Protocol for the development of an artificial intelligence extension to the Consolidated Health Economic Evaluation Reporting Standards (CHEERS) 2022

Introduction: AI interventions for health care are on the rise. Decisions about coverage and reimbursement are often informed by Health Technology Assessment (HTA) bodies, who rely on Health Economic Evaluations (HEEs) to estimate the value for money (cost effectiveness) of interventions. Transparent reporting of HEEs ensures they can be used for decision making. Reporting guidance exists to support this, such as the Consolidated Health Economic Reporting Standards (CHEERS) checklist. We aim to identify consensus about specific items should be reported by HEEs that evaluate AI interventions and, if such items are identified, to develop them into an extension to CHEERS: CHEERS-AI Methods and analysis: The project will have 4 phases: - Phase 1 is a literature review to help identify potential AI-related reporting items. - Phase 2 commences a Delphi process, with a series of surveys to elicit the importance of the potential AI-related reporting items. - Phase 3 is a consensus-generation meeting to agree on the final extension items. - Phase 4 is dissemination of the project outputs. ### Competing Interest Statement The authors have declared no competing interest. ### Funding Statement This study is supported by the Next Generation Health Technology Assessment (HTx) project. The HTx project has received funding from the European Union Horizon 2020 research and innovation programme under grant agreement No. 825162. This dissemination reflects only the views of the authors and the Commission is not responsible for any use that may be made of the information it contains.  ### Author Declarations I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained. Yes The details of the IRB/oversight body that provided approval or exemption for the research described are given below: Newcastle External Assessment Centre (EAC) of Newcastle University gave ethical approval for this work (reference: 28568/2022). I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals. Yes I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance). Yes I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable. Yes The findings will be available in as an open access article and disseminated through blogs, newsletters, and presentations.