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Table 2 Eligibility criteria and rationale

From: A randomised controlled trial to compare opt-in and opt-out parental consent for childhood vaccine safety surveillance using data linkage: study protocol

Criterion

Rationale

Inclusion criteria

 

Mothers who had a live and surviving birth at the WCH.

A birth must be viable and surviving to enable data linkage of immunisation encounters at two months and hospital admissions after birth.

Mother's age was equal or above 18 years.

This is the age accepted by HRECs where informed consent can be given by an individual.

Mother was a resident of SA.

The data linkage will involve only South Australian children whose immunisation encounters will be linked with admissions to a South Australian hospital. Cross-jurisdictional migration will be unaccounted for i.e., if a family moves interstate after the birth or an infant is admitted to an interstate hospital.

Exclusion criteria

 

Maternal death, stillbirth or neonatal death. In the instance of twins or triplets, if one died, the mother was excluded.

To avoid causing distress to a bereaved family.

Infant stays in the NICU of 2 weeks or longer.

To avoid causing distress to a family dealing with issues of infant illness and prematurity.

Home births and births that occurred at other hospitals and were subsequently managed at the WCH.

To ensure each mother had received the same type of care prior to discharge and data were available in the hospital patient management system for all variables of interest.