Abstract
BackgroundThere is a lack of standardised outcomes for haemorrhoidal disease making comparison between trials difficult. A need for a very well validated severity score is essential to facilitate meta-analysis of comparative studies, enabling evidence-based clinical practice.MethodsThe Hubble trial provides a large cohort of patients with haemorrhoidal disease randomised to rubber band ligation (RBL) or haemorrhoidal artery ligation. The haemorrhoid severity score (HSS) was collected on each patient at baseline, 6 weeks and 1 year after intervention. This allows for the responsiveness of the HSS instrument to be examined and compared with a more specific instrument, the Vaizey incontinence score (also collected). Responsiveness was tested using four methods (effect size, standardised response means (SRM), significance of change, and responsiveness statistic).ResultsThe four tests of responsiveness demonstrated that the HSS was more responsive to changes in the patient’s health status following both of the interventions compared to the Vaizey questionnaire. For example, between baseline and 6 weeks, the RBL intervention effect size scores and SRM calculations indicated a non-significant small amount of change (0.20 and 0.16 respectively). However, using the HSS, the effect size and SRM demonstrated a large magnitude of change (1.12 and 1.01, respectively) which was significant. Similar results were observed at 1 year. Significance of change scores and the index of responsiveness were also higher for the HSS questionnaire than the Vaizey across both treatment modalities.ConclusionsThe HSS is a highly responsive tool for the detection of changes in haemorrhoid symptoms. It should form an essential patient-reported outcome tool for future studies on haemorrhoidal disease.
Highlights
Haemorrhoidal disease is a common condition, and can present with symptoms including bleeding, pain and anal leakage
There is a range of surgical interventions available including rubber band ligation (RBL), haemorrhoid artery ligation (HAL), stapled haemorrhoidopexy and excisional haemorrhoidectomy, some of which have been assessed in randomised trials [1]
Effect size and standardised response mean (SRM) calculations indicated a small amount of change (0.20 and 0.16, respectively)
Summary
Haemorrhoidal disease is a common condition, and can present with symptoms including bleeding, pain and anal leakage. The haemorrhoid severity score (HSS) was collected on each patient at baseline, 6 weeks and 1 year after intervention. This allows for the responsiveness of the HSS instrument to be examined and compared with a more specific instrument, the Vaizey incontinence score ( collected). Between baseline and 6 weeks, the RBL intervention effect size scores and SRM calculations indicated a non-significant small amount of change (0.20 and 0.16 respectively). Conclusions The HSS is a highly responsive tool for the detection of changes in haemorrhoid symptoms It should form an essential patient-reported outcome tool for future studies on haemorrhoidal disease
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