Reporting the clinical importance of randomized controlled trials
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* Malcolm Man-Son-Hing
* Karen B.Y. Chan
* Frank J. Molnar
* Andreas Laupacis

Upon rereading the revised CONSORT statement,1 we still do not see an explicit recommendation that authors should discuss the clinical importance of their study results. We do not believe that the discussion of such an important component of the reporting of randomized controlled trials should have been relegated to the accompanying explanation and elaboration paper.2 We are delighted that the CONSORT statement is an ever-evolving tool and suggest that in the next version the checklist explicitly state that authors should (1) report and justify the magnitude of the minimal clinically important difference and (2) discuss and justify their interpretation of the clinical importance of the study result in relation to that difference.

We agree with Bart Harvey's comment. However, the goal for our study3 was to highlight an important shortcoming in the reporting of randomized controlled trials rather than to document the precise frequency of this phenomenon. We believe that we were able to accomplish this goal with our relatively small sample size.

## References

1.  1. 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.
    
    [CrossRef](http://www.cmaj.ca/lookup/external-ref?access_num=10.7326/0003-4819-134-8-200104170-00011&link_type=DOI) 
    
    [PubMed](http://www.cmaj.ca/lookup/external-ref?access_num=11304106&link_type=MED&atom=%2Fcmaj%2F166%2F6%2F712.2.atom) 
    
    [Web of Science](http://www.cmaj.ca/lookup/external-ref?access_num=000168177500005&link_type=ISI) 

2.  2. Chan KBY, Man-Son-Hing M, Molnar FJ, Laupacis A. How well is the clinical importance of study results reported? An assessment of randomized controlled trials. CMAJ 2001;165(9): 1197-202.
    
    [Abstract/FREE Full Text](http://www.cmaj.ca/lookup/ijlink/YTozOntzOjQ6InBhdGgiO3M6MTQ6Ii9sb29rdXAvaWpsaW5rIjtzOjU6InF1ZXJ5IjthOjQ6e3M6ODoibGlua1R5cGUiO3M6NDoiQUJTVCI7czoxMToiam91cm5hbENvZGUiO3M6NDoiY21haiI7czo1OiJyZXNpZCI7czoxMDoiMTY1LzkvMTE5NyI7czo0OiJhdG9tIjtzOjIyOiIvY21hai8xNjYvNi83MTIuMi5hdG9tIjt9czo4OiJmcmFnbWVudCI7czowOiIiO30=) 

3.  3. 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.
    
    [CrossRef](http://www.cmaj.ca/lookup/external-ref?access_num=10.7326/0003-4819-134-8-200104170-00012&link_type=DOI) 
    
    [PubMed](http://www.cmaj.ca/lookup/external-ref?access_num=11304107&link_type=MED&atom=%2Fcmaj%2F166%2F6%2F712.2.atom) 
    
    [Web of Science](http://www.cmaj.ca/lookup/external-ref?access_num=000168177500006&link_type=ISI)