Purpose/Objectives: To (a) develop the Women With
Vulvar Neoplasia—Patient-Reported Outcome (WOMANPRO)
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.
Design: Mixed-methods research project.
Setting: One Swiss and two German university hospitals.
Sample: 10 patients and 6 clinicians participated in the
pilot test.
Methods: The instrument was developed based on literature
searches, clinician feedback, and patient interviews. Thirtyseven
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.
Main Research Variables: Symptom experience and informational
needs of patients with vulvar neoplasia.
Findings: 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.
Implications for Nursing: 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 WOMANPRO
tool may provide an outcome measure for clinical trials