The Uptake of the Core Outcome Set for Non-Specific Low Back Pain Clinical Trials is Poor: A Meta-Epidemiological Study of Trial Registrations.

ABSTRACT

We conducted a meta-epidemiological study on all non-specific low back pain (NSLBP) trial registrations on the World Health Organization International Clinical Trials Registry Platform and ClinicalTrials.gov. We aimed to 1) assess the uptake of the core outcome set (COS) for NSLBP in clinical trials; 2) assess the uptake of the core outcome measurement set for NSLBP in clinical trials; and 3) determine whether specific study characteristics are associated with the COS uptake. After applying the relevant filters for the condition, study type, and phase of the trial, 240 registry entries were included in this study. Only 50 (20.8%) entries showed a full COS uptake, and this rate did not increase over time. Most registry entries that planned to measure physical functioning (n = 152) used the Roland-Morris Disability Questionnaire (n = 74; 48.7%); a small percentage used the numeric rating scale (n = 60; 27.3%) or Short Form-12 (n = 5; 8.3%) if they planned to measure pain intensity (n = 220) or health-related quality of life (n = 60), respectively. Only the planned sample size (OR = 1.02; 95% CI = 1.01, 1.03) showed a significant but small association with COS uptake. The uptake of the COS for NSLBP is poor. Only 21% of the randomized controlled trials aimed to measure all COS domains in their study registration and COS uptake is not increased over time. Great heterogeneity in measurement instruments was also observed, revealing poor core outcome measurement set uptake. PERSPECTIVE The Core Outcome Set (COS) for non-specific low back pain was published more than 20 years ago. We evaluated whether trial registrations are using this set of outcomes when testing interventions for low back pain. Full uptake was found only in 21% of the sample, and this is not increasing over time. Researchers should use the COS to ensure that trials measure relevant outcomes consistently.