Table 3.

Potential outcomes for PARDS studies.

Outcome	Timeframe	Advantages	Disadvantages
Mortality	Short term	Easy to obtain	Impractical given low baseline mortality
	28 or 60 days	Fixed time-point
	PICU	Related to acute process
	Hospital	Patient-centered
	Medium and long term	Potentially captures longer period of risk for unfavorable outcomes	Similarly low rate
	90 days		Harder to obtain follow-up
	1 year		More related to underlying comorbidities
VFD	28 days	Easy to obtain	Imbalance in components of the composite outcome
		Increases power to detect clinically meaningful improvements related to shortened ventilation	Only increases power if intervention benefits both mortality and ventilator days
Ventilator days	28 days	Easy to obtain	Needs non-invasive support explicitly defined
	PICU LOS	Related to pulmonary nature of PARDS	Unclear if patient-centered
ECMO/death	Short term	Increases power to detect efficacy of pre-ECMO “salvage therapies”	Subjective use of ECMO
			Imbalance in components of the composite outcome
			Unclear if patient-centered
Neurocognitive and functional (POPC/PCPC)	Medium and long term	Rapid (POCP/PCPC)	More thorough cognitive function requires longer testing
	90 days	Patient-centered
	1 year	Potentially completed over telephone	Changes with developmental age and with comorbidities
	Pre-return to school	Potentially more practical, as it is a prevalent outcome
Pulmonary outcomes	Medium and long term	Patient-centered Related to pulmonary nature of PARDS	Requires infrastructure (expertise and equipment) for in-person follow-up
	90 days
	1 year
	Pre-return to school
Biometric outcomes	Medium and long term	Patient-centered Does not require return to clinic Potentially improved response rate	Requires development, testing and validation Requires expertise HIPAA concerns Ownership concerns (who owns the data and how will it be used?)
	90 days
	1 year
	Pre-return to school
Psychiatric	Long term	Patient-centered	Requires infrastructure (expertise) for in-person follow-up
		Potentially completed over telephone
Health care utilization	Medium and long term	Patient-centered Does not require inpatient follow-up Related to pulmonary nature of PARDS Addresses cost to patient/family	Difficult to obtain Sensitive to local practices Potentially more related to underlying comorbidities than to PARDS
	90 days and 1 year re-hospitalization

ECMO, extracorporeal membrane oxygenation; LOS, length of stay; PARDS, pediatric acute respiratory distress syndrome; PCPC, pediatric cerebral performance category; POPC, pediatric overall performance category; PICU, pediatric intensive care unit; VFD, ventilator-free days.