Dissemin is shutting down on January 1st, 2025

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Oxford University Press, Pain Medicine, 2023

DOI: 10.1093/pm/pnad008

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The Back Pain Consortium (BACPAC) Research Program Data Harmonization: Rationale for Data Elements and Standards

This paper was not found in any repository, but could be made available legally by the author.
This paper was not found in any repository, but could be made available legally by the author.

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Abstract

Abstract Objective One aim of the Back Pain Consortium (BACPAC) Research Program is to develop an integrated model of chronic low back pain that is informed by combined data from translational research and clinical trials. We describe efforts to maximize data harmonization and accessibility to facilitate Consortium-wide analyses. Methods Consortium-wide working groups established harmonized data elements to be collected in all studies and developed standards for tabular and non-tabular data (e.g., imaging and omics). The BACPAC Data Portal was developed to facilitate research collaboration across the Consortium. Results Clinical experts developed the BACPAC Minimum Dataset with required domains and outcome measures to be collected using questionnaires across projects. Other non-required domain-specific measures are collected by multiple studies. To optimize cross-study analyses, a modified data standard was developed based on the Clinical Data Interchange Standards Consortium Study Data Tabulation Model to harmonize data structures and facilitate integration of baseline characteristics, participant-reported outcomes, chronic low back pain treatments, clinical exam, functional performance, psychosocial characteristics, quantitative sensory testing, imaging and biomechanical data. Standards to accommodate the unique features of chronic low back pain data were adopted. Research units submit standardized study data to the BACPAC Data Portal, developed as a secure cloud-based central data repository and computing infrastructure for researchers to access and conduct analyses on data collected by or acquired for BACPAC. Conclusions BACPAC harmonization efforts and data standards serve as an innovative model for data integration that could be used as a framework for other consortia with multiple, decentralized research programs.