Teaching Methodology

& Community Medicine

DR.UZMA NAZ
 Epidemiological Methods
Experimental studies and
Association
11/11/2017 Community medicine
 Review of last lecture
✔ Analytic epidemiology
✔ Cohort study
✔ Types of cohort study
✔ Method of cohort study
✔ Relative risk & Attributable risk
• Advantages & Disadvantages of cohort study

11/11/2017 Community medicine

 Lecture outline
❖ Experimental epidemiology
❖ Method of experimental study
❖ Blinding and its types
❖ Definition of Bias, Survey, Gold standard
❖ Association and its types
 Experimental studies

The study in which the researcher exercises

control over the independent variables
deliberately manipulating them is called
experimental studies.
• Experimental studies are similar in approach to
cohort studies excepting that the conditions in
which study is carried out are under the direct
control of the investigator.
• This may be conducted in animals or humans.
Aims
• To provide scientific proof of etiological or risk
factors.
• To provide a method of measuring the
effectiveness and efficiency of health services.
Types of experimental studies

1. Randomized control trials

2. Non-randomized control trials
 1.Randomized control trials

• Randomization is a process by which subjects

are allocated to one of two or more therapy
groups by chance, thus minimize selection bias.
• RCT is an epidemiological experiment.
• It is the number one method of evaluation for
new programs or new therapies.
 Types of RCTs
• Clinical trials
• Preventive trials
• Risk factors trials
• Cessation experiments
• Trials of etiological agents
• Evaluation of health services
Method of conducting RCTs
Basics steps are:
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
1.Drawing up a protocol

• It specifies aims, objectives, questions to be

answered, criteria or selection of study sample
size.
• Protocol once formed, cannot be changed
• It reduces bias and sources of error
• Pilot study can be done in this step.
2.Selecting reference population

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

if found successful are expected to be
applicable.
• E.g. whole population or population of school
children
3.Selecting experimental population

• It is derived from reference population.

• It is actual population which participates in
study.
• They must be randomly selected from reference
population.
• Criteria for participants:

• Must give informed consent

• Should be representative of reference population

• Should be eligible for trial

4. Randomization

• It is a statistical procedure by which participants

are allocated into groups usually called study
and control groups.
• Randomization is the heart of controlled trial.
• It will give the greatest confidence that the
groups are comparable so that like can be
compared with like.
5.Manipulation /intervention

• Manipulate the study group by the

deliberate application or withdrawal of the
suspected causal factor.
6.Follow up

• It may be short or may require many years.

• It implies examinations of experimental and
control group at defined intervals of time with
same circumstances in a standard manner.
7.Assessment
• It is the final step of assessment of outcome.
• Positive results
• Benefits of experimental measure such as
reduced incidence or severity of disease
• Negative results
• No benefit but rather more side effects and
complications
Disadvantage of experimental study

1. They are costly

2. Ethical problems exist
3. Non-feasibility
Non-Randomized Trials
2.Non-Randomized Trials

• RCT is better one but it is not always possible to

apply it. So in following situations non-
randomized trials are applied.
▪ Uncontrolled trials
▪ Natural experiments
▪ Before and after comparison
 Comparison b/w observational and
experimental study
Observational
1. The study in which nature is
allowed to take its own course,
investigation measures but not
intervene.
2. Researcher simply observe
different patients who had taken or
not taken the drug.
3. Ethical and practical
4. Not expensive
Experimental
1. The study in which investigator
deliberately manipulation
independent variables.
2. Investigator intervene, giving the
drug to one group of study but not
other.
3. Ethical issues can be raised and
impractical.
4. More expensive
 BIAS

• It is any factor which adversely affects

the outcome of study.
• It is a systematic error.
 Sources of Bias in observational
study

• Confounding
• Memory /recall bias
• Selection bias
• Interviewer's bias
• Design bias
• Sampling bias
Sources of Bias in RCT

• Bias in evaluation
• Bias in observer
• Bias in subject
 Blinding
• Bias may be arise from errors of assessment
of the outcome due to human element.
• In order to reduce this problem a
technique known as blinding adopted.
Types of blinding

• Single blind trial

• Double blind trial
• Triple blind trial
• Single blind trial
• This trial is so planned that the participant is not
aware whether he belongs to the study group or
control group.
• Double blind trial
• This trial is so planned that neither the doctor nor the
participant is aware of the group allocation and the
treatment received.
• Triple blind trial
• This is one step further.
• The participant, the investigator, the person analyzing the data are
all blind.
• Ideally triple blinding should be used.
• But the double blinding most frequently used method.
 Palcebo and Nocebo Effect

• Patient is given inert substance during study but he starts

feeling well and thinks that he is given actual drugs, it is
called Placebo effect.
• Patient is given inert substance during study but he starts
feeling adverse effects of the drug and thinks that he is given
actual drugs, it is called Nocebo effect.
 The 2*2 contingency table
• A table that consists of two columns (vertical)
that represent the presence or absence of
disease and two rows (horizontal) that
represent a positive or negative test result is
called a 2-by-2 table.
 Uses
✔ 2-by-2 table may be employed in risk factor studies
(where rows represent the presence or absence of
risk factor)
✔ It may be employed in hypothesis testing (where the
rows represent the acceptance or rejection of null
hypothesis)
 Survey
• A canvass of selected people or households in a population usually
used to infer demographic characteristics or trends for a larger
segment or all of the population.
• It can be defined as an investigation of opinions ,behavior for a
particular group of people which is usually done by asking them
questions.
• Open ended questionnaire
• A question on a survey that does not restrict the respondent to
specific choices ,but allows for a free response.
• Closed ended questionnaire
• A question on a survey that offers a set of specific
response choices those are mutually exclusive and
exhaustive.
 Gold Standard
• Any diagnostic procedure believed to identify diseased
person with certainty e.g biopsy for prostate cancer.
• It is a term used to describe a method ,procedure or measurement
that is widely accepted as being the best available.
• It is often used to compare with new methods.
Association

• Concurrence of two variables more often

than would be expected by chance is called
association.
Co-efficient of Correlation
• It indicates the degree of association b/w two
variables.
• Its symbol is “r”
• Its value ranges from -1 to +1.
Interpretation of association
• When r value is equal or more than +1, it indicates a strong
association b/w x and y variables. when one variable increases other
also increases.
• When r value is equal or less than -1, it indicates a strong negative
association b/w x and y variables. when one variable increases other
decreases.
• When r=0, it indicates that there is no association.
• When association is very strong, it is called
causation.
• e.g Myobacterium tuberculosis is a definite
cause of TB but smoking is not a definite cause
of lung cancer.
Classification of association

1. Spurious association
2. Indirect association
3. Direct association (one –to-one causal & Multifactor
causation)
Spurious association

• It means an observed association b/w a disease and

suspected factor may not be real.
• For example:
• Apparent perinatal mortality was higher in the hospital
births than in the home births. It might be concluded that
homes are safer place fro delivery than hospitals.
• Such conclusion is spurious. In general hospitals attract
women at high risk of delivery becoz of their special
equipment and expertise.
 Indirect association
• It is statistical association b/w a variable of interest and a
disease due to the presence of another factor known or
unknown, that is common to both the characteristics and
the disease.
• The third common factor is called confounding factor.
• Confounder is a variable associated with disease and
exposure and is distributed unequally among study and
control groups and it adversely affects outcome of study.
• High altitude & endemic goiter
• Endemic goiter is generally found in high altitudes, showing thereby
an association b/w altitude & endemic goiter. It shows how a
common factor i.e. iodine deficiency has resulted in an apparent
association b/w two variables ,when no association exists.
• Sucrose and CHD
Direct (causal) association
• Cause is there & there comes effect.
• One –to-one causal relationship
• Two variables (A,B) are said to be causually related,if a change in A is
followed by a change in B. This model suggest that when the factor A
is present The disease B Must result.
• E.g. Mycobacterium tuberculosis TB
Scarlet fever
• Hemolytic streptococci Streptococcal tonsillitis
Erypsipelas
Multi factorial causation
• Model of multifactorial causation:
Factor 1

Reaction
Factor 2 at Factor 3
cellular
level

Disease
• There may be alternative factors each acting
independently – e.g smoking, air pollution, and
exposure to asbestos can produce lung cancer
independently.
11/11/2017 Community medicine
11/11/2017 Community medicine