Section | Item no | SPIRIT 2013 item | Amendment | SPIRIT-AI item |
Administrative information | ||||
Title | 1 | Descriptive title identifying the study design, population, interventions and if applicable, trial acronym | Elaboration | Indicate that the intervention involves artificial intelligence/machine learning and specify the type of model. |
Elaboration | Specify the intended use of the AI intervention. | |||
Introduction | ||||
Background and rationale | 6a | Description of research question and justification for undertaking the trial, including summary of relevant studies (published and unpublished) examining benefits and harms for each intervention | Extension | Explain the intended use of the AI intervention in the context of the clinical pathway, including its purpose and its intended users (eg, healthcare professionals, patients, public). |
Extension | Describe any pre-existing evidence for the AI intervention. | |||
Methods: Participants, interventions and outcomes | ||||
Study Setting | 9 | Description of study settings (eg, community clinic, academic hospital) and list of countries where data will be collected. Reference to where list of study sites can be obtained | Extension | Describe the onsite and offsite requirements needed to integrate the AI intervention into the trial setting. |
Eligibility criteria | 10 | Inclusion and exclusion criteria for participants. If applicable, eligibility criteria for study centres and individuals who will perform the interventions (eg, surgeons, psychotherapists) | Elaboration | State the inclusion and exclusion criteria at the level of participants. |
Extension | State the inclusion and exclusion criteria at the level of the input data. | |||
Interventions | 11a | Interventions for each group with sufficient detail to allow replication, including how and when they will be administered | Extension | State which version of the AI algorithm will be used. |
Extension | Specify the procedure for acquiring and selecting the input data for the AI intervention. | |||
Extension | Specify the procedure for assessing and handling poor quality or unavailable input data. | |||
Extension | Specify whether there is human-AI interaction in the handling of the input data, and what level of expertise is required for users. | |||
Extension | Specify the output of the AI intervention. | |||
Extension | Explain the procedure for how the AI intervention’s output will contribute to decision making or other elements of clinical practice. | |||
Methods: Monitoring | ||||
Harms | 22 | Plans for collecting, assessing, reporting and managing solicited and spontaneously reported adverse events and other unintended effects of trial interventions or trial conduct | Extension | Specify any plans to identify and analyse performance errors. If there are no plans for this, justify why not. |
Access to data | 29 | Statement of who will have access to the final trial dataset and disclosure of contractual agreements that limit such access for investigators | Extension | State whether and how the AI intervention and/or its code can be accessed, including any restrictions to access or reuse. |
Table adapted from Cruz Rivera et al.21–23 Items within the SPIRIT 2013 statement that have not changed for the SPIRIT-AI statement have been omitted.
AI, artificial intelligence; SPIRIT, Standard Protocol Items: Recommendations for Interventional Trials.