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Developing a core outcome set for fistulising perianal Crohn's disease
Kapil Sahnan1,2, Phil J Tozer1,2, Samuel O Adegbola1,2
1Fistula Research Unit, St Mark's Hospital and Academic Institute, London, UK.
Gut
|February 14, 2018
Summary
A new core outcome set (COS) for fistulising perianal Crohn's disease (pCD) was developed. This standardized approach will improve treatment comparisons and patient care by reducing outcome reporting heterogeneity.
Area of Science:
- Gastroenterology and Surgery
- Clinical Trial Methodology
Background:
- Standardized outcomes are lacking for fistulising perianal Crohn's disease (pCD), hindering treatment analysis and comparison.
- Developing a core outcome set (COS) is crucial for resolving these data heterogeneity issues.
Purpose of the Study:
- To establish a definitive, consensus-driven core outcome set (COS) for fistulising perianal Crohn's disease (pCD).
- To standardize outcome reporting in clinical trials and real-world data for pCD.
Main Methods:
- Candidate outcomes identified via systematic reviews and patient interviews.
- A three-round Delphi process involving 187 national stakeholders across three panels (clinicians and patients).
- Final consensus achieved through a meeting of 41 experts and patients.
Main Results:
- 295 initial outcomes were refined to 49 prioritized outcomes.
- An eight-domain COS was agreed upon, including patient-reported outcomes (quality of life, incontinence, patient priorities) and clinician-reported outcomes (disease activity, abscess/sepsis, fistula recurrence, surgery, diversion).
Conclusions:
- A comprehensive COS for fistulising pCD has been successfully developed through multi-stakeholder consensus.
- Implementation of this COS will reduce heterogeneity in outcome reporting, enabling better treatment comparisons and data synthesis.
- The standardized COS is expected to ultimately benefit patient care in fistulising pCD.
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