Objective To examine interpretations of study information by women participating in ORACLE, a trial of antibiotics in preterm labour.
Design Questionnaire survey sent to women recruited to the ORACLE trial.
Setting United Kingdom.
Population A questionnaire was sent to 3074 ORACLE participants in a purposively selected sample of 55 collaborating maternity units, chosen to reflect a range of regions and of district general and teaching hospitals.
Methods Content analysis was applied to verbatim text provided in response to an open question. Responses were also compared with a framework based on key points about the purpose of ORACLE. Closed questions were analysed using descriptive statistics.
Main outcome measures Participants' interpretations of the purpose of the study.
Results A response rate of 61% was achieved, and 1462 participants provided written answers to a specific question on why the study was being carried out. Content analysis suggested that the information leaflet was highly valued as a source of information about the trial. There was evidence that women's interpretations of the purpose of the trial were not identical to those that the investigators intended. Of the five key points about the trial described in the information leaflet, 400 (27%) participants reported one key point, 550 (38%) two key points, 229 (16%) three key points and 23 (1.5%) four key points. None reported five key points and it was not possible to classify 46 responses (3%). Vague, confused understanding or poor recall were evident in 204 (14%) of responses.
Conclusion Although the ORACLE trial was run as a model of good practice at the time, this study suggests that it may not be possible to demonstrate full understanding of trial purpose and design by all participants. Emphasis should be on the provision of full information that involves consumers in its design and evaluation.