Reactions of Participants to the Results of a Randomised Controlled Trial: Exploratory Study
BMJ (British Medical Journal). 1998 Jul 4; 317(7150): 21-26.
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.
Attitudes; Communication; Comparative Studies; Control Groups; Disclosure; Emotions; Human Experimentation; Interviews; Minors; Morbidity; Mortality; Newborns; Parents; Psychological Stress; Random Selection; Research; Research Subjects; Researchers; Survey; Therapeutic Research; Treatment Outcome; Uncertainty; Ventilators;
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