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

Abstract

BackgroundBack 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/designBOLD 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.DiscussionBy 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.

Inadequacy of 3-month Oswestry Disability Index outcome for assessing individual longer-term patient experience after lumbar spine surgery

“…9,29 In light of the expense and difficulty associated with obtaining real-world PRO data, it has been suggested that short-term outcomes data might, in certain circumstances, serve as an adequate surrogate for long-term data. 25,32,39,43 Given the logistical challenges and financial restraints of collecting long-term patient-reported data at a scalable level, it is vital to understand how well short-term outcomes represent long-term outcomes for both patient populations and individual patients.…”

Clinical outcomes of early and later physical therapist services for older adults with back pain

“…The RMDQ is valid, reliable, commonly used, and recommended for back pain research [16,17]. The BOLD registry used a modified version that added ''leg pain/sciatica'' to each question [13]. The RMDQ is scored from 0 to 24, with 0 signifying no limitation in function and 24 being maximal functional limitation.…”

“…Because treatment received before the baseline interview could have affected the baseline questionnaire responses, we excluded participants who initiated PT more than 1 day before the baseline interview from our hypothesis testing analysis. The assembly of this cohort is further described by Jarvik et al [13].…”

Case Studies from the Clinic: Initiating and Implementing Patient-Reported Outcome Measures

“…In addition, instruments that are identified by sub-specialty clinics as measuring domains important to their care are also used. As an example, in the Center for Aids Research, PROs are collected in two phases: (1) a review of systems is done at each clinic visit, and (2) 21,22 The aim of the project was to determine if imaging of the lumbar spine within 6 weeks of the index visit (early imaging) was associated with worse patient-reported outcomes over time and increased health care utilization and costs. Researchers measured patient-reported pain characteristics (duration, location, severity, and interference with function, activity, and sleep); back-related disability; psychological distress; healthrelated quality of life; falls; and recovery expectation.…”