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Randomized Controlled Trials Overview

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Definition and Purpose: RCTs compare treatments using random assignment to control confounding factors
First clinical trial conducted by James Lind in 1747 for scurvy treatment
Modern RCT concept originated with Austin Bradford Hill in 1948
Key Components: Randomization reduces selection and allocation bias in treatment assignments
Blinding prevents participants from knowing treatment assignments
CONSORT guidelines standardize reporting of RCTs since 1996
Types and Design: Most common designs are parallel-group and crossover trials
RCTs can be explanatory (efficacy) or pragmatic (effectiveness)
Statistical methods vary based on outcome data characteristics
Importance and Limitations: Considered highest quality evidence in healthcare
Results can significantly impact clinical practice
Can be expensive and time-consuming to conduct
May not be suitable for rare or dramatic treatments
Ethical Considerations: Ethical issues arise with informed consent and randomization
Some RCTs may be unethical due to prior randomization
Industry funding can influence study outcomes