Decision-making in surgical practice is a highly complex interaction between the client (patient) and his or her professional advisor (surgeon). The client approaches the professional advisor full of expectations and fears. The expectations may be realistic or unrealistic, and, in the same way, the fears may be justified or unjustified. Furthermore, the client may have a variety of priorities not immediately apparent to the surgeon and may wish to express different degrees of autonomy. For example, some patients may demand the final say in determining the balance between length and quality of survival, whereas others would be happy to allow complete abrogation of their responsibilities to the surgeon, who is invited to make the difficult decisions concerning the patient's utilities. From the viewpoint of the surgeon, the transaction is equally complex, and his or her decisions may be constrained by resource allocation and time available. However, in the final analysis, assuming a beneficent doctor, the most appropriate decision will be determined by the weight of evidence that can be adduced in favor of any intervention.

Public health care systems in countries all over the world are confronted with increasing difficulties. The problems are mainly economic, but they also reflect difficulties of adaptation to changes both in society as a whole and within the health care services.

The atmosphere of a crisis results from internal struggles within the health care system and with other welfare and social services that face economical difficulties, while confronting accelerated demographical, social, technological, and cultural changes.

The situation is more acute because of the inability of modern society to provide the public health care system with resources (human and financial) according to the expectations that have developed in the welfare state since the end of World War II.

New welfare policy, adjusted to the changes that occur within the society, is needed. In this struggle, the public health services find themselves in the center of the discussion as one of the whole of public social services and in competition with other public welfare systems.

Economical and organizational problems are the most acute and attract a great deal of interest, and they are amply discussed in many articles and conferences. I shall not deal with them in this article.

In 1899, Charles H. Duell, Commissioner of the U.S. Office of Patents, urged President McKinley to abolish the Patent Office by saying, “Everything that can be invented has been invented.” Fortunately for the health care industry, there have been more significant “medical inventions” in the 89 years following Duell's utterance than in all of recorded history preceding it.

There is now a crisis in medical technology, and it has not been caused by a lack of ideas from innovative clinicians, inventors, and scientists. Instead, it is a result of sincere, but often spasmodic, efforts to control health care costs, which in the minds of many observers threaten the national economy, if not the country's survival.

The growing attention paid to the evaluation of health care has focused on hospitalbased techniques. Meanwhile, a variety of diagnostic, therapeutic, and administrative technologies have become important, though inadequately understood, additions to diverse health care settings outside of the hospital – notably ambulatory care centers, physicians' offices, and the home. This special section is devoted to an analysis of the technology used in these settings, particularly in the context of primary care.

This article is a review of liver transplantation in adults, in the context of ongoing technology assessments of the National Institutes of Health (NIH). Liver transplantation in adults has become an accepted therapeutic procedure for end-stage liver disease, as it is practiced in established programs of a number of experienced institutions. The number of medical centers instituting programs of liver transplantation has greatly increased since the 1983 NIH Consensus Conference on this subject, and this article traces the clear relationship between the experience level of the institution and the end result of adult transplantation. Five determinants of the survival rate, safety, and efficacy of liver transplantation are discussed: the supply of donor organs, the selection criteria for transplantation candidates, surgical technique, the support system and support staff available, and adequate suppression of the immunological response. Medical diagnoses most likely to produce successful results are enumerated.

The very title - “Expensive Medical and Surgical Technology” - expresses in coded form a myth that is widely prevalent among those who consider the political and economic aspects of health care. Strangely, it is a myth that finds favor mainly at the extreme ends of the range of attitudes toward health care. Monetarists see it as an incentive toward increasing private provision of health care, while extreme egalitarians see it as another example of unjust privilege. The content of the myth is that there is a definable group of costly procedures, which can somehow be isolated from the general practice of medicine and surgery, after which such procedures can either be made the subject of special private provision or, alternatively, discarded from a rationed system of health care.

This article describes criteria used by several organizations to select technologies for assessment and the factors that are common to most lists of criteria. It presents a framework or model (called TAPSS) that relates the most important factors. The model can be used to estimate the expected impact of an assessment on health and economic outcomes for a population. It incorporates information on such factors as the health and economic importance of the disease addressed by the technology, the expected impact of the technology on health and economic outcomes, variations in the technology's current use, and factors affecting the production and reception of an assessment. The article includes an example of an application of the method—screening for maple syrup urine disease.

It has been suggested that preoperative total parentetal nutrition may be used to reduce the risk of nutrition-associated postoperative complications in high-risk patients. These patients can be identified based on their nutritional status. The efficiency of this intervention is assessed using the technique of cost-utility analysis. Data from multiple sources is integrated to perform the economic assessment.

The cost-utility ratios for treating several malnourished patients with localized upper gastrointestinal cancer are below $40,000. These cost-utility ratios compare favorably with published results of other programs. The ratios increase considerably if patients who are better nourished (at lower risk of postoperative complication) receive the intervention. The analysis is very sensitive to the efficacy of the intervention.

This article examines technology in primary care and its implications for technology assessment. Following an overview of the primary care setting and the importance of medical technology to primary care providers, the article identifies the new decisionmakers in medicine who both direct and respond to technological change in primary care, focusing, in particular, on their needs for information on primary care technologies. Furthermore, new methodologic issues for technology assessors are posed and examined. Finally, the authors offer conclusions about the need for changes in technology assessment and speculate about its future in primary care.

This article enumerates and describes the wide range of sites at which primary care is now offered; analyzes the impact of diagnostic testing procedures used in locations outside the doctor's office, such as imaging centers, hospices, and nursing homes; and looks at the effect of this decentralization on patients and medicine.

Magnetic resonance imaging (MRI) is a high-cost, new technology with great potential for improving patient care. The lack of a coherent public policy for MRI, or its predecessor computed tomography (CT), has caused considerable problems. Lack of an enunciated public policy has led to inconsistent reimbursement and reimbursement levels that develop in haphazard ways. Furthermore, diffusion has been unpredictable and has led to geographical excesses and deficiencies.

Technology assessments of MRI, although numerous, have used inconsistent criteria to rate MRI's clinical efficacy. The lack of methodologically sound studies of MRI severely hampered early evaluation. This article examines these problems and suggests that the medical profession take a stronger leadership role in developing policies for expensive, promising new diagnostic technologies. The profession should promote, demand, and perform rigorous clinical evaluations of new technologies, and help develop a consensus regarding the criteria for what constitutes a clinically valuable advance in diagnostic technology.

The use of new therapeutic and diagnostic technologies has become commonplace in modern medical practice. To avoid both clinical disappointment and the waste of money, health, and lives, the introduction of these technologies will have to be based on evidence that these technologies will do more good than harm. The evidence supporting their use should be derived using research methods designed to deal with placebo effects, confounders, and biases. Some of these methods, and the rationale for their use, are discussed in this article. Although the value of evidence derived from randomized controlled trials is stressed, the importance of reviewing critically the methodological details of such trials and interpreting their results with caution is emphasized. The benefits and risks of relying on case-control and cohort studies are reviewed.

When it is well conducted, a randomized clinical provides the strongest evidence available for evaluating the comparative effectiveness of the interventions tested. Over the last two generations, we have learned much about various devices for strengthening them and about methods of avoiding between in their design, execution, analysis, and reporting. In a trial, we seek evidence for a causal link between treatment and observed outcomes. Becaues the controlled trial depends on an argument based on exculsion (i.e., no other causes or differences affected the experimental groups), we strengthen its inference by taking steps to exclude any such differences.

This article discusses a number of issues that deserve consideration: problems of multiplicity and generalizability, devices for strengthening trials, issues of power and sample size, the relationship between study design and reported gains, when to undertake a trial, the role of collaborative trials, and ways to make trials more feasible in clinical settings.

Technology assessment involves application of the scientific method to the practice of medicine. Finding all of the assessment reports in a given field is not an easy task. Proper evaluation of those assessments requires the conduct of a prospective experiment in which the sources and results are blinded when the choice is made of papers to exclude and to include, and the process should be carried in duplicate. There are several available data bases for carrying out the search, but because of problems they should be supplemented by reference to the bibliographies of pertinent published articles. Clinical trials included in meta-analyses should be graded by quality and thus facilitate sensitivity analyses. Attention must be paid to the possibility of publication bias. Finally, the advent of meta-analysis makes it desirable to begin randomized controlled trials in areas of uncertainty, even when there is no possibility that individual investigators will encounter enough patients to draw valid conclusions.

An inventory of the availability of medical devices and laboratory tests at primary health care centers in Sweden is reported. The availability is shown to depend on a number of medical, economic, societal, and organizational factors describing primary health care. Technical performance of devices, risk management, and training of users need special attention with regard to these applications.

This article considers the distinction between “explanatory” and “pragmatic” aims in clinical trials—the distinction between testing a biological hypothesis and providing evidence to permit a choice between alternative treatment policies. The choice of treatments to compare, the selection of patients for the trial, the study size, and how the treatment comparison should be made are among the matters discussed. In general, where explanatory and pragmatic aims conflict, the pragmatic aim will often take priority.

Medical-technical possibilities are often experienced as being strongly compelling. This imperative character of medical technology not only applies to the medical profession, but also to patients who frequently find it very difficult to refuse medical examinations or treatments. This article discusses the technological imperative with regard to patients. It attempts to discover relationships with decision theory, particularly concerning “anticipated decision regret:” The fact that prevention of regret plays an important role in the use of medical technology is illustrated through a number of examples: liver transplantation, prenatal diagnosis, screening, and in vitro fertilization.