Identification and Mapping Real-World Data Sources for Heart Failure, Acute Coronary Syndrome, and Atrial Fibrillation

Abstract

Background: Transparent and robust real-world evidence sources are increasingly important for global health, including cardiovascular (CV) diseases. We aimed to identify global real-world data (RWD) sources for heart failure (HF), acute coronary syndrome (ACS), and atrial fibrillation (AF). Methods: We conducted a systematic review of publications with RWD pertaining to HF, ACS, and AF (2010–2018), generating a list of unique data sources. Metadata were extracted based on the source type (e.g., electronic health records, genomics, and clinical data), study design, population size, clinical characteristics, follow-up duration, outcomes, and assessment of data availability for future studies and linkage. Results: Overall, 11,889 publications were retrieved for HF, 10,729 for ACS, and 6,262 for AF. From these, 322 (HF), 287 (ACS), and 220 (AF) data sources were selected for detailed review. The majority of data sources had near complete data on demographic variables (HF: 94%, ACS: 99%, and AF: 100%) and considerable data on comorbidities (HF: 77%, ACS: 93%, and AF: 97%). The least reported data categories were drug codes (HF, ACS, and AF: 10%) and caregiver involvement (HF: 6%, ACS: 1%, and AF: 1%). Only a minority of data sources provided information on access to data for other researchers (11%) or whether data could be linked to other data sources to maximize clinical impact (20%). The list and metadata for the RWD sources are publicly available at www.escardio.org/bigdata. Conclusions: This review has created a comprehensive resource of CV data sources, providing new avenues to improve future real-world research and to achieve better patient outcomes.

Systematic approach to outcome assessment from coded electronic healthcare records in the DaRe2THINK NHS-embedded randomised trial

“…In a published review of 450 EHR-based studies, only 19 (5.1%) were accompanied by a full set of clinical codes [45], severely limiting the value of those studies and their implementation to routine care. The emergence of EHR systems across the world provides an important opportunity for healthcare-embedded clinical research [1], but only when this is accompanied by a clear pathway from data collection to interpretation. [2] The broad scope of coded healthcare data has been a limiting factor in prior attempts at EHRembedded clinical trials.…”

“…Rapid uptake of electronic healthcare record (EHR) systems across the world have led to the opportunity for large-scale, real-world, longitudinal clinical research. [1] In countries with national health systems such as the United Kingdom, there is also the potential to link all EHRs for an individual patient, across both primary and secondary care, and from birth to death. Standardised coding systems provide the basis for harnessing medical information from different healthcare providers, with linkage allowing for a complete picture of each patient's history, healthcare utilisation and adverse events.…”

Artificial Intelligence, Wearables and Remote Monitoring for Heart Failure: Current and Future Applications

“…Moreover, industry-based sponsorship for clinical trials might complicate matters further, as data withholding and the creation of proprietary algorithms might be undertaken for industrial purposes [ 79 ]. With a push from the International Committee of Medical Journal Editors (ICMJE) and the National Institute of Health to encourage data sharing and the formulation of repositories such as BigData@Heart, and SWEDEHEART in recent years, the unification of data resources leading to more impactful clinical research might be attainable in the near future [ 79 , 80 , 81 ].…”

CODE-EHR best-practice framework for the use of structured electronic health-care records in clinical research

“…In the context of ageing populations and increasing multimorbidity in all disease areas, 1-3 large-scale, realworld data provide an opportunity to improve understanding of the epidemiology of rare and common conditions and to improve prevention strategies and treatment stratification for these conditions. 4 Specific management for individual patients is essential to reduce health-care costs and provide patient-centred care that can improve both the quality of life and prognosis of a patient. Use of controlled trials in real-world settings, either within registries or routine clinical practice, is now possible and could provide more generalisable results to the population at large than conventional studies which are often based on selected cohorts.…”