Reactions to treatment debriefing among the participants of a placebo controlled trial

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dc.contributor.author Di Blasi, Zelda
dc.contributor.author Crawford, Fay
dc.contributor.author Bradley, Colin P.
dc.contributor.author Kleijnen, Jos
dc.date.accessioned 2011-03-15T16:18:12Z
dc.date.available 2011-03-15T16:18:12Z
dc.date.issued 2005-04-22
dc.identifier.citation Di Blasi Z, Crawford F, Bradley C, Kleijnen J., 2005. Reactions to treatment debriefing among the participants of a placebo controlled trial. BioMed Central Health Services Research, 5 , pp.30-38. en
dc.identifier.volume 5 en
dc.identifier.startpage 30 en
dc.identifier.endpage 38 en
dc.identifier.issn 1472-6963
dc.identifier.uri http://hdl.handle.net/10468/248
dc.identifier.doi 10.1186/1472-6963-5-30
dc.description.abstract BACKGROUND: A significant proportion of trial participants respond to placebos for a variety of conditions. Despite the common conduct of these trials and the strong emphasis placed on informed consent, very little is known about informing participants about their individual treatment allocation at trial closure. This study aims to address this gap in the literature by exploring treatment beliefs and reactions to feedback about treatment allocation in the participants of a placebo-controlled randomized clinical trial (RCT). METHODS: Survey of trial participants using a semi-structured questionnaire including close and open-ended questions administered as telephone interviews and postal questionnaires. Trial participants were enrolled in a double-blind placebo-controlled RCT evaluating the effectiveness of corticosteroid for heel pain (ISRCTN36539116). The trial had closed and participants remained blind to treatment allocation. We assessed treatment expectations, the percentage of participants who wanted to be informed about their treatment allocation, their ability to guess and reactions to debriefing. RESULTS: Forty-six (73%) contactable participants responded to our survey. Forty-two were eligible (four participants with bilateral disease were excluded as they had received both treatments). Most (79%) participants did not have any expectations prior to receiving treatment, but many 'hoped' that something would help. Reasons for not having high expectations included the experimental nature of their care and possibility that they may get a placebo. Participants were hopeful because their pain was so severe and because they trusted the staff and services. Most (83%) wanted to be informed about their treatment allocation and study results. Over half (55%) said they could not guess which treatment they had been randomized to, and many of those who attempted a guess were incorrect. Reactions to treatment debriefing were generally positive, including in placebo responders. CONCLUSION: Our study suggests that most trial participants want to be informed about their treatment allocation and trial results. Further research is required to develop measure of hope and expectancy and to rigorously evaluate the effects of debriefing prospectively. en
dc.description.sponsorship Medical Research Council, United Kingdom (Health Service Research Council studentship) en
dc.format.mimetype application/pdf en
dc.language.iso en en
dc.publisher BioMed Central Ltd. en
dc.relation.uri http://www.biomedcentral.com/1472-6963/5/30
dc.rights © 2005 Di Blasi et al; licensee BioMed Central Ltd. en
dc.rights.uri http://www.biomedcentral.com/info/about/license en
dc.subject Randomized Controlled Trials as Topic/methods en
dc.subject.lcsh Clinical trials -- Evaluation en
dc.subject.lcsh Communication in medicine en
dc.subject.lcsh Placebos (Medicine) en
dc.subject.lcsh Patient participation en
dc.subject.lcsh Patient satisfaction en
dc.title Reactions to treatment debriefing among the participants of a placebo controlled trial en
dc.type Article (peer-reviewed) en
dc.internal.authorurl http://publish.ucc.ie/researchprofiles/A011/zdiblasi/ en
dc.internal.authorurl http://publish.ucc.ie/researchprofiles/C013/cbradley en
dc.internal.authorcontactother Zelda Di Blasi, Applied Psychology, University College Cork, Cork, Ireland. +353-21-490-3000 Email: z.diblasi@ucc.ie en
dc.internal.authorcontactother Colin P Bradley, Dept of General Practice, University College Cork, Cork, Ireland. Email: c.bradley@ucc.ie en
dc.internal.availability Full text available en
dc.internal.webversions http://www.ncbi.nlm.nih.gov/pubmed/15847683
dc.date.updated 2011-03-14T19:27:43Z
dc.description.version Published Version en
dc.internal.rssid 357327
dc.contributor.funder Medical Research Council, United Kingdom en
dc.contributor.funder Chief Scientist Office, Scotland en
dc.description.status Peer reviewed en
dc.identifier.journaltitle BioMed Central Health Services Research en
dc.internal.copyrightchecked RoMEO en
dc.internal.IRISemailaddress z.diblasi@ucc.ie en


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