BACPAC Modified CDISC Standards Facilitate Characterization of Patient Populations and Integration of Data Across Multiple Back Pain Studies

• Activity Number: 153 - Contributed Poster Presentations: Biopharmaceutical Section
• Type: Contributed
• Date/Time: Monday, August 8, 2022 : 10:30 AM to 12:20 PM
• Sponsor: Biopharmaceutical Section
• Author(s): Anna Batorsky* and Micah McCumber and Charity G. Patterson and Matthew A. Psioda
• Companies: University of North Carolina Chapel Hill and University of North Carolina Chapel Hill and Dept of Physical Therapy School of Health & Rehabilitation Sciences Univ of Pittsburgh and University of North Carolina at Chapel Hill
• Keywords: CDISC; Data standards; Data harmonization; Data Integration

Abstract

The Back Pain Consortium (BACPAC) consists of a Data Integration, Algorithm Development and Operations Management Center, three mechanistic research centers, four clinical trials, and seven technology sites focused on advancing knowledge of etiology and treatment of chronic low back pain (cLBP) as part of the NIH Helping End Addiction Long Term (HEAL) initiative®. BACPAC developed a modified data standard based on Clinical Data Interchange Standards Consortium (CDISC) standards, for which resources are readily available and widely used outside of academic research, to harmonize data collection and facilitate integration of data across BACPAC, NIH HEAL initiative®, and other studies of pain and cLBP. We use common domain types to harmonize tabular data for baseline characteristics, participant reported outcomes, cLBP treatments in observational studies, physical function, quantitative sensory testing, and biomechanical data. We adapted the standards to accommodate unique features of cLBP data and facilitate broad adoption. Consortium-wide working groups established harmonized measures and standards for tabular and non-tabular data including imaging and omics, and XML metadata.