Development and validation the uterine fibroid symptom and quality of life short-form: based on classical test theory and modern test theory

Abstract

Abstract Objectives Previous research has shown that the self-consciousness and sexual function domain of the uterine fibroid symptom and quality of life (UFS-QoL) questionnaire exhibited poor adaptability and clinical applicability. In light of this, our objective was to develop a shorter version of the UFS-QoL questionnaire, while ensuring its reliability, validity, and clinical applicability, in order to enhance routine clinical assessments. Methods A secondary analysis was conducted on a prospective cohort study involving 20 Chinese hospitals and 2,411 Chinese women with fibroids. We employed both classical test theory (CTT) and item response theory (IRT) to select two items for each UFS-QoL subscale. In cases where inconsistencies arose from these two methods, we utilized responsiveness to identify items with a higher ability to detect change in clinical therapy. The short-form scale was evaluated for dimensionality, internal consistency reliability, and criterion and known-group validity through factor analysis, Cronbach's alpha, Spearman correlations, and independent samples t-tests. To assess the ability to detect change, we compared pre-treatment and post-treatment (6 and 12 months) scores using effect size and standardized response mean. Results Considering the poor adaptability and clinical applicability, we made the decision to remove the self-consciousness subscale and retain only one item from the sexual functioning subscale. As a result, we administered and validated the 11-item short-form version of UFS-QoL (UFS-QoL-11). UFS-QoL-11 exhibited a strong correlation with UFS-QoL in each subscale, with correlation coefficients exceeding 0.7 (all P < 0.001). Exploratory factor analysis identified three subscales (symptom severity, concern, and daily life interference) with eigenvalues > 1 for UFS-QoL-11. The test items accounted for 64.46% of the total variance, slightly higher than the parent scale score of 63.60%. UFS-QoL-11 demonstrated excellent internal consistency and reliability across all subscales (> 0.7), representing a slight improvement compared to the full UFS-QoL. Furthermore, UFS-QoL-11 exhibited sensitivity in detecting varying levels of current health status, particularly at 6 and 12 months post-surgery. The responsiveness of UFS-QoL-11 was comparable to that of UFS-QoL, with all effect sizes > 0.5, demonstrating a strong ability to detect changes. Conclusion UFS-QoL-11 performs as well as the original version, while reducing the administrative burden by 70%. We firmly believe that the implementation of the newly developed UFS-QoL-11 has the potential to facilitate widespread, accurate, timely, and sensitive monitoring in both clinical and research settings.