Consent-to-continue in intensive care clinical trials: A scoping review and recommendation for reporting

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OBJECTIVES: In acute clinical scenarios, consent-to-continue (CTC) permits patient enrolment into clinical trials, and commencement of intervention, prior to obtaining consent. Consent, for continuation in the trial, is then sought once the emergent situation has passed. Despite implementation of CTC in intensive care unit (ICU) research, there are few studies investigating implementation and acceptability of this approach. Our objective was to describe implementation, experiences, and determinants of acceptability of CTC for ICU randomised controlled trials (RCTs). METHODS: A scoping review was conducted. Academic databases, and databases of ICU RCTs, were used to identify studies that reported the results of RCTs and/or the views and acceptability of CTC. RESULTS: 5,454 ICU RCTs were screened. 159 RCTs used CTC (2.9% of all ICU RCTs; 13/1,144 [1.1%] neonatal RCTs, 13/567 [2.3%] paediatric RCTs, 133/3,743 [3.6%] adult RCTs). CTC was used either alone (26/159; 16.4%) or in combination with another consent approach, predominantly prospective consent (128/159; 80.5%). 158/159 (99.4%) of studies were led from high-income settings and most (81.1%) were published in the past 10 years. Only 39 RCTs reported consent rates separately by method of consent. Analysis of 23 studies exploring experience of CTC revealed factors that enhanced acceptability included appropriate timing, clear communication, and perceived clinical benefit, whereas concerns about autonomy, perceived risk, and post-mortem consent reduced support. CONCLUSIONS: Despite many jurisdictions allowing CTC, it is still uncommon in ICU RCTs. These results will inform the development of future processes and materials to enhance understanding, implementation and reporting of CTC. IMPLICATIONS FOR CLINICAL PRACTICE: Co-designed educational and implementation resources, alongside better reporting standards, may enhance adoption and transparency, ultimately strengthening research quality and clinical outcomes.

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