This Article
Right arrow Full Text (PDF)
Right arrow Submit a response
Right arrow Alert me when this article is cited
Right arrow Alert me when eLetters are posted
Right arrow Alert me if a correction is posted
Right arrow Citation Map
Services
Right arrow Email this article to a friend
Right arrow Similar articles in this journal
Right arrow Similar articles in PubMed
Right arrow Alert me to new issues of the journal
Right arrow Download to citation manager
Citing Articles
Right arrow Citing Articles via Google Scholar
Google Scholar
Right arrow Articles by Moher, D.
Right arrow Articles by Schulz, K. F.
Right arrow Search for Related Content
PubMed
Right arrow PubMed Citation
Right arrow Articles by Moher, D.
Right arrow Articles by Schulz, K. F.
Related Collections
Right arrow Statistics & Research Methods
CMAJ • March 19, 2002; 166 (6)
© 2002 Canadian Medical Association or its licensors

Letters
Correspondance

Reporting the clinical importance of randomized controlled trials

David Moher*, Douglas G. Altman{dagger} and Kenneth F. Schulz{ddagger}

*Thomas C. Chalmers Center for Systematic Reviews, Children's Hospital of Eastern Ontario Research Institute, Ottawa, Ont.; {dagger}Professor of Statistics in Medicine, Centre for Statistics in Medicine, Institute of Health Sciences, Oxford, UK; {ddagger}Vice President, Quantitative Sciences, Family Health International, Research Triangle Park, NC

Karen Chan and colleagues address how well reports of randomized controlled trials discuss the issue of clinical importance.1 We agree with these authors and others2,3 that clinical importance needs to be discussed in the report of any randomized controlled trial.

Chan and colleagues defined clinical importance using 10 dimensions, such as an explicit statement of the primary outcome. We are surprised that they state early in their article that the CONSORT statement "failed to recommend specifically that authors discuss the clinical importance of their results." Perhaps they have not completely read the CONSORT statement4 and its accompanying explanation and elaboration paper,5 which definitely draw attention to this important issue. For example, item 6 of the CONSORT checklist explicitly recommends that authors of randomized controlled trials report "clearly defined primary and secondary outcome measures."4 Moreover, the explanatory paper is clear about the relevance of clinical importance: "The difference between statistical significance and clinical importance should always be borne in mind. Authors should particularly avoid the common error of interpreting a nonsignificant result as indicating equivalence of interventions. The confidence interval (item 17 of the checklist) provides valuable insight into whether the trial result is compatible with a clinically important effect, regardless of the P value."5

The CONSORT statement is an ever-evolving tool and the CONSORT group welcomes suggestions to further improve the quality of reports of randomized controlled trials. Unfortunately, in this instance, Chan and colleagues have apparently overlooked the existing CONSORT documents. Nevertheless, we congratulate them for their excellent study and for highlighting the issue of clinical importance.

References

  1. Chan KBY, Man-Son-Hing M, Molnar FJ, Laupacis A. How well is the clinical importance of study results reported? As assessment of randomized controlled trials. CMAJ 2001;165(9): 1197-202. [Abstract/Free Full Text]
  2. Clarke M, Chalmers I. Discussion sections in reports of controlled trials published in general medical journals: islands in search of continents? JAMA 1998;280:280-2.[Abstract/Free Full Text]
  3. Docherty M, Smith R. The case for structuring the discussion of scientific papers. BMJ 1999; 318: 1224-5. [Free Full Text]
  4. Moher D, Schulz KF, Altman DG, for the CONSORT group. The CONSORT statement: revised recommendations for improving the quality of reports of parallel-group randomized trials. Ann Intern Med 2001;134:657-62.[Abstract/Free Full Text]
  5. Altman DG, Schulz KF, Moher D, Egger M, Davidoff F, Elbourne DR, et al. The revised CONSORT statement for reporting randomized trials: explanation and elaboration. Ann Intern Med 2001;134:663-9.[Abstract/Free Full Text]




This Article
Right arrow Full Text (PDF)
Right arrow Submit a response
Right arrow Alert me when this article is cited
Right arrow Alert me when eLetters are posted
Right arrow Alert me if a correction is posted
Right arrow Citation Map
Services
Right arrow Email this article to a friend
Right arrow Similar articles in this journal
Right arrow Similar articles in PubMed
Right arrow Alert me to new issues of the journal
Right arrow Download to citation manager
Citing Articles
Right arrow Citing Articles via Google Scholar
Google Scholar
Right arrow Articles by Moher, D.
Right arrow Articles by Schulz, K. F.
Right arrow Search for Related Content
PubMed
Right arrow PubMed Citation
Right arrow Articles by Moher, D.
Right arrow Articles by Schulz, K. F.
Related Collections
Right arrow Statistics & Research Methods