The current body of literature lacks validated survey instruments to effectively measure financial distress in cancer patients, according to a systematic review.

“This review systematizes the methods and items that previous studies used for measuring the subjective financial distress of cancer patients,” wrote Julian Witte of Bielefeld (Germany) University and colleagues. Their report is in Annals of Oncology.

In this systematic review, the investigators searched major databases for studies that included data on perceived financial burden experienced by patients with cancer. The team collected and classified all usable validated survey tools, which are necessary to obtain high-quality data for analysis.

“We analyzed all detected instruments, items domains, and questions with regard to their wording, scales, and the domains of financial distress covered,” the researchers wrote.

After applying the search criteria, the investigators identified 40 studies that fit the inclusion criteria. Among those included, 352 unique questions have been used to describe financial distress in cancer patients.

After analysis, the researchers identified six distinct subdomains that characterized patient views and responses to financial distress. In particular, these domains were the use of passive financial resources, support seeking, coping with one’s lifestyle, coping with care, psychosocial responses, and active financial spending.

“We found an inconsistent coverage and use of these domains that makes it difficult to compare and quantify the prevalence of financial distress,” they wrote.

One key limitation of the study was the observational design, which could limit the generalizability of the findings.

“There is a need to join efforts to develop a common understanding of the concept of financial toxicity and related subjective financial distress,” they concluded.

The study was funded by IPSEN Pharma GmbH. The authors reported having no conflicts of interest.

SOURCE: Witte J et al. Ann Oncol. 2019 May 2. doi: 10.1093/annonc/mdz140.

The current body of literature lacks validated survey instruments to effectively measure financial distress in cancer patients, according to a systematic review.

“This review systematizes the methods and items that previous studies used for measuring the subjective financial distress of cancer patients,” wrote Julian Witte of Bielefeld (Germany) University and colleagues. Their report is in Annals of Oncology.

In this systematic review, the investigators searched major databases for studies that included data on perceived financial burden experienced by patients with cancer. The team collected and classified all usable validated survey tools, which are necessary to obtain high-quality data for analysis.

“We analyzed all detected instruments, items domains, and questions with regard to their wording, scales, and the domains of financial distress covered,” the researchers wrote.

After applying the search criteria, the investigators identified 40 studies that fit the inclusion criteria. Among those included, 352 unique questions have been used to describe financial distress in cancer patients.

After analysis, the researchers identified six distinct subdomains that characterized patient views and responses to financial distress. In particular, these domains were the use of passive financial resources, support seeking, coping with one’s lifestyle, coping with care, psychosocial responses, and active financial spending.

“We found an inconsistent coverage and use of these domains that makes it difficult to compare and quantify the prevalence of financial distress,” they wrote.

One key limitation of the study was the observational design, which could limit the generalizability of the findings.

“There is a need to join efforts to develop a common understanding of the concept of financial toxicity and related subjective financial distress,” they concluded.

The study was funded by IPSEN Pharma GmbH. The authors reported having no conflicts of interest.

SOURCE: Witte J et al. Ann Oncol. 2019 May 2. doi: 10.1093/annonc/mdz140.

The current body of literature lacks validated survey instruments to effectively measure financial distress in cancer patients, according to a systematic review.

“This review systematizes the methods and items that previous studies used for measuring the subjective financial distress of cancer patients,” wrote Julian Witte of Bielefeld (Germany) University and colleagues. Their report is in Annals of Oncology.

In this systematic review, the investigators searched major databases for studies that included data on perceived financial burden experienced by patients with cancer. The team collected and classified all usable validated survey tools, which are necessary to obtain high-quality data for analysis.

“We analyzed all detected instruments, items domains, and questions with regard to their wording, scales, and the domains of financial distress covered,” the researchers wrote.

After applying the search criteria, the investigators identified 40 studies that fit the inclusion criteria. Among those included, 352 unique questions have been used to describe financial distress in cancer patients.

After analysis, the researchers identified six distinct subdomains that characterized patient views and responses to financial distress. In particular, these domains were the use of passive financial resources, support seeking, coping with one’s lifestyle, coping with care, psychosocial responses, and active financial spending.

“We found an inconsistent coverage and use of these domains that makes it difficult to compare and quantify the prevalence of financial distress,” they wrote.

One key limitation of the study was the observational design, which could limit the generalizability of the findings.

“There is a need to join efforts to develop a common understanding of the concept of financial toxicity and related subjective financial distress,” they concluded.

The study was funded by IPSEN Pharma GmbH. The authors reported having no conflicts of interest.

SOURCE: Witte J et al. Ann Oncol. 2019 May 2. doi: 10.1093/annonc/mdz140.

A balanced, low-fat diet was associated with a lower risk of death from breast cancer in a large cohort of postmenopausal women who had no previous history of breast cancer.

Researchers studied nearly 49,000 postmenopausal women and found a 21% lower risk of death from breast cancer among women who followed the balanced, low-fat diet, compared with women who followed their normal diet.

This research is scheduled to be presented at the annual meeting of the American Society of Clinical Oncology.

Rowan Chlebowski, MD, PhD, of the Los Angeles Biomedical Research Institute at Harbor–UCLA Medical Center in Torrance, Calif., discussed the research during a press briefing in advance of the meeting.
 

About the study

The research is part of the Woman’s Health Initiative (NCT00000611), which is focused on investigating methods for preventing heart disease, breast and colorectal cancer, and osteoporotic fractures in postmenopausal women.

This trial enrolled 48,835 postmenopausal women, ages 50-79 years, with no history of breast cancer and normal mammograms at enrollment. From 1993 to 1998, the women were randomized to the study diet (n = 19,541) or their normal diet (n = 29,294).

With the normal diet, fat accounted for 32% or more of subjects’ daily calories. With the study diet, the goal was to reduce fat consumption to 20% or less of caloric intake. The study diet also required at least one daily serving of vegetables, fruits, and grains.

Dr. Chlebowski said the study diet is similar to DASH (Dietary Approaches to Stop Hypertension), but is slightly more focused on lowering fat intake.
 

Diet adherence

Subjects followed the study diet for a median of 8.5 years, and the median cumulative follow-up was 19.6 years.

Dr. Chlebowski noted that most women on the study diet were not able to reduce their daily fat consumption to the 20% goal. They did reduce fat consumption to 24.5% overall, which increased to 29% at the end of the intervention.

In the study-diet group, there was an average weight loss of 3%, significantly different from that of the normal-diet group (P less than .001).

Dr. Chlebowski said the weight loss indicates that subjects did adhere to the study diet, at least in part, as there was no change in physical activity among study participants. Furthermore, the researchers have evidence after 1 year that suggests subjects were incorporating more fruits and vegetables into their diets.
 

Breast cancer and death

At a median follow-up of 19.6 years, there were 3,374 cases of breast cancer, 1,011 deaths, and 383 deaths attributed to breast cancer.

The risk of death from breast cancer was significantly lower in the study-diet group than in the normal-diet group. The hazard ratio was 0.79 (95% confidence interval, 0.64-0.97; P = .025).

The risk of death (from any cause) after breast cancer was significantly lower in the study diet group as well, with a hazard ratio of 0.85 (95% confidence interval, 0.74-0.96; P = .01).

“Adoption of a low-fat dietary pattern reduces the risk of death from breast cancer in postmenopausal women,” Dr. Chlebowski said. “To our review, this is the only study providing randomized clinical trial evidence that an intervention can reduce a woman’s risk of dying from breast cancer.”

Dr. Chlebowski noted that the researchers have blood samples from all subjects enrolled in this study. The researchers plan to analyze those samples to further explore how the study diet affected the women and determine which components of the diet account for which effects.

The National Institutes of Health funded the study. The researchers disclosed relationships with Novartis, Pfizer, Amgen, AstraZeneca, Immunomedics, Metastat, Bayer, and Genentech/Roche.

SOURCE: Chlebowski R. et al. ASCO 2019. Abstract 520.

A balanced, low-fat diet was associated with a lower risk of death from breast cancer in a large cohort of postmenopausal women who had no previous history of breast cancer.

Researchers studied nearly 49,000 postmenopausal women and found a 21% lower risk of death from breast cancer among women who followed the balanced, low-fat diet, compared with women who followed their normal diet.

This research is scheduled to be presented at the annual meeting of the American Society of Clinical Oncology.

Rowan Chlebowski, MD, PhD, of the Los Angeles Biomedical Research Institute at Harbor–UCLA Medical Center in Torrance, Calif., discussed the research during a press briefing in advance of the meeting.
 

About the study

The research is part of the Woman’s Health Initiative (NCT00000611), which is focused on investigating methods for preventing heart disease, breast and colorectal cancer, and osteoporotic fractures in postmenopausal women.

This trial enrolled 48,835 postmenopausal women, ages 50-79 years, with no history of breast cancer and normal mammograms at enrollment. From 1993 to 1998, the women were randomized to the study diet (n = 19,541) or their normal diet (n = 29,294).

With the normal diet, fat accounted for 32% or more of subjects’ daily calories. With the study diet, the goal was to reduce fat consumption to 20% or less of caloric intake. The study diet also required at least one daily serving of vegetables, fruits, and grains.

Dr. Chlebowski said the study diet is similar to DASH (Dietary Approaches to Stop Hypertension), but is slightly more focused on lowering fat intake.
 

Diet adherence

Subjects followed the study diet for a median of 8.5 years, and the median cumulative follow-up was 19.6 years.

Dr. Chlebowski noted that most women on the study diet were not able to reduce their daily fat consumption to the 20% goal. They did reduce fat consumption to 24.5% overall, which increased to 29% at the end of the intervention.

In the study-diet group, there was an average weight loss of 3%, significantly different from that of the normal-diet group (P less than .001).

Dr. Chlebowski said the weight loss indicates that subjects did adhere to the study diet, at least in part, as there was no change in physical activity among study participants. Furthermore, the researchers have evidence after 1 year that suggests subjects were incorporating more fruits and vegetables into their diets.
 

Breast cancer and death

At a median follow-up of 19.6 years, there were 3,374 cases of breast cancer, 1,011 deaths, and 383 deaths attributed to breast cancer.

The risk of death from breast cancer was significantly lower in the study-diet group than in the normal-diet group. The hazard ratio was 0.79 (95% confidence interval, 0.64-0.97; P = .025).

The risk of death (from any cause) after breast cancer was significantly lower in the study diet group as well, with a hazard ratio of 0.85 (95% confidence interval, 0.74-0.96; P = .01).

“Adoption of a low-fat dietary pattern reduces the risk of death from breast cancer in postmenopausal women,” Dr. Chlebowski said. “To our review, this is the only study providing randomized clinical trial evidence that an intervention can reduce a woman’s risk of dying from breast cancer.”

Dr. Chlebowski noted that the researchers have blood samples from all subjects enrolled in this study. The researchers plan to analyze those samples to further explore how the study diet affected the women and determine which components of the diet account for which effects.

The National Institutes of Health funded the study. The researchers disclosed relationships with Novartis, Pfizer, Amgen, AstraZeneca, Immunomedics, Metastat, Bayer, and Genentech/Roche.

SOURCE: Chlebowski R. et al. ASCO 2019. Abstract 520.

A balanced, low-fat diet was associated with a lower risk of death from breast cancer in a large cohort of postmenopausal women who had no previous history of breast cancer.

Researchers studied nearly 49,000 postmenopausal women and found a 21% lower risk of death from breast cancer among women who followed the balanced, low-fat diet, compared with women who followed their normal diet.

This research is scheduled to be presented at the annual meeting of the American Society of Clinical Oncology.

Rowan Chlebowski, MD, PhD, of the Los Angeles Biomedical Research Institute at Harbor–UCLA Medical Center in Torrance, Calif., discussed the research during a press briefing in advance of the meeting.
 

About the study

The research is part of the Woman’s Health Initiative (NCT00000611), which is focused on investigating methods for preventing heart disease, breast and colorectal cancer, and osteoporotic fractures in postmenopausal women.

This trial enrolled 48,835 postmenopausal women, ages 50-79 years, with no history of breast cancer and normal mammograms at enrollment. From 1993 to 1998, the women were randomized to the study diet (n = 19,541) or their normal diet (n = 29,294).

With the normal diet, fat accounted for 32% or more of subjects’ daily calories. With the study diet, the goal was to reduce fat consumption to 20% or less of caloric intake. The study diet also required at least one daily serving of vegetables, fruits, and grains.

Dr. Chlebowski said the study diet is similar to DASH (Dietary Approaches to Stop Hypertension), but is slightly more focused on lowering fat intake.
 

Diet adherence

Subjects followed the study diet for a median of 8.5 years, and the median cumulative follow-up was 19.6 years.

Dr. Chlebowski noted that most women on the study diet were not able to reduce their daily fat consumption to the 20% goal. They did reduce fat consumption to 24.5% overall, which increased to 29% at the end of the intervention.

In the study-diet group, there was an average weight loss of 3%, significantly different from that of the normal-diet group (P less than .001).

Dr. Chlebowski said the weight loss indicates that subjects did adhere to the study diet, at least in part, as there was no change in physical activity among study participants. Furthermore, the researchers have evidence after 1 year that suggests subjects were incorporating more fruits and vegetables into their diets.
 

Breast cancer and death

At a median follow-up of 19.6 years, there were 3,374 cases of breast cancer, 1,011 deaths, and 383 deaths attributed to breast cancer.

The risk of death from breast cancer was significantly lower in the study-diet group than in the normal-diet group. The hazard ratio was 0.79 (95% confidence interval, 0.64-0.97; P = .025).

The risk of death (from any cause) after breast cancer was significantly lower in the study diet group as well, with a hazard ratio of 0.85 (95% confidence interval, 0.74-0.96; P = .01).

“Adoption of a low-fat dietary pattern reduces the risk of death from breast cancer in postmenopausal women,” Dr. Chlebowski said. “To our review, this is the only study providing randomized clinical trial evidence that an intervention can reduce a woman’s risk of dying from breast cancer.”

Dr. Chlebowski noted that the researchers have blood samples from all subjects enrolled in this study. The researchers plan to analyze those samples to further explore how the study diet affected the women and determine which components of the diet account for which effects.

The National Institutes of Health funded the study. The researchers disclosed relationships with Novartis, Pfizer, Amgen, AstraZeneca, Immunomedics, Metastat, Bayer, and Genentech/Roche.

SOURCE: Chlebowski R. et al. ASCO 2019. Abstract 520.

Five years after undergoing endoscopic sleeve gastroplasty (ESG), patients achieved a total body weight loss of about 15%, a retrospective study showed.

Vidyard Video

The finding comes from the first long-term analysis of outcomes following endoscopic sleeve gastroplasty, a relatively new, minimally invasive weight-loss procedure that offers patients an alternative to bariatric surgery.

“Endoscopic sleeve gastrectomy is a 1-day outpatient procedure that uses a suturing device attached to an endoscope to create a series of sutures that cinch the stomach like an accordion down to roughly the size of a banana, and leaves no scars,” lead study author Reem Z. Sharaiha, MD, MSc, said during a media briefing in advance of the annual Digestive Disease Week®. “The procedure causes patients to eat less because they feel full faster. This results in weight loss.”

Digestive Disease Week is jointly sponsored by the American Association for the Study of Liver Diseases (AASLD), the American Gastroenterological Association (AGA) Institute, the American Society for Gastrointestinal Endoscopy (ASGE), and the Society for Surgery of the Alimentary Tract (SSAT).

While previous studies have tracked ESG results for 1-2 years, her research team followed 203 patients who underwent the procedure between August 2013 and October 2018. “We felt that a longer-term study was needed to make sure weight loss was sustainable with this method of treatment, because research shows that if you keep weight loss for an extended period of time, you’re more likely to keep it off permanently, which is ultimately what we want for these patients,” said Dr. Sharaiha, who is an attending physician at New York–Presbyterian/Weill Cornell Medicine, New York.

At baseline, the mean age of the 203 patients was 46 years, 67% were female, and their mean body mass index was 39 kg/m². Dr. Sharaiha and colleagues observed that maximum weight loss was generally achieved by 24 months after the procedure, after which patients tended to regain a small amount of their lost weight. For example, at 1 year, the mean weight loss was 18.1 kg, with a total body weight loss of 15.2% (P less than .0001 for both associations). At 2 years, the mean weight loss was 17.3 kg, with a total body weight loss of 14.5% (P less than .0001 for both associations). At 3 years, the mean weight loss was 20.8 kg, with a total body weight loss of 14.5% (P less than .0001 for both associations). At 5 years, the mean weight loss was 18.7 kg (P = .0003) and the total body weight loss was 14.5% (P = .0002).


Overall, patients gained an average 2.4 kg of weight after achieving their minimum weight after ESG until the end of follow-up. The researchers also found that failure to lose at least 10% of total body weight within the first 3 months after ESG decreased the chance of subsequent significant weight loss by 80%. Fewer than 1% of patients experienced complications, an improvement over surgical procedures.

“Our study showed very sustainable, significant weight loss for our patients between the 1 and 5 year mark,” Dr. Sharaiha said. “Out to 5 years, there was an average 15% total body weight loss. This is significant, because studies have shown that when people lose at least 10% of their body weight, they see improvement in blood pressure, diabetes, and heart outcomes, which are the comorbidities associated with obesity. We hope these findings will help persuade insurance companies that ESG is not experimental, but has value over patients’ lifespans.”

Dr. Sharaiha and colleagues plan to follow the current cohort for the next 10-20 years. “It’s important to show the value of these endoscopic procedures, so we’ll be looking at improvement in comorbidities such as diabetes, high blood pressure, and cholesterol,” she said. “We’re also part of a randomized study that’s currently under way looking at ESG in combination with diet and exercise.”

She reported having no financial disclosures.

dbrunk@mdedge.com

Five years after undergoing endoscopic sleeve gastroplasty (ESG), patients achieved a total body weight loss of about 15%, a retrospective study showed.

Vidyard Video

The finding comes from the first long-term analysis of outcomes following endoscopic sleeve gastroplasty, a relatively new, minimally invasive weight-loss procedure that offers patients an alternative to bariatric surgery.

“Endoscopic sleeve gastrectomy is a 1-day outpatient procedure that uses a suturing device attached to an endoscope to create a series of sutures that cinch the stomach like an accordion down to roughly the size of a banana, and leaves no scars,” lead study author Reem Z. Sharaiha, MD, MSc, said during a media briefing in advance of the annual Digestive Disease Week®. “The procedure causes patients to eat less because they feel full faster. This results in weight loss.”

Digestive Disease Week is jointly sponsored by the American Association for the Study of Liver Diseases (AASLD), the American Gastroenterological Association (AGA) Institute, the American Society for Gastrointestinal Endoscopy (ASGE), and the Society for Surgery of the Alimentary Tract (SSAT).

While previous studies have tracked ESG results for 1-2 years, her research team followed 203 patients who underwent the procedure between August 2013 and October 2018. “We felt that a longer-term study was needed to make sure weight loss was sustainable with this method of treatment, because research shows that if you keep weight loss for an extended period of time, you’re more likely to keep it off permanently, which is ultimately what we want for these patients,” said Dr. Sharaiha, who is an attending physician at New York–Presbyterian/Weill Cornell Medicine, New York.

At baseline, the mean age of the 203 patients was 46 years, 67% were female, and their mean body mass index was 39 kg/m². Dr. Sharaiha and colleagues observed that maximum weight loss was generally achieved by 24 months after the procedure, after which patients tended to regain a small amount of their lost weight. For example, at 1 year, the mean weight loss was 18.1 kg, with a total body weight loss of 15.2% (P less than .0001 for both associations). At 2 years, the mean weight loss was 17.3 kg, with a total body weight loss of 14.5% (P less than .0001 for both associations). At 3 years, the mean weight loss was 20.8 kg, with a total body weight loss of 14.5% (P less than .0001 for both associations). At 5 years, the mean weight loss was 18.7 kg (P = .0003) and the total body weight loss was 14.5% (P = .0002).


Overall, patients gained an average 2.4 kg of weight after achieving their minimum weight after ESG until the end of follow-up. The researchers also found that failure to lose at least 10% of total body weight within the first 3 months after ESG decreased the chance of subsequent significant weight loss by 80%. Fewer than 1% of patients experienced complications, an improvement over surgical procedures.

“Our study showed very sustainable, significant weight loss for our patients between the 1 and 5 year mark,” Dr. Sharaiha said. “Out to 5 years, there was an average 15% total body weight loss. This is significant, because studies have shown that when people lose at least 10% of their body weight, they see improvement in blood pressure, diabetes, and heart outcomes, which are the comorbidities associated with obesity. We hope these findings will help persuade insurance companies that ESG is not experimental, but has value over patients’ lifespans.”

Dr. Sharaiha and colleagues plan to follow the current cohort for the next 10-20 years. “It’s important to show the value of these endoscopic procedures, so we’ll be looking at improvement in comorbidities such as diabetes, high blood pressure, and cholesterol,” she said. “We’re also part of a randomized study that’s currently under way looking at ESG in combination with diet and exercise.”

She reported having no financial disclosures.

dbrunk@mdedge.com

Five years after undergoing endoscopic sleeve gastroplasty (ESG), patients achieved a total body weight loss of about 15%, a retrospective study showed.

Vidyard Video

The finding comes from the first long-term analysis of outcomes following endoscopic sleeve gastroplasty, a relatively new, minimally invasive weight-loss procedure that offers patients an alternative to bariatric surgery.

“Endoscopic sleeve gastrectomy is a 1-day outpatient procedure that uses a suturing device attached to an endoscope to create a series of sutures that cinch the stomach like an accordion down to roughly the size of a banana, and leaves no scars,” lead study author Reem Z. Sharaiha, MD, MSc, said during a media briefing in advance of the annual Digestive Disease Week®. “The procedure causes patients to eat less because they feel full faster. This results in weight loss.”

Digestive Disease Week is jointly sponsored by the American Association for the Study of Liver Diseases (AASLD), the American Gastroenterological Association (AGA) Institute, the American Society for Gastrointestinal Endoscopy (ASGE), and the Society for Surgery of the Alimentary Tract (SSAT).

While previous studies have tracked ESG results for 1-2 years, her research team followed 203 patients who underwent the procedure between August 2013 and October 2018. “We felt that a longer-term study was needed to make sure weight loss was sustainable with this method of treatment, because research shows that if you keep weight loss for an extended period of time, you’re more likely to keep it off permanently, which is ultimately what we want for these patients,” said Dr. Sharaiha, who is an attending physician at New York–Presbyterian/Weill Cornell Medicine, New York.

At baseline, the mean age of the 203 patients was 46 years, 67% were female, and their mean body mass index was 39 kg/m². Dr. Sharaiha and colleagues observed that maximum weight loss was generally achieved by 24 months after the procedure, after which patients tended to regain a small amount of their lost weight. For example, at 1 year, the mean weight loss was 18.1 kg, with a total body weight loss of 15.2% (P less than .0001 for both associations). At 2 years, the mean weight loss was 17.3 kg, with a total body weight loss of 14.5% (P less than .0001 for both associations). At 3 years, the mean weight loss was 20.8 kg, with a total body weight loss of 14.5% (P less than .0001 for both associations). At 5 years, the mean weight loss was 18.7 kg (P = .0003) and the total body weight loss was 14.5% (P = .0002).


Overall, patients gained an average 2.4 kg of weight after achieving their minimum weight after ESG until the end of follow-up. The researchers also found that failure to lose at least 10% of total body weight within the first 3 months after ESG decreased the chance of subsequent significant weight loss by 80%. Fewer than 1% of patients experienced complications, an improvement over surgical procedures.

“Our study showed very sustainable, significant weight loss for our patients between the 1 and 5 year mark,” Dr. Sharaiha said. “Out to 5 years, there was an average 15% total body weight loss. This is significant, because studies have shown that when people lose at least 10% of their body weight, they see improvement in blood pressure, diabetes, and heart outcomes, which are the comorbidities associated with obesity. We hope these findings will help persuade insurance companies that ESG is not experimental, but has value over patients’ lifespans.”

Dr. Sharaiha and colleagues plan to follow the current cohort for the next 10-20 years. “It’s important to show the value of these endoscopic procedures, so we’ll be looking at improvement in comorbidities such as diabetes, high blood pressure, and cholesterol,” she said. “We’re also part of a randomized study that’s currently under way looking at ESG in combination with diet and exercise.”

She reported having no financial disclosures.

dbrunk@mdedge.com

Aclidinium bromide reduced exacerbations in adults with chronic obstructive pulmonary disease with no increased risk of major adverse cardiovascular events, compared with placebo, in a randomized trial of more than 3,000 patients.

Aclidinium, a long-acting muscarinic antagonist (LAMA), has been shown to reduce COPD exacerbation in the short term, but long-term effectiveness has not been examined, wrote Robert A. Wise, MD, of Johns Hopkins University, Baltimore, and colleagues.

ASCENT-COPD is a multicenter, double-blind, randomized, placebo-controlled, parallel-group noninferiority study conducted at 522 sites in the United States and Canada. A paper on recent data from ASCENT-COPD, published in JAMA, supports early findings reported last year at the American Thoracic Society meeting.

The researchers randomized adults with COPD to a 400-mg dose of aclidinium bromide twice daily, or placebo. The average age of the patients was 67 years; 59% were men. The median exposure time to aclidinium or placebo was 365 days during the first year of treatment, and the median exposure overall was 495 days for aclidinium patients and 478 days for placebo patients.

Of the 2,537 patients who completed the study, 69 (3.9%) in the aclidinium group and 76 (4.2%) in the placebo group experienced a major adverse cardiovascular event (MACE, defined as a composite of cardiovascular death, nonfatal myocardial infarction, and nonfatal stroke).

In addition, annual rates of moderate to severe COPD exacerbations were significantly lower in the aclidinium patients compared with placebo patients (0.44 vs. 0.57, P less than .001).

In a secondary analysis with a definition of MACE expanded to include heart failure, arrhythmias, or cerebrovascular disease, results remained similar between the groups; events occurred in 168 aclidinium patients (9.4%) and 160 placebo patients (8.9%). The rate of COPD exacerbations requiring hospitalization was significantly lower in aclidinium patients, compared with placebo patients (0.07 vs. 0.10, P = .006).

Overall, the most common treatment-emergent adverse events were similar in the aclidinium and placebo groups, respectively; pneumonia (6.1% vs. 5.8%), urinary tract infections (5.2% vs. 5.0%), and upper respiratory tract infections (4.8% vs. 5.6%). The most common serious adverse events (in at least 1% of patients) were pneumonia, atrial fibrillation, heart failure, and coronary artery disease. Dry mouth and urinary retention were rare, and occurred in less than 1% of patients in each group.

“No patient subgroup demonstrated a difference in efficacy except when analyzed by baseline COPD severity, in which the treatment benefit was observed only in patients with FEV₁ [forced expiratory volume in 1 second] of 50% predicted or less,” the researchers noted. “This may be explained by the lower exacerbation rate seen in the placebo group in patients with moderate airway obstruction vs. severe or very severe obstruction,” they said.

“Outcomes of this trial add data to the long-standing controversy over the safety of LAMAs in COPD” and support the need for additional research, they said.

The study findings were limited by several factors including insufficient power to detect cause-specific mortality and the use of a LAMA with low risk of systemic effects, the researchers noted.

SOURCE: Wise R et al. JAMA. 2019. 321:1693-1701.

Aclidinium bromide reduced exacerbations in adults with chronic obstructive pulmonary disease with no increased risk of major adverse cardiovascular events, compared with placebo, in a randomized trial of more than 3,000 patients.

Aclidinium, a long-acting muscarinic antagonist (LAMA), has been shown to reduce COPD exacerbation in the short term, but long-term effectiveness has not been examined, wrote Robert A. Wise, MD, of Johns Hopkins University, Baltimore, and colleagues.

ASCENT-COPD is a multicenter, double-blind, randomized, placebo-controlled, parallel-group noninferiority study conducted at 522 sites in the United States and Canada. A paper on recent data from ASCENT-COPD, published in JAMA, supports early findings reported last year at the American Thoracic Society meeting.

The researchers randomized adults with COPD to a 400-mg dose of aclidinium bromide twice daily, or placebo. The average age of the patients was 67 years; 59% were men. The median exposure time to aclidinium or placebo was 365 days during the first year of treatment, and the median exposure overall was 495 days for aclidinium patients and 478 days for placebo patients.

Of the 2,537 patients who completed the study, 69 (3.9%) in the aclidinium group and 76 (4.2%) in the placebo group experienced a major adverse cardiovascular event (MACE, defined as a composite of cardiovascular death, nonfatal myocardial infarction, and nonfatal stroke).

In addition, annual rates of moderate to severe COPD exacerbations were significantly lower in the aclidinium patients compared with placebo patients (0.44 vs. 0.57, P less than .001).

In a secondary analysis with a definition of MACE expanded to include heart failure, arrhythmias, or cerebrovascular disease, results remained similar between the groups; events occurred in 168 aclidinium patients (9.4%) and 160 placebo patients (8.9%). The rate of COPD exacerbations requiring hospitalization was significantly lower in aclidinium patients, compared with placebo patients (0.07 vs. 0.10, P = .006).

Overall, the most common treatment-emergent adverse events were similar in the aclidinium and placebo groups, respectively; pneumonia (6.1% vs. 5.8%), urinary tract infections (5.2% vs. 5.0%), and upper respiratory tract infections (4.8% vs. 5.6%). The most common serious adverse events (in at least 1% of patients) were pneumonia, atrial fibrillation, heart failure, and coronary artery disease. Dry mouth and urinary retention were rare, and occurred in less than 1% of patients in each group.

“No patient subgroup demonstrated a difference in efficacy except when analyzed by baseline COPD severity, in which the treatment benefit was observed only in patients with FEV₁ [forced expiratory volume in 1 second] of 50% predicted or less,” the researchers noted. “This may be explained by the lower exacerbation rate seen in the placebo group in patients with moderate airway obstruction vs. severe or very severe obstruction,” they said.

“Outcomes of this trial add data to the long-standing controversy over the safety of LAMAs in COPD” and support the need for additional research, they said.

The study findings were limited by several factors including insufficient power to detect cause-specific mortality and the use of a LAMA with low risk of systemic effects, the researchers noted.

SOURCE: Wise R et al. JAMA. 2019. 321:1693-1701.

Aclidinium bromide reduced exacerbations in adults with chronic obstructive pulmonary disease with no increased risk of major adverse cardiovascular events, compared with placebo, in a randomized trial of more than 3,000 patients.

Aclidinium, a long-acting muscarinic antagonist (LAMA), has been shown to reduce COPD exacerbation in the short term, but long-term effectiveness has not been examined, wrote Robert A. Wise, MD, of Johns Hopkins University, Baltimore, and colleagues.

ASCENT-COPD is a multicenter, double-blind, randomized, placebo-controlled, parallel-group noninferiority study conducted at 522 sites in the United States and Canada. A paper on recent data from ASCENT-COPD, published in JAMA, supports early findings reported last year at the American Thoracic Society meeting.

The researchers randomized adults with COPD to a 400-mg dose of aclidinium bromide twice daily, or placebo. The average age of the patients was 67 years; 59% were men. The median exposure time to aclidinium or placebo was 365 days during the first year of treatment, and the median exposure overall was 495 days for aclidinium patients and 478 days for placebo patients.

Of the 2,537 patients who completed the study, 69 (3.9%) in the aclidinium group and 76 (4.2%) in the placebo group experienced a major adverse cardiovascular event (MACE, defined as a composite of cardiovascular death, nonfatal myocardial infarction, and nonfatal stroke).

In addition, annual rates of moderate to severe COPD exacerbations were significantly lower in the aclidinium patients compared with placebo patients (0.44 vs. 0.57, P less than .001).

In a secondary analysis with a definition of MACE expanded to include heart failure, arrhythmias, or cerebrovascular disease, results remained similar between the groups; events occurred in 168 aclidinium patients (9.4%) and 160 placebo patients (8.9%). The rate of COPD exacerbations requiring hospitalization was significantly lower in aclidinium patients, compared with placebo patients (0.07 vs. 0.10, P = .006).

Overall, the most common treatment-emergent adverse events were similar in the aclidinium and placebo groups, respectively; pneumonia (6.1% vs. 5.8%), urinary tract infections (5.2% vs. 5.0%), and upper respiratory tract infections (4.8% vs. 5.6%). The most common serious adverse events (in at least 1% of patients) were pneumonia, atrial fibrillation, heart failure, and coronary artery disease. Dry mouth and urinary retention were rare, and occurred in less than 1% of patients in each group.

“No patient subgroup demonstrated a difference in efficacy except when analyzed by baseline COPD severity, in which the treatment benefit was observed only in patients with FEV₁ [forced expiratory volume in 1 second] of 50% predicted or less,” the researchers noted. “This may be explained by the lower exacerbation rate seen in the placebo group in patients with moderate airway obstruction vs. severe or very severe obstruction,” they said.

“Outcomes of this trial add data to the long-standing controversy over the safety of LAMAs in COPD” and support the need for additional research, they said.

The study findings were limited by several factors including insufficient power to detect cause-specific mortality and the use of a LAMA with low risk of systemic effects, the researchers noted.

SOURCE: Wise R et al. JAMA. 2019. 321:1693-1701.

For patients with oropharyngeal squamous cell carcinoma (OPSCC), initial staging with PET is associated with better cancer-specific survival (CSS) than staging with other imaging modalities, based on a retrospective analysis of more than 1,700 patients.

PET was associated with a better 3-year overall survival rate than either MRI without PET or CT alone, reported lead author Rustain L. Morgan, MD, of the University of Colorado at Denver, Aurora, and colleagues.

“To our knowledge, there have been no prospective, randomized, controlled trials to date to evaluate the effect of different imaging modalities at the time of initial staging on cancer-specific survival,” the investigators wrote in Cancer. “A population-based data source such as the Surveillance, Epidemiology, and End Results [SEER]–Medicare database provides an excellent opportunity to compare the impact of imaging modality differences on survival in patients with OPSCC.”

Using SEER data, the investigators identified more than 3,704 patients with oropharyngeal cancer; following exclusions, 1,765 patients were involved in the final analysis based on various factors, including survival beyond 2 months after diagnosis and squamous cell carcinoma histology. A Cox proportional hazards model was used to assess relationships between the primary outcome and 3-year CSS rate and imaging, sex, age, region, race, and education.

Results showed that most patients had PET imaging upon diagnosis (83.3%), while fewer had CT alone (11.4%) or MRI without PET (5.2%). Several underlying trends were found: Patients in the West were more likely to undergo PET than patients in the Midwest, South, or East; patients younger than 75 years were more likely to have PET than older patients; and men were more likely to be staged with PET than women. The 3-year CSS was longest for patients who underwent PET (56.8%), followed by MRI without PET (50.1%) and CT alone (47.3%). Controlling for treatment and stage of disease, multivariate analysis also suggested that PET is associated with better CSS; patients staged with MRI without PET had a hazard ratio of 1.748 (P = .0036) and those imaged with CT alone had an HR of 1.337 (P = .0491). Although the Cox proportional hazards model for overall survival revealed numerical trends, these lacked statistical significance for MRI without PET (HR, 1.365; P =.0683) and CT alone (HR, 1.213; P = .114).

“The current study demonstrated a significant difference in CSS based on initial imaging,” the investigators wrote. “These findings are consistent with a prior study that reported that PET imaging can improve the staging of patients with head and neck cancers, particularly as it relates to radiotherapy planning.

“The data from the current study suggest the need for further prospective research to evaluate whether CT or MRI should be considered adequate for the initial staging of patients with OPSCC,” the investigators concluded.

The study was funded by the University of Colorado Cancer Center. One coauthor reported relationships with the American Heart Association and the National Heart, Lung, and Blood Institute.

SOURCE: Morgan RL et al. Cancer. 2019 May 1. doi:10.1002/cncr.32148.

For patients with oropharyngeal squamous cell carcinoma (OPSCC), initial staging with PET is associated with better cancer-specific survival (CSS) than staging with other imaging modalities, based on a retrospective analysis of more than 1,700 patients.

PET was associated with a better 3-year overall survival rate than either MRI without PET or CT alone, reported lead author Rustain L. Morgan, MD, of the University of Colorado at Denver, Aurora, and colleagues.

“To our knowledge, there have been no prospective, randomized, controlled trials to date to evaluate the effect of different imaging modalities at the time of initial staging on cancer-specific survival,” the investigators wrote in Cancer. “A population-based data source such as the Surveillance, Epidemiology, and End Results [SEER]–Medicare database provides an excellent opportunity to compare the impact of imaging modality differences on survival in patients with OPSCC.”

Using SEER data, the investigators identified more than 3,704 patients with oropharyngeal cancer; following exclusions, 1,765 patients were involved in the final analysis based on various factors, including survival beyond 2 months after diagnosis and squamous cell carcinoma histology. A Cox proportional hazards model was used to assess relationships between the primary outcome and 3-year CSS rate and imaging, sex, age, region, race, and education.

Results showed that most patients had PET imaging upon diagnosis (83.3%), while fewer had CT alone (11.4%) or MRI without PET (5.2%). Several underlying trends were found: Patients in the West were more likely to undergo PET than patients in the Midwest, South, or East; patients younger than 75 years were more likely to have PET than older patients; and men were more likely to be staged with PET than women. The 3-year CSS was longest for patients who underwent PET (56.8%), followed by MRI without PET (50.1%) and CT alone (47.3%). Controlling for treatment and stage of disease, multivariate analysis also suggested that PET is associated with better CSS; patients staged with MRI without PET had a hazard ratio of 1.748 (P = .0036) and those imaged with CT alone had an HR of 1.337 (P = .0491). Although the Cox proportional hazards model for overall survival revealed numerical trends, these lacked statistical significance for MRI without PET (HR, 1.365; P =.0683) and CT alone (HR, 1.213; P = .114).

“The current study demonstrated a significant difference in CSS based on initial imaging,” the investigators wrote. “These findings are consistent with a prior study that reported that PET imaging can improve the staging of patients with head and neck cancers, particularly as it relates to radiotherapy planning.

“The data from the current study suggest the need for further prospective research to evaluate whether CT or MRI should be considered adequate for the initial staging of patients with OPSCC,” the investigators concluded.

The study was funded by the University of Colorado Cancer Center. One coauthor reported relationships with the American Heart Association and the National Heart, Lung, and Blood Institute.

SOURCE: Morgan RL et al. Cancer. 2019 May 1. doi:10.1002/cncr.32148.

For patients with oropharyngeal squamous cell carcinoma (OPSCC), initial staging with PET is associated with better cancer-specific survival (CSS) than staging with other imaging modalities, based on a retrospective analysis of more than 1,700 patients.

PET was associated with a better 3-year overall survival rate than either MRI without PET or CT alone, reported lead author Rustain L. Morgan, MD, of the University of Colorado at Denver, Aurora, and colleagues.

“To our knowledge, there have been no prospective, randomized, controlled trials to date to evaluate the effect of different imaging modalities at the time of initial staging on cancer-specific survival,” the investigators wrote in Cancer. “A population-based data source such as the Surveillance, Epidemiology, and End Results [SEER]–Medicare database provides an excellent opportunity to compare the impact of imaging modality differences on survival in patients with OPSCC.”

Using SEER data, the investigators identified more than 3,704 patients with oropharyngeal cancer; following exclusions, 1,765 patients were involved in the final analysis based on various factors, including survival beyond 2 months after diagnosis and squamous cell carcinoma histology. A Cox proportional hazards model was used to assess relationships between the primary outcome and 3-year CSS rate and imaging, sex, age, region, race, and education.

Results showed that most patients had PET imaging upon diagnosis (83.3%), while fewer had CT alone (11.4%) or MRI without PET (5.2%). Several underlying trends were found: Patients in the West were more likely to undergo PET than patients in the Midwest, South, or East; patients younger than 75 years were more likely to have PET than older patients; and men were more likely to be staged with PET than women. The 3-year CSS was longest for patients who underwent PET (56.8%), followed by MRI without PET (50.1%) and CT alone (47.3%). Controlling for treatment and stage of disease, multivariate analysis also suggested that PET is associated with better CSS; patients staged with MRI without PET had a hazard ratio of 1.748 (P = .0036) and those imaged with CT alone had an HR of 1.337 (P = .0491). Although the Cox proportional hazards model for overall survival revealed numerical trends, these lacked statistical significance for MRI without PET (HR, 1.365; P =.0683) and CT alone (HR, 1.213; P = .114).

“The current study demonstrated a significant difference in CSS based on initial imaging,” the investigators wrote. “These findings are consistent with a prior study that reported that PET imaging can improve the staging of patients with head and neck cancers, particularly as it relates to radiotherapy planning.

“The data from the current study suggest the need for further prospective research to evaluate whether CT or MRI should be considered adequate for the initial staging of patients with OPSCC,” the investigators concluded.

The study was funded by the University of Colorado Cancer Center. One coauthor reported relationships with the American Heart Association and the National Heart, Lung, and Blood Institute.

SOURCE: Morgan RL et al. Cancer. 2019 May 1. doi:10.1002/cncr.32148.

Results from a 13-year follow-up of a trial comparing two types of rituximab-based chemotherapy as upfront treatment for patients with follicular lymphoma show an “extraordinary improvement” in overall survival, compared with the prerituximab era.

Patho/Wikimedia Commons/CC BY-SA 3.0(http://creativecommons.org/licenses/by-sa/3.0)], via Wikimedia Commons

In a finding that the researchers termed “somewhat unexpected,” complete remission was the strongest factor in long-term survival.

Between March 2000 and May 2005, researchers enrolled 136 high-risk follicular lymphoma patients in the GITMO-IIL trial to evaluate the superiority of high-dose chemotherapy with rituximab and autograft (R-HDS) versus conventional chemotherapy with rituximab (R-CHOP) as frontline therapy. At a median follow-up of 4 years, there was no survival advantage for R-HDS.

In the current analysis – that had a 13-year median follow-up – median survival had not yet been reached. As of February 2017, two-thirds of all patients were alive at their last follow-up. Overall survival was 68.5% in the R-CHOP arm and 64.5% in the R-HDS arm, Riccardo Bruna, MD, of the European Institute of Oncology in Milano, Italy, and his colleagues, reported in Haematologica.

The main causes of death for the 46 patients who had died as of long-term follow-up were disease progression and secondary malignancies. Other causes included cardiovascular events, infections, graft failure following autograft, anaphylactic shock, and late sudden death.

Complete remission was seen in 98 patients (73.1%) overall – 59.1% in the R-CHOP arm and 86.7% in the R-HDS arm. Achieving durable complete remission was associated with prolonged survival, the researchers reported. Of the 79 patients in complete remission at 2 years after the start of treatment, 65 (82.3%) were alive at 13 years, compared with 21 (58.3%) of 36 patients who had an early relapse (P = .003).

“[Complete remission] achievement was the most important factor for prolonged survival,” the researchers wrote. “The importance of disease response is further emphasized by the first-time observation that [molecular remission] achievement is associated with survival duration and a high proportion of patients had prolonged survival in the absence of disease recurrence.”

The researchers reported that this is longest ever follow-up reported for first-line treatment of follicular lymphoma with rituximab-based chemotherapy.

This work was supported in part by the Ministero Italiano Università e Ricerca and by Banca del Piemonte. The initial clinical trial was supported by Compagnia di San Paolo, Regione Piemonte, and Roche, which provided rituximab for the study.

mschneider@mdedge.com

SOURCE: Bruna R et al. Haematologica. 2019 Apr 11. doi: 10.3324/haematol.2018.209932.

Results from a 13-year follow-up of a trial comparing two types of rituximab-based chemotherapy as upfront treatment for patients with follicular lymphoma show an “extraordinary improvement” in overall survival, compared with the prerituximab era.

Patho/Wikimedia Commons/CC BY-SA 3.0(http://creativecommons.org/licenses/by-sa/3.0)], via Wikimedia Commons

In a finding that the researchers termed “somewhat unexpected,” complete remission was the strongest factor in long-term survival.

Between March 2000 and May 2005, researchers enrolled 136 high-risk follicular lymphoma patients in the GITMO-IIL trial to evaluate the superiority of high-dose chemotherapy with rituximab and autograft (R-HDS) versus conventional chemotherapy with rituximab (R-CHOP) as frontline therapy. At a median follow-up of 4 years, there was no survival advantage for R-HDS.

In the current analysis – that had a 13-year median follow-up – median survival had not yet been reached. As of February 2017, two-thirds of all patients were alive at their last follow-up. Overall survival was 68.5% in the R-CHOP arm and 64.5% in the R-HDS arm, Riccardo Bruna, MD, of the European Institute of Oncology in Milano, Italy, and his colleagues, reported in Haematologica.

The main causes of death for the 46 patients who had died as of long-term follow-up were disease progression and secondary malignancies. Other causes included cardiovascular events, infections, graft failure following autograft, anaphylactic shock, and late sudden death.

Complete remission was seen in 98 patients (73.1%) overall – 59.1% in the R-CHOP arm and 86.7% in the R-HDS arm. Achieving durable complete remission was associated with prolonged survival, the researchers reported. Of the 79 patients in complete remission at 2 years after the start of treatment, 65 (82.3%) were alive at 13 years, compared with 21 (58.3%) of 36 patients who had an early relapse (P = .003).

“[Complete remission] achievement was the most important factor for prolonged survival,” the researchers wrote. “The importance of disease response is further emphasized by the first-time observation that [molecular remission] achievement is associated with survival duration and a high proportion of patients had prolonged survival in the absence of disease recurrence.”

The researchers reported that this is longest ever follow-up reported for first-line treatment of follicular lymphoma with rituximab-based chemotherapy.

This work was supported in part by the Ministero Italiano Università e Ricerca and by Banca del Piemonte. The initial clinical trial was supported by Compagnia di San Paolo, Regione Piemonte, and Roche, which provided rituximab for the study.

mschneider@mdedge.com

SOURCE: Bruna R et al. Haematologica. 2019 Apr 11. doi: 10.3324/haematol.2018.209932.

Results from a 13-year follow-up of a trial comparing two types of rituximab-based chemotherapy as upfront treatment for patients with follicular lymphoma show an “extraordinary improvement” in overall survival, compared with the prerituximab era.

Patho/Wikimedia Commons/CC BY-SA 3.0(http://creativecommons.org/licenses/by-sa/3.0)], via Wikimedia Commons

In a finding that the researchers termed “somewhat unexpected,” complete remission was the strongest factor in long-term survival.

Between March 2000 and May 2005, researchers enrolled 136 high-risk follicular lymphoma patients in the GITMO-IIL trial to evaluate the superiority of high-dose chemotherapy with rituximab and autograft (R-HDS) versus conventional chemotherapy with rituximab (R-CHOP) as frontline therapy. At a median follow-up of 4 years, there was no survival advantage for R-HDS.

In the current analysis – that had a 13-year median follow-up – median survival had not yet been reached. As of February 2017, two-thirds of all patients were alive at their last follow-up. Overall survival was 68.5% in the R-CHOP arm and 64.5% in the R-HDS arm, Riccardo Bruna, MD, of the European Institute of Oncology in Milano, Italy, and his colleagues, reported in Haematologica.

The main causes of death for the 46 patients who had died as of long-term follow-up were disease progression and secondary malignancies. Other causes included cardiovascular events, infections, graft failure following autograft, anaphylactic shock, and late sudden death.

Complete remission was seen in 98 patients (73.1%) overall – 59.1% in the R-CHOP arm and 86.7% in the R-HDS arm. Achieving durable complete remission was associated with prolonged survival, the researchers reported. Of the 79 patients in complete remission at 2 years after the start of treatment, 65 (82.3%) were alive at 13 years, compared with 21 (58.3%) of 36 patients who had an early relapse (P = .003).

“[Complete remission] achievement was the most important factor for prolonged survival,” the researchers wrote. “The importance of disease response is further emphasized by the first-time observation that [molecular remission] achievement is associated with survival duration and a high proportion of patients had prolonged survival in the absence of disease recurrence.”

The researchers reported that this is longest ever follow-up reported for first-line treatment of follicular lymphoma with rituximab-based chemotherapy.

This work was supported in part by the Ministero Italiano Università e Ricerca and by Banca del Piemonte. The initial clinical trial was supported by Compagnia di San Paolo, Regione Piemonte, and Roche, which provided rituximab for the study.

mschneider@mdedge.com

SOURCE: Bruna R et al. Haematologica. 2019 Apr 11. doi: 10.3324/haematol.2018.209932.

The debate over abortion rights could be headed to the U.S. Supreme Court after two recent state measures that aim to restrict access to abortion.

On May 7, 2019, Georgia Gov. Brian Kemp (R) signed into law a statute that bars physicians from performing an abortion after a heartbeat is detected – usually at about 6 weeks of pregnancy. The law allows exceptions if the pregnancy poses death or serious harm to the woman, and in cases of rape or incest.

A week later, the Alabama Senate on May 14 approved a measure that would ban abortion at every pregnancy stage and penalize physicians with a Class A felony for performing an abortion and charge them with a Class C felony for attempting to perform an abortion. The Alabama bill includes an exception if a woman’s life is at risk, but not for cases of rape or incest. Alabama Gov. Kay Ivey (R) signed the bill into law on May 15.

Both measures will likely be challenged in court; the Alabama law, in particular, could land in front of the U.S. Supreme Court as a direct challenge to Roe v. Wade.

Abortion critics have been encouraged by the Supreme Court appointment of right-leaning Associate Justice Brett M. Kavanaugh and hope the Alabama measure will drive the Supreme Court to reconsider its central holding in Roe, according to Fatima Goss Graves, president of the National Women’s Law Center, a liberal-leaning legal firm that advocates gender equality.

“After decades of chipping away at Roe, antiabortion legislators and advocates are feeling emboldened with the addition of Justice Kavanaugh on the Supreme Court and they are exposing their true goal – to ban abortion altogether,” Ms. Graves said in a statement. “And make no mistake, [passage of the Alabama bill] is extreme overreach: The vast majority of people in this country do not support criminalizing women or doctors and want abortion to be safe and legal.”

National antiabortion group Susan B. Anthony List called Alabama’s measure a landmark victory and indicated that the bill passage may ultimately change the outcome of Roe v. Wade.


“Across the nation there is growing momentum, informed by science and compassion, and spurred on in reaction to abortion extremism in New York and Virginia, to recognize the humanity of the unborn child in the law,” Susan B. Anthony List President Marjorie Dannenfelser said in a statement. “It is clearer than ever that Roe is far from being settled law in the eyes and hearts of the American people, and this is increasingly reflected in state legislatures. ... The time is coming for the Supreme Court to let that debate go forward.”

Other states have recently passed laws similar to Georgia’s measure, dubbed the “fetal heartbeat bills,” including Kentucky, Mississippi, and Ohio.

On May 15, the American Civil Liberties Union and Planned Parenthood of Greater Ohio issued a joint legal challenge against Ohio’s law, calling it blatantly unconstitutional. Meanwhile, the Center for Reproductive Rights has pledged to sue Georgia over its law.

Ted Anderson, MD, president of the American College of Obstetricians and Gynecologists, said the many recent restrictions to abortion access across the country are harmful to women’s health and detrimental to the physician-patient relationship.

“Lawmakers must support health policies based on sound science and evidence. Politicians must seek to improve access to care, not restrict it,” Dr. Anderson said in a statement. “Legislative restrictions fundamentally interfere with the patient-provider relationship and decrease access to necessary care for all women, and particularly for low-income women and those living long distances from health care providers. Health care decisions should be made jointly only by patients and their trusted health care professionals, not by politicians.”

agallegos@mdedge.com

The debate over abortion rights could be headed to the U.S. Supreme Court after two recent state measures that aim to restrict access to abortion.

On May 7, 2019, Georgia Gov. Brian Kemp (R) signed into law a statute that bars physicians from performing an abortion after a heartbeat is detected – usually at about 6 weeks of pregnancy. The law allows exceptions if the pregnancy poses death or serious harm to the woman, and in cases of rape or incest.

A week later, the Alabama Senate on May 14 approved a measure that would ban abortion at every pregnancy stage and penalize physicians with a Class A felony for performing an abortion and charge them with a Class C felony for attempting to perform an abortion. The Alabama bill includes an exception if a woman’s life is at risk, but not for cases of rape or incest. Alabama Gov. Kay Ivey (R) signed the bill into law on May 15.

Both measures will likely be challenged in court; the Alabama law, in particular, could land in front of the U.S. Supreme Court as a direct challenge to Roe v. Wade.

Abortion critics have been encouraged by the Supreme Court appointment of right-leaning Associate Justice Brett M. Kavanaugh and hope the Alabama measure will drive the Supreme Court to reconsider its central holding in Roe, according to Fatima Goss Graves, president of the National Women’s Law Center, a liberal-leaning legal firm that advocates gender equality.

“After decades of chipping away at Roe, antiabortion legislators and advocates are feeling emboldened with the addition of Justice Kavanaugh on the Supreme Court and they are exposing their true goal – to ban abortion altogether,” Ms. Graves said in a statement. “And make no mistake, [passage of the Alabama bill] is extreme overreach: The vast majority of people in this country do not support criminalizing women or doctors and want abortion to be safe and legal.”

National antiabortion group Susan B. Anthony List called Alabama’s measure a landmark victory and indicated that the bill passage may ultimately change the outcome of Roe v. Wade.


“Across the nation there is growing momentum, informed by science and compassion, and spurred on in reaction to abortion extremism in New York and Virginia, to recognize the humanity of the unborn child in the law,” Susan B. Anthony List President Marjorie Dannenfelser said in a statement. “It is clearer than ever that Roe is far from being settled law in the eyes and hearts of the American people, and this is increasingly reflected in state legislatures. ... The time is coming for the Supreme Court to let that debate go forward.”

Other states have recently passed laws similar to Georgia’s measure, dubbed the “fetal heartbeat bills,” including Kentucky, Mississippi, and Ohio.

On May 15, the American Civil Liberties Union and Planned Parenthood of Greater Ohio issued a joint legal challenge against Ohio’s law, calling it blatantly unconstitutional. Meanwhile, the Center for Reproductive Rights has pledged to sue Georgia over its law.

Ted Anderson, MD, president of the American College of Obstetricians and Gynecologists, said the many recent restrictions to abortion access across the country are harmful to women’s health and detrimental to the physician-patient relationship.

“Lawmakers must support health policies based on sound science and evidence. Politicians must seek to improve access to care, not restrict it,” Dr. Anderson said in a statement. “Legislative restrictions fundamentally interfere with the patient-provider relationship and decrease access to necessary care for all women, and particularly for low-income women and those living long distances from health care providers. Health care decisions should be made jointly only by patients and their trusted health care professionals, not by politicians.”

agallegos@mdedge.com

The debate over abortion rights could be headed to the U.S. Supreme Court after two recent state measures that aim to restrict access to abortion.

On May 7, 2019, Georgia Gov. Brian Kemp (R) signed into law a statute that bars physicians from performing an abortion after a heartbeat is detected – usually at about 6 weeks of pregnancy. The law allows exceptions if the pregnancy poses death or serious harm to the woman, and in cases of rape or incest.

A week later, the Alabama Senate on May 14 approved a measure that would ban abortion at every pregnancy stage and penalize physicians with a Class A felony for performing an abortion and charge them with a Class C felony for attempting to perform an abortion. The Alabama bill includes an exception if a woman’s life is at risk, but not for cases of rape or incest. Alabama Gov. Kay Ivey (R) signed the bill into law on May 15.

Both measures will likely be challenged in court; the Alabama law, in particular, could land in front of the U.S. Supreme Court as a direct challenge to Roe v. Wade.

Abortion critics have been encouraged by the Supreme Court appointment of right-leaning Associate Justice Brett M. Kavanaugh and hope the Alabama measure will drive the Supreme Court to reconsider its central holding in Roe, according to Fatima Goss Graves, president of the National Women’s Law Center, a liberal-leaning legal firm that advocates gender equality.

“After decades of chipping away at Roe, antiabortion legislators and advocates are feeling emboldened with the addition of Justice Kavanaugh on the Supreme Court and they are exposing their true goal – to ban abortion altogether,” Ms. Graves said in a statement. “And make no mistake, [passage of the Alabama bill] is extreme overreach: The vast majority of people in this country do not support criminalizing women or doctors and want abortion to be safe and legal.”

National antiabortion group Susan B. Anthony List called Alabama’s measure a landmark victory and indicated that the bill passage may ultimately change the outcome of Roe v. Wade.


“Across the nation there is growing momentum, informed by science and compassion, and spurred on in reaction to abortion extremism in New York and Virginia, to recognize the humanity of the unborn child in the law,” Susan B. Anthony List President Marjorie Dannenfelser said in a statement. “It is clearer than ever that Roe is far from being settled law in the eyes and hearts of the American people, and this is increasingly reflected in state legislatures. ... The time is coming for the Supreme Court to let that debate go forward.”

Other states have recently passed laws similar to Georgia’s measure, dubbed the “fetal heartbeat bills,” including Kentucky, Mississippi, and Ohio.

On May 15, the American Civil Liberties Union and Planned Parenthood of Greater Ohio issued a joint legal challenge against Ohio’s law, calling it blatantly unconstitutional. Meanwhile, the Center for Reproductive Rights has pledged to sue Georgia over its law.

Ted Anderson, MD, president of the American College of Obstetricians and Gynecologists, said the many recent restrictions to abortion access across the country are harmful to women’s health and detrimental to the physician-patient relationship.

“Lawmakers must support health policies based on sound science and evidence. Politicians must seek to improve access to care, not restrict it,” Dr. Anderson said in a statement. “Legislative restrictions fundamentally interfere with the patient-provider relationship and decrease access to necessary care for all women, and particularly for low-income women and those living long distances from health care providers. Health care decisions should be made jointly only by patients and their trusted health care professionals, not by politicians.”

agallegos@mdedge.com

BALTIMORE – Some infants, especially among those with persistent pulmonary hypertension, are at risk for developing iatrogenic neonatal abstinence syndrome, according to Amber Dave, MD, a neonatal-perinatal medicine fellow at Georgetown University Hospital in Washington.

M. Alexander Otto/MDedge News

Of 70 infants administered morphine or fentanyl for longer than a day in the neonatal ICU, almost a third (22, or 31%) developed iatrogenic neonatal abstinence syndrome (INAS). As a result, they needed prolonged respiratory support, more time to reach full feeds, and extended lengths of stay. Children exposed to opioids before birth were excluded from the analysis.

The greatest risk was in infants with persistent pulmonary hypertension; INAS was diagnosed in 13 of 22 (57%).

Opioid dosing also was all over the map for a given Neonatal Pain, Agitation, and Sedation Scale (N-PASS) score, Dr. Dave said. Some infants with an N-PASS pain score of 2, for instance, received no opioids, while others received up to 1,500 mg/kg morphine equivalents.

N-PASS is used in NICUs nationwide to guide dosing, but the variability seen in the study suggests that there’s need for a more objective measure of neonatal distress and for neonatologists to establish ground rules for NICU opioid use, she added.

The use of opioids has been increasing in NICUs for years (J Opioid Manag. 2015 Jul-Aug;11[4]:305-12), and at least one institution (J Perinatol. 2017 Sep;37[9]:1038-42) already has established guidelines to curb overuse. Dr. Dave said that several neonatologists, after viewing her poster at the Pediatric Academic Societies annual meeting, told her that they probably had the same problem at their NICUs but had not examined their data.

“We are using” these medications more in the NICU, “but how much is too much? We need to find that balance. We need to improve our practice.”

“The overarching question is if there are better alternatives for treating pain and stress in critically ill neonates.” Dexmedetomidine, an opioid-sparing alpha-2 agonist adrenoreceptor sedative, analgesic, and anxiolytic, is one of several options “being looked at closely in this population. We also need to think of nonpharmacologic measures,” Dr. Dave said.

In addition to infants with persistent pulmonary hypertension, the 22 INAS cases at the study site included, among others, three children on extracorporeal membrane oxygenation, one with meconium aspiration syndrome, and one surgical case, out of the 15 included in the study. The common denominator was the need to keep infants calm and comfortable during prolonged intubation, which was a mean of 10.5 days among INAS infants versus 5 among children who didn’t go into opioid withdrawal.

INAS infants had a daily mean morphine-equivalent dose of 106.6 mg/kg, with a mean exposure of 17 days and mean cumulative dose of 1,515 mg/kg. The daily mean morphine-equivalent dose among infants who didn’t develop INAS was 42.4 mg/kg, with a mean exposure of 4 days and mean cumulative dose of 246 mg/kg.

INAS infants spent a mean of 27 days in the hospital, and it took them a mean of almost 6 days to reach full feeds, versus 15 days for the other infants full feeds by day 4. Over half of the INAS infants (12) also were on midazolam, and they had higher cumulative doses of the sedative than infants who didn’t develop INAS (mean, 2.64 mg/kg vs. 0.19 mg/kg). The findings all were statistically significant.

Dr. Dave said the most surprising finding was the variability in opioid dosing. In another example, some infants received up to 1,400 mg/kg morphine equivalents even when their fraction of inspired oxygen requirement fell below 60%, which meant that they were getting better. Other infants by that point were off opioids altogether.

“This has definitely brought awareness to my practice. Before I would say, ‘Okay, let’s just go up,’ ” when a nurse requested an opioid increase based on N-PASS scores. Now, “I try to really figure out why they think the baby needs an increase, and I may say ‘Actually, we are turning a corner now, and maybe the baby can be a little bit more awake. How do you feel about that?’ ” she said.

“My long-term goal for this project is putting some guidelines in place,” she said.

There was no industry funding for the work, and Dr. Dave didn’t have any disclosures.

aotto@mdedge.com

BALTIMORE – Some infants, especially among those with persistent pulmonary hypertension, are at risk for developing iatrogenic neonatal abstinence syndrome, according to Amber Dave, MD, a neonatal-perinatal medicine fellow at Georgetown University Hospital in Washington.

M. Alexander Otto/MDedge News

Of 70 infants administered morphine or fentanyl for longer than a day in the neonatal ICU, almost a third (22, or 31%) developed iatrogenic neonatal abstinence syndrome (INAS). As a result, they needed prolonged respiratory support, more time to reach full feeds, and extended lengths of stay. Children exposed to opioids before birth were excluded from the analysis.

The greatest risk was in infants with persistent pulmonary hypertension; INAS was diagnosed in 13 of 22 (57%).

Opioid dosing also was all over the map for a given Neonatal Pain, Agitation, and Sedation Scale (N-PASS) score, Dr. Dave said. Some infants with an N-PASS pain score of 2, for instance, received no opioids, while others received up to 1,500 mg/kg morphine equivalents.

N-PASS is used in NICUs nationwide to guide dosing, but the variability seen in the study suggests that there’s need for a more objective measure of neonatal distress and for neonatologists to establish ground rules for NICU opioid use, she added.

The use of opioids has been increasing in NICUs for years (J Opioid Manag. 2015 Jul-Aug;11[4]:305-12), and at least one institution (J Perinatol. 2017 Sep;37[9]:1038-42) already has established guidelines to curb overuse. Dr. Dave said that several neonatologists, after viewing her poster at the Pediatric Academic Societies annual meeting, told her that they probably had the same problem at their NICUs but had not examined their data.

“We are using” these medications more in the NICU, “but how much is too much? We need to find that balance. We need to improve our practice.”

“The overarching question is if there are better alternatives for treating pain and stress in critically ill neonates.” Dexmedetomidine, an opioid-sparing alpha-2 agonist adrenoreceptor sedative, analgesic, and anxiolytic, is one of several options “being looked at closely in this population. We also need to think of nonpharmacologic measures,” Dr. Dave said.

In addition to infants with persistent pulmonary hypertension, the 22 INAS cases at the study site included, among others, three children on extracorporeal membrane oxygenation, one with meconium aspiration syndrome, and one surgical case, out of the 15 included in the study. The common denominator was the need to keep infants calm and comfortable during prolonged intubation, which was a mean of 10.5 days among INAS infants versus 5 among children who didn’t go into opioid withdrawal.

INAS infants had a daily mean morphine-equivalent dose of 106.6 mg/kg, with a mean exposure of 17 days and mean cumulative dose of 1,515 mg/kg. The daily mean morphine-equivalent dose among infants who didn’t develop INAS was 42.4 mg/kg, with a mean exposure of 4 days and mean cumulative dose of 246 mg/kg.

INAS infants spent a mean of 27 days in the hospital, and it took them a mean of almost 6 days to reach full feeds, versus 15 days for the other infants full feeds by day 4. Over half of the INAS infants (12) also were on midazolam, and they had higher cumulative doses of the sedative than infants who didn’t develop INAS (mean, 2.64 mg/kg vs. 0.19 mg/kg). The findings all were statistically significant.

Dr. Dave said the most surprising finding was the variability in opioid dosing. In another example, some infants received up to 1,400 mg/kg morphine equivalents even when their fraction of inspired oxygen requirement fell below 60%, which meant that they were getting better. Other infants by that point were off opioids altogether.

“This has definitely brought awareness to my practice. Before I would say, ‘Okay, let’s just go up,’ ” when a nurse requested an opioid increase based on N-PASS scores. Now, “I try to really figure out why they think the baby needs an increase, and I may say ‘Actually, we are turning a corner now, and maybe the baby can be a little bit more awake. How do you feel about that?’ ” she said.

“My long-term goal for this project is putting some guidelines in place,” she said.

There was no industry funding for the work, and Dr. Dave didn’t have any disclosures.

aotto@mdedge.com

BALTIMORE – Some infants, especially among those with persistent pulmonary hypertension, are at risk for developing iatrogenic neonatal abstinence syndrome, according to Amber Dave, MD, a neonatal-perinatal medicine fellow at Georgetown University Hospital in Washington.

M. Alexander Otto/MDedge News

Of 70 infants administered morphine or fentanyl for longer than a day in the neonatal ICU, almost a third (22, or 31%) developed iatrogenic neonatal abstinence syndrome (INAS). As a result, they needed prolonged respiratory support, more time to reach full feeds, and extended lengths of stay. Children exposed to opioids before birth were excluded from the analysis.

The greatest risk was in infants with persistent pulmonary hypertension; INAS was diagnosed in 13 of 22 (57%).

Opioid dosing also was all over the map for a given Neonatal Pain, Agitation, and Sedation Scale (N-PASS) score, Dr. Dave said. Some infants with an N-PASS pain score of 2, for instance, received no opioids, while others received up to 1,500 mg/kg morphine equivalents.

N-PASS is used in NICUs nationwide to guide dosing, but the variability seen in the study suggests that there’s need for a more objective measure of neonatal distress and for neonatologists to establish ground rules for NICU opioid use, she added.

The use of opioids has been increasing in NICUs for years (J Opioid Manag. 2015 Jul-Aug;11[4]:305-12), and at least one institution (J Perinatol. 2017 Sep;37[9]:1038-42) already has established guidelines to curb overuse. Dr. Dave said that several neonatologists, after viewing her poster at the Pediatric Academic Societies annual meeting, told her that they probably had the same problem at their NICUs but had not examined their data.

“We are using” these medications more in the NICU, “but how much is too much? We need to find that balance. We need to improve our practice.”

“The overarching question is if there are better alternatives for treating pain and stress in critically ill neonates.” Dexmedetomidine, an opioid-sparing alpha-2 agonist adrenoreceptor sedative, analgesic, and anxiolytic, is one of several options “being looked at closely in this population. We also need to think of nonpharmacologic measures,” Dr. Dave said.

In addition to infants with persistent pulmonary hypertension, the 22 INAS cases at the study site included, among others, three children on extracorporeal membrane oxygenation, one with meconium aspiration syndrome, and one surgical case, out of the 15 included in the study. The common denominator was the need to keep infants calm and comfortable during prolonged intubation, which was a mean of 10.5 days among INAS infants versus 5 among children who didn’t go into opioid withdrawal.

INAS infants had a daily mean morphine-equivalent dose of 106.6 mg/kg, with a mean exposure of 17 days and mean cumulative dose of 1,515 mg/kg. The daily mean morphine-equivalent dose among infants who didn’t develop INAS was 42.4 mg/kg, with a mean exposure of 4 days and mean cumulative dose of 246 mg/kg.

INAS infants spent a mean of 27 days in the hospital, and it took them a mean of almost 6 days to reach full feeds, versus 15 days for the other infants full feeds by day 4. Over half of the INAS infants (12) also were on midazolam, and they had higher cumulative doses of the sedative than infants who didn’t develop INAS (mean, 2.64 mg/kg vs. 0.19 mg/kg). The findings all were statistically significant.

Dr. Dave said the most surprising finding was the variability in opioid dosing. In another example, some infants received up to 1,400 mg/kg morphine equivalents even when their fraction of inspired oxygen requirement fell below 60%, which meant that they were getting better. Other infants by that point were off opioids altogether.

“This has definitely brought awareness to my practice. Before I would say, ‘Okay, let’s just go up,’ ” when a nurse requested an opioid increase based on N-PASS scores. Now, “I try to really figure out why they think the baby needs an increase, and I may say ‘Actually, we are turning a corner now, and maybe the baby can be a little bit more awake. How do you feel about that?’ ” she said.

“My long-term goal for this project is putting some guidelines in place,” she said.

There was no industry funding for the work, and Dr. Dave didn’t have any disclosures.

aotto@mdedge.com

The FP diagnosed granuloma annulare (GA) in this patient, based on the typical clinical appearance of a raised ring on the back of the hand with no scale.

GA is a common benign cutaneous, inflammatory disorder of unknown origin. It affects twice as many women as men. It features annular lesions that have raised borders and are skin-colored to erythematous. The rings may become hyperpigmented and often feature a central depression. These lesions are typically 1 to 5 cm wide. Although the classical appearance of GA is annular, the rings may not always be complete. Most importantly, there is no scaling, which one would expect to see in tinea infections, also known as “ringworm.”

The most common form of granuloma annulare is localized, as it was in this case. It typically presents on the dorsal surfaces of extremities, especially of the hands and feet. When the presentation is classic, there is no need for a biopsy to confirm the diagnosis.

The most effective treatment for local disease is intralesional triamcinolone (5mg/mL). (See Watch & Learn: Intralesional injections.) The FP offered this treatment to the patient, and she tolerated the procedure well. The GA resolved over the weeks that followed with some faint hypopigmentation that lasted for several months. The patient was happy with the results.

‌

Photos and text for Photo Rounds Friday courtesy of Richard P. Usatine, MD. This case was adapted from: Mauskar M, Usatine R. Granuloma annulare. In: Usatine R, Smith M, Mayeaux EJ, et al. Color Atlas and Synopsis of Family Medicine. 3rd ed. New York, NY: McGraw-Hill; 2019:1141-1146.

To learn more about the newest 3rd edition of the Color Atlas and Synopsis of Family Medicine, see: https://www.amazon.com/Color-Atlas-Synopsis-Family-Medicine/dp/1259862046/

You can get the Color Atlas of Family Medicine app by clicking on this link: usatinemedia.com

The FP diagnosed granuloma annulare (GA) in this patient, based on the typical clinical appearance of a raised ring on the back of the hand with no scale.

GA is a common benign cutaneous, inflammatory disorder of unknown origin. It affects twice as many women as men. It features annular lesions that have raised borders and are skin-colored to erythematous. The rings may become hyperpigmented and often feature a central depression. These lesions are typically 1 to 5 cm wide. Although the classical appearance of GA is annular, the rings may not always be complete. Most importantly, there is no scaling, which one would expect to see in tinea infections, also known as “ringworm.”

The most common form of granuloma annulare is localized, as it was in this case. It typically presents on the dorsal surfaces of extremities, especially of the hands and feet. When the presentation is classic, there is no need for a biopsy to confirm the diagnosis.

The most effective treatment for local disease is intralesional triamcinolone (5mg/mL). (See Watch & Learn: Intralesional injections.) The FP offered this treatment to the patient, and she tolerated the procedure well. The GA resolved over the weeks that followed with some faint hypopigmentation that lasted for several months. The patient was happy with the results.

‌

Photos and text for Photo Rounds Friday courtesy of Richard P. Usatine, MD. This case was adapted from: Mauskar M, Usatine R. Granuloma annulare. In: Usatine R, Smith M, Mayeaux EJ, et al. Color Atlas and Synopsis of Family Medicine. 3rd ed. New York, NY: McGraw-Hill; 2019:1141-1146.

To learn more about the newest 3rd edition of the Color Atlas and Synopsis of Family Medicine, see: https://www.amazon.com/Color-Atlas-Synopsis-Family-Medicine/dp/1259862046/

You can get the Color Atlas of Family Medicine app by clicking on this link: usatinemedia.com

The FP diagnosed granuloma annulare (GA) in this patient, based on the typical clinical appearance of a raised ring on the back of the hand with no scale.

GA is a common benign cutaneous, inflammatory disorder of unknown origin. It affects twice as many women as men. It features annular lesions that have raised borders and are skin-colored to erythematous. The rings may become hyperpigmented and often feature a central depression. These lesions are typically 1 to 5 cm wide. Although the classical appearance of GA is annular, the rings may not always be complete. Most importantly, there is no scaling, which one would expect to see in tinea infections, also known as “ringworm.”

The most common form of granuloma annulare is localized, as it was in this case. It typically presents on the dorsal surfaces of extremities, especially of the hands and feet. When the presentation is classic, there is no need for a biopsy to confirm the diagnosis.

The most effective treatment for local disease is intralesional triamcinolone (5mg/mL). (See Watch & Learn: Intralesional injections.) The FP offered this treatment to the patient, and she tolerated the procedure well. The GA resolved over the weeks that followed with some faint hypopigmentation that lasted for several months. The patient was happy with the results.

‌

Photos and text for Photo Rounds Friday courtesy of Richard P. Usatine, MD. This case was adapted from: Mauskar M, Usatine R. Granuloma annulare. In: Usatine R, Smith M, Mayeaux EJ, et al. Color Atlas and Synopsis of Family Medicine. 3rd ed. New York, NY: McGraw-Hill; 2019:1141-1146.

To learn more about the newest 3rd edition of the Color Atlas and Synopsis of Family Medicine, see: https://www.amazon.com/Color-Atlas-Synopsis-Family-Medicine/dp/1259862046/

You can get the Color Atlas of Family Medicine app by clicking on this link: usatinemedia.com

Occupational distress among physicians is tied to increased odds of substance use, sleep disturbance, binge eating, and poor health in general, a cross-sectional study of 417 U.K. doctors shows.

Wavebreakmedia/Getty Images

Burned-out or depressed doctors had higher risks of those health problems regardless of whether or not they worked in a hospital setting, according to Asta Medisauskaite, PhD, of University College London and Caroline Kamau, PhD, of the University of London. The study was published in BMJ Open.

The investigators asked the participants to answer a battery of validated questionnaires online, including the Alcohol Use Disorders Identification Test, the Eating Disorder Diagnostic Scale, and the Insomnia Severity Index.

The odds of many health problems were increased among the physicians with emotional exhaustion, as indicated by the Maslach Burnout Inventory, as was also the case with psychiatric disorders, according to the General Health Questionnaire-12, which investigators noted has been used extensively to examine medical doctors and other working populations.

Sleep disturbances were, for example, more likely in physicians with burnout or psychiatric morbidity, with odds ratios ranging from 1.344 to 3.826, the investigators reported. Likewise, these indicators of occupational distress increased the risk of suffering from frequent poor health, with odds ratios from 1.050 to 3.544, and of binge eating, with odds ratios from 1.311 to 1.841, Dr. Medisauskaite and Dr. Kamau reported.

Distressed doctors more often used alcohol, according to the researchers, who said that they found a higher risk of alcohol dependence (odds ratio, 6.165) among physicians reporting that they used substances to feel better or cope with stress. Those doctors also had higher risk of binge drinking, drinking larger quantities, and using alcohol more often, the data show. In fact, 44% of the physicians reported binge drinking, and 5% met the criteria for alcohol dependence, Dr. Medisauskaite and Dr. Kamau wrote. Binge drinking was defined as consuming more than six drinks on a single occasion.

Previous studies have indicated that occupational distress among physicians has negative effects on quality of care and patient safety, the authors noted. This latest cross-sectional study builds on those findings by showing that occupational distress increases risk of health problems among doctors. “The impact of occupational distress or ill health could increase levels of sickness-absence among doctors, thus reducing patient safety because of understaffing,” Dr. Medisauskaite and Dr. Kamau wrote.

Similarly, physicians with sleep problems or substance use related to occupational distress could perform poorly on the job because of being groggy, intoxicated, or hung over, they said.

“We recommend that doctors’ mentors, supervisors, peers, and occupational health support services recognize and act on (1) the prevalence of occupational distress and health problems among doctors; (2) the possibility that occupational distress raises the risk of several health problems; and (3) the need to provide early interventions,” Dr. Medisauskaite and Dr. Kamau wrote. Such interventions could help prevent physicians who are experiencing occupational distress from suffering the long-term health effects from sleep disturbances, binge drinking and binge eating, and ill health, they suggested.

One limitation cited was the study’s cross-sectional design, which makes it impossible to draw conclusions about causation. The researchers also conceded that some participants might not have been comfortable answering questions about illicit use of drugs or alcohol. Nevertheless, they said, recognizing the occupational stress faced by U.K. doctors could lead to prevention – and ultimately to better patient care.

Dr. Medisauskaite and Dr. Kamau declared no competing interests related to the study.

SOURCE: Medisauskaite A, Kamau C. BMJ Open. 2019 May 15. doi: 10.1136/bmjopen-2018-027362.

Occupational distress among physicians is tied to increased odds of substance use, sleep disturbance, binge eating, and poor health in general, a cross-sectional study of 417 U.K. doctors shows.

Wavebreakmedia/Getty Images

Burned-out or depressed doctors had higher risks of those health problems regardless of whether or not they worked in a hospital setting, according to Asta Medisauskaite, PhD, of University College London and Caroline Kamau, PhD, of the University of London. The study was published in BMJ Open.

The investigators asked the participants to answer a battery of validated questionnaires online, including the Alcohol Use Disorders Identification Test, the Eating Disorder Diagnostic Scale, and the Insomnia Severity Index.

The odds of many health problems were increased among the physicians with emotional exhaustion, as indicated by the Maslach Burnout Inventory, as was also the case with psychiatric disorders, according to the General Health Questionnaire-12, which investigators noted has been used extensively to examine medical doctors and other working populations.

Sleep disturbances were, for example, more likely in physicians with burnout or psychiatric morbidity, with odds ratios ranging from 1.344 to 3.826, the investigators reported. Likewise, these indicators of occupational distress increased the risk of suffering from frequent poor health, with odds ratios from 1.050 to 3.544, and of binge eating, with odds ratios from 1.311 to 1.841, Dr. Medisauskaite and Dr. Kamau reported.

Distressed doctors more often used alcohol, according to the researchers, who said that they found a higher risk of alcohol dependence (odds ratio, 6.165) among physicians reporting that they used substances to feel better or cope with stress. Those doctors also had higher risk of binge drinking, drinking larger quantities, and using alcohol more often, the data show. In fact, 44% of the physicians reported binge drinking, and 5% met the criteria for alcohol dependence, Dr. Medisauskaite and Dr. Kamau wrote. Binge drinking was defined as consuming more than six drinks on a single occasion.

Previous studies have indicated that occupational distress among physicians has negative effects on quality of care and patient safety, the authors noted. This latest cross-sectional study builds on those findings by showing that occupational distress increases risk of health problems among doctors. “The impact of occupational distress or ill health could increase levels of sickness-absence among doctors, thus reducing patient safety because of understaffing,” Dr. Medisauskaite and Dr. Kamau wrote.

Similarly, physicians with sleep problems or substance use related to occupational distress could perform poorly on the job because of being groggy, intoxicated, or hung over, they said.

“We recommend that doctors’ mentors, supervisors, peers, and occupational health support services recognize and act on (1) the prevalence of occupational distress and health problems among doctors; (2) the possibility that occupational distress raises the risk of several health problems; and (3) the need to provide early interventions,” Dr. Medisauskaite and Dr. Kamau wrote. Such interventions could help prevent physicians who are experiencing occupational distress from suffering the long-term health effects from sleep disturbances, binge drinking and binge eating, and ill health, they suggested.

One limitation cited was the study’s cross-sectional design, which makes it impossible to draw conclusions about causation. The researchers also conceded that some participants might not have been comfortable answering questions about illicit use of drugs or alcohol. Nevertheless, they said, recognizing the occupational stress faced by U.K. doctors could lead to prevention – and ultimately to better patient care.

Dr. Medisauskaite and Dr. Kamau declared no competing interests related to the study.

SOURCE: Medisauskaite A, Kamau C. BMJ Open. 2019 May 15. doi: 10.1136/bmjopen-2018-027362.

Occupational distress among physicians is tied to increased odds of substance use, sleep disturbance, binge eating, and poor health in general, a cross-sectional study of 417 U.K. doctors shows.

Wavebreakmedia/Getty Images

Burned-out or depressed doctors had higher risks of those health problems regardless of whether or not they worked in a hospital setting, according to Asta Medisauskaite, PhD, of University College London and Caroline Kamau, PhD, of the University of London. The study was published in BMJ Open.

The investigators asked the participants to answer a battery of validated questionnaires online, including the Alcohol Use Disorders Identification Test, the Eating Disorder Diagnostic Scale, and the Insomnia Severity Index.

The odds of many health problems were increased among the physicians with emotional exhaustion, as indicated by the Maslach Burnout Inventory, as was also the case with psychiatric disorders, according to the General Health Questionnaire-12, which investigators noted has been used extensively to examine medical doctors and other working populations.

Sleep disturbances were, for example, more likely in physicians with burnout or psychiatric morbidity, with odds ratios ranging from 1.344 to 3.826, the investigators reported. Likewise, these indicators of occupational distress increased the risk of suffering from frequent poor health, with odds ratios from 1.050 to 3.544, and of binge eating, with odds ratios from 1.311 to 1.841, Dr. Medisauskaite and Dr. Kamau reported.

Distressed doctors more often used alcohol, according to the researchers, who said that they found a higher risk of alcohol dependence (odds ratio, 6.165) among physicians reporting that they used substances to feel better or cope with stress. Those doctors also had higher risk of binge drinking, drinking larger quantities, and using alcohol more often, the data show. In fact, 44% of the physicians reported binge drinking, and 5% met the criteria for alcohol dependence, Dr. Medisauskaite and Dr. Kamau wrote. Binge drinking was defined as consuming more than six drinks on a single occasion.

Previous studies have indicated that occupational distress among physicians has negative effects on quality of care and patient safety, the authors noted. This latest cross-sectional study builds on those findings by showing that occupational distress increases risk of health problems among doctors. “The impact of occupational distress or ill health could increase levels of sickness-absence among doctors, thus reducing patient safety because of understaffing,” Dr. Medisauskaite and Dr. Kamau wrote.

Similarly, physicians with sleep problems or substance use related to occupational distress could perform poorly on the job because of being groggy, intoxicated, or hung over, they said.

“We recommend that doctors’ mentors, supervisors, peers, and occupational health support services recognize and act on (1) the prevalence of occupational distress and health problems among doctors; (2) the possibility that occupational distress raises the risk of several health problems; and (3) the need to provide early interventions,” Dr. Medisauskaite and Dr. Kamau wrote. Such interventions could help prevent physicians who are experiencing occupational distress from suffering the long-term health effects from sleep disturbances, binge drinking and binge eating, and ill health, they suggested.

One limitation cited was the study’s cross-sectional design, which makes it impossible to draw conclusions about causation. The researchers also conceded that some participants might not have been comfortable answering questions about illicit use of drugs or alcohol. Nevertheless, they said, recognizing the occupational stress faced by U.K. doctors could lead to prevention – and ultimately to better patient care.

Dr. Medisauskaite and Dr. Kamau declared no competing interests related to the study.

SOURCE: Medisauskaite A, Kamau C. BMJ Open. 2019 May 15. doi: 10.1136/bmjopen-2018-027362.