Is it any good? The evaluation of therapy by participants in a clinical trial.
Research into patients' perspectives on treatments, in concentrating on their compliance with medically prescribed regimens, have taken bio-medicine's evaluation of therapeutic efficacy and benefit for granted. This paper suggests that the clinical trial, the predominant method of evaluation, should become the object of research attention. Clinical trials of hyperbaric oxygen therapy for multiple sclerosis have failed to show any therapeutic benefit: people who themselves have the disease have however continued to employ it, arranging its delivery for themselves. This study focuses on the decision by a small number of participants in one such clinical trial whether or not to continue using the therapy afterwards. On the basis of in-depth interviews, concerning how the participants evaluated the therapy and came to their decision, it is suggested that at least in the case of this therapy and this condition, the assumptions inherent in the trial method, and its concept of genuine therapeutic benefit, structures the conclusions of the trial in a way that is profoundly at variance with the participants' own methodological assumptions and concept of benefit. Inter alia, the study challenges the view of patients as being inevitably driven by their disregard of proper scientific method to an unreasoning optimism in their assessments of possible treatments.
Wynne
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Brunel-ARMS Research Unit, Department of Human Sciences, Brunel University, Uxbridge, Middlesex, England.
D002986:Clinical Trials as Topic; D003258:Consumer Behavior; D003657:Decision Making; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D006931:Hyperbaric Oxygenation / Q000592:standards*; D008297:Male; D009103:Multiple Sclerosis / Q000523:psychology* / Q000628:therapy; D010349:Patient Compliance; D010358:Patient Participation; D011788:Quality of Life