Evidence map›Paper›PMID 38724581›Full record

ArticleNPJ digital medicine2024

Distribution shift detection for the postmarket surveillance of medical AI algorithms: a retrospective simulation study.

Lisa M Koch, Christian F Baumgartner, Philipp Berens

Abstract read
In one paragraph

Article in NPJ digital medicine, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 28 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
28citing 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

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

  1. Pooled it
  2. Article
  3. Review
  4. AI-based augmentation of oncology clinical trials.Nature reviews. Clinical oncology · 2026
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  15. Review
  16. An End-to-End Overview of Clinical Speech AI.IEEE transactions on audio, speech, and language processing (2025) · 2026
    Article
  17. Foundation Model-Guided Synthetic EHR Release: Performance Enhancement with Privacy Preservation.AMIA Joint Summits on Translational Science proceedings. AMIA Joint Summits on Translational Science · 2026
    Article
  18. Article
  19. Review
  20. 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

3 authors.

Lisa M KochHertie Institute for AI in Brain Health, University of Tübingen, Tübingen, Germany. lisa.koch@uni-tuebingen.de.ORCID http://orcid.org/0000-0003-4377-7074
Christian F BaumgartnerCluster of Excellence Machine Learning: New Perspectives for Science, University of Tübingen, Tübingen, Germany.ORCID http://orcid.org/0000-0002-3629-4384
Philipp BerensHertie Institute for AI in Brain Health, University of Tübingen, Tübingen, Germany.ORCID http://orcid.org/0000-0002-0199-4727

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Distribution shifts remain a problem for the safe application of regulated medical AI systems, and may impact their real-world performance if undetected. Postmarket shifts can occur for example if algorithms developed on data from various acquisition settings and a heterogeneous population are predominantly applied in hospitals with lower quality data acquisition or other centre-specific acquisition factors, or where some ethnicities are over-represented. Therefore, distribution shift detection could be important for monitoring AI-based medical products during postmarket surveillance. We implemented and evaluated three deep-learning based shift detection techniques (classifier-based, deep kernel, and multiple univariate kolmogorov-smirnov tests) on simulated shifts in a dataset of 130'486 retinal images. We trained a deep learning classifier for diabetic retinopathy grading. We then simulated population shifts by changing the prevalence of patients' sex, ethnicity, and co-morbidities, and example acquisition shifts by changes in image quality. We observed classification subgroup performance disparities w.r.t. image quality, patient sex, ethnicity and co-morbidity presence. The sensitivity at detecting referable diabetic retinopathy ranged from 0.50 to 0.79 for different ethnicities. This motivates the need for detecting shifts after deployment. Classifier-based tests performed best overall, with perfect detection rates for quality and co-morbidity subgroup shifts at a sample size of 1000. It was the only method to detect shifts in patient sex, but required large sample sizes (

Identifiers

PMID38724581
PMCPMC11082139

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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.