Study Designs

DESCRIPTIVE STUDY DESIGN

AND CASE DEFINITIONS
 Learning Objectives

When you have completed this session

you will be able to:

♦ Understand the difference between

analytical and descriptive epidemiology

♦ Describe types of descriptive studies

 Learning Objectives

♦ Explain uses, strengths, weaknesses of

descriptive study designs

♦ Develop a case definition for

surveillance and outbreak investigations
 Epidemiological Studies

Populations Ecologic

Descriptive Case-series
Individuals
Cross-sectional

Case-control

Observational
Prospective
Cohort
Analytical Retrospective

Intervention Clinical trials

Descriptive vs Analytic Epidemiology

♦ Descriptive epidemiology:
– generates idea(s) or hypothesis for
associations between risk factor and
illness

♦ Analytical epidemiology:
– uses a comparison group to establish
an association between risk factors
and illness in the two groups
 Descriptive study

“A study concerned with and designed

only to describe the existing distribution
of variables, without regard to causal or
other hypotheses”
 Descriptive Studies

♦ Used to describe the distribution of

disease by time, place, person

♦ Useful for hypothesis generation

♦ The most frequent design strategy

found in the epidemiologic literature
 Example
♦ Some studies simply describe
disease/health states/behaviours
– prevalence of smoking
– rates of lung cancer

♦ Note:
– Describing these factors does not link them
– However can identify unusual distributions
or correlations (e.g clusters)
– These insights used to generate interesting
hypothesis
 Hypothesis Formulation
♦ Person – “Who is getting the disease?”
Age, race, sex

♦ Place – “Where are the rates of disease

highest and lowest?”

♦ Time – “ When does the disease occur

commonly or rarely?” and “ Is the frequency
of the disease now different from the
corresponding frequency in the past?”
 Descriptive Epidemiology

Cases

Person Time
25
1200
1000
800
Place 20

15
600
10
400
200 5

0 0
0-4 '5-14 '15- '45- '64+ 1 2 3 4 5 6 7 8 9 10
44 64
Age Group

Who? Where? When?

 Types of Descriptive Studies

♦ Case report

♦ Case series

♦ Ecologic

♦ Cross-sectional
 Case report/s

♦ Individual unit of observation

♦ Clinical case with “unusual” clinical

picture

♦ Detailed report
 Case series

♦ Case report leads to case series

♦ Case reports collected

♦ Group of patients with “unusual”

condition

♦ Rare condition
 Why Needed?
Case report(s), case series:

♦ Identification of a potentially new

disease

♦ Alert for medication side effects

♦ Acts perhaps as an early warning

system
 Advantages

♦ Use available clinical data

♦ Detailed individual data

♦ Suggest need for investigation

(hypothesis generation)
 Disadvantages

♦ May reflect experience of one

person/clinician

♦ No explicit comparison group

♦ Causal effect cannot be determined

♦ Not viewed as scientifically sound

 Example

Aggressive Kaposi’s sarcoma in a 6 month

old African infant: case report and
review of the literature

Manji, K.P., Amir, H., Maduhu, I.Z. Tropical

Medicine & International Health; 5(2):85-87
 Example

Pneumocystis Pneumonia, five cases

– Los Angeles

CDC. MMWR; 30(21): June 5, 1981 (original)

Reprinted: Gottlieb, M.S. American Journal of
Public Health; 96(6):980-983, June 2006.
 Ecologic (Correlational) Studies

♦ Population/groups of people unit of

observation

♦ Characteristics of the population not

individual persons

♦ Used for between country comparisons

(heterogeneity)
 Ecologic Fallacy

♦ False assumption

♦ Inferences made to individuals rather

than the populations/groups examined

♦ Common mistake
 Advantages

♦ Simple

♦ Use of available group (aggregate) data

♦ Generate hypotheses for additional

study
 Disadvantages

♦ Unable to examine data for individuals

♦ Ecologic fallacy

♦ Persons with exposure may not be the

same as the ones with
disease/condition
 Example

Trends in antenatal human

immunodeficiency virus prevalence in
Western Kenya and Eastern Uganda:
evidence of differences in health policies?.
- HIV prevalence increasing Kenya
- HIV prevalence decreasing Uganda

Moore, D.M., Hogg, R.S. 2004. International Journal of

Epidemiology;33:542-548.
 Cross-sectional survey

♦ Sometimes called prevalence study

♦ Collection of data on several individuals

♦ At “one point in time”, snapshot

♦ Both exposure and disease examined

 Advantages

♦ Standardized data collection tool

♦ Data collection focus specific location/groups

♦ Comparisons among study participants

♦ Relatively quick

♦ Can be repeated (trends)

 Disadvantages

♦ Bias due to a lack of participation

♦ Reflects prevalence, not incidence

♦ Exposure and disease examined the

same time
 Example

Infection with HIV and intestinal parasites

among street dwellers in Gondar City,
Northwest Ethiopia April-August 2004

Moges, F. et al. Journal of Infectious Diseases. 2006;

59:
400-403.
 Cases of Disease

The bricks from which we build

epidemiology
 Case Definition

♦ Needed to count cases

♦ Used as a standard

♦ Aids in describing

♦ Can include clinical and also descriptive

criteria
 What is a Case Definition?
♦ A set of standard criteria

♦ Used to decide if a person has an

infection or condition

♦ Assures that differences in health

statistics are real

♦ Varies with the purpose

 Why use a Case Definition?

♦ Doctors, nurses, laboratories, and others

report notifiable events

♦ Standardization minimizes variability in

reporting.
– aids with: monitoring trends, data
quality and comparing areas
Case Definition Levels Of Certainty

♦ Confirmed

♦ Probable

♦ Possible

♦ Suspect
Not a Suspect Possible Probable Confirmed
Case
We Increase the Certainty That a Case is
Real by Adding More Restrictive Criteria.

Not a case Suspect Possible Probable Confirmed

Diarrhea Diarrhea Diarrhea Diarrhea Diarrhea

< 2 days ≥ 2 days ≥ 2 days ≥ 2 days ≥ 2 days
+Vomit +Vomit +Vomit
+Fever≥38C +Fever≥38C
+Shigella
Examples
Surveillance CD for human rabies

♦ Clinical:
– Encephalitis
– Death within 10 days of onset

♦ Laboratory:
– Direct FA of hair follicle, cornea or brain
– Anti-rabies IgG or IgM in an unvaccinated
person

♦ Epidemiological:
– Bite from a known reservoir animal species
– Bite from a rabid animal
 Example: Rabies Case Definition
♦ Suspect
– Encephalitis with death in ≤10 days

♦ Possible = suspect and

– animal bite

♦ Probable = suspect and

– bite from rabid animal

♦ Confirmed = suspect, possible or probable

– Rabies virus by direct FA from cornea, hair
follicle, or brain
– Or anti-rabies IgM in an unvaccinated person
 Some Data From Reported Rabies Cases
Which fit the case definitions?

E=encephalitis O= other animal

Y = Yes ND = Not done
N = No CI = Corneal Impression
R = Rabid Animal Br = Brain
Measles

♦ Generalized skin rash of 3 to 7 days

duration

♦ Fever > 38C

♦ Plus one or more of the following

– rhinorrea
– cough
– Conjunctival injection
 Infectious Gastroenteritis: Case Definition

♦ Clinical:
– Diarrhea (3+ liquid stools x 2 days)
– Fever
– No other cause (drugs -- antibiotics)

♦ Confirmed Laboratory:
– Organism identified in stool

♦ Epidemiological
– Hospitalized for minimum incubation period
– In hospital during incubation
 Example

WHO case definitions for AIDS

surveillance in adults and adolescents

Weekly Epidemiological Record

Releve Epidemiologique Hebdomadaire
1994, 69:273-280
 Example

Impact of the 1994 expanded World

Health Organization AIDS case
definition on AIDS surveillance in
university hospitals and tuberculosis
centers in Côte d’Ivoire.

Greenburg, A.E. 1997. AIDS; 11:1867-1872

 Session Review

♦ What is the difference between analytic

and descriptive study designs.

♦ List the four types of descriptive study

designs discussed today.

♦ Why do we use case definitions?

 What’s next?

♦ Study Questions