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Table 6 Rationale for waived patient consent in EPOCH

From: Evaluating processes of care and outcomes of children in hospital (EPOCH): study protocol for a randomized controlled trial

1

Consent for routine documentation practice is implied with hospital admission + this is also true for other practices including staffing, ICU consultation, physician review

+ Documentation is an inherent and routine part of hospital care

+ In intervention hospitals the BedsidePEWS becomes the accepted standard for documentation

+ In control hospitals and before implementation in hospitals randomized to implement BedsidePEWS, consenting to routine care in a situation where that there is no alternative is counter-intuitive

2

Patient-level data are retrospectively obtained and + does not require patient contact

+ does not require additional clinical investigation

+ precedent exists for waived consent for this type of data collection

3

Preemptive consent for events (including in-hospital cardiac arrest, death) that have not occurred - and that may not occur

+ Is potentially distressing to families

+ Is inefficient use of research resources

4

Obtaining consent is not feasible for 100,000 patients anticipated in the study sample

+ retrospective consent from families of deceased children may add burden and is potentially distressing to families

5

Incomplete enrollment would undermine and bias the scientific validity of the study

6

Data will be presented in aggregate.

No identifying information will leave the study office in the participating hospital