The American College of Rheumatology Updated Recommended Methods for Development of Disease Classification and Response Criteria

Disease classification criteria and response criteria are important tools in the conduct of observational studies and clinical trials for rheumatic diseases. This paper updates methodologic guidance for classification and response criteria funded, developed and/or endorsed by the American College of Rheumatology (ACR), incorporating contemporary methods and bias mitigation strategies. As current and previous committee chairs and staff charged with overseeing ACR criteria development and endorsement, we highlight guiding principles, outline a methodological approach, provide relevant examples, and emphasize considerations for ACR funding and endorsement. We provide an updated checklist to guide investigators and reviewers. The ACR Criteria Subcommittee, ACR Quality of Care Committee and the ACR Board of Directors have approved this paper.