caa a22 4500 606177833 CHVBK 20210128100753.0 cr unu---uuuuu 210128e20150101xx s 000 0 eng 10.1007/s11136-014-0755-z doi (NATIONALLICENCE)springer-10.1007/s11136-014-0755-z A qualitative study to develop a patient-reported outcome for dysmenorrhea [Elektronische Daten] [Allison Nguyen, Louise Humphrey, Helen Kitchen, Tayyaba Rehman, Josephine Norquist] Purpose: Dysmenorrhea refers to the experience of pelvic pain/cramps experienced by women around or during menstruation. A literature review indicated that no existing patient-reported outcome measure was adequate to support labeling claims in dysmenorrhea. Therefore, this study aimed to develop a new measure that could be used as a primary end point in dysmenorrhea clinical trials. Methods: Open-ended interviews were conducted with 52 dysmenorrhea patients, including a subset of 12 women with a comorbid pelvic pain condition (PPC). Verbatim transcripts were analyzed thematically. The findings were used to generate draft items for an electronic diary (eDiary). A further 24 dysmenorrhea patients pilot-tested the eDiary for 1-5weeks and completed cognitive interviews to assess content validity. Revisions to the eDiary were implemented based on the findings. Results: In the first set of interviews, 51 women (98%) spontaneously reported pain/cramps in or around the pelvic region (abdomen, lower back, legs/upper thighs, and vaginal area). Pain experiences reported were similar across dysmenorrhea and dysmenorrhea plus PPC subgroups, except that the pelvic pain among PPC patients occurred throughout the month, not only during menstruation. All participants described the detrimental impact of dysmenorrhea on health-related quality of life. Conclusions: The eDiary was conceptually comprehensive and easy to complete/understand during cognitive debriefing. The resulting nine-item diary included assessment of: menstrual bleeding severity; pain severity; use of analgesics; impact on work/school, physical activities, social and leisure activities, and sleep. Psychometric validation is ongoing and will assess the reliability, validity, and responsiveness of the eDiary as a comprehensive dysmenorrhea assessment. Springer International Publishing Switzerland, 2014 Dysmenorrhea nationallicence Patient-reported outcome nationallicence Qualitative nationallicence Patient experience nationallicence Pelvic pain nationallicence Cramps nationallicence Nguyen Allison Merck, Sharp & Dohme Corp., 351 North Sumneytown Pike, UGID-60, 19454, North Wales, PA, USA aut Humphrey Louise Adelphi Values Ltd, Adelphi Mill, SK10 5JB, Bollington, Cheshire, UK aut Kitchen Helen Adelphi Values Ltd, Adelphi Mill, SK10 5JB, Bollington, Cheshire, UK aut Rehman Tayyaba Merck, Sharp & Dohme Corp., 351 North Sumneytown Pike, UGID-60, 19454, North Wales, PA, USA aut Norquist Josephine Merck, Sharp & Dohme Corp., 351 North Sumneytown Pike, UGID-60, 19454, North Wales, PA, USA aut Quality of Life Research Springer International Publishing 24/1(2015-01-01), 181-191 0962-9343 24:1<181 2015 24 11136 https://doi.org/10.1007/s11136-014-0755-z text/html Onlinezugriff via DOI BK010053 XK010053 XK010000 Metadata rights reserved Springer special CC-BY-NC licence nationallicence 1 research-article jats NATIONALLICENCE NATIONALLICENCE NL-springer NATIONALLICENCE 856 40 https://doi.org/10.1007/s11136-014-0755-z text/html Onlinezugriff via DOI NATIONALLICENCE 700 1- Nguyen Allison Merck, Sharp & Dohme Corp., 351 North Sumneytown Pike, UGID-60, 19454, North Wales, PA, USA aut NATIONALLICENCE 700 1- Humphrey Louise Adelphi Values Ltd, Adelphi Mill, SK10 5JB, Bollington, Cheshire, UK aut NATIONALLICENCE 700 1- Kitchen Helen Adelphi Values Ltd, Adelphi Mill, SK10 5JB, Bollington, Cheshire, UK aut NATIONALLICENCE 700 1- Rehman Tayyaba Merck, Sharp & Dohme Corp., 351 North Sumneytown Pike, UGID-60, 19454, North Wales, PA, USA aut NATIONALLICENCE 700 1- Norquist Josephine Merck, Sharp & Dohme Corp., 351 North Sumneytown Pike, UGID-60, 19454, North Wales, PA, USA aut NATIONALLICENCE 773 0- Quality of Life Research Springer International Publishing 24/1(2015-01-01), 181-191 0962-9343 24:1<181 2015 24 11136