Scientific Research in Clinical Pharmacy
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Questions and Answers

What type of study is a case report?

  • A presentation of one patient's case (correct)
  • An analytical study comparing multiple groups
  • A presentation of at least two cases
  • A randomized control trial

    • A case report typically provides a clear explanation of causality.

    False

    What is the main purpose of writing a case report or case series?

    To provide information about rare diseases and unusual clinical presentations.

    The publication of the case report depends on how much the case is ______ for the health community.

    <p>interesting</p> Signup and view all the answers

    Match the following components to their descriptions for writing a case report:

    <p>Introduction = Overview of the case and its significance Case presentation = Detailed account of the patient's clinical picture Discussion = Analyzes the findings as compared to existing literature Follow up and outcomes = Details on the patient's response to treatment</p> Signup and view all the answers

    What is the primary purpose of the title in a case report checklist?

    <p>To indicate the diagnosis or intervention followed by the words 'case report'.</p> Signup and view all the answers

    The introduction of a case report should be limited to one paragraph summarizing the case.

    <p>False</p> Signup and view all the answers

    What should the 'Timeline' section of a case report include?

    <p>Historical and current information from the episode of care organized as a timeline.</p> Signup and view all the answers

    The main outcomes should be assessed in the ______ and Outcomes section of a case report.

    <p>Follow-Up</p> Signup and view all the answers

    Match the checklist item descriptions to their corresponding topics:

    <p>Diagnostic Assessment = Types of therapeutic intervention (such as pharmacologic, surgical, preventive, self-care). Follow-Up and Outcomes = Clinician and patient-assessed outcomes (if available). Clinical Findings = Describe significant physical examination (PE) and important clinical findings. Patient Information = De-identified patient specific information.</p> Signup and view all the answers

    What is one advantage of a case-control study?

    <p>Allows study of rare diseases with a small sample size</p> Signup and view all the answers

    A cohort study can establish causation between exposure and disease development.

    <p>False</p> Signup and view all the answers

    What measure is commonly used in case-control studies to express the association between an exposure and an outcome?

    <p>odds ratio</p> Signup and view all the answers

    In a case-control study, subjects with the outcome of interest are referred to as ______, while those without are referred to as ______.

    <p>cases; controls</p> Signup and view all the answers

    Match the following observational study types with their descriptions:

    <p>Case-Control Study = Enroll subjects based on outcome status and compare exposures Cohort Study = Identify subjects based on exposure status and follow for outcomes Cross-sectional Study = Assess exposure and outcome status at one point in time Observational Study = Involves no investigator intervention but only observation</p> Signup and view all the answers

    Study Notes

    Scientific Research

    • Engy Ahmed Wahsh is the head of the clinical pharmacy department at the Faculty of Pharmacy, October 6 University.
    • Research designs are categorized as primary clinical study designs, including observational, diagnostic, and interventional types.
    • Observational studies include descriptive (case report/series, cross-sectional, cohort), and analytical (cross-sectional, cohort, case-control).
    • Interventional studies include randomized controlled trials (RCTs), randomized cross-over trials, and adaptive clinical trials.

    Case Report and Case Series

    • A case report presents a single patient case of a rare/unexplained condition, novel treatments, or unusual events.
    • A case series presents two or more cases with similar characteristics.
    • Case reports must provide information on new diseases, symptoms, epidemiological outbreaks, and patient consent for publication.

    Advantages and Disadvantages of Case Report/Series

    • Advantages: Easy to perform and inexpensive
    • Disadvantages: Does not explain causality or association.
    • They do not provide explanation other than assumption and do not establish causality or association.
    • Titles should not state "study."

    Standard Reporting Guidelines (CARE Statement)

    • The CARE statement outlines the standard reporting guidelines for case reports and sets out a format for reporting.
    • A standard structure is used, including introduction, case presentation, clinical findings, diagnostic assessment, therapeutic intervention, and discussion.
    • Includes de-identified demographic information, clinical history, and follow-up information.
    • Includes the rationale for conclusions and primary lessons from the case.

    Observational Study Designs

    • Observational study designs do not involve investigator intervention and are used to study associations, not causality.
    • Types include: case-control, cohort, and cross-sectional studies.

    Case-Control Study

    • Subjects with the outcome (cases) and those without (controls) are enrolled.
    • The exposure is determined to identify an association with the outcome.
    • Retrospective, which helps study exposures for rare diseases or conditions that take a long time to develop.

    Case-Control Study- Advantages and Disadvantages

    • Advantages: Inexpensive, quick, and allows for the investigation of several exposures and rare diseases.
    • Disadvantages: Cannot calculate prevalence or incidence, prone to observational and recall bias, and difficulty with matching controls. (Case selection & control matching.)

    Cohort Study

    • Determines the association between exposures and the development of disease/condition.
    • Allows estimation of outcome risk and calculates relative risk.
    • Can be prospective (following people forward) or retrospective (following records backwards).

    Cohort Study- Strengths and Weaknesses

    • Strengths: Can calculate incidence and infer temporal relationship between exposure and outcome, and structured collection.
    • Weaknesses: Loss to follow-up or non-random data, and large sample sizes are often needed, long duration, and can be expensive.

    Cross-Sectional Study

    • Measures prevalence and characteristics of variables/conditions in a group of individuals at a given point in time.
    • A snapshot of data collection.
    • Easy to design and inexpensive, data collected at one point in time.

    Cross-Sectional Study - Advantages and Disadvantages

    • Advantages: Easy design, short duration, and inexpensive.
    • Disadvantages: Does not allow for studying a factor over time in individual subjects, difficult to study rare conditions, and difficult to determine temporal sequence between exposures/diseases.

    Types of Epidemiological Studies

    • Analytic studies are broken down into treatment studies (experimental) and observational studies.
    • Treatment studies (experimental) include randomized controlled trials (RCTs), randomized cross-over trials, and adaptive clinical trials, non-randomized trials (quasi-experiment).
    • Observational studies include cross-sectional studies, cohort studies, and case-control studies, and ecological studies.

    Standard Reporting Guidelines

    • Presents various checklists for reporting randomized controlled trials (CONSORT), observational studies (STROBE), diagnostic accuracy studies (STARD), systematic reviews (PRISMA), meta-analyses of controlled trials (PRISMA), and meta-analysis of observational studies (MOOSE).

    Study Design Example

    • Public health officials assess smoking prevalence/lung function by conducting a one-time survey. (Cross-sectional)

    Interventional Studies

    • Also known as experimental studies, designed to establish a causal relationship between exposures and outcomes.
    • Types: randomized vs. non-randomized controlled studies, single-arm vs. controlled studies, phase I-IV, pragmatic & explanatory.

    Random Allocation

    • In RCTs, subjects are randomly allocated to treatment groups to control unequal distribution.
    • Quasi-experimental trials (non-randomized) use other methods for allocation, such as patient preference or physician judgment.

    Single Arm vs. Controlled Trials

    • Single-arm trials involve a single experimental group, while controlled trials include more than one group (experimental vs. control).

    Ethical Issues

    • Research ethics committee approval is required for all research studies.
    • Clinical equipoise is necessary, researchers must have doubt about the relative effectiveness of treatments.

    Clinical Trial Types based on Hypothesis

    • Superiority: Experimental drug is better than control.
    • Non-inferiority: Experimental drug is not worse than control.
    • Equivalence: Experimental drug is equivalent to the control.

    Efficacy vs Effectiveness

    • Efficacy: Highest effect under standardized conditions from clinical trials, testing effectiveness under optimized circumstances or specific settings.
    • Effectiveness: Real-world effects in clinical practice from observational studies. All population in reality or in clinical practice.

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    Related Documents

    Lecture 4: Scientific Research PDF

    Description

    Explore the fundamentals of scientific research, particularly in clinical pharmacy, highlighting key study designs, including observational and interventional methods. Understand the significance of case reports and case series in clinical practice. This quiz will test your knowledge on these essential research components.

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