Evidence map›Paper›PMID 38704520›Full record

Trial reportBMC medical research methodology2024

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

Brittany Dennis, Adam Deane, François Lauzier, Nicole Zytaruk, Miranda Hardie, Naomi Hammond, Simon Finfer, Yaseen Arabi, John Marshall, Lois Saunders and 18 more

Abstract readRandomized Controlled TrialMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in BMC medical research methodology, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Trial
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

28 authors.

Brittany DennisDepartment of Medicine, McMaster University, Hamilton, Ontario, Canada.
Adam DeaneDepartment of Critical Care Or Medicine, Department of Critical Care Medicine, Melbourne Medical School, University of Melbourne, Parkville, Victoria, Australia.
François LauzierDepartments of Anesthesiology, Medicine and Critical Care Medicine, Université Laval, Québec, Canada.
Nicole ZytarukDepartment of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Ontario, Canada.
Miranda HardieCritical Care Program, Faculty of Medicine, The George Institute for Global Health, University of New South Wales, Sydney, NSW, Australia.
Naomi HammondCritical Care Program, Faculty of Medicine, The George Institute for Global Health, University of New South Wales, Sydney, NSW, Australia.
Simon FinferCritical Care Program, Faculty of Medicine, The George Institute for Global Health, University of New South Wales, Sydney, NSW, Australia.
Yaseen ArabiIntensive Care Department, Ministry of the National Guard-Health Affairs, Riyadh, Kingdom of Saudi Arabia.
John MarshallInterdepartmental Division of Critical Care, University of Toronto, Toronto, Ontario, Canada.
Lois SaundersDivision of Critical Care, Research Institute, St. Joseph's Healthcare Hamilton, Hamilton, Ontario, Canada.
Diane Heels-AnsdellDepartment of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Ontario, Canada.
John MyburghCritical Care Program, Faculty of Medicine, The George Institute for Global Health, University of New South Wales, Sydney, NSW, Australia.
Serena KnowlesCritical Care Program, Faculty of Medicine, The George Institute for Global Health, University of New South Wales, Sydney, NSW, Australia.
John MuscedereDepartment of Critical Care Medicine, Queen's University, Kingston, Ontario, Canada.
Marlies OstermannDepartment of Critical Care, King's College London, Thomas' Hospital, Guy's & St, London, UK.
Dorrilyn RajbhandariCritical Care Program, Faculty of Medicine, The George Institute for Global Health, University of New South Wales, Sydney, NSW, Australia.
Shane EnglishDepartment of Medicine, University of Ottawa, Ottawa, Ontario, Canada.
Karlo MaticDivision of Critical Care, Research Institute, St. Joseph's Healthcare Hamilton, Hamilton, Ontario, Canada.
Bala VenkateshCritical Care Program, Faculty of Medicine, The George Institute for Global Health, University of New South Wales, Sydney, NSW, Australia.
Abdulrahman Al FaresDepartments of Anesthesia, Critical Care Medicine, and Pain Medicine, Al-Amiri Center for Respiratory and Cardiac Failure, Al-Amiri Hospital, Ministry of Health, Kuwait Extracorporeal Life Support Program, Ministry of Health, Kuwait City, Kuwait.
Gordon GuyattDepartment of Medicine, McMaster University, Hamilton, Ontario, Canada.
Waleed AlhazzaniDepartment of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Ontario, Canada.
Hassan MumtazDepartment of Critical Care, Maroof Hospital, Islamabad, Pakistan.
Alexis PooleSchool of Public Health and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.
Feng XieDepartment of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Ontario, Canada.
Lehana ThabaneDepartment of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Ontario, Canada.
Richard HallDepartments of Anesthesia, Critical Care and Pharmacology, Dalhousie University, Halifax, NS, Canada.
Deborah CookDepartment of Medicine, McMaster University, Hamilton, Ontario, Canada. debcook@mcmaster.ca.

Funding

CIHR 202207CL3-492565-CTP-CEBA-19215
6 · The paper itself

Abstract

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

objectiveTo 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.

methodsREVISE 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.

resultsThe 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.

conclusionProtocol 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.

Indexed as

COVID-19Anti-Ulcer AgentsClinical ProtocolsFemaleGastrointestinal HemorrhageHumansIntensive Care UnitsMaleMiddle AgedPandemicsPantoprazoleRespiration, ArtificialSARS-CoV-2Anti-Ulcer AgentsPantoprazoleCOVID-19 PandemicCritically illGastrointestinal bleedingHospital transfersRandomizationStress ulcerationVentilator-associated pneumonia

Identifiers

PMID38704520
PMCPMC11069460

What OpenQuestion holds

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LicenceCC BY
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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.