Development of a postsurgical patient-reported outcome instrument for women with vulvar neoplasia

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.

Mixed-methods research project.

One Swiss and two German university hospitals.

10 patients and 6 clinicians participated in the pilot test.

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.

Symptom experience and informational needs of patients with vulvar neoplasia.

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).

The newly developed WOMAN-PRO instrument can guide patients and clinicians in assessing symptoms, informational needs, and related distress.

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.