Developing clinical trial protocols: The use of patient focus groups

Abstract

Abstract Can patient views, obtained through patient focus groups, make a contribution to the design of clinical trials? This paper describes the use of patient focus groups as a method of gaining information for the development of a randomised trial looking at community versus hospital care in breast cancer follow‐up. Focus groups were used as a method of obtaining qualitative data. Quick and easy access to patients was obtained through a local cancer support group network. Initial responses from the focus group participants appeared to be unfavourable to the protocol. In all, more than five issues were raised which might lead to reluctance to cooperate in the trial. Participants identified key issues related to their follow‐up. Changes were made to the protocol addressing the issues raised. It is suggested that where trials require informed consent, using focus groups to find out patients' perceptions at the initial stage may well save time and money, increase participation levels and lead to better outcomes.