In older patients with newly diagnosed mantle cell lymphoma (MCL), first-line therapy with rituximab- and bendamustine-based regimens significantly reduced 1-year mortality rates versus chemotherapy alone, according to a retrospective analysis.

Wikimedia Commons/TexasPathologistMSW/CC-ASA 4.0 International

“This study evaluated the comparative effectiveness of [rituximab, bortezomib, or bendamustine] in elderly patients newly diagnosed with MCL,” wrote Shuangshuang Fu, PhD, of the University of Texas MD Anderson Cancer Center, Houston, and colleagues. The findings were reported in Clinical Lymphoma, Myeloma & Leukemia.

The researchers studied population-based data from the Surveillance, Epidemiology, and End Results (SEER)-Medicare linked database. They identified all patients over age 65 years who received a new diagnosis of MCL between Jan. 1, 1999, and Dec. 31, 2013.

The study cohort included a total of 1,215 patients. Participants were classified into four different groups according to treatment regimen: chemotherapy alone, rituximab plus or minus chemotherapy, bendamustine plus or minus chemotherapy, and bortezomib plus or minus chemotherapy.

At 1-year follow-up, the team analyzed various mortality outcomes, including MCL-specific, all-cause, and noncancer mortality. The bortezomib results were not included in the primary analysis because of small sample size, according to the researchers.

After multivariable analysis, Dr. Fu and colleagues found that 1-year all-cause mortality rate was significantly lower for patients receiving rituximab-based regimens, compared with chemotherapy alone (hazard ratio, 0.38; 95% confidence interval, 0.25-0.59). There was a similar decline for MCL-specific mortality (HR, 0.38; 95% CI, 0.24-0.60).

The 1-year MCL-specific mortality was also significantly reduced in the bendamustine group, compared with chemotherapy alone (HR, 0.49; 95% CI, 0.24-0.99).

“Our findings comparing rituximab with chemotherapy alone further confirmed the benefit of adding rituximab to chemotherapy in newly diagnosed older MCL patients,” they wrote.

The researchers acknowledged that a key limitation of the study was the observational design. As a result, selection bias and unmeasured confounding could have influenced the results.

“Future studies evaluating the comparative effectiveness of those newly approved novel agents for MCL patients were warranted as more data are available,” they concluded.

The study was funded by the Duncan Family Institute, the Cancer Prevention Research Institute of Texas, and the National Institutes of Health. The authors reported having no conflicts of interest.

SOURCE: Fu S et al. Clin Lymphoma Myeloma Leuk. 2019 Aug 30. doi: 10.1016/j.clml.2019.08.014.

In older patients with newly diagnosed mantle cell lymphoma (MCL), first-line therapy with rituximab- and bendamustine-based regimens significantly reduced 1-year mortality rates versus chemotherapy alone, according to a retrospective analysis.

Wikimedia Commons/TexasPathologistMSW/CC-ASA 4.0 International

“This study evaluated the comparative effectiveness of [rituximab, bortezomib, or bendamustine] in elderly patients newly diagnosed with MCL,” wrote Shuangshuang Fu, PhD, of the University of Texas MD Anderson Cancer Center, Houston, and colleagues. The findings were reported in Clinical Lymphoma, Myeloma & Leukemia.

The researchers studied population-based data from the Surveillance, Epidemiology, and End Results (SEER)-Medicare linked database. They identified all patients over age 65 years who received a new diagnosis of MCL between Jan. 1, 1999, and Dec. 31, 2013.

The study cohort included a total of 1,215 patients. Participants were classified into four different groups according to treatment regimen: chemotherapy alone, rituximab plus or minus chemotherapy, bendamustine plus or minus chemotherapy, and bortezomib plus or minus chemotherapy.

At 1-year follow-up, the team analyzed various mortality outcomes, including MCL-specific, all-cause, and noncancer mortality. The bortezomib results were not included in the primary analysis because of small sample size, according to the researchers.

After multivariable analysis, Dr. Fu and colleagues found that 1-year all-cause mortality rate was significantly lower for patients receiving rituximab-based regimens, compared with chemotherapy alone (hazard ratio, 0.38; 95% confidence interval, 0.25-0.59). There was a similar decline for MCL-specific mortality (HR, 0.38; 95% CI, 0.24-0.60).

The 1-year MCL-specific mortality was also significantly reduced in the bendamustine group, compared with chemotherapy alone (HR, 0.49; 95% CI, 0.24-0.99).

“Our findings comparing rituximab with chemotherapy alone further confirmed the benefit of adding rituximab to chemotherapy in newly diagnosed older MCL patients,” they wrote.

The researchers acknowledged that a key limitation of the study was the observational design. As a result, selection bias and unmeasured confounding could have influenced the results.

“Future studies evaluating the comparative effectiveness of those newly approved novel agents for MCL patients were warranted as more data are available,” they concluded.

The study was funded by the Duncan Family Institute, the Cancer Prevention Research Institute of Texas, and the National Institutes of Health. The authors reported having no conflicts of interest.

SOURCE: Fu S et al. Clin Lymphoma Myeloma Leuk. 2019 Aug 30. doi: 10.1016/j.clml.2019.08.014.

In older patients with newly diagnosed mantle cell lymphoma (MCL), first-line therapy with rituximab- and bendamustine-based regimens significantly reduced 1-year mortality rates versus chemotherapy alone, according to a retrospective analysis.

Wikimedia Commons/TexasPathologistMSW/CC-ASA 4.0 International

“This study evaluated the comparative effectiveness of [rituximab, bortezomib, or bendamustine] in elderly patients newly diagnosed with MCL,” wrote Shuangshuang Fu, PhD, of the University of Texas MD Anderson Cancer Center, Houston, and colleagues. The findings were reported in Clinical Lymphoma, Myeloma & Leukemia.

The researchers studied population-based data from the Surveillance, Epidemiology, and End Results (SEER)-Medicare linked database. They identified all patients over age 65 years who received a new diagnosis of MCL between Jan. 1, 1999, and Dec. 31, 2013.

The study cohort included a total of 1,215 patients. Participants were classified into four different groups according to treatment regimen: chemotherapy alone, rituximab plus or minus chemotherapy, bendamustine plus or minus chemotherapy, and bortezomib plus or minus chemotherapy.

At 1-year follow-up, the team analyzed various mortality outcomes, including MCL-specific, all-cause, and noncancer mortality. The bortezomib results were not included in the primary analysis because of small sample size, according to the researchers.

After multivariable analysis, Dr. Fu and colleagues found that 1-year all-cause mortality rate was significantly lower for patients receiving rituximab-based regimens, compared with chemotherapy alone (hazard ratio, 0.38; 95% confidence interval, 0.25-0.59). There was a similar decline for MCL-specific mortality (HR, 0.38; 95% CI, 0.24-0.60).

The 1-year MCL-specific mortality was also significantly reduced in the bendamustine group, compared with chemotherapy alone (HR, 0.49; 95% CI, 0.24-0.99).

“Our findings comparing rituximab with chemotherapy alone further confirmed the benefit of adding rituximab to chemotherapy in newly diagnosed older MCL patients,” they wrote.

The researchers acknowledged that a key limitation of the study was the observational design. As a result, selection bias and unmeasured confounding could have influenced the results.

“Future studies evaluating the comparative effectiveness of those newly approved novel agents for MCL patients were warranted as more data are available,” they concluded.

The study was funded by the Duncan Family Institute, the Cancer Prevention Research Institute of Texas, and the National Institutes of Health. The authors reported having no conflicts of interest.

SOURCE: Fu S et al. Clin Lymphoma Myeloma Leuk. 2019 Aug 30. doi: 10.1016/j.clml.2019.08.014.

SAN DIEGO – An investigative dermal microcoring device designed for improvement of moderate to severe facial wrinkles and tightening is poised to become a game-changer in the minimally invasive aesthetics field.

Courtesy Jill S. Waibel, MD

A brainchild of dermatologists and plastic surgeons at Massachusetts General Hospital, Boston, the device features a proprietary needle design that makes a series of high throughput microexcisions in epidermal and dermal tissue, with minimal downtime and without using thermal energy.

“The idea is to get more significant improvement of tissue laxity by fractionally removing the skin,” Mathew M. Avram, MD, JD, explained at the annual Masters of Aesthetics Symposium. “You can do a facelift by cutting the skin on the side and pulling it back. This is skin tightening and improvement of wrinkles with a thousand micro punches. It’s called fractional tissue extraction.”

Instead of relying on laser, heat, light, or radiofrequency, the device uses needle mechanics to extract microsized cores of full-thickness skin below the size threshold that causes scarring. “Then, you have biomechanical remodeling; you close the channels right away,” said Dr. Avram, director of laser, cosmetics, and dermatologic surgery at Massachusetts General Hospital. “If you remove skin that is smaller than 500 micrometers in size, no scar is left behind.”

Courtesy Jill S. Waibel, MD

In trials of the device being carried out by Cytrellis Biosystems, more than 100 patients have been treated one to two times. During a separate presentation, one of the device investigators, Jill S. Waibel, MD, said that areas of treatment have included the upper and lower cheeks, perioral areas, and the submentum. On average, the amount of skin removed during each treatment session ranges from 5% to 8.5% and the mean down time is 3.8 days. According to combined data from two studies of 30 patients who had 60 areas treated and were followed at 90 or 180 days, subjects experienced an average 1.1 grade improvement on the Lemperle Rating Scale and showed an 80% improvement in moderate or severe wrinkles. In addition, 91% of investigators rated treatment areas as “improved” or “very much improved” on the Global Aesthetic Improvement Scale, and 88% of subjects were “satisfied” or “extremely satisfied” with the results.

“The safety profile of this device is amazing,” said Dr. Waibel, a dermatologist and owner of the Miami Dermatology and Laser Institute. “It provides an entirely new mode of treatment for skin laxity through highly approachable tissue removal with minimal to no pain or downtime. You can visually see the cores close through Optical Coherence Tomography before patients even leave the office. There have also been virtually no side effects except in one patient at another site who had minor postinflammatory hyperpigmentation.”

The device allows for local and scarless treatment of wrinkles in the areas in which they form, she continued, so results are natural and true to the underlying anatomy. “While its target testing has been in more severely lax patients, I think it has a great future for younger patients who want to stave off a future face lift,” Dr. Waibel said. “Initial treatments required preoperative lidocaine injections. However, recent trials using more tolerable analgesic methods have shown that this may not even be necessary. This is very exciting new technology and I have high hopes for the future of this device.”

Histological analysis from baseline to 60-90 days post treatment showed homogenization of elastosis, which signals reorganization of the papillary dermis, Dr. Avram said. It also showed a decrease in the grenz zone, rete ridge flattening, a slight increase in the collagen-to-elastin ratio, and no scarring. Pending clearance, he said, the device could be commercially available in 2020.

Dr. Avram disclosed that he has received consulting fees from Allergan, Merz, Sciton, Soliton, and Zalea. He also reported having ownership and/or shareholder interest in Cytrellis, Invasix, and Zalea and intellectual property rights with Cytrellis.

Dr. Waibel disclosed that she has conducted clinical research for AbbVie, Aquavit, Cytrellis, Lumenis, Lutronic, Michelson Diagnostics, RegenX, Sciton, Sebacia, and Syneron/Candela. She is also a consultant for RegenX, Strata, and Syneron/Candela and is a member of the advisory board for Dominion Technologies, Sciton, and Sebacia.

[email protected]

SAN DIEGO – An investigative dermal microcoring device designed for improvement of moderate to severe facial wrinkles and tightening is poised to become a game-changer in the minimally invasive aesthetics field.

Courtesy Jill S. Waibel, MD

A brainchild of dermatologists and plastic surgeons at Massachusetts General Hospital, Boston, the device features a proprietary needle design that makes a series of high throughput microexcisions in epidermal and dermal tissue, with minimal downtime and without using thermal energy.

“The idea is to get more significant improvement of tissue laxity by fractionally removing the skin,” Mathew M. Avram, MD, JD, explained at the annual Masters of Aesthetics Symposium. “You can do a facelift by cutting the skin on the side and pulling it back. This is skin tightening and improvement of wrinkles with a thousand micro punches. It’s called fractional tissue extraction.”

Instead of relying on laser, heat, light, or radiofrequency, the device uses needle mechanics to extract microsized cores of full-thickness skin below the size threshold that causes scarring. “Then, you have biomechanical remodeling; you close the channels right away,” said Dr. Avram, director of laser, cosmetics, and dermatologic surgery at Massachusetts General Hospital. “If you remove skin that is smaller than 500 micrometers in size, no scar is left behind.”

Courtesy Jill S. Waibel, MD

In trials of the device being carried out by Cytrellis Biosystems, more than 100 patients have been treated one to two times. During a separate presentation, one of the device investigators, Jill S. Waibel, MD, said that areas of treatment have included the upper and lower cheeks, perioral areas, and the submentum. On average, the amount of skin removed during each treatment session ranges from 5% to 8.5% and the mean down time is 3.8 days. According to combined data from two studies of 30 patients who had 60 areas treated and were followed at 90 or 180 days, subjects experienced an average 1.1 grade improvement on the Lemperle Rating Scale and showed an 80% improvement in moderate or severe wrinkles. In addition, 91% of investigators rated treatment areas as “improved” or “very much improved” on the Global Aesthetic Improvement Scale, and 88% of subjects were “satisfied” or “extremely satisfied” with the results.

“The safety profile of this device is amazing,” said Dr. Waibel, a dermatologist and owner of the Miami Dermatology and Laser Institute. “It provides an entirely new mode of treatment for skin laxity through highly approachable tissue removal with minimal to no pain or downtime. You can visually see the cores close through Optical Coherence Tomography before patients even leave the office. There have also been virtually no side effects except in one patient at another site who had minor postinflammatory hyperpigmentation.”

The device allows for local and scarless treatment of wrinkles in the areas in which they form, she continued, so results are natural and true to the underlying anatomy. “While its target testing has been in more severely lax patients, I think it has a great future for younger patients who want to stave off a future face lift,” Dr. Waibel said. “Initial treatments required preoperative lidocaine injections. However, recent trials using more tolerable analgesic methods have shown that this may not even be necessary. This is very exciting new technology and I have high hopes for the future of this device.”

Histological analysis from baseline to 60-90 days post treatment showed homogenization of elastosis, which signals reorganization of the papillary dermis, Dr. Avram said. It also showed a decrease in the grenz zone, rete ridge flattening, a slight increase in the collagen-to-elastin ratio, and no scarring. Pending clearance, he said, the device could be commercially available in 2020.

Dr. Avram disclosed that he has received consulting fees from Allergan, Merz, Sciton, Soliton, and Zalea. He also reported having ownership and/or shareholder interest in Cytrellis, Invasix, and Zalea and intellectual property rights with Cytrellis.

Dr. Waibel disclosed that she has conducted clinical research for AbbVie, Aquavit, Cytrellis, Lumenis, Lutronic, Michelson Diagnostics, RegenX, Sciton, Sebacia, and Syneron/Candela. She is also a consultant for RegenX, Strata, and Syneron/Candela and is a member of the advisory board for Dominion Technologies, Sciton, and Sebacia.

[email protected]

SAN DIEGO – An investigative dermal microcoring device designed for improvement of moderate to severe facial wrinkles and tightening is poised to become a game-changer in the minimally invasive aesthetics field.

Courtesy Jill S. Waibel, MD

A brainchild of dermatologists and plastic surgeons at Massachusetts General Hospital, Boston, the device features a proprietary needle design that makes a series of high throughput microexcisions in epidermal and dermal tissue, with minimal downtime and without using thermal energy.

“The idea is to get more significant improvement of tissue laxity by fractionally removing the skin,” Mathew M. Avram, MD, JD, explained at the annual Masters of Aesthetics Symposium. “You can do a facelift by cutting the skin on the side and pulling it back. This is skin tightening and improvement of wrinkles with a thousand micro punches. It’s called fractional tissue extraction.”

Instead of relying on laser, heat, light, or radiofrequency, the device uses needle mechanics to extract microsized cores of full-thickness skin below the size threshold that causes scarring. “Then, you have biomechanical remodeling; you close the channels right away,” said Dr. Avram, director of laser, cosmetics, and dermatologic surgery at Massachusetts General Hospital. “If you remove skin that is smaller than 500 micrometers in size, no scar is left behind.”

Courtesy Jill S. Waibel, MD

In trials of the device being carried out by Cytrellis Biosystems, more than 100 patients have been treated one to two times. During a separate presentation, one of the device investigators, Jill S. Waibel, MD, said that areas of treatment have included the upper and lower cheeks, perioral areas, and the submentum. On average, the amount of skin removed during each treatment session ranges from 5% to 8.5% and the mean down time is 3.8 days. According to combined data from two studies of 30 patients who had 60 areas treated and were followed at 90 or 180 days, subjects experienced an average 1.1 grade improvement on the Lemperle Rating Scale and showed an 80% improvement in moderate or severe wrinkles. In addition, 91% of investigators rated treatment areas as “improved” or “very much improved” on the Global Aesthetic Improvement Scale, and 88% of subjects were “satisfied” or “extremely satisfied” with the results.

“The safety profile of this device is amazing,” said Dr. Waibel, a dermatologist and owner of the Miami Dermatology and Laser Institute. “It provides an entirely new mode of treatment for skin laxity through highly approachable tissue removal with minimal to no pain or downtime. You can visually see the cores close through Optical Coherence Tomography before patients even leave the office. There have also been virtually no side effects except in one patient at another site who had minor postinflammatory hyperpigmentation.”

The device allows for local and scarless treatment of wrinkles in the areas in which they form, she continued, so results are natural and true to the underlying anatomy. “While its target testing has been in more severely lax patients, I think it has a great future for younger patients who want to stave off a future face lift,” Dr. Waibel said. “Initial treatments required preoperative lidocaine injections. However, recent trials using more tolerable analgesic methods have shown that this may not even be necessary. This is very exciting new technology and I have high hopes for the future of this device.”

Histological analysis from baseline to 60-90 days post treatment showed homogenization of elastosis, which signals reorganization of the papillary dermis, Dr. Avram said. It also showed a decrease in the grenz zone, rete ridge flattening, a slight increase in the collagen-to-elastin ratio, and no scarring. Pending clearance, he said, the device could be commercially available in 2020.

Dr. Avram disclosed that he has received consulting fees from Allergan, Merz, Sciton, Soliton, and Zalea. He also reported having ownership and/or shareholder interest in Cytrellis, Invasix, and Zalea and intellectual property rights with Cytrellis.

Dr. Waibel disclosed that she has conducted clinical research for AbbVie, Aquavit, Cytrellis, Lumenis, Lutronic, Michelson Diagnostics, RegenX, Sciton, Sebacia, and Syneron/Candela. She is also a consultant for RegenX, Strata, and Syneron/Candela and is a member of the advisory board for Dominion Technologies, Sciton, and Sebacia.

[email protected]

The Food and Drug Administration has approved nintedanib (Ofev) for the rare but sometimes deadly form of interstitial lung disease that’s caused by systemic sclerosis, or scleroderma.

Olivier Le Moal/Getty Images

Although scleroderma itself is rare, half of those patients present with scleroderma-related interstitial lung disease (SSc-ILD), and it remains the leading cause of death in scleroderma patients because it can lead to loss of pulmonary function. Nintedanib appears to slow the progress of SSc-ILD and is the first treatment approved for it, according to a news release from the FDA.

The approval is based on a randomized, double-blind, placebo-controlled trial of 576 patients aged 20-79 years with SSc-ILD. The primary efficacy endpoint was forced vital capacity, and patients on nintedanib showed less decline than did those on placebo.

The most frequent serious adverse event reported in this trial was pneumonia (2.8% with nintedanib vs. 0.3% with placebo). Adverse reactions that led to permanent dose reductions occurred in 34% of nintedanib patients and 4% of placebo-treated patients; the most common of these was diarrhea.

The full prescribing information, which is available on the FDA website, includes warnings for patients with moderate to severe hepatic impairment, elevated liver enzymes, and drug-induced liver injury, as well as those with gastrointestinal disorders. Nintedanib may cause embryo-fetal toxicity, so women of childbearing age should be counseled to avoid pregnancy while taking this drug.

Nintedanib received both Priority Review and Orphan Drug designation. The former meant the FDA intends to take action on the application within 6 months because the agency has determined that, if approved, it would have important effects on treatment of a serious condition. The latter provides incentives to assist and encourage development of drugs for rare diseases. The drug was approved in 2014 for adult patients with idiopathic pulmonary fibrosis, another interstitial lung disease.

The full release is available on the FDA website.

[email protected]

The Food and Drug Administration has approved nintedanib (Ofev) for the rare but sometimes deadly form of interstitial lung disease that’s caused by systemic sclerosis, or scleroderma.

Olivier Le Moal/Getty Images

Although scleroderma itself is rare, half of those patients present with scleroderma-related interstitial lung disease (SSc-ILD), and it remains the leading cause of death in scleroderma patients because it can lead to loss of pulmonary function. Nintedanib appears to slow the progress of SSc-ILD and is the first treatment approved for it, according to a news release from the FDA.

The approval is based on a randomized, double-blind, placebo-controlled trial of 576 patients aged 20-79 years with SSc-ILD. The primary efficacy endpoint was forced vital capacity, and patients on nintedanib showed less decline than did those on placebo.

The most frequent serious adverse event reported in this trial was pneumonia (2.8% with nintedanib vs. 0.3% with placebo). Adverse reactions that led to permanent dose reductions occurred in 34% of nintedanib patients and 4% of placebo-treated patients; the most common of these was diarrhea.

The full prescribing information, which is available on the FDA website, includes warnings for patients with moderate to severe hepatic impairment, elevated liver enzymes, and drug-induced liver injury, as well as those with gastrointestinal disorders. Nintedanib may cause embryo-fetal toxicity, so women of childbearing age should be counseled to avoid pregnancy while taking this drug.

Nintedanib received both Priority Review and Orphan Drug designation. The former meant the FDA intends to take action on the application within 6 months because the agency has determined that, if approved, it would have important effects on treatment of a serious condition. The latter provides incentives to assist and encourage development of drugs for rare diseases. The drug was approved in 2014 for adult patients with idiopathic pulmonary fibrosis, another interstitial lung disease.

The full release is available on the FDA website.

[email protected]

The Food and Drug Administration has approved nintedanib (Ofev) for the rare but sometimes deadly form of interstitial lung disease that’s caused by systemic sclerosis, or scleroderma.

Olivier Le Moal/Getty Images

Although scleroderma itself is rare, half of those patients present with scleroderma-related interstitial lung disease (SSc-ILD), and it remains the leading cause of death in scleroderma patients because it can lead to loss of pulmonary function. Nintedanib appears to slow the progress of SSc-ILD and is the first treatment approved for it, according to a news release from the FDA.

The approval is based on a randomized, double-blind, placebo-controlled trial of 576 patients aged 20-79 years with SSc-ILD. The primary efficacy endpoint was forced vital capacity, and patients on nintedanib showed less decline than did those on placebo.

The most frequent serious adverse event reported in this trial was pneumonia (2.8% with nintedanib vs. 0.3% with placebo). Adverse reactions that led to permanent dose reductions occurred in 34% of nintedanib patients and 4% of placebo-treated patients; the most common of these was diarrhea.

The full prescribing information, which is available on the FDA website, includes warnings for patients with moderate to severe hepatic impairment, elevated liver enzymes, and drug-induced liver injury, as well as those with gastrointestinal disorders. Nintedanib may cause embryo-fetal toxicity, so women of childbearing age should be counseled to avoid pregnancy while taking this drug.

Nintedanib received both Priority Review and Orphan Drug designation. The former meant the FDA intends to take action on the application within 6 months because the agency has determined that, if approved, it would have important effects on treatment of a serious condition. The latter provides incentives to assist and encourage development of drugs for rare diseases. The drug was approved in 2014 for adult patients with idiopathic pulmonary fibrosis, another interstitial lung disease.

The full release is available on the FDA website.

[email protected]

Physician groups are criticizing a judge’s decision to approve the merger of pharmacy chain CVS Health and health insurer Aetna, saying the deal will raise prices and lower quality.

Mathier/Thinkstock

Judge Richard J. Leon of the U.S. District Court for the District of Columbia allowed the merger to move forward on Sept. 4, ruling that the acquisition was legal under antitrust law. The merger was approved by the Department of Justice in October 2018 on the condition that Aetna sell its Medicare prescription drug plan (PDP) business to independently owned competitor, WellCare Health Plans. Judge Leon has been examining the government’s plan since late 2018.

In his decision, Judge Leon acknowledged that the merger will have widespread effects for millions of patients and noted the many industry stakeholders, consumer groups, and state regulatory bodies have raised concerns about the merger.

“Although [the opposition] raised substantial concerns that warranted serious consideration, CVS’s and the government’s witnesses, when combined with the existing record, persuasively support why the markets at issue are not only very competitive today, but are likely to remain so post merger,” Judge Leon wrote. “Consequently, the harms to the public interest the [opposition] raised were not sufficiently established to undermine the government’s conclusion to the contrary. As such, for all of the above reasons, I have concluded that the proposed settlement is well ‘within the reaches’ of the public interest and the government’s motion ... should therefore be granted.”

Patrice A. Harris, MD, president for the American Medical Association, said the judge’s decision fails patients and will likely raise prices, lower quality, reduce choice, and stifle innovation.

“The American people and our health system will not be served well by allowing a merger that combines health insurance giant Aetna Inc. with CVS Health Corporation,” Dr. Harris said in a statement. “For patients and employers struggling with recurrent increases to health insurance premiums, out-of-pocket costs, and prescription drug prices, it’s hard to find any upside to a merger that leaves them with fewer choices. Nothing in the deal guarantees reductions on insurance premiums or prescription drug costs. As for promised efficiency savings, that money will likely go straight to CVS’s bottom line.”

Angus Worthing, MD, government affairs committee chair for the American College of Rheumatology, said his group is concerned that the merger will hinder progress that has been made toward creating cost transparency and will make it easier for costs savings to remain secret.

“We hope that regulators will now actively watch the conduct of the merged company to ensure patients are protected,” Dr. Worthing said in a statement.

In a statement, CVS noted that CVS Health and Aetna have been one company since November 2018, stating that the court’s action “makes that 100 percent clear.”

“We remain focused on transforming the consumer health care experience in America,” they said.

CVS Health announced it would buy Aetna for $69 billion in 2017 and finalized the acquisition in 2018. CVS Health President and CEO Larry J. Merlo said the combined company would connect consumers with the powerful health resources of CVS Health in communities across the country and Aetna’s network of providers to help remove barriers to high quality care and build lasting relationships with patients.

Assistant Attorney General Makan Delrahim of the Justice Department’s antitrust division said the agency was pleased with the court’s decision to approve the government’s plan and finalize the merger.

“The divestiture of Aetna’s individual PDP business provides a comprehensive remedy to the harms the Justice Department identified,” Mr. Delrahim said in a statement. “The entry of the final judgment protects seniors and other vulnerable customers of individual PDPs from the anticompetitive effects that would have occurred if CVS and Aetna had merged their individual PDP businesses.”

[email protected]

Physician groups are criticizing a judge’s decision to approve the merger of pharmacy chain CVS Health and health insurer Aetna, saying the deal will raise prices and lower quality.

Mathier/Thinkstock

Judge Richard J. Leon of the U.S. District Court for the District of Columbia allowed the merger to move forward on Sept. 4, ruling that the acquisition was legal under antitrust law. The merger was approved by the Department of Justice in October 2018 on the condition that Aetna sell its Medicare prescription drug plan (PDP) business to independently owned competitor, WellCare Health Plans. Judge Leon has been examining the government’s plan since late 2018.

In his decision, Judge Leon acknowledged that the merger will have widespread effects for millions of patients and noted the many industry stakeholders, consumer groups, and state regulatory bodies have raised concerns about the merger.

“Although [the opposition] raised substantial concerns that warranted serious consideration, CVS’s and the government’s witnesses, when combined with the existing record, persuasively support why the markets at issue are not only very competitive today, but are likely to remain so post merger,” Judge Leon wrote. “Consequently, the harms to the public interest the [opposition] raised were not sufficiently established to undermine the government’s conclusion to the contrary. As such, for all of the above reasons, I have concluded that the proposed settlement is well ‘within the reaches’ of the public interest and the government’s motion ... should therefore be granted.”

Patrice A. Harris, MD, president for the American Medical Association, said the judge’s decision fails patients and will likely raise prices, lower quality, reduce choice, and stifle innovation.

“The American people and our health system will not be served well by allowing a merger that combines health insurance giant Aetna Inc. with CVS Health Corporation,” Dr. Harris said in a statement. “For patients and employers struggling with recurrent increases to health insurance premiums, out-of-pocket costs, and prescription drug prices, it’s hard to find any upside to a merger that leaves them with fewer choices. Nothing in the deal guarantees reductions on insurance premiums or prescription drug costs. As for promised efficiency savings, that money will likely go straight to CVS’s bottom line.”

Angus Worthing, MD, government affairs committee chair for the American College of Rheumatology, said his group is concerned that the merger will hinder progress that has been made toward creating cost transparency and will make it easier for costs savings to remain secret.

“We hope that regulators will now actively watch the conduct of the merged company to ensure patients are protected,” Dr. Worthing said in a statement.

In a statement, CVS noted that CVS Health and Aetna have been one company since November 2018, stating that the court’s action “makes that 100 percent clear.”

“We remain focused on transforming the consumer health care experience in America,” they said.

CVS Health announced it would buy Aetna for $69 billion in 2017 and finalized the acquisition in 2018. CVS Health President and CEO Larry J. Merlo said the combined company would connect consumers with the powerful health resources of CVS Health in communities across the country and Aetna’s network of providers to help remove barriers to high quality care and build lasting relationships with patients.

Assistant Attorney General Makan Delrahim of the Justice Department’s antitrust division said the agency was pleased with the court’s decision to approve the government’s plan and finalize the merger.

“The divestiture of Aetna’s individual PDP business provides a comprehensive remedy to the harms the Justice Department identified,” Mr. Delrahim said in a statement. “The entry of the final judgment protects seniors and other vulnerable customers of individual PDPs from the anticompetitive effects that would have occurred if CVS and Aetna had merged their individual PDP businesses.”

[email protected]

Physician groups are criticizing a judge’s decision to approve the merger of pharmacy chain CVS Health and health insurer Aetna, saying the deal will raise prices and lower quality.

Mathier/Thinkstock

Judge Richard J. Leon of the U.S. District Court for the District of Columbia allowed the merger to move forward on Sept. 4, ruling that the acquisition was legal under antitrust law. The merger was approved by the Department of Justice in October 2018 on the condition that Aetna sell its Medicare prescription drug plan (PDP) business to independently owned competitor, WellCare Health Plans. Judge Leon has been examining the government’s plan since late 2018.

In his decision, Judge Leon acknowledged that the merger will have widespread effects for millions of patients and noted the many industry stakeholders, consumer groups, and state regulatory bodies have raised concerns about the merger.

“Although [the opposition] raised substantial concerns that warranted serious consideration, CVS’s and the government’s witnesses, when combined with the existing record, persuasively support why the markets at issue are not only very competitive today, but are likely to remain so post merger,” Judge Leon wrote. “Consequently, the harms to the public interest the [opposition] raised were not sufficiently established to undermine the government’s conclusion to the contrary. As such, for all of the above reasons, I have concluded that the proposed settlement is well ‘within the reaches’ of the public interest and the government’s motion ... should therefore be granted.”

Patrice A. Harris, MD, president for the American Medical Association, said the judge’s decision fails patients and will likely raise prices, lower quality, reduce choice, and stifle innovation.

“The American people and our health system will not be served well by allowing a merger that combines health insurance giant Aetna Inc. with CVS Health Corporation,” Dr. Harris said in a statement. “For patients and employers struggling with recurrent increases to health insurance premiums, out-of-pocket costs, and prescription drug prices, it’s hard to find any upside to a merger that leaves them with fewer choices. Nothing in the deal guarantees reductions on insurance premiums or prescription drug costs. As for promised efficiency savings, that money will likely go straight to CVS’s bottom line.”

Angus Worthing, MD, government affairs committee chair for the American College of Rheumatology, said his group is concerned that the merger will hinder progress that has been made toward creating cost transparency and will make it easier for costs savings to remain secret.

“We hope that regulators will now actively watch the conduct of the merged company to ensure patients are protected,” Dr. Worthing said in a statement.

In a statement, CVS noted that CVS Health and Aetna have been one company since November 2018, stating that the court’s action “makes that 100 percent clear.”

“We remain focused on transforming the consumer health care experience in America,” they said.

CVS Health announced it would buy Aetna for $69 billion in 2017 and finalized the acquisition in 2018. CVS Health President and CEO Larry J. Merlo said the combined company would connect consumers with the powerful health resources of CVS Health in communities across the country and Aetna’s network of providers to help remove barriers to high quality care and build lasting relationships with patients.

Assistant Attorney General Makan Delrahim of the Justice Department’s antitrust division said the agency was pleased with the court’s decision to approve the government’s plan and finalize the merger.

“The divestiture of Aetna’s individual PDP business provides a comprehensive remedy to the harms the Justice Department identified,” Mr. Delrahim said in a statement. “The entry of the final judgment protects seniors and other vulnerable customers of individual PDPs from the anticompetitive effects that would have occurred if CVS and Aetna had merged their individual PDP businesses.”

[email protected]

Among patients with chronic obstructive pulmonary disease (COPD) and obstructive sleep apnea (OSA), lung function and continuous positive airway pressure (CPAP) use are independent predictors of COPD exacerbations and all‐cause mortality, according to a retrospective cohort study.

“These factors should be taken into account when considering the management and prognosis of these patients,” the researchers said in the Clinical Respiratory Journal.

Prior studies have found that patients with COPD and OSA – that is, with overlap syndrome – “have a substantially greater risk of morbidity and mortality, compared to those with either COPD or OSA alone,” said Philippe E. Jaoude, MD, and Ali A. El Solh, MD, both of the Veterans Affairs Western New York Healthcare System in Buffalo and the University at Buffalo.

To identify factors associated with COPD exacerbation and all‐cause mortality in patients with overlap syndrome, Dr. Jaoude and Dr. El Solh reviewed the electronic health records of patients with simultaneous COPD and OSA. They compared patients with overlap syndrome who had an acute exacerbation of COPD during a 42-month period with a control group of patients with overlap syndrome who did not have exacerbations during that time. Patients with exacerbations and controls were matched 1:1 by age and body mass index.

Eligible patients were aged 42-90 years, had objectively confirmed COPD, and had documented OSA by in-laboratory polysomnography (that is, at least five obstructive apneas and hypopneas per hour). The investigators defined a COPD exacerbation as a sustained worsening of a patient’s respiratory condition that warranted additional treatment.

Of 225 eligible patients, 92 had at least one COPD exacerbation between March 2014 and September 2017. Patients with COPD exacerbation and controls had a mean age of about 68 years. The group of patients with exacerbation had a higher percentage of active smokers (21% vs. 9%) and had poorer lung function (mean forced expiratory volume in 1 second percent predicted: 55.2% vs. 64.5%).

“Although the rate of CPAP adherence between the two groups was not significantly different, the average time of CPAP use was significantly higher in patients with no recorded exacerbation,” the researchers reported – 285.4 min/night versus 238.2 min/night.

In all, 146 patients (79.4%) survived, and 38 patients (20.6%) died during the study period. The crude mortality rate was significantly higher in the group with COPD exacerbations (14% vs. 7%).

“Multivariate logistic regression analysis identified the independent risk factors associated with COPD exacerbations as active smoking, worse airflow limitation, and lower CPAP utilization,” they said. “As for all-cause mortality, a higher burden of comorbidities, worse airflow limitation, and lower time of CPAP use were independently associated with poor outcome.”

The researchers noted that they cannot rule out the possibility that patients who were adherent to CPAP were systematically different from those who were not.

The authors had no conflicts of interest.

[email protected]

SOURCE: Jaoude P et al. Clin Respir J. 2019 Aug 22. doi: 10.1111/crj.13079.

Among patients with chronic obstructive pulmonary disease (COPD) and obstructive sleep apnea (OSA), lung function and continuous positive airway pressure (CPAP) use are independent predictors of COPD exacerbations and all‐cause mortality, according to a retrospective cohort study.

“These factors should be taken into account when considering the management and prognosis of these patients,” the researchers said in the Clinical Respiratory Journal.

Prior studies have found that patients with COPD and OSA – that is, with overlap syndrome – “have a substantially greater risk of morbidity and mortality, compared to those with either COPD or OSA alone,” said Philippe E. Jaoude, MD, and Ali A. El Solh, MD, both of the Veterans Affairs Western New York Healthcare System in Buffalo and the University at Buffalo.

To identify factors associated with COPD exacerbation and all‐cause mortality in patients with overlap syndrome, Dr. Jaoude and Dr. El Solh reviewed the electronic health records of patients with simultaneous COPD and OSA. They compared patients with overlap syndrome who had an acute exacerbation of COPD during a 42-month period with a control group of patients with overlap syndrome who did not have exacerbations during that time. Patients with exacerbations and controls were matched 1:1 by age and body mass index.

Eligible patients were aged 42-90 years, had objectively confirmed COPD, and had documented OSA by in-laboratory polysomnography (that is, at least five obstructive apneas and hypopneas per hour). The investigators defined a COPD exacerbation as a sustained worsening of a patient’s respiratory condition that warranted additional treatment.

Of 225 eligible patients, 92 had at least one COPD exacerbation between March 2014 and September 2017. Patients with COPD exacerbation and controls had a mean age of about 68 years. The group of patients with exacerbation had a higher percentage of active smokers (21% vs. 9%) and had poorer lung function (mean forced expiratory volume in 1 second percent predicted: 55.2% vs. 64.5%).

“Although the rate of CPAP adherence between the two groups was not significantly different, the average time of CPAP use was significantly higher in patients with no recorded exacerbation,” the researchers reported – 285.4 min/night versus 238.2 min/night.

In all, 146 patients (79.4%) survived, and 38 patients (20.6%) died during the study period. The crude mortality rate was significantly higher in the group with COPD exacerbations (14% vs. 7%).

“Multivariate logistic regression analysis identified the independent risk factors associated with COPD exacerbations as active smoking, worse airflow limitation, and lower CPAP utilization,” they said. “As for all-cause mortality, a higher burden of comorbidities, worse airflow limitation, and lower time of CPAP use were independently associated with poor outcome.”

The researchers noted that they cannot rule out the possibility that patients who were adherent to CPAP were systematically different from those who were not.

The authors had no conflicts of interest.

[email protected]

SOURCE: Jaoude P et al. Clin Respir J. 2019 Aug 22. doi: 10.1111/crj.13079.

Among patients with chronic obstructive pulmonary disease (COPD) and obstructive sleep apnea (OSA), lung function and continuous positive airway pressure (CPAP) use are independent predictors of COPD exacerbations and all‐cause mortality, according to a retrospective cohort study.

“These factors should be taken into account when considering the management and prognosis of these patients,” the researchers said in the Clinical Respiratory Journal.

Prior studies have found that patients with COPD and OSA – that is, with overlap syndrome – “have a substantially greater risk of morbidity and mortality, compared to those with either COPD or OSA alone,” said Philippe E. Jaoude, MD, and Ali A. El Solh, MD, both of the Veterans Affairs Western New York Healthcare System in Buffalo and the University at Buffalo.

To identify factors associated with COPD exacerbation and all‐cause mortality in patients with overlap syndrome, Dr. Jaoude and Dr. El Solh reviewed the electronic health records of patients with simultaneous COPD and OSA. They compared patients with overlap syndrome who had an acute exacerbation of COPD during a 42-month period with a control group of patients with overlap syndrome who did not have exacerbations during that time. Patients with exacerbations and controls were matched 1:1 by age and body mass index.

Eligible patients were aged 42-90 years, had objectively confirmed COPD, and had documented OSA by in-laboratory polysomnography (that is, at least five obstructive apneas and hypopneas per hour). The investigators defined a COPD exacerbation as a sustained worsening of a patient’s respiratory condition that warranted additional treatment.

Of 225 eligible patients, 92 had at least one COPD exacerbation between March 2014 and September 2017. Patients with COPD exacerbation and controls had a mean age of about 68 years. The group of patients with exacerbation had a higher percentage of active smokers (21% vs. 9%) and had poorer lung function (mean forced expiratory volume in 1 second percent predicted: 55.2% vs. 64.5%).

“Although the rate of CPAP adherence between the two groups was not significantly different, the average time of CPAP use was significantly higher in patients with no recorded exacerbation,” the researchers reported – 285.4 min/night versus 238.2 min/night.

In all, 146 patients (79.4%) survived, and 38 patients (20.6%) died during the study period. The crude mortality rate was significantly higher in the group with COPD exacerbations (14% vs. 7%).

“Multivariate logistic regression analysis identified the independent risk factors associated with COPD exacerbations as active smoking, worse airflow limitation, and lower CPAP utilization,” they said. “As for all-cause mortality, a higher burden of comorbidities, worse airflow limitation, and lower time of CPAP use were independently associated with poor outcome.”

The researchers noted that they cannot rule out the possibility that patients who were adherent to CPAP were systematically different from those who were not.

The authors had no conflicts of interest.

[email protected]

SOURCE: Jaoude P et al. Clin Respir J. 2019 Aug 22. doi: 10.1111/crj.13079.

Suicide rates in the United States climbed from 1999 to 2016, a new cross-sectional study found, and the increases were highest in rural areas.

“These findings are consistent with previous studies demonstrating higher and more rapidly increasing suicide rates in rural areas and are of considerable interest in light of the work by [Anne] Case and [Angus] Deaton,” wrote Danielle L. Steelesmith, PhD, and associates. “While increasing rates of suicide are well documented, little is known about contextual factors associated with county-level suicide rates.” The findings appear in JAMA Network Open.

To examine those contextual factors, Dr. Steelesmith, of the department of psychiatry and behavioral health at the Ohio State University, Columbus, and associates analyzed county-by-county suicide statistics from 1999 to 2016 for adults aged 25-64 years, noting that they “focused on this age range because most studies on mortality trends have focused on this age range.”

The researchers developed 3-year suicide averages for counties for rate “stabilization” purposes. They placed the counties into four categories (large metropolitan, small metropolitan, micropolitan, and rural), and used various data sources to gather various types of statistics about the communities.

The study reported that 453,577 suicides within the 25-64–year age group occurred from 1999 to 2016. Most of those who died by suicide were men (77%), and most (51%) were aged 45-64 years. The median suicide rate per county rose from 15 per 100,000 (1999-2001) to 21 per 100,000 (2014-2016), reported Dr. Steelesmith and associates.

Rural counties only made up 2% of the suicides, compared with 81% in large and small metropolitan counties, but suicide rates were “increasing most rapidly in rural areas, although all county types saw increases during the period studied,” Dr. Steelesmith and associates wrote.

They added that “counties with the highest excess risk of suicide tended to be in Western states (e.g., Colorado, New Mexico, Utah, and Wyoming), Appalachia (e.g., Kentucky, Virginia, and West Virginia), and the Ozarks (e.g., Arkansas and Missouri).”

In addition to the connections between increasing suicide rates, living in a rural area, and a higher density of gun shops, the researchers cited other contextual factors. Among those factors were higher median age and higher percentages of non-Hispanic whites, numbers of residents without health insurance, and veterans. They also found links between higher suicide rates and worse numbers on indexes designed to measure social capital; social fragmentation; and deprivation, a measure encompassing lower education, employment levels, and income.

“Long-term and persistent poverty appears to be more entrenched and economic opportunities more constrained in rural areas,” Dr. Steelesmith and associates wrote. “Greater social isolation, challenges related to transportation and interpersonal communication, and associated difficulties accessing health and mental health services likely contribute to the disproportionate association of deprivation with suicide in rural counties.”

Dr. Steelesmith and associates cited several limitations. One key limitation is that, because the study looked only at adults aged 25-64 years, the results might not be generalizable to youth or elderly adults.

No study funding was reported. One study author reported serving on the scientific advisory board of Clarigent Health and receiving grant support from the National Institute of Mental Health outside of the submitted work. No other disclosures were reported.

SOURCE: Steelesmith DL et al. JAMA Netw Open. 2019 Sep 6. doi: 10.1001/jamanetworkopen.2019.10936.

Suicide rates in the United States climbed from 1999 to 2016, a new cross-sectional study found, and the increases were highest in rural areas.

“These findings are consistent with previous studies demonstrating higher and more rapidly increasing suicide rates in rural areas and are of considerable interest in light of the work by [Anne] Case and [Angus] Deaton,” wrote Danielle L. Steelesmith, PhD, and associates. “While increasing rates of suicide are well documented, little is known about contextual factors associated with county-level suicide rates.” The findings appear in JAMA Network Open.

To examine those contextual factors, Dr. Steelesmith, of the department of psychiatry and behavioral health at the Ohio State University, Columbus, and associates analyzed county-by-county suicide statistics from 1999 to 2016 for adults aged 25-64 years, noting that they “focused on this age range because most studies on mortality trends have focused on this age range.”

The researchers developed 3-year suicide averages for counties for rate “stabilization” purposes. They placed the counties into four categories (large metropolitan, small metropolitan, micropolitan, and rural), and used various data sources to gather various types of statistics about the communities.

The study reported that 453,577 suicides within the 25-64–year age group occurred from 1999 to 2016. Most of those who died by suicide were men (77%), and most (51%) were aged 45-64 years. The median suicide rate per county rose from 15 per 100,000 (1999-2001) to 21 per 100,000 (2014-2016), reported Dr. Steelesmith and associates.

Rural counties only made up 2% of the suicides, compared with 81% in large and small metropolitan counties, but suicide rates were “increasing most rapidly in rural areas, although all county types saw increases during the period studied,” Dr. Steelesmith and associates wrote.

They added that “counties with the highest excess risk of suicide tended to be in Western states (e.g., Colorado, New Mexico, Utah, and Wyoming), Appalachia (e.g., Kentucky, Virginia, and West Virginia), and the Ozarks (e.g., Arkansas and Missouri).”

In addition to the connections between increasing suicide rates, living in a rural area, and a higher density of gun shops, the researchers cited other contextual factors. Among those factors were higher median age and higher percentages of non-Hispanic whites, numbers of residents without health insurance, and veterans. They also found links between higher suicide rates and worse numbers on indexes designed to measure social capital; social fragmentation; and deprivation, a measure encompassing lower education, employment levels, and income.

“Long-term and persistent poverty appears to be more entrenched and economic opportunities more constrained in rural areas,” Dr. Steelesmith and associates wrote. “Greater social isolation, challenges related to transportation and interpersonal communication, and associated difficulties accessing health and mental health services likely contribute to the disproportionate association of deprivation with suicide in rural counties.”

Dr. Steelesmith and associates cited several limitations. One key limitation is that, because the study looked only at adults aged 25-64 years, the results might not be generalizable to youth or elderly adults.

No study funding was reported. One study author reported serving on the scientific advisory board of Clarigent Health and receiving grant support from the National Institute of Mental Health outside of the submitted work. No other disclosures were reported.

SOURCE: Steelesmith DL et al. JAMA Netw Open. 2019 Sep 6. doi: 10.1001/jamanetworkopen.2019.10936.

Suicide rates in the United States climbed from 1999 to 2016, a new cross-sectional study found, and the increases were highest in rural areas.

“These findings are consistent with previous studies demonstrating higher and more rapidly increasing suicide rates in rural areas and are of considerable interest in light of the work by [Anne] Case and [Angus] Deaton,” wrote Danielle L. Steelesmith, PhD, and associates. “While increasing rates of suicide are well documented, little is known about contextual factors associated with county-level suicide rates.” The findings appear in JAMA Network Open.

To examine those contextual factors, Dr. Steelesmith, of the department of psychiatry and behavioral health at the Ohio State University, Columbus, and associates analyzed county-by-county suicide statistics from 1999 to 2016 for adults aged 25-64 years, noting that they “focused on this age range because most studies on mortality trends have focused on this age range.”

The researchers developed 3-year suicide averages for counties for rate “stabilization” purposes. They placed the counties into four categories (large metropolitan, small metropolitan, micropolitan, and rural), and used various data sources to gather various types of statistics about the communities.

The study reported that 453,577 suicides within the 25-64–year age group occurred from 1999 to 2016. Most of those who died by suicide were men (77%), and most (51%) were aged 45-64 years. The median suicide rate per county rose from 15 per 100,000 (1999-2001) to 21 per 100,000 (2014-2016), reported Dr. Steelesmith and associates.

Rural counties only made up 2% of the suicides, compared with 81% in large and small metropolitan counties, but suicide rates were “increasing most rapidly in rural areas, although all county types saw increases during the period studied,” Dr. Steelesmith and associates wrote.

They added that “counties with the highest excess risk of suicide tended to be in Western states (e.g., Colorado, New Mexico, Utah, and Wyoming), Appalachia (e.g., Kentucky, Virginia, and West Virginia), and the Ozarks (e.g., Arkansas and Missouri).”

In addition to the connections between increasing suicide rates, living in a rural area, and a higher density of gun shops, the researchers cited other contextual factors. Among those factors were higher median age and higher percentages of non-Hispanic whites, numbers of residents without health insurance, and veterans. They also found links between higher suicide rates and worse numbers on indexes designed to measure social capital; social fragmentation; and deprivation, a measure encompassing lower education, employment levels, and income.

“Long-term and persistent poverty appears to be more entrenched and economic opportunities more constrained in rural areas,” Dr. Steelesmith and associates wrote. “Greater social isolation, challenges related to transportation and interpersonal communication, and associated difficulties accessing health and mental health services likely contribute to the disproportionate association of deprivation with suicide in rural counties.”

Dr. Steelesmith and associates cited several limitations. One key limitation is that, because the study looked only at adults aged 25-64 years, the results might not be generalizable to youth or elderly adults.

No study funding was reported. One study author reported serving on the scientific advisory board of Clarigent Health and receiving grant support from the National Institute of Mental Health outside of the submitted work. No other disclosures were reported.

SOURCE: Steelesmith DL et al. JAMA Netw Open. 2019 Sep 6. doi: 10.1001/jamanetworkopen.2019.10936.

A blood test for elevated carbon dioxide may be used in screening adults for obesity hypoventilation syndrome, according to new guidelines.

Obese adults with sleep-disordered breathing and increased blood carbon dioxide levels during the day are likely to have obesity hypoventilation syndrome (OHS), a result of shallow or slow breathing that can lead to respiratory failure, heart failure, pulmonary hypertension, and death. Pulmonologists and sleep specialists may be the first to see and diagnose patients with OHS in the outpatient setting, while other cases are diagnosed in the hospital when patients present with hypercapnic respiratory failure.

Screening for OHS usually involves measuring arterial blood gases, which is not standard practice in outpatient clinics. Patients often remain undiagnosed and untreated until late in the course of the disease, according to the American Thoracic Society, which in August published a new diagnosis and management guideline aiming to boost early diagnosis and reduce variability in treatment (Am J Respir Crit Care Med. 2019;200:3,e6–e24).

The guideline authors, led by Babak Mokhlesi, MD, of the University of Chicago, recommend a simpler screening method – measuring serum bicarbonate only – to rule out OHS in obese patients with nighttime breathing problems.

Serum bicarbonate should be measured in obese patients with sleep-disordered breathing and a low likelihood of OHS, Dr. Mokhlesi and colleagues recommend in the guideline. If serum bicarbonate is below 27 mmol/L, it is not necessary to conduct further testing as the patient is unlikely to have OHS.

In patients whose serum bicarbonate is higher than 27 mmol/L, or who are strongly suspected of having OHS at presentation because of severe obesity or other symptoms, arterial blood gases should be measured and a sleep study conducted. The guideline authors said that there is insufficient evidence to recommend that pulse oximetry be used in the diagnostic pathway for OHS.

First-line treatment for stable, ambulatory patients with OHS should be positive airway pressure during sleep, rather than noninvasive ventilation, Dr. Mokhlesi and colleagues concluded. For patients with comorbid obstructive sleep apnea – as many as 70% of OHS patients also have OSA – the first-line treatment should be continuous positive airway pressure (CPAP) at night, the guideline states.

Patients hospitalized with respiratory failure and suspected of having OHS should be discharged with noninvasive ventilation until diagnostic procedures can be performed, along with PAP titration in a sleep lab.

In patients initially treated with CPAP who remain symptomatic or whose blood carbon dioxide does not improve, noninvasive ventilation can be tried, the guidelines say. Finally, patients diagnosed with OHS should be guided to weight loss interventions with the aim of reducing body weight by 25%-30%. This can include referral for bariatric surgery in patients without contraindications.

Dr. Mokhlesi and colleagues acknowledged that all of the recommendations contained in the guideline are classed as “conditional,” based on the quality of evidence assessed.

The American Thoracic Society funded the study. Dr. Mokhlesi and 7 coauthors disclosed financial conflicts of interest, while an additional 13 coauthors had none. Disclosures can be found on the AJRCCM website.

SOURCE: Mokhlesi B et al. Am J Respir Crit Care Med. 2019;200:3,e6-e24

A blood test for elevated carbon dioxide may be used in screening adults for obesity hypoventilation syndrome, according to new guidelines.

Obese adults with sleep-disordered breathing and increased blood carbon dioxide levels during the day are likely to have obesity hypoventilation syndrome (OHS), a result of shallow or slow breathing that can lead to respiratory failure, heart failure, pulmonary hypertension, and death. Pulmonologists and sleep specialists may be the first to see and diagnose patients with OHS in the outpatient setting, while other cases are diagnosed in the hospital when patients present with hypercapnic respiratory failure.

Screening for OHS usually involves measuring arterial blood gases, which is not standard practice in outpatient clinics. Patients often remain undiagnosed and untreated until late in the course of the disease, according to the American Thoracic Society, which in August published a new diagnosis and management guideline aiming to boost early diagnosis and reduce variability in treatment (Am J Respir Crit Care Med. 2019;200:3,e6–e24).

The guideline authors, led by Babak Mokhlesi, MD, of the University of Chicago, recommend a simpler screening method – measuring serum bicarbonate only – to rule out OHS in obese patients with nighttime breathing problems.

Serum bicarbonate should be measured in obese patients with sleep-disordered breathing and a low likelihood of OHS, Dr. Mokhlesi and colleagues recommend in the guideline. If serum bicarbonate is below 27 mmol/L, it is not necessary to conduct further testing as the patient is unlikely to have OHS.

In patients whose serum bicarbonate is higher than 27 mmol/L, or who are strongly suspected of having OHS at presentation because of severe obesity or other symptoms, arterial blood gases should be measured and a sleep study conducted. The guideline authors said that there is insufficient evidence to recommend that pulse oximetry be used in the diagnostic pathway for OHS.

First-line treatment for stable, ambulatory patients with OHS should be positive airway pressure during sleep, rather than noninvasive ventilation, Dr. Mokhlesi and colleagues concluded. For patients with comorbid obstructive sleep apnea – as many as 70% of OHS patients also have OSA – the first-line treatment should be continuous positive airway pressure (CPAP) at night, the guideline states.

Patients hospitalized with respiratory failure and suspected of having OHS should be discharged with noninvasive ventilation until diagnostic procedures can be performed, along with PAP titration in a sleep lab.

In patients initially treated with CPAP who remain symptomatic or whose blood carbon dioxide does not improve, noninvasive ventilation can be tried, the guidelines say. Finally, patients diagnosed with OHS should be guided to weight loss interventions with the aim of reducing body weight by 25%-30%. This can include referral for bariatric surgery in patients without contraindications.

Dr. Mokhlesi and colleagues acknowledged that all of the recommendations contained in the guideline are classed as “conditional,” based on the quality of evidence assessed.

The American Thoracic Society funded the study. Dr. Mokhlesi and 7 coauthors disclosed financial conflicts of interest, while an additional 13 coauthors had none. Disclosures can be found on the AJRCCM website.

SOURCE: Mokhlesi B et al. Am J Respir Crit Care Med. 2019;200:3,e6-e24

A blood test for elevated carbon dioxide may be used in screening adults for obesity hypoventilation syndrome, according to new guidelines.

Obese adults with sleep-disordered breathing and increased blood carbon dioxide levels during the day are likely to have obesity hypoventilation syndrome (OHS), a result of shallow or slow breathing that can lead to respiratory failure, heart failure, pulmonary hypertension, and death. Pulmonologists and sleep specialists may be the first to see and diagnose patients with OHS in the outpatient setting, while other cases are diagnosed in the hospital when patients present with hypercapnic respiratory failure.

Screening for OHS usually involves measuring arterial blood gases, which is not standard practice in outpatient clinics. Patients often remain undiagnosed and untreated until late in the course of the disease, according to the American Thoracic Society, which in August published a new diagnosis and management guideline aiming to boost early diagnosis and reduce variability in treatment (Am J Respir Crit Care Med. 2019;200:3,e6–e24).

The guideline authors, led by Babak Mokhlesi, MD, of the University of Chicago, recommend a simpler screening method – measuring serum bicarbonate only – to rule out OHS in obese patients with nighttime breathing problems.

Serum bicarbonate should be measured in obese patients with sleep-disordered breathing and a low likelihood of OHS, Dr. Mokhlesi and colleagues recommend in the guideline. If serum bicarbonate is below 27 mmol/L, it is not necessary to conduct further testing as the patient is unlikely to have OHS.

In patients whose serum bicarbonate is higher than 27 mmol/L, or who are strongly suspected of having OHS at presentation because of severe obesity or other symptoms, arterial blood gases should be measured and a sleep study conducted. The guideline authors said that there is insufficient evidence to recommend that pulse oximetry be used in the diagnostic pathway for OHS.

First-line treatment for stable, ambulatory patients with OHS should be positive airway pressure during sleep, rather than noninvasive ventilation, Dr. Mokhlesi and colleagues concluded. For patients with comorbid obstructive sleep apnea – as many as 70% of OHS patients also have OSA – the first-line treatment should be continuous positive airway pressure (CPAP) at night, the guideline states.

Patients hospitalized with respiratory failure and suspected of having OHS should be discharged with noninvasive ventilation until diagnostic procedures can be performed, along with PAP titration in a sleep lab.

In patients initially treated with CPAP who remain symptomatic or whose blood carbon dioxide does not improve, noninvasive ventilation can be tried, the guidelines say. Finally, patients diagnosed with OHS should be guided to weight loss interventions with the aim of reducing body weight by 25%-30%. This can include referral for bariatric surgery in patients without contraindications.

Dr. Mokhlesi and colleagues acknowledged that all of the recommendations contained in the guideline are classed as “conditional,” based on the quality of evidence assessed.

The American Thoracic Society funded the study. Dr. Mokhlesi and 7 coauthors disclosed financial conflicts of interest, while an additional 13 coauthors had none. Disclosures can be found on the AJRCCM website.

SOURCE: Mokhlesi B et al. Am J Respir Crit Care Med. 2019;200:3,e6-e24

Vitamin E acetate is one possible culprit in the mysterious vaping-associated lung disease that has killed three patients, sickened 450, and baffled clinicians and investigators all summer.

mauro grigollo/Thinkstock

Another death may be linked to the disorder, officials said during a joint press briefing held by the Centers for Disease Control and Prevention and the Food and Drug Administration. In all, 450 potential cases have been reported and e-cigarette use confirmed in 215. Cases have occurred in 33 states and one territory. A total of 84% of the patients reported having used tetrahydrocannabinol (THC) products in e-cigarette devices.

A preliminary report on the situation by Jennifer Layden, MD, of the department of public health in Illinois and colleagues – including a preliminary case definition – was simultaneously released in the New England Journal of Medicine (2019 Sep 6. doi: 10.1056/NEJMoa1911614).

No single device or substance was common to all the cases, leading officials to issue a blanket warning against e-cigarettes, especially those containing THC.

“We believe a chemical exposure is likely related, but more information is needed to determine what substances. Some labs have identified vitamin E acetate in some samples,” said Dana Meaney-Delman, MD, MPH, incident manager, CDC 2019 Lung Injury Response. “Continued investigation is needed to identify the risk associated with a specific product or substance.”

Besides vitamin E acetate, federal labs are looking at other cannabinoids, cutting agents, diluting agents, pesticides, opioids, and toxins.

Officials also issued a general warning about the products. Youths, young people, and pregnant women should never use e-cigarettes, they cautioned, and no one should buy them from a noncertified source, a street vendor, or a social contact. Even cartridges originally obtained from a certified source should never have been altered in any way.

Dr. Layden and colleagues reported that bilateral lung infiltrates was characterized in 98% of the 53 patients hospitalized with the recently reported e-cigarette–induced lung injury. Nonspecific constitutional symptoms, including fever, chills, weight loss, and fatigue, were present in all of the patients.

Patients may show some symptoms days or even weeks before acute respiratory failure develops, and many had sought medical help before that. All presented with bilateral lung infiltrates, part of an evolving case definition. Many complained of nonspecific constitutional symptoms, including fever, chills, gastrointestinal symptoms, and weight loss. Of the patients who underwent bronchoscopy, many were diagnosed as having lipoid pneumonia, a rare condition characterized by lipid-laden macrophages.

“We don’t know the significance of the lipid-containing macrophages, and we don’t know if the lipids are endogenous or exogenous,” Dr. Meaney-Delman said.

The incidence of such cases appears to be rising rapidly, Dr. Layden noted. An epidemiologic review of cases in Illinois found that the mean monthly rate of visits related to severe respiratory illness in June-August was twice that observed during the same months last year.
 

[email protected]

SOURCE: Layden JE et al. N Engl J Med. 2019 Sep 6. doi: 1 0.1056/NEJMoa1911614.

Vitamin E acetate is one possible culprit in the mysterious vaping-associated lung disease that has killed three patients, sickened 450, and baffled clinicians and investigators all summer.

mauro grigollo/Thinkstock

Another death may be linked to the disorder, officials said during a joint press briefing held by the Centers for Disease Control and Prevention and the Food and Drug Administration. In all, 450 potential cases have been reported and e-cigarette use confirmed in 215. Cases have occurred in 33 states and one territory. A total of 84% of the patients reported having used tetrahydrocannabinol (THC) products in e-cigarette devices.

A preliminary report on the situation by Jennifer Layden, MD, of the department of public health in Illinois and colleagues – including a preliminary case definition – was simultaneously released in the New England Journal of Medicine (2019 Sep 6. doi: 10.1056/NEJMoa1911614).

No single device or substance was common to all the cases, leading officials to issue a blanket warning against e-cigarettes, especially those containing THC.

“We believe a chemical exposure is likely related, but more information is needed to determine what substances. Some labs have identified vitamin E acetate in some samples,” said Dana Meaney-Delman, MD, MPH, incident manager, CDC 2019 Lung Injury Response. “Continued investigation is needed to identify the risk associated with a specific product or substance.”

Besides vitamin E acetate, federal labs are looking at other cannabinoids, cutting agents, diluting agents, pesticides, opioids, and toxins.

Officials also issued a general warning about the products. Youths, young people, and pregnant women should never use e-cigarettes, they cautioned, and no one should buy them from a noncertified source, a street vendor, or a social contact. Even cartridges originally obtained from a certified source should never have been altered in any way.

Dr. Layden and colleagues reported that bilateral lung infiltrates was characterized in 98% of the 53 patients hospitalized with the recently reported e-cigarette–induced lung injury. Nonspecific constitutional symptoms, including fever, chills, weight loss, and fatigue, were present in all of the patients.

Patients may show some symptoms days or even weeks before acute respiratory failure develops, and many had sought medical help before that. All presented with bilateral lung infiltrates, part of an evolving case definition. Many complained of nonspecific constitutional symptoms, including fever, chills, gastrointestinal symptoms, and weight loss. Of the patients who underwent bronchoscopy, many were diagnosed as having lipoid pneumonia, a rare condition characterized by lipid-laden macrophages.

“We don’t know the significance of the lipid-containing macrophages, and we don’t know if the lipids are endogenous or exogenous,” Dr. Meaney-Delman said.

The incidence of such cases appears to be rising rapidly, Dr. Layden noted. An epidemiologic review of cases in Illinois found that the mean monthly rate of visits related to severe respiratory illness in June-August was twice that observed during the same months last year.
 

[email protected]

SOURCE: Layden JE et al. N Engl J Med. 2019 Sep 6. doi: 1 0.1056/NEJMoa1911614.

Vitamin E acetate is one possible culprit in the mysterious vaping-associated lung disease that has killed three patients, sickened 450, and baffled clinicians and investigators all summer.

mauro grigollo/Thinkstock

Another death may be linked to the disorder, officials said during a joint press briefing held by the Centers for Disease Control and Prevention and the Food and Drug Administration. In all, 450 potential cases have been reported and e-cigarette use confirmed in 215. Cases have occurred in 33 states and one territory. A total of 84% of the patients reported having used tetrahydrocannabinol (THC) products in e-cigarette devices.

A preliminary report on the situation by Jennifer Layden, MD, of the department of public health in Illinois and colleagues – including a preliminary case definition – was simultaneously released in the New England Journal of Medicine (2019 Sep 6. doi: 10.1056/NEJMoa1911614).

No single device or substance was common to all the cases, leading officials to issue a blanket warning against e-cigarettes, especially those containing THC.

“We believe a chemical exposure is likely related, but more information is needed to determine what substances. Some labs have identified vitamin E acetate in some samples,” said Dana Meaney-Delman, MD, MPH, incident manager, CDC 2019 Lung Injury Response. “Continued investigation is needed to identify the risk associated with a specific product or substance.”

Besides vitamin E acetate, federal labs are looking at other cannabinoids, cutting agents, diluting agents, pesticides, opioids, and toxins.

Officials also issued a general warning about the products. Youths, young people, and pregnant women should never use e-cigarettes, they cautioned, and no one should buy them from a noncertified source, a street vendor, or a social contact. Even cartridges originally obtained from a certified source should never have been altered in any way.

Dr. Layden and colleagues reported that bilateral lung infiltrates was characterized in 98% of the 53 patients hospitalized with the recently reported e-cigarette–induced lung injury. Nonspecific constitutional symptoms, including fever, chills, weight loss, and fatigue, were present in all of the patients.

Patients may show some symptoms days or even weeks before acute respiratory failure develops, and many had sought medical help before that. All presented with bilateral lung infiltrates, part of an evolving case definition. Many complained of nonspecific constitutional symptoms, including fever, chills, gastrointestinal symptoms, and weight loss. Of the patients who underwent bronchoscopy, many were diagnosed as having lipoid pneumonia, a rare condition characterized by lipid-laden macrophages.

“We don’t know the significance of the lipid-containing macrophages, and we don’t know if the lipids are endogenous or exogenous,” Dr. Meaney-Delman said.

The incidence of such cases appears to be rising rapidly, Dr. Layden noted. An epidemiologic review of cases in Illinois found that the mean monthly rate of visits related to severe respiratory illness in June-August was twice that observed during the same months last year.
 

[email protected]

SOURCE: Layden JE et al. N Engl J Med. 2019 Sep 6. doi: 1 0.1056/NEJMoa1911614.

The U.K. National Institute for Health and Care Excellence (NICE) has issued new guidance on the combined usage of dapagliflozin and insulin for treating patients with type 1 diabetes inadequately controlled by insulin alone.

In a review of clinical trials, NICE found that dapagliflozin plus insulin conferred small benefits in hemoglobin A_1c, weight loss, and quality of life, compared with insulin alone. These benefits translated to a reduced risk of long-term complications over the lifetime of the patient.

In the new NICE guideline, dual treatment with dapagliflozin and insulin in adults with type 1 diabetes and a body mass index greater than 27 kg/m² is recommended only when they are receiving insulin doses of more than 0.5 units/kg per day; have undergone an evidence-based, quality-assured education program; and are supervised by a physician specializing in endocrinology and diabetes.

Hemoglobin A_1c levels should be assessed after 6 months and at regular intervals after that; if glycemic control is not improved, dapagliflozin should be stopped, as there is an increased risk of diabetic ketoacidosis.

Find the full technology appraisal guidance on the NICE website.

[email protected]

The U.K. National Institute for Health and Care Excellence (NICE) has issued new guidance on the combined usage of dapagliflozin and insulin for treating patients with type 1 diabetes inadequately controlled by insulin alone.

In a review of clinical trials, NICE found that dapagliflozin plus insulin conferred small benefits in hemoglobin A_1c, weight loss, and quality of life, compared with insulin alone. These benefits translated to a reduced risk of long-term complications over the lifetime of the patient.

In the new NICE guideline, dual treatment with dapagliflozin and insulin in adults with type 1 diabetes and a body mass index greater than 27 kg/m² is recommended only when they are receiving insulin doses of more than 0.5 units/kg per day; have undergone an evidence-based, quality-assured education program; and are supervised by a physician specializing in endocrinology and diabetes.

Hemoglobin A_1c levels should be assessed after 6 months and at regular intervals after that; if glycemic control is not improved, dapagliflozin should be stopped, as there is an increased risk of diabetic ketoacidosis.

Find the full technology appraisal guidance on the NICE website.

[email protected]

The U.K. National Institute for Health and Care Excellence (NICE) has issued new guidance on the combined usage of dapagliflozin and insulin for treating patients with type 1 diabetes inadequately controlled by insulin alone.

In a review of clinical trials, NICE found that dapagliflozin plus insulin conferred small benefits in hemoglobin A_1c, weight loss, and quality of life, compared with insulin alone. These benefits translated to a reduced risk of long-term complications over the lifetime of the patient.

In the new NICE guideline, dual treatment with dapagliflozin and insulin in adults with type 1 diabetes and a body mass index greater than 27 kg/m² is recommended only when they are receiving insulin doses of more than 0.5 units/kg per day; have undergone an evidence-based, quality-assured education program; and are supervised by a physician specializing in endocrinology and diabetes.

Hemoglobin A_1c levels should be assessed after 6 months and at regular intervals after that; if glycemic control is not improved, dapagliflozin should be stopped, as there is an increased risk of diabetic ketoacidosis.

Find the full technology appraisal guidance on the NICE website.

[email protected]

Hospitalist Rahul C. Borsadia, MD, had been working with Orlando Health Inpatient Medicine Group since the year of its founding in 2011.

The salaries of the practice’s physicians back then were based on relative value units (RVU) – the more patients that physicians saw, the higher their salaries. But a problem arose, Dr. Borsadia said. Physicians were trying to squeeze in two dozen or more patients a day “in a practice that is modeled for quality.”

“By the time the end of the day comes, it’s 9 or 10 p.m. and you are leaving but coming back at 6:30 the next morning. So, lack of sleep, more patients, striving to earn that higher salary,” he said. “The desire to perform quality work with that kind of patient load was not fulfilled and that lead to dissatisfaction and stress, which lead to irritation and exodus from the group.”

Three years ago, the practice transitioned to a throughput process with a census limit of 18 patients or less, without an RVU system, but with salary incentives based on patient satisfaction, billing, and documentation.

“We’ve not had anybody leave the hospital because of burnout or dissatisfaction” since the new system was put into place, Dr. Borsadia said. “Less burnout means more people are happy.”

Although symptoms of burnout still seem to be rampant across hospital medicine, hospitalists are putting potential solutions into place. And – sometimes – they are making progress, through tweaks in schedules and responsibilities, incentives suited to different goals, and better communication.
 

Scheduling problems

The need for continuing efforts to improve the work experience for hospitalists is apparent, said Henry Michtalik, MD, MPH, MHS, assistant professor of general internal medicine at Johns Hopkins, Baltimore, who led a workshop on the topic at the 2019 Annual Conference of the Society of Hospital Medicine (HM19).

A 2016 survey of academic general internal medicine clinicians – including about 600 hospitalists and outpatient physicians – found that 67% reported high stress, 38% said they were “burned out,” 50% said they felt they had “low control” over their work, and 60% said they felt high documentation pressures. Still, 68% said they were satisfied with the values of their departments.

Hospitalists surveyed were actually less likely to say they were burned out, compared with outpatient internists – 52%, compared with 55% – but they were more likely to score low on a scale measuring personal accomplishments, compared with the outpatient clinicians – 20% to 10%. The survey found no significant difference between the two groups in depression or suicidality. But with 40% reporting depression and 10% reporting thoughts of suicide, the numbers virtually cry out for solutions.

Hospitalists in the HM19 workshop, as in other sessions at the Annual Conference, questioned whether the standard 7-days-on, 7-days-off work schedule – seven 12-hour shifts followed by 7 days off – allows hospitalists to pair their works lives with their personal lives in a sustainable way. They described the way that the stress and fatigue of such an intense work period bleeds into the days off that follow after it.

“By the end of seven 12’s, they’re bleary eyed, they’re upset, they go home (for) 2 days of washout before they even start to enjoy whatever life they have left,” said Jonathan Martin, MD, director of medicine at Cumberland Medical Center in Crossville, Tenn. “It’s hard to get hospitalists to buy in, which increases their dissatisfaction.”

Dr. Michtalik had a similar perspective.

“You just shut the rest of your life down completely for those 7 days and then, on your 7 days off, you’ve scheduled your life,” he said. “But that last off day – day number 7 – you feel that pit in your stomach, that the streak is coming.” He joked that the feeling was similar to the dread inspired by the phrase “winter is coming” in the popular HBO series “Game of Thrones.”

Systematic reviews of the literature have found that it’s mostly changes at the organization level – rather than changes that an individual physician makes on his or her own – that tend to make significant differences. Changes to structure, communication, and scheduling tend to work better than working on mindfulness, education, or trying to improve resilience, Dr. Michtalik said.

In one study discussed at the HM19 workshop, researchers compared a schedule in which an intensivist works in-house for 7 days, with home call at night, to a schedule in which the intensivist is completely off at night, with an in-house intensivist covering the night shift. The schedule in which the intensivist was truly off for the night significantly reduced reports of burnout, while not affecting length of stay or patient-experience outcomes.

Dr. Michtalik said that another study compared 4-week rotations to 2-week rotations for attending physicians. Researchers found that the 2-week version resulted in lower reports of burnout, with readmissions and patient experience unaffected, although they noted that residents tended to prefer 4-week schedules because they felt it resulted in better relationships with the attending physician.

Perhaps the dominant factor in job satisfaction that’s been identified in surveys is how physicians, patients, and administrators relate to one another, Dr. Michtalik said.

“The important concept here is that relationships were really important in driving job satisfaction, whether that be with our colleagues, our patients, or with the staff that you’re working with,” he said. “It’s always easier to decline a consultation or have a bad interaction with someone over the phone than it is if you actually know them or you are communicating face to face. That’s why it’s important to develop these kinds of relationships, which also put a face to what’s going on.”
 

Beyond salary adjustments

Hospitalists attending the HM19 workshop said they thought that participating in administration committees at their own institutions helps keep hospitalists involved in hospital matters, limiting the effects of burnout and improving workplace satisfaction.

Kevin McAninch, DO, a hospitalist with Central Ohio Primary Care in Westerville, said a shift in work responsibilities has made an improvement at his hospital. There is now an “inpatient support center” – which has a physician and a nurse in an office taking calls from 6 p.m. to 7 a.m., so that rounders can stop taking floor calls during that time.

The system “takes the pressure off our admitters at night and our nurses because they’re not getting floor calls anymore, so they’re just taking care of the admissions from the ER,” he said.

A recurring theme of the discussion was that salary alone seems universally incapable of eradicating feelings of burnout. One hospitalist said that in surveys, higher-paid physicians insist that monetary compensation is their main driver, but still often complain of burnout because they must work extra shifts to earn that higher level of pay.

Instead, burnout and satisfaction indicators tend to have more do to with time, control, and support, Dr. Michtalik noted.

Mangla Gulati, MD, SFHM, chief quality officer at the University of Maryland Medical Center in Baltimore, said that there’s no big secret about what hospitalists want from their places of employment. They want things like getting patients to service faster so they can make diagnoses, making sure patients get the care they need, fixing the problems associated with electronic medical records, and having a work-life “integration.”

“The questions is – how do we get there?” Dr. Gulati wondered. She suggested that hospitalists have to be more assertive and explanatory in their interactions with members of the hospital C-suite.

“I think it’s really important for you to understand or ask your C-suite, ‘Where are you in this whole journey? What is your perception of wellness? Tell me some of the measures of staff wellness,’ ” she said.

If the C-suite says “we have no money” to make improvements, hospitalists must be willing to say, ‘Well, you’re going to have to invest a little bit.’ ” Dr. Gulati said. “What is the ROI (return on investment) on the turnover of a physician? Because when you turn a physician over, you have to recruit and hire new staff.”

Dr. Gulati said that hospitalists should provide C-suite leaders with a detailed walk-through of their actual workflows – what their workdays look like – because “it’s not something they’re familiar with.”

Aside from improving relations with hospital administration, Dr. Gulati suggested creating CME programs for wellness, offering time and funding for physician support meetings, supporting flexibility in work hours, and creating programs specifically to help clinicians with burnout symptoms.

She also touted the benefits of “Schwartz Rounds,” in which several medical disciplines gather to talk about a case that was particularly challenging, clinically complex, and emotionally draining for everyone involved.

At Cumberland Medical Center, Dr. Martin said he has two meetings a month with executives in the hospital’s C-suite. One is with his hospitalist group, TeamHealth, and one is more direct, between himself and hospital administrators. It’s just 2 hours a month, but these conversations have undoubtedly helped, he said, although he cautioned that “the meetings themselves don’t have as much meaning if you aren’t communicating effectively,” meaning hospitalists must understand how the C-suite thinks and learn to speak in terms they understand.

“When I go to the administration now and I say ‘Hey, this is a problem that we’re having. I need your help in solving it,’ the executives are much more likely to respond to me than if they’d never seen me, or only see me rarely,” Dr. Martin said.

As a result, a collaborative approach to such conversations tends to be more effective.

“If you go to the C-suite and say, ‘Here’s our issue, how can you help us?’ – as opposed to telling the administration, ‘This is what I need’ – they are more likely to work with you to generate a solution.”

Hospitalist Rahul C. Borsadia, MD, had been working with Orlando Health Inpatient Medicine Group since the year of its founding in 2011.

The salaries of the practice’s physicians back then were based on relative value units (RVU) – the more patients that physicians saw, the higher their salaries. But a problem arose, Dr. Borsadia said. Physicians were trying to squeeze in two dozen or more patients a day “in a practice that is modeled for quality.”

“By the time the end of the day comes, it’s 9 or 10 p.m. and you are leaving but coming back at 6:30 the next morning. So, lack of sleep, more patients, striving to earn that higher salary,” he said. “The desire to perform quality work with that kind of patient load was not fulfilled and that lead to dissatisfaction and stress, which lead to irritation and exodus from the group.”

Three years ago, the practice transitioned to a throughput process with a census limit of 18 patients or less, without an RVU system, but with salary incentives based on patient satisfaction, billing, and documentation.

“We’ve not had anybody leave the hospital because of burnout or dissatisfaction” since the new system was put into place, Dr. Borsadia said. “Less burnout means more people are happy.”

Although symptoms of burnout still seem to be rampant across hospital medicine, hospitalists are putting potential solutions into place. And – sometimes – they are making progress, through tweaks in schedules and responsibilities, incentives suited to different goals, and better communication.
 

Scheduling problems

The need for continuing efforts to improve the work experience for hospitalists is apparent, said Henry Michtalik, MD, MPH, MHS, assistant professor of general internal medicine at Johns Hopkins, Baltimore, who led a workshop on the topic at the 2019 Annual Conference of the Society of Hospital Medicine (HM19).

A 2016 survey of academic general internal medicine clinicians – including about 600 hospitalists and outpatient physicians – found that 67% reported high stress, 38% said they were “burned out,” 50% said they felt they had “low control” over their work, and 60% said they felt high documentation pressures. Still, 68% said they were satisfied with the values of their departments.

Hospitalists surveyed were actually less likely to say they were burned out, compared with outpatient internists – 52%, compared with 55% – but they were more likely to score low on a scale measuring personal accomplishments, compared with the outpatient clinicians – 20% to 10%. The survey found no significant difference between the two groups in depression or suicidality. But with 40% reporting depression and 10% reporting thoughts of suicide, the numbers virtually cry out for solutions.

Hospitalists in the HM19 workshop, as in other sessions at the Annual Conference, questioned whether the standard 7-days-on, 7-days-off work schedule – seven 12-hour shifts followed by 7 days off – allows hospitalists to pair their works lives with their personal lives in a sustainable way. They described the way that the stress and fatigue of such an intense work period bleeds into the days off that follow after it.

“By the end of seven 12’s, they’re bleary eyed, they’re upset, they go home (for) 2 days of washout before they even start to enjoy whatever life they have left,” said Jonathan Martin, MD, director of medicine at Cumberland Medical Center in Crossville, Tenn. “It’s hard to get hospitalists to buy in, which increases their dissatisfaction.”

Dr. Michtalik had a similar perspective.

“You just shut the rest of your life down completely for those 7 days and then, on your 7 days off, you’ve scheduled your life,” he said. “But that last off day – day number 7 – you feel that pit in your stomach, that the streak is coming.” He joked that the feeling was similar to the dread inspired by the phrase “winter is coming” in the popular HBO series “Game of Thrones.”

Systematic reviews of the literature have found that it’s mostly changes at the organization level – rather than changes that an individual physician makes on his or her own – that tend to make significant differences. Changes to structure, communication, and scheduling tend to work better than working on mindfulness, education, or trying to improve resilience, Dr. Michtalik said.

In one study discussed at the HM19 workshop, researchers compared a schedule in which an intensivist works in-house for 7 days, with home call at night, to a schedule in which the intensivist is completely off at night, with an in-house intensivist covering the night shift. The schedule in which the intensivist was truly off for the night significantly reduced reports of burnout, while not affecting length of stay or patient-experience outcomes.

Dr. Michtalik said that another study compared 4-week rotations to 2-week rotations for attending physicians. Researchers found that the 2-week version resulted in lower reports of burnout, with readmissions and patient experience unaffected, although they noted that residents tended to prefer 4-week schedules because they felt it resulted in better relationships with the attending physician.

Perhaps the dominant factor in job satisfaction that’s been identified in surveys is how physicians, patients, and administrators relate to one another, Dr. Michtalik said.

“The important concept here is that relationships were really important in driving job satisfaction, whether that be with our colleagues, our patients, or with the staff that you’re working with,” he said. “It’s always easier to decline a consultation or have a bad interaction with someone over the phone than it is if you actually know them or you are communicating face to face. That’s why it’s important to develop these kinds of relationships, which also put a face to what’s going on.”
 

Beyond salary adjustments

Hospitalists attending the HM19 workshop said they thought that participating in administration committees at their own institutions helps keep hospitalists involved in hospital matters, limiting the effects of burnout and improving workplace satisfaction.

Kevin McAninch, DO, a hospitalist with Central Ohio Primary Care in Westerville, said a shift in work responsibilities has made an improvement at his hospital. There is now an “inpatient support center” – which has a physician and a nurse in an office taking calls from 6 p.m. to 7 a.m., so that rounders can stop taking floor calls during that time.

The system “takes the pressure off our admitters at night and our nurses because they’re not getting floor calls anymore, so they’re just taking care of the admissions from the ER,” he said.

A recurring theme of the discussion was that salary alone seems universally incapable of eradicating feelings of burnout. One hospitalist said that in surveys, higher-paid physicians insist that monetary compensation is their main driver, but still often complain of burnout because they must work extra shifts to earn that higher level of pay.

Instead, burnout and satisfaction indicators tend to have more do to with time, control, and support, Dr. Michtalik noted.

Mangla Gulati, MD, SFHM, chief quality officer at the University of Maryland Medical Center in Baltimore, said that there’s no big secret about what hospitalists want from their places of employment. They want things like getting patients to service faster so they can make diagnoses, making sure patients get the care they need, fixing the problems associated with electronic medical records, and having a work-life “integration.”

“The questions is – how do we get there?” Dr. Gulati wondered. She suggested that hospitalists have to be more assertive and explanatory in their interactions with members of the hospital C-suite.

“I think it’s really important for you to understand or ask your C-suite, ‘Where are you in this whole journey? What is your perception of wellness? Tell me some of the measures of staff wellness,’ ” she said.

If the C-suite says “we have no money” to make improvements, hospitalists must be willing to say, ‘Well, you’re going to have to invest a little bit.’ ” Dr. Gulati said. “What is the ROI (return on investment) on the turnover of a physician? Because when you turn a physician over, you have to recruit and hire new staff.”

Dr. Gulati said that hospitalists should provide C-suite leaders with a detailed walk-through of their actual workflows – what their workdays look like – because “it’s not something they’re familiar with.”

Aside from improving relations with hospital administration, Dr. Gulati suggested creating CME programs for wellness, offering time and funding for physician support meetings, supporting flexibility in work hours, and creating programs specifically to help clinicians with burnout symptoms.

She also touted the benefits of “Schwartz Rounds,” in which several medical disciplines gather to talk about a case that was particularly challenging, clinically complex, and emotionally draining for everyone involved.

At Cumberland Medical Center, Dr. Martin said he has two meetings a month with executives in the hospital’s C-suite. One is with his hospitalist group, TeamHealth, and one is more direct, between himself and hospital administrators. It’s just 2 hours a month, but these conversations have undoubtedly helped, he said, although he cautioned that “the meetings themselves don’t have as much meaning if you aren’t communicating effectively,” meaning hospitalists must understand how the C-suite thinks and learn to speak in terms they understand.

“When I go to the administration now and I say ‘Hey, this is a problem that we’re having. I need your help in solving it,’ the executives are much more likely to respond to me than if they’d never seen me, or only see me rarely,” Dr. Martin said.

As a result, a collaborative approach to such conversations tends to be more effective.

“If you go to the C-suite and say, ‘Here’s our issue, how can you help us?’ – as opposed to telling the administration, ‘This is what I need’ – they are more likely to work with you to generate a solution.”

Hospitalist Rahul C. Borsadia, MD, had been working with Orlando Health Inpatient Medicine Group since the year of its founding in 2011.

The salaries of the practice’s physicians back then were based on relative value units (RVU) – the more patients that physicians saw, the higher their salaries. But a problem arose, Dr. Borsadia said. Physicians were trying to squeeze in two dozen or more patients a day “in a practice that is modeled for quality.”

“By the time the end of the day comes, it’s 9 or 10 p.m. and you are leaving but coming back at 6:30 the next morning. So, lack of sleep, more patients, striving to earn that higher salary,” he said. “The desire to perform quality work with that kind of patient load was not fulfilled and that lead to dissatisfaction and stress, which lead to irritation and exodus from the group.”

Three years ago, the practice transitioned to a throughput process with a census limit of 18 patients or less, without an RVU system, but with salary incentives based on patient satisfaction, billing, and documentation.

“We’ve not had anybody leave the hospital because of burnout or dissatisfaction” since the new system was put into place, Dr. Borsadia said. “Less burnout means more people are happy.”

Although symptoms of burnout still seem to be rampant across hospital medicine, hospitalists are putting potential solutions into place. And – sometimes – they are making progress, through tweaks in schedules and responsibilities, incentives suited to different goals, and better communication.
 

Scheduling problems

The need for continuing efforts to improve the work experience for hospitalists is apparent, said Henry Michtalik, MD, MPH, MHS, assistant professor of general internal medicine at Johns Hopkins, Baltimore, who led a workshop on the topic at the 2019 Annual Conference of the Society of Hospital Medicine (HM19).

A 2016 survey of academic general internal medicine clinicians – including about 600 hospitalists and outpatient physicians – found that 67% reported high stress, 38% said they were “burned out,” 50% said they felt they had “low control” over their work, and 60% said they felt high documentation pressures. Still, 68% said they were satisfied with the values of their departments.

Hospitalists surveyed were actually less likely to say they were burned out, compared with outpatient internists – 52%, compared with 55% – but they were more likely to score low on a scale measuring personal accomplishments, compared with the outpatient clinicians – 20% to 10%. The survey found no significant difference between the two groups in depression or suicidality. But with 40% reporting depression and 10% reporting thoughts of suicide, the numbers virtually cry out for solutions.

Hospitalists in the HM19 workshop, as in other sessions at the Annual Conference, questioned whether the standard 7-days-on, 7-days-off work schedule – seven 12-hour shifts followed by 7 days off – allows hospitalists to pair their works lives with their personal lives in a sustainable way. They described the way that the stress and fatigue of such an intense work period bleeds into the days off that follow after it.

“By the end of seven 12’s, they’re bleary eyed, they’re upset, they go home (for) 2 days of washout before they even start to enjoy whatever life they have left,” said Jonathan Martin, MD, director of medicine at Cumberland Medical Center in Crossville, Tenn. “It’s hard to get hospitalists to buy in, which increases their dissatisfaction.”

Dr. Michtalik had a similar perspective.

“You just shut the rest of your life down completely for those 7 days and then, on your 7 days off, you’ve scheduled your life,” he said. “But that last off day – day number 7 – you feel that pit in your stomach, that the streak is coming.” He joked that the feeling was similar to the dread inspired by the phrase “winter is coming” in the popular HBO series “Game of Thrones.”

Systematic reviews of the literature have found that it’s mostly changes at the organization level – rather than changes that an individual physician makes on his or her own – that tend to make significant differences. Changes to structure, communication, and scheduling tend to work better than working on mindfulness, education, or trying to improve resilience, Dr. Michtalik said.

In one study discussed at the HM19 workshop, researchers compared a schedule in which an intensivist works in-house for 7 days, with home call at night, to a schedule in which the intensivist is completely off at night, with an in-house intensivist covering the night shift. The schedule in which the intensivist was truly off for the night significantly reduced reports of burnout, while not affecting length of stay or patient-experience outcomes.

Dr. Michtalik said that another study compared 4-week rotations to 2-week rotations for attending physicians. Researchers found that the 2-week version resulted in lower reports of burnout, with readmissions and patient experience unaffected, although they noted that residents tended to prefer 4-week schedules because they felt it resulted in better relationships with the attending physician.

Perhaps the dominant factor in job satisfaction that’s been identified in surveys is how physicians, patients, and administrators relate to one another, Dr. Michtalik said.

“The important concept here is that relationships were really important in driving job satisfaction, whether that be with our colleagues, our patients, or with the staff that you’re working with,” he said. “It’s always easier to decline a consultation or have a bad interaction with someone over the phone than it is if you actually know them or you are communicating face to face. That’s why it’s important to develop these kinds of relationships, which also put a face to what’s going on.”
 

Beyond salary adjustments

Hospitalists attending the HM19 workshop said they thought that participating in administration committees at their own institutions helps keep hospitalists involved in hospital matters, limiting the effects of burnout and improving workplace satisfaction.

Kevin McAninch, DO, a hospitalist with Central Ohio Primary Care in Westerville, said a shift in work responsibilities has made an improvement at his hospital. There is now an “inpatient support center” – which has a physician and a nurse in an office taking calls from 6 p.m. to 7 a.m., so that rounders can stop taking floor calls during that time.

The system “takes the pressure off our admitters at night and our nurses because they’re not getting floor calls anymore, so they’re just taking care of the admissions from the ER,” he said.

A recurring theme of the discussion was that salary alone seems universally incapable of eradicating feelings of burnout. One hospitalist said that in surveys, higher-paid physicians insist that monetary compensation is their main driver, but still often complain of burnout because they must work extra shifts to earn that higher level of pay.

Instead, burnout and satisfaction indicators tend to have more do to with time, control, and support, Dr. Michtalik noted.

Mangla Gulati, MD, SFHM, chief quality officer at the University of Maryland Medical Center in Baltimore, said that there’s no big secret about what hospitalists want from their places of employment. They want things like getting patients to service faster so they can make diagnoses, making sure patients get the care they need, fixing the problems associated with electronic medical records, and having a work-life “integration.”

“The questions is – how do we get there?” Dr. Gulati wondered. She suggested that hospitalists have to be more assertive and explanatory in their interactions with members of the hospital C-suite.

“I think it’s really important for you to understand or ask your C-suite, ‘Where are you in this whole journey? What is your perception of wellness? Tell me some of the measures of staff wellness,’ ” she said.

If the C-suite says “we have no money” to make improvements, hospitalists must be willing to say, ‘Well, you’re going to have to invest a little bit.’ ” Dr. Gulati said. “What is the ROI (return on investment) on the turnover of a physician? Because when you turn a physician over, you have to recruit and hire new staff.”

Dr. Gulati said that hospitalists should provide C-suite leaders with a detailed walk-through of their actual workflows – what their workdays look like – because “it’s not something they’re familiar with.”

Aside from improving relations with hospital administration, Dr. Gulati suggested creating CME programs for wellness, offering time and funding for physician support meetings, supporting flexibility in work hours, and creating programs specifically to help clinicians with burnout symptoms.

She also touted the benefits of “Schwartz Rounds,” in which several medical disciplines gather to talk about a case that was particularly challenging, clinically complex, and emotionally draining for everyone involved.

At Cumberland Medical Center, Dr. Martin said he has two meetings a month with executives in the hospital’s C-suite. One is with his hospitalist group, TeamHealth, and one is more direct, between himself and hospital administrators. It’s just 2 hours a month, but these conversations have undoubtedly helped, he said, although he cautioned that “the meetings themselves don’t have as much meaning if you aren’t communicating effectively,” meaning hospitalists must understand how the C-suite thinks and learn to speak in terms they understand.

“When I go to the administration now and I say ‘Hey, this is a problem that we’re having. I need your help in solving it,’ the executives are much more likely to respond to me than if they’d never seen me, or only see me rarely,” Dr. Martin said.

As a result, a collaborative approach to such conversations tends to be more effective.

“If you go to the C-suite and say, ‘Here’s our issue, how can you help us?’ – as opposed to telling the administration, ‘This is what I need’ – they are more likely to work with you to generate a solution.”