Journal of Clinical Epidemiology
Volume 60, Issue 3 , Pages 241-249 , March 2007

Reporting in randomized clinical trials improved after adoption of the CONSORT statement

  • Robert L. Kane

      Affiliations

    • University of Minnesota Clinical Outcomes Research Center, Minneapolis, MN, USA
    • University of Minnesota School of Public Health, Division of Health Policy and Management, Minneapolis, MN, USA
    • Corresponding Author InformationCorresponding author. University of Minnesota School of Public Health, D351 Mayo (MMC 197), 420 Delaware Street SE, Minneapolis, MN 55455, USA. Tel.: 612-624-1185; fax: 612-624-8448.
    • ,
  • Jye Wang

      Affiliations

    • University of Minnesota School of Public Health, Division of Health Policy and Management, Minneapolis, MN, USA
    • ,
  • Judith Garrard

      Affiliations

    • University of Minnesota School of Public Health, Division of Health Policy and Management, Minneapolis, MN, USA

,Accepted 26 June 2006.

References 

  1. Peto R, Collins R, Gray R. Large-scale randomized evidence: large, simple trials and overviews of trials. J Clin Epidemiol. 1995;48:23–40
  2. Berger VW, Bears JD. When can a clinical trial be called ‘randomized’?. Vaccine. 2003;21:468–472
  3. Campbell DT. Reforms as social experiments. Am Psychol. 1969;24:409–429
  4. Cook TD, Campbell DT. Quasi-experimentation: design and analysis issues for field settings. Chicago, IL: Rand McNally; 1979;
  5. Shadish WR, Cook TD, Campbell DT. Experimental and quasi-experimental designs for generalized causal inference. Boston, MA: Houghton Mifflin Company; 2002;
  6. Deeg DJH. Attrition in longitudinal population studies: does it affect the generalizability of the findings? An introduction to the series. J Clin Epidemiol. 2002;55:213–215
  7. Dunn G, Maracy M, Dowrick C, Ayuso-Mateos J-L, Dalgard O, Page H, et al. Estimating psychological treatment effects from a randomised controlled trial with both non-compliance and loss to follow-up. Br J Psychiatry. 2003;183:323–331
  8. Dunn G. Estimating the causal effects of treatment. Epidemiol Psichiatr Soc. 2002;11:206–215
  9. White IR, Moodie E, Thompson SG, Croudace T. A modelling strategy for the analysis of clinical trials with partly missing longitudinal data. Int J Methods Psychiatr Res. 2003;12(3):139–150
  10. Van Beijsterveldt CEM, van Boxtel MP, Bosma H, Houx PJ, Buntinx F, Jolles J. Predictors of attrition in a longitudinal cognitive aging study: the Maastricht Aging Study (MAAS). J Clin Epidemiol. 2002;55:216–223
  11. Kempen GIJM, van Sonderen E. Psychological attributes and changes in disability among low-functioning older persons: does attrition affect the outcomes?. J Clin Epidemiol. 2002;55:224–229
  12. The Standards of Reporting Trials Group. A proposal for structured reporting of randomized controlled trials. JAMA. 1994;272:1926–1931
  13. International Committee of Medical Journal Editors . Uniform requirements for manuscripts submitted to biomedical journals. JAMA. 1993;269:2282–2286
  14. DerSimonian R, Charette LJ, McPeek B, Mosteller F. Reporting on methods in clinical trials. N Engl J Med. 1982;306:1332–1337
  15. Rennie D. Reporting randomized controlled trials: an experiment and a call for response from readers. JAMA. 1995;273:1054–1055
  16. Moher D, Dulberg CD, Wells GA. Statistical power, sample size, and their reporting in randomized controlled trials. JAMA. 1994;272:122–124
  17. Begg C, Cho M, Eastwood S, Horton R, Moher D, Olkin I, et al. Improving the quality of reporting of randomized controlled trials: the CONSORT statement. JAMA. 1996;276:637–649
  18. Working Group on Recommendations for Reporting of Clinical Trials in the Biomedical Literature . Call for comments on a proposal to improve reporting of clinical trials in the biomedical literature. Ann Intern Med. 1994;121:894–895
  19. Moher D, Schulz KF, Altman DG. The CONSORT statement: revised recommendations for improving the quality of reports of parallel-group randomised trials. Lancet. 2001;357:1191–1194
  20. Moher D, Jones A, Lepage L. Use of the CONSORT statement and quality of reports of randomized trials: a comparative before-and-after evaluation. JAMA. 2001;285:1992–1995
  21. Devereaux PJ, Manns BJ, Ghali WA, Quan H, Guyatt GH. 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
  22. Northridge MD, Levin B, Feinleib M, Susser MW. Statistics in the journal—significance, confidence, and all that. [Editorial] Am J Public Health. 1997;87:1092–1095
  23. Hollis S, Campbell F. What is meant by intention to treat analysis? Survey of published randomised controlled trials. BMJ. 1999;319:670–674
  24. Hill CL, LaValley MP, Felson DT. Discrepancy between published report and actual conduct of randomized clinical trials. J Clin Epidemiol. 2002;55:783–786
  25. Mennemeyer ST. Can econometrics rescue epidemiology?. Ann Epidemiol. 1997;7:249–250
  26. 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
  27. D'Agostino RH. Propensity score methods for bias reduction in the comparison of a treatment to a non-randomized control group. Stat Med. 1998;17:2265–2281
  28. Slavin RE. Best evidence synthesis: an intelligent alternative to meta-analysis. J Clin Epidemiol. 1995;48:9–18
  29. In:  Field M,  Lohr K editor. Guidelines for clinical practice: from development to use. Washington, DC: National Academy Press; 1992;

PII: S0895-4356(06)00257-5

doi: 10.1016/j.jclinepi.2006.06.016

Journal of Clinical Epidemiology
Volume 60, Issue 3 , Pages 241-249 , March 2007

Article Tools