ArticleMedical decision making : an international journal of the Society for Medical Decision Making2019
Cancer Screening Markers: A Simple Strategy to Substantially Reduce the Sample Size for Validation.
Article in Medical decision making : an international journal of the Society for Medical Decision Making, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.
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Who cites it
2 citing papers in PubMed.
- Prediagnostic evaluation of multicancer detection tests: design and analysis considerations.Journal of the National Cancer Institute · 2024Article
- Simple Methods for Evaluating 4 Types of Biomarkers: Surrogate Endpoint, Prognostic, Predictive, and Cancer Screening.Biomarker insights · 2020Review
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1 author.
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Abstract
backgroundStudies to validate a cancer prediction model based on cancer screening markers collected in stored specimens from asymptomatic persons typically require large specimen collection sample sizes. A standard sample size calculation targets a true-positive rate (TPR) of 0.8 with a 2.5% lower bound of 0.7 at a false-positive rate (FPR) of 0.01 with a 5% upper bound of 0.03. If the probability of developing cancer during the study is P = 0.01, the specimen collection sample size based on the standard calculation is 7600.
methodsThe strategy to reduce the specimen collection sample size is to decrease both the lower bound of TPR and the upper bound of FPR while keeping a positive lower bound on the anticipated clinical utility.
resultsThe new sample size calculation targets a TPR of 0.4 with a 2.5% lower bound of 0.10 and an FPR of 0.0 with a 5% upper bound of 0.005. With P = 0.01, the specimen collection sample size based on the new calculation is 1800 instead of 7600. LIMITATIONS: The new sample size calculation requires a minimum benefit/cost ratio (number of false positives traded for a true positive). With P = 0.01, the minimum cost-benefit ratio is 5, which is plausible in many studies.
conclusionIn validation studies for cancer screening markers, the strategy can substantially reduce the specimen collection sample size, substantially reducing costs and making some otherwise infeasible studies now feasible.
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