Amy Karon

A quality improvement program cut postoperative pneumonia rates by 43.6%, investigators reported July 23 in JAMA Surgery.

The small, single-center retrospective cohort study is the first to present long-term findings for such a program, said Dr. Hadiza Kazaure at Stanford (Calif.) University and her associates.

©Thomas Northcut/thinkstockphotos.com

The program, which investigators started at a Stanford-affiliated Veterans Affairs hospital, included coughing and deep-breathing exercises with incentive spirometry, a twice-daily oral chlorhexidine hygiene, ambulation with pain control, elevating the head of the bed by 30 degrees and sitting for meals, educating surgical nursing staff about their roles in preventing pneumonia, and automating physician orders for pneumonia prevention, the researchers said (JAMA Surg. 2014 July 23 [doi:10.1001/jamasurg.2014.1216]).

The investigators calculated postimplementation rates of ward-acquired pneumonia in all noncardiac, unventilated surgical patients in the 5 years after the program started, they said.

Among 4,099 hospitalized patients who were at risk, 18 (0.44%) developed postoperative pneumonia, a 43.6% drop from the preprogram rate of 0.78%, the investigators reported.

By comparison, the postintervention rate for the American College of Surgeons National Surgical Quality Improvement Program (ACS-NSQIP) was 582% higher than that of the VA hospital for 2008-2012. By achieving the VA hospital program’s results, the hospitals in the ACS-NSQIP could save about $280 million, Dr. Kazaure and her associates said.

The database abstraction methods used to choose patients were validated, but nonetheless could have caused selection errors. Also, few patients developed pneumonia, which kept the investigators from tracking trends over time on the ward, they said. "Based on published data, we used a national average of $46,400 cost of care per postoperative pneumonia case to estimate potential cost savings in our analyses," they added. "The validity of cost estimates in this study to individual hospitals must be considered because geographic variation in cost of care is well established."

The authors reported no funding sources or conflicts of interest.

A quality improvement program cut postoperative pneumonia rates by 43.6%, investigators reported July 23 in JAMA Surgery.

The small, single-center retrospective cohort study is the first to present long-term findings for such a program, said Dr. Hadiza Kazaure at Stanford (Calif.) University and her associates.

©Thomas Northcut/thinkstockphotos.com

The program, which investigators started at a Stanford-affiliated Veterans Affairs hospital, included coughing and deep-breathing exercises with incentive spirometry, a twice-daily oral chlorhexidine hygiene, ambulation with pain control, elevating the head of the bed by 30 degrees and sitting for meals, educating surgical nursing staff about their roles in preventing pneumonia, and automating physician orders for pneumonia prevention, the researchers said (JAMA Surg. 2014 July 23 [doi:10.1001/jamasurg.2014.1216]).

The investigators calculated postimplementation rates of ward-acquired pneumonia in all noncardiac, unventilated surgical patients in the 5 years after the program started, they said.

Among 4,099 hospitalized patients who were at risk, 18 (0.44%) developed postoperative pneumonia, a 43.6% drop from the preprogram rate of 0.78%, the investigators reported.

By comparison, the postintervention rate for the American College of Surgeons National Surgical Quality Improvement Program (ACS-NSQIP) was 582% higher than that of the VA hospital for 2008-2012. By achieving the VA hospital program’s results, the hospitals in the ACS-NSQIP could save about $280 million, Dr. Kazaure and her associates said.

The database abstraction methods used to choose patients were validated, but nonetheless could have caused selection errors. Also, few patients developed pneumonia, which kept the investigators from tracking trends over time on the ward, they said. "Based on published data, we used a national average of $46,400 cost of care per postoperative pneumonia case to estimate potential cost savings in our analyses," they added. "The validity of cost estimates in this study to individual hospitals must be considered because geographic variation in cost of care is well established."

The authors reported no funding sources or conflicts of interest.

A quality improvement program cut postoperative pneumonia rates by 43.6%, investigators reported July 23 in JAMA Surgery.

The small, single-center retrospective cohort study is the first to present long-term findings for such a program, said Dr. Hadiza Kazaure at Stanford (Calif.) University and her associates.

©Thomas Northcut/thinkstockphotos.com

The program, which investigators started at a Stanford-affiliated Veterans Affairs hospital, included coughing and deep-breathing exercises with incentive spirometry, a twice-daily oral chlorhexidine hygiene, ambulation with pain control, elevating the head of the bed by 30 degrees and sitting for meals, educating surgical nursing staff about their roles in preventing pneumonia, and automating physician orders for pneumonia prevention, the researchers said (JAMA Surg. 2014 July 23 [doi:10.1001/jamasurg.2014.1216]).

The investigators calculated postimplementation rates of ward-acquired pneumonia in all noncardiac, unventilated surgical patients in the 5 years after the program started, they said.

Among 4,099 hospitalized patients who were at risk, 18 (0.44%) developed postoperative pneumonia, a 43.6% drop from the preprogram rate of 0.78%, the investigators reported.

By comparison, the postintervention rate for the American College of Surgeons National Surgical Quality Improvement Program (ACS-NSQIP) was 582% higher than that of the VA hospital for 2008-2012. By achieving the VA hospital program’s results, the hospitals in the ACS-NSQIP could save about $280 million, Dr. Kazaure and her associates said.

The database abstraction methods used to choose patients were validated, but nonetheless could have caused selection errors. Also, few patients developed pneumonia, which kept the investigators from tracking trends over time on the ward, they said. "Based on published data, we used a national average of $46,400 cost of care per postoperative pneumonia case to estimate potential cost savings in our analyses," they added. "The validity of cost estimates in this study to individual hospitals must be considered because geographic variation in cost of care is well established."

The authors reported no funding sources or conflicts of interest.

A hospital’s program to enhance recovery after colorectal surgery cut length of stay by 3 days and saved up to $4,800 per patient without increasing postoperative morbidity or 30-day readmission rates, investigators reported online July 23 in JAMA Surgery.

The study extends the evidence base for colorectal enhanced recovery after surgery (ERAS) programs to community hospital settings, said Dr. Cristina Geltzeiler of Oregon Health and Science University in Portland and her associates.

The investigators studied practice patterns and patient outcomes for 1 year before and 2 years after starting a colorectal ERAS program for 244 patients. The program featured preadmission patient education, preoperative bowel preparation for left-sided and rectal procedures, use of intrathecal spinal anesthetics, conservative fluid management, minimal use of narcotics, and early resumption of oral intake and ambulation after surgery, the researchers reported (JAMA Surg. 2014 July 23 [doi: 10.1001/jamasurg.2014.675]). Discharge criteria did not change, they noted.

After program implementation, use of laparoscopy increased by almost 30% (from 57.4% to 88.8%; P less than .001) and length of stay fell by 3 days (from 6.7 to 3.7 days; P less than .001), while 30-day readmission rates did not increase (17.6% vs. 12.5%), the investigators reported.

The percentage of patients who used postoperative narcotic analgesia also fell substantially (from 63.2% to 15%; P less than .001), as did duration of narcotic use (from 67.8 hours to 47.1 hours; P = .02), ileus (from 13.2% to 2.5% of patients; P = .02) and intra-abdominal infections (from 7.4% to 2.5% of patients; P = .24), the investigators said. Outcomes did not differ significantly for patients with colorectal cancer, they added.

"Development and implementation of the program required multidisciplinary collaboration among surgeons, nursing staff, anesthesia providers, pharmacists, operating room staff, clinics, and preadmission services," said Dr. Geltzeiler and her associates. To gain program buy-in, leaders organized discussions and presentations of published ERAS literature, and also used clear, consistent messaging about expectations for patients’ activity, diet, and pain management throughout the perioperative period, the researchers added.

A trend toward referring patients to a smaller pool of colorectal specialists during the study period could have affected results, the investigators noted. They added that rates of superficial wound infection were probably underreported because such infections tend to occur after discharge.

The authors reported no funding sources or conflicts of interest.

A hospital’s program to enhance recovery after colorectal surgery cut length of stay by 3 days and saved up to $4,800 per patient without increasing postoperative morbidity or 30-day readmission rates, investigators reported online July 23 in JAMA Surgery.

The study extends the evidence base for colorectal enhanced recovery after surgery (ERAS) programs to community hospital settings, said Dr. Cristina Geltzeiler of Oregon Health and Science University in Portland and her associates.

The investigators studied practice patterns and patient outcomes for 1 year before and 2 years after starting a colorectal ERAS program for 244 patients. The program featured preadmission patient education, preoperative bowel preparation for left-sided and rectal procedures, use of intrathecal spinal anesthetics, conservative fluid management, minimal use of narcotics, and early resumption of oral intake and ambulation after surgery, the researchers reported (JAMA Surg. 2014 July 23 [doi: 10.1001/jamasurg.2014.675]). Discharge criteria did not change, they noted.

After program implementation, use of laparoscopy increased by almost 30% (from 57.4% to 88.8%; P less than .001) and length of stay fell by 3 days (from 6.7 to 3.7 days; P less than .001), while 30-day readmission rates did not increase (17.6% vs. 12.5%), the investigators reported.

The percentage of patients who used postoperative narcotic analgesia also fell substantially (from 63.2% to 15%; P less than .001), as did duration of narcotic use (from 67.8 hours to 47.1 hours; P = .02), ileus (from 13.2% to 2.5% of patients; P = .02) and intra-abdominal infections (from 7.4% to 2.5% of patients; P = .24), the investigators said. Outcomes did not differ significantly for patients with colorectal cancer, they added.

"Development and implementation of the program required multidisciplinary collaboration among surgeons, nursing staff, anesthesia providers, pharmacists, operating room staff, clinics, and preadmission services," said Dr. Geltzeiler and her associates. To gain program buy-in, leaders organized discussions and presentations of published ERAS literature, and also used clear, consistent messaging about expectations for patients’ activity, diet, and pain management throughout the perioperative period, the researchers added.

A trend toward referring patients to a smaller pool of colorectal specialists during the study period could have affected results, the investigators noted. They added that rates of superficial wound infection were probably underreported because such infections tend to occur after discharge.

The authors reported no funding sources or conflicts of interest.

A hospital’s program to enhance recovery after colorectal surgery cut length of stay by 3 days and saved up to $4,800 per patient without increasing postoperative morbidity or 30-day readmission rates, investigators reported online July 23 in JAMA Surgery.

The study extends the evidence base for colorectal enhanced recovery after surgery (ERAS) programs to community hospital settings, said Dr. Cristina Geltzeiler of Oregon Health and Science University in Portland and her associates.

The investigators studied practice patterns and patient outcomes for 1 year before and 2 years after starting a colorectal ERAS program for 244 patients. The program featured preadmission patient education, preoperative bowel preparation for left-sided and rectal procedures, use of intrathecal spinal anesthetics, conservative fluid management, minimal use of narcotics, and early resumption of oral intake and ambulation after surgery, the researchers reported (JAMA Surg. 2014 July 23 [doi: 10.1001/jamasurg.2014.675]). Discharge criteria did not change, they noted.

After program implementation, use of laparoscopy increased by almost 30% (from 57.4% to 88.8%; P less than .001) and length of stay fell by 3 days (from 6.7 to 3.7 days; P less than .001), while 30-day readmission rates did not increase (17.6% vs. 12.5%), the investigators reported.

The percentage of patients who used postoperative narcotic analgesia also fell substantially (from 63.2% to 15%; P less than .001), as did duration of narcotic use (from 67.8 hours to 47.1 hours; P = .02), ileus (from 13.2% to 2.5% of patients; P = .02) and intra-abdominal infections (from 7.4% to 2.5% of patients; P = .24), the investigators said. Outcomes did not differ significantly for patients with colorectal cancer, they added.

"Development and implementation of the program required multidisciplinary collaboration among surgeons, nursing staff, anesthesia providers, pharmacists, operating room staff, clinics, and preadmission services," said Dr. Geltzeiler and her associates. To gain program buy-in, leaders organized discussions and presentations of published ERAS literature, and also used clear, consistent messaging about expectations for patients’ activity, diet, and pain management throughout the perioperative period, the researchers added.

A trend toward referring patients to a smaller pool of colorectal specialists during the study period could have affected results, the investigators noted. They added that rates of superficial wound infection were probably underreported because such infections tend to occur after discharge.

The authors reported no funding sources or conflicts of interest.

Veterans with genotype 3 hepatitis C virus infection were 31% more likely to develop cirrhosis and 80% more likely to develop liver cancer than were patients with genotype 1 infection, reported the authors of a large observational retrospective study published in the July issue of Hepatology.

"Our findings have implications that involve the entire spectrum of care, from antiviral treatment to prevention and screening in patients with HCV genotype 3 infection," said Dr. Fasiha Kanwal, of the Michael E. DeBakey Veterans Affairs Medical Center in Houston, and her associates. "Given the accelerated progression to advanced liver disease, patients with HCV genotype 3 may serve as a high-risk group that will need to be prioritized in the era of new antiviral treatments."

But all-oral combination therapy with sofosbuvir and ribavirin may not achieve the high levels of sustained virologic response (SVR) found for patients with genotype 2 infection, Dr. Kanwal and her associates noted. And even if highly effective treatments for genotype 3 infection eventually become available, approximately one-quarter of affected patients would have progressed to cirrhosis and therefore would already be at increased risk for hepatocellular carcinoma, the researchers added.

The study included 110,484 patients with HCV infection from the VA HCV Clinical Case Registry. About 70% of patients were Vietnam-era veterans, the investigators said. Patients were followed for an average of 5.4 years between 2000 and 2009, and a total of 8,337, or 7.5%, had genotype 3 infection, the researchers reported (Hepatology 2014;60:98-105).

After adjustment for factors such as age and year of birth, diabetes, body mass index, and antiviral treatment, patients with genotype 3 infection had the highest risk of developing cirrhosis and hepatocellular carcinoma among all HCV genotypes. Compared with genotype 1–infected patients, genotype 3–infected patients had a 31% higher risk for cirrhosis (adjusted hazard ratio, 1.31; 95% confidence interval, 1.22-1.39) and an 80% higher risk for hepatocellular carcinoma (aHR, 1.81; 95% CI, 1.61-2.03), the investigators added. Furthermore, a subgroup analysis of patients with cirrhosis showed that the risk of hepatocellular carcinoma was 44% higher in patients with genotype 3 infection than in patients with genotype 1 infection, the researchers said.

"These data are relevant to the thousands of HCV patients with genotype 3 infection, and to their physicians who provide care and counseling to this population," said Dr. Kanwal and her associates. They added that the data might help in prioritizing who should first receive future generations of direct-acting antivirals.

The Houston VA Health Services Research and Development Center of Excellence helped fund the study. The authors did not report conflicts of interest.

Veterans with genotype 3 hepatitis C virus infection were 31% more likely to develop cirrhosis and 80% more likely to develop liver cancer than were patients with genotype 1 infection, reported the authors of a large observational retrospective study published in the July issue of Hepatology.

"Our findings have implications that involve the entire spectrum of care, from antiviral treatment to prevention and screening in patients with HCV genotype 3 infection," said Dr. Fasiha Kanwal, of the Michael E. DeBakey Veterans Affairs Medical Center in Houston, and her associates. "Given the accelerated progression to advanced liver disease, patients with HCV genotype 3 may serve as a high-risk group that will need to be prioritized in the era of new antiviral treatments."

But all-oral combination therapy with sofosbuvir and ribavirin may not achieve the high levels of sustained virologic response (SVR) found for patients with genotype 2 infection, Dr. Kanwal and her associates noted. And even if highly effective treatments for genotype 3 infection eventually become available, approximately one-quarter of affected patients would have progressed to cirrhosis and therefore would already be at increased risk for hepatocellular carcinoma, the researchers added.

The study included 110,484 patients with HCV infection from the VA HCV Clinical Case Registry. About 70% of patients were Vietnam-era veterans, the investigators said. Patients were followed for an average of 5.4 years between 2000 and 2009, and a total of 8,337, or 7.5%, had genotype 3 infection, the researchers reported (Hepatology 2014;60:98-105).

After adjustment for factors such as age and year of birth, diabetes, body mass index, and antiviral treatment, patients with genotype 3 infection had the highest risk of developing cirrhosis and hepatocellular carcinoma among all HCV genotypes. Compared with genotype 1–infected patients, genotype 3–infected patients had a 31% higher risk for cirrhosis (adjusted hazard ratio, 1.31; 95% confidence interval, 1.22-1.39) and an 80% higher risk for hepatocellular carcinoma (aHR, 1.81; 95% CI, 1.61-2.03), the investigators added. Furthermore, a subgroup analysis of patients with cirrhosis showed that the risk of hepatocellular carcinoma was 44% higher in patients with genotype 3 infection than in patients with genotype 1 infection, the researchers said.

"These data are relevant to the thousands of HCV patients with genotype 3 infection, and to their physicians who provide care and counseling to this population," said Dr. Kanwal and her associates. They added that the data might help in prioritizing who should first receive future generations of direct-acting antivirals.

The Houston VA Health Services Research and Development Center of Excellence helped fund the study. The authors did not report conflicts of interest.

Veterans with genotype 3 hepatitis C virus infection were 31% more likely to develop cirrhosis and 80% more likely to develop liver cancer than were patients with genotype 1 infection, reported the authors of a large observational retrospective study published in the July issue of Hepatology.

"Our findings have implications that involve the entire spectrum of care, from antiviral treatment to prevention and screening in patients with HCV genotype 3 infection," said Dr. Fasiha Kanwal, of the Michael E. DeBakey Veterans Affairs Medical Center in Houston, and her associates. "Given the accelerated progression to advanced liver disease, patients with HCV genotype 3 may serve as a high-risk group that will need to be prioritized in the era of new antiviral treatments."

But all-oral combination therapy with sofosbuvir and ribavirin may not achieve the high levels of sustained virologic response (SVR) found for patients with genotype 2 infection, Dr. Kanwal and her associates noted. And even if highly effective treatments for genotype 3 infection eventually become available, approximately one-quarter of affected patients would have progressed to cirrhosis and therefore would already be at increased risk for hepatocellular carcinoma, the researchers added.

The study included 110,484 patients with HCV infection from the VA HCV Clinical Case Registry. About 70% of patients were Vietnam-era veterans, the investigators said. Patients were followed for an average of 5.4 years between 2000 and 2009, and a total of 8,337, or 7.5%, had genotype 3 infection, the researchers reported (Hepatology 2014;60:98-105).

After adjustment for factors such as age and year of birth, diabetes, body mass index, and antiviral treatment, patients with genotype 3 infection had the highest risk of developing cirrhosis and hepatocellular carcinoma among all HCV genotypes. Compared with genotype 1–infected patients, genotype 3–infected patients had a 31% higher risk for cirrhosis (adjusted hazard ratio, 1.31; 95% confidence interval, 1.22-1.39) and an 80% higher risk for hepatocellular carcinoma (aHR, 1.81; 95% CI, 1.61-2.03), the investigators added. Furthermore, a subgroup analysis of patients with cirrhosis showed that the risk of hepatocellular carcinoma was 44% higher in patients with genotype 3 infection than in patients with genotype 1 infection, the researchers said.

"These data are relevant to the thousands of HCV patients with genotype 3 infection, and to their physicians who provide care and counseling to this population," said Dr. Kanwal and her associates. They added that the data might help in prioritizing who should first receive future generations of direct-acting antivirals.

The Houston VA Health Services Research and Development Center of Excellence helped fund the study. The authors did not report conflicts of interest.

Prenatal smoking by mothers and fathers was associated with a 29%-83% increase in the risk of pediatric attention-deficit/hyperactivity disorder, compared with children of nonsmoking parents, investigators reported online July 21 in Pediatrics.

"The association was consistently stronger for maternal smoking than for paternal smoking and was also found for mother’s use of nicotine replacement during pregnancy," wrote Jin Liang Zhu, Ph.D., of Aarhus University in Denmark and his associates.

©Jasmin Merdan/fotolia.com

The cohort study included data from 84,803 children from the Danish National Birth Cohort. A total of 2,009 (2.4%) children had been diagnosed with attention-deficit/hyperactivity disorder (ADHD) or had received medication for ADHD during the 7-year follow-up period, the researchers said (Pediatrics 2014;134:e382-8 [doi: 10.1542/peds.2014-0213]).

Compared with children of nonsmoking parents, children were at significantly increased risk of ADHD when both parents smoked (adjusted hazard ratio, 1.83), when only the mother smoked (aHR, 1.63), and when only the father smoked (aHR, 1.29), the investigators reported. However, children of smoking mothers and nonsmoking fathers had a higher risk of ADHD (aHR, 1.26) than did children of nonsmoking mothers and smoking fathers, the researchers said.

Information on parental smoking was self-reported, and relatively few mothers had used nicotine replacement therapy, leading to unstable estimates and wide confidence intervals, the researchers noted. In addition, the response rate to follow-up questions about ADHD was moderate, which could have led to selection bias, Dr. Zhu and his associates said.

The Tryg Foundation and the European Research Council funded the study. The authors reporting having no conflicts of interest.

Prenatal smoking by mothers and fathers was associated with a 29%-83% increase in the risk of pediatric attention-deficit/hyperactivity disorder, compared with children of nonsmoking parents, investigators reported online July 21 in Pediatrics.

"The association was consistently stronger for maternal smoking than for paternal smoking and was also found for mother’s use of nicotine replacement during pregnancy," wrote Jin Liang Zhu, Ph.D., of Aarhus University in Denmark and his associates.

©Jasmin Merdan/fotolia.com

The cohort study included data from 84,803 children from the Danish National Birth Cohort. A total of 2,009 (2.4%) children had been diagnosed with attention-deficit/hyperactivity disorder (ADHD) or had received medication for ADHD during the 7-year follow-up period, the researchers said (Pediatrics 2014;134:e382-8 [doi: 10.1542/peds.2014-0213]).

Compared with children of nonsmoking parents, children were at significantly increased risk of ADHD when both parents smoked (adjusted hazard ratio, 1.83), when only the mother smoked (aHR, 1.63), and when only the father smoked (aHR, 1.29), the investigators reported. However, children of smoking mothers and nonsmoking fathers had a higher risk of ADHD (aHR, 1.26) than did children of nonsmoking mothers and smoking fathers, the researchers said.

Information on parental smoking was self-reported, and relatively few mothers had used nicotine replacement therapy, leading to unstable estimates and wide confidence intervals, the researchers noted. In addition, the response rate to follow-up questions about ADHD was moderate, which could have led to selection bias, Dr. Zhu and his associates said.

The Tryg Foundation and the European Research Council funded the study. The authors reporting having no conflicts of interest.

Prenatal smoking by mothers and fathers was associated with a 29%-83% increase in the risk of pediatric attention-deficit/hyperactivity disorder, compared with children of nonsmoking parents, investigators reported online July 21 in Pediatrics.

"The association was consistently stronger for maternal smoking than for paternal smoking and was also found for mother’s use of nicotine replacement during pregnancy," wrote Jin Liang Zhu, Ph.D., of Aarhus University in Denmark and his associates.

©Jasmin Merdan/fotolia.com

The cohort study included data from 84,803 children from the Danish National Birth Cohort. A total of 2,009 (2.4%) children had been diagnosed with attention-deficit/hyperactivity disorder (ADHD) or had received medication for ADHD during the 7-year follow-up period, the researchers said (Pediatrics 2014;134:e382-8 [doi: 10.1542/peds.2014-0213]).

Compared with children of nonsmoking parents, children were at significantly increased risk of ADHD when both parents smoked (adjusted hazard ratio, 1.83), when only the mother smoked (aHR, 1.63), and when only the father smoked (aHR, 1.29), the investigators reported. However, children of smoking mothers and nonsmoking fathers had a higher risk of ADHD (aHR, 1.26) than did children of nonsmoking mothers and smoking fathers, the researchers said.

Information on parental smoking was self-reported, and relatively few mothers had used nicotine replacement therapy, leading to unstable estimates and wide confidence intervals, the researchers noted. In addition, the response rate to follow-up questions about ADHD was moderate, which could have led to selection bias, Dr. Zhu and his associates said.

The Tryg Foundation and the European Research Council funded the study. The authors reporting having no conflicts of interest.

Missouri women who used hormonal birth control were 1.4 times more likely to develop gestational diabetes, compared with those who used no birth control, according to a first-in-kind study published online July 17 in Preventing Chronic Disease.

"Although researchers have not established a causal relationship between hormonal contraception use and [gestational diabetes], results of our study suggest there may be an underlying correlating mechanism," wrote Brittney Kramer and her associates at the Missouri Department of Health and Senior Services.

The investigators conducted a logistic regression analysis of 2007-2008 data on 2,741 mothers from the Missouri component of the Pregnancy Risk Assessment Monitoring System, or PRAMS (Prev. Chronic Dis. July 17 [doi: 10.5888/pcd11.140059]).

In all, 8.3% of mothers reported having had gestational diabetes during their most recent pregnancy, and 17.9% reported having used hormonal birth control before pregnancy, the investigators said. The significant association between hormonal birth control and gestational diabetes (adjusted odds ratio, 1.43; 95% confidence interval, 1.32-1.55; P less than .001) existed even after adjusting maternal age, race, education, income, marital status, Medicaid status at delivery, and prenatal care, the researchers added.

Hormonal contraception can potentially alter the hypothalamic-pituitary axis and cortisol and carbohydrate metabolism, the investigators noted. In particular, long-term, high-dose estrogen treatment has been shown to increase unbound cortisol, leading to glucose intolerance, insulin resistance, and increased risk of diabetes, they said (Clin. Sci. (Lond.) 1999;96:513-23).

The PRAMS survey is self-reported by mothers 2-6 months after children are born, and therefore may be subject to recall bias, the researchers noted. Furthermore, the weighting method used for adjustment might not have fully controlled for nonresponse bias, they said.

PRAMS is a national surveillance program sponsored by the Centers for Disease Control and Prevention. The authors disclosed no conflicts of interest.

Missouri women who used hormonal birth control were 1.4 times more likely to develop gestational diabetes, compared with those who used no birth control, according to a first-in-kind study published online July 17 in Preventing Chronic Disease.

"Although researchers have not established a causal relationship between hormonal contraception use and [gestational diabetes], results of our study suggest there may be an underlying correlating mechanism," wrote Brittney Kramer and her associates at the Missouri Department of Health and Senior Services.

The investigators conducted a logistic regression analysis of 2007-2008 data on 2,741 mothers from the Missouri component of the Pregnancy Risk Assessment Monitoring System, or PRAMS (Prev. Chronic Dis. July 17 [doi: 10.5888/pcd11.140059]).

In all, 8.3% of mothers reported having had gestational diabetes during their most recent pregnancy, and 17.9% reported having used hormonal birth control before pregnancy, the investigators said. The significant association between hormonal birth control and gestational diabetes (adjusted odds ratio, 1.43; 95% confidence interval, 1.32-1.55; P less than .001) existed even after adjusting maternal age, race, education, income, marital status, Medicaid status at delivery, and prenatal care, the researchers added.

Hormonal contraception can potentially alter the hypothalamic-pituitary axis and cortisol and carbohydrate metabolism, the investigators noted. In particular, long-term, high-dose estrogen treatment has been shown to increase unbound cortisol, leading to glucose intolerance, insulin resistance, and increased risk of diabetes, they said (Clin. Sci. (Lond.) 1999;96:513-23).

The PRAMS survey is self-reported by mothers 2-6 months after children are born, and therefore may be subject to recall bias, the researchers noted. Furthermore, the weighting method used for adjustment might not have fully controlled for nonresponse bias, they said.

PRAMS is a national surveillance program sponsored by the Centers for Disease Control and Prevention. The authors disclosed no conflicts of interest.

Missouri women who used hormonal birth control were 1.4 times more likely to develop gestational diabetes, compared with those who used no birth control, according to a first-in-kind study published online July 17 in Preventing Chronic Disease.

"Although researchers have not established a causal relationship between hormonal contraception use and [gestational diabetes], results of our study suggest there may be an underlying correlating mechanism," wrote Brittney Kramer and her associates at the Missouri Department of Health and Senior Services.

The investigators conducted a logistic regression analysis of 2007-2008 data on 2,741 mothers from the Missouri component of the Pregnancy Risk Assessment Monitoring System, or PRAMS (Prev. Chronic Dis. July 17 [doi: 10.5888/pcd11.140059]).

In all, 8.3% of mothers reported having had gestational diabetes during their most recent pregnancy, and 17.9% reported having used hormonal birth control before pregnancy, the investigators said. The significant association between hormonal birth control and gestational diabetes (adjusted odds ratio, 1.43; 95% confidence interval, 1.32-1.55; P less than .001) existed even after adjusting maternal age, race, education, income, marital status, Medicaid status at delivery, and prenatal care, the researchers added.

Hormonal contraception can potentially alter the hypothalamic-pituitary axis and cortisol and carbohydrate metabolism, the investigators noted. In particular, long-term, high-dose estrogen treatment has been shown to increase unbound cortisol, leading to glucose intolerance, insulin resistance, and increased risk of diabetes, they said (Clin. Sci. (Lond.) 1999;96:513-23).

The PRAMS survey is self-reported by mothers 2-6 months after children are born, and therefore may be subject to recall bias, the researchers noted. Furthermore, the weighting method used for adjustment might not have fully controlled for nonresponse bias, they said.

PRAMS is a national surveillance program sponsored by the Centers for Disease Control and Prevention. The authors disclosed no conflicts of interest.

Widespread uptake of rotavirus vaccine in the United States saved an estimated 1.5 million diarrhea-related health care visits in 4 years, as well as $924 million in associated health care costs, according to a multiyear analysis.

Rotavirus-related hospitalizations fell by as much as 94% in the years after the Advisory Committee on Immunization Practices (ACIP) first recommended routine use of pentavalent rotavirus vaccine (RV5), reported Dr. Eyal Leshem and his associates at the Centers for Disease Control and Prevention in Atlanta.

CDC/Dr. Erskine Palmer

"Reductions in rotavirus and all-cause diarrhea-associated hospitalizations in U.S. children during the 2007-2008 and 2008-2009 rotavirus seasons have been well documented," the researchers said. "Our results demonstrate that these declines were sustained and were greater in the subsequent rotavirus seasons in 2009-2010 and 2010-2011."

The retrospective study cohort included more than 406,000 commercially insured children aged 5 years and younger from 37 U.S. states, the researchers said (Pediatrics 2014;34:15-23). By December 2010, 58% of the cohort had received at least one dose of RV5 and 5% had received at least one dose of monovalent RV1 vaccine.

In vaccinated children, rotavirus-related hospitalizations fell by 94% during 2009 through 2011, compared with the prevaccine period 2001 through 2006, the investigators said. Decreases were sustained across age groups, ranging from 87% in 1-year-olds to 81% in 4-year-olds. And in unvaccinated children, rotavirus-related hospitalizations also declined by 25%-77%.

"Both RV5 and RV1 were highly effective in preventing rotavirus-coded hospitalizations, and also prevented diarrhea-associated hospitalizations and emergency department visits," added Dr. Leshem and his associates. "The protection from RV5 vaccination against rotavirus-coded hospitalizations was sustained at a high level through 4 years of life, with no indication of waning immunity."

The study received no external funding, and the authors reported having no conflicts of interest.

Widespread uptake of rotavirus vaccine in the United States saved an estimated 1.5 million diarrhea-related health care visits in 4 years, as well as $924 million in associated health care costs, according to a multiyear analysis.

Rotavirus-related hospitalizations fell by as much as 94% in the years after the Advisory Committee on Immunization Practices (ACIP) first recommended routine use of pentavalent rotavirus vaccine (RV5), reported Dr. Eyal Leshem and his associates at the Centers for Disease Control and Prevention in Atlanta.

CDC/Dr. Erskine Palmer

"Reductions in rotavirus and all-cause diarrhea-associated hospitalizations in U.S. children during the 2007-2008 and 2008-2009 rotavirus seasons have been well documented," the researchers said. "Our results demonstrate that these declines were sustained and were greater in the subsequent rotavirus seasons in 2009-2010 and 2010-2011."

The retrospective study cohort included more than 406,000 commercially insured children aged 5 years and younger from 37 U.S. states, the researchers said (Pediatrics 2014;34:15-23). By December 2010, 58% of the cohort had received at least one dose of RV5 and 5% had received at least one dose of monovalent RV1 vaccine.

In vaccinated children, rotavirus-related hospitalizations fell by 94% during 2009 through 2011, compared with the prevaccine period 2001 through 2006, the investigators said. Decreases were sustained across age groups, ranging from 87% in 1-year-olds to 81% in 4-year-olds. And in unvaccinated children, rotavirus-related hospitalizations also declined by 25%-77%.

"Both RV5 and RV1 were highly effective in preventing rotavirus-coded hospitalizations, and also prevented diarrhea-associated hospitalizations and emergency department visits," added Dr. Leshem and his associates. "The protection from RV5 vaccination against rotavirus-coded hospitalizations was sustained at a high level through 4 years of life, with no indication of waning immunity."

The study received no external funding, and the authors reported having no conflicts of interest.

Widespread uptake of rotavirus vaccine in the United States saved an estimated 1.5 million diarrhea-related health care visits in 4 years, as well as $924 million in associated health care costs, according to a multiyear analysis.

Rotavirus-related hospitalizations fell by as much as 94% in the years after the Advisory Committee on Immunization Practices (ACIP) first recommended routine use of pentavalent rotavirus vaccine (RV5), reported Dr. Eyal Leshem and his associates at the Centers for Disease Control and Prevention in Atlanta.

CDC/Dr. Erskine Palmer

"Reductions in rotavirus and all-cause diarrhea-associated hospitalizations in U.S. children during the 2007-2008 and 2008-2009 rotavirus seasons have been well documented," the researchers said. "Our results demonstrate that these declines were sustained and were greater in the subsequent rotavirus seasons in 2009-2010 and 2010-2011."

The retrospective study cohort included more than 406,000 commercially insured children aged 5 years and younger from 37 U.S. states, the researchers said (Pediatrics 2014;34:15-23). By December 2010, 58% of the cohort had received at least one dose of RV5 and 5% had received at least one dose of monovalent RV1 vaccine.

In vaccinated children, rotavirus-related hospitalizations fell by 94% during 2009 through 2011, compared with the prevaccine period 2001 through 2006, the investigators said. Decreases were sustained across age groups, ranging from 87% in 1-year-olds to 81% in 4-year-olds. And in unvaccinated children, rotavirus-related hospitalizations also declined by 25%-77%.

"Both RV5 and RV1 were highly effective in preventing rotavirus-coded hospitalizations, and also prevented diarrhea-associated hospitalizations and emergency department visits," added Dr. Leshem and his associates. "The protection from RV5 vaccination against rotavirus-coded hospitalizations was sustained at a high level through 4 years of life, with no indication of waning immunity."

The study received no external funding, and the authors reported having no conflicts of interest.

An expert review panel from the American Society for Clinical Oncology largely endorsed new guidelines for "no ink on tumor" margins in early breast conservation surgery, while emphasizing the role of post-lumpectomy imaging in patients with microcalcifications and adding several other "minor qualifications."

Published earlier this year, the guidelines from the Society of Surgical Oncology (SSO) and the American Society of Radiation Oncology (ASTRO) focus on stage I and II breast cancer patients who are undergoing lumpectomy with whole-breast radiation. In these patients, a "no ink on tumor" margin "is associated with low rates of [ipsilateral breast tumor recurrence] and has the potential to decrease re-excision rates, improve cosmetic outcomes, and decrease health care costs," the guideline’s authors wrote (Ann. Surg. Oncol. 2014;21:704-16). The guidelines mark a step toward consensus on a historically controversial topic. "Widespread adoption of this guideline, which defines a margin as being adequate as long as there is no cancer at the inked lumpectomy surface by microscopic pathology evaluation, will result in fewer re-excision lumpectomies and enhanced cosmesis with breast conserving surgery," said Dr. Lisa Newman.

The recommended margin reflects the current era of treatment, in which better systemic therapies and earlier diagnosis of breast cancer mean that patients may no longer derive extra benefit from thicker or "widely negative" lumpectomy margins, Dr. Newman added in an interview.

Two staff members at ASCO reviewed the guidelines for developmental rigor. The guidelines "scored high (77%) in terms of methodologic quality, with only minor deviations from the ideal," members of the separate ad hoc panel of ASCO experts wrote (J. Clin. Onc. 2014 [doi:10.1200/JCO.2014.55.1572]). But panel members also called for flexibility in applying the guideline, citing the "inherent weaknesses" and "selection bias" of the retrospective, observational studies on which the recommendations were based.

The guidelines provide a framework, but clinical judgment remains important in managing breast-conserving surgery patients, emphasized Dr. Newman, who served as cochair on the ASCO panel that reviewed the guideline and who is a surgical oncologist, professor of surgery, and director of the Breast Care Center for the University of Michigan, Ann Arbor. She said clinicians should carefully evaluate lumpectomy margins, which "can provide important clues regarding the burden of disease in the breast, and the likelihood of successful treatment with lumpectomy and breast radiation."

ASCO panel members also stressed the importance of postsurgical imaging in cases involving microcalcifications. Imaging is important to minimize the risk of leaving pockets of disease in the breast despite achieving microscopically negative margins, Dr. Newman said. Surgeons can work with their colleagues in breast imaging to review microcalcifications and correlate them with pathology findings, she added.

In particular, a lumpectomy specimen that has several close margins and evidence of diffuse disease "may well represent a different category of risk regarding local recurrence, compared to a well defined, unifocal cancer that has a single microscopic focus of cancer abutting one margin," Dr. Newman added. Ideally, surgeons and radiation oncologists should discuss these aspects of cases, and should consider them when counseling patients about outcomes from lumpectomy surgery, she said.

Both ASCO and SSO/ASTRO recommended monitoring outcomes as institutions implement the new margin guidelines. Authors of the ASCO opinion reported having no conflicts of interest.

An expert review panel from the American Society for Clinical Oncology largely endorsed new guidelines for "no ink on tumor" margins in early breast conservation surgery, while emphasizing the role of post-lumpectomy imaging in patients with microcalcifications and adding several other "minor qualifications."

Published earlier this year, the guidelines from the Society of Surgical Oncology (SSO) and the American Society of Radiation Oncology (ASTRO) focus on stage I and II breast cancer patients who are undergoing lumpectomy with whole-breast radiation. In these patients, a "no ink on tumor" margin "is associated with low rates of [ipsilateral breast tumor recurrence] and has the potential to decrease re-excision rates, improve cosmetic outcomes, and decrease health care costs," the guideline’s authors wrote (Ann. Surg. Oncol. 2014;21:704-16). The guidelines mark a step toward consensus on a historically controversial topic. "Widespread adoption of this guideline, which defines a margin as being adequate as long as there is no cancer at the inked lumpectomy surface by microscopic pathology evaluation, will result in fewer re-excision lumpectomies and enhanced cosmesis with breast conserving surgery," said Dr. Lisa Newman.

The recommended margin reflects the current era of treatment, in which better systemic therapies and earlier diagnosis of breast cancer mean that patients may no longer derive extra benefit from thicker or "widely negative" lumpectomy margins, Dr. Newman added in an interview.

Two staff members at ASCO reviewed the guidelines for developmental rigor. The guidelines "scored high (77%) in terms of methodologic quality, with only minor deviations from the ideal," members of the separate ad hoc panel of ASCO experts wrote (J. Clin. Onc. 2014 [doi:10.1200/JCO.2014.55.1572]). But panel members also called for flexibility in applying the guideline, citing the "inherent weaknesses" and "selection bias" of the retrospective, observational studies on which the recommendations were based.

The guidelines provide a framework, but clinical judgment remains important in managing breast-conserving surgery patients, emphasized Dr. Newman, who served as cochair on the ASCO panel that reviewed the guideline and who is a surgical oncologist, professor of surgery, and director of the Breast Care Center for the University of Michigan, Ann Arbor. She said clinicians should carefully evaluate lumpectomy margins, which "can provide important clues regarding the burden of disease in the breast, and the likelihood of successful treatment with lumpectomy and breast radiation."

ASCO panel members also stressed the importance of postsurgical imaging in cases involving microcalcifications. Imaging is important to minimize the risk of leaving pockets of disease in the breast despite achieving microscopically negative margins, Dr. Newman said. Surgeons can work with their colleagues in breast imaging to review microcalcifications and correlate them with pathology findings, she added.

In particular, a lumpectomy specimen that has several close margins and evidence of diffuse disease "may well represent a different category of risk regarding local recurrence, compared to a well defined, unifocal cancer that has a single microscopic focus of cancer abutting one margin," Dr. Newman added. Ideally, surgeons and radiation oncologists should discuss these aspects of cases, and should consider them when counseling patients about outcomes from lumpectomy surgery, she said.

Both ASCO and SSO/ASTRO recommended monitoring outcomes as institutions implement the new margin guidelines. Authors of the ASCO opinion reported having no conflicts of interest.

An expert review panel from the American Society for Clinical Oncology largely endorsed new guidelines for "no ink on tumor" margins in early breast conservation surgery, while emphasizing the role of post-lumpectomy imaging in patients with microcalcifications and adding several other "minor qualifications."

Published earlier this year, the guidelines from the Society of Surgical Oncology (SSO) and the American Society of Radiation Oncology (ASTRO) focus on stage I and II breast cancer patients who are undergoing lumpectomy with whole-breast radiation. In these patients, a "no ink on tumor" margin "is associated with low rates of [ipsilateral breast tumor recurrence] and has the potential to decrease re-excision rates, improve cosmetic outcomes, and decrease health care costs," the guideline’s authors wrote (Ann. Surg. Oncol. 2014;21:704-16). The guidelines mark a step toward consensus on a historically controversial topic. "Widespread adoption of this guideline, which defines a margin as being adequate as long as there is no cancer at the inked lumpectomy surface by microscopic pathology evaluation, will result in fewer re-excision lumpectomies and enhanced cosmesis with breast conserving surgery," said Dr. Lisa Newman.

The recommended margin reflects the current era of treatment, in which better systemic therapies and earlier diagnosis of breast cancer mean that patients may no longer derive extra benefit from thicker or "widely negative" lumpectomy margins, Dr. Newman added in an interview.

Two staff members at ASCO reviewed the guidelines for developmental rigor. The guidelines "scored high (77%) in terms of methodologic quality, with only minor deviations from the ideal," members of the separate ad hoc panel of ASCO experts wrote (J. Clin. Onc. 2014 [doi:10.1200/JCO.2014.55.1572]). But panel members also called for flexibility in applying the guideline, citing the "inherent weaknesses" and "selection bias" of the retrospective, observational studies on which the recommendations were based.

The guidelines provide a framework, but clinical judgment remains important in managing breast-conserving surgery patients, emphasized Dr. Newman, who served as cochair on the ASCO panel that reviewed the guideline and who is a surgical oncologist, professor of surgery, and director of the Breast Care Center for the University of Michigan, Ann Arbor. She said clinicians should carefully evaluate lumpectomy margins, which "can provide important clues regarding the burden of disease in the breast, and the likelihood of successful treatment with lumpectomy and breast radiation."

ASCO panel members also stressed the importance of postsurgical imaging in cases involving microcalcifications. Imaging is important to minimize the risk of leaving pockets of disease in the breast despite achieving microscopically negative margins, Dr. Newman said. Surgeons can work with their colleagues in breast imaging to review microcalcifications and correlate them with pathology findings, she added.

In particular, a lumpectomy specimen that has several close margins and evidence of diffuse disease "may well represent a different category of risk regarding local recurrence, compared to a well defined, unifocal cancer that has a single microscopic focus of cancer abutting one margin," Dr. Newman added. Ideally, surgeons and radiation oncologists should discuss these aspects of cases, and should consider them when counseling patients about outcomes from lumpectomy surgery, she said.

Both ASCO and SSO/ASTRO recommended monitoring outcomes as institutions implement the new margin guidelines. Authors of the ASCO opinion reported having no conflicts of interest.

Clinicians should perform a basic six-step evaluation of women with symptoms of uncomplicated stress urinary incontinence before these patients undergo midurethral sling surgery, according to first-time guidelines from the American College of Obstetricians and Gynecologists and the American Urogynecologic Society.

The recommended steps exclude preoperative urodynamic testing, which has not been shown to improve surgical outcomes in patients with uncomplicated SUI, stated Committee Opinion No. 603, published in the June issue of Obstetrics and Gynecology (2014;123:1403-7).

"Until now, there has never been any consistency in the evaluation of uncomplicated SUI before surgery," said Dr. Charles Nager, professor of obstetrics and gynecology and director of female pelvic medicine and reconstructive surgery at the University of California, San Diego. "This is the first time the leading specialty organizations, ACOG and the American Urogynecologic Society [AUGS], have set a standard for physicians to follow before they operate on patients with uncomplicated SUI."

The criteria are common sense, are evidence based, and "don’t require that everyone undergo urodynamic testing," added Dr. Nager, who is president of AUGS and a member of ACOG’s subcommittee on urogynecology of the Committee on Gynecologic Practice, which was involved in drafting the guidelines.

The opinion guides clinicians in evaluating women with urinary leakage without necessarily requiring a costly work-up, said Dr. Cheryl Iglesia, who also contributed to the guidelines and is director of female pelvic medicine and reconstructive surgery at MedStar Washington (D.C.) Hospital Center and professor of obstetrics, gynecology, and urology at Georgetown University, Washington. If the minimum six-step evaluation confirms uncomplicated SUI, "you don’t need to do a test that would run upwards of thousands of dollars and doesn’t change the outcome," she said.

The recommended six-step evaluation includes:

1. A urologic, medical, neurologic, and medication history.

2. A urinalysis to rule out urinary tract infection.

3. A physical examination to assess for contributing or confounding factors, including urethral diverticulum, vaginal discharge, extraurethral incontinence, and pelvic organ prolapse (which leads to a diagnosis of complicated SUI if the prolapse is beyond the hymen).

4. A cough stress test to demonstrate SUI.

5. A urethral mobility assessment to help determine the likelihood of success from anti-incontinence surgery.

6. Measurement of postvoid residual urine volume to identify bladder-emptying abnormalities or incontinence resulting from chronic urinary retention.

Women with uncomplicated SUI will have urinary leakage from the urethra by provocative stress measures such as the cough test, a normal urinalysis that rules out urinary tract infection, no pelvic organ prolapse beyond the hymen, and a normal postvoid residual urine volume, the guidelines specify, adding that patients who meet these criteria and have not responded to conservative interventions do not need urodynamic testing before proceeding to surgery.

In contrast, women with complicated SUI "may benefit from multichannel urodynamic testing, particularly before surgical treatment," the guidelines stated. "In these women, the results of the basic six-step evaluation and clinical judgment should guide the decision to perform preoperative multichannel urodynamic testing."

Clinicians should perform a basic six-step evaluation of women with symptoms of uncomplicated stress urinary incontinence before these patients undergo midurethral sling surgery, according to first-time guidelines from the American College of Obstetricians and Gynecologists and the American Urogynecologic Society.

The recommended steps exclude preoperative urodynamic testing, which has not been shown to improve surgical outcomes in patients with uncomplicated SUI, stated Committee Opinion No. 603, published in the June issue of Obstetrics and Gynecology (2014;123:1403-7).

"Until now, there has never been any consistency in the evaluation of uncomplicated SUI before surgery," said Dr. Charles Nager, professor of obstetrics and gynecology and director of female pelvic medicine and reconstructive surgery at the University of California, San Diego. "This is the first time the leading specialty organizations, ACOG and the American Urogynecologic Society [AUGS], have set a standard for physicians to follow before they operate on patients with uncomplicated SUI."

The criteria are common sense, are evidence based, and "don’t require that everyone undergo urodynamic testing," added Dr. Nager, who is president of AUGS and a member of ACOG’s subcommittee on urogynecology of the Committee on Gynecologic Practice, which was involved in drafting the guidelines.

The opinion guides clinicians in evaluating women with urinary leakage without necessarily requiring a costly work-up, said Dr. Cheryl Iglesia, who also contributed to the guidelines and is director of female pelvic medicine and reconstructive surgery at MedStar Washington (D.C.) Hospital Center and professor of obstetrics, gynecology, and urology at Georgetown University, Washington. If the minimum six-step evaluation confirms uncomplicated SUI, "you don’t need to do a test that would run upwards of thousands of dollars and doesn’t change the outcome," she said.

The recommended six-step evaluation includes:

1. A urologic, medical, neurologic, and medication history.

2. A urinalysis to rule out urinary tract infection.

3. A physical examination to assess for contributing or confounding factors, including urethral diverticulum, vaginal discharge, extraurethral incontinence, and pelvic organ prolapse (which leads to a diagnosis of complicated SUI if the prolapse is beyond the hymen).

4. A cough stress test to demonstrate SUI.

5. A urethral mobility assessment to help determine the likelihood of success from anti-incontinence surgery.

6. Measurement of postvoid residual urine volume to identify bladder-emptying abnormalities or incontinence resulting from chronic urinary retention.

Women with uncomplicated SUI will have urinary leakage from the urethra by provocative stress measures such as the cough test, a normal urinalysis that rules out urinary tract infection, no pelvic organ prolapse beyond the hymen, and a normal postvoid residual urine volume, the guidelines specify, adding that patients who meet these criteria and have not responded to conservative interventions do not need urodynamic testing before proceeding to surgery.

In contrast, women with complicated SUI "may benefit from multichannel urodynamic testing, particularly before surgical treatment," the guidelines stated. "In these women, the results of the basic six-step evaluation and clinical judgment should guide the decision to perform preoperative multichannel urodynamic testing."

Clinicians should perform a basic six-step evaluation of women with symptoms of uncomplicated stress urinary incontinence before these patients undergo midurethral sling surgery, according to first-time guidelines from the American College of Obstetricians and Gynecologists and the American Urogynecologic Society.

The recommended steps exclude preoperative urodynamic testing, which has not been shown to improve surgical outcomes in patients with uncomplicated SUI, stated Committee Opinion No. 603, published in the June issue of Obstetrics and Gynecology (2014;123:1403-7).

"Until now, there has never been any consistency in the evaluation of uncomplicated SUI before surgery," said Dr. Charles Nager, professor of obstetrics and gynecology and director of female pelvic medicine and reconstructive surgery at the University of California, San Diego. "This is the first time the leading specialty organizations, ACOG and the American Urogynecologic Society [AUGS], have set a standard for physicians to follow before they operate on patients with uncomplicated SUI."

The criteria are common sense, are evidence based, and "don’t require that everyone undergo urodynamic testing," added Dr. Nager, who is president of AUGS and a member of ACOG’s subcommittee on urogynecology of the Committee on Gynecologic Practice, which was involved in drafting the guidelines.

The opinion guides clinicians in evaluating women with urinary leakage without necessarily requiring a costly work-up, said Dr. Cheryl Iglesia, who also contributed to the guidelines and is director of female pelvic medicine and reconstructive surgery at MedStar Washington (D.C.) Hospital Center and professor of obstetrics, gynecology, and urology at Georgetown University, Washington. If the minimum six-step evaluation confirms uncomplicated SUI, "you don’t need to do a test that would run upwards of thousands of dollars and doesn’t change the outcome," she said.

The recommended six-step evaluation includes:

1. A urologic, medical, neurologic, and medication history.

2. A urinalysis to rule out urinary tract infection.

3. A physical examination to assess for contributing or confounding factors, including urethral diverticulum, vaginal discharge, extraurethral incontinence, and pelvic organ prolapse (which leads to a diagnosis of complicated SUI if the prolapse is beyond the hymen).

4. A cough stress test to demonstrate SUI.

5. A urethral mobility assessment to help determine the likelihood of success from anti-incontinence surgery.

6. Measurement of postvoid residual urine volume to identify bladder-emptying abnormalities or incontinence resulting from chronic urinary retention.

Women with uncomplicated SUI will have urinary leakage from the urethra by provocative stress measures such as the cough test, a normal urinalysis that rules out urinary tract infection, no pelvic organ prolapse beyond the hymen, and a normal postvoid residual urine volume, the guidelines specify, adding that patients who meet these criteria and have not responded to conservative interventions do not need urodynamic testing before proceeding to surgery.

In contrast, women with complicated SUI "may benefit from multichannel urodynamic testing, particularly before surgical treatment," the guidelines stated. "In these women, the results of the basic six-step evaluation and clinical judgment should guide the decision to perform preoperative multichannel urodynamic testing."

A therapeutic vaccine combined with low-dose chemotherapy primed almost 85% of pancreatic ductal adenocarcinomas to potentially respond to immunotherapy, according to researchers.

The report was published online June 17 in Cancer Immunology Research.

The small trial "provides the strongest rationale so far for combining immune-modulating agents with vaccination in patients whose tumors do not naturally contain abundant effector T cells," said Dr. Eric Lutz of Johns Hopkins University, Baltimore, and his associates. "Here, we report the first description of tertiary lymphoid aggregates infiltrating human PDAC [pancreatic cell adenocarcinomas]. These aggregates develop 2 weeks after a single treatment with a PDAC vaccine," they added.

The researchers randomized 39 patients with resectable pancreatic cell adenocarcinomas to receive irradiated, granulocyte-macrophage colony-stimulating factor–secreting , allogeneic vaccine (GVAX) alone, GVAX plus a single intravenous dose of cyclophosphamide at 200 mg/m² 1 day before each vaccination, or GVAX plus oral cyclophosphamide 100 mg once daily for 1 week on and 1 week off. Two weeks after vaccination, all patients underwent tumor resection surgery (Cancer Immunol. Res. 2014 June 17 [doi: 10.1158/2326-6066.CIR-14-0027].

Histologic analysis showed that tumors from 33 of the 39 patients (84.6%) had formed vaccine-induced intratumoral tertiary lymphoid aggregates, the researchers said. "Immunohistochemical analysis showed these aggregates to be regulatory structures of adaptive immunity," they added, noting that after vaccination, the ratio of effector T cells to regulatory T cells increased, indicating immunogenicity.

Furthermore, the researchers found that lymphoid aggregates in tumors from patients who survived more than 3 years after vaccine therapy had significantly greater IL17A protein expression compared with patients who survived for less than 1.5 years after vaccination (P = .02).

"On the basis of the evidence available, this model explains why vaccination and immune modulation as single-agent therapies have failed in patients with PDAC," the investigators said. They cited their prior study, which showed objective responses when patients received a combination of GVAX and ipilimumab but not when they received ipilimumab alone (J. Immunother. 2013;36:382-9).

Researchers estimate that pancreatic ductal adenocarcinoma kills 95% of patients within 5 years of diagnosis.

The National Institutes of Health, Johns Hopkins School of Medicine Clinical Scientist Award, American Society of Clinical Oncology Young Investigator Award, Viragh Foundation and Skip Viragh Pancreatic Cancer Center at Johns Hopkins, National Pancreas Foundation, Lefkofsky Family Foundation, Lustgarten Foundation, Sol Goldman Pancreatic Cancer Center, and AACR-FNAB Fellows Grant for Translational Pancreatic Cancer Research Award funded the study. A coauthor disclosed ties to Bristol-Myers Squibb; the others declared no conflicts of interest.

A therapeutic vaccine combined with low-dose chemotherapy primed almost 85% of pancreatic ductal adenocarcinomas to potentially respond to immunotherapy, according to researchers.

The report was published online June 17 in Cancer Immunology Research.

The small trial "provides the strongest rationale so far for combining immune-modulating agents with vaccination in patients whose tumors do not naturally contain abundant effector T cells," said Dr. Eric Lutz of Johns Hopkins University, Baltimore, and his associates. "Here, we report the first description of tertiary lymphoid aggregates infiltrating human PDAC [pancreatic cell adenocarcinomas]. These aggregates develop 2 weeks after a single treatment with a PDAC vaccine," they added.

The researchers randomized 39 patients with resectable pancreatic cell adenocarcinomas to receive irradiated, granulocyte-macrophage colony-stimulating factor–secreting , allogeneic vaccine (GVAX) alone, GVAX plus a single intravenous dose of cyclophosphamide at 200 mg/m² 1 day before each vaccination, or GVAX plus oral cyclophosphamide 100 mg once daily for 1 week on and 1 week off. Two weeks after vaccination, all patients underwent tumor resection surgery (Cancer Immunol. Res. 2014 June 17 [doi: 10.1158/2326-6066.CIR-14-0027].

Histologic analysis showed that tumors from 33 of the 39 patients (84.6%) had formed vaccine-induced intratumoral tertiary lymphoid aggregates, the researchers said. "Immunohistochemical analysis showed these aggregates to be regulatory structures of adaptive immunity," they added, noting that after vaccination, the ratio of effector T cells to regulatory T cells increased, indicating immunogenicity.

Furthermore, the researchers found that lymphoid aggregates in tumors from patients who survived more than 3 years after vaccine therapy had significantly greater IL17A protein expression compared with patients who survived for less than 1.5 years after vaccination (P = .02).

"On the basis of the evidence available, this model explains why vaccination and immune modulation as single-agent therapies have failed in patients with PDAC," the investigators said. They cited their prior study, which showed objective responses when patients received a combination of GVAX and ipilimumab but not when they received ipilimumab alone (J. Immunother. 2013;36:382-9).

Researchers estimate that pancreatic ductal adenocarcinoma kills 95% of patients within 5 years of diagnosis.

The National Institutes of Health, Johns Hopkins School of Medicine Clinical Scientist Award, American Society of Clinical Oncology Young Investigator Award, Viragh Foundation and Skip Viragh Pancreatic Cancer Center at Johns Hopkins, National Pancreas Foundation, Lefkofsky Family Foundation, Lustgarten Foundation, Sol Goldman Pancreatic Cancer Center, and AACR-FNAB Fellows Grant for Translational Pancreatic Cancer Research Award funded the study. A coauthor disclosed ties to Bristol-Myers Squibb; the others declared no conflicts of interest.

A therapeutic vaccine combined with low-dose chemotherapy primed almost 85% of pancreatic ductal adenocarcinomas to potentially respond to immunotherapy, according to researchers.

The report was published online June 17 in Cancer Immunology Research.

The small trial "provides the strongest rationale so far for combining immune-modulating agents with vaccination in patients whose tumors do not naturally contain abundant effector T cells," said Dr. Eric Lutz of Johns Hopkins University, Baltimore, and his associates. "Here, we report the first description of tertiary lymphoid aggregates infiltrating human PDAC [pancreatic cell adenocarcinomas]. These aggregates develop 2 weeks after a single treatment with a PDAC vaccine," they added.

The researchers randomized 39 patients with resectable pancreatic cell adenocarcinomas to receive irradiated, granulocyte-macrophage colony-stimulating factor–secreting , allogeneic vaccine (GVAX) alone, GVAX plus a single intravenous dose of cyclophosphamide at 200 mg/m² 1 day before each vaccination, or GVAX plus oral cyclophosphamide 100 mg once daily for 1 week on and 1 week off. Two weeks after vaccination, all patients underwent tumor resection surgery (Cancer Immunol. Res. 2014 June 17 [doi: 10.1158/2326-6066.CIR-14-0027].

Histologic analysis showed that tumors from 33 of the 39 patients (84.6%) had formed vaccine-induced intratumoral tertiary lymphoid aggregates, the researchers said. "Immunohistochemical analysis showed these aggregates to be regulatory structures of adaptive immunity," they added, noting that after vaccination, the ratio of effector T cells to regulatory T cells increased, indicating immunogenicity.

Furthermore, the researchers found that lymphoid aggregates in tumors from patients who survived more than 3 years after vaccine therapy had significantly greater IL17A protein expression compared with patients who survived for less than 1.5 years after vaccination (P = .02).

"On the basis of the evidence available, this model explains why vaccination and immune modulation as single-agent therapies have failed in patients with PDAC," the investigators said. They cited their prior study, which showed objective responses when patients received a combination of GVAX and ipilimumab but not when they received ipilimumab alone (J. Immunother. 2013;36:382-9).

Researchers estimate that pancreatic ductal adenocarcinoma kills 95% of patients within 5 years of diagnosis.

The National Institutes of Health, Johns Hopkins School of Medicine Clinical Scientist Award, American Society of Clinical Oncology Young Investigator Award, Viragh Foundation and Skip Viragh Pancreatic Cancer Center at Johns Hopkins, National Pancreas Foundation, Lefkofsky Family Foundation, Lustgarten Foundation, Sol Goldman Pancreatic Cancer Center, and AACR-FNAB Fellows Grant for Translational Pancreatic Cancer Research Award funded the study. A coauthor disclosed ties to Bristol-Myers Squibb; the others declared no conflicts of interest.

A bionic insulin-glucagon pancreas achieved significantly better glycemic control than insulin pump therapy in adults and adolescents with type 1 diabetes, researchers reported at the annual scientific sessions of the American Diabetes Association.

The testing conditions in the two 5-day random-order crossover studies "simulated real-world outpatient settings with close monitoring for safety in adults and adolescents. Meals and physical activity were not regulated, in contrast with previous studies," wrote Dr. Stephen Russell at Massachusetts General Hospital and Harvard Medical School in Boston and his associates in a report published simultaneously with the presentation (N. Engl. J. Med. 2014 June 15 [doi: 10.1056/NEJMoa1314474]).

Adults achieved significantly lower mean plasma glucose levels during the bionic-pancreas period compared with the control period (7.4 vs. 8.8 mg/dL), as did adolescents (7.7 vs. 8.7 mg/dL), the investigators said. And differences were significant even though about 75% of patients had better baseline glycemic control than national averages, they said.

The studies included 20 adults from the Beacon Hill Study and 32 adolescents from the Summer Camp Study, said investigators. The bionic pancreas device included an Apple iPhone 4S, whose control algorithm received continuous glucose monitoring data and triggered dosing every 5 minutes, and a G4 Platinum continuous glucose monitor from Dexcom connected to the iPhone by a hardware interface. The device’s user interface showed continuous glucose readings and insulin and glucagon doses, and enabled the wearer to record meal sizes as typical, more than usual, less than usual, or a "small bite." Based on meal size, the device adapted the insulin dose to meet 75% of the estimated 4-hour postprandial need. If the glucose sensor failed, the device automatically delivered insulin based on the estimated amount calculated from that time on previous days, and also gave correction doses of insulin or glucagon based on manually entered fingerstick plasma glucose data.

During the control period, adults lived at home as usual, managing their diabetes with their own insulin pump, the investigators said. They wore the G4 Platinum monitor with alarms deactivated and the blood glucose level masked, kept diaries of exercise, hypoglycemic episodes, and carbohydrate interventions, received a food allowance, and were encouraged to eat at restaurants. Adolescents lived at the diabetes summer camp alongside teenagers who were not part of the study, and also wore the masked device during the control period, said Dr. Russell and his associates.

In addition to the difference in mean glucose levels, adults had 67% less time with low glucose readings on the bionic pancreas than on the insulin pump (4.1% vs. 7.3% of the time), the researchers said. Adolescents had a 50% decrease in the amount of carbohydrates given to treat hypoglycemia, but no significant difference in amount of time with low glucose readings, which the researcher said might be because the summer camp rapidly responded to hypoglycemic episodes.

Adults had no severe hypoglycemic events, but during the bionic pancreas period, two had nausea and one vomited within 2 hours after a glucagon dose, and four had infusion sets removed because of pain or swelling, said the investigators. Adolescents had no severe hypoglycemia during the bionic pancreas period, they said, but during the control period, one patient became confused and hypoglycemic.

The slow absorption of available rapid-acting subcutaneous insulin analogues and the poor stability of current glucagon formulations are challenges in designing these devices, according to Dr. Russell and associates. "Since a single device that integrates all the components of a bionic pancreas is not yet available, we had to rely on wireless connectivity to the insulin and glucagon pumps, which was not completely reliable," they wrote, adding that the device could overestimate blood glucose level if patients take acetaminophen. "The balance of risks and benefits associated with delivering more insulin to achieve more physiologic glycemic control will require further study," they added, noting that the long-term safety of small peripheral doses of glucagon also is unknown.

The National Institute of Diabetes and Digestive and Kidney Diseases, the Leona M. and Harry B. Helmsley Charitable Trust, the Earle Charlton Fund for Innovative Research in Diabetes, the Frederick Banting Foundation, and Ralph Faber and John Whitlock funded the study. Three authors have patents or pending patents for blood glucose control systems. Dr. Russell and one co-author reported receiving fees from Medtronic, Tandem Diabetes, Sanofi Aventis, Eli Lilly, Abbott Diabetes Care, Biodel, and Dexcom.

A bionic insulin-glucagon pancreas achieved significantly better glycemic control than insulin pump therapy in adults and adolescents with type 1 diabetes, researchers reported at the annual scientific sessions of the American Diabetes Association.

The testing conditions in the two 5-day random-order crossover studies "simulated real-world outpatient settings with close monitoring for safety in adults and adolescents. Meals and physical activity were not regulated, in contrast with previous studies," wrote Dr. Stephen Russell at Massachusetts General Hospital and Harvard Medical School in Boston and his associates in a report published simultaneously with the presentation (N. Engl. J. Med. 2014 June 15 [doi: 10.1056/NEJMoa1314474]).

Adults achieved significantly lower mean plasma glucose levels during the bionic-pancreas period compared with the control period (7.4 vs. 8.8 mg/dL), as did adolescents (7.7 vs. 8.7 mg/dL), the investigators said. And differences were significant even though about 75% of patients had better baseline glycemic control than national averages, they said.

The studies included 20 adults from the Beacon Hill Study and 32 adolescents from the Summer Camp Study, said investigators. The bionic pancreas device included an Apple iPhone 4S, whose control algorithm received continuous glucose monitoring data and triggered dosing every 5 minutes, and a G4 Platinum continuous glucose monitor from Dexcom connected to the iPhone by a hardware interface. The device’s user interface showed continuous glucose readings and insulin and glucagon doses, and enabled the wearer to record meal sizes as typical, more than usual, less than usual, or a "small bite." Based on meal size, the device adapted the insulin dose to meet 75% of the estimated 4-hour postprandial need. If the glucose sensor failed, the device automatically delivered insulin based on the estimated amount calculated from that time on previous days, and also gave correction doses of insulin or glucagon based on manually entered fingerstick plasma glucose data.

During the control period, adults lived at home as usual, managing their diabetes with their own insulin pump, the investigators said. They wore the G4 Platinum monitor with alarms deactivated and the blood glucose level masked, kept diaries of exercise, hypoglycemic episodes, and carbohydrate interventions, received a food allowance, and were encouraged to eat at restaurants. Adolescents lived at the diabetes summer camp alongside teenagers who were not part of the study, and also wore the masked device during the control period, said Dr. Russell and his associates.

In addition to the difference in mean glucose levels, adults had 67% less time with low glucose readings on the bionic pancreas than on the insulin pump (4.1% vs. 7.3% of the time), the researchers said. Adolescents had a 50% decrease in the amount of carbohydrates given to treat hypoglycemia, but no significant difference in amount of time with low glucose readings, which the researcher said might be because the summer camp rapidly responded to hypoglycemic episodes.

Adults had no severe hypoglycemic events, but during the bionic pancreas period, two had nausea and one vomited within 2 hours after a glucagon dose, and four had infusion sets removed because of pain or swelling, said the investigators. Adolescents had no severe hypoglycemia during the bionic pancreas period, they said, but during the control period, one patient became confused and hypoglycemic.

The slow absorption of available rapid-acting subcutaneous insulin analogues and the poor stability of current glucagon formulations are challenges in designing these devices, according to Dr. Russell and associates. "Since a single device that integrates all the components of a bionic pancreas is not yet available, we had to rely on wireless connectivity to the insulin and glucagon pumps, which was not completely reliable," they wrote, adding that the device could overestimate blood glucose level if patients take acetaminophen. "The balance of risks and benefits associated with delivering more insulin to achieve more physiologic glycemic control will require further study," they added, noting that the long-term safety of small peripheral doses of glucagon also is unknown.

The National Institute of Diabetes and Digestive and Kidney Diseases, the Leona M. and Harry B. Helmsley Charitable Trust, the Earle Charlton Fund for Innovative Research in Diabetes, the Frederick Banting Foundation, and Ralph Faber and John Whitlock funded the study. Three authors have patents or pending patents for blood glucose control systems. Dr. Russell and one co-author reported receiving fees from Medtronic, Tandem Diabetes, Sanofi Aventis, Eli Lilly, Abbott Diabetes Care, Biodel, and Dexcom.

A bionic insulin-glucagon pancreas achieved significantly better glycemic control than insulin pump therapy in adults and adolescents with type 1 diabetes, researchers reported at the annual scientific sessions of the American Diabetes Association.

The testing conditions in the two 5-day random-order crossover studies "simulated real-world outpatient settings with close monitoring for safety in adults and adolescents. Meals and physical activity were not regulated, in contrast with previous studies," wrote Dr. Stephen Russell at Massachusetts General Hospital and Harvard Medical School in Boston and his associates in a report published simultaneously with the presentation (N. Engl. J. Med. 2014 June 15 [doi: 10.1056/NEJMoa1314474]).

Adults achieved significantly lower mean plasma glucose levels during the bionic-pancreas period compared with the control period (7.4 vs. 8.8 mg/dL), as did adolescents (7.7 vs. 8.7 mg/dL), the investigators said. And differences were significant even though about 75% of patients had better baseline glycemic control than national averages, they said.

The studies included 20 adults from the Beacon Hill Study and 32 adolescents from the Summer Camp Study, said investigators. The bionic pancreas device included an Apple iPhone 4S, whose control algorithm received continuous glucose monitoring data and triggered dosing every 5 minutes, and a G4 Platinum continuous glucose monitor from Dexcom connected to the iPhone by a hardware interface. The device’s user interface showed continuous glucose readings and insulin and glucagon doses, and enabled the wearer to record meal sizes as typical, more than usual, less than usual, or a "small bite." Based on meal size, the device adapted the insulin dose to meet 75% of the estimated 4-hour postprandial need. If the glucose sensor failed, the device automatically delivered insulin based on the estimated amount calculated from that time on previous days, and also gave correction doses of insulin or glucagon based on manually entered fingerstick plasma glucose data.

During the control period, adults lived at home as usual, managing their diabetes with their own insulin pump, the investigators said. They wore the G4 Platinum monitor with alarms deactivated and the blood glucose level masked, kept diaries of exercise, hypoglycemic episodes, and carbohydrate interventions, received a food allowance, and were encouraged to eat at restaurants. Adolescents lived at the diabetes summer camp alongside teenagers who were not part of the study, and also wore the masked device during the control period, said Dr. Russell and his associates.

In addition to the difference in mean glucose levels, adults had 67% less time with low glucose readings on the bionic pancreas than on the insulin pump (4.1% vs. 7.3% of the time), the researchers said. Adolescents had a 50% decrease in the amount of carbohydrates given to treat hypoglycemia, but no significant difference in amount of time with low glucose readings, which the researcher said might be because the summer camp rapidly responded to hypoglycemic episodes.

Adults had no severe hypoglycemic events, but during the bionic pancreas period, two had nausea and one vomited within 2 hours after a glucagon dose, and four had infusion sets removed because of pain or swelling, said the investigators. Adolescents had no severe hypoglycemia during the bionic pancreas period, they said, but during the control period, one patient became confused and hypoglycemic.

The slow absorption of available rapid-acting subcutaneous insulin analogues and the poor stability of current glucagon formulations are challenges in designing these devices, according to Dr. Russell and associates. "Since a single device that integrates all the components of a bionic pancreas is not yet available, we had to rely on wireless connectivity to the insulin and glucagon pumps, which was not completely reliable," they wrote, adding that the device could overestimate blood glucose level if patients take acetaminophen. "The balance of risks and benefits associated with delivering more insulin to achieve more physiologic glycemic control will require further study," they added, noting that the long-term safety of small peripheral doses of glucagon also is unknown.

The National Institute of Diabetes and Digestive and Kidney Diseases, the Leona M. and Harry B. Helmsley Charitable Trust, the Earle Charlton Fund for Innovative Research in Diabetes, the Frederick Banting Foundation, and Ralph Faber and John Whitlock funded the study. Three authors have patents or pending patents for blood glucose control systems. Dr. Russell and one co-author reported receiving fees from Medtronic, Tandem Diabetes, Sanofi Aventis, Eli Lilly, Abbott Diabetes Care, Biodel, and Dexcom.