{"paper_id":"7a5f9c8c-a2a3-4215-8d70-5e71f5636e75","body_text":"Abstract\nDaily 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.\nSimilar content being viewed by others\nReferences\nMissmer SA, Hankinson SE, Spiegelman D, et al. Reproductive history and endometriosis among premenopausal women. Obstet Gynecol. 2004;104(5 pt 1):965–974.\nGiudice LC. Clinical practice. Endometriosis. N Engl J Med. 2010;362(25):2389–2398.\nMayo Clinic. Endometriosis: Diagnosis & Treatment 2018. https://www.mayoclinic.org/diseases-conditions/endometriosis/diagnosis-treatment/drc-20354661. Accessed July 10, 2018.\nNnoaham KE, Hummelshoj L, Webster P, et al. Impact of endometriosis on quality of life and work productivity: a multi-center study across ten countries. Fertil Steril. 2011;96(2): 366–373.e8.\nJia SZ, Leng JH, Shi JH, Sun PR, Lang JH. Health-related quality of life in women with endometriosis: a systematic review. J Ovarian Res. 2012;5(1): 29.\nSoliman AM, Yang H, Du EX, Kelley C, Winkel C. The direct and indirect costs associated with endometriosis: a systematic literature review. Hum Reprod. 2016;31(4):712–722.\nSimoens S, Dunselman G, Dirksen C, et al. The burden of endo-metriosis: costs and quality of life of women with endometriosis and treated in referral centres. Hum Reprod. 2012;27(5): 1292–1299.\nBiberoglu KO, Behrman SJ. Dosage aspects of danazol therapy in endometriosis: short-term and long-term effectiveness. Am J Obstet Gynecol. 1981;139(6):645–654.\nDmowski WP, Radwanska E, Binor Z, Tummon I, Pepping P. Ovarian suppression induced with Buserelin or danazol in the management of endometriosis: a randomized, comparative study. Fertil Steril. 1989;51(3):395–400.\nDlugi AM, Miller JD, Knittle J. Lupron depot (leuprolide acetate for depot suspension) in the treatment of endometriosis: a rando-mized, placebo-controlled, double-blind study. Lupron Study Group. Fertil Steril. 1990;54(3):419–427.\nWheeler JM, Knittle JD, Miller JD. Depot leuprolide versus dana-zol in treatment of women with symptomatic endometriosis. I. Efficacy results. Am J Obstet Gynecol. 1992;167(1): 1367–1371.\nHornstein MD, Surrey ES, Weisberg GW, Casino LA. Leuprolide acetate depot and hormonal add-back in endometriosis: a 12-month study. Lupron Add-Back Study Group. Obstet Gynecol. 1998;91(1): 16–24.\nShaw RW. An open randomized comparative study of the effect of goserelin depot and danazol in the treatment of endometriosis. Zoladex Endometriosis Study Team. Fertil Steril. 1992;58(2): 265–272.\nCrosignani PG, Luciano A, Ray A, Bergqvist A. Subcutaneous depot medroxyprogesterone acetate versus leuprolide acetate in the treatment of endometriosis-associated pain. Hum Reprod. 2006;21(1): 248–256.\nLockhat FB, Emembolu JO, Konje JC. The efficacy, side-effects and continuation rates in women with symptomatic endometriosis undergoing treatment with an intra-uterine administered proges-togen (levonorgestrel): a 3 year follow-up. Hum Reprod. 2005; 20(3):789–793.\nOverton CE, Lindsay PC, Johal B, et al. A randomized, double-blind, placebo-controlled study of luteal phase dydrogesterone (Duphaston) in women with minimal to mild endometriosis. Fertil Steril. 1994;62(4):701–707.\nDeal LS, DiBenedetti DB, Williams VS, Fehnel SE. The devel-opment and validation of the daily electronic endometriosis pain and bleeding diary. Health Qual Life Outcomes. 2010;8:64.\nVincent K, Kennedy S, Stratton P. Pain scoring in endometriosis: entry criteria and outcome measures for clinical trials. Report from the Art and Science of Endometriosis meeting. Fertil Steril. 2010;93(1): 62–67.\nTaylor HS, Giudice LC, Lessey BA, et al. Treatment of endometriosis-associated pain with elagolix, an oral GnRH antagonist. N Engl J Med. 2017;377(1): 28–40.\nFood and Drug Administration. Guidance for Industry Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims. 2009. http://www.fda.gov/downloads/Drugs/Guidances/UCM193282.pdf. Accessed July 10, 2018.\nCarr B, Guidice L, Dmowski WP, et al. Elagolix, an oral GnRH antagonist for endometrosis-associated pain: a randomized con-trolled study. J Endriomet Pelvic Pain Disord. 2013;5:105–115.\nJones G, Jenkinson C, Kennedy S. Development of the short form Endometriosis Health Profile Questionnaire: the EHP-5. Qual Life Res. 2004;13(3):695–704.\nMuhr T. User’s Manual for ATLAS. ti 5.0, ATLAS.ti Scientific Software Development. Berlin, Germany: Scientific Software Development GmbH; 2004.\nHinkle DE, Jurs SG, Wiersma W. Applied Statistics for the Behavioral Sciences. Boston, MA: Houghton Mifflin; 1988.\nDeyo RA, Diehr P, Patrick DL. Reproducibility and responsive-ness of health status measures. Control Clin Trials. 1991;12(4 suppl 1):142S–158S.\nLandis JR, Koch GG. The measurement of observer agreement for categorical data. Biometrics. 1977;33(1):159–174.\nHufford MR, Stone AA, Shiftman S, Schwartz JE, Broderick JE. Paper vs. electronic diaries: compliance and subject evaluations. Appl Clin Trials. August, 2002:38–43.\nStone AA, Shiffman S. Capturing momentary, self-report data: a proposal for reporting guidelines. Ann Behav Med. 2002;24(3): 236–243.\nDansie EJ, Turk DC. Assessment of patients with chronic pain. Br JAnaesth. 2013;111(1):19–25.\nAuthor information\nAuthors and Affiliations\nCorresponding author\nRights and permissions\nAbout this article\nCite this article\nWyrwich, K.W., O’Brien, C.F., Soliman, A.M. et al. Development and Validation of the Endometriosis Daily Pain Impact Diary Items to Assess Dysmenorrhea and Nonmenstrual Pelvic Pain. Reprod. Sci. 25, 1567–1576 (2018). https://doi.org/10.1177/1933719118789509\nPublished:\nVersion of record:\nIssue date:\nDOI: https://doi.org/10.1177/1933719118789509","source_license":"CC0","license_restricted":false}