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    Epidemiology Studies,Descriptive designs

    Addis Ababa University

    School of Public Health

    Negussie Deyessa, MD, MPH, PHD

    2011

    Negussie D, 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 studydesigns and depict how hypothesis is generated.

    4. Determine when to proceed with an analytic study tofurther test a hypothesis

    5. Describe the characteristics and design of analytic(observational) studies

    2

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    Negussie D, 2011

    Strategy of epidemiology

    Epidemiologic surveillance

    Epidemiologic research

    3

    Negussie D, 2011

    Purpose of Epidemiology1. 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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    Negussie D, 2011

    Definition

    The study of the frequency, distribution anddeterminantsof diseases and other health relatedproblems in human population and the application ofthis to the prevention and control of health problems.

    o Frequency: Quantification of the existence or occurrenceof disease

    o Distribution: Describes the events of disease in terms ofperson, place and time.

    o Determinants: deals with factors affecting the distributionor occurrence of disease or health problem.

    5

    Negussie D, 2011

    Scope of epidemiology Measuring the frequency of diseases and events

    (mortality, births, morbidity incidence andprevalence, hospital stays, drug use, injuries,health behaviors..);

    Solving epidemics;

    Looking for causes of disease and risk factors;

    Evaluating new diagnostic tests;

    Evaluating new treatments;6

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    Negussie D, 2011

    Cont

    Surveillance for new diseases and changes in oldones;

    Searching health services, their availability andtheir problem;

    Costing out alternative diagnostics, treatments orhealth service provisions.

    Thus, it is crucial to understand basic types of

    epidemiological study designs.

    7

    Negussie D, 2011

    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 certaindisease

    Specific factors related to causation

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

    e t c8

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    Negussie D, 2011

    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

    9

    Negussie D, 2011

    Assumptions for scientificresearch methods

    Objective reality exists independent from

    peoples perception

    Nature has order, regularity and consistency

    All phenomena have causes that can be

    discovered

    10

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    Negussie D, 2011

    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

    11

    Negussie D, 2011

    Categorizing ResearchTwo 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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    Negussie D, 2011

    Cont

    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)

    13

    Negussie D, 2011

    Major difference

    Basic research

    Goal:

    to understand and explain factsabout a phenomena

    Discipline specific

    Contribution:

    a theory to explain the phenomenaunder investigation

    Eg

    How did HIV replicate within ahuman cell?

    Applied Research

    Goal:

    to understand societal problemsand identify potential solution

    Takes an explanation to real-world problems

    Inter disciplinary

    Contribution:

    solutions to real world problems

    Eg

    How can epidemiologists controlthe spread of HIV/ AIDS?

    14

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    Negussie D, 2011

    Categories of epidemiologicalstudies

    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

    15

    Negussie D, 2011

    Cont

    2. Analytic epidemiological studies

    2.1 Observational studies

    o Case-control study

    o Cohort study

    2.2 Experimental / intervention studies

    16

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    Negussie D, 2011

    Case-control

    Cohort

    Individuals

    Intervention

    Retrospective

    Prospective

    Descriptive

    Populations

    Analytical

    Observational

    Case-series

    Cross-sectional

    Ecologic

    Clinical trials

    Epidemiological studies

    17

    Negussie D, 2011

    Descriptive versus Analyticalepidemiology

    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 hypothesis18

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    Negussie D, 2011

    1. Descriptive Studies

    Some studies simply describe occurrence of disease orhealth related problems

    Prevalence of a disease,

    Rate of certain behaviour

    Describing these factors does not link any thing

    However we can identify unusual distributions orcorrelations (e.g clusters)

    These insights can be used to generate interestinghypothesis

    (Case series, cross-sectional, ecological)

    19

    Negussie D, 2011

    We use descriptive studies forhypothesis formulation

    Person

    Who is getting the disease? Age, race, sex

    Place

    Where are the rates of disease highest/ lowest?

    TimeWhen 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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    Negussie D, 2011

    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.

    Cont.

    21

    Negussie D, 2011

    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 betested and refuted

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    Negussie D, 2011

    But sometimes also: Why?

    What is the source of infection for an outbreak ofdiarrhoeal disease?

    What are the risk factors for neonatal tetanus?

    What factors are associated with increased mortality forpersons with measles?

    Does smoking cause lung cancer?

    Analytical epidemiology23

    Negussie D, 2011

    Purpose/ Aim

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

    2. To search for cause and effect.Why?? How??

    3. To compare treatment regimens / prevention programs

    4. To assess diagnostic tests

    5. To quantify the association between exposure andoutcome

    Measure of association

    2. Analytic epidemiological studies

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    Negussie D, 2011

    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.

    25

    Negussie D, 2011

    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 diseaseoccurrence.

    26

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    Negussie D, 2011

    2.1 Observational studies

    Information is obtained by simple observation of theevent.

    Two basic types:a. Case control study:

    b. Cohort study design

    Major difference is in the method they initiate acomparison group

    Comparison of groups is made either by differencein disease occurrence (Cohort studies) ordifference in exposure status (Case control studies)

    27

    Negussie D, 2011

    a. Case control study Cases (subjects having a specific disease) and

    controls (subjects not having the disease) arecompared for their exposure status.

    Cases are first selected then controls are similarlyselected and analysis is made on, to observeamong 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 ratio28

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    Negussie D, 2011

    Design of case control

    Exposed

    Non-exposed

    Exposed

    Non-exposed

    Cases

    (People with

    disease)

    Controls

    (People without

    disease)

    Population

    TimeDirection of inquiry

    Starting of Observation29

    Negussie D, 2011

    b. Cohort study

    Healthy subjects are classified on the basis of theirspecific exposure status and are followed up for aspecific time to determine for the development of anew disease.

    Comparison between groups is made on differencein occurrence of a new disease between the twogroups

    There is usually a follow up.

    Relatively expensive (time, cost).

    Measure of association is using Relative risk

    30

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    Negussie D, 2011 31

    Negussie D, 2011

    Population

    People

    with

    out a

    disease

    Exposed

    Not -Exposed

    Disease

    Disease

    No disease

    No disease

    Direction of inquiry

    Time

    Cohort study design

    Simple Observation32

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    Negussie D, 2011

    2.2 Interventional/ Experimental

    o Investigator assigns subjects to exposure and non-exposureand makes follow up to measure for the occurrence of adisease.

    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)

    33

    Negussie D, 2011

    Population

    Patients

    with a

    disease

    Experimental

    group

    Nonexperimentalgroup

    Recover

    Recover

    Not recovering

    Not recovering

    Direction of inquiry

    Time

    Experimental study design (Clinical trial)

    Manipulation by investigator

    Selection of people to be exposed or not-exposed34

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    Negussie D, 2011

    Population

    People

    with

    out a

    disease

    Intervention

    No-intervention

    Disease

    Disease

    No disease

    No disease

    Direction of inquiry

    Time

    Experimental study design (field trial)

    35

    Manipulation by investigator

    Selection of people to be exposed or not-exposed

    Negussie D, 2011

    PopulationCommunity

    with out a

    disease

    Intervention

    No-intervention

    Disease

    Disease

    No disease

    No disease

    Direction of inquiry

    Time

    Experimental study design (community intervention trial)

    36

    Manipulation by investigator

    Selection of people to be exposed or not-exposed

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    Negussie D, 2011

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

    37

    Negussie D, 2011

    2. Descriptive epidemiology

    Objectives

    To evaluate trends in health and disease andallow comparisons among countries orsubgroups within countries

    To evaluate a basis for planning, provision andevaluation of services

    To identify problems to be studied by analyticmethods and generate a hypothesis related tothose problems

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    Cont.

    Describes the general characteristics of thedistribution 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 educationprograms.

    39

    Negussie D, 2011

    Cont

    It provides the first important cluesabout possible determinants of adisease (formulation of hypothesis).

    Hypothesis is formulated on an implicit

    comparison ie comparison with theexpectation or experience.

    40

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    Negussie D, 2011

    1. Method of difference:If the occurrence of a disease markedly differ then there isparticular factor.

    2. Method of agreement:Observation of a single factor common to a number ofcircumstances.

    Eg any diease and its symptoms

    3. Method of concomitant variation:Circumstances in which the frequency varies in proportionto frequency of disease. More on Correlational studies

    Hypothesis formulation

    41

    Negussie D, 2011

    Person

    Place

    Time

    Cases

    Descriptive Epidemiology

    Who? Where? When?

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    Negussie D, 2011

    Descriptive studies

    Population as study subject

    o Correlational /ecological studies

    Individual as study subjects

    o Case report / Case series

    o Cross-sectional surveys

    43

    Negussie D, 2011

    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.

    44

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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

    45

    Negussie D, 2011

    Levels of measure

    Source of data could be1. Aggregate measures:

    (mean, proportion) observations derived from individualsin a group. (eg proportion of smokers, mean familyincome)

    2. Environmental measures:Physical characteristics of a place in which each groupcommunities live or work (air-pollution, fluoride contentof water)

    3. Global measure:Attributes of groups, organizations or places, for whichthere is no measure at individual level,(eg population density, presence of specific law)

    46

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    Level of analysis

    Completely ecologic analysis; all variables areecologic measures and analysis is in a group.

    Partially ecologic analysis; addition of someindividual variables and ecologic variables

    Measures of analysis in Correlational studies isusing correlation coefficient (r)

    Correlation coefficient (r) is a descriptivemeasure between continuous variables thatvaries between -1 and +1)

    47

    Negussie D, 2011

    Cont.

    Fig. Factious data to show correlation between saltsold and mean diastolic BP. (positive r ~ 0.67)

    48

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    X

    Y

    X

    r ~ +1

    Y

    Xr ~ -1

    Y

    r ~ 0 r ~ 0 X

    Y

    Correlation coefficient

    49

    Negussie D, 2011

    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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    Negussie D, 2011

    Limitations

    Unable to link an exposure to occurrence ofdisease in a single individual.

    Lack of the ability to control for effect ofconfounders.

    Data represent average exposure levelsrather than actual individual values,

    ecological fallacy or bias.

    51

    Negussie D, 2011

    2. Case reports or case series

    Useful for the recognition of newdiseases,

    Useful for constructing of the naturalhistory of a disease,

    Use to formulate a hypothesis and todetect an epidemic

    52

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    Negussie D, 2011

    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 inarticles

    It is made using Simple history, Physical examination and

    Lab. / radiologic investigation.53

    Negussie D, 2011

    ContReport 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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    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 newdisease or an epidemics.

    Eg. The first five AIDS cases in USA.

    B. Case series

    55

    Negussie D, 2011

    ContExample:Five young, previously health homosexual menwere diagnosed as having Pneumocystis cariniipneumonia at Los Angeles hospital during a sixmonth period from 1980 to 1981.

    This form of pneumonia had been seen almostexclusively among older men and women whose

    immune systems were suppressed.

    This unusual circumstance suggested that theseindividuals were actually suffering with a previouslyunknown disease, subsequently it was called AIDS.

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    Cont

    Both case report and case series are able toformulate a hypothesis but are not able to test forpresence 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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    Negussie D, 2011

    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 assessedsimultaneously among individuals at the

    same point in time .

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    Negussie D, 2011

    Cont.

    Cross-sectional surveys could provideinformation about the frequency of a diseaseby furnishing a snapshot at a specified time.

    May be used first step in longitudinal or casecontrol studies.

    Data are obtained Only once.

    59

    Negussie D, 2011

    Cont.The study may stay for more than 10 years with

    continuous enrolment, and remains cross-sectional if data are obtained only once

    Measures of association is made using oddsratio.

    Has great value to public health providers to:

    Assess the health status and health care needs of a

    population

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    Negussie D, 2011

    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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    Negussie D, 2011

    Increased ByBy 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)

    Decreased ByShorter 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)

    Factors influencing Prevalence

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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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    Negussie D, 2011

    Advantage and disadvantage

    Advantages

    May study severaloutcomes

    Controls over selection ofsubjects

    Relatively short duration

    Good first step for cohortstudy

    Yields prevalence

    Disadvantages

    Doesnt establish sequenceof events,

    (temporal relationship)

    Potential bias in measuringexposure

    Potential survivor bias

    Not feasible for rare diseases

    Doesnt yield incidences ortrue relative risk

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    Learning Objectives

    When you have completed this session you will beable 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 designsand 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

    65

    Cohort study

    Negussie Deyessa, MD, PhD

    Dec, 2011

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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 anappropriate 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 cohortstudy design.

    6. Calculate appropriate measures of disease occurrence andexposure-disease association for a cohort study.

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    Negussie D, 2011

    Cohort study It is also called follow up, longitudinal,

    prospective study.

    The word cohort is used to designate a group ofpeople 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 measuresincidence of disease occurrence.

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    Negussie D, 2011

    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

    Exposed

    Unexposed

    Diseased

    No disease

    Diseased

    No disease

    PRESENT TIME FUTURE TIME

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    Negussie D, 2011

    1. Basic elements

    Disease free at entry

    Selected by exposure status rather thanoutcome

    Follow up is needed to determine theincidence of the outcome in each exposuregroup 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

    Eg. Cigarette Smocking (# of cigarette per 71

    Negussie D, 2011

    b. Possible outcomes in cohort

    No disease

    Disease

    Lost to follow up

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    Cohort studies

    Selected exposedand unexposed

    Exp+

    Exp -

    Incidentcase

    Incidentcase

    Non-case

    Non-case

    Ascertaincaseness

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    Negussie D, 2011

    2. Features of cohortstudy

    1. It shows temporal sequence

    2. Good to assess effect ofrare exposures

    3. Could assess multiple effects of a singleexposure

    Exposure

    Disease

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    Negussie D, 2011

    3. Types of cohort studies

    Two forms of cohort study

    The major difference is on the basis of

    Initiation of study and theoccurrence of disease.

    The two forms are similar, becauseselection of study subjects is made on the

    basis of theirexposure status.75

    Negussie D, 2011

    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 yetoccurred.

    2. Historical (Retrospective) Cohort Both the exposure and outcome have

    already occurred when the study isinitiated. 76

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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

    2. Retrospective cohort

    Exposure determined in the

    past from records

    Disease outcome ascertained

    at present

    Diseaseoutcome

    Diseaseoutcome

    Exposure

    Exposure

    Present FuturePast

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    Cohort study designClassical (prospective)

    1. measure exposure 2. measure outcome

    Historical (retrospective)

    2. measure outcome1. Record of exposure

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    Exposure

    ?

    1. Case controlDisease

    ?

    Exposure, (+) or (-)? To be determined

    Timing of case-control, prospective and retrospectivecohort study in relation to exposure and outcome.

    Exposure?

    ?

    2. Prospective CohortDisease

    3. Retrospective Cohort

    ??

    Exposure Disease

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    Cont. Some cohorts become ambi-directional,

    both retrospective and prospective forms.

    Such type of design is used when exposedpeople have both short-term and long-termeffects.

    Eg Radiation, risks a birth defect within short

    time and cancer later.

    If large sample size and follow up iscomplete, data from prospective study isreliable and informative when compared to

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    eps n a prospec ve co orstudy

    1.Define the population at risk (=cohort)

    2. Determine exposure status to a factor of interest

    of all subjects in the cohort

    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 theoutcome of interest

    5. Compare the outcomes in the exposed and theunexposed group with each other 81

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    Retrospective cohort studies1. 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)82

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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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    .studies

    1. Selection of exposed population It depends on a variety ofscientific 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/environmentalfactors)

    Choose specific groups

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    Negussie D, 2011

    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 ofresearch questions beingevaluated.

    Presence ofrecords within institution86

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    Cont

    2. Selection of comparison (non-exposed)group

    Difficult as in the selection of controls in case-

    control studies.

    Groups should be as similar as possible withrespect to all other factors except exposure

    status.

    General cohort, and an internal comparison.

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    Cont Information obtained from non-exposed should

    be adequately comparable with exposed.

    In use of rare occupational exposure, we canuse external comparison groups (generalpopulation.).

    Comparison from within the institution but not

    having exposureeg office workers Vs working in plants.

    Comparing with other factories but having nocontact with the exposure.

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    Comparison with general rates (such asmortalities, cancer incidents).

    Comparison with general population, (haslimitation Healthy worker effect) (Workers arerelatively healthier than the general population).

    Compare exposure with other cohort, havingsimilar demography but not exposed.

    Use of multiple comparison groups may beother option.

    Cont

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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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    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

    Cont

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    Cont

    2. Outcome data ascertaining:

    For diseases that are fatal, death certificatemay be the source.

    For cause specific deaths, it may be obtainedfrom autopsies, physician, verbal autopsiesand hospital records.

    For non-fatal end points, physician, hospital

    records and even examination by physicians orscreening can be obtained.

    NB: Any outcome measurement should be doneEQUALLY both to the exposed as well as non-exposedgroups.

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    Follow up is major challenge both cost-wiselyand timely.

    Length of follow up depends on the latencyperiod of the outcome. (days, months oryears)

    Unless follow up is nearly complete, it isdifficult to interpret. (it may be source of bias).

    Therefore, it is crucial to think and achievecomplete follow up.(People are mobile, changing job, changing address

    etc).

    6. Approaches to follow up

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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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    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)

    Cont

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    Interpretation

    As in other epidemiological studies,interpretation requires the role of Chance,bias, and confounding as explanations offindings.

    Role of bias

    Selection bias is less concern in cohort

    (prospective) studies, but if knowledge ofdisease affects selection of exposed and nonexposed (retrospective), selection bias mayresult.

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    7. Role of bias

    Any observational study is unlikely to categorizeall individuals correctly.

    Misclassification of exposure status or outcomestatus occurs in most cohort studies (two forms).

    A. Random (non-differential) misclassification :-inaccuracies occur in similar proportions in eachof the study group.(eg. smocking by # of cigarette Vs quality, pattern of

    smocking) Increases similarity between exposed and non-

    exposed

    This can dilute and could under- or overestimate the results.

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    B. Non-random (differential)misclassification:- when misclassificationproduces one sided difference, and resultedin difference of accuracy or quality of

    information.

    Smoking and bronchitis, (eg. Smokers get more

    medical attention, more diagnosed than non-

    smokers)

    Giving care in ascertaining both exposure

    Cont

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    8. Effect of loss to follow up

    Loss to follow up is the major source of bias incohort studies.

    Members of cohort may be lost to follow up, if thisproportion is large, > 20- 25 %, it becomes difficultto validate.

    Reduce loss to follow up to an absoluteminimum.

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    Losses to follow up: (Solution)

    1. Try to find outcome measures from all

    possible sources.

    2. Compare presence of difference indemographic characteristics between

    loss to follow up and follow up

    ascertained people,

    If no difference then it is not much a

    Cont

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    Cont3. Indirect estimation of their effect

    a. inclusion of assumption of all lose to followup as if they developed the outcome,

    b. inclusion of assumption of all loss to followup as if they didnt develop the outcome

    This gives the range of association itcould lie.

    If the estimate is within the range then it isgood estimation, else it shows that there is

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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 isnot on the internal validity but by difficulty to

    generalize (external validity).

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    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 resultsare able to be generalized.

    Cont

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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 diseasein 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 extremelyexpensive 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 case-

    control study

    In the real world: Case-control studiesusually do the job

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    Learning objectives

    1. Describe the characteristics of a cohort study.

    2. Describe the steps and application of cohortstudy design

    3. List the conditions under which a cohort study isan appropriate choice to address a researchquestion.

    4. List the types of bias most likely to affect a cohortstudy.