The risk of false-positive results in orthopaedic surgical trials.

The risk of concluding that the results of a particular study are true, when, in fact, they really are attributable to chance (or random sampling error) is underappreciated by investigators. This erroneous false-positive conclusion is designated as a Type I or alpha error. The extent to which random...

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Publicado en:Clinical Orthopaedics & Related Research® Vol. 413; pp. 63 - 70
Autores principales: Bhandari M, Whang W, Kuo JC, Devereaux PJ, Sprague S, Tornetta P III
Formato: research tables/charts Journal Article
Publicado: Lippincott Williams & Wilkins 2003 Aug
Acceso en línea:Ver este registro en EBSCOhost
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        atl: The risk of false-positive results in orthopaedic surgical trials.
      aug:
        au:
          Bhandari M
          Whang W
          Kuo JC
          Devereaux PJ
          Sprague S
          Tornetta P III
        affil: McMaster University Medical Center, Dept of Clinical Epidemiology and Biostatistics, 1200 Main St West, Room 2C3, Hamilton, Ontario, L8N 3Z5, Canada; bhandari@sympatico.ca
      sug:
        subj:
          Orthopedic Surgery
          Serial Publications
          Clinical Trials
          Type I Error
          Human
      ab: The risk of concluding that the results of a particular study are true, when, in fact, they really are attributable to chance (or random sampling error) is underappreciated by investigators. This erroneous false-positive conclusion is designated as a Type I or alpha error. The extent to which randomized trials in surgery risk Type I errors is unclear. The current authors hand-searched four orthopaedic journals, six general surgery journals, and five medical journals to identify recently published randomized trials (within the past 2 years). Information on outcomes and statistical adjustment for multiple outcomes was recorded for each study. The risk of a Type I error was calculated for each study that did not explicitly state a primary outcome measure for the main statistical comparison. One hundred fifty-nine studies met the inclusion criteria for the study: 60 studies from orthopaedic journals, 49 studies from nonorthopaedic surgical journals, and 50 studies from medical journals. Of the trials that did not state a primary outcome measure, the risk of Type I errors (false-positive results) in orthopaedic and nonorthopaedic surgery journals (mean 37.3% +/- 13.3% and 37.6% +/- 10.5%, respectively) were significantly greater than medical journals (10.1% +/- 1.9%). In the current review of randomized trials in surgery and medicine, the following is reported: (1) reporting of primary outcomes in trials was inadequate; (2) one in three trials in surgery and one in 10 trials in medicine risked false-positive results; and (3) few trials in surgery and medicine considered adjustment for multiple comparisons.
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        research
        tables/charts
        Journal Article
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    language: English
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