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Patient Preference and Validity of Randomized Controlled Trials
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To the Editor: Dr King and colleagues1 concluded that there is little evidence that preferences affect trial validity. However, as these were observational comparisons, any preference effects in these trials may have been confounded by characteristics associated with preference. We believe that a better approach to observing the role of patient preferences on study outcomes is to accept that a significant proportion of patients who consent to randomization will have a treatment preference, particularly for the novel therapy.2-3 We ask patients preferences before randomization and then randomize all consenting patients irrespective of their baseline preferences. In this way we can examine within the safety of a completely randomized design whether there is an interaction between baseline preference and outcome. We recommend that preferences be measured at baseline before random allocation in all studies where preference may affect the outcome.
David Torgerson, MSc, PhD
djt6@york.ac.uk Department of Health Sciences University of York York, England
Jennifer Klaber Moffett, MSCP, PhD
Institute of Rehabilitation University of Hull Hull, England
1. King M, Nazareth I, Lampe F, et al. Impact of participant and physician intervention preferences on randomized trials: a systematic review. JAMA. 2005;293:1089-1099.
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2. Torgerson DJ, Klaber Moffett J, Russell IT. Including patient preferences in randomised clinical trials. J Health Serv Res Policy. 1996;1:194-197.
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3. Klaber Moffett JA, Jackson DA, Richmond S, et al. Randomised trial of brief physiotherapy intervention compared with usual physiotherapy for neck pain patients: outcomes and patients preferences. BMJ. 2005;330:75.
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Letters Section Editor: Robert M. Golub, MD, Senior Editor.
JAMA. 2005;294:41-42.
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