Abstract
PurposeEndometriosis is a chronic disorder of the female reproductive system characterized by debilitating symptoms, particularly endometriosis-related pain (ERP). Patient-reported outcome (PRO) measures of symptoms and impacts are required to assess disease severity in ERP clinical studies and clinical practice. A content-valid instrument was developed by modifying the Dysmenorrhea Daily Diary (DysDD) to form the Endometriosis Daily Diary (EDD), an electronic PRO administered via handheld device.MethodsQualitative research with US females with ERP was conducted in three stages: (1) Development of an endometriosis conceptual model based on qualitative literature and conduct of concept elicitation (CE) interviews (N = 30). (2) Cognitive debriefing (CD) interviews (N = 30) conducted across two rounds to assess relevance and understanding of the EDD, with modifications between interview rounds. (3) Pilot testing to assess usability/feasibility of administrating the EDD daily on an electronic handheld device (N = 15). Clinical experts provided guidance throughout the study.ResultsThe conceptual model provided a comprehensive summary of endometriosis to inform modifications to the DysDD, forming the EDD. CD results demonstrated that EDD items were relevant for most participants. Instructions, items, response scales, and recall period were well-understood. The resulting daily diary assesses severity of cyclic and non-cyclic pelvic pain, dyspareunia, impact of ERP on functioning and daily life, symptoms associated with ERP, and bowel symptoms. Participants were able to complete the diary daily and found the device easy to use.ConclusionThe EDD demonstrated good content validity in females experiencing ERP. The next step is to perform psychometric validation in an ERP sample.
Highlights
Endometriosis is a chronic, progressive disease characterized by the presence of endometrial tissue outside the uterine cavity, causing irritation, bleeding, and inflammation in the ectopic tissue
The conceptual model provided a comprehensive summary of endometriosis to inform modifications to the Dysmenorrhea Daily Diary (DysDD), forming the Endometriosis Daily Diary (EDD)
The findings suggested that historically, the most commonly used instrument for assessing endometriosis symptoms in a clinical setting was the cliniciancompleted Biberoglu and Behrman (B&B) scale [11], the instrument is subject to potential rater bias and there is no documented evidence of patient input in the development process, which is an integral component for instruments being used in clinical trials for supporting regulatory claims [12]
Summary
Endometriosis is a chronic, progressive disease characterized by the presence of endometrial tissue outside the uterine cavity, causing irritation, bleeding, and inflammation in the ectopic tissue. Guan et al Journal of Patient-Reported Outcomes (2022) 6:5 estimated at 6–10% of women of reproductive age [1, 2]. Undergoing a surgical procedure (e.g., laparoscopy) can both confirm diagnosis and treat the disease, such invasive procedures are often only initiated after failure of therapeutic interventions (e.g. hormonal medication) [8]. Endometriosis patients face significant delays in diagnosis which can prolong suffering [8, 9]. One of the primary ways of determining disease severity is based on patient descriptions of their symptoms and how they impact their lives using patient-reported outcomes (PROs)
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