Podcast
Questions and Answers
What is the primary purpose of a control group in experimental studies?
What is the primary purpose of a control group in experimental studies?
- To provide a comparison for evaluating the effectiveness of the treatment (correct)
- To increase the variability of study results
- To ensure all subjects receive the investigational drug
- To randomly assign subjects to different treatment types
Which statement best describes a randomized controlled trial (RCT)?
Which statement best describes a randomized controlled trial (RCT)?
- It usually has lower costs than non-randomized trials.
- It involves non-random assignment of subjects to groups.
- It is the most reliable method for assessing treatment effectiveness. (correct)
- It allows for subjective bias in assigning treatments.
What type of trial allows subjects to be allocated to groups without randomization?
What type of trial allows subjects to be allocated to groups without randomization?
- Double-blind trial
- Non-randomized controlled trial (correct)
- Blinded trial
- Phase I trial
In a placebo-controlled study, what is the role of the placebo?
In a placebo-controlled study, what is the role of the placebo?
What is a characteristic of non-randomized controlled trials compared to randomized controlled trials?
What is a characteristic of non-randomized controlled trials compared to randomized controlled trials?
Which control is primarily used to compare a new intervention against existing standard treatments?
Which control is primarily used to compare a new intervention against existing standard treatments?
What is a common trait of all experimental controlled studies referenced?
What is a common trait of all experimental controlled studies referenced?
Which type of trial is least likely to provide reliable evidence for treatment effectiveness?
Which type of trial is least likely to provide reliable evidence for treatment effectiveness?
What is the primary purpose of a study design?
What is the primary purpose of a study design?
What can occur if a study is not well designed?
What can occur if a study is not well designed?
Why is understanding study design important for researchers?
Why is understanding study design important for researchers?
What does CONSORT provide for authors of trials?
What does CONSORT provide for authors of trials?
What is a limitation of using CONSORT guidelines?
What is a limitation of using CONSORT guidelines?
Which of the following is NOT a consequence of an improper study design?
Which of the following is NOT a consequence of an improper study design?
What is essential for pharmacy practitioners concerning literature evaluation?
What is essential for pharmacy practitioners concerning literature evaluation?
What distinguishes uncontrolled trials from controlled trials?
What distinguishes uncontrolled trials from controlled trials?
What can researchers do if they fail to use the correct study design?
What can researchers do if they fail to use the correct study design?
What is the primary purpose of blinding in clinical trials?
What is the primary purpose of blinding in clinical trials?
Which study design is considered the 'Gold Standard' in clinical research?
Which study design is considered the 'Gold Standard' in clinical research?
What is one purpose of a case series study?
What is one purpose of a case series study?
In a double-blind trial, who remains unaware of the treatment assignments?
In a double-blind trial, who remains unaware of the treatment assignments?
Which option best describes a case report?
Which option best describes a case report?
What is NOT a reason for researchers to select a particular study design?
What is NOT a reason for researchers to select a particular study design?
What characteristic is true about meta-analysis?
What characteristic is true about meta-analysis?
What is an unblinded or open label trial?
What is an unblinded or open label trial?
Which statement accurately describes an observational study?
Which statement accurately describes an observational study?
In descriptive studies, which type qualifies as documenting experiences of a patient series?
In descriptive studies, which type qualifies as documenting experiences of a patient series?
How does a historical control group function in a clinical trial?
How does a historical control group function in a clinical trial?
What aspect of case reports makes them unique in research?
What aspect of case reports makes them unique in research?
What advantage does blinding provide in clinical trials?
What advantage does blinding provide in clinical trials?
Which of the following is a drawback of descriptive studies?
Which of the following is a drawback of descriptive studies?
What is typically involved in the setup of an explanatory observational study?
What is typically involved in the setup of an explanatory observational study?
What is the primary direction of study in a case control study?
What is the primary direction of study in a case control study?
Which association measurement is used in case cohort studies?
Which association measurement is used in case cohort studies?
What is a disadvantage of case control studies?
What is a disadvantage of case control studies?
What is the main strength of case cohort studies compared to case control studies?
What is the main strength of case cohort studies compared to case control studies?
What aspect is predominantly assessed in a cross-sectional study?
What aspect is predominantly assessed in a cross-sectional study?
Which of the following is NOT an advantage of case control studies?
Which of the following is NOT an advantage of case control studies?
What is a common bias experienced in case control studies?
What is a common bias experienced in case control studies?
What limitation affects the implementation of case cohort studies?
What limitation affects the implementation of case cohort studies?
Which study type best helps in determining the prevalence of a condition?
Which study type best helps in determining the prevalence of a condition?
What is a significant disadvantage of cross-sectional studies?
What is a significant disadvantage of cross-sectional studies?
What is a notable characteristic of case control studies?
What is a notable characteristic of case control studies?
In case control studies, what is the typical size of the study population?
In case control studies, what is the typical size of the study population?
What type of study is primarily used to explore chronic diseases after they have developed?
What type of study is primarily used to explore chronic diseases after they have developed?
What type of bias might occur if disease publicity leads to increased reporting?
What type of bias might occur if disease publicity leads to increased reporting?
Flashcards
Study Design
Study Design
The methods and procedures used to collect and analyze data in a study to answer a specific research question.
Importance of Proper Study Design
Importance of Proper Study Design
Ensures the data collected is accurate and reliable, leading to valid statistical results.
Consequences of Poor Study Design
Consequences of Poor Study Design
The researchers may choose or execute an inappropriate study design, leading to inaccurate interpretations and conclusions.
CONSORT
CONSORT
A set of guidelines that ensure transparency and completeness in reporting clinical trial findings.
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CONSORT's Limitations
CONSORT's Limitations
CONSORT checklists provide a framework for transparent reporting, but they cannot prevent researchers from introducing bias.
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Importance of Critical Evaluation
Importance of Critical Evaluation
The ability to critically evaluate the research literature is essential for pharmacy practitioners.
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Critical Evaluation Skills
Critical Evaluation Skills
Critical evaluation involves assessing the study design, analyzing the data, and interpreting the conclusions to make informed decisions.
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Integrating Research into Practice
Integrating Research into Practice
Pharmacy practitioners must be able to evaluate research findings and incorporate them into their practice.
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Descriptive study
Descriptive study
A study that documents experiences or new events deemed important by the author. It involves gathering data through observations and drawing conclusions.
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Observational study
Observational study
A study that examines the natural course of health events. Researchers observe participants and gather data to classify and sort information.
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Case series
Case series
A study that documents observations from a group of patients, often used to estimate the incidence of adverse events related to a new treatment.
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Case report
Case report
A detailed report on the symptoms, diagnosis, treatment, and follow-up of a single patient, often focusing on unusual or new events.
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Non-experimental observational study
Non-experimental observational study
A study that investigates the relationship between variables without manipulating them. Participants are observed and categorized based on existing characteristics.
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Experimental study
Experimental study
A study that investigates the relationship between variables by manipulating one or more factors (independent variables) and observing their effect on the outcome (dependent variable).
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Controlled trial
Controlled trial
A study that compares two groups, one receiving a specific intervention (e.g., a drug) and the other receiving a placebo or standard care.
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Cohort study
Cohort study
A study that involves observing a single group of participants over time, tracking changes in health outcomes or risk factors.
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Randomized Controlled Trial (RCT)
Randomized Controlled Trial (RCT)
A study design where subjects are randomly assigned to different groups (experimental or control), allowing researchers to isolate the effect of the intervention.
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Non-Randomized Controlled Trial
Non-Randomized Controlled Trial
A study design where the allocation of subjects to different groups is not randomized but based on specific criteria. It does not offer the same level of evidence strength as RCTs.
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Uncontrolled Study
Uncontrolled Study
A study design where there is no control group for comparison. The effect of the intervention is observed in only one group.
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Explanatory Study
Explanatory Study
A study design that investigates the relationship between variables without manipulating any of them. It aims to explain or describe phenomena.
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Active Treatment Control
Active Treatment Control
The standard treatment or intervention used for the disease being studied. It is used as a baseline for comparison.
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Placebo Control
Placebo Control
Inert substance or procedure that resembles the actual treatment but has no therapeutic effect. Used to account for the placebo effect.
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No Treatment Control
No Treatment Control
A control group where subjects receive no intervention or treatment, allowing researchers to observe the natural course of the disease.
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Experimental Group
Experimental Group
The group that receives the experimental intervention or treatment being studied.
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Historical Controls
Historical Controls
Patients who were treated in a different setting or time compared to the current trial.
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Uncontrolled Trials
Uncontrolled Trials
They lack a control group, meaning researchers cannot control if subjects receive the treatment being studied.
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Blinding in Clinical Trials
Blinding in Clinical Trials
Blinding is a method used to hide information about treatment assignments from participants and researchers, minimizing bias in the design of a clinical trial.
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Double-Blind Trial
Double-Blind Trial
When no one (neither participants nor researchers) knows who receives which treatment.
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Meta-Analysis
Meta-Analysis
A study that combines the results of multiple studies to reach a stronger conclusion, improving statistical power.
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Gold Standard in Clinical Research
Gold Standard in Clinical Research
Research studies with a carefully designed control group are considered the most reliable in medicine.
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Combining Studies
Combining Studies
Analyzing several studies to arrive at a more robust conclusion.
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Critical Evaluation of Research
Critical Evaluation of Research
Used to assess the quality of research, ensuring accuracy and reliability in interpreting data.
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Case-Control Study
Case-Control Study
A type of observational study where researchers start with a group with a specific outcome (cases) and a group without it (controls), then look back in time to see if a particular exposure was more common in the cases. Often used to study the causes of diseases.
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Cross-Sectional Study
Cross-Sectional Study
A type of observational study where researchers gather data from a group of people at a single point in time to see the prevalence of a specific outcome and associated factors. Often used for quick snapshots of a population's health.
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Odds Ratio (OR)
Odds Ratio (OR)
This is a measure of association that is used in case-control studies. It is used to calculate the likelihood of exposure among cases compared to controls.
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Relative Risk (RR)
Relative Risk (RR)
This is a measure of association that is used in cohort studies. It compares the risk of developing an outcome in the exposed group to the risk of developing the outcome in the unexposed group.
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Recall Bias
Recall Bias
This bias can occur in case-control studies when people with the outcome (cases) are more likely to recall past exposures than people without the outcome (controls).
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Surveillance Bias
Surveillance Bias
This bias can occur in case-control studies when people with the outcome (cases) are more likely to be identified and enrolled in the study than those without the outcome (controls).
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Reporting Bias
Reporting Bias
This bias can occur in case-control studies when people with the outcome (cases) are more likely to report their exposure due to publicity or awareness of the condition.
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Quasi-Experimental Study
Quasi-Experimental Study
A type of experimental study that uses a pre-existing or natural grouping to study the effects of an intervention. Participants are not randomly assigned.
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Randomization
Randomization
This design seeks to minimize bias by ensuring that the treatment and control groups are as similar as possible at the beginning of the study.
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Type I Error (False Positive)
Type I Error (False Positive)
This is the chance that the observed results of a study are due to random variations rather than the actual effect of the intervention.
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Type II Error (False Negative)
Type II Error (False Negative)
This is the chance that the observed results of a study fail to detect a real effect of the intervention.
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Statistical Power
Statistical Power
The ability of a study to detect a real difference between the groups being compared in a study.
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Course Information
- Course title: Introduction to Drug Information
- Course code: PHAR200
- Institution: Lebanese International University
- School: School of Pharmacy
- Department: Pharmacy Practice Department
- Semester: Spring 2023-2024
- Chapter: Evaluation of Literature (Chapter 9)
Chapters Covered
- Medical Terminologies
- Drug Evaluation Monograph
- Pharmacist Patient Care Process (PPCP)
- Drug Information Resources
- Drug Consult
- Referencing
- Drug Information Center (DIC)
- Introduction to Biostatistics
- Evaluation of Literature
- Evaluation of Journal Club
- Evidence-based Clinical Practice Guidelines
What is a Study Design?
- 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 raise questions about the validity of results.
Importance of Understanding Study Design
- Researchers may use inappropriate study designs.
- Misinterpretation of results may occur
- Incorrect conclusions from studies may be drawn.
- Selective or incorrect reporting of results.
- Selective or incorrect referencing of other studies.
CONSORT
- Consolidated standards of reporting trials (CONSORT) provides checklists for trial authors to use when submitting manuscripts to medical journals.
- Adopted by different medical journals (Lancet, Annals of Internal Medicine, JAMA).
- CONSORT recommendations alone are not sufficient for critical evaluation of primary literature.
Study Design Selection
- Number of patients required for meaningful results.
- Complexity of the study.
- Time required to conduct the study.
- Cost of the study.
Types of Studies - Categorization
-
Descriptive studies document experiences or new events for the medical community. Investigators observe data, then draw conclusions.
- Case Series: Document outcomes of a group of patients. Useful to estimate the incidence of adverse events related to a new drug.
- Case Report: Detailed report of one patient's symptoms, signs, diagnosis, treatment, and follow-up. Usually for unusual or novel occurrences.
-
Explanatory studies try to explain health events.
- Observational studies examine the natural course of health events.
- Case-Control: Retrospective studies starting with an outcome and looking backward to find causes/risk factors (determined by an odds ratio). Ex. Alcohol and liver damage.
- Case Cohort: Prospective studies starting with causes/exposures and looking forward to see the outcome (determined by relative risk). Ex. Smoking and lung cancer.
- Cross-sectional: Data collected at one time point to determine prevalence. Ex. Prevalence of a disease in a population.
- Experimental studies actively test one or more treatments/procedures on subjects.
- Controlled Trial: Subjects randomly assigned to experimental or control groups.
- Randomized Controlled Trial (RCT): Best available evidence. Gold Standard.
- Non-randomized Controlled Trial: Not considered a 'gold standard'. Includes: placebo control, no treatment control, active treatment control, and historical control.
- Uncontrolled Trial: No control group.
- Controlled Trial: Subjects randomly assigned to experimental or control groups.
- Observational studies examine the natural course of health events.
Study Design - Evaluation Factors
- Advantages and Disadvantages of each study type summarized based on factors such as time, cost, determining prevalence, and establishing exposure. Analysis of factors such as rare exposure, need for time to pass between exposure and disease, and potential for bias.
- Methodological Strengths and Weakness of each design type discussed, including strengths and limitations.
- Study Type Summary Table comparing different types of studies providing characteristics such as design, study direction, measure of association, etc.
Blinding of Trials
- Blinding is a procedure to keep one or more parties uninformed of treatment assignments.
- It prevents bias in clinical trials.
- Blinding can be single-blind (participants unaware), double-blind (participants and clinicians unaware), or open-label (everyone aware).
Meta-Analysis
- Meta-analysis combines results from multiple published studies.
- Increases overall statistical power.
- Useful for small study samples or variable conclusions among different studies of an issue/occurrence/outcome.
Strength of Evidence
- Ranking of study designs by strength of evidence.
- Controlled randomized, double-blind trials, (RCTs) considered the "gold standard".
- Ranked from Strong (systematic reviews, meta-analysis) to weak (case reports, case series).
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