What counts as patient-important upper gastrointestinal bleeding in the ICU? A mixed-methods study protocol of patient and family perspectives

Deborah J Cook; Marilyn Swinton; Karla D Krewulak; Kirsten Fiest; Joanna Dionne; Sylvie Debigare; Gordon Guyatt; Shipra Taneja; Waleed Alhazzani; Karen E A Burns; John C Marshall; John Muscedere; Audrey Gouskos; Simon Finfer; Adam M Deane; John Myburgh; Bram Rochwerg; Ian Ball; Tina Mele; Daniel Niven; Shane English; Madeleine Verhovsek; Meredith Vanstone

doi:10.1136/bmjopen-2022-070966

What counts as patient-important upper gastrointestinal bleeding in the ICU? A mixed-methods study protocol of patient and family perspectives

BMJ Open. 2023 May 19;13(5):e070966. doi: 10.1136/bmjopen-2022-070966.

Authors

Deborah J Cook^{1

2

3}, Marilyn Swinton⁴, Karla D Krewulak⁵, Kirsten Fiest⁵, Joanna Dionne^{6

2

7}, Sylvie Debigare⁸, Gordon Guyatt^{6

2}, Shipra Taneja⁴, Waleed Alhazzani^{6

2

3}, Karen E A Burns⁹, John C Marshall¹⁰, John Muscedere¹¹, Audrey Gouskos¹², Simon Finfer^{13

14}, Adam M Deane¹⁵, John Myburgh¹³, Bram Rochwerg^{6

2

7}, Ian Ball¹⁶, Tina Mele¹⁷, Daniel Niven⁵, Shane English^{18

19}, Madeleine Verhovsek⁶, Meredith Vanstone⁴

Affiliations

¹ Medicine, McMaster University, Hamilton, Ontario, Canada [email protected].
² Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Ontario, Canada.
³ Critical Care, St. Joseph's Healthcare Hamilton, Hamilton, Ontario, Canada.
⁴ Family Medicine, McMaster University, Hamilton, Ontario, Canada.
⁵ Critical Care Medicine, University of Calgary Cumming School of Medicine, Calgary, Alberta, Canada.
⁶ Medicine, McMaster University, Hamilton, Ontario, Canada.
⁷ Critical Care, Hamilton Health Sciences, Hamilton, Ontario, Canada.
⁸ Patient and Family Partnership Committee, Canadian Critical Care Trials Group, Montreal, Quebec, Canada.
⁹ Interdepartmental Division of Critical Care Medicine, University of Toronto, Toronto, Ontario, Canada.
¹⁰ Surgery and Critical Care Medicine, University of Toronto, Toronto, Ontario, Canada.
¹¹ Critical Care Medicine, Kingston Health Sciences Center, Queens University, Kingston, Ontario, Canada.
¹² Patient and Family Advisory Committee and Steering Committee Representative, Toronto, Ontario, Canada.
¹³ Critical Care, The George Institute for Global Health, University of New South Wales, Sydney, New South Wales, Australia.
¹⁴ The George Institute for Global Health, School of Public Health, Imperial College London, London, UK.
¹⁵ Critical Care, Melbourne Medical School, University of Melbourne, Parkville, Victoria, Australia.
¹⁶ Medicine and Epidemiology and Biostatistics, Western University, London, Ontario, Canada.
¹⁷ Surgery and Critical Care Medicine, Western University, London, Ontario, Canada.
¹⁸ Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, Ontario, Canada.
¹⁹ Division of Critical Care, Department of Medicine, University of Ottawa, Ottawa, Ontario, Canada.

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.

Keywords: Adult intensive & critical care; INTENSIVE & CRITICAL CARE; Protocols & guidelines.

Publication types

Clinical Trial
Research Support, Non-U.S. Gov't

MeSH terms

Gastrointestinal Hemorrhage / therapy
Humans
Intensive Care Units
Multicenter Studies as Topic
Peptic Ulcer*
Research Design
Ulcer*

Associated data

ClinicalTrials.gov/NCT05506150