The SPIRIT-AI extension is a set of recommendations for clinical trial protocols evaluating interventions with an AI component. SPIRIT-AI includes 15 new items which should be routinely reported in addition to the core SPIRIT 2013 items. The checklist recommends that investigators provide clear descriptions of the AI intervention, prior evidence supporting the validation of the AI intervention, the proposed trial setting in which the AI intervention will be evaluated, specifying how the input and outputs of the AI intervention will be handled and description of the intended human-AI interaction during the trial.
As well as the checklist items, a number of illustrative examples are provided in the publication of SPIRIT-AI, to assist users in understanding and applying the principles of the reporting items.
We strongly recommend users read the explanation text associated with each item, which will help to contextualise the items.
When referring to the SPIRIT-AI guidelines, please cite one of the following articles: