Bruce K. Dixon

A Maine internist has distinguished himself by turning his exam room computers into time-saving patient education tools.

Dr. Mukesh Bhargava has developed a “show and tell” that helps patients learn how to examine themselves for skin, breast, and testicular cancers—and he used nothing more elaborate than commonly available software and a $20 microphone.

“We've created a short multimedia presentation that patients can view in the privacy of one of our three examination rooms,” said Dr. Bhargava, an internist in Sanford.

After each exam, Dr. Bhargava leaves the patient alone in the exam room to view the 2-minute presentation on a secure desktop computer. The half-dozen PowerPoint slides, which he narrates, walk the patient through the process of examining the skin for suspicious moles, or performing a breast or testicular self-exam.

Patients appreciate the presentation, Dr. Bhargava said, noting that it “reinforces the importance of proper self-care and saves me time in the process. They say this is more helpful than a handout, and they appreciate the fact that it is their own doctor doing the narration,” he said in an interview.

“All the literature says that medical advice carries more weight when it's your own doctor that's giving it,” he added.

There's no danger that a patient will access electronic medical records or other sensitive data, which are securely locked and password protected, he explained.

Dr. Bhargava welcomes inquiries about his multimedia project. You can reach Dr. Bhargava at mbhargava@gmail.com

A Maine internist has distinguished himself by turning his exam room computers into time-saving patient education tools.

Dr. Mukesh Bhargava has developed a “show and tell” that helps patients learn how to examine themselves for skin, breast, and testicular cancers—and he used nothing more elaborate than commonly available software and a $20 microphone.

“We've created a short multimedia presentation that patients can view in the privacy of one of our three examination rooms,” said Dr. Bhargava, an internist in Sanford.

After each exam, Dr. Bhargava leaves the patient alone in the exam room to view the 2-minute presentation on a secure desktop computer. The half-dozen PowerPoint slides, which he narrates, walk the patient through the process of examining the skin for suspicious moles, or performing a breast or testicular self-exam.

Patients appreciate the presentation, Dr. Bhargava said, noting that it “reinforces the importance of proper self-care and saves me time in the process. They say this is more helpful than a handout, and they appreciate the fact that it is their own doctor doing the narration,” he said in an interview.

“All the literature says that medical advice carries more weight when it's your own doctor that's giving it,” he added.

There's no danger that a patient will access electronic medical records or other sensitive data, which are securely locked and password protected, he explained.

Dr. Bhargava welcomes inquiries about his multimedia project. You can reach Dr. Bhargava at mbhargava@gmail.com

A Maine internist has distinguished himself by turning his exam room computers into time-saving patient education tools.

Dr. Mukesh Bhargava has developed a “show and tell” that helps patients learn how to examine themselves for skin, breast, and testicular cancers—and he used nothing more elaborate than commonly available software and a $20 microphone.

“We've created a short multimedia presentation that patients can view in the privacy of one of our three examination rooms,” said Dr. Bhargava, an internist in Sanford.

After each exam, Dr. Bhargava leaves the patient alone in the exam room to view the 2-minute presentation on a secure desktop computer. The half-dozen PowerPoint slides, which he narrates, walk the patient through the process of examining the skin for suspicious moles, or performing a breast or testicular self-exam.

Patients appreciate the presentation, Dr. Bhargava said, noting that it “reinforces the importance of proper self-care and saves me time in the process. They say this is more helpful than a handout, and they appreciate the fact that it is their own doctor doing the narration,” he said in an interview.

“All the literature says that medical advice carries more weight when it's your own doctor that's giving it,” he added.

There's no danger that a patient will access electronic medical records or other sensitive data, which are securely locked and password protected, he explained.

Dr. Bhargava welcomes inquiries about his multimedia project. You can reach Dr. Bhargava at mbhargava@gmail.com

SEATTLE — Percutaneous sacroplasty seems to be a safe, effective therapy for painful sacral insufficiency, according to a multicenter study presented at the annual meeting of the North American Spine Society.

“The rate of improvement is rapid, with a 50% or better reduction in pain even before patients left the office. Pain reduction occurs primarily within the first 3 months and is sustained to 1 year,” said Dr. Michael Frey of the Physiatric Association of Spine, Sport, and Occupational Rehabilitation in Fort Meyers, Fla. Sacral insufficiency fractures are a known cause of pain in patients with weakened bone, with a natural history similar to that of vertebral compression fractures. Symptoms gradually resolve, but recovery is slow and patients often resort to opioid analgesics for relief.

Previous studies have shown that injection of polymethylmethacrylate (PMMA) relieves pain quickly and thoroughly by stabilizing the fracture. However, those studies were small, and their follow-up intervals were 2–16 weeks, Dr. Frey said.

In this prospective, observational cohort study, 25 consecutive sacral insufficiency fracture patients were treated with sacro- plasty. There were 17 women and 8 men with a mean age of 74 years and a mean duration of pain of 41 days. Pain level was assessed using the visual analog scale (VAS), and patient satisfaction and analgesic use were determined. Each procedure was performed under light intravenous conscious sedation and fluoroscopic control, without use of computed tomography. Two bone trocars were inserted between the sacral foramen and sacroiliac joint. About 2–3 cc of PMMA were injected through each trocar under coronal view, Dr. Frey said.

At 1 year, 23 of the 25 patients were available for follow-up. One patient had died from unrelated pulmonary disease. The mean VAS score, which was 7.3 at baseline, plunged to 2.7 immediately post procedure, and at 1 year, was 0.3. Improvement was statistically significant at 1 year and at each follow-up interval (2, 4, 12, and 24 weeks). “We saw a dramatic reduction in the use of opioid analgesics and what we would expect to be an increase in the use of nonopioid pain medications,” he said.

SEATTLE — Percutaneous sacroplasty seems to be a safe, effective therapy for painful sacral insufficiency, according to a multicenter study presented at the annual meeting of the North American Spine Society.

“The rate of improvement is rapid, with a 50% or better reduction in pain even before patients left the office. Pain reduction occurs primarily within the first 3 months and is sustained to 1 year,” said Dr. Michael Frey of the Physiatric Association of Spine, Sport, and Occupational Rehabilitation in Fort Meyers, Fla. Sacral insufficiency fractures are a known cause of pain in patients with weakened bone, with a natural history similar to that of vertebral compression fractures. Symptoms gradually resolve, but recovery is slow and patients often resort to opioid analgesics for relief.

Previous studies have shown that injection of polymethylmethacrylate (PMMA) relieves pain quickly and thoroughly by stabilizing the fracture. However, those studies were small, and their follow-up intervals were 2–16 weeks, Dr. Frey said.

In this prospective, observational cohort study, 25 consecutive sacral insufficiency fracture patients were treated with sacro- plasty. There were 17 women and 8 men with a mean age of 74 years and a mean duration of pain of 41 days. Pain level was assessed using the visual analog scale (VAS), and patient satisfaction and analgesic use were determined. Each procedure was performed under light intravenous conscious sedation and fluoroscopic control, without use of computed tomography. Two bone trocars were inserted between the sacral foramen and sacroiliac joint. About 2–3 cc of PMMA were injected through each trocar under coronal view, Dr. Frey said.

At 1 year, 23 of the 25 patients were available for follow-up. One patient had died from unrelated pulmonary disease. The mean VAS score, which was 7.3 at baseline, plunged to 2.7 immediately post procedure, and at 1 year, was 0.3. Improvement was statistically significant at 1 year and at each follow-up interval (2, 4, 12, and 24 weeks). “We saw a dramatic reduction in the use of opioid analgesics and what we would expect to be an increase in the use of nonopioid pain medications,” he said.

SEATTLE — Percutaneous sacroplasty seems to be a safe, effective therapy for painful sacral insufficiency, according to a multicenter study presented at the annual meeting of the North American Spine Society.

“The rate of improvement is rapid, with a 50% or better reduction in pain even before patients left the office. Pain reduction occurs primarily within the first 3 months and is sustained to 1 year,” said Dr. Michael Frey of the Physiatric Association of Spine, Sport, and Occupational Rehabilitation in Fort Meyers, Fla. Sacral insufficiency fractures are a known cause of pain in patients with weakened bone, with a natural history similar to that of vertebral compression fractures. Symptoms gradually resolve, but recovery is slow and patients often resort to opioid analgesics for relief.

Previous studies have shown that injection of polymethylmethacrylate (PMMA) relieves pain quickly and thoroughly by stabilizing the fracture. However, those studies were small, and their follow-up intervals were 2–16 weeks, Dr. Frey said.

In this prospective, observational cohort study, 25 consecutive sacral insufficiency fracture patients were treated with sacro- plasty. There were 17 women and 8 men with a mean age of 74 years and a mean duration of pain of 41 days. Pain level was assessed using the visual analog scale (VAS), and patient satisfaction and analgesic use were determined. Each procedure was performed under light intravenous conscious sedation and fluoroscopic control, without use of computed tomography. Two bone trocars were inserted between the sacral foramen and sacroiliac joint. About 2–3 cc of PMMA were injected through each trocar under coronal view, Dr. Frey said.

At 1 year, 23 of the 25 patients were available for follow-up. One patient had died from unrelated pulmonary disease. The mean VAS score, which was 7.3 at baseline, plunged to 2.7 immediately post procedure, and at 1 year, was 0.3. Improvement was statistically significant at 1 year and at each follow-up interval (2, 4, 12, and 24 weeks). “We saw a dramatic reduction in the use of opioid analgesics and what we would expect to be an increase in the use of nonopioid pain medications,” he said.

LA JOLLA, CALIF. — Spermicides containing nonoxynol-9 are a safe alternative for women who are at low risk of acquiring sexually transmitted infections, according to a study from the University of Pittsburgh.

Use of an N-9 spermicide was compared with condom use in two cohorts of women in mutually monogamous heterosexual partnerships requiring long-term contraception, who had no sexually transmitted infections (STIs) or suspicion of STIs at the time of enrollment, said Dr. Bryna Harwood, now with the University of Illinois at Chicago.

“Overall, when we looked at users of any type of spermicide compared to condom users, the risk of having a lesion at follow-up colposcopy was similar in both groups. Interestingly, the condom group had a statistically significant increase in lesions characterized by epithelial disruption,” Dr. Harwood said at the annual meeting of the Association of Reproductive Health Professionals. Epithelial disruption is more commonly associated with N-9 spermicide use in high-risk settings, and lesions with epithelial disruption may increase the risk of acquiring HIV.

The finding comes 9 months after the Food and Drug Administration issued a nonbinding draft guidance warning that N-9 could irritate the vagina and rectum and increase STI risk. The FDA also recommended that the package inserts for latex condoms specify that they cannot entirely protect against STIs such as human papillomavirus and genital herpes.

The primary goal of this multicenter, randomized clinical trial was to compare the efficacy of different N-9 spermicide formulations. Participants were randomized to one of five formulations—gel, film, or suppository—for coital use. The colposcopic appearance of the genital epithelium was assessed in a substudy of 136 low-risk women assigned to one of the spermicide groups. At one center, 30 women whose partners used condoms were enrolled as a control group. All participants were followed over 6 months during spermicide or condom use. The mean numbers of coital acts per week (about two) were similar between groups.

Colposcopic lesions were described using CONRAD Program/World Health Organization standardized procedures, said Dr. Harwood, of the department of obstetrics and gynecology at the University of Illinois.

New lesions were identified in 48% of visits for spermicide users and in 51% of visits for condom users. However, lesions with epithelial disruption were present in only 11% of spermicide users versus 37% of condom users, Dr. Harwood explained.

In a discussion of the study, Dr. Christine Mauck said these findings are consistent with earlier observations that the differences in lesions between placebo and N-9 are seen only in frequent users. “I think the bottom line is that N-9 may be safe in women who don't use it frequently and are at low risk for HIV and STIs, and that's probably a lot of women we see in our practices, said Dr. Mauck, who is senior medical adviser for CONRAD in Arlington, Va.

LA JOLLA, CALIF. — Spermicides containing nonoxynol-9 are a safe alternative for women who are at low risk of acquiring sexually transmitted infections, according to a study from the University of Pittsburgh.

Use of an N-9 spermicide was compared with condom use in two cohorts of women in mutually monogamous heterosexual partnerships requiring long-term contraception, who had no sexually transmitted infections (STIs) or suspicion of STIs at the time of enrollment, said Dr. Bryna Harwood, now with the University of Illinois at Chicago.

“Overall, when we looked at users of any type of spermicide compared to condom users, the risk of having a lesion at follow-up colposcopy was similar in both groups. Interestingly, the condom group had a statistically significant increase in lesions characterized by epithelial disruption,” Dr. Harwood said at the annual meeting of the Association of Reproductive Health Professionals. Epithelial disruption is more commonly associated with N-9 spermicide use in high-risk settings, and lesions with epithelial disruption may increase the risk of acquiring HIV.

The finding comes 9 months after the Food and Drug Administration issued a nonbinding draft guidance warning that N-9 could irritate the vagina and rectum and increase STI risk. The FDA also recommended that the package inserts for latex condoms specify that they cannot entirely protect against STIs such as human papillomavirus and genital herpes.

The primary goal of this multicenter, randomized clinical trial was to compare the efficacy of different N-9 spermicide formulations. Participants were randomized to one of five formulations—gel, film, or suppository—for coital use. The colposcopic appearance of the genital epithelium was assessed in a substudy of 136 low-risk women assigned to one of the spermicide groups. At one center, 30 women whose partners used condoms were enrolled as a control group. All participants were followed over 6 months during spermicide or condom use. The mean numbers of coital acts per week (about two) were similar between groups.

Colposcopic lesions were described using CONRAD Program/World Health Organization standardized procedures, said Dr. Harwood, of the department of obstetrics and gynecology at the University of Illinois.

New lesions were identified in 48% of visits for spermicide users and in 51% of visits for condom users. However, lesions with epithelial disruption were present in only 11% of spermicide users versus 37% of condom users, Dr. Harwood explained.

In a discussion of the study, Dr. Christine Mauck said these findings are consistent with earlier observations that the differences in lesions between placebo and N-9 are seen only in frequent users. “I think the bottom line is that N-9 may be safe in women who don't use it frequently and are at low risk for HIV and STIs, and that's probably a lot of women we see in our practices, said Dr. Mauck, who is senior medical adviser for CONRAD in Arlington, Va.

LA JOLLA, CALIF. — Spermicides containing nonoxynol-9 are a safe alternative for women who are at low risk of acquiring sexually transmitted infections, according to a study from the University of Pittsburgh.

Use of an N-9 spermicide was compared with condom use in two cohorts of women in mutually monogamous heterosexual partnerships requiring long-term contraception, who had no sexually transmitted infections (STIs) or suspicion of STIs at the time of enrollment, said Dr. Bryna Harwood, now with the University of Illinois at Chicago.

“Overall, when we looked at users of any type of spermicide compared to condom users, the risk of having a lesion at follow-up colposcopy was similar in both groups. Interestingly, the condom group had a statistically significant increase in lesions characterized by epithelial disruption,” Dr. Harwood said at the annual meeting of the Association of Reproductive Health Professionals. Epithelial disruption is more commonly associated with N-9 spermicide use in high-risk settings, and lesions with epithelial disruption may increase the risk of acquiring HIV.

The finding comes 9 months after the Food and Drug Administration issued a nonbinding draft guidance warning that N-9 could irritate the vagina and rectum and increase STI risk. The FDA also recommended that the package inserts for latex condoms specify that they cannot entirely protect against STIs such as human papillomavirus and genital herpes.

The primary goal of this multicenter, randomized clinical trial was to compare the efficacy of different N-9 spermicide formulations. Participants were randomized to one of five formulations—gel, film, or suppository—for coital use. The colposcopic appearance of the genital epithelium was assessed in a substudy of 136 low-risk women assigned to one of the spermicide groups. At one center, 30 women whose partners used condoms were enrolled as a control group. All participants were followed over 6 months during spermicide or condom use. The mean numbers of coital acts per week (about two) were similar between groups.

Colposcopic lesions were described using CONRAD Program/World Health Organization standardized procedures, said Dr. Harwood, of the department of obstetrics and gynecology at the University of Illinois.

New lesions were identified in 48% of visits for spermicide users and in 51% of visits for condom users. However, lesions with epithelial disruption were present in only 11% of spermicide users versus 37% of condom users, Dr. Harwood explained.

In a discussion of the study, Dr. Christine Mauck said these findings are consistent with earlier observations that the differences in lesions between placebo and N-9 are seen only in frequent users. “I think the bottom line is that N-9 may be safe in women who don't use it frequently and are at low risk for HIV and STIs, and that's probably a lot of women we see in our practices, said Dr. Mauck, who is senior medical adviser for CONRAD in Arlington, Va.

SEATTLE — A majority of adults with degenerative lumbar scoliosis experienced pain relief after undergoing posterior decompression and fusion, according to a 42-patient study presented at the annual meeting of the North American Spine Society.

At an average follow-up of just over 4 years, 95% of patients reported excellent or good relief of leg pain, and nearly 90% had the same response when asked about back pain. In addition, 86% felt there was improvement in their lifestyle postoperatively, said Dr. Christopher Furey.

“Pain, function, image, and quality of life were all significantly improved, and 80% of patients felt their preoperative expectations had been met or exceeded,” said Dr. Furey, of the department of orthopedic surgery at Case Western Reserve University in Cleveland.

This type of repair is a major undertaking, he said. “Adults with degenerative lumbar scoliosis frequently have significant medical issues—including osteopenia and osteoporosis—that make them more of a challenge. These are lengthy surgeries with the potential for significant blood loss and long hospital stay, and complications are common,” Dr. Furey explained.

All patients in this retrospective analysis were first treated conservatively, and only those who were ready to proceed with elective surgery underwent decompression and fusion with pedicle screw instrumentation and iliac crest graft.

All levels with spinal stenosis were decompressed, including bilateral foraminotomies. All levels decompressed were fused, as were any levels with lateral listhesis greater than 6 mm. The proximal extent of the fusion was at the lowest neutral vertebra in the upper lumbar or lower thoracic spine. Fusion was extended to the sacrum only if an L5-S1 spondylolisthesis was present, but otherwise was stopped at L5, Dr. Furey said.

Two patients developed deep infections that required surgical debridement, and misplaced pedicle screws in two others had to be adjusted, he said. “Excluding those who had immediate postoperative treatment for infections, there was a 21% reoperation rate, which is high.”

Dr. Furey and his coauthor, Dr. Sanford Emery of West Virginia University, Charleston, said that because the procedure potentially can cause significant complications in older patients, it should be reserved for those who have failed conservative management and who are suitable medical candidates. “These patients deserve respect, and optimizing medical issues—including good intraoperative anesthesia support and postoperative observation—is critical,” Dr. Furey said.

SEATTLE — A majority of adults with degenerative lumbar scoliosis experienced pain relief after undergoing posterior decompression and fusion, according to a 42-patient study presented at the annual meeting of the North American Spine Society.

At an average follow-up of just over 4 years, 95% of patients reported excellent or good relief of leg pain, and nearly 90% had the same response when asked about back pain. In addition, 86% felt there was improvement in their lifestyle postoperatively, said Dr. Christopher Furey.

“Pain, function, image, and quality of life were all significantly improved, and 80% of patients felt their preoperative expectations had been met or exceeded,” said Dr. Furey, of the department of orthopedic surgery at Case Western Reserve University in Cleveland.

This type of repair is a major undertaking, he said. “Adults with degenerative lumbar scoliosis frequently have significant medical issues—including osteopenia and osteoporosis—that make them more of a challenge. These are lengthy surgeries with the potential for significant blood loss and long hospital stay, and complications are common,” Dr. Furey explained.

All patients in this retrospective analysis were first treated conservatively, and only those who were ready to proceed with elective surgery underwent decompression and fusion with pedicle screw instrumentation and iliac crest graft.

All levels with spinal stenosis were decompressed, including bilateral foraminotomies. All levels decompressed were fused, as were any levels with lateral listhesis greater than 6 mm. The proximal extent of the fusion was at the lowest neutral vertebra in the upper lumbar or lower thoracic spine. Fusion was extended to the sacrum only if an L5-S1 spondylolisthesis was present, but otherwise was stopped at L5, Dr. Furey said.

Two patients developed deep infections that required surgical debridement, and misplaced pedicle screws in two others had to be adjusted, he said. “Excluding those who had immediate postoperative treatment for infections, there was a 21% reoperation rate, which is high.”

Dr. Furey and his coauthor, Dr. Sanford Emery of West Virginia University, Charleston, said that because the procedure potentially can cause significant complications in older patients, it should be reserved for those who have failed conservative management and who are suitable medical candidates. “These patients deserve respect, and optimizing medical issues—including good intraoperative anesthesia support and postoperative observation—is critical,” Dr. Furey said.

SEATTLE — A majority of adults with degenerative lumbar scoliosis experienced pain relief after undergoing posterior decompression and fusion, according to a 42-patient study presented at the annual meeting of the North American Spine Society.

At an average follow-up of just over 4 years, 95% of patients reported excellent or good relief of leg pain, and nearly 90% had the same response when asked about back pain. In addition, 86% felt there was improvement in their lifestyle postoperatively, said Dr. Christopher Furey.

“Pain, function, image, and quality of life were all significantly improved, and 80% of patients felt their preoperative expectations had been met or exceeded,” said Dr. Furey, of the department of orthopedic surgery at Case Western Reserve University in Cleveland.

This type of repair is a major undertaking, he said. “Adults with degenerative lumbar scoliosis frequently have significant medical issues—including osteopenia and osteoporosis—that make them more of a challenge. These are lengthy surgeries with the potential for significant blood loss and long hospital stay, and complications are common,” Dr. Furey explained.

All patients in this retrospective analysis were first treated conservatively, and only those who were ready to proceed with elective surgery underwent decompression and fusion with pedicle screw instrumentation and iliac crest graft.

All levels with spinal stenosis were decompressed, including bilateral foraminotomies. All levels decompressed were fused, as were any levels with lateral listhesis greater than 6 mm. The proximal extent of the fusion was at the lowest neutral vertebra in the upper lumbar or lower thoracic spine. Fusion was extended to the sacrum only if an L5-S1 spondylolisthesis was present, but otherwise was stopped at L5, Dr. Furey said.

Two patients developed deep infections that required surgical debridement, and misplaced pedicle screws in two others had to be adjusted, he said. “Excluding those who had immediate postoperative treatment for infections, there was a 21% reoperation rate, which is high.”

Dr. Furey and his coauthor, Dr. Sanford Emery of West Virginia University, Charleston, said that because the procedure potentially can cause significant complications in older patients, it should be reserved for those who have failed conservative management and who are suitable medical candidates. “These patients deserve respect, and optimizing medical issues—including good intraoperative anesthesia support and postoperative observation—is critical,” Dr. Furey said.

LA JOLLA, CALIF. — Specific interventions to increase the availability of intrauterine devices hold considerable potential for improving the use of these convenient and highly effective contraceptive tools, Dr. Suzan Goodman said at the annual meeting of the Association of Reproductive Health Professionals.

The interventions studied include immediate postabortal insertion, simplified screening criteria, allowed insertion on initial visit, staff training that includes clinician instruction on intrauterine device (IUD) counseling and insertion, and reevaluation and improvement of IUD educational materials.

While IUDs are a highly effective form of birth control equal to tubal sterilization, only 1% of reproductive age women in the United States use them, compared with over 20% in many other countries, said Dr. Goodman, director of medical education at Planned Parenthood Golden Gate in San Francisco.

“We hypothesized that barriers to insertion of IUDs are central to low utilization in the U.S. Postabortal IUD insertion can be a rapid, effective form of contraception, and studies show that complication rates do not increase when IUDs are inserted immediately post abortion,” she explained.

The researchers obtained data on eight clinics' IUD utilization during three periods: an 18-month control group period, a 14-month period after initiation of postabortal insertion, and a 6-month period with all interventions, including the addition of same-day insertion with simplified screening criteria.

During the 3-year study a total of 2,184 IUDs were inserted, including 1,503 interval insertions and 681 postabortion insertions. About half the IUDs were nonhormonal ParaGuard devices and half were Mirena devices, which release a low dose of levonorgestrel. From period 1 to period 3, the average monthly ParaGuard insertions increased fourfold and Mirena insertions increased eightfold.

In the control period, 31 IUDs were inserted per month, on average, compared with 74 per month during the postabortal insertion period and 123 per month in the period with all interventions.

While the abortion rate in the clinics involved in the interventions increased 10%, IUD utilization increased 330%, showing that the observed IUD insertion trend was not just due to increasing abortions, Dr. Goodman said. A nearby Planned Parenthood affiliate that did not undertake these interventions had an increase in IUD utilization over the same period of 20%, she said.

A demographic analysis revealed that each progressive study period had more women using IUDs who were young, single, and of smaller mean family size. The number of white and black women using IUDs increased over the progressive study periods.

Over 90% of IUD users met Medicaid eligibility requirements.

Among the complications encountered were IUD expulsion, infection, pregnancy with the IUD in place, continuing viable pregnancy, and abortion. Dr. Goodman had no financial disclosures.

LA JOLLA, CALIF. — Specific interventions to increase the availability of intrauterine devices hold considerable potential for improving the use of these convenient and highly effective contraceptive tools, Dr. Suzan Goodman said at the annual meeting of the Association of Reproductive Health Professionals.

The interventions studied include immediate postabortal insertion, simplified screening criteria, allowed insertion on initial visit, staff training that includes clinician instruction on intrauterine device (IUD) counseling and insertion, and reevaluation and improvement of IUD educational materials.

While IUDs are a highly effective form of birth control equal to tubal sterilization, only 1% of reproductive age women in the United States use them, compared with over 20% in many other countries, said Dr. Goodman, director of medical education at Planned Parenthood Golden Gate in San Francisco.

“We hypothesized that barriers to insertion of IUDs are central to low utilization in the U.S. Postabortal IUD insertion can be a rapid, effective form of contraception, and studies show that complication rates do not increase when IUDs are inserted immediately post abortion,” she explained.

The researchers obtained data on eight clinics' IUD utilization during three periods: an 18-month control group period, a 14-month period after initiation of postabortal insertion, and a 6-month period with all interventions, including the addition of same-day insertion with simplified screening criteria.

During the 3-year study a total of 2,184 IUDs were inserted, including 1,503 interval insertions and 681 postabortion insertions. About half the IUDs were nonhormonal ParaGuard devices and half were Mirena devices, which release a low dose of levonorgestrel. From period 1 to period 3, the average monthly ParaGuard insertions increased fourfold and Mirena insertions increased eightfold.

In the control period, 31 IUDs were inserted per month, on average, compared with 74 per month during the postabortal insertion period and 123 per month in the period with all interventions.

While the abortion rate in the clinics involved in the interventions increased 10%, IUD utilization increased 330%, showing that the observed IUD insertion trend was not just due to increasing abortions, Dr. Goodman said. A nearby Planned Parenthood affiliate that did not undertake these interventions had an increase in IUD utilization over the same period of 20%, she said.

A demographic analysis revealed that each progressive study period had more women using IUDs who were young, single, and of smaller mean family size. The number of white and black women using IUDs increased over the progressive study periods.

Over 90% of IUD users met Medicaid eligibility requirements.

Among the complications encountered were IUD expulsion, infection, pregnancy with the IUD in place, continuing viable pregnancy, and abortion. Dr. Goodman had no financial disclosures.

LA JOLLA, CALIF. — Specific interventions to increase the availability of intrauterine devices hold considerable potential for improving the use of these convenient and highly effective contraceptive tools, Dr. Suzan Goodman said at the annual meeting of the Association of Reproductive Health Professionals.

The interventions studied include immediate postabortal insertion, simplified screening criteria, allowed insertion on initial visit, staff training that includes clinician instruction on intrauterine device (IUD) counseling and insertion, and reevaluation and improvement of IUD educational materials.

While IUDs are a highly effective form of birth control equal to tubal sterilization, only 1% of reproductive age women in the United States use them, compared with over 20% in many other countries, said Dr. Goodman, director of medical education at Planned Parenthood Golden Gate in San Francisco.

“We hypothesized that barriers to insertion of IUDs are central to low utilization in the U.S. Postabortal IUD insertion can be a rapid, effective form of contraception, and studies show that complication rates do not increase when IUDs are inserted immediately post abortion,” she explained.

The researchers obtained data on eight clinics' IUD utilization during three periods: an 18-month control group period, a 14-month period after initiation of postabortal insertion, and a 6-month period with all interventions, including the addition of same-day insertion with simplified screening criteria.

During the 3-year study a total of 2,184 IUDs were inserted, including 1,503 interval insertions and 681 postabortion insertions. About half the IUDs were nonhormonal ParaGuard devices and half were Mirena devices, which release a low dose of levonorgestrel. From period 1 to period 3, the average monthly ParaGuard insertions increased fourfold and Mirena insertions increased eightfold.

In the control period, 31 IUDs were inserted per month, on average, compared with 74 per month during the postabortal insertion period and 123 per month in the period with all interventions.

While the abortion rate in the clinics involved in the interventions increased 10%, IUD utilization increased 330%, showing that the observed IUD insertion trend was not just due to increasing abortions, Dr. Goodman said. A nearby Planned Parenthood affiliate that did not undertake these interventions had an increase in IUD utilization over the same period of 20%, she said.

A demographic analysis revealed that each progressive study period had more women using IUDs who were young, single, and of smaller mean family size. The number of white and black women using IUDs increased over the progressive study periods.

Over 90% of IUD users met Medicaid eligibility requirements.

Among the complications encountered were IUD expulsion, infection, pregnancy with the IUD in place, continuing viable pregnancy, and abortion. Dr. Goodman had no financial disclosures.

LA JOLLA, CALIF. — Hysterectomy and the levonorgestrel-releasing intrauterine system are equally effective for improving sexual functioning in women being treated for menorrhagia, Dr. Karoliina Halmesmaki said.

“One-third of women suffer from menorrhagia during their reproductive years, and as a result have a lower quality of life,” she said at the annual meeting of the Association of Reproductive Health Professionals.

The most common surgical treatment for this condition is hysterectomy, which has the potential to affect sexual functioning by disrupting the vaginal nerve supply and changing pelvic anatomy, explained Dr. Halmesmaki, a professor in the department of obstetrics and gynecology at the University of Helsinki.

“Previous randomized controlled trials comparing hysterectomy with medical treatment … have produced controversial results. The aim of our study was to compare these two treatments' effects on sexual functioning,” she said.

The study included 236 nondepressed women aged 35–49 years who were referred for menorrhagia to five university hospitals in Finland. Equal numbers of women were matched and randomized to either surgery or a levonorgestrel-releasing intrauterine system (LNG-IUS). Sexual functioning was assessed by a modified McCoy sexual scale, a questionnaire addressing sexual satisfaction, partner satisfaction, and sexual problems.

“Sexual satisfaction increased in both groups at 6 months' follow-up, but more so in the hysterectomy group,” Dr. Halmesmaki said. “However, the two groups did not differ at 12 months and 5 years.”

Sexual problems decreased among women with hysterectomies at 6 and 12 months, but again, there was no group difference at the 5-year follow-up.

“Interestingly, even though the two groups did not differ with regard to sexual satisfaction or sex problems at 5 years, the women using LNG-IUS were less satisfied with their partners at 1 year and beyond,” Dr. Halmesmaki said.

LA JOLLA, CALIF. — Hysterectomy and the levonorgestrel-releasing intrauterine system are equally effective for improving sexual functioning in women being treated for menorrhagia, Dr. Karoliina Halmesmaki said.

“One-third of women suffer from menorrhagia during their reproductive years, and as a result have a lower quality of life,” she said at the annual meeting of the Association of Reproductive Health Professionals.

The most common surgical treatment for this condition is hysterectomy, which has the potential to affect sexual functioning by disrupting the vaginal nerve supply and changing pelvic anatomy, explained Dr. Halmesmaki, a professor in the department of obstetrics and gynecology at the University of Helsinki.

“Previous randomized controlled trials comparing hysterectomy with medical treatment … have produced controversial results. The aim of our study was to compare these two treatments' effects on sexual functioning,” she said.

The study included 236 nondepressed women aged 35–49 years who were referred for menorrhagia to five university hospitals in Finland. Equal numbers of women were matched and randomized to either surgery or a levonorgestrel-releasing intrauterine system (LNG-IUS). Sexual functioning was assessed by a modified McCoy sexual scale, a questionnaire addressing sexual satisfaction, partner satisfaction, and sexual problems.

“Sexual satisfaction increased in both groups at 6 months' follow-up, but more so in the hysterectomy group,” Dr. Halmesmaki said. “However, the two groups did not differ at 12 months and 5 years.”

Sexual problems decreased among women with hysterectomies at 6 and 12 months, but again, there was no group difference at the 5-year follow-up.

“Interestingly, even though the two groups did not differ with regard to sexual satisfaction or sex problems at 5 years, the women using LNG-IUS were less satisfied with their partners at 1 year and beyond,” Dr. Halmesmaki said.

LA JOLLA, CALIF. — Hysterectomy and the levonorgestrel-releasing intrauterine system are equally effective for improving sexual functioning in women being treated for menorrhagia, Dr. Karoliina Halmesmaki said.

“One-third of women suffer from menorrhagia during their reproductive years, and as a result have a lower quality of life,” she said at the annual meeting of the Association of Reproductive Health Professionals.

The most common surgical treatment for this condition is hysterectomy, which has the potential to affect sexual functioning by disrupting the vaginal nerve supply and changing pelvic anatomy, explained Dr. Halmesmaki, a professor in the department of obstetrics and gynecology at the University of Helsinki.

“Previous randomized controlled trials comparing hysterectomy with medical treatment … have produced controversial results. The aim of our study was to compare these two treatments' effects on sexual functioning,” she said.

The study included 236 nondepressed women aged 35–49 years who were referred for menorrhagia to five university hospitals in Finland. Equal numbers of women were matched and randomized to either surgery or a levonorgestrel-releasing intrauterine system (LNG-IUS). Sexual functioning was assessed by a modified McCoy sexual scale, a questionnaire addressing sexual satisfaction, partner satisfaction, and sexual problems.

“Sexual satisfaction increased in both groups at 6 months' follow-up, but more so in the hysterectomy group,” Dr. Halmesmaki said. “However, the two groups did not differ at 12 months and 5 years.”

Sexual problems decreased among women with hysterectomies at 6 and 12 months, but again, there was no group difference at the 5-year follow-up.

“Interestingly, even though the two groups did not differ with regard to sexual satisfaction or sex problems at 5 years, the women using LNG-IUS were less satisfied with their partners at 1 year and beyond,” Dr. Halmesmaki said.

LA JOLLA, CALIF. — The new spermicidal microbicide BufferGel, when used with a diaphragm, is a safe, acceptable contraceptive with efficacy that is noninferior to the Gynol II-diaphragm combination, according to a phase III multicenter study.

“These important findings demonstrate that a new spermicide and potential microbicide works as well as the currently marketed nonoxynol-9-based product,” Dr. Kurt T. Barnhart said in an interview. “The advantages of this new product, the first nonsurfactant spermicide demonstrated to work in decades, is that it is potentially safer than N-9 and may also prevent HIV transmission,” said Dr. Barnhart, who is director of clinical research for the department of obstetrics and gynecology at the University of Pennsylvania in Philadelphia.

Whereas N-9 is a surfactant that indiscriminately disrupts epithelial cell membranes and kills sperm before they can enter the uterus, BufferGel is a nondetergent agent that keeps the pH in the vagina acidic instead of raising it to neutrality when sperm are introduced, Dr. Barnhart said at the annual meeting of the Association of Reproductive Health Professionals.

“By keeping those natural defenses acidic, BufferGel is toxic to both sperm and some microbes, including HIV, though the phase II-III HIV arm of the trial is still underway in Africa,” he explained.

These new findings emerged from an 11-center noninferiority trial stemming from the hypothesis that BufferGel is noninferior to Gynol II when both compounds are used with a diaphragm, with noninferiority being defined as within 6% of each other in terms of contraceptive efficacy.

This was a two-part trial: Study 1 was a double-blind, randomized, direct comparison of the two preparations. A total of 621 women used BufferGel and 300 received Gynol II. After completing six cycles, they could elect to continue for an additional six cycles as part of an open-label BufferGel study (study 2), and 234 did so. Of those, 63 discontinued before 6 months elapsed.

Study 1 showed the two compounds to be comparable in virtually all respects. “All the differences favor BufferGel, but those differences were within 6% of each other, so we can say these two products are noninferior to each other,” said Dr. Barnhart. About the same percentage (3%) in each group thought adverse events warranted discontinuation, Dr. Barnhart said.

At cycle six, 68% of BufferGel users and 70% of Gynol II users said they would definitely or probably use the product if available, while 54% of BufferGel users and 57% of Gynol II users preferred the system to condoms.

BufferGel's typical use pregnancy rate was 10% in this study sponsored by the National Institute of Child Health and Development Clinical Trials Network.

'Differences were within 6% …, so we can say these two products are noninferior to each other.' DR. BARNHART

LA JOLLA, CALIF. — The new spermicidal microbicide BufferGel, when used with a diaphragm, is a safe, acceptable contraceptive with efficacy that is noninferior to the Gynol II-diaphragm combination, according to a phase III multicenter study.

“These important findings demonstrate that a new spermicide and potential microbicide works as well as the currently marketed nonoxynol-9-based product,” Dr. Kurt T. Barnhart said in an interview. “The advantages of this new product, the first nonsurfactant spermicide demonstrated to work in decades, is that it is potentially safer than N-9 and may also prevent HIV transmission,” said Dr. Barnhart, who is director of clinical research for the department of obstetrics and gynecology at the University of Pennsylvania in Philadelphia.

Whereas N-9 is a surfactant that indiscriminately disrupts epithelial cell membranes and kills sperm before they can enter the uterus, BufferGel is a nondetergent agent that keeps the pH in the vagina acidic instead of raising it to neutrality when sperm are introduced, Dr. Barnhart said at the annual meeting of the Association of Reproductive Health Professionals.

“By keeping those natural defenses acidic, BufferGel is toxic to both sperm and some microbes, including HIV, though the phase II-III HIV arm of the trial is still underway in Africa,” he explained.

These new findings emerged from an 11-center noninferiority trial stemming from the hypothesis that BufferGel is noninferior to Gynol II when both compounds are used with a diaphragm, with noninferiority being defined as within 6% of each other in terms of contraceptive efficacy.

This was a two-part trial: Study 1 was a double-blind, randomized, direct comparison of the two preparations. A total of 621 women used BufferGel and 300 received Gynol II. After completing six cycles, they could elect to continue for an additional six cycles as part of an open-label BufferGel study (study 2), and 234 did so. Of those, 63 discontinued before 6 months elapsed.

Study 1 showed the two compounds to be comparable in virtually all respects. “All the differences favor BufferGel, but those differences were within 6% of each other, so we can say these two products are noninferior to each other,” said Dr. Barnhart. About the same percentage (3%) in each group thought adverse events warranted discontinuation, Dr. Barnhart said.

At cycle six, 68% of BufferGel users and 70% of Gynol II users said they would definitely or probably use the product if available, while 54% of BufferGel users and 57% of Gynol II users preferred the system to condoms.

BufferGel's typical use pregnancy rate was 10% in this study sponsored by the National Institute of Child Health and Development Clinical Trials Network.

'Differences were within 6% …, so we can say these two products are noninferior to each other.' DR. BARNHART

LA JOLLA, CALIF. — The new spermicidal microbicide BufferGel, when used with a diaphragm, is a safe, acceptable contraceptive with efficacy that is noninferior to the Gynol II-diaphragm combination, according to a phase III multicenter study.

“These important findings demonstrate that a new spermicide and potential microbicide works as well as the currently marketed nonoxynol-9-based product,” Dr. Kurt T. Barnhart said in an interview. “The advantages of this new product, the first nonsurfactant spermicide demonstrated to work in decades, is that it is potentially safer than N-9 and may also prevent HIV transmission,” said Dr. Barnhart, who is director of clinical research for the department of obstetrics and gynecology at the University of Pennsylvania in Philadelphia.

Whereas N-9 is a surfactant that indiscriminately disrupts epithelial cell membranes and kills sperm before they can enter the uterus, BufferGel is a nondetergent agent that keeps the pH in the vagina acidic instead of raising it to neutrality when sperm are introduced, Dr. Barnhart said at the annual meeting of the Association of Reproductive Health Professionals.

“By keeping those natural defenses acidic, BufferGel is toxic to both sperm and some microbes, including HIV, though the phase II-III HIV arm of the trial is still underway in Africa,” he explained.

These new findings emerged from an 11-center noninferiority trial stemming from the hypothesis that BufferGel is noninferior to Gynol II when both compounds are used with a diaphragm, with noninferiority being defined as within 6% of each other in terms of contraceptive efficacy.

This was a two-part trial: Study 1 was a double-blind, randomized, direct comparison of the two preparations. A total of 621 women used BufferGel and 300 received Gynol II. After completing six cycles, they could elect to continue for an additional six cycles as part of an open-label BufferGel study (study 2), and 234 did so. Of those, 63 discontinued before 6 months elapsed.

Study 1 showed the two compounds to be comparable in virtually all respects. “All the differences favor BufferGel, but those differences were within 6% of each other, so we can say these two products are noninferior to each other,” said Dr. Barnhart. About the same percentage (3%) in each group thought adverse events warranted discontinuation, Dr. Barnhart said.

At cycle six, 68% of BufferGel users and 70% of Gynol II users said they would definitely or probably use the product if available, while 54% of BufferGel users and 57% of Gynol II users preferred the system to condoms.

BufferGel's typical use pregnancy rate was 10% in this study sponsored by the National Institute of Child Health and Development Clinical Trials Network.

'Differences were within 6% …, so we can say these two products are noninferior to each other.' DR. BARNHART

LA JOLLA, CALIF. — Spermicides containing nonoxynol-9 are a safe alternative for women who are at low risk of acquiring sexually transmitted infections, according to a study from the University of Pittsburgh.

Use of an N-9 spermicide was compared with condom use in two cohorts of women in mutually monogamous heterosexual partnerships requiring long-term contraception, who had no sexually transmitted infections (STIs) or suspicion of STIs at the time of enrollment, said Dr. Bryna Harwood, now with the University of Illinois at Chicago.

“Overall, when we looked at users of any type of spermicide compared to condom users, the risk of having a lesion at follow-up colposcopy was similar in both groups. Interestingly, the condom group had a statistically significant increase in lesions characterized by epithelial disruption,” Dr. Harwood said at the annual meeting of the Association of Reproductive Health Professionals.

Epithelial disruption is more commonly associated with N-9 spermicide use in high-risk settings, and lesions with epithelial disruption may increase the risk of acquiring HIV.

The finding comes 9 months after the Food and Drug Administration issued a nonbinding draft guidance warning that N-9 could irritate the vagina and rectum and increase STI risk. The FDA also recommended that the package inserts for latex condoms specify that they cannot entirely protect against STIs such as human papillomavirus and genital herpes.

The primary goal of this multicenter, randomized clinical trial was to compare the efficacy of different N-9 spermicide formulations.

The participants were randomized to one of five formulations—gel, film, or suppository—for coital use. The colposcopic appearance of the genital epithelium was assessed in a substudy of 136 low-risk women assigned to one of the spermicide groups. At one center, 30 women whose partners used condoms were enrolled as a control group. All participants were followed over 6 months during spermicide or condom use. The mean numbers of coital acts per week (about two) were similar between groups.

Colposcopic lesions were described using CONRAD Program/World Health Organization standardized procedures, said Dr. Harwood, of the department of obstetrics and gynecology at the University of Illinois.

New lesions were identified in 48% of visits for spermicide users and in 51% of visits for condom users. However, lesions with epithelial disruption were present in only 11% of spermicide users versus 37% of condom users, Dr. Harwood explained.

In a discussion of the study, Dr. Christine Mauck said these findings are consistent with earlier observations that the differences in lesions between placebo and N-9 are seen only in frequent users.

“I think the bottom line is that N-9 may be safe in those women who don't use it frequently and who are at low risk for HIV and STIs, and that's probably a lot of the women we see in our practices. For them, I think that the risk of unintended pregnancy far outweighs the risk of getting HIV from the irritation caused by N-9,” concluded Dr. Mauck, who is the senior medical adviser for CONRAD in Arlington, Va.

'The condom group had a statistically significant increase in lesions characterized by epithelial disruption.' DR. HARWOOD

LA JOLLA, CALIF. — Spermicides containing nonoxynol-9 are a safe alternative for women who are at low risk of acquiring sexually transmitted infections, according to a study from the University of Pittsburgh.

Use of an N-9 spermicide was compared with condom use in two cohorts of women in mutually monogamous heterosexual partnerships requiring long-term contraception, who had no sexually transmitted infections (STIs) or suspicion of STIs at the time of enrollment, said Dr. Bryna Harwood, now with the University of Illinois at Chicago.

“Overall, when we looked at users of any type of spermicide compared to condom users, the risk of having a lesion at follow-up colposcopy was similar in both groups. Interestingly, the condom group had a statistically significant increase in lesions characterized by epithelial disruption,” Dr. Harwood said at the annual meeting of the Association of Reproductive Health Professionals.

Epithelial disruption is more commonly associated with N-9 spermicide use in high-risk settings, and lesions with epithelial disruption may increase the risk of acquiring HIV.

The finding comes 9 months after the Food and Drug Administration issued a nonbinding draft guidance warning that N-9 could irritate the vagina and rectum and increase STI risk. The FDA also recommended that the package inserts for latex condoms specify that they cannot entirely protect against STIs such as human papillomavirus and genital herpes.

The primary goal of this multicenter, randomized clinical trial was to compare the efficacy of different N-9 spermicide formulations.

The participants were randomized to one of five formulations—gel, film, or suppository—for coital use. The colposcopic appearance of the genital epithelium was assessed in a substudy of 136 low-risk women assigned to one of the spermicide groups. At one center, 30 women whose partners used condoms were enrolled as a control group. All participants were followed over 6 months during spermicide or condom use. The mean numbers of coital acts per week (about two) were similar between groups.

Colposcopic lesions were described using CONRAD Program/World Health Organization standardized procedures, said Dr. Harwood, of the department of obstetrics and gynecology at the University of Illinois.

New lesions were identified in 48% of visits for spermicide users and in 51% of visits for condom users. However, lesions with epithelial disruption were present in only 11% of spermicide users versus 37% of condom users, Dr. Harwood explained.

In a discussion of the study, Dr. Christine Mauck said these findings are consistent with earlier observations that the differences in lesions between placebo and N-9 are seen only in frequent users.

“I think the bottom line is that N-9 may be safe in those women who don't use it frequently and who are at low risk for HIV and STIs, and that's probably a lot of the women we see in our practices. For them, I think that the risk of unintended pregnancy far outweighs the risk of getting HIV from the irritation caused by N-9,” concluded Dr. Mauck, who is the senior medical adviser for CONRAD in Arlington, Va.

'The condom group had a statistically significant increase in lesions characterized by epithelial disruption.' DR. HARWOOD

LA JOLLA, CALIF. — Spermicides containing nonoxynol-9 are a safe alternative for women who are at low risk of acquiring sexually transmitted infections, according to a study from the University of Pittsburgh.

Use of an N-9 spermicide was compared with condom use in two cohorts of women in mutually monogamous heterosexual partnerships requiring long-term contraception, who had no sexually transmitted infections (STIs) or suspicion of STIs at the time of enrollment, said Dr. Bryna Harwood, now with the University of Illinois at Chicago.

“Overall, when we looked at users of any type of spermicide compared to condom users, the risk of having a lesion at follow-up colposcopy was similar in both groups. Interestingly, the condom group had a statistically significant increase in lesions characterized by epithelial disruption,” Dr. Harwood said at the annual meeting of the Association of Reproductive Health Professionals.

Epithelial disruption is more commonly associated with N-9 spermicide use in high-risk settings, and lesions with epithelial disruption may increase the risk of acquiring HIV.

The finding comes 9 months after the Food and Drug Administration issued a nonbinding draft guidance warning that N-9 could irritate the vagina and rectum and increase STI risk. The FDA also recommended that the package inserts for latex condoms specify that they cannot entirely protect against STIs such as human papillomavirus and genital herpes.

The primary goal of this multicenter, randomized clinical trial was to compare the efficacy of different N-9 spermicide formulations.

The participants were randomized to one of five formulations—gel, film, or suppository—for coital use. The colposcopic appearance of the genital epithelium was assessed in a substudy of 136 low-risk women assigned to one of the spermicide groups. At one center, 30 women whose partners used condoms were enrolled as a control group. All participants were followed over 6 months during spermicide or condom use. The mean numbers of coital acts per week (about two) were similar between groups.

Colposcopic lesions were described using CONRAD Program/World Health Organization standardized procedures, said Dr. Harwood, of the department of obstetrics and gynecology at the University of Illinois.

New lesions were identified in 48% of visits for spermicide users and in 51% of visits for condom users. However, lesions with epithelial disruption were present in only 11% of spermicide users versus 37% of condom users, Dr. Harwood explained.

In a discussion of the study, Dr. Christine Mauck said these findings are consistent with earlier observations that the differences in lesions between placebo and N-9 are seen only in frequent users.

“I think the bottom line is that N-9 may be safe in those women who don't use it frequently and who are at low risk for HIV and STIs, and that's probably a lot of the women we see in our practices. For them, I think that the risk of unintended pregnancy far outweighs the risk of getting HIV from the irritation caused by N-9,” concluded Dr. Mauck, who is the senior medical adviser for CONRAD in Arlington, Va.

'The condom group had a statistically significant increase in lesions characterized by epithelial disruption.' DR. HARWOOD

Earlier this year, we invited readers to tell us how they are dealing with the challenge of practicing in the era of information technology and performance measurement. Our goal was to learn about innovative ways to improve patient care or make medical practice more efficient.

After careful consideration of the dozens of contest entries that we received, the three members of our editorial board who served as contest judges identified the six contest participants who submitted the most practical and creative ideas.

The six physicians who submitted the winning entries are Dr. Richard B. Gremillion of Sandy, Utah; Dr. Arnold Jay Simon of Palm Springs, Fla.; Dr. Mukesh Bhargava of Sanford, Maine; Dr. Alan Brush of Cambridge, Mass.; Dr. Jonathan D. Krant of Pittsfield, Mass.; and Dr. Randolph J. Swiller of Coral Springs, Fla. Each of these contestants will receive a video iPod.

This month, we're presenting the first two winning contest entries—the two innovations that earned the highest marks from our contest judges.

As INTERNAL MEDICINE NEWS heads into 2007—the year that we'll be celebrating our 40th year of publication—you can continue reading about the practice-enhancing strategies that readers submitted during the contest. In addition to the ideas described on this page, we heard about patient education techniques, prescription refill systems, home visits to enhance patient care, the use of voice-recognition software, and many other innovations.

Although we're awarding prizes to six physicians, we also heard from other readers who deserve credit for submitting useful ideas. We'd like to express special thanks to the runner-up contestants:

▸ Dr. Asif Ali of Houston, Tex.

▸ Diane Atkinson, Office Manager for Dr. John P. Papp and Dr. John P. Papp Jr. of Grand Rapids, Mich.

▸ Dr. Ace Barash of Ukiah, Calif.

▸ Dr. S. Germain Cassiere of Shreveport, La.

▸ Tammy Cleary, on behalf of Dr. Kevin G. Cleary of Depew, N.Y.

▸ Dr. Roger C. Dunham of Santa Barbara, Calif.

▸ Dr. John Guzek of Scranton, Pa.

▸ Dr. Ronald Hirsch of Elgin, Ill.

▸ Dr. L. Allen Kindman of Oxford, N.C.

▸ Dr. Stephenie Lucas of Detroit, Mich.

▸ Dr. Sanyu Pawar of Oklahoma City, Okla.

▸ Dr. Timothy Rodgers of Bryn Mawr, Pa.

▸ Dr. Gerald Saliman of Hillsborough, Calif.

▸ Dr. Kenneth Stark of Tavares, Fla.

▸ Dr. Sharad Swami of Clinton, Okla.

▸ Dr. Rod Tanchanco of Middletown, Del.

▸ Dr. Anthony John Tarasenko of Summit, N.J.

▸ Dr. Benson W. Yu of Fairfax, Va.

The “Reinventing Your Practice” column will appear in the Practice Trends section in the first issue of each month. We hope you'll find ideas here that you can put to work in your own practice.

Earlier this year, we invited readers to tell us how they are dealing with the challenge of practicing in the era of information technology and performance measurement. Our goal was to learn about innovative ways to improve patient care or make medical practice more efficient.

After careful consideration of the dozens of contest entries that we received, the three members of our editorial board who served as contest judges identified the six contest participants who submitted the most practical and creative ideas.

The six physicians who submitted the winning entries are Dr. Richard B. Gremillion of Sandy, Utah; Dr. Arnold Jay Simon of Palm Springs, Fla.; Dr. Mukesh Bhargava of Sanford, Maine; Dr. Alan Brush of Cambridge, Mass.; Dr. Jonathan D. Krant of Pittsfield, Mass.; and Dr. Randolph J. Swiller of Coral Springs, Fla. Each of these contestants will receive a video iPod.

This month, we're presenting the first two winning contest entries—the two innovations that earned the highest marks from our contest judges.

As INTERNAL MEDICINE NEWS heads into 2007—the year that we'll be celebrating our 40th year of publication—you can continue reading about the practice-enhancing strategies that readers submitted during the contest. In addition to the ideas described on this page, we heard about patient education techniques, prescription refill systems, home visits to enhance patient care, the use of voice-recognition software, and many other innovations.

Although we're awarding prizes to six physicians, we also heard from other readers who deserve credit for submitting useful ideas. We'd like to express special thanks to the runner-up contestants:

▸ Dr. Asif Ali of Houston, Tex.

▸ Diane Atkinson, Office Manager for Dr. John P. Papp and Dr. John P. Papp Jr. of Grand Rapids, Mich.

▸ Dr. Ace Barash of Ukiah, Calif.

▸ Dr. S. Germain Cassiere of Shreveport, La.

▸ Tammy Cleary, on behalf of Dr. Kevin G. Cleary of Depew, N.Y.

▸ Dr. Roger C. Dunham of Santa Barbara, Calif.

▸ Dr. John Guzek of Scranton, Pa.

▸ Dr. Ronald Hirsch of Elgin, Ill.

▸ Dr. L. Allen Kindman of Oxford, N.C.

▸ Dr. Stephenie Lucas of Detroit, Mich.

▸ Dr. Sanyu Pawar of Oklahoma City, Okla.

▸ Dr. Timothy Rodgers of Bryn Mawr, Pa.

▸ Dr. Gerald Saliman of Hillsborough, Calif.

▸ Dr. Kenneth Stark of Tavares, Fla.

▸ Dr. Sharad Swami of Clinton, Okla.

▸ Dr. Rod Tanchanco of Middletown, Del.

▸ Dr. Anthony John Tarasenko of Summit, N.J.

▸ Dr. Benson W. Yu of Fairfax, Va.

The “Reinventing Your Practice” column will appear in the Practice Trends section in the first issue of each month. We hope you'll find ideas here that you can put to work in your own practice.

Earlier this year, we invited readers to tell us how they are dealing with the challenge of practicing in the era of information technology and performance measurement. Our goal was to learn about innovative ways to improve patient care or make medical practice more efficient.

After careful consideration of the dozens of contest entries that we received, the three members of our editorial board who served as contest judges identified the six contest participants who submitted the most practical and creative ideas.

The six physicians who submitted the winning entries are Dr. Richard B. Gremillion of Sandy, Utah; Dr. Arnold Jay Simon of Palm Springs, Fla.; Dr. Mukesh Bhargava of Sanford, Maine; Dr. Alan Brush of Cambridge, Mass.; Dr. Jonathan D. Krant of Pittsfield, Mass.; and Dr. Randolph J. Swiller of Coral Springs, Fla. Each of these contestants will receive a video iPod.

This month, we're presenting the first two winning contest entries—the two innovations that earned the highest marks from our contest judges.

As INTERNAL MEDICINE NEWS heads into 2007—the year that we'll be celebrating our 40th year of publication—you can continue reading about the practice-enhancing strategies that readers submitted during the contest. In addition to the ideas described on this page, we heard about patient education techniques, prescription refill systems, home visits to enhance patient care, the use of voice-recognition software, and many other innovations.

Although we're awarding prizes to six physicians, we also heard from other readers who deserve credit for submitting useful ideas. We'd like to express special thanks to the runner-up contestants:

▸ Dr. Asif Ali of Houston, Tex.

▸ Diane Atkinson, Office Manager for Dr. John P. Papp and Dr. John P. Papp Jr. of Grand Rapids, Mich.

▸ Dr. Ace Barash of Ukiah, Calif.

▸ Dr. S. Germain Cassiere of Shreveport, La.

▸ Tammy Cleary, on behalf of Dr. Kevin G. Cleary of Depew, N.Y.

▸ Dr. Roger C. Dunham of Santa Barbara, Calif.

▸ Dr. John Guzek of Scranton, Pa.

▸ Dr. Ronald Hirsch of Elgin, Ill.

▸ Dr. L. Allen Kindman of Oxford, N.C.

▸ Dr. Stephenie Lucas of Detroit, Mich.

▸ Dr. Sanyu Pawar of Oklahoma City, Okla.

▸ Dr. Timothy Rodgers of Bryn Mawr, Pa.

▸ Dr. Gerald Saliman of Hillsborough, Calif.

▸ Dr. Kenneth Stark of Tavares, Fla.

▸ Dr. Sharad Swami of Clinton, Okla.

▸ Dr. Rod Tanchanco of Middletown, Del.

▸ Dr. Anthony John Tarasenko of Summit, N.J.

▸ Dr. Benson W. Yu of Fairfax, Va.

The “Reinventing Your Practice” column will appear in the Practice Trends section in the first issue of each month. We hope you'll find ideas here that you can put to work in your own practice.

LA JOLLA, CALIF. — Women choosing medical abortion through 63 days' gestation can achieve effective results with simultaneous administration of mifepristone and misoprostol, according to a study presented at the annual meeting of the Association of Reproductive Health Professionals.

“Our study shows that using simultaneous administration of 200 mg mifepristone and 800 mcg vaginal misoprostol is as effective and as acceptable to patients as a 24-hour dosing interval,” reported Dr. Mitchell Creinin, professor and director of family planning at the University of Pittsburgh.

Success, defined as complete abortion that did not require suction aspiration for any reason, did not achieve equivalency in the simultaneous group, though this assessment was limited by undersampling for this secondary outcome, he said.

The standard regimen for medical abortion, approved by the Food and Drug Administration, consists of taking 600 mg of oral mifepristone on day 1 and 400 mcg oral misoprostol 36–40 hours later. This regimen typically is used up to 49 days gestation, Dr. Creinin said.

Previous research by Dr. Eric Schaff, medical director of Planned Parenthood of Delaware, had shown that, with the newer vaginal regimen, women favor a shorter dosing interval, Dr. Creinin explained. “And we do know that during the 36–48 hour interval in the standard regimen that up to half of women will begin to bleed, which may have something to do with its acceptability as well as the desire to get things over with more quickly.”

A 2004 study compared the 23- to 25- hour interval with a 6- to 8- hour interval and showed the two to be equivalent in effectiveness. This led to the idea of simultaneous administration, Dr. Creinin said. “In our pilot studies of medical abortion regimens, we tend to look at our expulsion rate with the idea that we don't want to doom women to a surgical abortion if they really don't want it, and we can rescue them with a standard vaginal dose at 24 hours should the new method not work,” he explained. The expulsion rates in those pilot studies was around 90%, which meant the researchers could forge ahead with a trial.

The four-center study enrolled more than 1,100 women between June 2004 and April 2006, with follow-up at 7 and 14 days and phone follow-up 5 weeks post treatment “to check to see if the women had a D&C or problems that caused them to go somewhere else for care,” said Dr. Creinin. If documented expulsion had not occurred by the first follow-up visit, women were given a repeat dose of misoprostol. Of the total sample, two women withdrew prior to randomization and 2% of the women were lost to follow-up, so that the final number of women taking the drugs was 1,126.

All study centers held teleconferences with site monitoring at regular intervals and data queries came from the coordinating center, based on irregularities in the data. “We performed two interim analyses when one-third and two-thirds of the women had completed follow-up, and these analyses were structured to both look at overall efficacy and to address efficacy by gestational age to see if there were problems with continuing on with the study,” Dr. Creinin said, adding that 40% of the women had had a prior abortion, one-fourth of which were medical. Treatment was considered a failure if suction aspiration was performed for any indication.

Overall efficacy between the groups was comparable, with the standard treatment group achieving a success rate of 96.7%—just short of the expected 97% success rate—and the simultaneous administration group achieving a success rate of 95%. Also, almost every gestational age group came close to reaching statistically significant noninferiority, Dr. Creinin said.

Failures, such as continued pregnancy and persistent sac at 2 and 5 weeks were evenly distributed between the cohorts. On day 4, two women in the simultaneous group requested a D&C. The larger incidence of side effects was in the simultaneous group; though it reached statistical significance, it was deemed clinically irrelevant. These side effects included nausea, diarrhea, warmth, and chills. There was no difference in pain and acceptability scores, he said.

“We had relatively few adverse events, though interestingly, there were four transfusions in the standard treatment group. There was one heterotopic pregnancy in the simultaneous group, and five women in each group developed infections and were treated as outpatients without hospitalization,” Dr. Creinin said.

On Nov. 4, 2005, the FDA issued a Public Health Advisory “to inform the public that it is aware of four women in California who died from sepsis following medical abortion with mifepristone and misoprostol.”

In two of the cases, the culprit bacteria were identified as Clostridium sordellii, anaerobic bacteria that in rare cases are fatal. The deaths followed the off-label use of oral mifepristone and vaginal misoprostol given as 200 mg mifepristone orally followed the next day by 800 mcg misoprostol inserted vaginally.

LA JOLLA, CALIF. — Women choosing medical abortion through 63 days' gestation can achieve effective results with simultaneous administration of mifepristone and misoprostol, according to a study presented at the annual meeting of the Association of Reproductive Health Professionals.

“Our study shows that using simultaneous administration of 200 mg mifepristone and 800 mcg vaginal misoprostol is as effective and as acceptable to patients as a 24-hour dosing interval,” reported Dr. Mitchell Creinin, professor and director of family planning at the University of Pittsburgh.

Success, defined as complete abortion that did not require suction aspiration for any reason, did not achieve equivalency in the simultaneous group, though this assessment was limited by undersampling for this secondary outcome, he said.

The standard regimen for medical abortion, approved by the Food and Drug Administration, consists of taking 600 mg of oral mifepristone on day 1 and 400 mcg oral misoprostol 36–40 hours later. This regimen typically is used up to 49 days gestation, Dr. Creinin said.

Previous research by Dr. Eric Schaff, medical director of Planned Parenthood of Delaware, had shown that, with the newer vaginal regimen, women favor a shorter dosing interval, Dr. Creinin explained. “And we do know that during the 36–48 hour interval in the standard regimen that up to half of women will begin to bleed, which may have something to do with its acceptability as well as the desire to get things over with more quickly.”

A 2004 study compared the 23- to 25- hour interval with a 6- to 8- hour interval and showed the two to be equivalent in effectiveness. This led to the idea of simultaneous administration, Dr. Creinin said. “In our pilot studies of medical abortion regimens, we tend to look at our expulsion rate with the idea that we don't want to doom women to a surgical abortion if they really don't want it, and we can rescue them with a standard vaginal dose at 24 hours should the new method not work,” he explained. The expulsion rates in those pilot studies was around 90%, which meant the researchers could forge ahead with a trial.

The four-center study enrolled more than 1,100 women between June 2004 and April 2006, with follow-up at 7 and 14 days and phone follow-up 5 weeks post treatment “to check to see if the women had a D&C or problems that caused them to go somewhere else for care,” said Dr. Creinin. If documented expulsion had not occurred by the first follow-up visit, women were given a repeat dose of misoprostol. Of the total sample, two women withdrew prior to randomization and 2% of the women were lost to follow-up, so that the final number of women taking the drugs was 1,126.

All study centers held teleconferences with site monitoring at regular intervals and data queries came from the coordinating center, based on irregularities in the data. “We performed two interim analyses when one-third and two-thirds of the women had completed follow-up, and these analyses were structured to both look at overall efficacy and to address efficacy by gestational age to see if there were problems with continuing on with the study,” Dr. Creinin said, adding that 40% of the women had had a prior abortion, one-fourth of which were medical. Treatment was considered a failure if suction aspiration was performed for any indication.

Overall efficacy between the groups was comparable, with the standard treatment group achieving a success rate of 96.7%—just short of the expected 97% success rate—and the simultaneous administration group achieving a success rate of 95%. Also, almost every gestational age group came close to reaching statistically significant noninferiority, Dr. Creinin said.

Failures, such as continued pregnancy and persistent sac at 2 and 5 weeks were evenly distributed between the cohorts. On day 4, two women in the simultaneous group requested a D&C. The larger incidence of side effects was in the simultaneous group; though it reached statistical significance, it was deemed clinically irrelevant. These side effects included nausea, diarrhea, warmth, and chills. There was no difference in pain and acceptability scores, he said.

“We had relatively few adverse events, though interestingly, there were four transfusions in the standard treatment group. There was one heterotopic pregnancy in the simultaneous group, and five women in each group developed infections and were treated as outpatients without hospitalization,” Dr. Creinin said.

On Nov. 4, 2005, the FDA issued a Public Health Advisory “to inform the public that it is aware of four women in California who died from sepsis following medical abortion with mifepristone and misoprostol.”

In two of the cases, the culprit bacteria were identified as Clostridium sordellii, anaerobic bacteria that in rare cases are fatal. The deaths followed the off-label use of oral mifepristone and vaginal misoprostol given as 200 mg mifepristone orally followed the next day by 800 mcg misoprostol inserted vaginally.

LA JOLLA, CALIF. — Women choosing medical abortion through 63 days' gestation can achieve effective results with simultaneous administration of mifepristone and misoprostol, according to a study presented at the annual meeting of the Association of Reproductive Health Professionals.

“Our study shows that using simultaneous administration of 200 mg mifepristone and 800 mcg vaginal misoprostol is as effective and as acceptable to patients as a 24-hour dosing interval,” reported Dr. Mitchell Creinin, professor and director of family planning at the University of Pittsburgh.

Success, defined as complete abortion that did not require suction aspiration for any reason, did not achieve equivalency in the simultaneous group, though this assessment was limited by undersampling for this secondary outcome, he said.

The standard regimen for medical abortion, approved by the Food and Drug Administration, consists of taking 600 mg of oral mifepristone on day 1 and 400 mcg oral misoprostol 36–40 hours later. This regimen typically is used up to 49 days gestation, Dr. Creinin said.

Previous research by Dr. Eric Schaff, medical director of Planned Parenthood of Delaware, had shown that, with the newer vaginal regimen, women favor a shorter dosing interval, Dr. Creinin explained. “And we do know that during the 36–48 hour interval in the standard regimen that up to half of women will begin to bleed, which may have something to do with its acceptability as well as the desire to get things over with more quickly.”

A 2004 study compared the 23- to 25- hour interval with a 6- to 8- hour interval and showed the two to be equivalent in effectiveness. This led to the idea of simultaneous administration, Dr. Creinin said. “In our pilot studies of medical abortion regimens, we tend to look at our expulsion rate with the idea that we don't want to doom women to a surgical abortion if they really don't want it, and we can rescue them with a standard vaginal dose at 24 hours should the new method not work,” he explained. The expulsion rates in those pilot studies was around 90%, which meant the researchers could forge ahead with a trial.

The four-center study enrolled more than 1,100 women between June 2004 and April 2006, with follow-up at 7 and 14 days and phone follow-up 5 weeks post treatment “to check to see if the women had a D&C or problems that caused them to go somewhere else for care,” said Dr. Creinin. If documented expulsion had not occurred by the first follow-up visit, women were given a repeat dose of misoprostol. Of the total sample, two women withdrew prior to randomization and 2% of the women were lost to follow-up, so that the final number of women taking the drugs was 1,126.

All study centers held teleconferences with site monitoring at regular intervals and data queries came from the coordinating center, based on irregularities in the data. “We performed two interim analyses when one-third and two-thirds of the women had completed follow-up, and these analyses were structured to both look at overall efficacy and to address efficacy by gestational age to see if there were problems with continuing on with the study,” Dr. Creinin said, adding that 40% of the women had had a prior abortion, one-fourth of which were medical. Treatment was considered a failure if suction aspiration was performed for any indication.

Overall efficacy between the groups was comparable, with the standard treatment group achieving a success rate of 96.7%—just short of the expected 97% success rate—and the simultaneous administration group achieving a success rate of 95%. Also, almost every gestational age group came close to reaching statistically significant noninferiority, Dr. Creinin said.

Failures, such as continued pregnancy and persistent sac at 2 and 5 weeks were evenly distributed between the cohorts. On day 4, two women in the simultaneous group requested a D&C. The larger incidence of side effects was in the simultaneous group; though it reached statistical significance, it was deemed clinically irrelevant. These side effects included nausea, diarrhea, warmth, and chills. There was no difference in pain and acceptability scores, he said.

“We had relatively few adverse events, though interestingly, there were four transfusions in the standard treatment group. There was one heterotopic pregnancy in the simultaneous group, and five women in each group developed infections and were treated as outpatients without hospitalization,” Dr. Creinin said.

On Nov. 4, 2005, the FDA issued a Public Health Advisory “to inform the public that it is aware of four women in California who died from sepsis following medical abortion with mifepristone and misoprostol.”

In two of the cases, the culprit bacteria were identified as Clostridium sordellii, anaerobic bacteria that in rare cases are fatal. The deaths followed the off-label use of oral mifepristone and vaginal misoprostol given as 200 mg mifepristone orally followed the next day by 800 mcg misoprostol inserted vaginally.