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

Anna Batorsky; Anton E Bowden; Jessa Darwin; Aaron J Fields; Carol M Greco; Richard E Harris; Trisha F Hue; Joseph Kakyomya; Wolf Mehling; Conor O'Neill; Charity G Patterson; Sara R Piva; Nico Sollmann; Vincent Toups; Ajay D Wasan; Ronald Wasserman; David A Williams; Nam V Vo; Matthew A Psioda; Micah McCumber

doi:10.1093/pm/pnad008

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

Pain Med. 2023 Aug 4;24(Suppl 1):S95-S104. doi: 10.1093/pm/pnad008.

Authors

Anna Batorsky¹, Anton E Bowden², Jessa Darwin³, Aaron J Fields⁴, Carol M Greco^{5

6}, Richard E Harris⁷, Trisha F Hue⁸, Joseph Kakyomya⁹, Wolf Mehling¹⁰, Conor O'Neill⁴, Charity G Patterson^{6

9}, Sara R Piva⁶, Nico Sollmann^{11

12

13

14}, Vincent Toups¹, Ajay D Wasan¹⁵, Ronald Wasserman^{16

17}, David A Williams^{7

17

18

19}, Nam V Vo^{20

21}, Matthew A Psioda¹, Micah McCumber¹

Affiliations

¹ Department of Biostatistics, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, Chapel Hill, NC, United States.
² Department of Mechanical Engineering, Brigham Young University, Provo, UT, United States.
³ Department of Physical Medicine and Rehabilitation, School of Medicine, University of Pittsburgh, Pittsburgh, PA, United States.
⁴ Department of Orthopaedic Surgery, University of California San Francisco, San Francisco, CA, United States.
⁵ Department of Psychiatry, University of Pittsburgh School of Medicine, Pittsburgh, PA, United States.
⁶ Department of Physical Therapy, School of Health and Rehabilitation Sciences, University of Pittsburgh, Pittsburgh, PA, United States.
⁷ Chronic Pain and Fatigue Research Center, Department of Anesthesiology, University of Michigan Medical School, Ann Arbor, MI, United States.
⁸ Department of Epidemiology & Biostatistics, University of California San Francisco, San Francisco, CA, United States.
⁹ School of Health and Rehabilitation Sciences Data Center, University of Pittsburgh, Pittsburgh, PA, United States.
¹⁰ Department of Family and Community Medicine, University of California San Francisco, San Francisco, CA, United States.
¹¹ Department of Radiology and Biomedical Imaging, University of California San Francisco, San Francisco, CA, United States.
¹² Department of Diagnostic and Interventional Radiology, University Hospital Ulm, Ulm, Germany.
¹³ Department of Diagnostic and Interventional Neuroradiology, School of Medicine, Klinikum rechts der Isar, Technical University of Munich, Munich, Germany.
¹⁴ TUM-Neuroimaging Center, Klinikum rechts der Isar, Technical University of Munich, Munich, Germany.
¹⁵ Department of Anesthesiology and Perioperative Medicine, School of Medicine, University of Pittsburgh, Pittsburgh, PA, United States.
¹⁶ Back and Pain Center, University of Michigan, Ann Arbor, MI, United States.
¹⁷ Department of Anesthesiology, University of Michigan, Ann Arbor, MI, United States.
¹⁸ Department of Psychiatry, University of Michigan Medical School, Ann Arbor, MI, United States.
¹⁹ Department of Internal Medicine-Rheumatology, University of Michigan Medical School, Ann Arbor, MI, United States.
²⁰ Department of Orthopaedic Surgery, University of Pittsburgh School of Medicine, Pittsburgh, PA, United States.
²¹ Ferguson Laboratory for Orthopaedic and Spine Research, University of Pittsburgh, Pittsburgh, PA, United States.

PMID: 36721327
DOI: 10.1093/pm/pnad008

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 nontabular data (eg, 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 by use of questionnaires across projects. Other nonrequired domain-specific measures are collected by multiple studies. To optimize cross-study analyses, a modified data standard was developed on the basis of 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.

Keywords: common data elements; data integration; data standards; harmonization; low back pain.

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

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