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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.
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.
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.
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
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.
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
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.
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.
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
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.
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.
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
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.
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