2014-12-26
A core outcome set for clinical trials on non-specific low back pain: Study protocol for the development of a core domain set
Publication
Publication
Trials , Volume 15 - Issue 1
Abstract
Background: 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.
Methods/Design: An International Steering Committee including researchers, clinicians, and patient representatives
from four continents was formed to guide the development of this COS. The approach of initiatives like Core Outcome
Measures in Effectiveness Trials (COMET) and Outcome Measures in Rheumatology (OMERACT) was followed. Participants
were invited to participate in a Delphi study aimed at generating a consensus-based core domain set for NSLBP. A list of
potential core domains was drafted and presented to the Delphi participants who were asked to judge which domains
were core. Participant suggestions about overlap, aggregation, or addition of potential core domains were addressed
during the study. The patients’ responses were isolated to assess whether there was substantial disagreement with the
rest of the Delphi panel. A priori thresholds for consensus were established before each Delphi round. All participants’
responses were analysed from a quantitative and qualitative perspective to ascertain that no substantial discrepancies
between the two approaches emerged.
Discussion: We present the initial step in developing a COS for NSLBP. The next step will be to determine which
measurement instruments adequately cover the domains.
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doi.org/10.1186/1745-6215-15-511, hdl.handle.net/1765/82813 | |
Trials | |
Organisation | Department of General Practice |
Chiarotto, A., Terwee, C., Deyo, R., Boers, M., Lin, C.-W. C., Buchbinder, R., … Ostelo, R. (2014). A core outcome set for clinical trials on non-specific low back pain: Study protocol for the development of a core domain set. Trials, 15(1). doi:10.1186/1745-6215-15-511 |