Improving the assessment of fatigue in Axial Spondyloarthropathy

• Research type

  Research Study

• Full title

  Evaluating Fatigue in Axial Spondyloarthropathy (AxSpA): quality and acceptability of a new patient-reported outcome measure (the Warwick AxSpA Tiredness and Energy questionnaire (WASTEd))

• IRAS ID

  220683

• Contact name

  Kirstie Haywood

• Contact email

  k.l.haywood@warwick.ac.uk

• Duration of Study in the UK

  2 years, 0 months, 5 days

• Research summary

  The purpose of this study is to evaluate a newly developed energy and fatigue-specific questionnaire - the Warwick Axial Spondyloarthropathy Tiredness and Energy questionnaire (WASTEd) - for use with patients with Axial Spondyloarthropathy (AxSpA).
  The study will use a two-phase postal survey- Phase 1: Field Test 1 (FT1) is a single, cross-sectional completion of a long-form version of the WASTEd, along with a package of other questionnaires and demographic questions; Phase 2: Field Test 2 (FT2) will be a longitudinal postal survey during which patients will complete the questionnaire package on three separate occasions: 1) baseline; 2) 3 month follow-up; and 3) 2 week retest. Two separate patient cohorts will be recruited for phases 1 (FT1) and 2 (FT2). The purpose of each field test, and anticipated sample sizes, are outlined below.

  1) Field test 1 (FT1)
  this field test seeks to determine which items best contribute to the measurement of fatigue, and establish what the internal structure (e.g. using an exploratory factor analyses) of the measure is. This will support item reduction and the crafting of a short-form version of the questionnaire for final, robust statistical evaluation in the second field test.

  FT1 sample size: 420 patients with AxSpA.

  2) Field-test 2(FT2):
  a thorough and robust evaluation of the short-form WASTEd measurement properties will be conducted. This evaluation will include data quality, validity, reliability, responsiveness and interpretability and use both traditional (Classic Test Theory) and modern (Rasch Analysis) psychometric methods.

  FT2 sample size: 600 patients with AxSpA.

• REC name

  South Central - Hampshire B Research Ethics Committee

• REC reference

  18/SC/0188

• Date of REC Opinion

  9 May 2018

• REC opinion

  Further Information Favourable Opinion