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A core outcome set was developed to standardize and prioritize clinically and personally meaningful measures in fecal incontinence research.  

The study published in June 2025 in the Lancet Gastroenterology and Hepatology on Fecal incontinence was recognized as a debilitating anorectal condition that hindered QoL, with inconsistent outcome reporting limiting evidence synthesis and overlooking outcomes important to daily living.  

Researchers conducted a retrospective study to develop a core outcome set (COS) for evaluating treatment efficacy in adults with fecal incontinence, incorporating perspectives from diverse stakeholders.  

They followed COMET initiative guidelines and conducted the study in 3 phases: identifying outcomes through patient interviews and a systematic literature review, refining outcomes using 2 Delphi survey rounds, and finalizing the COS in a stakeholder consensus meeting. The first Delphi round included 109 participants (73 healthcare professionals, researchers, and 36 patients), while the second round involved 74 participants (54 and 20, respectively). Participants rated each outcome on a 9-point Likert scale to determine its importance.  

The results showed that out of 58 outcomes assessed in round 1, along with 3 additional outcomes, 27 were excluded, and 34 proceeded to a consensus meeting. The final COS included 13 outcomes, comprising 7 related to the QoL (influence on daily activities, QoL, social functioning, treatment satisfaction, enjoyment in life, embarrassment, and peace of mind) and 6 clinical outcomes (severity of fecal incontinence, number of fecal incontinence episodes, urgency, stool consistency, adverse events, and adherence to therapy), which are particularly relevant for both clinical practice and surgery based interventions. 

Investigators concluded that the finalized COS provided a foundation for standardizing outcome reporting in fecal incontinence research, with further work needed to define measurement tools and timing. 

Source: thelancet.com/journals/langas/article/PIIS2468-1253(25)00013-5/abstract