The Adjudication Process at ACTION - Providing Real-World High-Quality Data

Abstract

Purpose Lack of both relevant clinical trials and real-world data (RWD) make it difficult to assess the effectiveness of any intervention in pediatric ventricular assist devices (VADs) population. Advanced Cardiac Therapies Improving Outcomes Network (ACTION) registry offers a means to capture RWD outside of traditional clinical trials. ACTION registry has introduced a standardized blinded adjudication process to provide VAD related adverse events (AEs) data with improved consistency and reliability. This study reviews the outcomes of the process at the end of its first year. Methods The ACTION adjudication committee, comprised of experts in the field, reviews all critical adverse events, including neurological dysfunction (ND), device malfunctions (DM) and events that lead to death, on a quarterly basis. The committee also reviews a randomly selected subset (15%) of major bleeding (MB) and major infection (MI). Pre-adjudication reports are sent to the centers to upload source documents to a secure portal. Documents are de-identified by the Data Coordinating Center (DCC) and are shared with the chair and two assigned adjudication reviewers. Each AE is presented by the assigned reviewers at a virtual meeting followed by a period of discussion and final adjudication. Committee recommendations are sent as post-adjudication reports to make necessary changes to the AE data entered in registry. Results Total of 658 AEs were reported in the registry through June 2020. Thus far, 182 (28%) AEs were adjudicated (59 Neuro AE, 48 events leading to death, 37 DM, and 38 randomly selected from other AEs). Majority of AEs [150 (82%)] were adjudicated as classified, however, 25 (14%) were classified as non-AEs (DMs = 22, MB = 2, ND = 1). Eight (4.5%) reported events were reclassified in different categories (MI = 2, ND = 4, Events leading to cause of death = 2). As a result of this process, 34 additional events (Events leading to cause of death = 21; Stroke = 4; Other neurological events = 3; Bleeding = 4; Infection = 1; Device malfunction = 1) were identified by the committee that were not originally reported to the registry. Conclusion ACTION adjudication process identified 18% misclassified and ∼5% unreported events, highlighting limitations of any registry data. However, an expert-led adjudication process with a follow-up DCC to site communications and training has the potential to improve the quality of RWD.