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.

---

© BMJ 2002
CiteULike    Complore    Connotea    Del.icio.us    Digg    Reddit    Technorati    What's this?

Relevant Articles

Detection of prostate cancer in unselected young men: prospective cohort nested within a randomised controlled trial

J Athene Lane, Joanne Howson, Jenny L Donovan, John R Goepel, Daniel J Dedman, Liz Down, Emma L Turner, David E Neal, and Freddie C Hamdy
BMJ 2007 335: 1139. [Abstract] [Full Text] [PDF]

Reply to letters on ethics of trials from bayesian perspective

Richard J Lilford
BMJ 2003 327: 105. [Extract] [Full Text]

Ethics of clinical trials from bayesian perspective: Randomisation to clinical trials may solve dilemma of treatment choice in prostate cancer

Freddie C Hamdy, Jenny L Donovan, J Athene Lane, and David E Neal
BMJ 2003 326: 1456. [Extract] [Full Text] [PDF]

Qualitative methods improve trial recruitment
BMJ 2002 325: 0. [Full Text]

Prostate specific antigen testing for prostate cancer

Hazel Thornton and Mary Dixon-Woods
BMJ 2002 325: 725-726. [Extract] [Full Text] [PDF]

Why men with prostate cancer want wider access to prostate specific antigen testing: qualitative study

Alison Chapple, Sue Ziebland, Sasha Shepperd, Rachel Miller, Andrew Herxheimer, and Ann McPherson
BMJ 2002 325: 737. [Abstract] [Full Text] [PDF]

Natural experiment examining impact of aggressive screening and treatment on prostate cancer mortality in two fixed cohorts from Seattle area and Connecticut

Grace Lu-Yao, Peter C Albertsen, Janet L Stanford, Therese A Stukel, Elizabeth S Walker-Corkery, and Michael J Barry
BMJ 2002 325: 740. [Abstract] [Full Text] [PDF]

Related external webpages:

NHS Health Technology Assessment Programme

This article has been cited by other articles:

• Bower, P., Wallace, P., Ward, E., Graffy, J., Miller, J., Delaney, B., Kinmonth, A. L. (2009). Improving recruitment to health research in primary care. Fam Pract 0: cmp037v1-cmp037 [Abstract] [Full text]  
• Albertsen, P. (2009). Androgen Deprivation in Prostate Cancer -- Step by Step. NEJM 360: 2572-2574 [Full text]  
• McCulloch, P. (2009). Developing appropriate methodology for the study of surgical techniques. JRSM 102: 51-55 [Full text]  
• O'Cathain, A. (2009). Editorial: Mixed Methods Research in the Health Sciences: A Quiet Revolution. Journal of Mixed Methods Research 3: 3-6  
• Mangset, M, Forde, R, Nessa, J, Berge, E, Wyller, T B. (2008). "I don't like that, it's tricking people too much...": acute informed consent to participation in a trial of thrombolysis for stroke. J. Med. Ethics 34: 751-756 [Abstract] [Full text]  
• de Salis, I., Tomlin, Z., Toerien, M., Donovan, J. (2008). Using qualitative research methods to improve recruitment to randomized controlled trials: the Quartet study. J Health Serv Res Policy 13: 92-96 [Abstract] [Full text]  
• Zuccolo, L., Harris, R., Gunnell, D., Oliver, S., Lane, J. A., Davis, M., Donovan, J., Neal, D., Hamdy, F., Beynon, R., Savovic, J., Martin, R. M. (2008). Height and Prostate Cancer Risk: A Large Nested Case-Control Study (ProtecT) and Meta-analysis. Cancer Epidemiol. Biomarkers Prev. 17: 2325-2336 [Abstract] [Full text]  
• Flemming, K., Adamson, J., Atkin, K. (2008). Improving the effectiveness of interventions in palliative care: the potential role of qualitative research in enhancing evidence from randomized controlled trials. Palliat Med 22: 123-131 [Abstract]  
• Lane, J A., Howson, J., Donovan, J. L, Goepel, J. R, Dedman, D. J, Down, L., Turner, E. L, Neal, D. E, Hamdy, F. C (2007). Detection of prostate cancer in unselected young men: prospective cohort nested within a randomised controlled trial. BMJ 335: 1139-1139 [Abstract] [Full text]  
• Merglen, A., Schmidlin, F., Fioretta, G., Verkooijen, H. M., Rapiti, E., Zanetti, R., Miralbell, R., Bouchardy, C. (2007). Short- and Long-term Mortality With Localized Prostate Cancer. Arch Intern Med 167: 1944-1950 [Abstract] [Full text]  
• Khan, N., Bower, P., Rogers, A. (2007). Guided self-help in primary care mental health: Meta-synthesis of qualitative studies of patient experience. Br. J. Psychiatry 191: 206-211 [Abstract] [Full text]  
• Fletcher, K., Mant, J., Holder, R., Fitzmaurice, D., Lip, G. Y., Hobbs, F. R. (2007). An analysis of factors that predict patient consent to take part in a randomized controlled trial. Fam Pract 24: 388-394 [Abstract] [Full text]  
• Marshall, S. L., Crowe, T. P., Oades, L. G., Deane, F. F., Kavanagh, D. J. (2007). A Review of Consumer Involvement in Evaluations of Case Management: Consistency With a Recovery Paradigm. Psychiatr. Serv. 58: 396-401 [Abstract] [Full text]  
• Chantler, T. E. A., Lees, A., Moxon, E. R., Mant, D., Pollard, A. J., Fiztpatrick, R. (2007). The Role Familiarity With Science and Medicine Plays in Parents' Decision Making About Enrolling a Child in Vaccine Research. Qual Health Res 17: 311-322 [Abstract]  
• Young, T., Ilic, D., O'Connor, D., Green, S., Wilt, T., Donovan, J., Martin, R., Heyns, C. (2007). Cochrane Column. Int J Epidemiol 36: 29-31 [Full text]  
• Blazeby, J. M., Avery, K., Sprangers, M., Pikhart, H., Fayers, P., Donovan, J. (2006). Health-Related Quality of Life Measurement in Randomized Clinical Trials in Surgical Oncology. JCO 24: 3178-3186 [Abstract] [Full text]  
• Kenyon, S, Dixon-Woods, M, Jackson, C J, Windridge, K, Pitchforth, E (2006). Participating in a trial in a critical situation: a qualitative study in pregnancy.. Qual Saf Health Care 15: 98-101 [Abstract] [Full text]  
• Jenkins, V, Fallowfield, L, Solis-Trapala, I, Langridge, C, Farewell, V (2005). Discussing randomised clinical trials of cancer therapy: evaluation of a Cancer Research UK training programme. BMJ 330: 400- [Abstract] [Full text]  
• Roberts, H, Curtis, K, Liabo, K, Rowland, D, DiGuiseppi, C, Roberts, I (2004). Putting public health evidence into practice: increasing the prevalence of working smoke alarms in disadvantaged inner city housing. J. Epidemiol. Community Health 58: 280-285 [Abstract] [Full text]  
• Oliver, S. E., Barrass, B., Gunnell, D. J., Donovan, J. L., Peters, T. J., Persad, R. A., Gillatt, D., Neal, D. E., Hamdy, F. C., Holly, J. M. P. (2004). Serum Insulin-Like Growth Factor-I Is Positively Associated with Serum Prostate-Specific Antigen in Middle-Aged Men without Evidence of Prostate Cancer. Cancer Epidemiol. Biomarkers Prev. 13: 163-165 [Abstract] [Full text]  
• Gunnell, D., Oliver, S. E., Donovan, J. L., Peters, T. J., Gillatt, D., Persad, R., Hamdy, F. C., Neal, D. E., Holly, J. M. P. (2004). Do Height-Related Variations in Insulin-Like Growth Factors Underlie the Associations of Stature with Adult Chronic Disease?. J. Clin. Endocrinol. Metab. 89: 213-218 [Abstract] [Full text]  
• Shannon, C. (2003). Better communication is key to recruiting patients to trials. BMJ 327: 1368-1368 [Full text]  
• Lilford, R. J (2003). Reply to letters on ethics of trials from bayesian perspective. BMJ 327: 105-105 [Full text]  
• Hamdy, F. C, Donovan, J. L, Lane, J A., Neal, D. E (2003). Ethics of clinical trials from bayesian perspective: Randomisation to clinical trials may solve dilemma of treatment choice in prostate cancer. BMJ 326: 1456-1456 [Full text]  
• Gattellari, M., Young, J. M, Ward, J. E (2003). GP and patient predictors of PSA screening in Australian general practice. Fam Pract 20: 294-303 [Abstract] [Full text]  
• Lilford, R. J (2003). Ethics of clinical trials from a bayesian and decision analytic perspective: whose equipoise is it anyway?. BMJ 326: 980-981 [Full text]  
• Thornton, H., Dixon-Woods, M. (2002). Prostate specific antigen testing for prostate cancer. BMJ 325: 725-726 [Full text]  

Rapid Responses:

Read all Rapid Responses

Did it help?

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

Active monitoring for localised prostate cancer

VINOD H. NARGUND
bmj.com, 13 Oct 2002 [Full text]

Online poll

Find out more >>