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Rheumatology
Protocol
Prognostic factors for work disability in patients with chronic widespread pain and fibromyalgia: protocol for a cohort study
  1. Pernille H Duhn1,2,
  2. Henning Locht2,
  3. Eva Ejlersen Wæhrens1,3,
  4. Robin Christensen1,4,
  5. Karsten Thielen5,
  6. Marius Henriksen1,
  7. Lars Erik Kristensen1,2,
  8. Henning Bliddal1,6,
  9. Kirstine Amris1,2
  1. 1Parker Institute, Frederiksberg Hospital, Frederiksberg, Denmark
  2. 2Rheumatology, Frederiksberg Hospital, Frederiksberg, Denmark
  3. 3Occupational Science & Occupational Therapy, User Perspectives and Community-Based Research, Department of Public Health, University of Southern Denmark, Odense, Denmark
  4. 4Research Unit of Rheumatology, Department of Clinical Research, University of Southern Denmark, Odense, Denmark
  5. 5Department of Social Medicine, University of Copenhagen, Kobenhavn, Denmark
  6. 6Clinical Medicine, University of Copenhagen, Kobenhavn, Denmark
  1. Correspondence to Dr Pernille H Duhn; pernille.hurup.duhn{at}regionh.dk

Abstract

Introduction The association between chronic widespread pain (CWP) and disability is well established. Although research support large interindividual differences in functional outcomes, limited studies are available on the socio-economic consequences of offering stratified treatment based on prognostic factors. Identification of predictors of long-term functional outcomes such as work disability as a critical consequence, could assist early and targeted personalised interventions. The primary objective of this cohort study is to identify prognostic factors for the primary endpoint work status (employed and working vs not working) in patients with CWP assessed 3 years from baseline, that is, at referral for specialist care.

Methods and analyses Data are collected at the diagnostic unit at Department of Rheumatology, Frederiksberg Hospital. The first 1000 patients ≥18 years of age registered in a clinical research database (DANFIB registry) with CWP either ‘employed and working’ or ‘not working’ will be enrolled. Participants must meet the American College of Rheumatology 1990 definition of CWP, that is, pain in all four body quadrants and axially for more than 3 months and are additionally screened for fulfilment of criteria for fibromyalgia. Clinical data and patient-reported outcomes are collected at referral (baseline) through clinical assessment and electronic questionnaires. Data on the primary endpoint work status at baseline and 3 years from baseline will be extracted from the Integrated Labour Market Database, Statistics Denmark and the nationwide Danish DREAM database. Prognostic factor analysis will be based on multivariable logistic regression modelling with the dichotomous work status as dependent variable.

Ethics and dissemination Sensitive personal data will be anonymised according to regulations by the Danish Data Protection Agency, and informed consent are obtained from all participants. Understanding and improving the prognosis of a health condition like CWP should be a priority in clinical research and practice. Results will be published in international peer-reviewed journals.

Trial registration number NCT04862520.

  • rheumatology
  • pain management
  • rheumatology
http://creativecommons.org/licenses/by-nc/4.0/

This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

https://doi.org/10.1136/bmjopen-2021-052919

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    Footnotes

    • Contributors KA is research coordinator and daily manager of the DANFIB registry. PHD is the principal investigator for this clinical cohort study. KA, PHD, RC, MH and KT will be responsible for data extraction and data analysis. PHD, HL, EEW, RC, LEK, HB, MH, KT and KA participated in the design of the cohort study and drafting of the protocol. All authors have given final approval for the protocol to be published.

    • Funding This work was supported by Minister Erna Hamilton foundation (J.nr. 21-2020), The Danish Rheumatism Association (R167-A5693) and The Fond of Bispebjerg and Frederiksberg Hospital (no funding number available). The Parker Institute, Bispebjerg and Frederiksberg Hospital is supported by a core grant from the Oak Foundation (OCAY-18-774-OFIL).

    • Competing interests MH: Advisory Board member at the Thuasne Group. LEK: received fees for speaking and/or consultancy from Pfizer, AbbVie, Amgen, UCB, Celgene, BMS, Biogen, Sanofi, MSD, Novartis, Eli Lilly, Janssen Pharmaceuticals. PHD, HL, EEW, RC, KT, HB and KA: none.

    • Patient and public involvement Patients and/or the public were involved in the design, or conduct, or reporting, or dissemination plans of this research. Refer to the Methods section for further details.

    • Provenance and peer review Not commissioned; externally peer reviewed.