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Patch Takes On Surgical Menopause
SAN FRANCISCO — An investigational testosterone patch applied twice weekly improved sexual functioning in as little as 4 weeks in surgically menopausal women, Sheryl Kingsberg, Ph.D., reported in a poster presentation at the annual meeting of the American College of Obstetricians and Gynecologists.
Two randomized, double-blind, placebo-controlled studies together involved 1,095 women aged 20–70 years with hypoactive sexual desire disorder (HSDD) an average of 9 years following oophorectomy. The women applied patches delivering 300 mcg/day of testosterone or placebo, twice a week for 24 weeks.
Patients kept a log of their sexual activity and completed questionnaires related to their sexual desire and distress, stated Dr. Kingsberg of Case Western Reserve University in Cleveland, and her coauthors, including an employee of Procter & Gamble Pharmaceuticals. The company plans to market the Intrinsa testosterone transdermal system pending approval by the Food and Drug Administration.
At the end of the 24 weeks, women on a placebo patch experienced an increase of 33% or 23% in total satisfying sexual activity in the two studies. Women on the testosterone patch experienced 74% and 51% increases respectively, a significant increase.
Similarly, the patch increased sexual desire (29% and 18% increases for placebo vs. 56% and 49% for testosterone) and decreased patients' distress relative to their lack of interest in sex (40% and 48% decreases for placebo vs. 65% and 68% for testosterone). All differences were statistically significant.
Increases in sexual desire and decreases in distress became statistically significant 4 weeks after the start of study medication, and increases in total satisfying sexual activity became statistically significant at 6 weeks. All three measures achieved maximal effects at 12–16 weeks, and this level was sustained until the conclusion of the study at 24 weeks.
The investigators observed no adverse events attributable to the study medication. The most common adverse event was an application site reaction, experienced by approximately 30%–40% of women using testosterone or placebo patches.
SAN FRANCISCO — An investigational testosterone patch applied twice weekly improved sexual functioning in as little as 4 weeks in surgically menopausal women, Sheryl Kingsberg, Ph.D., reported in a poster presentation at the annual meeting of the American College of Obstetricians and Gynecologists.
Two randomized, double-blind, placebo-controlled studies together involved 1,095 women aged 20–70 years with hypoactive sexual desire disorder (HSDD) an average of 9 years following oophorectomy. The women applied patches delivering 300 mcg/day of testosterone or placebo, twice a week for 24 weeks.
Patients kept a log of their sexual activity and completed questionnaires related to their sexual desire and distress, stated Dr. Kingsberg of Case Western Reserve University in Cleveland, and her coauthors, including an employee of Procter & Gamble Pharmaceuticals. The company plans to market the Intrinsa testosterone transdermal system pending approval by the Food and Drug Administration.
At the end of the 24 weeks, women on a placebo patch experienced an increase of 33% or 23% in total satisfying sexual activity in the two studies. Women on the testosterone patch experienced 74% and 51% increases respectively, a significant increase.
Similarly, the patch increased sexual desire (29% and 18% increases for placebo vs. 56% and 49% for testosterone) and decreased patients' distress relative to their lack of interest in sex (40% and 48% decreases for placebo vs. 65% and 68% for testosterone). All differences were statistically significant.
Increases in sexual desire and decreases in distress became statistically significant 4 weeks after the start of study medication, and increases in total satisfying sexual activity became statistically significant at 6 weeks. All three measures achieved maximal effects at 12–16 weeks, and this level was sustained until the conclusion of the study at 24 weeks.
The investigators observed no adverse events attributable to the study medication. The most common adverse event was an application site reaction, experienced by approximately 30%–40% of women using testosterone or placebo patches.
SAN FRANCISCO — An investigational testosterone patch applied twice weekly improved sexual functioning in as little as 4 weeks in surgically menopausal women, Sheryl Kingsberg, Ph.D., reported in a poster presentation at the annual meeting of the American College of Obstetricians and Gynecologists.
Two randomized, double-blind, placebo-controlled studies together involved 1,095 women aged 20–70 years with hypoactive sexual desire disorder (HSDD) an average of 9 years following oophorectomy. The women applied patches delivering 300 mcg/day of testosterone or placebo, twice a week for 24 weeks.
Patients kept a log of their sexual activity and completed questionnaires related to their sexual desire and distress, stated Dr. Kingsberg of Case Western Reserve University in Cleveland, and her coauthors, including an employee of Procter & Gamble Pharmaceuticals. The company plans to market the Intrinsa testosterone transdermal system pending approval by the Food and Drug Administration.
At the end of the 24 weeks, women on a placebo patch experienced an increase of 33% or 23% in total satisfying sexual activity in the two studies. Women on the testosterone patch experienced 74% and 51% increases respectively, a significant increase.
Similarly, the patch increased sexual desire (29% and 18% increases for placebo vs. 56% and 49% for testosterone) and decreased patients' distress relative to their lack of interest in sex (40% and 48% decreases for placebo vs. 65% and 68% for testosterone). All differences were statistically significant.
Increases in sexual desire and decreases in distress became statistically significant 4 weeks after the start of study medication, and increases in total satisfying sexual activity became statistically significant at 6 weeks. All three measures achieved maximal effects at 12–16 weeks, and this level was sustained until the conclusion of the study at 24 weeks.
The investigators observed no adverse events attributable to the study medication. The most common adverse event was an application site reaction, experienced by approximately 30%–40% of women using testosterone or placebo patches.
Low Expulsion Rate for NuvaRing Contraceptive
SAN FRANCISCO — In a year's experience with the NuvaRing contraceptive, 2.3% of women experience an expulsion, according to the results of four large, phase III clinical trials, Marc Kaptein, M.D., and Edio Zampaglione, M.D., said in a poster presentation at the annual meeting of the American College of Obstetricians and Gynecologists.
In a retrospective analysis of 3,333 women and 33,462 cycles, expulsion occurred in 0.5% of cycles, said the researchers from Organon International, which makes NuvaRing.
The proportion of cycles with expulsions decreased with time, likely due to experience. In the first three cycles, 1.7% reported an expulsion. Users were followed for 13 cycles. In the 11th, 12th, and 13th cycles, 0.2% experienced expulsions.
SAN FRANCISCO — In a year's experience with the NuvaRing contraceptive, 2.3% of women experience an expulsion, according to the results of four large, phase III clinical trials, Marc Kaptein, M.D., and Edio Zampaglione, M.D., said in a poster presentation at the annual meeting of the American College of Obstetricians and Gynecologists.
In a retrospective analysis of 3,333 women and 33,462 cycles, expulsion occurred in 0.5% of cycles, said the researchers from Organon International, which makes NuvaRing.
The proportion of cycles with expulsions decreased with time, likely due to experience. In the first three cycles, 1.7% reported an expulsion. Users were followed for 13 cycles. In the 11th, 12th, and 13th cycles, 0.2% experienced expulsions.
SAN FRANCISCO — In a year's experience with the NuvaRing contraceptive, 2.3% of women experience an expulsion, according to the results of four large, phase III clinical trials, Marc Kaptein, M.D., and Edio Zampaglione, M.D., said in a poster presentation at the annual meeting of the American College of Obstetricians and Gynecologists.
In a retrospective analysis of 3,333 women and 33,462 cycles, expulsion occurred in 0.5% of cycles, said the researchers from Organon International, which makes NuvaRing.
The proportion of cycles with expulsions decreased with time, likely due to experience. In the first three cycles, 1.7% reported an expulsion. Users were followed for 13 cycles. In the 11th, 12th, and 13th cycles, 0.2% experienced expulsions.
Urge Incontinence Treated With Flexible Dosing of Oxybutynin
SAN FRANCISCO — Almost half of patients on flexible-dosing schedules of extended-release oxybutynin for urge incontinence chose a dose of more than 10 mg/day, the level employed in two fixed-dose trials of the medication, Peter K. Sand, M.D., and Scott A. MacDiarmid, M.D., reported in a poster presentation at the annual meeting of the American College of Obstetricians and Gynecologists.
In a combined analysis of 368 patients from three clinical trials employing flexible dosing schedules of 5–30 mg/day, 47% of participants chose a final dose of 15, 20, 25, or 30 mg/day.
At all selected final doses of oxybutynin, 77%–83% of the patients reportedly achieved a reduction of at least 70% in the number of urge incontinence episodes, according to Dr. Sand of Northwestern University, Chicago, and Dr. MacDiarmid of Wake Forest University, Winston-Salem, N.C.
At final doses of 5 mg to 25 mg/day, patients achieved a reduction of about 85% in the number of urge incontinence levels.
But at 30 mg/day, the reduction in episodes was only 61%.
Given that the incidence of dry mouth (the most common side effect) was similar to that in the other groups, the investigators suggested that the finding of relatively low efficacy in the highest dose may be due to a relative insensitivity to anticholinergics among some of the patients.
Overall, 23.1% had moderate or severe dry mouth, but only 5 (or 1.4%) withdrew from their trial for this reason.
Ortho-McNeil Pharmaceutical Inc. sponsored the analysis.
SAN FRANCISCO — Almost half of patients on flexible-dosing schedules of extended-release oxybutynin for urge incontinence chose a dose of more than 10 mg/day, the level employed in two fixed-dose trials of the medication, Peter K. Sand, M.D., and Scott A. MacDiarmid, M.D., reported in a poster presentation at the annual meeting of the American College of Obstetricians and Gynecologists.
In a combined analysis of 368 patients from three clinical trials employing flexible dosing schedules of 5–30 mg/day, 47% of participants chose a final dose of 15, 20, 25, or 30 mg/day.
At all selected final doses of oxybutynin, 77%–83% of the patients reportedly achieved a reduction of at least 70% in the number of urge incontinence episodes, according to Dr. Sand of Northwestern University, Chicago, and Dr. MacDiarmid of Wake Forest University, Winston-Salem, N.C.
At final doses of 5 mg to 25 mg/day, patients achieved a reduction of about 85% in the number of urge incontinence levels.
But at 30 mg/day, the reduction in episodes was only 61%.
Given that the incidence of dry mouth (the most common side effect) was similar to that in the other groups, the investigators suggested that the finding of relatively low efficacy in the highest dose may be due to a relative insensitivity to anticholinergics among some of the patients.
Overall, 23.1% had moderate or severe dry mouth, but only 5 (or 1.4%) withdrew from their trial for this reason.
Ortho-McNeil Pharmaceutical Inc. sponsored the analysis.
SAN FRANCISCO — Almost half of patients on flexible-dosing schedules of extended-release oxybutynin for urge incontinence chose a dose of more than 10 mg/day, the level employed in two fixed-dose trials of the medication, Peter K. Sand, M.D., and Scott A. MacDiarmid, M.D., reported in a poster presentation at the annual meeting of the American College of Obstetricians and Gynecologists.
In a combined analysis of 368 patients from three clinical trials employing flexible dosing schedules of 5–30 mg/day, 47% of participants chose a final dose of 15, 20, 25, or 30 mg/day.
At all selected final doses of oxybutynin, 77%–83% of the patients reportedly achieved a reduction of at least 70% in the number of urge incontinence episodes, according to Dr. Sand of Northwestern University, Chicago, and Dr. MacDiarmid of Wake Forest University, Winston-Salem, N.C.
At final doses of 5 mg to 25 mg/day, patients achieved a reduction of about 85% in the number of urge incontinence levels.
But at 30 mg/day, the reduction in episodes was only 61%.
Given that the incidence of dry mouth (the most common side effect) was similar to that in the other groups, the investigators suggested that the finding of relatively low efficacy in the highest dose may be due to a relative insensitivity to anticholinergics among some of the patients.
Overall, 23.1% had moderate or severe dry mouth, but only 5 (or 1.4%) withdrew from their trial for this reason.
Ortho-McNeil Pharmaceutical Inc. sponsored the analysis.
Estrogen Alternatives Available for Hot Flashes : Remedies such as progestins often are proposed, but few have been evaluated in controlled studies.
SAN FRANCISCO — In the wake of the Women's Health Initiative, “It's easier to get OxyContin out of a doctor's office than Prempro,” Melissa A. McNeil, M.D., joked at the annual meeting of the American College of Physicians.
The question then is how is a physician to manage the vasomotor symptoms of menopause?asked Dr. McNeil, who is women's health program director at the University of Pittsburgh. Although many remedies have advocates, few have been evaluated in controlled studies. She offered several evidence-based suggestions:
▸ Time. Tincture of time works for many women. Although 75% of menopausal women do experience hot flashes, for 30%–50% of them, the symptoms improve within months, and hot flashes resolve completely for most women within 4–5 years.
“That can be a very long 4 or 5 years,” Dr. McNeil acknowledged. In addition, “A substantial minority will continue to have hot flashes for years beyond menopause.”
The fact that women's hot flashes frequently resolve spontaneously leads to a large placebo effect—in the neighborhood of 25%—in various studies of drugs and supplements.
▸ Progestins. There's good evidence from randomized, controlled trials for the efficacy of a number of progestins. Medroxyprogesterone and megestrol (Megace) both were reported to result in a 74% reduction in hot flashes. Depo-Provera was reported in one study to result in a 90% reduction in hot flashes. Uterine bleeding is a frequent side effect of progestin therapy, limiting its use in women who have uterine cysts. Furthermore, there are no long-term safety data available.
The most significant bar to progestin therapy, however, comes from Women's Health Initiative results, which suggest that progesterone supplementation may confer an increased risk of certain cancers or adverse cardiovascular events, compared with estrogen alone.
▸ Clonidine and methyldopa. Studies of antihypertensive agents such as clonidine and methyldopa suggest a relatively small effect on hot flashes. Use of clonidine, in particular, is limited by side effects, including dry mouth, constipation, and drowsiness. Still, these drugs may be useful in women who need blood pressure treatment in addition to relief from their hot flashes.
▸ Nonhormonal therapies. Antidepressants, which are the most promising nonhormonal therapies for hot flashes, have become the mainstay of treatment. Venlafaxine, fluoxetine, and paroxetine all appear to result in 50%–65% reductions in hot flashes in controlled trials, although some of those trials studied breast cancer survivors, who may not be exactly representative of the entire population of menopausal women.
One advantage of antidepressants is that their effect on hot flashes seems to begin relatively quickly. Some patients have reported results in about 1–2 weeks, compared with about a month for their effects on depression. This allows for relatively rapid dose titration.
▸ Gabapentin. This drug appears to have a modest effect on hot flashes, with a reduction of about 50% in one small trial. About half of the women who participated in that trial said they experienced at least one adverse event, including dizziness, somnolence, palpitations, or peripheral edema.
▸ Nutritional supplements. Although these supplements have received a lot of coverage in the lay press, scientific evidence of their efficacy in treating hot flashes generally is lacking. Soy phytoestrogens engendered a great deal of enthusiasm a few years ago, and several small studies seemed to indicate effectiveness. But more recently, a larger controlled trial found they had no effect on hot flashes.
Mixed evidence of effectiveness has been found for vitamin E and black cohosh, but most studies have been small and unblinded. Evening primrose oil, ginseng, and wild yam cream all have been shown to be ineffective.
In selecting a treatment for a patient's hot flashes, Dr. McNeil said that she always looks for a twofer. “If I'm treating depression, I'll go for an antidepressant,” she said. “If they have chronic pain, I think about gabapentin. And if they have hypertension I might use clonidine. If they're straight out of the starting block, I'd think about venlafaxine as my starting point.”
Dr. McNeil said she has no conflicts of interest with regard to her presentation at the meeting.
SAN FRANCISCO — In the wake of the Women's Health Initiative, “It's easier to get OxyContin out of a doctor's office than Prempro,” Melissa A. McNeil, M.D., joked at the annual meeting of the American College of Physicians.
The question then is how is a physician to manage the vasomotor symptoms of menopause?asked Dr. McNeil, who is women's health program director at the University of Pittsburgh. Although many remedies have advocates, few have been evaluated in controlled studies. She offered several evidence-based suggestions:
▸ Time. Tincture of time works for many women. Although 75% of menopausal women do experience hot flashes, for 30%–50% of them, the symptoms improve within months, and hot flashes resolve completely for most women within 4–5 years.
“That can be a very long 4 or 5 years,” Dr. McNeil acknowledged. In addition, “A substantial minority will continue to have hot flashes for years beyond menopause.”
The fact that women's hot flashes frequently resolve spontaneously leads to a large placebo effect—in the neighborhood of 25%—in various studies of drugs and supplements.
▸ Progestins. There's good evidence from randomized, controlled trials for the efficacy of a number of progestins. Medroxyprogesterone and megestrol (Megace) both were reported to result in a 74% reduction in hot flashes. Depo-Provera was reported in one study to result in a 90% reduction in hot flashes. Uterine bleeding is a frequent side effect of progestin therapy, limiting its use in women who have uterine cysts. Furthermore, there are no long-term safety data available.
The most significant bar to progestin therapy, however, comes from Women's Health Initiative results, which suggest that progesterone supplementation may confer an increased risk of certain cancers or adverse cardiovascular events, compared with estrogen alone.
▸ Clonidine and methyldopa. Studies of antihypertensive agents such as clonidine and methyldopa suggest a relatively small effect on hot flashes. Use of clonidine, in particular, is limited by side effects, including dry mouth, constipation, and drowsiness. Still, these drugs may be useful in women who need blood pressure treatment in addition to relief from their hot flashes.
▸ Nonhormonal therapies. Antidepressants, which are the most promising nonhormonal therapies for hot flashes, have become the mainstay of treatment. Venlafaxine, fluoxetine, and paroxetine all appear to result in 50%–65% reductions in hot flashes in controlled trials, although some of those trials studied breast cancer survivors, who may not be exactly representative of the entire population of menopausal women.
One advantage of antidepressants is that their effect on hot flashes seems to begin relatively quickly. Some patients have reported results in about 1–2 weeks, compared with about a month for their effects on depression. This allows for relatively rapid dose titration.
▸ Gabapentin. This drug appears to have a modest effect on hot flashes, with a reduction of about 50% in one small trial. About half of the women who participated in that trial said they experienced at least one adverse event, including dizziness, somnolence, palpitations, or peripheral edema.
▸ Nutritional supplements. Although these supplements have received a lot of coverage in the lay press, scientific evidence of their efficacy in treating hot flashes generally is lacking. Soy phytoestrogens engendered a great deal of enthusiasm a few years ago, and several small studies seemed to indicate effectiveness. But more recently, a larger controlled trial found they had no effect on hot flashes.
Mixed evidence of effectiveness has been found for vitamin E and black cohosh, but most studies have been small and unblinded. Evening primrose oil, ginseng, and wild yam cream all have been shown to be ineffective.
In selecting a treatment for a patient's hot flashes, Dr. McNeil said that she always looks for a twofer. “If I'm treating depression, I'll go for an antidepressant,” she said. “If they have chronic pain, I think about gabapentin. And if they have hypertension I might use clonidine. If they're straight out of the starting block, I'd think about venlafaxine as my starting point.”
Dr. McNeil said she has no conflicts of interest with regard to her presentation at the meeting.
SAN FRANCISCO — In the wake of the Women's Health Initiative, “It's easier to get OxyContin out of a doctor's office than Prempro,” Melissa A. McNeil, M.D., joked at the annual meeting of the American College of Physicians.
The question then is how is a physician to manage the vasomotor symptoms of menopause?asked Dr. McNeil, who is women's health program director at the University of Pittsburgh. Although many remedies have advocates, few have been evaluated in controlled studies. She offered several evidence-based suggestions:
▸ Time. Tincture of time works for many women. Although 75% of menopausal women do experience hot flashes, for 30%–50% of them, the symptoms improve within months, and hot flashes resolve completely for most women within 4–5 years.
“That can be a very long 4 or 5 years,” Dr. McNeil acknowledged. In addition, “A substantial minority will continue to have hot flashes for years beyond menopause.”
The fact that women's hot flashes frequently resolve spontaneously leads to a large placebo effect—in the neighborhood of 25%—in various studies of drugs and supplements.
▸ Progestins. There's good evidence from randomized, controlled trials for the efficacy of a number of progestins. Medroxyprogesterone and megestrol (Megace) both were reported to result in a 74% reduction in hot flashes. Depo-Provera was reported in one study to result in a 90% reduction in hot flashes. Uterine bleeding is a frequent side effect of progestin therapy, limiting its use in women who have uterine cysts. Furthermore, there are no long-term safety data available.
The most significant bar to progestin therapy, however, comes from Women's Health Initiative results, which suggest that progesterone supplementation may confer an increased risk of certain cancers or adverse cardiovascular events, compared with estrogen alone.
▸ Clonidine and methyldopa. Studies of antihypertensive agents such as clonidine and methyldopa suggest a relatively small effect on hot flashes. Use of clonidine, in particular, is limited by side effects, including dry mouth, constipation, and drowsiness. Still, these drugs may be useful in women who need blood pressure treatment in addition to relief from their hot flashes.
▸ Nonhormonal therapies. Antidepressants, which are the most promising nonhormonal therapies for hot flashes, have become the mainstay of treatment. Venlafaxine, fluoxetine, and paroxetine all appear to result in 50%–65% reductions in hot flashes in controlled trials, although some of those trials studied breast cancer survivors, who may not be exactly representative of the entire population of menopausal women.
One advantage of antidepressants is that their effect on hot flashes seems to begin relatively quickly. Some patients have reported results in about 1–2 weeks, compared with about a month for their effects on depression. This allows for relatively rapid dose titration.
▸ Gabapentin. This drug appears to have a modest effect on hot flashes, with a reduction of about 50% in one small trial. About half of the women who participated in that trial said they experienced at least one adverse event, including dizziness, somnolence, palpitations, or peripheral edema.
▸ Nutritional supplements. Although these supplements have received a lot of coverage in the lay press, scientific evidence of their efficacy in treating hot flashes generally is lacking. Soy phytoestrogens engendered a great deal of enthusiasm a few years ago, and several small studies seemed to indicate effectiveness. But more recently, a larger controlled trial found they had no effect on hot flashes.
Mixed evidence of effectiveness has been found for vitamin E and black cohosh, but most studies have been small and unblinded. Evening primrose oil, ginseng, and wild yam cream all have been shown to be ineffective.
In selecting a treatment for a patient's hot flashes, Dr. McNeil said that she always looks for a twofer. “If I'm treating depression, I'll go for an antidepressant,” she said. “If they have chronic pain, I think about gabapentin. And if they have hypertension I might use clonidine. If they're straight out of the starting block, I'd think about venlafaxine as my starting point.”
Dr. McNeil said she has no conflicts of interest with regard to her presentation at the meeting.
Treat Chronic Viral Hepatitis in Children?
SAN FRANCISCO — Although some therapies are available for treating chronic viral hepatitis, it remains unclear whether children should be treated, Frank R. Sinatra, M.D., said at a meeting on clinical pediatrics sponsored by the University of California, San Francisco.
There are good arguments on both sides of the issue, said Dr. Sinatra, director of the pediatric gastroenterology division at the University of Southern California, Los Angeles.
The arguments for treatment include the following:
▸ Early treatment can prevent fibrosis and cirrhosis.
▸ Children do at least as well as—and perhaps better than—adults, with current drugs.
▸ Treatment can help prevent the spread of chronic hepatitis B and hepatitis C.
▸ Many clinicians believe that any chronic viral infection must be eradicated.
The arguments against treatment include the following:
▸ Most children with chronic viral hepatitis are asymptomatic. “It's very hard to make an asymptomatic patient feel good,” Dr. Sinatra said.
▸ Fibrosis typically develops slowly.
▸ The side effects from current treatments are significant, and include growth retardation.
▸ Current therapy has a success rate of only 50%.
▸ Even without treatment, a small number of children will experience spontaneous resolution of their chronic infection.
▸ In Dr. Sinatra's view, the best argument against treating children who appear to be doing well is that there are better drugs on the horizon. He knows of at least eight that are in phase I, phase II, or phase III clinical trials.
Whether or not a clinician decides on treatment, these children need to be followed closely for evidence of progressive liver disease and the development of hepatocellular carcinoma, he said.
SAN FRANCISCO — Although some therapies are available for treating chronic viral hepatitis, it remains unclear whether children should be treated, Frank R. Sinatra, M.D., said at a meeting on clinical pediatrics sponsored by the University of California, San Francisco.
There are good arguments on both sides of the issue, said Dr. Sinatra, director of the pediatric gastroenterology division at the University of Southern California, Los Angeles.
The arguments for treatment include the following:
▸ Early treatment can prevent fibrosis and cirrhosis.
▸ Children do at least as well as—and perhaps better than—adults, with current drugs.
▸ Treatment can help prevent the spread of chronic hepatitis B and hepatitis C.
▸ Many clinicians believe that any chronic viral infection must be eradicated.
The arguments against treatment include the following:
▸ Most children with chronic viral hepatitis are asymptomatic. “It's very hard to make an asymptomatic patient feel good,” Dr. Sinatra said.
▸ Fibrosis typically develops slowly.
▸ The side effects from current treatments are significant, and include growth retardation.
▸ Current therapy has a success rate of only 50%.
▸ Even without treatment, a small number of children will experience spontaneous resolution of their chronic infection.
▸ In Dr. Sinatra's view, the best argument against treating children who appear to be doing well is that there are better drugs on the horizon. He knows of at least eight that are in phase I, phase II, or phase III clinical trials.
Whether or not a clinician decides on treatment, these children need to be followed closely for evidence of progressive liver disease and the development of hepatocellular carcinoma, he said.
SAN FRANCISCO — Although some therapies are available for treating chronic viral hepatitis, it remains unclear whether children should be treated, Frank R. Sinatra, M.D., said at a meeting on clinical pediatrics sponsored by the University of California, San Francisco.
There are good arguments on both sides of the issue, said Dr. Sinatra, director of the pediatric gastroenterology division at the University of Southern California, Los Angeles.
The arguments for treatment include the following:
▸ Early treatment can prevent fibrosis and cirrhosis.
▸ Children do at least as well as—and perhaps better than—adults, with current drugs.
▸ Treatment can help prevent the spread of chronic hepatitis B and hepatitis C.
▸ Many clinicians believe that any chronic viral infection must be eradicated.
The arguments against treatment include the following:
▸ Most children with chronic viral hepatitis are asymptomatic. “It's very hard to make an asymptomatic patient feel good,” Dr. Sinatra said.
▸ Fibrosis typically develops slowly.
▸ The side effects from current treatments are significant, and include growth retardation.
▸ Current therapy has a success rate of only 50%.
▸ Even without treatment, a small number of children will experience spontaneous resolution of their chronic infection.
▸ In Dr. Sinatra's view, the best argument against treating children who appear to be doing well is that there are better drugs on the horizon. He knows of at least eight that are in phase I, phase II, or phase III clinical trials.
Whether or not a clinician decides on treatment, these children need to be followed closely for evidence of progressive liver disease and the development of hepatocellular carcinoma, he said.
'Laborists' Branching Off From Hospitalist Trend : Ten U.S. hospital systems are now hiring physicians whose sole role is managing the patient in labor.
SAN FRANCISCO — The hospitalist movement is now poised to deliver results in the field of obstetrics.
Ten U.S. hospital systems have started or are about to start using “laborists”—physicians whose sole focus is managing the patient in labor—Louis Weinstein, M.D., reported at the annual meeting of the American College of Obstetricians and Gynecologists.
Laborists are expected to improve patient care and ease burnout among obstetricians, said Dr. Weinstein of Jefferson Medical College in Philadelphia.
The laborist profession offers predictable and limited work hours, while offering private ob.gyns. less disruption to their office and operating room schedules.
It also offers women in labor the benefit of prompt, continuous, and efficient care, he said.
Dr. Weinstein said he proposed the laborist model in 2003, modeling it on the rapidly growing hospitalist movement among internists (Am. J. Obstet. Gynecol. 2003;188:310–2). Some criticize the hospitalist movement for disruption of care, but studies have shown a high degree of patient satisfaction, reductions in resource utilization, and good clinical outcomes. Hospitalists report a high level of job satisfaction, a long-term commitment to remaining in the field, and the lowest burnout rates of any medical specialty.
To maintain 7-day, 24-hour coverage by a team of laborists, a hospital would need four physicians, each working four 10.5-hour shifts each week, Dr. Weinstein said.
He reached that estimate by assuming that the laborists would each earn $175,000 per year, and they would be given 1 week of CME time and 3 weeks of vacation annually. The hospital would have to provide a total of 12 weeks' vacation coverage for the time the laborists were away.
Laborists would receive benefits worth 28% of their salaries, and they would be covered under the hospital's liability policy at a cost of about $60,000 per laborist per year. The total annual cost to the hospital would be $1.2 million.
This scenario would make economic sense only in a hospital performing at least 2,000 deliveries per year. If laborists handled half of those deliveries at $1,200 per delivery, that would bring in $1.2 million per year, making the program “revenue neutral” from the hospital's perspective.
But hospitals would come out ahead if the use of laborists improved patient safety such that even one lawsuit were avoided every 5 years, Dr. Weinstein said.
Beyond these economic calculations are the benefits to individual physicians and to the profession of obstetrics and gynecology.
Dr. Weinstein cited studies showing a high rate of burnout among ob.gyns., which he attributed in part to their hectic and unpredictable schedules and to work weeks well in excess of 40 hours.
For the laborist model to succeed, there must be buy-in by the medical staff. “Clearly, if everybody says, 'Well, I'm not going to let the laborist do my deliveries,' then it won't work,” Dr. Weinstein said.
The ideal laborists work hard, respond efficiently but understand that “when it's their time to go [off shift], they go with good handoffs to the next laborist.”
SAN FRANCISCO — The hospitalist movement is now poised to deliver results in the field of obstetrics.
Ten U.S. hospital systems have started or are about to start using “laborists”—physicians whose sole focus is managing the patient in labor—Louis Weinstein, M.D., reported at the annual meeting of the American College of Obstetricians and Gynecologists.
Laborists are expected to improve patient care and ease burnout among obstetricians, said Dr. Weinstein of Jefferson Medical College in Philadelphia.
The laborist profession offers predictable and limited work hours, while offering private ob.gyns. less disruption to their office and operating room schedules.
It also offers women in labor the benefit of prompt, continuous, and efficient care, he said.
Dr. Weinstein said he proposed the laborist model in 2003, modeling it on the rapidly growing hospitalist movement among internists (Am. J. Obstet. Gynecol. 2003;188:310–2). Some criticize the hospitalist movement for disruption of care, but studies have shown a high degree of patient satisfaction, reductions in resource utilization, and good clinical outcomes. Hospitalists report a high level of job satisfaction, a long-term commitment to remaining in the field, and the lowest burnout rates of any medical specialty.
To maintain 7-day, 24-hour coverage by a team of laborists, a hospital would need four physicians, each working four 10.5-hour shifts each week, Dr. Weinstein said.
He reached that estimate by assuming that the laborists would each earn $175,000 per year, and they would be given 1 week of CME time and 3 weeks of vacation annually. The hospital would have to provide a total of 12 weeks' vacation coverage for the time the laborists were away.
Laborists would receive benefits worth 28% of their salaries, and they would be covered under the hospital's liability policy at a cost of about $60,000 per laborist per year. The total annual cost to the hospital would be $1.2 million.
This scenario would make economic sense only in a hospital performing at least 2,000 deliveries per year. If laborists handled half of those deliveries at $1,200 per delivery, that would bring in $1.2 million per year, making the program “revenue neutral” from the hospital's perspective.
But hospitals would come out ahead if the use of laborists improved patient safety such that even one lawsuit were avoided every 5 years, Dr. Weinstein said.
Beyond these economic calculations are the benefits to individual physicians and to the profession of obstetrics and gynecology.
Dr. Weinstein cited studies showing a high rate of burnout among ob.gyns., which he attributed in part to their hectic and unpredictable schedules and to work weeks well in excess of 40 hours.
For the laborist model to succeed, there must be buy-in by the medical staff. “Clearly, if everybody says, 'Well, I'm not going to let the laborist do my deliveries,' then it won't work,” Dr. Weinstein said.
The ideal laborists work hard, respond efficiently but understand that “when it's their time to go [off shift], they go with good handoffs to the next laborist.”
SAN FRANCISCO — The hospitalist movement is now poised to deliver results in the field of obstetrics.
Ten U.S. hospital systems have started or are about to start using “laborists”—physicians whose sole focus is managing the patient in labor—Louis Weinstein, M.D., reported at the annual meeting of the American College of Obstetricians and Gynecologists.
Laborists are expected to improve patient care and ease burnout among obstetricians, said Dr. Weinstein of Jefferson Medical College in Philadelphia.
The laborist profession offers predictable and limited work hours, while offering private ob.gyns. less disruption to their office and operating room schedules.
It also offers women in labor the benefit of prompt, continuous, and efficient care, he said.
Dr. Weinstein said he proposed the laborist model in 2003, modeling it on the rapidly growing hospitalist movement among internists (Am. J. Obstet. Gynecol. 2003;188:310–2). Some criticize the hospitalist movement for disruption of care, but studies have shown a high degree of patient satisfaction, reductions in resource utilization, and good clinical outcomes. Hospitalists report a high level of job satisfaction, a long-term commitment to remaining in the field, and the lowest burnout rates of any medical specialty.
To maintain 7-day, 24-hour coverage by a team of laborists, a hospital would need four physicians, each working four 10.5-hour shifts each week, Dr. Weinstein said.
He reached that estimate by assuming that the laborists would each earn $175,000 per year, and they would be given 1 week of CME time and 3 weeks of vacation annually. The hospital would have to provide a total of 12 weeks' vacation coverage for the time the laborists were away.
Laborists would receive benefits worth 28% of their salaries, and they would be covered under the hospital's liability policy at a cost of about $60,000 per laborist per year. The total annual cost to the hospital would be $1.2 million.
This scenario would make economic sense only in a hospital performing at least 2,000 deliveries per year. If laborists handled half of those deliveries at $1,200 per delivery, that would bring in $1.2 million per year, making the program “revenue neutral” from the hospital's perspective.
But hospitals would come out ahead if the use of laborists improved patient safety such that even one lawsuit were avoided every 5 years, Dr. Weinstein said.
Beyond these economic calculations are the benefits to individual physicians and to the profession of obstetrics and gynecology.
Dr. Weinstein cited studies showing a high rate of burnout among ob.gyns., which he attributed in part to their hectic and unpredictable schedules and to work weeks well in excess of 40 hours.
For the laborist model to succeed, there must be buy-in by the medical staff. “Clearly, if everybody says, 'Well, I'm not going to let the laborist do my deliveries,' then it won't work,” Dr. Weinstein said.
The ideal laborists work hard, respond efficiently but understand that “when it's their time to go [off shift], they go with good handoffs to the next laborist.”
Essure Approved With Two Ablation Techniques
SAN FRANCISCO — The Essure sterilization procedure can be used in combination with two methods of endometrial ablation, according to studies presented at the annual meeting of the American Association of Gynecologic Laparoscopists.
The Essure procedure may be performed immediately before or immediately after using the ThermaChoice uterine balloon ablation system. It also can be done immediately after—but not immediately before—using the NovaSure radiofrequency ablation system, investigators reported.
The Food and Drug Administration approved the use of the Essure system with ThermaChoice ablation in July 2004. The agency has not approved the use of Essure with NovaSure, and a spokesperson for Conceptus Inc., which distributes Essure, told this newspaper that the company has no plans to apply for such approval. “The majority of women who undergo endometrial ablation are in their reproductive years, so many of them request Essure sterilization to control fertility after or during endometrial ablation,” Rafael F. Valle, M.D., a consultant for Conceptus, reported.
“Because these two methods utilize the same approach, the transvaginal approach, they can be performed concomitantly,” said Dr. Valle of Northwestern University, Chicago. In his study, 40 women who were about to undergo hysterectomy for benign uterine bleeding consented to ThermaChoice endometrial ablation before or after placement of the Essure microinserts. Their average age was 43 years.
The microinserts were placed before ablation in 24 of the women, and in 16 of these women the combined procedure was successful. In the other eight, gross uterine pathology prevented proper placement of the microinserts.
A total of 16 women underwent ablation before placement of the Essure microinserts, and placement was successful in eight of those cases. The failures were caused by unsuspected pathology and debris remaining in the cornual regions after the ablation, which made it difficult to visualize the tubal ostia.
The combined procedure took an average of 25.7 minutes, including taking a second look by hysteroscopy.
The FDA requested a study on the temperature increase in the serosa during the combined procedure. Dr. Valle recruited nine additional women for this study: Seven underwent Essure insertion before ablation, and two underwent Essure insertion alone as controls. Each woman had eight thermocouples inserted via laparotomy before the procedure began.
The average maximum temperature in this subserosal space was 37.1° C, ranging from 34.7° C to 38.9° C. Tissue damage occurs only at temperatures above 45° C. Furthermore, no tissue damage could be seen either on gross or histologic examination.
Although the FDA required the investigators to perform the Essure procedure both before and after ThermaChoice ablation, in practice, “It doesn't make sense to do the endometrial ablation first,” Dr. Valle said.
When ablation was performed first, “there was a lot of tissue that sometimes even occluded the tubal os, and we had to remove it with forceps before we found the opening.”
Placing the Essure microinserts before ablation is not an option when NovaSure radiofrequency ablation is used, said Robert Sabbah, M.D., of Sacré-Couer Hospital in Montreal.
“We don't feel that using an electrical current with a metal tail in the cavity would be safe,” he said. “Therefore, we think the only way to go about doing it if you want to combine both procedures is to start first with endometrial ablation and follow later by the installation of the Essure.”
Dr. Sabbah stated that he had no relevant conflicts of interest.
SAN FRANCISCO — The Essure sterilization procedure can be used in combination with two methods of endometrial ablation, according to studies presented at the annual meeting of the American Association of Gynecologic Laparoscopists.
The Essure procedure may be performed immediately before or immediately after using the ThermaChoice uterine balloon ablation system. It also can be done immediately after—but not immediately before—using the NovaSure radiofrequency ablation system, investigators reported.
The Food and Drug Administration approved the use of the Essure system with ThermaChoice ablation in July 2004. The agency has not approved the use of Essure with NovaSure, and a spokesperson for Conceptus Inc., which distributes Essure, told this newspaper that the company has no plans to apply for such approval. “The majority of women who undergo endometrial ablation are in their reproductive years, so many of them request Essure sterilization to control fertility after or during endometrial ablation,” Rafael F. Valle, M.D., a consultant for Conceptus, reported.
“Because these two methods utilize the same approach, the transvaginal approach, they can be performed concomitantly,” said Dr. Valle of Northwestern University, Chicago. In his study, 40 women who were about to undergo hysterectomy for benign uterine bleeding consented to ThermaChoice endometrial ablation before or after placement of the Essure microinserts. Their average age was 43 years.
The microinserts were placed before ablation in 24 of the women, and in 16 of these women the combined procedure was successful. In the other eight, gross uterine pathology prevented proper placement of the microinserts.
A total of 16 women underwent ablation before placement of the Essure microinserts, and placement was successful in eight of those cases. The failures were caused by unsuspected pathology and debris remaining in the cornual regions after the ablation, which made it difficult to visualize the tubal ostia.
The combined procedure took an average of 25.7 minutes, including taking a second look by hysteroscopy.
The FDA requested a study on the temperature increase in the serosa during the combined procedure. Dr. Valle recruited nine additional women for this study: Seven underwent Essure insertion before ablation, and two underwent Essure insertion alone as controls. Each woman had eight thermocouples inserted via laparotomy before the procedure began.
The average maximum temperature in this subserosal space was 37.1° C, ranging from 34.7° C to 38.9° C. Tissue damage occurs only at temperatures above 45° C. Furthermore, no tissue damage could be seen either on gross or histologic examination.
Although the FDA required the investigators to perform the Essure procedure both before and after ThermaChoice ablation, in practice, “It doesn't make sense to do the endometrial ablation first,” Dr. Valle said.
When ablation was performed first, “there was a lot of tissue that sometimes even occluded the tubal os, and we had to remove it with forceps before we found the opening.”
Placing the Essure microinserts before ablation is not an option when NovaSure radiofrequency ablation is used, said Robert Sabbah, M.D., of Sacré-Couer Hospital in Montreal.
“We don't feel that using an electrical current with a metal tail in the cavity would be safe,” he said. “Therefore, we think the only way to go about doing it if you want to combine both procedures is to start first with endometrial ablation and follow later by the installation of the Essure.”
Dr. Sabbah stated that he had no relevant conflicts of interest.
SAN FRANCISCO — The Essure sterilization procedure can be used in combination with two methods of endometrial ablation, according to studies presented at the annual meeting of the American Association of Gynecologic Laparoscopists.
The Essure procedure may be performed immediately before or immediately after using the ThermaChoice uterine balloon ablation system. It also can be done immediately after—but not immediately before—using the NovaSure radiofrequency ablation system, investigators reported.
The Food and Drug Administration approved the use of the Essure system with ThermaChoice ablation in July 2004. The agency has not approved the use of Essure with NovaSure, and a spokesperson for Conceptus Inc., which distributes Essure, told this newspaper that the company has no plans to apply for such approval. “The majority of women who undergo endometrial ablation are in their reproductive years, so many of them request Essure sterilization to control fertility after or during endometrial ablation,” Rafael F. Valle, M.D., a consultant for Conceptus, reported.
“Because these two methods utilize the same approach, the transvaginal approach, they can be performed concomitantly,” said Dr. Valle of Northwestern University, Chicago. In his study, 40 women who were about to undergo hysterectomy for benign uterine bleeding consented to ThermaChoice endometrial ablation before or after placement of the Essure microinserts. Their average age was 43 years.
The microinserts were placed before ablation in 24 of the women, and in 16 of these women the combined procedure was successful. In the other eight, gross uterine pathology prevented proper placement of the microinserts.
A total of 16 women underwent ablation before placement of the Essure microinserts, and placement was successful in eight of those cases. The failures were caused by unsuspected pathology and debris remaining in the cornual regions after the ablation, which made it difficult to visualize the tubal ostia.
The combined procedure took an average of 25.7 minutes, including taking a second look by hysteroscopy.
The FDA requested a study on the temperature increase in the serosa during the combined procedure. Dr. Valle recruited nine additional women for this study: Seven underwent Essure insertion before ablation, and two underwent Essure insertion alone as controls. Each woman had eight thermocouples inserted via laparotomy before the procedure began.
The average maximum temperature in this subserosal space was 37.1° C, ranging from 34.7° C to 38.9° C. Tissue damage occurs only at temperatures above 45° C. Furthermore, no tissue damage could be seen either on gross or histologic examination.
Although the FDA required the investigators to perform the Essure procedure both before and after ThermaChoice ablation, in practice, “It doesn't make sense to do the endometrial ablation first,” Dr. Valle said.
When ablation was performed first, “there was a lot of tissue that sometimes even occluded the tubal os, and we had to remove it with forceps before we found the opening.”
Placing the Essure microinserts before ablation is not an option when NovaSure radiofrequency ablation is used, said Robert Sabbah, M.D., of Sacré-Couer Hospital in Montreal.
“We don't feel that using an electrical current with a metal tail in the cavity would be safe,” he said. “Therefore, we think the only way to go about doing it if you want to combine both procedures is to start first with endometrial ablation and follow later by the installation of the Essure.”
Dr. Sabbah stated that he had no relevant conflicts of interest.
Laborist Movement Poised to Take Off in 10 U.S. Hospital Systems
SAN FRANCISCO — Ten hospital systems in the United States have started or are about to start using “laborists”—physicians whose sole focus is managing the patient in labor—Louis Weinstein, M.D., reported at the annual meeting of the American College of Obstetricians and Gynecologists.
Using laborists makes sense, said Dr. Weinstein of Jefferson Medical College in Philadelphia. Laborists are expected to improve patient care and ease burnout among obstetricians.
The laborist profession offers obstetricians predictable and limited work hours, while reducing disruption of their office and operating room schedules. It also offers women in labor the benefit of prompt, continuous, and efficient care.
Dr. Weinstein demonstrated the laborist business model by calculating what it would cost a hospital to maintain 7-day, 24-hour coverage by a team of laborists. It would take four physicians, each working four 10.5-hour shifts each week. Dr. Weinstein assumed that the laborists would each earn $175,000 per year, and they would be given 1 week of CME time and 3 weeks of vacation annually. The hospital would have to provide a total of 12 weeks' vacation coverage for the time the laborists were away.
The laborists would receive benefits worth 28% of their salaries, and they would be covered under the hospital's liability policy at a cost of about $60,000 per laborist per year. The total annual cost to the hospital would be $1.2 million.
This scenario would make economic sense only in a hospital with at least 2,000 deliveries per year, he said. If laborists handled half of those deliveries at $1,200 per delivery, that would bring in $1.2 million/year, making the program “revenue neutral” from the hospital's perspective.
But hospitals would come out ahead if the use of hospitalists improved patient safety such that even one lawsuit were avoided every 5 years, Dr. Weinstein said.
Beyond these economic calculations are the benefits to individual obstetricians and to the profession of obstetrics and gynecology. Dr. Weinstein pointed to studies showing a very high rate of burnout among ob.gyns., which he attributed in part to their hectic and unpredictable schedules and to work weeks well in excess of 40 hours.
Dr. Weinstein said he proposed the laborist model in 2003, patterning it after the rapidly growing hospitalist movement among internists (Am. J. Obstet. Gynecol. 2003;188:310–2). Some criticize the hospitalist movement for a disruption in care when the hospitalist becomes responsible for a patient, but studies have shown high patient satisfaction and significant reductions in resource utilization while maintaining good clinical outcomes.
Hospitalists themselves report high job satisfaction, a long-term commitment to remaining in the field, and the lowest burnout rates of any medical specialty.
For the laborist model to succeed, there must be buy-in by the medical staff. “Clearly, if everybody says, 'Well, I'm not going to let the laborist do my deliveries,' then it won't work,” Dr. Weinstein said.
Additionally, laborists would have to receive respect from other ob.gyns.
SAN FRANCISCO — Ten hospital systems in the United States have started or are about to start using “laborists”—physicians whose sole focus is managing the patient in labor—Louis Weinstein, M.D., reported at the annual meeting of the American College of Obstetricians and Gynecologists.
Using laborists makes sense, said Dr. Weinstein of Jefferson Medical College in Philadelphia. Laborists are expected to improve patient care and ease burnout among obstetricians.
The laborist profession offers obstetricians predictable and limited work hours, while reducing disruption of their office and operating room schedules. It also offers women in labor the benefit of prompt, continuous, and efficient care.
Dr. Weinstein demonstrated the laborist business model by calculating what it would cost a hospital to maintain 7-day, 24-hour coverage by a team of laborists. It would take four physicians, each working four 10.5-hour shifts each week. Dr. Weinstein assumed that the laborists would each earn $175,000 per year, and they would be given 1 week of CME time and 3 weeks of vacation annually. The hospital would have to provide a total of 12 weeks' vacation coverage for the time the laborists were away.
The laborists would receive benefits worth 28% of their salaries, and they would be covered under the hospital's liability policy at a cost of about $60,000 per laborist per year. The total annual cost to the hospital would be $1.2 million.
This scenario would make economic sense only in a hospital with at least 2,000 deliveries per year, he said. If laborists handled half of those deliveries at $1,200 per delivery, that would bring in $1.2 million/year, making the program “revenue neutral” from the hospital's perspective.
But hospitals would come out ahead if the use of hospitalists improved patient safety such that even one lawsuit were avoided every 5 years, Dr. Weinstein said.
Beyond these economic calculations are the benefits to individual obstetricians and to the profession of obstetrics and gynecology. Dr. Weinstein pointed to studies showing a very high rate of burnout among ob.gyns., which he attributed in part to their hectic and unpredictable schedules and to work weeks well in excess of 40 hours.
Dr. Weinstein said he proposed the laborist model in 2003, patterning it after the rapidly growing hospitalist movement among internists (Am. J. Obstet. Gynecol. 2003;188:310–2). Some criticize the hospitalist movement for a disruption in care when the hospitalist becomes responsible for a patient, but studies have shown high patient satisfaction and significant reductions in resource utilization while maintaining good clinical outcomes.
Hospitalists themselves report high job satisfaction, a long-term commitment to remaining in the field, and the lowest burnout rates of any medical specialty.
For the laborist model to succeed, there must be buy-in by the medical staff. “Clearly, if everybody says, 'Well, I'm not going to let the laborist do my deliveries,' then it won't work,” Dr. Weinstein said.
Additionally, laborists would have to receive respect from other ob.gyns.
SAN FRANCISCO — Ten hospital systems in the United States have started or are about to start using “laborists”—physicians whose sole focus is managing the patient in labor—Louis Weinstein, M.D., reported at the annual meeting of the American College of Obstetricians and Gynecologists.
Using laborists makes sense, said Dr. Weinstein of Jefferson Medical College in Philadelphia. Laborists are expected to improve patient care and ease burnout among obstetricians.
The laborist profession offers obstetricians predictable and limited work hours, while reducing disruption of their office and operating room schedules. It also offers women in labor the benefit of prompt, continuous, and efficient care.
Dr. Weinstein demonstrated the laborist business model by calculating what it would cost a hospital to maintain 7-day, 24-hour coverage by a team of laborists. It would take four physicians, each working four 10.5-hour shifts each week. Dr. Weinstein assumed that the laborists would each earn $175,000 per year, and they would be given 1 week of CME time and 3 weeks of vacation annually. The hospital would have to provide a total of 12 weeks' vacation coverage for the time the laborists were away.
The laborists would receive benefits worth 28% of their salaries, and they would be covered under the hospital's liability policy at a cost of about $60,000 per laborist per year. The total annual cost to the hospital would be $1.2 million.
This scenario would make economic sense only in a hospital with at least 2,000 deliveries per year, he said. If laborists handled half of those deliveries at $1,200 per delivery, that would bring in $1.2 million/year, making the program “revenue neutral” from the hospital's perspective.
But hospitals would come out ahead if the use of hospitalists improved patient safety such that even one lawsuit were avoided every 5 years, Dr. Weinstein said.
Beyond these economic calculations are the benefits to individual obstetricians and to the profession of obstetrics and gynecology. Dr. Weinstein pointed to studies showing a very high rate of burnout among ob.gyns., which he attributed in part to their hectic and unpredictable schedules and to work weeks well in excess of 40 hours.
Dr. Weinstein said he proposed the laborist model in 2003, patterning it after the rapidly growing hospitalist movement among internists (Am. J. Obstet. Gynecol. 2003;188:310–2). Some criticize the hospitalist movement for a disruption in care when the hospitalist becomes responsible for a patient, but studies have shown high patient satisfaction and significant reductions in resource utilization while maintaining good clinical outcomes.
Hospitalists themselves report high job satisfaction, a long-term commitment to remaining in the field, and the lowest burnout rates of any medical specialty.
For the laborist model to succeed, there must be buy-in by the medical staff. “Clearly, if everybody says, 'Well, I'm not going to let the laborist do my deliveries,' then it won't work,” Dr. Weinstein said.
Additionally, laborists would have to receive respect from other ob.gyns.
ACOG Has Sanctioned 3 In Its Peer Review Process
SAN FRANCISCO — Since the American College of Obstetricians and Gynecologists established a procedure for peer review of expert witness testimony in 2002, approximately 20 cases have been brought, and three fellows of the college have been sanctioned for egregious testimony, Charles B. Hammond, M.D., said at the annual meeting of the college.
Two of those cases have been brought by Arnold W. Cohen, M.D., who described the process as cumbersome and tedious but very fair.
In one of those two cases the physician accused of egregious testimony resigned from ACOG before the grievance process could be completed, Dr. Cohen of the Albert Einstein Medical Center and Thomas Jefferson University, both in Philadelphia, said in an interview with this newspaper. No decision has yet been rendered in the other case, he said.
Before a 2002 case involving the American Association of Neurological Surgeons (AANS), ACOG was reluctant to undertake the review of unethical testimony for fear that ACOG would be sued by the sanctioned member, said Dr. Hammond of Duke University, Durham, N.C., who is a past president of ACOG.
But that attitude changed in January 2002 when the U.S. Supreme Court let stand a lower court ruling, which held that a professional society may discipline a member concerning courtroom testimony. The AANS had been sued by a neurosurgeon whose membership was suspended after a hearing that determined his expert testimony in a certain case had been egregious.
The ACOG grievance procedure has a number of requirements. First, an ACOG fellow must be reported by another fellow. The original court case must be closed, with all appeals concluded. The reporting fellow must provide court transcripts with all names removed. A committee then reviews those materials, and if it decides that the allegation has merit, both the reporting fellow and the one accused of egregious testimony are invited to a hearing, where they may be represented by attorneys if they wish.
The committee issues its decision, and if the allegation of egregious testimony is found to have merit, the committee may impose sanctions, including termination of ACOG fellowship.
“ACOG has a very fair process,” Dr. Cohen said. “It's fair to both the person who has given the testimony as well as the person who feels it's egregious. It's a very tedious process, and it's a confrontational process, when you're there with the other person in the same room [with] you saying that he said something wrong, and he's saying that he believes in what he said even though facts don't support it.”
Dr. Cohen was not directly involved in either case, except as the individual who reported the allegation. In the first case, an ob.gyn. testified for the plaintiff in a case that alleged that her doctor (the defendant) performed stripping the membranes, causing the baby to die of a β-streptococcal infection. The defendant declined to report an allegation of egregious testimony himself for fear of a countersuit, so Dr. Cohen, who has long been involved in the Coalition and Center for Ethical Medical Testimony and other medical-legal matters, chose to make the report. The ob.gyn. who testified on behalf of the plaintiff resigned from ACOG before a hearing could be held.
This option is an escape hatch that ACOG hopes to block in the future, Dr. Hammond said. One possibility is to rule that a fellow cannot resign before the hearing. Another is to report the committee's decision to the National Practitioner Data Bank as if the fellow had not resigned.
In Dr. Cohen's second case the expert witness testified that the use of home uterine activity monitoring to prolong pregnancy has a 95% chance of ensuring that babies go to term, an assertion Dr. Cohen said is not supported by the facts.
“It takes about 9 months to a year to get to the point where you finally give the testimony in front of ACOG,” Dr. Cohen said.
Neither Dr. Cohen nor the other physician chose to be represented by an attorney at the hearing. The committee chairman allowed each to make a 30-minute opening statement along with rebuttals, and each responded to questions from committee members.
“The process was very fair yet very formal,” Dr. Cohen said.
It's a process that's still evolving. For example, ACOG has recently decided to publicize the names of physicians who have been sanctioned for egregious expert testimony, Dr. Cohen said.
“I hope that members of the college will recognize that if you [witness] egregious testimony … you now have a resource, a place you can go and have it heard with the real option of sanctions being taken,” Dr. Hammond said. “I hope and pray that medical expert witnesses who provide clearly egregious testimony—the hired guns—I hope they hear this loud and clear, and I hope we have a way to at least improve the medical liability system as it now exists.”
SAN FRANCISCO — Since the American College of Obstetricians and Gynecologists established a procedure for peer review of expert witness testimony in 2002, approximately 20 cases have been brought, and three fellows of the college have been sanctioned for egregious testimony, Charles B. Hammond, M.D., said at the annual meeting of the college.
Two of those cases have been brought by Arnold W. Cohen, M.D., who described the process as cumbersome and tedious but very fair.
In one of those two cases the physician accused of egregious testimony resigned from ACOG before the grievance process could be completed, Dr. Cohen of the Albert Einstein Medical Center and Thomas Jefferson University, both in Philadelphia, said in an interview with this newspaper. No decision has yet been rendered in the other case, he said.
Before a 2002 case involving the American Association of Neurological Surgeons (AANS), ACOG was reluctant to undertake the review of unethical testimony for fear that ACOG would be sued by the sanctioned member, said Dr. Hammond of Duke University, Durham, N.C., who is a past president of ACOG.
But that attitude changed in January 2002 when the U.S. Supreme Court let stand a lower court ruling, which held that a professional society may discipline a member concerning courtroom testimony. The AANS had been sued by a neurosurgeon whose membership was suspended after a hearing that determined his expert testimony in a certain case had been egregious.
The ACOG grievance procedure has a number of requirements. First, an ACOG fellow must be reported by another fellow. The original court case must be closed, with all appeals concluded. The reporting fellow must provide court transcripts with all names removed. A committee then reviews those materials, and if it decides that the allegation has merit, both the reporting fellow and the one accused of egregious testimony are invited to a hearing, where they may be represented by attorneys if they wish.
The committee issues its decision, and if the allegation of egregious testimony is found to have merit, the committee may impose sanctions, including termination of ACOG fellowship.
“ACOG has a very fair process,” Dr. Cohen said. “It's fair to both the person who has given the testimony as well as the person who feels it's egregious. It's a very tedious process, and it's a confrontational process, when you're there with the other person in the same room [with] you saying that he said something wrong, and he's saying that he believes in what he said even though facts don't support it.”
Dr. Cohen was not directly involved in either case, except as the individual who reported the allegation. In the first case, an ob.gyn. testified for the plaintiff in a case that alleged that her doctor (the defendant) performed stripping the membranes, causing the baby to die of a β-streptococcal infection. The defendant declined to report an allegation of egregious testimony himself for fear of a countersuit, so Dr. Cohen, who has long been involved in the Coalition and Center for Ethical Medical Testimony and other medical-legal matters, chose to make the report. The ob.gyn. who testified on behalf of the plaintiff resigned from ACOG before a hearing could be held.
This option is an escape hatch that ACOG hopes to block in the future, Dr. Hammond said. One possibility is to rule that a fellow cannot resign before the hearing. Another is to report the committee's decision to the National Practitioner Data Bank as if the fellow had not resigned.
In Dr. Cohen's second case the expert witness testified that the use of home uterine activity monitoring to prolong pregnancy has a 95% chance of ensuring that babies go to term, an assertion Dr. Cohen said is not supported by the facts.
“It takes about 9 months to a year to get to the point where you finally give the testimony in front of ACOG,” Dr. Cohen said.
Neither Dr. Cohen nor the other physician chose to be represented by an attorney at the hearing. The committee chairman allowed each to make a 30-minute opening statement along with rebuttals, and each responded to questions from committee members.
“The process was very fair yet very formal,” Dr. Cohen said.
It's a process that's still evolving. For example, ACOG has recently decided to publicize the names of physicians who have been sanctioned for egregious expert testimony, Dr. Cohen said.
“I hope that members of the college will recognize that if you [witness] egregious testimony … you now have a resource, a place you can go and have it heard with the real option of sanctions being taken,” Dr. Hammond said. “I hope and pray that medical expert witnesses who provide clearly egregious testimony—the hired guns—I hope they hear this loud and clear, and I hope we have a way to at least improve the medical liability system as it now exists.”
SAN FRANCISCO — Since the American College of Obstetricians and Gynecologists established a procedure for peer review of expert witness testimony in 2002, approximately 20 cases have been brought, and three fellows of the college have been sanctioned for egregious testimony, Charles B. Hammond, M.D., said at the annual meeting of the college.
Two of those cases have been brought by Arnold W. Cohen, M.D., who described the process as cumbersome and tedious but very fair.
In one of those two cases the physician accused of egregious testimony resigned from ACOG before the grievance process could be completed, Dr. Cohen of the Albert Einstein Medical Center and Thomas Jefferson University, both in Philadelphia, said in an interview with this newspaper. No decision has yet been rendered in the other case, he said.
Before a 2002 case involving the American Association of Neurological Surgeons (AANS), ACOG was reluctant to undertake the review of unethical testimony for fear that ACOG would be sued by the sanctioned member, said Dr. Hammond of Duke University, Durham, N.C., who is a past president of ACOG.
But that attitude changed in January 2002 when the U.S. Supreme Court let stand a lower court ruling, which held that a professional society may discipline a member concerning courtroom testimony. The AANS had been sued by a neurosurgeon whose membership was suspended after a hearing that determined his expert testimony in a certain case had been egregious.
The ACOG grievance procedure has a number of requirements. First, an ACOG fellow must be reported by another fellow. The original court case must be closed, with all appeals concluded. The reporting fellow must provide court transcripts with all names removed. A committee then reviews those materials, and if it decides that the allegation has merit, both the reporting fellow and the one accused of egregious testimony are invited to a hearing, where they may be represented by attorneys if they wish.
The committee issues its decision, and if the allegation of egregious testimony is found to have merit, the committee may impose sanctions, including termination of ACOG fellowship.
“ACOG has a very fair process,” Dr. Cohen said. “It's fair to both the person who has given the testimony as well as the person who feels it's egregious. It's a very tedious process, and it's a confrontational process, when you're there with the other person in the same room [with] you saying that he said something wrong, and he's saying that he believes in what he said even though facts don't support it.”
Dr. Cohen was not directly involved in either case, except as the individual who reported the allegation. In the first case, an ob.gyn. testified for the plaintiff in a case that alleged that her doctor (the defendant) performed stripping the membranes, causing the baby to die of a β-streptococcal infection. The defendant declined to report an allegation of egregious testimony himself for fear of a countersuit, so Dr. Cohen, who has long been involved in the Coalition and Center for Ethical Medical Testimony and other medical-legal matters, chose to make the report. The ob.gyn. who testified on behalf of the plaintiff resigned from ACOG before a hearing could be held.
This option is an escape hatch that ACOG hopes to block in the future, Dr. Hammond said. One possibility is to rule that a fellow cannot resign before the hearing. Another is to report the committee's decision to the National Practitioner Data Bank as if the fellow had not resigned.
In Dr. Cohen's second case the expert witness testified that the use of home uterine activity monitoring to prolong pregnancy has a 95% chance of ensuring that babies go to term, an assertion Dr. Cohen said is not supported by the facts.
“It takes about 9 months to a year to get to the point where you finally give the testimony in front of ACOG,” Dr. Cohen said.
Neither Dr. Cohen nor the other physician chose to be represented by an attorney at the hearing. The committee chairman allowed each to make a 30-minute opening statement along with rebuttals, and each responded to questions from committee members.
“The process was very fair yet very formal,” Dr. Cohen said.
It's a process that's still evolving. For example, ACOG has recently decided to publicize the names of physicians who have been sanctioned for egregious expert testimony, Dr. Cohen said.
“I hope that members of the college will recognize that if you [witness] egregious testimony … you now have a resource, a place you can go and have it heard with the real option of sanctions being taken,” Dr. Hammond said. “I hope and pray that medical expert witnesses who provide clearly egregious testimony—the hired guns—I hope they hear this loud and clear, and I hope we have a way to at least improve the medical liability system as it now exists.”
Two-Thirds of Surveyed Ob.Gyns. Suffer Burnout : Higher rates of burnout were reported in women and African Americans.
SAN FRANCISCO — A survey of ob.gyns. from Delaware, New Jersey, and Pennsylvania revealed that almost two-thirds suffer the symptoms of burnout, Vincent A. Pellegrini, M.D., reported at the annual meeting of the American College of Obstetricians and Gynecologists.
All ACOG members in District III were surveyed in 2004, and 863 responded, for a response rate of 30%, reported Dr. Pellegrini, who is in private practice in West Reading, Pa. Of those physicians, 64% reported the symptoms of burnout, as judged by the Maslach Burnout Inventory. Burnout is defined as a syndrome of physical, emotional, and attitudinal exhaustion.
A total of 40% of respondents said they plan to retire early because of today's medical environment, 29% said they were physically exhausted, and 16% said they wanted to quit medicine, Dr. Pellegrini said. All those responses had a significant positive correlation with burnout symptoms.
Of the full sample, 49% said they would encourage their children to go into medicine, but only 23% said they themselves would again make the decision to go to medical school. Twenty percent said that they were satisfied with their practice situation, and 16% said that they were satisfied with being a physician.
Only 27% were comfortable with their balance between work and family. That could be due in part to the long hours most ob.gyns. work. On average, they're working 59 hours per week, not counting nights on call.
Physicians under age 50 were significantly more likely to report burnout symptoms than those age 50 or above (58% vs. 45%). “It seems that the older physicians had some type of survival factor that allowed them to find ways to cope,” Dr. Pellegrini said.
As far as manifesting symptoms of burnout, women appear to be faring worse than men (70% vs. 59%), and African Americans appear to be faring worse than other ob.gyns. (78% vs. 63%). While statistically significant, both of those differences may be confounded by the lower average ages of female and African American ob.gyns.
Workload played a major role in burnout symptoms. Physicians who reported a recent increase in workload had a burnout rate of 76%, while it was 46% for the few who reported a decrease in workload. Those who reported working full time had a 69% burnout rate, while it was 47% for those working part time.
The practice of obstetrics had a significant impact on burnout. The burnout rate was 70% among physicians still doing obstetrics but only 51% among those who had dropped obstetrics from their practice.
Given that, it's perhaps surprising that the survey uncovered no significant correlation between burnout and lawsuits. Fully 82% of the people who responded have had lawsuits filed against them, an average of 3.8 lawsuits apiece, with a range of 1–20.
Ob.gyns. with spouses who worked outside the home had a 66% burnout rate, while those with spouses who did not work outside the home had a 58% burnout rate. Among physicians who had children between the primary grades and college, there was a 72% burnout rate. But having younger or older children did not correlate significantly with burnout.
Dr. Pellegrini listed a number of factors that appeared to protect against burnout, and he divided them into controllable and less controllable categories.
Among the controllable factors are regular exercise, adequate sleep, working part time, practicing gynecology only, allowing 45 minutes for each new patient, and being connected to the community.
Among the less controllable factors are being older, being male, working in an academic environment, feeling adequately compensated, and having compatible colleagues.
SAN FRANCISCO — A survey of ob.gyns. from Delaware, New Jersey, and Pennsylvania revealed that almost two-thirds suffer the symptoms of burnout, Vincent A. Pellegrini, M.D., reported at the annual meeting of the American College of Obstetricians and Gynecologists.
All ACOG members in District III were surveyed in 2004, and 863 responded, for a response rate of 30%, reported Dr. Pellegrini, who is in private practice in West Reading, Pa. Of those physicians, 64% reported the symptoms of burnout, as judged by the Maslach Burnout Inventory. Burnout is defined as a syndrome of physical, emotional, and attitudinal exhaustion.
A total of 40% of respondents said they plan to retire early because of today's medical environment, 29% said they were physically exhausted, and 16% said they wanted to quit medicine, Dr. Pellegrini said. All those responses had a significant positive correlation with burnout symptoms.
Of the full sample, 49% said they would encourage their children to go into medicine, but only 23% said they themselves would again make the decision to go to medical school. Twenty percent said that they were satisfied with their practice situation, and 16% said that they were satisfied with being a physician.
Only 27% were comfortable with their balance between work and family. That could be due in part to the long hours most ob.gyns. work. On average, they're working 59 hours per week, not counting nights on call.
Physicians under age 50 were significantly more likely to report burnout symptoms than those age 50 or above (58% vs. 45%). “It seems that the older physicians had some type of survival factor that allowed them to find ways to cope,” Dr. Pellegrini said.
As far as manifesting symptoms of burnout, women appear to be faring worse than men (70% vs. 59%), and African Americans appear to be faring worse than other ob.gyns. (78% vs. 63%). While statistically significant, both of those differences may be confounded by the lower average ages of female and African American ob.gyns.
Workload played a major role in burnout symptoms. Physicians who reported a recent increase in workload had a burnout rate of 76%, while it was 46% for the few who reported a decrease in workload. Those who reported working full time had a 69% burnout rate, while it was 47% for those working part time.
The practice of obstetrics had a significant impact on burnout. The burnout rate was 70% among physicians still doing obstetrics but only 51% among those who had dropped obstetrics from their practice.
Given that, it's perhaps surprising that the survey uncovered no significant correlation between burnout and lawsuits. Fully 82% of the people who responded have had lawsuits filed against them, an average of 3.8 lawsuits apiece, with a range of 1–20.
Ob.gyns. with spouses who worked outside the home had a 66% burnout rate, while those with spouses who did not work outside the home had a 58% burnout rate. Among physicians who had children between the primary grades and college, there was a 72% burnout rate. But having younger or older children did not correlate significantly with burnout.
Dr. Pellegrini listed a number of factors that appeared to protect against burnout, and he divided them into controllable and less controllable categories.
Among the controllable factors are regular exercise, adequate sleep, working part time, practicing gynecology only, allowing 45 minutes for each new patient, and being connected to the community.
Among the less controllable factors are being older, being male, working in an academic environment, feeling adequately compensated, and having compatible colleagues.
SAN FRANCISCO — A survey of ob.gyns. from Delaware, New Jersey, and Pennsylvania revealed that almost two-thirds suffer the symptoms of burnout, Vincent A. Pellegrini, M.D., reported at the annual meeting of the American College of Obstetricians and Gynecologists.
All ACOG members in District III were surveyed in 2004, and 863 responded, for a response rate of 30%, reported Dr. Pellegrini, who is in private practice in West Reading, Pa. Of those physicians, 64% reported the symptoms of burnout, as judged by the Maslach Burnout Inventory. Burnout is defined as a syndrome of physical, emotional, and attitudinal exhaustion.
A total of 40% of respondents said they plan to retire early because of today's medical environment, 29% said they were physically exhausted, and 16% said they wanted to quit medicine, Dr. Pellegrini said. All those responses had a significant positive correlation with burnout symptoms.
Of the full sample, 49% said they would encourage their children to go into medicine, but only 23% said they themselves would again make the decision to go to medical school. Twenty percent said that they were satisfied with their practice situation, and 16% said that they were satisfied with being a physician.
Only 27% were comfortable with their balance between work and family. That could be due in part to the long hours most ob.gyns. work. On average, they're working 59 hours per week, not counting nights on call.
Physicians under age 50 were significantly more likely to report burnout symptoms than those age 50 or above (58% vs. 45%). “It seems that the older physicians had some type of survival factor that allowed them to find ways to cope,” Dr. Pellegrini said.
As far as manifesting symptoms of burnout, women appear to be faring worse than men (70% vs. 59%), and African Americans appear to be faring worse than other ob.gyns. (78% vs. 63%). While statistically significant, both of those differences may be confounded by the lower average ages of female and African American ob.gyns.
Workload played a major role in burnout symptoms. Physicians who reported a recent increase in workload had a burnout rate of 76%, while it was 46% for the few who reported a decrease in workload. Those who reported working full time had a 69% burnout rate, while it was 47% for those working part time.
The practice of obstetrics had a significant impact on burnout. The burnout rate was 70% among physicians still doing obstetrics but only 51% among those who had dropped obstetrics from their practice.
Given that, it's perhaps surprising that the survey uncovered no significant correlation between burnout and lawsuits. Fully 82% of the people who responded have had lawsuits filed against them, an average of 3.8 lawsuits apiece, with a range of 1–20.
Ob.gyns. with spouses who worked outside the home had a 66% burnout rate, while those with spouses who did not work outside the home had a 58% burnout rate. Among physicians who had children between the primary grades and college, there was a 72% burnout rate. But having younger or older children did not correlate significantly with burnout.
Dr. Pellegrini listed a number of factors that appeared to protect against burnout, and he divided them into controllable and less controllable categories.
Among the controllable factors are regular exercise, adequate sleep, working part time, practicing gynecology only, allowing 45 minutes for each new patient, and being connected to the community.
Among the less controllable factors are being older, being male, working in an academic environment, feeling adequately compensated, and having compatible colleagues.