The National Institutes of Health (NIH) has always carefully limited its responsibilities to biomedical research and knowledge development, including clinical trials, dissemination of results of research, and training. Ten years ago, NIH undertook to examine its possible role in the evaluation of medical technologies.

In 1976, the U.S. Congress became alarmed over the increase in health care costs: in particular, that a number of expensive technologies, such as coronary artery bypass surgery and electronic fetal monitoring, had entered the delivery system without adequate study of their safety, efficacy, cost, or other implications. At the time, there was no formal structure or forum in either the executive branch of the government or in the private sector for seeking a consensus that a medical innovation was actually safe, beneficial, and ready to be transferred into the health care delivery system. Similarly, there was no structured process through which the parties who comprise the delivery system could meet with representatives of the research community to examine the medical-scientific issues surrounding a given innovation along with cost and cost- effectiveness, ethics, and other societal issues of importance to the system.

Though technology assessment and quality assessment have much in common, they differ significantly in emphasis. Technology assessment judges technology itself; quality assessment examines the extent to which a technology is used well in its various settings. This article explores the nature of quality assessment–including the performance of individual practitioners as they care for individual patients and the care received by communities–and examines its interrelationship with technology assessment.

A rapidly evolving technology, percutaneous transluminal coronary angioplasty, is increasingly favored over bypass surgery for treating some types of coronary stenosis because of its less traumatic invasion, better recovery response, and lower initial cost. However, substantially higher failure rates in initial procedures offset PTCA's savings to an unknown extent and cloud analysis of its overall impact. Lack of randomized clinical data precludes valid cost-effectiveness comparison of the technologies at this time. Criteria for establishing valid data and evaluations of currently available data are described in this paper.

The evaluation of innovations which use old technology poses different problems than does the evaluation of new technologies. The main necessity is the targeting of its use rather than the technology itself. The need to evaluate the extent of use and its problems is illustrated by the example of progestin use among menopausal and postmenopausal women in the United States. There progestins are not of ficially approved for use in menopause, even though they have been on the market for a long time with other indications. Estrogen-replacement therapy was widely used from the early 1960s until 1975, when the claim that estrogens cause endometrial cancer notably decreased their use. The use of estrogens increased again in the early 1980s, and one reason for this revival was the claim that progestins offered protection against endometrial cancer. When recommendations for combined estrogen-progestin therapy have been made, other health effects have been ignored. Two consensus conferences as well as the drug control authority have recommended against combined estrogen-progestin therapy until further research is completed. Absence of good research, specialization in medicine, and advantages for prescribers and the drug industry may have contributed to the wide use of this unassessed treatment. Possible solutions for prevention of the diffusion of these kinds of innovations are discussed.

This article reviews milestones in the technological development of mammography since 1970. Mammography is particularly underutilized as a screening procedure for breast cancer and the reasons for its continued inappropriate and under use are explored. Although there are some known barriers to increased utilization among the female adult population, the majority of barriers reside within the domain of referring physicians. Remedies to address the low referral rates for screening mammography are outlined for federal agencies, radiology groups, mammography equipment companies, medical schools, and philanthropic groups. Until the developers of technological procedures such as mammography appreciate that the application of a technology and its appropriate utilization by professionals and the public are important to consider when the technology is developed, utilization rates may not do justice to the technology's potential.

The importance of health technology assessment for developing countries is unquestionable. Although these countries are still plagues by tropical diseases and primary health problems, they have been forced to import modern medical technologies because of internal and international pressures. Recognition of the potentoial of health technology assessment for improving the management of technology and health care delivery in developing countries leads to the critical question of how to promote the development of assessment activities there. But as technology assessment is itself also a technology, it can be assuned that its direct transfer to developing countries in the form that it has unfolded in the richer nations is doomed to failure. How successful transfer of health technology assessment can be achieved is outlined.

This paper discusses several practical problems in research design: Is it worth doing a relatively “quick and dirty” study or is a more thorough study using all available infotmation necessary? All the desired information may either not be available or be time-consuming to collect. What are the likely biases in going ahead and doing the research with the data base “in hand”? Such issues are important because of the limited resources for technology assessment (in terms of money, number of researchers, and research interest) and the great number of unstudies technologies.

Deapite the importance of understanding factors related to physician adoption and use of diagnostiv technologies, relatively few studies have been published. Results of a two-year study of the adoption of magnetiv resonance imaging (MRI) and its substitution for computed tomography scanning (CT) are presented. The literature on physician adoption and use of technologu is used to provide a frame-work for this study. Differences in adoption and substitution among medical specialties, early versus late adopters, and high versus low users of MRI are examined. Results show that neuerologists and internists more rapidly adopt MRI and substitute it for CT than do orthopedists and other surgical specialists. Referral of higher number of patients is the best predictor of more rapid substitution. Physicians who were late adopters more quickly substituted MRI for CT. The cost and social implications of empirical versus “ideal” substitution rates are discussed along with various regulatory, technology assessment, and finicial strategies influence substitution. The role of individual physicians, radiologists, and specialty societies in determining substitution rates is also discussed.

Using combined data from an independent survey by the American Hospital Association and the State of New York, the diffusion of two diagnostic technologies–the automated chemistry analyzer and the computed tomography (CT) scanner–among hospitals in New York State was analyzed. A linearized form of the logistic function was estimated using cumulative diffusion data for each. Diffusion patterns of both technologies fit the logistic curve well, with the coefficient of diffusion for the CT scanner being greater than that for the automated analyzer. Further analysis examined characteristics of early adopters of each technology. Similar hospital characteristics (e.g., high volume of admissions and medical school affiliation) were important in explaining early adoption of both technologies.

We analyze Argentina's demographic and socioeconomic data as the context for understanding its health sector. Health expenditures and the number of physicians are high in Argentina. Health coverage is extensive, but covers only about 50% of the per capita expenditures. The high expenditures in health do not correlate with improvements of indicators such as infant and general mortality. Evaluations of the way health care is provided are insufficient. Argentina's “medical-intensive” model of health is responsible for the expansion of the “small-ticket technology”, which accounts for a significant proportion of the increase in health expenditures. With this picture, we believe that health decision-makers could benefit from cost-effectiveness analysis (CEA), because this technique stresses the relationship between expenditures and appropriately defined goals. As a demonstration project, we look at the way that technology is used in Argentina using CEA to assess anesthesia procedures. The results of our study show that increasing the use of N2O would save us $670,000 per year, and 10,300 years of life to surgical patients of all ages.

In the mid-1970s, after decades of clinical use, the utility of electrocardiographic exercise testing for the evaluation of patients with suspected ischemic heart disease was critically examined and questioned. Concurrent with this critique, two sophisticated, more expensive and powerful “nuclear” exercise tests were introduced sequentially for clinical use: myocardial perfusion imaging with thallium-201 and radionuclide ventriculography with technetium 99m. The published indications for the two tests are similar, and both have been shown to offer advantages over ECG stress testing in selected populations. However, few data are available regarding the comparative utility of thallium versus ventriculographic imaging. As part of a prospective study to assess the efficacy of cardiovascular nuclear medicine studies, we undertook the present analysis to assess the clinical evolution of these tests and to elucidate factors responsible for clinicians' choice for the often competing examinations. The study examined 213 consecutive patient referrals for thallium scintigraphy and 183 referrals for ventriculography, ranging from patients with no symptoms or highly non-specific chest pain syndromes (21% of referrals) to patients with proven coronary disease (28% of the referrals). Twenty-one percent of patients were referred to confirm the clinical impression that the patient did not have coronary disease, 40% to confirm its presence, and 37% to determine its severity.

Analyses were undertaken to determine the factors that dictated a preference for thallium scintigraphy rather than ventriculography; only the physician's intent in testing and level of training were significant predictors for a particular nuclear test.

Despite many gains, the United States could do better in preventing health problems in infants and young children, says the congressional Office of Technology Assessment (OTA) in its new report, Healthy Children: Investing in the Future.

Rep. Henry Waxman (D-Calif.), Chairman, Subcommittee on Health and the Environment, Committee on Energy and Commerce, released the report at a hearing.

An interagency task force would be the best way to coordinate the many research and technology development projects aimed at mapping and sequencing genes, according to a report released by the Office of Technology Assessment at a hearing of the House Committee on Energy and Commerce. The immediate goal of these projects is not to completely understand human genetic information, but to create tools and lay a foundation to understand human genetics in the 21st century, OTA reports.

The Council on Health Care Technology of the Institute of Medicine, National Academy of Sciences, has published the Medical Technology Assessment Directory. The 712 page directory is an extensive compilation and description of activities in the field.

The publication is designed to help crystallize the subject matter of medical technology assessment and to identify and serve the emerging network of individuals, organizations, and institutions that generate and use technology assessments. The directory provides access to assessment people, programs, and resources to keep users up to date on developments in the field. It should be useful for reviewing available assessments of a particular technology before beginning an assessment project or making a decision on coverage, reimbursement, acquisition, medical practice, or standard setting.

The directory includes profiles of 68 assessment programs and a total of approximately 3,200 bibliographic citations of their assessment reports. These programs are located in public and private sector organizations, including professional, scientific, and industry associations, biomedical research institutions, educational institutions, government advisory bodies, regulatory agencies, third party payers, policy institutes, and for-profit corporations.

Human growth hormone (GH) has until recently been prepared commercially from pituitary glands collected at autopsy. Availability has been limited and cost high, so the indications for GH treatment have had to be “tight.” Owing to recent development in hybrid DNA technology, the availability of GH has increased dramatically. At the same time, the manufacturers have maintained constant prices, so that treatment costs continue to influence decision making about its use. This rapid transition has generated an interesting change of strategy, which is outlined in this review.

Herpes viruses are responsible for a wide spectrum of infections ranging from cold sores, genital herpes, and chicken pox to disseminated herpes infections in normal and more commonly in immunocompromised patients. Symptoms range from mildly distressing and uncomfortable to severe and life-threatening. The sophistication of virological methods is increasing. Specific types, classes, and subclasses of antibodies to viruses can now be determined, as well as the reactivity of T-lymphocytes. It is possible to detect herpes virus type-specific antibodies (to HSV-l or HSV-2) in a blood sample using the simple and inexpensive enzyme-linked immunosorbent assay (ELISA). The virus is usually type-determined rapidly and currently susceptibility or resistance to antiviral compounds can be defined in vitro. Such assays of antiviral resistance have been shown to be quick and effective. Effective antiviral therapies have been developed against a number of viral diseases. The concomitant need for isolation and evaluation of resistance patterns of herpes virus against different antiviral compounds appears to be of considerable importance. Pure clinical observations are no longer sufficient to distinguish the types, since HSV-l may be present in the genital region and HSV-2 at upper parts of the body–contrary to common belief.