randomized clinical trial; randomized controlled trial (RCT)
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Introduction
An experimental study that uses random assignment to create treatment & control groups so that changes can be inferred or attributed to the experimental treatment.
Advantages
- strong design for determining causation[1]
Disadvantages
- expensive, time consuming, limited follow-up duration
- not practical for many clinical situations[1]
- study intervention might unduly influence data outcome
- study population may not represent population of interest
Notes
- randomization may be by individuals, randomized controlled trial, or by cluster (i.e. nursing unit), cluster-randomized trial
- caution should be used when generalizing the results of a randomized controlled trial to populations other than those who would meet inclusion but not exclusion criteria for the study
- surrogate outcomes (i.e. biomarker such as LDL cholesterol or interim outcome such as progression-free survival) are more likely to show results favoring treatment than patient- relevant outcomes[3]
* see level of evidence for reliability of scientific investigations
More general terms
More specific terms
Additional terms
References
- ↑ 1.0 1.1 1.2 Medical Knowledge Self Assessment Program (MKSAP) 16, 17. American College of Physicians, Philadelphia 2012, 2015
- ↑ Ho PM, Peterson PN, Masoudi FA. Evaluating the evidence: is there a rigid hierarchy? Circulation. 2008 Oct 14;118(16):1675-84. PMID: https://www.ncbi.nlm.nih.gov/pubmed/18852378
- ↑ 3.0 3.1 Ciani O et al. Comparison of treatment effect sizes associated with surrogate and final patient relevant outcomes in randomised controlled trials: Meta-epidemiological study. BMJ 2013 Jan 29; 346:f457 PMID: https://www.ncbi.nlm.nih.gov/pubmed/23360719
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