Methods in the design and implementation of the Randomized Evaluation of Sedation Titration for Respiratory Failure (RESTORE) clinical trial

Table 3 Co-enrollment decision-making grid

	Impact of co-enrollment	Trial A	Trial B
Scientific integrity
Intervention-related
1. Population of concern	Overlap?
2. Enrollment window	Which closes first?
3. Timing of intervention	Overlap?
4. Study period	Overlap?
5. Exclusion criteria	Conflict?
Overlapping endpoints
6. Primary endpoint	Overlap?
6. Primary endpoint	Potential impact?
7. Secondary and exploratory endpoints	Overlap?
7. Secondary and exploratory endpoints	Potential impact?
Other
8. Magnitude of interaction	Known/unknown?
8. Magnitude of interaction	Dilution/enhancement of effect?
9. Level of randomization	Same/different?
10. Timing of randomization	Same/different?
11. Potential of imbalance	Yes/no?
12. Effect of co-enrollment	Contamination?
Data interpretation
13. Power to determine interactions	Sufficient/insufficient?
14. Attribution of adverse events	Easy/difficult?
Feasibility/burden
15. Parent/legal guardian burden	Yes/no?
16. Site investigator burden	Yes/no?
17. Bedside clinical team burden	Yes/no?
18. Current sharing scheme	Yes/no?
Additional considerations
19. Impact on publication	Known/unknown?
20. Intervention use off-protocol	Yes/no?
21. Priority	High/low?
22. Possible sharing arrangement

ISSN: 1745-6215