[Question] endpoint — what am I missing here
endpoint — what am I missing here. I would rather ask a basic question now than get this wrong quietly for two months.
Spent an evening with the appendix tables and found the subgroup detail that the entire thread had been speculating about.
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.
Research-use-only material is not approved for human use and nothing here should be read as a recommendation to use it.
best — the order this archive was captured in
Press-release posts get their own flair here. Nothing wrong with them, they are just a different kind of claim.
Agreed on comparators. "Superior" means nothing until you know superior to what and at what dose.
Correction: SURMOUNT is the obesity programme and SURPASS is the diabetes one. The figure you quoted belongs to the other one.
intention to treat versus completers changes the number substantially
The registered protocol is public. Comparing the registered primary endpoint with the reported one is a two-minute check and it is how outcome switching gets caught.
Right — trial participants get structured support. Comparing yourself to a trial mean is comparing across two different interventions.
The registered protocol is public.
Adding the check nobody runs — the registered protocol is public and takes two minutes to compare.
Is that intention-to-treat or completers?
Cardiovascular outcome trials are powered for events, not for weight, and are typically run in a different population with different inclusion criteria. Reading a weight number out of one is reading a secondary endpoint.
Which trial, and which arm?
That is the 68-week readout, not the 72-week one. Different trial, different duration.
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.
Relative risk reduction without the baseline rate is uninterpretable. A large relative reduction on a small absolute risk is a small absolute benefit.
Push back: an open-label extension tells you about the people who stayed. That is a different question.
Push back: an open-label extension tells you about the people who stayed.
anders_vermeulen is right about the programme names. They are different populations with different endpoints.
Agreed. Half the arguments on this site are two people quoting different trials at each other without noticing.
Small fix — that was the cardiovascular outcomes trial, so weight was a secondary endpoint and the population was different.
Careful with that mean. The distribution around it was wide enough that it describes very few individual participants.
Yes. The appendix tables are where the subgroup and the adverse event detail actually live.
Intention-to-treat analyses everybody randomised regardless of what they did afterwards. Completer analyses only those who finished. The second is systematically more flattering and both are legitimate if labelled.
Intention-to-treat analyses everybody randomised regardless of what they did afterwards.
Agreed. And the interval, not the point estimate, is what the trial actually established.
the confidence interval is the finding, the point estimate is the headline
a press release is not a publication
Open-label extensions lose their randomisation. Anybody still enrolled at week 104 is a selected group and the numbers describe that group.
phase 2 finds a dose, phase 3 measures the effect
Argued for a week about a result and then read the limitations section, which conceded most of my opponent’s point.
Discontinuation rates are a tolerability result. A trial with a strong efficacy number and heavy discontinuation is telling you two things and people only quote one.
- 1Careful with that mean. The distribution around it was wide enough that it…9 comments in this branch · started by u/forest_plot_fiona
- 2A confidence interval is the range of effects compatible with the data. Two…8 comments in this branch · started by u/anders_vermeulen