Informed Consent in an International Trial of Stress Ulcer Prophylaxis: Patterns and Predictors

Q: What does this research mean for the field?

In critical care trials, informed consent rates are significantly higher when using a deferred consent model, when patients are directly involved in the consent encounter, and during or after the COVID-19 pandemic. Novelty: ClaimNovelty.INCREMENTAL. Consensus alignment: ConsensusAlignment.NEUTRAL.

Sangeeta Mehta; Karen E. A. Burns; Nicole Zytaruk; Diane Heels-Ansdell; Lori Hand; France Clarke; M.J. Hardie; Vinayak Lad; Anna Geagea; Alexandra Binnie; François Lauzier; Jennifer L.Y. Tsang; Simon Finfer; Gabrielle Hanlon; Rebecca Gresham; John C. Marshall; Shane English; Bram Rochwerg; Neill K.J. Adhikari; Abdulrahman Al‐Fares; Draga Jichici; Paul Engels; Sunjay Sharma; Neeraj Bhadange; Wayne Stevens; Gilmar Reis; Patrick M. Archambault; Emmanuel Charbonney; Ryan Zarychanski; Gloria Vazquez-Grande; Daniel Ovakim; Tim Karachi; Joanna C. Dionne; Daniel J. Niven; Charles St.-Arnaud; Mir Waheed; DeborahJ. Cook

doi:10.1097/ccm.0000000000007314

Key Points

To describe the patterns and identify independent predictors of obtaining informed consent in an international critical care clinical trial.
Prospectively evaluated 5,024 consent encounters across participating centers within an international randomized trial of stress ulcer prophylaxis in invasively ventilated patients.
Tracked consent models (a priori vs. deferred consent), the individual approached (patient vs. substitute decision-maker [SDM]), encounter mode, and center characteristics using multilevel logistic regression.
The overall consent rate was 85.0% (ranging from 27.3% to 100%), with decline rates of 26.4% (696/2,638) in the a priori group compared to 2.4% (58/2,386) in the deferred consent group.
Higher consent rates were independently associated with the deferred consent model (OR 16.56, 95% CI 11.50–23.84), direct patient encounters (OR 2.67, 95% CI 1.63–4.37), and encounters during (OR 2.01, 95% CI 1.30–3.11) or after (OR 2.26, 95% CI 1.34–3.80) the COVID-19 pandemic.
Center-level factors, including intensive care unit size, research experience, and research coordinator experience, showed no significant association with consent rates.

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Implication

Prospective study reveals higher consent rates with deferred models and direct patient encounters in critically ill patients, highlighting key drivers of trial participation.

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Cite This Study

Mehta et al. (2026) studied this question.

synapsesocial.com/papers/6a8aae5c7677a341144476f4 https://doi.org/10.1097/ccm.0000000000007314

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Informed Consent in an International Trial of Stress Ulcer Prophylaxis: Patterns and Predictors

Key Points

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Implication

Discussion

Cite This Study

Informed Consent in an International Trial of Stress Ulcer Prophylaxis: Patterns and Predictors

Key Points

No abstract yet

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Implication

Discussion

Cite This Study

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