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Evidence · Study critique

Immortal time bias in a claims-database study — one year on

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Solved by p.trevino in post #5
Criticise the method, not the author: a paper with a weak design is not a bad paper by someone with bad intentions. It is a paper that answers a limited question. Sometimes that is what the sponsor wanted, sometimes the researchers did the best they could with constraints.

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VPoulsenTL3Regular28 Jun 2026#1

Posting this under the heading it deserves: Immortal time bias in a claims-database study — one year on Everything below is what sits behind that.

Comparing SURPASS-2 (N Engl J Med, 2021) with SURMOUNT-1 (N Engl J Med, 2022) and finding the comparison harder than it looks.

Different populations, different durations, different endpoints defined slightly differently, and in one case a different estimand. People compare the headline percentages anyway, including me until recently.

Is there a defensible way to put these side by side, or is the honest answer that there is not and we should stop?

26 likes 30d
MD
methods_draftTL2Member30 Jun 2026#2

Confounding: in observational data, is there a third variable that explains the apparent association? In randomised data, randomisation should balance unknown confounders, though known confounders can be adjusted for.

28 likes 28d
MM
m.marchettiTL2 Moderator1 Jul 2026#3

I disagree with the reply above, and I think the disagreement is substantive rather than terminological.

The distinction being drawn does not survive when you look at the published data for this specific question. I would be glad to be shown wrong on this, because the version I am arguing against is more convenient.

0 likes 27d
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gradient_reviewTL2Member1 Jul 2026#4

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.

5 likes 26d
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p.trevinoTL2 Moderator Solution2 Jul 2026#5

Criticise the method, not the author: a paper with a weak design is not a bad paper by someone with bad intentions. It is a paper that answers a limited question. Sometimes that is what the sponsor wanted, sometimes the researchers did the best they could with constraints.

20 likes 26d
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RodriguesTL3Regular3 Jul 2026#6

Building consensus on which criticisms matter: if everyone agrees that the sample size is small but only you think that affects the conclusion, maybe your criticism is more idiosyncratic. That does not make it wrong but it is worth noticing.

0 likes 25d
AZ
an.zamoraTL2 Moderator4 Jul 2026#7
VPoulsen, post #1: Posting this under the heading it deserves: Immortal time bias in a claims-database study — one year on Everything below is what sits behind that. Comparing SURPASS-2 ( N Engl J Med , 2021) with SURMOUNT-1 ( N Engl J Med , 2022) and finding the comparison harder than it looks. Different populations, different durations, different… Go to post

Thank you for the correction. I have edited my earlier post with a note rather than silently, so the thread still makes sense to read. The error was mine and it was the kind that comes from remembering a figure instead of looking it up.

2 likes in reply to #1 24d
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SHermansenTL2Member5 Jul 2026#8

Coming back to post #6, because the follow-up matters more than the original answer.

What makes a methodological criticism substantive: it identifies a specific feature of the design that materially affects what the paper can conclude. "Small sample size" alone is weak. "Small sample size for a rare outcome, so the confidence interval is wide" is stronger.

9 likes 23d
YA
y.adeyemiTL2 Moderator5 Jul 2026#9

Generalisability: do the inclusion/exclusion criteria narrow the population so much that results do not apply to real people asking about it? This is a fair criticism but requires specificity about which real people and why the difference matters.

27 likes 22d
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a.thorneTL2Wiki editor6 Jul 2026 · edited#10
p.trevino, post #5: Criticise the method, not the author: a paper with a weak design is not a bad paper by someone with bad intentions. It is a paper that answers a limited question. Sometimes that is what the sponsor wanted, sometimes the researchers did the best they could with constraints. Go to post

Publication bias: a single published positive trial is weaker evidence than multiple published trials with consistent results. Asking whether there are unpublished negative trials is a fair critical question.

0 likes in reply to #5 22d
SB
s.bergstromTL2 Moderator7 Jul 2026#11

Having read the exchange above, I think I was wrong earlier in this topic and I want to say so plainly rather than quietly editing.

The correction was fair and I had been repeating something I had not checked carefully enough.

0 likes 21d
K
KTurkingtonTL3Regular8 Jul 2026#12

Defending a paper against criticism: if the authors respond, they might clarify something the paper explained poorly. Their response might also miss your point. Either way, the exchange in public is more useful than quiet disagreement.

26 likes 20d
AM
a.mwangiTL2 Moderator8 Jul 2026#13
KTurkington, post #12: Defending a paper against criticism: if the authors respond, they might clarify something the paper explained poorly. Their response might also miss your point. Either way, the exchange in public is more useful than quiet disagreement. Go to post

Worth separating two things that post #9 runs together.

Choosing the worst interpretation: "The confidence interval includes a harmful effect" is true if the CI goes from -1 to +5. But assuming the worst-case scenario is not how you use the evidence. The point estimate and the precision both matter.

12 likes in reply to #12 20d
CD
cannula_driftTL3Regular9 Jul 2026 · edited#14

When you change your mind: if a reply convinces you that your criticism was not well-founded, say so plainly. The critique might still be real but smaller than you originally thought. That is not a failure — it is how discussion works.

4 likes 19d
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sa.vogelTL2 Moderator9 Jul 2026#15

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 18d
BR
buffer_reviewTL3Regular10 Jul 2026#16

Picking up post #13: that is the part I would want checked first.

Thank you for the correction. I have edited my earlier post with a note rather than silently, so the thread still makes sense to read. The error was mine and it was the kind that comes from remembering a figure instead of looking it up.

0 likes 18d
AC
a.cardosoTL2 Moderator11 Jul 2026#17
methods_draft, post #2: Confounding: in observational data, is there a third variable that explains the apparent association? In randomised data, randomisation should balance unknown confounders, though known confounders can be adjusted for. Go to post

Publication bias: a single published positive trial is weaker evidence than multiple published trials with consistent results. Asking whether there are unpublished negative trials is a fair critical question.

18 likes in reply to #2 17d
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LJankowiakTL3Regular11 Jul 2026#18

Choosing the worst interpretation: "The confidence interval includes a harmful effect" is true if the CI goes from -1 to +5. But assuming the worst-case scenario is not how you use the evidence. The point estimate and the precision both matter.

7 likes 17d
SL
s.leclercTL4 Moderator12 Jul 2026#19

I read post #17 twice before replying, because I had assumed the opposite.

Criticise the method, not the author: a paper with a weak design is not a bad paper by someone with bad intentions. It is a paper that answers a limited question. Sometimes that is what the sponsor wanted, sometimes the researchers did the best they could with constraints.

1 like 16d
LS
l.salinasTL2 Moderator13 Jul 2026#20
VPoulsen, post #1: Posting this under the heading it deserves: Immortal time bias in a claims-database study — one year on Everything below is what sits behind that. Comparing SURPASS-2 ( N Engl J Med , 2021) with SURMOUNT-1 ( N Engl J Med , 2022) and finding the comparison harder than it looks. Different populations, different durations, different… Go to post

What makes a methodological criticism substantive: it identifies a specific feature of the design that materially affects what the paper can conclude. "Small sample size" alone is weak. "Small sample size for a rare outcome, so the confidence interval is wide" is stronger.

0 likes in reply to #1 15d
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batchlogTL3Regular13 Jul 2026#21

When you change your mind: if a reply convinces you that your criticism was not well-founded, say so plainly. The critique might still be real but smaller than you originally thought. That is not a failure — it is how discussion works.

23 likes 15d
CC
c.chowdhuryTL2 Moderator14 Jul 2026#22

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.

0 likes 14d
BV
bias_varianceTL4Biostatistician14 Jul 2026 · edited#23
p.trevino, post #5: Criticise the method, not the author: a paper with a weak design is not a bad paper by someone with bad intentions. It is a paper that answers a limited question. Sometimes that is what the sponsor wanted, sometimes the researchers did the best they could with constraints. Go to post

Defending a paper against criticism: if the authors respond, they might clarify something the paper explained poorly. Their response might also miss your point. Either way, the exchange in public is more useful than quiet disagreement.

3 likes in reply to #5 14d
DF
d.ferreiraTL2 Moderator15 Jul 2026#24
s.bergstrom, post #11: Having read the exchange above, I think I was wrong earlier in this topic and I want to say so plainly rather than quietly editing. The correction was fair and I had been repeating something I had not checked carefully enough. Go to post

Worth separating two things that post #20 runs together.

Building consensus on which criticisms matter: if everyone agrees that the sample size is small but only you think that affects the conclusion, maybe your criticism is more idiosyncratic. That does not make it wrong but it is worth noticing.

11 likes in reply to #11 13d
JR
j.rasmussenTL2Regular15 Jul 2026#25

Thank you for the correction. I have edited my earlier post with a note rather than silently, so the thread still makes sense to read. The error was mine and it was the kind that comes from remembering a figure instead of looking it up.

31 likes 12d
YA
y.adeyemiTL2 Moderator16 Jul 2026#26

Generalisability: do the inclusion/exclusion criteria narrow the population so much that results do not apply to real people asking about it? This is a fair criticism but requires specificity about which real people and why the difference matters.

0 likes 12d
TY
two_year_lineTL3Regular17 Jul 2026#27

post #26 answers the question as asked. The question underneath it is different.

Confounding: in observational data, is there a third variable that explains the apparent association? In randomised data, randomisation should balance unknown confounders, though known confounders can be adjusted for.

6 likes 11d
GR
g.radichTL2 Moderator17 Jul 2026#28
sa.vogel, post #15: 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

On post #24 — agreed on the reasoning, with one qualification.

Confounding: in observational data, is there a third variable that explains the apparent association? In randomised data, randomisation should balance unknown confounders, though known confounders can be adjusted for.

16 likes in reply to #15 11d
TV
t.vasquezTL418 Jul 2026#29
JP
j.petrovTL2 Moderator18 Jul 2026#30
m.marchetti, post #3: I disagree with the reply above, and I think the disagreement is substantive rather than terminological. The distinction being drawn does not survive when you look at the published data for this specific question. I would be glad to be shown wrong on this, because the version I am arguing against is more convenient. Go to post

I read post #28 twice before replying, because I had assumed the opposite.

Generalisability: do the inclusion/exclusion criteria narrow the population so much that results do not apply to real people asking about it? This is a fair criticism but requires specificity about which real people and why the difference matters.

24 likes in reply to #3 10d