Table 1 SPIRIT-AI checklist

From: Guidelines for clinical trial protocols for interventions involving artificial intelligence: the SPIRIT-AI extension

Section Item SPIRIT 2013 itema SPIRIT-AI item Addressed on page numberb
Administrative information
Title 1 Descriptive title identifying the study design, population, interventions, and, if applicable, trial acronym SPIRIT-AI 1 (i) Elaboration Indicate that the intervention involves artificial intelligence/machine learning and specify the type of model.  
SPIRIT-AI 1 (ii) Elaboration Specify the intended use of the AI intervention.  
Trial registration 2a Trial identifier and registry name. If not yet registered, name of intended registry    
2b All items from the World Health Organization Trial Registration Dataset    
Protocol version 3 Date and version identifier    
Funding 4 Sources and types of financial, material, and other support    
Roles and responsibilities 5a Names, affiliations, and roles of protocol contributors    
5b Name and contact information for the trial sponsor    
5c Role of study sponsor and funders, if any, in study design; collection, management, analysis, and interpretation of data; writing of the report; and the decision to submit the report for publication, including whether they will have ultimate authority over any of these activities    
5d Composition, roles, and responsibilities of the coordinating center, steering committee, endpoint adjudication committee, data management team, and other individuals or groups overseeing the trial, if applicable (see Item 21a for data monitoring committee)    
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of research question and justification for undertaking the trial, including summary of relevant studies (published and unpublished) examining benefits and harms for each intervention SPIRIT-AI 6a (i) Extension Explain the intended use of the AI intervention in the context of the clinical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).  
SPIRIT-AI 6a (ii) Extension Describe any pre-existing evidence for the AI intervention.  
6b Explanation for choice of comparators    
Objectives 7 Specific objectives or hypotheses    
Trial design 8 Description of trial design including type of trial (for example, parallel group, crossover, factorial, single group), allocation ratio, and framework (for example, superiority, equivalence, noninferiority, exploratory)    
Methods: participants, interventions and outcomes
Study setting 9 Description of study settings (for example, community clinic, academic hospital) and list of countries where data will be collected. Reference to where list of study sites can be obtained SPIRIT-AI 9 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 centers and individuals who will perform the interventions (for example, surgeons, psychotherapists) SPIRIT-AI 10 (i) Elaboration State the inclusion and exclusion criteria at the level of participants.  
SPIRIT-AI 10 (ii) 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 SPIRIT-AI 11a (i) Extension State which version of the AI algorithm will be used.  
SPIRIT-AI 11a (ii) Extension Specify the procedure for acquiring and selecting the input data for the AI intervention.  
SPIRIT-AI 11a (iii) Extension Specify the procedure for assessing and handling poor-quality or unavailable input data.  
SPIRIT-AI 11a (iv) Extension Specify whether there is human–AI interaction in the handling of the input data, and what level of expertise is required for users.  
SPIRIT-AI 11a (v) Extension Specify the output of the AI intervention.  
SPIRIT-AI 11a (vi) Extension Explain the procedure for how the AI intervention’s output will contribute to decision-making or other elements of clinical practice.  
11b Criteria for discontinuing or modifying allocated interventions for a given trial participant (for example, drug dose change in response to harms, participant request, or improving/worsening disease)    
11c Strategies to improve adherence to intervention protocols, and any procedures for monitoring adherence (for example, drug tablet return, laboratory tests)    
11d Relevant concomitant care and interventions that are permitted or prohibited during the trial    
Outcomes 12 Primary, secondary, and other outcomes, including the specific measurement variable (for example, systolic blood pressure), analysis metric (for example, change from baseline, final value, time to event), method of aggregation (for example, median, proportion), and time point for each outcome. Explanation of the clinical relevance of chosen efficacy and harm outcomes is strongly recommended    
Participant timeline 13 Time schedule of enrollment, interventions (including any run-ins and washouts), assessments, and visits for participants. A schematic diagram is highly recommended (Fig. 1)    
Sample size 14 Estimated number of participants needed to achieve study objectives and how it was determined, including clinical and statistical assumptions supporting any sample size calculations    
Recruitment 15 Strategies for achieving adequate participant enrollment to reach target sample size    
Methods: assignment of interventions (for controlled trials)
Sequence generation 16a Method of generating the allocation sequence (for example, computer-generated random numbers), and list of any factors for stratification. To reduce predictability of a random sequence, details of any planned restriction (for example, blocking) should be provided in a separate document that is unavailable to those who enroll participants or assign interventions    
Allocation concealment mechanism 16b Mechanism of implementing the allocation sequence (for example, central telephone; sequentially numbered, opaque, sealed envelopes), describing any steps to conceal the sequence until interventions are assigned    
Implementation 16c Who will generate the allocation sequence, who will enroll participants, and who will assign participants to interventions    
Blinding (masking) 17a Who will be blinded after assignment to interventions (for example, trial participants, care providers, outcome assessors, data analysts), and how    
17b If blinded, circumstances under which unblinding is permissible, and procedure for revealing a participant’s allocated intervention during the trial    
Methods: data collection, management and analysis
Data collection methods 18a Plans for assessment and collection of outcome, baseline, and other trial data, including any related processes to promote data quality (for example, duplicate measurements, training of assessors) and a description of study instruments (for example, questionnaires, laboratory tests) along with their reliability and validity, if known. Reference to where data collection forms can be found, if not in the protocol    
18b Plans to promote participant retention and complete follow-up, including list of any outcome data to be collected for participants who discontinue or deviate from intervention protocols    
Data management 19 Plans for data entry, coding, security, and storage, including any related processes to promote data quality (for example, double data entry; range checks for data values). Reference to where details of data management procedures can be found, if not in the protocol    
Statistical methods 20a Statistical methods for analyzing primary and secondary outcomes. Reference to where other details of the statistical analysis plan can be found, if not in the protocol    
20b Methods for any additional analyses (for example, subgroup and adjusted analyses)    
20c Definition of analysis population relating to protocol non-adherence (for example, as randomized analysis), and any statistical methods to handle missing data (for example, multiple imputation)    
Methods: monitoring
Data monitoring 21a Composition of data monitoring committee (DMC); summary of its role and reporting structure; statement of whether it is independent from the sponsor and competing interests; and reference to where further details about its charter can be found, if not in the protocol. Alternatively, an explanation of why a DMC is not needed    
21b Description of any interim analyses and stopping guidelines, including who will have access to these interim results and make the final decision to terminate the trial    
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 SPIRIT-AI 22 Extension Specify any plans to identify and analyze performance errors. If there are no plans for this, justify why not.  
Auditing 23 Frequency and procedures for auditing trial conduct, if any, and whether the process will be independent from investigators and the sponsor    
Ethics and dissemination
Research ethics approval 24 Plans for seeking research ethics committee/institutional review board (REC/IRB) approval    
Protocol amendments 25 Plans for communicating important protocol modifications (for example, changes to eligibility criteria, outcomes, analyses) to relevant parties (for example, investigators, REC/IRBs, trial participants, trial registries, journals, regulators)    
Consent or ascent 26a Who will obtain informed consent or assent from potential trial participants or authorized surrogates, and how (see Item 32)    
26b Additional consent provisions for collection and use of participant data and biological specimens in ancillary studies, if applicable    
Confidentiality 27 How personal information about potential and enrolled participants will be collected, shared, and maintained in order to protect confidentiality before, during, and after the trial    
Declaration of interests 28 Financial and other competing interests for principal investigators for the overall trial and each study site    
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 SPIRIT-AI 29 Extension State whether and how the AI intervention and/or its code can be accessed, including any restrictions to access or re-use.  
Ancillary and post-trial care 30 Provisions, if any, for ancillary and post-trial care, and for compensation to those who suffer harm from trial participation    
Dissemination policy 31a Plans for investigators and sponsor to communicate trial results to participants, healthcare professionals, the public, and other relevant groups (for example, via publication, reporting in results databases, or other data sharing arrangements), including any publication restrictions    
31b Authorship eligibility guidelines and any intended use of professional writers    
31c Plans, if any, for granting public access to the full protocol, participant-level dataset, and statistical code    
Appendices
Informed consent materials 32 Model consent form and other related documentation given to participants and authorized surrogates    
Biological specimens 33 Plans for collection, laboratory evaluation, and storage of biological specimens for genetic or molecular analysis in the current trial and for future use in ancillary studies, if applicable    
  1. aIt is strongly recommended that this checklist be read in conjunction with the SPIRIT 2013 Explanation & Elaboration for important clarification on the items.
  2. bIndicates page numbers to be completed by authors during protocol development.