Randomized Trials Versus Common Sense and Clinical Observation: JACC Review Topic of the Week.

Fanaroff, Alexander C; Califf, Robert M; Harrington, Robert A; Granger, Christopher B; McMurray, John J V; Patel, Manesh R; Bhatt, Deepak L; Windecker, Stephan; Hernandez, Adrian F; Gibson, C Michael; Alexander, John H; Lopes, Renato D (2020). Randomized Trials Versus Common Sense and Clinical Observation: JACC Review Topic of the Week. Journal of the American College of Cardiology, 76(5), pp. 580-589. Elsevier 10.1016/j.jacc.2020.05.069

Text Randomized trials versus common sense and clinical observation.pdf - Published Version Restricted to registered users only Available under License Publisher holds Copyright. Download (412kB) | Request a copy

Concerns about the external validity of traditional randomized clinical trials (RCTs), together with the widespread availability of real-world data and advanced data analytic tools, have led to claims that common sense and clinical observation, rather than RCTs, should be the preferred method to generate evidence to support clinical decision-making. However, over the past 4 decades, results from well-done RCTs have repeatedly contradicted practices supported by common sense and clinical observation. Common sense and clinical observation fail for several reasons: incomplete understanding of pathophysiology, biases and unmeasured confounding in observational research, and failure to understand risks and benefits of treatments within complex systems. Concerns about traditional RCT models are legitimate, but randomization remains a critical tool to understand the causal relationship between treatments and outcomes. Instead, development and promulgation of tools to apply randomization to real-world data are needed to build the best evidence base in cardiovascular medicine.

Interest & Impact

Downloads

1 since deposited on 18 Nov 2020
0 in the past 12 months

Citations

5 Citations in Web of Science ®
6 Citations in Scopus

Search

in Google Scholar™

Services

Actions (login required)

Edit item

Actions (login required)

Edit item