Core outcome domains for clinical trials in non-specific low back pain

Abstract

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.

Identifying a core set of outcome domains to measure in clinical trials for shoulder disorders: a modified Delphi study

“…However, when selecting the threshold for inclusion in the COS, there was no requirement that at least one core domain needed to exist in each of the core areas. To generate definitions for each domain, terminology used in a previous Delphi study to develop a COS for non-specific low-back pain13 was consulted.…”

Global Consensus From Clinicians Regarding Low Back Pain Outcome Indicators for Older Adults: Pairwise Wiki Survey Using Crowdsourcing (Preprint)

“…Google) unless the exact survey web The response rate of the current study was 39.5%. In comparison, the response rate for Delphi studies that evaluated core outcome set for LBP was between 45% to 52% [22]. This slight discrepancy might be attributed to the recruitment methods (open advertisements on social media vs personal invitations).…”

“…The panel comprised a physiotherapist specialized in spinal pain management, a physiotherapist specialized in geriatric rehabilitation, an orthopedic surgeon, and a geriatrician. These seed answers were aligned with the core set of outcome domains (physical functioning, pain intensity, and health-related quality of life) derived from a Delphi study for measuring and reporting non-specific LBP in clinical trials [22] (Table 1). To evaluate the relevance of age-related outcome indicators in assessing LBP improvements of older adults, an age-specific outcome indicator (i.e.…”

The Canadian minimum dataset for chronic low back pain research: a cross-cultural adaptation of the National Institutes of Health Task Force Research Standards

“…Core outcomes for clinical trials involving patients with chronic pain or back pain are already the subject of consensuses. 29,32,33 …”