PHAR200 Chapter 9: Evaluation of Literature
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Questions and Answers

What factor is NOT considered when researchers select the design of their study?

  • Cost of the study
  • Length of patients' recovery (correct)
  • Study's complexity
  • Number of patients required

Which of the following is a major type of descriptive study?

  • Case series (correct)
  • Meta-analysis
  • Controlled trial
  • Cross-sectional study

What is a primary limitation of a case series study?

  • It can determine the effectiveness of one treatment over another. (correct)
  • It usually documents unique experiences of multiple patients.
  • It allows for statistical analysis of the observed data.
  • It provides definitive explanations for observed events.

An observational study primarily focuses on which of the following?

<p>Examine the natural course of health events (D)</p> Signup and view all the answers

Which type of study involves detailed reports of individual patients?

<p>Case report (A)</p> Signup and view all the answers

What is one of the main purposes of a case report?

<p>To describe unusual or novel occurrences (D)</p> Signup and view all the answers

What is a key characteristic of a controlled trial?

<p>It compares outcomes between treated and untreated groups. (C)</p> Signup and view all the answers

Which of the following is NOT a reason to select a particular study design?

<p>Understanding patient demographics (D)</p> Signup and view all the answers

What is the primary purpose of a study design?

<p>To collect and analyze data answering a research question (D)</p> Signup and view all the answers

What might occur if a study is not designed properly?

<p>The validity of the statistical results may be questionable (A)</p> Signup and view all the answers

What is a significant risk if researchers use the wrong study design?

<p>They may misinterpret the results (A)</p> Signup and view all the answers

What does CONSORT stand for?

<p>Consolidated Standard of Reporting Trials (A)</p> Signup and view all the answers

Which of the following is a limitation of CONSORT recommendations?

<p>They cannot prevent authors from bias (C)</p> Signup and view all the answers

Why is critical evaluation of primary literature essential for pharmacy practitioners?

<p>It enhances decision-making based on valid research (D)</p> Signup and view all the answers

What can happen when researchers selectively report their results?

<p>The findings could be misleading (C)</p> Signup and view all the answers

What is a crucial skill successful pharmacy practitioners must have regarding literature?

<p>Skill in critically evaluating primary literature (D)</p> Signup and view all the answers

What is the primary limitation of uncontrolled trials?

<p>They do not have a control group. (D)</p> Signup and view all the answers

Which type of blinding keeps participants unaware of the treatment, while allowing researchers to know the treatment assignments?

<p>Single blind (C)</p> Signup and view all the answers

Meta-analysis is particularly useful when studies have what characteristics?

<p>Contradictory outcomes (C)</p> Signup and view all the answers

Which of the following statements about historical controls is true?

<p>They are compared with currently treated patients. (B)</p> Signup and view all the answers

What type of trial design is considered the 'Gold Standard' in clinical research?

<p>Controlled, randomized, double-blind trials (D)</p> Signup and view all the answers

What purpose does blinding serve in a clinical trial?

<p>To ensure objectivity and reduce bias (B)</p> Signup and view all the answers

In an unblinded trial, what is known by all parties involved?

<p>The treatment assignments (C)</p> Signup and view all the answers

Which of the following best describes an uncontrolled trial?

<p>A trial without a defined comparison group. (C)</p> Signup and view all the answers

What is a key feature of a randomized controlled trial (RCT)?

<p>Subjects are randomly allocated to different treatment groups. (C)</p> Signup and view all the answers

Which type of control group is characterized by using an inert substance?

<p>Placebo control (C)</p> Signup and view all the answers

Why are randomized controlled trials considered the gold standard for assessing therapeutic agents?

<p>They allow for bias-free comparison between groups. (D)</p> Signup and view all the answers

How do non-randomized controlled trials differ from randomized controlled trials?

<p>Subjects are allocated to groups without random methods. (D)</p> Signup and view all the answers

What does an active treatment control compare in a clinical trial?

<p>A new drug against a standard drug or combination therapies. (B)</p> Signup and view all the answers

Which statement correctly describes a non-randomized controlled trial?

<p>It lacks randomness in group allocation. (C)</p> Signup and view all the answers

Which of the following is not typically considered a control in experimental studies?

<p>Experimental treatment control (A)</p> Signup and view all the answers

What is a limitation often associated with non-randomized controlled trials?

<p>They can lead to biased results due to group allocation. (B)</p> Signup and view all the answers

What is the primary direction of investigation in a case-control study?

<p>From effect to cause (B)</p> Signup and view all the answers

Which of the following best describes a case cohort study?

<p>Prospective investigation from cause to effect (B)</p> Signup and view all the answers

What is a significant disadvantage of using case-control studies?

<p>Reliance on patient recall and medical records (D)</p> Signup and view all the answers

Which measure of association is primarily used in a case cohort study?

<p>Relative risk (D)</p> Signup and view all the answers

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

<p>Higher assurance of characteristics leading to disease (B)</p> Signup and view all the answers

Which type of study design allows for the assessment of disease prevalence at a specific point in time?

<p>Case cross-sectional study (B)</p> Signup and view all the answers

What is a common disadvantage associated with case cross-sectional studies?

<p>Difficult to establish temporal relationships (B)</p> Signup and view all the answers

In the context of a case-control study, what does an odds ratio greater than 1 indicate?

<p>A possible association exists (B)</p> Signup and view all the answers

What is a characteristic feature of experimental studies such as clinical trials?

<p>Control as many variables as possible (D)</p> Signup and view all the answers

Which is not typically a disadvantage of case control studies?

<p>Long time to complete the study (B)</p> Signup and view all the answers

What is often the primary focus of case cohort studies compared to case-control studies?

<p>Establishing risk factors (D)</p> Signup and view all the answers

What type of bias is associated with case cohort studies that may affect the results?

<p>Selection bias due to control group difficulty (B)</p> Signup and view all the answers

Which characteristic of case-control studies contributes to their efficiency in studying chronic diseases?

<p>No requirement for follow-up (D)</p> Signup and view all the answers

Which statement accurately describes the nature of case cross-sectional studies?

<p>They measure subject characteristics at one specific point in time (D)</p> Signup and view all the answers

Flashcards

Study Design

The methods used to collect and analyze data in a study to answer a specific research question.

Valid Study Design

The study design ensures that the data generated is valid and proper analysis provides accurate results.

Flawed Study Design

A flawed study design makes the results unreliable and potentially inaccurate.

Appropriate Study Design

A study design that is appropriate for the research question.

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Research Bias

Researchers may use the wrong study design, implement methods incorrectly, misinterpret results, and report their findings selectively or inaccurately.

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CONSORT

A set of standards for reporting clinical trials, ensuring transparency and consistency.

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CONSORT Limitations

CONSORT guidelines are not enough to prevent bias by authors and require critical evaluation.

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Critical Evaluation Skills

Essential for pharmacy practitioners to evaluate research literature critically and ensure accuracy.

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Study Design Selection

The study design is chosen based on factors like the number of patients, research complexity, time needed, and its cost.

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Observational Study

A type of research study where the investigator observes and records data, without manipulating any variables.

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Explanatory - Observational Studies

Researchers examine the natural progression of health events, collecting data and classifying it to understand patterns and relationships.

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Case Report

A detailed description of a single case, often highlighting unusual or novel findings in a patient's medical history.

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Case Series

A collection of observations from a group of patients, usually used to estimate the frequency of an event or the effectiveness of a new drug.

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Experimental Study

A research study where researchers directly manipulate variables to test a hypothesis or explore a cause-and-effect relationship.

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Cohort Study

A specific type of observational study that involves examining a group of individuals over a period of time to track changes or outcomes.

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Cross-Sectional Study

A research study that analyzes data from a specific point in time, providing a snapshot of a population's characteristics at a particular moment.

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Controlled Studies

Research studies where the impact of an intervention is evaluated by comparing outcomes in a group that receives the intervention to a group that does not.

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Randomized Controlled Trial (RCT)

Subjects in a controlled study are assigned to groups randomly, ensuring each participant has an equal chance of receiving the intervention or placebo.

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RCTs as the Gold Standard

The gold standard for evaluating treatment effectiveness. It provides the most reliable scientific evidence.

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Non-Randomized Controlled Trial

Subjects are assigned to groups based on factors other than random assignment which can lead to potential bias.

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Placebo Control

A harmless substance that has no effect on the condition being studied. It's given to the control group to make comparisons fair.

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No Treatment Control

The control group receives no treatment or intervention during the study to serve as a basis for comparison.

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Active Treatment Control

Comparing a new treatment to an existing standard treatment for the same condition.

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Comparing New & Standard Therapies

Involves comparing a new drug to a standard drug or comparing a combination of drugs to standard therapy alone.

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Historical Control

Patients treated in a previous study or different setting used as a comparison group.

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Uncontrolled Trial

A study where researchers have no control over treatment assignment. Subjects receive the treatment being studied randomly.

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Blinding

A method to prevent bias in clinical trials by keeping one or more parties unaware of treatment assignments.

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Meta-Analysis

A study that combines data from multiple studies. It increases statistical power and helps draw stronger conclusions.

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Gold Standard Study Design

Randomized controlled trials are considered the most reliable study design. Results are more trustworthy.

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Case-control study

A retrospective study that begins with an outcome and then looks backward in time to identify potential causes or risk factors. The association is determined by the odds ratio, which is greater than 1 if the exposure is associated with the outcome.

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Case-cohort study

A prospective study that follows a group of individuals with a specific exposure over time to observe the development of an outcome. The association is determined by the relative risk, which is greater than 1 if the exposure is associated with the outcome.

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Case cross-sectional study

A study that collects data at a single point in time to assess the prevalence of a particular outcome or exposure. It does not examine the cause-and-effect relationship, but rather describes the relationship between the outcome and exposure at a given moment.

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Retrospective Study

A study that examines the relationship between an exposure and an outcome by looking backward in time. It starts with the presence or absence of an outcome and then investigates potential causes or risk factors.

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Prospective Study

A study that examines the relationship between an exposure and an outcome by following a group of individuals over time. It starts with a defined group and then observes the development of the outcome.

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Odds Ratio

The odds of having an outcome in the exposed group divided by the odds of having the outcome in the unexposed group. It is a measure of association used in case-control studies.

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Relative Risk

The risk of developing an outcome in the exposed group divided by the risk of developing the outcome in the unexposed group. It is a measure of association used in case-cohort studies.

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Recall Bias

A type of bias that occurs when individuals with a particular outcome are more likely to recall or report past exposures than individuals without the outcome.

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Surveillance Bias

A type of bias that occurs when the selection of participants into the study is influenced by the outcome. This could be due to different ways of diagnosing the outcome in different groups, or different levels of follow-up or surveillance of groups.

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Reporting Bias

A type of bias that occurs when the reporting of the outcome is influenced by publicity or awareness of the outcome. It leads to an artificial increase in reporting of the outcome.

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Prevalence

The proportion of individuals in a population who have a particular outcome at a given point in time. It is often used in cross-sectional studies to describe the prevalence of a condition.

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Clinical Trial

A type of experimental study that involves human participants. Clinical trials are typically conducted to assess the effectiveness and safety of a new drug or treatment.

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Study Notes

Course Information

  • Course Title: Introduction to Drug Information
  • Course Code: PHAR200
  • Institution: Lebanese International University
  • Department: School of Pharmacy, Pharmacy Practice Department
  • Semester: Spring 2023-2024
  • Chapter: Evaluation of Literature (Chapter 9)

Study Designs

  • Study designs are methods and procedures for collecting and analyzing data to answer research questions
  • Properly designed studies generate valid data leading to valid statistical results.
  • Poorly designed studies may lead to questionable or invalid statistical results.

Importance of Understanding Study Design

  • Researchers may use inappropriate designs
  • Results may be misinterpreted
  • Conclusions drawn from studies may be incorrect
  • References to other studies may be selective or incorrect

CONSORT

  • Consolidated Standards of Reporting Trials (CONSORT)
  • Provides checklists for authors to use in submitting trial manuscripts to medical journals
  • Adopted by medical journals (Lancet, Annals of Internal Medicine, JAMA)
  • Doesn't prevent author bias
  • CONSORT recommendations alone aren't sufficient for critical evaluation of primary literature

Study Design Selection

  • Researchers consider factors such as:
    • Number of patients needed for meaningful results
    • Complexity of the study
    • Time required to conduct the study
    • Cost of the study

Types of Studies

  • Descriptive Studies: Document experiences or new events important to the medical community

    • Case series: Document observations from groups or series of patients and record outcomes
      • Example: Estimating the incidence of an adverse event of a newly marketed drug (e.g., suicidal ideation following haloperidol use)
    • Case report: Detailed report of symptoms, signs, diagnosis, treatment, and follow-up of an individual patient
      • Describes unusual or novel occurrences

  • Explanatory Studies (Observational): Examine the natural course of health events and classify/sort data

    • Case-control studies: Work backward from effect to cause. Start with an outcome and look for causes/risk factors.
      • Useful to study chronic diseases when follow up time is long
      • Advantages: Quick and inexpensive with a small sample size
      • Disadvantages: Detailed mechanism isn't always clear, recall bias, selecting a suitable control group is hard, rare diseases may not be represented
    • Case-cohort studies: Work forward from cause to effect
      • Advantages: Easier to establish exposure, more robust than case-control, greater assurance that the characteristics of the study accurately reflect the disease, efficient for rare exposures, effective in detecting main risk factors, no recall bias
      • Disadvantages: More time intensive, costlier with large sample size, subject characteristics may change during follow-up, finding a suitable control group
    • Cross-sectional studies: Observe, collect data at a single point in time to determine prevalence.
      • Advantages: Fast and inexpensive, measure multiple outcomes, less resources intensive, useful to determine prevalence
      • Disadvantages: Can't directly describe the cause and effect or the sequence of events; not suitable for rare diseases

  • Explanatory Studies (Experimental): Designed to control variables to measure a specific outcome

    • Controlled trials:
      • Randomized Controlled Trials (RCTs): Randomly allocate treatments to patients. Considered the Gold Standard for assessing therapeutic agents' effectiveness.
      • Non-Randomized Controlled Trials: Non-random allocation of treatments. Less expensive.
      • Controls: Placebo control, "no treatment" control, active treatment control, and historical controls
    • Uncontrolled trials: No control group

Blinding of Trials

  • Blinding helps to reduce bias and is a procedure in trials where one or more parties aren't aware of which treatments participants are assigned.
    • Unblinded/Open label: everyone is aware of the treatments
    • Single-blind: Participants are unaware, but at least one other party is aware
    • Double-blind: Neither participants nor clinicians are aware of the treatments

Meta-Analysis

  • Meta-analysis combines results from published studies to create a broader conclusion, increasing statistical power.
  • Especially useful when individual studies have small subject numbers or vary in conclusions.

Strength of Evidence by Study Design

  • Strongest evidence from systematic reviews and meta-analyses, followed by RCTs, and then cohort studies
  • Less reliable evidence comes from case-control studies, cross-sectional studies, case reports, and case series.

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Related Documents

Chapter 7 - Evaluation of Literature - Lebanese International University

Description

This quiz focuses on Chapter 9 of the Introduction to Drug Information course, which covers the Evaluation of Literature. It highlights the significance of study designs in research, the impact of poorly constructed studies, and the importance of adhering to reporting standards such as CONSORT for valid results.

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