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INTRODUCTORY
EPIDEMIOLOGICAL
CONCEPTS – STUDY
DESIGN
XNN001 Population nutrition and physical activity
assessment
Refresh... why is epidemiology
important?
 What is epidemiology?
 Inform decisions
 Monitor change
 Equity
Why do we collect data?
 Monitoring and surveillance
 Identification of outbreaks
 Identification of areas of public health significance
 Effectiveness of programs
 Linking exposure and disease
 To identify causes of disease/ states of health
 Provides indication of risk of disease based on
exposure
Study design
Study
design
Observationa
l
Experiment
al
Analytic
- Ecological
- Cross-sectional
- Case-control
- Cohort
- Randomised
controlled trial
Descriptive
- Case reports
- Case series
Epidemiological approaches are
applied in situations in which we
are interested in upstream factors
i.e. Personal, community or
environmental risk factors known to
affect disease rates
What are we measuring?
 Need to have clear idea about what we are trying to determine
 Prevalence vs Incidence
Prevalence - proportion of population that has disease at given time (i.e. Existing
cases)
Number of people with disease at given point in time
___________________________________________
Total number of people in population
Incidence – rate at which people develop disease/ health outcome (i.e. New
cases)
Number of people who develop disease in given time period
_________________________________________________
Systematic
review
Randomised
controlled trial
Cohort study
Case-control study
Cross-sectional study
Ecological study
Case report, case series
Editorials, expert opinion
Case reports and case series
 Beginning point for scientific study – identify
potential health outcomes, stimulate interest in
area, potential to advance knowledge
 Detailed descriptions of one/ more cases that are
unusual
 Selective nature and limited amount of information
provided
 provide little evidence of causality
 cannot provide much information about patterns of
disease
Ecological study design
 First step in determining whether association
exists
 Studies of differences in health status (death
rates, disease patterns, health-risk
behaviours) between countries and regions,
or within the same region at different times
 Use existing data sources
 Aim to generate hypotheses about
environmental or behavioural exposures and
disease
 The group, rather than the individual, is the
unit of analysis
 Advantages
1. Data easily available - studies inexpensive
2. Hypothesis-generating – suggest avenues for
research
 Disadvantages
1. Ecological fallacy: might not accurately represent
the exposure – disease relationship at the
individual level
2. Cannot directly link “exposure” with the
“outcome”
Extending beyond surveys of
individuals
 Food supply data
 Nutrient composition of foods
 Australian Household Expenditure Survey
 International comparisons
Food supply data
 To calculate „available food for consumption‟ – Food balance
sheets
 Information on amounts of food (raw commodities)
available for consumption per year
Food available for use =
production + imports – exports
 Food available for consumption =
 production + imports – exports – industrial use – animal use
 Important – food available for consumption does NOT tell us
how much food is actually eaten!
Food supply data
 To compare food trends within Australia Apparent
food consumption data
Apparent consumption =
(commercial production + estimated home production +
imports + opening stocks)
(exports + usage for processed foods + non-food usage +
wastage + closing stocks)
MINUS
Cross-sectional study design
Begin with a 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
Advantages of cross-sectional study design
1. Relatively inexpensive
2. No follow-up required
3. Less participant burden
Disadvantages of cross-sectional study design
1. Cannot assess temprality
2. Can establish associations, but not causation
3. Considerable potential for confounding
4. Neyman (prevalence) bias
(diseases or exposures that are longer-lasting will be
over-represented relative to those of shorter
duration)
Australian Health Survey
 http://www.abs.gov.au/websitedbs/D3310114.n
sf/home/Australian+Health+Survey+-
+Frequently+Asked+Questions
Case-control study design
 Observational, retrospective & focused on
individuals
 Comparison of exposure frequencies
among diseased (case) and non-diseased
(Control) groups
NOT EXPOSED
EXPOSED
NOT EXPOSED
EXPOSED
Population
TIME
Adapted From: Fletcher et al (1996) Clinical Epidemiology: the essentials.
Baltimore: Williams and Wilkins.
CASES
(people with
disease)
TIME
Direction of inquiry
CONTROLS
(people without
disease)
Design of case-control study
Advantages of case-control study design
1. Suitable for rare diseases
2. Possible to evaluate a large number of
potential causes/risk factors
3. Efficient design, requiring less time and more
modest costs than prospective studies
4. Higher on hierarchy of study designs
Disadvantages of case-control study design
1. Potentially difficult to distinguish exposures that precede
disease (antecedent causes) from concurrent associated
factors
2. Requires representative samples of cases and controls
3. Selection of appropriate controls can be difficult
4. Generalisability of findings
 Refusals
 Representation of original populations
5. Results potentially flawed due to
 Reliance upon accurate historical information about exposure, in
particular recall may differ between cases and controls (recall bias)
 Unsuitability of controls (lack of comparability with cases or
overmatching)
6. Still cannot be CERTAIN that if exposure preceded the
disease, then it is in fact causal
Cohort study
 Observational, prospective & focused on
individuals
 Essence is comparison of disease
frequencies among exposed and non-
exposed groups
Population
People
without the
disease
TIME & Direction of inquiry
Disease
Disease
No disease
No disease
Adapted From: Fletcher et al (1996) Clinical Epidemiology:
the essentials. Baltimore: Williams and Wilkins.
Exposed
Not Exposed
Design of cohort study
Advantages of a cohort study
1. Possible to establish temporality
2. Possible to study several outcomes from
exposure to same hazard
3. Bias - less of a problem than case-control or
cross-sectional studies
Disadvantages of a cohort study
1. Expensive in terms of time and money
2. Large, representative sample required
3. Higher risk of attrition bias
4. Measures used in early steps of study may
change (eg, due to technological
improvements) and so results at different
points in time may not be directly
comparable
Randomised controlled trials
(RCT)
 Experimental, prospective
 Types
 Clinical trials – patients
 Prevention trials – healthy people
 Community trials – community level
The structure of a clinical trial
Population of
patients with
the condition
SAMPLE TIME
Improved
Improved
Not Improved
Not Improved
Experimental intervention
Comparison intervention
Randomised
Trials
Participants Non- participants
Experimental Population
Reference Population
ASSIGNMENT
Randomisation
Study
Group
Comparison
Group
Improved Not improved Improved Not improved
Advantages of RCT
Advantages of RCT
1. If randomisation is successful,
considered strongest design for causal
inference
2. Researchers control the exposure –
specific and accurate
Disadvantages of RCT
1. Expensive and time consuming
2. Attrition
3. Compliance
http://www.health.qut.edu.au/ens/research/nourish.
Hierarchy of study designs
Randomised control trial
Cohort study
Case-control study
Cross-sectional study
Ecological study
Experimental
Observational
Increasingcostandevidence
Systematic
review
Randomised
controlled trial
Cohort study
Case-control study
Cross-sectional study
Ecological study
Case report, case series
Editorials, expert opinion

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XNN001 Introductory epidemiological concepts - Study design

  • 1. INTRODUCTORY EPIDEMIOLOGICAL CONCEPTS – STUDY DESIGN XNN001 Population nutrition and physical activity assessment
  • 2. Refresh... why is epidemiology important?  What is epidemiology?  Inform decisions  Monitor change  Equity
  • 3. Why do we collect data?  Monitoring and surveillance  Identification of outbreaks  Identification of areas of public health significance  Effectiveness of programs  Linking exposure and disease  To identify causes of disease/ states of health  Provides indication of risk of disease based on exposure
  • 4. Study design Study design Observationa l Experiment al Analytic - Ecological - Cross-sectional - Case-control - Cohort - Randomised controlled trial Descriptive - Case reports - Case series
  • 5. Epidemiological approaches are applied in situations in which we are interested in upstream factors i.e. Personal, community or environmental risk factors known to affect disease rates
  • 6. What are we measuring?  Need to have clear idea about what we are trying to determine  Prevalence vs Incidence Prevalence - proportion of population that has disease at given time (i.e. Existing cases) Number of people with disease at given point in time ___________________________________________ Total number of people in population Incidence – rate at which people develop disease/ health outcome (i.e. New cases) Number of people who develop disease in given time period _________________________________________________
  • 7. Systematic review Randomised controlled trial Cohort study Case-control study Cross-sectional study Ecological study Case report, case series Editorials, expert opinion
  • 8. Case reports and case series  Beginning point for scientific study – identify potential health outcomes, stimulate interest in area, potential to advance knowledge  Detailed descriptions of one/ more cases that are unusual  Selective nature and limited amount of information provided  provide little evidence of causality  cannot provide much information about patterns of disease
  • 9. Ecological study design  First step in determining whether association exists  Studies of differences in health status (death rates, disease patterns, health-risk behaviours) between countries and regions, or within the same region at different times  Use existing data sources  Aim to generate hypotheses about environmental or behavioural exposures and disease
  • 10.  The group, rather than the individual, is the unit of analysis  Advantages 1. Data easily available - studies inexpensive 2. Hypothesis-generating – suggest avenues for research  Disadvantages 1. Ecological fallacy: might not accurately represent the exposure – disease relationship at the individual level 2. Cannot directly link “exposure” with the “outcome”
  • 11.
  • 12. Extending beyond surveys of individuals  Food supply data  Nutrient composition of foods  Australian Household Expenditure Survey  International comparisons
  • 13. Food supply data  To calculate „available food for consumption‟ – Food balance sheets  Information on amounts of food (raw commodities) available for consumption per year Food available for use = production + imports – exports  Food available for consumption =  production + imports – exports – industrial use – animal use  Important – food available for consumption does NOT tell us how much food is actually eaten!
  • 14. Food supply data  To compare food trends within Australia Apparent food consumption data Apparent consumption = (commercial production + estimated home production + imports + opening stocks) (exports + usage for processed foods + non-food usage + wastage + closing stocks) MINUS
  • 15. Cross-sectional study design Begin with a 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
  • 16. Advantages of cross-sectional study design 1. Relatively inexpensive 2. No follow-up required 3. Less participant burden Disadvantages of cross-sectional study design 1. Cannot assess temprality 2. Can establish associations, but not causation 3. Considerable potential for confounding 4. Neyman (prevalence) bias (diseases or exposures that are longer-lasting will be over-represented relative to those of shorter duration)
  • 17.
  • 18. Australian Health Survey  http://www.abs.gov.au/websitedbs/D3310114.n sf/home/Australian+Health+Survey+- +Frequently+Asked+Questions
  • 19. Case-control study design  Observational, retrospective & focused on individuals  Comparison of exposure frequencies among diseased (case) and non-diseased (Control) groups
  • 20. NOT EXPOSED EXPOSED NOT EXPOSED EXPOSED Population TIME Adapted From: Fletcher et al (1996) Clinical Epidemiology: the essentials. Baltimore: Williams and Wilkins. CASES (people with disease) TIME Direction of inquiry CONTROLS (people without disease) Design of case-control study
  • 21. Advantages of case-control study design 1. Suitable for rare diseases 2. Possible to evaluate a large number of potential causes/risk factors 3. Efficient design, requiring less time and more modest costs than prospective studies 4. Higher on hierarchy of study designs
  • 22. Disadvantages of case-control study design 1. Potentially difficult to distinguish exposures that precede disease (antecedent causes) from concurrent associated factors 2. Requires representative samples of cases and controls 3. Selection of appropriate controls can be difficult 4. Generalisability of findings  Refusals  Representation of original populations 5. Results potentially flawed due to  Reliance upon accurate historical information about exposure, in particular recall may differ between cases and controls (recall bias)  Unsuitability of controls (lack of comparability with cases or overmatching) 6. Still cannot be CERTAIN that if exposure preceded the disease, then it is in fact causal
  • 23.
  • 24. Cohort study  Observational, prospective & focused on individuals  Essence is comparison of disease frequencies among exposed and non- exposed groups
  • 25. Population People without the disease TIME & Direction of inquiry Disease Disease No disease No disease Adapted From: Fletcher et al (1996) Clinical Epidemiology: the essentials. Baltimore: Williams and Wilkins. Exposed Not Exposed Design of cohort study
  • 26. Advantages of a cohort study 1. Possible to establish temporality 2. Possible to study several outcomes from exposure to same hazard 3. Bias - less of a problem than case-control or cross-sectional studies
  • 27. Disadvantages of a cohort study 1. Expensive in terms of time and money 2. Large, representative sample required 3. Higher risk of attrition bias 4. Measures used in early steps of study may change (eg, due to technological improvements) and so results at different points in time may not be directly comparable
  • 28.
  • 29. Randomised controlled trials (RCT)  Experimental, prospective  Types  Clinical trials – patients  Prevention trials – healthy people  Community trials – community level
  • 30. The structure of a clinical trial Population of patients with the condition SAMPLE TIME Improved Improved Not Improved Not Improved Experimental intervention Comparison intervention
  • 31. Randomised Trials Participants Non- participants Experimental Population Reference Population ASSIGNMENT Randomisation Study Group Comparison Group Improved Not improved Improved Not improved
  • 32. Advantages of RCT Advantages of RCT 1. If randomisation is successful, considered strongest design for causal inference 2. Researchers control the exposure – specific and accurate Disadvantages of RCT 1. Expensive and time consuming 2. Attrition 3. Compliance
  • 34. Hierarchy of study designs Randomised control trial Cohort study Case-control study Cross-sectional study Ecological study Experimental Observational Increasingcostandevidence
  • 35. Systematic review Randomised controlled trial Cohort study Case-control study Cross-sectional study Ecological study Case report, case series Editorials, expert opinion

Notes de l'éditeur

  1. Descriptive – describes occurrences of disease or exposure. Most likely to be used to look for patterns of disease and to measure the occurrence of disease or risk factors.Analytic studies – involves planned comparisons between people with/ without disease or exposed/ not exposed groups.
  2. Time point for prevalence should always be reported.Long lasting disease may have high prevalence, but low incidence. Disease that rapidly resolves may have low prevalence, but high incidence. To measure incidence need to start with cohort of people who are disease free.
  3. Dietary behaviours are complex and are the culmination of a range of factors including access, availability and affordability to foods that, arguably, are beyond the realm of the individual and are characteristics of the food supply. This contrasts with physical activity, where there may be fewer contextual factors that may influence an individual’s behaviour. In understanding the epidemiology of dietary behaviours, nutrition-related health outcomes and trends among populations, an understanding of the food supply with which the population interacts is important. In bringing about better health among populations, the scope of public health nutrition extends beyond health promotion and policy strategies that encourage individuals to make more healthy dietary choices to ensuring that the available food supply also promotes these choices.
  4. In Australia, information about household expenditure on food is collected periodically as part of the Australian Bureau of Statistics’ Household Expenditure Survey. Limitations of this data are that it does not collect information on the quantity of foods purchased and the descriptions of foods purchased are not sufficient to allow for analyses of nutrient contents. Information on food supply can take a variety of factors into account, including production, imports, export, industrial and animal use of food, and waste.Food Balance Sheets Provide information about the amount of food available for human consumption in a country in a given year from the FAOtakes into account production, changes in stocks, imports & exports, agricultural & industrial use of foodstuffsrelates only to primary producegive trends in food supply over time both within & between countries Relates to national average, provides estimates per kg of food per head per year OR per grams of food per head per day.Important– food availability data is not the same as food consumption data (i.e. Information on the availability of food does not tell us how much food is actually eaten).
  5. To compare trends in ‘apparent’ food consumption over time: Still an estimate as not measuring actual intake at the household levelApparent Consumption Data Derived by ABS in way similar to food balance sheets, however reporting is not limited to primary produce Not used for all food products e.g. if there was a better way of deriving consumption or for foods for which all components of the equation were not available (some milk products, beer, eggs, wine, cheese etc)Gives overall trends & correlationsData is useful in nutrition planningLong term data minimizes daily & seasonal variationsLarge sample populations increase validity of conclusionsNo placebo effectNo participant error