Development and Validation of a Quality of Life Scale for Women with Pelvic Venous Disorder: A Mixed Methods Study

Background Pelvic venous disorder (PeVD) predominantly affects women, causing chronic pelvic pain, dyspareunia, and lower extremity varicose veins that severely impair quality of life (QoL). Owing to the lack of QoL assessment tools tailored to the impact of PeVD on female patients, diagnosis and management remain challenging. We developed a PeVD-specific QoL scale (PeVD-QoL) for women, providing a scientific basis to optimize diagnostic, therapeutic, and nursing strategies. Methods Using a mixed-methods design (literature review, qualitative interviews, Delphi expert consultations, and clinical testing), we developed and refined the scale. The preliminary 48-item version was validated in 527 Chinese women with PeVD to assess its validity (content, construct, convergent, and discriminant) and reliability (Cronbach’s α and test-retest reliability), thereby verifying its scientific rigor and reliability. Results The PeVD-QoL demonstrated a content validity index of 0.995. Exploratory factor analysis revealed that the 40 items of the PeVD-QoL loaded on six factors, accounting for 73.23% of the total variance; confirmatory factor analysis supported its six-factor structure with acceptable model fits. Each dimension exhibited acceptable convergent and discriminant validity (AVE = 0.38–0.93, CR = 0.82–0.98). The scale showed high internal consistency (Cronbach’s α = 0.96), with Cronbach’s α coefficients for each dimension ranging from 0.86 to 0.98. The test-retest reliability across dimensions after two weeks ranged from 0.82 to 0.90. Conclusions We developed and validated a novel scale for assessing QoL in PeVD women. This tool can comprehensively capture the effects of PeVD on women's health status, facilitating optimized diagnosis, treatment, and nursing strategies to improvetheir quality of life. Multicenter studies with larger, more diverse cohorts are needed to confirm the generalizability of the tool and establish minimal clinically important differences.