Back to Search
Start Over
Randomized Trials Versus Common Sense and Clinical Observation: JACC Review Topic of the Week
- Source :
- Journal of the American College of Cardiology
- Publication Year :
- 2020
-
Abstract
- 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.<br />Central Illustration<br />Highlights • Well-conducted RCTs have repeatedly contradicted practices supported by common sense and clinical observation. • Common sense and clinical observation fail because of the inability to fully understand complex biopsychosocial systems. • RCTs must be integrated into clinical practice to improve the evidence base in cardiology.
- Subjects :
- Consensus
Evidence-Based Medicine
real-world data
Myocardial Infarction
IABP, intra-aortic balloon pump
Article
HDL-C, high-density lipoprotein cholesterol
surrogate endpoints
randomized controlled trials
MI, myocardial infarction
Humans
RCT, randomized controlled trial
observational studies
SGLT2, sodium-glucose cotransporter 2
Randomized Controlled Trials as Topic
Subjects
Details
- ISSN :
- 15583597
- Volume :
- 76
- Issue :
- 5
- Database :
- OpenAIRE
- Journal :
- Journal of the American College of Cardiology
- Accession number :
- edsair.pmid..........9c741ccecde8ef0904e66475b6b6a64a