Evidence Review on Cardiometabolic Observational Studies (ERICAS): a global real-world evidence initiative
In this community post, Freya Tyrer, Briana Coles, Francesco Zaccardi, Sam Seidu and Kamlesh Khunti (University of Leicester, UK) introduce the ERICAS initiative.
Freya Tyrer, Briana Coles, Francesco Zaccardi, Sam Seidu and Kamlesh Khunti
Evidence obtained from the analysis of “real-world” data (“Real-world” evidence) is a rapidly rising phenomenon. The increasing availability of electronic health record and surveillance data means that researchers now have the ability to conduct relatively cheap analyses that have the power to complement and, in some cases, even replace clinical trials.
However, the meteoric rise in studies claiming to produce real-world evidence has also introduced teething problems. While clinical trials are a relatively simple and understood concept, real-world evidence studies are more complex, using difficult-to-grasp epidemiological methods, including propensity score methods, structural equation models and marginal structural models to reportedly estimate causal effects. With little guidance on how real-world evidence should be evaluated, and minimal training in epidemiology, clinicians often need to rely on authors’ interpretation of their findings, which may be based on flawed or unreliable estimates. As a result, the value of real-world evidence has been questioned.
Evidence Review on Cardiometabolic Studies (ERICAS)
The ERICAS initiative was introduced in July 2018 to improve the availability of high-quality real-world evidence for clinicians, researchers and policy makers working in cardiometabolic medicine, in order to facilitate clinical decision making in this area. Not only is the prevalence of cardiometabolic conditions is rising, but also the prevalence of comorbidities, aging and frailty, which typically preclude participation in clinical trials. It is our position that consideration of how these conditions and medications function in the real-world setting leads to more effective evidence-based clinical decision making.
ERICAS is a library website, publishing high quality contemporary real-world evidence in cardiometabolic medicine from the biomedical literature. Articles included in ERICAS undergo a robust selection process that includes: (i) retrieval of potential real-world observational studies using established electronic bibliographic databases, e.g. Medline; (ii) an initial evaluation process; (iii) comprehensive quality assessment using our own bespoke assessment tool; (iv) assignment of article category and broad disease area; and (v) clinical review by one of our faculty members. We currently have 21 ERICAS global faculty members who are all practicing clinicians in cardiometabolic medicine. We occasionally seek additional expertise from clinicians working in other areas, e.g. psychiatry, where relevant. As well as publications, ERICAS also publishes news, blogs and events that relate to real-world evidence. By subscribing to ERICAS, clinicians and researchers receive fortnightly updates on new publications and gain access to a subscribers’ area where on-line training, assessment tools and guidance can be downloaded.
Since the ERICAS website ‘went live’ in July 2018, ERICAS has attracted a range of subscribers from the pharmaceutical, research and medical community. The blog facility has been a huge success, with experts from England, USA, Canada and Singapore all contributing to the discussion on real-world evidence.
Another notable achievement from the team is the development of our quality assessment tool, ARROWS (Assessment of Real World Observational Studies). ARROWS has gone through a rigorous content validation and inter-rater reliability exercise. It has been found to have excellent content validity rating (as rated by a global panel of experts in epidemiology) and good inter-rater reliability. The tool will be available on the subscribers’ section of the ERICAS website once it has been formally published.
The ERICAS team have a number of ambitious plans for the future, including a suite of on-line training courses in real-world evidence and the use of the ARROWS to assess the quality of real-world evidence. We also plan to hold face-to-face training courses for more comprehensive training, including hands-on statistical techniques using Stata and R. Please subscribe at www.ericas.org to receive updates from the team.
About the authors
Freya Tyrer (Epidemiologist), Briana Coles (Epidemiologist), Francesco Zaccardi (Clinical Epidemiologist), Sam Seidu (Primary Care Fellow) and Kamlesh Khunti (Professor in Primary Care Diabetes and Vascular Medicine) all work at Leicester Diabetes Centre and Leicester Real World Evidence Unit, University of Leicester, UK.
ERICAS is funded from an unrestricted educational grant from AstraZeneca. To access the website, please go to www.ericas.org.