Injury
Volume 41 , Pages S20-S23 , July 2010

Challenging issues in randomised controlled trials

  • A.D. Nichol

      Affiliations

    • Australian and New Zealand Intensive Care - Research Centre (ANZIC-RC), Monash University, Melbourne, Victoria 3004, Australia
    • Alfred Hospital, Melbourne, Victoria 3004, Australia
    • Corresponding Author InformationCorresponding author at: Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University, Alfred Hospital Campus, 89 Commercial Road, Melbourne 3004, Australia. Tel.: +61 3 99030247; fax: +61 3 99030071.
    • ,
  • M. Bailey

      Affiliations

    • Australian and New Zealand Intensive Care - Research Centre (ANZIC-RC), Monash University, Melbourne, Victoria 3004, Australia
    • ,
  • D.J. Cooper

      Affiliations

    • Australian and New Zealand Intensive Care - Research Centre (ANZIC-RC), Monash University, Melbourne, Victoria 3004, Australia
    • Alfred Hospital, Melbourne, Victoria 3004, Australia
    • ,
  • On behalf of the POLAR and EPO investigators

      Affiliations

    • The POLAR Study investigators: D James Cooper, Stephen Bernard, Alistair Nichol, John Myburgh, Jeffery Presneil, Peter Cameron, Andrew Forbes, Lynne Murray, Jeffery Rosenfeld. The EPO-TBI Study investigators: Rinaldo Bellomo, D James Cooper, Alison Street, Alistair Nichol, Craig French, Jeffery Presneil, John McNeil, Neil Orford, Jeffery Rosenfeld, Gillian Syres, Michael Bailey, Ann Mak, Shirley Vallance, Lorraine Little.

References 

  1. Altman DG. Better reporting of randomised controlled trials: the CONSORT statement. BMJ. 1996;313:570–571
  2. Begg C, Cho M, Eastwood S, et al. Improving the quality of reporting of randomized controlled trials. The CONSORT statement. JAMA. 1996;276:637–639
  3. Brain_Trauma_Foundation . Guidelines for the management of severe traumatic brain injury. J Neurotrauma. 2007;24
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  10. Jadad AR, Rennie D. The randomized controlled trial gets a middle-aged checkup. JAMA. 1998;279:319–320
  11. Moher D, Schulz KF, Altman D. The CONSORT statement: revised recommendations for improving the quality of reports of parallel-group randomized trials. JAMA. 2001;285:1987–1991
  12. Myburgh J, Cooper DJ, Finfer S, et al. Saline or albumin for fluid resuscitation in patients with traumatic brain injury. N Engl J Med. 2007;357:874–884
  13. Myburgh JA, Cooper DJ, Finfer SR, et al. Epidemiology and 12-month outcomes from traumatic brain injury in Australia and New Zealand. J Trauma. 2008;64:854–862
  14. Sacks H, Chalmers TC, Smith H. Randomized versus historical controls for clinical trials. Am J Med. 1982;72:233–240
  15. Schulz KF, Chalmers I, Hayes RJ, Altman DG. Empirical evidence of bias. Dimensions of methodological quality associated with estimates of treatment effects in controlled trials. JAMA. 1995;273:408–412
  16. Stolberg HO, Norman G, Trop I. Randomized controlled trials. Am J Roentgenol. 2004;183:1539–1544
  17. Thornley B, Adams C. Content and quality of 2000 controlled trials in schizophrenia over 50 years. BMJ. 1998;317:1181–1184

PII: S0020-1383(10)00233-0

doi: 10.1016/j.injury.2010.03.033

Injury
Volume 41 , Pages S20-S23 , July 2010

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