Advancing research on strategies to reduce drug use and overdose-related harms: a community informed approach to establishing common data elements.

With the overdose crisis continuing to pose significant challenges in North America, harm reduction strategies are critical for public health systems to reduce mortality and morbidity. Despite the considerable strides in harm reduction research, high-quality evidence for decision-making is limited. This is compounded by a variation in reported outcomes, drug supply, administration changes, and policy and social impacts, which further challenge researchers and practitioners in their efforts to implement effective, nimble harm reduction interventions. Adoption of common data elements (CDEs) and common outcome measures (COMs) helps researchers standardize and enhance data collection and outcome reporting, ultimately improving the comparability and generalizability of research findings. To accelerate the pace and use of CDEs, members of the NIDA HEAL Research on Interventions for Stability and Engagement (RISE) engaged in prospective semantic harmonization and consensus on CDEs and COMs using a rigorous pragmatic Delphi community informed approach. This process resulted in a set of CDEs and COMs that standardized data collection and reporting across 10 harm reduction research projects. This paper describes this process and presents the derived CDEs and COMs, along with key considerations, challenges encountered, and lessons learned.