Neither the gender of examinees nor the gender of examiners affected the outcome of American Board of Surgery (ABS) certifying examinations, an analysis found.

Lead author Thai Q. Ong of the James Madison University Center for Assessment and Research Studies, Harrisonburg, Va., and colleagues examined data from the 2016-2017 ABS general surgery certifying exam (CE), which included 1,341 examinees and 216 examiners. Of examinees, 61% were male and of examiners, 82% were male. Investigators used factorial analysis of variance and logistic regression analyses to evaluate the effect of examinee and examiner gender on CE ratings and likelihood of passing the CE.

Results showed that gender was not a factor in rates received, and the gender of examiners had no bearing on the ratings they gave examinees of either gender, according to the study, published in the Journal of Surgical Research. In addition, examiner teams of different gender combinations did not affect their ratings of examinees. The investigators found also that examinee gender was not a significant predictor of session pass rates nor was examiner gender a factor in session pass rates.

The study authors concluded that there is no evidence of gender bias in ABS certifying exam rates or the likelihood of passing the exam. “Although these findings are favorable, the ABS continues to undertake efforts to minimize potential examiner bias in future examinations. All examiners are required to participate in rater training as well as implicit bias training in advance of the general surgery CE. The ABS has also added information on preventing implicit bias in the instructions that examiners receive in preparation for these exams.”

However, they noted, further studies should be conducted to replicate the results and explore other possible sources of examiner bias in CE ratings.

The authors reported no proprietary or commercial interest in any product mentioned or concept discussed in this article.

SOURCE: Ong et al. J Surg Res. 2018 June doi: 10.1016/j.jss.2018.06.014.

Neither the gender of examinees nor the gender of examiners affected the outcome of American Board of Surgery (ABS) certifying examinations, an analysis found.

Lead author Thai Q. Ong of the James Madison University Center for Assessment and Research Studies, Harrisonburg, Va., and colleagues examined data from the 2016-2017 ABS general surgery certifying exam (CE), which included 1,341 examinees and 216 examiners. Of examinees, 61% were male and of examiners, 82% were male. Investigators used factorial analysis of variance and logistic regression analyses to evaluate the effect of examinee and examiner gender on CE ratings and likelihood of passing the CE.

Results showed that gender was not a factor in rates received, and the gender of examiners had no bearing on the ratings they gave examinees of either gender, according to the study, published in the Journal of Surgical Research. In addition, examiner teams of different gender combinations did not affect their ratings of examinees. The investigators found also that examinee gender was not a significant predictor of session pass rates nor was examiner gender a factor in session pass rates.

The study authors concluded that there is no evidence of gender bias in ABS certifying exam rates or the likelihood of passing the exam. “Although these findings are favorable, the ABS continues to undertake efforts to minimize potential examiner bias in future examinations. All examiners are required to participate in rater training as well as implicit bias training in advance of the general surgery CE. The ABS has also added information on preventing implicit bias in the instructions that examiners receive in preparation for these exams.”

However, they noted, further studies should be conducted to replicate the results and explore other possible sources of examiner bias in CE ratings.

The authors reported no proprietary or commercial interest in any product mentioned or concept discussed in this article.

SOURCE: Ong et al. J Surg Res. 2018 June doi: 10.1016/j.jss.2018.06.014.

Neither the gender of examinees nor the gender of examiners affected the outcome of American Board of Surgery (ABS) certifying examinations, an analysis found.

Lead author Thai Q. Ong of the James Madison University Center for Assessment and Research Studies, Harrisonburg, Va., and colleagues examined data from the 2016-2017 ABS general surgery certifying exam (CE), which included 1,341 examinees and 216 examiners. Of examinees, 61% were male and of examiners, 82% were male. Investigators used factorial analysis of variance and logistic regression analyses to evaluate the effect of examinee and examiner gender on CE ratings and likelihood of passing the CE.

Results showed that gender was not a factor in rates received, and the gender of examiners had no bearing on the ratings they gave examinees of either gender, according to the study, published in the Journal of Surgical Research. In addition, examiner teams of different gender combinations did not affect their ratings of examinees. The investigators found also that examinee gender was not a significant predictor of session pass rates nor was examiner gender a factor in session pass rates.

The study authors concluded that there is no evidence of gender bias in ABS certifying exam rates or the likelihood of passing the exam. “Although these findings are favorable, the ABS continues to undertake efforts to minimize potential examiner bias in future examinations. All examiners are required to participate in rater training as well as implicit bias training in advance of the general surgery CE. The ABS has also added information on preventing implicit bias in the instructions that examiners receive in preparation for these exams.”

However, they noted, further studies should be conducted to replicate the results and explore other possible sources of examiner bias in CE ratings.

The authors reported no proprietary or commercial interest in any product mentioned or concept discussed in this article.

SOURCE: Ong et al. J Surg Res. 2018 June doi: 10.1016/j.jss.2018.06.014.

TORONTO – Febrile infants were less likely to undergo invasive diagnostic testing at community hospitals versus university-affiliated ones, but had similar outcomes, according to a study presented at the Pediatric Academic Societies annual meeting.

“The community hospitals are doing less procedures on the infants, but with basically the exact same outcomes,” said Beth C. Natt, MD, MPH, director of pediatric hospital medicine at Bridgeport (Conn.) Hospital.

Babies who presented to university-affiliated hospitals were more likely to be hospitalized (70% vs. 67%; P = .001) than were those at community hospitals, but had a similar likelihood of being diagnosed with bacteremia, meningitis, or urinary tract infection. The rates of missed bacterial infection were 0.8% for teaching hospitals and 1% for community hospitals (P = .346).

“There is some thought that in community settings, because we’re not completing the workup in the standard, protocolized way seen at teaching hospitals, we might be doing wrong by the children, but these data show we’re actually doing just fine,” Dr. Natt said in an interview.

She and her colleagues reviewed 9,884 febrile infant evaluations occurring at 132 hospitals participating in the Reducing Excessive Variation in the Infant Sepsis Evaluation (REVISE) quality improvement project. Two-thirds of the infants (n = 6,479) were evaluated across 78 university-affiliated hospitals and 3,405 (or 34%) were seen at 54 community hospitals. Hospital status was self-reported.

The teaching hospitals more often had at least one pediatric emergency medicine provider, compared with community hospitals (90% vs. 57%; P = .001) and were more likely to see babies between 7 and 30 days old (90% vs. 57%; P = .001). They also were more likely to obtain urine cultures (92% vs. 88%; P = 0.001), blood cultures (84% vs. 80%; P = .001), and cerebral spinal fluid cultures (62% vs. 57%; P = .001).

On the other hand, community hospitals were significantly more likely to see children presenting with respiratory symptoms (39% vs. 36% for teaching hospitals; P = .014), and were more likely to order chest x-rays on febrile infants (32% vs. 24% for university-affiliated hospitals; P = .001).

“As a community hospitalist, the results weren’t that surprising to me,” said Dr. Natt. “If anything was surprising it was how often we were doing chest x-rays, but I think that had to do with the fact that we had more children with respiratory symptoms coming to community hospitals.

“The American Academy of Pediatrics guidelines for fever were written last in 1993, when I was in high school, so they are very due to be revised,” said Dr. Natt. “I suspect the new guidelines will have us doing fewer spinal taps in children and more watchful waiting.”

TORONTO – Febrile infants were less likely to undergo invasive diagnostic testing at community hospitals versus university-affiliated ones, but had similar outcomes, according to a study presented at the Pediatric Academic Societies annual meeting.

“The community hospitals are doing less procedures on the infants, but with basically the exact same outcomes,” said Beth C. Natt, MD, MPH, director of pediatric hospital medicine at Bridgeport (Conn.) Hospital.

Babies who presented to university-affiliated hospitals were more likely to be hospitalized (70% vs. 67%; P = .001) than were those at community hospitals, but had a similar likelihood of being diagnosed with bacteremia, meningitis, or urinary tract infection. The rates of missed bacterial infection were 0.8% for teaching hospitals and 1% for community hospitals (P = .346).

“There is some thought that in community settings, because we’re not completing the workup in the standard, protocolized way seen at teaching hospitals, we might be doing wrong by the children, but these data show we’re actually doing just fine,” Dr. Natt said in an interview.

She and her colleagues reviewed 9,884 febrile infant evaluations occurring at 132 hospitals participating in the Reducing Excessive Variation in the Infant Sepsis Evaluation (REVISE) quality improvement project. Two-thirds of the infants (n = 6,479) were evaluated across 78 university-affiliated hospitals and 3,405 (or 34%) were seen at 54 community hospitals. Hospital status was self-reported.

The teaching hospitals more often had at least one pediatric emergency medicine provider, compared with community hospitals (90% vs. 57%; P = .001) and were more likely to see babies between 7 and 30 days old (90% vs. 57%; P = .001). They also were more likely to obtain urine cultures (92% vs. 88%; P = 0.001), blood cultures (84% vs. 80%; P = .001), and cerebral spinal fluid cultures (62% vs. 57%; P = .001).

On the other hand, community hospitals were significantly more likely to see children presenting with respiratory symptoms (39% vs. 36% for teaching hospitals; P = .014), and were more likely to order chest x-rays on febrile infants (32% vs. 24% for university-affiliated hospitals; P = .001).

“As a community hospitalist, the results weren’t that surprising to me,” said Dr. Natt. “If anything was surprising it was how often we were doing chest x-rays, but I think that had to do with the fact that we had more children with respiratory symptoms coming to community hospitals.

“The American Academy of Pediatrics guidelines for fever were written last in 1993, when I was in high school, so they are very due to be revised,” said Dr. Natt. “I suspect the new guidelines will have us doing fewer spinal taps in children and more watchful waiting.”

TORONTO – Febrile infants were less likely to undergo invasive diagnostic testing at community hospitals versus university-affiliated ones, but had similar outcomes, according to a study presented at the Pediatric Academic Societies annual meeting.

“The community hospitals are doing less procedures on the infants, but with basically the exact same outcomes,” said Beth C. Natt, MD, MPH, director of pediatric hospital medicine at Bridgeport (Conn.) Hospital.

Babies who presented to university-affiliated hospitals were more likely to be hospitalized (70% vs. 67%; P = .001) than were those at community hospitals, but had a similar likelihood of being diagnosed with bacteremia, meningitis, or urinary tract infection. The rates of missed bacterial infection were 0.8% for teaching hospitals and 1% for community hospitals (P = .346).

“There is some thought that in community settings, because we’re not completing the workup in the standard, protocolized way seen at teaching hospitals, we might be doing wrong by the children, but these data show we’re actually doing just fine,” Dr. Natt said in an interview.

She and her colleagues reviewed 9,884 febrile infant evaluations occurring at 132 hospitals participating in the Reducing Excessive Variation in the Infant Sepsis Evaluation (REVISE) quality improvement project. Two-thirds of the infants (n = 6,479) were evaluated across 78 university-affiliated hospitals and 3,405 (or 34%) were seen at 54 community hospitals. Hospital status was self-reported.

The teaching hospitals more often had at least one pediatric emergency medicine provider, compared with community hospitals (90% vs. 57%; P = .001) and were more likely to see babies between 7 and 30 days old (90% vs. 57%; P = .001). They also were more likely to obtain urine cultures (92% vs. 88%; P = 0.001), blood cultures (84% vs. 80%; P = .001), and cerebral spinal fluid cultures (62% vs. 57%; P = .001).

On the other hand, community hospitals were significantly more likely to see children presenting with respiratory symptoms (39% vs. 36% for teaching hospitals; P = .014), and were more likely to order chest x-rays on febrile infants (32% vs. 24% for university-affiliated hospitals; P = .001).

“As a community hospitalist, the results weren’t that surprising to me,” said Dr. Natt. “If anything was surprising it was how often we were doing chest x-rays, but I think that had to do with the fact that we had more children with respiratory symptoms coming to community hospitals.

“The American Academy of Pediatrics guidelines for fever were written last in 1993, when I was in high school, so they are very due to be revised,” said Dr. Natt. “I suspect the new guidelines will have us doing fewer spinal taps in children and more watchful waiting.”

Older age at diagnosis, diabetes, and poorer lung function are all predictors of reduced survival among adults diagnosed with cystic fibrosis, new research suggests.

Courtesy NHGRI

A growing number of people with cystic fibrosis are diagnosed in adulthood, partly because of increased awareness among physicians of variations in disease presentation, more accessible genotyping, and easier diagnostic criteria.

Adult-diagnosed cystic fibrosis patients generally have a milder form of the disease than that of those diagnosed in childhood; however, less is known about their prognosis and life expectancy.

Researchers reported the outcomes of a retrospective cohort study of 362 adults diagnosed with cystic fibrosis at age 18 years or older. The median age at diagnosis was 34.3 years, and 71% of patients presented with pulmonary and/or gastrointestinal symptoms. The study was published in Annals of the American Thoracic Society.

The patients were followed for a median of 7.7 years, during which time there were 15 lung transplants and 33 deaths without transplant. Overall, 10-year lung transplant–free survival was 87.7%, and 15-year survival was 86.1%.

Those who were diagnosed young and who had higher lung function had the best median survival times. For each 5-year increase in age at diagnosis, the risk of death or transplant increased by 24%, and for each 5% decrease in forced expiratory volume in one second (FEV₁), the risk was 35% higher.

Individuals who had diabetes at baseline had a more than fourfold higher risk of death or transplant than did those without diabetes.

“While newborn screening programs will reduce the rate of missed diagnoses in the future, clinicians still need to consider CF as a possible diagnosis if individuals are presenting with suspicious CF symptoms (e.g. GI or pulmonary symptoms) during adulthood, particularly if born prior to the introduction of newborn screening in their jurisdiction,” wrote Sameer Desai, of the University of British Columbia, Vancouver, and his coauthors.

Commenting on the association with diabetes, the authors noted that this finding had some uncertainty but suggested the additional inflammatory burden could increase the risk of death in individuals with cystic fibrosis.

The authors highlighted that fewer than 5% of people with adult-diagnosed cystic fibrosis had two copies of the F508del mutation, which is associated with severe, early-onset disease. However, those who were homozygous for that mutation tended to be diagnosed at a younger adult age, had worse nutritional status and a lower FEV₁ percent predicted, compared with the overall adult-diagnosed population.

“This finding suggests potential delays in CF diagnosis for these people leading to worse outcomes,” the authors wrote.

The researchers also identified 25 individuals who had a possible unconfirmed diagnosis based on the most recent cystic fibrosis diagnostic guidelines. These individuals were either asymptomatic or had unknown symptoms, had sweat chlorides at or below 60 mmol/L (where available), and either unknown or two non–cystic fibrosis–causing mutations. They were also more likely to be male, to be nonwhite, to have increased unknown mutations, and to be pancreatic sufficient, compared with individuals with a confirmed diagnosis.

The study looked at whether Pseudomonas aeruginosa and Burkholderia cepacia complex increased the risk of transplant or death, but found these did not significantly predict survival.

“Adult CF clinicians can use this information to educate newly diagnosed adults with CF about their prognosis and to guide treatment decisions, specifically those at high-risk for a worse prognosis,” the authors wrote.

The study was partly funded by the Rare Disease Foundation. Two authors declared support from Cystic Fibrosis Canada, but no other conflicts of interest were declared.

SOURCE: Desai A et al. Ann Am Thorac Soc. 2018 Jun 26. doi: 10.1513/AnnalsATS.201801-037OC.

Older age at diagnosis, diabetes, and poorer lung function are all predictors of reduced survival among adults diagnosed with cystic fibrosis, new research suggests.

Courtesy NHGRI

A growing number of people with cystic fibrosis are diagnosed in adulthood, partly because of increased awareness among physicians of variations in disease presentation, more accessible genotyping, and easier diagnostic criteria.

Adult-diagnosed cystic fibrosis patients generally have a milder form of the disease than that of those diagnosed in childhood; however, less is known about their prognosis and life expectancy.

Researchers reported the outcomes of a retrospective cohort study of 362 adults diagnosed with cystic fibrosis at age 18 years or older. The median age at diagnosis was 34.3 years, and 71% of patients presented with pulmonary and/or gastrointestinal symptoms. The study was published in Annals of the American Thoracic Society.

The patients were followed for a median of 7.7 years, during which time there were 15 lung transplants and 33 deaths without transplant. Overall, 10-year lung transplant–free survival was 87.7%, and 15-year survival was 86.1%.

Those who were diagnosed young and who had higher lung function had the best median survival times. For each 5-year increase in age at diagnosis, the risk of death or transplant increased by 24%, and for each 5% decrease in forced expiratory volume in one second (FEV₁), the risk was 35% higher.

Individuals who had diabetes at baseline had a more than fourfold higher risk of death or transplant than did those without diabetes.

“While newborn screening programs will reduce the rate of missed diagnoses in the future, clinicians still need to consider CF as a possible diagnosis if individuals are presenting with suspicious CF symptoms (e.g. GI or pulmonary symptoms) during adulthood, particularly if born prior to the introduction of newborn screening in their jurisdiction,” wrote Sameer Desai, of the University of British Columbia, Vancouver, and his coauthors.

Commenting on the association with diabetes, the authors noted that this finding had some uncertainty but suggested the additional inflammatory burden could increase the risk of death in individuals with cystic fibrosis.

The authors highlighted that fewer than 5% of people with adult-diagnosed cystic fibrosis had two copies of the F508del mutation, which is associated with severe, early-onset disease. However, those who were homozygous for that mutation tended to be diagnosed at a younger adult age, had worse nutritional status and a lower FEV₁ percent predicted, compared with the overall adult-diagnosed population.

“This finding suggests potential delays in CF diagnosis for these people leading to worse outcomes,” the authors wrote.

The researchers also identified 25 individuals who had a possible unconfirmed diagnosis based on the most recent cystic fibrosis diagnostic guidelines. These individuals were either asymptomatic or had unknown symptoms, had sweat chlorides at or below 60 mmol/L (where available), and either unknown or two non–cystic fibrosis–causing mutations. They were also more likely to be male, to be nonwhite, to have increased unknown mutations, and to be pancreatic sufficient, compared with individuals with a confirmed diagnosis.

The study looked at whether Pseudomonas aeruginosa and Burkholderia cepacia complex increased the risk of transplant or death, but found these did not significantly predict survival.

“Adult CF clinicians can use this information to educate newly diagnosed adults with CF about their prognosis and to guide treatment decisions, specifically those at high-risk for a worse prognosis,” the authors wrote.

The study was partly funded by the Rare Disease Foundation. Two authors declared support from Cystic Fibrosis Canada, but no other conflicts of interest were declared.

SOURCE: Desai A et al. Ann Am Thorac Soc. 2018 Jun 26. doi: 10.1513/AnnalsATS.201801-037OC.

Older age at diagnosis, diabetes, and poorer lung function are all predictors of reduced survival among adults diagnosed with cystic fibrosis, new research suggests.

Courtesy NHGRI

A growing number of people with cystic fibrosis are diagnosed in adulthood, partly because of increased awareness among physicians of variations in disease presentation, more accessible genotyping, and easier diagnostic criteria.

Adult-diagnosed cystic fibrosis patients generally have a milder form of the disease than that of those diagnosed in childhood; however, less is known about their prognosis and life expectancy.

Researchers reported the outcomes of a retrospective cohort study of 362 adults diagnosed with cystic fibrosis at age 18 years or older. The median age at diagnosis was 34.3 years, and 71% of patients presented with pulmonary and/or gastrointestinal symptoms. The study was published in Annals of the American Thoracic Society.

The patients were followed for a median of 7.7 years, during which time there were 15 lung transplants and 33 deaths without transplant. Overall, 10-year lung transplant–free survival was 87.7%, and 15-year survival was 86.1%.

Those who were diagnosed young and who had higher lung function had the best median survival times. For each 5-year increase in age at diagnosis, the risk of death or transplant increased by 24%, and for each 5% decrease in forced expiratory volume in one second (FEV₁), the risk was 35% higher.

Individuals who had diabetes at baseline had a more than fourfold higher risk of death or transplant than did those without diabetes.

“While newborn screening programs will reduce the rate of missed diagnoses in the future, clinicians still need to consider CF as a possible diagnosis if individuals are presenting with suspicious CF symptoms (e.g. GI or pulmonary symptoms) during adulthood, particularly if born prior to the introduction of newborn screening in their jurisdiction,” wrote Sameer Desai, of the University of British Columbia, Vancouver, and his coauthors.

Commenting on the association with diabetes, the authors noted that this finding had some uncertainty but suggested the additional inflammatory burden could increase the risk of death in individuals with cystic fibrosis.

The authors highlighted that fewer than 5% of people with adult-diagnosed cystic fibrosis had two copies of the F508del mutation, which is associated with severe, early-onset disease. However, those who were homozygous for that mutation tended to be diagnosed at a younger adult age, had worse nutritional status and a lower FEV₁ percent predicted, compared with the overall adult-diagnosed population.

“This finding suggests potential delays in CF diagnosis for these people leading to worse outcomes,” the authors wrote.

The researchers also identified 25 individuals who had a possible unconfirmed diagnosis based on the most recent cystic fibrosis diagnostic guidelines. These individuals were either asymptomatic or had unknown symptoms, had sweat chlorides at or below 60 mmol/L (where available), and either unknown or two non–cystic fibrosis–causing mutations. They were also more likely to be male, to be nonwhite, to have increased unknown mutations, and to be pancreatic sufficient, compared with individuals with a confirmed diagnosis.

The study looked at whether Pseudomonas aeruginosa and Burkholderia cepacia complex increased the risk of transplant or death, but found these did not significantly predict survival.

“Adult CF clinicians can use this information to educate newly diagnosed adults with CF about their prognosis and to guide treatment decisions, specifically those at high-risk for a worse prognosis,” the authors wrote.

The study was partly funded by the Rare Disease Foundation. Two authors declared support from Cystic Fibrosis Canada, but no other conflicts of interest were declared.

SOURCE: Desai A et al. Ann Am Thorac Soc. 2018 Jun 26. doi: 10.1513/AnnalsATS.201801-037OC.

The Food and Drug Administration has expanded the prostate cancer indication for enzalutamide to include nonmetastatic castration-resistant prostate cancer (CRPC). The androgen-receptor inhibitor was first approved in 2012 for the treatment of patients with metastatic CRPC who had previously received chemotherapy and was granted approval in 2014 for men with metastatic CRPC who had not received chemotherapy.

The current approval was based on a statistically significant improvement in metastasis-free survival for patients receiving enzalutamide in the phase 3 PROSPER trial, a trial that randomized 1,401 patients (2:1) with nonmetastatic CRPC to 160 mg of oral enzalutamide daily or to placebo. Median metastasis-free survival was 36.6 months for those receiving enzalutamide versus 14.7 months for those receiving placebo (hazard ratio, 0.29; 95% confidence interval, 0.24-0.35; P less than .0001), the FDA said in a press statement.

The most common adverse events were asthenia/fatigue, hot flush, hypertension, dizziness, nausea, and falls.

The recommended dose for enzalutamide, marketed as Xtandi by Astellas Pharma US, is 160 mg (four 40-mg capsules) administered orally once daily.

[email protected]

The Food and Drug Administration has expanded the prostate cancer indication for enzalutamide to include nonmetastatic castration-resistant prostate cancer (CRPC). The androgen-receptor inhibitor was first approved in 2012 for the treatment of patients with metastatic CRPC who had previously received chemotherapy and was granted approval in 2014 for men with metastatic CRPC who had not received chemotherapy.

The current approval was based on a statistically significant improvement in metastasis-free survival for patients receiving enzalutamide in the phase 3 PROSPER trial, a trial that randomized 1,401 patients (2:1) with nonmetastatic CRPC to 160 mg of oral enzalutamide daily or to placebo. Median metastasis-free survival was 36.6 months for those receiving enzalutamide versus 14.7 months for those receiving placebo (hazard ratio, 0.29; 95% confidence interval, 0.24-0.35; P less than .0001), the FDA said in a press statement.

The most common adverse events were asthenia/fatigue, hot flush, hypertension, dizziness, nausea, and falls.

The recommended dose for enzalutamide, marketed as Xtandi by Astellas Pharma US, is 160 mg (four 40-mg capsules) administered orally once daily.

[email protected]

The Food and Drug Administration has expanded the prostate cancer indication for enzalutamide to include nonmetastatic castration-resistant prostate cancer (CRPC). The androgen-receptor inhibitor was first approved in 2012 for the treatment of patients with metastatic CRPC who had previously received chemotherapy and was granted approval in 2014 for men with metastatic CRPC who had not received chemotherapy.

The current approval was based on a statistically significant improvement in metastasis-free survival for patients receiving enzalutamide in the phase 3 PROSPER trial, a trial that randomized 1,401 patients (2:1) with nonmetastatic CRPC to 160 mg of oral enzalutamide daily or to placebo. Median metastasis-free survival was 36.6 months for those receiving enzalutamide versus 14.7 months for those receiving placebo (hazard ratio, 0.29; 95% confidence interval, 0.24-0.35; P less than .0001), the FDA said in a press statement.

The most common adverse events were asthenia/fatigue, hot flush, hypertension, dizziness, nausea, and falls.

The recommended dose for enzalutamide, marketed as Xtandi by Astellas Pharma US, is 160 mg (four 40-mg capsules) administered orally once daily.

[email protected]

When it comes to inappropriate antibiotic prescribing, urgent care centers and retail clinics may have an outsized impact, a review of commercial insurance claims suggests.

Antibiotic prescription rates were at least twice as high in those settings, compared with emergency departments and medical office visits, according to the retrospective analysis.
The issue may be particularly pronounced in urgent care centers, based on this study, in which nearly half of visits for antibiotic-inappropriate respiratory diagnoses resulted in antibiotic prescribing.

Those findings suggest a need for “antibiotic stewardship interventions” to reduce unnecessary prescribing of antibiotics in ambulatory care settings, authors of the analysis reported in a research letter to JAMA Internal Medicine.

“Efforts targeting urgent care centers are urgently needed,” wrote Danielle L. Palms, MPH, of the Centers for Disease Control and Prevention, Atlanta, and her coauthors.

The retrospective study by Ms. Palms and her colleagues included claims from 2014 in a database of individuals 65 years of age or younger with employer-sponsored insurance.

The researchers included encounters in which medical and prescription coverage data were captured, including approximately 2.7 million urgent care center visits, 58,000 retail clinic visits, 4.8 million emergency department visits, and 148.5 million medical office visits.[[{"fid":"194045","view_mode":"medstat_image_flush_right","attributes":{"class":"media-element file-medstat-image-flush-right","data-delta":"1"},"fields":{"format":"medstat_image_flush_right","field_file_image_caption[und][0][value]":"","field_file_image_caption[und][0][format]":"filtered_html","field_file_image_credit[und][0][value]":"Sheep purple/flickr/CC BY 2.0 /en.wikipedia/CC BY-SA 4.0"},"type":"media","field_deltas":{"1":{"format":"medstat_image_flush_right","field_file_image_caption[und][0][value]":"","field_file_image_caption[und][0][format]":"filtered_html","field_file_image_credit[und][0][value]":"Sheep purple/flickr/CC BY 2.0 /en.wikipedia/CC BY-SA 4.0"}}}]]

They found antibiotic prescriptions linked to 39.0% of urgent care and 36.4% of retail clinic visits, compared with 13.8% of emergency department visits and 7.1% of medical office visits.

For respiratory diagnoses where antibiotics would be inappropriate, such as viral upper respiratory infections, antibiotics were nevertheless prescribed in 45.7% of urgent care visits, compared with 24.6% of emergency department, 17.0% of medical office visits, and 14.4% of retail clinic visits.

Those data show “substantial variability” that suggests case mix differences and evidence of antibiotic overuse, particularly in the urgent care setting, the researchers said in their letter.

In another recent study, looking at the 2010-2011 period, at least 30% of antibiotic prescriptions written in U.S. physician offices and emergency departments were unnecessary.

“The finding of the present study that antibiotic prescribing for antibiotic inappropriate respiratory diagnoses was highest in urgent care centers suggests that unnecessary antibiotic prescribing nationally in all outpatient settings may be higher than the estimated 30%,” wrote Ms. Palms and her coinvestigators.

The research was funded by the Centers for Disease Control and Prevention. Ms. Palms and her coauthors reported no conflicts of interest.

SOURCE: Palms DL et al. JAMA Intern Med. 2018 Jul 16.

When it comes to inappropriate antibiotic prescribing, urgent care centers and retail clinics may have an outsized impact, a review of commercial insurance claims suggests.

Antibiotic prescription rates were at least twice as high in those settings, compared with emergency departments and medical office visits, according to the retrospective analysis.
The issue may be particularly pronounced in urgent care centers, based on this study, in which nearly half of visits for antibiotic-inappropriate respiratory diagnoses resulted in antibiotic prescribing.

Those findings suggest a need for “antibiotic stewardship interventions” to reduce unnecessary prescribing of antibiotics in ambulatory care settings, authors of the analysis reported in a research letter to JAMA Internal Medicine.

“Efforts targeting urgent care centers are urgently needed,” wrote Danielle L. Palms, MPH, of the Centers for Disease Control and Prevention, Atlanta, and her coauthors.

The retrospective study by Ms. Palms and her colleagues included claims from 2014 in a database of individuals 65 years of age or younger with employer-sponsored insurance.

The researchers included encounters in which medical and prescription coverage data were captured, including approximately 2.7 million urgent care center visits, 58,000 retail clinic visits, 4.8 million emergency department visits, and 148.5 million medical office visits.[[{"fid":"194045","view_mode":"medstat_image_flush_right","attributes":{"class":"media-element file-medstat-image-flush-right","data-delta":"1"},"fields":{"format":"medstat_image_flush_right","field_file_image_caption[und][0][value]":"","field_file_image_caption[und][0][format]":"filtered_html","field_file_image_credit[und][0][value]":"Sheep purple/flickr/CC BY 2.0 /en.wikipedia/CC BY-SA 4.0"},"type":"media","field_deltas":{"1":{"format":"medstat_image_flush_right","field_file_image_caption[und][0][value]":"","field_file_image_caption[und][0][format]":"filtered_html","field_file_image_credit[und][0][value]":"Sheep purple/flickr/CC BY 2.0 /en.wikipedia/CC BY-SA 4.0"}}}]]

They found antibiotic prescriptions linked to 39.0% of urgent care and 36.4% of retail clinic visits, compared with 13.8% of emergency department visits and 7.1% of medical office visits.

For respiratory diagnoses where antibiotics would be inappropriate, such as viral upper respiratory infections, antibiotics were nevertheless prescribed in 45.7% of urgent care visits, compared with 24.6% of emergency department, 17.0% of medical office visits, and 14.4% of retail clinic visits.

Those data show “substantial variability” that suggests case mix differences and evidence of antibiotic overuse, particularly in the urgent care setting, the researchers said in their letter.

In another recent study, looking at the 2010-2011 period, at least 30% of antibiotic prescriptions written in U.S. physician offices and emergency departments were unnecessary.

“The finding of the present study that antibiotic prescribing for antibiotic inappropriate respiratory diagnoses was highest in urgent care centers suggests that unnecessary antibiotic prescribing nationally in all outpatient settings may be higher than the estimated 30%,” wrote Ms. Palms and her coinvestigators.

The research was funded by the Centers for Disease Control and Prevention. Ms. Palms and her coauthors reported no conflicts of interest.

SOURCE: Palms DL et al. JAMA Intern Med. 2018 Jul 16.

When it comes to inappropriate antibiotic prescribing, urgent care centers and retail clinics may have an outsized impact, a review of commercial insurance claims suggests.

Antibiotic prescription rates were at least twice as high in those settings, compared with emergency departments and medical office visits, according to the retrospective analysis.
The issue may be particularly pronounced in urgent care centers, based on this study, in which nearly half of visits for antibiotic-inappropriate respiratory diagnoses resulted in antibiotic prescribing.

Those findings suggest a need for “antibiotic stewardship interventions” to reduce unnecessary prescribing of antibiotics in ambulatory care settings, authors of the analysis reported in a research letter to JAMA Internal Medicine.

“Efforts targeting urgent care centers are urgently needed,” wrote Danielle L. Palms, MPH, of the Centers for Disease Control and Prevention, Atlanta, and her coauthors.

The retrospective study by Ms. Palms and her colleagues included claims from 2014 in a database of individuals 65 years of age or younger with employer-sponsored insurance.

The researchers included encounters in which medical and prescription coverage data were captured, including approximately 2.7 million urgent care center visits, 58,000 retail clinic visits, 4.8 million emergency department visits, and 148.5 million medical office visits.[[{"fid":"194045","view_mode":"medstat_image_flush_right","attributes":{"class":"media-element file-medstat-image-flush-right","data-delta":"1"},"fields":{"format":"medstat_image_flush_right","field_file_image_caption[und][0][value]":"","field_file_image_caption[und][0][format]":"filtered_html","field_file_image_credit[und][0][value]":"Sheep purple/flickr/CC BY 2.0 /en.wikipedia/CC BY-SA 4.0"},"type":"media","field_deltas":{"1":{"format":"medstat_image_flush_right","field_file_image_caption[und][0][value]":"","field_file_image_caption[und][0][format]":"filtered_html","field_file_image_credit[und][0][value]":"Sheep purple/flickr/CC BY 2.0 /en.wikipedia/CC BY-SA 4.0"}}}]]

They found antibiotic prescriptions linked to 39.0% of urgent care and 36.4% of retail clinic visits, compared with 13.8% of emergency department visits and 7.1% of medical office visits.

For respiratory diagnoses where antibiotics would be inappropriate, such as viral upper respiratory infections, antibiotics were nevertheless prescribed in 45.7% of urgent care visits, compared with 24.6% of emergency department, 17.0% of medical office visits, and 14.4% of retail clinic visits.

Those data show “substantial variability” that suggests case mix differences and evidence of antibiotic overuse, particularly in the urgent care setting, the researchers said in their letter.

In another recent study, looking at the 2010-2011 period, at least 30% of antibiotic prescriptions written in U.S. physician offices and emergency departments were unnecessary.

“The finding of the present study that antibiotic prescribing for antibiotic inappropriate respiratory diagnoses was highest in urgent care centers suggests that unnecessary antibiotic prescribing nationally in all outpatient settings may be higher than the estimated 30%,” wrote Ms. Palms and her coinvestigators.

The research was funded by the Centers for Disease Control and Prevention. Ms. Palms and her coauthors reported no conflicts of interest.

SOURCE: Palms DL et al. JAMA Intern Med. 2018 Jul 16.

“Suicide rates are increasing,” Dr. Igor Galynker said, “and I believe they will continue to rise. These are deaths of despair, and despair is increasing in our society.”

Dr. Miller is the coauthor of “Committed: The Battle Over Involuntary Psychiatric Care,” (Baltimore: Johns Hopkins University Press, 2016).

“Suicide rates are increasing,” Dr. Igor Galynker said, “and I believe they will continue to rise. These are deaths of despair, and despair is increasing in our society.”

Dr. Miller is the coauthor of “Committed: The Battle Over Involuntary Psychiatric Care,” (Baltimore: Johns Hopkins University Press, 2016).

“Suicide rates are increasing,” Dr. Igor Galynker said, “and I believe they will continue to rise. These are deaths of despair, and despair is increasing in our society.”

Dr. Miller is the coauthor of “Committed: The Battle Over Involuntary Psychiatric Care,” (Baltimore: Johns Hopkins University Press, 2016).

ORLANDO – Research suggests that HIV-positive people who take the latest generations of AIDS medications are living almost as long as everyone else. But they still face special medical challenges, and an endocrinologist urged colleagues to adjust their approaches to diabetes in these patients.

“The HIV population is indeed aging, diabetes is very common, and there are some unique pathophysiologic and management considerations,” said Todd T. Brown, MD, PhD, of Johns Hopkins Medicine, Baltimore, in a presentation at the annual scientific sessions of the American Diabetes Association.

It’s not just a matter of subbing in an alternate drug here or there. When it comes to diabetes, patients with HIV require significant adjustments to diagnosis and treatment, Dr. Brown said.

In terms of diagnosis, treatment guidelines approved by the Infectious Diseases Society of America and ADA recommend that all HIV-positive patients be tested for diabetes before they begin taking antiretroviral therapy. Then, the guidelines suggest, they should be tested 4-6 weeks after initiation of therapy, and every 6-12 months going forward.

“It’s a bit of overkill to go every 6 months,” said Dr. Brown, who prefers an annual testing approach. He added that research has suggested that the 2-hour postload glucose test is more sensitive than the fasting glucose test in some HIV-positive populations. However, he believes that it’s generally fine to give a fasting glucose test before initiation of therapy – and on an annual basis afterward – rather than the more cumbersome postload test.

Still, he said, the postload test may be appropriate in a patient with impaired glucose tolerance “if you really want to make the diagnosis, and especially if you’ll change your treatment based on it.”

Ongoing treatment of HIV-positive patients also presents unique challenges, he said. For one, antiretroviral therapy seems to affect glucose metabolism and body fat, he said, and findings from a 2016 study suggest HIV-positive people who begin antiretroviral therapy face a higher risk of developing diabetes after weight gain (J Acquir Immune Defic Syndr. 2016 Oct 1;73[2]:228-36).

One option is to switch patients to integrase inhibitors, but findings from a 2017 study suggested that this may also lead to more weight gain, Dr. Brown said.

“This has been an evolving story,” he said. “The clinical consequences of this are unclear. This is a topic that’s being hotly investigated now in the HIV health world” (JAIDS. 2017 Dec 15;76[5]:527-31).

As for other diabetes management issues, Dr. Brown noted that hemoglobin A_1c tests appear to underestimate glycemia in HIV-infected patients. He suggested that goal HbA_1c levels should be lower in diabetic patients with HIV, especially those with CD4+ counts under 500 cells /mm³ and/or mean cell volume over 100 fL.

Research suggests that lifestyle changes seem to work well in HIV-positive patients, he said, and metformin is the ideal first-line drug treatment just as in the HIV-negative population. “It’s a good drug. We all love it,” he said. “It may improve lipohypertrophy and coronary plaque.”

He added that proteinuria and neuropathy are more common in HIV-positive patients with diabetes. He said levels of neuropathy and nephropathy could be related to AIDS drugs.

On the medication front, Dr. Brown cautioned about certain drugs in HIV-positive patients: The HIV drug dolutegravir increases metformin concentrations by about 80%, he said, and there are concerns about bone and cardiac health in HIV-positive patients who take the diabetes medications known as thiazolidinediones (glitazones).

He added that there are sparse data about the use of several types of diabetes drugs – DPP IV inhibitors, GLP-1 receptor agonists, and SGLT2 inhibitors – in HIV-positive patients.

Dr. Brown discloses consulting for Gilead Sciences, ViiV, BMS, Merck, Theratechnologies, and EMD Serono.

ORLANDO – Research suggests that HIV-positive people who take the latest generations of AIDS medications are living almost as long as everyone else. But they still face special medical challenges, and an endocrinologist urged colleagues to adjust their approaches to diabetes in these patients.

“The HIV population is indeed aging, diabetes is very common, and there are some unique pathophysiologic and management considerations,” said Todd T. Brown, MD, PhD, of Johns Hopkins Medicine, Baltimore, in a presentation at the annual scientific sessions of the American Diabetes Association.

It’s not just a matter of subbing in an alternate drug here or there. When it comes to diabetes, patients with HIV require significant adjustments to diagnosis and treatment, Dr. Brown said.

In terms of diagnosis, treatment guidelines approved by the Infectious Diseases Society of America and ADA recommend that all HIV-positive patients be tested for diabetes before they begin taking antiretroviral therapy. Then, the guidelines suggest, they should be tested 4-6 weeks after initiation of therapy, and every 6-12 months going forward.

“It’s a bit of overkill to go every 6 months,” said Dr. Brown, who prefers an annual testing approach. He added that research has suggested that the 2-hour postload glucose test is more sensitive than the fasting glucose test in some HIV-positive populations. However, he believes that it’s generally fine to give a fasting glucose test before initiation of therapy – and on an annual basis afterward – rather than the more cumbersome postload test.

Still, he said, the postload test may be appropriate in a patient with impaired glucose tolerance “if you really want to make the diagnosis, and especially if you’ll change your treatment based on it.”

Ongoing treatment of HIV-positive patients also presents unique challenges, he said. For one, antiretroviral therapy seems to affect glucose metabolism and body fat, he said, and findings from a 2016 study suggest HIV-positive people who begin antiretroviral therapy face a higher risk of developing diabetes after weight gain (J Acquir Immune Defic Syndr. 2016 Oct 1;73[2]:228-36).

One option is to switch patients to integrase inhibitors, but findings from a 2017 study suggested that this may also lead to more weight gain, Dr. Brown said.

“This has been an evolving story,” he said. “The clinical consequences of this are unclear. This is a topic that’s being hotly investigated now in the HIV health world” (JAIDS. 2017 Dec 15;76[5]:527-31).

As for other diabetes management issues, Dr. Brown noted that hemoglobin A_1c tests appear to underestimate glycemia in HIV-infected patients. He suggested that goal HbA_1c levels should be lower in diabetic patients with HIV, especially those with CD4+ counts under 500 cells /mm³ and/or mean cell volume over 100 fL.

Research suggests that lifestyle changes seem to work well in HIV-positive patients, he said, and metformin is the ideal first-line drug treatment just as in the HIV-negative population. “It’s a good drug. We all love it,” he said. “It may improve lipohypertrophy and coronary plaque.”

He added that proteinuria and neuropathy are more common in HIV-positive patients with diabetes. He said levels of neuropathy and nephropathy could be related to AIDS drugs.

On the medication front, Dr. Brown cautioned about certain drugs in HIV-positive patients: The HIV drug dolutegravir increases metformin concentrations by about 80%, he said, and there are concerns about bone and cardiac health in HIV-positive patients who take the diabetes medications known as thiazolidinediones (glitazones).

He added that there are sparse data about the use of several types of diabetes drugs – DPP IV inhibitors, GLP-1 receptor agonists, and SGLT2 inhibitors – in HIV-positive patients.

Dr. Brown discloses consulting for Gilead Sciences, ViiV, BMS, Merck, Theratechnologies, and EMD Serono.

ORLANDO – Research suggests that HIV-positive people who take the latest generations of AIDS medications are living almost as long as everyone else. But they still face special medical challenges, and an endocrinologist urged colleagues to adjust their approaches to diabetes in these patients.

“The HIV population is indeed aging, diabetes is very common, and there are some unique pathophysiologic and management considerations,” said Todd T. Brown, MD, PhD, of Johns Hopkins Medicine, Baltimore, in a presentation at the annual scientific sessions of the American Diabetes Association.

It’s not just a matter of subbing in an alternate drug here or there. When it comes to diabetes, patients with HIV require significant adjustments to diagnosis and treatment, Dr. Brown said.

In terms of diagnosis, treatment guidelines approved by the Infectious Diseases Society of America and ADA recommend that all HIV-positive patients be tested for diabetes before they begin taking antiretroviral therapy. Then, the guidelines suggest, they should be tested 4-6 weeks after initiation of therapy, and every 6-12 months going forward.

“It’s a bit of overkill to go every 6 months,” said Dr. Brown, who prefers an annual testing approach. He added that research has suggested that the 2-hour postload glucose test is more sensitive than the fasting glucose test in some HIV-positive populations. However, he believes that it’s generally fine to give a fasting glucose test before initiation of therapy – and on an annual basis afterward – rather than the more cumbersome postload test.

Still, he said, the postload test may be appropriate in a patient with impaired glucose tolerance “if you really want to make the diagnosis, and especially if you’ll change your treatment based on it.”

Ongoing treatment of HIV-positive patients also presents unique challenges, he said. For one, antiretroviral therapy seems to affect glucose metabolism and body fat, he said, and findings from a 2016 study suggest HIV-positive people who begin antiretroviral therapy face a higher risk of developing diabetes after weight gain (J Acquir Immune Defic Syndr. 2016 Oct 1;73[2]:228-36).

One option is to switch patients to integrase inhibitors, but findings from a 2017 study suggested that this may also lead to more weight gain, Dr. Brown said.

“This has been an evolving story,” he said. “The clinical consequences of this are unclear. This is a topic that’s being hotly investigated now in the HIV health world” (JAIDS. 2017 Dec 15;76[5]:527-31).

As for other diabetes management issues, Dr. Brown noted that hemoglobin A_1c tests appear to underestimate glycemia in HIV-infected patients. He suggested that goal HbA_1c levels should be lower in diabetic patients with HIV, especially those with CD4+ counts under 500 cells /mm³ and/or mean cell volume over 100 fL.

Research suggests that lifestyle changes seem to work well in HIV-positive patients, he said, and metformin is the ideal first-line drug treatment just as in the HIV-negative population. “It’s a good drug. We all love it,” he said. “It may improve lipohypertrophy and coronary plaque.”

He added that proteinuria and neuropathy are more common in HIV-positive patients with diabetes. He said levels of neuropathy and nephropathy could be related to AIDS drugs.

On the medication front, Dr. Brown cautioned about certain drugs in HIV-positive patients: The HIV drug dolutegravir increases metformin concentrations by about 80%, he said, and there are concerns about bone and cardiac health in HIV-positive patients who take the diabetes medications known as thiazolidinediones (glitazones).

He added that there are sparse data about the use of several types of diabetes drugs – DPP IV inhibitors, GLP-1 receptor agonists, and SGLT2 inhibitors – in HIV-positive patients.

Dr. Brown discloses consulting for Gilead Sciences, ViiV, BMS, Merck, Theratechnologies, and EMD Serono.

Digital single-operator cholangioscopy (D-SOC) with electrohydraulic or laser lithotripsy achieved complete bile duct clearance in more than 95% of 407 consecutive patients who underwent the procedure for difficult bile duct stones in a multicenter retrospective analysis.

“D-SOC with either [electrohydraulic lithotripsy or laser lithotripsy] represents an efficient, highly valuable, safe and minimally invasive alternative to percutaneous or surgical approaches in the management of difficult biliary stones,” reported Olaya I. Brewer Gutierrez, MD, of Johns Hopkins Hospital, Baltimore, and her colleagues.

The study, published in Clinical Gastroenterology and Hepatology, involved 22 tertiary centers in the United States, the United Kingdom, and Korea. Patients had difficult biliary stones, defined as stones greater than 15 mm in size, multiple (more than three) stones, intrahepatic duct/cystic duct stones, impacted stones, and stones associated with Mirizzi syndrome or a difficult biliary anatomy such as stricture below the stone or duodenal diverticula.

Most patients (85.7%) had a prior failed treatment with endoscopic retrograde cholangiopancreatography (ERCP) for stone clearance at outside hospitals, with biliary sphincterotomy and the use of an extraction balloon attempted in 62.2% and 73.2% of these cases, respectively.

Of the 407 study patients, 306 (75.2%) were treated with electrohydraulic lithotripsy (EHL), and 101 (24.8%) were treated with laser lithotripsy (LL). Complete ductal clearance was achieved in 396 (97.3%) of patients with a median of one lithotripsy session (range of one to four sessions), and in 77.4% of patients in a single session. Stone clearance rates and procedure outcomes were similar between the two approaches, but the mean procedure time was significantly longer with EHL than with LL (74 vs. 50 minutes).

Eleven (2.7%) of the 407 patients failed EHL/LL and were treated either with surgery, extracorporeal shock-wave lithotripsy, or both. Adverse events were observed in 15 patients (3.7%), with cholangitis and abdominal pain most commonly reported.

In addition to evaluating the technical success of D-SOC for difficult bile duct stones and comparing the effectiveness of EHL and LL, the investigators looked for predictors of outcomes. On multivariate analysis, they found difficult anatomy/cannulation was associated with incomplete ductal clearance, and the duration of the procedure was a predictor of the need for more than one D-SOC.

The introduction of D-SOC several years ago has “improved the ease of SOC and markedly improved the image quality,” Dr. Gutierrez and her colleagues wrote. “These [improvements] have led to greater use of EHL or LL as part of the ERCP armamentarium to attempt stone clearance in difficult biliary or pancreatic stones.”

Still, given the retrospective nature of the study and subsequent selection bias, randomized controlled trials comparing D-SOC and EHL/LL with conventional techniques for stone extraction are needed, they say.

In an accompanying editorial, Dennis Yang, MD, of the University of Florida, and Jonathan M. Buscaglia, MD, AGAF, of State University of New York at Stony Brook commended the study for critically evaluating a new technology, but said that “it still remains unclear in whom D-SOC with EHL or LL should be considered over conventional ERCP with stone extraction techniques.”

Although most patients in the study had a prior failed ERCP, conventional stone extraction techniques such as endoscopic sphincterotomy with endoscopic papillary large balloon dilation (EPLBD) or mechanical lithotripsy were attempted in less than a quarter of the cases before D-SOC, they wrote. “In the era of high-cost health care, it is important that proven and effective measures for the treatment of stones ... be used adequately before moving up the ladder to cholangioscopy-based techniques.”

Eleven of the study authors reported serving as consultants for Boston Scientific, which manufactures the D-SOC system used at the study sites, and two of the investigators reported serving as speakers for the company. Dr. Gutierrez reported no conflicts of interest.

[email protected]

SOURCE: Brewer Gutierrez OI et al. Clin Gastroenterol Hepatol. 2018;16:918-26.

Digital single-operator cholangioscopy (D-SOC) with electrohydraulic or laser lithotripsy achieved complete bile duct clearance in more than 95% of 407 consecutive patients who underwent the procedure for difficult bile duct stones in a multicenter retrospective analysis.

“D-SOC with either [electrohydraulic lithotripsy or laser lithotripsy] represents an efficient, highly valuable, safe and minimally invasive alternative to percutaneous or surgical approaches in the management of difficult biliary stones,” reported Olaya I. Brewer Gutierrez, MD, of Johns Hopkins Hospital, Baltimore, and her colleagues.

The study, published in Clinical Gastroenterology and Hepatology, involved 22 tertiary centers in the United States, the United Kingdom, and Korea. Patients had difficult biliary stones, defined as stones greater than 15 mm in size, multiple (more than three) stones, intrahepatic duct/cystic duct stones, impacted stones, and stones associated with Mirizzi syndrome or a difficult biliary anatomy such as stricture below the stone or duodenal diverticula.

Most patients (85.7%) had a prior failed treatment with endoscopic retrograde cholangiopancreatography (ERCP) for stone clearance at outside hospitals, with biliary sphincterotomy and the use of an extraction balloon attempted in 62.2% and 73.2% of these cases, respectively.

Of the 407 study patients, 306 (75.2%) were treated with electrohydraulic lithotripsy (EHL), and 101 (24.8%) were treated with laser lithotripsy (LL). Complete ductal clearance was achieved in 396 (97.3%) of patients with a median of one lithotripsy session (range of one to four sessions), and in 77.4% of patients in a single session. Stone clearance rates and procedure outcomes were similar between the two approaches, but the mean procedure time was significantly longer with EHL than with LL (74 vs. 50 minutes).

Eleven (2.7%) of the 407 patients failed EHL/LL and were treated either with surgery, extracorporeal shock-wave lithotripsy, or both. Adverse events were observed in 15 patients (3.7%), with cholangitis and abdominal pain most commonly reported.

In addition to evaluating the technical success of D-SOC for difficult bile duct stones and comparing the effectiveness of EHL and LL, the investigators looked for predictors of outcomes. On multivariate analysis, they found difficult anatomy/cannulation was associated with incomplete ductal clearance, and the duration of the procedure was a predictor of the need for more than one D-SOC.

The introduction of D-SOC several years ago has “improved the ease of SOC and markedly improved the image quality,” Dr. Gutierrez and her colleagues wrote. “These [improvements] have led to greater use of EHL or LL as part of the ERCP armamentarium to attempt stone clearance in difficult biliary or pancreatic stones.”

Still, given the retrospective nature of the study and subsequent selection bias, randomized controlled trials comparing D-SOC and EHL/LL with conventional techniques for stone extraction are needed, they say.

In an accompanying editorial, Dennis Yang, MD, of the University of Florida, and Jonathan M. Buscaglia, MD, AGAF, of State University of New York at Stony Brook commended the study for critically evaluating a new technology, but said that “it still remains unclear in whom D-SOC with EHL or LL should be considered over conventional ERCP with stone extraction techniques.”

Although most patients in the study had a prior failed ERCP, conventional stone extraction techniques such as endoscopic sphincterotomy with endoscopic papillary large balloon dilation (EPLBD) or mechanical lithotripsy were attempted in less than a quarter of the cases before D-SOC, they wrote. “In the era of high-cost health care, it is important that proven and effective measures for the treatment of stones ... be used adequately before moving up the ladder to cholangioscopy-based techniques.”

Eleven of the study authors reported serving as consultants for Boston Scientific, which manufactures the D-SOC system used at the study sites, and two of the investigators reported serving as speakers for the company. Dr. Gutierrez reported no conflicts of interest.

[email protected]

SOURCE: Brewer Gutierrez OI et al. Clin Gastroenterol Hepatol. 2018;16:918-26.

Digital single-operator cholangioscopy (D-SOC) with electrohydraulic or laser lithotripsy achieved complete bile duct clearance in more than 95% of 407 consecutive patients who underwent the procedure for difficult bile duct stones in a multicenter retrospective analysis.

“D-SOC with either [electrohydraulic lithotripsy or laser lithotripsy] represents an efficient, highly valuable, safe and minimally invasive alternative to percutaneous or surgical approaches in the management of difficult biliary stones,” reported Olaya I. Brewer Gutierrez, MD, of Johns Hopkins Hospital, Baltimore, and her colleagues.

The study, published in Clinical Gastroenterology and Hepatology, involved 22 tertiary centers in the United States, the United Kingdom, and Korea. Patients had difficult biliary stones, defined as stones greater than 15 mm in size, multiple (more than three) stones, intrahepatic duct/cystic duct stones, impacted stones, and stones associated with Mirizzi syndrome or a difficult biliary anatomy such as stricture below the stone or duodenal diverticula.

Most patients (85.7%) had a prior failed treatment with endoscopic retrograde cholangiopancreatography (ERCP) for stone clearance at outside hospitals, with biliary sphincterotomy and the use of an extraction balloon attempted in 62.2% and 73.2% of these cases, respectively.

Of the 407 study patients, 306 (75.2%) were treated with electrohydraulic lithotripsy (EHL), and 101 (24.8%) were treated with laser lithotripsy (LL). Complete ductal clearance was achieved in 396 (97.3%) of patients with a median of one lithotripsy session (range of one to four sessions), and in 77.4% of patients in a single session. Stone clearance rates and procedure outcomes were similar between the two approaches, but the mean procedure time was significantly longer with EHL than with LL (74 vs. 50 minutes).

Eleven (2.7%) of the 407 patients failed EHL/LL and were treated either with surgery, extracorporeal shock-wave lithotripsy, or both. Adverse events were observed in 15 patients (3.7%), with cholangitis and abdominal pain most commonly reported.

In addition to evaluating the technical success of D-SOC for difficult bile duct stones and comparing the effectiveness of EHL and LL, the investigators looked for predictors of outcomes. On multivariate analysis, they found difficult anatomy/cannulation was associated with incomplete ductal clearance, and the duration of the procedure was a predictor of the need for more than one D-SOC.

The introduction of D-SOC several years ago has “improved the ease of SOC and markedly improved the image quality,” Dr. Gutierrez and her colleagues wrote. “These [improvements] have led to greater use of EHL or LL as part of the ERCP armamentarium to attempt stone clearance in difficult biliary or pancreatic stones.”

Still, given the retrospective nature of the study and subsequent selection bias, randomized controlled trials comparing D-SOC and EHL/LL with conventional techniques for stone extraction are needed, they say.

In an accompanying editorial, Dennis Yang, MD, of the University of Florida, and Jonathan M. Buscaglia, MD, AGAF, of State University of New York at Stony Brook commended the study for critically evaluating a new technology, but said that “it still remains unclear in whom D-SOC with EHL or LL should be considered over conventional ERCP with stone extraction techniques.”

Although most patients in the study had a prior failed ERCP, conventional stone extraction techniques such as endoscopic sphincterotomy with endoscopic papillary large balloon dilation (EPLBD) or mechanical lithotripsy were attempted in less than a quarter of the cases before D-SOC, they wrote. “In the era of high-cost health care, it is important that proven and effective measures for the treatment of stones ... be used adequately before moving up the ladder to cholangioscopy-based techniques.”

Eleven of the study authors reported serving as consultants for Boston Scientific, which manufactures the D-SOC system used at the study sites, and two of the investigators reported serving as speakers for the company. Dr. Gutierrez reported no conflicts of interest.

[email protected]

SOURCE: Brewer Gutierrez OI et al. Clin Gastroenterol Hepatol. 2018;16:918-26.

Learn all about coding at the SVS Coding & Reimbursement Workshop, set for Oct. 19 and 20 at the Renaissance Hotel in downtown Chicago. The intensive two-day program will address 2019 updates and proposed updates, the global surgical package and how it affects billing and reimbursement and applying modifiers for streamlined reimbursement. It is designed for vascular surgeons and their support staff. Learn more, see pricing and register here.

Learn all about coding at the SVS Coding & Reimbursement Workshop, set for Oct. 19 and 20 at the Renaissance Hotel in downtown Chicago. The intensive two-day program will address 2019 updates and proposed updates, the global surgical package and how it affects billing and reimbursement and applying modifiers for streamlined reimbursement. It is designed for vascular surgeons and their support staff. Learn more, see pricing and register here.

Learn all about coding at the SVS Coding & Reimbursement Workshop, set for Oct. 19 and 20 at the Renaissance Hotel in downtown Chicago. The intensive two-day program will address 2019 updates and proposed updates, the global surgical package and how it affects billing and reimbursement and applying modifiers for streamlined reimbursement. It is designed for vascular surgeons and their support staff. Learn more, see pricing and register here.

The deadline to submit applications for the SVS Foundation Research Career Development Travel Award is Aug. 15. This award aims to develop strong leaders in vascular surgery. Awardees are assigned an SVS research mentor and are provided with funds to attend an establish research career development course.

The deadline to submit applications for the SVS Foundation Research Career Development Travel Award is Aug. 15. This award aims to develop strong leaders in vascular surgery. Awardees are assigned an SVS research mentor and are provided with funds to attend an establish research career development course.

The deadline to submit applications for the SVS Foundation Research Career Development Travel Award is Aug. 15. This award aims to develop strong leaders in vascular surgery. Awardees are assigned an SVS research mentor and are provided with funds to attend an establish research career development course.