National, Centralised Hospital Datasets Can Inform Clinical Trial Outcomes In Prostate Cancer: A Pilot Study In The Stampede Trial

257Background: Hospital Episode Statistics (HES) are routinely collected data describing National Health Service (NHS) hospital visits in England, with procedure u0026 disease codes. This study, embedded in STAMPEDE, aimed to build a model using HES, linked to primary medical records u0026 trial case report forms (CRFs) to identify progressive disease events (PDEs), including skeletal-related events (SREs). Methods: Analysis of 5 STAMPEDE patients (pts) in 2 stages (data to Jul 16). 1: Detailed manual note review of 3 pts’ PDEs were compared to HES u0026 CRFs to build model. 2: Used model to use HES to identify possible PDEs in 2 pts, verified by note review u0026 compared to CRFs. Created algorithm rules to identify PDEs per 8 week interval plus further analysis of HES coding to find SREs. Results: Prostate cancer PDEs coincided with clustering of HES events. HES found 4 PDEs omitted from CRFs but missed 2 (total PDEs: HES 10, CRFs 8). HES found a false positive CRF PDE. Compared with note review HES missed 4 PDEs (fals...