Development and Validation of the Endometriosis Daily Pain Impact Diary Items to Assess Dysmenorrhea and Nonmenstrual Pelvic Pain

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AI-generated summary by claude@2026-06+body, 2026-06-07

This study developed and validated daily diary items to measure dysmenorrhea and nonmenstrual pelvic pain impact in endometriosis clinical trials, finding them reliable, valid, and responsive.

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AI-generated deep summary by claude@2026-06, 2026-06-07

The study developed and validated new daily diary items to assess the impact of dysmenorrhea and nonmenstrual pelvic pain, intended for use as outcome measures in endometriosis phase II clinical trial settings. Item wording and response options were generated through qualitative research (eight focus groups, 20 telephone interviews, and 15 face-to-face concept elicitation/cognitive debriefing sessions) involving adult women with endometriosis, followed by quantitative testing of reliability, convergent validity, and responsiveness in a phase II randomized controlled trial of an investigational endometriosis treatment. Quantitative analyses showed that dysmenorrhea and nonmenstrual pelvic pain impact items correlated with other pain-impact measures supporting convergent validity, and longitudinal properties (test-retest reliability and sensitivity to change) supported their adequacy for measuring therapeutic response. This paper does not explicitly discuss limitations in the provided text, but it is based on psychometric evaluation within a specific trial framework. This paper is centrally about endometriosis — it reports the development and validation of daily pain impact diary items for dysmenorrhea and nonmenstrual pelvic pain to measure treatment response in endometriosis.

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Condition tags

dysmenorrheaendometriosischronic_pelvic_pain

MeSH descriptors

Dysmenorrhea Endometriosis Patient Reported Outcome Measures Pelvic Pain Adult Dysmenorrhea Dysmenorrhea Dysmenorrhea Endometriosis Endometriosis Endometriosis Female Humans Middle Aged Pain Measurement Pelvic Pain Pelvic Pain Pelvic Pain Quality of Life Randomized Controlled Trials as Topic

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References (25)

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europepmc
last seen: 2026-06-11T06:19:48.454388+00:00
openalex
last seen: 2026-06-10T17:14:06.276822+00:00
pubmed
last seen: 2026-05-13T22:19:37.156494+00:00
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