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Cappelleri, J.C., and Trochim, W.M.K. (1995, December). "Ethical and scientific features of cutoff-based designs of clinical trials: A simulation study." (AHCPR grant HS07782). Medical Decision Making 15, pp. 387-394.

Some question whether the traditional randomized clinical trial (RCT) may be unethical when strong a priori evidence suggests that the experimental treatment may be more effective than the standard (control) treatment and when the disease under investigation is potentially life-threatening. For example, patients with acquired immunodeficiency syndrome (AIDS) or cancer, who are most in need of the presumably more beneficial test treatment and are willing to undertake its risk may be randomized to the control group. Other patients who are less in need of the test treatment and are currently well enough not to chance its side effects may be randomized to the test treatment. This article offers an alternative design strategy, the cutoff-based RCT. Patients who are the least sick are automatically assigned to the control treatment. Patients who are the most sick are automatically assigned to the test treatment. Patients who are moderately ill are randomly assigned.

East, T.D. (1995, September). "Resources for assessing innovations in mechanical ventilatory support: The missing link." (AHCPR grant HS06594). Respiratory Care 40(9), pp. 987-993.

Despite the explosion of new technology in respiratory care in the last 20 years, most innovations have not required proof of efficacy prior to introduction in the commercial clinical arena. The author explores the financial resources available for mechanical ventilation technology assessment through the Federal Government, industry, consumer groups, insurers, hospitals, health care organizations, and foundations. At present, industry provides the largest portion of the funding for such assessments, although it is far below the amount needed, according to the author. He concludes that mechanical ventilation is a field that is filled with unproven technology, and few resources are available to support assessments of this technology.

Fitzmaurice, J.M. (1995). "Computer-based patient records." in Bronzino, J.D., Ed., The Biomedical Engineering Handbook, Chapter 177, pp. 2623-2634, Boca Raton, FL: CRC Press.

In this book chapter, J. Michael Fitzmaurice, Ph.D., Director of the Agency for Health Care Policy and Research's Center for Information Technology, presents the computer-based patient record (CPR) as a powerful tool for organizing patient care data. He describes the role of the CPR in clinical decision support systems and its use in guiding and evaluating patient care processes, such as preventive care reminders for the physician. He discusses the real and perceived barriers to implementing a CPR, such as the physician's reluctance to enter data. In addition to developing research databases, medical knowledge, and quality assurance information that would otherwise require an inordinate amount of manual resources to obtain, the CPR can also benefit telemedicine by transferring digital images over long distances.

Gray, B.H., and Phillips, S.R. (1995). "Medical sociology and health policy: Where are the connections?" (National Research Service Award training grant T32 HS00052). Journal of Health and Social Behavior (extra issue), pp. 170-181.

The authors explore the connection between medical sociology and health policy and assert that there is potential interest among policymakers for sociological contributions to policy debates. However, the impact of sociologists on health policy has been limited by their ambivalence and academic career considerations and by changes in the field of health policy research. The authors suggest ways that sociologists can affect health policy, ranging from designing studies and disseminating research results to becoming more knowledgeable about the field of health policy research.

Horner, R.D., Bennett, C.L., Weinstein, R.A., and others (1995). "Relationship between procedures and health insurance for critically ill patients with Pneumocystis carinii pneumonia." (AHCPR grant HS06494). American Journal of Respiratory and Critical Care Medicine 152, 1435-1442.

Hospitalized Medicaid patients with Pneumocystis carinii pneumonia (PCP) are 40 percent less likely than privately insured patients to receive a bronchoscopy to confirm PCP, according to a recent study. PCP is a common and pote-tially deadly complication of infection with the human immunodeficiency virus (HIV). Bronchoscopy can differentiate PCP from other serious illnesses. Treating a patient for PCP without diagnostic confirmation by bronchoscopy may mean that tuberculosis or bacterial pneumonia go untreated. The researchers studied the in-hospital care of 890 patients who were treated for PCP or had a diagnostically confirmed case of PCP. They were covered either by Medicaid or Medicare, had private insurance, or were self-paying patients, and were treated at 56 hospitals in Chicago, Los Angeles, or Miami from 1987 to 1990. Medicaid patients were only half as likely as privately insured patients to have their PCP confirmed by bronchoscopy, and they were 75 percent more likely to die in the hospital. Medicaid reimbursement rates may have influenced who received a bronchoscopy, according to the authors, who note that in California, physicians receive $156 for a bronchoscopy for Medicaid patients ($70 in New York) and $551 for patients with a private insurance carrier ($700 in New York).

Mertz, H.R., Beck, C.K., Dixon, W., and others (1995). "Validation of a new measure of diarrhea." (AHCPR grant HS06775). Digestive Diseases and Sciences 40(9), pp. 1873-1882.

Assessment of diarrheal disease is important to evaluating a patient's severity of illness as well as the outcomes of various treatment strategies. The authors summarize development of a questionnaire designed to depict the extent of diarrhea experienced by patients infected with the human immunodeficiency virus (HIV), a group for whom diarrhea is a prevalent problem.

Moeller, J.F. (1995, Fall). "Gainers and losers under a tax-based health care reform plan." Inquiry 32, pp. 285-299.

In this study, John F. Moeller of the Center for Health Expenditures and Insurance Studies, Agency for Health Care Policy and Research, describes a tax-based health care reform plan. He uses data from the 1987 National Medical Expenditure Survey and the Health Insurance Plans Survey—adjusted for inflation and demographic growth to 1993—to develop a microsimulation model of the Federal personal income tax system. He discusses the methodology and assumptions used to identify persons who would be eligible to qualify for a premium subsidy for low-income, non-Medicaid-eligible individuals. This subsidy would be carried out at the Federal level, possibly using credits or deductions within the Federal personal income tax system. A tax on employer-provided health benefits would finance the subsidy. Dr. Moeller analyzes characteristics of gainers and losers under the plan.

Morise, A.P., and Diamond, G.A. (1995, October). "Comparison of the sensitivity and specificity of exercise electrocardiography in biased and unbiased populations of men and women." (AHCPR grant HS06065). American Heart Journal 130(4), pp. 741-747.

The authors assess sex-related differences in post-test referral biases by comparing the accuracy of exercise electrocardiography in biased (coronary angiography only) and unbiased (all unselected) populations with possible coronary disease. They analyzed clinical and exercise test data from 4,467 patients and found that the sensitivity and specificity of exercise electrocardiography were significantly greater in men than in women with use of biased or unbiased groups. However, the differences could not be explained on the basis of sex-related differences in post-test referral bias. Women with a low to intermediate probability of coronary disease are more prone to positive exercise test results than are similarly categorized men. However, given the relatively low frequency of positive test results in men and women, a strong case cannot be made for bypassing standard exercise electro-cardiography in favor of stress-imaging methods as the initial test in men or women with interpretable resting electrocardiograms.

Rudin, J.L. (1995, September). "A review of six computerized dental reference resources: Part 1." (National Research Service Award training grant T32 HS00036). Compendium of Continuing Education in Dentistry 16(9), pp. 866-872.

The author reviews the concepts of search strategy and describes the electronic textbooks published by Scientific American Medicine (SAM) and Keyboard Publishing that are available on CD-ROM and designed for use on both stand-alone and networked workstations. SAM CD-ROM is a full-text electronic version of SAM's textbook. It consists of 3,000 pages of comprehensive articles on internal medicine, as well as 1,000 charts, tables, photographs, illustrations, and animations. Keyboard Publishing has transformed the full text of a number of health-care related textbooks to the CD-ROM format. Among the resources reviewed by this author are the Robbins Pathologic Basis of Disease, 5th edition, The Merck Manual, 16th edition, Sherris Medical Microbiology, 3rd edition, and Essential Immunology, 8th edition.

Schwartz, M., Klimberg, R.K., Karp, M., and others (1995, June). "An integer programming model to limit hospital selection in studies with repeated sampling." (AHCPR grant HS06048). HSR: Health Services Research 30(2), pp. 359-376.

The authors describe an integer programming model that could be used by researchers to select a limited number of hospitals for medical record review when repeated sampling is required. The authors illustrate the model in the context of two studies, which share these common characteristics: hospitals are classified into categories, for example, high, medium, and low volume; the classification process is repeated several times, for example, for different medical conditions; medical records are selected separately for each iteration of the classification; and for budgetary and logistical reasons, reviews must be concentrated in a relatively small subset of hospitals. The researchers found the integer programming model to be useful for selecting a subset of hospitals at which more intensive reviews will be conducted. They caution, however, that limiting the number of hospitals at which records are reviewed may compromise the independence of the multiple analyses performed, since it ignores any overall "hospital effect."

Smith, T.J., and Bodurtha., J.N. "Ethical considerations in oncology: Balancing the interests of patients, oncologists, and society." (AHCPR grant HS06589). Journal of Clinical Oncology 13(9), pp. 2464-2470.

Chemotherapy for patients with metastatic cancer is fraught with high costs, clinical tradeoffs, and ethical dilemmas, which the authors outline in this study. Patients with metastatic cancer and their doctors often must decide when the use of chemotherapy can help the patient and when it cannot. However, often the medical care and health insurance systems make it easier for doctors to order reimbursable chemotherapy than to engage patients in painful discussions about their prognosis, note the researchers. They reviewed existing studies and analyzed case studies of cancer treatments to determine whether ethical principles can help the oncologist in everyday decisions with cancer patients. The researchers conclude that although understanding ethical principles can help daily oncology practice, such principles do not resolve current dilemmas such as the balance between fair allocation of medical resources and patient demands for continued therapy to which they are not responding.

Smith, T.J., Hillner, B.E., Neighbors, D.M., and others. (1995). "Economic evaluation of a randomized clinical trial comparing vinorelbine, vinorelbine plus cisplatin, and vindesine plus cisplatin for non-small-cell lung cancer." (AHCPR grant HS06589). Journal of Clinical Oncology 13(9), pp. 2166-2173.

Non-small-cell lung cancer (NSCLC) was responsible for 82 percent of lung cancer deaths in 1994. Chemotherapy for metastatic NSCLC is controversial, because few patients respond, and the therapy has minimal impact on long-term survival. However, a recent study shows that vinorelbine, a drug recently approved by the U.S. Food and Drug Administration, together with the standard anticancer agent, cisplatin, can prolong the life of patients with NSCLC, and the cost-effectiveness of the treatment is similar to life-saving treatments for heart disease. The researchers analyzed the use and associated costs of three chemotherapies randomly assigned to 612 European patients with NSCLC. Results showed that patients receiving vinorelbine plus cisplatin lived the longest, a mean of 49.6 weeks, followed by patients treated by vindesine plus cisplatin, 44.3 weeks, and those receiving vinorelbine, 41.6 weeks. Compared with vinorelbine alone, vinorelbine plus cisplatin added nearly two months (56 days) of life at a cost of $2,700 or $17,700 per year of life gained. Vindesine plus cisplatin added 19 days at a cost of $1,150 or $22,100 per year of life gained.

Zarkin, G.A., Garfinkel, S.A., Potter, F.J., and McNeill, J.J. (1995, Fall). "Employment-based health insurance: Implications of the sampling unit for policy analysis." (AHCPR grant HS06732). Inquiry 32, pp. 310-319.

Policymakers will continue to rely heavily on employment-based health insurance data in developing proposals for insurance reform. This article discusses one of the most important yet least recognized and understood aspects of these data—that is, whether the sampling unit should be the enterprise (the complete corporation) or the establishment (a single-location worksite within an enterprise). The authors demonstrate that the choice of sampling unit affects the size distribution of employees between large and small firms, as well as the estimated proportion of firms offering health insurance. Health insurance decisions in multi-establishment enterprises generally are made for the entire enterprise rather than individual establishments. The authors conclude that enterprise surveys are most appropriate for collecting information on the factors affecting the decision to provide health insurance coverage. An establishment-level survey may be preferred for evaluating decisions made at the State, regional, or industry level.

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AHCPR Publication No. 96-0041
Current as of March 1996

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