NEWS WATCH

CLINICAL INSIGHTS

HIGHLIGHTS FROM 2003 SMFM MEETING

Progesterone has significant effect on preterm births

Weekly injections of 17-

-hydroxyprogesterone (17-P) can cut the risk of preterm deliveries (<37 weeks' gestation) by about one third, according to a landmark study presented last month at the 23rd Annual Meeting of the Society for Maternal-Fetal Medicine.

In a large-scale, double-blind trial carried out at the 19 centers that make up the National Institute of Child Health and Human Development's Maternal-Fetal Medicine Units Network, investigators found that only 36.3% of women taking the hormone delivered prematurely, compared to 54.9% in the placebo group (RR 0.66, 95% CI 0.54–0.93, P=0.0001). The risk of delivering before 32 weeks was even smaller: Only 11.4% of patients on 17-P delivered in that time frame, versus 19.6% in the placebo group (RR 0.58, P=0.018).

Even more encouraging was the fact that the drug was just as effective in African Americans—who face a disproportionately high risk of prematurity when compared to white women.

Meis P for NICHD MFMU Network. 17-alpha hydroxyprogesterone caproate prevents recurrent preterm birth. (Abstract 1)

A new serum marker for preeclampsia?

Serum cystatin C, a diagnostic tool sometimes used to monitor glomerular filtration rate and renal status, may signal the presence of preeclampsia and hypertensive disease in pregnancy. At least that's the suggestion put forth in this SMFM presentation by Swedish and Danish researchers who looked at renal biopsy samples from 36 pregnant hypertensive patients and 12 normal women in their third trimester.

Serum cystatin levels increased as glomerular endotheliosis became more pronounced and also correlated closely with glomerular volume. While serum creatinine levels were typically altered in hypertensive patients as their kidneys began to fail, mean creatinine levels remained within the normal range for pregnant women in the study, suggesting that cystatin may be more sensitive than this more traditional renal marker. Also of note in the study, seven of 10 normal women showed glomerular endotheliosis, suggesting that this may not be pathognomonic for preeclampsia, as had been once thought.

Strevens H, Wide-Swensson D, et al. Serum cystatin C reflects glomerular endotheliosis in normal, hypertensive, and preeclamptic pregnancies. (Abstract 4)

A new serum marker for preeclampsia? Take 2

While cystatin C might possibly signal the presence of preeclampsia, another research team presented evidence to suggest that trophoblast cell viability may one day enable clinicians to predict the development of the disorder before the onset of symptoms.

When H8 trophoblast cells were cultivated and then incubated for 48 hours with serum from normotensive women, the cells were much more likely to die among women who eventually developed preeclampsia, when compared to women who did not (24% drop in cell viability vs. 3% in controls). In the researchers' words, "These findings... suggest that the assay may serve as the first step in a screening test for women at risk for developing preeclampsia."

Neale D, Demasio K, et al. Trophoblast viability predicts preeclampsia as early as the first trimester. (Abstract 56).

Factor V Leiden and pregnancy-related venous thromboembolism

Although a previous retrospective analysis had suggested that a woman with a factor V Leiden (FVL) mutation is more likely to develop venous thromboembolic disease (VTE), a new study that reviewed the charts of over 5,000 women doesn't support that contention.

Among 5,188 women with singleton pregnancies who were tested for FVL, 134 or 2.7% were found to be heterozygous carriers. Although there were four VTE events in the total population, none occurred in those carrying the gene.

Similarly, the investigators, led by Donna Dizon-Townson, MD, of the NICHD Maternal-Fetal Medicine Units Network, couldn't find any association between FVL and preeclampsia, abruption, or pregnancy loss.

Dizon-Townson D. The Factor V Leiden mutation does not increase risk of pregnancy-related thromboembolism. (Abstract 363).

Post-preeclamptic women may still be at risk for CVD

In other news from SMFM's San Francisco meeting, an international team tried to determine if preeclamptic women whose post-pregnancy blood pressure returned to normal were still at risk for cardiovascular disease. In a word, their answer was "Yes."

To arrive at that conclusion, they studied the cause of death among 37,470 Israeli women, including about 1,000 who had suffered preeclampsia earlier in life. Over a 24- to 36-year period, normotensive women who had once been preeclamptic were more than two and a half times more likely to die from cardiovascular disease than normotensives without preeclampsia. It's important to note that the increased mortality didn't surface during the first 20 years of follow-up, raising the question of whether these lives might have been spared with earlier recognition of the risks and with medical interventions, such as aggressive antihypertensive therapy.

Funai E, Friedlander, Y et al. Long-term mortality after preeclampsia. (Abstract 2).

(end of SMFM report)

Profiling genes: A better way to predict breast cancer survival?

A recently identified genetic profile can predict distant metastases and long-term survival in young women with stage I or II breast cancer with impressive accuracy. In time, this new approach may improve selection of patients for adjuvant systemic therapy, according to a recent study.

Using a 70-gene prognosis profile, researchers from the Netherlands classified 295 patients under the age of 53 with primary breast carcinomas as having a gene-expression signature associated with either a good or bad prognosis. Approximately half the women had lymph-node–negative disease, while the other half had lymph-node–positive disease.

The 10-year survival rate for the 180 women with a poor prognosis signature was 54.6% versus 94.5% for the 115 women with a good prognosis signature. Similarly, at 10 years, the women with a poor prognosis signature had a 50.6% chance of remaining free of distant metastases versus 85.2% in the group with a good prognosis signature.

The profile had the greatest predictive ability during the first 5 years after initial treatment. It worked equally well on the women with node-negative disease and the women with node-positive disease. And it worked consistently better than either the St. Gallen criteria or the National Institutes of Health consensus criteria.

van de Vijver MJ, He YD, van't Veer LJ, et al. A gene-expression signature as a predictor of survival in breast cancer. N Engl J Med. 2002;347:1999-2009.

Is abdominal myomectomy superior to uterine artery embolization?

Abdominal myomectomy—the standard of surgical care for women who wish to retain their uterus but who have symptomatic myomas unresponsive to medical treatment—results in fewer follow-up invasive treatments in the 3 to 5 years after the procedure than the more conservative uterine artery embolization. It also provides a similar level of patient satisfaction and symptom relief, according to a recent study.

Of the patients who received embolization, 29% required further invasive treatment for myomas versus 3% in the myomectomy group (P=0.004). Among the women not requiring further treatment, overall symptoms improved in 92% of the embolization group and in 90% of the myomectomy group (P=0.78). Ninety-four percent of the embolization group was at least somewhat satisfied with the procedure versus 79% of the myomectomy group (P=0.06).

Since the sample size of the study was small (81 patients) and symptom assessment was retrospective, the authors suggest the need for large, randomized trials to confirm their findings.

An accompanying editorial agrees on the limitations of the study, citing its use of nonrandomized controls among others. The editorialist says that short-term outcomes of embolization in terms of symptom relief and complications are quite good, but that there are currently insufficient data to allow for a proper comparison of the long-term outcomes of fibroid treatments. For women comfortable with this uncertainty and not planning future pregnancies, embolization is a viable treatment option, according to the author.

Broder MS, Goodwin S, Chen G, et al. Comparison of long-term outcomes of myomectomy and uterine artery embolization. Obstet Gynecol. 2002;100:864-868. Myers ER. Uterine artery embolization: what more do we need to know? Obstet Gynecol. 2002;100:847-848.

Nuchal translucency measurement: all we need to detect trisomy 21

Nuchal translucency measurement between 10 and 16 weeks' gestation accurately detects trisomy 21 more than 95% of the time, making additional markers unnecessary in most cases, according to a recent Spanish study.

Researchers measured the nuchal translucency of more than 11,000 fetuses and calculated an overall detection rate of 71.2% with a specificity of 95.4%, a positive predictive value of 14%, and a false-positive rate of 5%. The detection rate reached 100% when the measurement was performed between 10 and 14 weeks' gestation.

Noting that no other screening test detects as large a proportion of abnormalities with as low a false-positive rate, the authors of the study urge the inclusion of the measurement in routine antenatal care.

Comas C, Torrents M, Munoz A, et al. Measurement of nuchal translucency as a single strategy in trisomy 21 screening: should we use any other marker? Obstet Gynecol. 2002;100:648-654.

To treat or not to treat asymptomatic bacteriuria in women with diabetes

While giving antibiotics to diabetic women with asymptomatic bacteriuria clears the bacteriuria, it doesn't reduce the number of symptomatic episodes or hospitalizations, and it results in markedly increased use of antibiotics, according to a prospective, randomized trial.

Researchers found that the time to the first symptomatic episode, the number of urinary tract infections, the incidence of pyelonephritis, and the number of hospitalizations for UTI were similar in a group of women receiving placebo and a group receiving antibiotics for asymptomatic bacteriuria. The treated women spent almost five times the number of days on antibiotics for UTIs as did the women receiving placebo.

The data prompted investigators to conclude that the only women with diabetes who may benefit from ongoing screening and treatment for asymptomatic bacteriuria are those who are pregnant and those who have recently undergone renal transplant. For all others, antimicrobials should be reserved for symptomatic episodes.

Harding GK, Zhanel GG, Nicolle LE, et al. Antimicrobial treatment in diabetic women with asymptomatic bacteriuria. N Engl J Med. 2002;347:1576-1583.

Does fever during early pregnancy increase the risk of fetal death?

While hyperthermia in early pregnancy is teratogenic in some animals, a recent study finds no evidence that fever during the first 4 months of pregnancy increases the risk of fetal death.

Researchers in Denmark interviewed over 24,000 women about the frequency of fever during their first 16 weeks of pregnancy. Of the total, 18.5% experienced at least one episode of fever during that time; 4.8% of the total number of pregnancies resulted in miscarriage or stillbirth, but the researchers found no correlation between fever and pregnancy loss, regardless of how high women's temperature went, the duration or number of times they developed a fever, or gestational age at the time of the fever.

Andersen AM, Vastrup P, Wohifahrt J, et al. Fever in pregnancy and risk of fetal death: a cohort study. Lancet. 2002;360:1552-1556.

Epidurals do not cause long-term postpartum backaches

A randomized study of more than 300 women and approximately 2 years of follow-up reveals no difference in the incidence of long-term low back pain, disability, or movement restriction between women receiving epidural analgesia during labor and those receiving a nonepidural means of pain control.

Of note is that nearly one third of the women in both groups reported back pain in the week prior to being interviewed for the study, a prevalence far higher than that found in men. This finding seems to suggest that pregnancy in and of itself influences the onset and/or course of low-back pain.

Howell CJ, Dean T, Lucking L, et al. Randomised study of long term outcome after epidural versus non-epidural analgesia during labour. BMJ. 2002;325:357.

Many women prefer an extended OC schedule

Many women with unwanted hormone withdrawal symptoms seem to like an extended oral contraceptive schedule that either reduces or eliminates the hormone-free period, according to a recent retrospective review.

This large, long-term study of extended-use OCs, which looked at women complaining of such symptoms as headache, dysmenorrhea, hypermenorrhea, and premenstrual symptoms, found that more than half (59%) given the option to extend active pill days chose to continue the novel schedule. Follow-up ranged from 3 to 90 months with an average of 25 months. The typical extended regimen was 12 weeks and no unintended pregnancies were reported. Breakthrough bleeding/spotting was the reason most commonly reported by those who chose to return to a normal OC regimen.

Sulak PJ, Kuehl TJ, Ortiz M, et al. Acceptance of altering the standard 21-day/7-day oral contraceptive regimen to delay menses and reduce hormone withdrawal symptoms. Am J Obstet Gynecol. 2002;186:1142-1149.

Survey says ob/gyns need to brush-up on listeriosis

Prompted by a recent 50-case outbreak of listeriosis in the northeast, the US Department of Agriculture's Food Safety Inspection Service (USDA-FSIS) is developing new regulations for processing deli meats and poultry. Unfortunately, a recent survey of physicians in six medical specialties on food safety issues sponsored by the International Food Information Council has revealed that obstetricians and gynecologists know less about such foodborne illnesses than members of the other medical specialties.

Listeria has a death rate of 20 per 100 cases and favors pregnant women, frequently causing miscarriage or stillbirth; about one third of listeriosis cases occur in this subpopulation, making the risk of contracting the infection about 20 times greater for pregnant women than for other healthy adults.

In addition to ready-to-eat meats and poultry, sources of Listeria include soft cheeses, hot dogs, and un- or insufficiently pasteurized milk. Signs and symptoms include fever, muscle aches, nausea, and diarrhea. Pregnant women often experience mild flu-like symptoms. Treatment usually entails IV ampicillin, penicillin, or trimethoprim/sulfamethoxazole (TMP-SMX).

Volker R. Listeriosis outbreak prompts action—finally. JAMA. 2002;288:2675-2676.

PROFESSIONAL UPDATE

Are Planned Parenthood records confidential?

The answer to that question is still up in the air. The Iowa Supreme Court dismissed a lawsuit that sought to obtain pregnancy records from Planned Parenthood of Greater Iowa (PPGI) to assist in the investigation of a baby's death. The lawsuit would have examined whether the organization's patient records were protected by federal privacy laws.

The lawsuit was initially filed by the Buena Vista County attorney to stop a subpoena from being quashed, according to BNA's Health Law Reporter (11/14/02). The subpoena sought the medical records of women tested for pregnancy during a certain period. It was hoped that the records would help identify a baby who had been found dead.

In its defense, Planned Parenthood of Greater Iowa maintained that its files were medical records and subject to federal privacy laws. The county argued that "the records should not be subject to privacy laws because those administering PPGI's pregnancy tests were neither physicians nor nurses," reported BNA's Health Law Reporter.

The lawsuit was dismissed when the county decided it did not have the time nor money to pursue the litigation.

Planned Parenthood of Greater Iowa "saw the dismissal as both a victory and defeat." A spokeswoman for the organization said that although the dismissal protected its patients' privacy, there was no ruling on the case's merits.

"PPGI wanted the issue decided so that it would not have to face a medical records lawsuit again. The organization was confident that its patients' records would have been subject to privacy laws," she said.

Competency testing for Texas MDs?

When the Texas legislature opened its 2003 session, the Texas State Board of Medical Examiners pushed to have state lawmakers consider a bill, that would require physicians to undergo proficiency or competency testing every 10 years. If passed, Texas would become the first state in the nation to require such testing as early as 2005, reported American Medical News (11/25/02).

Support for the board's endorsement of competency testing of physicians has not been forthcoming from the Texas Medical Association, however. The TMA has reservations about implementing such testing, because "it's never been tried, and there is no scientific evidence to show that it provides what they're (the Texas medical board) hoping it will provide," TMA's Chair Ladon W. Homer, MD, told AMNews.

While no bill had been drafted at press time, the board was considering using some form of its Special Purpose Exam, also known as SPEX, which has been used to determine the qualifications of non-board-certified physicians from out-of-state who seek to practice medicine in Texas. Physicians, who would pay for their own testing, would be given three chances to pass the written test.

How states cope with liability insurance crisis

Tort reform aimed at easing the availability and affordability of medical liability insurance for physicians is still a high priority in 2003 as it was in 2002.

In 2002, four states approved legislation to help stabilize the liability insurance market for physicians—Mississippi, Nevada, Ohio, and Pennsylvania. Ohio was the fourth state in the nation to pass such legislation, after physicians there saw liability premiums increase an average of 40% during the past 2 years, according to American Medical News (1/13/03).

The Ohio measure places a $350,000 cap on noneconomic damages for each victim in most cases and a $500,000 cap on such damages for each victim in catastrophic injury cases. Among other things, the measure also places a statute of limitations on lawsuits filed against physicians: 4 years after an incident occurred.

The move toward tort reform continues in 2003. Earlier this year, medical office closures in Scranton, Pa., were averted, when Pennsylvania's governor promised to ask state lawmakers for tort reform measures that would immediately alleviate financial burdens to access insurance and offer long-term solutions to keep insurance affordable.

According to another AMNews report (1/20/03), the governor told physicians he would ask state lawmakers to exempt obstetricians, orthopedic surgeons, neurosurgeons, and general surgeons from paying premiums to the state injured-patient compensation fund. (All other physicians would receive a 50% discount on premiums.) In the long-term, the governor would seek legislation requiring that "an independent physician's certificate of merit be attached to medical malpractice lawsuits before they could be filed."

In West Virginia, too, the governor has promised to seek tort reform to address its state medical insurance crisis. Physicians there have been having trouble getting affordable insurance, or even any insurance at all. Moreover "some physicians have also been forced to pay hundreds of thousands of dollars in tail coverage."

In his State of the State address in January, the West Virginia governor's proposal to address malpractice reform included limiting liability for noneconomic loss and trauma care and limiting damage paid by a collateral source. He also recommended directing $20 million from the tobacco settlement medical trust fund to offset the costs of continuing medical liability protection for doctors who switch from private insurance to state coverage, and to provide assistance to physicians who choose to stay in the private sector.

Ten ways to avoid HIPAA liabilities

Under the Health Insurance Portability and Accountability Act of 1996, covered facilities are required to take steps to protect the privacy of patients—or else suffer serious consequences. According to the electronic newsletter MD Practice Alert (11/27/02), a rule of thumb to guard against HIPAA liabilities is to ensure that protected health information is secure where it is stored, and well protected when it is disclosed, transferred, or moved.

Health-care professionals should be aware of the ways that they can put a practice at risk of violating HIPAA rules. MD Practice Alert put together a list of 10 areas in which the protection of patients' health information can be compromised:

1. Making announcements for patients and their friends and family in public areas such as waiting rooms or over loud speakers.

2. Discussing protected health information among colleagues within earshot of others in elevators, cafeterias, or hallways.

3. Communicating protected health information to those not authorized to receive it, such as the press or in some cases, a patient's family members or friends.

4. Putting patient information on a wall, white boards, x-rays, or other similar illustrations.

5. Faxing protected health information from one location to another.

6. Using walkie-talkies or other speaker-intensive devices to communicate with other health-care professionals.

7. Leaving patient information on answering machines or communicating patient information by telephone.

8. Transferring patient information via e-mail.

9. Allowing off-site computer access to a facility's network.

10. Mishandling protected health information in paper form, including how paper files are created, photocopied, routed, or destroyed.

'Activated' patients cost the system less

In a randomized study of women with uncomplicated menorrhagia, researchers found that providing patients with detailed information and interviews to help them make truly informed decisions about their care ultimately reduced the cost of care, according to the Journal of the American Medical Association (12/4/02).

Participants in the study included 894 women cared for by physicians in southwest England between October 1996 and February 1998. The women were randomly assigned to one of three groups:

• a "control" group with no intervention;

• an "information only" group that received an information pack that included written, evidence-based information on menorrhagia, a video of interviews with women who had the same condition, and a "personal treatment plan" used to determine the participant's preferences; and,

• an "interview" group that received an information pack and, immediately before the woman's first consultation with a specialist, were interviewed by a research nurse to clarify the woman's preferences.

While the researchers did not find that any intervention had a major impact on the participant's health status, they did discover that women in the interview group were less likely to undergo hysterectomy than those in the control group and the information-only group.

In addition, the researchers found that the mean overall costs for treatment for each intervention group was lower than that of the control group. Indeed, the researchers found that the interview group had lower hysterectomy and inpatient and outpatient costs than either the information-only group or the control group.

Survey: Ob/gyns see double-digit liability insurance hikes

The average cost of malpractice insurance for obstetricians/gynecologists rose 19.6% from July 1, 2001 to July 1, 2002 vs. 9.2% the previous year, according to an annual survey of malpractice insurance rates. The survey conducted by Medical Liability Monitor found that, on average, the percentage of increase in the 12-month period for ob/gyns rose 113%.

The survey notes, however, that liability rates varied dramatically, depending on the state or area in which the ob/gyn is located. Still, looking at those areas that do not have a fund in place that picks up malpractice awards above a certain level, the survey found that the highest rates reported were for ob/gyns in Dade County, Fla., at $210,576. Cleveland-based ob/gyns had the second highest premiums at $152,496, and those in Clark Co., Nev., came in third with reported rates of $141,760.

Medical Liability Monitor cites a number of reasons for the rate hikes, including the rising cost of resolving malpractice claims and the downturn of the stock market, a resource, that in better days had provided insurers with extra dollars to offset rising claims costs during the 1990s when the market was more competitive.

The survey is based on reports from carriers in all 50 states and representing 65% to 70% of the market.

Keeping doctors in the profession

The health-care industry is facing a shortage of physicians, and the reasons can be attributed to "retirements (about 38% of the nation's 740,000 physicians are currently 50 or older), shrinking enrollments in medical schools, and skyrocketing medical malpractice costs," reports Managed Care (11/02).

Based on the responses of 5,200 hospitals, clinics, and physicians' practices nationwide, Martin/ Fletcher's "Annual Physician Compensation and Benefits Report (May 2002) found that increased compensation packages are being used to attract doctors in certain specialties. According to the survey, hospitalists saw a 15.5% increase in compensation from 2000 to 2001, while physicians specializing in psychiatry saw an 11% increase, followed by obstetricians/ gynecologists with a 9% increase.

The survey also found that all of the respondents offered to pay relocation costs—offering a low of $7,500 to full reimbursement. Signing bonuses were also offered by 90% of respondents; the average signing bonus was $17,500.

 

Clinical Insights/Professional Update. Contemporary Ob/Gyn 2003;3:15-26.