Are Randomized Controlled Trials Controlled? Patient Preferences and Unblind Trials

The most reliable information about treatment effects comes from randomized controlled trials (RCTs). However, the possibility of subtle interactions—for example, between treatment preferences and treatment effects—is generally subordinated in the quest for evidence about main treatment effects. If...

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Bibliographic Details
Published inJournal of the Royal Society of Medicine Vol. 90; no. 12; pp. 652 - 656
Main Authors Mcpherson, Klim, Britton, Annie R, Wennberg, John E
Format Journal Article
LanguageEnglish
Published London, England SAGE Publications 01.12.1997
Royal Society of Medicine
Subjects
Biological and medical sciences
Epidemiology
General aspects
Humans
Medical sciences
Methodology
Models, Theoretical
Patient Satisfaction
Public health. Hygiene
Public health. Hygiene-occupational medicine
Randomized Controlled Trials as Topic
Research Design
Treatment Outcome
Performance evaluation
Correlation
Randomization
Treatment efficiency
Statistical model
Theoretical study
Patient
Biological effect
Psychological effect
Epidemiology
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Summary:The most reliable information about treatment effects comes from randomized controlled trials (RCTs). However, the possibility of subtle interactions—for example, between treatment preferences and treatment effects—is generally subordinated in the quest for evidence about main treatment effects. If patient preferences can influence the effectiveness of treatments through poorly understood (psychological) pathways, then RCTs, particularly when unblinded, may wrongly attribute effects solely to a treatment's physiological/pharmacological properties. To interpret the RCT evidence base it is important to know whether any preference effects exist and, if so, by how much they affect outcome. Reliable measurement of these effects is difficult and will require new approaches to the conduct of trials. In view of the fanciful image with which such effects are portrayed and the uncertainties about their true nature and biological mechanisms, existing evidence is unlikely to provide sufficient justification for investment in trials. This is a Catch 22. Until an escape is found we might never know, even approximately, how much of modern medicine is attributable to psychological processes.
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ISSN:0141-0768
1758-1095
DOI:10.1177/014107689709001205