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Informing participants of allocation to placebo at trial closure: postal survey

Di Blasi, Z, Kaptchuk, T.J., Weinman, J. and Kleijnen, J. (2002) Informing participants of allocation to placebo at trial closure: postal survey. BMJ. pp. 1329-1331. ISSN 0959-8138

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Abstract

OBJECTIVES: To assess whether and how investigators of placebo controlled randomised trials inform participants of their treatment allocation at trial closure and to assess barriers to feedback. DESIGN: Postal survey with a semistructured questionnaire. PARTICIPANTS: All investigators who published a placebo controlled randomised trial in 2000 in five leading medical journals, and a random sample of 120 trials listed in the national research register database. MAIN OUTCOME MEASURES: Number of investigators who informed participants of their treatment allocation at trial closure, methods for delivering the information, and barriers to unmasking treatment. RESULTS: 45% of investigators informed either all or most participants of their treatment allocation, and 55% did not inform any participant or only informed those who asked. The main reasons for not informing participants were that the investigators never considered this option (40%) or to avoid biasing results at study follow up (24%). CONCLUSION: Further research is required to examine sensitive ways to communicate treatment information to trial participants.

Item Type: Article
Copyright, Publisher and Additional Information: © 2002 BMJ Publishing
Academic Units: The University of York > Centre for Health Economics (York)
Depositing User: Repository Officer
Date Deposited: 13 Oct 2004
Last Modified: 17 Oct 2013 14:31
Published Version: http://dx.doi.org/10.1136/bmj.325.7376.1329
Status: Published
Refereed: Yes
Related URLs:
URI: http://eprints.whiterose.ac.uk/id/eprint/135

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