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Open Access 01-12-2024 | COVID-19 | Research

Protocol implementation during the COVID-19 pandemic: experiences from a randomized trial of stress ulcer prophylaxis

Authors: Brittany Dennis, Adam Deane, François Lauzier, Nicole Zytaruk, Miranda Hardie, Naomi Hammond, Simon Finfer, Yaseen Arabi, John Marshall, Lois Saunders, Diane Heels-Ansdell, John Myburgh, Serena Knowles, John Muscedere, Marlies Ostermann, Dorrilyn Rajbhandari, Shane English, Karlo Matic, Bala Venkatesh, Abdulrahman Al Fares, Gordon Guyatt, Waleed Alhazzani, Hassan Mumtaz, Alexis Poole, Feng Xie, Lehana Thabane, Richard Hall, Deborah Cook

Published in: BMC Medical Research Methodology | Issue 1/2024

Abstract

Background

During the COVID-19 pandemic, many intensive care units (ICUs) halted research to focus on COVID-19-specific studies.

Objective

To describe the conduct of an international randomized trial of stress ulcer prophylaxis (Re-Evaluating the Inhibition of Stress Erosions in the ICU [REVISE]) during the pandemic, addressing enrolment patterns, center engagement, informed consent processes, data collection, a COVID-specific substudy, patient transfers, and data monitoring.

Methods

REVISE is a randomized trial among mechanically ventilated patients, comparing pantoprazole 40 mg IV to placebo on the primary efficacy outcome of clinically important upper gastrointestinal bleeding and the primary safety outcome of 90-day mortality. We documented protocol implementation status from March 11th 2020-August 30th 2022.

Results

The Steering Committee did not change the scientific protocol. From the first enrolment on July 9th 2019 to March 10th 2020 (8 months preceding the pandemic), 267 patients were enrolled in 18 centers. From March 11th 2020-August 30th 2022 (30 months thereafter), 41 new centers joined; 59 were participating by August 30th 2022 which enrolled 2961 patients. During a total of 1235 enrolment-months in the pandemic phase, enrolment paused for 106 (8.6%) months in aggregate (median 3 months, interquartile range 2;6). Protocol implementation involved a shift from the a priori consent model pre-pandemic (188, 58.8%) to the consent to continue model (1615, 54.1%, p < 0.01). In one new center, an opt-out model was approved. The informed consent rate increased slightly (80.7% to 85.0%, p = 0.05). Telephone consent encounters increased (16.6% to 68.2%, p < 0.001). Surge capacity necessitated intra-institutional transfers; receiving centers continued protocol implementation whenever possible. We developed a nested COVID-19 substudy. The Methods Centers continued central statistical monitoring of trial metrics. Site monitoring was initially remote, then in-person when restrictions lifted.

Conclusion

Protocol implementation adaptations during the pandemic included a shift in the consent model, a sustained high consent rate, and launch of a COVID-19 substudy. Recruitment increased as new centers joined, patient transfers were optimized, and monitoring methods were adapted.

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Title: Protocol implementation during the COVID-19 pandemic: experiences from a randomized trial of stress ulcer prophylaxis
Authors: Brittany Dennis
Adam Deane
François Lauzier
Nicole Zytaruk
Miranda Hardie
Naomi Hammond
Simon Finfer
Yaseen Arabi
John Marshall
Lois Saunders
Diane Heels-Ansdell
John Myburgh
Serena Knowles
John Muscedere
Marlies Ostermann
Dorrilyn Rajbhandari
Shane English
Karlo Matic
Bala Venkatesh
Abdulrahman Al Fares
Gordon Guyatt
Waleed Alhazzani
Hassan Mumtaz
Alexis Poole
Feng Xie
Lehana Thabane
Richard Hall
Deborah Cook
Publication date: 01-12-2024
Publisher: BioMed Central
Keywords: COVID-19
Gastrointestinal Bleeding
Published in: BMC Medical Research Methodology / Issue 1/2024
Electronic ISSN: 1471-2288
DOI: https://doi.org/10.1186/s12874-024-02233-2

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Protocol implementation during the COVID-19 pandemic: experiences from a randomized trial of stress ulcer prophylaxis

Abstract

Background

Objective

Methods

Results

Conclusion

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Abstract

Background

Objective

Methods

Results

Conclusion

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