Epidemiology Studies, Descriptive designs

Addis Ababa University School of Public Health

Negussie Deyessa, MD, MPH, PHD 2011

Learning Objectives
When you have completed this session you will be able to:
1. Describe well all types of epidemiological study designs 2. Explain the uses of the various descriptive study designs. 3. Illustrate well the characteristics of descriptive study designs and depict how hypothesis is generated. 4. Determine when to proceed with an analytic study to further test a hypothesis 5. Describe the characteristics and design of analytic (observational) studies
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Strategy of epidemiology
Epidemiologic surveillance Epidemiologic research

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Purpose of Epidemiology
1. To diagnosis community health problems 2. To identify natural history and etiology of diseases. 3. To evaluate and plan health services.
To achieve these purposes, it is crucial to understand basic types of epidemiological study designs.
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Definition
The study of the frequency, distribution and determinants of diseases and other health related problems in human population and the application of this to the prevention and control of health problems. o Frequency: Quantification of the existence or occurrence of disease o Distribution: Describes the events of disease in terms of person, place and time. o Determinants: deals with factors affecting the distribution or occurrence of disease or health problem.
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Scope of epidemiology
Measuring the frequency of diseases and events (mortality, births, morbidity incidence and prevalence, hospital stays, drug use, injuries, health behaviors..); Solving epidemics; Looking for causes of disease and risk factors; Evaluating new diagnostic tests; Evaluating new treatments;
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Cont
Surveillance for new diseases and changes in old ones; Searching health services, their availability and their problem; Costing out alternative diagnostics, treatments or health service provisions.
Thus, it is crucial to understand basic types of epidemiological study designs.
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Why Epidemiological Studies?

To answer questions like:
How big is the problem (magnitude)?
Prevalence, incidence, mortality

What, who and where of any health problem?

Person characteristic of affected population Place characteristics (locality)

What factors are associated with certain disease

Specific factors related to causation

To evaluate interventions

Which drug is best for patients with X disease To evaluate any program e

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What is a research?
It is a systematic approach to problem solving It Investigates a phenomenon to answer a burning question It tries to answer a vague study question
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Assumptions for scientific research methods

Objective reality exists independent from peoples perception Nature has order, regularity and consistency All phenomena have causes that can be discovered
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Limitations of research based on scientific methods

No single study proves or disproves a hypothesis Ethical issues can constrain researchers Adequate control is hard to maintain in a study
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Categorizing Research
Two forms of approach 1. Qualitative Vs Quantitative (Words Vs Numbers) Qualitative research
Data from words, pictures, gestures etc (more on social and psychological phenomena)

Quantitative research
Data from numbers,
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2. Basic Vs Applied research
Basic R: Undertaken to advance knowledge in a given area understanding relationships among phenomena (Research done within laboratories) Applied R: Undertaken to remedy a particular problem or modify a situation, to make decisions or evaluate techniques (Researches made within human beings behavior)
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Major difference
Basic research Goal: to understand and explain facts about a phenomena Applied Research Goal: to understand societal problems and identify potential solution Takes an explanation to realworld problems Inter disciplinary

Discipline specific Contribution: a theory to explain the phenomena under investigation Eg How did HIV replicate within a human cell?
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Contribution: solutions to real world problems Eg How can epidemiologists control the spread of HIV/ AIDS?
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Categories of epidemiological studies

1. Descriptive epidemiological studies
Population as study subject
o Correlational /ecological studies

Individual as study subjects

o Case report / Case series o Cross-sectional surveys

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Cont
2. Analytic epidemiological studies
2.1 Observational studies
o Case-control study o Cohort study

2.2 Experimental / intervention studies

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Epidemiological studies
Populations
Ecologic

Descriptive
Individuals

Case-series Cross-sectional Case-control

Observational

Prospective

Analytical
Intervention
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Cohort
Retrospective

Clinical trials
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Descriptive versus Analytical epidemiology

Descriptive epidemiology:
Generates idea(s)/ hypothesis to be tested using analytic study design

Analytical epidemiology:
Uses comparison groups to establish an association between risk factors and illness in the two groups Tests a hypothesis
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1. Descriptive Studies
Some studies simply describe occurrence of disease or health related problems Prevalence of a disease, Rate of certain behaviour Describing these factors does not link any thing However we can identify unusual distributions or correlations (e.g clusters) These insights can be used to generate interesting hypothesis (Case series, cross-sectional, ecological)
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We use descriptive studies for hypothesis formulation

Person Who is getting the disease? Age, race, sex Place Where are the rates of disease highest/ lowest? Time When does the disease occur commonly/ rarely? Is the frequency of the disease now different from the corresponding frequency in the past?
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Cont.
Descriptive design are useful for hypothesis generation Hypothesis is thought when observed exposure among cases is higher/ lower than expected; It is usually generated based on knowledge, experience or specific information we have.
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What is a Hypothesis?
In epidemiology, a hypothesis is:
a supposition, that comes from observation or reflection, that leads to refutable prediction any assumption in a form that will allow to be tested and refuted

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But sometimes also: Why?

What is the source of infection for an outbreak of diarrhoeal disease? What are the risk factors for neonatal tetanus? What factors are associated with increased mortality for persons with measles? Does smoking cause lung cancer?

Analytical epidemiology
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2. Analytic epidemiological studies

Purpose/ Aim 1. To test hypothesis about causal relationship
Proof Vs Sufficient evidence

2. To search for cause and effect.

Why?? How??

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Cont
It focuses on determinants of disease by testing hypothesis.
Try to answer questions like why and how of a disease.

Hypothesis is tested using explicit type of comparison using appropriate comparison group. Two study designs,
1. Observational 2. Interventional designs.
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Cont
Difference lies in the role of the investigator.
In Observational studies, the investigator simply observes the natural course of event In interventional studies, the investigator assigns study subjects to exposure and non-exposure then simply follows to measure for disease occurrence.

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2.1 Observational studies

Information is obtained by simple observation of the event. Two basic types:
a. b. Case control study: Cohort study design

Major difference is in the method they initiate a comparison group Comparison of groups is made either by difference in disease occurrence (Cohort studies) or difference in exposure status (Case control studies)
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a. Case control study

Cases (subjects having a specific disease) and controls (subjects not having the disease) are compared for their exposure status. Cases are first selected then controls are similarly selected and analysis is made on, to observe among whom the exposure status is higher It assess retrospectively on exposure status It is relatively cheaper, (Time and Cost) Measure of association is using Odds ratio
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Design of case control

Direction of inquiry

Time

Exposed Non-exposed Exposed Non-exposed

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Cases
(People with disease) Population

Controls
(People without disease)

Starting of Observation

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b. Cohort study
Healthy subjects are classified on the basis of their specific exposure status and are followed up for a specific time to determine for the development of a new disease. Comparison between groups is made on difference in occurrence of a new disease between the two groups There is usually a follow up. Relatively expensive (time, cost). Measure of association is using Relative risk
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Cohort study design

Time Direction of inquiry People with out a disease Exposed Disease No disease

Population

Not -Exposed

Disease No disease

Simple Observation
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2.2 Interventional/ Experimental

o Investigator assigns subjects to exposure and non-exposure and makes follow up to measure for the occurrence of a disease. o It is usually prospective. o Very expensive, o Difficult to overcome ethical issue. o Measure of association is using Relative risk o Three types
o Randomized controlled (clinical) trial (patients, treatment) o Field trial (healthy people, prevention) o Community trial (intervention at community level)
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Experimental study design (Clinical trial)

Time Direction of inquiry
Experimental group

Recover
Not recovering

Population

Patients with a disease

Nonexperimental group

Recover
Not recovering

Manipulation by investigator Selection of people to be exposed or not-exposed

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Experimental study design (field trial)

Time Direction of inquiry
Intervention

Disease No disease

Population

People with out a disease

No-intervention

Disease No disease

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Experimental study design (community intervention trial)

Time Direction of inquiry
Intervention

Disease No disease

Population

Community with out a disease

No-intervention

Disease No disease

Manipulation by investigator Selection of people to be exposed or not-exposed

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Temporal relationship of exposure and disease, and time of assessment of different study designs.

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2. Descriptive epidemiology
Objectives To evaluate trends in health and disease and allow comparisons among countries or subgroups within countries To evaluate a basis for planning, provision and evaluation of services To identify problems to be studied by analytic methods and generate a hypothesis related to those problems
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Cont.
Describes the general characteristics of the distribution of a disease in relation to person, place and time. Who? Where? When? It provides valuable information To allocate resources efficiently and To plan effective prevention or education programs.
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Cont
It provides the first important clues about possible determinants of a disease (formulation of hypothesis). Hypothesis is formulated on an implicit comparison ie comparison with the expectation or experience.

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Hypothesis formulation
1. Method of difference:
If the occurrence of a disease markedly differ then there is particular factor.

2. Method of agreement:
Observation of a single factor common to a number of circumstances. Eg any diease and its symptoms

3. Method of concomitant variation:

Circumstances in which the frequency varies in proportion to frequency of disease. More on Correlational studies
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Descriptive Epidemiology Cases

Person Place Time

Who?
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Where?

When?
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Descriptive studies
Population as study subject
o Correlational /ecological studies

Individual as study subjects

o Case report / Case series o Cross-sectional surveys

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1. Correlational/ Ecological study

Uses data from entire population (as a whole) to compare disease frequencies. (ie it doesnt need data from individuals) Can be done quickly and inexpensively, often using already available data.

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Rationale for ecological studies

1. Low cost and convenient 2. Measurement limitation (difficult to measure at individual level) (eg environmental contact, dietary exposure) 3. Other designs may be unable to measure 4. Interest on ecologic effect
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Levels of measure
Source of data could be
1. Aggregate measures: (mean, proportion) observations derived from individuals in a group. (eg proportion of smokers, mean family income) Environmental measures: Physical characteristics of a place in which each group communities live or work (air-pollution, fluoride content of water) Global measure: Attributes of groups, organizations or places, for which there is no measure at individual level, (eg population density, presence of specific law)
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2.

3.

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Level of analysis
Completely ecologic analysis; all variables are ecologic measures and analysis is in a group. Partially ecologic analysis; addition of some individual variables and ecologic variables Measures of analysis in Correlational studies is using correlation coefficient (r) Correlation coefficient (r) is a descriptive measure between continuous variables that varies between -1 and +1)
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Cont.
Fig. Factious data to show correlation between salt sold and mean diastolic BP. (positive r ~ 0.67)

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Correlation coefficient
Y Y

r ~ +1
Y

X Y

r ~ -1

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r~ 0

r~ 0

X
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Levels of inference
It depends on the goal of inference wanted:
It can be to make biologic (bio-behavioral) inference about individual risks, or (such inferences are usually vulnerable to bias called Ecological fallacy) It can be ecological inferences about effects on group rates. It is also possible to infer to contextual effect that may be similar to biological effect.

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Limitations
Unable to link an exposure to occurrence of disease in a single individual. Lack of the ability to control for effect of confounders. Data represent average exposure levels rather than actual individual values, ecological fallacy or bias.

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2. Case reports or case series

Useful for the recognition of new diseases, Useful for constructing of the natural history of a disease, Use to formulate a hypothesis and to detect an epidemic

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A. Case report:
It is the study of health profile of a single individual using a careful and detailed report by one or more clinicians. It is common form that is published in articles It is made using
Simple history, Physical examination and Lab. / radiologic investigation.
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Cont
Report is usually documented if there is unusual medical occurrence, thus it may be first clue for identification of a new disease. It is useful in constructing a natural history of individual disease.
It was a single case report that formulated the hypothesis of oral contraceptive use increases venous thrombo-embolism.
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B. Case series
Individual case report can be expanded to a case series, which describes characteristics of a number of patients (usually 5-12) with a similar disease. Similar to case report, it is usually made on cases having new and/ or unusual disease (giving interest to clinicians) It is often used to detect the emergence of new disease or an epidemics. Eg. The first five AIDS cases in USA.
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Example:

Cont

Five young, previously health homosexual men were diagnosed as having Pneumocystis carinii pneumonia at Los Angeles hospital during a six month period from 1980 to 1981. This form of pneumonia had been seen almost exclusively among older men and women whose immune systems were suppressed. This unusual circumstance suggested that these individuals were actually suffering with a previously unknown disease, subsequently it was called AIDS.
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Cont
Both case report and case series are able to formulate a hypothesis but are not able to test for presence of valid association. Fundamental limitation of case report is presence of a risk factor could be simply coincidental. You are not able to test for association because there is no relevant comparison group

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3. Cross-sectional surveys
Is generally called study of prevalence Survey is conducted in a population, to find prevalence of a disease and exposure. Exposure and disease status are assessed simultaneously among individuals at the same point in time .
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Cont.
Cross-sectional surveys could provide information about the frequency of a disease by furnishing a snapshot at a specified time. May be used first step in longitudinal or case control studies. Data are obtained Only once.

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Cont.
The study may stay for more than 10 years with continuous enrolment, and remains crosssectional if data are obtained only once Measures of association is made using odds ratio. Has great value to public health providers to:
Assess the health status and health care needs of a population
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Cont
It can be considered as analytic study, if it assesses presence of an association. For factors that remain unaltered overtime, such as sex, race, blood group,
it can provide a good evidence.

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Factors influencing Prevalence

Increased By
By longer duration of the disease Prolongation of life of patients without cure Increase in new cases (increase in incidence) In-migration of cases Out-migration of healthy people In-migration of susceptible people Improved diagnostic facilities (better reporting) Negussie D, 2011

Decreased By
Shorter duration of the disease High case fatality Decrease in new cases (decrease in incidence) In-migration of health people Out-migration of cases Out-migration of susceptible people Improved cure rate of cases)
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Limitations
Since exposure and disease status is assessed at a single point in time, temporal relationship between exposure and disease can not be clearly determined. Egg and hen phenomena

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Advantage and disadvantage

Advantages May study several outcomes Controls over selection of subjects Relatively short duration Good first step for cohort study Yields prevalence
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Disadvantages Doesnt establish sequence of events, (temporal relationship) Potential bias in measuring exposure Potential survivor bias Not feasible for rare diseases Doesnt yield incidences or true relative risk

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Learning Objectives
When you have completed this session you will be able to:
1. Describe well all types of epidemiological study designs 2. Explain the uses of the various descriptive study types. 3. Express well the characteristics of descriptive study designs and how hypothesis is generated. 4. Determine when to proceed with an analytic study to further test the hypothesis 5. Describe the characteristics and design of analytic (observational) studies
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Cohort study
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Learning objectives
1. 2. 3. 4. 5. 6. Describe the characteristics of a cohort study. Describe the steps and application of cohort study design List the conditions under which a cohort study is an appropriate choice to address a research question. List the types of bias most likely to affect a cohort study. Describe the advantages and disadvantages of a cohort study design. Calculate appropriate measures of disease occurrence and exposure-disease association for a cohort study.

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Cohort study
It is also called follow up, longitudinal, prospective study. The word cohort is used to designate a group of people who share a common experience. a Birth cohort, a Cohort of smokers, a Cohort of MPH graduates in 2009, etc. It is an observational study that measures incidence of disease occurrence.
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Cohort studies
An investigator studies a group of exposed and unexposed subjects and follows the study subjects over a period of time and compares the incidence of developing disease of interest in the 2 groups
PRESENT TIME Exposed
No disease

FUTURE TIME
Diseased

Unexposed
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Diseased
No disease
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1. Basic elements
Disease free at entry Selected by exposure status rather than outcome Follow up is needed to determine the incidence of the outcome in each exposure group
For non communicable chronic diseases this may take years

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a. Exposure status
Study subjects should be disease free Define study subjects using inclusion and exclusion criteria on the basis of exposure status
Environmental factors: smoking, air pollution, pesticides

Criteria can be specified by amount of exposure

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Eg. Cigarette Smocking (# of cigarette per

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b. Possible outcomes in cohort No disease Disease Lost to follow up

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Cohort studies
Incident case Noncase Selected exposed and unexposed Incident case

Exp+

Ascertain caseness

Exp Noncase
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2. Features of cohort study

1. It shows temporal sequence Exposur e Disease

2. Good to assess effect of rare exposures 3. Could assess multiple effects of a single exposure
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3. Types of cohort studies

Two forms of cohort study The major difference is on the basis of Initiation of study and the occurrence of disease. The two forms are similar, because selection of study subjects is made on the basis of their exposure status.
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Cont 1. Classical (Prospective) cohort

The exposure may or may not have occurred at the time when the study begin, but the outcome has certainly not yet occurred.

2. Historical (Retrospective) Cohort

Both the exposure and outcome have already occurred when the study is initiated. Negussie D, 2011

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Cont.
1. Prospective cohort Exposure status determined at present Study groups followed up and disease outcome will be ascertained in the future Past Present
Exposure

Future
Disease outcome

2. Retrospective cohort Exposure determined in the Exposure past from records Disease outcome ascertained at present
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Disease outcome

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Cohort study design

Classical (prospective)

1. measure exposure

2. measure outcome

Historical (retrospective)

1. Record of exposure
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2. measure outcome
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Timing of case-control, prospective and retrospective cohort study in relation to exposure and outcome.

1. Case control
Exposure ? ? Disease

2. Prospective Cohort
Exposure

Disease ? ?

3. Retrospective Cohort
Exposure Disease ? ? Exposure, (+) or (-)
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? To be determined
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Cont.
Some cohorts become ambi-directional, both retrospective and prospective forms. Such type of design is used when exposed people have both short-term and long-term effects.
Eg Radiation, risks a birth defect within short time and cancer later.

If large sample size and follow up is complete, data from prospective study is reliable and informative when compared to Negussie D, 2011 retrospective

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Steps in a prospective cohort study

1. Define the population at risk (=cohort)
of all subjects in the cohort

2. Determine exposure status to a factor of interest 3. Make sure that study subjects are free of the
disease of interest at time of enrolment

4. Follow exposed and non-exposed forward in

time to ascertain whether they develop the outcome of interest unexposed group with each other

5. Compare the outcomes in the exposed and the

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Retrospective cohort studies

1. Well defined population healthy for disease of interest 2. Selection of study subjects is on the bases of their exposure status from a record (exposure status in past) 3. Ascertain outcome (ill or not ill) at present 4. Compare cumulative incidence among exposed to non-exposed (relative risk) Negussie D, 2011

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Other classification
Open and closed cohort design

1. Closed (fixed) cohort

Members of the cohort will be followed without adding others. E.g 1000 children followed for 2 or 3 years

2. Open (Dynamic) cohort study

Other than initially chosen study group, others could be added or be lost. People at risk are measured using person-time (incidence density) Data may be analyzed using Time tables and Kaplan Meir/ Cox regression.
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Open (Dynamic) cohort study

Birth

In-migrants

Death

Out-migrants

E. g. Butajira Rural Health Program

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4. Issues in the design of cohort studies

1. Selection of exposed population
It depends on a variety of scientific and other feasibility considerations, including:

a) The frequency of exposure

(finding sufficient exposed individuals). Common exposures (Cigarette, coffee drinking etc) Sufficient exposed people could be found. Rare exposures (eg occupational/environmental factors) Choose specific groups
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Cont
b. Completeness of follow up
Recruiting stable professionals (Stable occupation). Eg. Doctors, Nurses, Veterans, Union members etc. In Ethiopia, who are people with stable occupation?

c. Nature of research questions being evaluated.

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Presence of records within institution R t ti h t

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Cont
2. Selection of comparison (non-exposed) group
Difficult as in the selection of controls in casecontrol studies. Groups should be as similar as possible with respect to all other factors except exposure status. General cohort, and an internal comparison.
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Eg Cigarette smocking dose variation

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Cont
Information obtained from non-exposed should be adequately comparable with exposed. In use of rare occupational exposure, we can use external comparison groups (general population.). Comparison from within the institution but not having exposure eg office workers Vs working in plants. Comparing with other factories but having no contact with the exposure. Negussie D, 2011

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Cont
Comparison with general rates (such as mortalities, cancer incidents). Comparison with general population, (has limitation Healthy worker effect) (Workers are relatively healthier than the general population). Compare exposure with other cohort, having similar demography but not exposed. Use of multiple comparison groups may be other option.
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5. Source of data
In general we need accurate and complete information on both exposure and outcome of interest.

1. Exposure ascertainment a. Pre-existing data:- records from institutions

Advantages; It is inexpensive. Provides hard and unbiased information. Disadvantage; May not contain detail, adequate and sufficient information (incomplete).
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Cont
b. Interviewing individuals
Able to find information that cant be recorded (eg life style of individuals). Disadvantage; Bias can be introduced, (recall bias). Desirability bias
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Cont
2. Outcome data ascertaining: For diseases that are fatal, death certificate may be the source. For cause specific deaths, it may be obtained from autopsies, physician, verbal autopsies and hospital records. For non-fatal end points, physician, hospital records and even examination by physicians or screening can be obtained.
NB: Any outcome measurement should be done EQUALLY both to the exposed as well as non-exposed groups.
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6. Approaches to follow up
Follow up is major challenge both cost-wisely and timely. Length of follow up depends on the latency period of the outcome. (days, months or years) Unless follow up is nearly complete, it is difficult to interpret. (it may be source of bias). Therefore, it is crucial to think and achieve complete follow up.
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(People are mobile, changing job, changing address etc).

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Issues in Analysis

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Cont.
Calculating incidence of outcomes among exposed vs non-exposed groups (RR). Incidences could also be compared among various levels of exposure and combinations. Denominators could be number of individuals or person-time units. (RR, AR)
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Cont
Incidence risk (Cumulative incidence)
Denominator = # of individuals at risk at baseline

Incidence (density) rate

Denominator = person time

Calculate rate ratio (relative risk) Attributable risk (risk difference)

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Interpretation
As in other epidemiological studies, interpretation requires the role of Chance, bias, and confounding as explanations of findings. Role of bias
Selection bias is less concern in cohort (prospective) studies, but if knowledge of disease affects selection of exposed and non exposed (retrospective), selection bias may result.
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7. Role of bias
Any observational study is unlikely to categorize all individuals correctly. Misclassification of exposure status or outcome status occurs in most cohort studies (two forms). A. Random (non-differential) misclassification :inaccuracies occur in similar proportions in each of the study group.
(eg. smocking by # of cigarette Vs quality, pattern of smocking)

Increases similarity between exposed and nonexposed This can dilute and could under- or over estimate the results.
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Cont
B. Non-random (differential)
misclassification:- when misclassification produces one sided difference, and resulted in difference of accuracy or quality of information.
Smoking and bronchitis, (eg. Smokers get more medical attention, more diagnosed than nonsmokers)

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Giving care in ascertaining both exposure 99 and

8. Effect of loss to follow up

Loss to follow up is the major source of bias in cohort studies. Members of cohort may be lost to follow up, if this proportion is large, > 20- 25 %, it becomes difficult to validate. Reduce loss to follow up to an absolute minimum.

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Cont
Losses to follow up: (Solution)
1. Try to find outcome measures from all possible sources. 2. Compare presence of difference in demographic characteristics between loss to follow up and follow up ascertained people,
If no difference then it is not much a problem
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Cont
3. Indirect estimation of their effect a. inclusion of assumption of all lose to follow up as if they developed the outcome, b. inclusion of assumption of all loss to follow up as if they didnt develop the outcome

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9. Effects of non-participation
Non-participants (non-response) are participants who are eligible to participate but who are not included in the study (non-volunteers). These who tend to participate differ to those who did not-participate on motivation, attitude to health and knowledge of risk status. The problem encountered by non-response is not on the internal validity but by difficulty to generalize (external validity).
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Cont
Effect of non-response can be assessed by comparing basic social and demographic characteristics of respondents and non-respondents.
If there is no difference in major demographic characteristics, then results are able to be generalized.

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Summary
Strength
1. Is of particular value when the exposure is rare. 2. Can examine multiple effects of a single exposure. 3. Can elucidate temporal relationship between exposure and disease. 4. Allows direct measurement of incidence of disease in the exposed and non exposed.
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Summary
Limitations 1. Is inefficient for the evaluation of rare diseases, 2. If prospective, can be extremely expensive and time consuming. 3. If retrospective, it requires the availability of adequate records. 4. Validity of results can be seriously affected by losses to follow up.
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Summary
Cohort studies allow measurement of risk Case-control studies are rapid, but not able to measure risk; (only estimate RR) In the ideal world: Prefer cohort to casecontrol study In the real world: Case-control studies usually do the job
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Learning objectives
1. Describe the characteristics of a cohort study. 2. Describe the steps and application of cohort study design 3. List the conditions under which a cohort study is an appropriate choice to address a research question. 4. List the types of bias most likely to affect a cohort study. 5. Describe the advantages and disadvantages of a cohort Negussie D, 2011 study design. 108

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