Establishment of a European Registry for hidradenitis suppurativa/acne inversa by using an open source software

Hidradenitis suppurativa/acne inversa (HS) is a chronic, inflammatory, recurrent, debilitating skin disease of the hair follicle that usually presents after puberty with painful, deep-seated, inflamed lesions in the apocrine gland-bearing areas of the body, most commonly the axillary, inguinal and anogenital regions (Dessauer definition, 2006).1 The inflamed lesions include nodules usually ending in abscesses and sinus tracts with suppuration and hypertrophic scars.2 European studies estimated a HS prevalence of approximately 1%.3, 4 HS has an important negative impact on the quality of life.5 The European HS foundation (EHSF e.V.) has initiated the development of a European Registry in order to: The new European HS Registry will run compatible with, complementary to and in cooperation with HISREG,6 the existing registry in the Scandinavian countries. In order to reach a consensus to create a unified HS questionnaire across Europe, questionnaires on HS currently used in several European countries were compared and adapted. A compromise to reduce the number of the core questions was reached in order to gain the most relevant information without discouraging physicians and patients to participate in the Registry. If the number of questions were larger, so would be the collected information, but the motivation of physicians and patients to participate could decrease. Removing the elements which can be calculated automatically (e.g. BMI), removing duplicate questions which describe similar parameters (e.g. Skindex and DLQI) and grouping several questions into one led to a reasonable reduction in the questionnaire items. By doing this, 79 questions remained and were included in the common questionnaire. This would lead to a more balanced result between accuracy and feasibility. Another essential step was to group the data in sections (Table 1). • Age • Gender • Occupational and educational status • Physical characteristics • Personal medical history • Gynecological history • Family history • Treatment • Life style • History-taking • Complications • Quality of life • Treatment • Physical examination • Therapeutic project Two different questionnaires will be employed: one for the first visit (Appendix S1) and a shorter one for the patients' follow-up. Another goal of this project is to make the registry adaptable. A core group of 32 obligatory questions has been selected among the 79 questionnaire items and can be forwarded to HISREG for comparative evaluations. The individual centres will be able to select additional questions of their interest among the remaining 47 ones. There will be no obligation to fulfil all questions included in the questionnaire. Moreover, conditional questions will be used (e.g. there are six questions for tobacco use, but if the first answer is ‘no’, the next five questions will not be asked). OpenClinica is a widely adopted software used to collect data from clinical trials or registries in electronic form (Figure 1). The community edition of OpenClinica is freely available and has been successfully used in several clinical trials.7 After obtaining the approval of the ethics committee and having installed the programme, each centre can adapt the questionnaire by selecting the questions of interest. Data comparison with other centres will always be possible but each centre will have control over its own database. The data collected with the questionnaire and OpenClinica can be extracted and added to the medical record of the patient. Such a procedure may impact both the research and the clinical practice. In the future, this database could enable us to unify diagnostic procedures and follow-up across Europe, improve knowledge about the disease, improve treatment and finally improve the quality of life of patients affected by HS. Please note: The publisher is not responsible for the content or functionality of any supporting information supplied by the authors. Any queries (other than missing content) should be directed to the corresponding author for the article.