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Development of a Core Outcome Set for the research and assessment of inoperable malignant bowel obstruction

Bravington, Alison; Obita, George; Baddeley, Elin; Johnson, Miriam J.; Murtagh, Fliss E.M.; Currow, David C.; Boland, Elaine G.; Nelson, Annmarie; Seddon, Kathy; Oliver, Alfred; Noble, Simon I. R.; Boland, Jason W.

Authors

George Obita

Elin Baddeley

David C. Currow

Elaine G. Boland

Annmarie Nelson

Kathy Seddon

Alfred Oliver

Simon I. R. Noble

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Dr Jason Boland J.Boland@hull.ac.uk
Senior Clinical Lecturer and Honorary Consultant in Palliative Medicine



Abstract

BACKGROUND: Malignant bowel obstruction is experienced by 15% of people with advanced cancer, preventing them from eating and drinking and causing pain, nausea and vomiting. Surgery is not always appropriate. Management options include tube or stent drainage of intestinal contents and symptom control using medication. Published literature describing palliative interventions uses a broad range of outcome measures, few of which are patient-relevant. This hinders evidence synthesis, and fails to consider the perspectives of people undergoing treatment. AIMS: To develop a Core Outcome Set for the assessment of inoperable malignant bowel obstruction with clinician, patient and caregiver involvement, using COMET methodology (Core Outcome Measures in Effectiveness Trials). METHODS: A systematic review of clinical trials and observational studies, a rapid review of the qualitative literature and in-depth patient and clinician interviews were conducted to identify a comprehensive list of outcomes. Outcomes were compared and consolidated by the study Steering Group and Patient and Public Involvement contributors, and presented to an international clinical Expert Panel for review. Outcomes from the finalised list were rated for importance in a three-round international Delphi process: results of two survey rounds were circulated to respondents, and two separate consensus meetings were conducted with clinicians and with patients and caregivers via virtual conferencing, using live polling to reach agreement on a Core Outcome Set. RESULTS: 130 unique outcomes were identified. Following the independent Expert Panel review, 82 outcomes were taken into round 1 of the Delphi survey; 24 outcomes reached criteria for critical importance across all stakeholder groups and none reached criteria for dropping. All outcomes rated critically important were taken forward for re-rating in round 2 and all other outcomes dropped. In round 2, all outcomes were voted critically important by at least one stakeholder group. Round 2 outcomes were presented again at online consensus meetings, categorised as high ranking (n = 9), middle ranking (n = 7) or low ranking (n = 8). Stakeholders reached agreement on 16 core outcomes across four key domains: Symptom control, Life impact, Treatment outcomes, and Communication and patient preferences. CONCLUSION: Use of this Core Outcome Set can help to address current challenges in making sense of the evidence around treatment for inoperable malignant bowel obstruction to date, and underpin a more robust future approach. Clearer communication and an honest understanding between all stakeholders will help to provide a basis for responsible decision-making in this distressing situation in clinical practice.

Citation

Bravington, A., Obita, G., Baddeley, E., Johnson, M. J., Murtagh, F. E., Currow, D. C., …Boland, J. W. (2023). Development of a Core Outcome Set for the research and assessment of inoperable malignant bowel obstruction. PLoS ONE, 18(8), Article e0289501. https://doi.org/10.1371/journal.pone.0289501

Journal Article Type Article
Acceptance Date Jul 20, 2023
Online Publication Date Aug 22, 2023
Publication Date Jan 1, 2023
Deposit Date Aug 24, 2023
Publicly Available Date Aug 24, 2023
Journal PloS one
Print ISSN 1932-6203
Electronic ISSN 1932-6203
Publisher Public Library of Science
Peer Reviewed Peer Reviewed
Volume 18
Issue 8
Article Number e0289501
DOI https://doi.org/10.1371/journal.pone.0289501
Keywords Multidisciplinary
Public URL https://hull-repository.worktribe.com/output/4367038

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Publisher Licence URL
http://creativecommons.org/licenses/by/4.0

Copyright Statement
Copyright: © 2023 Bravington et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.




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