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

Full text available as:

Preview

Text (kleijnenj1.pdf) kleijnenj1.pdf Download (221Kb)

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:	19 Feb 2013 12:00
Published Version:	http://dx.doi.org/10.1136/bmj.325.7376.1329
Status:	Published
Refereed:	Yes
Related URLs:	http://bmj.com/cgi/content/full/325/7376...
URI:	http://eprints.whiterose.ac.uk/id/eprint/135

Actions (login required)

View Item