Hughes Michael, Tracey Andrew, Bhushan Monica, Chakravarty Kuntal, Denton Christopher P, Dubey Shirish, Guiducci Serena, Muir Lindsay, Ong Voon, Parker Louise, Pauling John D, Prabu Athiveeraramapandian, Rogers Christine, Roberts Christopher, Herrick Ariane L
Centre for Musculoskeletal Research, The University of Manchester, Salford Royal NHS Foundation Trust, Manchester Academic Health Science Centre, Manchester, UK.
Department of Dermatology, Blackpool Teaching Hospitals NHS Foundation Trust, Clifton Hospital, Lytham St Annes, UK.
J Scleroderma Relat Disord. 2018 Jun 1;3(2):170-174. doi: 10.1177/2397198318764796. Epub 2018 Mar 27.
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.
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'.
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).
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.
据报道，临床医生对系统性硬化症相关指端溃疡的分级可靠性充其量只能说是差到中等，这对临床试验设计具有重要影响。本研究的目的是检验英国硬皮病研究组新提出的指端溃疡定义在对系统性硬化症感兴趣的英国临床医生中的可靠性。
评估者通过一个定制界面，对从系统性硬化症患者收集的一系列指端病变的90张图像（80张不同的和10张重复的）进行分级。病变按严重程度的有序量表进行分级：“无溃疡”、“愈合溃疡”或“指端溃疡”。
共有23名临床医生——18名风湿病学家、3名皮肤科医生、1名手外科医生和1名风湿病专科护士——完成了该研究。总共获得了2070次（1840次不同的+230次重复的）图像分级。对于评估者内部的可靠性，在所有图像中，总体加权kappa系数较高（0.71），在各个评估者中平均时为中等（0.55）。评估者之间的总体可靠性较差（0.15）。
虽然我们提出的指端溃疡定义具有较高的评估者内部可靠性，但评估者之间的总体可靠性较差。我们的研究突出了对系统性硬化症感兴趣的临床医生在评估指端溃疡方面面临的挑战，并为未来的临床试验设计提供了一些有用的见解。有必要进行进一步研究，以提高指端溃疡定义/分级作为临床试验结局指标的可靠性，包括研究客观测量技术的作用，以及开发指端溃疡患者报告的结局指标。
