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Evidence · Trials · continued

Adjudicated events and why the definition matters — the long version posts 31–60

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

EK
e.kuuselaTL23 Mar 2025#31

Absolute and relative effects answer different questions. Write down the event rate in each arm and the difference between them; everything quotable is derived from those two numbers.

The interesting part of this is the exception, and I do not understand the exception.

32 likes 17mo
C
chromatogramTL4Analytical chemist3 Mar 2025#32
c.okafor, post #26: Post #25 is the version of this I will quote in future. One addition. On Adjudicated events the community has more anecdote than the confidence in this thread implies, and I include my own contribution in that. Go to post

Worth separating two things that post #30 runs together.

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.

Written from notes rather than memory, which is why the numbers are specific.

0 likes in reply to #26 17mo
SC
s.coelhoTL24 Mar 2025#33

Post #32 answers the question as asked. The question underneath it is different.

I keep a log for Adjudicated events specifically because my memory of it turned out to be systematically wrong in one direction. Six weeks of notes cost nothing and settled it.

3 likes 17mo
JM
j.mwangiTL4 Moderator5 Mar 2025#34

Two things can be true about Adjudicated events at once: the mechanism is plausible and the evidence for the size of the effect is thin. Most of the argument here is people defending the first against attacks on the second.

11 likes 17mo
RP
r.petrovTL26 Mar 2025#35

Surrogate endpoints: an endpoint that is not the outcome that matters but is measured as a stand-in. HbA1c is a surrogate for long-term glucose control and the short-term complications it prevents. Weight loss is a surrogate for metabolic health and long-term outcomes. Surrogates are useful but not identical to the endpoint that matters.

0 likes 17mo
P
preregisteredTL3Research methods6 Mar 2025#36
c.okafor, post #26: Post #25 is the version of this I will quote in future. One addition. On Adjudicated events the community has more anecdote than the confidence in this thread implies, and I include my own contribution in that. Go to post

Small correction to my own earlier position on Adjudicated events. I had the units the wrong way round, which changes the conclusion by an order of magnitude and therefore changes it entirely.

1 like in reply to #26 17mo
BV
b.vanheckeTL27 Mar 2025#37

Narrowing post #36, because the general version has more than one answer.

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.

It is the sort of thing that seems obvious in retrospect and was not at the time.

6 likes 17mo
PE
ppm_errorTL3Analytical chemist8 Mar 2025#38

This is the first time the answer has come with its own limits attached. Appreciated.

17 likes 17mo
CV
c.vermeulenTL28 Mar 2025#39

Thank you for the correction. I would rather find out here than later.

0 likes 17mo
MS
m.silvaTL29 Mar 2025#40

Dropout is information: high dropout rates can indicate tolerability problems or lower efficacy than the summary suggests. Where the analysis handled dropouts matters. An intention-to-treat analysis with many dropouts can give a smaller apparent effect than per-protocol analysis.

3 likes 17mo
TD
titration_diaryTL310 Mar 2025#41
HF
h.falkTL211 Mar 2025 · edited#42
baseline_table, post #12: 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

Quietly grateful for the plain phrasing. Not every thread gets that.

9 likes in reply to #12 17mo
EF
e.ferreiraTL3Regular11 Mar 2025#43

Coming back to post #40, because the follow-up matters more than the original answer.

On Adjudicated events: the maintained page in the documentation commons covers the general case with citations and a review date, which is more reliable than any reply here including this one.

0 likes 17mo
TD
t.duarteTL212 Mar 2025#44

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.

0 likes 17mo
DS
d.szymanskiTL3Wiki editor13 Mar 2025#45
crossref_check, post #28: The practical version of Adjudicated events is three sentences long. The rigorous version is three pages and reaches the same conclusion with the conditions attached. Go to post

Adjudicated events is well covered in the tag pages, and the older discussions are better than the recent ones because they were argued out properly. Worth twenty minutes before adding to this one.

27 likes in reply to #28 17mo
SZ
s.zamoraTL213 Mar 2025#46
DSakamoto, post #18: Where I part company with post #16, and it is a narrow parting. Adjudicated events sits at the boundary between what this community can usefully discuss and what it cannot, and I think it falls on the discussable side, narrowly. Go to post

Adding the measurement that post #43 says would settle it.

Absolute and relative effects answer different questions. Write down the event rate in each arm and the difference between them; everything quotable is derived from those two numbers.

Nothing above should be read as advice about what anyone else should do.

13 likes in reply to #18 17mo
BW
bac_waterTL2Regular14 Mar 2025#47

What I would want before treating Adjudicated events as settled: the method, the sample, and whether anyone tried to find the opposite result. Two of the three are usually missing.

2 likes 16mo
IG
i.guerreroTL215 Mar 2025#48

My experience of Adjudicated events contradicts the reply above. I am posting it as a data point rather than as a refutation, because one person's experience is exactly that.

0 likes 16mo
RA
r.aldana_pharmdTL4Pharmacist15 Mar 2025#49
r.petrov, post #35: Surrogate endpoints: an endpoint that is not the outcome that matters but is measured as a stand-in. HbA1c is a surrogate for long-term glucose control and the short-term complications it prevents. Weight loss is a surrogate for metabolic health and long-term outcomes. Surrogates are useful but not identical to the endpoint that matters. Go to post

Reading back through, this was answered upthread and I missed it. My fault.

0 likes in reply to #35 16mo
EV
e.vargaTL216 Mar 2025#50
k.asante, post #25: A treatment-policy estimand asks what happens to people assigned to a strategy, including those who abandon it. A hypothetical estimand asks what would have happened had everyone continued. Both are legitimate and they give different numbers. Go to post

This follows post #47 rather than contradicting it.

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.

19 likes in reply to #25 16mo
DB
d.barrosTL217 Mar 2025 · edited#51

Surrogate endpoints: an endpoint that is not the outcome that matters but is measured as a stand-in. HbA1c is a surrogate for long-term glucose control and the short-term complications it prevents. Weight loss is a surrogate for metabolic health and long-term outcomes. Surrogates are useful but not identical to the endpoint that matters.

This is where my knowledge stops and I would rather mark the edge than blur it.

29 likes 16mo
HK
h.karlsenTL217 Mar 2025#52
ew.kuusela, post #11: An update on my earlier Adjudicated events post: the pattern held for another six weeks and then stopped, which I did not predict and cannot explain. Go to post

Post #48 describes the usual case. This is about the unusual one.

Where the Adjudicated events discussion usually stalls is that nobody wants to say "I do not know" and everyone is willing to say "it varies". Those are the same sentence with different clothes on.

0 likes in reply to #11 16mo
CA
c.adebayoTL218 Mar 2025#53

A treatment-policy estimand asks what happens to people assigned to a strategy, including those who abandon it. A hypothetical estimand asks what would have happened had everyone continued. Both are legitimate and they give different numbers.

I have seen it go both ways, which is why I hedge.

5 likes 16mo
SD
s.dziedzicTL219 Mar 2025#54

Offering a way to settle Adjudicated events rather than another opinion about it. Two measurements, taken the same way, a fortnight apart. If the difference is within the noise, the question was not answerable at this precision.

15 likes 16mo
SC
so.cardosoTL219 Mar 2025#55

Picking up post #54: that is the part I would want checked first.

Second-hand on Adjudicated events, so weight it accordingly — someone whose method I trust told me this and I have not verified it myself.

22 likes 16mo
VB
va.baptistaTL220 Mar 2025#56
DSakamoto, post #18: Where I part company with post #16, and it is a narrow parting. Adjudicated events sits at the boundary between what this community can usefully discuss and what it cannot, and I think it falls on the discussable side, narrowly. Go to post

On post #52 — agreed on the reasoning, with one qualification.

Absolute and relative effects answer different questions. Write down the event rate in each arm and the difference between them; everything quotable is derived from those two numbers.

0 likes in reply to #18 16mo
TV
t.vasquezTL4 Moderator20 Mar 2025#57
e.kuusela, post #31: Absolute and relative effects answer different questions. Write down the event rate in each arm and the difference between them; everything quotable is derived from those two numbers. The interesting part of this is the exception, and I do not understand the exception. Go to post

I have three months of notes on Adjudicated events and the honest summary is that the trend is real and the week-to-week numbers are noise. I nearly drew the opposite conclusion from the first fortnight.

2 likes in reply to #31 16mo
JA
j.asanteTL221 Mar 2025#58
SV
s.vanheckeTL222 Mar 2025#59

This follows post #57 rather than contradicting it.

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.

Scoping that to what I have actually seen rather than what I have read.

0 likes 16mo
EC
excursion_checkTL3Regular22 Mar 2025#60

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.

Second-hand, so weight it accordingly.

2 likes 16mo