CITF Questionnaire 1 Harmonization Protocol
The objective of the CITF Questionnaire 1 Harmonization Protocol is to provide harmonized background information on participants, COVID-19 testing history, and COVID-19 vaccination history across contributing studies at the initial CITF data collection event. The information can come from baseline or cross-sectional questionnaire data from participating studies. The generated dataset will allow for exploration of relationships and comparative analyses among sociodemographic determinants, history of immune boosting events, and COVID-19 health outcomes. This protocol will also provide proof of principle and inform methodology for prospective harmonization of individual participant data from separate COVID-19 surveys.
The variables included in this protocol will provide information about individual identity, location of residence, lifestyle, potentional infection risk factors, occupation, COVID-19 health outcomes, PCR and antigen test results, corresponding symptoms, participants' vaccination history, vaccine effectiveness, and vaccine safety.
Overview
- Harmonization Initiative
- CITF-HI
- Harmonization Protocol
- CITF-Questionnaire1-HP
- Version
- 1.0
- Number of Variables
Design
- Type
- Quantitative
- Approach
- Prospective
- Procedures
- Harmonized data is generated by a central harmonization team (with the collaboration of studies).
- Infrastructure
- Harmonized data can be transferred to external servers, and pooled data analysis can be achieved.
- Participant Inclusion
- All study participants with informed consent are eligible for inclusion
- Number of Participants
- 3,437
Information Content
The information included in this protocol will come from questionnaires and medical records. Participant inclusion criteria were specific to each study's design.
The harmonized dataset will cover participant information on:
- Individual characteristics (age, sex, gender, ethnicity, education, etc.)
- Location of residence
- Household conditions
- Health risk factors (smoking history, chronic medical conditions, access to physician)
- Occupation and working conditions
- Physical characteristics (weight, height)
- Travel frequency and destinations
- Social gathering attendences
- COVID-19 exposure prevention measures (physical distancing behaviours, hand washing, self isolation, mask wearing, etc.)
- COVID-19 testing history (dates, types, results)
- Symptoms
- Outcome of infection
- COVID-19 vaccine exposure (dosage, dates of administration, types)
- COVID-19 infection occurence after vaccination
- COVID-19 vaccine safety assessment (occurence and outcomes of any adverse reactions)
Harmonization Initiatives Included
| Acronym | Name |
|---|
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)
- Not Applicable - harmonization status is not relevant
- Undetermined - harmonization status not determined