Department of Pharmaceutics School of Pharmacy College of Medicine and Health Sciences University of Gondar Date: March 31, 2018 Hands on Exercises Introduction to Pharmacoepidemiology (Phar 4181, 5 EtCTS) For 4th Year Bachelor Pharmacy Regular Students Instructor Name: Berhanemeskel W.Gerima, Email: aberhaneth@gmail.com Phone No: +251912024213 Part I 1. Descriptive epidemiology includes all EXCEPT: a. what c. when e. why b. who d. where 2. The Cancer and Steroid Hormone (CASH) study, in which women with breast cancer and a comparable group of women without breast cancer were asked about their prior use of oral contraceptives (“the Pill”), is an example of which type of study? a. Experimental c. Cohort e. Clinical trial b. Observational d. Case-control 3. Recall bias occurs when: a. Researchers in a case control study ask more probing questions of cases than controls. b. Researchers are not blinded and they recall which subjects were cases and which subjects were controls. c. Subjects in one arm of a randomized controlled trial recall their treatment compliance better than subjects in the other arm of the randomized controlled trial. d. Cases and controls in a case control study know their disease (outcome) status and differentially report their exposure histories. e. The exposed and non-exposed subjects in a cohort study know their exposure status and differentially recall their exposure histories. 4. Which of the following best describes the retrospective design where subjects are sampled by disease status and is often used when the investigator is interested in rare diseases. a. intervention trial c. retrospective cohort e. none of the above b. case control study d. ecologic study 5. Which of the following best describes the study design that can be either retrospective or prospective and is often used when the investigators are interested in rare exposures. a. intervention trials c. prevalence studies e. none of the above b. cohort studies d. case control study 6. The strength of an association is one of the criteria for evaluating the cause and effect relationship between an exposure and outcome. Which of the following is a measure of the strength of association? (Choose one best answer). a. incidence rate among the exposed b. cumulative incidence among the exposed c. the ratio of odds of exposure among cases to the odds of exposure among the non-cases d. odds of disease among exposed relative to the prevalence of exposure in the source population e. none of the above 6. In a randomized controlled trial, the following types of biases are reduced by randomization: a. Ascertainment bias c. Recall bias e. Bias in handling dropout b. Selection bias d. Publication bias 1 Part II 7. A researcher conducted a prospective cohort study in adult females of which 1000 women were exercisers and 1000 women non exercisers. After 20 years of follow-up, 100 of the women in the exercise group are diagnosed with breast cancer while 400 women in the non-exercise group are diagnosed with breast cancer. a. What was the study design used? ____________________ b. Draw the 2X2 contingency table showing the disease on top and the exposure on the side. c. Calculate incidences of osteoporosis in women exercise and not exercise. d. Calculate the relative risk of developing osteoporosis between the two groups. 8. Researchers determine in a case control study that 20 of 100 patients with bladder cancer smoke cigarettes while 40 of 600 patients without bladder cancer smoke cigarettes. a. Calculate the appropriate measure of association for developing bladder cancer in smokers vs. non-smokers. b. Interpret the measure of association you calculated Part III 9. Define the following terms: a. descriptive study g. Confounding m. Case-control study b. case report h. Type I error n. Case series c. sampling i. Type II error o. Odds and odds ratio d. case selection j. Pharmacoepidemiology p. Risk, relative risk, cumulative risk, e. matching k. Clinical pharmacology attributable risk f. Bias l. Cohort study q. Post-marketing surveillance 10. Compare and contrast the following approaches: a. observational versus analytical epidemiology b. retrospective versus prospective designs 11. Compare and contrast the following study designs a. Case report and case series b. Case series and case control c. Ecological and cross sectional d. Case control and cohort e. Cohort and randomized clinical trial 2