TY - JOUR
T1 - A core outcome set for clinical trials on non-specific low back pain
T2 - Study protocol for the development of a core domain set
AU - Chiarotto, Alessandro
AU - Terwee, Caroline B.
AU - Deyo, Richard A.
AU - Boers, Maarten
AU - Lin, Chung Wei Christine
AU - Buchbinder, Rachelle
AU - Corbin, Terry P.
AU - Costa, Leonardo O.P.
AU - Foster, Nadine E.
AU - Grotle, Margreth
AU - Koes, Bart W.
AU - Kovacs, Francisco M.
AU - Maher, Chris G.
AU - Pearson, Adam M.
AU - Peul, Wilco C.
AU - Schoene, Mark L.
AU - Turk, Dennis C.
AU - van Tulder, Maurits W.
AU - Ostelo, Raymond W.
N1 - Funding Information:
This research project was funded by the Wetenschappelijk College Fysiotherapie (WCF) of the Royal Dutch Society for Physical Therapy (KNGF). The funding body did not have any role in trial design, collection, analysis, and interpretation of data, nor in writing the manuscript and deciding to submit this manuscript for publication. The views expressed here are those of the authors and do not necessarily reflect those of their funding bodies.
Publisher Copyright:
© Chiarotto et al.
PY - 2014/12/26
Y1 - 2014/12/26
N2 - 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.
AB - 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.
UR - http://www.scopus.com/inward/record.url?scp=84925125318&partnerID=8YFLogxK
U2 - 10.1186/1745-6215-15-511
DO - 10.1186/1745-6215-15-511
M3 - Article
C2 - 25540987
AN - SCOPUS:84925125318
SN - 1745-6215
VL - 15
JO - Trials
JF - Trials
IS - 1
M1 - 511
ER -