Quality improvement reportImproving design and conduct of randomised trials by embedding them in qualitative research: ProtecT (prostate testing for cancer and treatment) studyCommentary: presenting unbiased information to patients can be difficult

doi:10.1136/bmj.325.7367.766

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

Jenny Donovan, professor of social medicine (jenny.donovan{at}bris.ac.uk)a,
Nicola Mills, research associatea,
Monica Smith, research associateb,
Lucy Brindle, research associatea,
Ann Jacoby, professor of medical sociologyc,
Tim Peters, professor of primary care health services researchd,
Stephen Frankel, professor of epidemiology and public healtha,
David Neal, professor of surgerye,
Freddie Hamdy, professor of urology, for the Protect Study Groupf

^aDepartment of Social Medicine, University of Bristol, Bristol BS8 2PR
^bCentre for Health Services Research, University of Newcastle upon Tyne, Newcastle upon Tyne NE2 4AA
^cDepartment of Primary Care, University of Liverpool, Liverpool L69 3BX
^dDivision of Primary Health Care, University of Bristol, Bristol BS6 6JL
^eSchool of Surgical Sciences, University of Newcastle upon Tyne, Newcastle upon Tyne NE2 4HH
^fDivision of Clinical Sciences, University of Sheffield, Sheffield S5 7AU
Community Clinical Sciences (Primary Medical Care Group), University of Southampton, Aldermoor Health Centre, Southampton SO15 6ST

Correspondence to: J Donovan

Abstract

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.

Footnotes

Funding The research was funded jointly by the UK NHS research and development health technology assessment programme and the MRC health services research collaboration. Support for the ProtecT study also came from the South West NHS research and development directorate. The department of social medicine of the University of Bristol is the lead centre of the MRC health services research collaboration.
Conflict of interest None declared.

Commentary: presenting unbiased information to patients can be difficult

Paul Little, professor of primary care research. (psl3{at}soton.ac.uk)

^aDepartment of Social Medicine, University of Bristol, Bristol BS8 2PR
^bCentre for Health Services Research, University of Newcastle upon Tyne, Newcastle upon Tyne NE2 4AA
^cDepartment of Primary Care, University of Liverpool, Liverpool L69 3BX
^dDivision of Primary Health Care, University of Bristol, Bristol BS6 6JL
^eSchool of Surgical Sciences, University of Newcastle upon Tyne, Newcastle upon Tyne NE2 4HH
^fDivision of Clinical Sciences, University of Sheffield, Sheffield S5 7AU
Community Clinical Sciences (Primary Medical Care Group), University of Southampton, Aldermoor Health Centre, Southampton SO15 6ST