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May 8, 2020

When Should Clinicians Act on Non–Statistically Significant Results From Clinical Trials?

Author Affiliations
  • 1Medical Research Institute of New Zealand, Wellington, New Zealand
  • 2Wellington Hospital Intensive Care Unit, Wellington Hospital, Wellington, New Zealand
  • 3Alfred Hospital Intensive Care Unit, Alfred Hospital, Melbourne, Victoria, Australia
  • 4Monash University School of Public Health and Preventive Medicine, Melbourne, Victoria, Australia
  • 5Department of Intensive Care, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark
JAMA. 2020;323(22):2256-2257. doi:10.1001/jama.2020.3508

Understanding whether the results of a randomized clinical trial (RCT) are clinically actionable is challenging. Reporting standards adopted by JAMA and other leading journals lead to relative uniformity of presentation of RCT findings that help simplify critical appraisal.1 Such uniform reporting also means that the conclusion of the trial may be dichotomized as “positive” or “no difference” based on the statistical significance of the primary outcome. Dichotomization based on the statistical significance of the primary outcome variable reflects the correct, albeit narrow, interpretation of the experiment that the RCT represents. It also reflects decisions made by the investigators in the design of the study and highlights findings in relation to prespecified assumptions. However, there are situations in which a broader appreciation of the results may suggest that non–statistically significant results in the primary outcome of a clinical trial could influence and perhaps change practice. This includes consideration of the outcome in terms of effect size and accompanying CIs, placing the findings from the trial in the context of the totality of the existing relevant evidence.