Development and Validation of the Endometriosis Daily Pain Impact Diary Items to Assess Dysmenorrhea and Nonmenstrual Pelvic Pain
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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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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Cited by (18)
- Validity and reliability of the Hungarian version of the Pain Self-efficacy Questionnaire among women with endometriosis and chronic pelvic pain 2024
- Measurement of changes to the menstrual cycle: A transdisciplinary systematic review evaluating measure quality and utility for clinical trials 2024
- Association of Dysmenorrhea with Endometriosis: a Literature Review 2023
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- A systematic review to determine use of the Endometriosis Health Profiles to measure quality of life outcomes in women with endometriosis 2023
- Additional file 1 of Patients’ and clinicians’ perspectives on item importance, scoring, and clinically meaningful differences for the Endometriosis Symptom Diary (ESD) and Endometriosis Impact Scale (EIS) 2021
- The Physical, Psychological, and Social Day-to-Day Experience of Women Living With Endometriosis Compared to Healthy Age-Matched Controls—A Mixed-Methods Study 2021
- The ENDOPAIN 4D Questionnaire: A New Validated Tool for Assessing Pain in Endometriosis 2021
- Clinically Meaningful Reduction in Dyspareunia Is Associated with Significant Improvements in Health-Related Quality of Life Among Women with Moderate to Severe Pain Associated with Endometriosis: A Pooled Analysis of Two Phase III Trials of Elagolix 2020
- Responsiveness and thresholds for clinically meaningful changes in worst pain numerical rating scale for dysmenorrhea and nonmenstrual pelvic pain in women with moderate to severe endometriosis 2020
- Baseline endometriosis-associated pain burden: Data from 1600+ women enrolled in elagolix clinical trials 2019
- Achieving clinically meaningful response in endometriosis pain symptoms is associated with improvements in health-related quality of life and work productivity: analysis of 2 phase III clinical trials 2019
- Clinical Evaluation of the Oral Gonadotropin-Releasing Hormone-Antagonist Elagolix for the Management of Endometriosis-Associated Pain 2019
- Dyspareunia in their own words: A comprehensive qualitative description of endometriosis-associated sexual pain 2019
- Cost–effectiveness of elagolix versus leuprolide acetate for treating moderate-to-severe endometriosis pain in the USA 2019
- Psychometric assessment of the health-related productivity questionnaire (HRPQ) among women with endometriosis 2019
- Patient Preferences for Endometriosis Pain Treatments in the United States 2019
- Responsiveness Evaluation and Recommendation for Responder Thresholds for Endometriosis Health Profile-30: Analysis of Two Phase III Clinical Trials 2019
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