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Types of Studies |
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Therapeutic Studies – Investigating the results of treatment |
Prognostic Studies – Investigating the effect of a patient characteristic on the outcome of disease |
Diagnostic Studies – Investigating a diagnostic test |
Economic and Decision Analyses – Developing an economic or decision model |
Level I |
- High quality randomized trial with statistically significant difference or no statistically significant difference but narrow confidence intervals
- Systematic Review 2 of Level I RCTs (and study results were homogenous 3)
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- High quality prospective study 4 (all patients were enrolled at the same point in their disease with ≥ 80% follow up of enrolled patients)
- Systematic review 2 of Level I studies
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- Testing of previously developed diagnostic criteria on consecutive patients (with universally applied reference “gold” standard)
- Systematic review 2 of Level I studies
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- Sensible costs and alternatives; values obtained from many studies; with multiway sensitivity analyses
- Systematic review 2 of Level I studies
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Level II |
- Lesser quality RCT (e.g. < 80% follow up, no blinding, or improper randomization)
- Prospective 4 comparative study 5
- Systematic review 2 of Level II studies or Level 1 studies with inconsistent results
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- Retrospective 6 study
- Untreated controls from an RCT
- Lesser quality prospective study (e.g. patients enrolled at different points in their disease or <80% follow-up.)
- Systematic review 2 of Level II studies
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- Development of diagnostic criteria on consecutive patients (with universally applied reference “gold” standard)
- Systematic review 2 of Level II studies
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- Sensible costs and alternatives; values obtained from limited studies; with multiway sensitivity analyses
- Systematic review 2 of Level II studies
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Level III |
- Case control study7
- Retrospective 6 comparative study 5
- Systematic review 2 of Level III studies
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- Study of nonS consecutive patients; without consistently applied reference “gold” standard
- Systematic review 2 of Level III studies
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- Analyses based on limited alternatives and costs; and poor estimates
- Systematic review 2 of Level III studies
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Level IV |
Case Series 8 |
Case series |
- Case-control study
- Poor reference standard
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- Analyses with no sensitivity analyses
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Level V |
Expert Opinion |
Expert Opinion |
Expert Opinion |
Expert Opinion |