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Ischemic Heart Disease PORT finds benefits of hormone replacement therapy far outweigh risks for most women and reaffirms link between angioplasty volume and outcomes

The Ischemic Heart Disease Patient Outcomes Research Team (PORT) was funded in 1990 by the Agency for Health Care Policy and Research (HS06503) to conduct a 5-year study of the effectiveness of various surgical and nonsurgical treatments for ischemic heart disease. The PORT researchers, led by Elizabeth R. DeLong, Ph.D., of Duke University Medical Center, recently published two studies, which are summarized here. The first shows that the benefits of hormone replacement therapy outweigh the risks for most women, particularly those with one or more risk factors for coronary heart disease. The second study adds to the evidence from other studies which have shown that patients undergoing coronary angioplasty fare much better if their hospital and surgeon perform the procedure often.

Col, N.F., Eckman, M.H., Karas, R.H., and others (1997, April 9). "Patient-specific decisions about hormone replacement therapy in postmenopausal women." Journal of the American Medical Association 277(14), pp. 1140-1147.

Less than 1 percent of healthy, newly menopausal American women would fail to benefit from hormone replacement therapy (HRT), according to this study. The only women not expected to gain from HRT are those who are both at greatest risk for breast cancer (first-degree relatives with breast cancer) and have no risk factors for coronary heart disease (CHD). Even among women at high risk for breast cancer, the presence of just one risk factor for CHD—such as smoking or hypertension—tips the scale in favor of HRT, conclude the authors of the study. Recent studies have suggested that HRT raises the risks of breast cancer and endometrial cancer, while decreasing the risk of CHD and hip fracture.

Although the one-in-eight lifetime probability of developing breast cancer has been well publicized, the chances of developing heart disease are much higher than this for most women, assert the researchers. They sought a way to gauge the risks and benefits of HRT that could help millions of women facing the HRT decision now, since the results of many randomized controlled trials examining the impact of HRT on disease and longevity wont be available for a decade or more.

The researchers used a computerized decision model, which incorporated data linking risk factors with disease incidence and longevity, to analyze the impact of HRT on the life expectancy of postmenopausal women with different risk factors for CHD, breast cancer, and hip fracture. According to their analysis, HRT should increase life expectancy for nearly all postmenopausal women, with some gains exceeding 3 years, depending mainly on an individual's risk factors for CHD and breast cancer. This compares with 2.8 years of life expectancy gained for 35-year-old women who stop smoking. Half of these gains accrue after 10 years of treatment and 75 percent after 20 years of HRT.

The researchers encourage physicians to provide individually tailored risk estimates when advising women and to recommend that the women balance any estimated gains in life expectancy with their personal values. For instance, the extent to which women prefer to avoid breast cancer, CHD, or hip fracture will affect their decisions.

Hannan, E.L., Racz, M., Ryan, T.J., and others (1997, March 19). "Coronary angioplasty volume-outcome relationships for hospitals and cardiologists." Journal of the American Medical Association 277(11), pp. 892-898.

If you need to undergo coronary angioplasty, your best chance for a good outcome is to have the procedure performed by a surgeon who does it often at a hospital where angioplasty is performed often, according to the Ischemic Heart Disease PORT. The researchers compared the surgical outcomes of nearly 63,000 patients with the rate of percutaneous transluminal coronary angioplasty (PTCA) performed by individual physicians and at 31 individual hospitals in New York State from 1991 through 1994.

Patients undergoing angioplasty in hospitals with annual PTCA volumes less than 600 and those whose cardiologists performed fewer than 75 PTCAs per year experienced a 1 percent in-hospital mortality rate and nearly 4 percent same-stay bypass surgery rate (due to unsuccessful angioplasty), after accounting for other factors affecting mortality and further surgery. This was significantly higher than the 0.90 percent overall New York in-hospital mortality rate and 3.4 percent same-stay bypass surgery rate. On the other hand, same-stay bypass surgery rates for patients undergoing PTCA in hospitals with annual PTCA volumes of 600 to 999 performed by cardiologists with annual volumes of 75 to 174 and 175 or more were significantly lower (3 percent and 2.8 percent, respectively) than the overall State-wide rate.

In conclusion, the researchers note that, if in fact "practice makes perfect," then this study supports the growing move toward regionalization of cardiac facilities, where heart surgery patients are referred to regional centers that specialize in these procedures. These results also support raising the competency minimums recommended by the American College of Cardiology/ American Heart Association: 200 annual PTCAs for hospitals and 75 annual PTCAs for cardiologists.

The study was based on data from the Coronary Angioplasty Reporting System of the New York State Department of Health.

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Outcomes/Effectiveness Research

Higher costs of care for cardiac bypass patients do not necessarily correlate with better outcomes

Amidst the pressures of managed care and referral networks, more expensive hospitals are faced with the choice of either proving that higher treatment costs result in better outcomes or losing business. However, higher costs are not necessarily related to better outcomes, according to a recent study conducted by the Ischemic Heart Disease Patient Outcomes Research Team (PORT), led by Elizabeth R. DeLong, Ph.D., of Duke University Medical Center, and supported by the Agency for Health Care Policy and Research (HS06503).

Dr. DeLong and her colleagues found that deaths and hospital readmissions for patients undergoing coronary artery bypass graft (CABG) surgery were unrelated at the State level to the cost of care or length of hospital stay. The researchers retrospectively analyzed Medicare administrative files and American Hospital Association files to compare outcomes with costs and lengths of stay for 92,449 elderly and predominantly white bypass surgery patients.

After adjusting for clinical, hospital, demographic, and regional characteristics, costs and lengths of stay varied considerably by State. Even States with similar hospital stays varied widely with respect to costs. For example, California and Oregon had similar risk-adjusted 10-day stays, but the risk-adjusted cost for California exceeded that of Oregon by almost 20 percent ($17,769 vs. $15,108). If the CABG episode costs for patients exceeding the overall expected average were reduced to the average level without altering the observed length of stay, CABG costs in the Medicare population would decrease by 14 percent ($302 million out of $2.1 billion in the 1990 study population), estimated the researchers.

They also found no relation at the State level between level of resource use and either post-bypass death or 60-day mortality and readmission rates. This variability among States suggests considerable diversity in practice style, efficiency of care delivery, and/or quality of care across the country. The lack of association at the State level between resource use and rates of mortality and hospital readmission suggests that costs could be reduced in many areas of the United States without compromising quality of care.

For more details, see "Geographic variation in resource use for coronary artery bypass surgery," by Patricia A. Cowper, Ph.D., Dr. DeLong, Eric D. Peterson, M.D., M.P.H., and others, in Medical Care 35(4), pp. 320-333, 1997.

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Not all heart attack patients benefit from costly angiography and angioplasty

Angiography (x-ray image of the heart following catheter-infused contrast dye into the heart) is done to diagnose heart damage following heart attack in 30 to 81 percent of patients, depending on the treatment setting and area of the country. But for many of these patients, the benefit is questionable. Better outcomes are not always associated with more frequent use of either this procedure or the angioplasty that it often prompts, concludes a study supported by the Agency for Health Care Policy and Research (HS08071).

This literature review suggested, for example, that after the acute phase of heart attack, patients who show obvious signs of reduced blood flow to the heart, such as angina (sharp heart pain), appear to benefit from angiography, though for the remaining patients benefit is unknown. Patients who have heart attack complications, such as shock, usually undergo angiography, but the evidence supporting this practice is weak. One of the studies examined in this review found that a conservative strategy after heart attack would avoid 50 percent of angiograms without an increase in mortality rates compared with an invasive strategy, and would save more than $700 million per year.

Preliminary data from controlled trials at experienced centers suggest that heart attack patients who immediately have angiography and angioplasty fare better than patients who are treated first with thrombolytic (clot-busting) therapy, with angioplasty reserved for certain indications. However, a recent large observational study did not find a similar benefit, and the advantages of primary angioplasty over thrombolytic therapy are still being debated.

That more procedures do not necessarily mean better outcomes is evidenced by studies showing twice the rate of angiographies and many more angioplasties in heart attack patients in the United States than Canada. These differences were not associated with any difference in mortality or reinfarction (subsequent heart attack) rates, but the incidence of activity-limiting angina was slightly higher in Canada than in the United States.

For this study, researchers at Brigham and Women's Hospital, Harvard School of Public Health, and the University of Michigan Medical Center performed a critical review of studies published between 1970 and 1995 on the use of these procedures.

See "Coronary angiography and angioplasty after acute myocardial infarction," by David W. Bates, M.D., M.Sc., Elizabeth Miller, B.S., Steven J. Bernstein, M.D., and others, in the April 1, 1997, Annals of Internal Medicine 126, pp. 539-550.

Better management of patients already diagnosed with heart disease is more cost effective than primary prevention

The incidence of coronary heart disease (CHD) has declined about 1 percent each year over the last three decades, while deaths from CHD have declined between 2 percent and 4 percent per year. Various explanations have been suggested for the decline in CHD mortality, including the effect of risk-factor reductions and improvements in treatment of patients with CHD.

A recent study, supported in part by the Agency for Health Care Policy and Research (HS06258), found that only about one-fourth of the decline in CHD mortality between 1980 and 1990 was due to primary prevention (reducing risk factors such as smoking, obesity, and blood lipid levels in persons without CHD), and that most of the decline was explained by improvements in the management of patients in whom CHD had been diagnosed. Thus, focusing on patients with diagnosed CHD may be more cost-effective than primary prevention of CHD, according to Maria G.M. Hunink, M.D., Ph.D., of the Harvard School of Public Health, the study's lead author.

The researchers developed a computer-simulation model of the U.S. population between the ages of 35 and 84 to forecast coronary mortality. The model simulates changes in risk factors and case-fatality rates, as well as coronary event rates in patients with CHD. Based on this model, 71 percent of the decline in CHD deaths was explained by improvements in management of CHD (either by reducing risk factors in patients with CHD or improved treatment) and about 25 percent by reducing risk factors in persons without CHD. Improvement in low-density lipoprotein cholesterol levels explained one-third of the decline in CHD mortality. This effect could be related to changes in diet or to lipid-lowering medications, which can have a substantial impact, especially in patients with diagnosed CHD.

Improved treatment of heart attacks, including thrombolysis (clot-busting therapy) and angioplasty, has the potential to reduce mortality even further. The researchers point out, however, that although CHD incidence and mortality have decreased, absolute prevalence has increased. This implies a future increase in the financial burden associated with CHD, which currently amounts to $80 billion a year or 15 percent of the annual U.S. health care budget.

For more information, see "The recent decline in mortality from coronary heart disease, 1980-1990," by Maria G.M. Hunink, M.D., Ph.D., Lee Goldman, M.D., M.P.H., Anna N.A. Tosteson, Sc.D., and others, in the February 19, 1997, Journal of the American Medical Association 277(7), pp. 535-542.

Primary care physicians often see BPH patients, but their practices sometimes depart from treatment guidelines or urologists' practices

With the expanding role of primary care and availability of nonsurgical treatments for benign prostatic hyperplasia (BPH, enlarged prostate), primary care practitioners (PCPs) are managing more patients with BPH who formerly were cared for by urologists. But many PCPs do not use recommended methods in the diagnosis of BPH that are used by their more experienced urologist colleagues.

Nearly two-thirds of 444 PCPs responding to a mail survey report rarely using the American Urological Association (AUA) symptom index, which provides a reliable and valid way to measure a patient's symptom severity as well as his response to therapy, while two-thirds of 394 responding urologists report using the index routinely. Also, one-third of PCPs order upper tract imaging studies, such as renal ultrasound and transrectal ultrasound, which are not recommended; less than one-half of urologists order these studies. On the other hand, two-thirds of PCPs, but only one-fourth of urologists, routinely order guideline-recommended tests of serum creatinine levels.

In some cases, practices do not follow the clinical practice guideline on BPH released in 1994 by the Agency for Health Care Policy and Research. This suggests that some PCPs are either unaware of or disagree with the guideline recommendations, concludes the Prostatic Diseases Patient Outcomes Research Team (PORT), which is led by Michael J. Barry, M.D., of Massachusetts General Hospital, and supported by AHCPR (HS08397).

In a recent study, the PORT researchers surveyed a random sample of PCPs and urologists selected from the American Medical Association Registry about their approach to BPH management in 1995. Physicians were asked how they would initially evaluate a man over age 50 with symptoms suggesting BPH.

The survey showed that about 90 percent of PCPs and urologists ordered prostate-specific antigen (PSA) tests to detect prostate cancer, a test considered optional and less reliable in discriminating localized prostate cancer in men with suspected BPH than in other men. About 86 percent of PCPs had prescribed medications to treat BPH over the past year, with PCPs and urologists both prescribing alpha blockers more often than finasteride. PCPs reported seeing a median of 35 patients with BPH during the year, and they referred a median of 10 patients to a urologist. PCPs who saw fewer than 35 BPH patients a year were more apt to consult a urologist than other PCPs.

Details are in "Diagnosis and treatment of benign prostatic hyperplasia," by Mary McNaughton Collins, M.D., Dr. Barry, Lin Bin, Ph.D., and others, in the April 1997 Journal of General Internal Medicine 12, pp. 224-229.

Substantial differences found in the way American and British physicians care for patients at risk for stroke

Stroke is the third leading cause of death and a major cause of disability in both the United

Kingdom and the United States. But primary care physicians in both countries vary substantially in how they evaluate and treat patients at high risk for stroke. American physicians have more diagnostic services available and clearly use them, and they use anticoagulant medication for these patients more often than British physicians, finds a study by the Stroke Prevention Patient Outcomes Research Team (PORT).

For instance, more than 80 percent of American physicians compared with only 10 percent of British physicians reported availability of 24-hour electrocardiography (ECG), echocardiography, brain computerized tomography (CT) scan, brain magnetic resonance scan, carotid ultrasonography, and cerebral angiography. Almost 70 percent of U.S. physicians compared with 7 percent of British physicians said they always or often anticoagulate patients with atrial fibrillation, a condition that dramatically increases the risk of stroke. Substantially more American than British physicians referred patients with minor stroke or transient ischemic attack to neurologists (55 percent vs. 45 percent) or surgeons (39 percent vs. 19 percent); performed carotid ultrasonography (80 percent vs. 11 percent), echocardiography (45 percent vs. 5 percent), and brain CT scan (72 percent vs. 3 percent); and prescribed anticoagulants (53 percent vs. 4 percent).

These differences were underscored by similar surveys of generalist physicians in both countries on their stroke prevention practices. Many of the differences in practice revealed by these surveys may be directly related to differences in the organization of health care between the two countries, notes David Matchar, M.D., of Duke University, the PORT's lead investigator. The PORT is supported by the Agency for Health Care Policy and Research (PORT contract 290-91-0028). For instance, the relative lack of availability of diagnostic tests in the United Kingdom compared with the United States could potentially lead to their overuse in the U.S. and underuse in the U.K. in certain circumstances, concludes Dr. Matchar.

See "Primary care physician-reported secondary and tertiary stroke prevention practices: A comparison between the United States and the United Kingdom," by Larry B. Goldstein, M.D., Andrew Farmer, B.M., B.Ch., and Dr. Matchar, in the April 1997 Stroke 28(4), pp. 746-751.

Management of cataract patients varies greatly among developed countries

Developed countries vary dramatically in their management of healthy patients with cataracts. For instance, three preoperative procedures (refraction, fundus exam, and A-scanning) are used most of the time by more than 90 percent of surgeons in Canada, the United States, Barcelona, Spain, and Denmark. These are the only routine preoperative procedures recommended by the panel that developed the clinical practice guideline on the management of patients with cataracts, which was supported by the Agency for Health Care Policy and Research.

Preoperative medical screening tests, such as blood pressure and blood count, which are not recommended by the guideline panel for routine use, are virtually unused in Denmark but are used widely in Canada, the United States, and Barcelona. Also, within and between countries there is much variation in the number of followup visits and postoperative tests, according to a recent study that was supported in part by the Agency for Health Care Policy and Research (HS07085).

If the restricted use of medical screening tests reported in Denmark were to be considered appropriate for the other three countries, and if less intensive care were found not to be associated with poorer outcomes, there is the potential for less costly care of patients with cataracts, concludes Gerard F. Anderson, Ph.D., of Johns Hopkins University. Dr. Anderson and his colleagues surveyed a random sample of ophthalmologists in the United States (526), Canada (276), Barcelona, Spain (89), and Denmark (82). The physicians were asked to describe their clinical management of cataract patients with no coexisting medical or ocular conditions.

The following proportion of surgeons performed 100 or more cataract extractions within the last year: Denmark (84 percent), Canada (80 percent), the United States (70 percent), and Barcelona (56 percent). Nearly two-thirds of all extractions reported by U.S. and Canadian surgeons were done using phacoemulsification, the latest technique, compared with only one-third in Denmark and 5 percent in Barcelona, where the older technique—intracapsular cataract extraction—is still used. Fewer than 10 percent of physicians in all four countries used preoperative visual evoked response tests, electroretinograms, or color vision tests.

For more details, see "International variation in ophthalmologic management of patients with cataracts," by Jens Christian Norregaard, M.D., Ph.D., Oliver D. Schein, M.D., M.P.H., Dr. Anderson, and others, in the March 1997 Archives of Ophthalmology 115, pp. 399-404.

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