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Receiving a summary of the results of a trial: qualitative study of participants' views

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journal contribution
posted on 19.09.2006, 13:22 by Mary Dixon-Woods, Clare J. Jackson, Kate C. Windridge, Sara Kenyon
Objective: To explore trial participants’ responses to receiving a summary of the results of a trial in pregnancy. Design: Qualitative study with semistructured interviews. Participants: 20 women who had when pregnant participated in the ORACLE trial of antibiotics for preterm labour and preterm rupture of the membranes and requested a copy of the trial results. Results: Less than a fifth of women who participated in the ORACLE trial indicated that they wished to receive the trial results. Reactions to the leaflet summarising the trial results were generally positive or neutral, although some women had difficulty in understanding the leaflet, and there was evidence of possible negative implications for women who had adverse outcomes. Women requested the results because they were interested in being able to complete their own personal narrative. They wished to know to which arm of the trial they had been allocated and the implications for their own pregnancy, and they were disappointed with receiving a generic summary.Women’s accounts indicated some confusion about the trial findings. Conclusions: Recommendations that research participants be routinely provided with the results of studies have been made without the benefit of research to show the consequences of doing this or how it should best be managed. Caution is needed, as is more evaluation of how feedback of results should be handled, and assessment of the risks, benefits, and costs.

History

Citation

British Medical Journal, 2006, 332 : 206

Version

VoR (Version of Record)

Published in

British Medical Journal

Publisher

BMJ Publishing Group Ltd

issn

0959-8138

eissn

1756-1833

Copyright date

2006

Available date

19/09/2006

Publisher version

http://www.bmj.com/content/332/7535/206

Notes

First published online on 9th January 2006 (doi:10.1136/bmj.38675.677963.3A)

Language

en

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