Title: Measuring fatigue in Axial Spondyloarthritis (axSpA): refinement, application and evaluation of a new electronic patient-reported outcome measure (the Warwick Axial Spondyloarthritis Fatigue and Energy questionnaire (e-WASTEd)) in rheumatology clinical practice.
Funder: Department of Health and Social Care

Abstract: Background: Axial Spondyloarthritis (axSpA) is progressive, incurable, and disabling rheumatic disease, managed with long-term individualised physical and drug therapies. Affecting up to 30 per 10,000 UK adults, axSpA has a substantial impact on patients, families, and the NHS. Patients have identified pain, fatigue, reduced mobility, and psychological distress as important features. Current fatigue assessment undervalues fatigue s importance and impact. Improving fatigue assessment will improve patient s treatment. Working collaboratively with patients, we have completed five of six phases developing a patient-reported outcome measure (PROM) - the Warwick Axial Spondyloarthritis faTigue and Energy questionnaire (WASTEd). We need to complete phase 6, to prove that is is useful for clinical practice. The British Society for Rheumatology (BSR) ePROM platform was developed in 2020, responding to the need to support remote working during the COVID pandemic. NHS clinicians use this platform to support on-line ePROM completion by rheumatology patients. We will use this platform to test the WASTEd. Aims: Refine, test, and finalise the WASTEd, a fatigue-specific PROM for axSpA patients, for immediate implementation into clinical rheumatology and research settings. Objectives: Confirm content/face validity of the WASTEd. Develop an electronic version of the WASTEd Evaluate the quality and acceptability of the e-WASTEd Explore the experiences of patients and clinicians using the ePROM platform Methods Stage 1: 1.1 Confirm content/ face validity: We will interview 20 patients to confirm that reductions made to the original 30-item WASTEd to create a short-form 18-item version do not detract from the WASTEd s content/face validity. 1.2/1.3: Develop and pilot an electronic version of the WASTEd: using the BSR ePROM platform to support on-line completion. We will interview 10 patients to confirm usability, acceptability, feasibility, and equivalence between paper/e-versions. Stage 2: Longitudinal evaluation: An additional 380 patients will complete the e-WASTEd and several comparator ePROMs on the BSR ePROM platform at: baseline, two-weeks (to check temporal stability) and six-months (to check responsiveness to change in fatigue). Psychometric analysis will provide evidence of measurement quality (reliability, validity, and responsiveness) and acceptability of the WASTEd, confirming its suitability for immediate implementation into clinical practice. Stage 3: We will conduct six focus groups with 10 patients and 10 health professionals who have used the BSR ePROM platform. Their experiences will help us to understand ePROM use, improve implementation via the platform, and improve patient care. Delivery timelines Month 4: content/face validity confirmed Month 17: longitudinal evaluation complete. Month 22: focus groups complete. Month 22: psychometric analysis complete. WASTEd ready for dissemination. Impact Short term &ndash; The WASTEd will be immediately available on the BSR ePROM platform at study end, contributing to improved clinical care for axSpA patients with fatigue. Medium/Long-term &ndash; step change in the data quality of fatigue-related research, leading to improved treatment for axSpA patients. Dissemination Collaboration with the BSR ePROM platform will ensure that the e-WASTEd is freely available to UK rheumatology health professionals. Utilising our close links with professional and patient organisations, we will publish, present, and promote study findings to disseminate awareness of the WASTEd nationally and internationally.

Lay abstract: Aims: We will work with patients to refine and test a new questionnaire about fatigue in axial Spondyloarthritis (axSpA). This will help patients tell clinicians about their fatigue and get the treatment they need. We will make an on-line version which will be completed using a computer or tablet. We will provide guidance to support use. Background: AxSpA is a relatively common, incurable, and disabling, inflammatory disease. It primarily affects the back and hips. Pain, stiffness, reduced mobility, and fatigue are important problems. Patients have said that they would like more help coping with fatigue. However, the current way patients are asked about fatigue can undervalue its importance and impact. We have worked with patients to complete the first steps towards making a new questionnaire to assess fatigue. However, we need to complete this work before it can be used in clinical practice. A new on-line system is being used by NHS clinicians to support questionnaire completion by rheumatology patients. We will use this system to test our questionnaire and to find out what patients and clinicians think about it. For example, its ease of use and whether it helps communication between patients and clinicians. This will help us both to improve the system and ultimately improve patient care. Design and methods used: Stage 1: Refining and making an on-line questionnaire: Before making an on-line questionnaire, we need to check that the questions make sense to patients. Twenty patients will be asked to complete a paper copy of the questionnaire and tell us their views. Questions will be refined based on what they tell us. We will then develop an on-line version. Ten patients will be asked to complete this on-line to check how easy it is to complete and what they think about completing it on-line. Stage 2: Testing the on-line questionnaire: Three hundred axSpA patients will complete the on-line questionnaire three times over six-months. Additional questionnaires about their health and experiences of on-line questionnaire completion will be included. We will test how well the new questionnaire measures fatigue, and if it shows when fatigue gets better or worse. Stage 3: Exploring experiences of accessing and using the on-line platform: Finally, twenty patients and clinicians will discuss their experiences of using the on-line system and questionnaires in everyday rheumatology clinics. Patient and public involvement: We have worked with patients as research partners to make the questionnaire. They were involved in the study design and will continue to support all research stages. Dissemination &ndash; sharing the results: Findings will be shared with patients through easy-read articles and events with patient organisations, clinical and patient networks. We will present at national and international conferences and write papers and publish the findings.

Research activity codes: 2.5 RESEARCH DESIGN AND METHODOLOGIES (AETIOLOGY);7.1 INDIVIDUAL CARE NEEDS
Health categories: INFLAMMATORY AND IMMUNE SYSTEM