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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 OpenAlex

Why this work is in the frame

A frame that forgets how it found something cannot be audited. These are the routes that admitted this work.

aboutThe title or abstract carries a Canadian signal from the geographic lexicon.
no affNo Canadian affiliation: this work is invisible to an affiliation-only frame.
No Canadian affiliation. An affiliation-only frame, the usual design, would never have seen this work. It is one of the works that make the case for inverting the frame.

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.

Full frame distilled prediction

Teacher imitation

Not calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.

metaresearch head score (Codex)0.002
metaresearch head score (Gemma)0.003
Version: codex-gemma-dda1882f352aValidation status: machine_predicted_unvalidated
Candidate categoriesnone
Consensus categoriesnone
DomainCandidate signal: none · Consensus signal: none
Study designCandidate signal: Other design · Consensus signal: none
GenreCandidate signal: Review · Consensus signal: Review
Teacher disagreement score0.902
Threshold uncertainty score0.537

Codex and Gemma teacher scores by category

CategoryCodexGemma
Metaresearch0.0020.003
Meta-epidemiology (narrow)0.0000.000
Meta-epidemiology (broad)0.0020.000
Bibliometrics0.0000.000
Science and technology studies0.0000.000
Scholarly communication0.0000.000
Open science0.0000.000
Research integrity0.0000.000
Insufficient payload (model declined to judge)0.0000.000

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