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Research ArticleAccepted Article

Evaluation and validation of a patient completed psoriatic arthritis flare questionnaire

Philip S. Helliwell, William Tillett, Robin Waxman, Laura C. Coates, Mel Brooke, Oliver FitzGerald, Jonathan C. Packham and Neil McHugh on behalf of the PROMPT study group
The Journal of Rheumatology February 2021, jrheum.201317; DOI: https://doi.org/10.3899/jrheum.201317
Philip S. Helliwell
Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, and NIHR Leeds Biomedical Research Centre, Leeds Teaching Hospitals NHS Trust Department of Pharmacy and Pharmacology, University of Bath, UK; Royal National Hospital for Rheumatic Diseases, Royal United Hospitals, Bath, UK; Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, UK; Conway Institute for Biomolecular Research, University College Dublin (UCD), Dublin, Ireland; Division of Epidemiology and Public of Health, University of Nottingham, UK. This report is independent research funded by the National Institute for Health Research, Programme Grants for Applied Research [Early detection to improve outcome in patients with undiagnosed PsA (‘PROMPT’), RP-PG-1212-20007]. The views expressed are those of the authors and not necessarily those of the NIHR or the Department of Health and Social Care. Address correspondence to Dr Philip Helliwell, LIRMM, Chapel Allerton Hospital, Chapeltown Road, Leeds LS7 4SA, UK. Email: p.helliwell@leeds.ac.uk
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William Tillett
Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, and NIHR Leeds Biomedical Research Centre, Leeds Teaching Hospitals NHS Trust Department of Pharmacy and Pharmacology, University of Bath, UK; Royal National Hospital for Rheumatic Diseases, Royal United Hospitals, Bath, UK; Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, UK; Conway Institute for Biomolecular Research, University College Dublin (UCD), Dublin, Ireland; Division of Epidemiology and Public of Health, University of Nottingham, UK. This report is independent research funded by the National Institute for Health Research, Programme Grants for Applied Research [Early detection to improve outcome in patients with undiagnosed PsA (‘PROMPT’), RP-PG-1212-20007]. The views expressed are those of the authors and not necessarily those of the NIHR or the Department of Health and Social Care. Address correspondence to Dr Philip Helliwell, LIRMM, Chapel Allerton Hospital, Chapeltown Road, Leeds LS7 4SA, UK. Email: p.helliwell@leeds.ac.uk
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Robin Waxman
Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, and NIHR Leeds Biomedical Research Centre, Leeds Teaching Hospitals NHS Trust Department of Pharmacy and Pharmacology, University of Bath, UK; Royal National Hospital for Rheumatic Diseases, Royal United Hospitals, Bath, UK; Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, UK; Conway Institute for Biomolecular Research, University College Dublin (UCD), Dublin, Ireland; Division of Epidemiology and Public of Health, University of Nottingham, UK. This report is independent research funded by the National Institute for Health Research, Programme Grants for Applied Research [Early detection to improve outcome in patients with undiagnosed PsA (‘PROMPT’), RP-PG-1212-20007]. The views expressed are those of the authors and not necessarily those of the NIHR or the Department of Health and Social Care. Address correspondence to Dr Philip Helliwell, LIRMM, Chapel Allerton Hospital, Chapeltown Road, Leeds LS7 4SA, UK. Email: p.helliwell@leeds.ac.uk
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Laura C. Coates
Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, and NIHR Leeds Biomedical Research Centre, Leeds Teaching Hospitals NHS Trust Department of Pharmacy and Pharmacology, University of Bath, UK; Royal National Hospital for Rheumatic Diseases, Royal United Hospitals, Bath, UK; Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, UK; Conway Institute for Biomolecular Research, University College Dublin (UCD), Dublin, Ireland; Division of Epidemiology and Public of Health, University of Nottingham, UK. This report is independent research funded by the National Institute for Health Research, Programme Grants for Applied Research [Early detection to improve outcome in patients with undiagnosed PsA (‘PROMPT’), RP-PG-1212-20007]. The views expressed are those of the authors and not necessarily those of the NIHR or the Department of Health and Social Care. Address correspondence to Dr Philip Helliwell, LIRMM, Chapel Allerton Hospital, Chapeltown Road, Leeds LS7 4SA, UK. Email: p.helliwell@leeds.ac.uk
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Mel Brooke
Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, and NIHR Leeds Biomedical Research Centre, Leeds Teaching Hospitals NHS Trust Department of Pharmacy and Pharmacology, University of Bath, UK; Royal National Hospital for Rheumatic Diseases, Royal United Hospitals, Bath, UK; Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, UK; Conway Institute for Biomolecular Research, University College Dublin (UCD), Dublin, Ireland; Division of Epidemiology and Public of Health, University of Nottingham, UK. This report is independent research funded by the National Institute for Health Research, Programme Grants for Applied Research [Early detection to improve outcome in patients with undiagnosed PsA (‘PROMPT’), RP-PG-1212-20007]. The views expressed are those of the authors and not necessarily those of the NIHR or the Department of Health and Social Care. Address correspondence to Dr Philip Helliwell, LIRMM, Chapel Allerton Hospital, Chapeltown Road, Leeds LS7 4SA, UK. Email: p.helliwell@leeds.ac.uk
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Oliver FitzGerald
Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, and NIHR Leeds Biomedical Research Centre, Leeds Teaching Hospitals NHS Trust Department of Pharmacy and Pharmacology, University of Bath, UK; Royal National Hospital for Rheumatic Diseases, Royal United Hospitals, Bath, UK; Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, UK; Conway Institute for Biomolecular Research, University College Dublin (UCD), Dublin, Ireland; Division of Epidemiology and Public of Health, University of Nottingham, UK. This report is independent research funded by the National Institute for Health Research, Programme Grants for Applied Research [Early detection to improve outcome in patients with undiagnosed PsA (‘PROMPT’), RP-PG-1212-20007]. The views expressed are those of the authors and not necessarily those of the NIHR or the Department of Health and Social Care. Address correspondence to Dr Philip Helliwell, LIRMM, Chapel Allerton Hospital, Chapeltown Road, Leeds LS7 4SA, UK. Email: p.helliwell@leeds.ac.uk
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Jonathan C. Packham
Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, and NIHR Leeds Biomedical Research Centre, Leeds Teaching Hospitals NHS Trust Department of Pharmacy and Pharmacology, University of Bath, UK; Royal National Hospital for Rheumatic Diseases, Royal United Hospitals, Bath, UK; Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, UK; Conway Institute for Biomolecular Research, University College Dublin (UCD), Dublin, Ireland; Division of Epidemiology and Public of Health, University of Nottingham, UK. This report is independent research funded by the National Institute for Health Research, Programme Grants for Applied Research [Early detection to improve outcome in patients with undiagnosed PsA (‘PROMPT’), RP-PG-1212-20007]. The views expressed are those of the authors and not necessarily those of the NIHR or the Department of Health and Social Care. Address correspondence to Dr Philip Helliwell, LIRMM, Chapel Allerton Hospital, Chapeltown Road, Leeds LS7 4SA, UK. Email: p.helliwell@leeds.ac.uk
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Neil McHugh
Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, and NIHR Leeds Biomedical Research Centre, Leeds Teaching Hospitals NHS Trust Department of Pharmacy and Pharmacology, University of Bath, UK; Royal National Hospital for Rheumatic Diseases, Royal United Hospitals, Bath, UK; Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, UK; Conway Institute for Biomolecular Research, University College Dublin (UCD), Dublin, Ireland; Division of Epidemiology and Public of Health, University of Nottingham, UK. This report is independent research funded by the National Institute for Health Research, Programme Grants for Applied Research [Early detection to improve outcome in patients with undiagnosed PsA (‘PROMPT’), RP-PG-1212-20007]. The views expressed are those of the authors and not necessarily those of the NIHR or the Department of Health and Social Care. Address correspondence to Dr Philip Helliwell, LIRMM, Chapel Allerton Hospital, Chapeltown Road, Leeds LS7 4SA, UK. Email: p.helliwell@leeds.ac.uk
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Abstract

Objective Evaluation of a psoriatic arthritis (PsA), multidimensional, patient completed disease flare questionnaire (FLARE).

Methods The FLARE questionnaire was administered to 139 patients in a prospective observational study. The ‘gold standard’ of flare was based on patient opinion. Test-retest was evaluated by intra-class correlation coefficient (ICC). Disease activity was measured by the PASDAS, GRACE, CPDAI and DAPSA.

Results The most common symptoms of a PsA flare were musculoskeletal, followed by fatigue, frustration, loss of function and an increase in cutaneous symptoms. The test-retest ICC for the FLARE questionnaire was 0.87 (95% CI 0.72 – 0.94). The optimum cut-off to identify a flare of disease was 4/10 (sensitivity 0.82, specificity 0.76; area under curve 0.85). For those patients scoring 4 or above, the mean score for the composite measures was as follows (score for those not reporting a flare in brackets): PASDAS, 5.3 ± 1.3 (3.1 ± 1.6); GRACE, 4.5 ± 1.2 (2.2 ± 1.4); CPDAI, 8.9 ± 2.5 (4.7 ± 3.1); DAPSA, 38.2 ± 20.3 (16.8 ± 14.9). In a new flare the increase in composite measure score was calculated as follows; 1 for PASDAS and GRACE, 2 for CPDAI, 7 for DAPSA. Moderate agreement was found between the definition of flare using the cut-off of 4, indicated by subjects in a separate question.

Conclusion A PsA flare displays escalation of symptoms and signs across multiple domains; the FLARE questionnaire has external validity both in terms of composite disease activity and overall patient opinion of the state of their condition.

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1 Apr 2021
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Accepted manuscript
Evaluation and validation of a patient completed psoriatic arthritis flare questionnaire
Philip S. Helliwell, William Tillett, Robin Waxman, Laura C. Coates, Mel Brooke, Oliver FitzGerald, Jonathan C. Packham, Neil McHugh
The Journal of Rheumatology Feb 2021, jrheum.201317; DOI: 10.3899/jrheum.201317

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Accepted manuscript
Evaluation and validation of a patient completed psoriatic arthritis flare questionnaire
Philip S. Helliwell, William Tillett, Robin Waxman, Laura C. Coates, Mel Brooke, Oliver FitzGerald, Jonathan C. Packham, Neil McHugh
The Journal of Rheumatology Feb 2021, jrheum.201317; DOI: 10.3899/jrheum.201317
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