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    Case Series .

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    saraswathy s
    Case series are collections of patient case reports with a single exposure or outcome that are evaluated to describe clinical outcomes. They can be useful after drug approval to quantify adverse drug reactions and ensure rare reactions are not missed. However, case series lack a control group, so it is difficult to determine which features are uniquely associated with an exposure or outcome. Overall, case series provide clinical descriptions but not strong evidence of causation.

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    Case Series .

    Uploaded by

    saraswathy s
    36 views10 pages
    Case series are collections of patient case reports with a single exposure or outcome that are evaluated to describe clinical outcomes. They can be useful after drug approval to quantify adverse drug reactions and ensure rare reactions are not missed. However, case series lack a control group, so it is difficult to determine which features are uniquely associated with an exposure or outcome. Overall, case series provide clinical descriptions but not strong evidence of causation.

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    Case series are collections of patient case reports with a single exposure or outcome that are evaluated to describe clinical outcomes. They can be useful after drug approval to quantify adverse drug reactions and ensure rare reactions are not missed. However, case series lack a control group, so it is difficult to determine which features are uniquely associated with an exposure or outcome. Overall, case series provide clinical descriptions but not strong evidence of causation.

    Copyright:

    © All Rights Reserved
    Download as PPTX, PDF, TXT or read online from Scribd
    Download as pptx, pdf, or txt
    36 views10 pages

    Case Series .

    Uploaded by

    saraswathy s
    Case series are collections of patient case reports with a single exposure or outcome that are evaluated to describe clinical outcomes. They can be useful after drug approval to quantify adverse drug reactions and ensure rare reactions are not missed. However, case series lack a control group, so it is difficult to determine which features are uniquely associated with an exposure or outcome. Overall, case series provide clinical descriptions but not strong evidence of causation.

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    © All Rights Reserved
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    Case series

    • It is a group or cluster of case reports that may be


    generated by a single clinician, group of clinicians, a
    hospital, pharmaceutical company, or most importantly a
    regulatory agency.

    • Case series are collections of patients, all of whom have


    a single exposure, whose clinical outcomes are then
    evaluated and described.

    • Case series can be collections of patients with a single


    outcome, looking at their antecedent exposures
    • E g : case series on thalidomide induced
    phocomelia and fatal alcohol syndrome

    • Occasionally, case series may produce a false alarm


    when the relationship is strictly spurious.
    • For e.g. antiemetic doxylamine /pyridoxine, where
    original case series suggested it was a teratogen,
    but this was not confirmed by analysis of all
    available data.
    Advantages
    • After drug marketing, case series are most useful for
    two related purposes.

    Firstly they can be useful for quantifying the incidence


    of an ADR . The so-called “Phase IV” post marketing
    surveillance study of prazosin was conducted, to
    quantitate the incidence of first-dose syncope from
    prazosin.
    • Secondly, they can be useful for being certain that any particular
    adverse effect of concern does not occur when observed in a
    population which is larger than that studied prior to drug
    marketing.

    The “Phase IV” postmarketing surveillance study was


    conducted for cimetidine. Metiamide was an H-2 blocker, which
    was withdrawn after marketing outside the US because it caused
    agranulocytosis . Since cimetidine is chemically related to
    metiamide there was a concern that cimetidine might also cause
    Limitation
    • In the absence of a control group, one cannot be certain which
    features in the description of the patients are unique to the
    exposure, or outcome.

    • As an example, one might have a case series from a particular


    hospital of 100 individuals with a certain disease, and note that all
    were men over the age of 60. This might lead one to conclude that
    this disease seems to be associated with being a man over the age
    of 60.
    Conclusion
    • Case series is a pharmacoepidemiology study design.

    • It analyse the data from various case reports in series.

    • Case series are use full after marketing of drug to quantifying


    the incidence of an adverse reaction and to develop certainty
    between adverse reaction and exposure of the drug.

    • Case series are not very useful in determining causation, but


    provide clinical descriptions of a disease or of patients who
    receive an exposure.
    PARTS
    1. TITLE
    2. KEYWORDS
    3. ABSTRACT
    4. INTRODUCTION
    5. INDIVIDUAL CASE PRESENTATION
    6. DISCUSSION
    7. CONCLUSION
    8. REFERENCE

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