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Epidemiological Methods

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What You Will Learn

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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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