title: Development of a postsurgical patient-reported outcome instrument for women with vulvar neoplasia.
abstract: OBJECTIVE
  To (a) develop the Women With Vulvar Neoplasia-Patient-Reported Outcome (WOMAN-PRO) instrument as a measure of women's post-vulvar surgery symptom experience and informational needs, (b) examine its content validity, (c) describe modifications based on pilot testing, and (d) examine the content validity of the revised instrument.
  
  
  METHODS
  Mixed-methods research project.
  
  
  METHODS
  One Swiss and two German university hospitals.
  
  
  METHODS
  10 patients and 6 clinicians participated in the pilot test.
  
  
  METHODS
  The instrument was developed based on literature searches, clinician feedback, and patient interviews. Thirty-seven items were first pilot tested by patients and clinicians. The revised 36 items were pilot tested by patients. The content validity index (CVI) for each item and the entire instrument was calculated.
  
  
  METHODS
  Symptom experience and informational needs of patients with vulvar neoplasia.
  
  
  RESULTS
  The initial pilot test showed excellent scale CVI based on feedback from patients (CVI = 0.98) and clinicians (CVI = 0.92). After revising six items based on low individual CVIs and participant comments, the revised WOMAN-PRO showed excellent item and scale content validity (CVI = 1).
  
  
  CONCLUSIONS
  The newly developed WOMAN-PRO instrument can guide patients and clinicians in assessing symptoms, informational needs, and related distress.
  
  
  CONCLUSIONS
  Use of the WOMAN-PRO instrument in clinical practice can offer patients guidance in self-assessment and early recognition of symptoms. The instrument also can provide clinicians with systematic information about key symptoms from a patient perspective, as well as women's unmet informational needs. If the results of additional psychometric testing are promising, the WOMAN-PRO tool may provide an outcome measure for clinical trials.
authors.affiliation: Department of Obstetrics and Gynaecology, Bern University Hospital, Switzerland.
authors.forename: Beate
authors.initials: B
authors.lastname: Senn
authors.forename: Michael D
authors.initials: MD
authors.lastname: Mueller
authors.forename: Annette
authors.initials: A
authors.lastname: Hasenburg
authors.forename: Thomas
authors.initials: T
authors.lastname: Blankenstein
authors.forename: Beatrice
authors.initials: B
authors.lastname: Kammermann
authors.forename: Anke
authors.initials: A
authors.lastname: Hartmann
authors.forename: Heidi
authors.initials: H
authors.lastname: Donovan
authors.forename: Manuela
authors.initials: M
authors.lastname: Eicher
authors.forename: Rebecca
authors.initials: R
authors.lastname: Spirig
authors.forename: Sandra
authors.initials: S
authors.lastname: Engberg
mesh_terms: D059026:Diagnostic Self Evaluation; D005260:Female; D006801:Humans; D008875:Middle Aged; D011795:Surveys and Questionnaires; D016896:Treatment Outcome; D014846:Vulvar Neoplasms / Q000601:surgery*