Implementation Science to Improve the Diagnosis and Management of Hidradenitis Suppurativa: HELyx Study Design Overview

IntroductionHidradenitis suppurativa (HS) is a chronic, inflammatory skin disease associated with a high disease burden and substantial impact on patients' quality of life. Limited therapeutic options are available, with an unmet medical need for earlier diagnosis and treatment and more effective treatment options. Low awareness of HS amongst healthcare professionals (HCPs) leads to delayed diagnosis and a prolonged patient journey to HS-specific treatment. This article aims to describe the design of HELyx, an implementation science study in Germany, which aims to evaluate the effectiveness of an implementation strategy to improve screening and diagnosis of HS among HCPs (dermatologists and non-dermatologists) and timely referral to HS-treating dermatologists.MethodsHELyx is a hybrid, effectiveness-implementation science study with a pre-post design involving HCPs and is guided by the Consolidated Framework for Implementation Research. HELyx is being conducted in Germany over four consecutive phases (context analysis, pre-implementation, implementation, and post-implementation) in a sequential manner. A similar implementation science study is also being conducted in the United Arab Emirates (UAE) and Spain. HELyx aims to identify key unmet medical needs in the HS patient journey, to develop and implement a tailored medical education program, and to measure the effectiveness of the implementation.Planned outcomesThe primary endpoint is the change in the proportion of HCPs who used a diagnostic screening tool to identify patients with suspected HS during the 24 weeks of the post-implementation phase (assessed at Week 24) compared to the 24 weeks before implementation (assessed at baseline). Secondary endpoints include assessment of the use of HS disease severity assessment and patient-reported outcome tools and HCP referral behaviours.