Beating the empty pelvis syndrome: the PelvEx Collaborative core outcome set study protocol
Author(s)
PelvEx Collaborative
Type
Journal Article
Abstract
INTRODUCTION: The empty pelvis syndrome is a significant source of morbidity following pelvic exenteration surgery. It remains poorly defined with research in this field being heterogeneous and of low quality. Furthermore, there has been minimal engagement with patient representatives following pelvic exenteration with respect to the empty pelvic syndrome. 'PelvEx-Beating the empty pelvis syndrome' aims to engage both patient representatives and healthcare professionals to achieve an international consensus on a core outcome set, pathophysiology and mitigation of the empty pelvis syndrome. METHODS AND ANALYSIS: A modified-Delphi approach will be followed with a three-stage study design. First, statements will be longlisted using a recent systematic review, healthcare professional event, patient and public engagement, and Delphi piloting. Second, statements will be shortlisted using up to three rounds of online modified Delphi. Third, statements will be confirmed and instruments for measurable statements selected using a virtual patient-representative consensus meeting, and finally a face-to-face healthcare professional consensus meeting. ETHICS AND DISSEMINATION: The University of Southampton Faculty of Medicine ethics committee has approved this protocol, which is registered as a study with the Core Outcome Measures in Effectiveness Trials Initiative. Publication of this study will increase the potential for comparative research to further understanding and prevent the empty pelvis syndrome. TRIAL REGISTRATION NUMBER: NCT05683795.
Date Issued
2024-03-30
Date Acceptance
2023-12-20
Citation
BMJ Open, 2024, 14 (2)
ISSN
2044-6055
Publisher
BMJ Publishing Group
Journal / Book Title
BMJ Open
Volume
14
Issue
2
Copyright Statement
© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. http://creativecommons.org/licenses/by-nc/4.0/
This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.
This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.
Identifier
https://www.ncbi.nlm.nih.gov/pubmed/38316595
Subjects
Consensus
Delphi Technique
Health Personnel
Humans
Outcome Assessment, Health Care
Research Design
Treatment Outcome
Colorectal surgery
Gastrointestinal tumours
Gynaecological oncology
Plastic & reconstructive surgery
Surveys and Questionnaires
Urological tumours
Publication Status
Published
Coverage Spatial
England
Article Number
e076538
Date Publish Online
2023-03-05