BOLD Study Overview
Brief Summary
The overall objective of Back Pain Outcomes Using Longitudinal Data (BOLD) is to establish a large, community-based registry (at least 5000 subjects) of patients aged 65 years and older presenting with new episodes of healthcare visits for back pain. BOLD's primary aim is to create an infrastructure that allows for the conduct of prospective, controlled studies comparing the effectiveness of diagnostic and treatment strategies for back pain in older adults.
Detailed Description
The BOLD registry identifies subjects at the time of a new episode of back pain and captures data in a longitudinal fashion for up to 12 months. The registry captures self-report outcomes data as well as comprehensive utilization data including pharmacy and imaging data through the electronic medical record system. We are applying for additional funding to continue follow-up for up to 4 years from baseline.
Publications
- Jarvik JG, Comstock BA, Bresnahan BW, Nedeljkovic SS, Nerenz DR, Bauer Z, Avins AL, James K, Turner JA, Heagerty P, Kessler L, Friedly JL, Sullivan SD, Deyo RA. Study protocol: the Back Pain Outcomes using Longitudinal Data (BOLD) registry. BMC Musculoskelet Disord. 2012 May 3;13:64. doi: 10.1186/1471-2474-13-64.
- Jarvik JG, Comstock BA, Heagerty PJ, Turner JA, Sullivan SD, Shi X, Nerenz DR, Nedeljkovic SS, Kessler L, James K, Friedly JL, Bresnahan BW, Bauer Z, Avins AL, Deyo RA. Back pain in seniors: the Back pain Outcomes using Longitudinal Data (BOLD) cohort baseline data. BMC Musculoskelet Disord. 2014 Apr 23;15:134. doi: 10.1186/1471-2474-15-134.
ClinicalTrials.gov
BOLDER Study Overview
Description
Low back pain is an Institute of Medicine priority condition for comparative effectiveness research and it remains a particularly important problem for the elderly, an AHRQ priority population. Nearly one-third of the population over age 65 has severe low back pain and it is one of the most common reasons for physician visits. There is a paucity of evidence-based guidelines for the elderly, who have a different distribution of causal conditions than younger populations. Important questions remain unanswered regarding the comparative effectiveness of most commonly used diagnostic tests and treatments. Funded by a $10 million AHRQ/ARRA grant, we have enrolled a large inception cohort of senior patient with low back pain from three geographically and racially diverse HMOs: Kaiser Northern California, Henry Ford Health System and Harvard Vanguard/Harvard Pilgrim. Patients who enroll in the registry complete validated, standardized measures of pain, back-related disability, and health-related quality of life at enrollment and at regular follow-up intervals. The overall goal of our project, the Back pain Outcomes using Longitudinal Data- Extension of Research (BOLDER), is to extend the usefulness and improve the capabilities of the BOLD cohort infrastructure. Using a stakeholder engagement process, we will enhance the current data infrastructure to address stakeholder-relevant questions. Stakeholder engagement will include health system and payer stakeholders at the various sites as well as senior patients with back pain. Specifically, we will extend our existing data infrastructure by collecting longer-term patiet reported outcomes (PRO) and electronic medical record data collected from diverse data systems within and between health systems. We will use stakeholder input to focus our additional data collection on data that will be of greatest value to stakeholders and can address important questions regarding the long-term clinical effectiveness of back pain diagnostic and treatment interventions.
Public Health Relevance Statement
The significance of the Back pain Outcomes using Longitudinal Data- Extension of Research (BOLDER) project stems from the high prevalence and cost of low back pain combined with a lack of comparative effectiveness data in seniors. It is one of the most important causes of functional limitation and disability, an Institute of Medicine priority condition, and it remains a particularly important problem for the elderly, an AHRQ priority population. While there are numerous guidelines regarding the diagnosis and treatment of the general low back pain population, there is a paucity of evidence-based guidelines for the elderly and minorities. BOLDER will continue the work begun with BOLD, gathering important data about the effectiveness of diagnostic and therapeutic interventions in seniors with back pain.
NIH RePORT