Clinical Report: Impact of Co-enrolment in RECOVERY-RS Critical Care Trial
Overview
In the RECOVERY-RS trial involving 1,273 COVID-19 patients, 62% were co-enrolled in additional studies. Despite variability in co-enrolment rates across hospitals and differences in patient characteristics, co-enrolment did not materially affect key trial outcomes such as tracheal intubation or mortality.
Background
Co-enrolment allows patients to participate in multiple clinical studies simultaneously, which can optimize recruitment in critical care settings with limited patient pools. However, it raises challenges including regulatory issues, participant burden, and potential impacts on study results. The COVID-19 pandemic accelerated clinical research efforts, increasing opportunities for co-enrolment. The RECOVERY-RS trial evaluated non-invasive respiratory support strategies in COVID-19 acute hypoxaemic respiratory failure and provided a unique context to study co-enrolment effects.
Data Highlights
Parameter
Co-enrolled (n=789)
Not Co-enrolled (n=484)
p-value
Male, %
69
62
0.007
White ethnicity, %
74
67
0.006
No co-morbidities, %
40
33
0.013
Admission to critical care, %
62
56
0.022
Tracheal intubation, %
41
36
0.103
Mortality, %
18
20
0.361
Key Findings
62% of RECOVERY-RS participants were co-enrolled in at least one other study.
Co-enrolment rates varied widely across hospitals, ranging from 25% to 97%.
Co-enrolled patients were more often male, white, and without co-morbidities compared to non-co-enrolled patients.
Co-enrolled patients exhibited indicators of more severe illness, including lower baseline oxygenation ratios and increased use of awake prone positioning.
There was no statistically significant difference in tracheal intubation or mortality rates between co-enrolled and non-co-enrolled groups.
Co-enrolment did not materially influence the interpretation of primary trial outcomes.
Clinical Implications
High rates of co-enrolment in critical care trials are feasible and can be achieved without compromising trial integrity or outcomes. Clinicians and researchers should consider co-enrolment as a strategy to enhance trial recruitment, especially during pandemics or when patient populations are limited. Careful monitoring and reporting of co-enrolment practices remain important to ensure valid interpretation of trial results.
Conclusion
This secondary analysis demonstrates that co-enrolment is common and variable across sites but does not materially affect key clinical trial outcomes in critical care research. These findings support the safe and effective use of co-enrolment strategies in future trials.
References
RECOVERY-RS Study Group 2023 -- Concurrent Participation in Critical Care Research: A Secondary Analysis of the RECOVERY-RS Study
London - Brighton & Sussex Research Ethics Committee 2020 -- Ethical Approval for RECOVERY-RS
University of Warwick Biomedical and Scientific Research Ethics Committee 2023 -- Secondary Analysis Approval
