Core Outcome Measures in Effectiveness Trials

Core Outcome Set (COS) for cryptoglandular perianal fistulas (CPF): an international Delphi study in collaboration with European Society of ColoProctology (ESCP) representatives

General Information

Summary:
Cryptoglandular perianal fistula is a disorder with an incidence of around 2 per 10,000 per year in European countries. The most common reported symptoms are discharge and pain. Patients often suffer from social embarrassment and loss of quality of life. The most common used classification of CPF is the Parks’ classification describing the relation between the fistula and the sphincter complex. There are several guidelines for CPF describing different treatment algorithms. Nevertheless, there remains debate regarding the best treatment modality for each type of CPF.
Studies investigating the effectiveness of interventions for CPF have used a wide variety of outcomes and outcome measurement instruments. This hampers meta-analysis and evidence-based decision making regarding CPF. A solution for this heterogeneity in outcome reporting is the development of a Core Outcome Set (COS). A COS represents the minimum set of outcomes that should be assessed and reported in every study for a specific condition. The objective of this project is to develop a COS that can be used in studies evaluating interventions for CPF.
A list of candidate outcomes will be generated by a systematic review and patient interviews. Consensus will be established by an online Delphi process. During the Delphi process participants will receive feedback to facilitate convergence to a consensus opinion. The final COS will be discussed by all participants at a face-to-face meeting. Both healthcare professionals and patients will participate in the Delphi process. Healthcare professionals will be recruited internationally by contacting international representatives of the ESCP.

Contributors:
1. Astrid J.H.M. Machielsen, Department of Surgery and Colorectal Surgery, Maastricht University Medical Centre+, Maastricht, The Netherlands
2. Kapil Sahnan, Robin Phillips’ Fistula Research Unit, St Mark’s Hospital, London, UK
3. Samuel O. Adegbola, Robin Phillips’ Fistula Research Unit, St Mark’s Hospital, London, UK
4. Jos Kleijnen, Department of Family Practice; Care and Public Health Research Institute (CAPHRI), Maastricht University, Maastricht, The Netherlands
5. Carmen D. Dirksen, Department of Clinical Epidemiology and Medical Technology Assessment; Care and Public Health Research Institute (CAPHRI), Maastricht University Medical Centre+, Maastricht, The Netherlands
6. Nusrat Iqbal, Robin Phillips’ Fistula Research Unit, St Mark’s Hospital, London, UK
7. Carolynne Vaizey, Sir Alan Parks Physiology Unit, St Mark’s Hospital, London, UK
8. Phil J. Tozer, Robin Phillips’ Fistula Research Unit, St Mark’s Hospital, London, UK
9. Stéphanie O. Breukink, Department of Surgery and Colorectal Surgery, Maastricht University Medical Centre+, Maastricht, The Netherlands

National representatives of the European Society of ColoProctology (ESCP) are collaborators in this study.

Corresponding author: S.O. Breukink, s.breukink@mumc.nl, +31 43 3876543


Further Study Information

Current Stage:
Ongoing
Date:
May 2018 - December 2019
Funding source(s):
None

Health Area

Disease Category
Gastroenterology

Disease Name
Cryptoglandular perianal fistula

Target Population

Age Range
18 - 100

Sex
Either


Nature / type of Intervention
Drug
Surgery

Method(s)

Consensus meeting
Delphi process
Interview
Systematic review

This study will follow a multistep approach as recommended by COMET Initiative (http://www.comet-initiative.org/).

Phase 1 – systematic review and patient interviews
The clinical outcomes assessed and reported in interventional studies for CPF will be identified by performing a systematic review (Review 1). To ensure that the outcomes in the COS are not predominantly determined by healthcare professionals, patients will be interviewed to identify patient reported outcomes (Review 2). The outcomes resulting from the systematic review and patient interviews will be categorised into domains and taken forward to Phase 2 (Delphi process).

Phase 2 – Delphi process
Consensus on the outcomes that should be included in the COS for CPF will be established by performing an international Delphi study. In up to three Delphi rounds, healthcare professionals and patients will be asked to score the outcomes on a 9-point Likert scale. During the Delphi process responses will be summarized and reported anonymously facilitating convergence to a consensus opinion. Healthcare professionals will be recruited internationally by contacting international representatives of the ESCP.

Phase 3 – Consensus meeting
The final COS will be decided in a consensus meeting with all stakeholders during the annual ESCP meeting in September 2019.


Stakeholders Involved

Clinical experts
Consumers (patients)

Study Type

COS for clinical trials or clinical research
COS for practice

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