reviewNature MedicineSep 1, 2020HYBRID OA

Guidelines for clinical trial protocols for interventions involving artificial intelligence: the SPIRIT-AI extension

University of Birmingham · University Hospitals Birmingham NHS Foundation Trust · +36 more institutions

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Abstract

The SPIRIT 2013 statement aims to improve the completeness of clinical trial protocol reporting by providing evidence-based recommendations for the minimum set of items to be addressed. This guidance has been instrumental in promoting transparent evaluation of new interventions. More recently, there has been a growing recognition that interventions involving artificial intelligence (AI) need to undergo rigorous, prospective evaluation to demonstrate their impact on health outcomes. The SPIRIT-AI (Standard Protocol Items: Recommendations for Interventional Trials-Artificial Intelligence) extension is a new reporting guideline for clinical trial protocols evaluating interventions with an AI component. It was…

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