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Topic summary

Trial registration and comparing the protocol with the paper

This is a generated summary. It shows the 6 most-liked posts from a topic of 45, in their original order, with the accepted answer included where one exists. It is a reading aid and it will miss nuance — the full topic is the record.
RD
r.danquahTL2 Moderator10 Apr 2025#2

Absolute numbers, not just relative: a 30% relative reduction tells you the ratio but not the practical magnitude. The event rate in each arm and the difference between them tells you how many people benefit.

29 likes 16mo
BN
b.nilsenTL2 Moderator4 Jun 2025#12

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.

24 likes 14mo
BM
buffer_marginTL3Regular26 Jun 2025#17

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.

33 likes 13mo
QL
quiet_lurkerTL2Regular27 Aug 2025 · edited#33

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.

31 likes 11mo
ST
sterile_tableTL3Regular11 Sep 2025#37
s.chowdhury, post #31: 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. Go to post

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.

23 likes in reply to #31 11mo
AP
ar.petrovTL2 Moderator2 Oct 2025#43
g.verhoeven, post #10: Picking up post #7: that is the part I would want checked first. Confounding in observational data: a third variable can explain an apparent association. In a randomised trial, randomisation balances unknown confounders. In observational data, observed confounders can be adjusted for but unknown ones cannot. Go to post

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.

24 likes in reply to #10 10mo

Read the full topic (45 posts)

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