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Record W4410957636 · doi:10.1016/j.landig.2025.01.013

Importance of sample size on the quality and utility of AI-based prediction models for healthcare

2025· review· en· W4410957636 on OpenAlexaboutno aff
Richard D Riley, Joie Ensor, Kym I E Snell, Lucinda Archer, Rebecca Whittle, Paula Dhiman, Joseph Alderman, Xiaoxuan Liu, Laura Kirton, Jay Manson-Whitton, Maarten van Smeden, Karel G.M. Moons, Krishnarajah Nirantharakumar, Jean‐Baptiste Cazier, Alastair K. Denniston, Ben Van Calster, Gary S. Collins

Bibliographic record

VenueThe Lancet Digital Health · 2025
Typereview
Languageen
FieldMedicine
TopicArtificial Intelligence in Healthcare and Education
Canadian institutionsnot available
FundersEuropean Regional Development FundMedical Research CouncilVlaamse regeringSouth Asian Health FoundationVifor PharmaKU LeuvenNational Institute for Health and Care ResearchBirmingham Biomedical Research CentreEngineering and Physical Sciences Research CouncilCSL BehringUK Research and InnovationDepartment of Health and Social CareUniversity Hospitals Birmingham NHS Foundation TrustCancer Research UKWellcome TrustFonds Wetenschappelijk Onderzoek
KeywordsSample (material)Sample size determinationHealth careComputer scienceQuality (philosophy)Agency (philosophy)Artificial intelligenceOutcome (game theory)Machine learningData scienceData miningRisk analysis (engineering)MedicineStatisticsMathematics

Abstract

fetched live from OpenAlex

Rigorous study design and analytical standards are required to generate reliable findings in healthcare from artificial intelligence (AI) research. One crucial but often overlooked aspect is the determination of appropriate sample sizes for studies developing AI-based prediction models for individual diagnosis or prognosis. Specifically, the number of participants and outcome events required in datasets for model training and evaluation remains inadequately addressed. Most AI studies do not provide a rationale for their chosen sample sizes and frequently rely on datasets that are inadequate for training or evaluating a clinical prediction model. Among the ten principles of Good Machine Learning Practice established by the US Food and Drug Administration, the UK Medicines and Healthcare products Regulatory Agency, and Health Canada, guidance on sample size is directly relevant to at least three principles. To reinforce this recommendation, we outline seven reasons why inadequate sample size negatively affects model training, evaluation, and performance. Using a range of examples, we illustrate these issues and discuss the potentially harmful consequences for patient care and clinical adoption. Additionally, we address challenges associated with increasing sample sizes in AI research and highlight existing approaches and software for calculating the minimum sample sizes required for model training and evaluation.

Fetched live from OpenAlex and de-inverted. Abstracts are not stored in this database: the inverted indexes are 8.6 GB of the frame’s 9.3 GB of text, and the host has 13 GB free.

How this classification was reachedexpand

Full frame machine prediction

Teacher imitation

Not calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.

metaresearch head score (Codex)0.220
metaresearch head score (Gemma)0.458
Version: metacan-v3-hybrid-931329e0061cValidation status: machine_predicted_unvalidated
Candidate categoriesMetaresearch
Consensus categoriesMetaresearch
DomainCandidate signal: Methods · Consensus signal: none
Study designCandidate signal: Theoretical or conceptual · Consensus signal: none
GenreCandidate signal: Review · Consensus signal: Review
Teacher disagreement score0.780
Threshold uncertainty score0.962

Distilled classifier scores by category (both heads)

CategoryCodexGemma
Metaresearch0.2200.458
Meta-epidemiology (narrow)0.0010.001
Meta-epidemiology (broad)0.0050.003
Bibliometrics0.0020.002
Science and technology studies0.0010.004
Scholarly communication0.0040.005
Open science0.0030.002
Research integrity0.0040.005
Insufficient payload (model declined to judge)0.0040.001

Machine scores (provisional)

The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.

Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.

Opus teacher head0.528
GPT teacher head0.548
Teacher spread0.020 · how far apart the two teachers sit on this one work
Validation statusscore_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from it

Classification

machine, unvalidated

Machine predicted; the direct Gemma label and the distilled Codex classifier agree on what is shown here.

Study designTheoretical or conceptual
DomainMethods
GenreReview

How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".

Quick stats

Citations50
Published2025
Admission routes1
Has abstractyes

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