Chapter 2 Flashcards
researchers test an expermental drug or treatment in a small group of people 2 0 to 80 for the first time to evaluate its safety, determine a safe dosage range and identify side effects
phase I trials
the use of a specific group in the design of a study.
control trial
serves as a basis of comparison to ascertain the magnitude of the effect of comparison to ascertain the magnitude of the effect of an intervention. Results in the treatment group are compared to this.
control group
control trial without control group
pre/post design
difficult to determine if the effect is clinically meaningful or if the effect differs from the current standard of care.
pre/post design
a study in which there is at least one treatment group and one control group; group allocation is NOT random and often cannot be concealed; patients might be involved in the selection of treatment modality
control trial
observational studies that are usually large in size and longitudinal in duration. The groups in the study are determined by a given exposure, characteristic, or risk factor; patents are followed forward in time to monitor for the development of a given outcome
cohort studies
Framingham Heart Study is the example of what kind of study? It identified the risk factors that predict heart disease and stroke.
cohort studies
a study in which the allocation of patients to treatment or control groups is random and concealed. At least one control group must be utilized. Patients as well as providers are BLINDED (not informed) of which intervention patients receive
randomized control trial
experimental study drug or treatment is given to a larger group of people 100 to 300 to see if it is effetive and to further evaluate its safety
phase II trials
experimental study drug or treatment is given to larger group of people 1000 to 3000 to confirm its effectiveness, monitor side effects, compare it to commonly used treatment, and collect information that will allow the experimental drug or treatment to be used safety
phase III trials
postmarking studies delinate additional information, including the drug’s risk, benefit and optimal use
phase IV trials
a research procedure in which all prior studies on a given topic are brought together and analyzed collectively
systematic review
the leading organization in the world for this type of research, it sets the standards for design and quality of systemic reviews and meta anaylses
cochrane collaboration
a statistical analysis is performed to quantify the findings of the review
meta analysis
