Reliability of digital ulcer definitions as proposed by the UK Scleroderma Study Group: A challenge for clinical trial design

Author:

Hughes Michael1,Tracey Andrew1,Bhushan Monica2,Chakravarty Kuntal3,Denton Christopher P3,Dubey Shirish4,Guiducci Serena5,Muir Lindsay6,Ong Voon3,Parker Louise3,Pauling John D7,Prabu Athiveeraramapandian8,Rogers Christine9,Roberts Christopher10,Herrick Ariane L111

Affiliation:

1. Centre for Musculoskeletal Research, The University of Manchester, Salford Royal NHS Foundation Trust, Manchester Academic Health Science Centre, Manchester, UK

2. Department of Dermatology, Blackpool Teaching Hospitals NHS Foundation Trust, Clifton Hospital, Lytham St Annes, UK

3. Centre for Rheumatology and Connective Tissue Diseases, Royal Free Hospital, London, UK

4. Department of Rheumatology, University Hospitals Coventry and Warwickshire NHS Trust, Coventry, UK

5. Department of Experimental and Clinical Medicine, University of Florence, Florence, Italy

6. Department of Hand Surgery, Salford Royal NHS Foundation Trust, Salford, UK

7. Department of Pharmacy & Pharmacology, University of Bath, Bath, UK

8. Rheumatology Department, Birmingham City Hospital, Sandwell and West Birmingham Hospitals NHS Trust, Birmingham, UK

9. The University of Manchester, Manchester, UK

10. Centre for Biostatistics, Institute of Population Health, School of Medicine, The University of Manchester, Manchester, UK

11. NIHR Manchester Biomedical Research Centre, Central Manchester NHS Foundation Trust, Manchester Academic Health Science Centre, Manchester, UK

Abstract

Introduction: The reliability of clinician grading of systemic sclerosis–related digital ulcers has been reported to be poor to moderate at best, which has important implications for clinical trial design. The aim of this study was to examine the reliability of new proposed UK Scleroderma Study Group digital ulcer definitions among UK clinicians with an interest in systemic sclerosis. Methods: Raters graded (through a custom-built interface) 90 images (80 unique and 10 repeat) of a range of digital lesions collected from patients with systemic sclerosis. Lesions were graded on an ordinal scale of severity: ‘no ulcer’, ‘healed ulcer’ or ‘digital ulcer’. Results: A total of 23 clinicians – 18 rheumatologists, 3 dermatologists, 1 hand surgeon and 1 specialist rheumatology nurse – completed the study. A total of 2070 (1840 unique + 230 repeat) image gradings were obtained. For intra-rater reliability, across all images, the overall weighted kappa coefficient was high (0.71) and was moderate (0.55) when averaged across individual raters. Overall inter-rater reliability was poor (0.15). Conclusion: Although our proposed digital ulcer definitions had high intra-rater reliability, the overall inter-rater reliability was poor. Our study highlights the challenges of digital ulcer assessment by clinicians with an interest in systemic sclerosis and provides a number of useful insights for future clinical trial design. Further research is warranted to improve the reliability of digital ulcer definition/rating as an outcome measure in clinical trials, including examining the role for objective measurement techniques, and the development of digital ulcer patient–reported outcome measures.

Publisher

SAGE Publications

Subject

Immunology,Rheumatology,Immunology and Allergy

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