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Critical Appraisal

Hierarchy of Designs by Question Type

EM FINAL EXAMS Critical Appraisal · Study design Hierarchy of Designs by Question Type The “best” study design is not fixed — it depends on the clinical question being asked. Definition There is no single evidence pyramid that fits every question. The optimal design changes with the question type: therapy → RCT (or a systematic […]

EM FINAL EXAMS Critical Appraisal · Study design

Hierarchy of Designs by Question Type

The “best” study design is not fixed — it depends on the clinical question being asked.

Definition

There is no single evidence pyramid that fits every question. The optimal design changes with the question type: therapy → RCT (or a systematic review of RCTs); diagnosis → cross-sectional study comparing the test against a reference standard; prognosis → cohort study; harm / aetiology → cohort or case-control (an RCT only where exposure can be ethically allocated); cost → economic evaluation.

The picture
1 2 3 4 5 6 Systematic reviews & meta-analyses RCTs Cohort studies Case-control studies Case series & reports Expert opinion higher = lower risk of bias

This classic ranking answers therapy questions — other questions have their own top tier.

What it shows

The familiar pyramid (systematic reviews → RCTs → cohort → case-control → case series → expert opinion) is the hierarchy for therapy questions. For a prognosis question the cohort study becomes the appropriate top tier; for diagnostic accuracy it is a cross-sectional study against a reference standard; for harm a cohort or case-control study often leads, because randomising patients to a suspected harm is usually unethical.

How to read it

First classify the question (therapy, diagnosis, prognosis, harm/aetiology, cost), then pick the hierarchy that matches it. Only therapy questions sit naturally with RCT-on-top. Reaching for an RCT when the question is prognostic or about harm is choosing the wrong tool, not raising the standard of evidence.

Why it matters

Examiners test whether you can match design to question rather than reflexively crowning the RCT. A well-conducted cohort can be the strongest possible evidence for a prognosis or harm question — here an RCT may be impossible, unethical, or simply less relevant.

Key
  • Therapy → RCT / SR of RCTs
  • Diagnosis → cross-sectional vs reference standard
  • Prognosis → cohort · Harm → cohort / case-control
  • Cost → economic evaluation
Pitfall
Pitfall Applying the therapy hierarchy (RCT-on-top) to every question. For a prognosis or harm question the cohort study is the right top tier, and demanding an RCT can be impossible or unethical.
emfinalexams.com · FRCEM / MRCEM revision
EM trial in the wild

Choosing a design for an ED question — suppose you want to know why patients leave the emergency department before being seen. No RCT can answer that: you cannot randomise people to feel ignored. The fit-for-purpose design is qualitative — semi-structured interviews or focus groups exploring patient experience — possibly feeding a later cohort study to quantify which factors predict leaving. For a “why / what is the experience” question a qualitative or observational design sits at the top; an RCT here would be both unfeasible and the wrong tool entirely.

Examiner traps
  • Choosing the wrong design for the question type (e.g. an RCT for a prognosis question).
  • Assuming the RCT is always the answer — it is only the therapy top tier.
  • Ignoring feasibility and ethics — some exposures cannot be randomised.
Quick check

What is the best design to answer a PROGNOSIS question?
Answer: A cohort study — it follows a defined group over time to measure how outcomes unfold, which is exactly what a prognosis question asks. (An RCT is the wrong tool here.)

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