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level: Level 2

Questions and Answers List

level questions: Level 2

Question	Answer
Involves disguising of drug therapy to the patient and health professionals to minimize bias Controlled trial Single, Double, Triple	BLINDING
ONLY PATIENT IS UNAWARE of which tx grouped they are assigned	Single blinding
both patient and health professional evaluating the effect and collecting data are unaware of trial drug assignment	Double blinding
additional blinding of the biostatistician and Data Safety and Monitory Board → comparative safety and efficacy	Triple blinding
involves preparation of a SEPARATE MATCHING PLACEBO for each drug product Disadvantage- affect pt. adherence	"Double dummy" approach
asses trial protocol	Institutional Review Board (IRB)
provides that patients be informed of their rights to maintain the privacy of health information	Health Insurance Portability and Accountability Act of 1996 (HIPAA)
It means that even if the patient has stopped taking the medication, did not complete the assigned tx, or has been switched to an active alternative therapy, the data from the patient is included in the original tx group to which pt. is randomized. Lessen the likelihood of finding a difference between the treatments It is more analogous to what happens outside the clinical trial situation. It is the statistical feature of clinical trials	INTENTION TO TREAT ANALYSIS (ITA)
Lowering the statistical boundary at which the researcher will consider the results significantly different	ADJUSTMENT TO MULTIPLE COMPARISON
Once data is obtained, researchers re-analyzed data from different perspectives Ex: dividing the data into several different patient groups	SUBGROUP ANALYSIS
SUBGROUP ANALYSIS Potential causes of deceptive findings:	1 TRIAL WAS NOT DESIGNED TO ASSURE THERE WAS ADEQUATE SAMPLE SIZE for the subgroup analysis 2 Potentially CONFOUNDING VARIABLES were NOT MEASURED or controlled 3 INSUFFICIENT THEORETICAL UNDERPINNINGS for the test