Toward a core outcome set for faecal incontinence—A systematic review of outcomes reported in the literature

Aim
Faecal incontinence (FI) is a prevalent issue which can have a detrimental impact on the patient's quality of life. Current international guidelines lack strong treatment recommendations due to few studies in the field, in combination with the heterogeneity in outcome reporting. To address this, a core outcome set (COS) is proposed to standardize outcome reporting in FI studies, facilitating meta-analyses and enhancing therapeutic recommendations. Through several steps outlined by COMET ‘what’ to measure will be determined prior to determining ‘how’ to measure these outcomes. This systematic review aims to identify ‘what’ outcomes have been used in FI intervention studies so far in adult patients as a starting phase for the development of a future COS for FI.

Method
Medline, Embase and the Cochrane library were searched to identify all outcomes reported in comparative effectiveness trials assessing one or more treatment option in adult patients suffering from FI. The outcomes were categorized according to the Core Outcome Measurement in Effectiveness Trials (COMET) taxonomy to standardize outcome terminology, assess completeness, and inform subsequent steps in COS development.

Results
A total of 109 studies were included, which revealed 51 unique outcomes classified into 38 domains within four core areas. On average four outcomes were reported per study (range 1–11). The most commonly reported outcomes were “severity of FI” (83%), “quality of life” (64%), “number of FI episodes” (40%), “anorectal motor function” (39%), and “frequency of bowel movements” (16%).

Conclusion
This systematic review offers an overview of outcomes reported in FI studies, highlighting the heterogeneity between studies. This heterogeneity emphasizes the need for standardizing outcome reporting which can be established through the creation of a COS.

Contributors

Sadé L. Assmann, Evy Mulders, Merel L. Kimman, Daniel Keszthelyi, Stephanie O. Breukink

Publication

Journal: Colorectal Disease
Volume:
Issue:
Pages: -
Year: 2024
DOI: 10.1111/codi.17075

Further Study Information

Current Stage: Completed
Date:
Funding source(s): No funding was received for this systematic review.


Health Area

Disease Category: Gastroenterology

Disease Name: Fecal Incontinence

Target Population

Age Range: 18 - 120

Sex: Either

Nature of Intervention: Any

Stakeholders Involved

Study Type

- Systematic review of outcomes measured in trials

Method(s)

- Systematic review

Medline, Embase and the Cochrane library were searched to identify all out-comes reported in comparative effectiveness trials assessing one or more treatmentoption in adult patients suffering from FI. The outcomes were categorized according tothe Core Outcome Measurement in Effectiveness Trials (COMET) taxonomy to stand-ardize outcome terminology, assess completeness, and inform subsequent steps in COSdevelopment.