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Evidence · Study critique

A claim built entirely on a subgroup analysis

Solved
Solved by so.cardoso in post #10
Taking post #8 at face value and following it one step further. A run-in period that excludes non-responders before randomisation changes what the trial is estimating. It is legitimate design and it must be stated in any summary. I would treat that as a working assumption and revisit it.

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AS
a.salcedoTL3Regular20 Apr 2025#1

A claim built entirely on a subgroup analysis Writing it up because I had to work it out twice and would rather nobody else did.

I would like to disagree carefully with the settled view on claim built, and I would like to be argued out of it if the disagreement is bad.

The disagreement is about one step, not about the conclusion. If the step holds I withdraw it entirely.

26 likes 15mo
KH
k.haddadTL222 Apr 2025#2

The documentation on claim built is better than this thread and I say that as someone who has posted in the thread.

5 likes 15mo
MI
m.ivaturiTL223 Apr 2025#3

I had written a reply contradicting the opening post and deleted it. Here is what survived.

Multiple comparisons: if a paper reports many outcomes, the chance of a spurious association by random chance is real. Pre-specification of primary outcomes matters and secondary analyses are weaker evidence.

The literature is thinner on this than the confidence in the thread implies.

0 likes 15mo
AS
a.silvaTL224 Apr 2025#4

Adding a data point of agreement rather than a data point.

28 likes 15mo
NP
n.petrovTL225 Apr 2025#5
k.haddad, post #2: The documentation on claim built is better than this thread and I say that as someone who has posted in the thread. Go to post

The opening post describes the usual case. This is about the unusual one.

An observation about claim built that I cannot explain and am posting anyway, on the principle that unexplained observations are more useful public than private.

9 likes in reply to #2 15mo
DB
d.barrosTL225 Apr 2025#6
a.salcedo, post #1: A claim built entirely on a subgroup analysis Writing it up because I had to work it out twice and would rather nobody else did. I would like to disagree carefully with the settled view on claim built, and I would like to be argued out of it if the disagreement is bad. The disagreement is about one step, not about the conclusion. If the… Go to post

My understanding of claim built is a few years old and may have been superseded. If it has been, I would genuinely like to know rather than keep repeating it.

2 likes in reply to #1 15mo
SD
s.dziedzicTL226 Apr 2025#7
BN
b.nilsenTL227 Apr 2025 · edited#8

Post #5 is the version of this I will quote in future. One addition.

Attrition is the failure mode most likely to invalidate a result and the least likely to be discussed. Differential attrition between arms is the specific thing to look for.

The number is defensible. The precision I gave it is not.

21 likes 15mo
VB
va.baptistaTL228 Apr 2025#9

This is the answer, and the reason it is the answer is the more useful part.

27 likes 15mo
SC
so.cardosoTL2 Solution29 Apr 2025#10

Taking post #8 at face value and following it one step further.

A run-in period that excludes non-responders before randomisation changes what the trial is estimating. It is legitimate design and it must be stated in any summary.

I would treat that as a working assumption and revisit it.

13 likes 15mo
VK
v.klausenTL3Regular29 Apr 2025 · edited#11

Post #10 answers the question as asked. The question underneath it is different.

Claim built has been discussed here with more heat than it deserves, mostly because two definitions have been in play the whole time.

12 likes 15mo
CH
ca.haddadTL230 Apr 2025#12
d.barros, post #6: My understanding of claim built is a few years old and may have been superseded. If it has been, I would genuinely like to know rather than keep repeating it. Go to post

I read post #8 twice before replying, because I had assumed the opposite.

The most useful thing anyone has posted about claim built in this category was a table of what had been measured and by whom. That is what I would want again.

25 likes in reply to #6 15mo
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GDashwoodTL3Regular1 May 2025#13

Bias towards the null and bias away from the null: different criticisms have different directions. Differential dropout might bias away from null; conservative statistical analysis might bias toward null.

0 likes 15mo
JT
j.teixeiraTL22 May 2025#14

On claim built, the part that usually goes wrong is that the question is asked as though it has one answer. It has a range, and the width of the range is the interesting bit.

If you can post the two or three numbers you are working from, several people here will check the arithmetic rather than argue about the conclusion.

4 likes 15mo
GI
g.ibarraTL22 May 2025#15

Narrowing post #14, because the general version has more than one answer.

Two claims get bundled together under claim built and they need separating. The descriptive one — this is what was observed — is usually well supported. The causal one — this is why — usually is not.

Almost every disagreement in threads like this one dissolves once you say which of the two you are making.

7 likes 15mo
SC
s.cardosoTL23 May 2025#16
va.baptista, post #9: This is the answer, and the reason it is the answer is the more useful part. Go to post

Where a critique rests on a subgroup, check whether the interaction was tested. A difference between subgroups that is not statistically supported is not a difference.

This is the version I would want a new member to read first.

18 likes in reply to #9 15mo
BP
b.petrovTL24 May 2025#17
GDashwood, post #13: Bias towards the null and bias away from the null: different criticisms have different directions. Differential dropout might bias away from null; conservative statistical analysis might bias toward null. Go to post

Reading rather than answering, but this is the post I would point somebody at.

0 likes in reply to #13 15mo
JN
j.nwosuTL24 May 2025#18

Post #16 and I disagree about the size of the effect, not about the direction.

The useful distinction on claim built is between what was measured and what was inferred from it. Both end up in the same sentence and only one of them has error bars.

1 like 15mo
NS
n.stanescuTL25 May 2025#19
va.baptista, post #9: This is the answer, and the reason it is the answer is the more useful part. Go to post

Speaking only to claim built as I have actually seen it, rather than as it is usually described: the effect is real, it is smaller than the thread suggests, and the variance between people is larger than the effect.

24 likes in reply to #9 15mo
NH
n.haddadTL26 May 2025 · edited#20

Good question, well framed, and I would like to see it answered properly.

0 likes 15mo
TN
t.ndiayeTL26 May 2025#21
g.ibarra, post #15: Narrowing post #14, because the general version has more than one answer. Two claims get bundled together under claim built and they need separating. The descriptive one — this is what was observed — is usually well supported. The causal one — this is why — usually is not. Almost every disagreement in threads like this one dissolves… Go to post

Generalisability and validity are separate axes. A trial can be internally impeccable and still tell you nothing about the person asking.

That is my reading. Someone else read the same page differently and was reasonable.

17 likes in reply to #15 15mo
SB
s.bergstromTL27 May 2025#22

Narrowing post #21, because the general version has more than one answer.

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

7 likes 15mo
PM
p.mbekiTL27 May 2025#23

Noted, and I have changed what I was going to do on the strength of it.

1 like 15mo
AF
a.friskTL28 May 2025#24
s.bergstrom, post #22: Narrowing post #21, because the general version has more than one answer. I keep a log for claim built specifically because my memory of it turned out to be systematically wrong in one direction. Six weeks of notes cost nothing and settled it. Go to post

Before the thread moves on from claim built — what is the sample size behind the claim? I am not being difficult; I have seen the same figure quoted from an n of four and from an n of four hundred.

0 likes in reply to #22 15mo
JS
j.steinerTL29 May 2025#25

Surrogate endpoints are not automatically bad and their validity is compound-specific and population-specific. The question is whether this surrogate has been validated for this use.

11 likes 15mo
NM
n.moreauTL29 May 2025#26

Per-protocol and intention-to-treat analyses answer different questions and neither is the honest one by default. Reporting both is the practice worth insisting on.

3 likes 15mo
MB
m.brobergTL210 May 2025 · edited#27

Worth separating two things that post #25 runs together.

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

0 likes 15mo
AR
a.reyesTL4 Admin11 May 2025#28
p.mbeki, post #23: Noted, and I have changed what I was going to do on the strength of it. Go to post

This follows post #25 rather than contradicting it.

Worth separating claim built as a question about the compound from claim built as a question about the documentation. They get answered by different people and only one of them is answerable here.

33 likes in reply to #23 15mo
L
LJankowiakTL3Regular11 May 2025#29

Placebo-controlled versus active-controlled changes what a result means entirely, and comparing across the two is one of the most common errors in this subcategory.

Reading it again, the caveat matters more than the finding.

0 likes 15mo
MA
mi.amankwahTL212 May 2025#30