The Need to Prioritize Model-Updating Processes in Clinical Artificial Intelligence (AI) Models: Protocol for a Scoping Review

Abstract

Background: With an increase in the number of artificial intelligence (AI) and machine learning (ML) algorithms available for clinical settings, appropriate model updating and implementation of updates are imperative to ensure applicability, reproducibility, and patient safety. Objective: The objective of this scoping review was to evaluate and assess the model-updating practices of AI and ML clinical models that are used in direct patient-provider clinical decision-making. Methods: We used the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) checklist and the PRISMA-P protocol guidance in addition to a modified CHARMS (Checklist for Critical Appraisal and Data Extraction for Systematic Reviews of Prediction Modelling Studies) checklist to conduct this scoping review. A comprehensive medical literature search of databases, including Embase, MEDLINE, PsycINFO, Cochrane, Scopus, and Web of Science, was conducted to identify AI and ML algorithms that would impact clinical decision-making at the level of direct patient care. Our primary end point is the rate at which model updating is recommended by published algorithms; we will also conduct an assessment of study quality and risk of bias in all publications reviewed. In addition, we will evaluate the rate at which published algorithms include ethnic and gender demographic distribution information in their training data as a secondary end point. Results: Our initial literature search yielded approximately 13,693 articles, with approximately 7810 articles to consider for full reviews among our team of 7 reviewers. We plan to complete the review process and disseminate the results by spring of 2023. Conclusions: Although AI and ML applications in health care have the potential to improve patient care by reducing errors between measurement and model output, currently there exists more hype than hope because of the lack of proper external validation of these models. We expect to find that the AI and ML model-updating methods are proxies for model applicability and generalizability on implementation. Our findings will add to the field by determining the degree to which published models meet the criteria for clinical validity, real-life implementation, and best practices to optimize model development, and in so doing, reduce the overpromise and underachievement of the contemporary model development process.