Abstract
Background and purpose:
Inconsistent outcome reporting is a problematic issue in systematic reviews of clinical trials in non-specific LBP (NSLBP). To facilitate statistical pooling and improve reliability of reviews, the development of a core outcome set (COS) is recommended. In 1998, Deyo et al. proposed a standardized set of domains and measurement instruments for LBP clinical research. An international steering committee (ISC) was formed to update 1998 recommendations, and to determine, at first, which outcome domains should be included in a COS for clinical trials in NSLBP.
Methods:
The ISC used the OMERACT framework 2.0 to draw a list of potential core domains. This list was presented in a 3-round Delphi survey, in which researchers, clinicians and patients were invited to participate. Criteria for consensus were established a-priori and quantitative responses were analysed together with arguments provided by Delphi participants. The ISC discussed the results and made final decisions.
Results:
280 ‘experts’ were selected and invited to participate in the Delphi survey. Response rates in the three rounds were: 52%, 50%, and 45%. A list of 41 potential core domains was presented but 28 of them did not reach sufficient consensus to be presented in the third round, where overall consensus was reached on three domains: ‘physical functioning’, ‘pain intensity’ and ‘health-related quality of life’.
Conclusion:
‘Physical functioning’, ‘pain intensity’ and ‘health-related quality of life’ were included in this COS, together with the reporting on ‘number of deaths’. The next step in the development of this COS will be to determine which measurement instruments are most fit-for-purpose to measure these outcome domains.
