Abstract

BackgroundThe prevalence of axial spondyloarthritis (axSpA) is estimated between 0.15 and 1.2%, with many of those patients experiencing severe fatigue. Current axSpA assessment guidance recommends use of a single-item visual analogue scale for fatigue severity. However, concerns have been raised about the ability of such a limited assessment to identify patients with major fatigue, to detect important change in fatigue or to reflect the multi-dimensional nature of fatigue. The proposed systematic review will identify and evaluate the quality and acceptability of single- and multi-item patient-reported outcome measures (PROMs) used to assess fatigue in axSpA, seeking to make recommendations for the ‘best’ measures for research and/or clinical practice.Methods/designThe review will seek to include published studies which report evidence of the development and/or measurement and/or practical properties of clearly defined and reproducible measures of fatigue following completion by patients with axSpA. Five major databases will be searched from 1980 to August 2017: MEDLINE (OVID), EMBASE (OVID), PsycINFO (OVID), World of Science and CINAHL. Study methodological quality will be assessed against the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) checklist. The measurement and/or practical properties of reviewed measures will be assessed against current international standards. A short list of the ‘best’-quality PROMs will be produced. The review will be reported in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines.DiscussionThis study will provide the first robust and transparent evaluation of patient-reported measures of fatigue used in the axSpA population, synthesising evidence of quality, relevance and acceptability. The review will benefit patients, clinicians, health professionals and researchers wishing to enhance axSpA-fatigue assessment in routine practice, service evaluation and research. The findings will impact future research which seeks to better understand the nature of axSpA fatigue and evaluate the relative benefit of fatigue-management strategies.Systematic review registrationPROSPERO CRD42016042271

Highlights

  • The prevalence of axial spondyloarthritis is estimated between 0.15 and 1.2%, with many of those patients experiencing severe fatigue

  • This study will provide the first robust and transparent evaluation of patient-reported measures of fatigue used in the Axial spondyloarthritis (axSpA) population, synthesising evidence of quality, relevance and acceptability

  • The result was the development of a patientreported outcome measure (PROM) specific to rheumatoid arthritis (RA) fatigue—the Bristol Rheumatoid Arthritis Fatigue Multidimensional Questionnaire (BRAF-MDQ) [11, 12]

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Summary

Discussion

Awareness of the importance of fatigue in inflammatory conditions has grown over the past decade [20]. Whilst patients report fatigue as one of the key symptoms of their condition, there is limited evidence of an improved understanding of fatigue in axSpA and its impact on patients’ lives [3, 38, 39]. This study will provide the first robust and transparent evaluation of patient-reported measures of fatigue used in the axSpA population, synthesising evidence of quality, relevance and acceptability. The findings of this review will inform the selection of patient-reported fatigue assessment, impacting future research which seeks to better understand the nature of axSpA fatigue. All authors reviewed the manuscript, provided feedback and approved the final version. Author details 1Royal College of Nursing Research Institute, Division of Health Sciences, Warwick Medical School, University of Warwick, Coventry, UK. Author details 1Royal College of Nursing Research Institute, Division of Health Sciences, Warwick Medical School, University of Warwick, Coventry, UK. 2Institute of Applied Clinical Science, Keele University, Staffordshire, UK. 3Warwick Clinical Trials Unit, Warwick Medical School, University of Warwick, Coventry, UK

Background
Findings
29. US Food and Drug Administration Guidance for Industry
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