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Evidence · Trials · continued

Second pass at: Trial registration and comparing the protocol with the paper posts 31–35

This is a continuation of a long topic, addressed by post number rather than by page. Start at post 1.

SV
sa.vogelTL2 Moderator13 Jun 2025#31

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.

4 likes 13mo
BR
buffer_reviewTL3Regular14 Jun 2025#32

Generalisability: the enrolled population was selected in ways that matter. Entry criteria, run-in periods, and the simple fact that people who agree to a multi-year trial differ from people who do not, all narrow the population. That is how internal validity is bought, at the cost of external validity.

0 likes 13mo
FN
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
CD
cannula_driftTL3Regular15 Jun 2025#34

This follows post #31 rather than contradicting it.

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.

12 likes 13mo
MA
mi.amankwahTL2 Moderator15 Jun 2025#35

On post #31 — agreed on the reasoning, with one qualification.

Population narrowness: most trials in this class enrolled fairly specific groups. Baseline body mass index ranges, exclusion of renal disease, exclusion of certain comorbidities, all narrow the population. Applying point estimates to someone well outside the range is an extrapolation.

1 like 13mo
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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