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Analysis of 567,758 randomized controlled trials published over 30 years reveals trends in phrases used to discuss results that do not reach statistical significance

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  • Willem M Otte
  • Christiaan H Vinkers
  • Philippe C Habets
  • David G P van IJzendoorn
  • Joeri K Tijdink

Abstract

The power of language to modify the reader’s perception of interpreting biomedical results cannot be underestimated. Misreporting and misinterpretation are pressing problems in randomized controlled trials (RCT) output. This may be partially related to the statistical significance paradigm used in clinical trials centered around a P value below 0.05 cutoff. Strict use of this P value may lead to strategies of clinical researchers to describe their clinical results with P values approaching but not reaching the threshold to be “almost significant.” The question is how phrases expressing nonsignificant results have been reported in RCTs over the past 30 years. To this end, we conducted a quantitative analysis of English full texts containing 567,758 RCTs recorded in PubMed between 1990 and 2020 (81.5% of all published RCTs in PubMed). We determined the exact presence of 505 predefined phrases denoting results that approach but do not cross the line of formal statistical significance (P

Suggested Citation

  • Willem M Otte & Christiaan H Vinkers & Philippe C Habets & David G P van IJzendoorn & Joeri K Tijdink, 2022. "Analysis of 567,758 randomized controlled trials published over 30 years reveals trends in phrases used to discuss results that do not reach statistical significance," PLOS Biology, Public Library of Science, vol. 20(2), pages 1-15, February.
    • Handle: RePEc:plo:pbio00:3001562
    DOI: 10.1371/journal.pbio.3001562
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