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Combined anticoagulant/antiplatelet therapy reduces risk of stroke after mechanical heart-valve replacement

It is known that patients with prosthetic heart valves are at increased risk for sudden blockage of an artery by a blood clot, known as an arterial embolism. These patients are at particular risk for stroke. This stroke risk can be reduced by long-term treatment with oral anticoagulant therapy (usually warfarin).

Joseph Lau, M.D., and colleagues at the New England Medical Center, Tufts University School of Medicine, and Boston University School of Medicine performed a meta-analysis of five randomized controlled trials that compared the efficacy and safety of combined anticoagulant and antiplatelet therapy with that of anticoagulant therapy alone after prosthetic heart-valve replacement.

The investigators were able to show that the risk of stroke may be further reduced by adding antiplatelet agents such as aspirin (500 to 1,000 mg daily) or dipyridamole (400 mg daily) to the anticoagulant therapy of these patients. The combined regimen reduced embolism by approximately two-thirds (67 percent). Less than 3 percent of patients had an embolism when treated with the combined therapy compared with about 9 percent of patients treated with oral anticoagulants alone.

Although the combined regimen decreased overall mortality by 40 percent, it resulted in a 2.5-fold increase in major gastrointestinal hemorrhage. For every 1.6 patients in whom stroke was prevented by combination therapy, there was an excess of one major gastrointestinal bleed. Nevertheless, the researchers conclude that the benefits derived from the combined therapy outweigh its toxic effects. Lowering the dose of aspirin to between 75 and 100 mg per day may decrease the risk of hemorrhage, noted Dr. Lau, who led the study. This research was supported in part by the Agency for Health Care Policy and Research (HS07782).

For more information, see "Efficacy and safety of combined anticoagulant and antiplatelet therapy versus anticoagulant monotherapy after mechanical heart-valve replacement: A meta-analysis," by Joseph C. Cappelleri, Ph.D., M.P.H., M.S., Louis D. Fiore, M.D., Mary T. Brophy, M.D., and others, in the American Heart Journal 130(3), pp. 547-552, 1995.

Experts examine the relationship between early newborn discharge and neonatal jaundice

Some insurance plans require hospital discharge of mothers and newborn infants within 24 hours of the infant's birth if there are no recognized complications. Currently 1-4 percent of term infants are readmitted to the hospital in the first week of life—85 percent of these readmissions are for jaundice (hyperbilirubinemia). Many other complications or indicators of high risk for adverse outcomes also have been associated with early discharge.

Furthermore, there is some evidence that pediatric care providers have not adjusted adequately to new neonatal discharge policies. For example, early discharge policies have sometimes been applied inappropriately to groups such as premature infants. In addition, early-discharge infants usually are not scheduled for a pediatric appointment until 2 weeks after discharge. Thus undetected hyperbilirubinemia (excess of bilirubin, a byproduct of hemoglobin breakdown, in the blood) can result in neurotoxicity, a condition called kernicterus. Anecdotal reports have recently begun to surface of a reemergence of kernicterus, a condition that had virtually disappeared in the United States.

Participants at a recent workshop examined the potential impact of early discharge on newborn outcomes. The workshop was convened by the Agency for Health Care Policy and Research and the National Institute of Child Health and Human Development in March 1995. According to Lisa Simpson, M.B., B.Ch., a pediatrician and Deputy Administrator of AHCPR, conference participants found that there is an inadequate science base to determine the safety and appropriateness of discharge strategies, either new or old. Furthermore, there is virtually no reliable information on quality of care, health outcomes, impact on the public health, socioeconomic impact, or consequences of early discharge or other postpartum care strategies. Clearly, there is a pressing need for appropriate research to shed light on these important aspects of peri- and postnatal care, concluded Dr. Simpson.

In an article summarizing the conference, Dr. Simpson and her colleagues offer a series of practice and research recommendations, including epidemiologic and health services research on various aspects of postdelivery care, prenatal and perinatal education, strategies for postdischarge followup, economic analyses of various discharge protocols, clinical trials of specific treatments for hyperbilirubinemia, and studies of other aspects of pre- and postdischarge management.

See "Summary of workshop: Early discharge and neonatal hyperbilirubinemia," by Charlotte Catz, M.D., James W. Hanson, M.D., Dr. Simpson, and Sumner J. Yaffe, M.D., in Pediatrics 96(4), pp. 743-745, 1995.

Less than half of primary care physicians correctly diagnose alcohol abuse

The diagnosis of alcoholism or alcohol abuse is often missed by physicians, even though asking just four questions (using the CAGE questionnaire) is a reliable way of screening for alcoholism in the primary care setting. The CAGE questionnaire is considered a practical and reliable way to identify possible alcohol problems among patients. The questions are simple: Have you ever tried to Cut down on your drinking? Have you ever been Annoyed by anybody criticizing your drinking? Have you ever felt Guilty about your drinking? Have you ever had an Eye-opener (drink) in the morning? Two positive answers is considered a standard cutpoint for alcohol abuse.

In a study supported by the Agency for Health Care Policy and Research (HS06454), Paul G. Ramsey, M.D., and other University of Washington researchers evaluated the performance of 134 primary care doctors during a medical visit with 17 standardized patients (SPs). SPs are trained to present a typical medical profile to the physician.

The researchers found that more than 50 percent of the physicians asked an initial alcohol screening question of three-fourths of the patients they saw. However, few physicians further questioned patients who reported drinking more than one drink per day. Also, fewer than 50 percent of the doctors included alcohol abuse in the diagnosis for patients who drank four or more drinks per day.

The researchers conclude that many patients with moderate to heavy alcohol use may be missed because physicians do not go beyond an initial question about alcohol consumption to the brief but sensitive further CAGE screening. These results suggest the potential utility of using SPs to improve quality in primary care practice.

More details are in "Do primary care physicians screen patients about alcohol intake using the CAGE questions?" by Marjorie D. Wenrich, M.P.H., Douglas S. Paauw, M.D., Jan D. Carline, Ph.D., and others, in the November 1995 Journal of General Internal Medicine 10, p. 631-634.

Attention Researchers: On March 15, 1996, AHCPR released a Request for Applications (RFA HS-96-006) to conduct research related to patient referrals from primary to specialty care. Applications are sought for studies that (1) describe how changes in health care organization affect referral practices, and/or (2) measure quality of care or economic and other outcomes resulting from decisions by primary care providers to refer, or not refer, patients to specialty providers. Research under this RFA should address issues related to referrals in the ambulatory care setting.

Depending on the availability of funds, AHCPR expects to award up to $1.5 million for the first year of projects under this RFA. The deadline for applications is June 12, 1996. Direct programmatic questions to: David Lanier, M.D., Center for Primary Care Research, AHCPR (phone: 301-427-1567; E-mail:

Inappropriate monitoring of antiepileptic drug levels may result in higher hospital charges

Although many doctors monitor antiepileptic drug levels in their epileptic patients, a new study shows that only 27 percent of these drug level measurements are appropriately indicated, and half of the drug levels are not sampled correctly. Efforts to decrease this inappropriate monitoring may substantially reduce costs without missing important clinical results, conclude researchers from Brigham and Women's Hospital.

In a study supported by the Agency for Health Care Policy and Research (HS07107), the researchers assessed the drug levels at least 200 times for each of four antiepileptic drugs: phenytoin, carbamazepine, phenobarbital, and valproic acid in 330 hospital patients. Of the 624 antiepileptic drug level measurements considered inappropriate (73 percent), only four (0.6 percent) levels were potentially toxic, that is, more than 20 percent higher than the upper limit of normal. Moreover, none of the four patients had clinical signs of drug toxicity, and all four samples had been drawn too soon after administration of the drug.

Of the 27 percent of appropriate drug measurements, only 51 percent were sampled correctly, that is, drawn at the appropriate interval between doses. This resulted in an overall appropriateness rate of 14 percent. Most of the inappropriate drug level measurements were part of a series of daily repeated measurements performed after starting or changing the antiepileptic drug regimen but before a pharmacological steady state had been achieved, which can range from 3 days to 20 days depending on the drug. If these inappropriate measurements had not been performed, hospital charges would have decreased by $302,740.

Details are in "Appropriateness of antiepileptic drug level monitoring," by Ronald A. Schoenenberger, M.D., M.P.H., Milenko J. Tanasijevic, M.D., Ashish Jha, and David W. Bates, M.D., M.Sc., in the November 22/29, 1995, Journal of the American Medical Association 274(20), pp. 1622-1626.

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