The contribution of psychological disorders to the burden of skin disease has been poorly explored, and this is a large-scale study to ascertain the association between depression, anxiety, and suicidal ideation with various dermatological diagnoses. This international multicenter observational cross-sectional study was conducted in 13 European countries. In each dermatology clinic, 250 consecutive adult out-patients were recruited to complete a questionnaire, reporting socio-demographic information, negative life events, and suicidal ideation; depression and anxiety were assessed with the Hospital Anxiety and Depression Scale. A clinical examination was performed. A control group was recruited among hospital employees. There were 4,994 participants––3,635 patients and 1,359 controls. Clinical depression was present in 10.1% patients (controls 4.3%, odds ratio (OR) 2.40 (1.67–3.47)). Clinical anxiety was present in 17.2% (controls 11.1%, OR 2.18 (1.68–2.82)). Suicidal ideation was reported by 12.7% of all patients (controls 8.3%, OR 1.94 (1.33–2.82)). For individual diagnoses, only patients with psoriasis had significant association with suicidal ideation. The association with depression and anxiety was highest for patients with psoriasis, atopic dermatitis, hand eczema, and leg ulcers. These results identify a major additional burden of skin disease and have important clinical implications.

BackgroundAdvance Therapeutic Medicinal Products (ATMPs) are a novel class of therapeutics to provide more effective treatment of conditions or diseases that have not responded to conventional treatment. However, ATMPs are generally very expensive, limiting their availability. Indicated conditions are usually chronic and severe and can have an impact beyond the patient themselves, impairing the lives of partners and other family members. This family impact is a major secondary burden of disease that is often ignored. The Family Reported Outcome Measure (FROM-16) is the first generic questionnaire designed to measure the impact of any chronic disease on the quality of life of family members or partners of patients. It is simple-to-use and non-burdensome for those completing it.We aim to validate the FROM-16 instrument in the setting of patients receiving ATMPs by recruiting family members to complete FROM-16 and Global Health Score questionnaire and undergo a semi-structured interview.MethodsUp to 30 patients of any age who are preparing for, or who have received, ATMP treatment and their family members aged 18 years or older, attending NHS providers within the Midland-Wales Advanced Therapy Treatment Centre will be recruited into this study. Family members will be asked to complete the FROM-16 and Global Health Score questionnaires, provide basic demographic information and complete a short semi-structured interview. The interview will provide data to contextualise the FROM-16 responses and allow construct and content validity to be assessed. Themes of experience will be identified from interview transcripts. The FROM-16 responses will be evaluated for total score, domain score, and individual item score. Reliability of responses between and within domains will be assessed by intraclass correlation. DiscussionCollecting FROM data reliably is important for demonstrating the wider impact of disease and the extended value of treatments. We hypothesise that collecting FROMs using the FROM-16 tool is a valid method to measure this impact in the setting of patients receiving ATMPs and if so, could provide evidence in future of the overall quality of life impact on the partners and family members of such patients and greater understanding of the wider societal value of these costly treatments. Trial RegistrationThis trial has been adopted onto the NIHR portfolio (I.D. 51376) and registered with www.ClinicalTrials.gov (#NCT05141318) in December 2021.