The use of equipoise in clinical trials.

Randomised control trials (RCTs) are the standard method for treatment evaluation. Unfortunately RCTs are inherently difficult to recruit for, precisely because of the randomisation element that makes them so statistically attractive. Problems of low recruitment are now beginning to impact on trials, with many either not being started or being forced to stop, due to lack of participation. This paper examines one issue that bears on the recruitment problem: equipoise. Equipoise is defined as the point where a rational, informed person has no preference between two (or more) available treatments (Lilford and Jackson, 1995). The use of equipoise as the fundamental criterion for eligibility for a trial seems to impose a hurdle to recruitment. Here we examine the various arguments surrounding its use and measurement. We conclude that effective equipoise based upon constructed "zones of indifference" offers the best chance for bridging the gap between the individual's right to decide and the need for clinical trials to benefit society.

Qualitative medical sociology: what are its crowning achievements?

Doctors and epidemiologists seldom read or cite qualitative medical sociology; it is little published in medical journals. A large number of articles bewail this lack and provide arguments explaining and justifying the subject. Any examples used in such articles are selected ad hoc. We made a systematic search for the literature and used citation analysis to select the world's top 100 articles. We analysed this trawl and provide resumés of a selection from the 'classics'. Mental health and the organization of medicine are the themes within medical sociology with highest impact. Much highly cited work consists of historical and theoretical analysis done 'at the desk' rather than observation or interview 'in the field'. Citation rates, even for the most famous works in medical sociology, are a small fraction of those for high impact biomedical research.

Epidemiology of research into interventions for the treatment of osteoarthritis of the knee joint.

OBJECTIVE: To assess the published research base for interventions for osteoarthritis of the knee, and to identify areas in need of further research. METHODS: Literature searches were conducted on electronic databases (Medline, Embase, ISI, and Cochrane library), bibliographies of existing review articles were hand searched, and a postal questionnaire was sent to members of the Osteoarthritis Research Society International. All relevant articles were copied and searched for treatment type, study methodology, statistical results, conclusions, funding source, researcher affiliations, and year of publication, using a predetermined data extraction form. RESULTS: There have been marked changes in the literature over the period studied (1950-98), with a recent rise in trials of physical therapy, educational interventions, and complementary treatments. However, overall, most research was either drug (59.1%) or surgically (25.6%) related. Most of the studies reported positive results (94%). Research on oral drugs was significantly more likely to provide a positive result than research on any other intervention (p<0.001 by chi(2) test). Commercially funded studies were significantly more likely to produce a positive result than non-commercially funded research (p=0.0027 by chi(2) test). CONCLUSIONS: Analysis of time trends indicates that the research agenda does shadow changes in consumer demands. However, there are significant gaps in the research base that need to be considered.

Who should have priority for a knee joint replacement?

OBJECTIVES: To explore patients' views on who should have priority for total knee replacement (TKR). METHODS: In-depth, semistructured interviews were conducted with 25 patients on the waiting list for a TKR. RESULTS: All participants were willing to comment on waiting lists and prioritization for TKR. Two major themes emerged: what they thought should happen, and what they thought did happen. They thought that priority should be based on length and degree of suffering, pain severity, immobility, paid employment, payment of National Insurance contributions, and caring for dependants. In contrast, they thought that what actually happened depended on age and weight, excessive complaining and access to private practice. CONCLUSIONS: The participants agreed with health professionals that pain and disability should be key criteria on which to prioritize people for a TKR. However, they also argued for a fair decision-making process that also included additional factors specific to the patient's circumstances. Criteria to aid prioritization for joint surgery need to accommodate the views of patients as well as professionals.