BMJ 1998;317:21-26 ( 4 July )

Papers

Reactions of participants to the results of a randomised controlled trial: exploratory study

Claire Snowdon, research fellow, a Jo Garcia, social scientist, b Diana Elbourne, senior lecturer. a

a Medical Statistics Unit, London School of Hygiene and Tropical Medicine, University of London, London WC1E 7HT, b National Perinatal Epidemiology Unit, University of Oxford, Radcliffe Infirmary, Oxford OX2 6HE

Correspondence to: Ms C Snowdon, Centre for Family Research, University of Cambridge, Cambridge CB2 3RF CMS1000{at}cam.ac.uk

Objectives: To assess views of parents of babies who participated in a neonatal trial, about feedback of trial results.
Design: Qualitative analysis of interviews.
Setting: Parents' homes.
Subjects: Parents of 24 surviving babies enrolled in a UK randomised controlled trial comparing ventilatory support by extracorporeal membrane oxygenation with conventional management.
Main outcome measures: Views about contents of results, reactions to results, effect of hindsight, and importance of feedback.
Results: Information about mortality was well understood by the parents but morbidity was less clearly reported. Even when the content was emotionally exacting, the information was still wanted as it removed uncertainty; provided an endpoint to difficult events; promoted further discussion within couples; and acknowledged their contribution to answering an important clinical question.
Conclusions: Feedback of trial results to participants should be a consideration of researchers, but a careful approach is required. This study was based on a highly selective group of parents within a particularly sensitive trial. More research is needed to assess the extent to which these results can be generalised to other trials or to groups such as bereaved parents.

Key messages

  • Feedback of results of randomised controlled trials can be part of an open and inclusive approach to participation in medical research

  • The procedure for offering feedback should be considered at the start of a trial

  • Results should only be sent to people who respond positively to such an offer, and particular attention paid to feedback to potentially vulnerable groups

  • The effect of feedback of sensitive information needs evaluation in a variety of contexts



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Rapid Responses:

Read all Rapid Responses

Parents appreciate honesty from those they are forced to trust
Deborah Millicent Henshall
bmj.com, 6 Jul 1998 [Full text]
Re: Parents appreciate honesty - begs further questions about the research.
Brian Morgan
bmj.com, 10 Jul 1998 [Full text]
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