Objective Lack of standardised outcomes hampers
effective analysis and comparison of data when
comparing treatments in fistulising perianal Crohn’s
disease (pCD). Development of a standardised set of
outcomes would resolve these issues. This study provides
the definitive core outcome set (COS) for fistulising pCD.
Design Candidate outcomes were generated through
a systematic review and patient interviews. Consensus
was established via a three-round Delphi process using
a 9-point Likert scale based on how important they felt
it was in determining treatment success culminating in
a final consensus meeting. Stakeholders were recruited
nationally and grouped into three panels (surgeons
and radiologists, gastroenterologists and IBD specialist
nurses, and patients). Participants received feedback from
their panel (in the second round) and all participants (in
the third round) to allow refinement of their scores.
Results A total of 295 outcomes were identified from
systematic reviews and interviews that were categorised
into 92 domains. 187 stakeholders (response rate
78.5%) prioritised 49 outcomes through a three-round
Delphi study. The final consensus meeting of 41 experts
and patients generated agreement on an eight domain
COS. The COS comprised three patient-reported outcome
domains (quality of life, incontinence and a combined
score of patient priorities) and five clinician-reported
outcome domains (perianal disease activity, development
of new perianal abscess/sepsis, new/recurrent fistula,
unplanned surgery and faecal diversion).
Conclusion A fistulising pCD COS has been produced
by all key stakeholders. Application of the COS will
reduce heterogeneity in outcome reporting, thereby
facilitating more meaningful comparisons between
treatments, data synthesis and ultimately benefit patient
care.