Surgical innovation and its evaluation.

Early clinical trials, observational or randomized, hasten the prompt evaluation of new operations. Early clinical surveillance facilitates the design and implementation of randomized clinical trials when they are necessary. Of equal or greater importance, long-term surveillance of operations allows continuing evaluation when their use becomes widespread. Standards, coordination, review, and funding of the evaluation of new operations we believe should be centralized in a single national agency, for which an Institute of Health Care Assessment might be created. Implementation and regulation of the evaluation we believe should remain at the local or regional level with existing mechanisms and agencies being used, such as institutional human research committees and local health systems agencies.

Effects of thiopental sedation on learning and memory.

Subjects who were administered thiopental showed a loss of memory for events discussed while they were under sedation. We tested the subjects for recognition memory of pictures and recall of associated pairs of letters and words, and found that the subsequent memory loss was correlated with the concentration of thiopental in the venous blood at the time the material was learned. Retention did not appear to be state-dependent because the subject, while under sedation, could recall material learned prior to sedation, and because recall was not facilitated by reinstatement of the sedation.

Should surgery be regionalized?

The authors suggest that new surgical procedures be carried out initially in selected institutions and that complex procedures for which it has been or can be demonstrated that mortality is inversely related to the volume of experience also be regionalized. Regionalization in the latter instance can have a small overall impact on surgical practice but a large impact on the adverse consequences of high risk operations that are performed only occasionally.

Ivan Illich and the pursuit of health.

Fifty years ago, when medicine had relatively few effective treatments to offer, its value was unquestioned. Twenty-five years ago clinicians had become concerned that treatment could sometimes do harm and McKeown published epidemiological evidence claiming that medicine did little good. This state of affairs was used by Illich to bolster his crusade against technology in general. Today it is clear that medicine now makes a large contribution to health. But doubts still exist and alternative pathways to health are continually exhorted. Large-scale efforts at behavioural modification, encouraging the adoption of healthier lifestyles, have been largely unsuccessful. Social activists now argue that funds should be diverted from medical care to social programmes that, they claim, might contribute more to health. While it is true that health is strongly associated with socio-economic status (income, education and occupation), there is little sense of how best to reallocate scarce resources so as to improve the health impact of social and economic programmes. Social reform is not a substitute for medical care. Rather, our social environment is a second, important but quite separate, determinant of health and well-being.

Is efficacy the gold standard for quality assessment?

"Efficacy"-medical care that is achievable under optimal conditions-is generally considered to be the appropriate standard for quality assurance. In this paper I argue that what is needed is a broadened definition of efficacy that includes the appropriateness of an intervention as well as the level of technical skill used in its provision. To establish efficacy, so defined, I suggest that well-designed nonexperimental, as well as experimental, studies be undertaken that employ registries and data banks, as well as formal clinical trials, and that decision analysis be used to synthesize the results. This will require a significant effort and investment in outcome studies of medical and surgical technologies. With growing recognition by the public that quality can be highly variable-aided by the Health Care Financing Administration's publication of hospital mortality and morbidity data-the medical care system will ignore outcome studies and quality assurance at its own peril.

The President's Commission: do we need a sequel?

KIE: The authors argue that, while the President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research made significant contributions to medical practice, the creation of another commission may reduce or supplant the responsibilities of all federal health agencies to monitor the ethical aspects of their activities. Should the sporadic record of the federal government in this area necessitate the creation of another national body, they propose the creation of a private Institute for Health Care Evaluation, an idea that is also being studied by the nonfederal Institute of Medicine.^ieng

Freedom, responsibility, and health.

Freedom and responsibility, how much of each and how they are balanced, have profound implications for our personal lives and for our work. The health of a population and its achievement in the workplace are enhanced when individuals have some freedom and some responsibility, but not too much of either, and when civil associations of individuals rather than individuals acting alone are the essential social units. The consistent association of social contacts with health and productivity provides strong support for the premise that intimate relationships are the focus around which people's lives revolve. Membership of a "social network" may be merely conforming to a reigning social norm, and this could mean having to pay an important price in the loss of creativity associated with individualism. But social conformity should not prevent individuals from going their own way, and it should be possible to combine the luxury of individuality with an active life in civic affairs. Less than complete freedom may fall short of existential utopia, but it may be best for our health and wellbeing.