Srinivasan, Vamshek

BACKGROUND: Hemorrhoids are common and relief anchors on symptom improvement. Despite several available treatment options, the optimal patient-reported outcome measure for contemporary clinical trials is not established. OBJECTIVE: We aimed to systematically assess patient-reported outcome measures that measure hemorrhoid symptom severity and/or health-related quality of life. DATA SOURCES: A systematic review was performed using PubMed and Embase (1980-2025). STUDY SELECTION: Prospective development/validation studies evaluating patient-reported outcome measures relevant to hemorrhoidal disease. MAIN OUTCOME MEASURES: Patient-reported outcome measures were evaluated on key measurement properties of reliability, internal consistency, construct validity, and responsiveness according to COSMIN v2.0 criteria. RESULTS: Of the 1,266 total studies reviewed, nine patient-reported outcome measures were identified: seven measure symptom severity and six measure health-related quality-of-life. Three demonstrated reliability, internal consistency, construct validity, and responsiveness. The Patient Reported Outcome Measure-Haemorrhoidal Impact And Satisfaction Score comprehensively measures symptom severity, health-related quality-of-life, and treatment satisfaction. The Hemorrhoidal Disease Symptom Score classifies patients with high or low symptom load, and when used in combination with Short Health Scale-Hemorrhoidal Disease, also measures impact on health-related quality of life. LIMITATIONS: Preference toward specific measures may differ between clinical trials and clinical practice. CONCLUSIONS: We identify two viable patient-reported outcome measures for use in future clinical trials that evaluate hemorrhoid interventions.