Table 1 CONSORT-AI checklist

From: Reporting guidelines for clinical trial reports for interventions involving artificial intelligence: the CONSORT-AI extension

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.  
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    
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    
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    
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.  
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.  
  1. 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.