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c/trialwatch·posted 1 year ago by u/adaeze_weiss

[PSA] STEP is not what most of this community thinks it is

Readout Clean Column ×9

STEP is not what most of this community thinks it is — with the reasoning, because a rule without a reason gets ignored.

Started keeping the trial identifiers straight in a note file because I kept mixing up two programmes in the same sentence.

Quoted a figure here confidently, got asked whether it was ITT, went and checked, and it was not. Learned something.

Read a press release and the publication three months apart. The hedging in the second one was substantial.

I will update this if the picture changes rather than quietly leaving it up.

1,004 up / 361 down74% upvoted27 commentsid 10lrsh9 Aug 2024

27 comments

21 in this archive, depth 6

best — the order this archive was captured in

u/hsa_math47 points·1 year ago

How to read one of these papers in fifteen minutes, in the order that actually helps.

Start with the registered protocol and check the primary endpoint against what is reported. Then the methods: who was included, what the comparator was, how long the randomised phase ran. Then the discontinuation numbers, which are a tolerability result and are usually in a supplementary table.

Only then the efficacy figure, and read the interval rather than the point estimate. Finish with the limitations section, which is where the authors say what they actually think.

Fifteen minutes, and you will know more than any thread summarising it.

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u/hamza_zielinski39 points·1 year ago

A confidence interval is the range of effects compatible with the data. Two trials with overlapping intervals have not disagreed, whatever their point estimates look like next to each other.

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u/joaquin_stanescu12 points·1 year ago

Absolute or relative risk reduction?

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u/enzo_ferrari4 points·1 year ago

the appendix is where the interesting tables live

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u/hugo_bergstrom6 points·1 year ago

discontinuation rate is a result, not a footnote

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u/adaeze_weissOP68 points·1 year ago

Went looking for the registered protocol to see whether the endpoint had changed. It had not, which was reassuring and worth checking.

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u/ines_boateng29 points·1 year ago

SURPASS is the diabetes programme and reports glycaemic endpoints

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u/ahmed_iyer10 points·1 year ago

Spent an evening with the appendix tables and found the subgroup detail that the entire thread had been speculating about.

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[deleted]7 points·1 year ago

[deleted]

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u/rina_bergstrom3 points·1 year ago

registry entry, protocol, publication — three different documents

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u/tb500_tangent40 points·1 year ago

Careful with that mean. The distribution around it was wide enough that it describes very few individual participants.

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u/adaeze_weissOP-13 points·1 year ago·edited

Do you have the publication or the press release?

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u/nordic_pricing30 points·1 year ago

Small fix — that was the cardiovascular outcomes trial, so weight was a secondary endpoint and the population was different.

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u/bastian_ekstrom16 points·1 year ago

Agreed on comparators. "Superior" means nothing until you know superior to what and at what dose.

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u/iman_castellanos24 points·1 year ago

Not convinced. Cross-trial comparison between two programmes with different populations and designs is not a comparison.

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u/trialwatch_theoMOD31 points·1 year ago

Retitled: the original quoted a diabetes endpoint as an obesity result.

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u/bastian_ekstrom11 points·1 year ago

SELECT was cardiovascular outcomes, not weight

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u/iman_castellanos16 points·1 year ago

Push back: an open-label extension tells you about the people who stayed. That is a different question.

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u/rohan_steiner8 points·1 year ago

Push back: an open-label extension tells you about the people who stayed.

This is the distinction that would end about half the arguments on this board.

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u/adaeze_weissOP3 points·1 year ago

Compared myself to a trial mean for about six months before realising the trial arm had dietitian contact every fortnight.

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