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Article

Basics of study design: Practical considerations

Robert L. Chatburn, MHHS, RRT-NPS, FAARC
Cleveland Clinic Journal of Medicine September 2017, 84 (9 suppl 2) e10-e19; DOI: https://doi.org/10.3949/ccjm.84.s2.03
Robert L. Chatburn
Clinical Research Manager, Respiratory Institute
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  • FIGURE 1
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    FIGURE 1

    A structured approach for developing a formal research protocol.

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    FIGURE 2

    Schematic of pre-experimental research designs.

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    FIGURE 3

    Schematic of a quasi-experimental research design.

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    FIGURE 4

    The randomized controlled study design.

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    FIGURE 5

    Simple graphs that you should be able to make using a spreadsheet program that contains your experimental data.

    COPD = chronic obstructive pulmonary disease; PaCOs = partial pressure of carbon dioxide, artery; PS = pressure support; RDS = respiratory distress syndrome; SIMV = synchronized intermittent mandatory ventilation

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    FIGURE 6

    Example flowchart for selecting the appropriate statistical test.

    ANOVA = analysis of variance

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    FIGURE 7

    Types of errors in statistical decision making.

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    FIGURE 8

    Probabilities associated with type I and type II errors.

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    FIGURE 9

    Nomogram for calculating power and sample size.

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    TABLE 1

    Factors to consider when judging the feasibility of a new study

    FactorIssues
    SignificanceWhat is the potential cost/benefit?
    MeasurabilityCan you define and measure outcome variables?
    Time contraintsHow long to obtain needed sample size?
    Are that many subjects really available?
    What are your personal time constraints?
    Cost and equipmentWill you reimburse subjects?
    Will you need to pay constultants/ study personnel?
    What is the cost of study supplies?
    Need to rent/purchase equipment?
    ExperienceDo you have the skills to manage the study?
    Can you get help (eg, study coordinators)?
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Cleveland Clinic Journal of Medicine: 84 (9 suppl 2)
Cleveland Clinic Journal of Medicine
Vol. 84, Issue 9 suppl 2
1 Sep 2017
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Basics of study design: Practical considerations
Robert L. Chatburn
Cleveland Clinic Journal of Medicine Sep 2017, 84 (9 suppl 2) e10-e19; DOI: 10.3949/ccjm.84.s2.03

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Basics of study design: Practical considerations
Robert L. Chatburn
Cleveland Clinic Journal of Medicine Sep 2017, 84 (9 suppl 2) e10-e19; DOI: 10.3949/ccjm.84.s2.03
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  • Article
    • INTRODUCTION
    • DEVELOPING THE STUDY IDEA
    • EXAMPLES OF RESEARCH PROJECTS BY FELLOWS
    • HOW TO SEARCH THE LITERATURE
    • STUDY DESIGN
    • BASIC MEASUREMENT METHODS
    • STATISTICS FOR THE UNINTERESTED
    • JUDGING FEASIBILITY
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