NEWS WATCH

CLINICAL INSIGHTS

American Diabetes Association Annual Scientific Sessions

Using U/S to individualize gestational diabetes care

Using a flexible approach to gestational diabetes that relies on ultrasound to assess fetal sensitivity to insulin evidently improves pregnancy outcomes, according to Italian researchers presenting at this year's American Diabetes Association Annual Meeting in New Orleans.

To reach that conclusion, this multicenter study divided women with gestational diabetes into conventional and modified treatment groups. The target glycemic goals for the conventional group were fixed at 90 mg/dL for fasting plasma glucose and 120 mg/dL for postprandial readings. The fasting/postprandial targets for the modified group, however, were set at 80/100 if U/S revealed a fetal abdominal circumference at or above the 75th percentile, but only 100/140 if U/S fell below the 75th percentile. Abdominal circumference was measured every 2 weeks and diet and insulin therapy were adjusted based on changes in mean fasting and postprandial glycemia. In the final analysis, women whose insulin was modified based on U/S evidence of fetal hyperinsulinemia had fewer large-for-gestational age infants (7.9% vs. 17.9% in the conventional group, P<0.05) and fewer cases of macrosomia (3.3% vs. 11.5%, P<0.05), defined as a birthweight of 4,000 g or more.

Bonomo M, Cetin I, Pisoni MP, et al. A flexible approach to the treatment of gestational diabetes on indirect signs of fetal insulinization. Diabetes. 2003;52(suppl 1):A32.

When does gestational diabetes pave the way for type 2 disease?

To answer that question, Canadian investigators looked at several possible predictors and found that women who gain weight after pregnancy and those with a high body mass index (BMI) before pregnancy were more likely to develop type 2 diabetes over a 7- to 11-year follow-up. The researchers also found a 2-hour glucose tolerance test (GTT) was a more accurate way to detect type 2 diabetes than fasting glucose: Only 27% were identified with new onset disease using fasting glucose readings alone—but 60% were with a 2-hour GTT. The investigators conclude that women who have had gestational diabetes and either a high prepregnancy BMI or postpartum weight gain "should receive regular testing of their glucose metabolism with 2-hr GTT."

Malcolm JC, Lawson ML, Gaboury I, et al. Predictors of the development of type 2 diabetes mellitus in women following a gestational diabetic pregnancy. Diabetes. 2003;52(suppl 1):A568.

Does coffee prevent type 2 diabetes?

A large-scale epidemiologic survey suggests it may. Between 1986 and 1998, Harvard investigators followed over 85,000 American women, charting their coffee consumption every 2 to 4 years with questionnaires. Over time, they found that drinking four or more cups of coffee a day was associated with about a 30% drop in the risk of diabetes. The link remained strong even after other risk factors were accounted for, including age, body mass index, and smoking.¹

Their findings are consistent with a recent Lancet report that looked at over 17,000 Dutch men and women. After factoring out a variety of confounding variables, the study concluded that adults between the ages of 30 and 60 who drank at least seven cups of coffee a day were half as likely to develop type 2 diabetes disease, when compared to those who drank two cups or less.²

Both studies, which looked at the chronic effects of the beverage, contradict research on the acute effects of caffeine, which has found that it can reduce insulin sensitivity and, perhaps, impair metabolic management in patients who already have type 2 diabetes.³

1. Salazar-Martinez E, Willet W, Ascherio A, et al. Coffee consumption and risk of type 2 diabetes in men and women. Diabetes. 2003;52(suppl 1):A72.

2. van Dam RM, Feskens EJ. Coffee consumption and risk of type 2 diabetes. Lancet. 2002;360:1477-1478.

3. Robinson L, Savani S, Battram D, et al. Caffeine ingestion prior to an oral glucose tolerance test impairs blood glucose management in adults with type 2 diabetes. Diabetes. 2003;52(suppl 1):A72.

New WHI report confirms that HT increases CHD risk, but...

The final results from the Women's Health Initiative study of estrogen/progestin and risk of coronary heart disease (CHD) are in: During their first year on the therapy, women face an 81% greater risk of CHD, when compared to women on placebo (RR=1.81).¹ The previous WHI report had found that after 5.2 years on HT, the risk of heart disease was 29% greater, prompting some experts to theorize that subgroup analysis might reveal that taking the hormones for a shorter period of time might be less harmful.²

While the latest results indicate a greater risk of disease during the first year of hormone usage, this relative risk has to be put into perspective, keeping in mind the absolute risk of heart disease among healthy menopausal women in their early 50s—those who are mostly likely to seek symptomatic relief from estrogen/progestin. In the latest NEJM report, myocardial infarctions (MIs) occurred in 0.29% of women who were not taking HT during the first year of the study. The increased relative risk brought on by HT (1.81) meant that the absolute risk of an MI only increased to 0.5%. No doubt many women suffering from severe vasomotor symptoms will accept a less than 1% risk of heart disease.

Also of note is the study's finding that the cardiovascular risks of HT were not affected by age, time since menopause, body mass index, presence or absence of vasomotor symptoms at baseline, or the presence of coronary risk factors. The authors cautioned, too, that the increased risk of CHD associated with hormone therapy in women who had higher base-line LDL cholesterol levels may have simply been a result of chance.

1. Manson JE, Hsia J, Johnson KC, et al. Estrogen plus progestin and the risk of coronary heart disease. N Engl J Med. 2003;349:523-534.

2. Writing Group for the Women's Health Initiative Investigators. Risks and benefits of estrogen plus progestin in healthy postmenopausal women: principal results from the Women's Health Initiative randomized controlled trial. JAMA. 2002;288:321-333.

Should pregnant women avoid eating ocean fish?

Probably not, indicates an observational study of 779 mother-infant pairs residing in the Republic of Seychelles. While some previous studies found an association between adverse neuropsychological outcomes in school children and prenatal exposure to methylmercury (MeHg), this study found no neurodevelopmental risk associated with prenatal MeHg exposure resulting solely from ocean fish consumption.

Mothers in the study reported eating an average of 12 ocean-fish meals per week during pregnancy. The fish contained approximately the same concentration of MeHg as commercial fish available in the United States and elsewhere. Mean prenatal MeHg exposure was 6.9 parts per million (SD 4.5).

After assessing neurocognitive, language, memory, motor, perceptual-motor, and behavioral functions in the children at age 9, the authors of the study found only two of 21 tested endpoints associated with increased MeHg exposure: (1) Males were not as adept using a grooved pegboard with their nondominant hand, and (2) As exposure increased, scores on the hyperactivity index of the Conner's teacher rating scale improved; every 10 µg/g increase in MeHg exposure resulted in a drop of 1 to 6 points on the hyperactivity index suggesting that mercury actually improved cognitive function. The authors concluded that both of these findings were probably due to chance.

The authors proposed that one of the reasons for the difference in findings between their study and previous studies may be differences in MeHg concentration in the fish consumed; previous studies examined populations consuming primarily whale and shark, which can have five to seven times the MeHg of the fish consumed by the women in this study, which was more varied and more closely mirrors fish consumption in other parts of the world. Other possible reasons for the different findings include the use of different biomarkers (hair in this study vs. cord blood in another) or tests used and differences in the age at which testing was performed.

Myers GJ, Davidson PW, Cox C, et al. Prenatal methylmercury exposure from ocean fish consumption in the Seychelles child development study. Lancet. 2003; 361:1686-1692.

CORRECTION

The article "Do liquid-based Pap smears need a transformation zone component?" which appeared in the July issue, contained an author's error. On page 79, the article should have stated that "TZ-lacking smears were less likely to show cytologic abnormality than TZ-containing smears."

More choices, more time for emergency contraception

Norethindrone–ethinyl estradiol oral contraceptives (OCs) work just as well as levonorgestrel–ethinyl estradiol formulations (the Yuzpe method) as emergency contraception, and women may have up to 5 days after unprotected sex to start such therapy, instead of the traditional 72 hours, according to the findings of two separate but related randomized controlled trials appearing in a recent issue of Obstetrics and Gynecology.

In the first multicenter study, about 2,000 women presenting within 72 hours of unprotected intercourse and, refusing copper IUD insertion, were randomized to receive either the standard two-dose Yuzpe method of emergency contraception; the same two doses of more widely available norethindrone-containing pills; or only the first dose of the Yuzpe method followed 12 hours later by placebo.

Although the group given the standard Yuzpe regimen had a slightly lower failure rate (2.0% vs. 2.7% in the norethindrone group and 2.9% in the single-dose group), both types of pills were safe and effective, and those given the inactive second dose experienced less nausea and half the vomiting of the other women.

Efficacy in all the groups was not improved by taking the pills with food or by starting therapy earlier, as opposed to later, within the 72-hour period. The results point toward the notion that perhaps any OC used postcoitally would, in fact, be effective

The second study found the 72-hour cutoff for starting the Yuzpe method of emergency contraception after unprotected intercourse "unnecessarily restrictive."

Researchers compared a group of women starting the standard Yuzpe two-dose regimen of OCs within 72 hours of unprotected sex with a group of women starting the regimen on day 4 or 5. The results showed that with perfect use, pregnancy rates were almost identical (2.0% for therapy started at 72 hours or less vs. 1.9% for therapy started on day 4 or 5). With typical use, pregnancy rates were 2.5% for therapy started within 3 days and 3.6% for therapy taken on days 4 or 5.

Ellertson C, Webb A, Blanchard K, et al. Modifying the Yuzpe regimen of emergency contraception: a multicenter, randomized controlled trial. Obstet Gynecol. 2003;101:1160-1167.

Ellertson C, Evans M, Ferden S, et al. Extending the time limit for starting the Yuzpe regimen of emergency contraception to 120 hours. Obstet Gynecol. 2003;101:1168-1171.

PROFESSIONAL UPDATE

Cracking down on 'expert witnesses'

More and more medical societies have created "tribunals" to review the testimony of physicians who testify as experts in medical malpractice cases, according to The New York Times (7/6/03). The move is meant to ensure that the societies' members avoid giving testimony that is biased or irresponsible.

"The giving of expert testimony should be considered the practice of medicine, and it should be the subject of peer review. If someone comes into court and gives junk science, we don't want fraudulent testimony in court," says Dr. Donald J. Palmisano, president-elect of the American Medical Association.

Groups that have implemented peer review grievance procedures include the American Association of Neurological Surgeons and the American College of Obstetricians and Gynecologists. As part of ACOG's grievance procedures, members are asked to sign a statement affirming that any testimony they give will be complete and accurate, and to submit their testimony to peer review.

But, Dr. Albert L Strunk, vice president for fellowship activities at ACOG, says he isn't sure that peer review will prevent poor quality testimony. "When a medical society disciplines one of its members for this sort of thing, it just plays into the hands of personal injury lawyers," because lawyers then charge that the medical profession is "closing ranks" to prevent doctors from speaking out to help an injured patient.

The implementation of grievance procedures has also raised concerns among plaintiff's attorneys, who believe that peer review intimidates and discourages physicians from acting as expert witnesses.

Are insurers' adequately providing for women's health needs?

For many women, access to health services is often determined by the benefits provided by their employers. So, what kind of women's health benefits are employers currently offering? According to a survey of human resource professionals conducted by The Society for Human Resource Management, there's some good news and some bad news.

First the good news:

• 76% of respondents said their employers offered contraceptive coverage to employees in 2003—up from 70% in 2002.

• 41% of respondents said their employers offered infertility treatment coverage this year—up one percentage point from last year.

Now the bad news:

• 42% of respondents said their employer offered well-baby programs this year—the lowest percentage since 1999.

• 27% of respondents said their employer offered prenatal programs in 2003—the lowest percentage since 1999 and a drop of 17 percentage points from 2002. Last year marked the highest percentage of employers (44%) offering this benefit.

How are docs now depicted in the press?

Are physicians getting a fair shake when it comes to media coverage? That was the question posed by a recent Medical Economics (7/11/03) poll. The small poll suggested that doctors' perception of media coverage of their profession was more negative than was warranted by actual doctor-related news stories reported by nine leading daily newspapers and the three major TV networks' news programs over a 10-week period.

The physician poll found that 64% of the respondents think the media are biased against physicians, and 32% say that coverage of doctors is more negative than positive. In addition, almost half of the respondents believe that physicians are depicted poorly in news coverage of managed care issues, while just 17% think such coverage is positive and 35% think it is neutral.

In contrast, the Medical Economics analysis found that the majority of the 183 news stories that were published or broadcast between Dec. 18, 2002, and Feb. 27, 2003, were neutral in the way they portrayed physicians. During that time, the average newspaper or news show had 2.8 positive pieces, 4.1 negatives pieces, and 8.3 neutral ones. But when a point system was used to weigh these ratings, taking into account circulation and viewership of each newspaper and news show, the analysis found that neutral stories prevailed, while positive stories outscored negative ones. In the print media, negative articles outscored the positive ones but on television, positive pieces on physicians appeared more often than negative ones.

The nine newspapers included in the analysis were The Atlanta Journal-Constitution, The Boston Globe, Chicago Tribune, The Dallas Morning News, Los Angeles Times, The New York Times, St. Louis Post-Dispatch, USA Today, and The Washington Post. The television news broadcasts were ABC World News, CBS Evening News, and NBC Nightly News.

ACOG in NY to take brain-damaged infants out of tort reform

The New York legislature may soon consider a tort reform bill that could help reduce the mal-practice premiums for the state's obstetrician/gynecologists, according to Crain's New York Business (7/11/03). To be drafted by the fall by the American College of Obstetricians and Gynecologists in New York, the bill calls for the creation of a taxpayer-funded pool from which payouts could be made to children born with brain damage through no fault of the doctor. The pool would pay out almost $1 million for the child's lifetime needs.

ACOG-NY hopes that the implementation of a fund will reduce malpractice premiums by a double-digit percentage, since the payouts would stymie the big malpractice awards that often result from cases of infant brain damage. Currently, annual premiums for metro area ob/gyns range from $100,904 to $115,431, according to Crain's.

Apologizing just may reduce your risk of liability

When medical errors occur, studies have shown that the response to the error—rather than the error itself—determines whether patients or their families will sue. From a risk management standpoint, disclosing the error or adverse event, explaining how the consequences can be mitigated and what's being done to prevent recurrences, as well as a simple apology from caregivers can help improve patient relations and potentially prevent errors from occurring in the first place.

To that end, some states are providing legislative protection to physicians who say, "I'm sorry." According to amednews.com (7/28/03), two states—Colorado and Oregon—recently passed laws allowing physicians to express sympathy and condolences to patients without the fear that those words will come back to haunt them in court. Three other states—California, Massachusetts, and Texas—already have similar laws.

Individual facilities are also taking steps to be open with patients when an adverse event occurs. A Denver-based medical liability insurance carrier run by physicians has implemented a 3Rs program. The three Rs stand for recognize, respond, and resolve.

Under the program, physicians, with the help of specialists, recognize that an adverse event has occurred and discuss with patients and their families why it happened and what is being done to prevent a recurrence. After the disclosure, and depending on the adverse event, the program provides up to $30,000 to patients for expenses not covered by insurance.

In the program's first 14 months, amednews.com reported, only one lawsuit has been filed out of 148 disclosures to patients.

Elective C-sections on the rise

Cesarean section deliveries for which there may be no medical indication rose 20% in the United States, according to a report released recently by HealthGrades Inc. Based on data from 1,920 hospitals in 18 states, the healthcare quality company reported that the percentage of so-called patient-choice C/S rose from 1.56% in 1999 to 1.87% in 2001.

"There is a clear trend of women choosing C/S over vaginal births at an increasing rate, an issue that divides obstetricians," Dr. Samantha Collier, HealthGrades' vice president of medical affairs, said in a press release.

Opponents of patient-choice C/S believe that offering the option to patients could be construed as malpractice since the operation is medically unnecessary. Proponents contend that the surgery is safe and informed patients should have the right to choose it.

Appeals court gives medical groups OK to offer contract advice

In June, a three-judge panel of the Ninth U.S. Circuit Court of Appeals upheld a lower court ruling that medical societies are not violating antitrust laws when they advise their members about nonmonetary provisions in managed care contracts. The ruling applies to physicians in Alaska, Arizona, California, Hawaii, Idaho, Montana, Nevada, Oregon, and Washington.

The case was filed by two insurers—International Healthcare Management and Health Hawaii Network—against the Hawaii Medical Association, the Hawaii Coalition for Health, Queens Physician Group, and several physicians, according to American Medical News (6/30/03). The insurers claimed that the groups broke federal and state antitrust laws that make it illegal for physicians to collectively bargain with insurance companies.

The insurers claimed, for example, that the health coalition alerted its members to what it identified as flaws in the participating provider agreement. The flaws identified involved credential procedures, a 1-day notice for record inspections, and the like—not monetary provisions. The insurers charged that antitrust laws were violated when the health coalition specifically targeted its agreement, rather than informing members generally about what makes a good contract.

The panel of three judges disagreed. The judges wrote in their opinion, "In sum, the record shows no price-fixing agreement and none to boycott or threaten to boycott. No one was bound by what the organizations did, and their negotiations and communications had essentially no impact. In these circumstances, we conclude that no reasonable restraint of trade exists."

 

Clinical Insights/Professional Update. Contemporary Ob/Gyn Sep. 1, 2003;48:16-29.