Epidemiological study designs and

sampling techniques
by
Dr. PATRICIA EJIKEM
INTRODUCTION.
IDENTIFY BASIC EPIDEMIOLOGIC STUDY DESIGN
RECOGNIZE THE BASIC COMPONENTS
UNDERSTAND THE ADVANTAGES AND
DISADVANTAGES
 INTRODUCTION
 The major goal of epidemiologic research is to measure or assesse
the relationship of exposure with a disease or an outcome.
The ways by which the association between an exposure and an
outcome are evaluated are called study designs.
 The epidemiologist first defines the hypothesis based on the
research question.
How the researcher conducts the investigation is directed by the
chosen study design.
 Epidemiologic Study Designs

 DESCRIPTIVE STUDIES;
Case reports
 Case series
Cross sectional
Ecological studies
Seeks to measure the frequency of disease and/or collect descriptive data on
risk factors in a defined population.
They search for pattern by examining xteristics of TIME, PERSON AND PLACE.
Descriptive epidemiology provide a way of analyzing data on health and
disease in order to understand variations in disease.
Example;
A STUDY TO DETERMINE THE PREVALENCE OF SMOKING AMONG
UNDERGRADUATES IN ABSU.
This study will define,
 The FREQUENCY of smokers, ie the number of undergraduates that
smoke in ABSU (population) during a defined period.
The pattern of smoking, ie how smoking is distributed among the
students with relation to age, sex, faculties, classes, time of smoking
etc.
 ANALYTIC STUDIES
Analytical studies investigates the association between exposure to risk/protective
factors and outcome of interest.
Two categories exist; observational studies and experimental studies.
Observational studies;
This includes
 cross sectional .
Case control.
 cohort studies
Experimental /Interventional studies.
Randomized controlled TRIALS.
Non randomized controlled trials
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EXAMPLE:
 A STUDY TO DETERMINE THE PREVALENCE OF HIV AMONG
COMMERCIAL SEX WORKERS IN ABA.
This study will define,
 (I) EXPOSURE; number of women exposed to unprotected sex
OUTCOME OF INTEREST: HIV
 Cross-sectional studies

Measure exposures and outcomes simultaneously at one point in time. (snap shot)
Cross-sectional studies can be both descriptive and analytical.
Advantages
Often early study design in a line of investigation
Good for hypothesis generation
Relatively easy, quick and inexpensive…depends on question
Examine multiple exposures or outcomes
Estimate prevalence of disease and exposures
Results from the study can be used for planning of health services.
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Disadvantages
Cannot provide a cause-effect relationship (temporality)
May miss latent disease
May be subject to recall bias
It is the weakest of the observational studies.
Cannot be used to study incidence.
 RESEARCH QUESTIONS
Research Question
Determine whether there are differences in rates of stroke and
myocardial infarction by gender and race among patients.
Hypothesis
There will be differences in rates of stroke by gender and race.
There will be differences in rates of myocardial infarction by gender
and race.
 Case report/case series
 Case report/case study;
A detailed or intensive report of the diagnoses, treatment, response to
treatment or follow up after treatment of a single individual or specific group.
Case series
A collection of case reports involving patients who were given similar treatment.
Both studies are useful in the study of emerging conditions, adverse reactions to
treatments or new programs etc
They are generally descriptive,
Based on qualitative data through observations, interviews, questionnaires,
personal notes or clinical notes.
Case report/case series contd
Advantages
can be published quickly.
It provides very detailed information.
 Allows detailed investigatons into the situations which will be
unethical or impractical to perform using another study design
Disadvantage.
May include researcher bias.
Study is difficult to replicate.
Result not generalizable.
Case-Control studies
Case control is an example of analytical study looking at the relationship
between exposures and outcome.
Identifies individuals with existing disease/s and retrospectively measure
exposure .
This is a backward looking study.
Study participants are selected based on the outcome of interest.
Two or more groups are selected based on whether they have the
outcome under study ( cases) or do not ( controls).
Cases and controls are then assessed at the end of the study to
determine variations in their exposure risk factors.
EXAMPLE OF CASE-CONTROL STUDIES
Example;
A STUDY TO DETERMINE THE RELATIONSHIP BETWEEN ORAL CONTRACEPTIVES AND
THE DEVELOPMENT OF BREAST CANCER.
In this study,
The study participants will be selected based on the disease of interest; breast
cancer( i.e patients with breast cancer are selected at the beginning of the study).
THEY ARE COMPARED WITH ANOTHER GROUP OF PATIENTS WITH ANOTHER CANCER
TYPE FOR INSTANCE; CERVICAL CANCER. THIS GROUP WILL SERVE AS THE CONTROLS.
THE TWO GROUPS ARE THEN INVESTIGATED TO DETERMINE THEIR VARIOUS
EXPOSURES TO THE RISK FACTOR OF INTEREST AND IN THIS CASE IS EXPOSURE TO
ORAL CONTRACEPTIVE PILLS.
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Advantages of case control;
Relatively inexpensive
 Useful in studying multiple exposure
Hospital based studies and outbreaks.
It is quick to carry out.
Useful for studying rare diseases.
Estimates odds ratios
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Disadvantages;
Multiple outcomes cannot be studied
 It is prone to recall bias.
 Selection bias in the selection of suitable controls.
 Sampling bias
 COHORT STUDIES
 Cohort study collects data on a group of individuals who share a
common characteristics ( a cohort).
Examples of cohort could be final year medical students in ABSUTH.
It Identifies exposed and unexposed individuals and follow- them- up
over time measuring outcome.
Cohort studies can be analytical or descriptive.
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To carry out a cohort study, the participants need to be selected.
Selection of the study participants are done on the basis of being
exposed to the risk factor of interest.
The study participants should be free of the outcome of interest at
the beginning of the study.
the participants are followed up in time to determine who develops
the outcome of interest in the course of the study.
 TYPES OF COHORTS
Prospective cohorts;
A group of similar people (cohorts) are followed up over time until
the end of the study or the outcome of interest has been reached.
Retrospective cohorts;
Reserchers uses pre-existing data/records on exposures and outcome
of interest. as is seen in the use of medical records.
Combination of prospective and retrospective cohorts;
Participants are studied using previous records, follows them up over
time to see if they develop the outcome of interest.
 COHORT STUDY CONTINUED
Example;
A study to determine the relationship between smoking and the
development of lung cancer.
In this study, smoking is the exposure while the outcome of interest is
lung cancer.
 Participants are selected based on their smoking habits.
Participants are followed up over time to determine those who will
develops lung cancer.
Advantages of cohort studies

Used to estimate relative risk and risk ratio.

Good for rare exposures
Can determine cause and effect (Temporality )
Less likely to be subject to biases (recall and selection as compared to
Case-control)
Used to study a wide range of disease outcomes that might be
associated with the exposure of interest.
 Used to study disease incidence.
 DISADVANTAGES of COHORT
Impractical for rare diseases and diseases with a long latency
Expensive;
Often requires large study populations (Participants)
Takes a long time to carry out.
There could be lose of study participants.
ECOLOGICAL STUDIES
 Ecological studies are used when data at an individual level is unavailable.
It collects population level data rather than studying individuals within a
population.
This study could be cross-sectional (data collected at a single point in
time) or longitudinal in nature (data collected from a population over
time).
It can also be used when a large-scale comparisons are needed to study
the population-level effect of exposures on a disease condition.
For instance conducting a study to determine morbidity pattern of malaria
in sub-Saharan Africa.
Advantages;
Useful to study differences between populations; e.g. culture,
geographical variations.
 Cheap and quick to carry out.
Disadvantage;
Does not allow inferences to be made at individual level.
They are subject to a type of confounding called an ecological fallacy.
Analytical study
 EXPERIMENTAL/INTERVENTION
STUDIES
These studies are designed to determine the effect of a specific therapy or public
health practice in a well- defined population.
Participants are actively allocate to an intervention of interest in an experiment.
The outcome of such intervention is thereafter determined.
EXAMPLE;
Therapeutic trials;
Designed to test the effect of therapies like new drugs, vaccines, surgery etc.
Carried out in people who already have a particular disease. also known as clinacal
trials.
Preventive trials; carried out on people who do not have a particular disease but are
considered as ‘risks’.
Randomized controlled trials(RCTs)
The researcher randomly assigns the subjects to a control group and
an experimental group
The experimental group gets the exposure/treatment, which can be an
agent involved in causation, prevention, or treatment of a disease.
The control group receives no treatment, a placebo treatment, or
another standard of care treatment depending on the study's objective.
The groups are then followed prospectively to see who develops the
outcome of interest.
Gold Standard for causal inference
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ADVANTAGES
Least subject to biases of all studies(if designed and implemented well
Gives a strong evidence of the relationship between exposures and outcome.
DISADVANTAGES
RCT’s are expensive. To carry out
It is prone to ethical issues.
Non-compliance.
 Loss –to- follow- up.
Randomization issues
SUMMARY OF STUDY DESIGN
USES OF EPIDEMIOLOGY
To study disease trend.
For community diagnosis.
Used to determine the risk of an individual exposure to a disease.
Contributes to understanding the burden of disease in the
community.
Evaluation of a new therapy or a new health measures.
Planning and evaluation of health services.
Helps to Fill the gaps in the natural history of the disease.
CONCLUSION

The key function of an epidemiology study design is to enable the

researcher to address the research question with minimal ambiguity logical
Study design should be well thought of before initiating a research
investigation.
 Choosing an inappropriate study design may undermine overall study
validity.
Critical thinking about the possible study design issues beforehand will
ensure that the research question is adequately addressed.
•THANK YOU