Study protocol for the development of a pouch anal and vaginal fistula core outcome measurement set (PAVFCOMS)
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Published version
Author(s)
Type
Journal Article
Abstract
Pouch-related fistulae, such as pouch-anal and pouch-vaginal fistulae, are serious complications that impact ⁓5% of patients undergoing ileoanal pouch surgery, frequently leading to pouch failure. Research on treatment options is limited by small studies with inconsistent outcome reporting. To address this, the Pouch Anal and Vaginal Fistula Core Outcome Set (PAVFCOS) was developed, identifying seven key outcomes through stakeholder consensus. This study aims to create a core outcome measurement set (PAVFCOMS) to standardize how outcomes are measured in pouch fistula treatment, in line with Consensus-based Standards for the Selection of Health Measurement Instruments (COSMIN) guidelines. PAVFCOMS will incorporate validated patient-reported (PROMs) and clinician-reported (ClinROMs) outcome measures to provide a standardized tool for future clinical research. The study follows a two-phase process per COSMIN guidance. Phase one involves a systematic review to identify and assess current measurement instruments used in pouch fistula research and has been prospectively registered on PROSPERO (CRD42024505563). The second phase uses a Delphi process with international stakeholders, including patients, surgeons, gastroenterologists, radiologists and nurses, to reach consensus on the final measurement set. This will identify measurement instrument gaps and select the best available tools for each outcome. Reporting will adhere to ACCORD guidelines. This is the first international consensus to establish a core outcome measurement set for pouch fistula research. Standardized outcome measurement will enhance trial quality and facilitate stronger systematic reviews and meta-analyses. A key strength of this study is its patient-centred approach, ensuring the relevance of outcomes to the patient community, reflecting their lived experiences with pouch fistulae.
Date Issued
2025-01-06
Date Acceptance
2024-12-13
Citation
Journal of Surgical Protocols and Research Methodologies, 2025, 2025
ISSN
2752-616X
Publisher
Oxford University Press
Journal / Book Title
Journal of Surgical Protocols and Research Methodologies
Volume
2025
Copyright Statement
© The Author(s) 2025. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (https://creativecommons.org/licenses/by/4.0/), which
permits unrestricted reuse, distribution, and reproduction in any medium, provided the original work is properly cited.
permits unrestricted reuse, distribution, and reproduction in any medium, provided the original work is properly cited.
License URL
Identifier
https://doi.org/10.1093/jsprm/snae017
Publication Status
Published
Article Number
snae017
Date Publish Online
2025-01-06