Does the CONSORT checklist improve the quality of reports of randomised controlled trials? A systematic review

Amy C Plint, David Moher, Andra Morrison, Kenneth Schulz, Douglas G Altman, Catherine Hill and Isabelle Gaboury
Med J Aust 2006; 185 (5): 263-267.


Objective: To determine whether the adoption of the CONSORT checklist is associated with improvement in the quality of reporting of randomised controlled trials (RCTs).

Data sources: MEDLINE, EMBASE, Cochrane CENTRAL, and reference lists of included studies and of experts were searched to identify eligible studies published between 1996 and 2005.

Study selection: Studies were eligible if they (a) compared CONSORT-adopting and non-adopting journals after the publication of CONSORT, (b) compared CONSORT adopters before and after publication of CONSORT, or (c) a combination of (a) and (b). Outcomes examined included reports for any of the 22 items on the CONSORT checklist or overall trial quality.

Data synthesis: 1128 studies were retrieved, of which 248 were considered possibly relevant. Eight studies were included in the review. CONSORT adopters had significantly better reporting of the method of sequence generation (risk ratio [RR], 1.67; 95% CI, 1.19–2.33), allocation concealment (RR, 1.66; 95% CI, 1.37–2.00) and overall number of CONSORT items than non-adopters (standardised mean difference, 0.83; 95% CI, 0.46–1.19). CONSORT adoption had less effect on reporting of participant flow (RR, 1.14; 95% CI, 0.89–1.46) and blinding of participants (RR, 1.09; 95% CI, 0.84–1.43) or data analysts (RR, 5.44; 95% CI, 0.73–36.87). In studies examining CONSORT-adopting journals before and after the publication of CONSORT, description of the method of sequence generation (RR, 2.78; 95% CI, 1.78–4.33), participant flow (RR, 8.06; 95% CI, 4.10–15.83), and total CONSORT items (standardised mean difference, 3.67 items; 95% CI, 2.09–5.25) were improved after adoption of CONSORT by the journal.

Conclusions: Journal adoption of CONSORT is associated with improved reporting of RCTs.

  • Amy C Plint1
  • David Moher1,2
  • Andra Morrison3
  • Kenneth Schulz4
  • Douglas G Altman5
  • Catherine Hill6
  • Isabelle Gaboury2

  • 1 University of Ottawa, Ottawa, Ontario, Canada.
  • 2 Chalmers Research Group, Children’s Hospital of Eastern Ontario, Ottawa, Ontario, Canada.
  • 3 Canadian Coordinating Office for Health Technology Assessment, Ottawa, Ontario, Canada.
  • 4 Quantitative Sciences, Family Health International, Durham, NC, USA.
  • 5 Centre for Statistics in Medicine, Oxford, UK.
  • 6 Rheumatology Unit, Queen Elizabeth Hospital, Adelaide, SA.


Competing interests:

None identified.

  • 1. 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.
  • 2. Moher D, Schulz KF, Altman D for the CONSORT Group. The CONSORT statement: revised recommendations for improving the quality of reports of parallel-group randomized trials. JAMA 2001; 285: 1987-1991.
  • 3. Hollis S, Campbell F. What is meant by intention-to-treat analysis? Survey of published randomized controlled trials. BMJ 1999; 319: 670-674.
  • 4. Ruiz-Canela M, Martinez-Gonzalez MA, de Irala-Estevez J. Intention to treat analysis is related to methodological quality [letter]. BMJ 2000; 320: 1007-1008.
  • 5. 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.
  • 6. Moher D, Pham B, Jones A, et al. Does the quality of reports of randomised trials affect estimates of intervention efficacy reported in meta-analyses? Lancet 1998; 352: 609-613.
  • 7. Devereaux PJ, Manns BJ, Ghali WA, et al. The reporting of methodological factors in randomized controlled trials and the association with a journal policy to promote adherence to the Consolidated Standards of Reporting Trials (CONSORT) checklist. Control Clin Trials 2002; 23: 380-388.
  • 8. Moher D, Jones A, Lepage L for the CONSORT Group. Use of the CONSORT statement and quality of reports of randomized trials: a comparative before-and-after evaluation. JAMA 2001; 285: 1992-1995.
  • 9. Piggot M, McGee H, Feuer D. Has CONSORT improved the reporting of randomized controlled trials in the palliative care literature? A systematic review. Palliat Med 2004; 18: 32-38.
  • 10. Bhandari M, Guyaa G, Lochner H, et al. Application of the Consolidated Standards of Reporting Trials (CONSORT) in the fracture care literature. J Bone Joint Surg Am 2002; 84: 485-489.
  • 11. Jadad AR, Moore RA, Carroll D, et al. Assessing the quality of reports of randomized clinical trials: is blinding necessary? Control Clin Trials 1996; 17: 1-12.
  • 12. Campbell DC, Stanley JT. Experimental and quasi-experimental design for research. Boston: Houghton Mifflin Company, 1966.
  • 13. Hewitt C, Hahn S, Torgerson DJ, et al. Adequacy and reporting of allocation concealment: a review of recent trials published in four general medical journals. BMJ 2005; 330: 1057-1058.
  • 14. Halpern SH, Darani R, Douglas MJ, et al. Compliance with the CONSORT checklist in obstetric anaesthesia randomised controlled trials. Int J Obstet Anesth 2004; 13: 207-214.
  • 15. Faunce TA, Buckley NA. Of consents and CONSORTS: reporting ethics, law, and human rights in RCTs involving monitored overdose of healthy volunteers pre and post the “CONSORT” guidelines. J Toxicol Clin Toxicol 2003; 41: 93-99.
  • 16. Montori VM, Bhandari M, Devereaux PJ, et al. In the dark: the reporting of blinding status in randomized controlled trials. J Clin Epidemiol 2002; 55: 787-790.
  • 17. Hill CL, LaValley MP, Felson DT. Secular changes in the quality of published randomized clinical trials in rheumatology. Arthritis Rheum 2002; 46: 779-784.
  • 18. Sanchez-Thorin JC, Cortes MC, Montenegro M, Villate N. The quality of reporting of randomized clinical trials published in Ophthalmology. Ophthalmology 2001; 108: 410-415.
  • 19. Latronico N, Botteri M, Minelli C, et al. Quality of reporting of randomised controlled trials in the intensive care literature: a systematic analysis of papers published in Intensive Care Medicine over 26 years. Intensive Care Med 2002; 28: 1316-1323.
  • 20. Doig GS, Simpson F, Delaney A. A review of the true methodological quality of nutritional support trials conducted in the critically ill: time for improvement. Anesth Analg 2005; 100: 527-533.
  • 21. Torgerson CJ, Torgerson DJ, Birks YF, Porthouse J. A comparison of randomised trials in health and education. Br Educ Res J 2005; 31: 761-785.
  • 22. Stinson JN, McGrath PJ, Yamada JT. Clinical trials in the Journal of Pediatric Psychology: applying the CONSORT statement. J Pediatr Psychol 2003; 28: 159-167.
  • 23. Scherer RW, Crawley B. Reporting of randomized clinical trial descriptors and use of structured abstracts. JAMA 1998; 280: 269-272. Correction in JAMA 1998; 280: 1054.
  • 24. Altman DG. Endorsement of the CONSORT statement by high impact medical journals: a survey of instructions for authors. BMJ 2005; 330: 1056-1057.
  • 25. Mills E, Wu P, Gagnier J, et al. An analysis of general medical and specialist journals that endorse CONSORT found that reporting was not enforced consistently. J Clin Epidemiol 2005; 58: 662-667.
  • 26. Mills EJ, Wu P, Gagnier J, et al. The quality of randomized trial reporting in leading medical journals since the revised CONSORT statement. Contemp Clin Trials 2005; 26: 480-487.
  • 27. Devereaux PJ, Manns BJ, Ghali WA, et al. Physician interpretations and textbook definitions of blinding terminology in randomized controlled trials. JAMA 2001; 285: 2000-2003.


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