Mary Ann Moon

Endovascular repair of abdominal aortic aneurysms led to lower perioperative mortality than open surgical repair in a large randomized trial, as expected.

However, unlike in earlier studies, this early advantage was not offset by higher rates of late morbidity and mortality during 2 years of follow-up (JAMA 2009;302:1535-42). Two previous European studies showed that reintervention was more frequent with the endovascular approach, so that the early survival advantage it conferred was lost within 2 years of follow-up, said Dr. Frank A. Lederle and his associates in the Open Versus Endovascular Repair (OVER) study group.

The OVER study was undertaken because surgical techniques and devices have improved since the European trials were reported.

Dr. Lederle and his colleagues are performing an ongoing study comparing endovascular against open AAA repair, with the primary outcome of long-term all-cause mortality to be determined in 2011. The current report presents the interim results after 2 years of follow-up.

The 881 patients, aged 49 and older, were treated electively at 42 medical centers by 109 experienced vascular surgeons. A total of 444 patients were randomly assigned to endovascular repair in which an expandable graft system was introduced transluminally. The other 437 patients were assigned to open repair in which a vascular graft was placed anatomically via an abdominal or retroperitoneal incision. Eligible patients had a maximum external AAA diameter of at least 5.0 cm, an associated iliac aneurysm with a maximum diameter of at least 3.0 cm, or a maximum AAA diameter of 4.5 cm plus either rapid enlargement or sacular morphology.

The study subjects were followed in person at 1, 6, and 12 months, and yearly thereafter. They also were followed by phone every month for the first 14 months after the procedure, then annually between study visits, said Dr. Lederle of the Veterans Affairs Medical Center, Minneapolis, and his associates.

Endovascular repair required significantly less procedure time, duration of mechanical ventilation, ICU stay, and hospital stay, and it resulted in less blood loss and fewer transfusion requirements. However, it required substantial exposure to fluoroscopy.

Perioperative mortality was significantly higher with open repair (2.3%) than with endovascular repair (0.2%), as expected. However, unlike in previous studies, all-cause mortality did not increase to a greater degree with endovascular repair over time. There was no significant difference in all-cause mortality between open repair (9.8%) and endovascular repair (7.0%) at 2 years, the investigators said.

There also were no significant differences in procedure failure rates, the need for secondary procedures, aneurysm-related hospitalizations, or major morbidity. These findings remained consistent regardless of patient age and surgical risk status, the diameter of the aneurysm, the presence or absence of coronary artery disease, and the type of graft device used.

In addition, there were no significant differences between the two groups in health-related quality of life or in erectile function. “Erectile dysfunction has been reported to be reduced after endovascular repair compared with open repair, but these data are from nonrandomized retrospective surveys and are subject to recall and response bias,” Dr. Lederle and his associates said.

However, all four late deaths that were related to aneurysm in this study occurred in the endovascular group, they noted.

“Longer-term studies are needed to fully assess the relative merits of the two procedures,” the researchers said.

This study was supported by the U.S. Department of Veterans Affairs. Dr. Lederle reported no financial conflicts of interest. Several of his colleagues reported receiving funding from stent manufacturers.

'Longer-term studies are needed to fully assess the relative merits of the two procedures.'

Source DR. LEDERLE

Endovascular repair of abdominal aortic aneurysms led to lower perioperative mortality than open surgical repair in a large randomized trial, as expected.

However, unlike in earlier studies, this early advantage was not offset by higher rates of late morbidity and mortality during 2 years of follow-up (JAMA 2009;302:1535-42). Two previous European studies showed that reintervention was more frequent with the endovascular approach, so that the early survival advantage it conferred was lost within 2 years of follow-up, said Dr. Frank A. Lederle and his associates in the Open Versus Endovascular Repair (OVER) study group.

The OVER study was undertaken because surgical techniques and devices have improved since the European trials were reported.

Dr. Lederle and his colleagues are performing an ongoing study comparing endovascular against open AAA repair, with the primary outcome of long-term all-cause mortality to be determined in 2011. The current report presents the interim results after 2 years of follow-up.

The 881 patients, aged 49 and older, were treated electively at 42 medical centers by 109 experienced vascular surgeons. A total of 444 patients were randomly assigned to endovascular repair in which an expandable graft system was introduced transluminally. The other 437 patients were assigned to open repair in which a vascular graft was placed anatomically via an abdominal or retroperitoneal incision. Eligible patients had a maximum external AAA diameter of at least 5.0 cm, an associated iliac aneurysm with a maximum diameter of at least 3.0 cm, or a maximum AAA diameter of 4.5 cm plus either rapid enlargement or sacular morphology.

The study subjects were followed in person at 1, 6, and 12 months, and yearly thereafter. They also were followed by phone every month for the first 14 months after the procedure, then annually between study visits, said Dr. Lederle of the Veterans Affairs Medical Center, Minneapolis, and his associates.

Endovascular repair required significantly less procedure time, duration of mechanical ventilation, ICU stay, and hospital stay, and it resulted in less blood loss and fewer transfusion requirements. However, it required substantial exposure to fluoroscopy.

Perioperative mortality was significantly higher with open repair (2.3%) than with endovascular repair (0.2%), as expected. However, unlike in previous studies, all-cause mortality did not increase to a greater degree with endovascular repair over time. There was no significant difference in all-cause mortality between open repair (9.8%) and endovascular repair (7.0%) at 2 years, the investigators said.

There also were no significant differences in procedure failure rates, the need for secondary procedures, aneurysm-related hospitalizations, or major morbidity. These findings remained consistent regardless of patient age and surgical risk status, the diameter of the aneurysm, the presence or absence of coronary artery disease, and the type of graft device used.

In addition, there were no significant differences between the two groups in health-related quality of life or in erectile function. “Erectile dysfunction has been reported to be reduced after endovascular repair compared with open repair, but these data are from nonrandomized retrospective surveys and are subject to recall and response bias,” Dr. Lederle and his associates said.

However, all four late deaths that were related to aneurysm in this study occurred in the endovascular group, they noted.

“Longer-term studies are needed to fully assess the relative merits of the two procedures,” the researchers said.

This study was supported by the U.S. Department of Veterans Affairs. Dr. Lederle reported no financial conflicts of interest. Several of his colleagues reported receiving funding from stent manufacturers.

'Longer-term studies are needed to fully assess the relative merits of the two procedures.'

Source DR. LEDERLE

Endovascular repair of abdominal aortic aneurysms led to lower perioperative mortality than open surgical repair in a large randomized trial, as expected.

However, unlike in earlier studies, this early advantage was not offset by higher rates of late morbidity and mortality during 2 years of follow-up (JAMA 2009;302:1535-42). Two previous European studies showed that reintervention was more frequent with the endovascular approach, so that the early survival advantage it conferred was lost within 2 years of follow-up, said Dr. Frank A. Lederle and his associates in the Open Versus Endovascular Repair (OVER) study group.

The OVER study was undertaken because surgical techniques and devices have improved since the European trials were reported.

Dr. Lederle and his colleagues are performing an ongoing study comparing endovascular against open AAA repair, with the primary outcome of long-term all-cause mortality to be determined in 2011. The current report presents the interim results after 2 years of follow-up.

The 881 patients, aged 49 and older, were treated electively at 42 medical centers by 109 experienced vascular surgeons. A total of 444 patients were randomly assigned to endovascular repair in which an expandable graft system was introduced transluminally. The other 437 patients were assigned to open repair in which a vascular graft was placed anatomically via an abdominal or retroperitoneal incision. Eligible patients had a maximum external AAA diameter of at least 5.0 cm, an associated iliac aneurysm with a maximum diameter of at least 3.0 cm, or a maximum AAA diameter of 4.5 cm plus either rapid enlargement or sacular morphology.

The study subjects were followed in person at 1, 6, and 12 months, and yearly thereafter. They also were followed by phone every month for the first 14 months after the procedure, then annually between study visits, said Dr. Lederle of the Veterans Affairs Medical Center, Minneapolis, and his associates.

Endovascular repair required significantly less procedure time, duration of mechanical ventilation, ICU stay, and hospital stay, and it resulted in less blood loss and fewer transfusion requirements. However, it required substantial exposure to fluoroscopy.

Perioperative mortality was significantly higher with open repair (2.3%) than with endovascular repair (0.2%), as expected. However, unlike in previous studies, all-cause mortality did not increase to a greater degree with endovascular repair over time. There was no significant difference in all-cause mortality between open repair (9.8%) and endovascular repair (7.0%) at 2 years, the investigators said.

There also were no significant differences in procedure failure rates, the need for secondary procedures, aneurysm-related hospitalizations, or major morbidity. These findings remained consistent regardless of patient age and surgical risk status, the diameter of the aneurysm, the presence or absence of coronary artery disease, and the type of graft device used.

In addition, there were no significant differences between the two groups in health-related quality of life or in erectile function. “Erectile dysfunction has been reported to be reduced after endovascular repair compared with open repair, but these data are from nonrandomized retrospective surveys and are subject to recall and response bias,” Dr. Lederle and his associates said.

However, all four late deaths that were related to aneurysm in this study occurred in the endovascular group, they noted.

“Longer-term studies are needed to fully assess the relative merits of the two procedures,” the researchers said.

This study was supported by the U.S. Department of Veterans Affairs. Dr. Lederle reported no financial conflicts of interest. Several of his colleagues reported receiving funding from stent manufacturers.

'Longer-term studies are needed to fully assess the relative merits of the two procedures.'

Source DR. LEDERLE

The most common bariatric surgeries carry low rates of adverse perioperative outcomes when performed by experienced surgeons in established centers, according to a prospective, multicenter, observational study.

Thirty-day mortality was 0.3% and the rate of major complications was 4.1%, which are comparable to rates for other major operations. Those rates are considered low for bariatric surgery, because most patients are extremely obese and have multiple comorbid conditions, said Dr. David R. Flum of the University of Washington, Seattle, and his associates in the Longitudinal Assessment of Bariatric Surgery (LABS) study (N. Engl. J. Med. 2009;361:445–54).

The investigators evaluated 4,776 consecutive patients who underwent first-time bariatric surgery in 2005–2007, performed by 33 surgeons certified by the LABS consortium. “Our study provides standardized, prospective data on a cohort from multiple centers that is large enough to evaluate potential factors associated with safety outcomes,” they noted.

The most common procedure was Roux-en-Y gastric bypass (71% of patients), which was performed laparoscopically in 87% of cases and as an open procedure in 13% of cases. Another 25% of the study subjects underwent laparoscopic adjustable gastric banding, and the remaining 4% underwent other bariatric procedures.

The primary outcome of the study was a composite end point of death, deep-vein thrombosis, venous thromboembolism, reintervention, or failure to be discharged within 30 days. That occurred in 1% of the patients undergoing laparoscopic adjustable gastric banding, 4.8% of those undergoing laparoscopic Roux-en-Y gastric bypass, and 7.8% of those undergoing open Roux-en-Y gastric bypass.

Patients who had a history of thrombotic disorders, had poor functional status, or had sleep apnea were at increased risk of poor outcomes.

“Regardless of the type of procedure, the predicted probability of the composite end point was lowest among patients who did not have a history of deep-vein thrombosis or venous thromboembolism or of obstructive sleep apnea, and who were in the middle range of the spectrum of body mass index for the cohort,” Dr. Flum and his colleagues said.

The researchers added that the study focused on perioperative adverse events. Another study that has just completed recruitment (LABS-2) will assess the long-term effects of bariatric surgery on health conditions, quality of life, health care costs, and psychosocial issues.

Dr. Flum reported receiving grant support from Sanofi-Aventis and Covidien AG and serving as an expert witness on cases involving adverse events after bariatric surgery.

A history of thrombotic disorders, poor functional status, or sleep apnea yielded a risk of poor outcomes.

Source Dr. Flum

The most common bariatric surgeries carry low rates of adverse perioperative outcomes when performed by experienced surgeons in established centers, according to a prospective, multicenter, observational study.

Thirty-day mortality was 0.3% and the rate of major complications was 4.1%, which are comparable to rates for other major operations. Those rates are considered low for bariatric surgery, because most patients are extremely obese and have multiple comorbid conditions, said Dr. David R. Flum of the University of Washington, Seattle, and his associates in the Longitudinal Assessment of Bariatric Surgery (LABS) study (N. Engl. J. Med. 2009;361:445–54).

The investigators evaluated 4,776 consecutive patients who underwent first-time bariatric surgery in 2005–2007, performed by 33 surgeons certified by the LABS consortium. “Our study provides standardized, prospective data on a cohort from multiple centers that is large enough to evaluate potential factors associated with safety outcomes,” they noted.

The most common procedure was Roux-en-Y gastric bypass (71% of patients), which was performed laparoscopically in 87% of cases and as an open procedure in 13% of cases. Another 25% of the study subjects underwent laparoscopic adjustable gastric banding, and the remaining 4% underwent other bariatric procedures.

The primary outcome of the study was a composite end point of death, deep-vein thrombosis, venous thromboembolism, reintervention, or failure to be discharged within 30 days. That occurred in 1% of the patients undergoing laparoscopic adjustable gastric banding, 4.8% of those undergoing laparoscopic Roux-en-Y gastric bypass, and 7.8% of those undergoing open Roux-en-Y gastric bypass.

Patients who had a history of thrombotic disorders, had poor functional status, or had sleep apnea were at increased risk of poor outcomes.

“Regardless of the type of procedure, the predicted probability of the composite end point was lowest among patients who did not have a history of deep-vein thrombosis or venous thromboembolism or of obstructive sleep apnea, and who were in the middle range of the spectrum of body mass index for the cohort,” Dr. Flum and his colleagues said.

The researchers added that the study focused on perioperative adverse events. Another study that has just completed recruitment (LABS-2) will assess the long-term effects of bariatric surgery on health conditions, quality of life, health care costs, and psychosocial issues.

Dr. Flum reported receiving grant support from Sanofi-Aventis and Covidien AG and serving as an expert witness on cases involving adverse events after bariatric surgery.

A history of thrombotic disorders, poor functional status, or sleep apnea yielded a risk of poor outcomes.

Source Dr. Flum

The most common bariatric surgeries carry low rates of adverse perioperative outcomes when performed by experienced surgeons in established centers, according to a prospective, multicenter, observational study.

Thirty-day mortality was 0.3% and the rate of major complications was 4.1%, which are comparable to rates for other major operations. Those rates are considered low for bariatric surgery, because most patients are extremely obese and have multiple comorbid conditions, said Dr. David R. Flum of the University of Washington, Seattle, and his associates in the Longitudinal Assessment of Bariatric Surgery (LABS) study (N. Engl. J. Med. 2009;361:445–54).

The investigators evaluated 4,776 consecutive patients who underwent first-time bariatric surgery in 2005–2007, performed by 33 surgeons certified by the LABS consortium. “Our study provides standardized, prospective data on a cohort from multiple centers that is large enough to evaluate potential factors associated with safety outcomes,” they noted.

The most common procedure was Roux-en-Y gastric bypass (71% of patients), which was performed laparoscopically in 87% of cases and as an open procedure in 13% of cases. Another 25% of the study subjects underwent laparoscopic adjustable gastric banding, and the remaining 4% underwent other bariatric procedures.

The primary outcome of the study was a composite end point of death, deep-vein thrombosis, venous thromboembolism, reintervention, or failure to be discharged within 30 days. That occurred in 1% of the patients undergoing laparoscopic adjustable gastric banding, 4.8% of those undergoing laparoscopic Roux-en-Y gastric bypass, and 7.8% of those undergoing open Roux-en-Y gastric bypass.

Patients who had a history of thrombotic disorders, had poor functional status, or had sleep apnea were at increased risk of poor outcomes.

“Regardless of the type of procedure, the predicted probability of the composite end point was lowest among patients who did not have a history of deep-vein thrombosis or venous thromboembolism or of obstructive sleep apnea, and who were in the middle range of the spectrum of body mass index for the cohort,” Dr. Flum and his colleagues said.

The researchers added that the study focused on perioperative adverse events. Another study that has just completed recruitment (LABS-2) will assess the long-term effects of bariatric surgery on health conditions, quality of life, health care costs, and psychosocial issues.

Dr. Flum reported receiving grant support from Sanofi-Aventis and Covidien AG and serving as an expert witness on cases involving adverse events after bariatric surgery.

A history of thrombotic disorders, poor functional status, or sleep apnea yielded a risk of poor outcomes.

Source Dr. Flum

The risk of death for 1 year after bariatric surgery is significantly higher in patients who are “superobese” and those with a greater burden of preoperative comorbidity than in other patients undergoing the procedure, according to results of a retrospective study.

The findings suggest that bariatric surgery must be considered carefully in patients with body mass indexes of 50 kg/m

To define postsurgical mortality risk and identify associated factors, the researchers performed a retrospective study of 856 patients who underwent bariatric surgery at 12 Veterans Affairs medical centers between 2000 and 2007. The number of these procedures performed at VA centers per year rose more than threefold during this interval Arch. Surg. 2009;144:914–20).

The study population had a mean age of 54 years and was predominantly male (73%) and white (84%). Three-fourths of the procedures were open surgeries; the rest were laparoscopic. About a third (36%) of the patients were considered superobese, with BMIs of 50 or greater.

A total of 54 patients (6.5%) died during a median follow-up of 984 days. Overall, 30-day mortality was 1.3%, 90-day mortality was 2.1%, and 1-year mortality was 3.4%.

Superobese patients had a significantly higher rate of death, particularly at 90 days (3.6%) and at 1 year (5.2%), than did patients with lower BMIs. “Exclusion of superobese patients from our cohort would have reduced the overall 30-day, 90-day, and 1-year mortality rates by approximately one-third,” Dr. Arterburn and his colleagues wrote.

Possible explanations for this result include the greater technical difficulty of the surgery in superobese patients because of added visceral adiposity and hepatomegaly, which in turn increases intra-abdominal pressure and reduces visualization.

Superobese patients also appear to be at greater risk for wound complications such as infections or dehiscence, compared with less obese patients (incidence of wound complications 13.3% vs. 7.2%, respectively).

Patients with multiple or chronic comorbidities also were at greater risk of death in the year following bariatric surgery than were healthier patients. Their 30-day mortality was 1.5%, 90-day mortality was 5.8%, and 1-year mortality was 10.1%. Excluding patients with a diagnostic cost group score of 2 or more—a marker of health care utilization during the past year—from this cohort would have reduced the 90-day and 1-year mortality rates by approximately 20%, the investigators said.

Future research should compare the mortality risk of no surgery with that of bariatric surgery in superobese patients and in those with significant comorbidities, they added.

In an invited critique, Dr. Clifford W. Deveney of Oregon Health and Science University, Portland, noted that among study subjects who were superobese and had multiple concomitant disorders, 25% died during 3 years of follow-up. The study thus may have identified a subgroup of patients “in whom bariatric surgery may not offer a survival advantage,” he said (Arch. Surg. 2009;144:920).

This study was supported by the Department of Veterans Affairs. Neither Dr. Arterburn nor Dr. Deveney reported any financial conflict of interest.

The risk of death for 1 year after bariatric surgery is significantly higher in patients who are “superobese” and those with a greater burden of preoperative comorbidity than in other patients undergoing the procedure, according to results of a retrospective study.

The findings suggest that bariatric surgery must be considered carefully in patients with body mass indexes of 50 kg/m

To define postsurgical mortality risk and identify associated factors, the researchers performed a retrospective study of 856 patients who underwent bariatric surgery at 12 Veterans Affairs medical centers between 2000 and 2007. The number of these procedures performed at VA centers per year rose more than threefold during this interval Arch. Surg. 2009;144:914–20).

The study population had a mean age of 54 years and was predominantly male (73%) and white (84%). Three-fourths of the procedures were open surgeries; the rest were laparoscopic. About a third (36%) of the patients were considered superobese, with BMIs of 50 or greater.

A total of 54 patients (6.5%) died during a median follow-up of 984 days. Overall, 30-day mortality was 1.3%, 90-day mortality was 2.1%, and 1-year mortality was 3.4%.

Superobese patients had a significantly higher rate of death, particularly at 90 days (3.6%) and at 1 year (5.2%), than did patients with lower BMIs. “Exclusion of superobese patients from our cohort would have reduced the overall 30-day, 90-day, and 1-year mortality rates by approximately one-third,” Dr. Arterburn and his colleagues wrote.

Possible explanations for this result include the greater technical difficulty of the surgery in superobese patients because of added visceral adiposity and hepatomegaly, which in turn increases intra-abdominal pressure and reduces visualization.

Superobese patients also appear to be at greater risk for wound complications such as infections or dehiscence, compared with less obese patients (incidence of wound complications 13.3% vs. 7.2%, respectively).

Patients with multiple or chronic comorbidities also were at greater risk of death in the year following bariatric surgery than were healthier patients. Their 30-day mortality was 1.5%, 90-day mortality was 5.8%, and 1-year mortality was 10.1%. Excluding patients with a diagnostic cost group score of 2 or more—a marker of health care utilization during the past year—from this cohort would have reduced the 90-day and 1-year mortality rates by approximately 20%, the investigators said.

Future research should compare the mortality risk of no surgery with that of bariatric surgery in superobese patients and in those with significant comorbidities, they added.

In an invited critique, Dr. Clifford W. Deveney of Oregon Health and Science University, Portland, noted that among study subjects who were superobese and had multiple concomitant disorders, 25% died during 3 years of follow-up. The study thus may have identified a subgroup of patients “in whom bariatric surgery may not offer a survival advantage,” he said (Arch. Surg. 2009;144:920).

This study was supported by the Department of Veterans Affairs. Neither Dr. Arterburn nor Dr. Deveney reported any financial conflict of interest.

The risk of death for 1 year after bariatric surgery is significantly higher in patients who are “superobese” and those with a greater burden of preoperative comorbidity than in other patients undergoing the procedure, according to results of a retrospective study.

The findings suggest that bariatric surgery must be considered carefully in patients with body mass indexes of 50 kg/m

To define postsurgical mortality risk and identify associated factors, the researchers performed a retrospective study of 856 patients who underwent bariatric surgery at 12 Veterans Affairs medical centers between 2000 and 2007. The number of these procedures performed at VA centers per year rose more than threefold during this interval Arch. Surg. 2009;144:914–20).

The study population had a mean age of 54 years and was predominantly male (73%) and white (84%). Three-fourths of the procedures were open surgeries; the rest were laparoscopic. About a third (36%) of the patients were considered superobese, with BMIs of 50 or greater.

A total of 54 patients (6.5%) died during a median follow-up of 984 days. Overall, 30-day mortality was 1.3%, 90-day mortality was 2.1%, and 1-year mortality was 3.4%.

Superobese patients had a significantly higher rate of death, particularly at 90 days (3.6%) and at 1 year (5.2%), than did patients with lower BMIs. “Exclusion of superobese patients from our cohort would have reduced the overall 30-day, 90-day, and 1-year mortality rates by approximately one-third,” Dr. Arterburn and his colleagues wrote.

Possible explanations for this result include the greater technical difficulty of the surgery in superobese patients because of added visceral adiposity and hepatomegaly, which in turn increases intra-abdominal pressure and reduces visualization.

Superobese patients also appear to be at greater risk for wound complications such as infections or dehiscence, compared with less obese patients (incidence of wound complications 13.3% vs. 7.2%, respectively).

Patients with multiple or chronic comorbidities also were at greater risk of death in the year following bariatric surgery than were healthier patients. Their 30-day mortality was 1.5%, 90-day mortality was 5.8%, and 1-year mortality was 10.1%. Excluding patients with a diagnostic cost group score of 2 or more—a marker of health care utilization during the past year—from this cohort would have reduced the 90-day and 1-year mortality rates by approximately 20%, the investigators said.

Future research should compare the mortality risk of no surgery with that of bariatric surgery in superobese patients and in those with significant comorbidities, they added.

In an invited critique, Dr. Clifford W. Deveney of Oregon Health and Science University, Portland, noted that among study subjects who were superobese and had multiple concomitant disorders, 25% died during 3 years of follow-up. The study thus may have identified a subgroup of patients “in whom bariatric surgery may not offer a survival advantage,” he said (Arch. Surg. 2009;144:920).

This study was supported by the Department of Veterans Affairs. Neither Dr. Arterburn nor Dr. Deveney reported any financial conflict of interest.

Obstetric residency programs can be ranked according to the complication rates among patients delivered by the programs' graduates, according to a report in JAMA.

Moreover, the difference in maternal complication rates between graduates of the highest-ranked residency programs and graduates of the lowest-ranked programs was deemed relatively large. “A woman choosing an obstetrician who trained at a program in the top tier would face a 10.3% risk of a major complication, compared with 13.6% if she chose an obstetrician trained at a program from the bottom tier,” said Dr. David A. Asch of the Leonard Davis Institute of Health Economics at the University of Pennsylvania, Philadelphia, and his associates.

“These findings provide the first empirical support for widely held intuitions about the clinical implications of variation in medical education,” they added.

The investigators evaluated risk-adjusted rates of maternal complications in 4,906,169 births in New York and Florida between 1992 and 2007 “as measures to judge the quality of care” delivered by 4,124 graduates of 107 U.S. residency programs who attended these births. These residency programs were distributed among 22 states and represented 43% of the 249 currently accredited obstetric residency programs in the United States.

Six categories of complications were assessed individually and in three composites, for a total of nine measures. For vaginal births, lacerations, hemorrhage, and all other maternal complications such as infections and thrombotic events were assessed; for cesarean deliveries, hemorrhage, infection, and all other complications such as operative and thrombotic events were assessed.

The rate of each outcome for each residency program was estimated after the data were adjusted to account for numerous patient, hospital, and physician characteristics.

The complication rates of physicians trained in residency programs in the top quintile were substantially lower (absolute difference, 3.3%) than those of physicians trained in residency programs in the bottom quintile. “In general, the bottom-quintile programs had complication rates approximately one-third higher than those of the top-quintile programs,” Dr. Asch and his colleagues wrote (JAMA 2009;302:1277–83).

The rankings remained consistent when the data were broken down by the nine individual complication measures, suggesting that “these rates may reflect good measures of overall quality” in residency programs, they added.

A separate analysis was performed to examine “whether the estimated program rankings result from differences in a residency program's ability to attract talented residents,” as opposed to its ability to improve residents' skills.

Medical licensure test scores were available for a subset of 74% of the obstetricians in this study. Analysis showed that the caliber of medical students feeding into the residency programs had little effect on outcomes, suggesting that “skills developed during residency training are more important for producing good maternal outcomes than skills developed during medical school, and residency programs differ in skill development,” the investigators said.

“Recently, there has been significant interest within the graduate medical education community to assess the quality of residency training programs based on the academic (board pass rates, research productivity, etc.) and patient care outcomes of program graduates,” said Dr. Diane M. Hartmann, chair of the Council on Resident Education in Obstetrics and Gynecology.

“The academic indicators are relatively easy to compile. Clinical outcomes of program graduates are very difficult to obtain and virtually unavailable to training programs at this time. This study does raise an interesting question about the importance of facilitating a training program's ability to obtain this information and thus assess its own educational quality,” she said in an interview.

“Clinical outcomes of this type could potentially be used to highlight and replicate the components of excellent training environments. Ob.gyn. residency program directors across the country are committed to producing high-quality physicians. I believe that accurate information about the clinical performance of graduates would be a welcome addition to the information they use daily to alter and improve the obstetrical and gynecological training experience,” said Dr. Hartmann, also senior associate dean for graduate medical education and professor of obstetrics and gynecology at the University of Rochester (N.Y.).

This study was limited in that it examined deliveries in only two states, which likely do not represent all residency programs. It also assessed only maternal complications and did not include birth outcomes.

Additionally, this sample included obstetricians who completed residency at many different times. “A hospital's residency program in the 1960s might differ from its program in the 1990s because of different faculty, the evolution of new clinical techniques …, or trends in attracting different trainees,” Dr. Asch and his associates noted.

“Separate from these methodological limitations, stakeholders might object to the interpretation and use of the results,” they wrote.

This study was supported by a grant from the Stemmler Fund of the National Board of Medical Examiners. No financial conflicts of interest were reported.

Obstetric residency programs can be ranked according to the complication rates among patients delivered by the programs' graduates, according to a report in JAMA.

Moreover, the difference in maternal complication rates between graduates of the highest-ranked residency programs and graduates of the lowest-ranked programs was deemed relatively large. “A woman choosing an obstetrician who trained at a program in the top tier would face a 10.3% risk of a major complication, compared with 13.6% if she chose an obstetrician trained at a program from the bottom tier,” said Dr. David A. Asch of the Leonard Davis Institute of Health Economics at the University of Pennsylvania, Philadelphia, and his associates.

“These findings provide the first empirical support for widely held intuitions about the clinical implications of variation in medical education,” they added.

The investigators evaluated risk-adjusted rates of maternal complications in 4,906,169 births in New York and Florida between 1992 and 2007 “as measures to judge the quality of care” delivered by 4,124 graduates of 107 U.S. residency programs who attended these births. These residency programs were distributed among 22 states and represented 43% of the 249 currently accredited obstetric residency programs in the United States.

Six categories of complications were assessed individually and in three composites, for a total of nine measures. For vaginal births, lacerations, hemorrhage, and all other maternal complications such as infections and thrombotic events were assessed; for cesarean deliveries, hemorrhage, infection, and all other complications such as operative and thrombotic events were assessed.

The rate of each outcome for each residency program was estimated after the data were adjusted to account for numerous patient, hospital, and physician characteristics.

The complication rates of physicians trained in residency programs in the top quintile were substantially lower (absolute difference, 3.3%) than those of physicians trained in residency programs in the bottom quintile. “In general, the bottom-quintile programs had complication rates approximately one-third higher than those of the top-quintile programs,” Dr. Asch and his colleagues wrote (JAMA 2009;302:1277–83).

The rankings remained consistent when the data were broken down by the nine individual complication measures, suggesting that “these rates may reflect good measures of overall quality” in residency programs, they added.

A separate analysis was performed to examine “whether the estimated program rankings result from differences in a residency program's ability to attract talented residents,” as opposed to its ability to improve residents' skills.

Medical licensure test scores were available for a subset of 74% of the obstetricians in this study. Analysis showed that the caliber of medical students feeding into the residency programs had little effect on outcomes, suggesting that “skills developed during residency training are more important for producing good maternal outcomes than skills developed during medical school, and residency programs differ in skill development,” the investigators said.

“Recently, there has been significant interest within the graduate medical education community to assess the quality of residency training programs based on the academic (board pass rates, research productivity, etc.) and patient care outcomes of program graduates,” said Dr. Diane M. Hartmann, chair of the Council on Resident Education in Obstetrics and Gynecology.

“The academic indicators are relatively easy to compile. Clinical outcomes of program graduates are very difficult to obtain and virtually unavailable to training programs at this time. This study does raise an interesting question about the importance of facilitating a training program's ability to obtain this information and thus assess its own educational quality,” she said in an interview.

“Clinical outcomes of this type could potentially be used to highlight and replicate the components of excellent training environments. Ob.gyn. residency program directors across the country are committed to producing high-quality physicians. I believe that accurate information about the clinical performance of graduates would be a welcome addition to the information they use daily to alter and improve the obstetrical and gynecological training experience,” said Dr. Hartmann, also senior associate dean for graduate medical education and professor of obstetrics and gynecology at the University of Rochester (N.Y.).

This study was limited in that it examined deliveries in only two states, which likely do not represent all residency programs. It also assessed only maternal complications and did not include birth outcomes.

Additionally, this sample included obstetricians who completed residency at many different times. “A hospital's residency program in the 1960s might differ from its program in the 1990s because of different faculty, the evolution of new clinical techniques …, or trends in attracting different trainees,” Dr. Asch and his associates noted.

“Separate from these methodological limitations, stakeholders might object to the interpretation and use of the results,” they wrote.

This study was supported by a grant from the Stemmler Fund of the National Board of Medical Examiners. No financial conflicts of interest were reported.

Obstetric residency programs can be ranked according to the complication rates among patients delivered by the programs' graduates, according to a report in JAMA.

Moreover, the difference in maternal complication rates between graduates of the highest-ranked residency programs and graduates of the lowest-ranked programs was deemed relatively large. “A woman choosing an obstetrician who trained at a program in the top tier would face a 10.3% risk of a major complication, compared with 13.6% if she chose an obstetrician trained at a program from the bottom tier,” said Dr. David A. Asch of the Leonard Davis Institute of Health Economics at the University of Pennsylvania, Philadelphia, and his associates.

“These findings provide the first empirical support for widely held intuitions about the clinical implications of variation in medical education,” they added.

The investigators evaluated risk-adjusted rates of maternal complications in 4,906,169 births in New York and Florida between 1992 and 2007 “as measures to judge the quality of care” delivered by 4,124 graduates of 107 U.S. residency programs who attended these births. These residency programs were distributed among 22 states and represented 43% of the 249 currently accredited obstetric residency programs in the United States.

Six categories of complications were assessed individually and in three composites, for a total of nine measures. For vaginal births, lacerations, hemorrhage, and all other maternal complications such as infections and thrombotic events were assessed; for cesarean deliveries, hemorrhage, infection, and all other complications such as operative and thrombotic events were assessed.

The rate of each outcome for each residency program was estimated after the data were adjusted to account for numerous patient, hospital, and physician characteristics.

The complication rates of physicians trained in residency programs in the top quintile were substantially lower (absolute difference, 3.3%) than those of physicians trained in residency programs in the bottom quintile. “In general, the bottom-quintile programs had complication rates approximately one-third higher than those of the top-quintile programs,” Dr. Asch and his colleagues wrote (JAMA 2009;302:1277–83).

The rankings remained consistent when the data were broken down by the nine individual complication measures, suggesting that “these rates may reflect good measures of overall quality” in residency programs, they added.

A separate analysis was performed to examine “whether the estimated program rankings result from differences in a residency program's ability to attract talented residents,” as opposed to its ability to improve residents' skills.

Medical licensure test scores were available for a subset of 74% of the obstetricians in this study. Analysis showed that the caliber of medical students feeding into the residency programs had little effect on outcomes, suggesting that “skills developed during residency training are more important for producing good maternal outcomes than skills developed during medical school, and residency programs differ in skill development,” the investigators said.

“Recently, there has been significant interest within the graduate medical education community to assess the quality of residency training programs based on the academic (board pass rates, research productivity, etc.) and patient care outcomes of program graduates,” said Dr. Diane M. Hartmann, chair of the Council on Resident Education in Obstetrics and Gynecology.

“The academic indicators are relatively easy to compile. Clinical outcomes of program graduates are very difficult to obtain and virtually unavailable to training programs at this time. This study does raise an interesting question about the importance of facilitating a training program's ability to obtain this information and thus assess its own educational quality,” she said in an interview.

“Clinical outcomes of this type could potentially be used to highlight and replicate the components of excellent training environments. Ob.gyn. residency program directors across the country are committed to producing high-quality physicians. I believe that accurate information about the clinical performance of graduates would be a welcome addition to the information they use daily to alter and improve the obstetrical and gynecological training experience,” said Dr. Hartmann, also senior associate dean for graduate medical education and professor of obstetrics and gynecology at the University of Rochester (N.Y.).

This study was limited in that it examined deliveries in only two states, which likely do not represent all residency programs. It also assessed only maternal complications and did not include birth outcomes.

Additionally, this sample included obstetricians who completed residency at many different times. “A hospital's residency program in the 1960s might differ from its program in the 1990s because of different faculty, the evolution of new clinical techniques …, or trends in attracting different trainees,” Dr. Asch and his associates noted.

“Separate from these methodological limitations, stakeholders might object to the interpretation and use of the results,” they wrote.

This study was supported by a grant from the Stemmler Fund of the National Board of Medical Examiners. No financial conflicts of interest were reported.

Complication rates for elective surgical procedures were significantly higher when the attending physicians got less than 6 hours of sleep because of working during the previous night, according to a report in JAMA.

There was not a significantly increased rate of complications in the labor and delivery suite under the same conditions, but larger studies are needed in this setting, said Dr. Jeffrey M. Rothschild of Brigham and Women's Hospital, Boston, and his associates (JAMA 2009;302:1565–72).

“These data suggest that attending physicians, like residents and nurses, may be at increased risk of making errors when sleep deprived or working extended shifts,” the investigators noted. “The business as usual of a 'limitless workweek' for attending physicians is not optimal for patient care.”

The 2008 Institute of Medicine report on residents' working hours, which led to restrictions on those hours, “did not comment on attending physician work hour limitations,” and it has not been clear whether older and more experienced attending physicians are more or less able to cope with the physiological effects of fatigue than are residents.

Dr. Rothschild and his colleagues studied the complication rates of 86 attending surgeons and 134 attending ob.gyns. for 1,876 elective procedures they performed after being on duty the previous night. They compared these with complication rates of the same physicians for 7,497 similar control procedures they performed after being off duty the previous night.

Overall, the procedures performed the day after nighttime duty were not associated with significantly increased complication rates, compared with control procedures, the investigators said.

However, there was wide variation in the duration of sleep attending physicians were able to get during on-duty nights. When these data were analyzed further, surgical but not ob.gyn. postnighttime cases after 6 hours or less of sleep showed a substantially elevated rate of complications (6.2%), compared with cases in which sleep exceeded 6 hours (3.4%), they noted.

This difference was primarily a result of a higher complication rate in the operating room (8.5%) than in the labor and delivery suite (3.4%) on the day following nighttime duty with less than 6 hours of sleep.

Moreover, the risk of complications was higher, though not significantly so, for both surgery and ob.gyn. attending physicians who had just completed shifts of 12 hours or more, compared with when they had completed shifts of less than 12 hours.

Thus, both limited sleep and longer work shifts predicted higher complication rates, Dr. Rothschild and his associates said.

Several initiatives could counteract the risks of unsafe levels of fatigue during attending physicians' procedures.

“Large physician groups can avoid scheduling elective procedures following overnight on-call responsibilities or use hospital-based clinicians, such as obstetrical 'laborists' and surgical hospitalists, to cover nighttime emergencies. …

“When possible, adequate backup personnel should be available to relieve physicians who detect impaired performance due to severe fatigue in themselves and others,” the investigators said.

In addition, “attending physicians should consider canceling or postponing elective procedures if they are not alert enough to safely operate,” they said.

This study was supported by a grant from the Rx Foundation, Cambridge, Mass. Dr. Rothschild reported no financial conflicts of interest.

Complication rates for elective surgical procedures were significantly higher when the attending physicians got less than 6 hours of sleep because of working during the previous night, according to a report in JAMA.

There was not a significantly increased rate of complications in the labor and delivery suite under the same conditions, but larger studies are needed in this setting, said Dr. Jeffrey M. Rothschild of Brigham and Women's Hospital, Boston, and his associates (JAMA 2009;302:1565–72).

“These data suggest that attending physicians, like residents and nurses, may be at increased risk of making errors when sleep deprived or working extended shifts,” the investigators noted. “The business as usual of a 'limitless workweek' for attending physicians is not optimal for patient care.”

The 2008 Institute of Medicine report on residents' working hours, which led to restrictions on those hours, “did not comment on attending physician work hour limitations,” and it has not been clear whether older and more experienced attending physicians are more or less able to cope with the physiological effects of fatigue than are residents.

Dr. Rothschild and his colleagues studied the complication rates of 86 attending surgeons and 134 attending ob.gyns. for 1,876 elective procedures they performed after being on duty the previous night. They compared these with complication rates of the same physicians for 7,497 similar control procedures they performed after being off duty the previous night.

Overall, the procedures performed the day after nighttime duty were not associated with significantly increased complication rates, compared with control procedures, the investigators said.

However, there was wide variation in the duration of sleep attending physicians were able to get during on-duty nights. When these data were analyzed further, surgical but not ob.gyn. postnighttime cases after 6 hours or less of sleep showed a substantially elevated rate of complications (6.2%), compared with cases in which sleep exceeded 6 hours (3.4%), they noted.

This difference was primarily a result of a higher complication rate in the operating room (8.5%) than in the labor and delivery suite (3.4%) on the day following nighttime duty with less than 6 hours of sleep.

Moreover, the risk of complications was higher, though not significantly so, for both surgery and ob.gyn. attending physicians who had just completed shifts of 12 hours or more, compared with when they had completed shifts of less than 12 hours.

Thus, both limited sleep and longer work shifts predicted higher complication rates, Dr. Rothschild and his associates said.

Several initiatives could counteract the risks of unsafe levels of fatigue during attending physicians' procedures.

“Large physician groups can avoid scheduling elective procedures following overnight on-call responsibilities or use hospital-based clinicians, such as obstetrical 'laborists' and surgical hospitalists, to cover nighttime emergencies. …

“When possible, adequate backup personnel should be available to relieve physicians who detect impaired performance due to severe fatigue in themselves and others,” the investigators said.

In addition, “attending physicians should consider canceling or postponing elective procedures if they are not alert enough to safely operate,” they said.

This study was supported by a grant from the Rx Foundation, Cambridge, Mass. Dr. Rothschild reported no financial conflicts of interest.

Complication rates for elective surgical procedures were significantly higher when the attending physicians got less than 6 hours of sleep because of working during the previous night, according to a report in JAMA.

There was not a significantly increased rate of complications in the labor and delivery suite under the same conditions, but larger studies are needed in this setting, said Dr. Jeffrey M. Rothschild of Brigham and Women's Hospital, Boston, and his associates (JAMA 2009;302:1565–72).

“These data suggest that attending physicians, like residents and nurses, may be at increased risk of making errors when sleep deprived or working extended shifts,” the investigators noted. “The business as usual of a 'limitless workweek' for attending physicians is not optimal for patient care.”

The 2008 Institute of Medicine report on residents' working hours, which led to restrictions on those hours, “did not comment on attending physician work hour limitations,” and it has not been clear whether older and more experienced attending physicians are more or less able to cope with the physiological effects of fatigue than are residents.

Dr. Rothschild and his colleagues studied the complication rates of 86 attending surgeons and 134 attending ob.gyns. for 1,876 elective procedures they performed after being on duty the previous night. They compared these with complication rates of the same physicians for 7,497 similar control procedures they performed after being off duty the previous night.

Overall, the procedures performed the day after nighttime duty were not associated with significantly increased complication rates, compared with control procedures, the investigators said.

However, there was wide variation in the duration of sleep attending physicians were able to get during on-duty nights. When these data were analyzed further, surgical but not ob.gyn. postnighttime cases after 6 hours or less of sleep showed a substantially elevated rate of complications (6.2%), compared with cases in which sleep exceeded 6 hours (3.4%), they noted.

This difference was primarily a result of a higher complication rate in the operating room (8.5%) than in the labor and delivery suite (3.4%) on the day following nighttime duty with less than 6 hours of sleep.

Moreover, the risk of complications was higher, though not significantly so, for both surgery and ob.gyn. attending physicians who had just completed shifts of 12 hours or more, compared with when they had completed shifts of less than 12 hours.

Thus, both limited sleep and longer work shifts predicted higher complication rates, Dr. Rothschild and his associates said.

Several initiatives could counteract the risks of unsafe levels of fatigue during attending physicians' procedures.

“Large physician groups can avoid scheduling elective procedures following overnight on-call responsibilities or use hospital-based clinicians, such as obstetrical 'laborists' and surgical hospitalists, to cover nighttime emergencies. …

“When possible, adequate backup personnel should be available to relieve physicians who detect impaired performance due to severe fatigue in themselves and others,” the investigators said.

In addition, “attending physicians should consider canceling or postponing elective procedures if they are not alert enough to safely operate,” they said.

This study was supported by a grant from the Rx Foundation, Cambridge, Mass. Dr. Rothschild reported no financial conflicts of interest.

Uterosacral nerve ablation via laparoscopy failed to improve chronic pelvic pain, dysmenorrhea, dyspareunia, and quality of life in a clinical trial four times larger than any previously published study of the issue, according to a report in JAMA.

Laparoscopic uterosacral nerve ablation (LUNA), using either lasers or electrodiathermy, has become increasingly popular for chronic pelvic pain, even though systematic reviews of the evidence have been “inconclusive” as to the procedure's benefit. “Clinicians' beliefs about LUNA's effectiveness vary widely, and LUNA remains a controversial procedure,” reported Jane Daniels of Birmingham (Ungland) Women's Hospital, and her associates.

The investigators performed a randomized study of 487 women with chronic pelvic pain undergoing laparoscopy for a differential diagnosis at 18 British hospitals. Intraoperatively, the women were assigned to undergo immediate LUNA or no nerve ablation. The women were blinded to their treatment assignment.

“The ablation was performed as close to the posterior aspect of the cervix as possible and continued for a minimum of 1 cm posterolaterally on either side with the intended aim of destroying the sensory nerve fibers and the secondary ganglia as they left the uterus and lie within the uterosacral ligaments,” Ms. Daniels and her colleagues noted. “Full or partial transaction of the ligaments was achieved bilaterally with laser or electrodiathermy, according to the surgeon's preference.”

Median follow-up was 69 months. The patients assessed their pain and health-related quality of life at 3 and 6 months, and 1, 2, 3, and 5 years post procedure.

The investigators found no differences between women who had LUNA and those who did not in terms of severity of chronic pelvic pain, dysmenorrhea, or dyspareunia at any of those time points, Ms. Daniels and her colleagues reported (JAMA 2009;302:955–61).

There also was no difference in health-related quality of life. One year after the procedure, the two groups reported a similar number of visits to their general practitioners and a similar number of days off from work.

There were eight cases of minor hemorrhaging during the LUNA procedure and one case that required conversion to an open surgery.

The investigators reported no financial conflicts of interest.

Uterosacral nerve ablation via laparoscopy failed to improve chronic pelvic pain, dysmenorrhea, dyspareunia, and quality of life in a clinical trial four times larger than any previously published study of the issue, according to a report in JAMA.

Laparoscopic uterosacral nerve ablation (LUNA), using either lasers or electrodiathermy, has become increasingly popular for chronic pelvic pain, even though systematic reviews of the evidence have been “inconclusive” as to the procedure's benefit. “Clinicians' beliefs about LUNA's effectiveness vary widely, and LUNA remains a controversial procedure,” reported Jane Daniels of Birmingham (Ungland) Women's Hospital, and her associates.

The investigators performed a randomized study of 487 women with chronic pelvic pain undergoing laparoscopy for a differential diagnosis at 18 British hospitals. Intraoperatively, the women were assigned to undergo immediate LUNA or no nerve ablation. The women were blinded to their treatment assignment.

“The ablation was performed as close to the posterior aspect of the cervix as possible and continued for a minimum of 1 cm posterolaterally on either side with the intended aim of destroying the sensory nerve fibers and the secondary ganglia as they left the uterus and lie within the uterosacral ligaments,” Ms. Daniels and her colleagues noted. “Full or partial transaction of the ligaments was achieved bilaterally with laser or electrodiathermy, according to the surgeon's preference.”

Median follow-up was 69 months. The patients assessed their pain and health-related quality of life at 3 and 6 months, and 1, 2, 3, and 5 years post procedure.

The investigators found no differences between women who had LUNA and those who did not in terms of severity of chronic pelvic pain, dysmenorrhea, or dyspareunia at any of those time points, Ms. Daniels and her colleagues reported (JAMA 2009;302:955–61).

There also was no difference in health-related quality of life. One year after the procedure, the two groups reported a similar number of visits to their general practitioners and a similar number of days off from work.

There were eight cases of minor hemorrhaging during the LUNA procedure and one case that required conversion to an open surgery.

The investigators reported no financial conflicts of interest.

Uterosacral nerve ablation via laparoscopy failed to improve chronic pelvic pain, dysmenorrhea, dyspareunia, and quality of life in a clinical trial four times larger than any previously published study of the issue, according to a report in JAMA.

Laparoscopic uterosacral nerve ablation (LUNA), using either lasers or electrodiathermy, has become increasingly popular for chronic pelvic pain, even though systematic reviews of the evidence have been “inconclusive” as to the procedure's benefit. “Clinicians' beliefs about LUNA's effectiveness vary widely, and LUNA remains a controversial procedure,” reported Jane Daniels of Birmingham (Ungland) Women's Hospital, and her associates.

The investigators performed a randomized study of 487 women with chronic pelvic pain undergoing laparoscopy for a differential diagnosis at 18 British hospitals. Intraoperatively, the women were assigned to undergo immediate LUNA or no nerve ablation. The women were blinded to their treatment assignment.

“The ablation was performed as close to the posterior aspect of the cervix as possible and continued for a minimum of 1 cm posterolaterally on either side with the intended aim of destroying the sensory nerve fibers and the secondary ganglia as they left the uterus and lie within the uterosacral ligaments,” Ms. Daniels and her colleagues noted. “Full or partial transaction of the ligaments was achieved bilaterally with laser or electrodiathermy, according to the surgeon's preference.”

Median follow-up was 69 months. The patients assessed their pain and health-related quality of life at 3 and 6 months, and 1, 2, 3, and 5 years post procedure.

The investigators found no differences between women who had LUNA and those who did not in terms of severity of chronic pelvic pain, dysmenorrhea, or dyspareunia at any of those time points, Ms. Daniels and her colleagues reported (JAMA 2009;302:955–61).

There also was no difference in health-related quality of life. One year after the procedure, the two groups reported a similar number of visits to their general practitioners and a similar number of days off from work.

There were eight cases of minor hemorrhaging during the LUNA procedure and one case that required conversion to an open surgery.

The investigators reported no financial conflicts of interest.

Minimally invasive synthetic suburethral sling operations appear to be as effective as traditional suburethral slings for stress urinary incontinence, while requiring shorter operating time and producing less postsurgical voiding dysfunction and fewer de novo urgency symptoms, according to a Cochrane review published online.

In a review of 62 randomized clinical trials involving 7,101 women, minimally invasive synthetic slings were as effective as many other surgical treatments in the short term and now can be considered first-line surgery for stress urinary incontinence. However, there is little information about long-term efficacy and adverse effects as yet, noted Dr. Joseph Ogah of Leeds (England) University Teaching Hospital and his associates.

Until recently, open retropubic colposuspension had been considered the accepted standard of surgical treatment for the disorder, but it is gradually being supplanted by minimally invasive procedures in developed nations, they noted (Cochrane Database Syst Rev. 2009 [doi:10.1002/14651858.CD006375.pub2]).

Dr. Ogah and his colleagues found that the quality of evidence was only moderate for most of the clinical trials they reviewed.

Short-term effectiveness was comparable between open retropubic colposuspension (82%) and minimally invasive slings (79%), but there were fewer perioperative complications and less voiding dysfunction with the latter, as well as shorter operating times and hospital stays.

Quality-of-life scores were significantly better after the minimally invasive surgery than after open retropubic colposuspension. However, one complication—bladder perforation—was more common with the minimally invasive procedure (6%) than with the traditional procedure (1%).

The evidence comparing minimally invasive slings with laparoscopic colposuspension was conflicting, favoring one procedure in some cases and the other procedure in other cases. “Women who had minimally invasive synthetic suburethral sling operations had significantly less de novo urgency and urgency incontinence, and shorter operating time, hospital stay, and return to daily activities. Both procedures led to improvement of quality of life after surgery, but with no significant differences between the groups,” Dr. Ogah and his associates wrote.

A retropubic bottom-to-top route was found to be more effective than a top-to-bottom route, with less voiding dysfunction, fewer bladder perforations, and fewer tape erosions.

The retropubic route (88% cure rate) was more favorable than the obturator route (84% cure rate). The retropubic route also was associated with less voiding dysfunction, blood loss, and bladder perforation. However, patients' assessments of the success of their surgery were no different between these two approaches.

The investigators cautioned that a review of this nature could not detect major complications because such outcomes are “uncommon and unlikely to be picked up by small randomized clinical trials.”

In this review, the number of adverse events was generally low and they were rarely serious.

“It may be that rare but major complications will still be identified” as the use of the minimally invasive operations increases, they added.

Along with the “variable quality of many trials,” the researchers wrote, a major limitation of the findings is that long-term follow-up data for the effectiveness of many of these procedures are lacking.

Dr. Ogah reported no financial conflicts of interest.

Minimally invasive synthetic suburethral sling operations appear to be as effective as traditional suburethral slings for stress urinary incontinence, while requiring shorter operating time and producing less postsurgical voiding dysfunction and fewer de novo urgency symptoms, according to a Cochrane review published online.

In a review of 62 randomized clinical trials involving 7,101 women, minimally invasive synthetic slings were as effective as many other surgical treatments in the short term and now can be considered first-line surgery for stress urinary incontinence. However, there is little information about long-term efficacy and adverse effects as yet, noted Dr. Joseph Ogah of Leeds (England) University Teaching Hospital and his associates.

Until recently, open retropubic colposuspension had been considered the accepted standard of surgical treatment for the disorder, but it is gradually being supplanted by minimally invasive procedures in developed nations, they noted (Cochrane Database Syst Rev. 2009 [doi:10.1002/14651858.CD006375.pub2]).

Dr. Ogah and his colleagues found that the quality of evidence was only moderate for most of the clinical trials they reviewed.

Short-term effectiveness was comparable between open retropubic colposuspension (82%) and minimally invasive slings (79%), but there were fewer perioperative complications and less voiding dysfunction with the latter, as well as shorter operating times and hospital stays.

Quality-of-life scores were significantly better after the minimally invasive surgery than after open retropubic colposuspension. However, one complication—bladder perforation—was more common with the minimally invasive procedure (6%) than with the traditional procedure (1%).

The evidence comparing minimally invasive slings with laparoscopic colposuspension was conflicting, favoring one procedure in some cases and the other procedure in other cases. “Women who had minimally invasive synthetic suburethral sling operations had significantly less de novo urgency and urgency incontinence, and shorter operating time, hospital stay, and return to daily activities. Both procedures led to improvement of quality of life after surgery, but with no significant differences between the groups,” Dr. Ogah and his associates wrote.

A retropubic bottom-to-top route was found to be more effective than a top-to-bottom route, with less voiding dysfunction, fewer bladder perforations, and fewer tape erosions.

The retropubic route (88% cure rate) was more favorable than the obturator route (84% cure rate). The retropubic route also was associated with less voiding dysfunction, blood loss, and bladder perforation. However, patients' assessments of the success of their surgery were no different between these two approaches.

The investigators cautioned that a review of this nature could not detect major complications because such outcomes are “uncommon and unlikely to be picked up by small randomized clinical trials.”

In this review, the number of adverse events was generally low and they were rarely serious.

“It may be that rare but major complications will still be identified” as the use of the minimally invasive operations increases, they added.

Along with the “variable quality of many trials,” the researchers wrote, a major limitation of the findings is that long-term follow-up data for the effectiveness of many of these procedures are lacking.

Dr. Ogah reported no financial conflicts of interest.

Minimally invasive synthetic suburethral sling operations appear to be as effective as traditional suburethral slings for stress urinary incontinence, while requiring shorter operating time and producing less postsurgical voiding dysfunction and fewer de novo urgency symptoms, according to a Cochrane review published online.

In a review of 62 randomized clinical trials involving 7,101 women, minimally invasive synthetic slings were as effective as many other surgical treatments in the short term and now can be considered first-line surgery for stress urinary incontinence. However, there is little information about long-term efficacy and adverse effects as yet, noted Dr. Joseph Ogah of Leeds (England) University Teaching Hospital and his associates.

Until recently, open retropubic colposuspension had been considered the accepted standard of surgical treatment for the disorder, but it is gradually being supplanted by minimally invasive procedures in developed nations, they noted (Cochrane Database Syst Rev. 2009 [doi:10.1002/14651858.CD006375.pub2]).

Dr. Ogah and his colleagues found that the quality of evidence was only moderate for most of the clinical trials they reviewed.

Short-term effectiveness was comparable between open retropubic colposuspension (82%) and minimally invasive slings (79%), but there were fewer perioperative complications and less voiding dysfunction with the latter, as well as shorter operating times and hospital stays.

Quality-of-life scores were significantly better after the minimally invasive surgery than after open retropubic colposuspension. However, one complication—bladder perforation—was more common with the minimally invasive procedure (6%) than with the traditional procedure (1%).

The evidence comparing minimally invasive slings with laparoscopic colposuspension was conflicting, favoring one procedure in some cases and the other procedure in other cases. “Women who had minimally invasive synthetic suburethral sling operations had significantly less de novo urgency and urgency incontinence, and shorter operating time, hospital stay, and return to daily activities. Both procedures led to improvement of quality of life after surgery, but with no significant differences between the groups,” Dr. Ogah and his associates wrote.

A retropubic bottom-to-top route was found to be more effective than a top-to-bottom route, with less voiding dysfunction, fewer bladder perforations, and fewer tape erosions.

The retropubic route (88% cure rate) was more favorable than the obturator route (84% cure rate). The retropubic route also was associated with less voiding dysfunction, blood loss, and bladder perforation. However, patients' assessments of the success of their surgery were no different between these two approaches.

The investigators cautioned that a review of this nature could not detect major complications because such outcomes are “uncommon and unlikely to be picked up by small randomized clinical trials.”

In this review, the number of adverse events was generally low and they were rarely serious.

“It may be that rare but major complications will still be identified” as the use of the minimally invasive operations increases, they added.

Along with the “variable quality of many trials,” the researchers wrote, a major limitation of the findings is that long-term follow-up data for the effectiveness of many of these procedures are lacking.

Dr. Ogah reported no financial conflicts of interest.

Treating mild gestational diabetes lowered the risks of fetal overgrowth, shoulder dystocia, cesarean delivery, and gestational hypertension, as well as decreasing maternal weight gain, based on a study of almost 1,000 women.

However, treating mild gestational diabetes did not improve the composite primary outcome of neonatal mortality, hypoglycemia, hyperbilirubinemia, hyperinsulinemia, and birth trauma in a multicenter, randomized clinical trial designed to establish whether such treatment reduced perinatal and obstetric complications.

“The findings from our trial confirm a modest benefit from the identification and treatment of women with mild carbohydrate intolerance during pregnancy,” said Dr. Mark B. Landon and his associates in the National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network.

The investigators assessed 958 women who had mild gestational diabetes—defined as a fasting glucose level of less than 95 mg/dL plus two to three timed glucose measurements that exceeded established thresholds—between 24 and 31 weeks' gestation. A total of 473 were randomly assigned to receive standard prenatal care and 485 to receive formal nutritional counseling, diet therapy, and insulin as needed (N. Engl. J. Med. 2009;361:1339–48).

The intervention group performed daily self-monitoring of fasting and postprandial blood glucose levels. The researchers verified compliance with glycemic monitoring and documented that target glucose thresholds were achieved.

There was no difference between the two groups in the primary composite outcome of neonatal death and complications known to be associated with maternal hyperglycemia. Individual rates of these complications (neonatal hypoglycemia, hyperbilirubinemia, birth trauma, and elevated cord-blood C-peptide levels) also did not differ significantly, Dr. Landon of Ohio State University, Columbus, and his colleagues said.

However, the intervention significantly reduced mean birth weight, neonatal fat mass, the rate of large-for-gestational-age infants, and the rate of infants weighing 4,000 g or more.

Cesarean delivery was significantly less frequent in the intervention group (27%) than in the control group (34%), as were shoulder dystocia, gestational hypertension, and preeclampsia.

Moreover, both maternal body mass index at delivery and maternal weight gain during pregnancy were lower in the intervention group than in controls.

“Increased birth weight and neonatal fat mass may have long-term health implications for the offspring of mothers with gestational diabetes mellitus, including an increased risk of impaired glucose tolerance and childhood obesity. Long-term follow-up studies are needed to determine whether treatment of gestational diabetes mellitus can reduce the risk of these complications,” Dr. Landon and his associates wrote.

In the meantime, these study findings “provide further compelling evidence that among women who have gestational diabetes mellitus and normal fasting glucose levels, treatment that includes dietary intervention and insulin therapy, as necessary, reduces rates of fetal overgrowth, cesarean delivery, and preeclampsia,” they said.

This study was supported by grants from the National Institute of Child Health and Human Development, the General Clinical Research Centers, and the National Center for Research Resources. No financial conflicts of interest were reported.

Treating mild gestational diabetes lowered the risks of fetal overgrowth, shoulder dystocia, cesarean delivery, and gestational hypertension, as well as decreasing maternal weight gain, based on a study of almost 1,000 women.

However, treating mild gestational diabetes did not improve the composite primary outcome of neonatal mortality, hypoglycemia, hyperbilirubinemia, hyperinsulinemia, and birth trauma in a multicenter, randomized clinical trial designed to establish whether such treatment reduced perinatal and obstetric complications.

“The findings from our trial confirm a modest benefit from the identification and treatment of women with mild carbohydrate intolerance during pregnancy,” said Dr. Mark B. Landon and his associates in the National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network.

The investigators assessed 958 women who had mild gestational diabetes—defined as a fasting glucose level of less than 95 mg/dL plus two to three timed glucose measurements that exceeded established thresholds—between 24 and 31 weeks' gestation. A total of 473 were randomly assigned to receive standard prenatal care and 485 to receive formal nutritional counseling, diet therapy, and insulin as needed (N. Engl. J. Med. 2009;361:1339–48).

The intervention group performed daily self-monitoring of fasting and postprandial blood glucose levels. The researchers verified compliance with glycemic monitoring and documented that target glucose thresholds were achieved.

There was no difference between the two groups in the primary composite outcome of neonatal death and complications known to be associated with maternal hyperglycemia. Individual rates of these complications (neonatal hypoglycemia, hyperbilirubinemia, birth trauma, and elevated cord-blood C-peptide levels) also did not differ significantly, Dr. Landon of Ohio State University, Columbus, and his colleagues said.

However, the intervention significantly reduced mean birth weight, neonatal fat mass, the rate of large-for-gestational-age infants, and the rate of infants weighing 4,000 g or more.

Cesarean delivery was significantly less frequent in the intervention group (27%) than in the control group (34%), as were shoulder dystocia, gestational hypertension, and preeclampsia.

Moreover, both maternal body mass index at delivery and maternal weight gain during pregnancy were lower in the intervention group than in controls.

“Increased birth weight and neonatal fat mass may have long-term health implications for the offspring of mothers with gestational diabetes mellitus, including an increased risk of impaired glucose tolerance and childhood obesity. Long-term follow-up studies are needed to determine whether treatment of gestational diabetes mellitus can reduce the risk of these complications,” Dr. Landon and his associates wrote.

In the meantime, these study findings “provide further compelling evidence that among women who have gestational diabetes mellitus and normal fasting glucose levels, treatment that includes dietary intervention and insulin therapy, as necessary, reduces rates of fetal overgrowth, cesarean delivery, and preeclampsia,” they said.

This study was supported by grants from the National Institute of Child Health and Human Development, the General Clinical Research Centers, and the National Center for Research Resources. No financial conflicts of interest were reported.

Treating mild gestational diabetes lowered the risks of fetal overgrowth, shoulder dystocia, cesarean delivery, and gestational hypertension, as well as decreasing maternal weight gain, based on a study of almost 1,000 women.

However, treating mild gestational diabetes did not improve the composite primary outcome of neonatal mortality, hypoglycemia, hyperbilirubinemia, hyperinsulinemia, and birth trauma in a multicenter, randomized clinical trial designed to establish whether such treatment reduced perinatal and obstetric complications.

“The findings from our trial confirm a modest benefit from the identification and treatment of women with mild carbohydrate intolerance during pregnancy,” said Dr. Mark B. Landon and his associates in the National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network.

The investigators assessed 958 women who had mild gestational diabetes—defined as a fasting glucose level of less than 95 mg/dL plus two to three timed glucose measurements that exceeded established thresholds—between 24 and 31 weeks' gestation. A total of 473 were randomly assigned to receive standard prenatal care and 485 to receive formal nutritional counseling, diet therapy, and insulin as needed (N. Engl. J. Med. 2009;361:1339–48).

The intervention group performed daily self-monitoring of fasting and postprandial blood glucose levels. The researchers verified compliance with glycemic monitoring and documented that target glucose thresholds were achieved.

There was no difference between the two groups in the primary composite outcome of neonatal death and complications known to be associated with maternal hyperglycemia. Individual rates of these complications (neonatal hypoglycemia, hyperbilirubinemia, birth trauma, and elevated cord-blood C-peptide levels) also did not differ significantly, Dr. Landon of Ohio State University, Columbus, and his colleagues said.

However, the intervention significantly reduced mean birth weight, neonatal fat mass, the rate of large-for-gestational-age infants, and the rate of infants weighing 4,000 g or more.

Cesarean delivery was significantly less frequent in the intervention group (27%) than in the control group (34%), as were shoulder dystocia, gestational hypertension, and preeclampsia.

Moreover, both maternal body mass index at delivery and maternal weight gain during pregnancy were lower in the intervention group than in controls.

“Increased birth weight and neonatal fat mass may have long-term health implications for the offspring of mothers with gestational diabetes mellitus, including an increased risk of impaired glucose tolerance and childhood obesity. Long-term follow-up studies are needed to determine whether treatment of gestational diabetes mellitus can reduce the risk of these complications,” Dr. Landon and his associates wrote.

In the meantime, these study findings “provide further compelling evidence that among women who have gestational diabetes mellitus and normal fasting glucose levels, treatment that includes dietary intervention and insulin therapy, as necessary, reduces rates of fetal overgrowth, cesarean delivery, and preeclampsia,” they said.

This study was supported by grants from the National Institute of Child Health and Human Development, the General Clinical Research Centers, and the National Center for Research Resources. No financial conflicts of interest were reported.

Implantable cardioverter defibrillators do not reduce all-cause mortality in women who have advanced heart failure, unlike in men, according to a meta-analysis.

“ICDs are being implanted in hundreds of thousands of women without substantial evidence of benefit, apparently based on the assumption that, to paraphrase the old saying, 'What's good for the gander is good for the goose,'” Dr. Rita F. Redberg said in an accompanying editorial (Arch. Intern. Med. 2009;169:1460–1).

This finding is particularly concerning because a “recent analysis of the National Cardiovascular Data Registry found that women have a 70% higher risk of major adverse events after ICD implantation than do men,” noted Dr. Redberg, editor of the journal and director of women's cardiovascular services at the University of California, San Francisco.

Dr. Hamid Ghanbari and his associates at Providence Hospital in Southfield, Mich., pooled data from five randomized, controlled clinical trials that compared ICD implantation with medical therapy and included 934 women along with 3,810 men. Men who had heart failure with reduced left ventricular ejection fraction showed a significant decrease in all-cause mortality when they were given an ICD rather than medical therapy to prevent sudden cardiac death.

In contrast, women did not show a mortality benefit, either in the combined data or in any of the five individual trials, Dr. Ghanbari and his colleagues said (Arch. Intern. Med. 2009;169:1500–6).

Neither Dr. Ghanbari nor Dr. Redberg reported any financial conflicts of interest.

Implantable cardioverter defibrillators do not reduce all-cause mortality in women who have advanced heart failure, unlike in men, according to a meta-analysis.

“ICDs are being implanted in hundreds of thousands of women without substantial evidence of benefit, apparently based on the assumption that, to paraphrase the old saying, 'What's good for the gander is good for the goose,'” Dr. Rita F. Redberg said in an accompanying editorial (Arch. Intern. Med. 2009;169:1460–1).

This finding is particularly concerning because a “recent analysis of the National Cardiovascular Data Registry found that women have a 70% higher risk of major adverse events after ICD implantation than do men,” noted Dr. Redberg, editor of the journal and director of women's cardiovascular services at the University of California, San Francisco.

Dr. Hamid Ghanbari and his associates at Providence Hospital in Southfield, Mich., pooled data from five randomized, controlled clinical trials that compared ICD implantation with medical therapy and included 934 women along with 3,810 men. Men who had heart failure with reduced left ventricular ejection fraction showed a significant decrease in all-cause mortality when they were given an ICD rather than medical therapy to prevent sudden cardiac death.

In contrast, women did not show a mortality benefit, either in the combined data or in any of the five individual trials, Dr. Ghanbari and his colleagues said (Arch. Intern. Med. 2009;169:1500–6).

Neither Dr. Ghanbari nor Dr. Redberg reported any financial conflicts of interest.

Implantable cardioverter defibrillators do not reduce all-cause mortality in women who have advanced heart failure, unlike in men, according to a meta-analysis.

“ICDs are being implanted in hundreds of thousands of women without substantial evidence of benefit, apparently based on the assumption that, to paraphrase the old saying, 'What's good for the gander is good for the goose,'” Dr. Rita F. Redberg said in an accompanying editorial (Arch. Intern. Med. 2009;169:1460–1).

This finding is particularly concerning because a “recent analysis of the National Cardiovascular Data Registry found that women have a 70% higher risk of major adverse events after ICD implantation than do men,” noted Dr. Redberg, editor of the journal and director of women's cardiovascular services at the University of California, San Francisco.

Dr. Hamid Ghanbari and his associates at Providence Hospital in Southfield, Mich., pooled data from five randomized, controlled clinical trials that compared ICD implantation with medical therapy and included 934 women along with 3,810 men. Men who had heart failure with reduced left ventricular ejection fraction showed a significant decrease in all-cause mortality when they were given an ICD rather than medical therapy to prevent sudden cardiac death.

In contrast, women did not show a mortality benefit, either in the combined data or in any of the five individual trials, Dr. Ghanbari and his colleagues said (Arch. Intern. Med. 2009;169:1500–6).

Neither Dr. Ghanbari nor Dr. Redberg reported any financial conflicts of interest.

Long-term, low-dose trimethoprim-sulfamethoxazole “modestly” decreases the number of urinary tract infections in predisposed children.

However, it remains unknown whether this effect translates into preventing kidney damage from pyelonephritis, and “the magnitude of the benefit is likely to be small at best,” said Dr. Jonathan C. Craig of the University of Sydney and his associates.

The prophylactic use of antibiotics in this patient population is widespread but also has been widely questioned, “since adequately powered and well-designed, placebo-controlled trials … are lacking.” Dr. Craig and his colleagues conducted the Prevention of Recurrent Urinary Tract Infection in Children With Vesicoureteric Reflux and Normal Renal Tracts (PRIVENT) trial to determine whether the treatment is effective (N. Engl. J. Med. 2009;361:1748–59).

They assessed 576 children who had had at least one symptomatic UTI and were treated at four medical centers in Australia. Equal numbers of the study subjects were randomly assigned to receive either daily trimethoprim-sulfamethoxazole or a placebo matched for taste, color, and texture; they were followed at 3-month intervals for 1 year. The median age was 14 months. Most of the subjects were girls (64%), and 42% had known vesicoureteral reflux.

Recurrent UTI, the primary outcome measure, developed in 13% of the antibiotic group and 19% of the placebo group. “At 12 months, 14 patients would need to have been treated to prevent one UTI,” they said. Similarly, urinary tract infection with fever developed in 7% of the antibiotic group and 13% of the placebo group.

However, “any benefits of long-term antibiotic use in reducing the risk of new kidney damage from pyelonephritis remain speculative, since our study was not powered to analyze this outcome,” they noted. The rate of adverse events was not significantly different between the two groups.

Overall, the findings indicate that in children who have had a single UTI, “prophylaxis with trimethoprim-sulfamethoxazole should be considered but not routinely recommended,” Dr. Craig and his associates wrote.

In an editorial comment, Dr. Alejandro Hoberman of Children's Hospital of Pittsburgh and Dr. Ron Keren of Children's Hospital of Philadelphia said that recent smaller clinical trials, which demonstrated no benefit from antibiotic prophylaxis, “led some clinicians to become skeptical about the role of prophylaxis or the need to evaluate children with recurrent UTI for vesicoureteral reflux.” However, these trials were insufficiently powered and were otherwise flawed in their methodology to offer definitive conclusions, they said (N. Engl. J. Med. 2009;361:1804–6).

In contrast, Dr. Craig and his colleagues have established that antibiotic prophylaxis has a “modest but significant” preventive effect. Ongoing trials in Sweden and the United States may determine whether this benefit also prevents actual kidney damage. Until then, “early diagnosis and treatment of UTI and treatment of dysfunctional voiding, which predisposes many children to UTI, are likely to go a long way toward preventing long-term renal damage,” wrote Dr. Hoberman and Dr. Keren.

This study was funded by the National Health and Medical Research Council of Australia and the Financial Markets Foundation for Children of Australia. Dr. Craig, Dr. Hoberman, and Dr. Keren reported no financial conflicts of interest.

Long-term, low-dose trimethoprim-sulfamethoxazole “modestly” decreases the number of urinary tract infections in predisposed children.

However, it remains unknown whether this effect translates into preventing kidney damage from pyelonephritis, and “the magnitude of the benefit is likely to be small at best,” said Dr. Jonathan C. Craig of the University of Sydney and his associates.

The prophylactic use of antibiotics in this patient population is widespread but also has been widely questioned, “since adequately powered and well-designed, placebo-controlled trials … are lacking.” Dr. Craig and his colleagues conducted the Prevention of Recurrent Urinary Tract Infection in Children With Vesicoureteric Reflux and Normal Renal Tracts (PRIVENT) trial to determine whether the treatment is effective (N. Engl. J. Med. 2009;361:1748–59).

They assessed 576 children who had had at least one symptomatic UTI and were treated at four medical centers in Australia. Equal numbers of the study subjects were randomly assigned to receive either daily trimethoprim-sulfamethoxazole or a placebo matched for taste, color, and texture; they were followed at 3-month intervals for 1 year. The median age was 14 months. Most of the subjects were girls (64%), and 42% had known vesicoureteral reflux.

Recurrent UTI, the primary outcome measure, developed in 13% of the antibiotic group and 19% of the placebo group. “At 12 months, 14 patients would need to have been treated to prevent one UTI,” they said. Similarly, urinary tract infection with fever developed in 7% of the antibiotic group and 13% of the placebo group.

However, “any benefits of long-term antibiotic use in reducing the risk of new kidney damage from pyelonephritis remain speculative, since our study was not powered to analyze this outcome,” they noted. The rate of adverse events was not significantly different between the two groups.

Overall, the findings indicate that in children who have had a single UTI, “prophylaxis with trimethoprim-sulfamethoxazole should be considered but not routinely recommended,” Dr. Craig and his associates wrote.

In an editorial comment, Dr. Alejandro Hoberman of Children's Hospital of Pittsburgh and Dr. Ron Keren of Children's Hospital of Philadelphia said that recent smaller clinical trials, which demonstrated no benefit from antibiotic prophylaxis, “led some clinicians to become skeptical about the role of prophylaxis or the need to evaluate children with recurrent UTI for vesicoureteral reflux.” However, these trials were insufficiently powered and were otherwise flawed in their methodology to offer definitive conclusions, they said (N. Engl. J. Med. 2009;361:1804–6).

In contrast, Dr. Craig and his colleagues have established that antibiotic prophylaxis has a “modest but significant” preventive effect. Ongoing trials in Sweden and the United States may determine whether this benefit also prevents actual kidney damage. Until then, “early diagnosis and treatment of UTI and treatment of dysfunctional voiding, which predisposes many children to UTI, are likely to go a long way toward preventing long-term renal damage,” wrote Dr. Hoberman and Dr. Keren.

This study was funded by the National Health and Medical Research Council of Australia and the Financial Markets Foundation for Children of Australia. Dr. Craig, Dr. Hoberman, and Dr. Keren reported no financial conflicts of interest.

Long-term, low-dose trimethoprim-sulfamethoxazole “modestly” decreases the number of urinary tract infections in predisposed children.

However, it remains unknown whether this effect translates into preventing kidney damage from pyelonephritis, and “the magnitude of the benefit is likely to be small at best,” said Dr. Jonathan C. Craig of the University of Sydney and his associates.

The prophylactic use of antibiotics in this patient population is widespread but also has been widely questioned, “since adequately powered and well-designed, placebo-controlled trials … are lacking.” Dr. Craig and his colleagues conducted the Prevention of Recurrent Urinary Tract Infection in Children With Vesicoureteric Reflux and Normal Renal Tracts (PRIVENT) trial to determine whether the treatment is effective (N. Engl. J. Med. 2009;361:1748–59).

They assessed 576 children who had had at least one symptomatic UTI and were treated at four medical centers in Australia. Equal numbers of the study subjects were randomly assigned to receive either daily trimethoprim-sulfamethoxazole or a placebo matched for taste, color, and texture; they were followed at 3-month intervals for 1 year. The median age was 14 months. Most of the subjects were girls (64%), and 42% had known vesicoureteral reflux.

Recurrent UTI, the primary outcome measure, developed in 13% of the antibiotic group and 19% of the placebo group. “At 12 months, 14 patients would need to have been treated to prevent one UTI,” they said. Similarly, urinary tract infection with fever developed in 7% of the antibiotic group and 13% of the placebo group.

However, “any benefits of long-term antibiotic use in reducing the risk of new kidney damage from pyelonephritis remain speculative, since our study was not powered to analyze this outcome,” they noted. The rate of adverse events was not significantly different between the two groups.

Overall, the findings indicate that in children who have had a single UTI, “prophylaxis with trimethoprim-sulfamethoxazole should be considered but not routinely recommended,” Dr. Craig and his associates wrote.

In an editorial comment, Dr. Alejandro Hoberman of Children's Hospital of Pittsburgh and Dr. Ron Keren of Children's Hospital of Philadelphia said that recent smaller clinical trials, which demonstrated no benefit from antibiotic prophylaxis, “led some clinicians to become skeptical about the role of prophylaxis or the need to evaluate children with recurrent UTI for vesicoureteral reflux.” However, these trials were insufficiently powered and were otherwise flawed in their methodology to offer definitive conclusions, they said (N. Engl. J. Med. 2009;361:1804–6).

In contrast, Dr. Craig and his colleagues have established that antibiotic prophylaxis has a “modest but significant” preventive effect. Ongoing trials in Sweden and the United States may determine whether this benefit also prevents actual kidney damage. Until then, “early diagnosis and treatment of UTI and treatment of dysfunctional voiding, which predisposes many children to UTI, are likely to go a long way toward preventing long-term renal damage,” wrote Dr. Hoberman and Dr. Keren.

This study was funded by the National Health and Medical Research Council of Australia and the Financial Markets Foundation for Children of Australia. Dr. Craig, Dr. Hoberman, and Dr. Keren reported no financial conflicts of interest.