Journal of Clinical Epidemiology
Volume 62, Issue 5 , Pages 464-475 , May 2009

A pragmatic–explanatory continuum indicator summary (PRECIS): a tool to help trial designers

  • Kevin E. Thorpe

      Affiliations

    • Dalla Lana School of Public Health, University of Toronto, Toronto, Ontario, Canada M5T 3M7
    • Corresponding Author InformationCorresponding author. Tel.: +416 864 5776; fax: +416 864 6057.
    • ,
  • Merrick Zwarenstein

      Affiliations

    • Centre for Health Services Sciences, Sunnybrook Research Institute, Sunnybrook Health Sciences Centre; Institute for Clinical Evaluative Sciences; Department of Health Policy, Management and Evaluation, University of Toronto, Toronto, Ontario, Canada
    • ,
  • Andrew D. Oxman

      Affiliations

    • Preventive and International Health Care Unit, Norwegian Knowledge Centre for the Health Services, Oslo, Norway
    • ,
  • Shaun Treweek

      Affiliations

    • Division of Clinical & Population Sciences and Education, University of Dundee, Dundee, UK; Norwegian Knowledge Centre for the Health Services, Oslo, Norway
    • ,
  • Curt D. Furberg

      Affiliations

    • Division of Public Health Sciences, Wake Forest University School of Medicine, Winston-Salem, NC, USA
    • ,
  • Douglas G. Altman

      Affiliations

    • Centre for Statistics in Medicine, University of Oxford, Oxford, UK
    • ,
  • Sean Tunis

      Affiliations

    • Center for Medical Technology Policy, Baltimore, MD, USA
    • ,
  • Eduardo Bergel

      Affiliations

    • UNDP/UNFPA/WHO/World Bank Special Programme of Research, Development and Research Training in Human Reproduction, Department of Reproductive Health and Research, World Health Organization, Geneva, Switzerland
    • ,
  • Ian Harvey

      Affiliations

    • Faculty of Health, University of East Anglia, Norwich, UK
    • ,
  • David J. Magid

      Affiliations

    • Institute for Health Research, Kaiser Permanente Colorado; Departments of Preventive Medicine and Biometrics and Emergency Medicine, University of Colorado Health Sciences Center, Denver, CO, USA
    • ,
  • Kalipso Chalkidou

      Affiliations

    • National Institute for Health and Clinical Excellence, London, UK

,Accepted 13 December 2008.

References 

  1. Schwartz D, Lellouch J. Explanatory and pragmatic attitudes in therapeutical trials. J Chronic Dis. 1967;20:637–648[reprinted in this issue; J Clin Epidemiol 2009;62:498–504]
  2. Sackett DL. Explanatory vs. management trials. In:  Haynes RB,  Sackett DL,  Guyatt GH,  Tugwell P editor. Clinical epidemiology: how to do clinical practice research. Philadelphia: Lippincott, Williams and Wilkins; 2006;
  3. Gartlehner G, Hansen RA, Nissman D, Lohr KN, Carey TS. A simple and valid tool distinguished efficacy from effectiveness studies. J Clin Epidemiol. 2006;59:1040–1048
  4. Zwarenstein M, Treweek S, Gagnier J, Altman DG, Tunis S, Haynes B, et al. Improving the reporting of pragmatic trials: an extension of the CONSORT statement. BMJ 2008;337:a2390.
  5. Tunis SR, Stryer DB, Clancy CM. Practical clinical trials: Increasing the value of clinical research for decision making in clinical and health policy. JAMA. 2003;290:1624–1632
  6. Tunis SR. A clinical research strategy to support shared decision making. Health Aff. 2005;24:180–184
  7. Pragmatic Randomized Controlled Trials in HealthCare . http://www.practihc.org/
  8. Scheel IB, Hagen KB, Herrin J, Carling C, Oxman AD. Blind faith? The effects of promoting active sick leave for back pain patients. A cluster-randomized trial. Spine. 2002;27:2734–2740
  9. Zwarenstein M, Schoeman JH, Vundule C, Lombard CJ, Tatley M. Randomised controlled trial of self-supervised and directly observed treatment of tuberculosis. Lancet. 1998;352:1340–1343
  10. North American Symptomatic Carotid Endarterectomy Trial Collaborators. Beneficial effect of carotid endarterectomy in symptomatic patients with high-grade carotid stenosis. N Engl J Med. 1991;325:445–453
  11. CLASP (Collaborative Low-dose Aspirin Study in Pregnancy) Collaborative Group. CLASP: a randomized trial of low-dose aspirin for the prevention and treatment of pre-eclampsia among 9364 pregnant women. Lancet. 1994;343:619–629
  12. Caritis S, Sibai B, Hauth J, Lindheimer MD, Klebanoff M, Thom E, et al. Low-dose aspirin to prevent preeclampsia in women at high risk. N Engl J Med. 1998;338:701–705
  13. Rothwell PM. External validity of randomised controlled trials: “to whom do the results of this trial apply?. Lancet. 2005;365:82–93

 This article is being published in both the Canadian Medical Association Journal and the Journal of Clinical Epidemiology.

PII: S0895-4356(09)00048-1

doi: 10.1016/j.jclinepi.2008.12.011

Journal of Clinical Epidemiology
Volume 62, Issue 5 , Pages 464-475 , May 2009

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