Development and content validation of a patient-reported endometriosis pain daily diary.

ABSTRACT:

Background

Endometriosis is a common gynecological disorder that causes inflammation and pelvic pain. Endometriosis-related pain is best captured with patient-reported outcome (PRO) measures, however, assessment of endometriosis-related pain in clinical trials has been difficult in the absence of a reliable and valid PRO instrument. We describe the development of the Endometriosis Pain Daily Diary (EPDD), an electronic PRO developed as a survey instrument to assess endometriosis-related pain and its impact on patients' lives.

Methods

The EPDD was initially developed on the basis of an existing Endometriosis Pain and Bleeding Diary, a targeted review of relevant literature, clinical expert interviews, and open-ended (concept elicitation) patient interviews in the United State

SUBMITTER: van Nooten FE 

PROVIDER: S-EPMC5753477 | biostudies-literature | 2018 Jan

REPOSITORIES: biostudies-literature