What do they know?: a content analysis of women's perceptions of trial information.
OBJECTIVE
To examine interpretations of study information by women participating in ORACLE, a trial of antibiotics in preterm labour.


METHODS
Questionnaire survey sent to women recruited to the ORACLE trial.


METHODS
United Kingdom.


METHODS
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.


METHODS
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.


CONCLUSIONS
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.
Kenyon
Sara
S
Clinical Division of Obstetrics and Gynaecology, Department of Cancer Studies and Molecular Medicine, University of Leicester, UK.
Dixon-Woods
Mary
M
D000900:Anti-Bacterial Agents / Q000627:therapeutic use; D001294:Attitude to Health; D002986:Clinical Trials as Topic / Q000523:psychology* / Q000592:standards; D005260:Female; D006801:Humans; D007752:Obstetric Labor, Premature / Q000523:psychology; D010353:Patient Education as Topic / Q000379:methods / Q000592:standards*; D010465:Perception; D011247:Pregnancy / Q000523:psychology*; D011795:Surveys and Questionnaires
D000900:Anti-Bacterial Agents