Alicia Ault

The Centers for Medicare and Medicaid Services has chosen 14 communities to participate in the agency's demonstration project aimed at reducing unnecessary hospital readmissions.

The CMS had already put hospitals on notice that it would find a way to curb readmissions, which have proved to be very costly to the Medicare program. In his fiscal 2011 budget blueprint, President Barack Obama said that readmissions would be targeted, largely through bundling of payments to hospitals and physicians. The budget document stated that 18% of Medicare hospitalizations result in readmissions. About $26 billion could be saved over 10 years by reducing those rehospitalizations, according to the budget document.

The CMS Care Transitions Project “is a new approach” for the agency, Dr. Barry M. Straube, the agency's chief medical officer, said in a statement. Participants “will look in their own backyards to learn why hospital readmissions occur locally and how patients transition between health care settings.” Care transitions teams will then design strategies to go after the “underlying local drivers of readmissions.”

The pilot sites will be Providence, R.I.; Upper Capital Region, N.Y.; Western Pennsylvania; Southwestern New Jersey; Metro Atlanta East; Miami; Tuscaloosa, Ala.; Evansville, Ind.; Greater Lansing (Mich.) area; Omaha, Neb.; Baton Rouge, La.; Northwest Denver; Harlingen, Tex.; and Whatcom County, Wash.

The pilot will continue through summer 2011. The agency plans to make readmission rates at hospitals around the country available to the public later this year on the Hospital Compare Web site at www.hospitalcompare.hhs.gov

The Centers for Medicare and Medicaid Services has chosen 14 communities to participate in the agency's demonstration project aimed at reducing unnecessary hospital readmissions.

The CMS had already put hospitals on notice that it would find a way to curb readmissions, which have proved to be very costly to the Medicare program. In his fiscal 2011 budget blueprint, President Barack Obama said that readmissions would be targeted, largely through bundling of payments to hospitals and physicians. The budget document stated that 18% of Medicare hospitalizations result in readmissions. About $26 billion could be saved over 10 years by reducing those rehospitalizations, according to the budget document.

The CMS Care Transitions Project “is a new approach” for the agency, Dr. Barry M. Straube, the agency's chief medical officer, said in a statement. Participants “will look in their own backyards to learn why hospital readmissions occur locally and how patients transition between health care settings.” Care transitions teams will then design strategies to go after the “underlying local drivers of readmissions.”

The pilot sites will be Providence, R.I.; Upper Capital Region, N.Y.; Western Pennsylvania; Southwestern New Jersey; Metro Atlanta East; Miami; Tuscaloosa, Ala.; Evansville, Ind.; Greater Lansing (Mich.) area; Omaha, Neb.; Baton Rouge, La.; Northwest Denver; Harlingen, Tex.; and Whatcom County, Wash.

The pilot will continue through summer 2011. The agency plans to make readmission rates at hospitals around the country available to the public later this year on the Hospital Compare Web site at www.hospitalcompare.hhs.gov

The Centers for Medicare and Medicaid Services has chosen 14 communities to participate in the agency's demonstration project aimed at reducing unnecessary hospital readmissions.

The CMS had already put hospitals on notice that it would find a way to curb readmissions, which have proved to be very costly to the Medicare program. In his fiscal 2011 budget blueprint, President Barack Obama said that readmissions would be targeted, largely through bundling of payments to hospitals and physicians. The budget document stated that 18% of Medicare hospitalizations result in readmissions. About $26 billion could be saved over 10 years by reducing those rehospitalizations, according to the budget document.

The CMS Care Transitions Project “is a new approach” for the agency, Dr. Barry M. Straube, the agency's chief medical officer, said in a statement. Participants “will look in their own backyards to learn why hospital readmissions occur locally and how patients transition between health care settings.” Care transitions teams will then design strategies to go after the “underlying local drivers of readmissions.”

The pilot sites will be Providence, R.I.; Upper Capital Region, N.Y.; Western Pennsylvania; Southwestern New Jersey; Metro Atlanta East; Miami; Tuscaloosa, Ala.; Evansville, Ind.; Greater Lansing (Mich.) area; Omaha, Neb.; Baton Rouge, La.; Northwest Denver; Harlingen, Tex.; and Whatcom County, Wash.

The pilot will continue through summer 2011. The agency plans to make readmission rates at hospitals around the country available to the public later this year on the Hospital Compare Web site at www.hospitalcompare.hhs.gov

NEW ORLEANS — Surgical simulators offer important benefits over traditional educational approaches when it comes to gauging laparoscopic proficiency, according to a multicenter, randomized, controlled study of 56 ob.gyn. residents.

Simulators are likely to see more use and gain in importance, with the explosion in technology that has increased the number of modalities residents are expected to be comfortable using, Dr. Rajiv Gala said at the Society of Gynecologic Surgeons annual meeting. In addition, the restriction on residents' hours means many are having less actual operating room experience.

The current study was open to all ob.gyn. residents at seven medical centers. Dr. Gala, an ob.gyn. at Ochsner Medical Center in New Orleans, presented results on 56 program year 1 and PGY2 residents. The average number of laparoscopic cases at baseline was 5.2.

After residents performed one laparoscopic salpingectomy, they were randomized to training with a laparoscopic surgeon on a simulator station with five tasks or to no simulator training. Simulator training included five 30-minute sessions on five exercises: pattern cutting, Peg-Board transfer, endoloop suturing, and intracorporeal and extracorporeal knot tying.

Ten residents dropped out of the study, leaving 18 who received simulator training and 28 who received only traditional training. Then all residents were evaluated in the operating room while performing a laparoscopic salpingectomy. The faculty reviewer was blinded to the resident's training.

All the residents improved, but trained residents had significantly greater levels of improvement on all five tasks. With use of competency scores for laparoscopic skills established in 2003 (Surg. Endosc. 2003;17:964–7), which set a cutoff of 270, no residents were considered competent at the study's initiation. By the trial's conclusion, 94% of trained residents were judged competent with a mean score of 355, and 43% of nontrained residents were judged competent with a mean score of 235. Operating room performance was evaluated with the University of Toronto's Objective Structured Assessment of Technical Skills, which includes a series of checklists and a separate global rating score.

Limitations of the study included the number of dropouts and the fact that some residents had to complete the second procedure outside of the initial rotation. Strengths included the use of validated tasks for laparoscopic surgery and construct validity—all residents improved with training, said Dr. Gala.

“We believe that proficiency-based simulation does offer some significant benefit over traditional [gynecologic] education,” he said, adding that he hoped the study would push educators to “move from quantity performance to quality performance.”

Dr. Paul Tulikangas, ob.gyn. fellowship program director at Hartford (Conn.) Hospital, said Dr. Gala's paper was important, because “surgical simulation is going to be playing a bigger and bigger role for all surgeons.”

He praised the researchers for testing residents in the operating room after they had shown competency on the simulator. His daughter professes to be a golfer after playing with the Nintendo Wii simulator, but once she steps onto an actual course, she's not as competent, he said. This study “put the resident in the tee box.”

Some improvement, however, might have been due to the fact that the simulator-trained group spent more time with faculty, he said.

The project was funded by an educational grant from the Society of Gynecologic Surgeons.

NEW ORLEANS — Surgical simulators offer important benefits over traditional educational approaches when it comes to gauging laparoscopic proficiency, according to a multicenter, randomized, controlled study of 56 ob.gyn. residents.

Simulators are likely to see more use and gain in importance, with the explosion in technology that has increased the number of modalities residents are expected to be comfortable using, Dr. Rajiv Gala said at the Society of Gynecologic Surgeons annual meeting. In addition, the restriction on residents' hours means many are having less actual operating room experience.

The current study was open to all ob.gyn. residents at seven medical centers. Dr. Gala, an ob.gyn. at Ochsner Medical Center in New Orleans, presented results on 56 program year 1 and PGY2 residents. The average number of laparoscopic cases at baseline was 5.2.

After residents performed one laparoscopic salpingectomy, they were randomized to training with a laparoscopic surgeon on a simulator station with five tasks or to no simulator training. Simulator training included five 30-minute sessions on five exercises: pattern cutting, Peg-Board transfer, endoloop suturing, and intracorporeal and extracorporeal knot tying.

Ten residents dropped out of the study, leaving 18 who received simulator training and 28 who received only traditional training. Then all residents were evaluated in the operating room while performing a laparoscopic salpingectomy. The faculty reviewer was blinded to the resident's training.

All the residents improved, but trained residents had significantly greater levels of improvement on all five tasks. With use of competency scores for laparoscopic skills established in 2003 (Surg. Endosc. 2003;17:964–7), which set a cutoff of 270, no residents were considered competent at the study's initiation. By the trial's conclusion, 94% of trained residents were judged competent with a mean score of 355, and 43% of nontrained residents were judged competent with a mean score of 235. Operating room performance was evaluated with the University of Toronto's Objective Structured Assessment of Technical Skills, which includes a series of checklists and a separate global rating score.

Limitations of the study included the number of dropouts and the fact that some residents had to complete the second procedure outside of the initial rotation. Strengths included the use of validated tasks for laparoscopic surgery and construct validity—all residents improved with training, said Dr. Gala.

“We believe that proficiency-based simulation does offer some significant benefit over traditional [gynecologic] education,” he said, adding that he hoped the study would push educators to “move from quantity performance to quality performance.”

Dr. Paul Tulikangas, ob.gyn. fellowship program director at Hartford (Conn.) Hospital, said Dr. Gala's paper was important, because “surgical simulation is going to be playing a bigger and bigger role for all surgeons.”

He praised the researchers for testing residents in the operating room after they had shown competency on the simulator. His daughter professes to be a golfer after playing with the Nintendo Wii simulator, but once she steps onto an actual course, she's not as competent, he said. This study “put the resident in the tee box.”

Some improvement, however, might have been due to the fact that the simulator-trained group spent more time with faculty, he said.

The project was funded by an educational grant from the Society of Gynecologic Surgeons.

NEW ORLEANS — Surgical simulators offer important benefits over traditional educational approaches when it comes to gauging laparoscopic proficiency, according to a multicenter, randomized, controlled study of 56 ob.gyn. residents.

Simulators are likely to see more use and gain in importance, with the explosion in technology that has increased the number of modalities residents are expected to be comfortable using, Dr. Rajiv Gala said at the Society of Gynecologic Surgeons annual meeting. In addition, the restriction on residents' hours means many are having less actual operating room experience.

The current study was open to all ob.gyn. residents at seven medical centers. Dr. Gala, an ob.gyn. at Ochsner Medical Center in New Orleans, presented results on 56 program year 1 and PGY2 residents. The average number of laparoscopic cases at baseline was 5.2.

After residents performed one laparoscopic salpingectomy, they were randomized to training with a laparoscopic surgeon on a simulator station with five tasks or to no simulator training. Simulator training included five 30-minute sessions on five exercises: pattern cutting, Peg-Board transfer, endoloop suturing, and intracorporeal and extracorporeal knot tying.

Ten residents dropped out of the study, leaving 18 who received simulator training and 28 who received only traditional training. Then all residents were evaluated in the operating room while performing a laparoscopic salpingectomy. The faculty reviewer was blinded to the resident's training.

All the residents improved, but trained residents had significantly greater levels of improvement on all five tasks. With use of competency scores for laparoscopic skills established in 2003 (Surg. Endosc. 2003;17:964–7), which set a cutoff of 270, no residents were considered competent at the study's initiation. By the trial's conclusion, 94% of trained residents were judged competent with a mean score of 355, and 43% of nontrained residents were judged competent with a mean score of 235. Operating room performance was evaluated with the University of Toronto's Objective Structured Assessment of Technical Skills, which includes a series of checklists and a separate global rating score.

Limitations of the study included the number of dropouts and the fact that some residents had to complete the second procedure outside of the initial rotation. Strengths included the use of validated tasks for laparoscopic surgery and construct validity—all residents improved with training, said Dr. Gala.

“We believe that proficiency-based simulation does offer some significant benefit over traditional [gynecologic] education,” he said, adding that he hoped the study would push educators to “move from quantity performance to quality performance.”

Dr. Paul Tulikangas, ob.gyn. fellowship program director at Hartford (Conn.) Hospital, said Dr. Gala's paper was important, because “surgical simulation is going to be playing a bigger and bigger role for all surgeons.”

He praised the researchers for testing residents in the operating room after they had shown competency on the simulator. His daughter professes to be a golfer after playing with the Nintendo Wii simulator, but once she steps onto an actual course, she's not as competent, he said. This study “put the resident in the tee box.”

Some improvement, however, might have been due to the fact that the simulator-trained group spent more time with faculty, he said.

The project was funded by an educational grant from the Society of Gynecologic Surgeons.

NEW ORLEANS — The pubovaginal Mersilene mesh sling is effective in treating complicated urinary stress incontinence and holds up as long as 15 years, based on follow-up data for 296 patients in a trial first reported on in 2001.

The goal of follow-up was to determine the short- (less than 2 years), intermediate- (2–5 years), and long-term (more than 5 years up through 18 years) objective and subjective efficacy of the mesh sling for three at-risk urinary stress incontinence (USI) subgroups, Dr. Stephen B. Young said at the annual meeting of the Society of Gynecologic Surgeons.

Overall, the objective cure rate was 89% in the 194 patients who had short-term urodynamic studies. In the 45 patients in the intermediate group, the objective cure rate was 87%, and in the 57 patients in the long-term group, it was 91% (see chart).

The subjects in the study were diagnosed with urinary stress incontinence between 1990 and 2008. The results of the initial 5-year study were published in 2001 in the American Journal of Obstetrics and Gynecology (185:32–40), with Dr. Young as the lead author.

The procedures were all performed by a single surgeon at a single institution.

The patients were followed at 1, 5, 10, and 15 years with urodynamic studies.

Of the 306 patients in the initial study, 133 (43%) had intrinsic sphincter deficiency, 82 (27%) had recurrent USI, and 91 (30%) had chronically increased intra-abdominal pressure. (Ten patients were not followed because they did not have the urodynamic studies.)

The short-term cure rate was 81% for intrinsic sphincter deficiency patients, 96% for the recurrent USI group, and 96% for the intra-abdominal pressure group. At the longer mark, cure rates were 90% for the intrinsic sphincter deficiency group, 84% for the USI group, and 100% for the intra-abdominal group, Dr. Young, chief of urogynecology and reconstructive pelvic surgery at UMass Memorial Medical Center in Worcester, reported.

The subjective cure rate was based on patients' response to question 17 on the Pelvic Floor Distress Inventory-Short Form 20 (PFDI-20), which asked whether there was leakage related to coughing, sneezing, or laughing.

Only 136 patients completed the PFDI and the short form of the Pelvic Floor Impact Questionnaire (PFIQ-17), however. Dr. Young said that he and his colleagues plan a complete analysis of the two questionnaires and of a home pad test.

And yet another study will analyze all the adverse events for the 306 patients.

Discussant Dr. Ralph Chesson, section chief of urogynecology and pelvic surgery at the Louisiana State University Health Sciences Center, New Orleans, said that the study proved that the mesh sling “had excellent short- and long-term success rates in a beautiful study.”

But he noted, just having a single surgeon somewhat weakened results.

Dr. Young said he had no disclosures to report.

ELSEVIER GLOBAL MEDICAL NEWS

NEW ORLEANS — The pubovaginal Mersilene mesh sling is effective in treating complicated urinary stress incontinence and holds up as long as 15 years, based on follow-up data for 296 patients in a trial first reported on in 2001.

The goal of follow-up was to determine the short- (less than 2 years), intermediate- (2–5 years), and long-term (more than 5 years up through 18 years) objective and subjective efficacy of the mesh sling for three at-risk urinary stress incontinence (USI) subgroups, Dr. Stephen B. Young said at the annual meeting of the Society of Gynecologic Surgeons.

Overall, the objective cure rate was 89% in the 194 patients who had short-term urodynamic studies. In the 45 patients in the intermediate group, the objective cure rate was 87%, and in the 57 patients in the long-term group, it was 91% (see chart).

The subjects in the study were diagnosed with urinary stress incontinence between 1990 and 2008. The results of the initial 5-year study were published in 2001 in the American Journal of Obstetrics and Gynecology (185:32–40), with Dr. Young as the lead author.

The procedures were all performed by a single surgeon at a single institution.

The patients were followed at 1, 5, 10, and 15 years with urodynamic studies.

Of the 306 patients in the initial study, 133 (43%) had intrinsic sphincter deficiency, 82 (27%) had recurrent USI, and 91 (30%) had chronically increased intra-abdominal pressure. (Ten patients were not followed because they did not have the urodynamic studies.)

The short-term cure rate was 81% for intrinsic sphincter deficiency patients, 96% for the recurrent USI group, and 96% for the intra-abdominal pressure group. At the longer mark, cure rates were 90% for the intrinsic sphincter deficiency group, 84% for the USI group, and 100% for the intra-abdominal group, Dr. Young, chief of urogynecology and reconstructive pelvic surgery at UMass Memorial Medical Center in Worcester, reported.

The subjective cure rate was based on patients' response to question 17 on the Pelvic Floor Distress Inventory-Short Form 20 (PFDI-20), which asked whether there was leakage related to coughing, sneezing, or laughing.

Only 136 patients completed the PFDI and the short form of the Pelvic Floor Impact Questionnaire (PFIQ-17), however. Dr. Young said that he and his colleagues plan a complete analysis of the two questionnaires and of a home pad test.

And yet another study will analyze all the adverse events for the 306 patients.

Discussant Dr. Ralph Chesson, section chief of urogynecology and pelvic surgery at the Louisiana State University Health Sciences Center, New Orleans, said that the study proved that the mesh sling “had excellent short- and long-term success rates in a beautiful study.”

But he noted, just having a single surgeon somewhat weakened results.

Dr. Young said he had no disclosures to report.

ELSEVIER GLOBAL MEDICAL NEWS

NEW ORLEANS — The pubovaginal Mersilene mesh sling is effective in treating complicated urinary stress incontinence and holds up as long as 15 years, based on follow-up data for 296 patients in a trial first reported on in 2001.

The goal of follow-up was to determine the short- (less than 2 years), intermediate- (2–5 years), and long-term (more than 5 years up through 18 years) objective and subjective efficacy of the mesh sling for three at-risk urinary stress incontinence (USI) subgroups, Dr. Stephen B. Young said at the annual meeting of the Society of Gynecologic Surgeons.

Overall, the objective cure rate was 89% in the 194 patients who had short-term urodynamic studies. In the 45 patients in the intermediate group, the objective cure rate was 87%, and in the 57 patients in the long-term group, it was 91% (see chart).

The subjects in the study were diagnosed with urinary stress incontinence between 1990 and 2008. The results of the initial 5-year study were published in 2001 in the American Journal of Obstetrics and Gynecology (185:32–40), with Dr. Young as the lead author.

The procedures were all performed by a single surgeon at a single institution.

The patients were followed at 1, 5, 10, and 15 years with urodynamic studies.

Of the 306 patients in the initial study, 133 (43%) had intrinsic sphincter deficiency, 82 (27%) had recurrent USI, and 91 (30%) had chronically increased intra-abdominal pressure. (Ten patients were not followed because they did not have the urodynamic studies.)

The short-term cure rate was 81% for intrinsic sphincter deficiency patients, 96% for the recurrent USI group, and 96% for the intra-abdominal pressure group. At the longer mark, cure rates were 90% for the intrinsic sphincter deficiency group, 84% for the USI group, and 100% for the intra-abdominal group, Dr. Young, chief of urogynecology and reconstructive pelvic surgery at UMass Memorial Medical Center in Worcester, reported.

The subjective cure rate was based on patients' response to question 17 on the Pelvic Floor Distress Inventory-Short Form 20 (PFDI-20), which asked whether there was leakage related to coughing, sneezing, or laughing.

Only 136 patients completed the PFDI and the short form of the Pelvic Floor Impact Questionnaire (PFIQ-17), however. Dr. Young said that he and his colleagues plan a complete analysis of the two questionnaires and of a home pad test.

And yet another study will analyze all the adverse events for the 306 patients.

Discussant Dr. Ralph Chesson, section chief of urogynecology and pelvic surgery at the Louisiana State University Health Sciences Center, New Orleans, said that the study proved that the mesh sling “had excellent short- and long-term success rates in a beautiful study.”

But he noted, just having a single surgeon somewhat weakened results.

Dr. Young said he had no disclosures to report.

ELSEVIER GLOBAL MEDICAL NEWS

NEW ORLEANS — Laparoendoscopic single-site surgery has been gaining credibility in urology and general surgery but has been less accepted in gynecologic surgery, even though it offers many advantages to patients and is not much different from traditional laparoscopic surgery, said Dr. Kevin Stepp.

Dr. Stepp, director of gynecologic surgery education at MetroHealth/Cleveland Clinic, presented a video on basic laparoendoscopic single-site (LESS) techniques for a total hysterectomy and related his experience using the procedure to the Society of Gynecologic Surgeons at its annual meeting.

With LESS, there is only one incision through the umbilicus. Specific instrumentation and a single port that allows multiple devices to access the abdomen are used. Dr. Stepp said he has employed the TriPort laparoscopic access device, made by Advanced Surgical Concepts.

Other techniques and ports are available, and each has its own advantages, he said.

The surgical entry is through the traditional laparoscopic technique, with instruments advanced through the TriPort.

The port's plastic sleeve is pulled up as the port and instruments are advanced, until the port is firmly in place against the abdomen, said Dr. Stepp. The port is clamped in place.

Dr. Stepp recommended suturing the peritoneum to the fascia in obese patients to prevent the port's inner ring from slipping into the pre-peritoneal space.

With laparoscopy, there is always the potential for what Dr. Stepp called “sword fighting” or the clashing of instruments. With a single port, instrument handles are close together. But LESS-specific instrumentation—designed with flexible tips—helps minimize the potential for sword fights, he said. Olympus makes a camera that can flex greater than 90 degrees in any direction, for instance.

Several companies make instruments with reticulated hands that allow the operator to triangulate and increase the distance from each operating hand.

The LESS total hysterectomy is performed in a manner similar to the laparoscopic technique. “For total hysterectomies, we find it easier to begin with the primary surgeon standing near the patient's left shoulder,” said Dr. Stepp.

Once the uterus is ready for removal, it can be delivered vaginally, he said. The vaginal cut can be closed laparoscopically, but the learning curve is greater, he said.

Suturing can be facilitated with a suturing device, but with a multichannel port, the suture sometimes can get wrapped around other devices. “We suggest removing them if possible” during suturing, he said.

Initial experience has shown that LESS is not much different from conventional three-port laparoscopy, said Dr. Stepp.

It is important to keep the instruments lubricated and maintain the seal around the port.

The camera can be kept in a vertical position, which is good for posterior views and helps it stay out of the way of operative instruments outside the body.

Or the camera can be kept in a more horizontal position, flat against the patient's abdomen and chest; that also keeps it out of the way of the operative instruments.

And by using the right and left flexion on the camera, the distance can be increased even further, providing more work space, he said.

“If you use three ports for your laparoscopy, you can do this,” Dr. Stepp told attendees.

It also is possible to do it without losing money, if device purchases are made judiciously. TriPort and its competitors seem to cost $300-$350. Some tools already on the shelf can be used, but the newer LESS-specific devices may run $100-$400 each.

Dr. Stepp reported on 22 patients who underwent LESS at MetroHealth, 19 of them for hysterectomies.

The initial operative time was just under 3 hours, but so far in 2009, the surgeons have shaved 30 minutes off the procedure, and they're doing larger uteri, he said. Surgery time was directly related to body mass index and uterine weight.

The mean uterine weight was 324 g, but the procedure has been done on uteri weighing up to 1,600 g.

To Dr. Stepp, the most exciting development was the reduction in narcotics use.

Patients were taking narcotics an average of 2.5 days, and then using ibuprofen for 5 days.

Patients desiring to go back to work were on the job in 3.5 days, the surgeon reported.

The presence of adhesions did not change operative time.

There were no interoperative complications and no conversions. Vaginal bleeding on day 6 in one patient was repaired with sutures.

Dr. Stepp and his colleagues have performed LESS on all patients they would have addressed with three surgical incisions, including emergent cases.

“It is truly an amazing time, an exciting time for minimally invasive surgery,” Dr. James Carter, director of gynecologic minimally invasive surgery at the Medical University of South Carolina, Charleston, said in discussing Dr. Stepp's work.

He said that it should encourage gynecologic surgeons to push the envelope, as urology and general surgery colleagues have.

The tips from Dr. Stepp “should perhaps shorten the learning curve,” he added.

Dr. Stepp disclosed that he is a consultant for Covidien, a health care device and supplies company.

NEW ORLEANS — Laparoendoscopic single-site surgery has been gaining credibility in urology and general surgery but has been less accepted in gynecologic surgery, even though it offers many advantages to patients and is not much different from traditional laparoscopic surgery, said Dr. Kevin Stepp.

Dr. Stepp, director of gynecologic surgery education at MetroHealth/Cleveland Clinic, presented a video on basic laparoendoscopic single-site (LESS) techniques for a total hysterectomy and related his experience using the procedure to the Society of Gynecologic Surgeons at its annual meeting.

With LESS, there is only one incision through the umbilicus. Specific instrumentation and a single port that allows multiple devices to access the abdomen are used. Dr. Stepp said he has employed the TriPort laparoscopic access device, made by Advanced Surgical Concepts.

Other techniques and ports are available, and each has its own advantages, he said.

The surgical entry is through the traditional laparoscopic technique, with instruments advanced through the TriPort.

The port's plastic sleeve is pulled up as the port and instruments are advanced, until the port is firmly in place against the abdomen, said Dr. Stepp. The port is clamped in place.

Dr. Stepp recommended suturing the peritoneum to the fascia in obese patients to prevent the port's inner ring from slipping into the pre-peritoneal space.

With laparoscopy, there is always the potential for what Dr. Stepp called “sword fighting” or the clashing of instruments. With a single port, instrument handles are close together. But LESS-specific instrumentation—designed with flexible tips—helps minimize the potential for sword fights, he said. Olympus makes a camera that can flex greater than 90 degrees in any direction, for instance.

Several companies make instruments with reticulated hands that allow the operator to triangulate and increase the distance from each operating hand.

The LESS total hysterectomy is performed in a manner similar to the laparoscopic technique. “For total hysterectomies, we find it easier to begin with the primary surgeon standing near the patient's left shoulder,” said Dr. Stepp.

Once the uterus is ready for removal, it can be delivered vaginally, he said. The vaginal cut can be closed laparoscopically, but the learning curve is greater, he said.

Suturing can be facilitated with a suturing device, but with a multichannel port, the suture sometimes can get wrapped around other devices. “We suggest removing them if possible” during suturing, he said.

Initial experience has shown that LESS is not much different from conventional three-port laparoscopy, said Dr. Stepp.

It is important to keep the instruments lubricated and maintain the seal around the port.

The camera can be kept in a vertical position, which is good for posterior views and helps it stay out of the way of operative instruments outside the body.

Or the camera can be kept in a more horizontal position, flat against the patient's abdomen and chest; that also keeps it out of the way of the operative instruments.

And by using the right and left flexion on the camera, the distance can be increased even further, providing more work space, he said.

“If you use three ports for your laparoscopy, you can do this,” Dr. Stepp told attendees.

It also is possible to do it without losing money, if device purchases are made judiciously. TriPort and its competitors seem to cost $300-$350. Some tools already on the shelf can be used, but the newer LESS-specific devices may run $100-$400 each.

Dr. Stepp reported on 22 patients who underwent LESS at MetroHealth, 19 of them for hysterectomies.

The initial operative time was just under 3 hours, but so far in 2009, the surgeons have shaved 30 minutes off the procedure, and they're doing larger uteri, he said. Surgery time was directly related to body mass index and uterine weight.

The mean uterine weight was 324 g, but the procedure has been done on uteri weighing up to 1,600 g.

To Dr. Stepp, the most exciting development was the reduction in narcotics use.

Patients were taking narcotics an average of 2.5 days, and then using ibuprofen for 5 days.

Patients desiring to go back to work were on the job in 3.5 days, the surgeon reported.

The presence of adhesions did not change operative time.

There were no interoperative complications and no conversions. Vaginal bleeding on day 6 in one patient was repaired with sutures.

Dr. Stepp and his colleagues have performed LESS on all patients they would have addressed with three surgical incisions, including emergent cases.

“It is truly an amazing time, an exciting time for minimally invasive surgery,” Dr. James Carter, director of gynecologic minimally invasive surgery at the Medical University of South Carolina, Charleston, said in discussing Dr. Stepp's work.

He said that it should encourage gynecologic surgeons to push the envelope, as urology and general surgery colleagues have.

The tips from Dr. Stepp “should perhaps shorten the learning curve,” he added.

Dr. Stepp disclosed that he is a consultant for Covidien, a health care device and supplies company.

NEW ORLEANS — Laparoendoscopic single-site surgery has been gaining credibility in urology and general surgery but has been less accepted in gynecologic surgery, even though it offers many advantages to patients and is not much different from traditional laparoscopic surgery, said Dr. Kevin Stepp.

Dr. Stepp, director of gynecologic surgery education at MetroHealth/Cleveland Clinic, presented a video on basic laparoendoscopic single-site (LESS) techniques for a total hysterectomy and related his experience using the procedure to the Society of Gynecologic Surgeons at its annual meeting.

With LESS, there is only one incision through the umbilicus. Specific instrumentation and a single port that allows multiple devices to access the abdomen are used. Dr. Stepp said he has employed the TriPort laparoscopic access device, made by Advanced Surgical Concepts.

Other techniques and ports are available, and each has its own advantages, he said.

The surgical entry is through the traditional laparoscopic technique, with instruments advanced through the TriPort.

The port's plastic sleeve is pulled up as the port and instruments are advanced, until the port is firmly in place against the abdomen, said Dr. Stepp. The port is clamped in place.

Dr. Stepp recommended suturing the peritoneum to the fascia in obese patients to prevent the port's inner ring from slipping into the pre-peritoneal space.

With laparoscopy, there is always the potential for what Dr. Stepp called “sword fighting” or the clashing of instruments. With a single port, instrument handles are close together. But LESS-specific instrumentation—designed with flexible tips—helps minimize the potential for sword fights, he said. Olympus makes a camera that can flex greater than 90 degrees in any direction, for instance.

Several companies make instruments with reticulated hands that allow the operator to triangulate and increase the distance from each operating hand.

The LESS total hysterectomy is performed in a manner similar to the laparoscopic technique. “For total hysterectomies, we find it easier to begin with the primary surgeon standing near the patient's left shoulder,” said Dr. Stepp.

Once the uterus is ready for removal, it can be delivered vaginally, he said. The vaginal cut can be closed laparoscopically, but the learning curve is greater, he said.

Suturing can be facilitated with a suturing device, but with a multichannel port, the suture sometimes can get wrapped around other devices. “We suggest removing them if possible” during suturing, he said.

Initial experience has shown that LESS is not much different from conventional three-port laparoscopy, said Dr. Stepp.

It is important to keep the instruments lubricated and maintain the seal around the port.

The camera can be kept in a vertical position, which is good for posterior views and helps it stay out of the way of operative instruments outside the body.

Or the camera can be kept in a more horizontal position, flat against the patient's abdomen and chest; that also keeps it out of the way of the operative instruments.

And by using the right and left flexion on the camera, the distance can be increased even further, providing more work space, he said.

“If you use three ports for your laparoscopy, you can do this,” Dr. Stepp told attendees.

It also is possible to do it without losing money, if device purchases are made judiciously. TriPort and its competitors seem to cost $300-$350. Some tools already on the shelf can be used, but the newer LESS-specific devices may run $100-$400 each.

Dr. Stepp reported on 22 patients who underwent LESS at MetroHealth, 19 of them for hysterectomies.

The initial operative time was just under 3 hours, but so far in 2009, the surgeons have shaved 30 minutes off the procedure, and they're doing larger uteri, he said. Surgery time was directly related to body mass index and uterine weight.

The mean uterine weight was 324 g, but the procedure has been done on uteri weighing up to 1,600 g.

To Dr. Stepp, the most exciting development was the reduction in narcotics use.

Patients were taking narcotics an average of 2.5 days, and then using ibuprofen for 5 days.

Patients desiring to go back to work were on the job in 3.5 days, the surgeon reported.

The presence of adhesions did not change operative time.

There were no interoperative complications and no conversions. Vaginal bleeding on day 6 in one patient was repaired with sutures.

Dr. Stepp and his colleagues have performed LESS on all patients they would have addressed with three surgical incisions, including emergent cases.

“It is truly an amazing time, an exciting time for minimally invasive surgery,” Dr. James Carter, director of gynecologic minimally invasive surgery at the Medical University of South Carolina, Charleston, said in discussing Dr. Stepp's work.

He said that it should encourage gynecologic surgeons to push the envelope, as urology and general surgery colleagues have.

The tips from Dr. Stepp “should perhaps shorten the learning curve,” he added.

Dr. Stepp disclosed that he is a consultant for Covidien, a health care device and supplies company.

Hospitals are barely meeting quality and efficiency standards, according to findings from a survey issued by the Leapfrog Group, an organization made up of some of America's largest employers.

When it came to efficiency (offering the highest quality at the lowest cost) only 24% of hospitals met the group's standard for coronary artery bypass surgery, only 21% for coronary angioplasty, and 14% for acute myocardial infarction and pneumonia, reported the group.

“The big word is going to have to be 'disappointing,'” said Leapfrog Group CEO Leah Binder in a briefing on the 2008 results. For high-risk procedures in particular, the results “do not give me comfort that any hospital in this country can adequately care for my family,” she said, adding that, although there have been improvements over the past few years, the “numbers simply aren't adequate for the most expensive health care system in the world and what should be the best health care system in the world.”

Since 2000, the Leapfrog Group has asked hospitals to voluntarily complete a quality survey. The data are used to guide benefits design and purchasing decisions, said Ms. Binder.

Leapfrog data are also used by hundreds of employers who are not part of the group, and it is publicly available, down to the individual hospital, on Leapfrog's Web site (www.leapfroggroup.org

In 2008, 1,282 hospitals in 44 states completed the survey. Leapfrog has created the quality standards, but they are based partly on existing validated measures and were rooted in the seminal 1999 Institute of Medicine report on quality that estimated that 45,000–98,000 U.S. patients were dying each year because of preventable medical errors, according to Ms. Binder.

For instance, Leapfrog says that having an intensivist can reduce mortality by 40% in the ICU and 30% overall. And yet, only 31% of surveyed hospitals met the Leapfrog standards for ICU staffing in 2008. That is progress, as only 10% met the standard in 2002, said Barbara Rudolph, director of the Leapfrog survey. Leapfrog also queried facilities on whether they met volume and risk-adjusted mortality standards and were adhering to national, evidence-based guidelines for certain high-risk procedures. Only 5% met aortic abdominal aneurysm repair standards, and only 7% met standards for aortic valve replacement. Some 32% met the standard for high-risk deliveries. At the high end, 43% hit the mark for coronary artery bypass surgery. Ms. Rudolph said she believed that the CABG numbers were improving because there has been so much public reporting of these data, through Medicare and various state efforts.

Never-events—such as wrong-site surgery—have also been in the limelight recently. Medicare has said it will not pay for these events. Leapfrog's standard goes somewhat further: Hospitals must agree to apologize to the patient and/or family for the event, to report the event to a patient safety organization, to study the event to determine why it happened, and to not charge for care related to the event. In 2008, 65% of facilities agreed to the standard, up from 53% in the previous year.

Like Medicare, Leapfrog has also been looking at hospital-acquired conditions such as pressure ulcers and injuries that occur during an admission. The group found that 25%-30% of hospitals met the standards, but that there was wide variation among facilities.

Hospitals did especially poorly when it came to meeting the computerized order-entry system standard (that is, entering at least 75% of medication orders and using Leapfrog's evaluation tool to assess the system). Such systems can prevent up to 3 million serious errors, said Ms. Rudolph. But only 7% of hospitals were meeting that standard. There was improvement in all categories, she said, adding that some hospitals that are coming up with very innovative solutions.

Leapfrog Group was founded in November 2000 by the Business Roundtable. It is supported by its members, which include major employers such as the General Electric Co., employer purchasing coalitions, and pension plans. The Robert Wood Johnson Foundation, the Commonwealth Fund, and the Agency for Healthcare Research and Quality also provide support.

Hospitals are barely meeting quality and efficiency standards, according to findings from a survey issued by the Leapfrog Group, an organization made up of some of America's largest employers.

When it came to efficiency (offering the highest quality at the lowest cost) only 24% of hospitals met the group's standard for coronary artery bypass surgery, only 21% for coronary angioplasty, and 14% for acute myocardial infarction and pneumonia, reported the group.

“The big word is going to have to be 'disappointing,'” said Leapfrog Group CEO Leah Binder in a briefing on the 2008 results. For high-risk procedures in particular, the results “do not give me comfort that any hospital in this country can adequately care for my family,” she said, adding that, although there have been improvements over the past few years, the “numbers simply aren't adequate for the most expensive health care system in the world and what should be the best health care system in the world.”

Since 2000, the Leapfrog Group has asked hospitals to voluntarily complete a quality survey. The data are used to guide benefits design and purchasing decisions, said Ms. Binder.

Leapfrog data are also used by hundreds of employers who are not part of the group, and it is publicly available, down to the individual hospital, on Leapfrog's Web site (www.leapfroggroup.org

In 2008, 1,282 hospitals in 44 states completed the survey. Leapfrog has created the quality standards, but they are based partly on existing validated measures and were rooted in the seminal 1999 Institute of Medicine report on quality that estimated that 45,000–98,000 U.S. patients were dying each year because of preventable medical errors, according to Ms. Binder.

For instance, Leapfrog says that having an intensivist can reduce mortality by 40% in the ICU and 30% overall. And yet, only 31% of surveyed hospitals met the Leapfrog standards for ICU staffing in 2008. That is progress, as only 10% met the standard in 2002, said Barbara Rudolph, director of the Leapfrog survey. Leapfrog also queried facilities on whether they met volume and risk-adjusted mortality standards and were adhering to national, evidence-based guidelines for certain high-risk procedures. Only 5% met aortic abdominal aneurysm repair standards, and only 7% met standards for aortic valve replacement. Some 32% met the standard for high-risk deliveries. At the high end, 43% hit the mark for coronary artery bypass surgery. Ms. Rudolph said she believed that the CABG numbers were improving because there has been so much public reporting of these data, through Medicare and various state efforts.

Never-events—such as wrong-site surgery—have also been in the limelight recently. Medicare has said it will not pay for these events. Leapfrog's standard goes somewhat further: Hospitals must agree to apologize to the patient and/or family for the event, to report the event to a patient safety organization, to study the event to determine why it happened, and to not charge for care related to the event. In 2008, 65% of facilities agreed to the standard, up from 53% in the previous year.

Like Medicare, Leapfrog has also been looking at hospital-acquired conditions such as pressure ulcers and injuries that occur during an admission. The group found that 25%-30% of hospitals met the standards, but that there was wide variation among facilities.

Hospitals did especially poorly when it came to meeting the computerized order-entry system standard (that is, entering at least 75% of medication orders and using Leapfrog's evaluation tool to assess the system). Such systems can prevent up to 3 million serious errors, said Ms. Rudolph. But only 7% of hospitals were meeting that standard. There was improvement in all categories, she said, adding that some hospitals that are coming up with very innovative solutions.

Leapfrog Group was founded in November 2000 by the Business Roundtable. It is supported by its members, which include major employers such as the General Electric Co., employer purchasing coalitions, and pension plans. The Robert Wood Johnson Foundation, the Commonwealth Fund, and the Agency for Healthcare Research and Quality also provide support.

Hospitals are barely meeting quality and efficiency standards, according to findings from a survey issued by the Leapfrog Group, an organization made up of some of America's largest employers.

When it came to efficiency (offering the highest quality at the lowest cost) only 24% of hospitals met the group's standard for coronary artery bypass surgery, only 21% for coronary angioplasty, and 14% for acute myocardial infarction and pneumonia, reported the group.

“The big word is going to have to be 'disappointing,'” said Leapfrog Group CEO Leah Binder in a briefing on the 2008 results. For high-risk procedures in particular, the results “do not give me comfort that any hospital in this country can adequately care for my family,” she said, adding that, although there have been improvements over the past few years, the “numbers simply aren't adequate for the most expensive health care system in the world and what should be the best health care system in the world.”

Since 2000, the Leapfrog Group has asked hospitals to voluntarily complete a quality survey. The data are used to guide benefits design and purchasing decisions, said Ms. Binder.

Leapfrog data are also used by hundreds of employers who are not part of the group, and it is publicly available, down to the individual hospital, on Leapfrog's Web site (www.leapfroggroup.org

In 2008, 1,282 hospitals in 44 states completed the survey. Leapfrog has created the quality standards, but they are based partly on existing validated measures and were rooted in the seminal 1999 Institute of Medicine report on quality that estimated that 45,000–98,000 U.S. patients were dying each year because of preventable medical errors, according to Ms. Binder.

For instance, Leapfrog says that having an intensivist can reduce mortality by 40% in the ICU and 30% overall. And yet, only 31% of surveyed hospitals met the Leapfrog standards for ICU staffing in 2008. That is progress, as only 10% met the standard in 2002, said Barbara Rudolph, director of the Leapfrog survey. Leapfrog also queried facilities on whether they met volume and risk-adjusted mortality standards and were adhering to national, evidence-based guidelines for certain high-risk procedures. Only 5% met aortic abdominal aneurysm repair standards, and only 7% met standards for aortic valve replacement. Some 32% met the standard for high-risk deliveries. At the high end, 43% hit the mark for coronary artery bypass surgery. Ms. Rudolph said she believed that the CABG numbers were improving because there has been so much public reporting of these data, through Medicare and various state efforts.

Never-events—such as wrong-site surgery—have also been in the limelight recently. Medicare has said it will not pay for these events. Leapfrog's standard goes somewhat further: Hospitals must agree to apologize to the patient and/or family for the event, to report the event to a patient safety organization, to study the event to determine why it happened, and to not charge for care related to the event. In 2008, 65% of facilities agreed to the standard, up from 53% in the previous year.

Like Medicare, Leapfrog has also been looking at hospital-acquired conditions such as pressure ulcers and injuries that occur during an admission. The group found that 25%-30% of hospitals met the standards, but that there was wide variation among facilities.

Hospitals did especially poorly when it came to meeting the computerized order-entry system standard (that is, entering at least 75% of medication orders and using Leapfrog's evaluation tool to assess the system). Such systems can prevent up to 3 million serious errors, said Ms. Rudolph. But only 7% of hospitals were meeting that standard. There was improvement in all categories, she said, adding that some hospitals that are coming up with very innovative solutions.

Leapfrog Group was founded in November 2000 by the Business Roundtable. It is supported by its members, which include major employers such as the General Electric Co., employer purchasing coalitions, and pension plans. The Robert Wood Johnson Foundation, the Commonwealth Fund, and the Agency for Healthcare Research and Quality also provide support.

WASHINGTON — The three committees with jurisdiction over health care in the House of Representatives will make their health reform “framework” public by early June, Rep. Henry Waxman (D-Calif.) said at a forum sponsored by the policy analysis firm Avalere Health.

Rep. Waxman, chairman of the House Energy and Commerce Committee, said that his staff, along with the staffs of both the Ways and Means and the Education and Labor committees, have been working together to create a “proposal that will allow all three to start from a common point.” Once the framework has been developed, House Republicans will be brought into the process, Rep. Waxman said, emphasizing that Democrats will work “very, very closely” with their colleagues across the aisle.

After the plan has been released publicly, the three committees will hold hearings to get “viewpoints from stakeholders,” he added.

Then the committees will work with the Rules Committee and the House leadership to bring the bill to the House floor, Rep. Waxman said. He predicted passage of a reform bill by the end of July in the House and by the end of the year for both the House and the Senate.

Rep. Waxman was less certain regarding the substance of the legislation. “It must solve the problems of coverage, cost, and quality together,” he said, adding, “There's no real way to solve one without dealing with the others.”

The bill will build on what's currently in place, including Medicare, Medicaid, and private insurance, he said. But he left no doubt where he stood on having a government-supported “public plan” as an option for those who could not buy insurance in the private market.

“This system will work better if there is a public health insurance plan available as an alternative to private health insurance,” Rep. Waxman said. But he also said he wanted to ensure that public and private plans would be placed on a “level playing field. We must allow private insurers a fair opportunity to compete.”

Rep. Waxman said that he was confident that health reform will succeed in 2009, noting that President Obama has given it a high priority, and that House and Senate leaders, as well almost all other players in the debate, are unified in achieving that goal.

Not surprisingly, Rep. Waxman said that he sees action by the Energy and Commerce Committee as a significant predictor of how health reform will fare in the Congress overall. Noting that the panel has 59 members, the chairman said that the panel comprises 15% of the House and numerically represents 60% of the Senate. The committee balances urban and rural areas, and conservative and liberal ideologies, he said.

WASHINGTON — The three committees with jurisdiction over health care in the House of Representatives will make their health reform “framework” public by early June, Rep. Henry Waxman (D-Calif.) said at a forum sponsored by the policy analysis firm Avalere Health.

Rep. Waxman, chairman of the House Energy and Commerce Committee, said that his staff, along with the staffs of both the Ways and Means and the Education and Labor committees, have been working together to create a “proposal that will allow all three to start from a common point.” Once the framework has been developed, House Republicans will be brought into the process, Rep. Waxman said, emphasizing that Democrats will work “very, very closely” with their colleagues across the aisle.

After the plan has been released publicly, the three committees will hold hearings to get “viewpoints from stakeholders,” he added.

Then the committees will work with the Rules Committee and the House leadership to bring the bill to the House floor, Rep. Waxman said. He predicted passage of a reform bill by the end of July in the House and by the end of the year for both the House and the Senate.

Rep. Waxman was less certain regarding the substance of the legislation. “It must solve the problems of coverage, cost, and quality together,” he said, adding, “There's no real way to solve one without dealing with the others.”

The bill will build on what's currently in place, including Medicare, Medicaid, and private insurance, he said. But he left no doubt where he stood on having a government-supported “public plan” as an option for those who could not buy insurance in the private market.

“This system will work better if there is a public health insurance plan available as an alternative to private health insurance,” Rep. Waxman said. But he also said he wanted to ensure that public and private plans would be placed on a “level playing field. We must allow private insurers a fair opportunity to compete.”

Rep. Waxman said that he was confident that health reform will succeed in 2009, noting that President Obama has given it a high priority, and that House and Senate leaders, as well almost all other players in the debate, are unified in achieving that goal.

Not surprisingly, Rep. Waxman said that he sees action by the Energy and Commerce Committee as a significant predictor of how health reform will fare in the Congress overall. Noting that the panel has 59 members, the chairman said that the panel comprises 15% of the House and numerically represents 60% of the Senate. The committee balances urban and rural areas, and conservative and liberal ideologies, he said.

WASHINGTON — The three committees with jurisdiction over health care in the House of Representatives will make their health reform “framework” public by early June, Rep. Henry Waxman (D-Calif.) said at a forum sponsored by the policy analysis firm Avalere Health.

Rep. Waxman, chairman of the House Energy and Commerce Committee, said that his staff, along with the staffs of both the Ways and Means and the Education and Labor committees, have been working together to create a “proposal that will allow all three to start from a common point.” Once the framework has been developed, House Republicans will be brought into the process, Rep. Waxman said, emphasizing that Democrats will work “very, very closely” with their colleagues across the aisle.

After the plan has been released publicly, the three committees will hold hearings to get “viewpoints from stakeholders,” he added.

Then the committees will work with the Rules Committee and the House leadership to bring the bill to the House floor, Rep. Waxman said. He predicted passage of a reform bill by the end of July in the House and by the end of the year for both the House and the Senate.

Rep. Waxman was less certain regarding the substance of the legislation. “It must solve the problems of coverage, cost, and quality together,” he said, adding, “There's no real way to solve one without dealing with the others.”

The bill will build on what's currently in place, including Medicare, Medicaid, and private insurance, he said. But he left no doubt where he stood on having a government-supported “public plan” as an option for those who could not buy insurance in the private market.

“This system will work better if there is a public health insurance plan available as an alternative to private health insurance,” Rep. Waxman said. But he also said he wanted to ensure that public and private plans would be placed on a “level playing field. We must allow private insurers a fair opportunity to compete.”

Rep. Waxman said that he was confident that health reform will succeed in 2009, noting that President Obama has given it a high priority, and that House and Senate leaders, as well almost all other players in the debate, are unified in achieving that goal.

Not surprisingly, Rep. Waxman said that he sees action by the Energy and Commerce Committee as a significant predictor of how health reform will fare in the Congress overall. Noting that the panel has 59 members, the chairman said that the panel comprises 15% of the House and numerically represents 60% of the Senate. The committee balances urban and rural areas, and conservative and liberal ideologies, he said.

Imaging Penalties Proposed

The Senate Finance Committee is proposing a “lower payment for ordering physicians who were determined to be outliers for inappropriate ordering” of imaging. The Department of Health and Human Services would work with national groups to create appropriateness criteria for imaging services. The Senate committee envisioned a monitoring system that would report how imaging is being used. Among other options is the use of radiology benefit managers. In a written statement, the Access to Medical Imaging Coalition endorsed the committee's plan to create and promote appropriateness criteria and a proposal to establish a network to give physicians access to patients' previous imaging studies. But the coalition “remains very concerned” about radiology benefit managers.

IAEA Seeks Radiology Protection

The International Atomic Energy Agency is developing measures to protect patients from what it deems an alarming growth in radiation exposure from imaging procedures. “The medical application of ionizing radiation is the fastest growing source” of exposure, Renate Czarwinski, head of IAEA's radiation and safety monitoring section, said in a statement. The collective radiation dose to the world's population has increased 17% in the past 10 years, according to the IAEA. The agency is developing a “smart card” to log how much radiation each person receives over a lifetime. The agency also seeks to identify factors that contribute to unnecessary doses.

Women Seek Hypertension Tx

Hypertension was the most common condition for which women sought treatment in 2006, according to the Agency for Health Research and Quality. That year, 25 million women sought treatment for high blood pressure. Seeking treatment for mental disorders was common in women aged 64 or younger. For instance, 8.3 million women aged 45–64, and 5 million aged 30–44, sought treatment for depression or other mental disorders in 2006. After hypertension, hyperlipidemia was the most common condition for which women over 65 sought treatment (7.1 million in 2006).

PhRMA Revises Trial Standards

The Pharmaceutical Research and Manufacturers of America has revised its voluntary standards for how drug manufacturers run clinical trials and communicate results. The new standards call on drug makers to register on a Web site all interventional clinical trials, including some phase I studies. Companies must “greatly expand transparency in medical research” by providing summaries of results from all interventional clinical trials, regardless of whether the research is discontinued or the medication being studied is ever approved. The standards also call for drug makers to adopt the authorship standards of the International Committee of Medical Journal Editors, which indicate that only individuals who make substantial contributions to a manuscript be included as authors.

Imaging Penalties Proposed

The Senate Finance Committee is proposing a “lower payment for ordering physicians who were determined to be outliers for inappropriate ordering” of imaging. The Department of Health and Human Services would work with national groups to create appropriateness criteria for imaging services. The Senate committee envisioned a monitoring system that would report how imaging is being used. Among other options is the use of radiology benefit managers. In a written statement, the Access to Medical Imaging Coalition endorsed the committee's plan to create and promote appropriateness criteria and a proposal to establish a network to give physicians access to patients' previous imaging studies. But the coalition “remains very concerned” about radiology benefit managers.

IAEA Seeks Radiology Protection

The International Atomic Energy Agency is developing measures to protect patients from what it deems an alarming growth in radiation exposure from imaging procedures. “The medical application of ionizing radiation is the fastest growing source” of exposure, Renate Czarwinski, head of IAEA's radiation and safety monitoring section, said in a statement. The collective radiation dose to the world's population has increased 17% in the past 10 years, according to the IAEA. The agency is developing a “smart card” to log how much radiation each person receives over a lifetime. The agency also seeks to identify factors that contribute to unnecessary doses.

Women Seek Hypertension Tx

Hypertension was the most common condition for which women sought treatment in 2006, according to the Agency for Health Research and Quality. That year, 25 million women sought treatment for high blood pressure. Seeking treatment for mental disorders was common in women aged 64 or younger. For instance, 8.3 million women aged 45–64, and 5 million aged 30–44, sought treatment for depression or other mental disorders in 2006. After hypertension, hyperlipidemia was the most common condition for which women over 65 sought treatment (7.1 million in 2006).

PhRMA Revises Trial Standards

The Pharmaceutical Research and Manufacturers of America has revised its voluntary standards for how drug manufacturers run clinical trials and communicate results. The new standards call on drug makers to register on a Web site all interventional clinical trials, including some phase I studies. Companies must “greatly expand transparency in medical research” by providing summaries of results from all interventional clinical trials, regardless of whether the research is discontinued or the medication being studied is ever approved. The standards also call for drug makers to adopt the authorship standards of the International Committee of Medical Journal Editors, which indicate that only individuals who make substantial contributions to a manuscript be included as authors.

Imaging Penalties Proposed

The Senate Finance Committee is proposing a “lower payment for ordering physicians who were determined to be outliers for inappropriate ordering” of imaging. The Department of Health and Human Services would work with national groups to create appropriateness criteria for imaging services. The Senate committee envisioned a monitoring system that would report how imaging is being used. Among other options is the use of radiology benefit managers. In a written statement, the Access to Medical Imaging Coalition endorsed the committee's plan to create and promote appropriateness criteria and a proposal to establish a network to give physicians access to patients' previous imaging studies. But the coalition “remains very concerned” about radiology benefit managers.

IAEA Seeks Radiology Protection

The International Atomic Energy Agency is developing measures to protect patients from what it deems an alarming growth in radiation exposure from imaging procedures. “The medical application of ionizing radiation is the fastest growing source” of exposure, Renate Czarwinski, head of IAEA's radiation and safety monitoring section, said in a statement. The collective radiation dose to the world's population has increased 17% in the past 10 years, according to the IAEA. The agency is developing a “smart card” to log how much radiation each person receives over a lifetime. The agency also seeks to identify factors that contribute to unnecessary doses.

Women Seek Hypertension Tx

Hypertension was the most common condition for which women sought treatment in 2006, according to the Agency for Health Research and Quality. That year, 25 million women sought treatment for high blood pressure. Seeking treatment for mental disorders was common in women aged 64 or younger. For instance, 8.3 million women aged 45–64, and 5 million aged 30–44, sought treatment for depression or other mental disorders in 2006. After hypertension, hyperlipidemia was the most common condition for which women over 65 sought treatment (7.1 million in 2006).

PhRMA Revises Trial Standards

The Pharmaceutical Research and Manufacturers of America has revised its voluntary standards for how drug manufacturers run clinical trials and communicate results. The new standards call on drug makers to register on a Web site all interventional clinical trials, including some phase I studies. Companies must “greatly expand transparency in medical research” by providing summaries of results from all interventional clinical trials, regardless of whether the research is discontinued or the medication being studied is ever approved. The standards also call for drug makers to adopt the authorship standards of the International Committee of Medical Journal Editors, which indicate that only individuals who make substantial contributions to a manuscript be included as authors.

AUSTIN, TEX. — The commonly accepted standard of using 5-mm margins for surgical excision of melanoma in situ may not be enough to clear the large majority of tumors, said Dr. Joy Kunishige.

Speaking at the annual meeting of the American College of Mohs Surgery, Dr. Kunishige, a dermatologist in private practice in Pittsburgh, said that since several studies have shown a 5-mm margin to be inadequate, she and her colleagues gathered the latest evidence on clearance rates to update previous National Institutes of Health guidelines, set in 1992 (NIH Consens. Statement 1992;10:1–26). The goal was to clear at least 97% of tumors.

They evaluated all primary melanoma in situ cases that were collected as part of a prospective database started in 1982 at the practice. The database included 1,072 patients with 1,120 primary tumors. Of the patients, 675 (63%) were male, mean age was 65 years, and mean follow-up was 4.7 years. A total of 593 (53%) of the lesions were on the face, 235 (21%) were on the extremities, and 201 (18%) were on the trunk, with the remainder in other locations.

All lesions were excised using the fresh tissue technique of Mohs, with frozen section examination of the margin.

Using 6-mm margins, 86% of the tumors were cleared. With a 9-mm margin, there was a 98% clearance rate; and with a 12-mm margin, a 99.4% clearance rate, said Dr. Kunishige.

The 9-mm margin was equally effective regardless of sex, location, or diameter of the lesion, she said. The overall 5-year survival was 93%; the 5-year melanoma in situ survival was 99.5%. Three patients died of melanoma in situ. Two died from a separate invasive melanoma, and 90 died of other causes, free of melanoma. The overall survival curve was what would have been expected for this age group, she said.

The overall recurrence rate in this evaluation was 0.3%. Three patients had a local recurrence, with reappearance of tumors at 9, 10, or 11 years.

Dr. Kunishige and her colleagues concluded that a 9-mm margin was superior to the 6-mm margin, with a P value of less than .0001.

She reported no disclosures.

A 5-mm margin may not be adequate for removing the majority of tumors. In this study, clearance was 98% with a 9-mm margin and 86% with a 6-mm margin. COURTESY JOY KUNISHIGE, M.D.

AUSTIN, TEX. — The commonly accepted standard of using 5-mm margins for surgical excision of melanoma in situ may not be enough to clear the large majority of tumors, said Dr. Joy Kunishige.

Speaking at the annual meeting of the American College of Mohs Surgery, Dr. Kunishige, a dermatologist in private practice in Pittsburgh, said that since several studies have shown a 5-mm margin to be inadequate, she and her colleagues gathered the latest evidence on clearance rates to update previous National Institutes of Health guidelines, set in 1992 (NIH Consens. Statement 1992;10:1–26). The goal was to clear at least 97% of tumors.

They evaluated all primary melanoma in situ cases that were collected as part of a prospective database started in 1982 at the practice. The database included 1,072 patients with 1,120 primary tumors. Of the patients, 675 (63%) were male, mean age was 65 years, and mean follow-up was 4.7 years. A total of 593 (53%) of the lesions were on the face, 235 (21%) were on the extremities, and 201 (18%) were on the trunk, with the remainder in other locations.

All lesions were excised using the fresh tissue technique of Mohs, with frozen section examination of the margin.

Using 6-mm margins, 86% of the tumors were cleared. With a 9-mm margin, there was a 98% clearance rate; and with a 12-mm margin, a 99.4% clearance rate, said Dr. Kunishige.

The 9-mm margin was equally effective regardless of sex, location, or diameter of the lesion, she said. The overall 5-year survival was 93%; the 5-year melanoma in situ survival was 99.5%. Three patients died of melanoma in situ. Two died from a separate invasive melanoma, and 90 died of other causes, free of melanoma. The overall survival curve was what would have been expected for this age group, she said.

The overall recurrence rate in this evaluation was 0.3%. Three patients had a local recurrence, with reappearance of tumors at 9, 10, or 11 years.

Dr. Kunishige and her colleagues concluded that a 9-mm margin was superior to the 6-mm margin, with a P value of less than .0001.

She reported no disclosures.

A 5-mm margin may not be adequate for removing the majority of tumors. In this study, clearance was 98% with a 9-mm margin and 86% with a 6-mm margin. COURTESY JOY KUNISHIGE, M.D.

AUSTIN, TEX. — The commonly accepted standard of using 5-mm margins for surgical excision of melanoma in situ may not be enough to clear the large majority of tumors, said Dr. Joy Kunishige.

Speaking at the annual meeting of the American College of Mohs Surgery, Dr. Kunishige, a dermatologist in private practice in Pittsburgh, said that since several studies have shown a 5-mm margin to be inadequate, she and her colleagues gathered the latest evidence on clearance rates to update previous National Institutes of Health guidelines, set in 1992 (NIH Consens. Statement 1992;10:1–26). The goal was to clear at least 97% of tumors.

They evaluated all primary melanoma in situ cases that were collected as part of a prospective database started in 1982 at the practice. The database included 1,072 patients with 1,120 primary tumors. Of the patients, 675 (63%) were male, mean age was 65 years, and mean follow-up was 4.7 years. A total of 593 (53%) of the lesions were on the face, 235 (21%) were on the extremities, and 201 (18%) were on the trunk, with the remainder in other locations.

All lesions were excised using the fresh tissue technique of Mohs, with frozen section examination of the margin.

Using 6-mm margins, 86% of the tumors were cleared. With a 9-mm margin, there was a 98% clearance rate; and with a 12-mm margin, a 99.4% clearance rate, said Dr. Kunishige.

The 9-mm margin was equally effective regardless of sex, location, or diameter of the lesion, she said. The overall 5-year survival was 93%; the 5-year melanoma in situ survival was 99.5%. Three patients died of melanoma in situ. Two died from a separate invasive melanoma, and 90 died of other causes, free of melanoma. The overall survival curve was what would have been expected for this age group, she said.

The overall recurrence rate in this evaluation was 0.3%. Three patients had a local recurrence, with reappearance of tumors at 9, 10, or 11 years.

Dr. Kunishige and her colleagues concluded that a 9-mm margin was superior to the 6-mm margin, with a P value of less than .0001.

She reported no disclosures.

A 5-mm margin may not be adequate for removing the majority of tumors. In this study, clearance was 98% with a 9-mm margin and 86% with a 6-mm margin. COURTESY JOY KUNISHIGE, M.D.

Medicaid Limits Curb Rx Access

Medicaid limits on prescription drugs for mental illness often have adverse consequences for patients, according to a survey of 600 psychiatrists and 1,600 patients (Psychiatr. Serv. 2009;60:601-10). Researchers found medication access was a greater problem in states with more limits, such as prior authorization or restrictive formularies. More than a third of respondents said they could not get a therapy because Medicaid would not cover or approve it. About 30% said the preferred medication could not be prescribed because it was not approved or because the patient could not afford the copay. In addition, the survey found that patients who have problems making a copayment were eight times more likely to suffer an adverse event. Those patients who had trouble accessing a medication experienced a 3.6 times greater likelihood of adverse events, including emergency room visits, hospitalizations, homelessness, suicidal ideation or behavior, or incarceration.

Insurance Dictates Teens' Care

Health insurance is a major determinant as to whether adolescents with major depressive episodes receive treatment, according to a report by the Substance Abuse and Mental Health Services Administration (SAMHSA). The data are based on SAMHSA's 2007 National Survey on Drug Use and Health, which includes a representative sample of 22,000 adolescents. The survey found that 8% of adolescents aged 12-17 years had experienced at least one major depressive episode in the past year, but only 39% of them had received treatment. When broken down by insurance status, only 17% of uninsured teens got treatment, compared with 43% of those on Medicaid or a State Children's Health Insurance Plan, and 41% of those with private insurance.

Mental Illness Costly For Kids

The most expensive condition to treat in children in 2008 was mental illness, according to the Agency for Healthcare Research and Quality. Treating mental disorders in noninstitutionalized children 17 years or younger cost $8.9 billion in 2008, according to the agency. The data are taken from the Medical Expenditure Panel Survey. The second-most expensive disorder was asthma, at $8 billion, followed by trauma, at $6.1 billion.

Pot Potency Doubles

Marijuana potency keeps rising. The latest figures from the University of Mississippi's Potency Monitoring Project, show tetrahydrocannabinol (THC) levels in marijuana are, for the second year in a row, the highest ever recorded. The project has analyzed marijuana samples for the National Institute on Drug Abuse since 1976. In 2008, an analysis of 1,500 samples found THC levels at 10.1%, a doubling since 1983, but up just slightly from the previous year, when THC levels were about 9.6%. The most potent sample had a THC concentration of 27%. The project also found that samples crossing the Southwest borders are as potent as what has been seen in domestic sources.

Parity Comments Due

The federal government is seeking public comments before implementing the Mental Health Parity and Addiction Equity Act of 2008. The Health and Human Services department and the Labor department said they want to know the financial and treatment limits that health plans currently impose, their practices in determining medical necessity for and denying mental health benefits, and how plans handle out-of-network mental health benefits.

Using Methadone Safely

The Food and Drug Administration and SAMHSA have launched a public outreach program to teach consumers, health professionals, and clinicians on how to safely use methadone for pain and drug addiction treatment. Methadone poisoning deaths have been on the rise, tripling since 2004, according to the Centers for Disease Control and Prevention. FDA and SAMHSA are making available to the public and health professionals a brochure, poster, and fact sheet and have created an information sheet that pharmacies can give to patients.

PhRMA Revises Trial Standards

The Pharmaceutical Research and Manufacturers of America has revised its voluntary standards for how drug manufacturers run clinical trials and communicate trial results. The new standards call on drug makers to register on a public Web site all interventional clinical trials, including some phase I studies. The standards also call for companies to “greatly expand transparency” by providing summaries of results from all interventional clinical trials, regardless of whether the research is discontinued or the medication being studied is ever approved. The standards also call for drug makers to adopt the authorship standards of the International Committee of Medical Journal Editors.

Medicaid Limits Curb Rx Access

Medicaid limits on prescription drugs for mental illness often have adverse consequences for patients, according to a survey of 600 psychiatrists and 1,600 patients (Psychiatr. Serv. 2009;60:601-10). Researchers found medication access was a greater problem in states with more limits, such as prior authorization or restrictive formularies. More than a third of respondents said they could not get a therapy because Medicaid would not cover or approve it. About 30% said the preferred medication could not be prescribed because it was not approved or because the patient could not afford the copay. In addition, the survey found that patients who have problems making a copayment were eight times more likely to suffer an adverse event. Those patients who had trouble accessing a medication experienced a 3.6 times greater likelihood of adverse events, including emergency room visits, hospitalizations, homelessness, suicidal ideation or behavior, or incarceration.

Insurance Dictates Teens' Care

Health insurance is a major determinant as to whether adolescents with major depressive episodes receive treatment, according to a report by the Substance Abuse and Mental Health Services Administration (SAMHSA). The data are based on SAMHSA's 2007 National Survey on Drug Use and Health, which includes a representative sample of 22,000 adolescents. The survey found that 8% of adolescents aged 12-17 years had experienced at least one major depressive episode in the past year, but only 39% of them had received treatment. When broken down by insurance status, only 17% of uninsured teens got treatment, compared with 43% of those on Medicaid or a State Children's Health Insurance Plan, and 41% of those with private insurance.

Mental Illness Costly For Kids

The most expensive condition to treat in children in 2008 was mental illness, according to the Agency for Healthcare Research and Quality. Treating mental disorders in noninstitutionalized children 17 years or younger cost $8.9 billion in 2008, according to the agency. The data are taken from the Medical Expenditure Panel Survey. The second-most expensive disorder was asthma, at $8 billion, followed by trauma, at $6.1 billion.

Pot Potency Doubles

Marijuana potency keeps rising. The latest figures from the University of Mississippi's Potency Monitoring Project, show tetrahydrocannabinol (THC) levels in marijuana are, for the second year in a row, the highest ever recorded. The project has analyzed marijuana samples for the National Institute on Drug Abuse since 1976. In 2008, an analysis of 1,500 samples found THC levels at 10.1%, a doubling since 1983, but up just slightly from the previous year, when THC levels were about 9.6%. The most potent sample had a THC concentration of 27%. The project also found that samples crossing the Southwest borders are as potent as what has been seen in domestic sources.

Parity Comments Due

The federal government is seeking public comments before implementing the Mental Health Parity and Addiction Equity Act of 2008. The Health and Human Services department and the Labor department said they want to know the financial and treatment limits that health plans currently impose, their practices in determining medical necessity for and denying mental health benefits, and how plans handle out-of-network mental health benefits.

Using Methadone Safely

The Food and Drug Administration and SAMHSA have launched a public outreach program to teach consumers, health professionals, and clinicians on how to safely use methadone for pain and drug addiction treatment. Methadone poisoning deaths have been on the rise, tripling since 2004, according to the Centers for Disease Control and Prevention. FDA and SAMHSA are making available to the public and health professionals a brochure, poster, and fact sheet and have created an information sheet that pharmacies can give to patients.

PhRMA Revises Trial Standards

The Pharmaceutical Research and Manufacturers of America has revised its voluntary standards for how drug manufacturers run clinical trials and communicate trial results. The new standards call on drug makers to register on a public Web site all interventional clinical trials, including some phase I studies. The standards also call for companies to “greatly expand transparency” by providing summaries of results from all interventional clinical trials, regardless of whether the research is discontinued or the medication being studied is ever approved. The standards also call for drug makers to adopt the authorship standards of the International Committee of Medical Journal Editors.

Medicaid Limits Curb Rx Access

Medicaid limits on prescription drugs for mental illness often have adverse consequences for patients, according to a survey of 600 psychiatrists and 1,600 patients (Psychiatr. Serv. 2009;60:601-10). Researchers found medication access was a greater problem in states with more limits, such as prior authorization or restrictive formularies. More than a third of respondents said they could not get a therapy because Medicaid would not cover or approve it. About 30% said the preferred medication could not be prescribed because it was not approved or because the patient could not afford the copay. In addition, the survey found that patients who have problems making a copayment were eight times more likely to suffer an adverse event. Those patients who had trouble accessing a medication experienced a 3.6 times greater likelihood of adverse events, including emergency room visits, hospitalizations, homelessness, suicidal ideation or behavior, or incarceration.

Insurance Dictates Teens' Care

Health insurance is a major determinant as to whether adolescents with major depressive episodes receive treatment, according to a report by the Substance Abuse and Mental Health Services Administration (SAMHSA). The data are based on SAMHSA's 2007 National Survey on Drug Use and Health, which includes a representative sample of 22,000 adolescents. The survey found that 8% of adolescents aged 12-17 years had experienced at least one major depressive episode in the past year, but only 39% of them had received treatment. When broken down by insurance status, only 17% of uninsured teens got treatment, compared with 43% of those on Medicaid or a State Children's Health Insurance Plan, and 41% of those with private insurance.

Mental Illness Costly For Kids

The most expensive condition to treat in children in 2008 was mental illness, according to the Agency for Healthcare Research and Quality. Treating mental disorders in noninstitutionalized children 17 years or younger cost $8.9 billion in 2008, according to the agency. The data are taken from the Medical Expenditure Panel Survey. The second-most expensive disorder was asthma, at $8 billion, followed by trauma, at $6.1 billion.

Pot Potency Doubles

Marijuana potency keeps rising. The latest figures from the University of Mississippi's Potency Monitoring Project, show tetrahydrocannabinol (THC) levels in marijuana are, for the second year in a row, the highest ever recorded. The project has analyzed marijuana samples for the National Institute on Drug Abuse since 1976. In 2008, an analysis of 1,500 samples found THC levels at 10.1%, a doubling since 1983, but up just slightly from the previous year, when THC levels were about 9.6%. The most potent sample had a THC concentration of 27%. The project also found that samples crossing the Southwest borders are as potent as what has been seen in domestic sources.

Parity Comments Due

The federal government is seeking public comments before implementing the Mental Health Parity and Addiction Equity Act of 2008. The Health and Human Services department and the Labor department said they want to know the financial and treatment limits that health plans currently impose, their practices in determining medical necessity for and denying mental health benefits, and how plans handle out-of-network mental health benefits.

Using Methadone Safely

The Food and Drug Administration and SAMHSA have launched a public outreach program to teach consumers, health professionals, and clinicians on how to safely use methadone for pain and drug addiction treatment. Methadone poisoning deaths have been on the rise, tripling since 2004, according to the Centers for Disease Control and Prevention. FDA and SAMHSA are making available to the public and health professionals a brochure, poster, and fact sheet and have created an information sheet that pharmacies can give to patients.

PhRMA Revises Trial Standards

The Pharmaceutical Research and Manufacturers of America has revised its voluntary standards for how drug manufacturers run clinical trials and communicate trial results. The new standards call on drug makers to register on a public Web site all interventional clinical trials, including some phase I studies. The standards also call for companies to “greatly expand transparency” by providing summaries of results from all interventional clinical trials, regardless of whether the research is discontinued or the medication being studied is ever approved. The standards also call for drug makers to adopt the authorship standards of the International Committee of Medical Journal Editors.

WASHINGTON – President Obama will not back away from the belief that a government-funded health plan must be part of a health reform plan, Health and Human Services Secretary Kathleen Sebelius testified during her first formal appearance before the House Ways and Means Committe. “His charge to me is to work closely with [congressional] committees as proposals are being developed,” she said. Ms. Sebelius, former governor of Kansas, has been applauded for her bipartisan approach to governing.

Kathleen Sebelius plans to work closely with congressional committees. ©

WASHINGTON – President Obama will not back away from the belief that a government-funded health plan must be part of a health reform plan, Health and Human Services Secretary Kathleen Sebelius testified during her first formal appearance before the House Ways and Means Committe. “His charge to me is to work closely with [congressional] committees as proposals are being developed,” she said. Ms. Sebelius, former governor of Kansas, has been applauded for her bipartisan approach to governing.

Kathleen Sebelius plans to work closely with congressional committees. ©

WASHINGTON – President Obama will not back away from the belief that a government-funded health plan must be part of a health reform plan, Health and Human Services Secretary Kathleen Sebelius testified during her first formal appearance before the House Ways and Means Committe. “His charge to me is to work closely with [congressional] committees as proposals are being developed,” she said. Ms. Sebelius, former governor of Kansas, has been applauded for her bipartisan approach to governing.

Kathleen Sebelius plans to work closely with congressional committees. ©