Evidence map›Paper›PMID 39731030›Full record

ArticleBMC medical research methodology2024

The necessity of validity diagnostics when drawing causal inferences from observational data: lessons from a multi-database evaluation of the risk of non-infectious uveitis among patients exposed to Remicade

James Weaver, Erica A Voss, Guy Cafri, Kathleen Beyrau, Michelle Nashleanas, Robert Suruki

Abstract read
In one paragraph

Article in BMC medical research methodology, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Article
  3. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

6 authors.

James WeaverJanssen Research & Development LLC, Global Epidemiology Organization, Raritan, NJ, USA. jweave17@its.jnj.com.
Erica A VossJanssen Research & Development LLC, Global Epidemiology Organization, Raritan, NJ, USA.
Guy CafriJohnson & Johnson MedTech Epidemiology and Real-World Data Sciences, New Brunswick, NJ, USA.
Kathleen BeyrauJohnson & Johnson Global Medical Safety, New Brunswick, NJ, USA.
Michelle NashleanasJohnson & Johnson Global Medical Safety, New Brunswick, NJ, USA.
Robert SurukiJanssen Research & Development LLC, Global Epidemiology Organization, Raritan, NJ, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundAutoimmune disorders have primary manifestations such as joint pain and bowel inflammation but can also have secondary manifestations such as non-infectious uveitis (NIU). A regulatory health authority raised concerns after receiving spontaneous reports for NIU following exposure to Remicade

methodsWe assessed the risk of NIU among patients exposed to Remicade

resultsOf the 80 total analyses and the 20 analyses pre-specified as primary, 24% and 20% passed diagnostics, respectively. Among patients with IBD, we observed no evidence of increased risk for NIU relative to other similarly indicated biologics (pooled hazard ratio [HR] 0.75, 95% confidence interval [CI] 0.38-1.40). For patients with RA, we observed no increased risk relative to similarly indicated biologics, although results were imprecise (HR: 1.23, 95% CI 0.14-10.47).

conclusionsWe applied validity diagnostics on a heterogenous, observational setting to answer a specific research question. The results indicated that safety effect estimates from many analyses would be inappropriate to interpret as causal, given the data available and methods employed. Validity diagnostics should always be used to determine if the design and analysis are of sufficient quality to support causal inferences. The clinical implications of our findings on IBD suggests that, if an increased risk exists, it is unlikely to be greater than 40% given the 1.40 upper bound of the pooled HR confidence interval.

Indexed as

UveitisArthritis, RheumatoidBiological ProductsColitis, UlcerativeDatabases, FactualFemaleHumansInflammatory Bowel DiseasesMaleObservational Studies as TopicPropensity ScorePsoriasisReproducibility of ResultsSpondylitis, AnkylosingBiological ProductsAutoimmune disordersBiologic agentsCausal inferenceNon-infectious uveitisObservational study

Identifiers

PMID39731030
PMCPMC11681708

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.