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The importance of being external. methodological insights for the external validation of machine learning models in medicine
Open accessAbstract
Background and Objective Medical machine learning (ML) models tend to perform better on data from the same cohort than on new data, often due to overfitting, or co-variate shifts. For these reasons, external validation (EV) is a necessary practice in the evaluation of medical ML. However, there is still a gap in the literature on how to interpret EV results and hence assess the robustness of ML models.Methods We fill this gap by proposing a meta-validation method, to assess the soundness of EV procedures. In doing so, we complement the usual way to assess EV by considering both dataset cardinality, and the similarity of the EV dataset with respect to the training set. We then investigate how the notions of cardinality and similarity can be used to inform on the reliability of a validation procedure, by integrating them into two summative data visualizations.Results We illustrate our methodology by applying it to the validation of a state-of-the-art COVID-19 diagnostic model on 8 EV sets, collected across 3 different continents. The model performance was moderately impacted by data similarity (Pearson ρ = 0.38, p< 0.001). In the EV, the validated model reported good AUC (average: 0.84), acceptable calibration (average: 0.17) and utility (average: 0.50). The validation datasets were adequate in terms of dataset cardinality and similarity, thus suggesting the soundness of the results. We also provide a qualitative guideline to evaluate the reliability of validation procedures, and we discuss the importance of proper external validation in light of the obtained results.Conclusions In this paper, we propose a novel, lean methodology to: 1) study how the similarity between training and validation sets impacts the generalizability of a ML model; 2) assess the soundness of EV evaluations along three complementary performance dimensions: discrimination, utility and calibration; 3) draw conclusions on the robustness of the model under validation. We applied this methodology to a state-of-the-art model for the diagnosis of COVID-19 from routine blood tests, and showed how to interpret the results in light of the presented framework.
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Metadata
- Authors
- Cabitza, F., Campagner, A., Soares, F., García de Guadiana-Romualdo, L., Challa, F., Sulejmani, A., Seghezzi, M., & Carobene, A.
- Affiliations
- University of Milano-Bicocca (IT)
- Universidade Federal do Rio Grande do Sul (BR)
- Ethiopian Public Health Institute (ET)
- Ospedale Papa Giovanni XXIII (IT)
- IRCCS Ospedale San Raffaele (IT)
- Corresponding author
- Cabitza, Federico
- Venue
- Computer Methods and Programs in Biomedicine
- Publisher
- Elsevier BV
- Published
- 2021-09
- Volume
- 208
- Pages
- 106288
- ISSN
- 0169-2607 (ISSN-L)
- OpenAlex
- W3183421885
- Cited by
- 284
- References
- 89
- Citations by year
- 2026: 71 · 2025: 83 · 2024: 70 · 2023: 33 · 2022: 26 · 2021: 1
- FWCI
- 28.33
- Type
- journal article
- Language
- en
- Open access
- green
- hdl.handle.net
- Licence
- Locations
- Computer Methods and Programs in Biomedicine (publishedVersion)
- PubMed (publishedVersion)
- BOA (University of Milano-Bicocca) (submittedVersion, other-oa)
- Topics
- Health Sciences › Health Professions › Health Information Management › Artificial Intelligence in Healthcare
- Physical Sciences › Computer Science › Artificial Intelligence › Machine Learning in Healthcare
- Health Sciences › Medicine › Health Informatics › Artificial Intelligence in Healthcare and Education
- Keywords
- external validation, machine learning in medicine, covariate shift, overfitting, generalizability, dataset similarity, model robustness, COVID-19 diagnosis, routine blood tests, discrimination (statistics), calibration, clinical utility
- MeSH terms
- Machine Learning, COVID-19, SARS-CoV-2, Humans, Reproducibility of Results, Cohort Studies
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