A core outcome set for clinical trials on non-specific low back pain: study protocol for the development of a core domain set

A core outcome set for clinical trials on non-specific low back pain: study protocol for the development of a core domain set

Trials, December 2014

25540987

Alessandro Chiarotto, Caroline B Terwee, Richard A Deyo, Maarten Boers, Chung-Wei Christine Lin, Rachelle Buchbinder, Terry P Corbin, Leonardo OP Costa, Nadine E Foster, Margreth Grotle, Bart W Koes, Francisco M Kovacs, Chris G Maher, Adam M Pearson, Wilco C Peul, Mark L Schoene, Dennis C Turk, Maurits W van Tulder, Raymond W Ostelo

Low back pain (LBP) is one of the most disabling and costly disorders affecting modern society, and approximately 90% of patients are labelled as having non-specific LBP (NSLBP). Several interventions for patients with NSLBP have been assessed in clinical trials, but heterogeneous reporting of outcomes in these trials has hindered comparison of results and performance of meta-analyses. Moreover, there is a risk of selective outcome reporting bias. To address these issues, the development of a core outcome set (COS) that should be measured in all clinical trials for a specific health condition has been recommended. A standardized set of outcomes for LBP was proposed in 1998, however, with evolution in COS development methodology, new instruments, interventions, and understanding of measurement properties, it is appropriate to update that proposal. This protocol describes the methods used in the initial step in developing a COS for NSLBP, namely, establishing a core domain set that should be measured in all clinical trials.