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Interpretation of Clinical Significance Not Stated

Interpretation of Clinical Significance of Results Often Absent in Published Papers

NEW YORK (Reuters Health) Dec 10 -

Researchers who conduct randomized controlled trials often fail to provide their own personal interpretation of the clinical importance of their findings, Canadian researchers have found. Authors also do not consistently provide readers with enough information to judge the importance of the results for themselves.

Dr. Malcolm Man-Son-Hing of Ottawa Hospital and colleagues report their findings in the current issue of the Canadian Medical Association Journal dated October 30th. They had four independent reviewers assess the quality of reporting of a number of specific factors related to clinical relevance in a random sample of 27 published randomized controlled trials.

"Ideally, each published randomized controlled trial should report an explicit primary outcome, a sample size delta value that reflects the authors' perception of the minimal clinically important difference [MCID] of their intervention, the statistical significance of the primary outcome, confidence intervals surrounding the point estimates for the primary outcome and an explicit discussion of the clinical importance of the study results," they write.

Of the 27 articles, only 20 included comments on why the findings were important to clinical practice and, of these, only 5 included supporting facts to justify their clinical interpretation of the results. Eleven of the 27 studies included confidence intervals and 22 explicitly reported one primary outcome.

Eighteen of the 20 articles that provided a sample size calculation reported a delta value, but only 2 explained that this was based on the MCID.

In comments to Reuters Health, Dr. Man-Son-Hing urged "authors of clinical studies...to place more emphasis on interpreting their results from the perspective of clinical importance rather than statistical significance."

CMAJ 2001;165:1197-1202.


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