HeLTI - Mothers - Pregnancy Visit 2 Harmonization Protocol
Networks
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Variables
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The objective of the Pregnancy Visit 2 Harmonization Protocol was to define a list of core variables prospectively to be collected by the four mother and child randomized controlled trials to address the research aims of the HeLTI Initiative.
- Version
- 1.0
- Approach
- Prospective
- Type
- Quantitative
- Procedures
- Harmonized data is generated locally by studies (with the collaboration of the harmonization team).
- Participant Inclusion
- HeLTI participating mothers from the four studies
- Infrastructure
- Harmonized data must remain on study servers, but federated data analysis can be achieved
Information Content
The HeLTI Pregnancy Visit 2 harmonized dataset includes information about:
- Lifestyle and behaviours (Breastfeeding Self-Efficacy Scale (BSES), alcohol use, tobacco use, drug use, diet and nutrition, Pittsburgh Sleep Quality Index (PSQI) and Global Physical Activity Questionnaire (GPAQ))
- Diseases
- Medication and supplements
- Adverse events (hospitalization, disability/incapacity, assault, homicidal behaviour, life-threatening conditions)
- COVID-19 (risk factors, symptoms, testing, diagnosis, self-isolation)
- Physical measures and assessments (weight, blood pressure, gestational age and length of the fetus)
- Laboratory measurements (blood sample)
- Cognitive measures and assessments (Edinburgh Postnatal Depression Scale (EPDS), Patient Health Questionnaire (PHQ-9), Generalized Anxiety Disorder Scale (GAD-7), Perceived Stress Scale (PSS))
- Social environment and relationships (Social Provisions Scale (SPS))
- Administrative information
Studies Included
| Study | Population | Data Collection Event |
|---|---|---|
| BUKHALI | ||
| EINSTEIN | ||
| HeLTI Canada | ||
| SCHeLTI-LIFE TREE |
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
| Variable | BUKHALI | EINSTEIN | HeLTI Canada | SCHeLTI-LIFE TREE |
|---|