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KUANetal.

Mechanism-based reasoning

Mechanism-based reasoning

Mechanism-based reasoning

Mechanism-based reasoning

matching to local circumstances b Local nonrandom sample b Case series b Not applicable

Not applicable

TABLE III.1 2011 Oxford levels of evidence. 18 Question Step 1 (Level 1 a ) Step 2 (Level 2 a ) Step 3 (Level 3 a ) Level 4 (Level 4 a ) Step 5 (Level 5) How common is the problem? Systematic review of surveys that allow

prognostic cohort study b

reference standard b

Nonrandomized controlled cohort/follow-up study b Case series, case–control studies, or historically controlled studies b

or historically controlled studies b

or historically controlled studies b

Case–control studies or poor a or nonindependent

Case series or case–control studies, or poor-quality

Case series, case–control,

Case series, case–control,

follow-up must be sufficient.) b

studies without consistently applied reference standards b

Randomized trial Nonrandomized controlled cohort/follow-up study b

Inception cohort studies Cohort study or control arm of randomized trail er Randomized trial or

Nonrandomized controlled cohort/follow-up study

(postmarketing surveillance), provided there are sufficient numbers to rule out a

common harm. (For long-term harms, the duration of

Nonconsecutive studies, or

trial or (exceptionally)

observational study with dramatic effect

Individual cross-sectional studies with consistently applied reference

standard and blinding

observational study with dramatic effect

Randomized trial or (exceptionally)

observational study with dramatic effect

Individual randomized

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

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

n -of-1 trial with the patient you

sample surveys (or censuses) Systematic review of

Systematic review of inception cohort studies

Systematic review of randomized trials, systematic review of nested case–control studies,

are raising the question about, or observational study with dramatic effect

cross-sectional studies with

consistently applied reference standard and blinding

Systematic review of randomized trials

Local and current random

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

What are the COMMON harms? (Treatment Harms)

monitoring test accurate? (Diagnosis)

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

Is this diagnostic or

Does the intervention help? (Treatment Benefits)

What are the RARE harms? (Treatment Harms)

a Level may be graded down on the basis of study quality, imprecision, indirectness (study PICO does not match questions PICO), inconsistency between studies, or very small absolute effect size; level may be graded up if there is a large or very large effect size. b As always, a systematic review is generally better than an individual study.