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?

Examine the natural course of health events Signup and view all the answers

Which type of study involves detailed reports of individual patients?

Case report Signup and view all the answers

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

To describe unusual or novel occurrences Signup and view all the answers

What is a key characteristic of a controlled trial?

It compares outcomes between treated and untreated groups. Signup and view all the answers

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

Understanding patient demographics Signup and view all the answers

What is the primary purpose of a study design?

To collect and analyze data answering a research question Signup and view all the answers

What might occur if a study is not designed properly?

The validity of the statistical results may be questionable Signup and view all the answers

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

They may misinterpret the results Signup and view all the answers

What does CONSORT stand for?

Consolidated Standard of Reporting Trials Signup and view all the answers

Which of the following is a limitation of CONSORT recommendations?

They cannot prevent authors from bias Signup and view all the answers

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

It enhances decision-making based on valid research Signup and view all the answers

What can happen when researchers selectively report their results?

The findings could be misleading Signup and view all the answers

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

Skill in critically evaluating primary literature Signup and view all the answers

What is the primary limitation of uncontrolled trials?

They do not have a control group. Signup and view all the answers

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

Single blind Signup and view all the answers

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

Contradictory outcomes Signup and view all the answers

Which of the following statements about historical controls is true?

They are compared with currently treated patients. Signup and view all the answers

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

Controlled, randomized, double-blind trials Signup and view all the answers

What purpose does blinding serve in a clinical trial?

To ensure objectivity and reduce bias Signup and view all the answers

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

The treatment assignments Signup and view all the answers

Which of the following best describes an uncontrolled trial?

A trial without a defined comparison group. Signup and view all the answers

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

Subjects are randomly allocated to different treatment groups. Signup and view all the answers

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

Placebo control Signup and view all the answers

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

They allow for bias-free comparison between groups. Signup and view all the answers

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

Subjects are allocated to groups without random methods. Signup and view all the answers

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

A new drug against a standard drug or combination therapies. Signup and view all the answers

Which statement correctly describes a non-randomized controlled trial?

It lacks randomness in group allocation. Signup and view all the answers

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

Experimental treatment control Signup and view all the answers

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

They can lead to biased results due to group allocation. Signup and view all the answers

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

From effect to cause Signup and view all the answers

Which of the following best describes a case cohort study?

Prospective investigation from cause to effect Signup and view all the answers

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

Reliance on patient recall and medical records Signup and view all the answers

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

Relative risk Signup and view all the answers

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

Higher assurance of characteristics leading to disease Signup and view all the answers

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

Case cross-sectional study Signup and view all the answers

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

Difficult to establish temporal relationships Signup and view all the answers

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

A possible association exists Signup and view all the answers

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

Control as many variables as possible Signup and view all the answers

Which is not typically a disadvantage of case control studies?

Long time to complete the study Signup and view all the answers

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

Establishing risk factors Signup and view all the answers

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

Selection bias due to control group difficulty Signup and view all the answers

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

No requirement for follow-up Signup and view all the answers

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

They measure subject characteristics at one specific point in time Signup and view all the answers

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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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.