Abstract / Summary
Abstract Background Hemorrhoidal disease (HD) is characterized by heterogeneous symptoms including bleeding, prolapse, pain, itching, and soiling. Currently available patient-reported outcome measures evaluate complementary but distinct symptom dimensions. The aim of this study was to develop and perform an initial evaluation of the GRAVITY score (Grading Severity and Frequency in Hemorrhoidal Disease), a composite patient-reported outcome measure integrating symptom severity and symptom frequency in HD. Methods This prospective multicentric observational study included 265 consecutive patients with HD evaluated between October 2025 and March 2026. Symptoms were assessed using the symptom domain of the PROM-HISS and HDSS/SHS HD instruments, from which the composite GRAVITY score was derived. Internal consistency was assessed using Cronbach’s α. Correlations among the symptom domains of the PROM-HISS, HDSS/SHS HD , and GRAVITY were evaluated overall and according to Goligher grade using Pearson’s correlation coefficient and coefficient of determination ( R 2 ). Longitudinal responsiveness was assessed in a separate cohort of 42 patients undergoing 3% polidocanol foam sclerotherapy, with score assessment at baseline and 30 days after treatment. Results Significant differences in the symptom domains of the PROM-HISS, HDSS/SHS HD , and GRAVITY were observed across Goligher grades ( p < 0.001). Cronbach’s α was 0.908. In the overall cohort, the symptom domains of the HISS and HDSS/SHS HD shared 70% of explained variance ( r = 0.839, R 2 = 0.704), indicating partial overlap between symptom severity and frequency domains. The GRAVITY score demonstrated stronger correlations with both PROM-HISS ( r = 0.946, R 2 = 0.895) and HDSS/SHS HD symptom domains ( r = 0.970, R 2 = 0.941). Stratified analyses showed that the correlation among the symptom domains of the PROM-HISS and the HDSS/SHS HD weakened in early and advanced disease (Goligher I and IV), whereas GRAVITY maintained consistently high correlations across all grades. In the longitudinal cohort, baseline correlation among the symptom domains of the PROM-HISS and the HDSS/SHS HD was substantially lower ( r = 0.413, R 2 = 0.170), while GRAVITY continued to demonstrate robust correlations with both instruments. After sclerotherapy, all PROMs significantly improved ( p < 0.001), confirming responsiveness to clinical change. Conclusions By integrating symptom severity and symptom frequency into a single composite measure, the GRAVITY score demonstrated acceptable internal consistency, strong correlations with both parent instruments, and responsiveness to clinical change. These findings provide preliminary evidence supporting GRAVITY as a potentially useful composite PROM for baseline assessment, longitudinal follow-up, and comparison of treatment outcomes in HD. Further psychometric validation is required before broader clinical implementation.