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© 2023 Author(s) (or their employer(s)) 2023. 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/ . Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.

Abstract

Introduction

Clinically important upper gastrointestinal bleeding is conventionally defined as bleeding accompanied by haemodynamic changes, requiring red blood cell transfusions or other invasive interventions. However, it is unclear if this clinical definition reflects patient values and preferences. This protocol describes a study to elicit views from patients and families regarding features, tests, and treatments for upper gastrointestinal bleeding that are important to them.

Methods and analysis

This is a sequential mixed-methods qualitative-dominant multi-centre study with an instrument-building aim. We developed orientation tools and educational materials in partnership with patients and family members, including a slide deck and executive summary. We will invite intensive care unit (ICU) survivors and family members of former ICU patients to participate. Following a virtual interactive presentation, participants will share their perspectives in an interview or focus group. Qualitative data will be analysed using inductive qualitative content analysis, wherein codes will be derived directly from the data rather than using preconceived categories. Concurrent data collection and analysis will occur. Quantitative data will include self-reported demographic characteristics. This study will synthesise the values and perspectives of patients and family members to create a new trial outcome for a randomised trial of stress ulcer prophylaxis. This study is planned for May 2022 to August 2023. The pilot work was completed in Spring 2021.

Ethics and dissemination

This study has ethics approval from McMaster University and the University of Calgary. Findings will be disseminated via manuscript and through incorporation as a secondary trial outcome on stress ulcer prophylaxis.

Trial registration number

NCT05506150.

Details

Title
What counts as patient-important upper gastrointestinal bleeding in the ICU? A mixed-methods study protocol of patient and family perspectives
Author
Cook, Deborah J 1   VIAFID ORCID Logo  ; Swinton, Marilyn E 2 ; Krewulak, Karla D 3   VIAFID ORCID Logo  ; Fiest, Kirsten 3   VIAFID ORCID Logo  ; Dionne, Joanna C 4   VIAFID ORCID Logo  ; Debigare, Sylvie 5 ; Guyatt, Gordon H 6 ; Taneja, Shipra 2 ; Alhazzani, Waleed 1 ; Burns, Karen E A 7 ; Marshall, John C 8 ; Muscedere, John G 9 ; Gouskos, Audrey 10 ; Finfer, Simon 11 ; Deane, Adam M 12 ; Myburgh, John A 13 ; Rochwerg, Bram 4   VIAFID ORCID Logo  ; Ball, Ian 14 ; Mele, Tina 15   VIAFID ORCID Logo  ; Niven, Daniel J 3 ; English, Shane W 16 ; Verhovsek, Madeleine 17 ; Vanstone, Meredith 2   VIAFID ORCID Logo 

 Medicine, McMaster University, Hamilton, Ontario, Canada; Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Ontario, Canada; Critical Care, St. Joseph’s Healthcare Hamilton, Hamilton, Ontario, Canada 
 Family Medicine, McMaster University, Hamilton, Ontario, Canada 
 Critical Care Medicine, University of Calgary Cumming School of Medicine, Calgary, Alberta, Canada 
 Medicine, McMaster University, Hamilton, Ontario, Canada; Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Ontario, Canada; Critical Care, Hamilton Health Sciences, Hamilton, Ontario, Canada 
 Patient and Family Partnership Committee, Canadian Critical Care Trials Group, Montreal, Quebec, Canada 
 Medicine, McMaster University, Hamilton, Ontario, Canada; Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Ontario, Canada 
 Interdepartmental Division of Critical Care Medicine, University of Toronto, Toronto, Ontario, Canada 
 Surgery and Critical Care Medicine, University of Toronto, Toronto, Ontario, Canada 
 Critical Care Medicine, Kingston Health Sciences Center, Queens University, Kingston, Ontario, Canada 
10  Patient and Family Advisory Committee and Steering Committee Representative, Toronto, Ontario, Canada 
11  Critical Care, The George Institute for Global Health, University of New South Wales, Sydney, New South Wales, Australia; The George Institute for Global Health, School of Public Health, Imperial College London, London, UK 
12  Critical Care, Melbourne Medical School, University of Melbourne, Parkville, Victoria, Australia 
13  Critical Care, The George Institute for Global Health, University of New South Wales, Sydney, New South Wales, Australia 
14  Medicine and Epidemiology and Biostatistics, Western University, London, Ontario, Canada 
15  Surgery and Critical Care Medicine, Western University, London, Ontario, Canada 
16  Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, Ontario, Canada; Division of Critical Care, Department of Medicine, University of Ottawa, Ottawa, Ontario, Canada 
17  Medicine, McMaster University, Hamilton, Ontario, Canada 
First page
e070966
Section
Intensive care
Publication year
2023
Publication date
2023
Publisher
BMJ Publishing Group LTD
e-ISSN
20446055
Source type
Scholarly Journal
Language of publication
English
ProQuest document ID
2815227103
Copyright
© 2023 Author(s) (or their employer(s)) 2023. 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/ . Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.