Table 2.
Adherence to CONSORT-AI (Consolidated Standards of Reporting Trials–Artificial Intelligence) extension items.
| Item | Item description | Total (n=19), n (%; 95%CI) |
| CONSORT-AI 1a Elaboration | Indicate that the intervention involves artificial intelligence or machine learning in the title and abstract and specify the type of model. | 16 (84; 60-97) |
| CONSORT-AI 1b(ii) Elaboration | State the intended use of the AIa intervention within the trial in the title and abstract. | 19 (100; 82-100) |
| CONSORT-AI 2a(i) Extension | Explain the intended use of the AI intervention in the context of the clinical pathway, including its purpose and its intended users (eg, health care professionals, patients, public). | 19 (100; 82-100) |
| CONSORT-AI 4a(i) Elaboration | State the inclusion and exclusion criteria at the level of participants | 18 (95; 74-100) |
| CONSORT-AI 4a(ii) Extension | State the inclusion and exclusion criteria at the level of the input data. | 5 (26; 9-51) |
| CONSORT-AI 4b Extension | Describe how the AI intervention was integrated into the trial setting, including any onsite or offsite requirements. | 19 (100; 82-100) |
| CONSORT-AI 5(i) Extension | State which version of the AI algorithm was used. | 12 (63; 38-84) |
| CONSORT-AI 5(ii) Extension | Describe how the input data were acquired and selected for the AI intervention. | 13 (68; 43-87) |
| CONSORT-AI 5(iii) Extension | Describe how poor quality or unavailable input data were assessed and handled. | 2 (11; 1-33) |
| CONSORT-AI 5(iv) Extension | Specify whether there was human-AI interaction in the handling of the input data, and what level of expertise was required of users. | 15 (79; 54-94) |
| CONSORT-AI 5(v) Extension | Specify the output of the AI intervention. | 15 (79; 54-94) |
| CONSORT-AI 5(vi) Extension | Explain how the AI intervention’s outputs contributed to decision-making or other elements of clinical practice. | 14 (74; 49-91) |
| CONSORT-AI 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. | 2 (11; 1-33) |
| CONSORT-AI 25 Extension | State whether and how the AI intervention and/or its code can be accessed, including any restrictions to access or re-use. | 3 (16; 3-40) |
aAI: artificial intelligence.