Table 1.
Section | CONSORT 2010 itema | CONSORT-AI item | Addressed on page numberb | ||
---|---|---|---|---|---|
Title and abstract | |||||
Title and Abstract | 1a | Identification as a randomized trial in the title | CONSORT-AI 1a,b Elaboration | (i) Indicate that the intervention involves artificial intelligence/machine learning in the title and/or abstract and specify the type of model. | |
1b | Structured summary of trial design, methods, results, and conclusions (for specific guidance see CONSORT for abstracts) | (ii) 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 | 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 (for example, healthcare professionals, patients, public). | |
2b | Specific objectives or hypotheses | ||||
Methods | |||||
Trial design | 3a | Description of trial design (such as parallel, factorial) including allocation ratio | |||
3b | Important changes to methods after trial commencement (such as eligibility criteria), with reasons | ||||
Participants | 4a | Eligibility criteria for participants | CONSORT-AI 4a (i) Elaboration | State the inclusion and exclusion criteria at the level of participants. | |
CONSORT-AI 4a (ii) Extension | State the inclusion and exclusion criteria at the level of the input data. | ||||
4b | Settings and locations where the data were collected | CONSORT-AI 4b 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 | CONSORT-AI 5 (i) Extension | State which version of the AI algorithm was used. | |
CONSORT-AI 5 (ii) Extension | Describe how the input data were acquired and selected for the AI intervention. | ||||
CONSORT-AI 5 (iii) Extension | Describe how poor quality or unavailable input data were assessed and handled. | ||||
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. | ||||
CONSORT-AI 5 (v) Extension | Specify the output of the AI intervention | ||||
CONSORT-AI 5 (vi) Extension | Explain how the AI intervention’s outputs contributed to decision-making or other elements of clinical practice. | ||||
Outcomes | 6a | Completely defined pre-specified primary and secondary outcome measures, including how and when they were assessed | |||
6b | Any changes to trial outcomes after the trial commenced, with reasons | ||||
Sample size | 7a | How sample size was determined | |||
7b | When applicable, explanation of any interim analyses and stopping guidelines | ||||
Randomization | |||||
Sequence generation | 8a | Method used to generate the random allocation sequence | |||
8b | Type of randomization; details of any restriction (such as blocking and block size) | ||||
Allocation concealment mechanism | 9 | Mechanism used to implement the random allocation sequence (such as sequentially numbered containers), describing any steps taken to conceal the sequence until interventions were assigned | |||
Implementation | 10 | Who generated the random allocation sequence, who enrolled participants, and who assigned participants to interventions | |||
Blinding | 11a | If done, who was blinded after assignment to interventions (for example, participants, care providers, those assessing outcomes) and how | |||
11b | If relevant, description of the similarity of interventions | ||||
Statistical methods | 12a | Statistical methods used to compare groups for primary and secondary outcomes | |||
12b | Methods for additional analyses, such as subgroup analyses and adjusted analyses | ||||
Results | |||||
Participant flow (a diagram is strongly recommended) | 13a | For each group, the numbers of participants who were randomly assigned, received intended treatment, and were analyzed for the primary outcome | |||
13b | For each group, losses and exclusions after randomization, together with reasons | ||||
Recruitment | 14a | Dates defining the periods of recruitment and follow-up | |||
14b | Why the trial ended or was stopped | ||||
Baseline data | 15 | A table showing baseline demographic and clinical characteristics for each group | |||
Numbers analyzed | 16 | For each group, number of participants (denominator) included in each analysis and whether the analysis was by original assigned groups | |||
Outcomes and estimation | 17a | For each primary and secondary outcome, results for each group, and the estimated effect size and its precision (such as 95% confidence interval) | |||
17b | For binary outcomes, presentation of both absolute and relative effect sizes is recommended | ||||
Ancillary analyses | 18 | Results of any other analyses performed, including subgroup analyses and adjusted analyses, distinguishing pre-specified from exploratory | |||
Harms | 19 | All important harms or unintended effects in each group (for specific guidance see CONSORT for harms) | 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. | |
Discussion | |||||
Limitations | 20 | Trial limitations, addressing sources of potential bias, imprecision, and, if relevant, multiplicity of analyses | |||
Generalizability | 21 | Generalizability (external validity, applicability) of the trial findings | |||
Interpretation | 22 | Interpretation consistent with results, balancing benefits and harms, and considering other relevant evidence | |||
Other Information | |||||
Registration | 23 | Registration number and name of trial registry | |||
Protocol | 24 | Where the full trial protocol can be accessed, if available | |||
Funding | 25 | Sources of funding and other support (such as supply of drugs), role of funders | 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. |
aWe strongly recommend reading this statement in conjunction with the CONSORT 2010 Explanation and Elaboration for important clarifications on all the items. bIndicates page numbers to be completed by authors during protocol development.