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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