Purpose Inconsistent reporting of outcomes in clinical trials of patients with non-specific low back pain (NSLBP) hinders comparison of findings and the reliability of systematic reviews. A core outcome set (COS) can address this issue as it defines a minimum set of outcomes that should be reported in all clinical trials. In 1998, Deyo et al. recommended a standardized set of outcomes for LBP clinical research. The aim of this study was to update these recommendations by determining which outcome domains should be included in a COS for clinical trials in NSLBP.
Methods An International Steering Committee established the methodology to develop this COS. The OMERACT Filter 2.0 framework was used to draw a list of potential core domains that were presented in a Delphi study. Researchers, care providers and patients were invited to participate in three Delphi rounds and were asked to judge which domains were core. A priori criteria for consensus were established before each round and were analysed together with arguments provided by panellists on importance, overlap, aggregation and/or addition of potential core domains. The Steering Committee discussed the final results and made final decisions.
Results A set of 280 experts was invited to participate in the Delphi; response rates in the three rounds were 52, 50 and 45 %. Of 41 potential core domains presented in the first round, 13 had sufficient support to be presented for rating in the third round. Overall consensus was reached for the inclusion of three domains in this COS: ‘physical functioning’, ‘pain intensity’ and ‘health-related quality of life’. Consensus on ‘physical functioning’ and ‘pain intensity’ was consistent across all stakeholders, ‘health-related quality of life’ was not supported by the patients, and all the other domains were not supported by two or more groups of stakeholders. Weighting all possible argumentations, the Steering Committee decided to include in the COS the three domains that reached overall consensus and the domain ‘number of deaths’.
Conclusions The following outcome domains were included in this updated COS: ‘physical functioning’, ‘pain intensity’, ‘health-related quality of life’ and ‘number of deaths’. The next step for the development of this COS will be to determine which measurement instruments best measure these domains.
The aim of this study was to update these recommendations by determining which outcome domains should be included in a COS for clinical trials in NSLBP
ContributorsAlessandro Chiarotto, Richard A. Deyo, Caroline B. Terwee, Maarten Boers, Rachelle Buchbinder, Terry P. Corbin, Leonardo O. P. Costa, Nadine E. Foster, Margreth Grotle, Bart W. Koes, Francisco M. Kovacs, Chung-Wei Christine Lin, Chris G. Maher, Adam M. Pearson, Wilco C. Peul, Mark L. Schoene, Dennis C. Turk, Maurits W. van Tulder, Raymond W. Ostelo
Disease Category: Orthopaedics & trauma
Disease Name: Low back pain
Age Range: 18 - 100
Sex: Either
Nature of Intervention: Any
- Clinical experts
- Consumers (patients)
- Patient/ support group representatives
- Researchers
- COS for clinical trials or clinical research
- Delphi process
- Literature review
An International Steering Committee including researchers, clinicians and patient representatives from four continents was formed to guide development of this COS. The approach of initiatives like Core Outcome Measures in Effectiveness Trials (COMET) and Outcome Measures in Rheumatology (OMERACT) was followed. The Steering Committee identified other relevant initiatives in the field and determined the scope of this COS. Different stakeholders were invited to participate in a Delphi study aimed at reaching consensus on core outcome domains 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 were emerging between the two approaches. The Steering Committee discussed and made final interpretations of Delphi results.
A full report of the methods used in this study is available at the following link: http://www.trialsjournal.com/content/15/1/511