Figure 1.
Schematic of the High-STEACS trial design and linkage of electronic patient record data sources
(A) Diagram illustrating how screening, enrolment, adjudication, and follow-up were done by use of linked routine health-care data in Scotland. The Community Health Index is a population health-care register that includes all individuals resident in Scotland. The Community Health Index number, date and time of presentation, and study inclusion and exclusion criteria were extracted from the TrakCare software application and linked to the ARCHITECT assay platform to identify eligible patients. This number was also used to link all data sources, which are held securely within the NHS safe haven of each Health Board. Eligible patients were assigned a unique study ID and all identifiable data were removed. Anonymised data were transferred to a national analytical platform in the Farr Institute of Health Informatics Research (Edinburgh Bioquarter) for analysis and reporting. (B) Study design, in which sites were separated into early and late implementation designs. ICD-10=International Classification of Diseases, tenth edition. PIS=Prescribing Information System. SIMD=Scottish Index of Multiple Deprivation.