OBJECTIVE: This article reports the results of a multisite pilot project utilizing New York Chiropractic College's 3 off-campus health centers. In the project, we sought to examine generic issues related to research infrastructure and feasibility, perform pilot testing of the responsiveness of the revised Oswestry Disability Index (ODI) and the Bournemouth Questionnaire (BQ), and develop estimates of change and population size for the possible future projects.
METHODS: We describe the infrastructure created to conduct the project, including an on-site clinician research manager; on-site student research assistants; identification, recruitment, and patient flow; demographic and clinical characteristics; and abstraction instruments. Responsiveness study subjects completed 3 health-related quality-of-life assessments at baseline, 15 days, and 30 days. At 45 days, or at discharge, subjects completed the same questionnaires and a global rating of change. Responsiveness is reported by analysis of standardized estimates of change, relative efficiency, and receiver operator characteristic (ROC) curve plots.
RESULTS: We successfully identified 82% of possible study patients; the real eligibility rate in our population was 30%. In 4 months, 70 patients were accrued, and 26 patients followed through to provide global ratings of change scores. Responsiveness by standardized change scores was numerical rating scale (NRS) = 1.19, ODI = 0.91, BQ = 0.78; by relative efficiency it was BQ/ODI = 0.86, ODI/NRS = 0.76, BQ/NRS = 0.66. Area under the curves ranged from 0.69 for the BQ to 0.86 for the NRS.
CONCLUSIONS: Recommendations for modification and use of the infrastructure, research capacity, and future outcome and appropriateness assessment projects are offered.
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