Research proposal

February 2022, Version 1.1

Summary

Hidradenitis suppurative is a chronic inflammatory disease that leads to a severe impairment of quality of life due to the recurrence of inflammatory lesions in the form of abscesses, inflammatory nodules or fistula tracts. In addition to the initial approval of the first biologic for the treatment of moderate to severe forms of HS, numerous other substances are currently being tested in clinical trials. This proposal summarises the concept of implementing an online-based German registry for HS. The alignment of variables with the European registry project will allow for future expansion and potential two-way integration of datasets between the two projects. 
 
The aim of the registry is to assess and analyse the clinical course, clinical types, disease burden and patient needs in real-life care of HS, as well as to investigate current treatment standards and outcomes. As a further option, the efficacy and safety of current and future medicines for HS can be investigated. An expansion into a pharmacovigilance registry is possible.

Mission

The mission of the current program is to gain knowledge of clinical types and real-world care for HS as well as to establish a uniform long-term disease registry in Germany. Worldwide there is high need for real-world data by HCPs, decision makers in politics, payers, the patients and the public. Using registry data will enlarge the knowledge and the velocity of analyses of real-world data on HS, to emphasize the impact and burden of the disease. However, routine data are currently rarely used in a systematic and logic way for comprehensive analyses. Thus, the data integration from different centers specialized in dermatology care for HS will provide high added value. For such, this advanced technology of data generation and integration as well as analysis of multisource data is needed. Furthermore, an administration and governance structure is to be established and an electronic database to be started which is the goal of this first project series.

Objectives

1. To adapt, install and validate a web-based electronic solution for an disease registry on HS 
2. To establish an administrative body and found a governance structure for the project
3. To define standards of data fields, documentation and outcomes measurement
4. To run a uniform database integrating routine and/or research registry data

Data set

Clinical data, history and patient-reported outcomes will be obtained in regular visits during routine treatment of the patients.
The data sets will be used for descriptive and confirmative analyses on a regular basis following the study protocol.

Observation period

Each patient included will be observed for 2 years in routine treatment regardless of therapy applied. Time points of measurement will be 0-3-6-12-24 months.

Publications

A series of peer-review publications will be prepared. Moreover, submissions to congresses will be performed on a regular basis.

Time planning

The overall project can be started at any time point in 2022. The registry operation is planned for six years, observing each patient for at least two years. The consecutive phases will be started as needed. 

Patients

An expected total of n=3000 patients will be recruited within 3 years and each patient observed for 2 years (prolongation to 5 years possible). No limit will be placed for the patient inclusions but only patients with proven diagnoses are accepted. 
The patient basis will involve the HS patients routinely documented in the single centers after informed consent has been obtained. All data from these centers will be completely worked up and used for analysis.