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

Daily diary-based dysmenorrhea and nonmenstrual pelvic pain impact items were developed and validated to measure efficacy in endometriosis clinical trial settings. Items were developed across 3 stages of qualitative research, and their psychometric properties were explored in a phase II randomized c...

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Bibliographic Details
Published in:Reproductive sciences (Thousand Oaks, Calif.) Calif.), 2018-11, Vol.25 (11), p.1567-1576
Main Authors: Wyrwich, Kathleen W., O’Brien, Christopher F., Soliman, Ahmed M., Chwalisz, Kristof
Format: Article
Language:English
Subjects:
Adult
Dysmenorrhea - complications
Dysmenorrhea - diagnosis
Dysmenorrhea - psychology
Embryology
Endometriosis - complications
Endometriosis - diagnosis
Endometriosis - psychology
Female
Humans
Medicine & Public Health
Middle Aged
Obstetrics/Perinatology/Midwifery
Original Article
Pain Measurement
Patient Reported Outcome Measures
Pelvic Pain - complications
Pelvic Pain - diagnosis
Pelvic Pain - psychology
Quality of Life
Randomized Controlled Trials as Topic
Reproducibility of Results
Reproductive Medicine
Young Adult
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Summary:Daily diary-based dysmenorrhea and nonmenstrual pelvic pain impact items were developed and validated to measure efficacy in endometriosis clinical trial settings. Items were developed across 3 stages of qualitative research, and their psychometric properties were explored in a phase II randomized controlled trial. Eight focus groups, 20 semistructured telephone interviews, and 15 face-to-face concept elicitation and cognitive debriefing interviews constituted the qualitative phase of the research. Psychometric properties of reliability, convergent validity, and responsiveness of the dysmenorrhea and nonmenstrual pelvic pain daily items were examined quantitatively in a phase II clinical trial of an investigational endometriosis treatment. Both qualitative concept elicitation and cognitive debriefing research yielded wording for item response options that resonated with adult women with endometriosis. Daily assessment of dysmenorrhea and nonmenstrual pelvic pain impact was the preferred measurement approach among adult women with endometriosis. Quantitatively, correlations between the dysmenorrhea and nonmenstrual pelvic pain items and other measures of pain impact provided endorsement for the items’ convergent validity. Longitudinal measurement properties, involving test–retest reliability and sensitivity to change/responsiveness, offered evidence for the adequacy of the measurement properties of the daily diary-based dysmenorrhea and nonmenstrual pelvic pain impact items. Data from a phase II trial provided evidence that the daily dysmenorrhea and nonmenstrual pelvic pain impact items, developed and tested through qualitative research involving both focus groups and individual interviews, are well-defined, reliable, valid, and responsive for measuring the impact of pain in endometriosis to assess therapeutic response.
ISSN:1933-7191
1933-7205
DOI:10.1177/1933719118789509