PUBH 3131 Lecture Notes - Lecture 9: Informed Consent, Clinical Trial, Recall Bias
Document Summary
Rct (random controlled trial): gold standard of internal validity. Epidemiological experiment in which subjects in a population are randomly allocated into groups: receive or not receive an intervention. Placebo effect: impact just by taking effect. Autonomy: participant freely chooses-implying they know and understand choices. Justice: risks and benefits are fairly distributed in society. Equipoise: treatment must have benefit or no effect. Blinding/masking: one does not know what you get. Single blind: subject/investigator does not know the assigned variable. Subjects are unaware of whether they are participating in the treatment or control conditions. Double blind: subject and investigator both don"t know. Neither participants nor investigators are aware of who has been assigned to the treatment or control conditions. Cannot be used for harmful risk factors. Establishes efficacy but not effectiveness time/resource intensive. Intention to treat analysis: reality is not intended, loses randomization.
