Clinical Scorecard: Concurrent Participation in Critical Care Research: A Secondary Analysis of the RECOVERY-RS Study

At a Glance

Key Highlights

• 62% of patients in RECOVERY-RS were co-enrolled in another clinical study during the COVID-19 pandemic.
• Co-enrolment rates varied widely across hospitals, ranging from 25% to 97%.
• Co-enrolment did not materially influence trial outcomes of tracheal intubation or mortality.

Guideline-Based Recommendations

Diagnosis

• Identify patients with COVID-19 acute hypoxaemic respiratory failure eligible for respiratory support trials.

Management

• Randomise patients to CPAP, HFNO, or conventional oxygen therapy as per RECOVERY-RS protocol.
• Consider co-enrolment in multiple studies to optimise trial recruitment in critical care settings.

Monitoring & Follow-up

• Monitor outcomes including tracheal intubation and mortality.
• Track co-enrolment status to assess potential impact on study findings.

Risks

• Be aware of regulatory and participant burden challenges associated with co-enrolment.
• Consider potential influence of co-enrolment on study data interpretation, though evidence suggests minimal impact.

Patient & Prescribing Data

Critically ill COVID-19 patients enrolled in respiratory support trials

Co-enrolment is common and feasible without materially affecting primary trial outcomes.

Clinical Best Practices

• Implement co-enrolment strategies to maximise recruitment in critical care research.
• Ensure ethical and regulatory approvals address co-enrolment considerations.
• Collect and analyse co-enrolment data to understand its influence on trial results.
• Engage multidisciplinary teams and patients to support high co-enrolment rates.
• Use logistic regression or similar methods to evaluate co-enrolment impact on outcomes.

References

• RECOVERY-RS trial registration
• RECOVERY-RS study publication
• Previous co-enrolment reports in critical care trials
• Confederation of Respiratory Critical Care Trials