Generating real-world evidence: Using automated data extraction to replace manual chart review.

Abstract

e18096 Background: Real world evidence is a valuable resource to help guide clinical care beyond evidence generated from clinical trials, for example safety and effectiveness of novel treatments in special populations. Administrative databases often lack sufficient clinical detail to address gaps in the improvement of patient management and quality of care. Detailed clinical data collection and curation are resource intensive, limiting the ability to generate and maintain large informative cancer databases. Darwen, novel technology developed by Pentavere, enables the automation of data abstraction from unstructured hospital electronic medical records and may eliminate the need for manual chart review. Methods: Health records were identified through an institutional cancer registry from patients with stage IIIB/IV lung cancer (NSCLC or SCLC) diagnosed and treated at the Princess Margaret Cancer Centre between 01/01/2015 and 31/12/2017. Cases underwent automated data extraction including demographics, comorbidities, treatment, concurrent medications and outcomes until 30/06/2018. Agreement with data fields extracted using manual data collection in an external validation set of patients is planned. Results: Of 1210 patients identified, 538 were eligible for analysis. From automated data abstraction, 9.9% were reported to have SCLC, 67.5% adenocarcinoma, 11.2% squamous carcinoma, 28% EGFR mutations, 5.8% ALK fusions and 9.3% tumour PDL1 > = 50%. Of the 304 (56.5%) that received systemic therapy, initial treatment was chemotherapy for 55.6%, targeted therapy in 34.2% and immunotherapy in 10.2%. Additional outcome data and agreement with manually curated data fields will be presented. Conclusions: Automated software to extract clinical data is a powerful new tool to generate and maintain databases that yield high quality real world clinical evidence. This is a critical next step to improve clinical decision making, inform evidence-based practice and improve quality of cancer care.