Quiz Chapter 7 and 8 Protocol, Clinical Trials, Community Trials

2.5 / 2.5 points Match the term with the definition below: protocol Question options: A study plan on which all clinical trials are based Any of the treatment groups in a randomized trial The process of learning the key facts about a clinical trial before deciding whether or not to participa A modification of the effect of the drug when administered with another drug None of the above 2.5 / 2.5 points The purpose of double-blinding in clinical trials is to: Question options: reduce error that results from the way in which the outcome is assessed reduce error that results from subjects' knowledge of their assignment to study conditions reduce error that results from non-random assignment to study conditions all of the above 2.5 / 2.5 points Which types of health issues are likely to be addressed in community trials? Question options: Smoking cessation HIV/AIDS Healthy eating All of the above topics 2.5 / 2.5 points Which type of evaluation requires the collection of baseline information before the program starts? Question options: Process evaluation Impact evaluation Outcome evaluation None of the above 2.5 / 2.5 points Identify which of the following six types of study designs most appropriately characterizes the situation described below. To test the efÏcacy of a health education program in reducing the risk of foodborne and waterborne diseases, the residents of two Peruvian villages were given an intensive health education program. At the end of two years, the incidence rates of important water-borne and food-borne diseases in these villages were compared with those in two similar control villages without any education program. Question options: nal study l study cohort study rospective cohort study l trial A major advantage of cohort studies over case-control studies with respect to the role of a suspected factor in the etiology of a disease is that: Question options: they take less time and are less costly they can utilize a more representative population it is easier to obtain controls that are not exposed to the suspected factor they permit direct estimation of risk of disease in those exposed to the suspected factor they can be done on a double-blind basis 2.5 / 2.5 points Subjects for an exposure-based cohort study would be selected most appropriately from: Question options: certain occupational groups such as battery workers the residents of a large U.S. county male Harvard alumni from 1916 to 1950 all of the above 2.5 / 2.5 points Match the term with the definition below: arm Question options: A study plan on which all clinical trials are based Any of the treatment groups in a randomized trial The process of learning the key facts about a clinical trial before deciding whether or not to participa A modification of the effect of the drug when administered with another drug None of the above 2.5 / 2.5 points As an epidemiologist, you are going to investigate the effect of a drug suspected of causing malformations in newborn infants when the drug in question is taken by pregnant women. For your sample, you will use the next 200 single births occurring in a given hospital. For each birth, a medication history will be taken from the new mother and from her doctor. In addition, you will review medical records to verify use of the drug. Note: These mothers are considered to have been followed prospectively during the entire course of their pregnancies, because a complete and accurate record of drug use was maintained during pregnancy. The resultant data are: Forty mothers have taken the suspected drug during their pregnancies. Of these mothers, 35 have delivered malformed infants. In addition, 10 other infants are born with malfunctions. Suppose that a relative risk of 0.5 has been found. Which interpretation might follow? Question options: congenital malformations is half as high among users of the drug as among non-users. congenital malformations is equal among users and non-users of the drug. congenital malformations is twice as high among users of the drug as among non-users of the drug. drug is a protective factor for congenital malformations. Identify which of the following six types of study designs most appropriately characterizes the situation described below. You are interested in finding out whether middle-aged men who have premature ventricular contractions (PVCs) are at greater risk of developing a myocardial infarction (heart attack) than men whose heartbeats are regular. Electrocardiogram (ECG) examinations are performed on all male ofÏce employees 35 years of age or older who work for oil companies in Houston. The ECG tracings are classified as irregular or regular. Five years later, myocardial infarction rates are compared between those with and those without baseline ECG irregularities. Question options: onal study ol study cohort study prospective cohort study al y trial A therapeutic trial involves the study of the effectiveness of a substance or program to prevent disease. Question options: 1) True 2) False 2.5 / 2.5 points Survival curves may be used to portray patients' survival in clinical studies. Question options: 1) True 2) False 2.5 / 2.5 points Relative risk is the ratio of the risk of disease among the exposed to the risk among the unexposed. Question options: 1) True 2) False 2.5 / 2.5 points In community intervention studies, it is important for the investigator to evaluate whether a program has achieved its intended results before assuming the benefits of the intervention. Question options: 1) True 2) False 2.5 / 2.5 points Treatment crossover refers to any change of treatment for a patient in a clinical trial that involves a switch of study treatments. Question options: 1) True 2) False 2.5 / 2.5 points Cohort studies preserve the temporality of cause (exposure) happening before the effect (disease). Question options: 1) True 2) False 2.5 / 2.5 points Clinical trials enroll individual subjects and enable randomization of subjects to receive or not receive the intervention. Question options: 1) True 2) False 2.5 / 2.5 points Exposure-based cohort studies permit investigations of exposures that are uncommon. Question options: 1) True 2) False 2.5 / 2.5 points Randomized controlled trials at the community level are typically used in special situations where there is a simple intervention. Question options: 1) True 2) False 2.5 / 2.5 points Repeated cross-sectional surveys may underestimate past smoking behavior of older-age cohorts. Question options: 1) True 2) False 50>/>50>->A 50>/>50>->A