Reactions of participants to the results of a randomised controlled trial: exploratory study.
OBJECTIVE
To assess views of parents of babies who participated in a neonatal trial, about feedback of trial results.


METHODS
Qualitative analysis of interviews.


METHODS
Parents' homes.


METHODS
Parents of 24 surviving babies enrolled in a UK randomised controlled trial comparing ventilatory support by extracorporeal membrane oxygenation with conventional management.


METHODS
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.
Snowdon
C
C
Medical Statistics Unit, London School of Hygiene and Tropical Medicine, University of London, London WC1E 7HT. CMS1000@cam.ac.uk
Garcia
J
J
Elbourne
D
D
D000328:Adult; D001007:Anxiety; D001294:Attitude to Health; D003142:Communication; D035061:Control Groups; D030881:Disclosure; D004644:Emotions; D015199:Extracorporeal Membrane Oxygenation; D005246:Feedback; D006801:Humans; D007231:Infant, Newborn; D008875:Middle Aged; D010290:Parents / Q000523:psychology*; D017060:Patient Satisfaction; D010865:Pilot Projects; D011369:Professional-Patient Relations; D036301:Qualitative Research; D016032:Randomized Controlled Trials as Topic / Q000523:psychology*; D012106:Research; D035842:Research Subjects; D036302:Therapeutic Human Experimentation