Stigmatisation and body image impairment in dermatological patients: protocol for an observational multicentre study in 16 European countries

Contains fulltext : 200406.pdf (publisher's version ) (Open Access)INTRODUCTION: Patients with common skin diseases may have substantial psychosocial comorbidity and reduced quality of life. This study aims at exploring further the psychosocial burden of skin diseases by assessing stigmatisation and body image problems in a large sample of patients with skin disease across Europe. METHODS AND ANALYSIS: The study is an observational cross-sectional multicentre study across 16 European countries comparing stigmatisation and body image in patients with skin disease compared with controls. Consecutive patients will be recruited in outpatient clinics and will complete validated questionnaires prior to clinical examination by a dermatologist at each recruitment site. In addition to sociodemographic background information, the outcomes will be: mood disorders assessed by short versions of the Patient Health Questionnaire and the General Anxiety Disorder Assessment; general health assessed by the EuroQol-Visual Analogue Scale; stigmatisation experience assessed by the Perceived Stigmatisation Questionnaire; stress assessed by the Perceived Stress Scale and body image assessed by the Dysmorphic Concern Questionnaire. The main criteria for eligibility are to be 18 years old or more. The analysis will include comparison between patients and controls for the main outcomes using t-tests, analyses of covariance and multivariate logistic regression models adjusting for potential confounding factors. ETHICS AND DISSEMINATION: The study protocol is approved by the University of Giessen and by the local Ethical Committee in each recruitment centre. Informed consent will be given by each participant. The results of the study will be disseminated by publications in international peer-reviewed journals and presented at international conferences and general public conferences. Results will influence support intervention and management of patients with skin disease across Europe. TRIAL REGISTRATION NUMBER: DRKS00012745; Pre-results