A wider stakeholder group list has been identified based on WHO, Bill & Melinda Gates Foundation and Brighton Collaboration contact lists for key persons that may be interested in the GAIA project and review of terms and definitions. The first communication with the wider stakeholder group was sent on Friday 13th March and invited colleagues to confirm their interest in participating and staying updated on the GAIA project progress on a regular (quarterly) basis.
GAIA aims to provide standards and tools to establish a globally shared understanding of outcomes and approaches to monitoring them with specific focus on LMIC needs and requirements.
Case definitions of key obstetric and neonatal outcomes
A set of about 20 standardised case definitions for key obstetric and neonatal events for global monitoring of immunisation in pregnancy Accompanied by a larger glossary of well-defined enabling terms: terms of relevance to monitoring of many key events
Shared terminology and code mapping
- A structured ontology of terms to demonstrate hierarchical and conceptual dependencies to promote a common understanding and shared language, synonyms of enabling terms and those describing key events
- Case definitions with the glossary and ontology of terms will enable creation of a map of disease codes used in healthcare databases, hospital discharge diagnoses and primary care claims registries
- Standard blocks of case identification algorithms are developed for observational studies
Tools for harmonised data collection
- Minimal guidance for collection, analysis and presentation of clinical safety outcome data of immunisation in pregnancy studies
- A data collection matrix as a checklist informing protocol writing and the development of case report forms
- An online tool for automated case classification (single case or batch classification) of events according to the standardised case definitions
Evaluation and implementation
- Investigator and stakeholder meeting determining the needs and requirements of the various stakeholders and sharing experience with implementation of the interim standards and guidance documents.
- Targeted stakeholder consultations and solicitation of feedback from investigators and parallel projects, partners from LMIC for the evaluation of applicability and usefulness of the standards and tools developed.
- The finalised standards will be submitted for review and recommendation by pertinent technical, public health, and regulatory bodies