What You Will Learn
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- Observational studies
- Descriptive studies
- Analytic studies
- 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:
- 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
- Often uses selected populations: issue of generalizability
- Ethical concerns in etiological applications
Advantages
Disadvantages
Quasi-Experimental trials or Population-based trials
Practice Questions
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