Selina M Kronthaler, Tatzber Dr. Anna, Kosman Eden, Beier Prof. Klaus M, Hatzler Dr. Laura

(283) LEVERAGING REAL WORLD EVIDENCE FOR NEGLECTED MEDICAL NEEDS: PUTTING WOMEN’S NEEDS AT THE CENTRE OF A DIGITAL HEALTH APPLICATION DEVELOPMENT

  • Urology
  • Reproductive Medicine
  • Endocrinology
  • Endocrinology, Diabetes and Metabolism
  • Psychiatry and Mental health
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Abstract Objectives Although a large number of women affected by sexual dysfunctions seek medical help, their needs are barely addressed in the health care system. Regulatory pathways are key for the translation of real world evidence into accessible personalized health care solutions. Since 2019 the Digital Healthcare Act creates a pathway in Germany for the development and reimbursement of digital tools collecting patient-reported outcome measures (PROMs), patient-reported experience measures (PREMs) and product's meta-data. The purpose of this study is to develop a mobile digital intervention for women with gynecological conditions and sexual distress. Methods Women with sexual distress participate in the iterative process during the software and content development of a mobile digital application. Health care needs, relevance of therapeutic content, desired outcomes and exercises for sexual distress, partner involvement, integration of health care professionals and dissemination strategies are addressed in qualitative interviews and focus groups including up to 50 women. Results will be validated in user testings. Additionally, prototypes of the app will be tested for usability and feasibility with affected women. Results The preliminary results show the outcomes of qualitative research and active patient involvement to design a digital therapy for women with sexual pain disorders. The findings have an important impact on the iterative development of the software, the content and the regulatory pathway of the application. Furthermore the results are translated into a study design which meets the requirements of innovative regulatory and reimbursement pathways in Germany. Conclusions The findings show how to translate women’s need into patient-centered therapy and how to tailor a digital intervention to target outcomes which are relevant to women affected by sexual distress. Evidence based research implemented in innovative regulatory pathways has potential to give rise to value based health solutions. Conflicts of Interest -

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