Department of Dermatology, University Hospital Heidelberg, Heidelberg, Germany.
Institute of Medical Biometry and Informatics, University of Heidelberg, Heidelberg, Germany.
BMJ Open. 2018 May 17;8(5):e018461. doi: 10.1136/bmjopen-2017-018461.
Reliable and accurate assessment of severity in psoriasis is very important in order to meet indication criteria for initiation of systemic treatment or to evaluate treatment efficacy. The most acknowledged tool for measuring the extent of psoriatic skin changes is the Psoriasis Area and Severity Index (PASI). However, the calculation of PASI can be tedious and subjective and high intraobserver and interobserver variability is an important concern. Therefore, there is a great need for a standardised and objective method that guarantees a reproducible PASI calculation. Within this study we will investigate the precision and reproducibility of automated, computer-guided PASI measurements in comparison to trained physicians to address these limitations.
Non-interventional analyses of PASI calculations by either physicians in a prospective versus retrospective setting or an automated computer-guided algorithm in 120 patients with plaque psoriasis. All retrospective PASI calculations by physicians or by the computer algorithm are based on total body digital images. The primary objective of this study is comparison of automated computer-guided PASI measurements by means of digital image analysis versus conventional, prospective or retrospective physicians' PASI assessments. Secondary endpoints include (1) the assessment of physicians' interobserver variance in PASI calculations, (2) the assessment of physicians' intraobserver variance in PASI assessments of the same patients' images after a time interval of at least 4 weeks, (3) the assessment of the deviation between physicians' prospective versus retrospective PASI calculations, and (4) the reproducibility of automated computer-guided PASI measurements by assessment of two sets of total body digital images of the same patients taken at one time point.
Ethical approval was provided by the Ethics Committee of the Medical Faculty of the University of Heidelberg (ethics approval number S-379/2016).
DRKS00011818; Results.
为了满足启动全身治疗的指征或评估治疗效果，可靠且准确地评估银屑病的严重程度非常重要。评估银屑病皮肤变化程度的最公认的工具是银屑病面积和严重程度指数（PASI）。然而，PASI 的计算可能繁琐且主观，观察者内和观察者间的高度变异性是一个重要关注点。因此，非常需要一种标准化和客观的方法，以保证可重复的 PASI 计算。在这项研究中，我们将研究自动化、计算机引导的 PASI 测量的精确性和可重复性，以解决这些局限性，并与训练有素的医生进行比较。
对 120 例斑块型银屑病患者进行前瞻性或回顾性的医生 PASI 计算的非干预性分析，或使用自动化计算机引导算法进行分析。所有回顾性 PASI 计算都是基于全身数字图像。该研究的主要目的是比较数字图像分析的自动化计算机引导 PASI 测量与传统的、前瞻性或回顾性医生 PASI 评估。次要终点包括：（1）评估医生在 PASI 计算中的观察者间变异性；（2）评估医生在至少 4 周后对同一患者图像的 PASI 评估中的观察者内变异性；（3）评估医生前瞻性与回顾性 PASI 计算之间的偏差；（4）通过评估同一患者同一时间点的两组全身数字图像来评估自动化计算机引导 PASI 测量的可重复性。
海德堡大学医学系伦理委员会（伦理批准号 S-379/2016）提供了伦理批准。
DRKS00011818；结果。
