EPIDEMIOLOGICAL STUDY

DESIGNS AND MEASURES:

PART 1
Paulyn Jean A. Claro, MSc

Managerial Epidemiology, Session 4

MBA in Health, AGSB

Learning Objectives
At the end of the session, you are expected to :
1. To distinguish between the different types of
epidemiological study designs:
why do we conduct them
different types
strengths and weaknesses
understanding the results
2. To describe the features of a cross-sectional
study
3. To describe the features of a case-control
study

Review
Identifying needs and problems
Analysis
Q6. Why does the problem occur? What are the main
factors involved here?
Methods for health problems:
-epidemiological studies and surveys
Methods for health services problems:
-strategic planning, SWOT analysis, participatory
rapid appraisal (PRA), rights-based approach,
objectives oriented project planning

Process of epidemiologic research

Question (hypothesis)
Design (planning of investigation)
choose study design
conceptualization > operationalization
ideas > action
Conduct of study (data collection)
> pilot study
Analysis
Interpretation of results
Recommendations

Epidemiologic Study

Bonita, Beaglehole, Kjellstrom, 2006

Types of Epidemiologic Study

Observational studies
Descriptive
person, place time
who, what, where, when?

Analytical
relationships between health status and other
variables
how and why?

Experimental studies

Types of Epidemiologic Study

Experimental studies
involve an active attempt to change a disease
determinant such as an exposure or a behavior or
the progress of a disease through treatment, and are
similar in design to experiments in other sciences

Bonita, Beaglehole, Kjellstrom, 2006

Descriptive Study
Concerned with and designed only to describe the
existing distribution of variables without regard to
causal or other hypotheses

David A Grimes, Kenneth F Schulz, Descriptive Studies:

What They Can Do and Cannot Do, LANCET, 2002

Types of Descriptive Study

Case report
Case series report
Surveillance
Ecological (correlational) studies

Cross-sectional (prevalence) studies

Case report

Case report

Case series report

Case series report

Surveillance
ongoing systematic collection, analysis, and
interpretation of health data essential to the
planning, implementation, and evaluation of public
health practice, closely integrated with the timely
dissemination of these data to those who need to
know

Surveillance

Passive
involves passive notification through regular
reporting of disease data by all facilities that see
patients or test specimens.

Active
involves visiting health facilities, talking to healthcare providers and reviewing medical records to
identify suspected cases of the disease under
surveillance; usually used when a disease is targeted
for eradication or elimination, when every possible
case must be found and investigated; also used in
outbreak investigations.

Surveillance

Sentinel
Instead of attempting to gather surveillance data from
all, it involves notifications from a limited number of
carefully selected reporting sites (usually referral
hospitals), with a high probability of seeing cases of the
disease in question, good laboratory facilities, and
experienced well-qualified staff.

http://www.who.int/immunization/monitoring_surveillance/burden/VPDs/en/

Surveillance

Surveillance

http://www.doh.gov.ph/disease-surveillance.html

Surveillance

Surveillance

Ecological study
the units of analysis are groups of people rather
than individuals
can also be done by comparing populations in
different places
at the same time, or
in a time series by comparing the same
population in one place at different times

Ecological study

Ecological study

A Working Paper of the Results for

Development Institute (R4D)
www.resultsfordevelopment.org

Ecological study
An ecological fallacy or bias results if inappropriate
conclusions are drawn on the basis of ecological
data. The bias occurs because the association
observed between variables at the group level does
not necessarily represent the association that exists
at the individual level.
What ecological fallacy can be committed in the
earlier graphs presented?

Cross-sectional (prevalence) study

describe the health of populations
periodic surveys done by government or
international agencies
provide a snapshot of the population at a particular
time
exposure and outcome are ascertained at the same
time temporal ambiguity
(exception: long-standing exposures such as
sex or blood type)
Examples: NDHS, YAFS, other national prevalence
surveys, etc.

Uses of Descriptive Study

Trend analysis
health care administrators monitor the health
of populations
often provided by ongoing surveillance

Health care / program planning

plan for resources
Hypothesis generation

Advantages and Disadvantages

of a Descriptive Study

often, data are already available

inexpensive and efficient to use
few ethical difficulties exist
temporal associations are unclear
overstepping the data incorrect
interpretations and conclusions

Analytic terminology
Exposure variable "E"
risk factor / predictor variable
Outcome variable (disease) "D"
case definition
response/effect variable
Examples of ED relations:
smoking lung cancer
unsafe water diarrhea
poor urban design road traffic injuries
Dimensions
directionality
timing

Observational studies: directionality

Temporal relationship between observations
of E and D
Forward
start with exposure (E)
Backward
start with outcome/disease (D)
Non-directional
E and D simultaneously

Observational studies: timing

Chronological relationship between onset of
study and occurrence of disease
Prospective
study onset D
Retrospective (historical)
D study onset

Study Design

Cross-sectional study
The current or historical status of individuals is
assessed and may be examined in relation to some
current or past exposure.
most useful for conditions that are not rapidly fatal,
not terribly rare, and/or not routinely brought to
medical attention

Cross-sectional study
Since participants for a cross-sectional study are
generally chosen without previous knowledge of
their disease or exposure status, such studies can be
used to estimate prevalence of both diseases and
exposures and compute prevalence ratios and
prevalence odds ratios.

Cross-sectional study:
PR (prevalence ratio)

Cross-sectional study:
POR (prevalence odds ratio)
Similar to OR in a case-control study

Cross-sectional study:
Example

P exposed?
P unexposed?
PR? POR? Interpretation

Cross-sectional study:
Example

http://www.cdc.gov/globalhealth/fetp/training_modules/19/desc-and-analyticstudies_ppt_final_09252013.pdf

Cross-sectional study:

Case-control study

Schulz, Grimes. Lancet 2002: 359: 43134

Case-control study
Selection of cases and controls
begins with the selection of cases; these cases should represent
all the cases in a specified population group.
Cases are selected on the basis of disease, not exposure.
Controls are people without the disease.
The most difficult task is to select controls so as to sample the
exposure prevalence in the population that generated the
cases.

Case-control study
Selection of cases
clear case definition: clinical symptoms, laboratory results,
diagnostic method used
eligibility criteria e.g., age range, location (clinic, hospital,
population-based)
Ideally, case-control studies use new (incident) cases
diagnostic patterns change over time
to avoid the difficulty of separating factors related to
causation and survival (or recovery)
although studies have often been conducted using
prevalence data (for example, case-control studies of
congenital malformations)

Case-control study
Selection of controls
The control group provides the background proportion of
exposure expected in the case group.
Controls should be representative of those individuals who
would have been selected as cases had they developed the
disease. In other words, controls should represent the
population at risk of becoming cases.

Case-control study
Selection of controls

Schulz, Grimes. Lancet 2002: 359: 43134

Case-control study
Measurement of exposure
ascertainment of past exposures (especially those that
happened a long time ago)
cases often remember exposures differently than controls

if data collectors know the case or control status of the

participants they can elicit information differently

Case-control study
Advantages and disadvantages
most efficient design in terms of money, time and effort
when incidence rate of outcome is low
for investigation of diseases with long latency period
inefficient when:
frequency of exposure is low
biases result due to methodological issues in choosing a control
group and measurement of exposure

Case-control study
When to conduct?
The outcome of interest is rare.
Multiple exposures may be associated with a single
outcome.
Funding or time is limited.

Case control study:

OR (odds ratio)

Case control study:

OR (odds ratio)

Note: a+b+c+d is an artificial population, with

overrepresentation of cases (by design). Cant get
incidence from this information.

Case control study:

OR (odds ratio)

http://www.cdc.gov/globalhealth/fetp/training_modules/19/desc-and-analyticstudies_ppt_final_09252013.pdf

Case control study:

OR (odds ratio)
Association between meat consumption
and enteritis necroticans in Papua New Guinea
recent meat
ingestion

Cases

Controls

Yes

50

16

No

11

41

Total

61

57

Bonita, Beaglehole, Kjellstrom, 2006

Summary

Bonita, Beaglehole, Kjellstrom, 2006

Questions
Background:
Cardiovascular disease (CVD) is of growing concern;
however your country has no recent data on the burden
of this disease. You want to estimate the burden of
cardiovascular disease in the two main cities in your
country.
Questions:
1. What type of study would you conduct and why?
2. What is the measure of association to calculate for
this study?

Questions
Background:
The prevalence of prostate cancer has increased in your
country over the last 5 years. You want to examine the
association between calcium intake and prostate cancer
risk. You have limited time and funding to conduct this
study.
Questions:
1. What type of study would you conduct and why?
2. What is the measure of association to calculate for
this study?

EPIDEMIOLOGICAL STUDY
DESIGNS AND MEASURES:
PART 1
Paulyn Jean A. Claro, MSc

Managerial Epidemiology, Session 4

MBA in Health, AGSB