Clinical and biobehavioral phenotypic assessments and data harmonization for the RE-JOIN research consortium: Recommendations for common data element selection

•The Restoring Joint Health and Function to Reduce Pain (RE-JOIN) Consortium is part of the Helping to End Addiction Long-term® (HEAL) Initiative with the over-arching goal to define how joint pain-mediating neurons innervate different articular and peri-articular tissues employing the latest neuroscience approaches.•We aim to elucidate the human data gathered by the RE-JOIN consortium, as well as to expound upon its underlying rationale and the methodologies and protocols for harmonization and standardization that have been instituted by the RE-JOIN Consortium.•The harmonized phenotypic information obtained will significantly enhance our understanding of the neurobiology of the pain-pathology relationships in humans, providing valuable insights for comparison with pre-clinical models. The Restoring Joint Health and Function to Reduce Pain (RE-JOIN) Consortium is part of the Helping to End Addiction Long-term® (HEAL) Initiative. HEAL is an ambitious, NIH-wide initiative to speed scientific solutions to stem the national opioid public health crisis. The RE-JOIN consortium’s over-arching goal is to define how chronic joint pain-mediating neurons innervate different articular and peri-articular tissues, with a focus on the knee and temporomandibular joints (TMJ) across species employing the latest neuroscience approaches. The aim of this manuscript is to elucidate the human data gathered by the RE-JOIN consortium, as well as to expound upon its underlying rationale and the methodologies and protocols for harmonization and standardization that have been instituted by the RE-JOIN Consortium. The consortium-wide human models working subgroup established the RE-JOIN minimal harmonized data elements that will be collected across all human studies and set the stage to develop parallel pre-clinical data collection standards. Data harmonization considerations included requirements from the HEAL program and recommendations from the consortium’s researchers and experts on informatics, knowledge management, and data curation. Multidisciplinary experts − including preclinical and clinical researchers, with both clinician-scientists- developed the RE-JOIN’s Minimal Human Data Standard with required domains and outcome measures to be collected across projects and institutions. The RE-JOIN minimal data standard will include HEAL Common Data Elements (CDEs) (e.g., standardized demographics, general pain, psychosocial and functional measures), and RE-JOIN common data elements