A ___________ study design is a useful study design to use when the modes of action of two drugs are different and the anticipated outcomes for the two drugs are independent.
True or false: The net effect of noncompliance on a randomized trial's results is an increase in observed differences, moving the difference toward the null because the treatment group will include some who did not receive the therapy, and the no-treatment group may include some who received the treatment.
A problem that arises in an ecologic study if we ascribe "to members of a group some characteristic that they in fact do not possess as an individuals" is called ecologic ________________. " (pg. 151)
True or false: A benefit of randomization is that the likelihood that the groups will be comparable will be increased.
The first approach in determining whether an association exists may be a study of group characteristics by carrying out a(an) _____________ study.
A cross-sectional study is also called a "________________" study.
Stratified randomization occurs _____________ the intervention in a clinical trial.
In a cohort study, if the person who decides whether the disease has developed in each subject also knows whether that subject was exposed, and knows the hypothesis being tested, that person's judgement as to whether the disease developed may be biased by that knowledge, and that type of bias is called _____________ bias.
Zika virus is transmitted by __________ mosquitoes and it was originally isolated from a rhesus monkey in the Zika forest in Uganda.
A synonym for a "randomized trial" is a(an) "experimental ________." (TABLE 7.11)
The best study design to use when the disease or health-related outcome (case) is rare is a(an) ____________-control study.
__________ matching consists of selecting the controls in such a manner that the proportion of controls with a certain characteristic is identical to the proportion of cases with the same characteristic.
The randomized trial (or randomized clinical trial) is the "__________" standard for studying interventions, such as investigating the effects of receiving an experimental treatment.
Verticales
True or false: Within the four phase sequence of testing by the U.S. Food and Drug Administration to evaluate new agents (drugs), Phase I studies are large, randomized trials to investigate the safety and potential side effects of the new treatment.
____________ occurs in a clinical trial if there is inadequate time in the "washout period" to assure that first treatment (or therapy) has remained before the second treatment (or therapy) is started.
The major purpose of random assignment in a clinical trial is to __________ selection bias in the allocation of treatment.
The process of selecting the controls so that they are similar to the cases in certain characteristics, such as age and, in our example in class, estrogen usage.
The Framingham Study (of cardiovascular disease) that began in 1948 is a(an) _____________ cohort study.
The purpose of a double-blind study is to avoid observer and _____________ bias.
The only difference between the designs for the prospective and retrospective or historical cohort study is ______________ time.
The _________ Calmette-Guerin vaccination offers protection against tuberculosis.
When compared with other types of epidemiologic studies, a nested case-control study minimizes possible selection and recall ________.
In the design of a randomized trial the critical element of randomization is the ____predictability of the next assignment.
True of false: In a randomized trial, a planned crossover design enhances the generalizability of the study's results.
In a randomized clinical trial stratified randomization occurs __________ the intervention.
"________-ins" are individuals in randomized trials who inadvertently take the agent (or drug) assigned to the other study group.
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