title: A qualitative study to develop a patient-reported outcome for dysmenorrhea.
abstract: OBJECTIVE
  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 1-5 weeks 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.
authors.affiliation: Merck, Sharp & Dohme Corp., 351 North Sumneytown Pike, UGID-60, North Wales, PA, 19454, USA, allison_martin@merck.com.
authors.forename: Allison Martin
authors.initials: AM
authors.lastname: Nguyen
authors.forename: Louise
authors.initials: L
authors.lastname: Humphrey
authors.forename: Helen
authors.initials: H
authors.lastname: Kitchen
authors.forename: Tayyaba
authors.initials: T
authors.lastname: Rehman
authors.forename: Josephine M
authors.initials: JM
authors.lastname: Norquist
mesh_terms: D000328:Adult; D004412:Dysmenorrhea / Q000523:psychology*; D005260:Female; D006801:Humans; D008875:Middle Aged; D017063:Outcome Assessment, Health Care / Q000379:methods*; D010146:Pain; D063868:Patient Outcome Assessment; D011594:Psychometrics; D036301:Qualitative Research; D011788:Quality of Life / Q000523:psychology*; D015203:Reproducibility of Results; D057566:Self Report