Informing patients about research: Evaluation of an information leaflet

Objectives. To develop and evaluate an information sheet in order to effectively increase background knowledge about medical research, including reasons for participation, risks and benefits and the processes of recruitment and consent. Design. Recorded telephone questionnaire conducted at least 24 hours after receiving the information leaflet. Setting. Recruitment from antenatal/paediatric clinics and Newcastle-under-Lyme town center. Participants. Fifty recruits of whom 37 gave interviews. Main outcome measure. Understanding of the leaflet as judged by answers to the specific questions. Results. In general the understanding of the leaflet was good and 90% of the participants indicated that they had understood most of it. It was thought to be generally informative. The question that caused greatest difficulty related to the correct explanation of informed consent, with only 65% giving a correct response. Other areas of difficulty related to questions about whether new treatments would be better or worse than standard treatments and details of consent in children. It was suggested that examples would be helpful addition to the leaflet. Having read the leaflet, more than 70% of the participants would be prepared in principle to participate in research. Less that 10% felt that they would be less likely to participate in research after reading the leaflet. Conclusion. The idea of providing a general leaflet about research was supported by the results of the survey. A number of areas of improvement were identified. The leaflet has now been modified to take account of these suggestions.