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Level of Evidence
Saurab Sharma, MPT
Lecturer, KUSMS
EBPP
Lecturer 4
Objectives
• At the end of the class, students should be
able to:
– list various scales for level of evidences
– elaborate...
GRADE
• Grading of Recommendations, Assessment,
Development, and Evaluation
•
3Saurab S, KUSMS 14'
GRADE
4Saurab S, KUSMS 14'
NHMRC
5Saurab S, KUSMS 14'
NHMRC
(National Health and Medical Research Council)
Level Design
I Systematic reivew of Randomized controlled trials (RCT...
Oxford Centre for Evidence-based
Medicine Levels of Evidence (March 2009)
Level Therapy/Prevention,
Aetiology/Harm
Prognos...
Oxford Centre for Evidence-based Medicine
Levels of Evidence (March 2009)
Level Therapy/Prevention, Aetiology/Harm
1a SR (...
Sackett
11Saurab S, KUSMS 14'
Type of question and study design
12Saurab S, KUSMS 14'
Type of question Suggested study
Therapy RCT > prospective cohort
...
Summary
13Saurab S, KUSMS 14'
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4. level of evidence

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Level of evidence.

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4. level of evidence

  1. 1. Level of Evidence Saurab Sharma, MPT Lecturer, KUSMS EBPP Lecturer 4
  2. 2. Objectives • At the end of the class, students should be able to: – list various scales for level of evidences – elaborate Sackett’s level of evidence 2Saurab S, KUSMS 14'
  3. 3. GRADE • Grading of Recommendations, Assessment, Development, and Evaluation • 3Saurab S, KUSMS 14'
  4. 4. GRADE 4Saurab S, KUSMS 14'
  5. 5. NHMRC 5Saurab S, KUSMS 14'
  6. 6. NHMRC (National Health and Medical Research Council) Level Design I Systematic reivew of Randomized controlled trials (RCTs) II RCT III- 1 A pseudo-randomised controlled trial III- 2 A comparative study with concurrent controls: ▪ Non-randomised, experimental trial ▪ Cohort study ▪ Case-control study III- 3 A comparative study without concurrent controls: ▪ Historical control study ▪ Two or more single arm study ▪ Interrupted time series without a parallel control group IV Case series with either post-test or pre-test/post-test outcomes V Expert opinion 6Saurab S, KUSMS 14'
  7. 7. Oxford Centre for Evidence-based Medicine Levels of Evidence (March 2009) Level Therapy/Prevention, Aetiology/Harm Prognosis Diagnosis Differential diagnosis/symptom prevalence study Economic and decision analyses 1a SR (with homogeneity*) of RCTs SR (with homogeneity*) of inception cohort studies; CDR† validated in different populations SR (with homogeneity*) of Level 1 diagnostic studies; CDR† with 1b studies from different clinical centres SR (with homogeneity*) of prospective cohort studies SR (with homogeneity*) of Level 1 economic studies 1b Individual RCT (with narrow Confidence Interval‡) Individual inception cohort study with > 80% follow-up; CDR† validated in a single population Validating** cohort study with good††† reference standards; or CDR† tested within one clinical centre Prospective cohort study with good follow-up**** Analysis based on clinically sensible costs or alternatives; systematic review(s) of the evidence; and including multi- way sensitivity analyses 1c All or none§ All or none case-series Absolute SpPins and SnNouts†† All or none case-series Absolute better-value or worse-value analyses †††† 2a SR (with homogeneity*) of cohort studies SR (with homogeneity*) of either retrospective cohort studies or untreated control groups in RCTs SR (with homogeneity*) of Level >2 diagnostic studies SR (with homogeneity*) of 2b and better studies SR (with homogeneity*) of Level >2 economic studies 2b Individual cohort study (including low quality RCT; e.g., <80% follow- up) Retrospective cohort study or follow-up of untreated control patients in an RCT; Derivation of CDR† or validated on split-sample§§§ only Exploratory** cohort study with good††† reference standards; CDR† after derivation, or validated only on split-sample§§§ or databases Retrospective cohort study, or poor follow-up Analysis based on clinically sensible costs or alternatives; limited review(s) of the evidence, or single studies; and including multi-way sensitivity analyses 2c "Outcomes" Research; Ecological studies "Outcomes" Research Ecological studies Audit or outcomes research 3a SR (with homogeneity*) of case- control studies SR (with homogeneity*) of 3b and better studies SR (with homogeneity*) of 3b and better studies SR (with homogeneity*) of 3b and better studies 3b Individual Case-Control Study Non-consecutive study; or without consistently applied reference standards Non-consecutive cohort study, or very limited population Analysis based on limited alternatives or costs, poor quality estimates of data, but including sensitivity analyses incorporating clinically sensible variations. 4 Case-series (and poor quality cohort and case-control studies§§) Case-series (and poor quality prognostic cohort studies***) Case-control study, poor or non- independent reference standard Case-series or superseded reference standards Analysis with no sensitivity analysis 5 Expert opinion without explicit critical appraisal, or based on physiology, bench research or "first principles" Expert opinion without explicit critical appraisal, or based on physiology, bench research or "first principles" Expert opinion without explicit critical appraisal, or based on physiology, bench research or "first principles" Expert opinion without explicit critical appraisal, or based on physiology, bench research or "first principles" Expert opinion without explicit critical appraisal, or based on economic theory or "first principles" 9Saurab S, KUSMS 14'
  8. 8. Oxford Centre for Evidence-based Medicine Levels of Evidence (March 2009) Level Therapy/Prevention, Aetiology/Harm 1a SR (with homogeneity) of RCTs 1b Individual RCT (with narrow Confidence Interval) 1c All or none 2a SR (with homogeneity) of cohort studies 2b Individual cohort study (including low quality RCT; e.g., <80% follow-up) 2c "Outcomes" Research; Ecological studies 3a SR (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" 10Saurab S, KUSMS 14'
  9. 9. Sackett 11Saurab S, KUSMS 14'
  10. 10. Type of question and study design 12Saurab S, KUSMS 14' Type of question Suggested study Therapy RCT > prospective cohort Diagnosis Prospective, blind comparison to a gold standard Etiology/Harm RCT > cohort > case control > case series Prognosis Cohort study > case control > Case series Prevention RCT > cohort study >case control > case series Cost Economic analysis
  11. 11. Summary 13Saurab S, KUSMS 14'

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