Abstract
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. 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. 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'. 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.
Highlights
The Global Burden of Disease study has highlighted that low back pain (LBP) is the leading global contributor to years lived with disability and the sixth global contributor to disability-adjusted life years [1, 2]
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 core outcome set (COS): ‘physical functioning’, ‘pain intensity’ and ‘health-related quality of life’
Summary
The Global Burden of Disease study has highlighted that low back pain (LBP) is the leading global contributor to years lived with disability and the sixth global contributor to disability-adjusted life years [1, 2]. A wide range of health interventions exists for patients with NSLBP and related clinical trials are often summarized in systematic reviews [9, 10]. Authors of these reviews report that outcomes are inconsistently measured and reported across trials [11,12,13]. This inconsistency may limit the comparison of findings among trials and hinder statistical pooling [14]. Inconsistent reporting can be due to selective reporting bias (e.g. reporting only favourable outcomes in a publication), which may strongly affect the conclusions of systematic reviews [15]
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