Core Outcome Measures in Effectiveness Trials

Developing a core outcome set for in rectovaginal fistula

General Information

Summary:
Introduction

Innovations in rectovaginal fistula have led to a proliferation of techniques; however, lack of standardised outcome measures hamper effective analysis and comparison of data. The development of standardised outcome measures can solve these issues and this study defines a core outcome set (COS) for rectovaginal fistula.

Methods

In Phase 1, identify a long-list of candidate outcomes that could be measured in rectovaginal fistula trials, and categorise outcomes into domains. This will be done through a systematic review of the literature and patient interviews.

In Phase 2, outcome domains will be presented via a web-based Delphi system to assess key stakeholders’ views on the importance of each domain. Participants will be asked to score each outcome on a nine-point Likert scale based upon how important they felt it was in deciding whether the overall treatment of [their/their patient’s] rectovaginal fistula had worked well. The stakeholders will be identified from (inter)national organisations, and include a range of healthcare professionals and people living with rectovaginal fistula. In round 1 of this process participants will also be given the opportunity

In Phase 3, a face-to-face consensus meeting with all stakeholders will be used to finalise and ratify the core outcome set.



Results

In total, 187/238 (78.5%) of the recruited participants completed phase one (92 outcomes), 176/187 (94.1%) completed phase two (80 outcomes, including five de-novo outcomes) and 183/187 (97.9%) completed phase three (50 outcomes).

The consensus meeting of 41 experts (across all stakeholder groups) generated agreement on an eight domain COS. This constituted three patient-reported outcome domains (quality of life, incontinence and a combined score of patient priorities), five clinician-reported outcome domains (perianal disease activity, development of new perianal abscess/sepsis, new/recurrent fistula, unplanned surgery and faecal diversion).


Conclusion

A COS in fistulating pCD will reduce the heterogeneity of outcome reporting with the overall aim to improve the quality of research to benefit patient care.


Contributors:
Kapil Sahnan - St Mark's Hospital
Phil Tozer - St Mark's Hospital

Further Study Information

Current Stage:
Ongoing
Date:
January 2018 - January 2019
Funding source(s):
St Mark's Hospital, Fistula Research Unit

Health Area

Disease Category
Pregnancy & childbirth

Disease Name
Rectovaginal fistula

Target Population

Age Range
18 - 100

Sex
Female


Nature / type of Intervention
Surgery

Method(s)

Consensus conference
Consensus meeting
Delphi process
Interview
Literature review
Semi structured discussion
Survey
Systematic review

Stakeholders Involved

Charities
Clinical experts
Conference participants
Consumers (caregivers)
Consumers (patients)
Patient/ support group representatives
Researchers

Study Type

COS for clinical trials or clinical research
COS for practice

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