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Epidemiological Methods

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    1. Observational studies
      1. Descriptive studies
      2. Analytic studies
    2. Investigational studies
      • Interventional/Experimental experiment

    The aim of a descriptive study to formulate hypothesis and identify any associations with the aetiology of the disease

    A descriptive study is one in which information is collected without changing the environment (i.e., nothing is manipulated).

    In human research, a descriptive study can provide information about the naturally occurring health status, behavior, attitudes or other characteristics of a particular group. Descriptive studies are also conducted to demonstrate associations or relationships between things in the world around you.

    3 variables for description

    • Time
    • Place
    • Person
      • These 3 variables helps descriptive epidemiology to determine the distribution of a disease (time, place and person)

    3 types of descriptive studies

    • Case report
    • Case series
    • Cross-sectional/prevalence studies

    Case Report

    It is a report of a single (or a handful) case of unusual or new findings (in scientific meetings for others to learn from)

    E.g. reporting the use of OCP can cause DVT;

    Advantages

    • We can aggregate cases from disparate (unrelated or incomparable) sources to generate Hypothesis and describe new syndromes. Example: Hepatitis, AIDS

    Limitations

    • We cannot test for statistical association because there is no relevant comparison group

    Case Series

    Report of multiple/accumulated cases of similar findings; i.e. cases series reports a single individual or a group of individual with the same diagnosis

    It assesses prevalent disease

    Also reports on unusual or new conditions, as well

    Advantages

    • Useful for hypothesis generation
    • Informative for very rare disease with few established risk factors

    Disadvantages

    • Cannot study cause and effect relationships
    • Cannot assess disease frequency

    Cross-sectional/Prevalence studies

    Measures disease and exposure simultaneously in a well-defined population i.e. it assess the prevalence of disease and the prevalence of risk factors at the same point in time in a defined population

    It is the simplest form of an observational study.

    It is based on a single examination of a cross-section of population at one point in time – the results of which can be projected on the whole population provided the sampling was done correctly.

    Advantages

    • They cut across the general population, not simply those seeking medical care
    • Good for identifying prevalence of common outcomes, such as arthritis, blood pressure and allergies
    • Not costly to perform and does not require a lot of time
    • Contains multiple variables at the time of ‘data snapshot’
    • Many findings and outcomes can be analyzed to creates new theories/studies or in-depth research
    • There is no loss of follow-up

    Disadvantages

    • Difficult to determine temporal relationship between exposure and outcome (because of lack of time element; i.e. data is not collected over a period of time)
    • Prevalence-incidence bias (a.k.a. Neyman bias). Especially in the case of longer-lasting disease, any risk factor that results in death will be under represented among those with the disease

    2 types

    • Case-control studies
    • Cohort studies

    Case-Control Studies

    A retrospective study; a.k.a. case-history study

    You have:

    • People with a disease (= Case) e.g. Cancer of the lungs
    • People with another disease (control) e.g. stomach cancer
    • A suspected cause e.g. Cigarette smoking

    You want to test if the suspected cause is the actual cause.

    So, you impute your data like this:

    Next, do your analysis. For your level,

    Next, interpretation

    • If OR = 1, no relationship between cigarette smoking and lung cancer
    • If OR >1, smoking is a cause cancer; i.e. the more you smoke the more likelihood of developing cancer
    • If OR <1. Smoking is protective; the more you smoke the less likelihood of developing cancer

    Advantages of case-control

    • Used to study rare diseases
    • Used for disease with long-incubation period
    • Easy to carry out; no manipulation of studies
    • Quick to carry out
    • Cheap
    • Use to establish relationship btw multiple risk factors

    Disadvantages

    • Missing information, especially for long-period cases
    • Biased, in terms of selection of cases and control
    • Misclassification of cases and control
    • Unable to calculate incidence rate

    Cohort Studies

    A prospective study

    Here, you deal with healthy populations, who may be at risk of having a disease, with exposure to a particular risk factor. This is unlike the case-control study where the subjects are diseased

    E.g. correlation between alcohol consumption and cirrhosis

    • 2 Groups: A group of healthy patients consume alcohol; the other group of equal number do not consume alcohol. After monitoring both groups, determine the number of patients that have cirrhosis in both alcoholic group & non-alcoholic groups

    Analysis: Relative Risk (RR)

    Interpretation

    • RR = 1; No relationship between alcohol intake and liver cirrhosis
    • RR > 1; more intake of alcohol, more risk of liver cirrhosis
    • RR < 1; alcohol is protective i.e. more alcohol, less cirrhosis

    Advantages

    • IR can be calculated
    • ATTRIBUTABLE RISK can also be calculated
    • RELATIVE RISK can be calculated
    • Dose-response ratios can also be calculated
    • Gives a more direct estimation of the risk from exposure to each factor
    • Several possible outcomes related to exposure can be studied simultaneously

    Disadvantages

    • Very expensive
    • Take long time to complete (e.g. 20-30 years)
    • More difficult to do
    • Involves a large no. of people
    • Generally not suitable for investigating uncommon diseases or diseases with low incidence in the population.
    • Problem of attrition e.g. people dropping out of the study
    • Ethical problems
    • Problem with follow-up

    Experimental study

    Here, the investigator manipulates exposure

    Is PROSPECTIVE in nature

    And is done over a long period of time, on most cases

    Involves studies in which one group which is deliberately subjected to an experience is compared with a control group which has not had a similar experience.

    2 Examples:

    • Clinical or therapeutic trial
    • Population-based trial

    Clinical trial or Therapeutic trial or Randomized clinical trial

    • Is conducted among individual with a particular disease to test the efficacy and side effects of a drug or procedure, before you generalizing the drug use for the Nation
    • Usually a technique known as BLINDING is adopted, which will ensure that the outcome is not biased
      • Single blind trial
      • Double blind trial
      • Triple Blind trial

    Types

    Randomized controlled/clinical trials (RCT)

    Normally used in testing new drugs and treatments

    There is an Experimental group and Control group (receiving placebo); members of these groups were ‘randomly’ allocated to either experimental or control group, by chance

    Usually a technique known as BLINDING is adopted, which will ensure that the outcome is not biased

    • Single blind trial: is when neither the investigator nor the study participant is aware of treatment assignments. However, this design is not always possible
    • Double blind trial: is when neither the investigator nor the study participant is aware of treatment assignments. However, this design is not always possible
    • Triple Blind trial:
    • Advantages

      • Controls for all main forms of bias;
      • Good for both etiological and evaluative research
      • To test preventive interventions
      • Can calc. Absolute Risk Reduction
      • Can calc. Relative Risk Reduction

      Disadvantages

      • Often uses selected populations: issue of generalizability
      • Ethical concerns in etiological applications

    Quasi-Experimental trials or Population-based trials


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