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Table 2 Oxford Centre for Evidence-based Medicine (OCEBM) levels of evidence (2011) [45]

From: The European guideline on management of major bleeding and coagulopathy following trauma: fifth edition

Question

Step 1 (level 1*)

Step 2 (level 2*)

Step 3 (level 3*)

Step 4 (level 4*)

Step 5 (level 5)

How common is the problem?

Local and current random sample surveys (or censuses)

Systematic review of surveys that allow matching to local circumstances**

Local non-random sample**

Case-series**

N/A

Is this diagnostic or monitoring test accurate? (diagnosis)

Systematic review of cross-sectional studies with consistently applied reference standard and blinding

Individual cross-sectional studies with consistently applied reference standard and blinding

Non-consecutive studies or studies without consistently applied reference standards**

Case-control studies or poor or non-independent reference standard**

Mechanism-based reasoning

What will happen if we do not add a therapy? (prognosis)

Systematic review of inception cohort studies

Inception cohort studies

Cohort study or control arm of randomised trial*

Case-series or case-control studies or poor-quality prognostic cohort study**

N/A

Does this intervention help? (treatment benefits)

Systematic review of randomised trials or n-of-1 trials

Randomised trial or observational study with dramatic effect

Non-randomised controlled cohort/follow-up study**

Case-series, case-control studies or historically controlled studies**

Mechanism-based reasoning

What are the common harms? (treatment harms)

Systematic review of randomised trials, systematic review of nested case-control studies, n-of-1 trial with the patient you are raising the question about, or observational study with dramatic effect

Individual randomised trial or (exceptionally) observational study with dramatic effect

Non-randomised controlled cohort/follow-up study (post-marketing surveillance) provided there are sufficient numbers to rule out a common harm. (For long-term harms the duration of follow-up must be sufficient.)**

Case-series, case-control or historically controlled studies**

Mechanism-based reasoning

What are the rare harms? (treatment harms)

Systematic review of randomised trials or n-of-1 trial

Randomised trial or (exceptionally) observational study with dramatic effect

Is this (early detection) test worthwhile? (screening)

Systematic review of randomised trials

Randomised trial

Non-randomised controlled cohort/follow-up study**

Case-series, case-control or historically controlled studies**

Mechanism-based reasoning

  1. *Level may be graded down on the basis of study quality, imprecision, indirectness [study PICO (patient, problem or population, intervention, comparison, control or comparator, outcome) does not match questions PICO)], because of inconsistency between studies, or because the absolute effect size is very small; level may be graded up if there is a large or very large effect size
  2. **As always, a systematic review is generally better than an individual study
  3. N/A not applicable