HLSC 3805U Lecture Notes - Randomized Controlled Trial, Case Series, Case Report
Document Summary
All studies: descriptive, person, place, time. Start with assign exposure follow up check for outcome. Random assignment: experimental group- assign exposure randomly, assess baseline characteristics, measure outcome (time 2, non- experimental group (controls)- assign exposure randomly, assess baseline characteristics (time 1, measure outcome (time 2) Well-controlled studies where exposure is randomly allocated. Generally considered the strongest epidemiologic design (gold standard) Need to test it out to something else (placebo) Safety: exclude population that will be sensitive to events (e. g. pregnant women) To determine if there is a true difference in effectiveness of treatment/prevention and comparison groups, it is crucial that you enroll an adequate number of individuals in the experimental study. Need to calculate statistical power using: anticipated difference between the treatment/prevention and comparison group, background rate of the outcome, probability of making statistical errors known as alpha and beta errors. Computer generated lists of random numbers (most commonly used: e. g. , 3, 5, 9, 4, 2.
