HeLTI - Mothers - Pregnancy Visit 1 Harmonization Protocol
Networks
-
Variables
-
The objective of the Pregnancy Visit 1 Harmonization Protocol was to define a list of core variables prospectively to be collected by three of 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 three out of the four studies (no data collection at this timepoint in Canada)
- Infrastructure
- Harmonized data must remain on study servers, but federated data analysis can be achieved
Information Content
The HeLTI Pregnancy Visit 1 harmonized dataset includes information about:
- Socio-demographic and economic characteristics (age and sex, household composition, education level, country of birth, employment status)
- Lifestyle and behaviours (alcohol use, tobacco use, drug use, diet and nutrition, Pittsburgh Sleep Quality Index (PSQI) and Global Physical Activity Questionnaire (GPAQ))
- Reproductive health history (number of pregnancies, number of abortions or miscarriages)
- 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 (General Self-Efficacy Scale (GSE), Patient Health Questionnaire (PHQ-9), Generalized Anxiety Disorder Scale (GAD-7))
- Administrative information
Studies Included
| Study | Population | Data Collection Event |
|---|---|---|
| BUKHALI | ||
| EINSTEIN | ||
| 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 | SCHeLTI-LIFE TREE |
|---|