Table 3

Additional criteria to be included for studies relating to AI interventions within the CONSORT-AI statement (in addition to the CONSORT 2010 statement)

Section	Item no	CONSORT 2010 item	Amendment	CONSORT-AI item
Title and abstract
Title and abstract	1a	Identification as a randomised trial in the title	Elaboration	Indicate that the intervention involves artificial intelligence/machine learning in the title and/or abstract and specify the type of model.
Title and abstract	1b	Structured summary of trial design, methods, results and conclusions	Elaboration	State the intended use of the AI intervention within the trial in the title and/or abstract.
Introduction
Background and objectives	2a	Scientific background and explanation of rationale	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).
Methods
Participants	4a	Eligibility criteria for participants	Elaboration	State the inclusion and exclusion criteria at the level of participants.
	4a	Eligibility criteria for participants	Extension	State the inclusion and exclusion criteria at the level of the input data.
	4b	Settings and locations where the data were collected	Extension	Describe how the AI intervention was integrated into the trial setting, including any onsite or offsite requirements.
Interventions	5	The interventions for each group with sufficient details to allow replication, including how and when they were actually administered	Extension	State which version of the AI algorithm was used.
			Extension	Describe how the input data were acquired and selected for the AI intervention.
			Extension	Describe how poor quality or unavailable input data were assessed and handled
			Extension	Specify whether there was human–AI interaction in the handling of the input data, and what level of expertise was required of users.
			Extension	Specify the output of the AI intervention.
			Extension	Explain how the AI intervention’s outputs contributed to decision making or other elements of clinical practice.
Results
Harms	19		Extension	Describe results of any analysis of performance errors and how errors were identified, where applicable. If no such analysis was planned or done, justify why not.
Discussion
Funding	25		Extension	State whether and how the AI intervention and/or its code can be accessed, including any restrictions to access or re-use.

Table adapted from Liu et al.17–19 Items within the CONSORT 2010 statement that have not been changed for the CONSORT-AI statement have been omitted.
AI, artificial intelligence; CONSORT, Consolidated Standards of Reporting Trials.