Kristan’s analysis required a daily dose of about 1 mcg/kg, she said. These real-world results support the idea that many patients on checkpoint inhibitors retain some thyroid reserve.

Dr. Kristan said that based on these findings, she and her collaborators recommend monitoring thyroid function every 4-6 weeks for patients taking immune checkpoint inhibitors. Patients with preexisting thyroid disease should not have an empiric adjustment of levothyroxine dose on checkpoint inhibitor initiation. For patients who develop thyroiditis after starting therapy, initiating a dose at 1 mcg/kg per day of ideal body weight is a good place to start, and treatment response should be monitored.

The study was limited by its retrospective nature and the small sample size, acknowledged Dr. Kristan. In addition, there were confounding variables and different frequencies of testing across institutions, and antibody status was not available and may have affected the results. Testing was performable for all participants.

Dr. Kristan said that the analysis opens up areas for further study, such as which patient populations are at risk for developing thyroid toxicity, what baseline characteristics can help predict which patients develop toxicity, and whether particular checkpoint inhibitors are more likely to cause toxicity. In addition, she said, a subset of patients will develop hyperthyroidism on checkpoint inhibitor therapy, and little is known about how to treat that complication.

Dr. Kristan reported no conflicts of interest. The research she presented was completed during her residency at Georgetown University.
 

SOURCE: Kristan M et al. ATA 2019, Oral Abstract 25.

Current dosing recommendations for thyroid replacement during immune checkpoint inhibitor therapy may overshoot the mark, both for patients with preexisting and de novo hypothyroidism.

Kari Oakes/MDedge News
Dr. Megan Kristan

The real-world data, presented by Megan Kristan, MD, at the annual meeting of the American Thyroid Association, refine recommendations for dosing by body weight for levothyroxine in patients receiving checkpoint inhibitor therapy.

Immune checkpoint inhibitors stand a good chance of turning the tide against melanoma, some lung cancers, and other malignancies that have long been considered lethal. However, as more patients are exposed to the therapies, endocrinologists are seeing a wave of thyroid abnormalities, and must decide when, and at what doses, to treat hypothyroidism, said Dr. Kristan, a diabetes, endocrinology, and nutrition fellow at the University of Maryland, Baltimore.

Six checkpoint inhibitors are currently approved to hit a variety of molecular targets, and the prevalence of thyroid toxicity and hypothyroidism across the drug class ranges from a reported 9% to 40%, said Dr. Kristan.

The acknowledged thyroid toxicity of these drugs led the American Society for Clinical Oncology (ASCO) to issue guidelines advising that oncologists obtain baseline thyroid function tests before initiating checkpoint inhibitors, and that values be rechecked frequently – every 4-6 weeks – during therapy.

The guidelines advise dosing levothyroxine at approximately 1.6 mcg/kg per day, based on ideal patient body weight. The recommendation is limited to patients without risk factors, and approximates full levothyroxine replacement.

However, some patients enter cancer treatment with hypothyroidism, and some develop it de novo after beginning checkpoint inhibitor therapy. It is not known how best to treat each group, said Dr. Kristan.

To help answer that question, she and her collaborators at Georgetown University Hospital, McLean, Va., made use of a database drawn from five hospitals to perform a retrospective chart review. They looked at 822 patients who had received checkpoint inhibitor therapy, and from those patients, they selected 118 who had a diagnosis of hypothyroidism, or who received a prescription for levothyroxine during the 8-year study period.

The investigators assembled all available relevant data for each patient, including thyroid function tests, levothyroxine dosing, type of cancer, and type of therapy. They sorted participants into those who had received a diagnosis of hypothyroidism before or after receiving the first dose of checkpoint inhibitor therapy.

At baseline, 81 patients had preexisting hypothyroidism and were receiving a mean levothyroxine dose of 88.2 mcg. After treatment, the mean dose was 94.3 mcg, a nonsignificant difference. The median dose for this group remained at 88 mcg through treatment.

For the 37 patients who developed hypothyroidism de novo during checkpoint inhibitor therapy, the final observed levothyroxine dose was 71.2 mcg.

The mean age of the patients at baseline was 69 years. About half were women, and 91% were white. Either nivolumab or pembrolizumab was used in 72% of patients, making them the most commonly used checkpoint inhibitors, though 90% of patients received combination therapy. Taken together, melanoma and lung cancer accounted for about two-thirds of the cancers seen.

For both groups, the on-treatment levothyroxine dose was considerably lower than the ASCO-recommended, weight-based dosing, which would have been 122.9 mcg for those with preexisting hypothyroidism and 115.7 mcg for those who developed hypothyroidism on treatment (P less than .001 for both).

Dr. Kristan noted that thyroid stimulating hormone (TSH) values for patients with pretreatment hypothyroidism peaked between weeks 12 and 20, though there was no preemptive adjustment of levothyroxine dosing.

For those who developed on-treatment hypothyroidism, TSH values peaked at a series of times, at about weeks 8, 16, and 32. These waves of TSH elevation, she said, support the 4- to 6-week follow-up interval recommended in the ASCO guidelines.

However, she said, patients with de novo hypothyroidism “should not be started on the 1.6-mcg/kg-a-day weight-based dosing.” The cohort with de novo hypothyroidism in Dr. Kristan’s analysis required a daily dose of about 1 mcg/kg, she said. These real-world results support the idea that many patients on checkpoint inhibitors retain some thyroid reserve.

Dr. Kristan said that based on these findings, she and her collaborators recommend monitoring thyroid function every 4-6 weeks for patients taking immune checkpoint inhibitors. Patients with preexisting thyroid disease should not have an empiric adjustment of levothyroxine dose on checkpoint inhibitor initiation. For patients who develop thyroiditis after starting therapy, initiating a dose at 1 mcg/kg per day of ideal body weight is a good place to start, and treatment response should be monitored.

The study was limited by its retrospective nature and the small sample size, acknowledged Dr. Kristan. In addition, there were confounding variables and different frequencies of testing across institutions, and antibody status was not available and may have affected the results. Testing was performable for all participants.

Dr. Kristan said that the analysis opens up areas for further study, such as which patient populations are at risk for developing thyroid toxicity, what baseline characteristics can help predict which patients develop toxicity, and whether particular checkpoint inhibitors are more likely to cause toxicity. In addition, she said, a subset of patients will develop hyperthyroidism on checkpoint inhibitor therapy, and little is known about how to treat that complication.

Dr. Kristan reported no conflicts of interest. The research she presented was completed during her residency at Georgetown University.
 

SOURCE: Kristan M et al. ATA 2019, Oral Abstract 25.

Publications
Publications
Topics
Article Type
Sections
Article Source

REPORTING FROM ATA 2019

Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Disqus Comments
Default
Use ProPublica
Hide sidebar & use full width
render the right sidebar.

T3 levels are higher in combatants with PTSD

Article Type
Changed
Mon, 11/04/2019 - 14:24

– Higher levels of triiodothyronine (T3) were seen in combatants with PTSD, compared with patients whose PTSD arose from other adverse experiences, according to findings from a systematic review and meta-analysis.

Dr. Freddy J.K. Toloza

Patients with combat-related PTSD had higher levels of free T3 and total T3, compared with control participants who had experienced childhood or sexual abuse or were a wartime refugee without PTSD (FT3, 0.36 pg/mL higher, and total T3, 31.6 ng/mL higher, respectively; P = .0004 and P less than .00001).

“We found statistically higher free T3 and total T3 levels in patients with [combat-related] PTSD, compared with controls,” said Freddy J.K. Toloza, MD, in an interview during a poster session of the annual meeting of the American Thyroid Association.

However, he noted that there were no overall differences in thyroid-stimulating hormone, free tetraiodothyronine (T4), and total T4 levels between individuals with PTSD and the non-PTSD control participants. In addition, though free and total T3 levels were significantly higher for the overall PTSD cohort than for control participants, the differences were driven by the studies that included combat-exposed individuals.

Dr. Toloza and colleagues included 10 observational studies in their final review and meta-analysis. Five studies looked at war veterans; the others examined individuals who had experienced child abuse or sexual abuse, who were refugees, or who were from the general population.

For inclusion, the studies had to report both mean values and standard deviations for standard thyroid-hormone test values in patients with PTSD, compared with a non-PTSD control group. These included 373 patients with PTSD and 301 control participants. Just under half (47%) were women. None of the studies, wrote the investigators, “compared rates of overt/subclinical thyroid disease between groups.”

There are known links between many endocrine disorders and psychiatric conditions, said Dr. Toloza, but the interplay between disordered thyroid function and neuropsychiatric problems is still being examined. Looking at PTSD is important because it’s estimated that 6%-9% of the U.S. adult population has experienced PTSD over the course of a lifetime.

Levels of thyroid hormones in the systematic review and meta-analysis were still within normal range for the participants with PTSD, acknowledged Dr. Toloza, a research fellow in the division of endocrinology and metabolism at University of Arkansas for Medical Sciences, Little Rock.

However, even though there was no sign of frank thyroid disease in the PTSD population, the elevated T3 levels seen in the analysis are consistent with other studies showing a correlation between higher T3 levels and more-severe PTSD.

It is not known exactly why significant increases in the levels of total and free T3 were seen only in the combat-exposed PTSD population, Dr. Toloza said. “The type of trauma trigger may influence the adaptive responses to stress and might result in diverse thyroid alterations.”

Elevated catecholamine levels, seen in individuals with PTSD, can increase peripheral conversion of T4 to T3, explained Dr. Toloza. Ongoing catecholamine elevation may account for the isolated elevation in T3 levels in the PTSD population. Beta1-adrenergic blockade is an accepted pharmacologic strategy to help alleviate PTSD symptoms.

Dr. Toloza and coinvestigators did not have access to data that would have allowed them to ascertain what types of injuries were sustained by individuals with combat-related PTSD, but he noted in response to a question, that it would be worthwhile to see whether combatants who were blast exposed had different thyroid hormone values than those who were not, because hypothalamic injury is common in blast. This is a future direction Dr. Toloza wishes to pursue.

“Our findings add to the growing literature suggesting that thyroid function changes may be associated with PTSD,” the investigators wrote, but “further research is needed to ascertain the role of thyroid function alterations in PTSD.”

Dr. Toloza reported no financial disclosures or conflicts of interest.

Meeting/Event
Publications
Topics
Sections
Meeting/Event
Meeting/Event

– Higher levels of triiodothyronine (T3) were seen in combatants with PTSD, compared with patients whose PTSD arose from other adverse experiences, according to findings from a systematic review and meta-analysis.

Dr. Freddy J.K. Toloza

Patients with combat-related PTSD had higher levels of free T3 and total T3, compared with control participants who had experienced childhood or sexual abuse or were a wartime refugee without PTSD (FT3, 0.36 pg/mL higher, and total T3, 31.6 ng/mL higher, respectively; P = .0004 and P less than .00001).

“We found statistically higher free T3 and total T3 levels in patients with [combat-related] PTSD, compared with controls,” said Freddy J.K. Toloza, MD, in an interview during a poster session of the annual meeting of the American Thyroid Association.

However, he noted that there were no overall differences in thyroid-stimulating hormone, free tetraiodothyronine (T4), and total T4 levels between individuals with PTSD and the non-PTSD control participants. In addition, though free and total T3 levels were significantly higher for the overall PTSD cohort than for control participants, the differences were driven by the studies that included combat-exposed individuals.

Dr. Toloza and colleagues included 10 observational studies in their final review and meta-analysis. Five studies looked at war veterans; the others examined individuals who had experienced child abuse or sexual abuse, who were refugees, or who were from the general population.

For inclusion, the studies had to report both mean values and standard deviations for standard thyroid-hormone test values in patients with PTSD, compared with a non-PTSD control group. These included 373 patients with PTSD and 301 control participants. Just under half (47%) were women. None of the studies, wrote the investigators, “compared rates of overt/subclinical thyroid disease between groups.”

There are known links between many endocrine disorders and psychiatric conditions, said Dr. Toloza, but the interplay between disordered thyroid function and neuropsychiatric problems is still being examined. Looking at PTSD is important because it’s estimated that 6%-9% of the U.S. adult population has experienced PTSD over the course of a lifetime.

Levels of thyroid hormones in the systematic review and meta-analysis were still within normal range for the participants with PTSD, acknowledged Dr. Toloza, a research fellow in the division of endocrinology and metabolism at University of Arkansas for Medical Sciences, Little Rock.

However, even though there was no sign of frank thyroid disease in the PTSD population, the elevated T3 levels seen in the analysis are consistent with other studies showing a correlation between higher T3 levels and more-severe PTSD.

It is not known exactly why significant increases in the levels of total and free T3 were seen only in the combat-exposed PTSD population, Dr. Toloza said. “The type of trauma trigger may influence the adaptive responses to stress and might result in diverse thyroid alterations.”

Elevated catecholamine levels, seen in individuals with PTSD, can increase peripheral conversion of T4 to T3, explained Dr. Toloza. Ongoing catecholamine elevation may account for the isolated elevation in T3 levels in the PTSD population. Beta1-adrenergic blockade is an accepted pharmacologic strategy to help alleviate PTSD symptoms.

Dr. Toloza and coinvestigators did not have access to data that would have allowed them to ascertain what types of injuries were sustained by individuals with combat-related PTSD, but he noted in response to a question, that it would be worthwhile to see whether combatants who were blast exposed had different thyroid hormone values than those who were not, because hypothalamic injury is common in blast. This is a future direction Dr. Toloza wishes to pursue.

“Our findings add to the growing literature suggesting that thyroid function changes may be associated with PTSD,” the investigators wrote, but “further research is needed to ascertain the role of thyroid function alterations in PTSD.”

Dr. Toloza reported no financial disclosures or conflicts of interest.

– Higher levels of triiodothyronine (T3) were seen in combatants with PTSD, compared with patients whose PTSD arose from other adverse experiences, according to findings from a systematic review and meta-analysis.

Dr. Freddy J.K. Toloza

Patients with combat-related PTSD had higher levels of free T3 and total T3, compared with control participants who had experienced childhood or sexual abuse or were a wartime refugee without PTSD (FT3, 0.36 pg/mL higher, and total T3, 31.6 ng/mL higher, respectively; P = .0004 and P less than .00001).

“We found statistically higher free T3 and total T3 levels in patients with [combat-related] PTSD, compared with controls,” said Freddy J.K. Toloza, MD, in an interview during a poster session of the annual meeting of the American Thyroid Association.

However, he noted that there were no overall differences in thyroid-stimulating hormone, free tetraiodothyronine (T4), and total T4 levels between individuals with PTSD and the non-PTSD control participants. In addition, though free and total T3 levels were significantly higher for the overall PTSD cohort than for control participants, the differences were driven by the studies that included combat-exposed individuals.

Dr. Toloza and colleagues included 10 observational studies in their final review and meta-analysis. Five studies looked at war veterans; the others examined individuals who had experienced child abuse or sexual abuse, who were refugees, or who were from the general population.

For inclusion, the studies had to report both mean values and standard deviations for standard thyroid-hormone test values in patients with PTSD, compared with a non-PTSD control group. These included 373 patients with PTSD and 301 control participants. Just under half (47%) were women. None of the studies, wrote the investigators, “compared rates of overt/subclinical thyroid disease between groups.”

There are known links between many endocrine disorders and psychiatric conditions, said Dr. Toloza, but the interplay between disordered thyroid function and neuropsychiatric problems is still being examined. Looking at PTSD is important because it’s estimated that 6%-9% of the U.S. adult population has experienced PTSD over the course of a lifetime.

Levels of thyroid hormones in the systematic review and meta-analysis were still within normal range for the participants with PTSD, acknowledged Dr. Toloza, a research fellow in the division of endocrinology and metabolism at University of Arkansas for Medical Sciences, Little Rock.

However, even though there was no sign of frank thyroid disease in the PTSD population, the elevated T3 levels seen in the analysis are consistent with other studies showing a correlation between higher T3 levels and more-severe PTSD.

It is not known exactly why significant increases in the levels of total and free T3 were seen only in the combat-exposed PTSD population, Dr. Toloza said. “The type of trauma trigger may influence the adaptive responses to stress and might result in diverse thyroid alterations.”

Elevated catecholamine levels, seen in individuals with PTSD, can increase peripheral conversion of T4 to T3, explained Dr. Toloza. Ongoing catecholamine elevation may account for the isolated elevation in T3 levels in the PTSD population. Beta1-adrenergic blockade is an accepted pharmacologic strategy to help alleviate PTSD symptoms.

Dr. Toloza and coinvestigators did not have access to data that would have allowed them to ascertain what types of injuries were sustained by individuals with combat-related PTSD, but he noted in response to a question, that it would be worthwhile to see whether combatants who were blast exposed had different thyroid hormone values than those who were not, because hypothalamic injury is common in blast. This is a future direction Dr. Toloza wishes to pursue.

“Our findings add to the growing literature suggesting that thyroid function changes may be associated with PTSD,” the investigators wrote, but “further research is needed to ascertain the role of thyroid function alterations in PTSD.”

Dr. Toloza reported no financial disclosures or conflicts of interest.

Publications
Publications
Topics
Article Type
Sections
Article Source

REPORTING FROM ATA 2019

Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Disqus Comments
Default
Use ProPublica
Hide sidebar & use full width
render the right sidebar.

Blood banking experts nab leadership positions at AABB

Article Type
Changed
Mon, 11/04/2019 - 12:59

Beth Shaz, MD, has started her term as president of AABB (formerly the American Association of Blood Banks). Dr. Shaz, who will be president for the 2019-2020 term, was inaugurated during the 2019 AABB annual meeting. She succeeds Michael Murphy, MD, as president.

Dr. Beth Shaz

Dr. Shaz is the executive vice president and chief medical and scientific officer at the New York Blood Center in New York. She is a scientific member of Biomedical Excellence for Safer Transfusion, an associate editor of Transfusion, and an editorial board member of Blood. She received her medical degree from University of Michigan in Ann Arbor and a bachelor’s degree in chemical engineering from Cornell University in Ithaca, N.Y.

AABB also has a new president-elect, David Green. Mr. Green is president and chief executive officer of Vitalant, and he is based in Scottsdale, Ariz. Mr. Green previously led the Vitalant blood services division. Before that, he was president and chief executive officer of Mississippi Valley Regional Blood Center in Davenport, Iowa.

David Green


Mr. Green has served as chairman of Blood Centers of America and president of America’s Blood Centers. He earned a bachelor’s degree from Knox College in Gallesburg, Ill., and a master’s degree from Central Michigan University in Mount Pleasant, Mich.

Dana Devine, PhD, is the new vice president of AABB. Dr. Devine is the chief medical and scientific officer at Canadian Blood Services. She is also a professor at the University of British Columbia in Vancouver and a founding member of the university’s Centre for Blood Research.

Dr. Dana Devine


Dr. Devine’s research is focused on platelet biology, complement biochemistry, coagulation, and blood product processing and storage. Dr. Devine is the editor in chief of Vox Sanguinis. She earned her PhD from Duke University in Durham, N.C.

Steven Sloan, MD, PhD, is the new secretary of AABB. Dr. Sloan is an associate professor at Harvard Medical School in Boston and blood bank medical director at Children’s Hospital Boston.

Dr. Steven Sloan


Dr. Sloan’s research is focused on intracellular signaling and transcription regulation in B cells during immune responses. Dr. Sloan attended medical school at New York University in New York, and completed his residency and fellowship at the Hospital of the University of Pennsylvania in Philadelphia.

Publications
Topics
Sections

Beth Shaz, MD, has started her term as president of AABB (formerly the American Association of Blood Banks). Dr. Shaz, who will be president for the 2019-2020 term, was inaugurated during the 2019 AABB annual meeting. She succeeds Michael Murphy, MD, as president.

Dr. Beth Shaz

Dr. Shaz is the executive vice president and chief medical and scientific officer at the New York Blood Center in New York. She is a scientific member of Biomedical Excellence for Safer Transfusion, an associate editor of Transfusion, and an editorial board member of Blood. She received her medical degree from University of Michigan in Ann Arbor and a bachelor’s degree in chemical engineering from Cornell University in Ithaca, N.Y.

AABB also has a new president-elect, David Green. Mr. Green is president and chief executive officer of Vitalant, and he is based in Scottsdale, Ariz. Mr. Green previously led the Vitalant blood services division. Before that, he was president and chief executive officer of Mississippi Valley Regional Blood Center in Davenport, Iowa.

David Green


Mr. Green has served as chairman of Blood Centers of America and president of America’s Blood Centers. He earned a bachelor’s degree from Knox College in Gallesburg, Ill., and a master’s degree from Central Michigan University in Mount Pleasant, Mich.

Dana Devine, PhD, is the new vice president of AABB. Dr. Devine is the chief medical and scientific officer at Canadian Blood Services. She is also a professor at the University of British Columbia in Vancouver and a founding member of the university’s Centre for Blood Research.

Dr. Dana Devine


Dr. Devine’s research is focused on platelet biology, complement biochemistry, coagulation, and blood product processing and storage. Dr. Devine is the editor in chief of Vox Sanguinis. She earned her PhD from Duke University in Durham, N.C.

Steven Sloan, MD, PhD, is the new secretary of AABB. Dr. Sloan is an associate professor at Harvard Medical School in Boston and blood bank medical director at Children’s Hospital Boston.

Dr. Steven Sloan


Dr. Sloan’s research is focused on intracellular signaling and transcription regulation in B cells during immune responses. Dr. Sloan attended medical school at New York University in New York, and completed his residency and fellowship at the Hospital of the University of Pennsylvania in Philadelphia.

Beth Shaz, MD, has started her term as president of AABB (formerly the American Association of Blood Banks). Dr. Shaz, who will be president for the 2019-2020 term, was inaugurated during the 2019 AABB annual meeting. She succeeds Michael Murphy, MD, as president.

Dr. Beth Shaz

Dr. Shaz is the executive vice president and chief medical and scientific officer at the New York Blood Center in New York. She is a scientific member of Biomedical Excellence for Safer Transfusion, an associate editor of Transfusion, and an editorial board member of Blood. She received her medical degree from University of Michigan in Ann Arbor and a bachelor’s degree in chemical engineering from Cornell University in Ithaca, N.Y.

AABB also has a new president-elect, David Green. Mr. Green is president and chief executive officer of Vitalant, and he is based in Scottsdale, Ariz. Mr. Green previously led the Vitalant blood services division. Before that, he was president and chief executive officer of Mississippi Valley Regional Blood Center in Davenport, Iowa.

David Green


Mr. Green has served as chairman of Blood Centers of America and president of America’s Blood Centers. He earned a bachelor’s degree from Knox College in Gallesburg, Ill., and a master’s degree from Central Michigan University in Mount Pleasant, Mich.

Dana Devine, PhD, is the new vice president of AABB. Dr. Devine is the chief medical and scientific officer at Canadian Blood Services. She is also a professor at the University of British Columbia in Vancouver and a founding member of the university’s Centre for Blood Research.

Dr. Dana Devine


Dr. Devine’s research is focused on platelet biology, complement biochemistry, coagulation, and blood product processing and storage. Dr. Devine is the editor in chief of Vox Sanguinis. She earned her PhD from Duke University in Durham, N.C.

Steven Sloan, MD, PhD, is the new secretary of AABB. Dr. Sloan is an associate professor at Harvard Medical School in Boston and blood bank medical director at Children’s Hospital Boston.

Dr. Steven Sloan


Dr. Sloan’s research is focused on intracellular signaling and transcription regulation in B cells during immune responses. Dr. Sloan attended medical school at New York University in New York, and completed his residency and fellowship at the Hospital of the University of Pennsylvania in Philadelphia.

Publications
Publications
Topics
Article Type
Sections
Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Disqus Comments
Default
Use ProPublica
Hide sidebar & use full width
render the right sidebar.