PHAR 6123 Exam 2 Chicago State University
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Free PHAR 6123 Exam 2 Chicago State University Questions
An observational study that surveys exposure and disease status at a single point in time is:
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Cross-sectional study
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Cohort study
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Case-control study
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None of the above
Explanation
Correct Answer: A) Cross-sectional study
A cross-sectional study is an observational study design that measures both the exposure and the outcome (disease status) simultaneously at a single point in time within a defined population. It provides a snapshot of the population and is commonly used to determine the prevalence of a condition.
Because exposure and outcome are measured at the same time, it cannot establish temporal sequence or causality. A cohort study follows participants over time based on exposure status. A case-control study starts with the disease outcome and looks backward at exposure. Neither of these designs measures exposure and disease status at a single point in time.
Which of the following best describes how healthcare databases have improved the study of drug utilization trends?
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Improves third party billing
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Researchers can study the use of a drug in an unstudied population or an unstudied use
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Creates a sterile environment and a clear relationship between the drug and its effect
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Allows the study of the factors that determine the occurrence and distribution of diseases in populations
Explanation
Explanation:
Correct Answer: (B) Researchers can study the use of a drug in an unstudied population or an unstudied use
Healthcare databases provide access to large, real-world datasets that allow researchers to examine drug utilization patterns across diverse and previously unstudied populations or for unstudied indications. This greatly expands the scope of pharmacoepidemiologic research beyond what is possible in controlled clinical trials.
A. Improving third party billing — While electronic health databases may support billing processes, this is not how they improve the study of drug utilization trends. C. Creates a sterile environment with a clear causal relationship — Healthcare databases are observational in nature and do not establish clear causal relationships; that is a limitation, not an advantage. D. Allows the study of factors determining disease occurrence and distribution — This describes the broader field of epidemiology, not specifically how healthcare databases improve drug utilization research.
Tertiary references include only studies or original report of data published in biomedical journals.
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True
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False
Explanation
Explanation:
Correct Answer: (B) False
Tertiary references are compiled, synthesized sources of information such as textbooks, drug compendia (e.g., Drug Facts and Comparisons, Micromedex), encyclopedias, and clinical guidelines. They do not contain original research data. It is primary references (original research articles) that contain original reports of data published in biomedical journals. Tertiary references summarize and consolidate information from both primary and secondary sources for quick reference use.
The term "power" in power analysis refers to:
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The probability of making a Type I error
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The ability to avoid all statistical errors
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The probability of correctly rejecting a false null hypothesis
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The strength of the correlation between variables
Explanation
Explanation:
Correct Answer: (C) The probability of correctly rejecting a false null hypothesis
Statistical power is defined as 1 - β, representing the probability of correctly detecting a true effect — that is, rejecting the null hypothesis when it is indeed false. Higher power reduces the risk of a Type II error (missing a real effect).
A. The probability of making a Type I error — This describes the significance level (α), not power. B. The ability to avoid all statistical errors — Power specifically addresses Type II errors, not all statistical errors. D. The strength of the correlation between variables — This describes a correlation coefficient, not statistical power.
Which of the following are strengths of the drug approval process (i.e., the validity of the results)? Select all that apply.
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Follows the scientific process and defines a clear relationship between the drug and its effect
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Excludes certain groups such as children and women of childbearing age
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Use within the trial and use in real life may be different
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Ensures safety and efficacy of the drug
Explanation
Explanation:
Correct Answers: (A) Follows the scientific process and defines a clear relationship between the drug and its effect and (D) Ensures safety and efficacy of the drug
The drug approval process is a structured, scientifically rigorous pathway that establishes a clear causal relationship between a drug and its effects through controlled clinical trials. It also ensures that a drug meets established standards for both safety and efficacy before being approved for public use.
B. Excludes certain groups such as children and women of childbearing age — This is a limitation of clinical trials, not a strength. Exclusion of these groups reduces the generalizability of findings. C. Use within the trial and use in real life may be different — This is also a limitation, describing the gap between efficacy in controlled trial conditions and effectiveness in real-world settings.
Which of the following is the most appropriate statistical method to compare the means of three or more groups?
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ANOVA
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Paired t-test
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Wilcoxon signed-rank test
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All of the above
Explanation
Explanation:
Correct Answer: (A) ANOVA
Analysis of Variance (ANOVA) is specifically designed to compare the means of three or more independent groups simultaneously. It tests whether at least one group mean is significantly different from the others while controlling the overall Type I error rate.
B. Paired t-test — Used to compare the means of two related or matched groups (e.g., before and after measurements in the same subjects), not three or more groups. C. Wilcoxon signed-rank test — A non-parametric test used to compare two related groups when data is not normally distributed, not for three or more groups. D. All of the above — Incorrect because only ANOVA is appropriate for comparing three or more group means.
A clinical study has a power of 0.80. What is the probability of detecting a true effect?
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20%
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80%
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5%
Explanation
Explanation:
Correct Answer: (B) 80%
A statistical power of 0.80 means there is an 80% probability of correctly detecting a true effect (i.e., correctly rejecting a false null hypothesis) if one truly exists. Conversely, there is a 20% probability of committing a Type II error (missing the true effect). A power of 0.80 is the conventionally accepted minimum standard in clinical research.
A. 20% — This represents the probability of a Type II error (β = 1 - 0.80 = 0.20), not the probability of detecting a true effect. C. 5% — This represents the conventional significance level (α = 0.05) used for Type I error, not statistical power.
Descriptive statistics are primarily used to:
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Make predictions about future outcomes
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Summarize and describe collected data
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Test hypotheses about a population
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Eliminate bias in research
Explanation
Correct Answer: B) Summarize and describe collected data
Descriptive statistics are used to organize, summarize, and describe the main features of a dataset in a meaningful way. They include measures of central tendency such as mean, median, and mode, as well as measures of variability such as range and standard deviation, and graphical representations such as charts and histograms.
Descriptive statistics do not make predictions or draw conclusions beyond the data collected — that is the role of inferential statistics. Testing hypotheses about a population is the function of inferential statistics. Eliminating bias is achieved through study design and methodology, not through statistical techniques.
A meta-regression model measuring the effect of medication adherence (predictor) on blood pressure control (outcome) shows a statistically significant result. A clinician argues the finding is not clinically significant. Which of the following best explains this situation?
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Measured adherence for a statistically significant result on blood pressure control is not clinically significant
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There is strong evidence that medication adherence and blood pressure control is not verified
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The association between medication adherence and blood pressure control is not clinically significant
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The result is inconclusive because the p-value is too high
Explanation
Explanation:
Correct Answer: (C) The association between medication adherence and blood pressure control is not clinically significant
Statistical significance and clinical significance are distinct concepts. A statistically significant result means the finding is unlikely due to chance, but it does not necessarily mean the effect is large enough to matter in real-world clinical practice. The clinician is correctly noting that even though the p-value is significant, the actual magnitude of the effect on blood pressure may be too small to be meaningful clinically.
A. This option is partially correct but poorly worded and does not fully capture the distinction between statistical and clinical significance. B. Strong evidence against the association contradicts the finding of statistical significance. D. A high p-value would indicate lack of statistical significance, which is the opposite of what the scenario describes.
Which of the following is the best definition for pharmacovigilance?
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The science and activities relating to the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problem
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The extent to which a person's behavior coincides with medical or health advice
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The injury resulting from the use of a drug
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The study of the use and effects of drugs in large numbers of people
Explanation
Explanation:
Correct Answer: (A) The science and activities relating to the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problem
Pharmacovigilance is officially defined by the WHO as the science and activities relating to the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problems. It encompasses the entire process of monitoring drug safety throughout the product lifecycle.
B. This defines adherence — the degree to which a patient's behavior matches medical recommendations. C. This defines a medication error, focusing specifically on injury resulting from drug use. D. This defines pharmacoepidemiology, which studies the use and effects of drugs in large populations.
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