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    Study Design Epidemiology

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    bang_roy
    This document discusses study design in epidemiology, describing various study types including descriptive and analytical observational and experimental designs. Descriptive designs like case reports, case series, and surveys aim to describe characteristics without making comparisons, while analytical designs like cross-sectional, cohort, and case-control observational studies and experimental designs seek to make comparisons to infer relationships between exposures and outcomes. Observational studies vary in their level of investigator control, difficulty, and ability to prove causal relationships compared to experimental designs like randomized controlled trials which allow for the highest level of control.

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    Study Design Epidemiology

    Uploaded by

    bang_roy
    198 views35 pages
    This document discusses study design in epidemiology, describing various study types including descriptive and analytical observational and experimental designs. Descriptive designs like case reports, case series, and surveys aim to describe characteristics without making comparisons, while analytical designs like cross-sectional, cohort, and case-control observational studies and experimental designs seek to make comparisons to infer relationships between exposures and outcomes. Observational studies vary in their level of investigator control, difficulty, and ability to prove causal relationships compared to experimental designs like randomized controlled trials which allow for the highest level of control.

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    Study design epidemiology

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    This document discusses study design in epidemiology, describing various study types including descriptive and analytical observational and experimental designs. Descriptive designs like case reports, case series, and surveys aim to describe characteristics without making comparisons, while analytical designs like cross-sectional, cohort, and case-control observational studies and experimental designs seek to make comparisons to infer relationships between exposures and outcomes. Observational studies vary in their level of investigator control, difficulty, and ability to prove causal relationships compared to experimental designs like randomized controlled trials which allow for the highest level of control.

    Copyright:

    Attribution Non-Commercial (BY-NC)
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    198 views35 pages

    Study Design Epidemiology

    Uploaded by

    bang_roy
    This document discusses study design in epidemiology, describing various study types including descriptive and analytical observational and experimental designs. Descriptive designs like case reports, case series, and surveys aim to describe characteristics without making comparisons, while analytical designs like cross-sectional, cohort, and case-control observational studies and experimental designs seek to make comparisons to infer relationships between exposures and outcomes. Observational studies vary in their level of investigator control, difficulty, and ability to prove causal relationships compared to experimental designs like randomized controlled trials which allow for the highest level of control.

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    of 35

    Study design in Epidemiology

    Kristen Reyher Centre for Veterinary Epidemiological Research Atlantic Veterinary College University of Prince Edward Island

    The theory behind study design


    We want to design studies to
    Identify causal factors for disease, so that we can
    Focus on target points to work towards prevention Minimise harmful effects of treatments or management changes

    Study types
    Descriptive Explanatory (Analytical)

    Case Report

    Case Series

    Survey

    Observational

    Experimental

    Crosssectional

    Cohort

    Casecontrol

    Laboratory

    Controlled Trials

    Descriptive vs. Analytical


    Descriptive
    Describe characteristics Do not make comparisons case report case series survey

    Analytical (explanatory)
    Seek to make comparisons inference about exposures (risk factors, treatments) and outcomes (disease, death, production) Experimental vs. observational

    Descriptive studies 1
    Case study
    Report on one or a few cases Usually a rare condition Limited to real world conditions? Any conclusions about cause or outcome are authors conjecture

    Descriptive studies 2
    Case series
    Describe (often unusual) clinical course of condition of interest Might provide information about prognosis if cases are representative of all cases Again, no direct data but features might help build hypotheses

    Descriptive study 3
    Survey
    Estimate the frequency and distribution of outcomes Provides some data (say about disease in a population) Need to take care re: sampling (Signe) and design of questions Surveys including exposures and outcomes = cross-sectional analytic studies!

    Analytical studies
    Experimental
    Investigator can allocate study subjects Advantages
    stronger evidence of causation control of confounders through randomisation

    Disadvantages
    limited range of hypotheses may not be do-able

    Analytical studies
    Observational
    No allocation of study subjects
    Do not confuse random sampling with random allocation! Observation in a real-world setting

    Advantage
    Complex web of causation might not be otherwise reproducible
    practically ethically economically

    Observational studies
    Prospective vs. Retrospective
    Has outcome occurred before study starts?
    yes = retrospective no = prospective

    Advantage of prospective
    data quality better able to study incidence

    Observational studies
    Classified by subject selection
    Cross-sectional studies Cohort studies Case-control studies

    10

    Observational study 1
    Cross-sectional
    Most frequent study design in vet epi = straightforward Random sample of subjects from a population
    Try to represent population in sample

    Non-directional in time = snapshot Simultaneously classify according to


    Disease status (or outcome) Study factor or risk factor
    determinant exposure
    11

    Cross-sectional

    F-/D+ F+/D+ Study Population F+/DF-/D-

    Time

    Past

    Present

    Future

    12

    Cross-sectional studies
    Limitations
    Only suitable for chronic conditions occurring at a moderate level in the population Only quantifies prevalence of exposure and outcome
    May over-represent factors affecting incidence and duration Can confuse protective risk factors

    Reverse-causation
    Best for time-invariant exposures (sex, breed, housing) Can confuse procedures implemented in response to disease

    13

    Cross-sectional studies
    Example:
    100 dairy herds selected randomly from the Dairy Herd Improvement (DHI) register to answer a questionnaire assessing treatment of dry cows Each farm is classified according to exposure (which dry cow therapy used) and according to outcome (>30% fresh cow mastitis or <30% fresh cow mastitis)

    14

    Cross-sectional
    Used DryClox / >30% mastitis Used CefaDri / >30% mastitis

    F+/D+ 100 F+/DUsed DryClox / <30% mastitis

    farms

    F-/D+

    F-/D-

    Used DryClox / <30% mastitis

    Time

    Past

    Present

    Future

    15

    Cross-sectional studies
    Pros
    Representative of population Potentially efficient Low cost Rapid

    Cons
    Must verify that risk factor came before the disease

    16

    Observational study 2
    Cohort
    Identify subjects
    with exposure without exposure

    Follow the groups through time to determine if disease develops


    usually prospective

    17

    Cohort
    D+
    exposed

    D-

    D+
    nonexposed

    DTime

    Past

    Present

    Future

    18

    Cohort studies special case


    Single cohort = longitudinal study
    Follows an entire population through time Record all exposures of interest
    Investigate multiple exposures at once

    Record all outcomes of interest


    Outcomes must follow exposure!

    Useful in measuring incidence of disease

    19

    Cohort Studies
    Example:
    500 healthy cows (D-) from farms using dry cow therapy (E+) were randomly selected from a list of cows in DHI databases across Canada 500 healthy cows (D-) from farms not using dry cow therapy (E-) were also randomly selected from the same list of cows Followed for two years Assessed for clinical mastitis during that time

    20

    Cohort
    Farms using dry cow therapy

    Mastitis

    No mastitis

    Mastitis
    Farms not using dry cow therapy

    No mastitis

    Time

    Past

    Present

    Future

    21

    Cohort studies
    Pros:
    Less susceptible to bias compared to case-control More control over quality of data No confusion on time order of exposure and disease

    Cons:
    Expensive Time-consuming Potential losses to follow-up Only works for diseases common in a population

    22

    Observational study 3
    Case-Control
    Identify subjects
    with disease without disease

    Compare histories of risk factor (exposure)


    Usually retrospective

    23

    Case-control
    exposed

    D+
    nonexposed

    exposed

    Dnonexposed

    Time

    Past

    Present

    Future

    24

    Case-control studies
    Used for rare diseases Relatively quick and inexpensive (if quality data is accessible)

    25

    Case-control studies
    Limitations
    Finding source of cases Defining a case Appropriate controls are often difficult to identify. These should be animals that would have been cases if they got the disease (but not always as straightforward as that sounds!)

    26

    Case-control
    Example:
    A rare mastitis is being studied. 50 farms in Quebec has confirmed cases of this type of mastitis (D+) 50 comparable farms in Quebec with no confirmed cases (D-) are also identified for the study All 100 farmers are asked about management practices (type of dry cow therapies) used on their farms (exposure)
    27

    Case-control
    Used CefaDri Used DryClox Used CefaDri Used DryClox
    50 without mastitis 50 farms with mastitis

    Time

    Past

    Present

    Future

    28

    Case-control studies
    Pros:
    Rare diseases Potentially efficient Low cost Potential for rapid completion

    Cons:
    Highly susceptible to bias related to selection of controls

    29

    Summary of observational studies


    Study type Minimal cost Short time (little to no follow-up) Control selection difficult Representative of population Good for rare disease Good for rare exposure Time sequence known Cross-sectional Cohort Case-control

    30

    Experimental studies
    Laboratory-based Randomised controlled trials

    31

    Experimental study 1
    Laboratory-based
    Carried out under strictly controlled conditions Investigator has almost complete control over experimental conditions Evidence of association of exposure and outcome is the best evidence of causation Relavance to real-world conditions often doubtful

    32

    Experimental study 2
    Randomised controlled trials
    Covered by Signe next!

    33

    Characteristics of various study types


    Level of investigator control Descriptive Case report Case series Survey very easy easy moderate very low very low moderate n/a n/a n/a
    low to high low to high high

    Type of study

    Level of difficulty

    Strength of proof of causal association

    Relevance to real-world situations

    Explanatory - experimental Laboratory Controlled trial moderate moderate very high high very high very high
    low high

    Explanatory - observational Cross-sectional Cohort Case-control n/a = not applicable moderate difficult moderate low high moderate low high moderate
    moderate high high

    34

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