Cited by 286Statistical Methods in EpidemiologyArtificial Intelligence in HealthcareMeta-analysis and systematic reviews

There is no such thing as a validated prediction model

Open access
Van Calster, Ben, Steyerberg, Ewout W., Wynants, Laure, van Smeden, Maarten·2023·BMC Medicine

Abstract

BACKGROUND: Clinical prediction models should be validated before implementation in clinical practice. But is favorable performance at internal validation or one external validation sufficient to claim that a prediction model works well in the intended clinical context? MAIN BODY: We argue to the contrary because (1) patient populations vary, (2) measurement procedures vary, and (3) populations and measurements change over time. Hence, we have to expect heterogeneity in model performance between locations and settings, and across time. It follows that prediction models are never truly validated. This does not imply that validation is not important. Rather, the current focus on developing new models should shift to a focus on more extensive, well-conducted, and well-reported validation studies of promising models. CONCLUSION: Principled validation strategies are needed to understand and quantify heterogeneity, monitor performance over time, and update prediction models when appropriate. Such strategies will help to ensure that prediction models stay up-to-date and safe to support clinical decision-making.

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  • There are widespread concerns that the performance of AI tools in early validation studies may not reflect their use in practice.

    “There are widespread concerns that the performance of these tools in early validation studies may not reflect their use in practice.19,20”
  • Heterogeneity in model performance should be expected based on differences in populations and measurement procedures between locations, settings, or time periods.

    “Second, heterogeneity in model performance should be expected based on differences in populations and measurement procedures between locations, settings, or time periods.”
  • Miscalibration is often not just a problem of the model but a sign that we need to improve our understanding of the various contexts in which the model is validated and used.

    “Miscalibration is often not just a problem of the model but a sign that we need to improve our understanding of the various contexts in which the model is validated and used.”
  • One successful external validation does not establish transportability to many other settings, and requiring external validation might lead to selective reporting of validation data.

    “One successful external validation, however, does not establish transportability to many other settings, while such a requirement might lead to the selective reporting of validation data.100”

    From Developing clinical prediction models: a step-by-step guide (2024) · cites this paper as [100]

  • Using data from 2001 to 2011, EuroSCORE was shown to consistently overestimate mortality and its calibration deteriorated over time.

    “Using data from 2001 to 2011, EuroSCORE was shown to consistently overestimate mortality and its calibration deteriorated over time.100”

    From Developing clinical prediction models: a step-by-step guide (2024) · cites this paper as [100]

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Authors
Van Calster, B., Steyerberg, E. W., Wynants, L., & van Smeden, M.
Affiliations
  • KU Leuven (BE)
  • Maastricht University (NL)
Venue
BMC Medicine
Published
2023-02-24
Volume
21
Issue
1
Pages
70-70
ISSN
1741-7015 (ISSN-L)
OpenAlex
W4321782827
Cited by
286
References
56
Citations by year
2026: 99 · 2025: 91 · 2024: 67 · 2023: 29
FWCI
58.07
Type
journal article
Language
en
Open access
Locations
  • BMC Medicine (publishedVersion, cc-by)
  • PubMed Central (publishedVersion, cc-by)
  • PubMed (publishedVersion)
  • Research Publications (Maastricht University) (publishedVersion, cc-by)
  • Leiden Repository (Leiden University) (submittedVersion, cc-by)
  • Lirias (KU Leuven) (submittedVersion, other-oa)
  • DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion, cc-by-sa)
  • Utrecht University Repository (Utrecht University) (submittedVersion, other-oa)
Funders
Fonds Wetenschappelijk Onderzoek (G097322N)
Topics
  • Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods in Epidemiology
  • Health Sciences › Health Professions › Health Information Management › Artificial Intelligence in Healthcare
  • Social Sciences › Decision Sciences › Statistics, Probability and Uncertainty › Meta-analysis and systematic reviews
Keywords
clinical prediction model, model validation, external validation, internal validation, model updating, clinical decision support

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