Evidence topics tagged randomised trial

Journal club: indirect comparison between two programmes, defended and attacked Writing it up because I had to work it out twice and would rather nobody else did. Comparing SUSTAIN 6 ( N Engl J Med , 2016)…

Journal club: STEP 1 and the treatment-policy estimand Writing it up because I had to work it out twice and would rather nobody else did. Comparing SUSTAIN 6 ( N Engl J Med , 2016) with STEP 8 ( JAMA , 2022)…

What a statistical analysis plan adds that the paper does not — that is the question, and I have not found it answered plainly anywhere I have looked. I have seen SCALE ( N Engl J Med , 2015) cited in support…

Second pass at: Reading a trial's population section before its results Writing it up because I had to work it out twice and would rather nobody else did. I have seen STEP 1 ( N Engl J Med , 2021) cited in…

On the subject in the title: Primary endpoint hierarchies and why order matters — one year on Working notes rather than a conclusion. Comparing SELECT ( N Engl J Med , 2023) with SURPASS-2 ( N Engl J Med ,…

Composite endpoints and the component doing the work Writing it up because I had to work it out twice and would rather nobody else did. I have seen SURPASS-4 ( Lancet , 2021) cited in support of a claim I do…

Posting this under the heading it deserves: Journal club: STEP 8 and the fairness of the comparator dose — a second dataset Everything below is what sits behind that. Session topic: SURPASS-2 ( N Engl J Med ,…

Posting this under the heading it deserves: Journal club: semaglutide in MASH, and surrogate endpoints Everything below is what sits behind that. Comparing SCALE ( N Engl J Med , 2015) with SURMOUNT-2 (…

Asking directly, because I could not find a straight answer: Journal club: STEP 1 and the treatment-policy estimand — does this still hold? Comparing STEP 2 ( Lancet , 2021) with SURPASS-2 ( N Engl J Med ,…

On the subject in the title: Journal club: the CagriSema phase 2 combination paper Working notes rather than a conclusion. I have seen SURMOUNT-1 ( N Engl J Med , 2022) cited in support of a claim I do not…

On the subject in the title: Journal club: what we got wrong in an earlier session Working notes rather than a conclusion. Session topic: SURMOUNT-1 ( N Engl J Med , 2022). Please read it before posting; the…

Subgroup analyses: pre-specified versus discovered — setting out what I have, and where I think it stops being reliable. Comparing SURMOUNT-2 ( Lancet , 2023) with SURPASS-4 ( Lancet , 2021) and finding the…

On the subject in the title: Journal club: SUSTAIN 6 and its retinopathy signal Working notes rather than a conclusion. I have seen SELECT ( N Engl J Med , 2023) cited in support of a claim I do not think it…

Journal club: orforglipron phase 2 and the non-peptide question Writing it up because I had to work it out twice and would rather nobody else did. I have seen SUSTAIN 6 ( N Engl J Med , 2016) cited in support…

Journal club: FLOW and the renal composite, component by component Writing it up because I had to work it out twice and would rather nobody else did. I have seen SUSTAIN 6 ( N Engl J Med , 2016) cited in…

Interim analyses and stopping rules Writing it up because I had to work it out twice and would rather nobody else did. I have seen SUSTAIN 6 ( N Engl J Med , 2016) cited in support of a claim I do not think…

Posting this under the heading it deserves: Journal club: STEP 3 and the intensive behavioural therapy floor Everything below is what sits behind that. Comparing SCALE ( N Engl J Med , 2015) with STEP 4 (…

On the subject in the title: Run-in periods and the population they select Working notes rather than a conclusion. Session topic: PIONEER 6 ( N Engl J Med , 2019). Please read it before posting; the…

Journal club: SELECT, absolute risk, and how it was reported Writing it up because I had to work it out twice and would rather nobody else did. Session topic: SURMOUNT-OSA ( N Engl J Med , 2024). Please read…

On the subject in the title: Journal club: SELECT, absolute risk, and how it was reported — a second dataset Working notes rather than a conclusion. Comparing SURMOUNT-1 ( N Engl J Med , 2022) with SELECT ( N…

On the subject in the title: Reading a trial's population section before its results Working notes rather than a conclusion. I have seen STEP 2 ( Lancet , 2021) cited in support of a claim I do not think it…

On the subject in the title: Subgroup analyses: pre-specified versus discovered — a second dataset Working notes rather than a conclusion. Comparing SURMOUNT-1 ( N Engl J Med , 2022) with SURPASS-4 ( Lancet ,…

Primary endpoint hierarchies and why order matters Writing it up because I had to work it out twice and would rather nobody else did. Comparing SURMOUNT-OSA ( N Engl J Med , 2024) with SURPASS-2 ( N Engl J…

Journal club: is percentage weight change the right endpoint? I have a specific reason for asking rather than idle curiosity, and the context is below. Comparing SURPASS-4 ( Lancet , 2021) with SURMOUNT-OSA (…

What a statistical analysis plan adds that the paper does not I have a specific reason for asking rather than idle curiosity, and the context is below. I have seen SUSTAIN 6 ( N Engl J Med , 2016) cited in…

Posting this under the heading it deserves: Open-label extensions: what survives and what does not Everything below is what sits behind that. Comparing STEP 8 ( JAMA , 2022) with PIONEER 6 ( N Engl J Med ,…

Run-in periods and the population they select — the long version Writing it up because I had to work it out twice and would rather nobody else did. Session topic: SUSTAIN 6 ( N Engl J Med , 2016). Please read…

Posting this under the heading it deserves: Journal club: PIONEER 6 as a safety trial Everything below is what sits behind that. Session topic: SURMOUNT-4 ( JAMA , 2024). Please read it before posting; the…

Non-inferiority margins: how they are chosen and how they are abused — a second dataset — setting out what I have, and where I think it stops being reliable. Comparing FLOW ( N Engl J Med , 2024) with…

On the subject in the title: Reading a supplementary appendix and finding the interesting part Working notes rather than a conclusion. Comparing SELECT ( N Engl J Med , 2023) with FLOW ( N Engl J Med , 2024)…