This article is concerned with principles that might help to ensure that procedures and tools used in primary care are appropriate to people's needs and expectations. It urges attention, not first to technology, but to the broad range of purposes served by primary care and to the relevance of procedures to them. Other criteria for ensuring appropriateness are also proposed.

Review of a large data base on 76 patients who had suffered head injuries and whose metabolic changes were being studied demonstrated the variability of their neurological courses and the importance of considering confounding factors in the analysis of such a group. It was apparent that many such patients continue to change neurologically and functionally for long periods of time, and that their ultimate outcome cannot be determined for at least 1 year. The study demonstrates the inherent complexity of a group of patients with head injuries and the need to use sophisticated statistical tools and a computer to demonstrate whether apparent trends are statistically valid in light of confounding factors and variabilities. Failure to take this complexity into account seems to be a major factor in many of the ongoing controversies in research on head injuries. A possible solution to the problem of potential biases introduced by lost patients would be to develop a method to use government records to obtain current addresses for patients involved in federally funded research.

The benefit for patients with operable breast cancer treated with adjuvant systemic therapy is small, if reduction of early mortality within the context of randomized control trials is used for treatment comparison. One might consider that the 75%–85% of patients who die despite treatment are overtreated, as are patients who remain alive even without therapy within a given time frame. Larger treatment benefits in terms of avoided or delayed breast cancer relapse have been demonstrated even at early phases of follow-up in the vast majority of adjuvant trials. Exposure of all patients to adjuvant therapy at a time at which no symptoms of disease are present is detrimental in terms of quality of life.

Based on our assumption that the quality of life of the patient is typically altered both by subjective toxic effects of adjuvant treatment and by the appearance of relapse, we developed a method of comparing treatment effects in terms of time without symptoms of disease and toxicity of treatment (TWiST). Because the impact of treatment on relapse rates appears earlier than survival effects in all adjuvant therapy trials, and because the value of time without relapse in terms of the quality of life of the patients is as yet poorly defined, we have generalized our method of comparing treatment attitudes to include individual qualitative judgment values. The experience gained from integrating quality-of-life issues into clinical trials for breast cancer might also be applied to other diseases characterized by a chronic course, toxic treatments, and gains in periods of relative or absolute freedom from toxic effects and progressive disease.

This article examines the meaning of appropriate technology in the World Health Organization's comprehensive definition of primary care. The author concludes that broad-ranging aspects of health maintenance, such as public health, personal lifestyles, and scientific research, as well as traditional diagnostic and therapeutic practices, need to be subjected to clear and careful scrutiny. It is vital that the results of these technology assessment studies be disseminated as widely as possible to both health care professionals and the public.

Current practices of donor recruitment for medical fertilization procedures are analyzed in the light of Marcel Mauss' essay on the gift in primitive societies. In this perspective, donor policies seem primarily designed to spare infertile recipients the obligation to recognize the donor's contribution to these procedures, thus avoiding the kinship issues that they raise. Questions of meaning concerning donation, social recognition of the donor's role, and clarification of the relational issues underlying fertilization procedures are nevertheless essential elements in establishing their social legitimacy.

The Cancer Research Campaign (CRC) Trial demonstrates a decreased incidence of local recurrence for patients randomized to prophylactic radiotherapy following mastectomy. Irradiated patients alive after 5 years, however, have a small increased risk of dying from causes other than breast cancer. How to estimate the cost-benefit of such therapy is discussed.

A colorimetric instrument for the noninvasive quantification of hemoglobin, designed using color shades resembling those observed in the conjunctiva, was tested. The instrument's colors are contrasted against the color of the conjunctiva to measure hemoglobin content. Sensitivity, specificity, negative predictive value, and false-negative value were estimated to test the instrument's accuracy; kappa coefficients were used to estimate inter- and intraobserver variability. Physician field evaluations of conjunctiva color for the screening of anemia, reported in the literature, have had sensitivities and specificities as high as 70%. Readings with the instrument demonstrated a 63% sensitivity, 72% specificity, and 38% false negatives for screening hemoglobin values of less than or equal to 13 g/dl. The interobserver kappa coefficients for three pairs of readers were good to excellent for the same hemoglobin screening value. Statistically significant differences were noted, however, between observers during the reliability test. The instrument can be used by unskilled personnel to improve their decision-making about whom to send for futher care or for supplementation with iron.

Of the four randomized controlled trials of mass mammography completed to date, the New York HIP trial used obsolete technology and was not designed to assess mammography in the absence of physical examination; the Swedish Two-County trial had serious methodological flaws; the U.K. trial was incompletely documented but showed no significant benefit; and the Malmö trial, which was perfect in design and execution, showed no benefit.

Paradoxicially, with each successive trial and an increasing sophistication of mammography, the benefit of screening was becoming not greater but less. This may be summarized by comparing the number of women who would have to be offered mammography for one breast cancer death prevented or postponed in the respective trials: 5,000 in the HIP trial, 13,000 in the Two-County trial, 18,000 in the U.K. trial, and 68,000 in the Malmä trial.

The enthusiasts in favor of mass mammography have created an atmosphere of false optimism. They have not informed the public about the very small potential benefit nor about the risks associated with screening, especially the risks of false positive diagnoses and of unnecessary surgical operations. This is an unacceptable situation, and the ethical vacuum in which population screening takes place needs to be filled with guidelines to protect women who are “targeted” for screening.

This article highlights some of th issues ralsed by technology and primary health care (PHC) in the Western lndustrialized world. The author contends that while technology assessment has been focused mostly on hospital-based technology, the wider scope of PHC demands comprehensive assessment projects that would examine virtually every aspect of public health.

Coronary bypass surgery developed as another in a line of surgical procedures dating back more than 60 years. The medical profession at first assessed this procedure with time-honored anecdotal techniques. Gradually, for a variety of reasons, improved methods of comparisons worked their way into assessments of bypass surgery. Randomized controlled trials met resistance but have been very influential. Assessment of percutaneous transluminal coronary angioplasty has benefited from the knowledge generated during the last 25 years, but clinicians have been slower to apply the most advanced techniques.

This article presents an overview of technology assessment in the United States. The authors argue that while there are numerous institutions carrying out assessments, the United States requires an overall plan that would provide a national system for technology assessment. If technology assessment were more organized and systematized, the authors argue, it would be more efficient and would reach the public and the medical world effectively.

Carotid endarterectomy and EC/IC bypass grafting have been widely adopted for patients considered at risk from stroke, without good evidence of efficacy. Unjustified claims for surgery usually derive from overestimating the dangers of the disease without surgery, while perioperative risks are underestimated. Inadequate follow-up and choosing irrelevant outcome measures often add to the confusion. All these factors apply to surgery for stroke. A trial of EC/lC bypass in 1,377 patients from three continents took 8 years to complete and showed no benefit in patients randomized to surgery. Reluctance to accept this result led to detailed critiques of this trial in several journals, largely based on the discovery that many patients had been operated on in some centers without having been randomized. In reply, the investigators showed that these cases did not affect the “resounding negativity of the results.” Lack of good data about the prognosis of patients with TlAs or minor strokes was the fundamental reason for so much misplaced surgical effort. This applies equally to carotid endarterectomy, for which large trials are currently being completed. Had there been a reliable data base of patients at risk of stroke, prospectively collected and followed, the efficacy of these two operations could have been determined much sooner, and inappropriate diffusion might have been prevented.

In 1977, in the middle of a protracted debate on the costs and methods of paying for health care, the federal minister for health established a Committee on Applications and Costs of Modern Technology in Medical Practice. In 1978, the committee produced its report, which reviewed a number of cost containment strategies, including the reduction or regulation of fees paid to medical practitioners for specific procedures. It recommended that a national panel be established to collect information on medical technology and advise on its introduction in Australia.

In 1982, the National Health Technology Advisory Panel (NHTAP) was created to identify and examine existing and emerging medical technology, to determine methods and priorities for assessment, and to make recommendations to the minister for health with respect to assessment and funding of new technology.