Open Access Highly Accessed Study protocol

Study protocol: The back pain outcomes using longitudinal data (BOLD) registry

Jeffrey G Jarvik12378*, Bryan A Comstock3, Brian W Bresnahan3, Srdjan S Nedeljkovic4, David R Nerenz5, Zoya Bauer3, Andrew L Avins6, Kathryn James3, Judith A Turner3, Patrick Heagerty3, Larry Kessler7, Janna L Friedly3, Sean D Sullivan8 and Richard A Deyo9

Author Affiliations

1 Department of Radiology, University of Washington, Seattle, WA, USA

2 Department of Neurological Surgery, University of Washington, Seattle, WA, USA

3 Comparative Effectiveness, Cost and Outcomes Research Center, University of Washington, Seattle, WA, USA

4 Department of Anesthesiology, Perioperative and Pain Medicine, Brigham and Women’s Hospital, Boston, MA, USA

5 Neuroscience Institute, Henry Ford Hospital, Detroit, MI, USA

6 Division of Research, Kaiser Permanente Northern California, Oakland, CA, USA

7 Department of Health Services, University of Washington, Seattle, WA, USA

8 Department of Pharmacy, University of Washington, Seattle, WA, USA

9 Departments of Family Medicine and Internal Medicine, Oregon Health Sciences University, Portland, OR, USA

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BMC Musculoskeletal Disorders 2012, 13:64  doi:10.1186/1471-2474-13-64

Published: 3 May 2012

Abstract

Background

Back pain is one of the most important causes of functional limitation, disability, and utilization of health care resources for adults of all ages, but especially among older adults. Despite the high prevalence of back pain in this population, important questions remain unanswered regarding the comparative effectiveness of commonly used diagnostic tests and treatments in the elderly. The overall goal of the Back pain Outcomes using Longitudinal Data (BOLD) project is to establish a rich, sustainable registry to describe the natural history and evaluate prospectively the effectiveness, safety, and cost-effectiveness of interventions for patients 65 and older with back pain.

Methods/design

BOLD is enrolling 5,000 patients ≥ 65 years old who present to a primary care physician with a new episode of back pain. We are recruiting study participants from three integrated health systems (Kaiser-Permanente Northern California, Henry Ford Health System in Detroit and Harvard Vanguard Medical Associates/ Harvard Pilgrim Health Care in Boston). Registry patients complete validated, standardized measures of pain, back pain-related disability, and health-related quality of life at enrollment and 3, 6 and 12 months later. We also have available for analysis the clinical and administrative data in the participating health systems’ electronic medical records. Using registry data, we will conduct an observational cohort study of early imaging compared to no early imaging among patients with new episodes of back pain. The aims are to: 1) identify predictors of early imaging and; 2) compare pain, functional outcomes, diagnostic testing and treatment utilization of patients who receive early imaging versus patients who do not receive early imaging. In terms of predictors, we will examine patient factors as well as physician factors.

Discussion

By establishing the BOLD registry, we are creating a resource that contains patient-reported outcome measures as well as electronic medical record data for elderly patients with back pain. The richness of our data will allow better matching for comparative effectiveness studies than is currently possible with existing datasets. BOLD will enrich the existing knowledge base regarding back pain in the elderly to help clinicians and patients make informed, evidence-based decisions regarding their care.

Keywords:
Low back pain; Registry; Cohort studies; Aged; Primary health care