Development and validation of a physical examination scale to assess vaginal atrophy and inflammation.

Background: The assessment of vaginal atrophy is central to menopause-related research and clinical practice. However, methods of grading vaginal atrophy have not been subjected to reliability and validity assessments.

Objective: To assess the validity and reproducibility of selected vaginal examination findings proposed to represent vaginal atrophy and inflammation.

Design: Cross-sectional study.

Participants: A convenience sample of 40 postmenopausal volunteers with past history of breast cancer.

Measurements: Participants completed questionnaires to assess vaginal symptoms. Pelvic examinations were carried out using specified criteria to assess the vaginal appearance. Vaginal cytological smears and pH measurements were performed using standardized techniques.

Results: A four-item physical examination atrophy scale had an alpha reliability of 0.48 and was statistically significantly correlated with pH (r = 0.55) and parabasal cells (r = 0.50). A three-item physical examination inflammation scale had an alpha reliability of 0.45. It was not significantly associated with vaginal smear-measured inflammation. Masked inter-rater agreement for the examination was 90%. Self-reported symptoms of itching/irritation or dryness were poorly related to findings on physical examination.

Conclusions: These results offer objective validation that the physical characteristics proposed to represent atrophy are related to biomarkers of this condition. A relationship between examination characteristics believed to represent inflammation and inflammation biomarkers was not upheld.