Randomized trials versus common sense and clinical observation
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2020Autor
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.
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Resumo
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. (J Am Coll Cardiol 2020;76:580–9) © 2020 by the American College of
Cardiology Foundation.
Palabras clave
Randomized trials; Clinical observation; COVID-19Link para o recurso
https://doi.org/10.1016/j.jacc.2020.05.069Collections
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