Table 2.

Summary of recommendations for identifying practice misalignments in clinical trials of titrated therapies

Pretrial Design Phase
Selected Strategies	Potentially Useful Methods
• Fully characterize current practices	• Literature review including expert guidelines
• Identify patient characteristics used by providers to titrate therapy	• Consider performing any or all of the following:
	- Retrospective chart review study
• Simulate the randomization of target populations:
	- Provider survey
- Is it reasonable and informative to assign all patients enrolled to either arm of the trial?
	- Prospective observational study
Determine whether noncomparable practice misalignments might be created in each study arm	- Pilot studies of titration protocols

Partially reproduced from Crit Care Med 2007, 35(6):1509-1516 ¹⁰