Background Informed consent rates are inconsistently incorporated in trial reports, and literature on consent patterns and predictions is sparse, particularly in the field of critical care.

Objective The overall objective of this study is to describe the patterns and predictors of consent rates in REVISE. The specific aims are to analyze the consent models used, consent rates, participants in the consent encounter, reasons for declined consent, and factors associated with obtaining consent.

Methods This is a pre-planned secondary study of the REVISE Trial (NCT03374800) which compared pantoprazole to placebo on the outcome of clinically important upper gastrointestinal bleeding among invasively ventilated patients in the intensive care unit (ICU). Research ethics committees approved the protocol in all jurisdictions. Research personnel prospectively collected standardized data for each consent encounter, including the consent model (a priori, deferred, or opt-out), the role of the individual who provided or declined consent (patient, SDM, other), and the reasons for declined consent, the role of the individual who requested consent (research coordinator, site investigator, ICU physician) and the consent encounter method (in person or via telephone). When consent was provided and then later revoked, who revoked consent (patient, SDM, other) and timing (in ICU, in hospital, post hospital), as well as details about permission for data retention were collected. In this study, consent rates will be calculated across REVISE sites, and in relation to the COVID-19 pandemic. We will also calculate the consent rates for a priori and deferred consent models, the timing from deferred recruitment to consent provided or declined, which personnel requested consent (research coordinator, site investigator, ICU physicians, other), and who engaged in the consent encounter for each consent model (patient, SDM, other). Multilevel logistic regression analysis will be conducted to evaluate variables independently associated with consent including additional site and staff variables.

Results By analyzing the frequency and impact of consent models, and consent encounters with various stakeholders, results will highlight the acceptability of different approaches, and the impact of different approaches in this critical care trial.

Conclusions This pre-planned retrospective sub-study using an international randomized controlled trial database will provide useful informed consent metrics and knowledge that is relevant to contemporary global trial conduct.

The authors have declared no competing interest.

NCT03374800

Funding for this analysis was from the Sinai Health System Department of Medicine. REVISE was funded by peer-reviewed grants [Canadian Institutes of Health Research 201610PJT-378226-PJT-CEBA-18373; Canadian Institutes of Health Research 202207CL3-492565-CTP-CEBA-19215]. The National Health and Medical Research Council of Australia grant [GNT1124675] funded enrolment in Australia. REVISE was approved by the National Institute for Health Research (NIHR) in the UK as a Portfolio Study [CPMS ID 45782], eligible for support from the NIHR Clinical Research Network. [https://www.nihr.ac.uk/researchers/collaborations-services-and-support-for-your-research/run-your-study/crn-portfolio.htm]. This trial received no support from the commercial or private sector.  

I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained.

Yes

The details of the IRB/oversight body that provided approval or exemption for the research described are given below:

Hamilton Integrated Health Ethics Board

I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals.

Yes

I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance).

Yes

I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable.

Yes

for the REVISE Research Coordinators, REVISE Investigators, Canadian Critical Care Trials Group and the Australian and New Zealand Intensive Care Society Clinical Trials Group

Not applicable - Protocol Manuscript