title: Content validation of the patient-reported outcomes measurement information system (PROMIS) framework in women with urinary incontinence.
abstract: OBJECTIVE
  To assess whether the existing National Institutes of Health (NIH) Patient Reported Outcomes Measurement Information System (PROMIS) conceptual framework and item banks sufficiently capture the concerns of women with urinary incontinence (UI).
  
  
  METHODS
  Thirty-five women with UI were recruited between February-April 2009 for 4 structured focus groups to develop and assess the content validity of a conceptual framework for the impact of UI. This framework included domains from the NIH PROMIS framework and item banks including broad domains of physical and social function and mental health. All sessions were transcribed, coded, and qualitatively and quantitatively analyzed using analytic induction and deductive analysis to identify new themes and domains relevant to women with UI.
  
  
  RESULTS
  The focus groups provided information that confirmed the relevance of existing PROMIS domains and identified new outcome domains that are important to this patient population. The groups confirmed the relevance of the physical and social functioning, and mental health domains. Additional themes that emerged included the distinction between ability versus participation and satisfaction, role functioning, external mediators, re-calibration/coping, cognitive function and new possibilities. Participants also felt strongly that not all domains and items apply to all women with UI and an option to tailor questionnaires and skip non-relevant items was important.
  
  
  CONCLUSIONS
  The PROMIS framework domains are relevant to women with UI, but additional patient-important themes are identified that may improve the comprehensiveness of this assessment framework for measuring outcomes important to women with UI. These results will inform future item content development for UI.
authors.affiliation: The Division of Urogynecology and Reconstructive Pelvic Surgery, Department of Obstetrics and Gynecology, Alpert Medical School of Brown University, Providence, Rhode Island 02903, USA. vsung@wihri.org
authors.forename: Vivian W
authors.initials: VW
authors.lastname: Sung
authors.forename: Felisha
authors.initials: F
authors.lastname: Marques
authors.forename: Rebecca R
authors.initials: RR
authors.lastname: Rogers
authors.forename: David A
authors.initials: DA
authors.lastname: Williams
authors.forename: Deborah L
authors.initials: DL
authors.lastname: Myers
authors.forename: Melissa A
authors.initials: MA
authors.lastname: Clark
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D005260:Female; D017144:Focus Groups; D006304:Health Status; D006801:Humans; D008875:Middle Aged; D017063:Outcome Assessment, Health Care / Q000379:methods*; D011594:Psychometrics; D011788:Quality of Life; D011795:Surveys and Questionnaires; D016896:Treatment Outcome; D014549:Urinary Incontinence / Q000628:therapy*; D014930:Women