Immortal time bias in a claims-database study

This follows post #12 rather than contradicting it.

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.

I read post #14 twice before replying, because I had assumed the opposite.

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.

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.

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 Asking whether there are unpublished negative trials is a fair critical question.

Picking up post #16: that is the part I would want checked first.

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.

Practical note that does not fit anywhere else. Whatever you conclude from this topic, write down what you did and when. The single most useful thing in your own records is not any individual result; it is that they are dated and consecutive.

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.

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.

On post #19 — agreed on the reasoning, with one qualification.

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.

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.

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.

This follows post #23 rather than contradicting it.

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.

Worth separating two things that post #23 runs together.

Practical note that does not fit anywhere else. Whatever you conclude from this topic, write down what you did and when. The single most useful thing in your own records is not any individual result; it is that they are dated and consecutive.

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.

Coming back to post #27, because the follow-up matters more than the original answer.

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.

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.