Saturday, March 19, 2016

Levels of Evidence



From the Centre for Evidence-Based Medicine, Oxford
For the most up-to-date levels of evidence, see www.cebm.net/?o=1025

Therapy/Prevention/Etiology/Harm:
1a:
Systematic reviews (with homogeneity) of randomized controlled trials
1b:
Individual randomized controlled trials (with narrow confidence interval)
1c:
All or none randomized controlled trials
2a:
Systematic reviews (with homogeneity) of cohort studies
2b:
Individual cohort study or low quality randomized controlled trials (e.g. <80 follow-up="" span="">
2c:
"Outcomes" Research; ecological studies
3a:
Systematic review (with homogeneity) of case-control studies
3b:
Individual case-control study
4:
Case-series (and poor quality cohort and case-control studies)
5:
Expert opinion without explicit critical appraisal, or based on physiology, bench research or "first principles"

Diagnosis:
1a:
Systematic review (with homogeneity) of Level 1 diagnostic studies; or a clinical decision rule with 1b studies from different clinical centers.
1b:
Validating cohort study with good reference standards; or clinical decision rule tested within one clinical center
1c:
Absolute SpPins And SnNouts (An Absolute SpPin is a diagnostic finding whose Specificity is so high that a Positive result rules-in the diagnosis. An Absolute SnNout is a diagnostic finding whose Sensitivity is so high that a Negative result rules-out the diagnosis).
2a:
Systematic review (with homogeneity) of Level >2 diagnostic studies
2b:
Exploratory cohort study with good reference standards; clinical decision rule after derivation, or validated only on split-sample or databases
3a:
Systematic review (with homogeneity) of 3b and better studies
3b:
Non-consecutive study; or without consistently applied reference standards
4:
Case-control study, poor or non-independent reference standard
5:
Expert opinion without explicit critical appraisal, or based on physiology, bench research or "first principles"

Prognosis:
1a:
Systematic review (with homogeneity) of inception cohort studies; or a clinical decision rule validated in different populations.
1b:
Individual inception cohort study with > 80% follow-up; or a clinical decision rule validated on a single population
1c:
All or none case-series
2a:
Systematic review (with homogeneity) of either retrospective cohort studies or untreated control groups in randomized controlled trials.
2b:
Retrospective cohort study or follow-up of untreated control patients in a randomized controlled trial; or derivation of a clinical decision rule or validated on split-sample only
2c:
"Outcomes" research
4:
Case-series (and poor quality prognostic cohort studies)
5:
Expert opinion without explicit critical appraisal, or based on physiology, bench research or "first principles"

Note: A minus sign "-" may be added to denote evidence that fails to provide a conclusive answer because it is either (a) a single result with a wide Confidence Interval; OR (b) a Systematic Review with troublesome heterogeneity. Such evidence is inconclusive, and therefore can only generate Grade D recommendations.


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