NEWSLINE: Clinical Insights/Professional Update





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Choose article section...NY court: Women can sue after miscarriage, stillbirth The traits of a 'disciplined' doctor HHS issues warning to physicians in concierge practice CLINICAL INSIGHTS Finding a cost-effective way to wipe out cervical cancer Amniocentesis/CVS cost-effective even for women under age 35 or at low risk Ready access to 'morning after' pill doesn't increase unprotected teen sex CDC finds no link between loratadine and hypospadias Dental x-rays during pregnancy associated with low birthweight Treatment of early breast cancer varies widely within the US IUD vs. hysterectomy for menorrhagia When patients try to estimate their ovulation 'window' MEETING HIGHLIGHTS 2004 ACOG Annual Meeting Patient Safety: What's wrong with this picture? Linking fetal fibronectin to labor induction Does uterine artery embolization increase pregnancy risks? Can this electronic gauge help ward off liability hassles? Testosterone increases sexual desire

NY court: Women can sue after miscarriage, stillbirth

The New York Court of Appeals overturned decades of case law recently by allowing a woman to sue if a miscarriage or stillbirth is a result of medical malpractice. The decision brings the state in line with the majority of other states in the nation that already allow this kind of recovery for expectant moms, according to American Medical News (4/26/04).

Obviously the 6-1 decision has the state's physicians worried. They are concerned the appellate decision opens the door for women to sue for emotional distress despite no evidence of negligence and to convince sympathetic jurors to award pain and suffering damages in these cases.

Moreover, physicians fear the decision could spur even more increases in their malpractice insurance rates. New York is already one of 19 states facing a liability insurance crisis, as determined by the American Medical Association, and overall obstetrician/gynecologists already pay some of the highest premiums nationwide.

The traits of a 'disciplined' doctor

What puts a physician in California at higher risk of being disciplined by the state's licensing board? Practicing in certain specialties, increasing age, and being male are some characteristics, according to a recent study in the Archives of Internal Medicine (3/22/04).

Obstetrician/gynecologists, general practitioners, psychiatrists, and family practitioners were more likely to be disciplined than internal medicine physicians, according to researchers from the Medical Board of California and the University of California, San Francisco. Moreover, increasing age in 20-year intervals and being male "were positively and independently associated with an increased likelihood of discipline."

The researchers, who reviewed 890 physicians disciplined by the state licensing board between July 1, 1998 and June 30, 2001, also found that physicians who were board certified were less likely to have action taken against their licenses. In contrast, those who received their medical education outside of the United States or Canada were more at risk for being disciplined.

HHS issues warning to physicians in concierge practice

The Department of Health and Human Services has put physicians who offer personalized, "deluxe" services to Medicare patients for a fee on alert. According to The New York Times (4/13/04), the department warned physicians in so-called concierge or boutique practices that, if they charge extra for services already covered by Medicare, they could face a fine or be expelled from federal health programs.

Despite the alert, physicians who offer deluxe services such as round-the-clock access, same-day appointments, or counseling for healthy living aren't too worried, reported Modern Healthcare (4/12/04). They stated that they believed their practices, which charge for amenities and patient convenience, were in line with the law.

Still, attorneys caution physicians in these practices to carefully delineate on a case-by-case basis those services that are covered by Medicare and those that are not.

"If you're doing what are clearly noncovered activities, you should be fine," Michael Blau, a lawyer with McDermott, Will & Emery, told Modern Healthcare.


Finding a cost-effective way to wipe out cervical cancer

A human papillomavirus 16/18 vaccine along with cytologic screening could reduce the absolute lifetime risk of cervical cancer by 94%, according to a recent study.

Because such a vaccine may be commercially available in a few years, researchers sought to determine the most beneficial and cost-effective strategy for its use. They found that the most effective method of implementation with an incremental cost-effectiveness ratio of less than $60,000 per quality-adjusted life year is one that follows vaccination of adolescent women at age 12 with triennial conventional cytologic screening beginning at age 25. The next best strategy is vaccination and cytologic screening every 5 years beginning at age 21.

In terms of the vaccine, results from a Phase II trial indicate 100% efficacy over an 18-month period in preventing persistent HPV 16 infection and HPV 16-specific cervical intraepithelial neoplasia. Larger Phase III trials of vaccines targeting different HPV types are under way.

While a vaccine is not yet available, the Food and Drug Administration recently approved HPV DNA testing for adjunctive use with cervical cytology in women aged 30 years or older. The question is whether HPV DNA testing in conjunction with cervical cytology for primary screening of these women provides any greater benefit, when compared to HPV DNA testing for only women with equivocal cytologic results.

Researchers from Harvard and Columbia Universities found that for women aged 30 and older, any biennial or triennial screening strategy that uses either HPV DNA testing in combination with cytology for primary screening or cytology with reflex HPV DNA testing for women with equivocal results provides greater reduction in cancer incidence and at a lower cost than annual conventional cytologic screening alone.

Estimated reduction in lifetime risk of cervical cancer varied from 81% to 93% depending on the screening frequency, type of cytology, and test strategy used. Cost-effectiveness ratios ranged from $95,300 to $228,700 per year of life gained.

Strategies that provided minimal additional benefit but that greatly increased costs included primary screening with cytology and HPV DNA testing in women younger than age 30 and annual screening with combined HPV DNA testing and cytology. The latter provided only a few hours of additional life expectancy and had a cost-effectiveness ratio of more than $2 million per life-year gained.

Goldie SJ, Kohli M, Grima D, et al. Projected clinical benefits and cost-effectiveness of a human papillomavirus 16/18 vaccine. J Natl Cancer Inst. 2004;96:604-615.

Goldie SJ, Kim JJ, Wright TC. Cost-effectiveness of human papillomavirus DNA testing for cervical cancer screening in women aged 30 years or more. Obstet Gynecol. 2004;103:619-631.

Amniocentesis/CVS cost-effective even for women under age 35 or at low risk

Forget about age- and risk-based thresholds when it comes to offering pregnant women prenatal diagnostic testing with amniocentesis or chorionic villus sampling (CVS). Both tests are cost-effective, regardless of maternal age or risk of carrying an affected fetus, according to the cost-effectiveness analysis of over 500 pregnant women.

Researchers calculated that in the US, compared with no prenatal diagnostic testing, amniocentesis costs less than $15,000 per quality-adjusted life-year gained for women of all ages and risk levels. They found no age threshold below which prenatal diagnosis was cost-ineffective (i.e., greater than $50,000 per quality-adjusted life-year gained).

While the results did not depend on age or risk level, they were very sensitive to the degree of reassurance a woman required from the test. In other words, the more worried a woman was about chromosomal abnormalities and to a lesser extent, about miscarriage, the more cost-effective the test became.

Harris RA, Washington E, Nease RF Jr, et al. Cost utility of prenatal diagnosis and the risk-based threshold. Lancet. 2004;363:276-282.

Ready access to 'morning after' pill doesn't increase unprotected teen sex

Providing emergency contraception (EC) to sexually active adolescents in advance does not lead to more unprotected intercourse, according to a randomized trial of adolescents visiting an urban, hospital-based clinic in Pittsburgh, Pa.

Researchers studied 301 predominantly minority, low-income, sexually active women between the ages of 15 and 20 who were not using long-acting contraception. At 1- and 6-month follow-up interviews, they found no differences in reports of unprotected intercourse between those women given EC in advance and a control group.

They did, however, find at the first follow-up visit that the group given advance EC was about twice as likely to use it as the control group (15% vs. 8%, respectively). By 6 months, use evened out between the groups (8% vs. 6%, respectively). In addition, compared with the control group, the group given EC in advance began using it significantly sooner after unprotected intercourse (11.4 hours vs. 21.8 hours, respectively) when it is more likely to be effective.

Gold MA, Wolford JE, Smith KA, et al. The effects of advance provision of emergency contraception on adolescent women's sexual and contraceptive behaviors. J Pediatr Adolesc Gynecol. 2004;17:87-96.

CDC finds no link between loratadine and hypospadias

Contrary to an earlier report, loratadine does not seem to increase the risk of hypospadias in the male offspring of pregnant mothers who took it 1 month before or 3 months after getting pregnant, according to this Centers for Disease Control and Prevention analysis of data on more than 2,000 boys.

Hypospadias generally occurs in about 7 of every 1,000 male infants in the US. A study from Sweden in 2002 reported the rate to be about twice that in males born to women who took loratadine during pregnancy. A 2003 study using data from four countries found the rate to be the same as that for the general population. To further assess any possible association, the CDC analyzed data from the National Birth Defects Prevention Study, an ongoing, multistate, case–control study of environmental and genetic risk factors for major birth defects.

Not only was loratadine not associated with any increased risk, but use of any nonsedating or sedating antihistamine was not associated with an increased risk for hypospadias.

Centers for Disease Control and Prevention. Evaluation of an association between loratadine and hypospadias—United States, 1997-2001. MMWR Morb Mortal Weekly Rep. 2004;53(10):219-221.

Dental x-rays during pregnancy associated with low birthweight

Pregnant women who are exposed to more than 0.4 mGy of dental radiation are more than twice as likely (adjusted odds ratio 2.27) as pregnant women who are not exposed to deliver a low-birthweight (LBW) infant. They are more than three-and-a-half times as likely to have a term LBW infant, according to a population-based case–control study.

Researchers studied over 1,100 women enrolled in a dental insurance plan and living in Washington State. Approximately 10% of the study population had dental x-rays while pregnant.

The researchers acknowledge that eliminating all dental x-rays during pregnancy is probably impossible because pregnancy status is not always known, but they estimate that if the relationship is truly causal and if most dental radiography during pregnancy could be eliminated, the prevalence of term LBW infants could be reduced by about 5%.

Hujoel PP, Bollen AM, Noonan CJ, et al. Antepartum dental radiography and infant low birth weight. JAMA. 2004;291:1987-1993.

Treatment of early breast cancer varies widely within the US

Treatment of ductal carcinoma in situ (DCIS) varies greatly by region and even by practitioner in the US, according to an analysis of the National Cancer Institute's Surveillance, Epidemiology, and End Results (SEER) database.

The good news is that the number of women who received a mastectomy for DCIS decreased from 43% in 1992 to 28% in 1999. But researchers found that while many women received overly aggressive treatment, many others received treatment that wasn't aggressive enough. Overall, almost half (42%) of women undergoing mastectomy received axillary dissection, despite current treatment guidelines for DCIS recommending against it. In addition, almost half the women who received lumpectomy received no radiation therapy, despite treatment guidelines since at least 1993 recommending it.

Of the geographic areas examined, Atlanta had the highest rate of axillary dissection with mastectomy, followed by Iowa and Los Angeles. Hawaii had the highest rate of radiation therapy after breast-conserving therapy, followed by Iowa and Connecticut.

Baxter NN, Virnig BA, Durham SB, et al. Trends in the treatment of ductal carcinoma in situ of the breast. J Natl Cancer Inst. 2004;96:443-448.

IUD vs. hysterectomy for menorrhagia

The levonorgestrel-releasing intrauterine system (LNG-IUS) can provide a cost-effective alternative to hysterectomy for women with menorrhagia, according to a recent controlled trial reported in JAMA.

Finnish researchers randomized 236 women with a mean age of 43 years and menorrhagia to treatment with either the LNG-IUS or hysterectomy. After 5 years of follow-up, the two groups did not differ substantially in either health-related quality of life or psychosocial well-being. Satisfaction with treatment was similar in both groups. While 42% of the LNG-IUS group eventually received hysterectomy, after 5 years direct and indirect costs in the LNG-IUS group remained about 40% lower than for the hysterectomy group.

Hurskainen R, Teperi J, Rissanen P, et al. Clinical outcomes and costs with the levonorgestrel-releasing intrauterine system or hysterectomy for treatment of menorrhagia: randomized trial 5-year follow-up. JAMA. 2004;291:1456-1463.

When patients try to estimate their ovulation 'window'

Determining exactly when ovulation occurs remains difficult for women to do on their own. Of two widely available methods, one overestimates, while the other underestimates the actual window of fertility, according to a recently published study.

Researchers compared the beginning, peak, and length of the fertile period in a woman's menstrual cycle as determined by the Clearplan Easy Fertility Monitor (CPEFM) with the beginning, peak, and length of the fertile period as determined by self-monitoring of cervical mucus. The CPEFM measures urinary metabolites of estrogen and luteinizing hormone and provides the user with a daily indication of "low," "high," and "peak" fertility.

The beginning of the fertile window was, on average, day 11.8 with the monitor and day 9.9 with mucus monitoring. The average first day of peak fertility was day 16.5 with the monitor and day 16.3 with mucus monitoring. And the mean length of the fertile window was 7.7 days with the monitor and 10.9 days with self-monitoring.

The bottom line is that either method is appropriate for couples trying to conceive, but the investigators stopped short of recommending the test kit, which may underestimate the length of the fertile window, to help a couple avoid pregnancy.

Fehring RJ, Raviele K, Schneider M. A comparison of the fertile phase as determined by the Clearplan Easy Fertility Monitor and self-assessment of cervical mucus. Contraception. 2004;69:9-14.


2004 ACOG Annual Meeting

Patient Safety: What's wrong with this picture?

It's a given: There would be fewer liability suits if there were fewer medical errors. But too few hospitals and clinicians seem to be addressing one fundamental issue: patient safety. According to one top expert in this undervalued specialty, the systems we have in place to protect patients and administer care have serious flaws, which require major changes in design and in the work flow process.

Speaking at the 2004 annual clinical meeting (ACM), Lucian Leape, MD, of Harvard School of Public Health, pointed out that "medical errors are not caused by bad people but by bad systems," and by a culture that has yet to put patient safety ahead of the medical pecking order. He used a simple example to drive home the point. In a culture that truly valued patients' well-being, if a physician were to forget to wash his or her hands before examining a patient, an attending RN would not hesitate for a moment to remind him to wash. And if he refused, this subordinate would not hesitate to report him to management. And management would welcome the report. In essence, Dr. Leape insisted that we need to create a culture in which patient safety is an organizational priority, and one that's supported by expertise, training, and information technology.

To address the practical implications of that philosophy, Benjamin Sachs, MD, from Beth Israel Deaconess Medical Center in Boston presented the results of a multicenter study that included seven labor and delivery units and over 47,000 deliveries. To see if a team approach and a systems redesign could reduce the number of clinical errors, his group used the Crew Resource Management (CRM) program that has reduced fatal errors on commercial airlines and in the military over the last two decades. Before the system was put in place in the hospitals, there were 26 "indemnity experiences"—malpractice claims and related incidents—among 13,000 deliveries at Beth Israel Deaconess Medical Center. That number dropped to 13 after the training. CRM also led to a 53% drop in the adverse outcome index in Dr. Sachs' hospital (results for all the L&D units involved in the study are not yet available). Equally encouraging, the company providing liability insurance for the Harvard-affiliated L&Ds actually lowered its premiums by 10%.

Although Dr. Sach's team has yet to release the details on the training program, he did outline some basics: 4 hours of classroom instruction that emphasized teamwork, problem solving, and better communication skills; and lots of hands-on training to re-educate L&D staffers to buy into the new culture.

Linking fetal fibronectin to labor induction

Can measuring fetal fibronectin (fFN) help predict the success of labor induction? Two studies presented at ACM tried to answer that question. In an observational study that looked at 235 women undergoing preinduction cervical ripening, 55% finally delivered vaginally, but a positive fFN (>50 ng/mL) wasn't able to signal a successful labor induction. Despite this disappointing news, women with a positive fFN did require less oxytocin and had shorter induction times.

On a more positive note, a multi-center clinical trial sponsored by the makers of the fFN test, which enrolled 875 women, suggested that a positive test did in fact predict a successful labor induction. About 43% of women with a positive reading entered active labor, compared to 17.4% who had a positive fFN with a failed induction.

Deluca S, Benson J, Vakili B, et al. Fetal fibronectin and the prediction of vaginal delivery in nulliparous women undergoing labor induction. Obstet Gynecol. 2004;103(4 suppl): 69S.

Yeast JD, Hickok D, Williams C. A positive fetal fibronectin test is associated with a reduced risk of failed induction. Obstet Gynecol. 2004;103(4 suppl):70S.

Does uterine artery embolization increase pregnancy risks?

This retrospective case analysis suggests it may. Investigators from Jefferson Medical College looked at pregnancy outcomes following uterine artery embolization (UAE) and laparoscopic myomectomy in several published studies and found that preterm delivery was more than five times as common after UAE (Odds ratio 5.72, 95% CI 1.50–21.78). Similarly the odds ratio for postpartum hemorrhage after UAE was 10.19 (95% CI 0.88–117.57). The procedure also seemed to increase the threat of spontaneous abortion and malpresentation. But the very wide confidence intervals suggest that individual patients' risks vary widely.

Goldberg J, Pereira L, Berghella V, et al. Pregnancy outcomes following uterine artery embolization versus laparoscopic myomectomy. Obstet Gynecol. 2004;103(4 suppl):30S.

Can this electronic gauge help ward off liability hassles?

The Vacuum Birth Safeguard, a gauge that attaches to standard vacuum delivery devices, may help ob/gyns better defend themselves in a lawsuit, according to investigators from Nova Scotia. A pilot study presented at ACOG shows that the electronic device permanently and accurately records details of delivery on tracings from standard maternal/fetal monitors.

Investigators from Dalhousie University used the Vacuum Birth Safeguard (Medevco Inc., Dallas, Tex.) in conjunction with the Kiwi OmniCup vacuum device during 20 vacuum-assisted deliveries. Mean duration of cup application was 4.5 minutes, mean cup vacuum was 55 cm Hg, mean number of pulls was 2, and number of "pop-offs" was 7. In 14 deliveries the vacuum cup was positioned at flexing median; in the remaining deliveries, it was at flexing paramedian. The Vacuum Birth Safeguard, the study's authors say, recorded all of this information accurately and in real time on the uterine activity channel of a standard maternal/fetal monitor.

Baskett TF, Harrington B, Fannin CA, et al. Pilot study of a new electronic vacuum monitoring device for use during vacuum-assisted delivery. Obstet Gynecol. 2004;103 (4 suppl):74S.

Testosterone increases sexual desire

Testosterone increases sexual desire in oophorectomized women, according to two randomized, double-blind trials presented at ACM. One study compared methyltestosterone (MT) combined with esterified estrogens (EE) versus EE alone; the second study evaluated oral or transdermal estrogen in combination with transdermal testosterone (T) or placebo. In the study of MT and EE, conducted by researchers at Gynecology of South Florida, Aventura, Fla., one group consisted of surgically menopausal patients and the second was a mix of surgically and naturally menopausal women. MT was used at doses of 1.25 and 2.5 mg and EE at doses of 0.625 and 1.25 mg.

The surgically menopausal group had better scores in the Menopausal Sexual Interest Questionnaire when they received the higher doses than did the women in the "mixed" group (9.1 for EE + MT, 4.6 for EE; P=0.02 vs. 7.3 for EE + MT, 2.9 for EE; P<0.01). Statistically significant differences in sex hormone-binding globulin changes were noted between treatments (P<0.10 and 0.001).

The transdermal patch study, headed by a researcher from George Washington University, Washington, D.C., enrolled 562 women with a mean age of 49 who averaged 8.5 years since oophorectomy. All were diagnosed with hypoactive sexual desire disorder and were on stable doses of oral or transdermal estrogen; their mean relationship length was 19 years. These women received placebo or 300 µg/d of T in a patch twice weekly for 24 weeks.

The primary endpoint was change in total satisfying sexual activity from the Sexual Activity Log at 24 weeks. Seven domains of sexual function were assessed with the Profile of Female Sexual Function (PFSF). At 24 weeks, the T group had a 74% increase in frequency of total satisfying sexual activity and a 56% increase in sexual desire compared with baseline. The women on T experienced 2.13 satisfying sexual episodes per week for 4 weeks, compared with 0.98 for those on placebo. Statistically significant improvements also were seen in all other PFSF domains.

Goldsmith CL, Maly J, Swanson S, et al. Esterified estrogens and methyltestosterone: effects on sexual interest and hormone profiles. Obstet Gynecol. 2004;103(4 suppl):63S.

Simon JA, Nachtigal LE, Davis SR, et al. Transdermal testosterone patch improves sexual activity and desire in surgically menopausal women. Obstet Gynecol. 2004;103(4 suppl):64S.


NEWSLINE: Professional Update/Clinical Insights. Contemporary Ob/Gyn Jun. 1, 2004;49:12-23.

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