ReACH PAE Harmonization Protocol
Networks
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Variables
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The objectives of the ReACH PAE Harmonization Protocol were to:
* Generate a harmonized dataset across Canadian pregnancy-and-birth cohorts to address the research objectives of the ReACH Prenatal Alcohol Exposure Harmonization Initiative.
* Provide proof of principle and inform methodology for retrospective harmonization of individual participant data from separate pregnancy-and-birth cohort studies.
- Version
- 3.0
- Number of Participants
- 11,448
- Approach
- Retrospective
- Type
- Quantitative
- Procedures
- Harmonized data is generated by a central harmonization team (with the collaboration of studies).
- Participant Inclusion
- All study participants are eligible for inclusion.
- Infrastructure
- Harmonized data can be transferred to external servers, and pooled data analysis can be achieved.
Information Content
The PAE harmonization protocol includes variables covering the pregnancy and delivery period, using data from 2 to 4 data collection events per study. Studies had to have information collected on alcohol use before, during, and after pregnancy, information collected on birthweight and gestational age at delivery, a minimum of 500 women in the cohort, and ongoing recruitment and/or follow-up of children. Data sources include questionnaires and medical records.
The harmonized dataset covers information on:
* Mothers' lifestyle and behaviors before and during pregnancy
* Mothers' sociodemographic and economic information
* Mother's reproductive health history
* Mothers' physical measures
* Pregnancy complications
* Pregnancy, delivery, and birth outcomes
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