title: Study protocol: the Back Pain Outcomes using Longitudinal Data (BOLD) registry.
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
  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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Department of Radiology, University of Washington, Seattle, WA, USA. jarvikj@u.washington.edu
authors.forename: Jeffrey G
authors.initials: JG
authors.lastname: Jarvik
authors.forename: Bryan A
authors.initials: BA
authors.lastname: Comstock
authors.forename: Brian W
authors.initials: BW
authors.lastname: Bresnahan
authors.forename: Srdjan S
authors.initials: SS
authors.lastname: Nedeljkovic
authors.forename: David R
authors.initials: DR
authors.lastname: Nerenz
authors.forename: Zoya
authors.initials: Z
authors.lastname: Bauer
authors.forename: Andrew L
authors.initials: AL
authors.lastname: Avins
authors.forename: Kathryn
authors.initials: K
authors.lastname: James
authors.forename: Judith A
authors.initials: JA
authors.lastname: Turner
authors.forename: Patrick
authors.initials: P
authors.lastname: Heagerty
authors.forename: Larry
authors.initials: L
authors.lastname: Kessler
authors.forename: Janna L
authors.initials: JL
authors.lastname: Friedly
authors.forename: Sean D
authors.initials: SD
authors.lastname: Sullivan
authors.forename: Richard A
authors.initials: RA
authors.lastname: Deyo
mesh_terms: D000368:Aged; D002985:Clinical Protocols; D015331:Cohort Studies; D003362:Cost-Benefit Analysis; D004185:Disability Evaluation; D042241:Early Diagnosis; D005260:Female; D006801:Humans; D017116:Low Back Pain / Q000175:diagnosis* / Q000191:economics / Q000628:therapy*; D008297:Male; D017063:Outcome Assessment, Health Care / Q000379:methods*; D010147:Pain Measurement; D011320:Primary Health Care; D012042:Registries; D012107:Research Design; D011795:Surveys and Questionnaires; D016896:Treatment Outcome