Automated, computer-guided PASI measurements by digital image analysis versus conventional physicians' PASI calculations: study protocol for a comparative, single-centre, observational study

Introduction 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 (PAS!). 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. Methods and analysis 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. Ethics Ethical approval was provided by the Ethics Committee of the Medical Faculty of the University of Heidelberg (ethics approval number S-379/2016).