NEWSLINE

CLINICAL INSIGHTS

Drawing more attention to bleeding disorders in women

Clinicians need to be more aware of the presenceof specific bleeding disorders and develop strategies for correctly diagnosing the 2.5 million American women with abnormal bleeding who are at risk for unnecessary hysterectomies.

That's the message being spread by leading hematologists and ob/gyns who recently met in Seattle for the first-ever conference on women's bleeding disorders. Sponsored by the National Hemophilia Foundation, the Centers for Disease Control and Prevention, and ZLB-Behring, the purpose of the conference was to counter the lack of information and awareness about women's bleeding disorders. The conference, titled "Project Red Flag: Real Talk About Women's Bleeding Disorders," is part of an ongoing effort to identify where the greatest gaps in knowledge exist. A recent survey found, for example, that despite the fact that about one third of women report having "heavy" periods—the number one symptom of von Willebrand disease—most women (91%) have never heard of VWD.

National Hemophilia Foundation. Real talk about women's bleeding disorders: Getting women and their doctors to listen. www.hemophilia.org/News/prfnews/prf_05_13-04.htm .

Stopping oxytocin mid-labor shortens the process and reduces C-sections

Despite its widespread use throughout the labor process, no advantage exists to continuing oxytocin infusion after the onset of active labor, according to a small trial of 104 women in Israel. Researchers found that stopping oxytocin at 5 cm dilation, instead of continuing it until delivery, shortened labor, though not significantly so, and halved the number of cesarean sections required.

The researchers admit that the study was underpowered and that the findings could be the result of chance, but their results also support the hypothesis that continuing oxytocin once the active phase of labor has begun actually complicates labor by desensitizing uterine receptors to exogenous and endogenous oxytocin.

Daniel-Spiegel E, Weiner Z, Ben-Shlomo I, et al. For how long should oxytocin be continued during induction of labour? BJOG. 2004;111:331-334.

Abortion and the risk of breast cancer

While giving birth reduces a woman's long-term risk of breast cancer, having a spontaneous or induced abortion does not increase a woman's risk of developing the disease, according to a reanalysis of data from 53 epidemiologic studies.

The studies included data on 83,000 women with breast cancer from 16 countries. Compared to women who have had no spontaneous or induced abortions, the researchers calculated that the overall relative risk of breast cancer for women who have had one or more spontaneous abortions was 0.98 (95% CI; 0.92–1.04); for women who have had one or more induced abortions, it was 0.93 (0.89–0.96, P=0.0002).

Beral V, Bull D, Doll R, et al.; Collaborative Group on Hormonal Factors in Breast Cancer. Breast cancer and abortion: collaborative reanalysis of data from 53 epidemiologic studies, including 83,000 women with breast cancer from 16 countries. Lancet. 2004;363:1007-1016.

Linking homocysteine and fractures

Elevated homocysteine levels can be added to the list of risk factors for osteoporotic fractures in older men and women, according to two major studies.

The first study from the Netherlands involving 2,406 people aged 55 or older found that people with homocysteine levels in the highest age-specific quartile were at almost twice the risk of nonvertebral osteoporotic fractures as people in the other quartiles. Every increase of 1 SD in natural-log–transformed homocysteine level increased the relative risk of fracture by 1.4 (95% CI; 1.2–1.6) in both men and women. The authors found no association between homocysteine levels and bone mineral density (BMD) at the femoral neck or lumbar spine.

The second study involving 2,000 men and women between the ages of 59 and 91 found that a plasma homocysteine level in the highest quartile put women at two times and men at almost four times the risk of hip fracture as gender-matched participants in the lowest quartile.

The findings indicate that the effect of a high homocysteine level on fracture risk is similar in magnitude to risk factors such as low BMD, cognitive impairment, and recent falls.

To support their findings, both research teams point out that the rare autosomal-recessive condition homocystinuria involving high homocysteine levels is associated with osteoporosis. But an editorial in the same issue of the New England Journal of Medicine asserts that it is difficult to know whether high homocysteine levels actually cause osteoporotic fractures or whether high homocysteine is simply a reflection of other risk factors for osteoporosis, like poor nutrition or estrogen deficiency. The only way to know for sure would be to conduct a randomized, placebo-controlled clinical trial to determine whether reducing homocysteine levels with nutritional supplements decreases the incidence of fracture in patients with osteoporosis.

van Meurs JB, Dhonukshe-Rutten RA, Pluijm SM, et al. Homocysteine levels and the risk of osteoporotic fracture. N Engl J Med. 2004;350:2033-2041.

McLean RR, Jacques PF, Selhub J, et al. Homocysteine as a predictive factor for hip fracture in older persons. N Engl J Med. 2004;350:2042-2049.

Raisz LG. Homocysteine and osteoporotic fractures—culprit or bystander? N Engl J Med. 2004;350:2089-2090.

Glucosamine really works on knee OA

Glucosamine sulfate not only improves the symptoms of osteoarthritis of the knee in postmenopausal women, but actually alters the course of disease, according to two 3-year studies. The studies are the first to demonstrate that a pharmacologic intervention has both a disease-modifying and symptom-modifying effect specifically in postmenopausal, osteoarthritic women.

Researchers included 319 postmenopausal women in the two studies. After 3 years, they found that the women given glucosamine sulfate showed no joint space narrowing, while the women given placebo demonstrated a narrowing of 20.33 mm. Using the WOMAC index, women given glucosamine demonstrated improvement (214.1%), while women given placebo demonstrated a trend for worsening (5.4%).

Bruyere O, Pavelka K, Rovati LC, et al. Glucosamine sulfate reduces osteoarthritis progression in postmenopausal women with knee osteoarthritis: evidence from two 3-year studies. Menopause. 2004;11:138-143.

Don't worry; get pregnant

Women who worry excessively about getting pregnant through assisted reproductive technologies (i.e., IVF and GIFT) tend to produce fewer eggs and have a significantly lower chance of becoming pregnant than women who worry less, according to a prospective study from the University of California San Diego.

The researchers found that women who worried more about the medical aspects of the procedures had 20% fewer eggs retrieved and 19% fewer eggs fertilized than women who were less concerned about such factors as side effects, pain, recovery, surgery, and anesthesia. Women who were highly concerned about missing work had 30% fewer eggs fertilized than women who were less so. And those who were very concerned about the cost of the procedures were 11 times less likely than women who were less so to achieve a live birth delivery.

Klonoff-Cohen H, Natarajan L. The concerns during assisted reproductive technologies (CART) scale and pregnancy outcomes. Fertil Steril. 2004;81:982-988.

Management options for urinary incontinence in women

Several effective nonpharmacologic, pharmacologic, and surgical options exist for the management of urinary incontinence in women, according to a recent literature review. Because urinary incontinence impacts quality of life greatly and can affect up to one half of all women at some point in their lives, such options should be explored.

Effective nonpharmacologic options include pelvic floor muscle training, electrical stimulation, bladder training, and prompted voiding. Studies show that anticholinergic drugs are effective in the treatment of urge incontinence. Surgical interventions, including open retropubic colposuspension and the suburethral sling procedure, have had success in the management of stress incontinence.

Holroyd-Leduc JM, Straus SE. Management of urinary incontinence in women: scientific review. JAMA. 2004;291:986-995.

Do lawn care products endanger the unborn?

A recent study indicates that exposure to commonly used agricultural and lawn care products, such as weed and insect killers and fertilizers, at concentrations previously thought to be without adverse health effects, caused injury to developing mouse embryos. The injuries observed included slowed embryonic development and a reduction in the number of cells comprising the embryo. In humans, such injuries could contribute to implantation failure, spontaneous abortion, and delays in achieving pregnancy.

The active ingredients tested included six herbicides (atrazine, dicamba, metolachlor, 2,4-D, pendimethalin, MCPP); three insecticides (chlorpyrifos, terbufos, permethrin); two fungicides (chlorothalonil, mancozeb); one drying agent (diquat); and one fertilizer (ammonium nitrate).

According to the study's lead investigator, in the absence of human data on the subject, "Women considering or trying to become pregnant should make every effort to minimize exposure to lawn and agrochemical products."

Greenlee AR, Ellis TM, Berg RL. Low-dose agrochemicals and lawn-care pesticides induce developmental toxicity in murine preimplanted embryos. Environ Health Perspect. 2004;112:703-709.

Preeclampsia: a risk factor for cancer?

Having had preeclampsia may increase one's overall risk of cancer and increase the threat of specific malignancies, including stomach, breast, ovary, lung, and larynx cancer, according to follow-up data of the Jerusalem perinatal study cohort. But whether the relationship is causal or a reflection of the fact that environmental and genetic factors are common to the development of both conditions in Middle Eastern populations is unknown.

The study included data on just over 37,000 women. Preeclampsia was recorded in 1,070 women. Cancer developed in 91 of the women who had preeclampsia and in 2,204 of those who did not.

The age-adjusted hazard ratiofor cancer at any site after preeclampsia was 1.27, for stomach cancer was 3.1, for breast cancer was 1.38, for ovarian cancer was 2.32, and for cancer of the lung/larynx was 2.81.

Paltiel O, Friedlander Y, Tiram E, et al. Cancer after pre-eclampsia: follow up of the Jerusalem perinatal study cohort. BMJ. 2004;328:919-921.

Day vs. traditional ward care for antenatal complications

While women report greater satisfaction with day care rather than ward care for antenatal complications, day care provides no cost advantage, according to a recent randomized trial.

Researchers included 395 women with diagnoses of either non-proteinuric hypertension, proteinuric hypertension, or preterm premature rupture of membranes and provided either day care or standard care on an antenatal hospital ward.

While the total duration of antenatal care episodes and overall stay were shorter in the day care group, the researchers found no differences between the two groups in terms of antenatal tests, investigations, or intrapartum interventions performed, in maternal or perinatal outcomes, or in either average cost per patient or average cost per day of care. The researchers concluded that perhaps the choice should be left to the individual patient.

Turnbull DA, Wilkinson C, Gerard K, et al. Clinical, psychosocial, and economic effects of antenatal day care for three medical complications of pregnancy: a randomized controlled trial of 395 women. Lancet. 2004;363:1104-1109.

Atosiban or hexoprenaline for acute tocolysis?

While both atosiban and hexoprenaline are effective for halting uterine contractions during fetal distress, atosiban seems to cause fewer maternal adverse events, faster resumption of contractions (8 vs. 14 minutes, respectively), and can be given faster as an IV bolus (1 vs. 5 minutes, respectively), according to a prospective, randomized pilot trial.

Austrian researchers studied 1,431 women with singleton, cephalic presentation, term pregnancies. Tocolysis was achieved in 92% of the atosiban group and in 100% of the hexoprenaline group. Only one woman in the atosiban group showed no reaction to the drug, which could be due to the fact that the drug was administered during the second stage of labor; all other women receiving the agent received it during the first stage.

Afschar P, Scholl W, Bader A, et al. A prospective randomized trial of atosiban versus hexoprenaline for acute tocolysis and intrauterine resuscitation. BJOG. 2004;111:316-318.

PROFESSIONAL UPDATE

Can apologizing actually prevent a malpractice lawsuit?

Some insurers and hospitals are rethinking the traditional approach of discouraging physicians from apologizing to harmed patients. Instead, they are encouraging such acts of contrition in the hopes of avoiding malpractice lawsuits—or at least reducing the huge amounts of money paid to settle such cases.

As a legal strategy, the new approach is considered risky; admitting fault is believed to fuel more lawsuits. Still, The Wall Street Journal (5/18/04) cited several examples of patients who had dropped lawsuits or settled cases for smaller amounts than they could have gotten in court—just because an apology was issued.

To back up the anecdotes, the newspaper also cited a 1999 study and a recent survey in the Annals of Internal Medicine. The 1999 study found that when health-care staff at a Lexington, Ky., Veterans Affairs Hospital disclosed medical errors and apologized to affected patients, the average cost of error-related payouts was just $15,622. A survey in the same journal found that while there is no guarantee that an apology will deter lawsuits, "respondents were 1.5 times as likely to seek legal advice when a medical error was not disclosed and no apology was given."

Insurers, such as GE Medical Protective in Fort Wayne, Ind., and the Cooperative of American Physicians-Mutual Protection Trust in Los Angeles, are now taking the lead in this movement to encourage apologies given in a way that doesn't increase legal risk. Similarly, hospitals such as Johns Hopkins in Baltimore and Dana-Farber Cancer Institute in Boston have created policies that encourage apologies to harmed patients.

To address concerns that an apology could be used against physicians, at least two states—Colorado and Oregon—have passed laws prohibiting the use of an apology in court.

Wisc. physicians can't be forced to testify as expert witnesses

The Wisconsin Supreme Court recently ruled that an obstetrician-gynecologist cannot be compelled to testify against a patient's former physician when a lawyer misses a deadline to name an expert witness. The decision, which reversed a lower court's decision, fell in line with friend-of-the-court briefs filed by the American Medical Association and the Wisconsin Medical Society.

Had the Supreme Court allowed the lower court's decision to stand, ob/gyn Charles Koh, MD, would have been forced to testify as an expert witness in a medical malpractice case against a patient's former ob/gyn. Koh had been reluctant to testify.

The supreme court, however, agreed with the argument presented by the AMA and WMS that upholding the lower court's decision "would have stripped doctors and other professionals of the right to decide whether they would provide their time and knowledge to the court," reported American Medical News (4/19/04).

Do surly physicians cause more medical errors?

Physicians had better watch their attitudes when nurses or pharmacists question or express concern about a prescribed medication. Based on a survey of 2,099 health-care practitioners, the Institute for Safe Medication Practices found that physician intimidation and condescension contributes to medical errors by preventing those who carry out orders from obtaining clarification about the appropriateness of a drug.

According to Modern Healthcare (4/5/04), the survey, conducted in November 2003, found that 40% of respondents chose to believe that a prescription was correct rather than question an intimidating physician or other prescriber. Moreover, 49% said that when they did voice their concerns, they still felt compelled to administer the medication. Of all the respondents, 7% said they were involved in a medication error, in which intimidation by a prescriber played a role.

The survey also found that more than 20% of responding nurses and pharmacists experienced at least 10 run-ins with a condescending or impatient prescriber in the past year. Nearly half of all respondents said these past experiences affected how they handled questions or clarifications.

2003 saw jump in number of disciplined docs

The percentage of physicians who have been disciplined rose 10% from 2002 to 2003—the largest 1-year increase in nearly a decade. An annual summary of board actions by the Federation of State Medical Boards found that state licensing boards took 4,590 disciplinary actions against physicians in 2003 versus 4,169 in 2002.

Reform within licensing boards to improve how they process complaints, regulate physicians, or conduct business is cited by the federation as one contributing factor to increased disciplinary action against physicians, according to American Medical News (4/26/04). The federation also cited greater awareness of patient safety among the public and a growing physician population.

Disagreeing with the federation, however, is the Public Citizen's Health Research Group. The group, which has spoken out against the allegedly lax discipline by state boards, said the increase in disciplinary action when weighed against the physician population is "negligible," reported Modern Healthcare (4/12/04).

Weighing disciplinary actions versus physician population, there were 5.6 actions per 1,000 nonfederal doctors in 2003, up slightly from about 5.3 actions per 1,000 doctors in 2002.

Interim final rule on Stark Law issued

The Centers for Medicare & Medicaid Services has issued the second phase of its interim final regulations designed to provide guidance on laws that ban physician self-referral. These new regulations are meant to clear up issues arising from the laws' implementation and will take effect July 26.

Under the so-called Stark law, physicians are prohibited from referring Medicare or Medicaid patients for certain designated health services to facilities in which they have a direct or indirect financial interest. The new regulations clarify the types of compensation arrangements physicians can enter into, and for the first time discussed exceptions addressing technology or services provided to enable physicians to participate in community health-information systems, reported Modern Healthcare (3/29/04).

Specifically, the updates allow some percentage compensation arrangements, which are set in advance and do not change based on the volume or value of referrals. CMS also clarified that all physicians can be paid bonuses based on the work they perform, but not on referrals for ancillary services. Hourly payments to physicians are also allowed as long as they are based on fair market value, a key requirement for most compensation arrangement exceptions.

To encourage the use of electronic health records, CMS has created an exception that allows a facility to provide a physician with certain information technology in order to participate in a community-wide health information system. The catch: The arrangement between facility and physician must not take into account the volume or value of referrals or violate the anti-kickback statute or other federal or state law governing billing or claims submissions.

Finally, while entities that provide designated health services are required to disclose information about financial relationships with physicians, the new regulations specify that such reporting is only required upon request.

Waivers, extra fees can help offset malpractice premiums

Skyrocketing malpractice premiums have prompted some physicians to require patients to sign waivers agreeing not to sue, according to The Washington Times (5/17/04). In addition, a growing number of physicians are charging extra fees for services such as telephone consultations or completing disability or insurance forms.

Defending the actions of these physicians, Paul Kitchen, executive vice president of the Medical Society of Virginia, told AARP Bulletin (5/04), "This is about recovery of lost income, rather than a revenue-making scheme."

However, others recommend caution when implementing these practices. For one, it's uncertain whether patient waivers will stand up in court. For another, charging extra to Medicare patients for services that were once free may violate the terms of federal health programs—a breach that the U.S. Department of Health and Human Services recently warned could result in physicians facing fines or being barred from participation.

Why patient follow-up makes good legal sense

When you suspect that a patient has breast cancer, ACOG guidelines place a duty on you to discuss testing and treatment options such as mammography, biopsy, or surgery. It might seem obvious, but it's also a good idea to follow up on your patients' testing and treatments; doing so can help reduce the likelihood that a patient will win a failure-to-diagnose claim against you. To ensure that patients receive appropriate follow-up, and to minimize legal risk, ACOG Today (May/June 2004) recommends the following:

• Refer patients to physicians you know or recommend.

• Advise patients to contact you for additional referrals if they are unable to see one of the referred physicians.

• Make sure your patients understand the importance of going for follow-up tests.

• Follow-up on your patients' test results and discuss the results with them.

• Contact patients who do not comply with prescribed actions to find out why.

• Document attempts to contact patients in the medical record.

Nation gets unsatisfactory grade in women's health

The United States as a whole and individual states are falling short of meeting national health goals set by the U.S. Department of Health and Human Services' Healthy People 2010 agenda. According to the 2004 "Making the Grade on Women's Health: A National and State-by-State Report Card," the nation received an "unsatisfactory" grade and no state received a "satisfactory" grade.

Released by the National Women's Law Center and Oregon Health & Science University in May, the report found that the nation as a whole only met two out of 27 benchmark indicators. The two goals achieved were ensuring that women 40 and older get mammograms regularly and promoting annual dental visits.

As further indication that the health needs of women are not being met, the top grade among individual states was "satisfactory minus"; just eight states earned that grade—Minnesota, Massachusetts, Vermont, Connecticut, New Hampshire, Hawaii, Colorado, and Utah. Six states—Texas, Oklahoma, West Virginia, Arkansas, Louisiana, and Mississippi—received failing grades.

Examining 67 policy indicators, which are based on state legislation and programs that address certain health problems, all states met just one policy goal—namely, every state has Medicaid coverage for breast and cervical cancer patients. Just three states—New York, California, and Rhode Island—met at least 35 policy goals. The states with the weakest health policies were Idaho, South Dakota, and Mississippi.

More docs are hiring PAs

More and more physicians in solo and group practices are discovering the benefits of hiring physician assistants. And the numbers show it: Employment for PAs in these settings has increased, while employment for PAs in hospitals and community health centers has decreased slightly, reported American Medical News (11/17/03), citing statistics from the American Academy of Physician Assistants.

A 2003 survey conducted by the academy found that the percentage of PAs working in solo practices rose from 9.1% in 1998 to 12.9% in 2003. Likewise, the percentage of those working in group practices climbed from 26.3% in 1998 to 30.4% in 2003. During the same period, the percentage of PAs working in hospitals dropped from 37.2% to 36.4%, while the percentage of those working in community health centers decreased from 11.1% to 8.3%. The academy also found that in 2003, PAs found jobs in family or general medicine (30.9%), followed by surgical subspecialities (20.4%) and emergency medicine (10%). Don't rule out obstetrics and gynecology, either: 2.8% of PAs found employment in this specialty, as well.

Medical malpractice cases decrease in Pa.

The number of medical malpractice suits filed in Pennsylvania in 2003 fell by 28.6% vs. the previous 3-year period, according to preliminary data compiled by the state's Supreme Court. Philadelphia showed the greatest decrease with a 58% drop, with Pittsburgh coming in second with a 31.5% drop.

The decrease in the number of medical malpractice cases was attributed to two tort reform measures adopted in 2003. One measure requires attorneys to confirm that a suit is not frivolous by obtaining a certificate of merit from a medical professional. The other measure limits the filing of cases to the county where the cause of action took place, reported Medical Malpractice Monitor (4/04).

Critics of the state's first effort to track the number of medical malpractice suits cautioned that the data evaluating just 1 year do not indicate a trend. They also noted that the data failed to evaluate the severity of awards and settlements or whether the number of meritless lawsuits decreased.

 

NEWSLINE: Clinical Insights/Professional Update. Contemporary Ob/Gyn Jul. 1, 2004;49:16-33.