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level: Level 2

Questions and Answers List

level questions: Level 2

QuestionAnswer
Involves disguising of drug therapy to the patient and health professionals to minimize bias Controlled trial Single, Double, TripleBLINDING
ONLY PATIENT IS UNAWARE of which tx grouped they are assignedSingle blinding
both patient and health professional evaluating the effect and collecting data are unaware of trial drug assignmentDouble blinding
additional blinding of the biostatistician and Data Safety and Monitory Board → comparative safety and efficacyTriple blinding
involves preparation of a SEPARATE MATCHING PLACEBO for each drug product Disadvantage- affect pt. adherence"Double dummy" approach
asses trial protocolInstitutional Review Board (IRB)
provides that patients be informed of their rights to maintain the privacy of health informationHealth 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 trialsINTENTION TO TREAT ANALYSIS (ITA)
Lowering the statistical boundary at which the researcher will consider the results significantly differentADJUSTMENT TO MULTIPLE COMPARISON
Once data is obtained, researchers re-analyzed data from different perspectives Ex: dividing the data into several different patient groupsSUBGROUP 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