Pharmacology Case Reports
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Questions and Answers

What is one of the advantages of case-control studies?

  • They can study the outcome of a disease over time
  • They are inexpensive and can be conducted quickly (correct)
  • They can investigate only one variable at a time
  • They can be used to study rare diseases
  • What is a critical assumption in case-control studies?

  • That the outcome of the disease is known
  • That the exposure is always present
  • That controls are representative of the general population that does not have the disease (correct)
  • That cases are selected to be representative of those who do not have the disease
  • What is a disadvantage of case-control studies?

  • They can only be used to study rare diseases
  • They are susceptible to bias (correct)
  • They can only investigate one variable at a time
  • They are too expensive to conduct
  • What is a use of case-control studies?

    <p>To generate hypotheses about the causes of a new outbreak of disease</p> Signup and view all the answers

    What type of study follows a defined population over time?

    <p>Cohort study</p> Signup and view all the answers

    Why are case-control studies useful for studying rare diseases?

    <p>Because they are the only practical way to study rare diseases</p> Signup and view all the answers

    What is a limitation of case-control studies?

    <p>They are susceptible to bias</p> Signup and view all the answers

    What is a difference between case-control studies and cohort studies?

    <p>Case-control studies are retrospective, while cohort studies are prospective</p> Signup and view all the answers

    What is the major difference between cohort and case-control studies?

    <p>The basis of patient recruitment</p> Signup and view all the answers

    What is a major advantage of cohort studies over case-control studies?

    <p>They are free from the problem of selecting an undiseased control group</p> Signup and view all the answers

    When are cohort studies particularly useful?

    <p>When studying multiple possible outcomes from a single exposure</p> Signup and view all the answers

    What is an advantage of prospective cohort design?

    <p>It is a powerful strategy for assessing incidence</p> Signup and view all the answers

    What is a disadvantage of cohort studies?

    <p>They can require extremely large sample sizes to study relatively uncommon outcomes</p> Signup and view all the answers

    What is a limitation of retrospective cohort studies?

    <p>They are less costly and time-consuming</p> Signup and view all the answers

    What is a potential problem with prospective cohort studies?

    <p>They can require a prolonged time period to study delayed drug effects</p> Signup and view all the answers

    Why are cohort studies useful in postmarketing drug surveillance studies?

    <p>Because they are useful for studying multiple possible outcomes from a single exposure</p> Signup and view all the answers

    What was the concern about cimetidine after metiamide was withdrawn?

    <p>It would cause agranulocytosis</p> Signup and view all the answers

    What is a limitation of case series in determining causation?

    <p>They lack a control group</p> Signup and view all the answers

    What is an advantage of case reports and case series?

    <p>They provide clinical descriptions of a disease</p> Signup and view all the answers

    What is examined in analyses of secular trends?

    <p>Trends in an exposure and a disease over time or across geographic boundaries</p> Signup and view all the answers

    What is a characteristic of ecological studies?

    <p>They use data from entire populations</p> Signup and view all the answers

    What is an example of a type of study that analyzes data from a single region and examines how the trend changes over time?

    <p>Analysis of secular trends</p> Signup and view all the answers

    What is a disadvantage of case reports and case series?

    <p>They do not provide explanation other than conjecture</p> Signup and view all the answers

    What is the purpose of examining trends in an exposure and a disease over time or across geographic boundaries?

    <p>To test whether the trends coincide</p> Signup and view all the answers

    What is a case report typically used for in pharmacovigilance?

    <p>To raise hypotheses about drug effects and guide further studies</p> Signup and view all the answers

    What is an exception to the general rule that a case report cannot be used to make a statement about causation?

    <p>When the outcome is very rare and characteristic of the exposure</p> Signup and view all the answers

    What is the major strength of a randomized clinical trial?

    <p>Random assignment</p> Signup and view all the answers

    What is a case series?

    <p>A collection of patients with a single exposure, whose clinical outcomes are evaluated</p> Signup and view all the answers

    What is the main reason why associations demonstrated in randomized clinical trials are more likely to be causal associations?

    <p>Because they use random assignment</p> Signup and view all the answers

    What is a common limitation of case reports?

    <p>One cannot determine whether the adverse outcome was due to the drug exposure or would have happened anyway</p> Signup and view all the answers

    What is the primary purpose of randomization in a randomized clinical trial?

    <p>To minimize confounding variables</p> Signup and view all the answers

    What is an example of a case series?

    <p>100 consecutive women under the age of 50 who suffered from a pulmonary embolism and were taking oral contraceptives</p> Signup and view all the answers

    What is the primary purpose of a case series after drug marketing?

    <p>To quantify the incidence of an adverse reaction</p> Signup and view all the answers

    What is the purpose of a control group in a randomized clinical trial?

    <p>To compare the outcomes of the intervention group</p> Signup and view all the answers

    What is an example of a postmarketing surveillance study?

    <p>A study designed to quantify the incidence of an adverse reaction</p> Signup and view all the answers

    What type of question can be answered by a randomized clinical trial?

    <p>Is this drug better than placebo or the current established treatment?</p> Signup and view all the answers

    What is the purpose of stratification in a randomized clinical trial?

    <p>To minimize bias by controlling for confounding variables</p> Signup and view all the answers

    What is the main difference between a case report and a case series?

    <p>The number of patients involved</p> Signup and view all the answers

    What is the primary advantage of using a randomized clinical trial design?

    <p>It minimizes bias through randomization</p> Signup and view all the answers

    What is the purpose of an intervention group in a randomized clinical trial?

    <p>To receive the new intervention or treatment</p> Signup and view all the answers

    Study Notes

    Case Reports

    • Describe a single patient who was exposed to a drug and experienced a particular outcome, usually adverse.
    • Useful for raising hypotheses about drug effects, but cannot determine whether the adverse outcome was due to the drug exposure or would have happened anyway.

    Case Series

    • A collection of patients with a single exposure, whose clinical outcomes are evaluated and described.
    • Can also be a collection of patients with a single outcome, looking at their antecedent exposures.
    • Useful for quantifying the incidence of an adverse reaction and being certain that any particular adverse effect of concern does not occur in a larger population than studied prior to drug marketing.

    Advantages and Disadvantages of Case Reports and Case Series

    • Advantages: Hypotheses are formed, easy to perform, and inexpensive.
    • Disadvantages: Does not provide explanation other than conjecture and does not establish causality or association.
    • Examine trends in an exposure that is a presumed cause and trends in a disease that is a presumed effect and test whether the trends coincide.
    • Can be examined over time or across geographic boundaries.

    Case-Control Studies

    • Useful for studying rare diseases or diseases that take long periods to develop.
    • Critical assumptions to minimize bias:
      • Cases are representative of those who have the disease.
      • Controls are representative of the general population that does not have the disease and are as identical as possible to the cases, minus the presence of the disease.
      • Information is collected from cases and controls in the same way.
    • Advantages:
      • Inexpensive and can be conducted quickly.
      • Allows investigation of several possible exposures or associations.
    • Disadvantages:
      • Confounding must be controlled.
      • Only one outcome can be studied.
      • Susceptible to bias.

    Cohort Studies

    • Identify subsets of a defined population and follow them over time, looking for differences in their outcome.
    • Advantages:
      • Free of the problem of selecting an undiseased control group.
      • Prospective cohort studies are free of the problem of the questionable validity of retrospectively collected data.
      • Particularly useful when studying multiple possible outcomes from a single exposure, especially a relatively uncommon exposure.
    • Disadvantages:
      • Can require extremely large sample sizes to study relatively uncommon outcomes.
      • Inefficiency for studying rare outcomes.
      • Prospective cohort studies can require a prolonged time period to study delayed drug effects.

    Randomized Clinical Trials (RCTs)

    • Participants are randomly allocated to either one intervention or another.
    • Each group is followed up for a specified period of time.
    • Analyzed in terms of specific outcomes defined at the start of the study.
    • Two groups should be identical as possible, with the only difference being the intervention.
    • Advantages:
      • Allows assessment of causality.
      • Minimizes bias through randomization and/or stratification.
      • Questions that can be answered by a RCT:
        • Is this drug better than placebo or the current established treatment?
        • Is this new surgical procedure better than current practice?
        • Is a leaflet better than verbal advice in helping patients make informed choices about treatment options?
        • Is this new service better than the usual service?

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    Description

    A quiz about case reports in pharmacology, exploring their role in identifying adverse drug effects and raising hypotheses.

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