Faecal incontinence core outcome set: an international Delphi consensus exercise among patients, health-care professionals, and researchers
1Department of Surgery and Colorectal Surgery, Maastricht University Medical Centre, Maastricht, Netherlands; Department of Gastroenterology-Hepatology, Maastricht University Medical Centre, Maastricht, Netherlands; Institute of Nutrition and Translational Research in Metabolism, Maastricht University, Maastricht, Netherlands.
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Summary
This study developed a core outcome set (COS) for faecal incontinence research, ensuring patient-centered outcomes are prioritized alongside clinical measures. The new COS includes 13 essential outcomes to improve treatment evaluation and patient care.
Area of Science:
- Anorectal Disorders Research
- Patient-Reported Outcomes
- Clinical Trial Methodology
Background:
- Faecal incontinence significantly impacts quality of life, yet treatment studies often lack standardized, patient-relevant outcome measures.
- Variability in reported outcomes hinders evidence synthesis and weakens treatment recommendations for faecal incontinence.
- Existing research frequently overlooks patient-centric outcomes crucial for daily living.
Framework:
- Developed a Core Outcome Set (COS) for faecal incontinence research following COMET initiative guidelines.
- Employed a three-step process: outcome identification (patient interviews, literature review), outcome refinement (Delphi surveys), and finalization (consensus meeting).
- Incorporated diverse stakeholder perspectives, including patients, healthcare professionals, and researchers.
Implementation:
- Conducted two rounds of Delphi surveys with 109 and 74 participants, respectively.
- Utilized a 9-point Likert scale for ranking potential outcomes.
- A consensus meeting finalized the COS after discussing 34 potential outcomes.
Implications:
- The finalized COS includes 13 outcomes: 7 quality of life-related and 6 clinical outcomes.
- This standardized set aims to improve the quality and comparability of faecal incontinence treatment research.
- Future research is needed to identify appropriate measurement instruments and assessment timing for the COS outcomes.