The FATIGUE-PRO: a new patient-reported outcome instrument to quantify fatigue in patients affected by systemic lupus erythematosus

Thomas Morel, Stefan Cuno, Susan J Bartlett, Caroline Gordon, Birgit Haier, A Regnault , Matthias Schneider, Christian Stach, Sophie Cleanthous

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Objectives: This study aimed to implement a patient-centred and evidence-based approach to develop a novel patient-reported outcome (PRO) instrument to measure fatigue in patients with systemic lupus erythematosus (SLE).

Methods: A three-step mixed methods psychometric (MMP) approach was followed. Steps comprised: (1) first draft item generation and review using interview data; (2) evaluation and refinement of second draft items using mixed methods data, including interview and quantitative data from a phase 2 clinical study in SLE analysed using Rasch Measurement Theory (RMT) analysis; and (3) evaluation of the final FATIGUE-PRO items using RMT and complementary Classical Test Theory (CTT) analyses. Guided by MMP criteria, a team of clinicians and outcome-measurement experts assessed evidence to inform instrument development.

Results: Step 1 culminated in 55 items (n = 39 patients interviewed). Their refinement in Step 2 using mixed methods evidence led to the final FATIGUE-PRO instrument comprising 31 items across three scales of fatigue: physical fatigue (9 items), mental and cognitive fatigue (11 items), and susceptibility to fatigue (11 items). Qualitative (n = 43 patients) and quantitative (n = 106 patients) evidence strongly supported the scales’ content comprehensiveness and targeting, item quality and fit, conceptual uniqueness, and appropriateness of the response scale. The FATIGUE-PRO further benefited from excellent reliability (RMT: 0.92–0.94 and CTT: 0.95–0.96) and supportive evidence of construct validity from assessments against other PROs.

Conclusion: The conceptual advances, comprehensive coverage, and strong psychometric properties of the FATIGUE-PRO will significantly progress the measurement and management of fatigue in SLE, both in clinical trials and routine practice.
Original languageEnglish
Pages (from-to)3329–3340
Number of pages13
Issue number8
Publication statusPublished - 20 Jan 2022


  • Pharmacology (medical)
  • Rheumatology


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