Work Package 2 - Building EUROlinkCAT Central Results Repository
This WP will be led by Dr. Maria Loane (Ulster University) and Dr. James Densem (BIOMEDical Computing Ltd.) Statistical expertise and advice will be provided by Professor Joan Morris (QMUL). This work package is focussed on the development of standard operating procedures to enable each participating registry to create a linked standardized dataset so that aggregate data and any analytical results can be collectively pooled for a pan-European analysis.
Through building a Central Results Repository capable of producing and collating standardised output tables and individual registry analysis results will enable a pan-European analysis of mortality, morbidity and educational achievements and needs of children with congenital anomalies.
The functions of this WP are (i) to enable each participating registry to create a linked standardised dataset using the coding protocols, algorithms and Data Quality Indicators (DQIs) developed in this WP (ii) to create the EUROlinkCAT Central Results Repository to collate linked standardised aggregated tables and analysis results (ii) to transfer the pooled tables to the relevant task leaders involved in WP3, 4, 5 and 6 and (iv) to create the EUROlinkCAT website including interactive data tables. This WP includes all registries contributing linked aggregate data for use in specific WPs as the registries are responsible for providing the information on their local databases, for obtaining local governance approval to participate in the linkage studies, for linking the relevant local databases and for generating the output tables for analysis. The leaders of WP 3-6 are also involved as they provide the study protocols specifying the study design, study variables, analysis plan, and the outline structure of the tables to collectively pool the results from each registry for analysis. Each participating registry will send standard aggregate tables and analysis results to be included in the Central Results Repository. Linked individual case data will be retained locally. Each task/ component task lists the participants involved.
The work package will proceed in the following way:
- Ascertain individual registry capacity to link existing administrative/ clinical/ educational/ prescription data to their
congenital anomaly data in the EUROCAT Data Management Program (EDMP) (lead partner UU). For each registry:
- Catalogue and document the datasets available for linkage, including regional or national coverage, years included
and the availability of children without anomalies (controls) [All registries, UU]
- Produce meta-data/ data dictionary to describe these datasets. This includes a description of the dataset and variable
names, variable descriptions/ definitions, coding instructions/ values (in English) [UU, BIOMED]
- Conduct an initial scoping exercise to assess the quality of the data to be linked (Quality Assurance) i.e. for study
inclusion/ exclusion criteria purposes and for creating derived variables we need to ascertain if the variables are mostly
complete or incomplete. [All registries, UU]
- Upload all the above documentation to the membership-only section of the website as individual WP leaders using
linked data need this information for developing study protocols [UU]
- Develop a detailed data management plan conforming to all EU and national legislation.
- Oversee local registry ethics / research governance permission for conducting linkage studies [UU]
- Apply for ethical permission at Ulster University to hold the EUROlinkCATCentral Results Repository [UU]
- Standardise linked data across participating registries (lead partners UU, BIOMED).
- Create a common data model (independent from study protocol/ study design). This task ensures that all variables/
proxy variables are standardised across all registries [UU, BIOMED, QMUL]
- Develop rules for each registry to generate derived study variables from the existing data [UU, BIOMED, QMUL]
- Develop rules for each registry to implement different study designs for example according to whether children without
anomalies are available as controls [UU, BIOMED, QMUL]
- Agree the common model with registries to ensure correct interpretation of local variables [UU, all registries]
- Create the linked datasets needed for the protocols of WP3-6 (lead partners UU, QMUL).
- Create registry-specific syntax scripts to derive study variables, to implement study designs, and to run the pre-defined analysis for each WP study. These will be replicated by another individual for quality assurance [UU, BIOMED, QMUL]
- Registry data providers run the registry-specific syntax scripts using STATA, SPSS, or equivalent program to generate the required output aggregated tables and analytical results for WP3-6 analysis [All registries]
- Each registry/ data provider produces a data linkage report for quality assessment. This includes verification and validation of the derived variables/ data transformations, the methodology used to link cases in the different datasets, and matching success [All registries, UU]
- Develop a set of DQIs for the Central Results Repository to assess data quality i.e. to compare registries against the EUROCAT average [UU, QMUL]
- Upload all the above documentation to the membership-only section of the website for internal documentation [UU]
- Develop the EUROlinkCAT Central Results Repository and associated website (lead partners BIOMED, UU)
- Build the website and install a CMS on the website [BIOMED]
- Develop a Central Results Repository for holding the registry aggregate output tables and analysis results (such as Odds Ratios and adjusted Odds Ratios) to be used in European meta-analysis [BIOMED]
- Implement DQIs in the Central Results Repository for comparison of registries to the EUROlinkCAT average [BIOMED]
- Create interactive web tables hosting aggregate tables: detailed information will be available on a membership-only section of the website, whilst more aggregated data will be available on the public section of the website [BIOMED,QMUL]
- Provide text for website relating to Central Results Repository [BIOMED, UU, QMUL]
- Provide appropriate standard operating procedures documenting the Central Results Repository resource i.e. definitions, processes, activities, data security and data archiving [UU]
- Provide linked aggregate data (tables or analysis results) to other WPs to assess mortality, morbidity and educational outcomes of children with congenital anomalies [UU]
- Co-ordinate external data requests [UU, QMUL]