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Rheumatology International

, Volume 39, Issue 1, pp 141–146 | Cite as

Evaluation of the performance of extreme patient-reported outcomes as surrogate markers for fibromyalgia in axial spondyloarthritis

  • Daniela Santos-FariaEmail author
  • Maxime Dougados
  • Laure Gossec
  • Serge Perrot
  • Anna Moltó
Patient Opinion
  • 45 Downloads

Abstract

Objectives

The aim of the study is to evaluate the performance of extreme patient-reported outcomes (PRO) against definitions of fibromyalgia (FM) in patients with axial spondyloarthritis (axSpA).

Methods

Ancillary analysis of the Predict-SpA trial, an observational study of axSpA patients receiving TNF-α inhibitor, was performed. ‘Extreme PRO’ was defined as a score ≥ 8 on three out of the first five Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) questions (scored 0–10). FM was defined by the American College of Rheumatology (ACR) 1990 criteria and the Fibromyalgia Rapid Screening Test (FiRST). Performances of ‘extreme PRO’ for FM were evaluated by the sensitivity, specificity and positive likelihood ratio using the 1990 ACR criteria as gold standard. As secondary analysis, the FiRST was used as the external standard.

Results

The prevalence of ‘extreme PRO’ in this population was 28.8% at baseline and decreased to 9.9% at 12 weeks. ‘Extreme PRO’ had low sensitivity 12 weeks after TNF initiation (0.18, 95% confidence interval [CI] 0.10–0.27 vs 0.60, 95% CI 0.50–0.71, at baseline), but high specificity (0.92, 95% CI 0.89–0.94 vs 0.78, 95% 0.74–0.82, at baseline), using ACR 1990 criteria as gold standard. Performances when tested against FiRST at 12 weeks showed higher sensitivity (0.27, 95% CI 0.20–0.35) and specificity (0.96, 95% CI 0.94–0.98).

Conclusion

The proposed extreme PRO definition showed great specificity for FM recognition in patients with axSpA, suggesting it could be used in observational studies when specific items for FM classification are not available.

Keywords

Patient-reported outcomes BASDAI Fibromyalgia Spondyloarthritis 

Notes

Funding

This study was conducted thanks to an unrestricted grant from MSD.

Compliance with ethical standards

Conflict of interest

None of the authors has any conflicts of interest to declare for the present study.

Ethics committee

CPP Île de France 3 - date 24/10/2014. The manuscript has been read and approved by all the authors and we confirm that each individual named as an author meets the journal’s criteria for authorship.

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Copyright information

© Springer-Verlag GmbH Germany, part of Springer Nature 2018

Authors and Affiliations

  1. 1.Rheumatology Department, Unidade Local de Saúde do Alto Minho (ULSAM)Hospital Conde de BertiandosPonte de LimaPortugal
  2. 2.Rheumatology Department, Cochin HospitalParis Descartes University, AP-HPParisFrance
  3. 3.INSERM (U1153), Clinical Epidemiology and BiostatisticsPRES Sorbonne Paris-CitéParisFrance
  4. 4.Department of Rheumatology, Pitié-Salpêtrière HospitalSorbonne Universités, UPMC Université, AP-HPParisFrance
  5. 5.Pain Center and INSERM U987, Cochin HospitalParis Descartes University, AP-HPParisFrance

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