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Disseminating results to clinical trial participants: a qualitative review of patient understanding in a post-trial population.

Abstract：

OBJECTIVE:To identify the most appropriate format for results dissemination to maximise understanding of trial results. DESIGN:Qualitative. SETTING:Of the original 58 4-T trial centres, 34 agreed to take part in this ancillary research. PARTICIPANTS:All participants from these centres were eligible. All 343 participants were sent questionnaires. PRIMARY AND SECONDARY OUTCOME MEASURES:The low response rate meant that we were unable to make any firm conclusions about the patients' preferred method of dissemination; however, we were able to comment on the level of understanding demonstrated by the trial participants. RESULTS:All 40 (12%) returned questionnaires were received from 15 centres. We received no questionnaires from over half of the centres. The questionnaires which were returned demonstrated broad satisfaction with the results letter, general enthusiasm for the trial and a variable level of understanding of the results; however, there was a high proportion of responders who were not clear on why the research was undertaken or what the results meant. CONCLUSIONS:The low response rate may be related to delays during the trial set-up process suggesting that interest in a study quickly wanes for both patients and centres. From this we deduce that rapid dissemination of results is needed if it is to have any impact at all. The responders are likely to reflect a biased cohort who were both enthusiastic about the research and who had a good experience during their 3 years in the 4-T trial. It is perhaps not surprising therefore that the overview is positive. That this population was still not fully informed about the purpose of the research would seem to confirm a low level of understanding among the general public which we suggest should be addressed during the consent process.

journal_name

BMJ Open

journal_title

BMJ open

authors

Darbyshire JL,Price HC

doi

10.1136/bmjopen-2012-001252

subject

Has Abstract

pub_date

2012-09-24 00:00:00

issue

5

issn

2044-6055

pii

bmjopen-2012-001252

journal_volume

2

pub_type

杂志文章

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