Frailty increasingly has been seen as a factor in procedural outcomes, including vascular surgery. Nutrition factors among older adults have also become an issue of concern, and older adults undergoing interventions for peripheral arterial disease (PAD) may be at risk for malnutrition. In Friday’s Scientific Session 6, Laura Drudi, MD, of McGill University, Montreal, will report on a study that she and her colleagues performed to determine the association between preprocedural nutritional status and all-cause mortality in patients being treated for PAD.

Dr. Drudi will report on their post hoc analysis of the FRAILED (Frailty Assessment in Lower Extremity arterial Disease) prospective cohort, which comprised two centers recruiting patients during July 1, 2015–Oct.1, 2016. Individuals who underwent vascular interventions for Rutherford class 3 or higher PAD were enrolled.

Trained observers used the Mini Nutritional Assessment (MNA)–Short Form to assess the patients before their procedures. Scores less than or equal to 7 on a 14-point scale were considered malnourished, with scores of 8-11 indicated that patients were at risk for malnutrition.

The modified Essential Frailty Toolset (mEFT) was simultaneously used to measure frailty, with scores of 3 or less on a 5-point scale considered frail. The primary endpoint of the study was all-cause mortality at 12 months after the procedure. Dr. Drudi will report on the results of the cohort of 148 patients (39.2% women) with a mean age of 70 years, and a mean body mass index of 26.7 kg/m². Among these patients, 59 (40%) had claudication and 89 (60%) had chronic limb-threatening ischemia. A total of 98 (66%) patients underwent endovascular revascularization and 50 (34%) underwent open or hybrid revascularization.

Overall, 3% of subjects were classified as malnourished and 33% were at risk for malnutrition. There were 9 (6%) deaths at 12 months. Mini Nutritional Assessment–Short Form scores were modestly but significantly correlated with the mEFT scores (Pearson’s R = –0.48; P less than .001).

”We found that patients with malnourishment or at risk of malnourishment had a 2.5-fold higher crude 1-year mortality, compared with those with normal nutritional status,” said Dr. Drudi.

In the 41% of patients deemed frail, malnutrition was associated with all-cause mortality (adjusted odds ratio, 2.08 per point decrease in MNA scores); whereas in the nonfrail patients, MNA scores had little or no effect on mortality (adjusted OR, 1.05).

“Preprocedural nutritional status is associated with mortality in frail older adults undergoing interventions for PAD. Clinical trials are needed to determine whether pre- and postprocedural nutritional interventions can improve clinical outcomes in these vulnerable individuals,” Dr. Drudi concluded. 

Friday, June 21
1:30-3:00 p.m.
Gaylord National, Potomac A/B
S6: Scientific Session 6: RS16

Frailty increasingly has been seen as a factor in procedural outcomes, including vascular surgery. Nutrition factors among older adults have also become an issue of concern, and older adults undergoing interventions for peripheral arterial disease (PAD) may be at risk for malnutrition. In Friday’s Scientific Session 6, Laura Drudi, MD, of McGill University, Montreal, will report on a study that she and her colleagues performed to determine the association between preprocedural nutritional status and all-cause mortality in patients being treated for PAD.

Dr. Drudi will report on their post hoc analysis of the FRAILED (Frailty Assessment in Lower Extremity arterial Disease) prospective cohort, which comprised two centers recruiting patients during July 1, 2015–Oct.1, 2016. Individuals who underwent vascular interventions for Rutherford class 3 or higher PAD were enrolled.

Trained observers used the Mini Nutritional Assessment (MNA)–Short Form to assess the patients before their procedures. Scores less than or equal to 7 on a 14-point scale were considered malnourished, with scores of 8-11 indicated that patients were at risk for malnutrition.

The modified Essential Frailty Toolset (mEFT) was simultaneously used to measure frailty, with scores of 3 or less on a 5-point scale considered frail. The primary endpoint of the study was all-cause mortality at 12 months after the procedure. Dr. Drudi will report on the results of the cohort of 148 patients (39.2% women) with a mean age of 70 years, and a mean body mass index of 26.7 kg/m². Among these patients, 59 (40%) had claudication and 89 (60%) had chronic limb-threatening ischemia. A total of 98 (66%) patients underwent endovascular revascularization and 50 (34%) underwent open or hybrid revascularization.

Overall, 3% of subjects were classified as malnourished and 33% were at risk for malnutrition. There were 9 (6%) deaths at 12 months. Mini Nutritional Assessment–Short Form scores were modestly but significantly correlated with the mEFT scores (Pearson’s R = –0.48; P less than .001).

”We found that patients with malnourishment or at risk of malnourishment had a 2.5-fold higher crude 1-year mortality, compared with those with normal nutritional status,” said Dr. Drudi.

In the 41% of patients deemed frail, malnutrition was associated with all-cause mortality (adjusted odds ratio, 2.08 per point decrease in MNA scores); whereas in the nonfrail patients, MNA scores had little or no effect on mortality (adjusted OR, 1.05).

“Preprocedural nutritional status is associated with mortality in frail older adults undergoing interventions for PAD. Clinical trials are needed to determine whether pre- and postprocedural nutritional interventions can improve clinical outcomes in these vulnerable individuals,” Dr. Drudi concluded. 

Friday, June 21
1:30-3:00 p.m.
Gaylord National, Potomac A/B
S6: Scientific Session 6: RS16

Frailty increasingly has been seen as a factor in procedural outcomes, including vascular surgery. Nutrition factors among older adults have also become an issue of concern, and older adults undergoing interventions for peripheral arterial disease (PAD) may be at risk for malnutrition. In Friday’s Scientific Session 6, Laura Drudi, MD, of McGill University, Montreal, will report on a study that she and her colleagues performed to determine the association between preprocedural nutritional status and all-cause mortality in patients being treated for PAD.

Dr. Drudi will report on their post hoc analysis of the FRAILED (Frailty Assessment in Lower Extremity arterial Disease) prospective cohort, which comprised two centers recruiting patients during July 1, 2015–Oct.1, 2016. Individuals who underwent vascular interventions for Rutherford class 3 or higher PAD were enrolled.

Trained observers used the Mini Nutritional Assessment (MNA)–Short Form to assess the patients before their procedures. Scores less than or equal to 7 on a 14-point scale were considered malnourished, with scores of 8-11 indicated that patients were at risk for malnutrition.

The modified Essential Frailty Toolset (mEFT) was simultaneously used to measure frailty, with scores of 3 or less on a 5-point scale considered frail. The primary endpoint of the study was all-cause mortality at 12 months after the procedure. Dr. Drudi will report on the results of the cohort of 148 patients (39.2% women) with a mean age of 70 years, and a mean body mass index of 26.7 kg/m². Among these patients, 59 (40%) had claudication and 89 (60%) had chronic limb-threatening ischemia. A total of 98 (66%) patients underwent endovascular revascularization and 50 (34%) underwent open or hybrid revascularization.

Overall, 3% of subjects were classified as malnourished and 33% were at risk for malnutrition. There were 9 (6%) deaths at 12 months. Mini Nutritional Assessment–Short Form scores were modestly but significantly correlated with the mEFT scores (Pearson’s R = –0.48; P less than .001).

”We found that patients with malnourishment or at risk of malnourishment had a 2.5-fold higher crude 1-year mortality, compared with those with normal nutritional status,” said Dr. Drudi.

In the 41% of patients deemed frail, malnutrition was associated with all-cause mortality (adjusted odds ratio, 2.08 per point decrease in MNA scores); whereas in the nonfrail patients, MNA scores had little or no effect on mortality (adjusted OR, 1.05).

“Preprocedural nutritional status is associated with mortality in frail older adults undergoing interventions for PAD. Clinical trials are needed to determine whether pre- and postprocedural nutritional interventions can improve clinical outcomes in these vulnerable individuals,” Dr. Drudi concluded. 

Friday, June 21
1:30-3:00 p.m.
Gaylord National, Potomac A/B
S6: Scientific Session 6: RS16

After months of planning, the day is finally here! Friday evening, 500 people will be living the high life at the  “Vascular Spectacular” gala, celebrating the specialty and each other.

RUSSELLTATEdotCOM/DigitalVision Vectors

But everyone, no matter where they are in the world, may participate in the gala’s Silent Auction, right until it closes this evening.

In fact, bidding on nearly 70 items began in late May. Here’s how to join in the fun:

• Sign up on vam19gala.givesmart.com and peruse the selections.

• Place a bid. All bidders will be identified by name.

• If desired, monitor the bidding, by setting up notifications to learn when someone else ups the ante.

• Continue to bid until the auction closes during the gala itself.

• Wait for your prizes to be mailed to you — and know you have contributed to continuing the important work of the SVS Foundation.

The live auction takes place at the gala in its entirety and only those present can bid.

The Gala Committee is comprised of Drs. Cynthia Shortell and Benjamin Starnes, cochairs; and Enrico Ascher, William Jordan Jr., Melina Kibbe, Richard Lynn, Matthew Mell, Ben Pearce, Amy Reed, Russell Samson, William Shutze, Mal Sheahan, Maureen Sheehan and Anton Sidawy. 

What’s available? Dr. Clem Darling’s “Darling Magical Whiskery Tour” to sample top-tier whiskey in the mutually agreed-upon city; a stay in Lake Tahoe, a beach-front condo in Florida and a spacious townhome at the entrance to Rehoboth Beach, Del.; wildlife photos; fine art; jewelry; fine wine; portraits for people and pets; sports-related items; Maui Jim sunglasses; free admission to attractions from coast to coast and more. There are even one-on-one sessions with a number of vascular surgeons. 

In addition, Cydar Medical is offering a one-year subscription to Cydar EV Fusion Imaging, the world’s first AI-powered image fusion platform, valued at $50,000.  

All proceeds benefit the SVS Foundation.
 

After months of planning, the day is finally here! Friday evening, 500 people will be living the high life at the  “Vascular Spectacular” gala, celebrating the specialty and each other.

RUSSELLTATEdotCOM/DigitalVision Vectors

But everyone, no matter where they are in the world, may participate in the gala’s Silent Auction, right until it closes this evening.

In fact, bidding on nearly 70 items began in late May. Here’s how to join in the fun:

• Sign up on vam19gala.givesmart.com and peruse the selections.

• Place a bid. All bidders will be identified by name.

• If desired, monitor the bidding, by setting up notifications to learn when someone else ups the ante.

• Continue to bid until the auction closes during the gala itself.

• Wait for your prizes to be mailed to you — and know you have contributed to continuing the important work of the SVS Foundation.

The live auction takes place at the gala in its entirety and only those present can bid.

The Gala Committee is comprised of Drs. Cynthia Shortell and Benjamin Starnes, cochairs; and Enrico Ascher, William Jordan Jr., Melina Kibbe, Richard Lynn, Matthew Mell, Ben Pearce, Amy Reed, Russell Samson, William Shutze, Mal Sheahan, Maureen Sheehan and Anton Sidawy. 

What’s available? Dr. Clem Darling’s “Darling Magical Whiskery Tour” to sample top-tier whiskey in the mutually agreed-upon city; a stay in Lake Tahoe, a beach-front condo in Florida and a spacious townhome at the entrance to Rehoboth Beach, Del.; wildlife photos; fine art; jewelry; fine wine; portraits for people and pets; sports-related items; Maui Jim sunglasses; free admission to attractions from coast to coast and more. There are even one-on-one sessions with a number of vascular surgeons. 

In addition, Cydar Medical is offering a one-year subscription to Cydar EV Fusion Imaging, the world’s first AI-powered image fusion platform, valued at $50,000.  

All proceeds benefit the SVS Foundation.
 

After months of planning, the day is finally here! Friday evening, 500 people will be living the high life at the  “Vascular Spectacular” gala, celebrating the specialty and each other.

RUSSELLTATEdotCOM/DigitalVision Vectors

But everyone, no matter where they are in the world, may participate in the gala’s Silent Auction, right until it closes this evening.

In fact, bidding on nearly 70 items began in late May. Here’s how to join in the fun:

• Sign up on vam19gala.givesmart.com and peruse the selections.

• Place a bid. All bidders will be identified by name.

• If desired, monitor the bidding, by setting up notifications to learn when someone else ups the ante.

• Continue to bid until the auction closes during the gala itself.

• Wait for your prizes to be mailed to you — and know you have contributed to continuing the important work of the SVS Foundation.

The live auction takes place at the gala in its entirety and only those present can bid.

The Gala Committee is comprised of Drs. Cynthia Shortell and Benjamin Starnes, cochairs; and Enrico Ascher, William Jordan Jr., Melina Kibbe, Richard Lynn, Matthew Mell, Ben Pearce, Amy Reed, Russell Samson, William Shutze, Mal Sheahan, Maureen Sheehan and Anton Sidawy. 

What’s available? Dr. Clem Darling’s “Darling Magical Whiskery Tour” to sample top-tier whiskey in the mutually agreed-upon city; a stay in Lake Tahoe, a beach-front condo in Florida and a spacious townhome at the entrance to Rehoboth Beach, Del.; wildlife photos; fine art; jewelry; fine wine; portraits for people and pets; sports-related items; Maui Jim sunglasses; free admission to attractions from coast to coast and more. There are even one-on-one sessions with a number of vascular surgeons. 

In addition, Cydar Medical is offering a one-year subscription to Cydar EV Fusion Imaging, the world’s first AI-powered image fusion platform, valued at $50,000.  

All proceeds benefit the SVS Foundation.
 

Starting a vascular surgery integrated program or fellowship can be a daunting process. There exist a number of misconceptions about required case volume, program affiliations, and required number of faculty.

Requirements for creating such programs have recently been lightened. And the SVS and the Association of Program Directors in Vascular Surgery have a number of initiatives in place to help.

SVS will host an informational session for anyone interested in starting a program from 9:30 to 10:30 a.m. Friday, June 14, in National Harbor 4. Most of the session will be interactive, with experienced program directors offering participants useful information and practical advice. 

Starting a vascular surgery integrated program or fellowship can be a daunting process. There exist a number of misconceptions about required case volume, program affiliations, and required number of faculty.

Requirements for creating such programs have recently been lightened. And the SVS and the Association of Program Directors in Vascular Surgery have a number of initiatives in place to help.

SVS will host an informational session for anyone interested in starting a program from 9:30 to 10:30 a.m. Friday, June 14, in National Harbor 4. Most of the session will be interactive, with experienced program directors offering participants useful information and practical advice. 

Starting a vascular surgery integrated program or fellowship can be a daunting process. There exist a number of misconceptions about required case volume, program affiliations, and required number of faculty.

Requirements for creating such programs have recently been lightened. And the SVS and the Association of Program Directors in Vascular Surgery have a number of initiatives in place to help.

SVS will host an informational session for anyone interested in starting a program from 9:30 to 10:30 a.m. Friday, June 14, in National Harbor 4. Most of the session will be interactive, with experienced program directors offering participants useful information and practical advice. 

CHICAGO – Olanzapine plus aprepitant, palonosetron, and dexamethasone (APD) can be considered a new standard antiemetic therapy for patients receiving cisplatin-based chemotherapy, according to a speaker at the annual meeting of the American Society for Clinical Oncology.

A 5 mg dose of olanzapine plus APD produced significantly higher complete response (CR) rates than APD plus placebo in a phase 3 trial, said Hironobu Hashimoto, BPharm, of the National Cancer Center Hospital in Tokyo.

In addition, olanzapine plus APD had a significantly longer time to treatment failure and produced higher rates of complete control and total control. However, rates of somnolence, dizziness, and dry mouth were significantly higher with olanzapine plus APD.

In the phase 3 J-FORCE study, Mr. Hashimoto and his colleagues evaluated olanzapine at 5 mg plus standard antiemetic therapy (APD) for the prevention of chemotherapy-induced nausea and vomiting.

The trial enrolled 710 patients, ages 22-75 years, who had malignant solid tumors and were receiving cisplatin-based chemotherapy for the first time. The patients were randomized to olanzapine plus APD or APD plus placebo.

There were 354 patients evaluable for efficacy in the olanzapine arm and 351 in the placebo arm. The primary endpoint was CR, which was defined as no vomiting and no rescue medications, in the delayed phase (24 hours to 120 hours).

The CR rate in the delayed phase was 79% in the olanzapine arm and 66% in the placebo arm (P less than .001). The CR rate in the acute phase (0 to 24 hours) was 95% and 89%, respectively (P equal to .002), and the overall CR rate was 78% and 64%, respectively (P less than .001).

The time to treatment failure was significantly longer in the olanzapine arm (P less than .001).

The rate of complete control in the overall period (0 to 120 hours) was 76% in the olanzapine arm and 61% in the placebo arm (P less than .001). Complete control was defined as no emesis, no rescue medication, and no nausea or low-grade nausea.

The rate of total control in the overall period was 59% in the olanzapine arm and 48% in the placebo arm (P = .005). Total control was defined as no emesis, no rescue medication, and no nausea.

Treatment-related adverse events (in the olanzapine and placebo arms, respectively) included constipation (15% and 11%), hiccups (10% and 6%), somnolence (43% and 33%), insomnia (5% and 7%), dizziness (8% and 3%), and dry mouth (21% and 9%).

Adverse events that occurred significantly more often with olanzapine were somnolence (P = .011), dizziness (P = .004), and dry mouth (P  less than .001).

This study was sponsored by the Japan Agency for Medical Research and Development (AMED). Mr. Hashimoto said he had nothing to disclose. Other investigators involved in this study disclosed relationships with numerous pharmaceutical companies.

jensmith@mdedge.com

SOURCE: Hashimoto H et al. ASCO 2019. Abstract 11503.

CHICAGO – Olanzapine plus aprepitant, palonosetron, and dexamethasone (APD) can be considered a new standard antiemetic therapy for patients receiving cisplatin-based chemotherapy, according to a speaker at the annual meeting of the American Society for Clinical Oncology.

A 5 mg dose of olanzapine plus APD produced significantly higher complete response (CR) rates than APD plus placebo in a phase 3 trial, said Hironobu Hashimoto, BPharm, of the National Cancer Center Hospital in Tokyo.

In addition, olanzapine plus APD had a significantly longer time to treatment failure and produced higher rates of complete control and total control. However, rates of somnolence, dizziness, and dry mouth were significantly higher with olanzapine plus APD.

In the phase 3 J-FORCE study, Mr. Hashimoto and his colleagues evaluated olanzapine at 5 mg plus standard antiemetic therapy (APD) for the prevention of chemotherapy-induced nausea and vomiting.

The trial enrolled 710 patients, ages 22-75 years, who had malignant solid tumors and were receiving cisplatin-based chemotherapy for the first time. The patients were randomized to olanzapine plus APD or APD plus placebo.

There were 354 patients evaluable for efficacy in the olanzapine arm and 351 in the placebo arm. The primary endpoint was CR, which was defined as no vomiting and no rescue medications, in the delayed phase (24 hours to 120 hours).

The CR rate in the delayed phase was 79% in the olanzapine arm and 66% in the placebo arm (P less than .001). The CR rate in the acute phase (0 to 24 hours) was 95% and 89%, respectively (P equal to .002), and the overall CR rate was 78% and 64%, respectively (P less than .001).

The time to treatment failure was significantly longer in the olanzapine arm (P less than .001).

The rate of complete control in the overall period (0 to 120 hours) was 76% in the olanzapine arm and 61% in the placebo arm (P less than .001). Complete control was defined as no emesis, no rescue medication, and no nausea or low-grade nausea.

The rate of total control in the overall period was 59% in the olanzapine arm and 48% in the placebo arm (P = .005). Total control was defined as no emesis, no rescue medication, and no nausea.

Treatment-related adverse events (in the olanzapine and placebo arms, respectively) included constipation (15% and 11%), hiccups (10% and 6%), somnolence (43% and 33%), insomnia (5% and 7%), dizziness (8% and 3%), and dry mouth (21% and 9%).

Adverse events that occurred significantly more often with olanzapine were somnolence (P = .011), dizziness (P = .004), and dry mouth (P  less than .001).

This study was sponsored by the Japan Agency for Medical Research and Development (AMED). Mr. Hashimoto said he had nothing to disclose. Other investigators involved in this study disclosed relationships with numerous pharmaceutical companies.

jensmith@mdedge.com

SOURCE: Hashimoto H et al. ASCO 2019. Abstract 11503.

CHICAGO – Olanzapine plus aprepitant, palonosetron, and dexamethasone (APD) can be considered a new standard antiemetic therapy for patients receiving cisplatin-based chemotherapy, according to a speaker at the annual meeting of the American Society for Clinical Oncology.

A 5 mg dose of olanzapine plus APD produced significantly higher complete response (CR) rates than APD plus placebo in a phase 3 trial, said Hironobu Hashimoto, BPharm, of the National Cancer Center Hospital in Tokyo.

In addition, olanzapine plus APD had a significantly longer time to treatment failure and produced higher rates of complete control and total control. However, rates of somnolence, dizziness, and dry mouth were significantly higher with olanzapine plus APD.

In the phase 3 J-FORCE study, Mr. Hashimoto and his colleagues evaluated olanzapine at 5 mg plus standard antiemetic therapy (APD) for the prevention of chemotherapy-induced nausea and vomiting.

The trial enrolled 710 patients, ages 22-75 years, who had malignant solid tumors and were receiving cisplatin-based chemotherapy for the first time. The patients were randomized to olanzapine plus APD or APD plus placebo.

There were 354 patients evaluable for efficacy in the olanzapine arm and 351 in the placebo arm. The primary endpoint was CR, which was defined as no vomiting and no rescue medications, in the delayed phase (24 hours to 120 hours).

The CR rate in the delayed phase was 79% in the olanzapine arm and 66% in the placebo arm (P less than .001). The CR rate in the acute phase (0 to 24 hours) was 95% and 89%, respectively (P equal to .002), and the overall CR rate was 78% and 64%, respectively (P less than .001).

The time to treatment failure was significantly longer in the olanzapine arm (P less than .001).

The rate of complete control in the overall period (0 to 120 hours) was 76% in the olanzapine arm and 61% in the placebo arm (P less than .001). Complete control was defined as no emesis, no rescue medication, and no nausea or low-grade nausea.

The rate of total control in the overall period was 59% in the olanzapine arm and 48% in the placebo arm (P = .005). Total control was defined as no emesis, no rescue medication, and no nausea.

Treatment-related adverse events (in the olanzapine and placebo arms, respectively) included constipation (15% and 11%), hiccups (10% and 6%), somnolence (43% and 33%), insomnia (5% and 7%), dizziness (8% and 3%), and dry mouth (21% and 9%).

Adverse events that occurred significantly more often with olanzapine were somnolence (P = .011), dizziness (P = .004), and dry mouth (P  less than .001).

This study was sponsored by the Japan Agency for Medical Research and Development (AMED). Mr. Hashimoto said he had nothing to disclose. Other investigators involved in this study disclosed relationships with numerous pharmaceutical companies.

jensmith@mdedge.com

SOURCE: Hashimoto H et al. ASCO 2019. Abstract 11503.

Got an idea on how to reduce administrative burden to help reduce the cost of delivering health care? The Centers for Medicare & Medicaid Services wants to hear from you.

In a request for information published June 6, the agency seeks parties across the health care spectrum “to recommend further changes to rules, policies, and procedures that would shift more of clinicians’ time and our health care system’s resources from needless paperwork to high-quality care that improves patient health,” CMS officials said in a statement.

The request for information, part of the agency’s Patients Over Paperwork initiative, seeks suggestions on how to reduce hassles associated with reporting and documentation, coding, prior authorization, rural issues, dual eligible patients, enrollment/eligibility determination and the agency’s own process for issuing regulations and policies.

“Patients over Paperwork has made great inroads in clearing away needlessly complex, outdated, or duplicative requirements that drain clinicians’ time but contribute little to quality of care or patient health,” CMS Administrator Seema Verma said in a statement. “Our goal is to ensure that doctors are spending more time with their patients and less time in administrative tasks.”

The request for information is scheduled to published in the Federal Register on June 11. Comments are due to the agency on Aug. 12. Comments can be made at www.regulations.gov and should refer to file code CMS-6082-NC.
 

gtwachtman@mdedge.com

SOURCE: Federal Register, CMS-6082-NC, https://federalregister.gov/d/2019-12215.

Got an idea on how to reduce administrative burden to help reduce the cost of delivering health care? The Centers for Medicare & Medicaid Services wants to hear from you.

In a request for information published June 6, the agency seeks parties across the health care spectrum “to recommend further changes to rules, policies, and procedures that would shift more of clinicians’ time and our health care system’s resources from needless paperwork to high-quality care that improves patient health,” CMS officials said in a statement.

The request for information, part of the agency’s Patients Over Paperwork initiative, seeks suggestions on how to reduce hassles associated with reporting and documentation, coding, prior authorization, rural issues, dual eligible patients, enrollment/eligibility determination and the agency’s own process for issuing regulations and policies.

“Patients over Paperwork has made great inroads in clearing away needlessly complex, outdated, or duplicative requirements that drain clinicians’ time but contribute little to quality of care or patient health,” CMS Administrator Seema Verma said in a statement. “Our goal is to ensure that doctors are spending more time with their patients and less time in administrative tasks.”

The request for information is scheduled to published in the Federal Register on June 11. Comments are due to the agency on Aug. 12. Comments can be made at www.regulations.gov and should refer to file code CMS-6082-NC.
 

gtwachtman@mdedge.com

SOURCE: Federal Register, CMS-6082-NC, https://federalregister.gov/d/2019-12215.

Got an idea on how to reduce administrative burden to help reduce the cost of delivering health care? The Centers for Medicare & Medicaid Services wants to hear from you.

In a request for information published June 6, the agency seeks parties across the health care spectrum “to recommend further changes to rules, policies, and procedures that would shift more of clinicians’ time and our health care system’s resources from needless paperwork to high-quality care that improves patient health,” CMS officials said in a statement.

The request for information, part of the agency’s Patients Over Paperwork initiative, seeks suggestions on how to reduce hassles associated with reporting and documentation, coding, prior authorization, rural issues, dual eligible patients, enrollment/eligibility determination and the agency’s own process for issuing regulations and policies.

“Patients over Paperwork has made great inroads in clearing away needlessly complex, outdated, or duplicative requirements that drain clinicians’ time but contribute little to quality of care or patient health,” CMS Administrator Seema Verma said in a statement. “Our goal is to ensure that doctors are spending more time with their patients and less time in administrative tasks.”

The request for information is scheduled to published in the Federal Register on June 11. Comments are due to the agency on Aug. 12. Comments can be made at www.regulations.gov and should refer to file code CMS-6082-NC.
 

gtwachtman@mdedge.com

SOURCE: Federal Register, CMS-6082-NC, https://federalregister.gov/d/2019-12215.

SAN FRANCISCO – Vitamin D supplementation did not significantly reduce the risk of progression from prediabetes to type 2 diabetes, according to the landmark D2d study.

A possible reason why the observed reduction was not statistically significant was that most participants already had acceptable levels of vitamin D. Still, the intervention “did not significantly reduce the risk [of diabetes],” Anastassios G. Pittas, MD, professor of medicine at Tufts Medical Center, Boston, said at the annual scientific sessions of the American Diabetes Association.

Vitamin D supplementation has been a hot topic on a range of medical fronts. As a 2016 report noted, “low vitamin D levels are also associated with hypertension, cancer, and cardiovascular disease. In addition, [diabetes] and chronic kidney disease (CKD) are also related to vitamin D levels. Vitamin D deficiency has been linked to onset and progression of [diabetes],” (World J Diabetes. 2016;7[5]:89-100).

However, as the report noted, “evidence regarding vitamin D levels and [diabetes] is contradictory, and well-controlled studies are needed.”

For the D2d study, which was coordinated out of the division of endocrinology at Tufts Medical Center, Dr. Pittas and associates recruited 2,423 patients who were considered to have prediabetes, with at least 2 of 3 ADA criteria: fasting plasma glucose level of 100-125 mg/dL; plasma glucose level 2 hours after a 75-g oral glucose load of 140-199 mg/dL; and hemoglobin A_1c (HbA_1c) level of 5.7%-6.4%.

All of the patients were at least 30 years old with the exception of American Indians, Alaska Natives, Native Hawaiians and other Pacific Islanders who were allowed to be aged 25-30 years. About 22% had low vitamin D levels.

The mean age of the patients was 60 years, mean body mass index was 32, 45% were women, and 33% were non-white. The trial was powered to show a reduction of 25% or more in diabetes risk with vitamin D.

The researchers randomly assigned 1,211 patients to take a once-daily capsule of vitamin D3 (cholecalciferol; 4,000 IU per day); 1,212 received a placebo.

Patients in the vitamin D group greatly boosted their mean serum 25-hydroxyvitamin D levels, from 27.7 ng/mL at baseline to 54.3 ng/mL at 24 months. In contrast, those in the placebo group saw little change, going from 28.2 ng/mL at baseline to 28.8 ng/mL at 24 months.

At a median follow-up of 2.5 years, with 99% of the study participants remaining in the trial, 616 patients developed diabetes (293 in the vitamin D group, 323 in the placebo group).

The risk was lower in the vitamin D group although the difference was not statistically significant. An analysis revealed no clear differences in any of the subgroups (race, age, body mass index, latitude-based geographic location, calcium supplement intake, and others).

However, a post hoc analysis of patients with vitamin D deficiency, which is defined by the National Academy of Medicine as having a 25-hydroxyvitamin D level of less than 12 ng/mL, showed that the vitamin D group had a 62% reduction in risk of diabetes, compared with placebo.

“Response to a nutritional intervention depends on nutritional status at baseline. Thus, if vitamin D has an effect on diabetes prevention, then people with lower levels of serum 25-hydroxyvitamin D would be expected to have a larger effect from supplementation than would those with higher baseline levels,” Dr. Pittas said.

SOURCE: Pittas AG et al. ADA 2019

This article was updated on 6/18/2019.

SAN FRANCISCO – Vitamin D supplementation did not significantly reduce the risk of progression from prediabetes to type 2 diabetes, according to the landmark D2d study.

A possible reason why the observed reduction was not statistically significant was that most participants already had acceptable levels of vitamin D. Still, the intervention “did not significantly reduce the risk [of diabetes],” Anastassios G. Pittas, MD, professor of medicine at Tufts Medical Center, Boston, said at the annual scientific sessions of the American Diabetes Association.

Vitamin D supplementation has been a hot topic on a range of medical fronts. As a 2016 report noted, “low vitamin D levels are also associated with hypertension, cancer, and cardiovascular disease. In addition, [diabetes] and chronic kidney disease (CKD) are also related to vitamin D levels. Vitamin D deficiency has been linked to onset and progression of [diabetes],” (World J Diabetes. 2016;7[5]:89-100).

However, as the report noted, “evidence regarding vitamin D levels and [diabetes] is contradictory, and well-controlled studies are needed.”

For the D2d study, which was coordinated out of the division of endocrinology at Tufts Medical Center, Dr. Pittas and associates recruited 2,423 patients who were considered to have prediabetes, with at least 2 of 3 ADA criteria: fasting plasma glucose level of 100-125 mg/dL; plasma glucose level 2 hours after a 75-g oral glucose load of 140-199 mg/dL; and hemoglobin A_1c (HbA_1c) level of 5.7%-6.4%.

All of the patients were at least 30 years old with the exception of American Indians, Alaska Natives, Native Hawaiians and other Pacific Islanders who were allowed to be aged 25-30 years. About 22% had low vitamin D levels.

The mean age of the patients was 60 years, mean body mass index was 32, 45% were women, and 33% were non-white. The trial was powered to show a reduction of 25% or more in diabetes risk with vitamin D.

The researchers randomly assigned 1,211 patients to take a once-daily capsule of vitamin D3 (cholecalciferol; 4,000 IU per day); 1,212 received a placebo.

Patients in the vitamin D group greatly boosted their mean serum 25-hydroxyvitamin D levels, from 27.7 ng/mL at baseline to 54.3 ng/mL at 24 months. In contrast, those in the placebo group saw little change, going from 28.2 ng/mL at baseline to 28.8 ng/mL at 24 months.

At a median follow-up of 2.5 years, with 99% of the study participants remaining in the trial, 616 patients developed diabetes (293 in the vitamin D group, 323 in the placebo group).

The risk was lower in the vitamin D group although the difference was not statistically significant. An analysis revealed no clear differences in any of the subgroups (race, age, body mass index, latitude-based geographic location, calcium supplement intake, and others).

However, a post hoc analysis of patients with vitamin D deficiency, which is defined by the National Academy of Medicine as having a 25-hydroxyvitamin D level of less than 12 ng/mL, showed that the vitamin D group had a 62% reduction in risk of diabetes, compared with placebo.

“Response to a nutritional intervention depends on nutritional status at baseline. Thus, if vitamin D has an effect on diabetes prevention, then people with lower levels of serum 25-hydroxyvitamin D would be expected to have a larger effect from supplementation than would those with higher baseline levels,” Dr. Pittas said.

SOURCE: Pittas AG et al. ADA 2019

This article was updated on 6/18/2019.

SAN FRANCISCO – Vitamin D supplementation did not significantly reduce the risk of progression from prediabetes to type 2 diabetes, according to the landmark D2d study.

A possible reason why the observed reduction was not statistically significant was that most participants already had acceptable levels of vitamin D. Still, the intervention “did not significantly reduce the risk [of diabetes],” Anastassios G. Pittas, MD, professor of medicine at Tufts Medical Center, Boston, said at the annual scientific sessions of the American Diabetes Association.

Vitamin D supplementation has been a hot topic on a range of medical fronts. As a 2016 report noted, “low vitamin D levels are also associated with hypertension, cancer, and cardiovascular disease. In addition, [diabetes] and chronic kidney disease (CKD) are also related to vitamin D levels. Vitamin D deficiency has been linked to onset and progression of [diabetes],” (World J Diabetes. 2016;7[5]:89-100).

However, as the report noted, “evidence regarding vitamin D levels and [diabetes] is contradictory, and well-controlled studies are needed.”

For the D2d study, which was coordinated out of the division of endocrinology at Tufts Medical Center, Dr. Pittas and associates recruited 2,423 patients who were considered to have prediabetes, with at least 2 of 3 ADA criteria: fasting plasma glucose level of 100-125 mg/dL; plasma glucose level 2 hours after a 75-g oral glucose load of 140-199 mg/dL; and hemoglobin A_1c (HbA_1c) level of 5.7%-6.4%.

All of the patients were at least 30 years old with the exception of American Indians, Alaska Natives, Native Hawaiians and other Pacific Islanders who were allowed to be aged 25-30 years. About 22% had low vitamin D levels.

The mean age of the patients was 60 years, mean body mass index was 32, 45% were women, and 33% were non-white. The trial was powered to show a reduction of 25% or more in diabetes risk with vitamin D.

The researchers randomly assigned 1,211 patients to take a once-daily capsule of vitamin D3 (cholecalciferol; 4,000 IU per day); 1,212 received a placebo.

Patients in the vitamin D group greatly boosted their mean serum 25-hydroxyvitamin D levels, from 27.7 ng/mL at baseline to 54.3 ng/mL at 24 months. In contrast, those in the placebo group saw little change, going from 28.2 ng/mL at baseline to 28.8 ng/mL at 24 months.

At a median follow-up of 2.5 years, with 99% of the study participants remaining in the trial, 616 patients developed diabetes (293 in the vitamin D group, 323 in the placebo group).

The risk was lower in the vitamin D group although the difference was not statistically significant. An analysis revealed no clear differences in any of the subgroups (race, age, body mass index, latitude-based geographic location, calcium supplement intake, and others).

However, a post hoc analysis of patients with vitamin D deficiency, which is defined by the National Academy of Medicine as having a 25-hydroxyvitamin D level of less than 12 ng/mL, showed that the vitamin D group had a 62% reduction in risk of diabetes, compared with placebo.

“Response to a nutritional intervention depends on nutritional status at baseline. Thus, if vitamin D has an effect on diabetes prevention, then people with lower levels of serum 25-hydroxyvitamin D would be expected to have a larger effect from supplementation than would those with higher baseline levels,” Dr. Pittas said.

SOURCE: Pittas AG et al. ADA 2019

This article was updated on 6/18/2019.

Work-related pain and disability have been reported in the literature among various surgical specialties and can influence surgeon productivity and burnout. In Friday’s Scientific Session 4, Max Wohlauer, MD, of the University of Colorado, Denver, will report on a study that he and his colleagues performed to identify the prevalence and severity of pain symptoms in vascular surgeons.

Dr. Wohlauer will report on their survey, which was emailed to 2,910 members of the Society for Vascular Surgery. Pain was reported using the 0–10 Borg’s CR-10 scale, with 0 = no pain, 3 = moderate, 4 = somewhat strong, 5 = strong, and 10 = maximum pain.

Dr. Wohlauer and his colleagues received responses from 775 (26.6%) of the vascular surgeons; with retirees excluded from the study. Among those actively working, the mean age was 51.4 years, and the surgeons had a mean of 17.2 years in practice; 83.6% of the respondents were men.

According to the survey, after a full day of open surgery, the majority of vascular surgeons reported being in a somewhat strong amount of pain (mean score 4.4), while after a full day of endovascular procedures, most vascular surgeons reported being in a moderate amount of pain (mean score 3.9).

Pain following a day of open surgery was highest in the neck (45%) and lower back (39%);after endovascular procedures, respondents reported pain to be most severe in the lower back (44%) and neck (24%). Surgeons performing endovenous procedures report the lowest pain scores (mean 2.0).

In terms of treatment, 242 (36.9%) vascular surgeons reported having sought medical care for work-related issues, with 61 (8.3%) taking time away from the operating room. A total of 72 surgeons (10%) reported requiring surgery and other procedures (including traction), and 22 (3%) had been placed on short- or long-term disability.

In total, 193 (26.2%) of surgeons report pain severe enough that it interfered with sleep, with 9 (1.2%) leaving their career because of disability from work-related pain, and high work-related physical discomfort was significantly associated with Maslach Burnout Inventory single-item measure of burnout for open surgery, endovascular, and endovenous procedures, according to Dr. Wohlauer.

Altogether, 334 (50.6%) of the vascular surgeons surveyed reported that physical discomfort will affect the longevity of their career. This is borne out by the fact that, of the 39 respondents no longer practicing surgery, 26% (10) retired because of disability from work-related pain.

“Our study shows that the majority of practicing vascular surgeons are in pain after a day of operating. Work-related disability is significantly diminishing the workforce. Addressing work-related pain serves to improve the lives and careers of vascular surgeons, while enhancing surgical longevity would help address the current national workforce shortage,” Dr. Wohlauer concluded. 

Friday
8-9:30 a.m.
Gaylor National, Potomac A/B
S4: Scientific Session 4: SS12

Work-related pain and disability have been reported in the literature among various surgical specialties and can influence surgeon productivity and burnout. In Friday’s Scientific Session 4, Max Wohlauer, MD, of the University of Colorado, Denver, will report on a study that he and his colleagues performed to identify the prevalence and severity of pain symptoms in vascular surgeons.

Dr. Wohlauer will report on their survey, which was emailed to 2,910 members of the Society for Vascular Surgery. Pain was reported using the 0–10 Borg’s CR-10 scale, with 0 = no pain, 3 = moderate, 4 = somewhat strong, 5 = strong, and 10 = maximum pain.

Dr. Wohlauer and his colleagues received responses from 775 (26.6%) of the vascular surgeons; with retirees excluded from the study. Among those actively working, the mean age was 51.4 years, and the surgeons had a mean of 17.2 years in practice; 83.6% of the respondents were men.

According to the survey, after a full day of open surgery, the majority of vascular surgeons reported being in a somewhat strong amount of pain (mean score 4.4), while after a full day of endovascular procedures, most vascular surgeons reported being in a moderate amount of pain (mean score 3.9).

Pain following a day of open surgery was highest in the neck (45%) and lower back (39%);after endovascular procedures, respondents reported pain to be most severe in the lower back (44%) and neck (24%). Surgeons performing endovenous procedures report the lowest pain scores (mean 2.0).

In terms of treatment, 242 (36.9%) vascular surgeons reported having sought medical care for work-related issues, with 61 (8.3%) taking time away from the operating room. A total of 72 surgeons (10%) reported requiring surgery and other procedures (including traction), and 22 (3%) had been placed on short- or long-term disability.

In total, 193 (26.2%) of surgeons report pain severe enough that it interfered with sleep, with 9 (1.2%) leaving their career because of disability from work-related pain, and high work-related physical discomfort was significantly associated with Maslach Burnout Inventory single-item measure of burnout for open surgery, endovascular, and endovenous procedures, according to Dr. Wohlauer.

Altogether, 334 (50.6%) of the vascular surgeons surveyed reported that physical discomfort will affect the longevity of their career. This is borne out by the fact that, of the 39 respondents no longer practicing surgery, 26% (10) retired because of disability from work-related pain.

“Our study shows that the majority of practicing vascular surgeons are in pain after a day of operating. Work-related disability is significantly diminishing the workforce. Addressing work-related pain serves to improve the lives and careers of vascular surgeons, while enhancing surgical longevity would help address the current national workforce shortage,” Dr. Wohlauer concluded. 

Friday
8-9:30 a.m.
Gaylor National, Potomac A/B
S4: Scientific Session 4: SS12

Work-related pain and disability have been reported in the literature among various surgical specialties and can influence surgeon productivity and burnout. In Friday’s Scientific Session 4, Max Wohlauer, MD, of the University of Colorado, Denver, will report on a study that he and his colleagues performed to identify the prevalence and severity of pain symptoms in vascular surgeons.

Dr. Wohlauer will report on their survey, which was emailed to 2,910 members of the Society for Vascular Surgery. Pain was reported using the 0–10 Borg’s CR-10 scale, with 0 = no pain, 3 = moderate, 4 = somewhat strong, 5 = strong, and 10 = maximum pain.

Dr. Wohlauer and his colleagues received responses from 775 (26.6%) of the vascular surgeons; with retirees excluded from the study. Among those actively working, the mean age was 51.4 years, and the surgeons had a mean of 17.2 years in practice; 83.6% of the respondents were men.

According to the survey, after a full day of open surgery, the majority of vascular surgeons reported being in a somewhat strong amount of pain (mean score 4.4), while after a full day of endovascular procedures, most vascular surgeons reported being in a moderate amount of pain (mean score 3.9).

Pain following a day of open surgery was highest in the neck (45%) and lower back (39%);after endovascular procedures, respondents reported pain to be most severe in the lower back (44%) and neck (24%). Surgeons performing endovenous procedures report the lowest pain scores (mean 2.0).

In terms of treatment, 242 (36.9%) vascular surgeons reported having sought medical care for work-related issues, with 61 (8.3%) taking time away from the operating room. A total of 72 surgeons (10%) reported requiring surgery and other procedures (including traction), and 22 (3%) had been placed on short- or long-term disability.

In total, 193 (26.2%) of surgeons report pain severe enough that it interfered with sleep, with 9 (1.2%) leaving their career because of disability from work-related pain, and high work-related physical discomfort was significantly associated with Maslach Burnout Inventory single-item measure of burnout for open surgery, endovascular, and endovenous procedures, according to Dr. Wohlauer.

Altogether, 334 (50.6%) of the vascular surgeons surveyed reported that physical discomfort will affect the longevity of their career. This is borne out by the fact that, of the 39 respondents no longer practicing surgery, 26% (10) retired because of disability from work-related pain.

“Our study shows that the majority of practicing vascular surgeons are in pain after a day of operating. Work-related disability is significantly diminishing the workforce. Addressing work-related pain serves to improve the lives and careers of vascular surgeons, while enhancing surgical longevity would help address the current national workforce shortage,” Dr. Wohlauer concluded. 

Friday
8-9:30 a.m.
Gaylor National, Potomac A/B
S4: Scientific Session 4: SS12

Society for Vascular Surgery President Michel S. Makaroun, MD, will reflect on his presidency during the 2019 Presidential Address, on Friday, June 14, from 11:15 a.m. to 12:15 p.m. President-Elect Kim Hodgson, MD, will introduce Dr. Makaroun, beginning at 11 a.m.

Dr. Makaroun is professor of surgery and clinical translational science at the University of Pittsburgh. He is the chair of vascular surgery and codirector of the University of Pittsburgh Medical Center Heart and Vascular Institute.

His address, “I am in Favor of Progress ... It is Change I Do Not Like,” will take place in Ballroom A/B. 

Society for Vascular Surgery President Michel S. Makaroun, MD, will reflect on his presidency during the 2019 Presidential Address, on Friday, June 14, from 11:15 a.m. to 12:15 p.m. President-Elect Kim Hodgson, MD, will introduce Dr. Makaroun, beginning at 11 a.m.

Dr. Makaroun is professor of surgery and clinical translational science at the University of Pittsburgh. He is the chair of vascular surgery and codirector of the University of Pittsburgh Medical Center Heart and Vascular Institute.

His address, “I am in Favor of Progress ... It is Change I Do Not Like,” will take place in Ballroom A/B. 

Society for Vascular Surgery President Michel S. Makaroun, MD, will reflect on his presidency during the 2019 Presidential Address, on Friday, June 14, from 11:15 a.m. to 12:15 p.m. President-Elect Kim Hodgson, MD, will introduce Dr. Makaroun, beginning at 11 a.m.

Dr. Makaroun is professor of surgery and clinical translational science at the University of Pittsburgh. He is the chair of vascular surgery and codirector of the University of Pittsburgh Medical Center Heart and Vascular Institute.

His address, “I am in Favor of Progress ... It is Change I Do Not Like,” will take place in Ballroom A/B. 

U.S. soldiers who own firearms, store a loaded gun at home, or carry a gun publicly when not on duty are at significantly greater risk of suicide death, a case-control study of 135 U.S. Army soldiers who died by suicide shows.

“Our findings concurred with earlier studies by showing that factors beyond ownership of a firearm were associated with an increased risk of suicide,” wrote Catherine L. Dempsey, PhD, MPH, and her coauthors.

Since 2004, the rate of suicide deaths among Army soldiers has exceeded the rate of combat deaths each year, which prompted Dr. Dempsey, of the Center for the Study of Traumatic Stress at the Uniformed Services University of the Health Sciences, Bethesda, Md., and her coauthors to investigate whether increased access to firearms might be associated with an increased risk of suicide. The study was published by JAMA Network Open.

In the study, the researchers interviewed the next of kin or supervisors of 135 Army soldiers who had taken their own lives while on active duty between 2011 and 2013, 55% of whom used firearms to do so. They compared those findings with those 137 controls matched for suicide propensity based on sociodemographic and Army history risk factors, and 118 soldiers who had experienced suicidal ideation in the past year.

This analysis showed that soldiers who had stored a loaded gun with ammunition at home, or who had carried a personal gun in public had nearly fourfold higher odds of suicide (odds ratio, 3.9; P = .002), compared with propensity-matched controls.

Similarly, those who owned one or more handguns, stored a gun loaded with ammunition at home, and carried a personal gun in public had a greater than threefold odds of suicide.

The study found that soldiers who died by suicide were 90% more likely than matched controls to own at least one gun, four times more likely to store that gun loaded with ammunition at home, and three times more likely to carry a gun in public, compared with controls.

There was the suggestion that the use of safety locks at home was protective, but this did not reach statistical significance.

However, the study did not find significant differences in firearm accessibility characteristics between the soldiers who died by suicide, and the controls with suicidal ideation.

“Some current theories of suicide (eg., the interpersonal theory of suicide) suggest that fatal suicidal behavior results require not only the presence of suicidal desire but also a developed capability or capacity for suicidal behavior,” the authors wrote. “According to the interpersonal theory of suicide, this capability for lethal self-injury is acquired through repeated exposure to painful and fear-inducing experiences, thus habituating an individual to the pain and fear required to enact a fatal suicide attempt.”

Dr. Dempsey and her coauthors argued that their study supported a continued focus on “means restriction” counseling; limiting or removing access to lethal methods for suicide; and “motivational interviewing.”

They cited the fairly small sample size and relatively small response rates to surveys as limitations. However, they wrote, the response rates “were high for multi-informant interviews conducted within a military population.”

The study was supported by the U.S. Department of the Army, U.S. Department of Defense, U.S. Department of Health & Human Services, National Institutes of Health, and National Institute of Mental Health. One author declared grants from the Military Suicide Research Consortium outside the submitted work, and one author declared support, consultancies, and advisory board positions with the pharmaceutical industry, and co-ownership of a mental health market research firm. No other conflicts of interest were declared.

SOURCE: Dempsey CL et al. JAMA Netw Open. 2019 Jun 7. doi: 10.1001/jamanetworkopen.2019.5383.

U.S. soldiers who own firearms, store a loaded gun at home, or carry a gun publicly when not on duty are at significantly greater risk of suicide death, a case-control study of 135 U.S. Army soldiers who died by suicide shows.

“Our findings concurred with earlier studies by showing that factors beyond ownership of a firearm were associated with an increased risk of suicide,” wrote Catherine L. Dempsey, PhD, MPH, and her coauthors.

Since 2004, the rate of suicide deaths among Army soldiers has exceeded the rate of combat deaths each year, which prompted Dr. Dempsey, of the Center for the Study of Traumatic Stress at the Uniformed Services University of the Health Sciences, Bethesda, Md., and her coauthors to investigate whether increased access to firearms might be associated with an increased risk of suicide. The study was published by JAMA Network Open.

In the study, the researchers interviewed the next of kin or supervisors of 135 Army soldiers who had taken their own lives while on active duty between 2011 and 2013, 55% of whom used firearms to do so. They compared those findings with those 137 controls matched for suicide propensity based on sociodemographic and Army history risk factors, and 118 soldiers who had experienced suicidal ideation in the past year.

This analysis showed that soldiers who had stored a loaded gun with ammunition at home, or who had carried a personal gun in public had nearly fourfold higher odds of suicide (odds ratio, 3.9; P = .002), compared with propensity-matched controls.

Similarly, those who owned one or more handguns, stored a gun loaded with ammunition at home, and carried a personal gun in public had a greater than threefold odds of suicide.

The study found that soldiers who died by suicide were 90% more likely than matched controls to own at least one gun, four times more likely to store that gun loaded with ammunition at home, and three times more likely to carry a gun in public, compared with controls.

There was the suggestion that the use of safety locks at home was protective, but this did not reach statistical significance.

However, the study did not find significant differences in firearm accessibility characteristics between the soldiers who died by suicide, and the controls with suicidal ideation.

“Some current theories of suicide (eg., the interpersonal theory of suicide) suggest that fatal suicidal behavior results require not only the presence of suicidal desire but also a developed capability or capacity for suicidal behavior,” the authors wrote. “According to the interpersonal theory of suicide, this capability for lethal self-injury is acquired through repeated exposure to painful and fear-inducing experiences, thus habituating an individual to the pain and fear required to enact a fatal suicide attempt.”

Dr. Dempsey and her coauthors argued that their study supported a continued focus on “means restriction” counseling; limiting or removing access to lethal methods for suicide; and “motivational interviewing.”

They cited the fairly small sample size and relatively small response rates to surveys as limitations. However, they wrote, the response rates “were high for multi-informant interviews conducted within a military population.”

The study was supported by the U.S. Department of the Army, U.S. Department of Defense, U.S. Department of Health & Human Services, National Institutes of Health, and National Institute of Mental Health. One author declared grants from the Military Suicide Research Consortium outside the submitted work, and one author declared support, consultancies, and advisory board positions with the pharmaceutical industry, and co-ownership of a mental health market research firm. No other conflicts of interest were declared.

SOURCE: Dempsey CL et al. JAMA Netw Open. 2019 Jun 7. doi: 10.1001/jamanetworkopen.2019.5383.

U.S. soldiers who own firearms, store a loaded gun at home, or carry a gun publicly when not on duty are at significantly greater risk of suicide death, a case-control study of 135 U.S. Army soldiers who died by suicide shows.

“Our findings concurred with earlier studies by showing that factors beyond ownership of a firearm were associated with an increased risk of suicide,” wrote Catherine L. Dempsey, PhD, MPH, and her coauthors.

Since 2004, the rate of suicide deaths among Army soldiers has exceeded the rate of combat deaths each year, which prompted Dr. Dempsey, of the Center for the Study of Traumatic Stress at the Uniformed Services University of the Health Sciences, Bethesda, Md., and her coauthors to investigate whether increased access to firearms might be associated with an increased risk of suicide. The study was published by JAMA Network Open.

In the study, the researchers interviewed the next of kin or supervisors of 135 Army soldiers who had taken their own lives while on active duty between 2011 and 2013, 55% of whom used firearms to do so. They compared those findings with those 137 controls matched for suicide propensity based on sociodemographic and Army history risk factors, and 118 soldiers who had experienced suicidal ideation in the past year.

This analysis showed that soldiers who had stored a loaded gun with ammunition at home, or who had carried a personal gun in public had nearly fourfold higher odds of suicide (odds ratio, 3.9; P = .002), compared with propensity-matched controls.

Similarly, those who owned one or more handguns, stored a gun loaded with ammunition at home, and carried a personal gun in public had a greater than threefold odds of suicide.

The study found that soldiers who died by suicide were 90% more likely than matched controls to own at least one gun, four times more likely to store that gun loaded with ammunition at home, and three times more likely to carry a gun in public, compared with controls.

There was the suggestion that the use of safety locks at home was protective, but this did not reach statistical significance.

However, the study did not find significant differences in firearm accessibility characteristics between the soldiers who died by suicide, and the controls with suicidal ideation.

“Some current theories of suicide (eg., the interpersonal theory of suicide) suggest that fatal suicidal behavior results require not only the presence of suicidal desire but also a developed capability or capacity for suicidal behavior,” the authors wrote. “According to the interpersonal theory of suicide, this capability for lethal self-injury is acquired through repeated exposure to painful and fear-inducing experiences, thus habituating an individual to the pain and fear required to enact a fatal suicide attempt.”

Dr. Dempsey and her coauthors argued that their study supported a continued focus on “means restriction” counseling; limiting or removing access to lethal methods for suicide; and “motivational interviewing.”

They cited the fairly small sample size and relatively small response rates to surveys as limitations. However, they wrote, the response rates “were high for multi-informant interviews conducted within a military population.”

The study was supported by the U.S. Department of the Army, U.S. Department of Defense, U.S. Department of Health & Human Services, National Institutes of Health, and National Institute of Mental Health. One author declared grants from the Military Suicide Research Consortium outside the submitted work, and one author declared support, consultancies, and advisory board positions with the pharmaceutical industry, and co-ownership of a mental health market research firm. No other conflicts of interest were declared.

SOURCE: Dempsey CL et al. JAMA Netw Open. 2019 Jun 7. doi: 10.1001/jamanetworkopen.2019.5383.

In this edition of “How I will treat my next patient,” I take a look at two recent trials in non–small cell lung cancer (NSCLC). One summarizes a late analysis of a previously published randomized trial in stage IV NSCLC with three or fewer sites of metastasis – oligometastatic disease. The other reviews deidentified patient data to discern whether immune-targeted treatment might be valuable in particular subsets of NSCLC patients with EGFR mutations.

Local consolidative therapy

Daniel R. Gomez, MD, and colleagues published an updated analysis of progression-free survival (PFS) and an initial analysis of overall survival (OS) data in a randomized phase 2 trial in oligometastatic NSCLC. As originally published, patients were randomized to local consolidative treatment (LCT) versus standard maintenance therapy or observation (MT/O). Patients were required to have responding or stable disease after first-line systemic therapy prior to randomization.

Among the 49 patients who received LCT, there was a clear benefit of LCT (PFS of 14.2 months vs. 4.4 months for MT/O; P = .022; and median OS 41.2 months vs. 17.0 months; P = .017). The OS benefit was seen despite allowing crossover to LCT for patients who demonstrated disease progression in the MT/O arm.
 

What this means in practice

These data are exciting and move clinical research forward – if not, at this time, clinical practice. They support the ongoing clinical trials in NSCLC (NRG LU002) and breast cancer (NRG BR002) investigating the role of LCT in the oligometastatic setting.

For patients who are not candidates for (or choose not to participate in) these important phase 2R/3 trials, I believe that LCT should be discussed with all of the caveats that the authors appropriately mention, from the small number of patients because of the premature closure of the trial, to heterogeneous systemic regimens, to the lack of clarity on whether newer systemic therapies are better.

Immune checkpoint blockade

Historically, EGFR-mutated NSCLCs have not derived comparable benefit to EGFR-wild type (WT) tumors from checkpoint inhibitors. For that reason, in EGFR-mutated tumors, guidelines from the National Comprehensive Cancer Network (NCCN) suggest immune-targeted treatment should be used only on clinical trials or after receipt of EGFR-targeted tyrosine kinase inhibitors and cytotoxic chemotherapy. Several recent studies (IMpower and ATLANTIC), however, have suggested that selected EGFR-mutated patients can benefit from immune-targeted treatment.

Katherine Hastings, PhD, of Yale University, New Haven, Conn., and associates found, in a multi-institution clinical-molecular data review, that among the 44 of 171 EGFR-mutated tumors with L858R mutations, benefit from checkpoint inhibitors was comparable to WT tumors with regard to overall response rate and OS, but not PFS. Additionally, tumors with the EGFR T790M mutation demonstrated similar benefit from checkpoint inhibitors as in WT tumors, L858R-mutated tumors (but not exon 19 deleted tumors) had high tumor mutation burden, and PD-L1 expression did not influence outcome from immunotherapy.
 

What this means in practice

I agree with the modesty of the authors’ conclusion that these findings should not change clinical practice but rather should encourage further research into which patients with EGFR-mutant disease might benefit from immune-targeted therapy. For now, outside of a clinical trial, in EGFR-mutated patients, I will follow NCCN guidelines, using immune-targeted therapy off-study only with attentiveness to the particular immunotherapy regimens that have shown promise in the literature – and later, not earlier.

Dr. Lyss has been a community-based medical oncologist and clinical researcher for more than 35 years, practicing in St. Louis. His clinical and research interests are in the prevention, diagnosis, and treatment of breast and lung cancers and in expanding access to clinical trials to medically underserved populations.

In this edition of “How I will treat my next patient,” I take a look at two recent trials in non–small cell lung cancer (NSCLC). One summarizes a late analysis of a previously published randomized trial in stage IV NSCLC with three or fewer sites of metastasis – oligometastatic disease. The other reviews deidentified patient data to discern whether immune-targeted treatment might be valuable in particular subsets of NSCLC patients with EGFR mutations.

Local consolidative therapy

Daniel R. Gomez, MD, and colleagues published an updated analysis of progression-free survival (PFS) and an initial analysis of overall survival (OS) data in a randomized phase 2 trial in oligometastatic NSCLC. As originally published, patients were randomized to local consolidative treatment (LCT) versus standard maintenance therapy or observation (MT/O). Patients were required to have responding or stable disease after first-line systemic therapy prior to randomization.

Among the 49 patients who received LCT, there was a clear benefit of LCT (PFS of 14.2 months vs. 4.4 months for MT/O; P = .022; and median OS 41.2 months vs. 17.0 months; P = .017). The OS benefit was seen despite allowing crossover to LCT for patients who demonstrated disease progression in the MT/O arm.
 

What this means in practice

These data are exciting and move clinical research forward – if not, at this time, clinical practice. They support the ongoing clinical trials in NSCLC (NRG LU002) and breast cancer (NRG BR002) investigating the role of LCT in the oligometastatic setting.

For patients who are not candidates for (or choose not to participate in) these important phase 2R/3 trials, I believe that LCT should be discussed with all of the caveats that the authors appropriately mention, from the small number of patients because of the premature closure of the trial, to heterogeneous systemic regimens, to the lack of clarity on whether newer systemic therapies are better.

Immune checkpoint blockade

Historically, EGFR-mutated NSCLCs have not derived comparable benefit to EGFR-wild type (WT) tumors from checkpoint inhibitors. For that reason, in EGFR-mutated tumors, guidelines from the National Comprehensive Cancer Network (NCCN) suggest immune-targeted treatment should be used only on clinical trials or after receipt of EGFR-targeted tyrosine kinase inhibitors and cytotoxic chemotherapy. Several recent studies (IMpower and ATLANTIC), however, have suggested that selected EGFR-mutated patients can benefit from immune-targeted treatment.

Katherine Hastings, PhD, of Yale University, New Haven, Conn., and associates found, in a multi-institution clinical-molecular data review, that among the 44 of 171 EGFR-mutated tumors with L858R mutations, benefit from checkpoint inhibitors was comparable to WT tumors with regard to overall response rate and OS, but not PFS. Additionally, tumors with the EGFR T790M mutation demonstrated similar benefit from checkpoint inhibitors as in WT tumors, L858R-mutated tumors (but not exon 19 deleted tumors) had high tumor mutation burden, and PD-L1 expression did not influence outcome from immunotherapy.
 

What this means in practice

I agree with the modesty of the authors’ conclusion that these findings should not change clinical practice but rather should encourage further research into which patients with EGFR-mutant disease might benefit from immune-targeted therapy. For now, outside of a clinical trial, in EGFR-mutated patients, I will follow NCCN guidelines, using immune-targeted therapy off-study only with attentiveness to the particular immunotherapy regimens that have shown promise in the literature – and later, not earlier.

Dr. Lyss has been a community-based medical oncologist and clinical researcher for more than 35 years, practicing in St. Louis. His clinical and research interests are in the prevention, diagnosis, and treatment of breast and lung cancers and in expanding access to clinical trials to medically underserved populations.

In this edition of “How I will treat my next patient,” I take a look at two recent trials in non–small cell lung cancer (NSCLC). One summarizes a late analysis of a previously published randomized trial in stage IV NSCLC with three or fewer sites of metastasis – oligometastatic disease. The other reviews deidentified patient data to discern whether immune-targeted treatment might be valuable in particular subsets of NSCLC patients with EGFR mutations.

Local consolidative therapy

Daniel R. Gomez, MD, and colleagues published an updated analysis of progression-free survival (PFS) and an initial analysis of overall survival (OS) data in a randomized phase 2 trial in oligometastatic NSCLC. As originally published, patients were randomized to local consolidative treatment (LCT) versus standard maintenance therapy or observation (MT/O). Patients were required to have responding or stable disease after first-line systemic therapy prior to randomization.

Among the 49 patients who received LCT, there was a clear benefit of LCT (PFS of 14.2 months vs. 4.4 months for MT/O; P = .022; and median OS 41.2 months vs. 17.0 months; P = .017). The OS benefit was seen despite allowing crossover to LCT for patients who demonstrated disease progression in the MT/O arm.
 

What this means in practice

These data are exciting and move clinical research forward – if not, at this time, clinical practice. They support the ongoing clinical trials in NSCLC (NRG LU002) and breast cancer (NRG BR002) investigating the role of LCT in the oligometastatic setting.

For patients who are not candidates for (or choose not to participate in) these important phase 2R/3 trials, I believe that LCT should be discussed with all of the caveats that the authors appropriately mention, from the small number of patients because of the premature closure of the trial, to heterogeneous systemic regimens, to the lack of clarity on whether newer systemic therapies are better.

Immune checkpoint blockade

Historically, EGFR-mutated NSCLCs have not derived comparable benefit to EGFR-wild type (WT) tumors from checkpoint inhibitors. For that reason, in EGFR-mutated tumors, guidelines from the National Comprehensive Cancer Network (NCCN) suggest immune-targeted treatment should be used only on clinical trials or after receipt of EGFR-targeted tyrosine kinase inhibitors and cytotoxic chemotherapy. Several recent studies (IMpower and ATLANTIC), however, have suggested that selected EGFR-mutated patients can benefit from immune-targeted treatment.

Katherine Hastings, PhD, of Yale University, New Haven, Conn., and associates found, in a multi-institution clinical-molecular data review, that among the 44 of 171 EGFR-mutated tumors with L858R mutations, benefit from checkpoint inhibitors was comparable to WT tumors with regard to overall response rate and OS, but not PFS. Additionally, tumors with the EGFR T790M mutation demonstrated similar benefit from checkpoint inhibitors as in WT tumors, L858R-mutated tumors (but not exon 19 deleted tumors) had high tumor mutation burden, and PD-L1 expression did not influence outcome from immunotherapy.
 

What this means in practice

I agree with the modesty of the authors’ conclusion that these findings should not change clinical practice but rather should encourage further research into which patients with EGFR-mutant disease might benefit from immune-targeted therapy. For now, outside of a clinical trial, in EGFR-mutated patients, I will follow NCCN guidelines, using immune-targeted therapy off-study only with attentiveness to the particular immunotherapy regimens that have shown promise in the literature – and later, not earlier.

Dr. Lyss has been a community-based medical oncologist and clinical researcher for more than 35 years, practicing in St. Louis. His clinical and research interests are in the prevention, diagnosis, and treatment of breast and lung cancers and in expanding access to clinical trials to medically underserved populations.