Receiving a summary of the results of a trial: qualitative study of participants' views.
OBJECTIVE
To explore trial participants' responses to receiving a summary of the results of a trial in pregnancy.


METHODS
Qualitative study with semistructured interviews.


METHODS
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.
Dixon-Woods
Mary
M
Social Science Group, Department of Health Sciences, University of Leicester, Leicester LE1 6TP. md11@le.ac.uk
Jackson
Clare
C
Windridge
Kate C
KC
Kenyon
Sara
S
D000900:Anti-Bacterial Agents / Q000627:therapeutic use; D001294:Attitude to Health; D030881:Disclosure; D005246:Feedback; D005260:Female; D005322:Premature Rupture of Fetal Membranes / Q000188:drug therapy; D006801:Humans; D007752:Obstetric Labor, Premature / Q000188:drug therapy; D010174:Pamphlets; D017060:Patient Satisfaction; D011247:Pregnancy; D016032:Randomized Controlled Trials as Topic / Q000379:methods*; D035842:Research Subjects / Q000523:psychology*
D000900:Anti-Bacterial Agents