OBJECTIVES: Genital herpes (GH) is a common and highly contagious infection typically spread through sexual contact. GH affects more than 600 million people worldwide (CDC, 2016). New treatments in development are designed to reduce duration and severity of signs and symptoms. In order to accurately assess these treatment benefits, fit for purpose measures are required.
METHODS: In alignment with the FDA PRO Guidance (FDA, 2009), a rigorous qualitative research study was undertaken to identify concepts of relevance and importance to patients with GH. Specifically, following a targeted literature review, semi-structured interview guides were created: one for use with clinical experts and a second for use with adult patients with GH. Individual interviews were conducted by trained staff and concept saturation was tracked. Diary items were generated following standard qualitative evaluation and pilot-tested in two rounds of interviews with a new sample of GH patients.
RESULTS: Four clinical experts participated in individual interviews. Experts endorsed concepts identified in the literature and described challenges/proposed solutions for the measurement of signs and symptoms for GH. Patient input was gathered via in-depth interviews (n=20) of individuals with varying disease duration, severity and a mix of educational background and ethnicity. The result was a preliminary list of patient derived disease state attributes and an initial version of a conceptual framework. Items were tested and refined utilizing cognitive debriefing interviews with a new sample. The result is an 8-item diary (GH-SSD) designed for daily administration in a clinical trial setting with three items to assess the presence of GH lesions, lesion type, and the presence of prodrome symptoms. The remaining items assess itching, pain, pain with urination, draining/discharge, and swelling.
CONCLUSIONS: The GH-SSD is a brief PROM developed in full alignment with the FDA PRO guidance. Content validity was supported, and psychometric assessment is underway.
