Gynecology

ORLANDO – Injuring the bladder during a hysterectomy is associated with a greater likelihood of developing a postoperative vesicovaginal fistula, according to a retrospective analysis presented at the annual scientific meeting of the Society of Gynecologic Surgeons.

In data captured from 641,056 hysterectomies performed in California, New York, and Florida in 2005-2010, the odds ratio of a vesicovaginal fistula was nearly 19 times higher if a urinary tract injury was sustained at the time of hysterectomy, a complication that increased in frequency during the 5-year study period, reported Dr. Rony A. Adam, professor of obstetrics and gynecology in the division of female pelvic and reconstructive surgery at Vanderbilt University Medical Center, Nashville, Tenn.

“Although we do not know all the factors that impact formation of vesicovaginal fistula post hysterectomy, it is clear that bladder injury at the time of hysterectomy even when identified and repaired is significantly associated [with this complication],” Dr. Adam reported at the meeting, jointly sponsored by the American College of Surgeons.

The statistical analyses were conducted with the inpatient and ambulatory surgery databases from the Healthcare Cost and Utilization Project (HCUP) for the three states. The large geographically diverse populations were considered by the authors to be nationally representative.

For this analysis, vesicovaginal fistulas and urinary tract injuries were tracked for total abdominal hysterectomy, subtotal abdominal hysterectomy, and total vaginal hysterectomy with or without laparoscopic assistance. Over the 5-year study period, urinary tract injuries climbed steadily in all three groups. When the last year of analysis was compared with the first, a greater increase in odds ratio was observed in the total abdominal group (1.88) than in the subtotal (1.27) or the vaginal (1.26) groups, but each increase was significant.

“The uniformly increasing bladder injury rate may be explained by the increasing cesarean section rates,” according to Dr. Adam, who cited evidence suggesting that cesarean section increases risk of urinary tract injuries in subsequent hysterectomy.

The rate of vesicovaginal fistulas was 21.07 per 1,000 women when a urinary tract injury was incurred during hysterectomy versus 0.95 per 1,000 women when it was not (odds ratio, 18.91). The overall rate of vesicovaginal injury increased in the last year of the study relative to the first (OR, 1.28), although this increase fell just short of statistical significant (P = .059).

“It is possible that surgeons have gotten better at detecting and repairing urinary tract injury, which could explain why the vesicovaginal fistula rate has remained stable in the face of an increasing rate of urinary tract injuries,” Dr. Adam reported.

Not only did the rate of urinary tract injuries climb faster over the study period in those undergoing total abdominal hysterectomy, but also there was a stronger association in patients undergoing this form of hysterectomy between urinary tract injury and vesicovaginal fistula formation, said Dr. Adam. Overall, the OR for vesicovaginal fistula after urinary tract injury was about half as great when either subtotal or vaginal hysterectomy was compared to total abdominal hysterectomy

Although Dr. Adam emphasized that a retrospective study of this type can only establish an association and cannot confirm causation, he said that this study suggests urinary tract injury may be a useful quality-of-care measure for performance of hysterectomy. The SGS-invited discussant Dr. Blair Washington, a urogynecologist at Virginia Mason Hospital and Medical Center, Seattle, agreed.

“Characterizing morbidity associated with hysterectomy is increasingly important as we define benchmarks for quality outcomes in the changing health care economy,” Dr. Washington said. Calling this study “outstanding,” she suggested these data are potentially helpful for counseling patients about risks of hysterectomy, and identifying and evaluating strategies that will help to improve outcomes.

Dr. Adam reported no relevant financial disclosures.

ORLANDO – Injuring the bladder during a hysterectomy is associated with a greater likelihood of developing a postoperative vesicovaginal fistula, according to a retrospective analysis presented at the annual scientific meeting of the Society of Gynecologic Surgeons.

In data captured from 641,056 hysterectomies performed in California, New York, and Florida in 2005-2010, the odds ratio of a vesicovaginal fistula was nearly 19 times higher if a urinary tract injury was sustained at the time of hysterectomy, a complication that increased in frequency during the 5-year study period, reported Dr. Rony A. Adam, professor of obstetrics and gynecology in the division of female pelvic and reconstructive surgery at Vanderbilt University Medical Center, Nashville, Tenn.

“Although we do not know all the factors that impact formation of vesicovaginal fistula post hysterectomy, it is clear that bladder injury at the time of hysterectomy even when identified and repaired is significantly associated [with this complication],” Dr. Adam reported at the meeting, jointly sponsored by the American College of Surgeons.

The statistical analyses were conducted with the inpatient and ambulatory surgery databases from the Healthcare Cost and Utilization Project (HCUP) for the three states. The large geographically diverse populations were considered by the authors to be nationally representative.

For this analysis, vesicovaginal fistulas and urinary tract injuries were tracked for total abdominal hysterectomy, subtotal abdominal hysterectomy, and total vaginal hysterectomy with or without laparoscopic assistance. Over the 5-year study period, urinary tract injuries climbed steadily in all three groups. When the last year of analysis was compared with the first, a greater increase in odds ratio was observed in the total abdominal group (1.88) than in the subtotal (1.27) or the vaginal (1.26) groups, but each increase was significant.

“The uniformly increasing bladder injury rate may be explained by the increasing cesarean section rates,” according to Dr. Adam, who cited evidence suggesting that cesarean section increases risk of urinary tract injuries in subsequent hysterectomy.

The rate of vesicovaginal fistulas was 21.07 per 1,000 women when a urinary tract injury was incurred during hysterectomy versus 0.95 per 1,000 women when it was not (odds ratio, 18.91). The overall rate of vesicovaginal injury increased in the last year of the study relative to the first (OR, 1.28), although this increase fell just short of statistical significant (P = .059).

“It is possible that surgeons have gotten better at detecting and repairing urinary tract injury, which could explain why the vesicovaginal fistula rate has remained stable in the face of an increasing rate of urinary tract injuries,” Dr. Adam reported.

Not only did the rate of urinary tract injuries climb faster over the study period in those undergoing total abdominal hysterectomy, but also there was a stronger association in patients undergoing this form of hysterectomy between urinary tract injury and vesicovaginal fistula formation, said Dr. Adam. Overall, the OR for vesicovaginal fistula after urinary tract injury was about half as great when either subtotal or vaginal hysterectomy was compared to total abdominal hysterectomy

Although Dr. Adam emphasized that a retrospective study of this type can only establish an association and cannot confirm causation, he said that this study suggests urinary tract injury may be a useful quality-of-care measure for performance of hysterectomy. The SGS-invited discussant Dr. Blair Washington, a urogynecologist at Virginia Mason Hospital and Medical Center, Seattle, agreed.

“Characterizing morbidity associated with hysterectomy is increasingly important as we define benchmarks for quality outcomes in the changing health care economy,” Dr. Washington said. Calling this study “outstanding,” she suggested these data are potentially helpful for counseling patients about risks of hysterectomy, and identifying and evaluating strategies that will help to improve outcomes.

Dr. Adam reported no relevant financial disclosures.

ORLANDO – Injuring the bladder during a hysterectomy is associated with a greater likelihood of developing a postoperative vesicovaginal fistula, according to a retrospective analysis presented at the annual scientific meeting of the Society of Gynecologic Surgeons.

In data captured from 641,056 hysterectomies performed in California, New York, and Florida in 2005-2010, the odds ratio of a vesicovaginal fistula was nearly 19 times higher if a urinary tract injury was sustained at the time of hysterectomy, a complication that increased in frequency during the 5-year study period, reported Dr. Rony A. Adam, professor of obstetrics and gynecology in the division of female pelvic and reconstructive surgery at Vanderbilt University Medical Center, Nashville, Tenn.

“Although we do not know all the factors that impact formation of vesicovaginal fistula post hysterectomy, it is clear that bladder injury at the time of hysterectomy even when identified and repaired is significantly associated [with this complication],” Dr. Adam reported at the meeting, jointly sponsored by the American College of Surgeons.

The statistical analyses were conducted with the inpatient and ambulatory surgery databases from the Healthcare Cost and Utilization Project (HCUP) for the three states. The large geographically diverse populations were considered by the authors to be nationally representative.

For this analysis, vesicovaginal fistulas and urinary tract injuries were tracked for total abdominal hysterectomy, subtotal abdominal hysterectomy, and total vaginal hysterectomy with or without laparoscopic assistance. Over the 5-year study period, urinary tract injuries climbed steadily in all three groups. When the last year of analysis was compared with the first, a greater increase in odds ratio was observed in the total abdominal group (1.88) than in the subtotal (1.27) or the vaginal (1.26) groups, but each increase was significant.

“The uniformly increasing bladder injury rate may be explained by the increasing cesarean section rates,” according to Dr. Adam, who cited evidence suggesting that cesarean section increases risk of urinary tract injuries in subsequent hysterectomy.

The rate of vesicovaginal fistulas was 21.07 per 1,000 women when a urinary tract injury was incurred during hysterectomy versus 0.95 per 1,000 women when it was not (odds ratio, 18.91). The overall rate of vesicovaginal injury increased in the last year of the study relative to the first (OR, 1.28), although this increase fell just short of statistical significant (P = .059).

“It is possible that surgeons have gotten better at detecting and repairing urinary tract injury, which could explain why the vesicovaginal fistula rate has remained stable in the face of an increasing rate of urinary tract injuries,” Dr. Adam reported.

Not only did the rate of urinary tract injuries climb faster over the study period in those undergoing total abdominal hysterectomy, but also there was a stronger association in patients undergoing this form of hysterectomy between urinary tract injury and vesicovaginal fistula formation, said Dr. Adam. Overall, the OR for vesicovaginal fistula after urinary tract injury was about half as great when either subtotal or vaginal hysterectomy was compared to total abdominal hysterectomy

Although Dr. Adam emphasized that a retrospective study of this type can only establish an association and cannot confirm causation, he said that this study suggests urinary tract injury may be a useful quality-of-care measure for performance of hysterectomy. The SGS-invited discussant Dr. Blair Washington, a urogynecologist at Virginia Mason Hospital and Medical Center, Seattle, agreed.

“Characterizing morbidity associated with hysterectomy is increasingly important as we define benchmarks for quality outcomes in the changing health care economy,” Dr. Washington said. Calling this study “outstanding,” she suggested these data are potentially helpful for counseling patients about risks of hysterectomy, and identifying and evaluating strategies that will help to improve outcomes.

Dr. Adam reported no relevant financial disclosures.

ORLANDO – Financial penalties designed to induce hospitals with high surgical site infection rates to improve this aspect of quality of care are likely to be distributed unfairly, according to an analysis presented at the annual scientific meeting of the Society of Gynecologic Surgeons.

The plan, to be initiated in 2016 as part of the Hospital-Acquired Condition (HAC) Reduction Program of the Centers for Medicare & Medicaid, is to levy a 1% penalty for all hospitals that fall into the quartile with the greatest rate of surgical site infections (SSI), but only a proportion of these appear to be outliers, reported Dr. Daniel M. Morgan, an ob.gyn. at the University of Michigan, Ann Arbor.

Leaving aside the question of whether all hospitals in the bottom 25% for avoiding SSI are true outliers and, therefore, deserve a penalty, the study in Michigan suggested that the methodology proposed to rank SSI rates does not appear to be properly adjusted for risk.

In this study, SSI associated with hysterectomy was evaluated in 49 hospitals participating in a statewide surgical quality collaborative in which at least 10 hysterectomies were performed. Using data from the 16,000 hysterectomies in this database, hospitals were stratified by SSI rates using the National Healthcare Safety Network (NHSN) protocol (Infect. Control Hosp. Epidemiol. 2011;32:970-86). This is the methodology planned for the HAC reduction program.

While risk adjustment with the NHSN model was restricted to age, American Society of Anesthesiologists (ASA) class, surgical time, use of laparoscopy, and bed size, the Michigan initiative used a multivariate mixed logistic regression model to identify other factors found to significantly influence SSI rates. These included body mass index (BMI) >30, a gynecologic cancer diagnosis, and payment for services through Medicaid.

Using a quartile stratification, 12 of the 49 hospitals would warrant a penalty under the proposed HAC reduction program, but using the Michigan risk adjustment, 8 of these hospitals, or two-thirds of the total, would not have SSI rates significantly different from the mean and would be penalized unfairly.

Several of the hospitals changed quartiles when the Michigan risk adjustment methodology used the additional risk modifiers over those employed in the NHSN protocol. A change in ranking was more common in smaller hospitals relative to those with more than 500 beds, Dr. Morgan said at the meeting, jointly sponsored by the American College of Surgeons.

These data predict “some serious deficiencies in the planned protocol” that will result in “inappropriate targeting of some hospitals that fall into the bottom quartile,” Dr. Morgan said.

It is reasonable to target SSI rates as a strategy to improve quality of care, according to the SGS-invited discussant for this study, Dr. Kristen Matteson, an ob.gyn. at Brown University, Providence, R.I. She said that SSI is an important cause of morbidity and a significant driver of increased costs and it is appropriate to target those with ineffective or substandard processes for preventing infection. However, defining the outliers, “as demonstrated by these authors, it is a complicated process,” she said.

In an interview, Dr. Matteson suggested that it is not only developing a methodology for accurate risk adjustment but also confirming that the bottom 25% actually have rates that are clinically different than higher quartiles. Mathematically, there is always a bottom 25% on any scale, so it makes more sense to develop a cut-off that establishes true outliers rather than those that happen to fall in the bottom quartile.

These policies are going to be implemented soon, and data such as those in this study suggest that they may target hospitals that do not deserve to be targeted, Dr. Matteson said.

Dr. Morgan reported no relevant financial disclosures.

ORLANDO – Financial penalties designed to induce hospitals with high surgical site infection rates to improve this aspect of quality of care are likely to be distributed unfairly, according to an analysis presented at the annual scientific meeting of the Society of Gynecologic Surgeons.

The plan, to be initiated in 2016 as part of the Hospital-Acquired Condition (HAC) Reduction Program of the Centers for Medicare & Medicaid, is to levy a 1% penalty for all hospitals that fall into the quartile with the greatest rate of surgical site infections (SSI), but only a proportion of these appear to be outliers, reported Dr. Daniel M. Morgan, an ob.gyn. at the University of Michigan, Ann Arbor.

Leaving aside the question of whether all hospitals in the bottom 25% for avoiding SSI are true outliers and, therefore, deserve a penalty, the study in Michigan suggested that the methodology proposed to rank SSI rates does not appear to be properly adjusted for risk.

In this study, SSI associated with hysterectomy was evaluated in 49 hospitals participating in a statewide surgical quality collaborative in which at least 10 hysterectomies were performed. Using data from the 16,000 hysterectomies in this database, hospitals were stratified by SSI rates using the National Healthcare Safety Network (NHSN) protocol (Infect. Control Hosp. Epidemiol. 2011;32:970-86). This is the methodology planned for the HAC reduction program.

While risk adjustment with the NHSN model was restricted to age, American Society of Anesthesiologists (ASA) class, surgical time, use of laparoscopy, and bed size, the Michigan initiative used a multivariate mixed logistic regression model to identify other factors found to significantly influence SSI rates. These included body mass index (BMI) >30, a gynecologic cancer diagnosis, and payment for services through Medicaid.

Using a quartile stratification, 12 of the 49 hospitals would warrant a penalty under the proposed HAC reduction program, but using the Michigan risk adjustment, 8 of these hospitals, or two-thirds of the total, would not have SSI rates significantly different from the mean and would be penalized unfairly.

Several of the hospitals changed quartiles when the Michigan risk adjustment methodology used the additional risk modifiers over those employed in the NHSN protocol. A change in ranking was more common in smaller hospitals relative to those with more than 500 beds, Dr. Morgan said at the meeting, jointly sponsored by the American College of Surgeons.

These data predict “some serious deficiencies in the planned protocol” that will result in “inappropriate targeting of some hospitals that fall into the bottom quartile,” Dr. Morgan said.

It is reasonable to target SSI rates as a strategy to improve quality of care, according to the SGS-invited discussant for this study, Dr. Kristen Matteson, an ob.gyn. at Brown University, Providence, R.I. She said that SSI is an important cause of morbidity and a significant driver of increased costs and it is appropriate to target those with ineffective or substandard processes for preventing infection. However, defining the outliers, “as demonstrated by these authors, it is a complicated process,” she said.

In an interview, Dr. Matteson suggested that it is not only developing a methodology for accurate risk adjustment but also confirming that the bottom 25% actually have rates that are clinically different than higher quartiles. Mathematically, there is always a bottom 25% on any scale, so it makes more sense to develop a cut-off that establishes true outliers rather than those that happen to fall in the bottom quartile.

These policies are going to be implemented soon, and data such as those in this study suggest that they may target hospitals that do not deserve to be targeted, Dr. Matteson said.

Dr. Morgan reported no relevant financial disclosures.

ORLANDO – Financial penalties designed to induce hospitals with high surgical site infection rates to improve this aspect of quality of care are likely to be distributed unfairly, according to an analysis presented at the annual scientific meeting of the Society of Gynecologic Surgeons.

The plan, to be initiated in 2016 as part of the Hospital-Acquired Condition (HAC) Reduction Program of the Centers for Medicare & Medicaid, is to levy a 1% penalty for all hospitals that fall into the quartile with the greatest rate of surgical site infections (SSI), but only a proportion of these appear to be outliers, reported Dr. Daniel M. Morgan, an ob.gyn. at the University of Michigan, Ann Arbor.

Leaving aside the question of whether all hospitals in the bottom 25% for avoiding SSI are true outliers and, therefore, deserve a penalty, the study in Michigan suggested that the methodology proposed to rank SSI rates does not appear to be properly adjusted for risk.

In this study, SSI associated with hysterectomy was evaluated in 49 hospitals participating in a statewide surgical quality collaborative in which at least 10 hysterectomies were performed. Using data from the 16,000 hysterectomies in this database, hospitals were stratified by SSI rates using the National Healthcare Safety Network (NHSN) protocol (Infect. Control Hosp. Epidemiol. 2011;32:970-86). This is the methodology planned for the HAC reduction program.

While risk adjustment with the NHSN model was restricted to age, American Society of Anesthesiologists (ASA) class, surgical time, use of laparoscopy, and bed size, the Michigan initiative used a multivariate mixed logistic regression model to identify other factors found to significantly influence SSI rates. These included body mass index (BMI) >30, a gynecologic cancer diagnosis, and payment for services through Medicaid.

Using a quartile stratification, 12 of the 49 hospitals would warrant a penalty under the proposed HAC reduction program, but using the Michigan risk adjustment, 8 of these hospitals, or two-thirds of the total, would not have SSI rates significantly different from the mean and would be penalized unfairly.

Several of the hospitals changed quartiles when the Michigan risk adjustment methodology used the additional risk modifiers over those employed in the NHSN protocol. A change in ranking was more common in smaller hospitals relative to those with more than 500 beds, Dr. Morgan said at the meeting, jointly sponsored by the American College of Surgeons.

These data predict “some serious deficiencies in the planned protocol” that will result in “inappropriate targeting of some hospitals that fall into the bottom quartile,” Dr. Morgan said.

It is reasonable to target SSI rates as a strategy to improve quality of care, according to the SGS-invited discussant for this study, Dr. Kristen Matteson, an ob.gyn. at Brown University, Providence, R.I. She said that SSI is an important cause of morbidity and a significant driver of increased costs and it is appropriate to target those with ineffective or substandard processes for preventing infection. However, defining the outliers, “as demonstrated by these authors, it is a complicated process,” she said.

In an interview, Dr. Matteson suggested that it is not only developing a methodology for accurate risk adjustment but also confirming that the bottom 25% actually have rates that are clinically different than higher quartiles. Mathematically, there is always a bottom 25% on any scale, so it makes more sense to develop a cut-off that establishes true outliers rather than those that happen to fall in the bottom quartile.

These policies are going to be implemented soon, and data such as those in this study suggest that they may target hospitals that do not deserve to be targeted, Dr. Matteson said.

Dr. Morgan reported no relevant financial disclosures.

Despite birth rates among American teenagers continuing to decrease in recent years, not enough sexually active teens know of and use LARC, which the Centers for Disease Control and Prevention calls the most effective type of reversible birth control currently available and is highlighting in their latest Vital Signs report.

Long-acting reversible contraception (LARC) is a contraceptive method that involves using either an intrauterine device (IUD) or an implant to prevent pregnancy. The IUD comes in hormonal and copper variants; the former releases progestin in the uterus and can be effective for up to 5 years, while the latter is effective for up to 10 years. The LARC implant is a device placed into a patient’s arm, secreting progestin to stop ovulation; it lasts 3 years.

“Nearly 90% of teens used birth control the last time they had sex, [but] most teens used condoms and birth control pills, which are not always used consistently or correctly,” CDC Principal Deputy Director Ileana Arias, Ph.D., said during a media telebriefing, stressing that LARC is entirely reversible and that studies have shown that fewer than 1% of women become pregnant in their first year of using LARC.

According to findings made by the Title X Family Planning program in a study undertaken jointly by the CDC and the Department of Health and Human Services’ Office of Population Affairs (OPA), there were more than 273,000 infants born to parents aged 15-19 years in 2013. However, more teens are abstaining from sex, and higher numbers of teens who are sexually active are using contraceptives. LARC is proving popular in certain states, particularly Colorado, where 26% of teens used it in 2013, while rates in other states ranged from less than 1% to 20%.

Nationwide, LARC usage increased from 0.4% to 7.1% between 2005 and 2013, with implants being favored more than IUDs: Of 616,148 female teens seeking contraception in 2013, 4.3% used implants and 2.8% used IUDs. LARC was more popular in older teens (aged 18-19 years) than younger teens (aged 15-17 years), with 7.6% of older teens using LARC, compared with only 6.5% of younger teens (P < .001).

Dr. Arias highlighted the need for more outreach and awareness of LARC, putting the onus on domestic health care professionals to ensure that teenagers across the nation have all the resources they need to make informed decisions about birth control. To do this, she explained, requires dispelling misconceptions and eliminating barriers that stand in the way of teens having access to LARC.

In a press release, the CDC noted that clinics have reported high upfront costs for LARC supplies, lack of training, and “misplaced concerns about the safety and appropriateness of LARC for teens” as the main obstacles standing in the way of more pervasive LARC adoption. Furthermore, teenagers themselves often know very little, if anything, about LARC, and often think they can’t use it because of their age.

“Health care professionals [can] encourage teens not to have sex and discuss the use of IUDs and implants as contraceptive options available to teens who choose to be sexually active,” Dr. Arias said in a statement. “[LARC] is safe for teens, easy to use, and very effective [and] we need to remove barriers and increase awareness, access, and availability of long-acting reversible contraception such as IUDs and implants.”

Dr. Arias’s sentiments were echoed by the American College of Obstetricians and Gynecologists, which lauded the CDC’s ongoing efforts to promote LARCs efficacy and safety to American teenagers.

“Obstetrician-gynecologists play an integral role in reducing teen pregnancy rates through increased education and access to birth control [and] we firmly believe that increased adoption of [LARC] methods can play a role in reducing unintended pregnancy,” Dr. Hal C. Lawrence, ACOG CEO and executive vice president, said in a statement. He added that, “data have demonstrated that LARC methods of birth control are just as safe and as effective when used by adolescents as adults. That’s why ACOG recommends use of LARC in its committee opinion #539 entitled, ‘Adolescents and Long-Acting Reversible Contraception: Implants and Intrauterine Devices’ (Obstet. Gynecol. 2012;120:983-8).”

dchitnis@frontlinemedcom.com

Despite birth rates among American teenagers continuing to decrease in recent years, not enough sexually active teens know of and use LARC, which the Centers for Disease Control and Prevention calls the most effective type of reversible birth control currently available and is highlighting in their latest Vital Signs report.

Long-acting reversible contraception (LARC) is a contraceptive method that involves using either an intrauterine device (IUD) or an implant to prevent pregnancy. The IUD comes in hormonal and copper variants; the former releases progestin in the uterus and can be effective for up to 5 years, while the latter is effective for up to 10 years. The LARC implant is a device placed into a patient’s arm, secreting progestin to stop ovulation; it lasts 3 years.

“Nearly 90% of teens used birth control the last time they had sex, [but] most teens used condoms and birth control pills, which are not always used consistently or correctly,” CDC Principal Deputy Director Ileana Arias, Ph.D., said during a media telebriefing, stressing that LARC is entirely reversible and that studies have shown that fewer than 1% of women become pregnant in their first year of using LARC.

According to findings made by the Title X Family Planning program in a study undertaken jointly by the CDC and the Department of Health and Human Services’ Office of Population Affairs (OPA), there were more than 273,000 infants born to parents aged 15-19 years in 2013. However, more teens are abstaining from sex, and higher numbers of teens who are sexually active are using contraceptives. LARC is proving popular in certain states, particularly Colorado, where 26% of teens used it in 2013, while rates in other states ranged from less than 1% to 20%.

Nationwide, LARC usage increased from 0.4% to 7.1% between 2005 and 2013, with implants being favored more than IUDs: Of 616,148 female teens seeking contraception in 2013, 4.3% used implants and 2.8% used IUDs. LARC was more popular in older teens (aged 18-19 years) than younger teens (aged 15-17 years), with 7.6% of older teens using LARC, compared with only 6.5% of younger teens (P < .001).

Dr. Arias highlighted the need for more outreach and awareness of LARC, putting the onus on domestic health care professionals to ensure that teenagers across the nation have all the resources they need to make informed decisions about birth control. To do this, she explained, requires dispelling misconceptions and eliminating barriers that stand in the way of teens having access to LARC.

In a press release, the CDC noted that clinics have reported high upfront costs for LARC supplies, lack of training, and “misplaced concerns about the safety and appropriateness of LARC for teens” as the main obstacles standing in the way of more pervasive LARC adoption. Furthermore, teenagers themselves often know very little, if anything, about LARC, and often think they can’t use it because of their age.

“Health care professionals [can] encourage teens not to have sex and discuss the use of IUDs and implants as contraceptive options available to teens who choose to be sexually active,” Dr. Arias said in a statement. “[LARC] is safe for teens, easy to use, and very effective [and] we need to remove barriers and increase awareness, access, and availability of long-acting reversible contraception such as IUDs and implants.”

Dr. Arias’s sentiments were echoed by the American College of Obstetricians and Gynecologists, which lauded the CDC’s ongoing efforts to promote LARCs efficacy and safety to American teenagers.

“Obstetrician-gynecologists play an integral role in reducing teen pregnancy rates through increased education and access to birth control [and] we firmly believe that increased adoption of [LARC] methods can play a role in reducing unintended pregnancy,” Dr. Hal C. Lawrence, ACOG CEO and executive vice president, said in a statement. He added that, “data have demonstrated that LARC methods of birth control are just as safe and as effective when used by adolescents as adults. That’s why ACOG recommends use of LARC in its committee opinion #539 entitled, ‘Adolescents and Long-Acting Reversible Contraception: Implants and Intrauterine Devices’ (Obstet. Gynecol. 2012;120:983-8).”

dchitnis@frontlinemedcom.com

Despite birth rates among American teenagers continuing to decrease in recent years, not enough sexually active teens know of and use LARC, which the Centers for Disease Control and Prevention calls the most effective type of reversible birth control currently available and is highlighting in their latest Vital Signs report.

Long-acting reversible contraception (LARC) is a contraceptive method that involves using either an intrauterine device (IUD) or an implant to prevent pregnancy. The IUD comes in hormonal and copper variants; the former releases progestin in the uterus and can be effective for up to 5 years, while the latter is effective for up to 10 years. The LARC implant is a device placed into a patient’s arm, secreting progestin to stop ovulation; it lasts 3 years.

“Nearly 90% of teens used birth control the last time they had sex, [but] most teens used condoms and birth control pills, which are not always used consistently or correctly,” CDC Principal Deputy Director Ileana Arias, Ph.D., said during a media telebriefing, stressing that LARC is entirely reversible and that studies have shown that fewer than 1% of women become pregnant in their first year of using LARC.

According to findings made by the Title X Family Planning program in a study undertaken jointly by the CDC and the Department of Health and Human Services’ Office of Population Affairs (OPA), there were more than 273,000 infants born to parents aged 15-19 years in 2013. However, more teens are abstaining from sex, and higher numbers of teens who are sexually active are using contraceptives. LARC is proving popular in certain states, particularly Colorado, where 26% of teens used it in 2013, while rates in other states ranged from less than 1% to 20%.

Nationwide, LARC usage increased from 0.4% to 7.1% between 2005 and 2013, with implants being favored more than IUDs: Of 616,148 female teens seeking contraception in 2013, 4.3% used implants and 2.8% used IUDs. LARC was more popular in older teens (aged 18-19 years) than younger teens (aged 15-17 years), with 7.6% of older teens using LARC, compared with only 6.5% of younger teens (P < .001).

Dr. Arias highlighted the need for more outreach and awareness of LARC, putting the onus on domestic health care professionals to ensure that teenagers across the nation have all the resources they need to make informed decisions about birth control. To do this, she explained, requires dispelling misconceptions and eliminating barriers that stand in the way of teens having access to LARC.

In a press release, the CDC noted that clinics have reported high upfront costs for LARC supplies, lack of training, and “misplaced concerns about the safety and appropriateness of LARC for teens” as the main obstacles standing in the way of more pervasive LARC adoption. Furthermore, teenagers themselves often know very little, if anything, about LARC, and often think they can’t use it because of their age.

“Health care professionals [can] encourage teens not to have sex and discuss the use of IUDs and implants as contraceptive options available to teens who choose to be sexually active,” Dr. Arias said in a statement. “[LARC] is safe for teens, easy to use, and very effective [and] we need to remove barriers and increase awareness, access, and availability of long-acting reversible contraception such as IUDs and implants.”

Dr. Arias’s sentiments were echoed by the American College of Obstetricians and Gynecologists, which lauded the CDC’s ongoing efforts to promote LARCs efficacy and safety to American teenagers.

“Obstetrician-gynecologists play an integral role in reducing teen pregnancy rates through increased education and access to birth control [and] we firmly believe that increased adoption of [LARC] methods can play a role in reducing unintended pregnancy,” Dr. Hal C. Lawrence, ACOG CEO and executive vice president, said in a statement. He added that, “data have demonstrated that LARC methods of birth control are just as safe and as effective when used by adolescents as adults. That’s why ACOG recommends use of LARC in its committee opinion #539 entitled, ‘Adolescents and Long-Acting Reversible Contraception: Implants and Intrauterine Devices’ (Obstet. Gynecol. 2012;120:983-8).”

dchitnis@frontlinemedcom.com

MIAMI BEACH – Two novel therapies have potential for the treatment of genital warts, according to Dr. Theodore Rosen.

The first of these “way-off-label” treatments involves application of 5% potassium hydroxide (KOH) solution daily for 12 weeks, said Dr. Rosen, professor of dermatology at Baylor College of Medicine in Houston, Tex.

In a randomized, open-label study of 60 patients conducted in Turkey, researchers compared the KOH treatment with a 10% salicylic acid and 0.5% 5-fluorouracil compound available outside of the United States. The compound used in the study is similar to the WartPEEL (MedCara Pharmaceuticals) product available in the United States, Dr. Rosen said at the South Beach Symposium.

Both treatments were associated with a significant decrease in the number of lesions, and the outcomes were similar in both groups at 12 weeks (mean decrease from 17.03 to 3.73 lesions with KOH and from 16.13 to 3.10 with the 5-FU product). The investigators reported that excellent clearance was achieved by 70% and 76.7% of patients in the KOH and 5-FU groups, respectively, and marked improvement was seen in 13.3% and 20% of patients in the groups, respectively (Int. J. Dermatol. 2014; 53:1145-50).

No difference was seen between the groups in the rate of relapse at 16 weeks, and no serious adverse events were reported.

“This is a dirt-cheap way to treat genital warts,” Dr. Rosen said, adding that clinicians can simply give patients 5% KOH in a small bottle and instruct them to apply it once daily.

A second potential – but “not-so-dirt-cheap” – treatment worth noting is ingenol mebutate, based on findings from another small study, Dr. Rosen said.

Ingenol mebutate (Picato), which is approved for the treatment of actinic keratosis, was shown in 10 patients with human papillomovirus-6–positive genital warts to provide complete clearance with a single application.

The treatment was compared with vehicle in each patient – ingenol mebutate was applied to one affected area, and vehicle was applied to another affected area. The areas with active treatment were completely clear within 3-7 days, and the areas where vehicle was applied were not clear. No recurrence was noted at 3 months in the areas treated with ingenol mebutate.

Not surprisingly, the treatment was associated with mild to moderate burning, but it is a “very, very interesting, very short treatment,” Dr. Rosen said.

Dr. Rosen reported having no relevant disclosures.

MIAMI BEACH – Two novel therapies have potential for the treatment of genital warts, according to Dr. Theodore Rosen.

The first of these “way-off-label” treatments involves application of 5% potassium hydroxide (KOH) solution daily for 12 weeks, said Dr. Rosen, professor of dermatology at Baylor College of Medicine in Houston, Tex.

In a randomized, open-label study of 60 patients conducted in Turkey, researchers compared the KOH treatment with a 10% salicylic acid and 0.5% 5-fluorouracil compound available outside of the United States. The compound used in the study is similar to the WartPEEL (MedCara Pharmaceuticals) product available in the United States, Dr. Rosen said at the South Beach Symposium.

Both treatments were associated with a significant decrease in the number of lesions, and the outcomes were similar in both groups at 12 weeks (mean decrease from 17.03 to 3.73 lesions with KOH and from 16.13 to 3.10 with the 5-FU product). The investigators reported that excellent clearance was achieved by 70% and 76.7% of patients in the KOH and 5-FU groups, respectively, and marked improvement was seen in 13.3% and 20% of patients in the groups, respectively (Int. J. Dermatol. 2014; 53:1145-50).

No difference was seen between the groups in the rate of relapse at 16 weeks, and no serious adverse events were reported.

“This is a dirt-cheap way to treat genital warts,” Dr. Rosen said, adding that clinicians can simply give patients 5% KOH in a small bottle and instruct them to apply it once daily.

A second potential – but “not-so-dirt-cheap” – treatment worth noting is ingenol mebutate, based on findings from another small study, Dr. Rosen said.

Ingenol mebutate (Picato), which is approved for the treatment of actinic keratosis, was shown in 10 patients with human papillomovirus-6–positive genital warts to provide complete clearance with a single application.

The treatment was compared with vehicle in each patient – ingenol mebutate was applied to one affected area, and vehicle was applied to another affected area. The areas with active treatment were completely clear within 3-7 days, and the areas where vehicle was applied were not clear. No recurrence was noted at 3 months in the areas treated with ingenol mebutate.

Not surprisingly, the treatment was associated with mild to moderate burning, but it is a “very, very interesting, very short treatment,” Dr. Rosen said.

Dr. Rosen reported having no relevant disclosures.

MIAMI BEACH – Two novel therapies have potential for the treatment of genital warts, according to Dr. Theodore Rosen.

The first of these “way-off-label” treatments involves application of 5% potassium hydroxide (KOH) solution daily for 12 weeks, said Dr. Rosen, professor of dermatology at Baylor College of Medicine in Houston, Tex.

In a randomized, open-label study of 60 patients conducted in Turkey, researchers compared the KOH treatment with a 10% salicylic acid and 0.5% 5-fluorouracil compound available outside of the United States. The compound used in the study is similar to the WartPEEL (MedCara Pharmaceuticals) product available in the United States, Dr. Rosen said at the South Beach Symposium.

Both treatments were associated with a significant decrease in the number of lesions, and the outcomes were similar in both groups at 12 weeks (mean decrease from 17.03 to 3.73 lesions with KOH and from 16.13 to 3.10 with the 5-FU product). The investigators reported that excellent clearance was achieved by 70% and 76.7% of patients in the KOH and 5-FU groups, respectively, and marked improvement was seen in 13.3% and 20% of patients in the groups, respectively (Int. J. Dermatol. 2014; 53:1145-50).

No difference was seen between the groups in the rate of relapse at 16 weeks, and no serious adverse events were reported.

“This is a dirt-cheap way to treat genital warts,” Dr. Rosen said, adding that clinicians can simply give patients 5% KOH in a small bottle and instruct them to apply it once daily.

A second potential – but “not-so-dirt-cheap” – treatment worth noting is ingenol mebutate, based on findings from another small study, Dr. Rosen said.

Ingenol mebutate (Picato), which is approved for the treatment of actinic keratosis, was shown in 10 patients with human papillomovirus-6–positive genital warts to provide complete clearance with a single application.

The treatment was compared with vehicle in each patient – ingenol mebutate was applied to one affected area, and vehicle was applied to another affected area. The areas with active treatment were completely clear within 3-7 days, and the areas where vehicle was applied were not clear. No recurrence was noted at 3 months in the areas treated with ingenol mebutate.

Not surprisingly, the treatment was associated with mild to moderate burning, but it is a “very, very interesting, very short treatment,” Dr. Rosen said.

Dr. Rosen reported having no relevant disclosures.

ORLANDO – The American College of Obstetricians and Gynecologists is taking steps intended to reverse the declining rates of vaginal hysterectomy, the preferred procedure for benign indications, according to an outline of plans presented at the annual scientific meeting of the Society of Gynecologic Surgeons.

The immediate focus is on building skills both during and after training programs, said Dr. Sandra A. Carson, ACOG’s vice president for education. She reported that overall rates of hysterectomies have been declining over the past decade, but the decline has been especially steep for vaginal procedures. This has an adverse impact on training.

“Data show that over the past 10 years, residents have performed on average 8 fewer hysterectomies, but the average number of vaginal hysterectomies has been essentially halved to 17 or 18 over 4 years of residency training,” said Dr. Carson, who made her remarks as part of the invited TeLinde lecture.

This rate of vaginal hysterectomies during training is generally considered to be insufficient to provide training graduates with the confidence to perform them in routine practice, she said.

The vaginal approach has long been identified by ACOG as the preferred route of hysterectomy for benign disease because of evidence of better outcomes and fewer complications. In an ACOG committee opinion #444 entitled “Choosing the Route of Hysterectomy for Benign Disease” (reaffirmed in 2011), laparoscopic, abdominal, and robotic procedures were characterized as alternatives when vaginal hysterectomy is not feasible (Obstet. Gynecol. 2009;114:1156-8).

“We know that vaginal hysterectomy overall is better for women, so we need to get honest with ourselves about doing something about the trends,” she said at the SGS meeting, jointly sponsored by the American College of Surgeons.

Of strategies to reverse the trend, training is key, said Dr. Carson. This has led ACOG to develop several programs, including a CME-accredited surgical skills training module that includes objectives, instruction, information on how to construct a low-cost simulator, and an assessment tool. There is also a program available designed to help teachers teach vaginal hysterectomy.

ACOG also is developing a task force of teachers for mentoring. The goal is to advise surgeons who have learned the techniques of vaginal hysterectomy but may not yet have the confidence to perform them on their own. Ten experts already have volunteered to serve on the task force, and several training programs have expressed interest in receiving this form of support, Dr. Carson said.

However, she acknowledged several potential obstacles for widespread implementation of the task force that require resolution, such as providing credentialing, liability insurance, and reimbursement for advisers. ACOG has been active in considering solutions for each of these, such as using operating room cameras that would allow advisers to participate remotely.

In addition to training, however, Dr. Carson reported that ACOG is looking at strategies to align incentives that would encourage vaginal hysterectomies. This could include convincing third-party payers to provide greater reimbursement for an approach that may be less costly than alternatives, particularly robotic hysterectomy.

“We all need to decide that this is the right thing for women, but if you want to do this, we want to help you,” Dr. Carson told the audience of gynecologic surgeons.

Concern about the declining rates of vaginal hysterectomy is not new, said Dr. Ernest G. Lockrow, professor and vice chairman obstetrics and gynecology, Uniformed Services University of the Health Services, Bethesda, Md. In an interview, he suggested that there has long been hand-wringing about how to halt the decline in the approach. What is new, according to Dr. Lockrow, is the ACOG commitment for change.

“Based on what we heard today, it appears that ACOG is getting a little more serious about doing something about this issue,” Dr. Lockrow said. He is not certain how effective the strategies outlined by Dr. Carson will be in turning around current trends, “but I think we are seeing some steps in the right direction.”

Dr. Carson reported no relevant financial disclosures

ORLANDO – The American College of Obstetricians and Gynecologists is taking steps intended to reverse the declining rates of vaginal hysterectomy, the preferred procedure for benign indications, according to an outline of plans presented at the annual scientific meeting of the Society of Gynecologic Surgeons.

The immediate focus is on building skills both during and after training programs, said Dr. Sandra A. Carson, ACOG’s vice president for education. She reported that overall rates of hysterectomies have been declining over the past decade, but the decline has been especially steep for vaginal procedures. This has an adverse impact on training.

“Data show that over the past 10 years, residents have performed on average 8 fewer hysterectomies, but the average number of vaginal hysterectomies has been essentially halved to 17 or 18 over 4 years of residency training,” said Dr. Carson, who made her remarks as part of the invited TeLinde lecture.

This rate of vaginal hysterectomies during training is generally considered to be insufficient to provide training graduates with the confidence to perform them in routine practice, she said.

The vaginal approach has long been identified by ACOG as the preferred route of hysterectomy for benign disease because of evidence of better outcomes and fewer complications. In an ACOG committee opinion #444 entitled “Choosing the Route of Hysterectomy for Benign Disease” (reaffirmed in 2011), laparoscopic, abdominal, and robotic procedures were characterized as alternatives when vaginal hysterectomy is not feasible (Obstet. Gynecol. 2009;114:1156-8).

“We know that vaginal hysterectomy overall is better for women, so we need to get honest with ourselves about doing something about the trends,” she said at the SGS meeting, jointly sponsored by the American College of Surgeons.

Of strategies to reverse the trend, training is key, said Dr. Carson. This has led ACOG to develop several programs, including a CME-accredited surgical skills training module that includes objectives, instruction, information on how to construct a low-cost simulator, and an assessment tool. There is also a program available designed to help teachers teach vaginal hysterectomy.

ACOG also is developing a task force of teachers for mentoring. The goal is to advise surgeons who have learned the techniques of vaginal hysterectomy but may not yet have the confidence to perform them on their own. Ten experts already have volunteered to serve on the task force, and several training programs have expressed interest in receiving this form of support, Dr. Carson said.

However, she acknowledged several potential obstacles for widespread implementation of the task force that require resolution, such as providing credentialing, liability insurance, and reimbursement for advisers. ACOG has been active in considering solutions for each of these, such as using operating room cameras that would allow advisers to participate remotely.

In addition to training, however, Dr. Carson reported that ACOG is looking at strategies to align incentives that would encourage vaginal hysterectomies. This could include convincing third-party payers to provide greater reimbursement for an approach that may be less costly than alternatives, particularly robotic hysterectomy.

“We all need to decide that this is the right thing for women, but if you want to do this, we want to help you,” Dr. Carson told the audience of gynecologic surgeons.

Concern about the declining rates of vaginal hysterectomy is not new, said Dr. Ernest G. Lockrow, professor and vice chairman obstetrics and gynecology, Uniformed Services University of the Health Services, Bethesda, Md. In an interview, he suggested that there has long been hand-wringing about how to halt the decline in the approach. What is new, according to Dr. Lockrow, is the ACOG commitment for change.

“Based on what we heard today, it appears that ACOG is getting a little more serious about doing something about this issue,” Dr. Lockrow said. He is not certain how effective the strategies outlined by Dr. Carson will be in turning around current trends, “but I think we are seeing some steps in the right direction.”

Dr. Carson reported no relevant financial disclosures

ORLANDO – The American College of Obstetricians and Gynecologists is taking steps intended to reverse the declining rates of vaginal hysterectomy, the preferred procedure for benign indications, according to an outline of plans presented at the annual scientific meeting of the Society of Gynecologic Surgeons.

The immediate focus is on building skills both during and after training programs, said Dr. Sandra A. Carson, ACOG’s vice president for education. She reported that overall rates of hysterectomies have been declining over the past decade, but the decline has been especially steep for vaginal procedures. This has an adverse impact on training.

“Data show that over the past 10 years, residents have performed on average 8 fewer hysterectomies, but the average number of vaginal hysterectomies has been essentially halved to 17 or 18 over 4 years of residency training,” said Dr. Carson, who made her remarks as part of the invited TeLinde lecture.

This rate of vaginal hysterectomies during training is generally considered to be insufficient to provide training graduates with the confidence to perform them in routine practice, she said.

The vaginal approach has long been identified by ACOG as the preferred route of hysterectomy for benign disease because of evidence of better outcomes and fewer complications. In an ACOG committee opinion #444 entitled “Choosing the Route of Hysterectomy for Benign Disease” (reaffirmed in 2011), laparoscopic, abdominal, and robotic procedures were characterized as alternatives when vaginal hysterectomy is not feasible (Obstet. Gynecol. 2009;114:1156-8).

“We know that vaginal hysterectomy overall is better for women, so we need to get honest with ourselves about doing something about the trends,” she said at the SGS meeting, jointly sponsored by the American College of Surgeons.

Of strategies to reverse the trend, training is key, said Dr. Carson. This has led ACOG to develop several programs, including a CME-accredited surgical skills training module that includes objectives, instruction, information on how to construct a low-cost simulator, and an assessment tool. There is also a program available designed to help teachers teach vaginal hysterectomy.

ACOG also is developing a task force of teachers for mentoring. The goal is to advise surgeons who have learned the techniques of vaginal hysterectomy but may not yet have the confidence to perform them on their own. Ten experts already have volunteered to serve on the task force, and several training programs have expressed interest in receiving this form of support, Dr. Carson said.

However, she acknowledged several potential obstacles for widespread implementation of the task force that require resolution, such as providing credentialing, liability insurance, and reimbursement for advisers. ACOG has been active in considering solutions for each of these, such as using operating room cameras that would allow advisers to participate remotely.

In addition to training, however, Dr. Carson reported that ACOG is looking at strategies to align incentives that would encourage vaginal hysterectomies. This could include convincing third-party payers to provide greater reimbursement for an approach that may be less costly than alternatives, particularly robotic hysterectomy.

“We all need to decide that this is the right thing for women, but if you want to do this, we want to help you,” Dr. Carson told the audience of gynecologic surgeons.

Concern about the declining rates of vaginal hysterectomy is not new, said Dr. Ernest G. Lockrow, professor and vice chairman obstetrics and gynecology, Uniformed Services University of the Health Services, Bethesda, Md. In an interview, he suggested that there has long been hand-wringing about how to halt the decline in the approach. What is new, according to Dr. Lockrow, is the ACOG commitment for change.

“Based on what we heard today, it appears that ACOG is getting a little more serious about doing something about this issue,” Dr. Lockrow said. He is not certain how effective the strategies outlined by Dr. Carson will be in turning around current trends, “but I think we are seeing some steps in the right direction.”

Dr. Carson reported no relevant financial disclosures

ORLANDO – Women diagnosed with a gynecologic malignancy have a strong likelihood of presenting with a coexisting pelvic floor disorder, according to data collected prospectively from a cancer survivorship cohort.

Bladder symptoms on validated questionnaires completed soon after diagnosis and prior to surgical treatment were especially common, with an overall urinary incontinence rate of 46.1% and a stress incontinence (SUI) rate of 59.5%, Dr. C. Emi Bretschneider reported at the annual scientific meeting of the Society of Gynecologic Surgeons.

“We think increased awareness of pelvic health issues will allow for more individualized and comprehensive counseling and care of these women,” said Dr. Bretschneider of the department of obstetrics and gynecology at the University of North Carolina, Chapel Hill.

She identified pelvic floor disorders as a major potential source of diminished quality of life in women with gynecologic malignancies.

Dr. C. Bryce Bowling, a urogynecologist at the University of Tennessee, Knoxville, agreed. Although he observed that the risk of both pelvic floor disorders and gynecologic malignancies increase with age, he said the reported rates at which they coexist is “sobering.”

“These are important data for those who are not already aware of this relationship,” Dr. Bowling, a discussant invited by the Society of Gynecologic Surgeons, said in an interview.

At many institutions, including his own, screening for pelvic floor disorders in women with gynecologic malignancies is already routine.

“Screening for incontinence is a very important consideration even for those with a poor prognosis,” he said. “Control of urinary symptoms over the course of the woman’s survival will have a very positive impact on quality of life.”

The data on pelvic floor disorders was drawn from 154 women with gynecologic cancers who completed baseline evaluations of bowel and bladder symptoms using two validated questionnaires in a recent 10-month period. Most (62%) had endometrial cancer, but other cancers, such as ovarian (17%) and cervical (11%) were represented. There were no significant differences in the rates of pelvic floor disorders among the cancer types.

In addition to the substantial rates of urinary incontinence and SUI, 40.8% of patients reported urinary incontinence with urgency and 21.5% reported nocturia most or every night. The rate of enuresis was 7.2%. In addition, 3.9% reported fecal incontinence.

Complaints of abdominal pain (46.8%), constipation (42.2%), and diarrhea (20.1%) were also common, Dr. Bretschneider reported at the meeting, jointly sponsored by the American College of Surgeons.

When women older than 50 years were compared to younger women, the rates of nearly every indicator of a pelvic floor disorder were higher. Most differences, such as overall urinary incontinence (P = .009), SUI (P = .005), and abdominal pain (P = .002) had a high degree of statistical significance. However, overall urinary incontinence and SUI were not significantly associated with age when modeled as a continuous variable.

Recognizing pelvic floor disorders at the time of the diagnosis of gynecologic malignancy can be relevant to planning cancer treatment, according to Dr. Bretschnieder. The study results highlight the need for a proactive approach that includes screening at the time of diagnosis, she said.

ORLANDO – Women diagnosed with a gynecologic malignancy have a strong likelihood of presenting with a coexisting pelvic floor disorder, according to data collected prospectively from a cancer survivorship cohort.

Bladder symptoms on validated questionnaires completed soon after diagnosis and prior to surgical treatment were especially common, with an overall urinary incontinence rate of 46.1% and a stress incontinence (SUI) rate of 59.5%, Dr. C. Emi Bretschneider reported at the annual scientific meeting of the Society of Gynecologic Surgeons.

“We think increased awareness of pelvic health issues will allow for more individualized and comprehensive counseling and care of these women,” said Dr. Bretschneider of the department of obstetrics and gynecology at the University of North Carolina, Chapel Hill.

She identified pelvic floor disorders as a major potential source of diminished quality of life in women with gynecologic malignancies.

Dr. C. Bryce Bowling, a urogynecologist at the University of Tennessee, Knoxville, agreed. Although he observed that the risk of both pelvic floor disorders and gynecologic malignancies increase with age, he said the reported rates at which they coexist is “sobering.”

“These are important data for those who are not already aware of this relationship,” Dr. Bowling, a discussant invited by the Society of Gynecologic Surgeons, said in an interview.

At many institutions, including his own, screening for pelvic floor disorders in women with gynecologic malignancies is already routine.

“Screening for incontinence is a very important consideration even for those with a poor prognosis,” he said. “Control of urinary symptoms over the course of the woman’s survival will have a very positive impact on quality of life.”

The data on pelvic floor disorders was drawn from 154 women with gynecologic cancers who completed baseline evaluations of bowel and bladder symptoms using two validated questionnaires in a recent 10-month period. Most (62%) had endometrial cancer, but other cancers, such as ovarian (17%) and cervical (11%) were represented. There were no significant differences in the rates of pelvic floor disorders among the cancer types.

In addition to the substantial rates of urinary incontinence and SUI, 40.8% of patients reported urinary incontinence with urgency and 21.5% reported nocturia most or every night. The rate of enuresis was 7.2%. In addition, 3.9% reported fecal incontinence.

Complaints of abdominal pain (46.8%), constipation (42.2%), and diarrhea (20.1%) were also common, Dr. Bretschneider reported at the meeting, jointly sponsored by the American College of Surgeons.

When women older than 50 years were compared to younger women, the rates of nearly every indicator of a pelvic floor disorder were higher. Most differences, such as overall urinary incontinence (P = .009), SUI (P = .005), and abdominal pain (P = .002) had a high degree of statistical significance. However, overall urinary incontinence and SUI were not significantly associated with age when modeled as a continuous variable.

Recognizing pelvic floor disorders at the time of the diagnosis of gynecologic malignancy can be relevant to planning cancer treatment, according to Dr. Bretschnieder. The study results highlight the need for a proactive approach that includes screening at the time of diagnosis, she said.

ORLANDO – Women diagnosed with a gynecologic malignancy have a strong likelihood of presenting with a coexisting pelvic floor disorder, according to data collected prospectively from a cancer survivorship cohort.

Bladder symptoms on validated questionnaires completed soon after diagnosis and prior to surgical treatment were especially common, with an overall urinary incontinence rate of 46.1% and a stress incontinence (SUI) rate of 59.5%, Dr. C. Emi Bretschneider reported at the annual scientific meeting of the Society of Gynecologic Surgeons.

“We think increased awareness of pelvic health issues will allow for more individualized and comprehensive counseling and care of these women,” said Dr. Bretschneider of the department of obstetrics and gynecology at the University of North Carolina, Chapel Hill.

She identified pelvic floor disorders as a major potential source of diminished quality of life in women with gynecologic malignancies.

Dr. C. Bryce Bowling, a urogynecologist at the University of Tennessee, Knoxville, agreed. Although he observed that the risk of both pelvic floor disorders and gynecologic malignancies increase with age, he said the reported rates at which they coexist is “sobering.”

“These are important data for those who are not already aware of this relationship,” Dr. Bowling, a discussant invited by the Society of Gynecologic Surgeons, said in an interview.

At many institutions, including his own, screening for pelvic floor disorders in women with gynecologic malignancies is already routine.

“Screening for incontinence is a very important consideration even for those with a poor prognosis,” he said. “Control of urinary symptoms over the course of the woman’s survival will have a very positive impact on quality of life.”

The data on pelvic floor disorders was drawn from 154 women with gynecologic cancers who completed baseline evaluations of bowel and bladder symptoms using two validated questionnaires in a recent 10-month period. Most (62%) had endometrial cancer, but other cancers, such as ovarian (17%) and cervical (11%) were represented. There were no significant differences in the rates of pelvic floor disorders among the cancer types.

In addition to the substantial rates of urinary incontinence and SUI, 40.8% of patients reported urinary incontinence with urgency and 21.5% reported nocturia most or every night. The rate of enuresis was 7.2%. In addition, 3.9% reported fecal incontinence.

Complaints of abdominal pain (46.8%), constipation (42.2%), and diarrhea (20.1%) were also common, Dr. Bretschneider reported at the meeting, jointly sponsored by the American College of Surgeons.

When women older than 50 years were compared to younger women, the rates of nearly every indicator of a pelvic floor disorder were higher. Most differences, such as overall urinary incontinence (P = .009), SUI (P = .005), and abdominal pain (P = .002) had a high degree of statistical significance. However, overall urinary incontinence and SUI were not significantly associated with age when modeled as a continuous variable.

Recognizing pelvic floor disorders at the time of the diagnosis of gynecologic malignancy can be relevant to planning cancer treatment, according to Dr. Bretschnieder. The study results highlight the need for a proactive approach that includes screening at the time of diagnosis, she said.

ORLANDO – A proprietary self-fixating polypropylene mesh system implanted with minimally invasive surgery provides a high rate of success against refractory fecal incontinence, according to data from a multicenter prospective trial.

Whether measured at 3, 6, or 12 months, approximately 65% of patients achieved treatment success, defined as at least a 50% reduction in episodes of fecal incontinence, Dr. Dee E. Fenner reported at the annual scientific meeting of the Society of Gynecologic Surgeons.

The mesh system, which remains in clinical development, is called TOPAS. It was evaluated in 152 patients enrolled at 14 centers in the United States. All patients had failed at least two conservative treatments, such as pelvic floor exercises with or without biofeedback. The average duration of fecal incontinence was 110 months.

From a baseline of nine episodes per week, the median number of episodes of fecal incontinence fell to 2.5 times per week after surgery. This did not change when evaluated at 3, 6, or 12 months. The median number of episodes with urgency decreased from two at baseline to zero. In 19% of patients, fecal incontinence remained completely resolved over the 12 months of follow-up, according to Dr. Fenner, the study’s lead investigator and director of gynecology at the University of Michigan, Ann Arbor.

The mean procedure time for the minimally invasive surgery required to create the tunnel adjacent to the anus in which the mesh system is placed was 33 minutes. The average length of stay in the hospital was 11 hours.

Of the 104 adverse events recorded in the study, 98 were not considered serious. These included pelvic pain that resolved without treatment and infections treated with antibiotics. The two serious adverse events with the greatest potential to be treatment related were a deep venous thrombosis (DVT) and a case of worsening prolapse. There were no revisions, extrusions, or treatment-related deaths, Dr. Fenner said.

Quality of life analyses measured with standardized questionnaires demonstrated significant improvements in domains for lifestyle, coping, depression, and embarrassment, Dr. Fenner reported at the meeting, which was jointly sponsored by the American College of Surgeons.

In a critique invited by the SGS, Dr. Holly E. Richter, director of the division of urogynecology and pelvic reconstructive surgery at the University of Alabama at Birmingham, called the evidence of benefit after 12 months of follow-up “credible.” She agreed with Dr. Fenner’s conclusion that this a promising surgical therapy for refractory patients.

“These results are very good for a difficult population, but I think it is important to first demonstrate that patients cannot achieve an adequate reduction in symptoms with nonsurgical approaches before this approach is considered,” Dr. Richter said in an interview.

The study had no control arm because there were no proven treatments for patients with refractory incontinence at the time of its design, according to Dr. Fenner. Several options, including sacral nerve stimulation, have since become available, she said.

The TOPASsystem is currently under review by the Food and Drug Administration. Dr. Fenner said that approval, if granted, might still be a year away.

Dr. Fenner reported receiving research support from American Medical Systems, which manufactures the TOPAS system.

ORLANDO – A proprietary self-fixating polypropylene mesh system implanted with minimally invasive surgery provides a high rate of success against refractory fecal incontinence, according to data from a multicenter prospective trial.

Whether measured at 3, 6, or 12 months, approximately 65% of patients achieved treatment success, defined as at least a 50% reduction in episodes of fecal incontinence, Dr. Dee E. Fenner reported at the annual scientific meeting of the Society of Gynecologic Surgeons.

The mesh system, which remains in clinical development, is called TOPAS. It was evaluated in 152 patients enrolled at 14 centers in the United States. All patients had failed at least two conservative treatments, such as pelvic floor exercises with or without biofeedback. The average duration of fecal incontinence was 110 months.

From a baseline of nine episodes per week, the median number of episodes of fecal incontinence fell to 2.5 times per week after surgery. This did not change when evaluated at 3, 6, or 12 months. The median number of episodes with urgency decreased from two at baseline to zero. In 19% of patients, fecal incontinence remained completely resolved over the 12 months of follow-up, according to Dr. Fenner, the study’s lead investigator and director of gynecology at the University of Michigan, Ann Arbor.

The mean procedure time for the minimally invasive surgery required to create the tunnel adjacent to the anus in which the mesh system is placed was 33 minutes. The average length of stay in the hospital was 11 hours.

Of the 104 adverse events recorded in the study, 98 were not considered serious. These included pelvic pain that resolved without treatment and infections treated with antibiotics. The two serious adverse events with the greatest potential to be treatment related were a deep venous thrombosis (DVT) and a case of worsening prolapse. There were no revisions, extrusions, or treatment-related deaths, Dr. Fenner said.

Quality of life analyses measured with standardized questionnaires demonstrated significant improvements in domains for lifestyle, coping, depression, and embarrassment, Dr. Fenner reported at the meeting, which was jointly sponsored by the American College of Surgeons.

In a critique invited by the SGS, Dr. Holly E. Richter, director of the division of urogynecology and pelvic reconstructive surgery at the University of Alabama at Birmingham, called the evidence of benefit after 12 months of follow-up “credible.” She agreed with Dr. Fenner’s conclusion that this a promising surgical therapy for refractory patients.

“These results are very good for a difficult population, but I think it is important to first demonstrate that patients cannot achieve an adequate reduction in symptoms with nonsurgical approaches before this approach is considered,” Dr. Richter said in an interview.

The study had no control arm because there were no proven treatments for patients with refractory incontinence at the time of its design, according to Dr. Fenner. Several options, including sacral nerve stimulation, have since become available, she said.

The TOPASsystem is currently under review by the Food and Drug Administration. Dr. Fenner said that approval, if granted, might still be a year away.

Dr. Fenner reported receiving research support from American Medical Systems, which manufactures the TOPAS system.

ORLANDO – A proprietary self-fixating polypropylene mesh system implanted with minimally invasive surgery provides a high rate of success against refractory fecal incontinence, according to data from a multicenter prospective trial.

Whether measured at 3, 6, or 12 months, approximately 65% of patients achieved treatment success, defined as at least a 50% reduction in episodes of fecal incontinence, Dr. Dee E. Fenner reported at the annual scientific meeting of the Society of Gynecologic Surgeons.

The mesh system, which remains in clinical development, is called TOPAS. It was evaluated in 152 patients enrolled at 14 centers in the United States. All patients had failed at least two conservative treatments, such as pelvic floor exercises with or without biofeedback. The average duration of fecal incontinence was 110 months.

From a baseline of nine episodes per week, the median number of episodes of fecal incontinence fell to 2.5 times per week after surgery. This did not change when evaluated at 3, 6, or 12 months. The median number of episodes with urgency decreased from two at baseline to zero. In 19% of patients, fecal incontinence remained completely resolved over the 12 months of follow-up, according to Dr. Fenner, the study’s lead investigator and director of gynecology at the University of Michigan, Ann Arbor.

The mean procedure time for the minimally invasive surgery required to create the tunnel adjacent to the anus in which the mesh system is placed was 33 minutes. The average length of stay in the hospital was 11 hours.

Of the 104 adverse events recorded in the study, 98 were not considered serious. These included pelvic pain that resolved without treatment and infections treated with antibiotics. The two serious adverse events with the greatest potential to be treatment related were a deep venous thrombosis (DVT) and a case of worsening prolapse. There were no revisions, extrusions, or treatment-related deaths, Dr. Fenner said.

Quality of life analyses measured with standardized questionnaires demonstrated significant improvements in domains for lifestyle, coping, depression, and embarrassment, Dr. Fenner reported at the meeting, which was jointly sponsored by the American College of Surgeons.

In a critique invited by the SGS, Dr. Holly E. Richter, director of the division of urogynecology and pelvic reconstructive surgery at the University of Alabama at Birmingham, called the evidence of benefit after 12 months of follow-up “credible.” She agreed with Dr. Fenner’s conclusion that this a promising surgical therapy for refractory patients.

“These results are very good for a difficult population, but I think it is important to first demonstrate that patients cannot achieve an adequate reduction in symptoms with nonsurgical approaches before this approach is considered,” Dr. Richter said in an interview.

The study had no control arm because there were no proven treatments for patients with refractory incontinence at the time of its design, according to Dr. Fenner. Several options, including sacral nerve stimulation, have since become available, she said.

The TOPASsystem is currently under review by the Food and Drug Administration. Dr. Fenner said that approval, if granted, might still be a year away.

Dr. Fenner reported receiving research support from American Medical Systems, which manufactures the TOPAS system.

SAN DIEGO – An estimated 26-33 million prescriptions for compounded, non–FDA-approved menopausal hormone therapy are filled in the United States each year, with annual sales reaching $1.3-$1.7 billion, results from a national pharmacist survey suggest.

What’s more, 69% of pharmacists expect their custom-compounded hormone therapy business to grow over the next 2 years.

“This is key, because if you expect that there’s nearly equivalent prescribing of compounded hormone therapy and menopausal hormone therapy, then it behooves us as care providers to make sure that [consumers] understand the difference between something that’s FDA approved, monitored, and regulated, and something that’s compounded, less well-regulated, and that is not FDA monitored or tested in rigorous clinical trials,” lead study author JoAnn Pinkerton said during a press briefing at the annual meeting of the Endocrine Society. “There are concerns about overdosing and under-dosing, sterility issues, the issue of batch-to-batch stability, and also the fact that if you get an FDA-approved product, you get a ‘black box’ warning of everything that’s been reported for HT [hormone therapy]. If you get a compounded product, they’re not required to give you any information about the risks. Many women are using these products. They’re being prescribed and we want people to be educated about the differences.”

Following the release of Women’s Health Initiative (WHI) data linking menopausal hormone therapy (MHT) to certain health risks, FDA-approved MHT users decreased from about 17.9 million in 2002 to about 3.7 million in 2013, said Dr. Pinkerton, a professor of obstetrics and gynecology at the University of Virginia Health System, Charlottesville. “This resulted in a marked increase in the compounded ‘bioidentical’ hormone therapy market primarily, we believe, because of a lot of hype that they might be safer, more effective, and that estriol might prevent breast cancer,” Dr. Pinkerton said. Specifically, the compounded ‘bioidentical’ hormone therapy (CHT) market has grown “from almost a negligible amount to about 2.5 million women, which is about 2% of U.S. women based on consumer surveys and U.S Census data. In earlier consumer surveys, most women who use these products were not aware that they are not FDA approved. There’s a knowledge gap for providers and women to learn about.”

For the study, Dr. Pinkerton and her associates evaluated results from an online national survey that was e-mailed to 12,250 independent community pharmacies and independent compounding pharmacies in the fall of 2014. Respondents “had to be knowledgeable of the annual revenue and the volume of compounded and noncompounded [prescriptions] at the pharmacy locations,” Dr. Pinkerton said. “We asked questions including the percentage of nonsterile compounding volume that is CHT, the percentage of monthly prescriptions for each type of CHT, and the likelihood of MHT prescribing over the next 2 years.”

Based on complete responses from 483 pharmacists, the researchers found that an estimated 26-33 million CHT prescriptions are filled each year, which is similar to the number of FDA-approved MHT prescriptions filled each year. In addition, based on an average compounded price of $50, the estimated sales of CHT currently range from $1.3 to $1.7 billion. More than half of compounding pharmacies (69%) expected demand for CHT to grow by 5%-25%. “Very few expected that the market would ‘explode,’ and very few thought that it would decrease,” Dr. Pinkerton said.

Dr. Pinkerton disclosed that she has received grants and research support (paid to the University of Virginia) from Pfizer, Inc., TherapeuticsMD, Noven, Shionogi, and TXMD.

dbrunk@frontlinemedcom.com

On Twitter @dougbrunk

SAN DIEGO – An estimated 26-33 million prescriptions for compounded, non–FDA-approved menopausal hormone therapy are filled in the United States each year, with annual sales reaching $1.3-$1.7 billion, results from a national pharmacist survey suggest.

What’s more, 69% of pharmacists expect their custom-compounded hormone therapy business to grow over the next 2 years.

“This is key, because if you expect that there’s nearly equivalent prescribing of compounded hormone therapy and menopausal hormone therapy, then it behooves us as care providers to make sure that [consumers] understand the difference between something that’s FDA approved, monitored, and regulated, and something that’s compounded, less well-regulated, and that is not FDA monitored or tested in rigorous clinical trials,” lead study author JoAnn Pinkerton said during a press briefing at the annual meeting of the Endocrine Society. “There are concerns about overdosing and under-dosing, sterility issues, the issue of batch-to-batch stability, and also the fact that if you get an FDA-approved product, you get a ‘black box’ warning of everything that’s been reported for HT [hormone therapy]. If you get a compounded product, they’re not required to give you any information about the risks. Many women are using these products. They’re being prescribed and we want people to be educated about the differences.”

Following the release of Women’s Health Initiative (WHI) data linking menopausal hormone therapy (MHT) to certain health risks, FDA-approved MHT users decreased from about 17.9 million in 2002 to about 3.7 million in 2013, said Dr. Pinkerton, a professor of obstetrics and gynecology at the University of Virginia Health System, Charlottesville. “This resulted in a marked increase in the compounded ‘bioidentical’ hormone therapy market primarily, we believe, because of a lot of hype that they might be safer, more effective, and that estriol might prevent breast cancer,” Dr. Pinkerton said. Specifically, the compounded ‘bioidentical’ hormone therapy (CHT) market has grown “from almost a negligible amount to about 2.5 million women, which is about 2% of U.S. women based on consumer surveys and U.S Census data. In earlier consumer surveys, most women who use these products were not aware that they are not FDA approved. There’s a knowledge gap for providers and women to learn about.”

For the study, Dr. Pinkerton and her associates evaluated results from an online national survey that was e-mailed to 12,250 independent community pharmacies and independent compounding pharmacies in the fall of 2014. Respondents “had to be knowledgeable of the annual revenue and the volume of compounded and noncompounded [prescriptions] at the pharmacy locations,” Dr. Pinkerton said. “We asked questions including the percentage of nonsterile compounding volume that is CHT, the percentage of monthly prescriptions for each type of CHT, and the likelihood of MHT prescribing over the next 2 years.”

Based on complete responses from 483 pharmacists, the researchers found that an estimated 26-33 million CHT prescriptions are filled each year, which is similar to the number of FDA-approved MHT prescriptions filled each year. In addition, based on an average compounded price of $50, the estimated sales of CHT currently range from $1.3 to $1.7 billion. More than half of compounding pharmacies (69%) expected demand for CHT to grow by 5%-25%. “Very few expected that the market would ‘explode,’ and very few thought that it would decrease,” Dr. Pinkerton said.

Dr. Pinkerton disclosed that she has received grants and research support (paid to the University of Virginia) from Pfizer, Inc., TherapeuticsMD, Noven, Shionogi, and TXMD.

dbrunk@frontlinemedcom.com

On Twitter @dougbrunk

SAN DIEGO – An estimated 26-33 million prescriptions for compounded, non–FDA-approved menopausal hormone therapy are filled in the United States each year, with annual sales reaching $1.3-$1.7 billion, results from a national pharmacist survey suggest.

What’s more, 69% of pharmacists expect their custom-compounded hormone therapy business to grow over the next 2 years.

“This is key, because if you expect that there’s nearly equivalent prescribing of compounded hormone therapy and menopausal hormone therapy, then it behooves us as care providers to make sure that [consumers] understand the difference between something that’s FDA approved, monitored, and regulated, and something that’s compounded, less well-regulated, and that is not FDA monitored or tested in rigorous clinical trials,” lead study author JoAnn Pinkerton said during a press briefing at the annual meeting of the Endocrine Society. “There are concerns about overdosing and under-dosing, sterility issues, the issue of batch-to-batch stability, and also the fact that if you get an FDA-approved product, you get a ‘black box’ warning of everything that’s been reported for HT [hormone therapy]. If you get a compounded product, they’re not required to give you any information about the risks. Many women are using these products. They’re being prescribed and we want people to be educated about the differences.”

Following the release of Women’s Health Initiative (WHI) data linking menopausal hormone therapy (MHT) to certain health risks, FDA-approved MHT users decreased from about 17.9 million in 2002 to about 3.7 million in 2013, said Dr. Pinkerton, a professor of obstetrics and gynecology at the University of Virginia Health System, Charlottesville. “This resulted in a marked increase in the compounded ‘bioidentical’ hormone therapy market primarily, we believe, because of a lot of hype that they might be safer, more effective, and that estriol might prevent breast cancer,” Dr. Pinkerton said. Specifically, the compounded ‘bioidentical’ hormone therapy (CHT) market has grown “from almost a negligible amount to about 2.5 million women, which is about 2% of U.S. women based on consumer surveys and U.S Census data. In earlier consumer surveys, most women who use these products were not aware that they are not FDA approved. There’s a knowledge gap for providers and women to learn about.”

For the study, Dr. Pinkerton and her associates evaluated results from an online national survey that was e-mailed to 12,250 independent community pharmacies and independent compounding pharmacies in the fall of 2014. Respondents “had to be knowledgeable of the annual revenue and the volume of compounded and noncompounded [prescriptions] at the pharmacy locations,” Dr. Pinkerton said. “We asked questions including the percentage of nonsterile compounding volume that is CHT, the percentage of monthly prescriptions for each type of CHT, and the likelihood of MHT prescribing over the next 2 years.”

Based on complete responses from 483 pharmacists, the researchers found that an estimated 26-33 million CHT prescriptions are filled each year, which is similar to the number of FDA-approved MHT prescriptions filled each year. In addition, based on an average compounded price of $50, the estimated sales of CHT currently range from $1.3 to $1.7 billion. More than half of compounding pharmacies (69%) expected demand for CHT to grow by 5%-25%. “Very few expected that the market would ‘explode,’ and very few thought that it would decrease,” Dr. Pinkerton said.

Dr. Pinkerton disclosed that she has received grants and research support (paid to the University of Virginia) from Pfizer, Inc., TherapeuticsMD, Noven, Shionogi, and TXMD.

dbrunk@frontlinemedcom.com

On Twitter @dougbrunk

The health insurance giant UnitedHealthcare will soon require physicians to obtain prior authorization for hysterectomies, except vaginal hysterectomies conducted on an outpatient basis.

But the policy, which takes effect April 6, is being criticized by some physicians for interfering with the physician-patient relationship.

In a recent coverage update, UnitedHealthcare cited a committee opinion from the American Congress of Obstetricians and Gynecologists stating that vaginal hysterectomies are the preferred method because of evidence demonstrating that they are associated with better outcomes and fewer complications than are laparoscopic or abdominal hysterectomies.

The coverage policy will affect abdominal, laparoscopic, and laparoscopy-assisted vaginal hysterectomies, as well as vaginal hysterectomies not performed on an outpatient basis.

But ACOG officials themselves questioned the move. In a statement, they acknowledged that vaginal hysterectomy, when possible, produces the best outcomes for patients. “However, many factors are considered when making decisions about the ideal route of hysterectomy for each individual patient,” ACOG wrote. “These decisions are best made between a physician and a patient, not a third party administrative decision-maker.”

Officials at the AAGL, or the American Association of Gynecologic Laparoscopists, said they were still reviewing the change and declined to comment on it.

And physicians in practice are asking whether the decision is wise considering that an increasing number of ob.gyns. are becoming more proficient in performing laparoscopic procedures.

“The number of vaginal hysterectomies that residents do during their training has decreased substantially, whereas the number of laparoscopic cases increased,” Dr. Catherine A. Matthews, division chief of urogynecology and reconstructive pelvic surgery at the University of North Carolina, Chapel Hill, said in an interview. “It is an art that is slowly dying. I think it’s very fair to say more residents are more comfortable with the laparoscopic approach than with the vaginal approach.”

Dr. Isaac Schiff, chief of the department of obstetrics and gynecology at Massachusetts General Hospital in Boston, agreed.

“The problem may be that some doctors may not quite have the skills for vaginal hysterectomy that they have for laparoscopic hysterectomy,” he said in an interview. “They may feel more comfortable doing it laparoscopically than vaginally, and now they are being forced to do it vaginally.”

It is patients’ individual needs that may be getting lost in the debate, though, Dr. Matthews said.

With more surgeons performing laparoscopic procedures, “patients may have been steered [toward] having one mode of hysterectomy over another, based on an individual surgeon’s competence and bias, but it may not actually have been the best thing for any one individual patient,” she said.

The UnitedHealthcare coverage decision may actually promote a procedure that is typically better for patients, Dr. Matthews added, but unless physicians have the necessary training and comfort with it, a shift toward more vaginal hysterectomies won’t necessarily lead to better outcomes.

“If you get a bunch of laparoscopic surgeons trying to do vaginal hysterectomy, the morbidity may well increase, so it may not remain the least morbid intervention,” Dr. Matthews said.

In the future, changes in payment models could also push physicians toward vaginal hysterectomies, Dr. Matthews said. If more insurers adopt systems that offer a single rate of payments for all hysterectomies, regardless of the type of procedure, vaginal hysterectomies could become the preferred method since they are less costly to perform, she said.

gtwachtman@frontlinemedcom.com

The health insurance giant UnitedHealthcare will soon require physicians to obtain prior authorization for hysterectomies, except vaginal hysterectomies conducted on an outpatient basis.

But the policy, which takes effect April 6, is being criticized by some physicians for interfering with the physician-patient relationship.

In a recent coverage update, UnitedHealthcare cited a committee opinion from the American Congress of Obstetricians and Gynecologists stating that vaginal hysterectomies are the preferred method because of evidence demonstrating that they are associated with better outcomes and fewer complications than are laparoscopic or abdominal hysterectomies.

The coverage policy will affect abdominal, laparoscopic, and laparoscopy-assisted vaginal hysterectomies, as well as vaginal hysterectomies not performed on an outpatient basis.

But ACOG officials themselves questioned the move. In a statement, they acknowledged that vaginal hysterectomy, when possible, produces the best outcomes for patients. “However, many factors are considered when making decisions about the ideal route of hysterectomy for each individual patient,” ACOG wrote. “These decisions are best made between a physician and a patient, not a third party administrative decision-maker.”

Officials at the AAGL, or the American Association of Gynecologic Laparoscopists, said they were still reviewing the change and declined to comment on it.

And physicians in practice are asking whether the decision is wise considering that an increasing number of ob.gyns. are becoming more proficient in performing laparoscopic procedures.

“The number of vaginal hysterectomies that residents do during their training has decreased substantially, whereas the number of laparoscopic cases increased,” Dr. Catherine A. Matthews, division chief of urogynecology and reconstructive pelvic surgery at the University of North Carolina, Chapel Hill, said in an interview. “It is an art that is slowly dying. I think it’s very fair to say more residents are more comfortable with the laparoscopic approach than with the vaginal approach.”

Dr. Isaac Schiff, chief of the department of obstetrics and gynecology at Massachusetts General Hospital in Boston, agreed.

“The problem may be that some doctors may not quite have the skills for vaginal hysterectomy that they have for laparoscopic hysterectomy,” he said in an interview. “They may feel more comfortable doing it laparoscopically than vaginally, and now they are being forced to do it vaginally.”

It is patients’ individual needs that may be getting lost in the debate, though, Dr. Matthews said.

With more surgeons performing laparoscopic procedures, “patients may have been steered [toward] having one mode of hysterectomy over another, based on an individual surgeon’s competence and bias, but it may not actually have been the best thing for any one individual patient,” she said.

The UnitedHealthcare coverage decision may actually promote a procedure that is typically better for patients, Dr. Matthews added, but unless physicians have the necessary training and comfort with it, a shift toward more vaginal hysterectomies won’t necessarily lead to better outcomes.

“If you get a bunch of laparoscopic surgeons trying to do vaginal hysterectomy, the morbidity may well increase, so it may not remain the least morbid intervention,” Dr. Matthews said.

In the future, changes in payment models could also push physicians toward vaginal hysterectomies, Dr. Matthews said. If more insurers adopt systems that offer a single rate of payments for all hysterectomies, regardless of the type of procedure, vaginal hysterectomies could become the preferred method since they are less costly to perform, she said.

gtwachtman@frontlinemedcom.com

The health insurance giant UnitedHealthcare will soon require physicians to obtain prior authorization for hysterectomies, except vaginal hysterectomies conducted on an outpatient basis.

But the policy, which takes effect April 6, is being criticized by some physicians for interfering with the physician-patient relationship.

In a recent coverage update, UnitedHealthcare cited a committee opinion from the American Congress of Obstetricians and Gynecologists stating that vaginal hysterectomies are the preferred method because of evidence demonstrating that they are associated with better outcomes and fewer complications than are laparoscopic or abdominal hysterectomies.

The coverage policy will affect abdominal, laparoscopic, and laparoscopy-assisted vaginal hysterectomies, as well as vaginal hysterectomies not performed on an outpatient basis.

But ACOG officials themselves questioned the move. In a statement, they acknowledged that vaginal hysterectomy, when possible, produces the best outcomes for patients. “However, many factors are considered when making decisions about the ideal route of hysterectomy for each individual patient,” ACOG wrote. “These decisions are best made between a physician and a patient, not a third party administrative decision-maker.”

Officials at the AAGL, or the American Association of Gynecologic Laparoscopists, said they were still reviewing the change and declined to comment on it.

And physicians in practice are asking whether the decision is wise considering that an increasing number of ob.gyns. are becoming more proficient in performing laparoscopic procedures.

“The number of vaginal hysterectomies that residents do during their training has decreased substantially, whereas the number of laparoscopic cases increased,” Dr. Catherine A. Matthews, division chief of urogynecology and reconstructive pelvic surgery at the University of North Carolina, Chapel Hill, said in an interview. “It is an art that is slowly dying. I think it’s very fair to say more residents are more comfortable with the laparoscopic approach than with the vaginal approach.”

Dr. Isaac Schiff, chief of the department of obstetrics and gynecology at Massachusetts General Hospital in Boston, agreed.

“The problem may be that some doctors may not quite have the skills for vaginal hysterectomy that they have for laparoscopic hysterectomy,” he said in an interview. “They may feel more comfortable doing it laparoscopically than vaginally, and now they are being forced to do it vaginally.”

It is patients’ individual needs that may be getting lost in the debate, though, Dr. Matthews said.

With more surgeons performing laparoscopic procedures, “patients may have been steered [toward] having one mode of hysterectomy over another, based on an individual surgeon’s competence and bias, but it may not actually have been the best thing for any one individual patient,” she said.

The UnitedHealthcare coverage decision may actually promote a procedure that is typically better for patients, Dr. Matthews added, but unless physicians have the necessary training and comfort with it, a shift toward more vaginal hysterectomies won’t necessarily lead to better outcomes.

“If you get a bunch of laparoscopic surgeons trying to do vaginal hysterectomy, the morbidity may well increase, so it may not remain the least morbid intervention,” Dr. Matthews said.

In the future, changes in payment models could also push physicians toward vaginal hysterectomies, Dr. Matthews said. If more insurers adopt systems that offer a single rate of payments for all hysterectomies, regardless of the type of procedure, vaginal hysterectomies could become the preferred method since they are less costly to perform, she said.

gtwachtman@frontlinemedcom.com

Researchers have developed nomograms based on a variety of newly identified prognostic factors – tools that can enhance clinicians’ estimates of 2-year progression-free survival, 5-year overall survival, and pelvic recurrence for locally advanced cervical cancer, according to a report published online March 3 in Journal of Clinical Oncology.

Nomograms are graphic tools that allow rapid, simple calculation of a complex formula – in this case, survival odds and recurrence rates – based on the user’s input of relatively few data points. To develop the nomograms in this study, investigators first analyzed data from six multicenter Gynecologic Oncology Group clinical trials involving 2,042 patients with locally advanced cervical cancer. Most of these participants (65%) were treated with standard cisplatin-based chemoradiotherapy, and the remainder received either radiotherapy alone or a noncisplatin regimen, said Dr. Peter G. Rose of the Cleveland Clinic Foundation, and his associates.

They assessed numerous clinicopathologic and demographic factors to determine which ones were most useful for predicting survival and pelvic recurrence. Previous survival estimates for cervical cancer have been based primarily on disease stage, and, as expected, Dr. Rose and his colleagues found that disease stage, tumor size, pelvic node status, and performance status were significantly associated with progression-free and overall survival. But disease stage accounted for only 60% of the prognostic information in these study participants; the researchers discovered that tumor histology, patient race/ethnicity, tumor grade, and type of treatment also were significant predictors of survival.

They then used this information to devise the nomograms and to then validate their accuracy. The nomograms can now be used to more accurately estimate patient survival and disease recurrence, both in individual patients and in study populations, Dr. Rose and his associates said (J. Clin. Oncol. 2015 March 3 [doi:10.1200/JCO.2014.57.7122]). One limitation of basing the nomograms on clinical trial participants is that such patients tend to have better performance status, to be more motivated to treat their cancer aggressively, and to be more compliant with treatment than is the general population of patients encountered in real-world clinical practice, the investigators added.

Researchers have developed nomograms based on a variety of newly identified prognostic factors – tools that can enhance clinicians’ estimates of 2-year progression-free survival, 5-year overall survival, and pelvic recurrence for locally advanced cervical cancer, according to a report published online March 3 in Journal of Clinical Oncology.

Nomograms are graphic tools that allow rapid, simple calculation of a complex formula – in this case, survival odds and recurrence rates – based on the user’s input of relatively few data points. To develop the nomograms in this study, investigators first analyzed data from six multicenter Gynecologic Oncology Group clinical trials involving 2,042 patients with locally advanced cervical cancer. Most of these participants (65%) were treated with standard cisplatin-based chemoradiotherapy, and the remainder received either radiotherapy alone or a noncisplatin regimen, said Dr. Peter G. Rose of the Cleveland Clinic Foundation, and his associates.

They assessed numerous clinicopathologic and demographic factors to determine which ones were most useful for predicting survival and pelvic recurrence. Previous survival estimates for cervical cancer have been based primarily on disease stage, and, as expected, Dr. Rose and his colleagues found that disease stage, tumor size, pelvic node status, and performance status were significantly associated with progression-free and overall survival. But disease stage accounted for only 60% of the prognostic information in these study participants; the researchers discovered that tumor histology, patient race/ethnicity, tumor grade, and type of treatment also were significant predictors of survival.

They then used this information to devise the nomograms and to then validate their accuracy. The nomograms can now be used to more accurately estimate patient survival and disease recurrence, both in individual patients and in study populations, Dr. Rose and his associates said (J. Clin. Oncol. 2015 March 3 [doi:10.1200/JCO.2014.57.7122]). One limitation of basing the nomograms on clinical trial participants is that such patients tend to have better performance status, to be more motivated to treat their cancer aggressively, and to be more compliant with treatment than is the general population of patients encountered in real-world clinical practice, the investigators added.

Researchers have developed nomograms based on a variety of newly identified prognostic factors – tools that can enhance clinicians’ estimates of 2-year progression-free survival, 5-year overall survival, and pelvic recurrence for locally advanced cervical cancer, according to a report published online March 3 in Journal of Clinical Oncology.

Nomograms are graphic tools that allow rapid, simple calculation of a complex formula – in this case, survival odds and recurrence rates – based on the user’s input of relatively few data points. To develop the nomograms in this study, investigators first analyzed data from six multicenter Gynecologic Oncology Group clinical trials involving 2,042 patients with locally advanced cervical cancer. Most of these participants (65%) were treated with standard cisplatin-based chemoradiotherapy, and the remainder received either radiotherapy alone or a noncisplatin regimen, said Dr. Peter G. Rose of the Cleveland Clinic Foundation, and his associates.

They assessed numerous clinicopathologic and demographic factors to determine which ones were most useful for predicting survival and pelvic recurrence. Previous survival estimates for cervical cancer have been based primarily on disease stage, and, as expected, Dr. Rose and his colleagues found that disease stage, tumor size, pelvic node status, and performance status were significantly associated with progression-free and overall survival. But disease stage accounted for only 60% of the prognostic information in these study participants; the researchers discovered that tumor histology, patient race/ethnicity, tumor grade, and type of treatment also were significant predictors of survival.

They then used this information to devise the nomograms and to then validate their accuracy. The nomograms can now be used to more accurately estimate patient survival and disease recurrence, both in individual patients and in study populations, Dr. Rose and his associates said (J. Clin. Oncol. 2015 March 3 [doi:10.1200/JCO.2014.57.7122]). One limitation of basing the nomograms on clinical trial participants is that such patients tend to have better performance status, to be more motivated to treat their cancer aggressively, and to be more compliant with treatment than is the general population of patients encountered in real-world clinical practice, the investigators added.