Topic summary

Second pass at: Trial registration and comparing the protocol with the paper

Evidence › Trials estimand discontinuation & dropout randomised trial open label

This is a generated summary. It shows the 5 most-liked posts from a topic of 35, 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.

h.kjeldsenTL1Member31 May 2025#6

mira.patel, post #1: Posting this under the heading it deserves: Second pass at: Trial registration and comparing the protocol with the paper Everything below is what sits behind that. I have seen SCALE ( N Engl J Med , 2015) cited in support of a claim I do not think it supports, twice this month, so I would like to work through what it actually shows. My… Go to post

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.

30 likes in reply to #1 14mo

sterile_fileTL3Regular5 Jun 2025#15

f.petrov, post #12: This follows post #9 rather than contradicting it. For anyone arriving from a search: the marked solution above is the direct answer, and the replies underneath it add the caveats that make it safe to use. Go to post

Coming back to post #13, because the follow-up matters more than the original answer.

Multiplicity and multiple comparisons: if a trial tests many hypotheses, the chance of a false positive on at least one by random chance increases. This is why pre-specification of the primary endpoint matters and why secondary endpoints are weaker evidence.

29 likes in reply to #12 14mo

NorringtonTL3Regular9 Jun 2025#22

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.

30 likes 14mo

z.nakamuraTL2 Moderator12 Jun 2025#29

This follows post #26 rather than contradicting it.

29 likes 13mo

f.novakTL2 Moderator14 Jun 2025 · edited#33

a.stephanopoulos, post #13: 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. Go to post

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.

25 likes in reply to #13 13mo

Read the full topic (35 posts)

Promoted into the documentation commons. The content of this topic is maintained at Cagrilintide plus semaglutide phase 2 — trial digest, with named maintainers and a review date. The promotion was discussed in doc review. Corrections are best raised against the document, which is the version that gets kept current.

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