Reliability of digital ulcer definitions as proposed by the UK Scleroderma Study Group: A challenge for clinical trial design
| Autor: | Kuntal Chakravarty, Shirish Dubey, Christopher P. Denton, Athiveeraramapandian Prabu, M. Bhushan, Ariane L. Herrick, Lindsay Muir, Chris Roberts, Andrew Tracey, Michael Hughes, Serena Guiducci, Louise Parker, Christine Rogers, John D Pauling, Voon H Ong |
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| Rok vydání: | 2018 |
| Předmět: |
medicine.medical_specialty
Immunology Outcome measures Article Scleroderma 03 medical and health sciences Clinical trials 0302 clinical medicine Cohen's kappa Rheumatology.nurse Rheumatology Immunology and Allergy Medicine 030212 general & internal medicine Grading (education) Healed ulcer Reliability (statistics) 030203 arthritis & rheumatology business.industry Clinical study design Digital ulcers medicine.disease Clinical trial Physical therapy Systemic sclerosis business |
| Zdroj: | Hughes, M, Tracey, A, Bhushan, M, Chakravarty, K, Denton, C P, Dubey, S, Guiducci, S, Muir, L, Ong, V, Parker, L, Pauling, J D, Prabu, A, Rogers, C, Roberts, C & Herrick, A 2018, ' Reliability of digital ulcer definitions as proposed by the UK Scleroderma Study Group: a challenge for clinical trial design ', Journal of Scleroderma and Related Disorders, vol. 3, no. 2, pp. 170-174 . https://doi.org/10.1177/2397198318764796 Hughes, M, Tracey, A, Bhushan, M, Chakravarty, K, Denton, C P, Dubey, S, Guiducci, S, Muir, L, Ong, V, Parker, L, Pauling, J D, Prabu, A, Rogers, C, Roberts, C & Herrick, A L 2018, ' Reliability of digital ulcer definitions as proposed by the UK Scleroderma Study Group : A challenge for clinical trial design ', Journal of Scleroderma and Related Disorders, vol. 3, no. 2, pp. 170-174 . https://doi.org/10.1177/2397198318764796 |
| ISSN: | 2397-1991 2397-1983 |
| DOI: | 10.1177/2397198318764796 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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