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Updated: Jun 18 2021

Level of Evidence

  • Introduction
    • A method utilized in the 3rd step of evidence based medicine (EBM) to determine the clinical value of a study
      • five steps of EBM
        • formulate an answerable question
        • gather the evidence
        • appraise the evidence
        • implement the evidence
        • evaluate the process
    • See details of Clinical Design Trials
  • Different Levels of Evidence
      • Different Levels of Evidence
      • 1. Randomized controlled trial (RCT)
      •  a study in which patients are randomly assigned to the treatment or control group and are followed prospectively
      • 2. Meta-analysis of randomized trials with homogeneous results
      • 1.  Poorly designed RCT
      •  Follow up less than 80%
      • 2. Prospective cohort study (therapeutic)
      • A study in which patient groups are separated non-randomly by exposure or treatment, with exposure occurring after the initiation of the study
      • 3.  Meta-analysis of Level 2 studies
      • 1. Retrospective cohort study
      • A study in which patient groups are separated non-randomly by exposure or treatment, with exposure occurring before the initiation of the study
      • 2. Case-control study
      • A study in which patient groups are separated by the current presence or absence of disease and examined for the prior exposure of interest
      • 3. Meta-analysis of Level 3 studies
      • Level 4
      • 1. Case series
      • A report of multiple patients with the same treatment, but no control group or comparison group
      • 1. Case report (a report of a single case)
      • 2. Expert opinion
      • 3. Personal observation
  •  JBJS Level of evidence
      • AAOS Evidence-Based Practice Committee Recommendations in Clinical Practice Guidelines
      • Strong
      • Two or more HIGH quality studies
      • Moderate
      • One HIGH or 2 MODERATE quality studies
      • Weak
      • One MODERATE or 1 or more LOW quality studies
      • Consensus
      • Expert opinion (no studies)
      • *Only used in one circumstance: It pertains to medical interventions that potentially prevent loss of life or limb (catastrophic consequences).
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