Developing a core outcome set for fistulising perianal Crohn’s disease

Abstract

ObjectiveLack 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.DesignCandidate 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.ResultsA 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).ConclusionA 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.

The Association of Coloproctology of Great Britain and Ireland consensus guidelines in surgery for inflammatory bowel disease

“…Patients with IBD have demonstrated significant engagement with research processes that prioritize patient‐centred outcomes , and a willingness to be involved in research .

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Methodology in core outcome sets

“…There is a burden that goes with completion of surveys and we recognize this as a limit of the method. By comparison, the recent COS for Crohn's anal fistula secured responses from 120 clinicians in round 1 of responses . The point of this comparison is that the outcomes ranked by clinicians in the latter study are likely to be more reflective of clinician opinion than the limited sample in the former. Patient involvement: Typically COS development includes some focus group or qualitative work .…”

“…The authors of this study have gone a step further and proposed primary and secondary outcomes. We are not aware of this step being taken in other COS development studies in surgery . We believe that patient‐focused outcomes are important; however, there are study designs where a non‐patient‐reported outcome measure would be appropriate as the primary measure, e.g.…”

The IDEAL and the EQUATOR

“…When considering how to evaluate innovation, core outcome sets (COS) have been proposed as the minimum that should be measured and reported in all clinical trials of a specific condition. Across a wide range of diseases, core outcomes exist, and the COMET website (http://www.comet-initiative.org/) lists over 1000, many are directly relevant to colorectal surgery . Better design of research will lead to higher quality studies and wider applicability.…”