BACKGROUND: There are no adequately validated tools to evaluate symptoms or disease-specific health-related quality of life in hemorrhoidal disease.
OBJECTIVE: The purpose of this study was to assess validity, reliability, and responsiveness of a symptom score of patient-reported pain, itching, bleeding, soiling, and prolapse (Hemorrhoidal Disease Symptom Score). In addition, the study set out to assess reliability and responsiveness of an instrument to measure health-related quality of life in patients with hemorrhoids (Short Health ScaleHD), with 1 item in its 4 dimensions: symptom load, functional status, disease-specific worries, and general well-being.
DESIGN: This was a cross-sectional (validity and reliability) and longitudinal (responsiveness) study.
SETTINGS: The study was conducted at a single center.
PATIENTS: Cohort 1 included 295 patients with hemorrhoids to study validity and 60 patients with test-retest scores to study reliability. Cohort 2 included 128 and 121 patients operated for hemorrhoids to study responsiveness of the Hemorrhoidal Disease Symptom Score and the Short Health ScaleHD.
MAIN OUTCOME MEASURES: The study evaluated validity, reliability, and responsiveness. Patient-reported symptom load on a 7-point Likert scale was used as comparator, and receiver operating characteristics curve assessed discriminative validity. Interclass correlation assessed reliability. Receiver operating characteristics curve assessed responsiveness, meaning the ability to discriminate between patients with and without improvement after surgery.
RESULTS: The Hemorrhoidal Disease Symptom Score demonstrated the ability to discriminate between patients reporting high or low symptom load (area under the curve = 0.786 (95% CI, 0.725-0.848)). The Hemorrhoidal Disease Symptom Score and the Short Health ScaleHD demonstrated adequate reliability and responsiveness, with interclass correlation of 0.822 (95% CI, 0.715-0.891) and 0.763 (95% CI, 0.634-0.851) and area under the curve of 0.843 (95% CI, 0.756-0.929) and 0.840 (95% CI, 0.752-0.929).
LIMITATIONS: We had no gold standard comparator to assess validity and responsiveness.
CONCLUSIONS: The findings suggest that the Hemorrhoidal Disease Symptom Score is valid, reliable, and responsive and that the Short Health ScaleHD is reliable and responsive. Used together, these tools provide a good overview of symptoms and their impact on patient well-being. See Video Abstract at http://links.lww.com/DCR/A770.