Journal of Clinical Epidemiology
Volume 59, Issue 11 , Pages 1127-1133 , November 2006

The Trial Protocol Tool: the PRACTIHC software tool that supported the writing of protocols for pragmatic randomized controlled trials

  • Shaun Treweek

      Affiliations

    • Tayside Centre for General Practice, University of Dundee, DD2 4BF Dundee, UK
    • Corresponding Author InformationCorresponding author. University of Dundee, Tayside Centre for General Practice, Mackenzie Building, Kirsty Semple Way, Dundee DD2 4AD, United Kingdom.
  • ,
  • Kirsty McCormack

      Affiliations

    • Health Services Research Unit, University of Aberdeen, Polwarth Bldg, Foresterhill, AB25 2ZD Aberdeen, UK
  • ,
  • Edgardo Abalos

      Affiliations

    • Centro Rosarino De Estudios Perinatales (CREP), Pueyrredon 985, (2000) Rosario, Argentina
  • ,
  • Marion Campbell

      Affiliations

    • Health Services Research Unit, University of Aberdeen, Polwarth Bldg, Foresterhill, AB25 2ZD Aberdeen, UK
  • ,
  • Craig Ramsay

      Affiliations

    • Health Services Research Unit, University of Aberdeen, Polwarth Bldg, Foresterhill, AB25 2ZD Aberdeen, UK
  • ,
  • Merrick Zwarenstein

      Affiliations

    • Institute for Clinical Evaluative Sciences and Department of Health Policy, Management and Evaluation, University of Toronto, 2075 Bayview Ave, Toronto, Ontario M4N 3M5, Canada
  • ,
  • on behalf of the PRACTIHC collaboration

,Accepted 24 December 2005.

References 

  1. Altman DG. Better reporting of randomised controlled trials: the CONSORT statement. BMJ. 1996;313:570–571
  2. Pocock SJ. Clinical trials: a practical approach. Chichester: Wiley; 1996;
  3. Smith R. Closing the digital divide. BMJ. 2003;326:238
  4. ICH Harmonised Tripartite Guideline: Guideline for Good Clinical Practice E6(R1) (Current Step 4 Version dated June 10, 1996). Available at http://www.ich.org/cache/compo/276-254-1.html. Accessed March 2003
  5. HIV Prevention Trials Network . HPTN protocol template. Available at http://www.hptn.org/network_information/network_templates.htm. Accessed March 2003
  6. Centers for Disease Control and Prevention . Developing a protocol: a guide for CDC investigators. Available at http://www.cdc.gov/niosh/nas/mining/pdfs/Protocol%Checklist.pdf. Accessed March 2003
  7. Campbell MJ, Julious SA, Altman DG. Estimating sample sizes for binary, ordered categorical and continuous outcomes in two group comparisons. BMJ. 1995;311:1145–1148
  8. In:  Haynes RB,  Sackett DL,  Guyatt GH,  Tugwell P editor. Clinical epidemiology: how to do clinical practice research. 3rd ed. Philadelphia: Lippincott Williams & Wilkins; 2005;

PII: S0895-4356(06)00237-X

doi: 10.1016/j.jclinepi.2005.12.019

Journal of Clinical Epidemiology
Volume 59, Issue 11 , Pages 1127-1133 , November 2006