Evidence Library

Title: Improving design and conduct of randomised controlled trials by embedding them in qualitative research: ProtecT (prostate testing for cancer and treatment) study.
Author: Donovan, J., Mills, N., Smith, M., Brindle, L., Jacoby, A., Peters, T., Frankel, S., Neal, D. & Hamdy, F.
Date Published: 2002
Reference: BMJ, 325, 766-770.
Are service users or carers authors: No/Not Known


Aim: To examine the impact of qualitative research on the design and conduct of a controversial randomised clinical trial for prostate cancer.

Methods: In-depth interviews were carried out with men who had been invited to join the trial to find what they had understood from the study information. Recruitment appointments were also tape recorded to find out how recruiters presented the trial. The findings were used to change the content and presentation of the study information.

Findings/recommendations: Changes to the way the information about the trial was presented and the way different elements were described increased the men's understanding of the nature and purpose of the trial. Recruitment rates increased from 40% to 70%. The authors recommend that similar approaches are used more widely, especially when a trial is thought to be difficult to carry out.

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Categories: health
Designing research
impact on research ethics
impact of public involvement
journal article

Date Entered: 2007/02/22

Date Edited: 2012/12/06

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