As a disease characterized by pain, Patient-Reported Outcomes (PROs) are important for determining disease severity and evaluating the efficacy of endometriosis treatments. In the absence of existing PROs that comply with the FDA PRO Guidance, two new PROs have been developed: The Endometriosis Symptom Diary (ESD) and Endometriosis Impact Scale (EIS). The content validity of these instruments has been demonstrated by extensive qualitative and quantitative research with women with endometriosis. The first investigations of the reliability and validity of scores derived from the ESD and EIS are presented herein.
Measuring the symptoms and impacts of endometriosis
Psychometric validation of the endometriosis symptom diary and endometriosis impact scale
Gater, A., Moore, A., Coon, CD., Chen, W-H., Wichmann, K., Hartisch, C., Filonenko, A., Seitz, C., & Gerlinger, C. (2015). Measuring the symptoms and impacts of endometriosis: Psychometric validation of the endometriosis symptom diary and endometriosis impact scale. Value in Health, 18(3), A26. https://doi.org/10.1016/j.jval.2015.03.158