Mary Ann Moon

The WEE1 tyrosine kinase inhibitor AZD1775 enhanced carboplatin’s antitumor activity in a phase II proof-of-concept trial of refractory or resistant TP53-mediated ovarian cancer, according to a report in the Journal of Clinical Oncology.

The manufacturer-sponsored open-label nonrandomized trial involved 23 women (median age, 58 years; range, 25-74 years) who had epithelial ovarian cancer and TP53 mutations and whose disease didn’t respond to or recurred after first-line platinum plus paclitaxel therapy. All the participants also underwent either primary or interval debulking surgery, said Suzanne Leijen, MD, PhD, of The Netherlands Cancer Institute, Amsterdam, and her associates.

The patients took 225 mg AZD1775 orally twice a day for 3 days along with IV carboplatin in 21-day cycles, until the cancer progressed. The primary outcome measure, overall response rate, was 43% in the 21 evaluable patients. After two treatment cycles, one patient had a complete response, eight had a partial response, seven had stable disease, and five had progressive disease.

“This response rate exceeds the effect that could be expected with second-line single-agent treatment options, including paclitaxel, pegylated liposomal doxorubicin, bevacizumab, and topotecan, which have reported response rates of 11%-21%,” the investigators said (J Clin Oncol. 2016 Oct. 31. doi: 10.1200/JCO.2016.67.5942).

The median progression-free survival was 5.3 months and median overall survival was 12.6 months. One patient showed a partial response for 31 months and another showed a complete response for 42 months, and both continue to receive the treatment.

AZD1775 plus carboplatin “was generally well tolerated and demonstrated manageable toxicity,” including nausea, vomiting, diarrhea, fatigue, bone marrow suppression, thrombocytopenia, and neutropenia.

This study was supported by Merck, which was involved in the data analysis and interpretation. Dr. Leijen reported having no relevant financial disclosures; her associates reported ties to Merck, AstraZeneca, Roche, Novartis, Advaxis, and Modra Pharmaceuticals.

The WEE1 tyrosine kinase inhibitor AZD1775 enhanced carboplatin’s antitumor activity in a phase II proof-of-concept trial of refractory or resistant TP53-mediated ovarian cancer, according to a report in the Journal of Clinical Oncology.

The manufacturer-sponsored open-label nonrandomized trial involved 23 women (median age, 58 years; range, 25-74 years) who had epithelial ovarian cancer and TP53 mutations and whose disease didn’t respond to or recurred after first-line platinum plus paclitaxel therapy. All the participants also underwent either primary or interval debulking surgery, said Suzanne Leijen, MD, PhD, of The Netherlands Cancer Institute, Amsterdam, and her associates.

The patients took 225 mg AZD1775 orally twice a day for 3 days along with IV carboplatin in 21-day cycles, until the cancer progressed. The primary outcome measure, overall response rate, was 43% in the 21 evaluable patients. After two treatment cycles, one patient had a complete response, eight had a partial response, seven had stable disease, and five had progressive disease.

“This response rate exceeds the effect that could be expected with second-line single-agent treatment options, including paclitaxel, pegylated liposomal doxorubicin, bevacizumab, and topotecan, which have reported response rates of 11%-21%,” the investigators said (J Clin Oncol. 2016 Oct. 31. doi: 10.1200/JCO.2016.67.5942).

The median progression-free survival was 5.3 months and median overall survival was 12.6 months. One patient showed a partial response for 31 months and another showed a complete response for 42 months, and both continue to receive the treatment.

AZD1775 plus carboplatin “was generally well tolerated and demonstrated manageable toxicity,” including nausea, vomiting, diarrhea, fatigue, bone marrow suppression, thrombocytopenia, and neutropenia.

This study was supported by Merck, which was involved in the data analysis and interpretation. Dr. Leijen reported having no relevant financial disclosures; her associates reported ties to Merck, AstraZeneca, Roche, Novartis, Advaxis, and Modra Pharmaceuticals.

The WEE1 tyrosine kinase inhibitor AZD1775 enhanced carboplatin’s antitumor activity in a phase II proof-of-concept trial of refractory or resistant TP53-mediated ovarian cancer, according to a report in the Journal of Clinical Oncology.

The manufacturer-sponsored open-label nonrandomized trial involved 23 women (median age, 58 years; range, 25-74 years) who had epithelial ovarian cancer and TP53 mutations and whose disease didn’t respond to or recurred after first-line platinum plus paclitaxel therapy. All the participants also underwent either primary or interval debulking surgery, said Suzanne Leijen, MD, PhD, of The Netherlands Cancer Institute, Amsterdam, and her associates.

The patients took 225 mg AZD1775 orally twice a day for 3 days along with IV carboplatin in 21-day cycles, until the cancer progressed. The primary outcome measure, overall response rate, was 43% in the 21 evaluable patients. After two treatment cycles, one patient had a complete response, eight had a partial response, seven had stable disease, and five had progressive disease.

“This response rate exceeds the effect that could be expected with second-line single-agent treatment options, including paclitaxel, pegylated liposomal doxorubicin, bevacizumab, and topotecan, which have reported response rates of 11%-21%,” the investigators said (J Clin Oncol. 2016 Oct. 31. doi: 10.1200/JCO.2016.67.5942).

The median progression-free survival was 5.3 months and median overall survival was 12.6 months. One patient showed a partial response for 31 months and another showed a complete response for 42 months, and both continue to receive the treatment.

AZD1775 plus carboplatin “was generally well tolerated and demonstrated manageable toxicity,” including nausea, vomiting, diarrhea, fatigue, bone marrow suppression, thrombocytopenia, and neutropenia.

This study was supported by Merck, which was involved in the data analysis and interpretation. Dr. Leijen reported having no relevant financial disclosures; her associates reported ties to Merck, AstraZeneca, Roche, Novartis, Advaxis, and Modra Pharmaceuticals.

Percutaneous coronary intervention (PCI) using everolimus-eluting stents was found noninferior to coronary artery bypass grafting (CABG) with respect to the composite end point of death, stroke, or myocardial infarction at 3 years among patients with left main coronary artery disease and low or intermediate anatomical complexity, according to a report presented at the Transcatheter Cardiovascular Therapeutics annual meeting and published simultaneously in the New England Journal of Medicine.

The rate of this composite outcome was lower with PCI than with CABG during the first 30 days following the procedure, but higher between day 30 and year 3. In addition, the 3-year rate of revascularization was slightly higher with PCI (23.1% vs 19.1%), but the rate of periprocedural MI and major adverse events was lower (8.1% vs 23.0%).

Taken together, these results “suggest that PCI with everolimus-eluting stents is an acceptable or perhaps preferred alternative to CABG in selected patients with left main CAD who are candidates for either procedure,” said Gregg W. Stone, MD, of Columbia University Medical Center, New York, and his associates in the EXCEL (Evaluation of XIENCE versus CABG for Effectiveness of Left Main Revascularization) trial.

This study was funded by Abbott Vascular, maker of the everolimus-eluting stent (the XIENCE). The company also participated in the design of the trial and in the selection and management of the treatment sites.

Until now, it was generally agreed that most patients with left main CAD would have better outcomes with CABG than with PCI, based on the results of earlier trials comparing the two approaches. But contemporary drug-eluting stents have better safety and efficacy profiles than first-generation stents, and surgical techniques have also improved over time, so a study comparing the current standards of care was warranted, Dr. Stone and his associates said (New Engl J Med. 2016 Oct 31. doi:10.1056/NEJMoa1610227).

They assessed 1,905 patients at 126 medical centers in 17 countries in the open-label noninferiority trial. Participants had left main coronary artery stenosis of 70% or more (estimated visually) or of 50%-70% (estimated by invasive or noninvasive testing) if the stenosis was judged to be hemodynamically significant. The study participants also were required to have low or intermediate anatomical complexity of the involved portion of the coronary artery, as defined by a SYNTAX score of 32 or lower. A total of 948 patients were randomly assigned to PCI and 957 to CABG.

The primary composite end point – the rate of death, stroke, or MI assessed at a median of 3 years of follow-up – was 15.4% with PCI and 14.7% with CABG, a nonsignificant difference (Hazard Ratio, 1.00) that demonstrates the noninferiority of PCI. This rate was consistently noninferior across all subgroups of patients, regardless of age, sex, and the presence or absence of diabetes or chronic kidney disease.

At 30 days, the rate of the composite end point was 4.9% with PCI and 7.9% with CABG, which also demonstrates the noninferiority of PCI. At 3 years, secondary end points including the rate of ischemia-driven revascularization also showed the noninferiority of PCI, as did each of the individual components of the primary composite end point.

The rate of death, stroke, or MI was lower at 30 days with PCI than with CABG, mainly because there were fewer MIs with PCI. But a post-hoc analysis showed that this rate was higher with PCI than with CABG after 30 days.

During follow-up, ischemia-driven revascularization was more common after PCI (12.6%) than after CABG (7.5%). However, symptomatic graft occlusion after CABG (5.4%) was more frequent than definite stent thrombosis after PCI (0.7%).

Periprocedural major adverse events developed in 8.1% of the PCI group and 23.0% of the CABG group, and the difference was attributed mainly to fewer arrhythmias, infections, and blood transfusions in the PCI group. Cardiovascular mortality was similar between the two study groups, though all-cause mortality was higher with PCI due to an excess of fatal infections and malignancies in that group.

The investigators noted several limitations with the EXCEL trial. First, treatment blinding wasn’t possible, so some degree of bias may have resulted.

Second, prerandomization SYNTAX scores estimating the anatomical complexity of the affected vessels weren’t always accurate, and 24% of the patients in this study proved to have complex lesions when their procedures were undertaken. However, the rate of the primary composite end point was the same in this subgroup of patients as in the overall patient population.

Third, long-term medications after PCI differ from those after CABG, and the investigators said further study is needed to determine how these differences may have contributed to patient outcomes. And finally, longer follow-up is needed to assess whether more differences between the two study groups emerge over time. Five-year follow-up of this study population is now under way.

Dr. Stone and his associates reported ties to numerous industry sources.

Percutaneous coronary intervention (PCI) using everolimus-eluting stents was found noninferior to coronary artery bypass grafting (CABG) with respect to the composite end point of death, stroke, or myocardial infarction at 3 years among patients with left main coronary artery disease and low or intermediate anatomical complexity, according to a report presented at the Transcatheter Cardiovascular Therapeutics annual meeting and published simultaneously in the New England Journal of Medicine.

The rate of this composite outcome was lower with PCI than with CABG during the first 30 days following the procedure, but higher between day 30 and year 3. In addition, the 3-year rate of revascularization was slightly higher with PCI (23.1% vs 19.1%), but the rate of periprocedural MI and major adverse events was lower (8.1% vs 23.0%).

Taken together, these results “suggest that PCI with everolimus-eluting stents is an acceptable or perhaps preferred alternative to CABG in selected patients with left main CAD who are candidates for either procedure,” said Gregg W. Stone, MD, of Columbia University Medical Center, New York, and his associates in the EXCEL (Evaluation of XIENCE versus CABG for Effectiveness of Left Main Revascularization) trial.

This study was funded by Abbott Vascular, maker of the everolimus-eluting stent (the XIENCE). The company also participated in the design of the trial and in the selection and management of the treatment sites.

Until now, it was generally agreed that most patients with left main CAD would have better outcomes with CABG than with PCI, based on the results of earlier trials comparing the two approaches. But contemporary drug-eluting stents have better safety and efficacy profiles than first-generation stents, and surgical techniques have also improved over time, so a study comparing the current standards of care was warranted, Dr. Stone and his associates said (New Engl J Med. 2016 Oct 31. doi:10.1056/NEJMoa1610227).

They assessed 1,905 patients at 126 medical centers in 17 countries in the open-label noninferiority trial. Participants had left main coronary artery stenosis of 70% or more (estimated visually) or of 50%-70% (estimated by invasive or noninvasive testing) if the stenosis was judged to be hemodynamically significant. The study participants also were required to have low or intermediate anatomical complexity of the involved portion of the coronary artery, as defined by a SYNTAX score of 32 or lower. A total of 948 patients were randomly assigned to PCI and 957 to CABG.

The primary composite end point – the rate of death, stroke, or MI assessed at a median of 3 years of follow-up – was 15.4% with PCI and 14.7% with CABG, a nonsignificant difference (Hazard Ratio, 1.00) that demonstrates the noninferiority of PCI. This rate was consistently noninferior across all subgroups of patients, regardless of age, sex, and the presence or absence of diabetes or chronic kidney disease.

At 30 days, the rate of the composite end point was 4.9% with PCI and 7.9% with CABG, which also demonstrates the noninferiority of PCI. At 3 years, secondary end points including the rate of ischemia-driven revascularization also showed the noninferiority of PCI, as did each of the individual components of the primary composite end point.

The rate of death, stroke, or MI was lower at 30 days with PCI than with CABG, mainly because there were fewer MIs with PCI. But a post-hoc analysis showed that this rate was higher with PCI than with CABG after 30 days.

During follow-up, ischemia-driven revascularization was more common after PCI (12.6%) than after CABG (7.5%). However, symptomatic graft occlusion after CABG (5.4%) was more frequent than definite stent thrombosis after PCI (0.7%).

Periprocedural major adverse events developed in 8.1% of the PCI group and 23.0% of the CABG group, and the difference was attributed mainly to fewer arrhythmias, infections, and blood transfusions in the PCI group. Cardiovascular mortality was similar between the two study groups, though all-cause mortality was higher with PCI due to an excess of fatal infections and malignancies in that group.

The investigators noted several limitations with the EXCEL trial. First, treatment blinding wasn’t possible, so some degree of bias may have resulted.

Second, prerandomization SYNTAX scores estimating the anatomical complexity of the affected vessels weren’t always accurate, and 24% of the patients in this study proved to have complex lesions when their procedures were undertaken. However, the rate of the primary composite end point was the same in this subgroup of patients as in the overall patient population.

Third, long-term medications after PCI differ from those after CABG, and the investigators said further study is needed to determine how these differences may have contributed to patient outcomes. And finally, longer follow-up is needed to assess whether more differences between the two study groups emerge over time. Five-year follow-up of this study population is now under way.

Dr. Stone and his associates reported ties to numerous industry sources.

Percutaneous coronary intervention (PCI) using everolimus-eluting stents was found noninferior to coronary artery bypass grafting (CABG) with respect to the composite end point of death, stroke, or myocardial infarction at 3 years among patients with left main coronary artery disease and low or intermediate anatomical complexity, according to a report presented at the Transcatheter Cardiovascular Therapeutics annual meeting and published simultaneously in the New England Journal of Medicine.

The rate of this composite outcome was lower with PCI than with CABG during the first 30 days following the procedure, but higher between day 30 and year 3. In addition, the 3-year rate of revascularization was slightly higher with PCI (23.1% vs 19.1%), but the rate of periprocedural MI and major adverse events was lower (8.1% vs 23.0%).

Taken together, these results “suggest that PCI with everolimus-eluting stents is an acceptable or perhaps preferred alternative to CABG in selected patients with left main CAD who are candidates for either procedure,” said Gregg W. Stone, MD, of Columbia University Medical Center, New York, and his associates in the EXCEL (Evaluation of XIENCE versus CABG for Effectiveness of Left Main Revascularization) trial.

This study was funded by Abbott Vascular, maker of the everolimus-eluting stent (the XIENCE). The company also participated in the design of the trial and in the selection and management of the treatment sites.

Until now, it was generally agreed that most patients with left main CAD would have better outcomes with CABG than with PCI, based on the results of earlier trials comparing the two approaches. But contemporary drug-eluting stents have better safety and efficacy profiles than first-generation stents, and surgical techniques have also improved over time, so a study comparing the current standards of care was warranted, Dr. Stone and his associates said (New Engl J Med. 2016 Oct 31. doi:10.1056/NEJMoa1610227).

They assessed 1,905 patients at 126 medical centers in 17 countries in the open-label noninferiority trial. Participants had left main coronary artery stenosis of 70% or more (estimated visually) or of 50%-70% (estimated by invasive or noninvasive testing) if the stenosis was judged to be hemodynamically significant. The study participants also were required to have low or intermediate anatomical complexity of the involved portion of the coronary artery, as defined by a SYNTAX score of 32 or lower. A total of 948 patients were randomly assigned to PCI and 957 to CABG.

The primary composite end point – the rate of death, stroke, or MI assessed at a median of 3 years of follow-up – was 15.4% with PCI and 14.7% with CABG, a nonsignificant difference (Hazard Ratio, 1.00) that demonstrates the noninferiority of PCI. This rate was consistently noninferior across all subgroups of patients, regardless of age, sex, and the presence or absence of diabetes or chronic kidney disease.

At 30 days, the rate of the composite end point was 4.9% with PCI and 7.9% with CABG, which also demonstrates the noninferiority of PCI. At 3 years, secondary end points including the rate of ischemia-driven revascularization also showed the noninferiority of PCI, as did each of the individual components of the primary composite end point.

The rate of death, stroke, or MI was lower at 30 days with PCI than with CABG, mainly because there were fewer MIs with PCI. But a post-hoc analysis showed that this rate was higher with PCI than with CABG after 30 days.

During follow-up, ischemia-driven revascularization was more common after PCI (12.6%) than after CABG (7.5%). However, symptomatic graft occlusion after CABG (5.4%) was more frequent than definite stent thrombosis after PCI (0.7%).

Periprocedural major adverse events developed in 8.1% of the PCI group and 23.0% of the CABG group, and the difference was attributed mainly to fewer arrhythmias, infections, and blood transfusions in the PCI group. Cardiovascular mortality was similar between the two study groups, though all-cause mortality was higher with PCI due to an excess of fatal infections and malignancies in that group.

The investigators noted several limitations with the EXCEL trial. First, treatment blinding wasn’t possible, so some degree of bias may have resulted.

Second, prerandomization SYNTAX scores estimating the anatomical complexity of the affected vessels weren’t always accurate, and 24% of the patients in this study proved to have complex lesions when their procedures were undertaken. However, the rate of the primary composite end point was the same in this subgroup of patients as in the overall patient population.

Third, long-term medications after PCI differ from those after CABG, and the investigators said further study is needed to determine how these differences may have contributed to patient outcomes. And finally, longer follow-up is needed to assess whether more differences between the two study groups emerge over time. Five-year follow-up of this study population is now under way.

Dr. Stone and his associates reported ties to numerous industry sources.

Approximately 20% of adult cancer survivors in the United States – roughly 2.5 million – take medication for anxiety or depression, a rate that is approximately twice that of the general population, according to a report published online in Journal of Clinical Oncology.

Considering that previous research reported that more than 30% of cancer survivors discuss psychosocial concerns with their medical providers, this finding suggests that “even more survivors might benefit from pharmacologic treatment than were receiving treatment at the time of this study,” said Nikki A. Hawkins, PhD, of the Centers for Disease Control and Prevention, and her associates.

“If left unaddressed and untreated, anxiety and depression have been found to negatively affect health behaviors, the body’s inflammatory response, and even survival.” Yet rates of medication use have not been examined until now, the investigators noted.

Dr. Hawkins and her associates analyzed data from the National Health Interview Surveys for 2010 through 2013 to determine population-based prevalence rates. Their study population comprised a nationally representative sample of 48,181 adults, of whom 3,184 were cancer survivors.

Compared with the general population, cancer survivors were approximately twice as likely to self-report taking medication for anxiety (16.8% vs 8.6%), depression (14.1% vs 7.8%), both conditions (11.8% vs 6.1%), and one or both conditions combined (19.1% vs 10.3%). When these results were extrapolated to the entire country, an estimated 2.5 million cancer survivors were found to currently use these medications, the investigators reported (J Clin Oncol. 2016 Oct 26. doi: 10.1200/JCO.2016.67.7690).

“Interestingly, medication use did not vary significantly by time since cancer diagnosis, which is consistent with recent research that has shown elevated rates of depression and mental disorders for cancer survivors as much as 10 years after diagnosis,” they wrote.

The highest rates (greater than 20%) of antianxiety and antidepressant use occurred among patients who were middle aged (those aged 40-64 years), had never married, had three or more chronic health conditions, expected to have a short survival time, or had ovarian or uterine cancer.

Nine types of cancer were included in this study: breast, prostate, melanoma, cervical, colorectal, hematologic, ovarian/uterine, “short survival,” and other. Of these, patients with prostate cancer were the least likely to use antianxiety or antidepressant medications, and patients with ovarian/uterine and short survival cancers were the most likely to.

“Efforts to improve the psychosocial care of cancer survivors will be aided by continued tracking of the treatment received for mental health. Good medical care requires systematic evaluation, screening for new problems, and making adjustments to the prescribed therapies as needed, and survivors’ mental health deserves the same detailed, evidence-based, and ongoing attention,” Dr. Hawkins and her associates said.

This study was supported by the Centers for Disease Control and Prevention. Dr. Hawkins and her associates reported having no relevant financial disclosures.

Approximately 20% of adult cancer survivors in the United States – roughly 2.5 million – take medication for anxiety or depression, a rate that is approximately twice that of the general population, according to a report published online in Journal of Clinical Oncology.

Considering that previous research reported that more than 30% of cancer survivors discuss psychosocial concerns with their medical providers, this finding suggests that “even more survivors might benefit from pharmacologic treatment than were receiving treatment at the time of this study,” said Nikki A. Hawkins, PhD, of the Centers for Disease Control and Prevention, and her associates.

“If left unaddressed and untreated, anxiety and depression have been found to negatively affect health behaviors, the body’s inflammatory response, and even survival.” Yet rates of medication use have not been examined until now, the investigators noted.

Dr. Hawkins and her associates analyzed data from the National Health Interview Surveys for 2010 through 2013 to determine population-based prevalence rates. Their study population comprised a nationally representative sample of 48,181 adults, of whom 3,184 were cancer survivors.

Compared with the general population, cancer survivors were approximately twice as likely to self-report taking medication for anxiety (16.8% vs 8.6%), depression (14.1% vs 7.8%), both conditions (11.8% vs 6.1%), and one or both conditions combined (19.1% vs 10.3%). When these results were extrapolated to the entire country, an estimated 2.5 million cancer survivors were found to currently use these medications, the investigators reported (J Clin Oncol. 2016 Oct 26. doi: 10.1200/JCO.2016.67.7690).

“Interestingly, medication use did not vary significantly by time since cancer diagnosis, which is consistent with recent research that has shown elevated rates of depression and mental disorders for cancer survivors as much as 10 years after diagnosis,” they wrote.

The highest rates (greater than 20%) of antianxiety and antidepressant use occurred among patients who were middle aged (those aged 40-64 years), had never married, had three or more chronic health conditions, expected to have a short survival time, or had ovarian or uterine cancer.

Nine types of cancer were included in this study: breast, prostate, melanoma, cervical, colorectal, hematologic, ovarian/uterine, “short survival,” and other. Of these, patients with prostate cancer were the least likely to use antianxiety or antidepressant medications, and patients with ovarian/uterine and short survival cancers were the most likely to.

“Efforts to improve the psychosocial care of cancer survivors will be aided by continued tracking of the treatment received for mental health. Good medical care requires systematic evaluation, screening for new problems, and making adjustments to the prescribed therapies as needed, and survivors’ mental health deserves the same detailed, evidence-based, and ongoing attention,” Dr. Hawkins and her associates said.

This study was supported by the Centers for Disease Control and Prevention. Dr. Hawkins and her associates reported having no relevant financial disclosures.

Approximately 20% of adult cancer survivors in the United States – roughly 2.5 million – take medication for anxiety or depression, a rate that is approximately twice that of the general population, according to a report published online in Journal of Clinical Oncology.

Considering that previous research reported that more than 30% of cancer survivors discuss psychosocial concerns with their medical providers, this finding suggests that “even more survivors might benefit from pharmacologic treatment than were receiving treatment at the time of this study,” said Nikki A. Hawkins, PhD, of the Centers for Disease Control and Prevention, and her associates.

“If left unaddressed and untreated, anxiety and depression have been found to negatively affect health behaviors, the body’s inflammatory response, and even survival.” Yet rates of medication use have not been examined until now, the investigators noted.

Dr. Hawkins and her associates analyzed data from the National Health Interview Surveys for 2010 through 2013 to determine population-based prevalence rates. Their study population comprised a nationally representative sample of 48,181 adults, of whom 3,184 were cancer survivors.

Compared with the general population, cancer survivors were approximately twice as likely to self-report taking medication for anxiety (16.8% vs 8.6%), depression (14.1% vs 7.8%), both conditions (11.8% vs 6.1%), and one or both conditions combined (19.1% vs 10.3%). When these results were extrapolated to the entire country, an estimated 2.5 million cancer survivors were found to currently use these medications, the investigators reported (J Clin Oncol. 2016 Oct 26. doi: 10.1200/JCO.2016.67.7690).

“Interestingly, medication use did not vary significantly by time since cancer diagnosis, which is consistent with recent research that has shown elevated rates of depression and mental disorders for cancer survivors as much as 10 years after diagnosis,” they wrote.

The highest rates (greater than 20%) of antianxiety and antidepressant use occurred among patients who were middle aged (those aged 40-64 years), had never married, had three or more chronic health conditions, expected to have a short survival time, or had ovarian or uterine cancer.

Nine types of cancer were included in this study: breast, prostate, melanoma, cervical, colorectal, hematologic, ovarian/uterine, “short survival,” and other. Of these, patients with prostate cancer were the least likely to use antianxiety or antidepressant medications, and patients with ovarian/uterine and short survival cancers were the most likely to.

“Efforts to improve the psychosocial care of cancer survivors will be aided by continued tracking of the treatment received for mental health. Good medical care requires systematic evaluation, screening for new problems, and making adjustments to the prescribed therapies as needed, and survivors’ mental health deserves the same detailed, evidence-based, and ongoing attention,” Dr. Hawkins and her associates said.

This study was supported by the Centers for Disease Control and Prevention. Dr. Hawkins and her associates reported having no relevant financial disclosures.

Adding seribantumab to paclitaxel did not extend survival as was hoped in unselected patients with platinum-resistant or refractory ovarian cancer, according to a report published online in Journal of Clinical Oncology.

However, exploratory analyses of data from this manufacturer-sponsored open-label phase II trial showed that certain biomarkers might identify a subgroup of patients who may benefit from the addition of seribantumab, said Joyce F. Liu, MD, of Dana-Farber Cancer Institute, Boston, and her associates.

[email protected]

Adding seribantumab to paclitaxel did not extend survival as was hoped in unselected patients with platinum-resistant or refractory ovarian cancer, according to a report published online in Journal of Clinical Oncology.

However, exploratory analyses of data from this manufacturer-sponsored open-label phase II trial showed that certain biomarkers might identify a subgroup of patients who may benefit from the addition of seribantumab, said Joyce F. Liu, MD, of Dana-Farber Cancer Institute, Boston, and her associates.

[email protected]

Adding seribantumab to paclitaxel did not extend survival as was hoped in unselected patients with platinum-resistant or refractory ovarian cancer, according to a report published online in Journal of Clinical Oncology.

However, exploratory analyses of data from this manufacturer-sponsored open-label phase II trial showed that certain biomarkers might identify a subgroup of patients who may benefit from the addition of seribantumab, said Joyce F. Liu, MD, of Dana-Farber Cancer Institute, Boston, and her associates.

[email protected]

A Web-based risk test endorsed by the American Medical Association, the American Diabetes Association, and the Centers for Disease Control and Prevention would label 59%-81% of adults as prediabetic if it were applied to the general U.S. population, according to a Research Letter to the Editor published online Oct. 3 in JAMA Internal Medicine.

The test is intended to evaluate the risk for prediabetes of any adult patient, and it advises those it identifies as prediabetic to see their physicians for confirmatory blood glucose testing. But given the results of their study, labeling this many people as prediabetic constitutes overmedicalization and could have the unintended consequence of diluting access to health care for people who actually have type 2 diabetes and other chronic conditions, said Saeid Shahraz, MD, PhD, of the Predictive Analytics and Comparative Effectiveness Center, Tufts Medical Center, Boston, and his associates.

The investigators assessed how many people this test would classify as prediabetic by analyzing data for a nationally representative sample of 10,175 adults who participated in the National Health and Nutrition Examination Survey in 2013-2014. They extracted the same information from participant responses to the NHANES survey that is elicited by the Web-based test: age, sex, history of gestational diabetes, first-degree relatives with diabetes, hypertension, physical activity level, and weight.

Among Americans aged 40 years and older, this test would classify an estimated 73.3 million, or 58.7%, as prediabetic; among those aged 60 years and older, it would classify 80.8% as prediabetic. The test also would advise all those people to see their physicians and undergo blood glucose testing for confirmation, Dr. Shahraz and his associates said (JAMA Intern Med. 2016 Oct 3. doi: 10.1001/jamainternmed.2016.5919).

This would be “premature” for many reasons. Intensive lifestyle modifications are not known to be beneficial for such patients, even those who are found to have impaired glucose tolerance. And there is no direct evidence that preventing type 2 diabetes actually reduces the risk for diabetes-related complications. Moreover, the natural progression from prediabetes to type 2 diabetes is likely to be slow, which calls into question the need for any intervention, particularly for older patients likely to die from competing causes, the researchers noted.

“A valid method to examine for prediabetes should avoid unnecessary medicalization by labeling a disease predecessor as a medical condition and seek to concentrate on people at highest risk to allow for efficient distribution of limited health care resources,” they added.

A Web-based risk test endorsed by the American Medical Association, the American Diabetes Association, and the Centers for Disease Control and Prevention would label 59%-81% of adults as prediabetic if it were applied to the general U.S. population, according to a Research Letter to the Editor published online Oct. 3 in JAMA Internal Medicine.

The test is intended to evaluate the risk for prediabetes of any adult patient, and it advises those it identifies as prediabetic to see their physicians for confirmatory blood glucose testing. But given the results of their study, labeling this many people as prediabetic constitutes overmedicalization and could have the unintended consequence of diluting access to health care for people who actually have type 2 diabetes and other chronic conditions, said Saeid Shahraz, MD, PhD, of the Predictive Analytics and Comparative Effectiveness Center, Tufts Medical Center, Boston, and his associates.

The investigators assessed how many people this test would classify as prediabetic by analyzing data for a nationally representative sample of 10,175 adults who participated in the National Health and Nutrition Examination Survey in 2013-2014. They extracted the same information from participant responses to the NHANES survey that is elicited by the Web-based test: age, sex, history of gestational diabetes, first-degree relatives with diabetes, hypertension, physical activity level, and weight.

Among Americans aged 40 years and older, this test would classify an estimated 73.3 million, or 58.7%, as prediabetic; among those aged 60 years and older, it would classify 80.8% as prediabetic. The test also would advise all those people to see their physicians and undergo blood glucose testing for confirmation, Dr. Shahraz and his associates said (JAMA Intern Med. 2016 Oct 3. doi: 10.1001/jamainternmed.2016.5919).

This would be “premature” for many reasons. Intensive lifestyle modifications are not known to be beneficial for such patients, even those who are found to have impaired glucose tolerance. And there is no direct evidence that preventing type 2 diabetes actually reduces the risk for diabetes-related complications. Moreover, the natural progression from prediabetes to type 2 diabetes is likely to be slow, which calls into question the need for any intervention, particularly for older patients likely to die from competing causes, the researchers noted.

“A valid method to examine for prediabetes should avoid unnecessary medicalization by labeling a disease predecessor as a medical condition and seek to concentrate on people at highest risk to allow for efficient distribution of limited health care resources,” they added.

A Web-based risk test endorsed by the American Medical Association, the American Diabetes Association, and the Centers for Disease Control and Prevention would label 59%-81% of adults as prediabetic if it were applied to the general U.S. population, according to a Research Letter to the Editor published online Oct. 3 in JAMA Internal Medicine.

The test is intended to evaluate the risk for prediabetes of any adult patient, and it advises those it identifies as prediabetic to see their physicians for confirmatory blood glucose testing. But given the results of their study, labeling this many people as prediabetic constitutes overmedicalization and could have the unintended consequence of diluting access to health care for people who actually have type 2 diabetes and other chronic conditions, said Saeid Shahraz, MD, PhD, of the Predictive Analytics and Comparative Effectiveness Center, Tufts Medical Center, Boston, and his associates.

The investigators assessed how many people this test would classify as prediabetic by analyzing data for a nationally representative sample of 10,175 adults who participated in the National Health and Nutrition Examination Survey in 2013-2014. They extracted the same information from participant responses to the NHANES survey that is elicited by the Web-based test: age, sex, history of gestational diabetes, first-degree relatives with diabetes, hypertension, physical activity level, and weight.

Among Americans aged 40 years and older, this test would classify an estimated 73.3 million, or 58.7%, as prediabetic; among those aged 60 years and older, it would classify 80.8% as prediabetic. The test also would advise all those people to see their physicians and undergo blood glucose testing for confirmation, Dr. Shahraz and his associates said (JAMA Intern Med. 2016 Oct 3. doi: 10.1001/jamainternmed.2016.5919).

This would be “premature” for many reasons. Intensive lifestyle modifications are not known to be beneficial for such patients, even those who are found to have impaired glucose tolerance. And there is no direct evidence that preventing type 2 diabetes actually reduces the risk for diabetes-related complications. Moreover, the natural progression from prediabetes to type 2 diabetes is likely to be slow, which calls into question the need for any intervention, particularly for older patients likely to die from competing causes, the researchers noted.

“A valid method to examine for prediabetes should avoid unnecessary medicalization by labeling a disease predecessor as a medical condition and seek to concentrate on people at highest risk to allow for efficient distribution of limited health care resources,” they added.

Both dietary and supplemental calcium should be considered safe for the cardiovascular system as long as total intake doesn’t exceed 2,000-2,500 mg/day – the maximal tolerable level defined by the National Academy of Medicine, according to an updated Clinical Practice Guideline published online October 24 in Annals of Internal Medicine.

For generally healthy patients who don’t consume adequate calcium and take supplements, either alone or in combination with vitamin D, to prevent osteoporosis and related fractures, “discontinuation of supplemental calcium for safety reasons is not necessary and may be harmful to bone health,” said Stephen L. Kopecky, MD, of the Mayo Clinic, Rochester Minn., and his associates on the expert panel that wrote the new guideline.

Both dietary and supplemental calcium should be considered safe for the cardiovascular system as long as total intake doesn’t exceed 2,000-2,500 mg/day – the maximal tolerable level defined by the National Academy of Medicine, according to an updated Clinical Practice Guideline published online October 24 in Annals of Internal Medicine.

For generally healthy patients who don’t consume adequate calcium and take supplements, either alone or in combination with vitamin D, to prevent osteoporosis and related fractures, “discontinuation of supplemental calcium for safety reasons is not necessary and may be harmful to bone health,” said Stephen L. Kopecky, MD, of the Mayo Clinic, Rochester Minn., and his associates on the expert panel that wrote the new guideline.

Both dietary and supplemental calcium should be considered safe for the cardiovascular system as long as total intake doesn’t exceed 2,000-2,500 mg/day – the maximal tolerable level defined by the National Academy of Medicine, according to an updated Clinical Practice Guideline published online October 24 in Annals of Internal Medicine.

For generally healthy patients who don’t consume adequate calcium and take supplements, either alone or in combination with vitamin D, to prevent osteoporosis and related fractures, “discontinuation of supplemental calcium for safety reasons is not necessary and may be harmful to bone health,” said Stephen L. Kopecky, MD, of the Mayo Clinic, Rochester Minn., and his associates on the expert panel that wrote the new guideline.

Inpatients are at increased risk for Clostridium difficile infection if the previous occupant of their hospital bed received antibiotics, according to a report published online October 10 in JAMA Internal Medicine.

The increase in risk was characterized as “modest,” but it is important because the use of antibiotics in hospitals is so common. “Our results show that antibiotics can potentially cause harm to patients who do not themselves receive the antibiotics and thus emphasize the value of antibiotic stewardship,” said Daniel E. Freedberg, MD, a gastroenterologist at Columbia University, New York, and his associates (JAMA Intern Med. 2016 Oct 10. doi: 10.1001/jamainternmed.2016.6193).

They performed a large retrospective cohort study of sequentially hospitalized adults at four New York City area hospitals between 2010 and 2015. They focused on 100,615 pairs of patients in which the first patient was hospitalized for at least 24 hours and was discharged less than 1 week before the second patient was hospitalized in the same bed for at least 48 hours. A total of 576 “second patients” developed C. difficile infection 2 to14 days after hospitalization.

There were no C. difficile outbreaks during the study period, and the incidence of C. difficile infections remained constant. The “first patient” occupied the bed for a median of 3.0 days, and the median interval before the “second patient” arrived at the bed was 10 hours. Among those who developed a C. difficile infection, the median time from admission into the bed to the development of the infection was 6.4 days.

The cumulative incidence of C. difficile infections was significantly higher among second patients when the prior bed occupants had received antibiotics (0.72%) than when the prior bed occupants had not received antibiotics (0.43%). This correlation remained strong and significant when the data were adjusted to account for potential confounders such as the second patient’s comorbidities and use of antibiotics, the number of nearby patients who already had a C. difficile infection, and the type of hospital ward involved.

The strong association also persisted through numerous sensitivity analyses, including one that excluded the 1,497 patient pairs in which the first patient had had a recent C. difficile infection (adjusted hazard ratio, 1.20). In a further analysis examining multiple risk factors for infection, receipt of antibiotics by the “first patient” was the only factor associated with subsequent patients’ infection risk. The investigators noted that the four hospitals involved in this study were among the many that routinely single out the rooms of patients with C. difficile infection for intensive cleaning, including UV radiation.

These findings “support the hypothesis that antibiotics given to one patient may alter the local microenvironment to influence a different patients’ risk” for C. difficile infection, the investigators concluded.

The study was supported in part by the American Gastroenterological Association and the National Center for Advancing Translational Sciences. Dr. Freedberg and his associates reported having no relevant financial disclosures.

[email protected]

Inpatients are at increased risk for Clostridium difficile infection if the previous occupant of their hospital bed received antibiotics, according to a report published online October 10 in JAMA Internal Medicine.

The increase in risk was characterized as “modest,” but it is important because the use of antibiotics in hospitals is so common. “Our results show that antibiotics can potentially cause harm to patients who do not themselves receive the antibiotics and thus emphasize the value of antibiotic stewardship,” said Daniel E. Freedberg, MD, a gastroenterologist at Columbia University, New York, and his associates (JAMA Intern Med. 2016 Oct 10. doi: 10.1001/jamainternmed.2016.6193).

They performed a large retrospective cohort study of sequentially hospitalized adults at four New York City area hospitals between 2010 and 2015. They focused on 100,615 pairs of patients in which the first patient was hospitalized for at least 24 hours and was discharged less than 1 week before the second patient was hospitalized in the same bed for at least 48 hours. A total of 576 “second patients” developed C. difficile infection 2 to14 days after hospitalization.

There were no C. difficile outbreaks during the study period, and the incidence of C. difficile infections remained constant. The “first patient” occupied the bed for a median of 3.0 days, and the median interval before the “second patient” arrived at the bed was 10 hours. Among those who developed a C. difficile infection, the median time from admission into the bed to the development of the infection was 6.4 days.

The cumulative incidence of C. difficile infections was significantly higher among second patients when the prior bed occupants had received antibiotics (0.72%) than when the prior bed occupants had not received antibiotics (0.43%). This correlation remained strong and significant when the data were adjusted to account for potential confounders such as the second patient’s comorbidities and use of antibiotics, the number of nearby patients who already had a C. difficile infection, and the type of hospital ward involved.

The strong association also persisted through numerous sensitivity analyses, including one that excluded the 1,497 patient pairs in which the first patient had had a recent C. difficile infection (adjusted hazard ratio, 1.20). In a further analysis examining multiple risk factors for infection, receipt of antibiotics by the “first patient” was the only factor associated with subsequent patients’ infection risk. The investigators noted that the four hospitals involved in this study were among the many that routinely single out the rooms of patients with C. difficile infection for intensive cleaning, including UV radiation.

These findings “support the hypothesis that antibiotics given to one patient may alter the local microenvironment to influence a different patients’ risk” for C. difficile infection, the investigators concluded.

The study was supported in part by the American Gastroenterological Association and the National Center for Advancing Translational Sciences. Dr. Freedberg and his associates reported having no relevant financial disclosures.

[email protected]

Inpatients are at increased risk for Clostridium difficile infection if the previous occupant of their hospital bed received antibiotics, according to a report published online October 10 in JAMA Internal Medicine.

The increase in risk was characterized as “modest,” but it is important because the use of antibiotics in hospitals is so common. “Our results show that antibiotics can potentially cause harm to patients who do not themselves receive the antibiotics and thus emphasize the value of antibiotic stewardship,” said Daniel E. Freedberg, MD, a gastroenterologist at Columbia University, New York, and his associates (JAMA Intern Med. 2016 Oct 10. doi: 10.1001/jamainternmed.2016.6193).

They performed a large retrospective cohort study of sequentially hospitalized adults at four New York City area hospitals between 2010 and 2015. They focused on 100,615 pairs of patients in which the first patient was hospitalized for at least 24 hours and was discharged less than 1 week before the second patient was hospitalized in the same bed for at least 48 hours. A total of 576 “second patients” developed C. difficile infection 2 to14 days after hospitalization.

There were no C. difficile outbreaks during the study period, and the incidence of C. difficile infections remained constant. The “first patient” occupied the bed for a median of 3.0 days, and the median interval before the “second patient” arrived at the bed was 10 hours. Among those who developed a C. difficile infection, the median time from admission into the bed to the development of the infection was 6.4 days.

The cumulative incidence of C. difficile infections was significantly higher among second patients when the prior bed occupants had received antibiotics (0.72%) than when the prior bed occupants had not received antibiotics (0.43%). This correlation remained strong and significant when the data were adjusted to account for potential confounders such as the second patient’s comorbidities and use of antibiotics, the number of nearby patients who already had a C. difficile infection, and the type of hospital ward involved.

The strong association also persisted through numerous sensitivity analyses, including one that excluded the 1,497 patient pairs in which the first patient had had a recent C. difficile infection (adjusted hazard ratio, 1.20). In a further analysis examining multiple risk factors for infection, receipt of antibiotics by the “first patient” was the only factor associated with subsequent patients’ infection risk. The investigators noted that the four hospitals involved in this study were among the many that routinely single out the rooms of patients with C. difficile infection for intensive cleaning, including UV radiation.

These findings “support the hypothesis that antibiotics given to one patient may alter the local microenvironment to influence a different patients’ risk” for C. difficile infection, the investigators concluded.

The study was supported in part by the American Gastroenterological Association and the National Center for Advancing Translational Sciences. Dr. Freedberg and his associates reported having no relevant financial disclosures.

[email protected]

When specifically looked for, pulmonary embolism was identified in approximately 17% of adults hospitalized for a first episode of syncope, according to a report published in the New England Journal of Medicine.

Most medical textbooks include pulmonary embolism (PE) in the differential diagnosis of syncope, but “current international guidelines, including those from the European Society of Cardiology and the American Heart Association, pay little attention to establishing a diagnostic workup for PE in these patients. Hence, when a patient is admitted to a hospital for an episode of syncope, PE – a potentially fatal disease that can be effectively treated – is rarely considered as a possible cause,” said Paolo Prandoni, MD, PhD, of the vascular medicine unit, University of Padua (Italy), and his associates in the PESY (Prevalence of Pulmonary Embolism in Patients With Syncope) trial.

The investigators used a systematic diagnostic work-up to determine the prevalence of PE in a cross-sectional study involving 560 adults hospitalized for syncope at 11 medical centers across Italy during a 2.5-year period. Most of these patients were elderly (mean age, 76 years), and most had clinical evidence indicating that a factor other than PE had caused their fainting. For this study, syncope was defined as a transient loss of consciousness with rapid onset, short duration (less than 1 minute), and spontaneous resolution, with obvious causes ruled out (such as epileptic seizure, stroke, or head trauma).

Copyright pixelheadphoto/Thinkstock

When specifically looked for, pulmonary embolism was identified in approximately 17% of adults hospitalized for a first episode of syncope, according to a report published in the New England Journal of Medicine.

Most medical textbooks include pulmonary embolism (PE) in the differential diagnosis of syncope, but “current international guidelines, including those from the European Society of Cardiology and the American Heart Association, pay little attention to establishing a diagnostic workup for PE in these patients. Hence, when a patient is admitted to a hospital for an episode of syncope, PE – a potentially fatal disease that can be effectively treated – is rarely considered as a possible cause,” said Paolo Prandoni, MD, PhD, of the vascular medicine unit, University of Padua (Italy), and his associates in the PESY (Prevalence of Pulmonary Embolism in Patients With Syncope) trial.

The investigators used a systematic diagnostic work-up to determine the prevalence of PE in a cross-sectional study involving 560 adults hospitalized for syncope at 11 medical centers across Italy during a 2.5-year period. Most of these patients were elderly (mean age, 76 years), and most had clinical evidence indicating that a factor other than PE had caused their fainting. For this study, syncope was defined as a transient loss of consciousness with rapid onset, short duration (less than 1 minute), and spontaneous resolution, with obvious causes ruled out (such as epileptic seizure, stroke, or head trauma).

Copyright pixelheadphoto/Thinkstock

When specifically looked for, pulmonary embolism was identified in approximately 17% of adults hospitalized for a first episode of syncope, according to a report published in the New England Journal of Medicine.

Most medical textbooks include pulmonary embolism (PE) in the differential diagnosis of syncope, but “current international guidelines, including those from the European Society of Cardiology and the American Heart Association, pay little attention to establishing a diagnostic workup for PE in these patients. Hence, when a patient is admitted to a hospital for an episode of syncope, PE – a potentially fatal disease that can be effectively treated – is rarely considered as a possible cause,” said Paolo Prandoni, MD, PhD, of the vascular medicine unit, University of Padua (Italy), and his associates in the PESY (Prevalence of Pulmonary Embolism in Patients With Syncope) trial.

The investigators used a systematic diagnostic work-up to determine the prevalence of PE in a cross-sectional study involving 560 adults hospitalized for syncope at 11 medical centers across Italy during a 2.5-year period. Most of these patients were elderly (mean age, 76 years), and most had clinical evidence indicating that a factor other than PE had caused their fainting. For this study, syncope was defined as a transient loss of consciousness with rapid onset, short duration (less than 1 minute), and spontaneous resolution, with obvious causes ruled out (such as epileptic seizure, stroke, or head trauma).

Copyright pixelheadphoto/Thinkstock

Among patients undergoing elective incisional repair of abdominal wall hernias, the use of mesh reinforcement decreases the short-term recurrence rate by 5% but increases major complications by approximately the same amount over the subsequent 5 years, Dunja Kokotovic, MB, reported at the annual clinical congress of the American College of Surgeons.

“Given the continuously increasing incidence of mesh-related complications with time, it is expected that, with even longer follow-up up than the 5 years observed in this study, mesh-related complications continue to accrue,” said Dr. Kokotovic of the Center for Surgical Science, Zealand University Hospital, Koge, Denmark. The findings of this observational registry-based cohort study were presented at the congress and simultaneously published online in JAMA (2016 Oct 17. doi: 10.1001/jama.2016.15217).

These results highlight the need to assess the long-term safety of interventions before making definitive conclusions about their benefits and widely adopting them. In the United States, manufacturers are required to demonstrate the long-term safety of drugs but not of some devices, including hernia meshes. There were approximately 190,000 such hernia repairs performed in the United States alone during the most recent year for which data are available, and mesh is estimated to have been used in at least half, Dr. Kokotovic noted.

She and her associates analyzed the 5-year outcomes for virtually all incisional hernia repairs performed in Denmark from 2007 through 2010 using data in a mandatory national registry. Their analysis included 3,242 patients (mean age, 58 years): 1,119 (34.5%) who had open mesh repair, 1,757 (54.2%) who had laparoscopic mesh repair, and 366 (11.3%) who had nonmesh repair.

The cumulative risk of reoperation for hernia recurrence was significantly lower for patients who had open mesh repair (12.3%) or laparoscopic mesh repair (10.6%) than for those who had nonmesh repair (17.1%). However, this benefit was offset by the rate of major mesh-related complications requiring surgical intervention – including surgical site infection, formation of a chronic sinus tract, late-onset intra-abdominal abscess, enterocutaneous fistula, bowel obstruction, and bowel perforation – which progressively increased over time. The cumulative incidence of such complications was 5.6% for open mesh repair and 3.7% for laparoscopic mesh repair.

This study was limited in that it was observational rather than being based on randomized data, so selection bias and imbalances among the study groups couldn’t be fully controlled for. However, two strengths of this study were that it reflects the real-world experience of an entire country and all the surgeons performing hernia repairs there, and it had 100% follow-up, the researchers said.

This study was partly funded by the Edgar Schnohr and Wife Gilberte Schnohr’s Foundation supporting independent surgical and anesthesiological research. Dr. Kokotovic reported having no relevant financial disclosures; one investigator reported receiving personal fees from Bard and Etichon for educational presentations.

Among patients undergoing elective incisional repair of abdominal wall hernias, the use of mesh reinforcement decreases the short-term recurrence rate by 5% but increases major complications by approximately the same amount over the subsequent 5 years, Dunja Kokotovic, MB, reported at the annual clinical congress of the American College of Surgeons.

“Given the continuously increasing incidence of mesh-related complications with time, it is expected that, with even longer follow-up up than the 5 years observed in this study, mesh-related complications continue to accrue,” said Dr. Kokotovic of the Center for Surgical Science, Zealand University Hospital, Koge, Denmark. The findings of this observational registry-based cohort study were presented at the congress and simultaneously published online in JAMA (2016 Oct 17. doi: 10.1001/jama.2016.15217).

These results highlight the need to assess the long-term safety of interventions before making definitive conclusions about their benefits and widely adopting them. In the United States, manufacturers are required to demonstrate the long-term safety of drugs but not of some devices, including hernia meshes. There were approximately 190,000 such hernia repairs performed in the United States alone during the most recent year for which data are available, and mesh is estimated to have been used in at least half, Dr. Kokotovic noted.

She and her associates analyzed the 5-year outcomes for virtually all incisional hernia repairs performed in Denmark from 2007 through 2010 using data in a mandatory national registry. Their analysis included 3,242 patients (mean age, 58 years): 1,119 (34.5%) who had open mesh repair, 1,757 (54.2%) who had laparoscopic mesh repair, and 366 (11.3%) who had nonmesh repair.

The cumulative risk of reoperation for hernia recurrence was significantly lower for patients who had open mesh repair (12.3%) or laparoscopic mesh repair (10.6%) than for those who had nonmesh repair (17.1%). However, this benefit was offset by the rate of major mesh-related complications requiring surgical intervention – including surgical site infection, formation of a chronic sinus tract, late-onset intra-abdominal abscess, enterocutaneous fistula, bowel obstruction, and bowel perforation – which progressively increased over time. The cumulative incidence of such complications was 5.6% for open mesh repair and 3.7% for laparoscopic mesh repair.

This study was limited in that it was observational rather than being based on randomized data, so selection bias and imbalances among the study groups couldn’t be fully controlled for. However, two strengths of this study were that it reflects the real-world experience of an entire country and all the surgeons performing hernia repairs there, and it had 100% follow-up, the researchers said.

This study was partly funded by the Edgar Schnohr and Wife Gilberte Schnohr’s Foundation supporting independent surgical and anesthesiological research. Dr. Kokotovic reported having no relevant financial disclosures; one investigator reported receiving personal fees from Bard and Etichon for educational presentations.

Among patients undergoing elective incisional repair of abdominal wall hernias, the use of mesh reinforcement decreases the short-term recurrence rate by 5% but increases major complications by approximately the same amount over the subsequent 5 years, Dunja Kokotovic, MB, reported at the annual clinical congress of the American College of Surgeons.

“Given the continuously increasing incidence of mesh-related complications with time, it is expected that, with even longer follow-up up than the 5 years observed in this study, mesh-related complications continue to accrue,” said Dr. Kokotovic of the Center for Surgical Science, Zealand University Hospital, Koge, Denmark. The findings of this observational registry-based cohort study were presented at the congress and simultaneously published online in JAMA (2016 Oct 17. doi: 10.1001/jama.2016.15217).

These results highlight the need to assess the long-term safety of interventions before making definitive conclusions about their benefits and widely adopting them. In the United States, manufacturers are required to demonstrate the long-term safety of drugs but not of some devices, including hernia meshes. There were approximately 190,000 such hernia repairs performed in the United States alone during the most recent year for which data are available, and mesh is estimated to have been used in at least half, Dr. Kokotovic noted.

She and her associates analyzed the 5-year outcomes for virtually all incisional hernia repairs performed in Denmark from 2007 through 2010 using data in a mandatory national registry. Their analysis included 3,242 patients (mean age, 58 years): 1,119 (34.5%) who had open mesh repair, 1,757 (54.2%) who had laparoscopic mesh repair, and 366 (11.3%) who had nonmesh repair.

The cumulative risk of reoperation for hernia recurrence was significantly lower for patients who had open mesh repair (12.3%) or laparoscopic mesh repair (10.6%) than for those who had nonmesh repair (17.1%). However, this benefit was offset by the rate of major mesh-related complications requiring surgical intervention – including surgical site infection, formation of a chronic sinus tract, late-onset intra-abdominal abscess, enterocutaneous fistula, bowel obstruction, and bowel perforation – which progressively increased over time. The cumulative incidence of such complications was 5.6% for open mesh repair and 3.7% for laparoscopic mesh repair.

This study was limited in that it was observational rather than being based on randomized data, so selection bias and imbalances among the study groups couldn’t be fully controlled for. However, two strengths of this study were that it reflects the real-world experience of an entire country and all the surgeons performing hernia repairs there, and it had 100% follow-up, the researchers said.

This study was partly funded by the Edgar Schnohr and Wife Gilberte Schnohr’s Foundation supporting independent surgical and anesthesiological research. Dr. Kokotovic reported having no relevant financial disclosures; one investigator reported receiving personal fees from Bard and Etichon for educational presentations.

The clinical quality of outpatient care for adults in the United States did not improve consistently from 2002 to 2013, despite numerous local, regional, and national efforts to make it better, according to a report published online Oct. 17 in JAMA Internal Medicine.

“Current deficits in care continue to pose serious hazards to the health of the American public in the form of missed care opportunities as well as waste and potential harm from overuse,” said David M. Levine, MD, of Brigham and Women’s Hospital and Harvard Medical School, Boston, and his associates.

Since a 2003 report showing that American adults received about half of the recommended health care services, many programs have sought to make improvements by expanding quality measurements and public reporting, increasing pay for performance, increasing value-based purchasing by payers, increasing the use of electronic medical records, improving coverage for recommended services, and expanding patient-centered medical homes.

Yet few data are available by which to gauge whether these efforts have been effective, the investigators noted (JAMA Intern Med. 2016 Oct 17; doi:10.1001/jamainternmed.2016.6217).

They analyzed data from a nationally representative annual outpatient survey to determine whether 46 indicators of care quality changed from 2002 to 2013. Sample sizes ranged from 20,679 to 26,509 adults per year, and that information was supplemented by responses from the patients’ clinicians, pharmacies, and employers.

Overall, rates of recommended treatment delivery showed an “anemic” improvement from 36% to 42%, with a few areas showing marked improvement while others showed little improvement or actual declines.

For example, rates of recommended medications for heart failure increased from 41% to 65%; rates for recommended statin therapy for stroke patients increased from 34% to 57%; and rates of recommended smoking-cessation counseling increased from 49% to 61%. However, rates of inappropriate antibiotic prescribing and inappropriate medications in the elderly both worsened.

Recommended colorectal cancer screening improved from 48% to 63%; but recommended breast cancer screening declined from 81% to 77%, and recommended cervical cancer screening declined from 90% to 86%.

Inappropriate cervical cancer screening in the elderly improved, but inappropriate colorectal cancer screening in the elderly worsened.

Of greatest concern, approximately half of elderly adults underwent inappropriate cancer screening when it was unlikely to prolong life. And approximately half of adults who saw a clinician for a viral illness received inappropriate antibiotics. In addition, approximately 15% who consulted a clinician for back pain received an inappropriate lumbar radiograph.

“These areas represent prime targets for efforts to improve the value of care delivered by eliminating services that have a neutral or negative impact on health,” Dr. Levine and his associates said.

The investigators emphasized that these data do not reflect changes resulting from the Affordable Care Act, which was implemented in late 2013. The ACA has encouraged many organizational changes, renewed the focus on primary care, and expanded health insurance coverage to 30 million more people. All of these changes are expected to improve overall health care quality, the study authors noted. But it is not yet known whether these changes will have their intended effect.

This study was supported in part by the National Institutes of Health and the Ryoichi Sasakawa Fellowship Fund. Dr. Levine and his associates reported having no relevant financial disclosures.

The clinical quality of outpatient care for adults in the United States did not improve consistently from 2002 to 2013, despite numerous local, regional, and national efforts to make it better, according to a report published online Oct. 17 in JAMA Internal Medicine.

“Current deficits in care continue to pose serious hazards to the health of the American public in the form of missed care opportunities as well as waste and potential harm from overuse,” said David M. Levine, MD, of Brigham and Women’s Hospital and Harvard Medical School, Boston, and his associates.

Since a 2003 report showing that American adults received about half of the recommended health care services, many programs have sought to make improvements by expanding quality measurements and public reporting, increasing pay for performance, increasing value-based purchasing by payers, increasing the use of electronic medical records, improving coverage for recommended services, and expanding patient-centered medical homes.

Yet few data are available by which to gauge whether these efforts have been effective, the investigators noted (JAMA Intern Med. 2016 Oct 17; doi:10.1001/jamainternmed.2016.6217).

They analyzed data from a nationally representative annual outpatient survey to determine whether 46 indicators of care quality changed from 2002 to 2013. Sample sizes ranged from 20,679 to 26,509 adults per year, and that information was supplemented by responses from the patients’ clinicians, pharmacies, and employers.

Overall, rates of recommended treatment delivery showed an “anemic” improvement from 36% to 42%, with a few areas showing marked improvement while others showed little improvement or actual declines.

For example, rates of recommended medications for heart failure increased from 41% to 65%; rates for recommended statin therapy for stroke patients increased from 34% to 57%; and rates of recommended smoking-cessation counseling increased from 49% to 61%. However, rates of inappropriate antibiotic prescribing and inappropriate medications in the elderly both worsened.

Recommended colorectal cancer screening improved from 48% to 63%; but recommended breast cancer screening declined from 81% to 77%, and recommended cervical cancer screening declined from 90% to 86%.

Inappropriate cervical cancer screening in the elderly improved, but inappropriate colorectal cancer screening in the elderly worsened.

Of greatest concern, approximately half of elderly adults underwent inappropriate cancer screening when it was unlikely to prolong life. And approximately half of adults who saw a clinician for a viral illness received inappropriate antibiotics. In addition, approximately 15% who consulted a clinician for back pain received an inappropriate lumbar radiograph.

“These areas represent prime targets for efforts to improve the value of care delivered by eliminating services that have a neutral or negative impact on health,” Dr. Levine and his associates said.

The investigators emphasized that these data do not reflect changes resulting from the Affordable Care Act, which was implemented in late 2013. The ACA has encouraged many organizational changes, renewed the focus on primary care, and expanded health insurance coverage to 30 million more people. All of these changes are expected to improve overall health care quality, the study authors noted. But it is not yet known whether these changes will have their intended effect.

This study was supported in part by the National Institutes of Health and the Ryoichi Sasakawa Fellowship Fund. Dr. Levine and his associates reported having no relevant financial disclosures.

The clinical quality of outpatient care for adults in the United States did not improve consistently from 2002 to 2013, despite numerous local, regional, and national efforts to make it better, according to a report published online Oct. 17 in JAMA Internal Medicine.

“Current deficits in care continue to pose serious hazards to the health of the American public in the form of missed care opportunities as well as waste and potential harm from overuse,” said David M. Levine, MD, of Brigham and Women’s Hospital and Harvard Medical School, Boston, and his associates.

Since a 2003 report showing that American adults received about half of the recommended health care services, many programs have sought to make improvements by expanding quality measurements and public reporting, increasing pay for performance, increasing value-based purchasing by payers, increasing the use of electronic medical records, improving coverage for recommended services, and expanding patient-centered medical homes.

Yet few data are available by which to gauge whether these efforts have been effective, the investigators noted (JAMA Intern Med. 2016 Oct 17; doi:10.1001/jamainternmed.2016.6217).

They analyzed data from a nationally representative annual outpatient survey to determine whether 46 indicators of care quality changed from 2002 to 2013. Sample sizes ranged from 20,679 to 26,509 adults per year, and that information was supplemented by responses from the patients’ clinicians, pharmacies, and employers.

Overall, rates of recommended treatment delivery showed an “anemic” improvement from 36% to 42%, with a few areas showing marked improvement while others showed little improvement or actual declines.

For example, rates of recommended medications for heart failure increased from 41% to 65%; rates for recommended statin therapy for stroke patients increased from 34% to 57%; and rates of recommended smoking-cessation counseling increased from 49% to 61%. However, rates of inappropriate antibiotic prescribing and inappropriate medications in the elderly both worsened.

Recommended colorectal cancer screening improved from 48% to 63%; but recommended breast cancer screening declined from 81% to 77%, and recommended cervical cancer screening declined from 90% to 86%.

Inappropriate cervical cancer screening in the elderly improved, but inappropriate colorectal cancer screening in the elderly worsened.

Of greatest concern, approximately half of elderly adults underwent inappropriate cancer screening when it was unlikely to prolong life. And approximately half of adults who saw a clinician for a viral illness received inappropriate antibiotics. In addition, approximately 15% who consulted a clinician for back pain received an inappropriate lumbar radiograph.

“These areas represent prime targets for efforts to improve the value of care delivered by eliminating services that have a neutral or negative impact on health,” Dr. Levine and his associates said.

The investigators emphasized that these data do not reflect changes resulting from the Affordable Care Act, which was implemented in late 2013. The ACA has encouraged many organizational changes, renewed the focus on primary care, and expanded health insurance coverage to 30 million more people. All of these changes are expected to improve overall health care quality, the study authors noted. But it is not yet known whether these changes will have their intended effect.

This study was supported in part by the National Institutes of Health and the Ryoichi Sasakawa Fellowship Fund. Dr. Levine and his associates reported having no relevant financial disclosures.