Table 1 VPASS Assessment tool domains for evaluating data collection system-sites to support active safety surveillance for vaccine exposures during pregnancy in LMICs
Domain | Brief description and Reporting suggestion |
|---|---|
Purpose of the system | Description of the uses of the data obtained by the system such as surveillance, research and/or, clinical care |
Geographical location | Name of the site or sites currently using the system for MNCH data collection such as country, city, region or district |
Scale of implementation | System coverage scale at the site such as National, Provincial, Regional, district, etc |
Experience in MNCH data collection | Time of system use at the site in months or years |
MNCH variables under surveillance | List of MNCH variables/outcomes collected routinely: GAIA Maternal and Neonatal Outcome Case Definitions [21] |
Data capture place | Where the data collection takes place such as at health facility or at community level |
Level of data disaggregation | Whether the data is aggregated or disaggregated (individual data) |
Method and frequency of data collection | If the Data is collected prospectively or retrospectively. If it is collected routinely and without interruption or only under specific circumstances |
Data capture format | Whether the data is captured onto an electronic form and/or paper based |
Data standardization on MNCH variables | If the system and site comply with applicable standards for data formats and coding schemes; and explain if relevant |
Newborn follow-up | Whether they follow up newborns and for how long (in days, weeks, or months) |
Representativeness | If they follow the whole population or if there are groups that are systematically excluded from the reporting system. Explain if relevant |
Reliability | Possibility to link between identifier number (ID) of the mother and identifier number (ID) of the newborn |
Integration with other registers | Capability to integrate data with other health registers such as registers that provide vaccine-related information (i.e., vaccine type, number of doses, injection site) |
Feasibility of adding new variables | Whether the site can implement new healthcare coding standards (e.g., ICD-10) or new MNCH variables; and explain if relevant |
Data management policies | If they comply with applicable federal and state statutes and regulations |
Data confidentiality | Whether the procedures to ensure patient privacy and data confidentiality are in place |
Staff training | Whether those operating the system receive training and what type of training |
Site experience in MNCH active safety surveillance | Explain if the site has performed MNCH active safety surveillance |
Availability of baseline data | Report if the site has baseline data for potential use when conducting active safety surveillance |
Internal data quality monitoring | If the site or system perform a real-time internal data validation during the data entry process; include explanation if relevant |
External data quality monitoring | Whether they perform external/audits assessments for data validation; and how |
Data quality and data completeness (*) | If data quality and data completeness is appropriate enough to the point, they can support active safety surveillance |
Timeliness (*) | Whether the time between crucial data reporting steps appropriate is appropriate |