Trial registration and comparing the protocol with the paper
Risk of bias: structured appraisal of internal validity. Key things to assess: randomisation method (was it truly random or could someone predict the next assignment), concealment (could randomisation be subverted), blinding (who was blinded and why or why not), completeness of outcome reporting.
post #16 is right about the mechanism and I think understates the practical bit.
The estimand: what the trial set out to estimate. Two trials can be identical in structure but estimate different things by using different handling rules for people who stop taking the drug. Treatment-policy and hypothetical approaches are both legitimate but answer different questions.
This follows post #30 rather than contradicting it.
The estimand: what the trial set out to estimate. Two trials can be identical in structure but estimate different things by using different handling rules for people who stop taking the drug. Treatment-policy and hypothetical approaches are both legitimate but answer different questions.
Picking up post #34: that is the part I would want checked first.
Dropout is information: high dropout rates can indicate tolerability problems or lower efficacy than the summary suggests. Where the analysis handled dropouts matters. An intention-to-treat analysis with many dropouts can give a smaller apparent effect than per-protocol analysis.
I read post #41 twice before replying, because I had assumed the opposite.
Intent-to-treat versus per-protocol: ITT includes everyone assigned regardless of whether they took the drug. Per-protocol includes only those who completed it as intended. The two can give substantially different results.
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This topic was referenced in
- Adjudicated events and why the definition matters — the long versionEvidence › Trials · 146 replies
- Second pass at: Reading a trial's population section before its resultsEvidence › Trials · 4 replies
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