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Introduction to Study
designs
Department of Epidemiology and Biostatistics,
MUHAS.
Case-control
Cohort
Individuals
Intervention
Retrospective
Prospective
Descriptive
Populations
Analytical
Observational
Case-series
Cross-sectional
Correlational/ecological
Clinical trials
Epidemiological studies
Why do epidemiologic studies?
 How big is the problem?
 Are two factors related, (cause and effect)?
FELP
Introduction to Descriptive
studies
Case-control
Cohort
Individuals
Intervention
Retrospective
Prospective
Descriptive
Populations
Analytical
Observational
Case-series
Cross-sectional
Correlational/ecological
Clinical trials
Epidemiological studies
Learning Objectives
When you have completed this session you will be
able to:
 Describe the differences between and descriptive
and analytic studies
 Describe the differences between a case report and
a case series
 Describe the characteristics of an ecological study
 Describe a cross sectional study and explain its
advantages and disadvantages
 Explain the uses of the descriptive study types
Descriptive versus Analytical
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 Studies
 The most frequent design strategy found in
the epidemiologic literature
 Used to describe the distribution of disease
by time, place, person and assoc. factors
 Describing these factors does not link them
 However we can identify unusual distributions
or correlations
 Useful for Hypothesis generation and health
planning
Using Descriptive Studies for
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?”
Person
Place
Time
Cases
0
5
10
15
20
25
1 2 3 4 5 6 7 8 9 10
0
200
400
600
800
1000
1200
0-4 '5-14 '15-
44
'45-
64
'64+
Age Group
Descriptive Epidemiology
Who? Where? When?
Categories of Descriptive Studies
 Populations (correlational or ecological studies)
 Individuals
 Case reports
 Case series
 Cross-sectional surveys
Correlational or Ecological Studies
Based on aggregate measures of exposure and
outcome from several populations.
The population is the unit of observation available
for study.
Exposures:
- What percent of a population smokes?
- What percent of 1-year old children are
vaccinated against measles?
- What percent of a population has piped water?
Correlational or Ecological Studies
Outcomes:
- What percentage of a population died from MI?
- What percentage of children had measles last
year?
- What percentage of population had episodes of
diarrhea?
Correlational or Ecological Studies
Advantages
-Easy to do
-Use available data (“administrative” or other
aggregate data)
-Can be done in population with widely differing
characteistics
-Generate hypotheses for additional study
Correlational or Ecological Studies
Disadvantages
-Unable to examine data for individuals; data on
exposure and data on outcome are collected
independently
-No assurance that persons with exposure (risk
factor) of interest are the same ones with the
outcome (disease) of interest
-Association at the aggregate level may not reflect
association at the individual level - the ecologic
fallacy
-Unable to adjust for potential confounding factors.
-Poor correlation doesn’t mean no association
Descriptive Studies
 Populations (correlational or ecological studies)
 Individuals
 Case reports
 Case series
 Cross-sectional surveys
Case reports
The individual is the unit of observation
available for study.
Clinical case with “unusual” clinical picture
May suggest an etiological association
Case series
First case report may stimulate compilation
of additional case reports….a case series
(e.g. occurrence of Pneumocystis carinii
among a group of young, homosexual men
with no history of immune deficiency)
Case reports or Case series
Advantages:
Use available clinical data
Detailed individual data
Suggest need for investigation (hypothesis
generation)
Disadvantages:
May reflect experience of one person or one
clinician
No explicit comparison group
Descriptive Studies
 Populations (correlational or ecological studies)
 Individuals
 Case reports
 Case series
 Cross-sectional surveys
Design of cross-sectional study
Defined population
Exposed: Have
disease
Exposed; Do
not have
disease
Not exposed;
Have disease
Not exposed:
Do not have
disease
Gather data on exposure and disease
Cross Sectional Study
Exposure
Occurrence ?
Time of studyDisease
Occurrence ?
+
-
+ -
ill
exp
Selection of
population
Cross-sectional study
 Also known as “prevalence” study
Design
Identify research question
Specify target and accessible population
Sample the population
Measure variables of interest (usually a survey)
Thus: participants classified by exposure and disease status
at the same time. This allows identification of prevalent
cases, calculation of prevalence rates.
Cross-sectional surveys
 Measure variable(s) at a single time:
 prevalence studies (“snapshot”)
 useful for events/diseases when
 chronic
 common
 non-fatal
 temporal relationship cannot be established unless
exposure permanent
 If exposure unalterable, cross-sectional survey ≈
analytical study
Cross-sectional study
 Strengths/Advantages
 Can study entire populations or a representative
sample
 Provide estimates of prevalence of all factors
measured
 Standardized data collection tool.
 May be quick and inexpensive
 Valuable in assessing health status and health
care needs of a population
 Can be repeated to get trend data
 Help in hypothesis generation
Cross-sectional study
 Weaknesses/disadvantages
 Information on disease and exposure collected
simultaneously, therefore difficulty establishing
that cause antedated effect.
 Use of prevalent cases means data reflects
determinants of survival as well as etiology
 Cases may be misclassified due to changes in
exposure or poor memory of earlier exposures
 Not good for rare diseases or exposures
 Cannot measure risk
 Cant study temporal relationship
Data analysis and interpretation of
descriptive studies
 Cross-sectional studies and surveys are
measuring prevalence
 Well-suited for describing variables and their
distributions – Eg. Kenya Demographic and
Health Survey
Design of a cross-sectional study
Disease No Disease
Job A
Job B
a b
c d
Prevalence of disease in exposed (Job A) = a/a+b
Prevalence of disease in unexposed (Job B) = c/c+d
Presentation of Cross Sectional Data
2x2 table
Exposed
Not exposed
ill not ill
a
c
b
d
Prevalence in exposed (Pe+) = a/
(a+b)
Prevalence in non-exposed (Pe-) = c/
(c+d)
Prevalence ratio = a/(a+b) / c/(c+d)
Job A (hazardous)
80 healthy 80 well
100 workers
20 resp 10 ill
symptoms
Job B (non- hazardous)
95 healthy 80 well
100 workers
5 ill 10 ill
Prevalence ill job A: 20/100 = 20%
Prevalence ill job B: 5/100 = 4%
Prevalence ratio: 5
Cross-sectional surveys
Association Measures in Cross
Sectional Studies
Example: Corporal hygiene and trachoma
Poor Hygiene Trachoma Healthy Total
Yes 54 337 391
No 50 1 459 1 509
Total 104 1 796 1 900
Prevalence ratio = 13.8 / 3.3 = 4.2
Prevalence
13.8 %
3.3 %
% exp 51.9% 18.8%
Recap
Now that you have completed this session you will be
able to:
 Describe the differences between and descriptive
and analytic studies
 Describe the differences between a case report and
a case series
 Describe the characteristics of an ecological study
 Describe a cross sectional study and explain its
advantages and disadvantages
 Explain the uses of the descriptive study types
What is the prevalence of trachoma, and is it
associated with poor hygiene?
 Population of 1900
Poor hygiene Trachoma
Yes No
Yes 54 337
No 50 1459
Exercise
Calculate Prevalence of Chlamydia in this
population of STI patients.
Calculate prevalence ratio for Chlamydia
among OCP users vs. non-users.

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Malimu introduction to study designs

  • 1. Introduction to Study designs Department of Epidemiology and Biostatistics, MUHAS.
  • 3. Why do epidemiologic studies?  How big is the problem?  Are two factors related, (cause and effect)?
  • 6. Learning Objectives When you have completed this session you will be able to:  Describe the differences between and descriptive and analytic studies  Describe the differences between a case report and a case series  Describe the characteristics of an ecological study  Describe a cross sectional study and explain its advantages and disadvantages  Explain the uses of the descriptive study types
  • 7. Descriptive versus Analytical 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
  • 8. Descriptive Studies  The most frequent design strategy found in the epidemiologic literature  Used to describe the distribution of disease by time, place, person and assoc. factors  Describing these factors does not link them  However we can identify unusual distributions or correlations  Useful for Hypothesis generation and health planning
  • 9. Using Descriptive Studies for 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?”
  • 10. Person Place Time Cases 0 5 10 15 20 25 1 2 3 4 5 6 7 8 9 10 0 200 400 600 800 1000 1200 0-4 '5-14 '15- 44 '45- 64 '64+ Age Group Descriptive Epidemiology Who? Where? When?
  • 11. Categories of Descriptive Studies  Populations (correlational or ecological studies)  Individuals  Case reports  Case series  Cross-sectional surveys
  • 12. Correlational or Ecological Studies Based on aggregate measures of exposure and outcome from several populations. The population is the unit of observation available for study. Exposures: - What percent of a population smokes? - What percent of 1-year old children are vaccinated against measles? - What percent of a population has piped water?
  • 13. Correlational or Ecological Studies Outcomes: - What percentage of a population died from MI? - What percentage of children had measles last year? - What percentage of population had episodes of diarrhea?
  • 14. Correlational or Ecological Studies Advantages -Easy to do -Use available data (“administrative” or other aggregate data) -Can be done in population with widely differing characteistics -Generate hypotheses for additional study
  • 15. Correlational or Ecological Studies Disadvantages -Unable to examine data for individuals; data on exposure and data on outcome are collected independently -No assurance that persons with exposure (risk factor) of interest are the same ones with the outcome (disease) of interest -Association at the aggregate level may not reflect association at the individual level - the ecologic fallacy -Unable to adjust for potential confounding factors. -Poor correlation doesn’t mean no association
  • 16. Descriptive Studies  Populations (correlational or ecological studies)  Individuals  Case reports  Case series  Cross-sectional surveys
  • 17. Case reports The individual is the unit of observation available for study. Clinical case with “unusual” clinical picture May suggest an etiological association
  • 18. Case series First case report may stimulate compilation of additional case reports….a case series (e.g. occurrence of Pneumocystis carinii among a group of young, homosexual men with no history of immune deficiency)
  • 19. Case reports or Case series Advantages: Use available clinical data Detailed individual data Suggest need for investigation (hypothesis generation) Disadvantages: May reflect experience of one person or one clinician No explicit comparison group
  • 20. Descriptive Studies  Populations (correlational or ecological studies)  Individuals  Case reports  Case series  Cross-sectional surveys
  • 21. Design of cross-sectional study Defined population Exposed: Have disease Exposed; Do not have disease Not exposed; Have disease Not exposed: Do not have disease Gather data on exposure and disease
  • 22. Cross Sectional Study Exposure Occurrence ? Time of studyDisease Occurrence ? + - + - ill exp Selection of population
  • 23. Cross-sectional study  Also known as “prevalence” study Design Identify research question Specify target and accessible population Sample the population Measure variables of interest (usually a survey) Thus: participants classified by exposure and disease status at the same time. This allows identification of prevalent cases, calculation of prevalence rates.
  • 24. Cross-sectional surveys  Measure variable(s) at a single time:  prevalence studies (“snapshot”)  useful for events/diseases when  chronic  common  non-fatal  temporal relationship cannot be established unless exposure permanent  If exposure unalterable, cross-sectional survey ≈ analytical study
  • 25. Cross-sectional study  Strengths/Advantages  Can study entire populations or a representative sample  Provide estimates of prevalence of all factors measured  Standardized data collection tool.  May be quick and inexpensive  Valuable in assessing health status and health care needs of a population  Can be repeated to get trend data  Help in hypothesis generation
  • 26. Cross-sectional study  Weaknesses/disadvantages  Information on disease and exposure collected simultaneously, therefore difficulty establishing that cause antedated effect.  Use of prevalent cases means data reflects determinants of survival as well as etiology  Cases may be misclassified due to changes in exposure or poor memory of earlier exposures  Not good for rare diseases or exposures  Cannot measure risk  Cant study temporal relationship
  • 27. Data analysis and interpretation of descriptive studies  Cross-sectional studies and surveys are measuring prevalence  Well-suited for describing variables and their distributions – Eg. Kenya Demographic and Health Survey
  • 28. Design of a cross-sectional study Disease No Disease Job A Job B a b c d Prevalence of disease in exposed (Job A) = a/a+b Prevalence of disease in unexposed (Job B) = c/c+d
  • 29. Presentation of Cross Sectional Data 2x2 table Exposed Not exposed ill not ill a c b d Prevalence in exposed (Pe+) = a/ (a+b) Prevalence in non-exposed (Pe-) = c/ (c+d) Prevalence ratio = a/(a+b) / c/(c+d)
  • 30. Job A (hazardous) 80 healthy 80 well 100 workers 20 resp 10 ill symptoms Job B (non- hazardous) 95 healthy 80 well 100 workers 5 ill 10 ill Prevalence ill job A: 20/100 = 20% Prevalence ill job B: 5/100 = 4% Prevalence ratio: 5 Cross-sectional surveys
  • 31. Association Measures in Cross Sectional Studies Example: Corporal hygiene and trachoma Poor Hygiene Trachoma Healthy Total Yes 54 337 391 No 50 1 459 1 509 Total 104 1 796 1 900 Prevalence ratio = 13.8 / 3.3 = 4.2 Prevalence 13.8 % 3.3 % % exp 51.9% 18.8%
  • 32. Recap Now that you have completed this session you will be able to:  Describe the differences between and descriptive and analytic studies  Describe the differences between a case report and a case series  Describe the characteristics of an ecological study  Describe a cross sectional study and explain its advantages and disadvantages  Explain the uses of the descriptive study types
  • 33. What is the prevalence of trachoma, and is it associated with poor hygiene?  Population of 1900 Poor hygiene Trachoma Yes No Yes 54 337 No 50 1459
  • 34. Exercise Calculate Prevalence of Chlamydia in this population of STI patients. Calculate prevalence ratio for Chlamydia among OCP users vs. non-users.

Editor's Notes

  1. Please do not change the learning objectives without notifying the team. Move any learning objectives that you don’t expect to cover in class to the “What’s next” slide at the end of the presentation.
  2. Optional slide-delete if irrelevant to your topic
  3. Optional slide-delete if irrelevant to your topic
  4. Optional slide-delete if irrelevant to your topic
  5. Please do not change the learning objectives without notifying the team. Move any learning objectives that you don’t expect to cover in class to the “What’s next” slide at the end of the presentation.
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