NEWSLINE: Clinical Insights/Professional Update





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Choose article section... A breath of fresh air for preeclampsia? Second opinions reduce C/S rate—slightly Laser surgery for TTTS New data on epidurals and labor progress Be ready to increase levothyroxine in women with hypothyroidism Multivitamins delay HIV progression in pregnancy PROFESSIONAL UPDATE Fear of lawsuits keeps physicians away from obstetrics Supreme Court decision puts physicians at high liability risk N.Y. Court of Appeals allows mothers to recover damages for lost fetuses N.J. law gives physicians some relief from liability premiums Insurance doesn't cover newer reproductive health options Feds outline plan for EMRs Physician coalition launches advocacy campaign for tort reform Conn. ob/gyns pressure state legislators with ob surcharges Court ruling allows physicians to know accusers, but...

Is mammography advice falling on deaf ears?

Only about 6% of women age 40 and older have had the American Cancer Society's recommended mammograms performed annually over a 10 year period, according to the largest study to date to examine use of the life-saving exam.

Researchers found that the vast majority of women in this age group received half the recommended number of mammograms in that time period—just five. This is despite the fact that women who are screened annually and are diagnosed with breast cancer die from the disease half as often as those who don't.

Poor women, those without health insurance, and those from non-white racial and ethnic groups are least likely to adhere to an annual schedule, while those between the ages of 55 and 65 years and those who have previously had breast cancer are more likely. But the study found that no group of women consistently used the technology as often as they should.

While the solution to this compliance problem is probably multi-faceted, the researchers point out that more than 100 studies have proven that postal and telephone reminders can improve the compliance rate.

Blanchard K, Colbert JA, Puri D, et al. Mammographic screening: patterns of use and estimated impact on breast carcinoma survival. Cancer. Online June 21, 2004.

A breath of fresh air for preeclampsia?

Breath markers may soon help to predict whether a woman will develop preeclampsia. It turns out that breath markers of oxidative stress are significantly higher in women with preeclampsia than in pregnant women without the condition or in nonpregnant women, according to a recent cross-sectional study.

Researchers have found that a predictive model employing five volatile organic compounds in alveolar breath, which were analyzed by gas chromatography/ mass spectroscopy, distinguished preeclampsia from uncomplicated pregnancy with a sensitivity of 92.3% and a specificity of 89.7%.

Previous studies have indicated that oxidative stress may play a role in the pathogenesis of preeclampsia. One proposed mechanism is that "cross-talk" between the diseased placenta and maternal dyslipidemia promotes free radical reactions.

Moretti M, Phillips M, Abouzeid A, et al. Increased breath markers of oxidative stress in normal pregnancy and in preeclampsia. Am J Obstet Gynecol. 2004;190:1184-1190.

Second opinions reduce C/S rate—slightly

A policy of requiring a second opinion before performing a cesarean section in 34 Latin American hospitals reduced the number of these procedures by about 22 per 1,000 deliveries without adversely affecting maternal or perinatal morbidity or reducing mothers' satisfaction with care, according to a randomized controlled trial. But the authors of the trial found that 96% of second opinions agreed with the attending physician's decision; and only 1.5% of the second opinions led to initial C/S rulings being reversed. Reduction in incidence occurred for the most part in C-sections involving intrapartum dystocia and/or fetal distress; in these situations, relative reductions of 20.2% and 21.6% occurred respectively. There was no change in elective C/S rates.

About 90% of the women in each group looked favorably upon their physicians consulting another professional about their case. Most women in both groups (87.9% in the second opinion group vs. 87% of the single opinion group) said they would return to the hospital to deliver another baby or would recommend the hospital to other women giving birth (91.2% vs. 93.2%, respectively).

And before the final results became available, more than half of the participating physicians (54%) judged the mandatory second opinion procedure to be "effective" or "very effective" at reducing the C/S rate. Eighty-seven percent thought the strategy would be feasible in public hospitals; 41% thought so with regard to private hospitals. Ninety-one percent said they'd recommend the strategy in public hospitals, and 65% said they'd do so for private hospitals.

Some experts question whether 22 fewer procedures per 1,000 deliveries justifies the use of mandatory second opinions, while others argue that any step in the direction of WHO's target rate of a 15% reduction in C-sections is worth trying.

Althabe F, Belizán JM, Villar J, et al. Mandatory second opinion to reduce rates of unnecessary caesarean sections in Latin America: A cluster randomised controlled trial. Lancet. 2004;363:1934-1940.

Laser surgery for TTTS

Fetoscopic laser coagulation of placental vascular anastomoses is significantly more effective than serial amnioreduction for severe twin-to-twin transfusion syndrome (TTTS) at midgestation, according to a study that ended early because of the clear benefit.

The randomized multicenter trial conducted in Europe involved 142 pregnant women. Compared with the amnioreduction group, the women receiving laser surgery had a significantly higher rate of survival of at least one twin to 28 days of age (76% vs 56%) and to 6 months of age (76% vs 51%).

In addition, the infants in the laser group were less than half as likely as infants in the amnioreduction group to develop cystic periventricular leukomalacia (6% vs 14%), were far less likely to have neurologic complications by 6 months of age (31% vs. 52%), had higher birthweights (1,757 g vs. 1,359 g), and were born 4 weeks later (median 33 weeks vs. 29 weeks).

While 11 women in the amnioreduction group requested and underwent pregnancy termination between 21 and 25 weeks' gestation (usually because of severe fetal complications), none in the laser group did so. The rate of pregnancy loss within 7 days of the procedure was higher in the laser group, but not significantly so.

The reason for the laser procedure's greater success seems to stem from its attempt to address the cause of TTTS, rather than amnioreduction's band-aid approach of preventing preterm delivery related to polyhydramnios and improving fetal hemodynamics by decreasing pressure on the placental surface.

The authors of an editorial in the same issue of New England Journal of Medicine concluded that perhaps the "simpler, safer, but less effective procedures, such as amnioreduction and septostomy, are preferred for cases with a good prognosis, and that technically challenging procedures, such as cord occlusion and laser therapy . . . should be reserved for cases with a poor prognosis."

Senat MV, Deprest J, Boulvain M, et al. Endoscopic laser surgery versus serial amnioreduction for severe twin-to-twin transfusion syndrome. N Engl J Med. 2004;351:136-144.

Fisk NM, Galea P. Twin–twin transfusion—As good as it gets? N Engl J Med. 2004;351:2.

New data on epidurals and labor progress

Epidural anesthesia using low concentrations of bupivacaine doesn't seem to increase the risk of Cesarean delivery, but may increase the likelihood of an instrumental vaginal delivery in nulliparous women, according to a recent meta-analysis.

The authors of the review, which included data from seven randomized, controlled trials, reported the risk of an instrumental vaginal delivery in women receiving epidural anesthesia to be about twice that of women not receiving an epidural. Women receiving the regional anesthesia also had longer second-stage labor, although their newborns seemed unharmed by it.

On a more positive note, epidurals seem to successfully do what they are supposed to do: provide adequate pain relief. Fewer of the women receiving epidurals changed to parenteral opioids than vice versa. And the neonates of women receiving epidurals were less likely to need naloxone than the neonates of women who received opioid analgesia.

Liu EHC, Sia ATH. Rates of caesarean section and instrumental vaginal delivery in nulliparous women after low concentration epidural infusions or opioid analgesia: Systematic review. BMJ. 2004;328:1410-1412.

Be ready to increase levothyroxine in women with hypothyroidism

Because levothyroxine requirements increase as early as the fifth week of gestation–which is often before a first obstetric visit—and because maternal hypothyroidism can lead to fetal cognitive deficits and even death, women with hypothyroidism may need to increase their dose of levothyroxine by about 30% as soon as pregnancy is confirmed.

The recommendation comes from a prospective study involving 19 women and 17 full-term births. The researchers found that a mean increase of 47% in levothyroxine dose was required in 17 of 20 pregnancies (85%) to maintain thyrotropin concentrations at prepregnancy values. The increase was required within the first half of the pregnancies, often by 8 weeks' gestation, and remained necessary until delivery.

The increase in thyrotropin occurred whether or not the women had a history of thyroid cancer. Women who became pregnant by means of assisted reproductive technologies had even greater increases in thyrotropin early in gestation than those who conceived spontaneously. They also had significantly higher concentrations of serum estradiol at 7 weeks' gestation. Increased estradiol is what many experts believe is at the core of why extra levothyroxine is required. Estradiol causes an increase in serum concentrations of thyroxine-binding globulin, which, in turn, decreases the thyroid hormone-binding ratio.

The necessary increase in levothyroxine translates into about two daily doses per week. The author of an editorial in the same issue of the Journal posits that increasing the dose by 25 to 50 µg daily and requesting thyroid-function testing within the following 4 to 6 weeks makes practical sense. The author also suggests that the findings of the latest study support the need to measure serum thyroxine, thyrotropin, or both, in all women of childbearing age to detect unrecognized thyroid failure before pregnancy occurs.

Alexander EK, Marqusee E, Lawrence J, et al. Timing and magnitude of increases in levothyroxine requirements during pregnancy in women with hypothyroidism. N Engl J Med. 2004;351:241-249.

Toft A. Increased levothyroxine requirements in pregnancy—Why, when, and how much? N Engl J Med. 2004;351:292-294.

Multivitamins delay HIV progression in pregnancy

Simple, over-the-counter multivitamin supplements containing vitamins B, C, and E taken daily can delay the progression of human immunodeficiency virus disease and delay the need to start antiretroviral therapy in infected women, according to researchers from Harvard University and Tanzania.

In a study that followed just over 1,000 women for approximately 6 years, researchers found that 24.7% of the women who took daily multivitamin supplements progressed to World Health Organization (WHO)-defined stage 4 disease or died, versus 31.1% of those who took placebo. In addition, the women who took the multivitamins had significantly improved CD4+ and CD8+ counts and significantly lower viral loads.

Adding vitamin A to the multivitamin regimen, however, actually reduced the benefits gained, and the benefits of vitamin A alone were even smaller and, for the most part, not significantly different from placebo.

While it's possible that the benefits of vitamin supplementation in Tanzanian women may not fully translate to an American population—whose diets are more nutrient dense—independent research has shown that higher doses of vitamins B, C, and E also slow down HIV progression in American patients.

Fawzi WW, Msamanga GI, Spiegelman D, et al. A randomized trial of multivitamin supplements and HIV disease progression and mortality. N Engl J Med. 2004;351:23-32.


Fear of lawsuits keeps physicians away from obstetrics

Concerns about medical malpractice claims and skyrocketing liability insurance costs are causing ob/gyns to change the way they practice, says a national survey of ACOG members.

According to the survey, the risk of liability claims has caused ACOG Fellows to decrease their participation in high-risk obstetric care by 22%, stop performing vaginal births after Cesarean births (14.8%), and stop practicing obstetrics altogether (14%). In addition, respondents cited the lack of affordable medical malpractice insurance as the reason they've cut back on providing high-risk obstetric care (25.2%), gynecologic surgical procedures (14.8%), and deliveries (12.2%).

The survey also found that ob/gyns faced more obstetric claims (61%) than gynecologic claims (38%). The most frequently cited obstetric claims involved neurologically impaired infants (34%), followed by stillbirths or neonatal death (15%). The most frequently cited gynecologic claims involved a delay or failure to diagnose (29%), followed by major and minor patient injury (25% and 15%, respectively).

On the brighter side, almost half of all claims against ob/gyns are dropped, dismissed, or settled without payment. Of the cases that do wind up in court, judgments are made in favor of the ob/gyn 8 out of 10 times.

Supreme Court decision puts physicians at high liability risk

A recent decision by the Supreme Court leaves physicians vulnerable to more malpractice lawsuits, say physician groups. In a unanimous decision, the high court limited patients' ability to sue managed care plans in state court.

The Supreme Court justices dismissed negligence lawsuits filed by 2 patients who claimed their HMOs wrongly denied them coverage for necessary medical care. The lawsuits were filed under a Texas law that allows patients to sue HMOs. The justices held, however, that such state laws are "completely pre-empted" by the federal Employee Retirement Income Security Act (ERISA).

"This decision puts a shield around managed-care companies, thereby leaving physicians as the only ones now subject to tort actions resulting from bad treatment decisions—decisions that the physicians didn't even make," Bohn Allen, president of the Texas Medical Association, told Modern Healthcare (6/28/04).

The decision has renewed calls to enact a federal patients' bill of rights. In 2001, two bills allowing patients to sue health insurers for malpractice were passed separately in the Senate and House of Representatives but were never reconciled.

N.Y. Court of Appeals allows mothers to recover damages for lost fetuses

A recent ruling by the N.Y. Court of Appeals leaves obstetricians in the state vulnerable to liability claims brought by expectant mothers who experience stillbirth or miscarriage. The decision reverses a nearly 20-year-old precedent that had protected obstetricians from being sued by an expectant mother for emotional distress unless she could demonstrate a separate and distinct injury from the lost fetus.

In reviewing 2 cases—one in which a placental abruption caused a fetus to die before delivery and another that claimed an obstetrician's failure to diagnose and treat a cervical condition resulted in the premature expulsion of a fetus—the high court acknowledged that it could no longer stand by its own 1985 decision. It found that medical professionals owed a duty to both the developing fetus and the expectant mother. Based on this reasoning, the high court held that even without an independent injury, "an expectant mother may seek damages for emotional distress based on medical malpractice resulting in miscarriage or stillbirth," reported Health Law Digest (6/04).

N.J. law gives physicians some relief from liability premiums

New Jersey lawmakers took action recently to provide medical malpractice reform for physicians in the state. On June 7, the state's governor signed the New Jersey Medical Care Access and Responsibility and Patients First Act into law.

The new law creates a $78 million temporary fund to help cover the cost of insurance premiums, among other things, reported State Health Notes (6/14/04), a publication of the National Conference of State Legislatures. To raise money for the fund (set to expire in 3 years), the law imposes an annual surcharge of $75 on physicians, podiatrists, chiropractors, dentists, optometrists, and lawyers, as well as $3 per employee from all employers covered under the state's Unemployment Compensation Law.

State legislators earmarked $17 million to help pay the insurance premiums of those health-care providers who experience rate increases above a specified amount. Funds were also reserved to subsidize hospital charity care, a student loan expense reimbursement program for ob/gyns who practice in underserved areas for at least 4 years, and a program for pregnant women who do not qualify for Medicaid and cannot afford health care.

While the law does not provide caps on damages in malpractice lawsuits, it does allow physicians to join "purchasing alliances" to better negotiate insurance premiums for members, and it prevents insurers from raising clinicians' insurance rates if a medical malpractice claim against them is dismissed.

Insurance doesn't cover newer reproductive health options

Compared to traditional methods of contraception such as birth control pills, newer reproductive health options—including patches, rings, and new sterilization methods—are poorly covered by insurance companies, according to a survey of 250 benefits managers in midsize and large companies nationwide.

The survey found that while 89% of companies provide coverage of reversible contraception through their insurance plans, the level of coverage depends on the type of contraception. More than 80% of insurers provide partial or full coverage of oral contraceptives. In contrast, newer products such as the patch (59% reported coverage), Nuva Ring or diaphragms (54%), contraceptive injections (51%), and emergency contraception (18%) had lower rates of coverage.

When it comes to permanent contraception options for women, 54% of respondents reported that tubal ligation was covered by their insurer. Just 36% could make the same claim for hysteroscopic sterilization.

In addition, the survey found that only 28% of insurers provided coverage for in vitro fertilization. A slightly lower rate of coverage was found for ovulation induction drugs and procedures, artificial insemination, and uterine arterial embolization (26% each). Less than a quarter of companies (22%) said their insurer covered myomectomies.

The survey was conducted by Greenberg Quinlan Rosner Research and was sponsored by the Association of Reproductive Health Professionals, the Black Women's Health Imperative, and the Planned Parenthood Federation of America.

Feds outline plan for EMRs

Responding to a call by President Bush to provide Americans with electronic medical records (EMRs) within a decade, the Department of Health and Human Services released a report outlining a broad strategy for accomplishing that goal.

The strategy has four aims: (1) to bring EMRs directly into clinical practice by providing incentives for health-care providers to change current practices and reducing the risk of investing in information technology; (2) to create an "interoperable infrastructure" that will allow health information to become portable, moving with the patient from one point of care to another; (3) to promote patients' involvement in their own care; and (4) to provide a better means of monitoring public health, measuring quality of care, and bringing medical research to the bedside.

Released in July, "The Decade of Health Information Technology" report notes that implementing modern information technology in health-care settings "has the potential to transform the delivery of health care for the better." The report says that using this technology would, among other things, reduce medical errors and save about $140 billion a year, or nearly 10% of total U.S. health spending.

The report acknowledges that incentives will be needed to promote the adoption of EMRs in health-care settings. Providing low-rate loans to clinicians and providers, offering Medicare reimbursement for specific EMR use, and creating exceptions to physician self-referral and anti-kickback statutes are some of the incentives under consideration.

Physician coalition launches advocacy campaign for tort reform

A coalition of more than 230,000 medical specialists launched an advocacy campaign recently to demonstrate how the lack of medical liability tort reform has limited patients' access to health care.

The Protect Patients Now campaign in Georgia is designed to raise awareness among the state's citizens about "the growing access-to-health care crisis" and to promote the passage of federal legislation that would place a cap on noneconomic damages in medical malpractice cases. The coalition notes that escalating jury awards and the high cost of defending lawsuits has led to skyrocketing insurance premiums, which, in turn, have forced many physicians to limit or abandon their practices.

The campaign includes a 30-minute television newsmagazine featuring physicians and patients discussing Georgia's "fragile" health-care system, as well as radio and print ads targeting the state's candidates for the U.S. Senate.

The coalition, called Doctors for Medical Liability Reform, includes physician's groups such as ACOG, the American College of Cardiology, and the American College of Emergency Physicians.

Conn. ob/gyns pressure state legislators with ob surcharges

A practice of 150 ob/gyns in Connecticut will begin charging an extra $500 per pregnancy this month to help cover its medical liability premiums. When Women's Health Connecticut announced its plans in May to implement the liability surcharge, it said it would forgo the fee if state legislators passed "meaningful medical malpractice reform," reported American Medical News (6/14/04).

The practice's surcharge is designed to force the hands of state legislators, who had passed a reform bill that did not include a cap on noneconomic damages in medical liability cases. That bill was vetoed by Connecticut's governor with the support of physicians, who want stronger tort reform to help curtail dramatic increases in insurance premiums.

Other states are watching how a liability fee will be received by patients, legislators, and insurers. The state's attorney general is also looking into the legality of the practice's action.

Court ruling allows physicians to know accusers, but...

An Illinois Appellate Court has provided guidance for defendant physicians who want to gain access to the name of a doctor who anonymously signs an affidavit vouching for the merit of a medical malpractice case. The court's opinion will not be published, however, a move that prevents attorneys from using the case in future lawsuits.

The appeals court ruled that a physician named in a malpractice lawsuit can obtain the name of the doctor who signs a certificate of merit if it can be shown that the affidavit was created in bad faith, according to American Medical News (6/7/04). The court further ruled that defendant physicians who sue to gain access to these names can use evidence from the initial case or new findings to prove their cases.

Illinois is one of 14 states that require a physician to sign a certificate of merit before a malpractice lawsuit can be filed. It is 1 of 5 states that does not require the disclosure of the name of the doctor signing the affidavit.

Because the court refused to publish the opinion, it cannot be used as legal precedent. The state legislature, though, is considering a package of tort reform bills—one of which would require that the name and address of the professional signing the certificate of merit be stated.


Clinical Insights/Professional Update. Contemporary Ob/Gyn Sep. 1, 2004;49:15-26.

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