Podcast
Questions and Answers
A new rare side effect of a medication is suspected to occur after several years of continuous use. Randomized controlled trials for this medication typically have a follow-up period of 1-2 years. Which type of study would be most suitable for initially investigating this potential long-term side effect?
A new rare side effect of a medication is suspected to occur after several years of continuous use. Randomized controlled trials for this medication typically have a follow-up period of 1-2 years. Which type of study would be most suitable for initially investigating this potential long-term side effect?
- An observational study with a long follow-up period. (correct)
- A small-scale pharmacokinetic study.
- A meta-analysis of existing randomized controlled trials.
- A short-term randomized controlled trial with a large sample size.
The initial approval of Diethylstilberol (DES) in 1947 was based on clinical trials that did not highlight negative effects. However, later, a link between prenatal DES exposure and clear cell adenocarcinoma (CCA) in young women was discovered through:
The initial approval of Diethylstilberol (DES) in 1947 was based on clinical trials that did not highlight negative effects. However, later, a link between prenatal DES exposure and clear cell adenocarcinoma (CCA) in young women was discovered through:
- Subsequent, longer randomized controlled trials.
- Post-marketing surveillance programs relying solely on spontaneous reporting.
- Preclinical animal studies.
- Case-series and case-control studies, which are types of observational studies. (correct)
Researchers are investigating the effectiveness of a newly implemented pharmacist-led medication reconciliation program on reducing hospital readmission rates. Due to ethical considerations and the nature of integrating this program into routine care, it is not feasible to randomize hospitals. What type of study design is most likely to be used?
Researchers are investigating the effectiveness of a newly implemented pharmacist-led medication reconciliation program on reducing hospital readmission rates. Due to ethical considerations and the nature of integrating this program into routine care, it is not feasible to randomize hospitals. What type of study design is most likely to be used?
- A blinded, randomized controlled trial.
- An observational study comparing hospitals with and without the program. (correct)
- A crossover study.
- A placebo-controlled trial.
In a study comparing the risk of cardiovascular events between users of two different non-steroidal anti-inflammatory drugs (NSAIDs), the group taking NSAID A appears to have a lower risk. However, NSAID A is preferentially prescribed to healthier patients with fewer comorbidities. This difference in baseline health status between the groups could lead to:
In a study comparing the risk of cardiovascular events between users of two different non-steroidal anti-inflammatory drugs (NSAIDs), the group taking NSAID A appears to have a lower risk. However, NSAID A is preferentially prescribed to healthier patients with fewer comorbidities. This difference in baseline health status between the groups could lead to:
A researcher is conducting a case-control study to investigate the association between a specific dietary supplement and the risk of a rare disease. They select cases from a hospital registry. For the control group, they recruit friends and family members of the cases. This method of control selection might introduce:
A researcher is conducting a case-control study to investigate the association between a specific dietary supplement and the risk of a rare disease. They select cases from a hospital registry. For the control group, they recruit friends and family members of the cases. This method of control selection might introduce:
A study finds an association between regular exercise and a lower risk of depression. However, it's possible that individuals who are already in a better mood are more likely to engage in regular exercise. This situation exemplifies:
A study finds an association between regular exercise and a lower risk of depression. However, it's possible that individuals who are already in a better mood are more likely to engage in regular exercise. This situation exemplifies:
To address confounding in an observational study, researchers can employ various strategies during the study design phase. Which of the following is a method primarily used to control for confounding during the design phase?
To address confounding in an observational study, researchers can employ various strategies during the study design phase. Which of the following is a method primarily used to control for confounding during the design phase?
In a cohort study following patients with a chronic condition, a significant number of participants drop out over time due to various reasons unrelated to the exposure or outcome. This loss to follow-up could potentially introduce:
In a cohort study following patients with a chronic condition, a significant number of participants drop out over time due to various reasons unrelated to the exposure or outcome. This loss to follow-up could potentially introduce:
The STROBE statement provides guidelines for:
The STROBE statement provides guidelines for:
When reading the "Methods" section of an observational study report, according to STROBE guidelines, you should expect to find information on:
When reading the "Methods" section of an observational study report, according to STROBE guidelines, you should expect to find information on:
A researcher wants to investigate the association between long-term use of a proton pump inhibitor (PPI) and the risk of osteoporosis-related fractures. They use a large database of insured patients and find a statistically significant increased risk. However, PPIs are often prescribed for conditions that might independently increase fracture risk (e.g., older age, frailty). This scenario highlights the importance of addressing:
A researcher wants to investigate the association between long-term use of a proton pump inhibitor (PPI) and the risk of osteoporosis-related fractures. They use a large database of insured patients and find a statistically significant increased risk. However, PPIs are often prescribed for conditions that might independently increase fracture risk (e.g., older age, frailty). This scenario highlights the importance of addressing:
In a case-control study examining risk factors for a rare childhood cancer, researchers rely on parents' recall of exposures their children had many years ago. This reliance on memory might introduce:
In a case-control study examining risk factors for a rare childhood cancer, researchers rely on parents' recall of exposures their children had many years ago. This reliance on memory might introduce:
The "Healthy Worker Effect" is a type of:
The "Healthy Worker Effect" is a type of:
When reporting the results of an observational cohort study, the STROBE guidelines recommend providing:
When reporting the results of an observational cohort study, the STROBE guidelines recommend providing:
A study investigates the association between statin use and the risk of developing dementia using a large electronic health record database. The researchers acknowledge that statin users might be generally more health-conscious and receive more comprehensive medical care, potentially leading to earlier dementia diagnosis (detection bias). This scenario describes a potential issue related to:
A study investigates the association between statin use and the risk of developing dementia using a large electronic health record database. The researchers acknowledge that statin users might be generally more health-conscious and receive more comprehensive medical care, potentially leading to earlier dementia diagnosis (detection bias). This scenario describes a potential issue related to:
Flashcards
What is an observational study?
What is an observational study?
A study where researchers observe subjects without manipulating them.
What is bias in research?
What is bias in research?
A distortion of results due to factors not controlled by the study.
What is 'confounding' in studies?
What is 'confounding' in studies?
Occurs when a factor is associated with both the exposure and the outcome, distorting the true relationship.
What is reversed causation?
What is reversed causation?
Signup and view all the flashcards
What is selection bias?
What is selection bias?
Signup and view all the flashcards
What is measurement bias?
What is measurement bias?
Signup and view all the flashcards
What is the STROBE statement?
What is the STROBE statement?
Signup and view all the flashcards
What is the Hawthorne effect?
What is the Hawthorne effect?
Signup and view all the flashcards
What is the 'Healthy Worker Effect'?
What is the 'Healthy Worker Effect'?
Signup and view all the flashcards
Study Notes
- This is a quiz for pharmacy students on observational studies.
- The goal is to test understanding of observational studies, bias, limitations, and result interpretation.
Case Study 1
- A rare medication side effect is suspected after years of use.
- Randomized controlled trials typically have a short follow-up (1-2 years).
- An observational study with a long follow-up period is most suitable for investigating the possible long-term side effect initially.
Case Study 2
- Diethylstilberol (DES) was initially approved in 1947 based on clinical trials.
- Later, case-series and case-control studies uncovered a link between prenatal DES exposure and clear cell adenocarcinoma (CCA) in young women.
Case Study 3
- A pharmacist-led medication reconciliation program's effectiveness on hospital readmission rates is being investigated.
- An observational study comparing hospitals using the new program vs. those that do not is most likely the best study design.
Case Study 4
- NSAID A appears to have a lower risk of cardiovascular events compared to NSAID B.
- NSAID A is preferentially prescribed to healthier patients with fewer comorbidities.
- Confounding may lead to an apparent protective effect of NSAID A due to the healthier baseline of the patients receiving it.
Case Study 5
- A case-control study is done to investigate a dietary supplement and the risk of a rare disease, using a hospital registry for selecting cases.
- Selection bias is introduced by recruiting friends and family as the control group, if their health behaviors differ systematically from the general population.
Case Study 6
- A study finds an association between exercise and a lower risk of depression.
- Reversed causation is where mood might influence the exposure (exercise).
Case Study 7
- To address confounding, researchers use various strategies during the study design.
- Randomization (though mostly absent in observational studies) highlights the concept of controlling confounders at design.
Case Study 8
- In a cohort study, many participants drop out for reasons unrelated to exposure/outcome.
- Selection bias results from loss to follow-up if the characteristics of those who remain in the study differ from those who dropped out.
Case Study 9
- The STROBE (Strengthening the Reporting of Observational studies in Epidemiology) statement provides guidelines for reporting observational studies in epidemiology.
Case Study 10
- According to STROBE guidelines, the "Methods" section of an observational study should include study design, setting, participants, and variables.
Case Study 11
- Studying the association between long-term proton pump inhibitor (PPI) use and osteoporosis-related fractures uses a large insured patient database and finds a statistically significant increased risk.
- Confounding is important to address with the underlying medical conditions for which PPIs are prescribed, which could independently increase fracture risk.
Case Study 12
- A case-control study examines risk factors for childhood cancer, relying on parents' recall of exposures.
- Measurement bias may be introduced if recall accuracy differs between parents of cases and controls.
Case Study 13
- The "Healthy Worker Effect" is a type of selection bias.
- It occurs when studying currently employed people, who tend to be healthier than the general population.
Case Study 14
- When reporting an observational cohort study, STROBE guidelines recommend providing the number of outcome events and summary measures over time for exposed and unexposed groups.
Case Study 15
- A study investigates the association between statin use and dementia risk via a large electronic health record database.
- Measurement bias or information bias involves the ascertainment of the outcome (dementia) because statin users might be more health-conscious, get more medical care and thus have an easier path to an earlier dementia diagnosis.
Studying That Suits You
Use AI to generate personalized quizzes and flashcards to suit your learning preferences.
