BMJ 2002;325:766-770 ( 5 October )

Education and debate

Quality improvement report

Improving design and conduct of randomised trials by embedding them in qualitative research: ProtecT (prostate testing for cancer and treatment) study

Editorial by Thornton Papers pp 737,740

Jenny Donovan, professor of social medicine, ^a Nicola Mills, research associate, ^a Monica Smith, research associate, ^b Lucy Brindle, research associate, ^a Ann Jacoby, professor of medical sociology, ^c Tim Peters, professor of primary care health services research, ^d Stephen Frankel, professor of epidemiology and public health, ^a David Neal, professor of surgery, ^e Freddie Hamdy, professor of urology, ^f for the Protect Study Group.

^a Department of Social Medicine, University of Bristol, Bristol BS8 2PR, ^b Centre for Health Services Research, University of Newcastle upon Tyne, Newcastle upon Tyne NE2 4AA, ^c Department of Primary Care, University of Liverpool, Liverpool L69 3BX, ^d Division of Primary Health Care, University of Bristol, Bristol BS6 6JL, ^e School of Surgical Sciences, University of Newcastle upon Tyne, Newcastle upon Tyne NE2 4HH, ^f Division of Clinical Sciences, University of Sheffield, Sheffield S5 7AU

Correspondence to: J Donovan jenny.donovan{at}bris.ac.uk

Problem: Recruitment to randomised trials is often difficult, and many important trials are not mounted because recruitment is thought to be "impossible."
Design: Controversial ProtecT (prostate testing for cancer and treatment) trial embedded within qualitative research.
Background and setting: Screening for prostate cancer is hotly debated, and evidence from trials about the effectiveness of treatments (surgery, radiotherapy, and monitoring) is lacking. Mounting a treatment trial is controversial because of past failures and concerns that differences in complications of treatment but not survival make randomisation unacceptable to patients and clinicians, particularly for a trial including monitoring.
Strategy for change: In-depth interviews explored interpretation of study information. Audiotape recordings of recruitment appointments enabled scrutiny of content and presentation of study information by recruiters. Initial qualitative findings showed that recruiters had difficulty discussing equipoise and presenting treatments equally; they unknowingly used terminology that was misinterpreted by participants. Findings were used to determine changes to content and presentation of information.
Effects of change: Changes to the order of presenting treatments encouraged emphasis on equivalence, misinterpreted terms were avoided, the non-radical arm was redefined, and randomisation and clinical equipoise were presented more convincingly. The randomisation rate increased from 40% to 70%, all treatments became acceptable, and the three arm trial became the preferred design.
Lessons learnt: Changes to information and presentation resulted in efficient recruitment acceptable to patients and clinicians. Embedding this controversial trial within qualitative research improved recruitment. Such methods probably have wider applicability and may enable even the most difficult evaluative questions to be tackled.

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© BMJ 2002
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Rapid Responses:

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Did it help?

Jackie Smith
bmj.com, 4 Oct 2002 [Full text]

Active monitoring for localised prostate cancer

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bmj.com, 13 Oct 2002 [Full text]