A validated severity score for haemorrhoids as an essential prerequisite for future haemorrhoid trials

Abstract

Background There 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. Methods The 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). Results The 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. 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.

Symptom‐based scoring for haemorrhoidal disease: a systematic review

“…This utilised the COS-MIN methodology and produced adequate results for the criteria for good measurement properties. The two studies from Lee et al [18] and Rørvik et al [21] showed the HSS to have satisfactory responsiveness, suggesting that it is suitable for use in clinical trials. The HSS was used in two major trials, the HuBBle trial and the eTHoS trial ('Comparison of stapled haemorrhoidopexy with traditional excisional surgery for haemorrhoidal disease') [19,23].…”

Short-Term Results of Sclerotherapy with 3% Polidocanol Foam for Symptomatic Second- and Third-Degree Hemorrhoidal Disease

“…Recently, it has been successfully validated and considered as an essential tool for future hemorrhoid trials [22].…”

Radiofrequency ablation for the treatment of haemorrhoidal disease: a minimally invasive and effective treatment modality

“…Face-to-face and telephone interviews were conducted pre- and postoperatively by the direct care team to collect data on patient demographics; diagnostics; postoperative pain and satisfaction scores; and procedure-related complications. We also gave patients a questionnaire to assess their Haemorrhoid Severity Score (HSS), including pain, itching, discomfort, bleeding, soiling, and haemorrhoidal tissue prolapse [9, 10] (Table 1); anal incontinence and quality of life 2–3 weeks before and 6–8 weeks after the procedure. Cleveland Incontinence Score (CIS), European Quality-of-Life Five Dimension, Five Level (EQ-5D-5L), and Visual Analogue Scale (VAS) scores were assessed before and 2 months after the procedure.…”