Harmonization Protocol / Registry

Registry
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Registry
Networks -
Variables -

Demographic, physiological, injury and outcome data from the clinical records of TBI patients.

Number of Participants
5,753
Approach
Prospective
Type
Qualitative
Procedures
General approach
Participant Inclusion
All participants (n=5753) of the individual datasets (CENTER-TBI n=4509, Oz-ENTER n=198, CINTER-TBI India n=1046) are included in the harmonized dataset.
Associated initiative TBI Registry: Harmonized

Information Content

The E-CRF used was the same for CENTER-TBI, OzENTER, and CINTER-TBI India. All three studies were longitudinal cohort studies with harmonized data points and outcome assessments, and the same inclusion criteria were valid, but for logistic reasons, not all variables from CENTER-TBI have been captured in OzENTER and CINTER-TBI India.

Studies Included

Study Population Data Collection Event
CENTER-TBI Registry TBI patients CENTER-TBI Registy CENTER-TBI data collection
CINTER-TBI India Registry TBI patients CINTER-TBI Registy CINTER-TBI data collection

Initiatives Included

Harmonization

Complete - study-specific variable is the same as DataSchema variable (status detail = identical) or needs transformation to generate DataSchema variable (status detail = compatible)
Partial - categorical study-specific variable (status detail = proximate) or other types (status detail = tentative) could generate DataSchema variable but with loss of information
Impossible - study does not collect DataSchema variable (status detail = unavailable) or cannot be used to generate DataSchema variable (status detail = incompatible)
Undetermined - harmonization status not determined
Not Applicable - harmonization status is not relevant
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