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Experimental Epidemiology

Experimental epidemiology involves deliberately manipulating independent variables under a researcher's control to study causes of disease. Randomized controlled trials (RCTs) are the gold standard, as subjects are randomly allocated to therapy groups to minimize bias. Key steps of an RCT include developing a study protocol, selecting and randomizing experimental/control populations, implementing interventions, follow-up, and assessing outcomes. Non-randomized controlled trials can also provide evidence but introduce more potential for bias than RCTs.

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647 views23 pages

Experimental Epidemiology

Experimental epidemiology involves deliberately manipulating independent variables under a researcher's control to study causes of disease. Randomized controlled trials (RCTs) are the gold standard, as subjects are randomly allocated to therapy groups to minimize bias. Key steps of an RCT include developing a study protocol, selecting and randomizing experimental/control populations, implementing interventions, follow-up, and assessing outcomes. Non-randomized controlled trials can also provide evidence but introduce more potential for bias than RCTs.

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Muqadas Batool
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EXPERIMENTAL

EPIDEMIOLOGY
Experimental epidemiology
• The study in which the researcher exercises control over
the independent variables (cause of change), deliberately
manipulating them is called “experimental studies”.

• Similar in approach to cohort studies except that the


conditions in which study is carried out are under the
direct control of the investigator .
Aims
• To provide scientific proof of etiology or risk factors.

• To provide a method of measuring the effectiveness and


efficiency of health services.
Types
• Randomized controlled trials.
• Non-randomized controlled trials.
Randomized Controlled Trial
• Subjects are allocated to one of the two or more therapy
groups by chance and thus minimize selection bias.

• RCT is an epidemiological experiment.

• For new programs or new therapies, RCT is number 1


method of evaluation.
TYPES
• Clinical trials (evaluation of beta-blockers in reducing
cardiovascular mortality in patients surviving the acute
phase of MI).
• Preventive trials (vaccinations).
• Risk factor trials (risk factors for IHD).
• Cessation experiments (Cigarette smoking and lung
cancer).
• Trial of etiological agents.
• Evaluation of health services (chemotherapy for
tuberculosis).
Basic Steps
• 1. Drawing up a protocol.
• 2. Selecting reference population.
• 3. Selecting experimental population.
• 4. Randomization.
• 5. Manipulation or intervention.
• 6. Follow-up.
• 7. Assessment of outcome.
Drawing up a protocol
• Study is conducted under strict protocol.

• The protocol specifies the aims & objectives of the study,


questions to be answered, criteria for selection of study
and control groups, size of sample, the procedures
involved and treatments to be applied.

• Sometimes before a protocol a pilot study is done.


Selecting reference population

• It is the population to which the findings of trial, if found


successful are expected to be applicable.

• The reference population may be population of whole city


or a population of school children.
Selecting experimental
population
• The study or experimental population is derived from
reference population.

• The actual population that participates in the study


• Ideally it must be randomly chosen from reference
population so that it has same characters of reference
population.
• The participants must fulfill the following criteria:

-Informed consent.
-Representative of the reference population.
-Should be eligible for the trial.
Randomization
• A statistical procedure by which participants are allocated
into groups (study and control groups).

• Eliminates bias and allow for comparability.

• Randomization is the heart of control trial.


Manipulation/intervention
• Intervention applied to the study group.
Follow-up
• Examination of experimental and control subjects at
defined intervals of time in a standard manner with equal
intensity under the same given circumstances.

• Follow-up may be short or may require years.


assessment
• Final step is to assess the outcomes of the trial in terms
of:

-Positive results.
-Negative results.
Non-randomized controlled trials
• Uncontrolled trials.
• Natural experiment.
• Before and after study.
Uncontrolled trials
• Trials with no comparison group.

• Screening reduces mortality with cancer.

• Initially uncontrolled trials may be useful in evaluation


whether a specific therapy appears to have any value in a
particular disease, to determine appropriate dose, to
investigate adverse reactions.
Natural experiment
• People themselves have separated them into two natural
groups.

• It would be easy for epidemiologists to test an hypothesis.

• Smokers and non smokers.

• Religious and social groups.


Before and after comparison
• Without control:
-Compare incidence of diseases before and after
introduction of preventive measures.
-Seat belts and accidents.

• With control:
-Compare with control group and also before and
after intervention.
blinding
• Single blind (participant unaware).

• Double blind (doctor and participant unaware).

• Triple blind (doctor, participant and researcher unaware).

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