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    Types of Study Design

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    Mina Mesri
    This document discusses different types of clinical evidence and study designs for research questions. It covers what makes a good research question, including ensuring it is feasible, interesting, novel, ethical and relevant. It also discusses different types of study designs like randomized controlled trials, cohort studies, case-control studies, and cross-sectional studies, outlining their pros and cons. Key aspects of developing a research proposal are covered, such as defining the population, intervention, comparison, and outcomes (PICO) as well as addressing ethical issues and minimizing bias and confounding. Reporting guidelines for different study types are also mentioned.

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    Types of Study Design

    Uploaded by

    Mina Mesri
    251 views28 pages
    This document discusses different types of clinical evidence and study designs for research questions. It covers what makes a good research question, including ensuring it is feasible, interesting, novel, ethical and relevant. It also discusses different types of study designs like randomized controlled trials, cohort studies, case-control studies, and cross-sectional studies, outlining their pros and cons. Key aspects of developing a research proposal are covered, such as defining the population, intervention, comparison, and outcomes (PICO) as well as addressing ethical issues and minimizing bias and confounding. Reporting guidelines for different study types are also mentioned.

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    This document discusses different types of clinical evidence and study designs for research questions. It covers what makes a good research question, including ensuring it is feasible, interesting, novel, ethical and relevant. It also discusses different types of study designs like randomized controlled trials, cohort studies, case-control studies, and cross-sectional studies, outlining their pros and cons. Key aspects of developing a research proposal are covered, such as defining the population, intervention, comparison, and outcomes (PICO) as well as addressing ethical issues and minimizing bias and confounding. Reporting guidelines for different study types are also mentioned.

    Copyright:

    © All Rights Reserved
    Download as PPT, PDF, TXT or read online from Scribd
    Download as ppt, pdf, or txt
    251 views28 pages

    Types of Study Design

    Uploaded by

    Mina Mesri
    This document discusses different types of clinical evidence and study designs for research questions. It covers what makes a good research question, including ensuring it is feasible, interesting, novel, ethical and relevant. It also discusses different types of study designs like randomized controlled trials, cohort studies, case-control studies, and cross-sectional studies, outlining their pros and cons. Key aspects of developing a research proposal are covered, such as defining the population, intervention, comparison, and outcomes (PICO) as well as addressing ethical issues and minimizing bias and confounding. Reporting guidelines for different study types are also mentioned.

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    of 28

    Different types of

    clinical evidence
    and study design
    Dr Trish Groves
    Deputy editor,
    BMJ

    The research question

    What is a research question?

    The researcher asks a very specific question


    and tests a specific hypothesis. Broad
    questions are usually broken into smaller,
    testable hypotheses or questions.
    Often called an objective or aim, though calling
    it a question tends to help with focusing the
    hypothesis and thinking about how to find an
    answer

    What makes a poor research question?


    a question that matters to nobody, even you
    hoping one emerges from routine clinical records
    the records will be biased and confounded
    theyll lack information you need to answer your question
    reliably, because they were collected for another reason

    fishing expedition/data dredging gathering new


    data
    and hoping a question will emerge

    What makes a good question?


    Feasible (answerable with a robust
    method)
    Interesting
    Novel
    Ethical
    Relevant
    FINER criteria

    Real research questions


    Is five days treatment with
    injectable ampicillin plus
    gentamicin
    more effective than
    chloramphenicol in children under
    5
    with very severe pneumonia in
    low
    resource settings?

    What is the prevalence of HIV


    infection in India, and how many
    premature deaths does it cause?

    How to focus your question

    brief literature search for previous evidence


    discuss with colleagues
    narrow down the question time, place, group
    what answer do you expect to find?

    Turning a research question into a


    proposal
    who am I collecting information from?
    what kinds of information do I need?
    how much information will I need? *
    how will I use the information?
    how will I minimise chance/bias/confounding?
    how will I collect the information ethically?
    * sample size ask a statistician for help
    http://www.bmj.com/collections/statsbk/13.dtl

    Minimising bias and confounding

    Chance - measurements are nearly always subject to random


    variation. Minimise error by ensuring adequate sample size and
    using statistical analysis of the play of chance
    Bias - caused by systematic variation/error in selecting patients,
    measuring outcomes, analysing data take extra care
    Confounding - factors that affect the interpretation of outcomes
    eg people who carry matches are more likely to develop lung
    cancer, but smoking is the confounding factor so measure likely
    confounders too

    Ethical issues the wider aspects

    what information to give before seeking consent?


    deviation from normal clinical practice?
    what full burden will be imposed on participants?
    what risks will participants/others be exposed to?
    what benefit might participants or others receive?
    how might society/future patients benefit in time?
    might publication reveal patients identities?

    Exactly what are you planning to do?


    PICO
    P - who are the patients or whats the
    problem?
    I - what is the intervention or exposure?
    C what is the comparison group?
    O - what is the outcome or endpoint?

    More on PICO
    Patients
    disease or condition
    stage, severity
    demographic characteristics (age, gender, etc.)
    Intervention
    type of intervention or exposure
    dose, duration, timing, route, etc.
    Comparison
    risk or treatment
    placebo or other active treatment
    Outcome
    frequency, risk, benefit, harm
    dichotomous or continuous
    type: mortality, morbidity, quality of life, etc.

    Study designs

    Population (P) Outcomes (O)


    Interventions (I) or Exposures (E)
    Centre for Evidence Based Medicine, Oxford, UK www.cebm.net

    Are you going to observe or


    experiment?
    observational cross sectional, case series, case-control studies,
    cohort studies
    identify participants
    observe and record characteristics
    look for associations
    experimental before and after studies, comparative trials
    (controlled or head to head), randomised trials (ditto)
    identify participants
    place in common context
    intervene
    observe/evaluate effects of intervention

    Pros and cons of the RCT


    An experimental comparison study where participants are allocated
    to
    treatment/intervention or control/placebo groups using a random
    mechanism. Best for studying the effect of an intervention.
    Advantages:
    unbiased distribution of confounders
    blinding more likely
    randomisation facilitates statistical analysis
    Disadvantages:
    expensive: time and money
    volunteer bias
    ethically problematic at times

    Pros and cons of crossover trial


    A controlled trial where each participant has both therapies
    e.g is randomised to treatment A first then starts treatment B.
    Advantages:
    all participants serve as own controls and error variance is reduced,
    thus reducing sample size needed
    all participants receive treatment (at least some of the time)
    statistical tests assuming randomisation can be used
    blinding can be maintained
    Disadvantages:
    all participants receive placebo or alternative treatment at some point
    washout period lengthy or unknown
    cannot be used for treatments with permanent effects

    Pros and cons of cohort study


    Data obtained from groups who have already been exposed, or not
    exposed, to the factor of interest. No allocation of exposure is made by
    the
    researcher. Best for studying effects of risk factors on an outcome.
    Advantages:
    ethically safe
    participants can be matched
    can establish timing and directionality of events
    eligibility criteria and outcome assessments can be standardised
    Disadvantages:
    controls may be difficult to identify
    exposure may be linked to a hidden confounder
    blinding is difficult
    for rare disease, large sample sizes or long follow-up necessary

    Cohort study

    Chronic kidney disease and


    risk
    of major cardiovascular
    disease
    and non-vascular mortality:
    Prospective population
    based
    cohort study.
    Di Angelantonio E, et al.
    BMJ 341:doi:10.1136/bmj.c4986

    Pros and cons of case-control study


    Patients with a certain outcome or disease and an appropriate group of
    controls, without the outcome or disease, are selected (usually with some
    matching) then information is obtained on whether the subjects have been
    exposed to the factor under investigation.
    Advantages:
    quick and cheap as fewer people needed than cross-sectional studies
    only feasible method for very rare disorders or those with long lag
    between exposure and outcome
    Disadvantages:
    reliance on recall or records to determine exposure status
    confounders
    selection of control groups is difficult
    potential bias: recall, selection

    Case-control study

    Effectiveness of rotavirus
    vaccination against
    childhood
    diarrhoea in El Salvador:
    case-control study.
    de Palma O et al.
    BMJ 340:doi:10.1136/bmj.c2825

    Pros and cons of cross sectional study


    Examines the relationship between 1) diseases/other health
    related characteristics and 2) other variables of interest as they exist in a
    defined population at one time. Exposure and outcomes both measured at
    the same time. Quantifies prevalence, risk, or diagnostic test accuracy
    Advantages:
    cheap and simple
    ethically safe
    Disadvantages:
    establishes association at most, not causality
    recall bias, social desirability bias
    researchers (Neyman) bias
    group sizes may be unequal
    confounders may be unequally distributed

    Cross sectional study

    Sociodemographic
    patterning of
    non-communicable disease
    risk
    factors in rural India: a
    cross
    sectional study.
    Kinra S et al.
    BMJ 341:doi:10.1136/bmj.c4974

    Reporting statements
    CONSORT for randomised controlled trials
    STARD for diagnostic accuracy studies
    STROBE for observational studies
    PRISMA for systematic reviews of trials
    MOOSE for meta-analyses of observational
    studies
    EQUATOR network
    equator-network.org/resource-centre/library-of-health-research
    reporting/

    CONSORT 2010
    CONsolidated Standards of Reporting Trials

    CONSORT 2010 cont.

    Thanks
    [email protected]

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