Access and validation

Governance details

Documents or webpages that describe the overall governance of the data source and processes and procedures for data capture and management, data quality check and validation results (governing data access or utilisation for research purposes).
https://www.regresearchnetwork.org/adept-committee/

Biospecimen access

Are biospecimens available in the data source (e.g., tissue samples)?

No

Access to subject details

Can individual patients/practitioners/practices included in the data source be contacted?

Yes

Description of data collection

The data source is electronic medical record (EMR) data from participating GP practices. At the end of the outcome evaluation period, the study team will receive a single, fully anonymised dataset of EMR data from participating practices. Extracted EMR data will contain both structured or coded entries (Read, SNOMED and ICD10 codes), and unstructured information (e.g. clinical notes). EMR data will be supplemented with patient reported information/outcome data in a subgroup of patients. collected during the associated trial (PREVAIL).
Event triggering registration

Event triggering registration of a person in the data source

Disease diagnosis

Event triggering de-registration of a person in the data source

Loss to follow up

Event triggering creation of a record in the data source

Patient visit
Data source linkage

Linkage

Is the data source described created by the linkage of other data sources (prelinked data source) and/or can the data source be linked to other data source on an ad-hoc basis?

Yes

Linkage description, possible linkage

CONQUEST collects patient electronic medical records (EMR), supplemented with patient reported information/outcome data in a subgroup of patients. This data collected in primary care can be linked to secondary care/hospital data for the relevant patients. GP Practices participating in CONQUEST have consented to linkage of primary care data from CONQUEST in OPCRD to HES data supplied by NHS Digital/England via OPCRD-NEXUS. OPCRD has NHS HRA Research Ethics Committee (REC) approval, and CAG Section 251 approval (CAG Ref: 21/CAG/0001) to undertake quarterly, deterministic, patient-level linkage of HES data which is held in a separate database named OPCRD-NEXUS. The linkage involves approved use of direct patient identifiers (i.e. NHS number, data of birth, sex) which are securely transferred from participating sites to NHS Digital, with options for patient to opt out. Access to anonymised primary care and HES linked research datasets will be provided to ADEPT- approved researchers for study analysis and research. Further information is available at https://www.opcrd.optimumpatientcare.org/opcrd-nexus

Linked data source 1

Pre linked

Is the data source described created by the linkage of other data sources?

No

Data source, other

Hospital Episode Statistics (HES)

Linkage strategy

Deterministic

Linkage variable

The CONQUEST database could be linked to other data sources using individual patient NHS numbers. Specifically for England Hospital Episodes Statistics HES data linkage, the linkage variables are patient NHS numbers, date of births, sex and unique OPCRD study ID. OPC would perform the linkage of the required dataset and run or perform the analysis of the dataset on behalf of the applicant and supply the applicant with an anonymised (aggregated and small-number suppressed) output dataset for further analysis.

Linkage completeness

Estimated linkage completeness is 60-80%, though true percentage will be determined upon actual linkage.
Data management specifications that apply for the data source

Data source refresh

Monthly

Informed consent for use of data for research

Other

Informed consent, other

There is a committee to evaluate requests for data access

Possibility of data validation

Can validity of the data in the data source be verified (e.g., access to original medical charts)?

Yes

Data source preservation

Are records preserved in the data source indefinitely?

Yes

Approval for publication

Is an approval needed for publishing the results of a study using the data source?

Yes

Data source last refresh

Common Data Model (CDM) mapping

CDM mapping

Has the data source been converted (ETL-ed) to a common data model?

No