Abstract
PurposeOver the last decade, many studies were performed regarding treatment options for hemorrhoidal disease. Randomised controlled trials (RCTs) should have well-defined primary and secondary outcomes. However, the reported outcome measures are numerous and diverse. The heterogeneity of outcome definition in clinical trials limits transparency and paves the way for bias. The development of a core outcome set (COS) helps minimizing this problem. A COS is an agreed minimum set of outcomes that should be measured and reported in all clinical trials of a specific disease. The aim of this project is to generate a COS regarding the outcome of treatment after hemorrhoidal disease.MethodsA Delphi study will be performed by an international steering group healthcare professionals and patients with the intention to create a standard outcome set for future clinical trials for the treatment of hemorrhoidal disease. First, a literature review will be conducted to establish which outcomes are used in clinical trials for hemorrhoidal disease. Secondly, both healthcare professionals and patients will participate in several consecutive rounds of online questionnaires and a face-to-face meeting to refine the content of the COS.DiscussionDevelopment of a COS for hemorrhoidal disease defines a minimum outcome-reporting standard and will improve the quality of research in the future.
Highlights
Hemorrhoidal disease is one of the most common anorectal disorders presenting to coloproctological units, with a prevalence of 5–35% in the overall population [1, 2]
Grade III and IV hemorrhoidal disease is often directly treated by more invasive surgical interventions including the sutured hemorrhoidopexy [6], the stapled hemorrhoidopexy [7, 8], the Doppler-guided hemorrhoidal artery ligation (DGHAL) [9,10,11], and the traditional hemorrhoidectomy [12, 13]
The ability to compare findings between studies and synthesize data in meta-analysis is limited because the outcomes are inconsistently defined and reported in clinical trials
Summary
Hemorrhoidal disease is one of the most common anorectal disorders presenting to coloproctological units, with a prevalence of 5–35% in the overall population [1, 2]. Conservative and/or medical treatment, including diet, lifestyle changes, and application of topical ointments, is often offered first [3]. When these treatment options fail, a common treatment step is rubber band ligation (RBL) [4, 5]. The ability to compare findings between studies and synthesize data in meta-analysis is limited because the outcomes are inconsistently defined and reported in clinical trials. This hampers interpreting treatment effect and making evidencebased healthcare decisions [14, 15]. This paper describes the study protocol developing a COS that should be considered mandatory for inclusion in all future clinical trials on treatment of hemorrhoidal disease
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