Journal of Clinical Epidemiology
Volume 62, Issue 1 , Pages 29-36 , January 2009

Development of a complex intervention improved randomization and informed consent in a randomized controlled trial

  • Jenny L. Donovan

      Affiliations

    • Department of Social Medicine, University of Bristol, Bristol BS8 2PR, UK
    • Corresponding Author InformationCorresponding author. Tel.: 44 0 117 9287214; Fax: 44 0 117 9287325.
    • ,
  • J. Athene Lane

      Affiliations

    • Department of Social Medicine, University of Bristol, Bristol BS8 2PR, UK
    • ,
  • Tim J. Peters

      Affiliations

    • Department of Community Based Medicine, University of Bristol, Bristol BS8 2AA, UK
    • ,
  • Lucy Brindle

      Affiliations

    • School of Nursing and Midwifery, University of Southampton, S16 7PX, UK
    • ,
  • Elizabeth Salter

      Affiliations

    • Department of Social Medicine, University of Bristol, Bristol BS8 2PR, UK
    • ,
  • David Gillatt

      Affiliations

    • Bristol Urological Institute, Southmead Hospital, Bristol BS10 5NB, UK
    • ,
  • Philip Powell

      Affiliations

    • Department of Urology, Freeman Hospital, Newcastle-upon-Tyne NE7 7DN, UK
    • ,
  • Prasad Bollina

      Affiliations

    • Western General Hospital, Edinburgh EH4 2XU, UK
    • ,
  • David E. Neal

      Affiliations

    • Oncology Centre, University of Cambridge, CB2 2QQ, UK
    • ,
  • Freddie C. Hamdy

      Affiliations

    • Division of Clinical Sciences, University of Sheffield, S5 7AU, UK
    • ,
  • for the ProtecT Study Group

,Accepted 12 February 2008.

References 

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  2. Hunninghake DB, Darby CA, Probstfield JL. Recruitment experience in clinical trials: literature summary and annotated bibliography. Control Clin Trials. 1987;8:6S–30S
  3. Haidich A-B, Ioannidis JPA. Patterns of patient enrollment in randomized controlled trials. J Clin Epidemiol. 2001;54:877–883
  4. Lovato LC, Hill K, Hertert S, Hunninghake DB, Probstfield JL. Recruitment for controlled clinical trials: literature summary and annotated bibliography. Control Clin Trials. 1997;18:328–357
  5. Ross S, Grant A, Counsell C, Gillespie W, Russell I, Prescott R. Barriers to participation in randomised controlled trials: a systematic review. J Clin Epidemiol. 1999;52:1143–1156
  6. Mapstone J, Elbourne D, Roberts I. Strategies to Improve recruitment to research studies (Review). The Cochrane Library. 2002;1–15
  7. Donovan J, Peters TJ, Noble S, Powell P, Gillatt D, Oliver SE, et al. who can best recruit to randomized trials? Randomized trial comparing surgeons and nurses recruiting patients to a trial of treatments for localized prostate cancer (the ProtecT study). J Clin Epidemiol. 2003;56:605–609
  8. McDaid C, Hodges Z, Fayter D, Stirk L, Eastwood A. Systematic review of interventions to increase participation of cancer patients in randomised controlled trials. Trials. 2006;17:16
  9. Donovan J, Mills N, Smith M, Brindle L, Jacoby A, Peters T, et al. Improving the design and conduct of randomised trials by embedding them in qualitative research: ProtecT (prostate testing for cancer and treatment) study. BMJ. 2002;325:766–770
  10. Donovan JL, Sanders C. Key issues in the analysis of qualitative data in health services research. In:  Bowling A,  Ebrahim S editor. Handbook of health research methods. Maidenhead: Open University Press; 2005;p. 515–532
  11. Silverman D. Interpreting qualitative data: Methods for analysing talk, text and interaction. London: Sage; 1993;
  12. Plsek PE, Greenhalgh T. Complexity Science: the challenge of complexity in healthcare. BMJ. 2001;323:625–628
  13. Cornwall A, Jewkes R. What is participatory research?. Soc Sci Med. 1995;41:1667–1676
  14. Lienard JL, Quinaux E, Fabre-Guillevin E, Piedbois P, Jouhaud A, Decoster G, et al. Impact of on-site initiation visits on patient recruitment and data quality in a randomized trial of adjuvant chemotherapy for breast cancer. Clin Trials. 2006;3:486–492
  15. Lilford R, Braunholtz D, Harris J, Gill T. Trials in surgery. Br J Surg. 2004;91:6–16
  16. Featherstone K, Donovan JL. Why don't they just tell me straight, why allocate it?” The struggle to make sense of participating in a randomised controlled trial. Soc Sci Med. 2002;55:709–719
  17. Mills N, Donovan JL, Smith M, Jacoby A, Neal DE, Hamdy FC. Perceptions of equipoise are crucial to trial participation: a qualitative study of men in the ProtecT Study. Controlled Clin Trials. 2003;24:272–282
  18. Ward LC, Slegg GP, Dunn JA, Harvey P, Hallissey MT, Hyde C, et al. A systematic review reporting doctors' and patients' attitudes toward participation in clinical research trials. NHS Cancer R&D Programme NCP/ICV/022/D 1999.
  19. Tournaoux C, Katsahian S, Chevret S, Levy V. Factors influencing inclusion of patients with malignancies in clinical trials. Cancer. 2006;106:258–270

PII: S0895-4356(08)00060-7

doi: 10.1016/j.jclinepi.2008.02.010

Journal of Clinical Epidemiology
Volume 62, Issue 1 , Pages 29-36 , January 2009

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