Robert Finn

SAN FRANCISCO — The manual vacuum aspirator is an important but often neglected tool for pregnancy terminations, Dr. Frederick W. Hopkins said at a conference on contraceptive technology sponsored by Contemporary Forums.

“We've done a lot of educating women about medical abortion,” said Dr. Hopkins, an ob.gyn. in group practice in San Jose, Calif. “We haven't done as much education about how gentle and brief early surgical abortion is. And [the manual vacuum aspirator] can be very well utilized in the emergency room [with] women who are having miscarriages.” Its use can help avoid a trip to the operating room.

“In the developing world, this instrument is saving women's lives,” he added.

There's little practical difference between the electric vacuum aspirator (EVA) and the manual vacuum aspirator (MVA). The only difference is the source of the vacuum. One advantage of the EVA is that it provides a limitless source of suction. The suction in the MVA needs to be recharged occasionally.

On the other hand, the MVA is much quieter than the EVA. Because some physicians believe that patients will associate the noise of the electric motor with the pain of their uterine contractions, the EVA unit is placed in another room, its suction tubes coming through the wall.

Although some believe that the EVA can help physicians complete the procedure more rapidly, Dr. Hopkins said “with the MVA, in 30 seconds I can empty a uterus for somebody who's less than 8 weeks [pregnant].”

The MVA has the additional advantages of being reusable and portable and of not requiring a source of electrical power. Even when Dr. Hopkins is using an EVA, “I always have an MVA next to me in case the electricity goes out.”

And he finds that the MVA is somewhat gentler on the tissue it extracts. The gestational sac often becomes shredded by an EVA, while the sac tends to remain intact with an MVA. This makes it simpler to identify the products of conception, ensuring that the procedure is complete and saving the time and expense of subsequent pregnancy testing. This is especially important in rural communities or other situations in which women must travel long distances for an abortion.

For the same reason, the MVA can allow an early diagnosis of ectopic pregnancy.

At least five studies of more than 17,000 patients demonstrated efficacy rates of 98%–99% for MVA, Dr. Hopkins said.

Contemporary Forums and this news organization are wholly owned subsidiaries of Reed Elsevier.

SAN FRANCISCO — The manual vacuum aspirator is an important but often neglected tool for pregnancy terminations, Dr. Frederick W. Hopkins said at a conference on contraceptive technology sponsored by Contemporary Forums.

“We've done a lot of educating women about medical abortion,” said Dr. Hopkins, an ob.gyn. in group practice in San Jose, Calif. “We haven't done as much education about how gentle and brief early surgical abortion is. And [the manual vacuum aspirator] can be very well utilized in the emergency room [with] women who are having miscarriages.” Its use can help avoid a trip to the operating room.

“In the developing world, this instrument is saving women's lives,” he added.

There's little practical difference between the electric vacuum aspirator (EVA) and the manual vacuum aspirator (MVA). The only difference is the source of the vacuum. One advantage of the EVA is that it provides a limitless source of suction. The suction in the MVA needs to be recharged occasionally.

On the other hand, the MVA is much quieter than the EVA. Because some physicians believe that patients will associate the noise of the electric motor with the pain of their uterine contractions, the EVA unit is placed in another room, its suction tubes coming through the wall.

Although some believe that the EVA can help physicians complete the procedure more rapidly, Dr. Hopkins said “with the MVA, in 30 seconds I can empty a uterus for somebody who's less than 8 weeks [pregnant].”

The MVA has the additional advantages of being reusable and portable and of not requiring a source of electrical power. Even when Dr. Hopkins is using an EVA, “I always have an MVA next to me in case the electricity goes out.”

And he finds that the MVA is somewhat gentler on the tissue it extracts. The gestational sac often becomes shredded by an EVA, while the sac tends to remain intact with an MVA. This makes it simpler to identify the products of conception, ensuring that the procedure is complete and saving the time and expense of subsequent pregnancy testing. This is especially important in rural communities or other situations in which women must travel long distances for an abortion.

For the same reason, the MVA can allow an early diagnosis of ectopic pregnancy.

At least five studies of more than 17,000 patients demonstrated efficacy rates of 98%–99% for MVA, Dr. Hopkins said.

Contemporary Forums and this news organization are wholly owned subsidiaries of Reed Elsevier.

SAN FRANCISCO — The manual vacuum aspirator is an important but often neglected tool for pregnancy terminations, Dr. Frederick W. Hopkins said at a conference on contraceptive technology sponsored by Contemporary Forums.

“We've done a lot of educating women about medical abortion,” said Dr. Hopkins, an ob.gyn. in group practice in San Jose, Calif. “We haven't done as much education about how gentle and brief early surgical abortion is. And [the manual vacuum aspirator] can be very well utilized in the emergency room [with] women who are having miscarriages.” Its use can help avoid a trip to the operating room.

“In the developing world, this instrument is saving women's lives,” he added.

There's little practical difference between the electric vacuum aspirator (EVA) and the manual vacuum aspirator (MVA). The only difference is the source of the vacuum. One advantage of the EVA is that it provides a limitless source of suction. The suction in the MVA needs to be recharged occasionally.

On the other hand, the MVA is much quieter than the EVA. Because some physicians believe that patients will associate the noise of the electric motor with the pain of their uterine contractions, the EVA unit is placed in another room, its suction tubes coming through the wall.

Although some believe that the EVA can help physicians complete the procedure more rapidly, Dr. Hopkins said “with the MVA, in 30 seconds I can empty a uterus for somebody who's less than 8 weeks [pregnant].”

The MVA has the additional advantages of being reusable and portable and of not requiring a source of electrical power. Even when Dr. Hopkins is using an EVA, “I always have an MVA next to me in case the electricity goes out.”

And he finds that the MVA is somewhat gentler on the tissue it extracts. The gestational sac often becomes shredded by an EVA, while the sac tends to remain intact with an MVA. This makes it simpler to identify the products of conception, ensuring that the procedure is complete and saving the time and expense of subsequent pregnancy testing. This is especially important in rural communities or other situations in which women must travel long distances for an abortion.

For the same reason, the MVA can allow an early diagnosis of ectopic pregnancy.

At least five studies of more than 17,000 patients demonstrated efficacy rates of 98%–99% for MVA, Dr. Hopkins said.

Contemporary Forums and this news organization are wholly owned subsidiaries of Reed Elsevier.

SAN FRANCISCO — Trichomoniasis is the cause of about 20% of vaginitis complaints, and there are two new diagnostic tests and one new treatment available for this disorder, Dr. Jeanne Marrazzo said at a conference on contraceptive technology sponsored by Contemporary Forums.

The wet prep remains a valuable diagnostic tool, and metronidazole remains an entirely acceptable treatment, but Dr. Marrazzo, of the University of Washington, Seattle, said that the newer diagnostic techniques are “woefully underused,” and that tinidazole has a number of advantages as a treatment.

Accurate diagnosis is critical because, “Although we think of trich as causing a purulent vaginal discharge, often malodorous, many if not most women with trichomoniasis are asymptomatic,” Dr. Marrazzo said. And a woman may have trichomoniasis even if she hasn't had sex in many months or years. The organism can remain hidden in the subepithelial glands, only to reemerge during a period of antibiotic use or changing hormonal status.

Although Trichomonas can usually be seen in a wet prep, the detection rate increases with practice. It's important to look at the wet prep very quickly; 20% of the organisms disappear within 10 minutes, and they're all gone within a half-hour.

The most common alternative is the BD Affirm VPIII Microbial Identification Test from Becton, Dickinson and Co. Based on nucleic acid hybridization technology, BD Affirm tests for the presence of Trichomonas, Gardnerella, and Candida species. Results take about 45 minutes.

But there are two quicker alternatives. The XenoStrip-Tv T vaginalis test from Xenotope Diagnostics Inc., and the OSOM Trichomonas Rapid Test from Genzyme Corp. both use dipstick technology and return results in about 10 minutes. Compared with wet mounts, these tests have a sensitivity of 67%–83% and a specificity of 98%–100%.

Until recently, metronidazole, either as a single-dose (2 g) or as an oral regimen, was the only treatment for trichomoniasis. Recently, however, single-dose tinidazole (2 g as well) has been added to the treatment guidelines for trichomoniasis, giardiasis, and amoebiasis.

Tinidazole has a better safety and side-effect profile, and women experience much less of the nausea and vomiting commonly seen with metronidazole. The half-life of tinidazole is longer, however, meaning that women must avoid alcohol for 3 days after treatment. Moreover, tinidazole is not safe during pregnancy.

With either metronidazole or tinidazole, systemic treatment is necessary and local treatment is ineffective. Dr. Marrazzo disclosed serving as a consultant or speaker for Ther-Rx Corp., Quindel Corp., Mission Pharmacal Co., Merck & Co., and 3M.

Contemporary Forums and this news organization are wholly owned subsidiaries of Reed Elsevier.

SAN FRANCISCO — Trichomoniasis is the cause of about 20% of vaginitis complaints, and there are two new diagnostic tests and one new treatment available for this disorder, Dr. Jeanne Marrazzo said at a conference on contraceptive technology sponsored by Contemporary Forums.

The wet prep remains a valuable diagnostic tool, and metronidazole remains an entirely acceptable treatment, but Dr. Marrazzo, of the University of Washington, Seattle, said that the newer diagnostic techniques are “woefully underused,” and that tinidazole has a number of advantages as a treatment.

Accurate diagnosis is critical because, “Although we think of trich as causing a purulent vaginal discharge, often malodorous, many if not most women with trichomoniasis are asymptomatic,” Dr. Marrazzo said. And a woman may have trichomoniasis even if she hasn't had sex in many months or years. The organism can remain hidden in the subepithelial glands, only to reemerge during a period of antibiotic use or changing hormonal status.

Although Trichomonas can usually be seen in a wet prep, the detection rate increases with practice. It's important to look at the wet prep very quickly; 20% of the organisms disappear within 10 minutes, and they're all gone within a half-hour.

The most common alternative is the BD Affirm VPIII Microbial Identification Test from Becton, Dickinson and Co. Based on nucleic acid hybridization technology, BD Affirm tests for the presence of Trichomonas, Gardnerella, and Candida species. Results take about 45 minutes.

But there are two quicker alternatives. The XenoStrip-Tv T vaginalis test from Xenotope Diagnostics Inc., and the OSOM Trichomonas Rapid Test from Genzyme Corp. both use dipstick technology and return results in about 10 minutes. Compared with wet mounts, these tests have a sensitivity of 67%–83% and a specificity of 98%–100%.

Until recently, metronidazole, either as a single-dose (2 g) or as an oral regimen, was the only treatment for trichomoniasis. Recently, however, single-dose tinidazole (2 g as well) has been added to the treatment guidelines for trichomoniasis, giardiasis, and amoebiasis.

Tinidazole has a better safety and side-effect profile, and women experience much less of the nausea and vomiting commonly seen with metronidazole. The half-life of tinidazole is longer, however, meaning that women must avoid alcohol for 3 days after treatment. Moreover, tinidazole is not safe during pregnancy.

With either metronidazole or tinidazole, systemic treatment is necessary and local treatment is ineffective. Dr. Marrazzo disclosed serving as a consultant or speaker for Ther-Rx Corp., Quindel Corp., Mission Pharmacal Co., Merck & Co., and 3M.

Contemporary Forums and this news organization are wholly owned subsidiaries of Reed Elsevier.

SAN FRANCISCO — Trichomoniasis is the cause of about 20% of vaginitis complaints, and there are two new diagnostic tests and one new treatment available for this disorder, Dr. Jeanne Marrazzo said at a conference on contraceptive technology sponsored by Contemporary Forums.

The wet prep remains a valuable diagnostic tool, and metronidazole remains an entirely acceptable treatment, but Dr. Marrazzo, of the University of Washington, Seattle, said that the newer diagnostic techniques are “woefully underused,” and that tinidazole has a number of advantages as a treatment.

Accurate diagnosis is critical because, “Although we think of trich as causing a purulent vaginal discharge, often malodorous, many if not most women with trichomoniasis are asymptomatic,” Dr. Marrazzo said. And a woman may have trichomoniasis even if she hasn't had sex in many months or years. The organism can remain hidden in the subepithelial glands, only to reemerge during a period of antibiotic use or changing hormonal status.

Although Trichomonas can usually be seen in a wet prep, the detection rate increases with practice. It's important to look at the wet prep very quickly; 20% of the organisms disappear within 10 minutes, and they're all gone within a half-hour.

The most common alternative is the BD Affirm VPIII Microbial Identification Test from Becton, Dickinson and Co. Based on nucleic acid hybridization technology, BD Affirm tests for the presence of Trichomonas, Gardnerella, and Candida species. Results take about 45 minutes.

But there are two quicker alternatives. The XenoStrip-Tv T vaginalis test from Xenotope Diagnostics Inc., and the OSOM Trichomonas Rapid Test from Genzyme Corp. both use dipstick technology and return results in about 10 minutes. Compared with wet mounts, these tests have a sensitivity of 67%–83% and a specificity of 98%–100%.

Until recently, metronidazole, either as a single-dose (2 g) or as an oral regimen, was the only treatment for trichomoniasis. Recently, however, single-dose tinidazole (2 g as well) has been added to the treatment guidelines for trichomoniasis, giardiasis, and amoebiasis.

Tinidazole has a better safety and side-effect profile, and women experience much less of the nausea and vomiting commonly seen with metronidazole. The half-life of tinidazole is longer, however, meaning that women must avoid alcohol for 3 days after treatment. Moreover, tinidazole is not safe during pregnancy.

With either metronidazole or tinidazole, systemic treatment is necessary and local treatment is ineffective. Dr. Marrazzo disclosed serving as a consultant or speaker for Ther-Rx Corp., Quindel Corp., Mission Pharmacal Co., Merck & Co., and 3M.

Contemporary Forums and this news organization are wholly owned subsidiaries of Reed Elsevier.

SAN FRANCISCO — Seasonale and Seasonique are already on the market, and they will soon be joined by several other extended contraception options that will allow women to regulate their menstrual periods in a multiplicity of different ways, Dr. Carolyn L. Westhoff said at a conference on contraceptive technology sponsored by Contemporary Forums.

“From a medical point of view, there is no necessity to mimic regular cycling,” said Dr. Westhoff of Columbia University, New York. “Lots of women are happy with the 21/7 pill, … but it's like the Model T of birth control. You don't have to do it that way anymore.”

A continuous monophasic pill designed to be taken daily for 365 days is nearing Food and Drug Administration approval, she said. The pill's anticipated trade name is Lybrel.

And there are numerous other extended formulations in development. Beyond that, individual physicians and their patients are experimenting with the off-label use of options that are currently on the market.

“I would predict that we're not even going to see new pills with 21/7 [cycling] anymore,” Dr. Westhoff said. “I think every variation is reasonable, whether it's 2 months or 3 months or 4 months or 6 months, [depending on] what the patient might want. Or it could be a 3-month cycle once in a while. Those sorts of regimens probably aren't going to be FDA approved, because it's hard to go to the FDA with data to cover all those different flexible possibilities.”

Although a monthly cycle that repeats throughout a woman's adult life may seem normal, in fact contemporary women experience far more periods than their hunter-gatherer ancestors did. Calculations taking into account a later age of menarche, a younger age at first birth, a larger number of live births, and a longer period of breast-feeding suggest that a hunter-gatherer woman experienced approximately 160 menstrual periods in her lifetime. In contrast, contemporary women experience about 450.

Furthermore, there are many health advantages to medically regulating menstruation, including reductions in menorrhagia, uterine fibroids, adenomyosis, endometriosis, iron-deficiency anemia, and catamenial conditions such as migraine headaches and seizures.

On the other side, there's little scientific evidence that monthly menstruation is necessary for “cleansing the system,” or because it's a “natural” state.

Another possible benefit of monthly menstruation is that it serves as a sign that a woman is not pregnant, and menstruation is sometimes seen as a symbol of femininity, fertility, and youth.

Among other currently available medical options for reducing menstruation are injectable progestin-only contraceptives such as depot medroxyprogesterone acetate, a progestin-releasing intrauterine device (Mirena), oral progestins such as norethindrone acetate, danazol (a gonadotropin inhibitor with progestational and androgenic properties), gonadotropin-releasing hormone analogues such as leuprolide acetate, and extended regimens of the vaginal ring and the transdermal patch.

“All of the studies of extended cycling show more unscheduled bleeding and spotting in the beginning, and then it always gets a little better with time,” Dr. Westhoff said. “Very few women are amenorrheic at the beginning of continuous pill use.”

Although extended regimens of the vaginal ring and the transdermal patch seem to be safe and effective in clinical trials, Dr. Westhoff cautioned that uncertainties remain. For example, pharmacokinetic profiles suggest that steady-state ethinyl estradiol levels go a little higher each week than the week before. “We don't have data telling us what will happen with circulating levels if one would use the patch for 4, 6, 8, or 12 weeks,” she said.

Dr. Westhoff noted that her talk was prepared by an expert committee of the Association of Reproductive Health Professionals and was made possible by an unrestricted educational grant from Wyeth. Dr. Westhoff also disclosed receiving research support and serving as a consultant for Barr Pharmaceuticals and Organon.

Contemporary Forums and this news organization are wholly owned subsidiaries of Reed Elsevier.

SAN FRANCISCO — Seasonale and Seasonique are already on the market, and they will soon be joined by several other extended contraception options that will allow women to regulate their menstrual periods in a multiplicity of different ways, Dr. Carolyn L. Westhoff said at a conference on contraceptive technology sponsored by Contemporary Forums.

“From a medical point of view, there is no necessity to mimic regular cycling,” said Dr. Westhoff of Columbia University, New York. “Lots of women are happy with the 21/7 pill, … but it's like the Model T of birth control. You don't have to do it that way anymore.”

A continuous monophasic pill designed to be taken daily for 365 days is nearing Food and Drug Administration approval, she said. The pill's anticipated trade name is Lybrel.

And there are numerous other extended formulations in development. Beyond that, individual physicians and their patients are experimenting with the off-label use of options that are currently on the market.

“I would predict that we're not even going to see new pills with 21/7 [cycling] anymore,” Dr. Westhoff said. “I think every variation is reasonable, whether it's 2 months or 3 months or 4 months or 6 months, [depending on] what the patient might want. Or it could be a 3-month cycle once in a while. Those sorts of regimens probably aren't going to be FDA approved, because it's hard to go to the FDA with data to cover all those different flexible possibilities.”

Although a monthly cycle that repeats throughout a woman's adult life may seem normal, in fact contemporary women experience far more periods than their hunter-gatherer ancestors did. Calculations taking into account a later age of menarche, a younger age at first birth, a larger number of live births, and a longer period of breast-feeding suggest that a hunter-gatherer woman experienced approximately 160 menstrual periods in her lifetime. In contrast, contemporary women experience about 450.

Furthermore, there are many health advantages to medically regulating menstruation, including reductions in menorrhagia, uterine fibroids, adenomyosis, endometriosis, iron-deficiency anemia, and catamenial conditions such as migraine headaches and seizures.

On the other side, there's little scientific evidence that monthly menstruation is necessary for “cleansing the system,” or because it's a “natural” state.

Another possible benefit of monthly menstruation is that it serves as a sign that a woman is not pregnant, and menstruation is sometimes seen as a symbol of femininity, fertility, and youth.

Among other currently available medical options for reducing menstruation are injectable progestin-only contraceptives such as depot medroxyprogesterone acetate, a progestin-releasing intrauterine device (Mirena), oral progestins such as norethindrone acetate, danazol (a gonadotropin inhibitor with progestational and androgenic properties), gonadotropin-releasing hormone analogues such as leuprolide acetate, and extended regimens of the vaginal ring and the transdermal patch.

“All of the studies of extended cycling show more unscheduled bleeding and spotting in the beginning, and then it always gets a little better with time,” Dr. Westhoff said. “Very few women are amenorrheic at the beginning of continuous pill use.”

Although extended regimens of the vaginal ring and the transdermal patch seem to be safe and effective in clinical trials, Dr. Westhoff cautioned that uncertainties remain. For example, pharmacokinetic profiles suggest that steady-state ethinyl estradiol levels go a little higher each week than the week before. “We don't have data telling us what will happen with circulating levels if one would use the patch for 4, 6, 8, or 12 weeks,” she said.

Dr. Westhoff noted that her talk was prepared by an expert committee of the Association of Reproductive Health Professionals and was made possible by an unrestricted educational grant from Wyeth. Dr. Westhoff also disclosed receiving research support and serving as a consultant for Barr Pharmaceuticals and Organon.

Contemporary Forums and this news organization are wholly owned subsidiaries of Reed Elsevier.

SAN FRANCISCO — Seasonale and Seasonique are already on the market, and they will soon be joined by several other extended contraception options that will allow women to regulate their menstrual periods in a multiplicity of different ways, Dr. Carolyn L. Westhoff said at a conference on contraceptive technology sponsored by Contemporary Forums.

“From a medical point of view, there is no necessity to mimic regular cycling,” said Dr. Westhoff of Columbia University, New York. “Lots of women are happy with the 21/7 pill, … but it's like the Model T of birth control. You don't have to do it that way anymore.”

A continuous monophasic pill designed to be taken daily for 365 days is nearing Food and Drug Administration approval, she said. The pill's anticipated trade name is Lybrel.

And there are numerous other extended formulations in development. Beyond that, individual physicians and their patients are experimenting with the off-label use of options that are currently on the market.

“I would predict that we're not even going to see new pills with 21/7 [cycling] anymore,” Dr. Westhoff said. “I think every variation is reasonable, whether it's 2 months or 3 months or 4 months or 6 months, [depending on] what the patient might want. Or it could be a 3-month cycle once in a while. Those sorts of regimens probably aren't going to be FDA approved, because it's hard to go to the FDA with data to cover all those different flexible possibilities.”

Although a monthly cycle that repeats throughout a woman's adult life may seem normal, in fact contemporary women experience far more periods than their hunter-gatherer ancestors did. Calculations taking into account a later age of menarche, a younger age at first birth, a larger number of live births, and a longer period of breast-feeding suggest that a hunter-gatherer woman experienced approximately 160 menstrual periods in her lifetime. In contrast, contemporary women experience about 450.

Furthermore, there are many health advantages to medically regulating menstruation, including reductions in menorrhagia, uterine fibroids, adenomyosis, endometriosis, iron-deficiency anemia, and catamenial conditions such as migraine headaches and seizures.

On the other side, there's little scientific evidence that monthly menstruation is necessary for “cleansing the system,” or because it's a “natural” state.

Another possible benefit of monthly menstruation is that it serves as a sign that a woman is not pregnant, and menstruation is sometimes seen as a symbol of femininity, fertility, and youth.

Among other currently available medical options for reducing menstruation are injectable progestin-only contraceptives such as depot medroxyprogesterone acetate, a progestin-releasing intrauterine device (Mirena), oral progestins such as norethindrone acetate, danazol (a gonadotropin inhibitor with progestational and androgenic properties), gonadotropin-releasing hormone analogues such as leuprolide acetate, and extended regimens of the vaginal ring and the transdermal patch.

“All of the studies of extended cycling show more unscheduled bleeding and spotting in the beginning, and then it always gets a little better with time,” Dr. Westhoff said. “Very few women are amenorrheic at the beginning of continuous pill use.”

Although extended regimens of the vaginal ring and the transdermal patch seem to be safe and effective in clinical trials, Dr. Westhoff cautioned that uncertainties remain. For example, pharmacokinetic profiles suggest that steady-state ethinyl estradiol levels go a little higher each week than the week before. “We don't have data telling us what will happen with circulating levels if one would use the patch for 4, 6, 8, or 12 weeks,” she said.

Dr. Westhoff noted that her talk was prepared by an expert committee of the Association of Reproductive Health Professionals and was made possible by an unrestricted educational grant from Wyeth. Dr. Westhoff also disclosed receiving research support and serving as a consultant for Barr Pharmaceuticals and Organon.

Contemporary Forums and this news organization are wholly owned subsidiaries of Reed Elsevier.

SAN FRANCISCO — A review of 11 studies examining the impact of increased access to emergency contraceptive pills finds no evidence that this increased access reduces the number of pregnancies or the number of abortions at a population level, James Trussell, Ph.D., reported at a meeting on contraceptive technology sponsored by Contemporary Forums.

In an often-cited 1992 paper, Dr. Trussell of Family Health International, Research Triangle Park, N.C., used modeling to suggest that access to emergency contraception could prevent half of all unintended pregnancies and abortions in the United States (Fam. Plann. Perspect. 1992;24:269–73).

But in nine randomized trials and one cohort study in which a total of 11,830 women were enrolled, and in one demonstration project in which 17,831 women were given emergency contraceptive pills (ECPs), not one of the studies found clinically or statistically significant differences between intervention and control groups in pregnancy or abortion.

Dr. Trussell noted that although many of these studies had substantial flaws, including small sample size, huge losses to follow-up (up to 62%), weak interventions, good access to ECPs among the comparison group, a low baseline risk of pregnancy, and a lack of randomization, none of the studies had all of those problems and some were very good.

“The consistency of these findings is hard to ignore,” Dr. Trussell said.

Dr. Trussell considered several other possible explanations for the failure of access to ECPs to reduce unintended pregnancies and abortions. Some have suggested that easy availability of emergency contraception would increase risk taking among women. But the studies found no evidence of an increase in unprotected sex or decrease in use of regular contraception with enhanced ECP access. Furthermore, two of the studies fail to find any increase in sexually transmitted infections with increased ECP access, also arguing against the increased-risk-taking hypothesis.

A third hypothesis is that emergency contraceptive pills have intrinsically low efficacy. The labeling on Plan B (two doses of levonorgestrel) quotes an 89% reduction in pregnancy risk after a single act of coitus, and estimates of risk reduction in the published literature range from 60% to 94%. But Dr. Trussell called all these estimates into question because it's difficult to accurately estimate the expected number of pregnancies that would have occurred without emergency contraception.

Expected pregnancies are calculated by determining the day of the menstrual cycle when the coital act occurred, and by using published charts listing probabilities of pregnancy by cycle day. But those charts might not apply in this population since they were constructed from data in women who wanted to become pregnant. Women using ECP don't want to become pregnant, and that could lead to possible differences in fecundity, the frequency of unprotected sex, and the accuracy of self-reports. Dr. Trussell concluded that the numbers of expected pregnancies reported by studies are probably too high and that most published efficacy figures are probably overestimates. Nevertheless, it's clear that emergency contraceptives produce physiologic effects that are incompatible with pregnancy and that at the very least they are more effective than nothing.

The fourth hypothesis is that even when they have easy access to ECPs, women don't use them sufficiently. The studies showed that repeated use of ECP was uncommon, that many unprotected acts remained uncovered by ECPs, and that no ECPs were used in most pregnancy cycles.

Women in the studies cited several reasons for non-use including a failure to perceive pregnancy risk, a lack of motivation to use emergency contraception, forgetfulness, and inconvenience. (Dr. Trussell expressed amazement that some women cited inconvenience as an excuse in view of the fact that they had free, study-supplied ECPs in their possession.)

Expense and side effects further reduce ECP use in the real world. Dr. Trussell concluded that insufficient use is definitely a problem and likely contributed to the failure of ECPs to reduce unintended pregnancies.

As for how physicians should respond to this new information, Dr. Trussell urged honesty. Physicians should not oversell emergency contraception by implying that Plan B will reduce unintended pregnancy at a population level, he said.

Contemporary Forums and this news organization are both wholly owned subsidiaries of Reed Elsevier.

SAN FRANCISCO — A review of 11 studies examining the impact of increased access to emergency contraceptive pills finds no evidence that this increased access reduces the number of pregnancies or the number of abortions at a population level, James Trussell, Ph.D., reported at a meeting on contraceptive technology sponsored by Contemporary Forums.

In an often-cited 1992 paper, Dr. Trussell of Family Health International, Research Triangle Park, N.C., used modeling to suggest that access to emergency contraception could prevent half of all unintended pregnancies and abortions in the United States (Fam. Plann. Perspect. 1992;24:269–73).

But in nine randomized trials and one cohort study in which a total of 11,830 women were enrolled, and in one demonstration project in which 17,831 women were given emergency contraceptive pills (ECPs), not one of the studies found clinically or statistically significant differences between intervention and control groups in pregnancy or abortion.

Dr. Trussell noted that although many of these studies had substantial flaws, including small sample size, huge losses to follow-up (up to 62%), weak interventions, good access to ECPs among the comparison group, a low baseline risk of pregnancy, and a lack of randomization, none of the studies had all of those problems and some were very good.

“The consistency of these findings is hard to ignore,” Dr. Trussell said.

Dr. Trussell considered several other possible explanations for the failure of access to ECPs to reduce unintended pregnancies and abortions. Some have suggested that easy availability of emergency contraception would increase risk taking among women. But the studies found no evidence of an increase in unprotected sex or decrease in use of regular contraception with enhanced ECP access. Furthermore, two of the studies fail to find any increase in sexually transmitted infections with increased ECP access, also arguing against the increased-risk-taking hypothesis.

A third hypothesis is that emergency contraceptive pills have intrinsically low efficacy. The labeling on Plan B (two doses of levonorgestrel) quotes an 89% reduction in pregnancy risk after a single act of coitus, and estimates of risk reduction in the published literature range from 60% to 94%. But Dr. Trussell called all these estimates into question because it's difficult to accurately estimate the expected number of pregnancies that would have occurred without emergency contraception.

Expected pregnancies are calculated by determining the day of the menstrual cycle when the coital act occurred, and by using published charts listing probabilities of pregnancy by cycle day. But those charts might not apply in this population since they were constructed from data in women who wanted to become pregnant. Women using ECP don't want to become pregnant, and that could lead to possible differences in fecundity, the frequency of unprotected sex, and the accuracy of self-reports. Dr. Trussell concluded that the numbers of expected pregnancies reported by studies are probably too high and that most published efficacy figures are probably overestimates. Nevertheless, it's clear that emergency contraceptives produce physiologic effects that are incompatible with pregnancy and that at the very least they are more effective than nothing.

The fourth hypothesis is that even when they have easy access to ECPs, women don't use them sufficiently. The studies showed that repeated use of ECP was uncommon, that many unprotected acts remained uncovered by ECPs, and that no ECPs were used in most pregnancy cycles.

Women in the studies cited several reasons for non-use including a failure to perceive pregnancy risk, a lack of motivation to use emergency contraception, forgetfulness, and inconvenience. (Dr. Trussell expressed amazement that some women cited inconvenience as an excuse in view of the fact that they had free, study-supplied ECPs in their possession.)

Expense and side effects further reduce ECP use in the real world. Dr. Trussell concluded that insufficient use is definitely a problem and likely contributed to the failure of ECPs to reduce unintended pregnancies.

As for how physicians should respond to this new information, Dr. Trussell urged honesty. Physicians should not oversell emergency contraception by implying that Plan B will reduce unintended pregnancy at a population level, he said.

Contemporary Forums and this news organization are both wholly owned subsidiaries of Reed Elsevier.

SAN FRANCISCO — A review of 11 studies examining the impact of increased access to emergency contraceptive pills finds no evidence that this increased access reduces the number of pregnancies or the number of abortions at a population level, James Trussell, Ph.D., reported at a meeting on contraceptive technology sponsored by Contemporary Forums.

In an often-cited 1992 paper, Dr. Trussell of Family Health International, Research Triangle Park, N.C., used modeling to suggest that access to emergency contraception could prevent half of all unintended pregnancies and abortions in the United States (Fam. Plann. Perspect. 1992;24:269–73).

But in nine randomized trials and one cohort study in which a total of 11,830 women were enrolled, and in one demonstration project in which 17,831 women were given emergency contraceptive pills (ECPs), not one of the studies found clinically or statistically significant differences between intervention and control groups in pregnancy or abortion.

Dr. Trussell noted that although many of these studies had substantial flaws, including small sample size, huge losses to follow-up (up to 62%), weak interventions, good access to ECPs among the comparison group, a low baseline risk of pregnancy, and a lack of randomization, none of the studies had all of those problems and some were very good.

“The consistency of these findings is hard to ignore,” Dr. Trussell said.

Dr. Trussell considered several other possible explanations for the failure of access to ECPs to reduce unintended pregnancies and abortions. Some have suggested that easy availability of emergency contraception would increase risk taking among women. But the studies found no evidence of an increase in unprotected sex or decrease in use of regular contraception with enhanced ECP access. Furthermore, two of the studies fail to find any increase in sexually transmitted infections with increased ECP access, also arguing against the increased-risk-taking hypothesis.

A third hypothesis is that emergency contraceptive pills have intrinsically low efficacy. The labeling on Plan B (two doses of levonorgestrel) quotes an 89% reduction in pregnancy risk after a single act of coitus, and estimates of risk reduction in the published literature range from 60% to 94%. But Dr. Trussell called all these estimates into question because it's difficult to accurately estimate the expected number of pregnancies that would have occurred without emergency contraception.

Expected pregnancies are calculated by determining the day of the menstrual cycle when the coital act occurred, and by using published charts listing probabilities of pregnancy by cycle day. But those charts might not apply in this population since they were constructed from data in women who wanted to become pregnant. Women using ECP don't want to become pregnant, and that could lead to possible differences in fecundity, the frequency of unprotected sex, and the accuracy of self-reports. Dr. Trussell concluded that the numbers of expected pregnancies reported by studies are probably too high and that most published efficacy figures are probably overestimates. Nevertheless, it's clear that emergency contraceptives produce physiologic effects that are incompatible with pregnancy and that at the very least they are more effective than nothing.

The fourth hypothesis is that even when they have easy access to ECPs, women don't use them sufficiently. The studies showed that repeated use of ECP was uncommon, that many unprotected acts remained uncovered by ECPs, and that no ECPs were used in most pregnancy cycles.

Women in the studies cited several reasons for non-use including a failure to perceive pregnancy risk, a lack of motivation to use emergency contraception, forgetfulness, and inconvenience. (Dr. Trussell expressed amazement that some women cited inconvenience as an excuse in view of the fact that they had free, study-supplied ECPs in their possession.)

Expense and side effects further reduce ECP use in the real world. Dr. Trussell concluded that insufficient use is definitely a problem and likely contributed to the failure of ECPs to reduce unintended pregnancies.

As for how physicians should respond to this new information, Dr. Trussell urged honesty. Physicians should not oversell emergency contraception by implying that Plan B will reduce unintended pregnancy at a population level, he said.

Contemporary Forums and this news organization are both wholly owned subsidiaries of Reed Elsevier.

SAN DIEGO — An old medical myth—that patients who are allergic to seafood are at risk of adverse reactions to radiologic contrast media—persists even among cardiologists, despite having been thoroughly debunked, Dr. Andrew D. Beaty reported at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.

In a survey of 231 specialists at six academic medical centers, 69% of the physicians admitted asking patients about seafood allergy before radiologic procedures using contrast media. Of those surveyed, 37% of the physicians admitted withholding contrast media or premedicating seafood-allergic patients with corticosteroids or antihistamines before the procedure.

Many studies over the past 30 years have failed to find any special relationship between seafood allergy and adverse reactions to radiologic contrast media (RCM). According to some, atopic patients in general may have a fourfold to fivefold increased risk of adverse events in response to RCM. However, the baseline rate of these events is so low that even if these studies were to be confirmed in larger populations, less than 1% of atopic patients would be affected.

About 10 million procedures using RCM are conducted every year in the United States. Life-threatening reactions occur in about 0.2% of patients receiving high-osmolarity contrast media and 0.04% of those getting low-osmolarity contrast media.

The origin of the seafood allergy myth is unknown. But Dr. Beaty, of St. Louis University, has traced it at least as far as a 1975 paper in the American Journal of Roentgenology that stated that 15% of patients who experienced adverse reactions to RCM reported having seafood allergy (Am. J. Roentgenol. Radium Ther. Nucl. Med. 1975;124:145–52). The authors of that study hypothesized that the iodine in seafood cross-reacted with the iodine in RCM. They never verified those patient reports, however, and similar percentages of patients with adverse reactions in their study reported allergies to other common foods such as milk and eggs.

Since then, it has been determined that seafood allergy is mediated by immunoglobulin E (IgE) antibodies to proteins in meat, with iodine playing no role. Furthermore, IgE does not mediate severe RCM reactions. The combination of these two findings effectively discounts the hypothesis of iodine cross-reactivity.

For his study, Dr. Beaty and his colleagues mailed anonymous questionnaires to 231 faculty members at six prominent academic medical centers in the Midwest. Of the individuals queried, 49% responded.

The survey consisted of eight brief questions, but only two of them related to seafood allergy and RCM. The other six were intended as distractors.

The first seafood-related question was, “Do you or someone on your behalf inquire about a history of seafood or shellfish allergy prior to administration of contrast media?” Sixty-five percent of the radiologists and 89% of the cardiologists answered, “Yes.”

The second question was, “Would you withhold RCM administration or recommend pretreatment with corticosteroids and/or antihistamines based on a history of seafood or shellfish allergy?” Thirty-five percent of the radiologists and 50% of the cardiologists answered, “Yes.”

While 69% of the total respondents said that they would ask patients about seafood allergy, only 37% said that they would change management based on that information. That suggests that about 32% would ask the question even if the answer would not affect patient management.

Merely asking that question may serve to perpetuate the myth among patients, Dr. Beaty said. He pointed to a separate study indicating that 65% of patients with seafood allergy had either read or been told by their physician to avoid RCM, and 92% believed that iodine in seafood was responsible for their allergy (Allergy Asthma Proc. 2005;26:468–9).

Several physicians in the audience rose to describe their experiences with this medical myth. One described a radiologic technician who received an official reprimand for failing to ask a patient about seafood allergy. Another physician said that at his institution no allergic patients were allowed to receive RCM unless they were premedicated.

A third physician said that at his institution, the computer system automatically categorized every patient with a seafood allergy as being sensitive to RCM, and every patient who was sensitive to RCM as having a seafood allergy. That has now been changed, but patients who were seen before the change will have that erroneous information persist in their records until someone changes it manually.

Half of the cardiologists in the survey said that they would withhold RCM or pretreat patients with seafood allergies. Lynda Banzi/Elsevier Global Medical News

SAN DIEGO — An old medical myth—that patients who are allergic to seafood are at risk of adverse reactions to radiologic contrast media—persists even among cardiologists, despite having been thoroughly debunked, Dr. Andrew D. Beaty reported at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.

In a survey of 231 specialists at six academic medical centers, 69% of the physicians admitted asking patients about seafood allergy before radiologic procedures using contrast media. Of those surveyed, 37% of the physicians admitted withholding contrast media or premedicating seafood-allergic patients with corticosteroids or antihistamines before the procedure.

Many studies over the past 30 years have failed to find any special relationship between seafood allergy and adverse reactions to radiologic contrast media (RCM). According to some, atopic patients in general may have a fourfold to fivefold increased risk of adverse events in response to RCM. However, the baseline rate of these events is so low that even if these studies were to be confirmed in larger populations, less than 1% of atopic patients would be affected.

About 10 million procedures using RCM are conducted every year in the United States. Life-threatening reactions occur in about 0.2% of patients receiving high-osmolarity contrast media and 0.04% of those getting low-osmolarity contrast media.

The origin of the seafood allergy myth is unknown. But Dr. Beaty, of St. Louis University, has traced it at least as far as a 1975 paper in the American Journal of Roentgenology that stated that 15% of patients who experienced adverse reactions to RCM reported having seafood allergy (Am. J. Roentgenol. Radium Ther. Nucl. Med. 1975;124:145–52). The authors of that study hypothesized that the iodine in seafood cross-reacted with the iodine in RCM. They never verified those patient reports, however, and similar percentages of patients with adverse reactions in their study reported allergies to other common foods such as milk and eggs.

Since then, it has been determined that seafood allergy is mediated by immunoglobulin E (IgE) antibodies to proteins in meat, with iodine playing no role. Furthermore, IgE does not mediate severe RCM reactions. The combination of these two findings effectively discounts the hypothesis of iodine cross-reactivity.

For his study, Dr. Beaty and his colleagues mailed anonymous questionnaires to 231 faculty members at six prominent academic medical centers in the Midwest. Of the individuals queried, 49% responded.

The survey consisted of eight brief questions, but only two of them related to seafood allergy and RCM. The other six were intended as distractors.

The first seafood-related question was, “Do you or someone on your behalf inquire about a history of seafood or shellfish allergy prior to administration of contrast media?” Sixty-five percent of the radiologists and 89% of the cardiologists answered, “Yes.”

The second question was, “Would you withhold RCM administration or recommend pretreatment with corticosteroids and/or antihistamines based on a history of seafood or shellfish allergy?” Thirty-five percent of the radiologists and 50% of the cardiologists answered, “Yes.”

While 69% of the total respondents said that they would ask patients about seafood allergy, only 37% said that they would change management based on that information. That suggests that about 32% would ask the question even if the answer would not affect patient management.

Merely asking that question may serve to perpetuate the myth among patients, Dr. Beaty said. He pointed to a separate study indicating that 65% of patients with seafood allergy had either read or been told by their physician to avoid RCM, and 92% believed that iodine in seafood was responsible for their allergy (Allergy Asthma Proc. 2005;26:468–9).

Several physicians in the audience rose to describe their experiences with this medical myth. One described a radiologic technician who received an official reprimand for failing to ask a patient about seafood allergy. Another physician said that at his institution no allergic patients were allowed to receive RCM unless they were premedicated.

A third physician said that at his institution, the computer system automatically categorized every patient with a seafood allergy as being sensitive to RCM, and every patient who was sensitive to RCM as having a seafood allergy. That has now been changed, but patients who were seen before the change will have that erroneous information persist in their records until someone changes it manually.

Half of the cardiologists in the survey said that they would withhold RCM or pretreat patients with seafood allergies. Lynda Banzi/Elsevier Global Medical News

SAN DIEGO — An old medical myth—that patients who are allergic to seafood are at risk of adverse reactions to radiologic contrast media—persists even among cardiologists, despite having been thoroughly debunked, Dr. Andrew D. Beaty reported at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.

In a survey of 231 specialists at six academic medical centers, 69% of the physicians admitted asking patients about seafood allergy before radiologic procedures using contrast media. Of those surveyed, 37% of the physicians admitted withholding contrast media or premedicating seafood-allergic patients with corticosteroids or antihistamines before the procedure.

Many studies over the past 30 years have failed to find any special relationship between seafood allergy and adverse reactions to radiologic contrast media (RCM). According to some, atopic patients in general may have a fourfold to fivefold increased risk of adverse events in response to RCM. However, the baseline rate of these events is so low that even if these studies were to be confirmed in larger populations, less than 1% of atopic patients would be affected.

About 10 million procedures using RCM are conducted every year in the United States. Life-threatening reactions occur in about 0.2% of patients receiving high-osmolarity contrast media and 0.04% of those getting low-osmolarity contrast media.

The origin of the seafood allergy myth is unknown. But Dr. Beaty, of St. Louis University, has traced it at least as far as a 1975 paper in the American Journal of Roentgenology that stated that 15% of patients who experienced adverse reactions to RCM reported having seafood allergy (Am. J. Roentgenol. Radium Ther. Nucl. Med. 1975;124:145–52). The authors of that study hypothesized that the iodine in seafood cross-reacted with the iodine in RCM. They never verified those patient reports, however, and similar percentages of patients with adverse reactions in their study reported allergies to other common foods such as milk and eggs.

Since then, it has been determined that seafood allergy is mediated by immunoglobulin E (IgE) antibodies to proteins in meat, with iodine playing no role. Furthermore, IgE does not mediate severe RCM reactions. The combination of these two findings effectively discounts the hypothesis of iodine cross-reactivity.

For his study, Dr. Beaty and his colleagues mailed anonymous questionnaires to 231 faculty members at six prominent academic medical centers in the Midwest. Of the individuals queried, 49% responded.

The survey consisted of eight brief questions, but only two of them related to seafood allergy and RCM. The other six were intended as distractors.

The first seafood-related question was, “Do you or someone on your behalf inquire about a history of seafood or shellfish allergy prior to administration of contrast media?” Sixty-five percent of the radiologists and 89% of the cardiologists answered, “Yes.”

The second question was, “Would you withhold RCM administration or recommend pretreatment with corticosteroids and/or antihistamines based on a history of seafood or shellfish allergy?” Thirty-five percent of the radiologists and 50% of the cardiologists answered, “Yes.”

While 69% of the total respondents said that they would ask patients about seafood allergy, only 37% said that they would change management based on that information. That suggests that about 32% would ask the question even if the answer would not affect patient management.

Merely asking that question may serve to perpetuate the myth among patients, Dr. Beaty said. He pointed to a separate study indicating that 65% of patients with seafood allergy had either read or been told by their physician to avoid RCM, and 92% believed that iodine in seafood was responsible for their allergy (Allergy Asthma Proc. 2005;26:468–9).

Several physicians in the audience rose to describe their experiences with this medical myth. One described a radiologic technician who received an official reprimand for failing to ask a patient about seafood allergy. Another physician said that at his institution no allergic patients were allowed to receive RCM unless they were premedicated.

A third physician said that at his institution, the computer system automatically categorized every patient with a seafood allergy as being sensitive to RCM, and every patient who was sensitive to RCM as having a seafood allergy. That has now been changed, but patients who were seen before the change will have that erroneous information persist in their records until someone changes it manually.

Half of the cardiologists in the survey said that they would withhold RCM or pretreat patients with seafood allergies. Lynda Banzi/Elsevier Global Medical News

SAN FRANCISCO — Condoms and vasectomy remain the only options for male contraception, but that may change within a few years if promising methods under investigation pan out in clinical trials, Sharon Myoji Schnare said at a meeting on contraceptive technology sponsored by Contemporary Forms.

Ms. Schnare, a nurse-practitioner, and nurse-midwife at the South Kitsap Family Care Clinic in Port Orchard, Wash., highlighted five of the most promising approaches:

▸ Reversible inhibition of sperm under guidance (RISUG). This method of male contraception involves vas deferens injections of styrene maleic anhydride in the solvent dimethyl sulfoxide. Currently in phase 3 trials, RISUG seems to be highly effective and is regarded by many as the most promising of the male contraceptives. No pregnancies have been reported from men who were treated as long ago as 10–15 years. Primate studies indicate that this method may be reversible, but there have been no official reversibility tests in humans.

RISUG inhibits fertility by providing a partial physical block to sperm transport through the vas deferens and stripping membranes from the sperm that make it through, making it impossible for them to fuse with the oocyte.

Skilled practitioners can complete the no-scalpel procedure in about 15 minutes, with the only immediate side effects being a slight, painless swelling of the testes. Although viable sperm can be found for up to 3 months after vasectomy, RISUG seems to produce infertility in as little as 10 days afterward.

▸ Adjudin (also called AF-2364). This is an analogue of an old anticancer drug called lonidamine that is conjugated to follicle-stimulating hormone (FSH). Lonidamine alone is known to cause kidney damage and its' bioavailability is extremely low. But conjugated to FSH, small amounts of the drug go directly to the Sertoli cells of the testes, the only cells in the male body with FSH receptors. The sperm made by these cells are incapable of fertilizing an egg. Adjudin is currently in phase 2 human trials.

▸ The Intra Vas Device (IVD). This device is composed of a set of two flexible silicon plugs, 1 inch long and either 1.2 mm or 1.4 mm in diameter. The plugs are inserted in the vas deferens, separated by a small space, and they physically block the passage of sperm.

The no-scalpel procedure can be performed by anyone experienced in vasectomy. It's expected to cost about $1,000, which is comparable to a vasectomy. Unlike a vasectomy, however, reversal would theoretically be simpler and less expensive. In May 2006, the Food and Drug Administation approved human trials with this device, and if all goes according to plan, approval is expected in Europe, Canada, and the United States by 2010.

▸ Suppression of spermatogenesis with transdermal testosterone gels plus various progestins. In one such study, 100 mg per day of testosterone gel and 300 mg per 3 months of depot medroxyprogesterone acetate (DMPA) resulted in dramatic decreases in spermatogenesis in 90% of the 44 men who were tested. There were no serious adverse events and only minimal changes in weight, lipids, and PSA.

▸ Several gene-therapy strategies under consideration. Some researchers hope to target genes controlling sperm development; others, the genes that control the sperm's entry into the oocyte; and still others, the genes that control the sperm's tail and affect motility.

For more information, Ms. Schnare suggested visiting www.malecontraceptives.org

SAN FRANCISCO — Condoms and vasectomy remain the only options for male contraception, but that may change within a few years if promising methods under investigation pan out in clinical trials, Sharon Myoji Schnare said at a meeting on contraceptive technology sponsored by Contemporary Forms.

Ms. Schnare, a nurse-practitioner, and nurse-midwife at the South Kitsap Family Care Clinic in Port Orchard, Wash., highlighted five of the most promising approaches:

▸ Reversible inhibition of sperm under guidance (RISUG). This method of male contraception involves vas deferens injections of styrene maleic anhydride in the solvent dimethyl sulfoxide. Currently in phase 3 trials, RISUG seems to be highly effective and is regarded by many as the most promising of the male contraceptives. No pregnancies have been reported from men who were treated as long ago as 10–15 years. Primate studies indicate that this method may be reversible, but there have been no official reversibility tests in humans.

RISUG inhibits fertility by providing a partial physical block to sperm transport through the vas deferens and stripping membranes from the sperm that make it through, making it impossible for them to fuse with the oocyte.

Skilled practitioners can complete the no-scalpel procedure in about 15 minutes, with the only immediate side effects being a slight, painless swelling of the testes. Although viable sperm can be found for up to 3 months after vasectomy, RISUG seems to produce infertility in as little as 10 days afterward.

▸ Adjudin (also called AF-2364). This is an analogue of an old anticancer drug called lonidamine that is conjugated to follicle-stimulating hormone (FSH). Lonidamine alone is known to cause kidney damage and its' bioavailability is extremely low. But conjugated to FSH, small amounts of the drug go directly to the Sertoli cells of the testes, the only cells in the male body with FSH receptors. The sperm made by these cells are incapable of fertilizing an egg. Adjudin is currently in phase 2 human trials.

▸ The Intra Vas Device (IVD). This device is composed of a set of two flexible silicon plugs, 1 inch long and either 1.2 mm or 1.4 mm in diameter. The plugs are inserted in the vas deferens, separated by a small space, and they physically block the passage of sperm.

The no-scalpel procedure can be performed by anyone experienced in vasectomy. It's expected to cost about $1,000, which is comparable to a vasectomy. Unlike a vasectomy, however, reversal would theoretically be simpler and less expensive. In May 2006, the Food and Drug Administation approved human trials with this device, and if all goes according to plan, approval is expected in Europe, Canada, and the United States by 2010.

▸ Suppression of spermatogenesis with transdermal testosterone gels plus various progestins. In one such study, 100 mg per day of testosterone gel and 300 mg per 3 months of depot medroxyprogesterone acetate (DMPA) resulted in dramatic decreases in spermatogenesis in 90% of the 44 men who were tested. There were no serious adverse events and only minimal changes in weight, lipids, and PSA.

▸ Several gene-therapy strategies under consideration. Some researchers hope to target genes controlling sperm development; others, the genes that control the sperm's entry into the oocyte; and still others, the genes that control the sperm's tail and affect motility.

For more information, Ms. Schnare suggested visiting www.malecontraceptives.org

SAN FRANCISCO — Condoms and vasectomy remain the only options for male contraception, but that may change within a few years if promising methods under investigation pan out in clinical trials, Sharon Myoji Schnare said at a meeting on contraceptive technology sponsored by Contemporary Forms.

Ms. Schnare, a nurse-practitioner, and nurse-midwife at the South Kitsap Family Care Clinic in Port Orchard, Wash., highlighted five of the most promising approaches:

▸ Reversible inhibition of sperm under guidance (RISUG). This method of male contraception involves vas deferens injections of styrene maleic anhydride in the solvent dimethyl sulfoxide. Currently in phase 3 trials, RISUG seems to be highly effective and is regarded by many as the most promising of the male contraceptives. No pregnancies have been reported from men who were treated as long ago as 10–15 years. Primate studies indicate that this method may be reversible, but there have been no official reversibility tests in humans.

RISUG inhibits fertility by providing a partial physical block to sperm transport through the vas deferens and stripping membranes from the sperm that make it through, making it impossible for them to fuse with the oocyte.

Skilled practitioners can complete the no-scalpel procedure in about 15 minutes, with the only immediate side effects being a slight, painless swelling of the testes. Although viable sperm can be found for up to 3 months after vasectomy, RISUG seems to produce infertility in as little as 10 days afterward.

▸ Adjudin (also called AF-2364). This is an analogue of an old anticancer drug called lonidamine that is conjugated to follicle-stimulating hormone (FSH). Lonidamine alone is known to cause kidney damage and its' bioavailability is extremely low. But conjugated to FSH, small amounts of the drug go directly to the Sertoli cells of the testes, the only cells in the male body with FSH receptors. The sperm made by these cells are incapable of fertilizing an egg. Adjudin is currently in phase 2 human trials.

▸ The Intra Vas Device (IVD). This device is composed of a set of two flexible silicon plugs, 1 inch long and either 1.2 mm or 1.4 mm in diameter. The plugs are inserted in the vas deferens, separated by a small space, and they physically block the passage of sperm.

The no-scalpel procedure can be performed by anyone experienced in vasectomy. It's expected to cost about $1,000, which is comparable to a vasectomy. Unlike a vasectomy, however, reversal would theoretically be simpler and less expensive. In May 2006, the Food and Drug Administation approved human trials with this device, and if all goes according to plan, approval is expected in Europe, Canada, and the United States by 2010.

▸ Suppression of spermatogenesis with transdermal testosterone gels plus various progestins. In one such study, 100 mg per day of testosterone gel and 300 mg per 3 months of depot medroxyprogesterone acetate (DMPA) resulted in dramatic decreases in spermatogenesis in 90% of the 44 men who were tested. There were no serious adverse events and only minimal changes in weight, lipids, and PSA.

▸ Several gene-therapy strategies under consideration. Some researchers hope to target genes controlling sperm development; others, the genes that control the sperm's entry into the oocyte; and still others, the genes that control the sperm's tail and affect motility.

For more information, Ms. Schnare suggested visiting www.malecontraceptives.org

SAN FRANCISCO — Plain radiographs are an excellent first-line option for evaluating an individual with an injured shoulder, Dr. C. Benjamin Ma said at a conference on sports medicine sponsored by the University of California, San Francisco.

But the key is to be very specific about the views one wants.

For example, a simple order for anterior-posterior (AP) films of the shoulder will give an oblique and relatively uninformative view of the glenohumeral joint. That's because the shoulder blades are not flat. They're tilted forward, and as a result the glenohumeral joint is rotated toward the midline.

Instead, one should specify an AP view of the glenohumeral joint. The technician will know to tilt the patient slightly before shooting the film.

There are three things that Dr. Ma, of UCSF, said he wants to be able to visualize in the radiographs: the glenohumeral joint, the acromioclavicular joint, and the shape of the acromion.

In addition to the AP view of the glenohumeral joint, Dr. Ma will usually order an axillary lateral view, a supraspinatus outlet view, and an AP view of the acromioclavicular joint.

The axillary lateral film provides a good view of the humeral head sitting in the glenoid fossa. This joint has been likened to a golf ball sitting on a tee. When the shoulder is dislocated, the axillary lateral view allows one to determine whether the golf ball has fallen off the tee toward the front or toward the back.

Anterior dislocations are far more common than are posterior dislocations.

Finally, Dr. Ma said that a weight-bearing view of the shoulder can reveal otherwise hidden problems. He described one patient whom he suspected of having osteoarthritis, but nothing seemed amiss on the regular AP view of the glenohumeral joint. With the patient holding a 1-pound weight, however, it became obvious that there was direct bone-on-bone contact between the humeral head and the glenoid fossa.

To get this view, one should order an AP of the glenohumeral joint with the patient holding a 1-pound weight at 45–60 degrees of abduction.

SAN FRANCISCO — Plain radiographs are an excellent first-line option for evaluating an individual with an injured shoulder, Dr. C. Benjamin Ma said at a conference on sports medicine sponsored by the University of California, San Francisco.

But the key is to be very specific about the views one wants.

For example, a simple order for anterior-posterior (AP) films of the shoulder will give an oblique and relatively uninformative view of the glenohumeral joint. That's because the shoulder blades are not flat. They're tilted forward, and as a result the glenohumeral joint is rotated toward the midline.

Instead, one should specify an AP view of the glenohumeral joint. The technician will know to tilt the patient slightly before shooting the film.

There are three things that Dr. Ma, of UCSF, said he wants to be able to visualize in the radiographs: the glenohumeral joint, the acromioclavicular joint, and the shape of the acromion.

In addition to the AP view of the glenohumeral joint, Dr. Ma will usually order an axillary lateral view, a supraspinatus outlet view, and an AP view of the acromioclavicular joint.

The axillary lateral film provides a good view of the humeral head sitting in the glenoid fossa. This joint has been likened to a golf ball sitting on a tee. When the shoulder is dislocated, the axillary lateral view allows one to determine whether the golf ball has fallen off the tee toward the front or toward the back.

Anterior dislocations are far more common than are posterior dislocations.

Finally, Dr. Ma said that a weight-bearing view of the shoulder can reveal otherwise hidden problems. He described one patient whom he suspected of having osteoarthritis, but nothing seemed amiss on the regular AP view of the glenohumeral joint. With the patient holding a 1-pound weight, however, it became obvious that there was direct bone-on-bone contact between the humeral head and the glenoid fossa.

To get this view, one should order an AP of the glenohumeral joint with the patient holding a 1-pound weight at 45–60 degrees of abduction.

SAN FRANCISCO — Plain radiographs are an excellent first-line option for evaluating an individual with an injured shoulder, Dr. C. Benjamin Ma said at a conference on sports medicine sponsored by the University of California, San Francisco.

But the key is to be very specific about the views one wants.

For example, a simple order for anterior-posterior (AP) films of the shoulder will give an oblique and relatively uninformative view of the glenohumeral joint. That's because the shoulder blades are not flat. They're tilted forward, and as a result the glenohumeral joint is rotated toward the midline.

Instead, one should specify an AP view of the glenohumeral joint. The technician will know to tilt the patient slightly before shooting the film.

There are three things that Dr. Ma, of UCSF, said he wants to be able to visualize in the radiographs: the glenohumeral joint, the acromioclavicular joint, and the shape of the acromion.

In addition to the AP view of the glenohumeral joint, Dr. Ma will usually order an axillary lateral view, a supraspinatus outlet view, and an AP view of the acromioclavicular joint.

The axillary lateral film provides a good view of the humeral head sitting in the glenoid fossa. This joint has been likened to a golf ball sitting on a tee. When the shoulder is dislocated, the axillary lateral view allows one to determine whether the golf ball has fallen off the tee toward the front or toward the back.

Anterior dislocations are far more common than are posterior dislocations.

Finally, Dr. Ma said that a weight-bearing view of the shoulder can reveal otherwise hidden problems. He described one patient whom he suspected of having osteoarthritis, but nothing seemed amiss on the regular AP view of the glenohumeral joint. With the patient holding a 1-pound weight, however, it became obvious that there was direct bone-on-bone contact between the humeral head and the glenoid fossa.

To get this view, one should order an AP of the glenohumeral joint with the patient holding a 1-pound weight at 45–60 degrees of abduction.

New Mexico obstetricians are crying foul over an agreement forged by the state's human services department, several managed care organizations, and the state's midwives that will allow for Medicaid reimbursement for home births yet not require the midwives to carry liability insurance.

New Mexico has unusual parity in its numbers of midwives and obstetricians. According to the state Department of Health, there are 55 licensed midwives and 144 certified nurse-midwives in the state, a total of 199. According to the American College of Obstetricians and Gynecologists, there are 146 ACOG members (plus 51 junior fellows) in the state. In 1997, the New Mexico Medicaid program was privatized, and it's now run by managed care organizations (MCOs). The state requires that MCOs carry medical malpractice insurance, and MCOs in turn require the same of all their providers.

Midwives performing home births typically do not carry malpractice insurance. When that insurance is available, the cost is prohibitive, but few insurance companies are willing to write policies covering home births at any cost. It's not that there have been a large number of expensive claims, said Roberta Moore, maternal health program manager for the New Mexico Department of Health. Insurers simply don't see this market as profitable.

The new agreement provides for reimbursement of midwives provided that Medicaid-eligible women who choose to use their services acknowledge that they are aware of the midwife's lack of insurance and formally waive their rights to pursue legal again action against the state, the MCOs, or the midwife. The relatively small number of obstetricians in New Mexico and the state's rural character helped proponents of the agreement argue that it offers women in underserved remote areas access to care that they ordinarily would not have.

Dr. Sharon T. Phelan, professor of obstetrics and gynecology at the University of New Mexico, Albuquerque, doesn't buy this argument. In an interview, she noted that family physicians frequently perform births in rural areas of New Mexico where there are no obstetricians, so these areas are not really underserved. Those family physicians have mandatory malpractice insurance.

In addition, the agreement does not limit Medicaid reimbursement to midwives in rural areas. An Albuquerque-based midwife would receive reimbursement, even though there are many obstetricians in that city, Dr. Phelan pointed out.

Furthermore, there is a fundamental unfairness in allowing midwives to go without malpractice insurance while receiving about the same fee as an obstetrician does for a birth, Dr. Phelan said.

“When you're getting paid $1,200 for 9 months of care and a delivery, there are places where docs are having to deliver a hundred babies just to meet their malpractice [insurance premiums],” Dr. Phelan said, noting that with premiums of approximately $80,000 annually, New Mexico obstetricians are getting somewhat of a bargain, compared with colleagues in other parts of the country. New Mexico authorities basically treated the malpractice insurance problem “with an aspirin, which is to say [that midwives] are an exception to the rule and they don't have to carry insurance and they could still get paid. But they did not deal with the underlying problem,” which is the malpractice insurance crisis.

And she noted that when a home birth starts going wrong, mother and baby would be transferred to a hospital. Supposing the infant or the mother dies or the child has an ongoing deficit, “who's going to be sued?” Dr. Phelan asked. “It's the doctor who inherited a problem that was already in development, because he or she is the one with the malpractice insurance. We're the ones with the deep pockets, so we're the ones who are going to get dragged to court and have to spend days in depositions and in court going through all that emotional stuff on our own.”

The Midwives Alliance of North America (MANA), one of the two national midwifery associations (the other is the American College of Nurse-Midwives), said that it's true that midwives aren't sued very often, but the reasons are unclear. According to Diane Holzer, MANA's president and a licensed midwife, part of the reason may be that patients are more satisfied with their care or that midwives are able to develop more of a personal connection with their clients.

She noted that even in the nine states in which Medicaid reimbursement for home births technically is permitted, many midwives cannot actually receive reimbursement. California, for example, allows for Medi-Cal reimbursement of home births only if the licensed midwife is being supervised by a physician. But according to Ms. Holzer, not a single physician in California is willing to supervise midwives.

Why is that? “It's the question of the ages,” Ms. Holzer said in an interview. “The doctors all say it's a legal liability. They don't believe [home birth] is safe. But there are lots of studies out there that show that it is safe. I don't think that safety is the question if you take a look at the data out there. A lot of physicians have told us that their insurance companies have actually come out and said that if they back up out-of-hospital practitioners, they will be dropped.”

Physicians tend to be more accepting of nurse-midwives than of those without nursing degrees, Dr. Phelan said, adding that she has worked alongside nurse-midwives for 30 years, has helped train them, and is highly supportive of the use of nurse-midwives in birthing centers and hospitals. Some physicians may have the impression that someone can call herself a midwife after attending a 2-day workshop and participating in a handful of births. In reality, the requirements are more stringent. (See box, previous page.)

Despite the malpractice crisis that is causing many physicians to move away from obstetrics, the number of home births nationwide appears to be holding steady, Ms. Holzer said. “Birth is a natural process, and doesn't need to be interfered with to the extent that it has become in this country,” she added.

“I understand the reason why some women want home births,” Dr. Phelan said. “There is the perception of the rigidity of hospital settings, the unwillingness to have family in attendance, [the concern that] we're going to cut episiotomies, the higher rate of C-section, all of those kinds of things. But I think much of that has changed. … I think more and more hospitals are trying to have a more homelike birth experience with the ability to still provide the current technology and safety.”

ELSEVIER GLOBAL MEDICAL NEWS

Midwife Classifications Defined

A Certified Midwife (CM) is an individual educated in the discipline of midwifery who possesses evidence of certification according to the requirements of the American College of Nurse-Midwives. This term also is used in certain states as a designation of certification by the state or midwifery organization.

A Certified Professional Midwife (CPM) is a knowledgeable, skilled, and professional independent midwifery practitioner who has met the standards for certification set by the North American Registry of Midwives and is qualified to provide the midwifery model of care. The CPM is the only international credential that requires knowledge about and experience in out-of-hospital settings. CMs and CNMs typically practice in hospitals or clinics.

A Certified Nurse-Midwife (CNM) is an individual educated in the two disciplines of nursing and midwifery, who possesses evidence of certification according to the requirements of the American College of Nurse-Midwives. Unlike CMs or CPMs, CNMs are licensed in all 50 states.

A Direct-Entry Midwife (DEM) is an independent practitioner educated in the discipline of midwifery through self-study, apprenticeship, a midwifery school, or a college- or university-based program distinct from the discipline of nursing. A direct-entry midwife typically provides care to healthy women and newborns throughout the childbearing cycle, primarily in out-of-hospital settings.

The term Lay Midwife is used to designate an uncertified or unlicensed midwife who was educated through informal routes such as self-study or apprenticeship rather than through a formal program. Other similar terms to describe uncertified or unlicensed midwives are traditional midwife, traditional birth attendant, granny midwife, and independent midwife.

A Licensed Midwife (LM) is a midwife who is licensed to practice in a particular jurisdiction (usually a state or province).

Sources: Midwives Alliance of North America; American College of Nurse-Midwives

Licensing Requirements in New Mexico

To be licensed as a direct-entry midwife in New Mexico, an applicant must complete 12 months of theoretical and clinical education at an accredited midwifery school, pass a licensing exam, and show evidence of the following clinical experience:

▸ Observing and managing 40 labors.

▸ Delivering 25 newborns and placentas.

▸ Completing 25 well-women health assessments.

▸ Making 100 prenatal visits with at least 15 different women.

▸ Starting one successful intravenous line.

▸ Performing 30 newborn examinations.

▸ Administering 15 uses of prophylactic eye medications.

▸ Making 30 postpartum visits with mothers and babies within 36 hours of deliveries.

▸ Collecting blood from 15 newborns for metabolic screening.

▸ Performing 15 6-week postpartum and/or yearly physical exams and Pap smears.

▸ Making 30 family planning visits, consultations, and/or referrals.

▸ Observing one neonatal-intensive-care nursery.

▸ Observing one high-risk obstetric-care case.

▸ Providing one complete series of prepared childbirth classes.

▸ Observing one complete breast-feeding information series.

These requirements apply to direct-entry midwives only; certified nurse-midwives are registered nurses with additional certification from the American College of Nurse-Midwives after 2 years of advanced training.

Source: New Mexico Department of Health

New Mexico obstetricians are crying foul over an agreement forged by the state's human services department, several managed care organizations, and the state's midwives that will allow for Medicaid reimbursement for home births yet not require the midwives to carry liability insurance.

New Mexico has unusual parity in its numbers of midwives and obstetricians. According to the state Department of Health, there are 55 licensed midwives and 144 certified nurse-midwives in the state, a total of 199. According to the American College of Obstetricians and Gynecologists, there are 146 ACOG members (plus 51 junior fellows) in the state. In 1997, the New Mexico Medicaid program was privatized, and it's now run by managed care organizations (MCOs). The state requires that MCOs carry medical malpractice insurance, and MCOs in turn require the same of all their providers.

Midwives performing home births typically do not carry malpractice insurance. When that insurance is available, the cost is prohibitive, but few insurance companies are willing to write policies covering home births at any cost. It's not that there have been a large number of expensive claims, said Roberta Moore, maternal health program manager for the New Mexico Department of Health. Insurers simply don't see this market as profitable.

The new agreement provides for reimbursement of midwives provided that Medicaid-eligible women who choose to use their services acknowledge that they are aware of the midwife's lack of insurance and formally waive their rights to pursue legal again action against the state, the MCOs, or the midwife. The relatively small number of obstetricians in New Mexico and the state's rural character helped proponents of the agreement argue that it offers women in underserved remote areas access to care that they ordinarily would not have.

Dr. Sharon T. Phelan, professor of obstetrics and gynecology at the University of New Mexico, Albuquerque, doesn't buy this argument. In an interview, she noted that family physicians frequently perform births in rural areas of New Mexico where there are no obstetricians, so these areas are not really underserved. Those family physicians have mandatory malpractice insurance.

In addition, the agreement does not limit Medicaid reimbursement to midwives in rural areas. An Albuquerque-based midwife would receive reimbursement, even though there are many obstetricians in that city, Dr. Phelan pointed out.

Furthermore, there is a fundamental unfairness in allowing midwives to go without malpractice insurance while receiving about the same fee as an obstetrician does for a birth, Dr. Phelan said.

“When you're getting paid $1,200 for 9 months of care and a delivery, there are places where docs are having to deliver a hundred babies just to meet their malpractice [insurance premiums],” Dr. Phelan said, noting that with premiums of approximately $80,000 annually, New Mexico obstetricians are getting somewhat of a bargain, compared with colleagues in other parts of the country. New Mexico authorities basically treated the malpractice insurance problem “with an aspirin, which is to say [that midwives] are an exception to the rule and they don't have to carry insurance and they could still get paid. But they did not deal with the underlying problem,” which is the malpractice insurance crisis.

And she noted that when a home birth starts going wrong, mother and baby would be transferred to a hospital. Supposing the infant or the mother dies or the child has an ongoing deficit, “who's going to be sued?” Dr. Phelan asked. “It's the doctor who inherited a problem that was already in development, because he or she is the one with the malpractice insurance. We're the ones with the deep pockets, so we're the ones who are going to get dragged to court and have to spend days in depositions and in court going through all that emotional stuff on our own.”

The Midwives Alliance of North America (MANA), one of the two national midwifery associations (the other is the American College of Nurse-Midwives), said that it's true that midwives aren't sued very often, but the reasons are unclear. According to Diane Holzer, MANA's president and a licensed midwife, part of the reason may be that patients are more satisfied with their care or that midwives are able to develop more of a personal connection with their clients.

She noted that even in the nine states in which Medicaid reimbursement for home births technically is permitted, many midwives cannot actually receive reimbursement. California, for example, allows for Medi-Cal reimbursement of home births only if the licensed midwife is being supervised by a physician. But according to Ms. Holzer, not a single physician in California is willing to supervise midwives.

Why is that? “It's the question of the ages,” Ms. Holzer said in an interview. “The doctors all say it's a legal liability. They don't believe [home birth] is safe. But there are lots of studies out there that show that it is safe. I don't think that safety is the question if you take a look at the data out there. A lot of physicians have told us that their insurance companies have actually come out and said that if they back up out-of-hospital practitioners, they will be dropped.”

Physicians tend to be more accepting of nurse-midwives than of those without nursing degrees, Dr. Phelan said, adding that she has worked alongside nurse-midwives for 30 years, has helped train them, and is highly supportive of the use of nurse-midwives in birthing centers and hospitals. Some physicians may have the impression that someone can call herself a midwife after attending a 2-day workshop and participating in a handful of births. In reality, the requirements are more stringent. (See box, previous page.)

Despite the malpractice crisis that is causing many physicians to move away from obstetrics, the number of home births nationwide appears to be holding steady, Ms. Holzer said. “Birth is a natural process, and doesn't need to be interfered with to the extent that it has become in this country,” she added.

“I understand the reason why some women want home births,” Dr. Phelan said. “There is the perception of the rigidity of hospital settings, the unwillingness to have family in attendance, [the concern that] we're going to cut episiotomies, the higher rate of C-section, all of those kinds of things. But I think much of that has changed. … I think more and more hospitals are trying to have a more homelike birth experience with the ability to still provide the current technology and safety.”

ELSEVIER GLOBAL MEDICAL NEWS

Midwife Classifications Defined

A Certified Midwife (CM) is an individual educated in the discipline of midwifery who possesses evidence of certification according to the requirements of the American College of Nurse-Midwives. This term also is used in certain states as a designation of certification by the state or midwifery organization.

A Certified Professional Midwife (CPM) is a knowledgeable, skilled, and professional independent midwifery practitioner who has met the standards for certification set by the North American Registry of Midwives and is qualified to provide the midwifery model of care. The CPM is the only international credential that requires knowledge about and experience in out-of-hospital settings. CMs and CNMs typically practice in hospitals or clinics.

A Certified Nurse-Midwife (CNM) is an individual educated in the two disciplines of nursing and midwifery, who possesses evidence of certification according to the requirements of the American College of Nurse-Midwives. Unlike CMs or CPMs, CNMs are licensed in all 50 states.

A Direct-Entry Midwife (DEM) is an independent practitioner educated in the discipline of midwifery through self-study, apprenticeship, a midwifery school, or a college- or university-based program distinct from the discipline of nursing. A direct-entry midwife typically provides care to healthy women and newborns throughout the childbearing cycle, primarily in out-of-hospital settings.

The term Lay Midwife is used to designate an uncertified or unlicensed midwife who was educated through informal routes such as self-study or apprenticeship rather than through a formal program. Other similar terms to describe uncertified or unlicensed midwives are traditional midwife, traditional birth attendant, granny midwife, and independent midwife.

A Licensed Midwife (LM) is a midwife who is licensed to practice in a particular jurisdiction (usually a state or province).

Sources: Midwives Alliance of North America; American College of Nurse-Midwives

Licensing Requirements in New Mexico

To be licensed as a direct-entry midwife in New Mexico, an applicant must complete 12 months of theoretical and clinical education at an accredited midwifery school, pass a licensing exam, and show evidence of the following clinical experience:

▸ Observing and managing 40 labors.

▸ Delivering 25 newborns and placentas.

▸ Completing 25 well-women health assessments.

▸ Making 100 prenatal visits with at least 15 different women.

▸ Starting one successful intravenous line.

▸ Performing 30 newborn examinations.

▸ Administering 15 uses of prophylactic eye medications.

▸ Making 30 postpartum visits with mothers and babies within 36 hours of deliveries.

▸ Collecting blood from 15 newborns for metabolic screening.

▸ Performing 15 6-week postpartum and/or yearly physical exams and Pap smears.

▸ Making 30 family planning visits, consultations, and/or referrals.

▸ Observing one neonatal-intensive-care nursery.

▸ Observing one high-risk obstetric-care case.

▸ Providing one complete series of prepared childbirth classes.

▸ Observing one complete breast-feeding information series.

These requirements apply to direct-entry midwives only; certified nurse-midwives are registered nurses with additional certification from the American College of Nurse-Midwives after 2 years of advanced training.

Source: New Mexico Department of Health

New Mexico obstetricians are crying foul over an agreement forged by the state's human services department, several managed care organizations, and the state's midwives that will allow for Medicaid reimbursement for home births yet not require the midwives to carry liability insurance.

New Mexico has unusual parity in its numbers of midwives and obstetricians. According to the state Department of Health, there are 55 licensed midwives and 144 certified nurse-midwives in the state, a total of 199. According to the American College of Obstetricians and Gynecologists, there are 146 ACOG members (plus 51 junior fellows) in the state. In 1997, the New Mexico Medicaid program was privatized, and it's now run by managed care organizations (MCOs). The state requires that MCOs carry medical malpractice insurance, and MCOs in turn require the same of all their providers.

Midwives performing home births typically do not carry malpractice insurance. When that insurance is available, the cost is prohibitive, but few insurance companies are willing to write policies covering home births at any cost. It's not that there have been a large number of expensive claims, said Roberta Moore, maternal health program manager for the New Mexico Department of Health. Insurers simply don't see this market as profitable.

The new agreement provides for reimbursement of midwives provided that Medicaid-eligible women who choose to use their services acknowledge that they are aware of the midwife's lack of insurance and formally waive their rights to pursue legal again action against the state, the MCOs, or the midwife. The relatively small number of obstetricians in New Mexico and the state's rural character helped proponents of the agreement argue that it offers women in underserved remote areas access to care that they ordinarily would not have.

Dr. Sharon T. Phelan, professor of obstetrics and gynecology at the University of New Mexico, Albuquerque, doesn't buy this argument. In an interview, she noted that family physicians frequently perform births in rural areas of New Mexico where there are no obstetricians, so these areas are not really underserved. Those family physicians have mandatory malpractice insurance.

In addition, the agreement does not limit Medicaid reimbursement to midwives in rural areas. An Albuquerque-based midwife would receive reimbursement, even though there are many obstetricians in that city, Dr. Phelan pointed out.

Furthermore, there is a fundamental unfairness in allowing midwives to go without malpractice insurance while receiving about the same fee as an obstetrician does for a birth, Dr. Phelan said.

“When you're getting paid $1,200 for 9 months of care and a delivery, there are places where docs are having to deliver a hundred babies just to meet their malpractice [insurance premiums],” Dr. Phelan said, noting that with premiums of approximately $80,000 annually, New Mexico obstetricians are getting somewhat of a bargain, compared with colleagues in other parts of the country. New Mexico authorities basically treated the malpractice insurance problem “with an aspirin, which is to say [that midwives] are an exception to the rule and they don't have to carry insurance and they could still get paid. But they did not deal with the underlying problem,” which is the malpractice insurance crisis.

And she noted that when a home birth starts going wrong, mother and baby would be transferred to a hospital. Supposing the infant or the mother dies or the child has an ongoing deficit, “who's going to be sued?” Dr. Phelan asked. “It's the doctor who inherited a problem that was already in development, because he or she is the one with the malpractice insurance. We're the ones with the deep pockets, so we're the ones who are going to get dragged to court and have to spend days in depositions and in court going through all that emotional stuff on our own.”

The Midwives Alliance of North America (MANA), one of the two national midwifery associations (the other is the American College of Nurse-Midwives), said that it's true that midwives aren't sued very often, but the reasons are unclear. According to Diane Holzer, MANA's president and a licensed midwife, part of the reason may be that patients are more satisfied with their care or that midwives are able to develop more of a personal connection with their clients.

She noted that even in the nine states in which Medicaid reimbursement for home births technically is permitted, many midwives cannot actually receive reimbursement. California, for example, allows for Medi-Cal reimbursement of home births only if the licensed midwife is being supervised by a physician. But according to Ms. Holzer, not a single physician in California is willing to supervise midwives.

Why is that? “It's the question of the ages,” Ms. Holzer said in an interview. “The doctors all say it's a legal liability. They don't believe [home birth] is safe. But there are lots of studies out there that show that it is safe. I don't think that safety is the question if you take a look at the data out there. A lot of physicians have told us that their insurance companies have actually come out and said that if they back up out-of-hospital practitioners, they will be dropped.”

Physicians tend to be more accepting of nurse-midwives than of those without nursing degrees, Dr. Phelan said, adding that she has worked alongside nurse-midwives for 30 years, has helped train them, and is highly supportive of the use of nurse-midwives in birthing centers and hospitals. Some physicians may have the impression that someone can call herself a midwife after attending a 2-day workshop and participating in a handful of births. In reality, the requirements are more stringent. (See box, previous page.)

Despite the malpractice crisis that is causing many physicians to move away from obstetrics, the number of home births nationwide appears to be holding steady, Ms. Holzer said. “Birth is a natural process, and doesn't need to be interfered with to the extent that it has become in this country,” she added.

“I understand the reason why some women want home births,” Dr. Phelan said. “There is the perception of the rigidity of hospital settings, the unwillingness to have family in attendance, [the concern that] we're going to cut episiotomies, the higher rate of C-section, all of those kinds of things. But I think much of that has changed. … I think more and more hospitals are trying to have a more homelike birth experience with the ability to still provide the current technology and safety.”

ELSEVIER GLOBAL MEDICAL NEWS

Midwife Classifications Defined

A Certified Midwife (CM) is an individual educated in the discipline of midwifery who possesses evidence of certification according to the requirements of the American College of Nurse-Midwives. This term also is used in certain states as a designation of certification by the state or midwifery organization.

A Certified Professional Midwife (CPM) is a knowledgeable, skilled, and professional independent midwifery practitioner who has met the standards for certification set by the North American Registry of Midwives and is qualified to provide the midwifery model of care. The CPM is the only international credential that requires knowledge about and experience in out-of-hospital settings. CMs and CNMs typically practice in hospitals or clinics.

A Certified Nurse-Midwife (CNM) is an individual educated in the two disciplines of nursing and midwifery, who possesses evidence of certification according to the requirements of the American College of Nurse-Midwives. Unlike CMs or CPMs, CNMs are licensed in all 50 states.

A Direct-Entry Midwife (DEM) is an independent practitioner educated in the discipline of midwifery through self-study, apprenticeship, a midwifery school, or a college- or university-based program distinct from the discipline of nursing. A direct-entry midwife typically provides care to healthy women and newborns throughout the childbearing cycle, primarily in out-of-hospital settings.

The term Lay Midwife is used to designate an uncertified or unlicensed midwife who was educated through informal routes such as self-study or apprenticeship rather than through a formal program. Other similar terms to describe uncertified or unlicensed midwives are traditional midwife, traditional birth attendant, granny midwife, and independent midwife.

A Licensed Midwife (LM) is a midwife who is licensed to practice in a particular jurisdiction (usually a state or province).

Sources: Midwives Alliance of North America; American College of Nurse-Midwives

Licensing Requirements in New Mexico

To be licensed as a direct-entry midwife in New Mexico, an applicant must complete 12 months of theoretical and clinical education at an accredited midwifery school, pass a licensing exam, and show evidence of the following clinical experience:

▸ Observing and managing 40 labors.

▸ Delivering 25 newborns and placentas.

▸ Completing 25 well-women health assessments.

▸ Making 100 prenatal visits with at least 15 different women.

▸ Starting one successful intravenous line.

▸ Performing 30 newborn examinations.

▸ Administering 15 uses of prophylactic eye medications.

▸ Making 30 postpartum visits with mothers and babies within 36 hours of deliveries.

▸ Collecting blood from 15 newborns for metabolic screening.

▸ Performing 15 6-week postpartum and/or yearly physical exams and Pap smears.

▸ Making 30 family planning visits, consultations, and/or referrals.

▸ Observing one neonatal-intensive-care nursery.

▸ Observing one high-risk obstetric-care case.

▸ Providing one complete series of prepared childbirth classes.

▸ Observing one complete breast-feeding information series.

These requirements apply to direct-entry midwives only; certified nurse-midwives are registered nurses with additional certification from the American College of Nurse-Midwives after 2 years of advanced training.

Source: New Mexico Department of Health

SAN FRANCISCO — Because there are at least six commercial products available for viscosupplementation with hyaluronic acid, it can be hard to determine which to use, according to Dr. Anthony Luke, who provided tips and clinical pearls at a conference on sports medicine sponsored by the University of California, San Francisco.

Viscosupplementation with hyaluronic acid derivatives is FDA approved for treatment for mild knee osteoarthritis. However, available hyaluronic acid products differ in molecular weight, concentration, and suggested dosing, said Dr. Luke of the university.

The molecular weight of hyaluronic acid in synovial fluid is 6,000–7,000 kd, so one would expect that products at 6,000 kd, the closest in molecular weight to the natural substance, might perform best, Dr. Luke said. However, one study suggests that high-molecular weight injections result in better pain relief than low-molecular weight injections (Clin. Ther. 1999;21:1549–62), and another determined that the effect of hyaluronic acid on osteoblasts increased with molecular weight (Bone 2003;33:703–10).

On the other hand, low-molecular weight preparations may achieve higher concentrations in the desired tissue, he said. A recently published randomized controlled trial demonstrated that two hyaluronic acid preparations of different molecular weights were both more effective than placebo, but there was no statistically significant difference between them (Rheumatol. Int. 2006;26:325–30).

Studies have shown that viscosupplementation is similar to steroid injections in success in reducing pain in mild osteoarthritis, he said. But viscosupplementation appears to have a more prolonged effect than corticosteroids.

Dr. Luke said that he prefers a superolateral approach with a 1.5-inch needle, finding it to be more accurate than the bent-knee approach. If the patient's knee has an effusion, it should first be drained with a 22-gauge needle to avoid diluting the hyaluronic acid.

Dr. Luke said that he occasionally uses the treatment in patients with severe osteoarthritis of the knee who can't take steroids.

SAN FRANCISCO — Because there are at least six commercial products available for viscosupplementation with hyaluronic acid, it can be hard to determine which to use, according to Dr. Anthony Luke, who provided tips and clinical pearls at a conference on sports medicine sponsored by the University of California, San Francisco.

Viscosupplementation with hyaluronic acid derivatives is FDA approved for treatment for mild knee osteoarthritis. However, available hyaluronic acid products differ in molecular weight, concentration, and suggested dosing, said Dr. Luke of the university.

The molecular weight of hyaluronic acid in synovial fluid is 6,000–7,000 kd, so one would expect that products at 6,000 kd, the closest in molecular weight to the natural substance, might perform best, Dr. Luke said. However, one study suggests that high-molecular weight injections result in better pain relief than low-molecular weight injections (Clin. Ther. 1999;21:1549–62), and another determined that the effect of hyaluronic acid on osteoblasts increased with molecular weight (Bone 2003;33:703–10).

On the other hand, low-molecular weight preparations may achieve higher concentrations in the desired tissue, he said. A recently published randomized controlled trial demonstrated that two hyaluronic acid preparations of different molecular weights were both more effective than placebo, but there was no statistically significant difference between them (Rheumatol. Int. 2006;26:325–30).

Studies have shown that viscosupplementation is similar to steroid injections in success in reducing pain in mild osteoarthritis, he said. But viscosupplementation appears to have a more prolonged effect than corticosteroids.

Dr. Luke said that he prefers a superolateral approach with a 1.5-inch needle, finding it to be more accurate than the bent-knee approach. If the patient's knee has an effusion, it should first be drained with a 22-gauge needle to avoid diluting the hyaluronic acid.

Dr. Luke said that he occasionally uses the treatment in patients with severe osteoarthritis of the knee who can't take steroids.

SAN FRANCISCO — Because there are at least six commercial products available for viscosupplementation with hyaluronic acid, it can be hard to determine which to use, according to Dr. Anthony Luke, who provided tips and clinical pearls at a conference on sports medicine sponsored by the University of California, San Francisco.

Viscosupplementation with hyaluronic acid derivatives is FDA approved for treatment for mild knee osteoarthritis. However, available hyaluronic acid products differ in molecular weight, concentration, and suggested dosing, said Dr. Luke of the university.

The molecular weight of hyaluronic acid in synovial fluid is 6,000–7,000 kd, so one would expect that products at 6,000 kd, the closest in molecular weight to the natural substance, might perform best, Dr. Luke said. However, one study suggests that high-molecular weight injections result in better pain relief than low-molecular weight injections (Clin. Ther. 1999;21:1549–62), and another determined that the effect of hyaluronic acid on osteoblasts increased with molecular weight (Bone 2003;33:703–10).

On the other hand, low-molecular weight preparations may achieve higher concentrations in the desired tissue, he said. A recently published randomized controlled trial demonstrated that two hyaluronic acid preparations of different molecular weights were both more effective than placebo, but there was no statistically significant difference between them (Rheumatol. Int. 2006;26:325–30).

Studies have shown that viscosupplementation is similar to steroid injections in success in reducing pain in mild osteoarthritis, he said. But viscosupplementation appears to have a more prolonged effect than corticosteroids.

Dr. Luke said that he prefers a superolateral approach with a 1.5-inch needle, finding it to be more accurate than the bent-knee approach. If the patient's knee has an effusion, it should first be drained with a 22-gauge needle to avoid diluting the hyaluronic acid.

Dr. Luke said that he occasionally uses the treatment in patients with severe osteoarthritis of the knee who can't take steroids.

Insomnia is highly prevalent among elderly patients, but a new study suggests that a brief behavioral treatment can significantly improve insomnia in this population.

In a pilot study, Anne Germain, Ph.D., and her colleagues at the University of Pittsburgh demonstrated that a 45-minute training session followed 2 weeks later by a 30-minute booster session significantly improved scores on the Pittsburgh Sleep Quality Index (PSQI), decreased the time it took to fall asleep, and decreased the amount of wake time after sleep onset (J. Clin. Sleep Med. 2006;2:403–6).

The behavioral training was delivered by a master's-level adult psychiatric and primary-care nurse practitioner who had been trained in the technique. But in an interview, Dr. Germain said, “I think we can train any health care worker at this point to deliver the intervention.” She specifically mentioned clinical nurse assistants.

The 35 participants in the study lived in the community, but Dr. Germain said the technique would also be applicable in nursing homes, assisted living centers, and even hospices.

The participants, whose average age was 70 years, were randomized to receive either the brief behavioral treatment or an “information-only control:” brochures published by the American Academy of Sleep Medicine on insomnia, sleep and aging, and sleep hygiene. This was intended to emulate the type of behavioral instructions most primary-care patients might receive.

In the initial treatment session, study participants were given four individually tailored instructions. They were told to reduce the time spent in bed to closely match their number of hours of sleep, to get up at the same time every day of the week, not to go to bed unless they were sleepy, and not to stay in bed unless they were asleep.

Several of these instructions get at the notion of “sleep restriction,” which Dr. Germain explained this way: “A lot of people with insomnia tend to increase the amount of time they spend in bed, hoping to catch up on their sleep. They hope that if they stay in bed longer maybe they're going to sleep longer. This typically feeds back into the insomnia by conditioning the body and the brain that the bed is no longer a place only to sleep, but also to be awake.”

Allowing the patients to be in their beds only when they are actually asleep conditions them to associate the bed with sleep and not with reading, thinking, watching television, or other activities, she said.

At the booster session, the sleep schedules were modified if necessary. For example, if patients were falling asleep in less than 30 minutes and were waking up during the night for less than 30 minutes, they were told to increase their time in bed by 15 minutes, and to maintain that new time in bed for 1 week.

If after that week they were still falling asleep in less than 30 minutes and waking up during the night for less than 30 minutes, they were allowed to increase their time in bed by another 15 minutes.

In contrast, if it took them longer than 30 minutes to fall asleep or they awoke during the night for more than 30 minutes, they were instructed to decrease their time in bed by 15 minutes.

Twelve (71%) of the 17 participants who received the behavioral treatment met the study criteria for response, and 9 (53%) also met the criteria for remission. Among the patients in the control group, 6 of 18 (33%) met the criteria for response, and 3 (17%) met criteria for remission.

On average, patients receiving the behavioral treatment lost about four points on the Pittsburgh Sleep Quality Index, while scores among the control patients remained unchanged.

Average sleep latency (the time it takes to fall asleep) fell from 38 minutes to 17 minutes among the patients in the treatment group, and from 30 minutes to 27 minutes among the control patients. The number of minutes of wakefulness after sleep onset fell from 61 minutes to 28 minutes among the treated patients, and from 48 minutes to 36 minutes among the control patients.

All three of these differences between treated and control patients were statistically significant.

On the other hand, there were no statistically significant differences in total sleep time, but this may have been an artifact of the sleep-restriction aspect of the behavioral treatment as well as the relatively short length of follow-up in this pilot study–just 4 weeks after the initial treatment and 2 weeks after the booster session, she noted.

“We didn't have enough time to verify whether or not in the long run we do increase people's total sleep time,” Dr. Germain said.

“When we start looking at the longer-term data that is collected in those same patients, only then will we be able to determine whether or not the intervention was effective at changing total sleep time. At 4 weeks I think it's just too short, and it's really a reflection of the artifact that is imposed by the sleep restriction,” she told this newspaper.

Dr. Germain said institutions might have to be willing to make some modification such as allowing individualized lights-out for specific residents.

They also might need to provide quiet activities for residents who need to stay up late or get up early (because of their sleep-restriction regimen) so they do not disturb anyone else.

Insomnia is highly prevalent among elderly patients, but a new study suggests that a brief behavioral treatment can significantly improve insomnia in this population.

In a pilot study, Anne Germain, Ph.D., and her colleagues at the University of Pittsburgh demonstrated that a 45-minute training session followed 2 weeks later by a 30-minute booster session significantly improved scores on the Pittsburgh Sleep Quality Index (PSQI), decreased the time it took to fall asleep, and decreased the amount of wake time after sleep onset (J. Clin. Sleep Med. 2006;2:403–6).

The behavioral training was delivered by a master's-level adult psychiatric and primary-care nurse practitioner who had been trained in the technique. But in an interview, Dr. Germain said, “I think we can train any health care worker at this point to deliver the intervention.” She specifically mentioned clinical nurse assistants.

The 35 participants in the study lived in the community, but Dr. Germain said the technique would also be applicable in nursing homes, assisted living centers, and even hospices.

The participants, whose average age was 70 years, were randomized to receive either the brief behavioral treatment or an “information-only control:” brochures published by the American Academy of Sleep Medicine on insomnia, sleep and aging, and sleep hygiene. This was intended to emulate the type of behavioral instructions most primary-care patients might receive.

In the initial treatment session, study participants were given four individually tailored instructions. They were told to reduce the time spent in bed to closely match their number of hours of sleep, to get up at the same time every day of the week, not to go to bed unless they were sleepy, and not to stay in bed unless they were asleep.

Several of these instructions get at the notion of “sleep restriction,” which Dr. Germain explained this way: “A lot of people with insomnia tend to increase the amount of time they spend in bed, hoping to catch up on their sleep. They hope that if they stay in bed longer maybe they're going to sleep longer. This typically feeds back into the insomnia by conditioning the body and the brain that the bed is no longer a place only to sleep, but also to be awake.”

Allowing the patients to be in their beds only when they are actually asleep conditions them to associate the bed with sleep and not with reading, thinking, watching television, or other activities, she said.

At the booster session, the sleep schedules were modified if necessary. For example, if patients were falling asleep in less than 30 minutes and were waking up during the night for less than 30 minutes, they were told to increase their time in bed by 15 minutes, and to maintain that new time in bed for 1 week.

If after that week they were still falling asleep in less than 30 minutes and waking up during the night for less than 30 minutes, they were allowed to increase their time in bed by another 15 minutes.

In contrast, if it took them longer than 30 minutes to fall asleep or they awoke during the night for more than 30 minutes, they were instructed to decrease their time in bed by 15 minutes.

Twelve (71%) of the 17 participants who received the behavioral treatment met the study criteria for response, and 9 (53%) also met the criteria for remission. Among the patients in the control group, 6 of 18 (33%) met the criteria for response, and 3 (17%) met criteria for remission.

On average, patients receiving the behavioral treatment lost about four points on the Pittsburgh Sleep Quality Index, while scores among the control patients remained unchanged.

Average sleep latency (the time it takes to fall asleep) fell from 38 minutes to 17 minutes among the patients in the treatment group, and from 30 minutes to 27 minutes among the control patients. The number of minutes of wakefulness after sleep onset fell from 61 minutes to 28 minutes among the treated patients, and from 48 minutes to 36 minutes among the control patients.

All three of these differences between treated and control patients were statistically significant.

On the other hand, there were no statistically significant differences in total sleep time, but this may have been an artifact of the sleep-restriction aspect of the behavioral treatment as well as the relatively short length of follow-up in this pilot study–just 4 weeks after the initial treatment and 2 weeks after the booster session, she noted.

“We didn't have enough time to verify whether or not in the long run we do increase people's total sleep time,” Dr. Germain said.

“When we start looking at the longer-term data that is collected in those same patients, only then will we be able to determine whether or not the intervention was effective at changing total sleep time. At 4 weeks I think it's just too short, and it's really a reflection of the artifact that is imposed by the sleep restriction,” she told this newspaper.

Dr. Germain said institutions might have to be willing to make some modification such as allowing individualized lights-out for specific residents.

They also might need to provide quiet activities for residents who need to stay up late or get up early (because of their sleep-restriction regimen) so they do not disturb anyone else.

Insomnia is highly prevalent among elderly patients, but a new study suggests that a brief behavioral treatment can significantly improve insomnia in this population.

In a pilot study, Anne Germain, Ph.D., and her colleagues at the University of Pittsburgh demonstrated that a 45-minute training session followed 2 weeks later by a 30-minute booster session significantly improved scores on the Pittsburgh Sleep Quality Index (PSQI), decreased the time it took to fall asleep, and decreased the amount of wake time after sleep onset (J. Clin. Sleep Med. 2006;2:403–6).

The behavioral training was delivered by a master's-level adult psychiatric and primary-care nurse practitioner who had been trained in the technique. But in an interview, Dr. Germain said, “I think we can train any health care worker at this point to deliver the intervention.” She specifically mentioned clinical nurse assistants.

The 35 participants in the study lived in the community, but Dr. Germain said the technique would also be applicable in nursing homes, assisted living centers, and even hospices.

The participants, whose average age was 70 years, were randomized to receive either the brief behavioral treatment or an “information-only control:” brochures published by the American Academy of Sleep Medicine on insomnia, sleep and aging, and sleep hygiene. This was intended to emulate the type of behavioral instructions most primary-care patients might receive.

In the initial treatment session, study participants were given four individually tailored instructions. They were told to reduce the time spent in bed to closely match their number of hours of sleep, to get up at the same time every day of the week, not to go to bed unless they were sleepy, and not to stay in bed unless they were asleep.

Several of these instructions get at the notion of “sleep restriction,” which Dr. Germain explained this way: “A lot of people with insomnia tend to increase the amount of time they spend in bed, hoping to catch up on their sleep. They hope that if they stay in bed longer maybe they're going to sleep longer. This typically feeds back into the insomnia by conditioning the body and the brain that the bed is no longer a place only to sleep, but also to be awake.”

Allowing the patients to be in their beds only when they are actually asleep conditions them to associate the bed with sleep and not with reading, thinking, watching television, or other activities, she said.

At the booster session, the sleep schedules were modified if necessary. For example, if patients were falling asleep in less than 30 minutes and were waking up during the night for less than 30 minutes, they were told to increase their time in bed by 15 minutes, and to maintain that new time in bed for 1 week.

If after that week they were still falling asleep in less than 30 minutes and waking up during the night for less than 30 minutes, they were allowed to increase their time in bed by another 15 minutes.

In contrast, if it took them longer than 30 minutes to fall asleep or they awoke during the night for more than 30 minutes, they were instructed to decrease their time in bed by 15 minutes.

Twelve (71%) of the 17 participants who received the behavioral treatment met the study criteria for response, and 9 (53%) also met the criteria for remission. Among the patients in the control group, 6 of 18 (33%) met the criteria for response, and 3 (17%) met criteria for remission.

On average, patients receiving the behavioral treatment lost about four points on the Pittsburgh Sleep Quality Index, while scores among the control patients remained unchanged.

Average sleep latency (the time it takes to fall asleep) fell from 38 minutes to 17 minutes among the patients in the treatment group, and from 30 minutes to 27 minutes among the control patients. The number of minutes of wakefulness after sleep onset fell from 61 minutes to 28 minutes among the treated patients, and from 48 minutes to 36 minutes among the control patients.

All three of these differences between treated and control patients were statistically significant.

On the other hand, there were no statistically significant differences in total sleep time, but this may have been an artifact of the sleep-restriction aspect of the behavioral treatment as well as the relatively short length of follow-up in this pilot study–just 4 weeks after the initial treatment and 2 weeks after the booster session, she noted.

“We didn't have enough time to verify whether or not in the long run we do increase people's total sleep time,” Dr. Germain said.

“When we start looking at the longer-term data that is collected in those same patients, only then will we be able to determine whether or not the intervention was effective at changing total sleep time. At 4 weeks I think it's just too short, and it's really a reflection of the artifact that is imposed by the sleep restriction,” she told this newspaper.

Dr. Germain said institutions might have to be willing to make some modification such as allowing individualized lights-out for specific residents.

They also might need to provide quiet activities for residents who need to stay up late or get up early (because of their sleep-restriction regimen) so they do not disturb anyone else.