Occ IntroductiontoOccupationalEpidemiologyfortheIH

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    Introduction to Occupational

    Epidemiology for the IndustrialHygienist

    Based on a Professional Development Coursewritten by Dr. Chris Rennix, Dr. Robin Leonard,

    and Mr. Phill Hunt

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    Learning ObjectivesObjectives: Upon completion, the participant will be able to:

    Describe the basic roles played by industrial hygienists inoccupational epidemiology

    Identify basic epidemiologic terms and apply them to typical

    worksite examples during general discussions Select the appropriate disease model based on latency, body

    burden, and human physiology

    Calculate basic ratios and rates used in epidemiologic studies

    Describe basic epidemiologic principles in terms related toindustrial hygiene exposure assessments during generaldiscussions

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    Introduction orAre we sampling for health or

    compliance? Current view - How is occupational epidemiologydefined?

    History - Where did occupational epidemiologyoriginate?

    Players - Who does what to whom?

    Disease - Does the disease process dictate howand who we sample?

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    Current View of Epidemiology

    Public perception Current legal precedents

    Media perception Medical perception

    IH perception

    Epidemiologist perception

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    History

    History of Epidemiology Cholera

    Lyme disease

    History of Occupational Epidemiology

    Lung cancer

    Bladder cancer

    Hearing loss

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    Players

    The corporation The worker

    The physician The IH

    The epidemiologist

    The lawyers

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    Disease Models

    Exposure Induction

    Latency Single hit model

    Multistage model

    Time-windows of exposure

    Promotion

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    References

    Checkowayand Pearce. Research Methodsin Occupational Epidemiology. OxfordUniversity Press, 1989

    Rothman. Epidemiology: an introduction.Oxford University Press, 2002.

    Ahlbomand Norell. Introduction to Modern

    Epidemiology. Epidemiology ResourcesInc, 1990.

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    Definitions

    Exposure - Presence of a substance in an areawhere a person works

    Induction - Time from first exposure to diseaseinitiation

    Latency - The time from disease initiation to therecognition of effects

    Why are these concepts important to the IH and theepidemiologist?

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    Single Hit vsMultistageDisease Models

    R

    ISK

    Time

    Exposure

    Unexposed worker

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    Single Hit vsMultistageDisease Models II

    R

    ISK

    Time

    Exposure

    Unexposed or lessexposed worker

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    Single Hit vsMultistageDisease Models III

    R

    ISK

    Time

    Exposure to A

    Unexposed to Aand/or B

    Exposure to B

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    Time WindowsDisease Model

    Time/Age

    Menarche 1st Birth Perimenopause Menopause

    Assuming constantexposure to Chemical

    A

    Birth of 1st

    child before25 yrs old

    Birth of 1st

    child after 30yrs old

    Nonparous

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    Occupational Epidemiology StudyTypes and Calculations

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    Describe health status of apopulation Explain the etiology of disease (identify risk

    factors, modes of transmission)

    Predict the occurrence of disease

    Evaluate impact of an intervention

    Prevent new occurrence, eradicate existingdisease

    Objectives of Epidemiologists

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    Definitions Types of Studies

    Cross-sectional

    Cohort

    Case-Control

    Case-Cohort

    Measures of disease frequency

    Measures of risk

    Measures of exposure

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    Incidence

    number of new cases of a disease within a definedpopulation, over a specified period of time

    Prevalence all cases of a disease within a definedpopulation, over

    a specified period of time

    Mortality estimate of the proportion of apopulationthat dies

    during a specified period

    Measures of Disease Frequency

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    Measuring disease frequency Count number of cases (numerator)

    Count number at risk (denominator)

    Lung Cancer in Males

    10/320 = .03 6/180 = .03 1/250 = .004

    Prevalence (all cases, single point in time)

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    The Importance of Denominators

    Rates, Ratios, Proportions all require definition ofa whole-- whole group, whole plant, wholepopulation

    Cohort definition is critical, because that is howwe establish a rate

    Industry studies examined very carefully for

    inclusion, exclusion criteria

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    Experimental

    Assignment of exposure under investigator

    control (clinical trials)Non-Experimental

    DescriptiveCollecting, sorting, analyzing data can elucidate

    important patterns

    AnalyticCross-sectional

    Longitudinal

    Types of Studies

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    How old is the plant? Continuous operation?

    What kinds, and how much, chemicals or other toxics areused, produced, shipped?

    How do we describe the jobs of a group of people in ananalyzable way?

    Identifyjob titles, departments, and specific tasksIdentifyhomogeneous exposure groupsUseIH monitoring data to categorize

    Where do we get this information?

    HR Department; EH&S; Industrial Hygiene

    Descriptive EpidemiologyDescribes

    What, for example?

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    Data on disease and exposure available foreach individual

    Longitudinal

    Cohort

    Prospective

    Retrospective

    Case-Control

    Case-Cohort Cross-Sectional

    Analytic Studies

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    Individuals enter the study on the basis ofexposure and non-exposure.

    Prospective: disease has not occurred at the

    time exposed and non-exposed groups aredefined.

    Retrospective: disease has occurred at the time

    exposure groups are defined.

    Cohort Studies

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    Cohort studies Prospective Design data collection

    to take advantage ofparticipantsavailability

    Less bias with

    ascertainment ofdisease

    Better able to track

    changes in exposure

    Retrospective Less detail is generally

    available onparticipantscharacteristics orexposures.

    Comparisons are madeto a general populationor to a cohort selectedto closely resemble thestudy group.

    Exposures of the pastare being evaluated.

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    Comparinghealth of different groupsCohort Studies

    Cohort: any designated group of persons who arefollowed or traced over a period of time

    Individuals enter a cohort study on the basis of

    exposure and non-exposure. Prospective: disease has not occurred at the time

    exposed and non-exposed groups are defined.

    Retrospective: disease has occurred at the timeexposure groups are defined.

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    Less detail is generally available on participantscharacteristics or exposures.

    Comparisons are made to a general population or

    to a cohort selected to closely resemble the studygroup.

    Exposures of the past are being evaluated.

    Retrospective Cohort Studies

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    Now you understand

    Descriptive epidemiology: the profile ofthe population of interest

    Cross-sectional epidemiology: one point in

    time; health status and risk factor known atthe level of the individuals

    Prevalence : all cases divided by the totalpopulation at one point in time

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    ?

    ?

    Case-Control (Case-Cohort) Study

    ??

    Exposure Disease

    Investigator atbeginning of study

    ? =To be determined

    P

    A

    Prospective CohortExposure Disease

    ?

    ?

    P

    A

    Retrospective CohortExposureDisease

    PA

    P = present A = absent(Basis of group selection at beginning of study)

    =

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    EX POSURE

    YES NO

    No. initial ly at risk 4000 16,000Deaths 30 60

    Person-years at risk 7970 31,940

    Risk Ratio = 30/4000 7.5 per 1000

    = = 2.000060/16,000 3.75 per 1000

    Rate Ratio = 30/7970 pyrs 3.76 per 1000 pyrs

    = = 2.0038

    60/31,940 pyrs 1.88 per 1000 pyrs

    Disease Odds Ratio = 30/(4000-30) 0.00756

    = = 2.007660/(16,000-60) 0.00376

    Hypothetical Data from a Cohort of 20,000 persons followed up for two years

    (from Cancer Epidemiology: Principles and Methods, by Isabel dos Santos Silva, WHO,1999)

    Measuresof RelativeRisk

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    Case-Control Studies

    Investigator looks backward from diseaseto exposure

    Identification is via disease

    Evaluates a number of exposures in relationto one disease

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    Odds RatioOdds Ratio

    a+b+c+db + da + c

    c + ddcNoDisease

    a + bbaDisease

    UnexposedExposed

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    Nested Case-Control Studies

    Used to focus on findings from a cohortstudy.

    Directed toward identifying specific causal

    risk factors.

    Findings can be extrapolated to cohort from

    which the cases and controls came. Risks expressed as odds ratios.

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    Case-Cohort Studies

    All cases from the full cohort are collected asstudy cases

    A random sample of the full cohort is thesource of the comparison group It is possible that cases may be selected as controls,

    in which case they are included in the referencesubcohortuntil their deaths (mortality studies) ordate of diagnosis (morbidity studies).

    Takes advantage of the statistical power ofcohort studies and the focused use of specificexposure data of the case-control approach.

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    Bias, Confounders, Effect Modifiers,

    Risk Co-factors Healthy Worker Effect

    Bias

    Selection

    Recall

    Informational

    Confoundermust be associated with both theexposure of interest and the outcome

    Certain enzyme polymorphisms cause rapid

    metabolism of toxicants

    Both cigarette smoking and working top-side on acoke oven cause lung cancer

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    Epidemiologic Concept of Causality

    Strength of association: How strong is the association between the

    exposure and disease?

    Usually expressed as relative risk or an oddsratio

    The farther the risk from the number one, the

    stronger the association

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    Epidemiologic Causality

    Consistency: Is the association observed by differentresearchers in different conditions,circumstances, places,or times?

    Specificity: Is the cause usually found when the disease is

    present?

    Does the disease usually result when the causeis present?

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    Epidemiologic Causality Relationship in time:

    Does the exposure (or causal factor) precedethe disease or outcome?

    Temporalitythe exposuremustprecede theoutcome

    Biological gradient:

    Does more exposure (higher amounts per unit

    time or longer duration of time exposed) lead tomore severe disease or increased incidence ofdisease?

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    Epidemiologic Causality

    Biological plausibility: Is the observed association consistent with

    biological ideas about the disease process?

    Coherence of the evidence: Does the entire set of observations fit together?

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    Epidemiologic Causality

    Experiment: Does removal of the exposure result in a change

    in disease frequency?

    How does treatment affect different groups in arandomized trial?

    Reasoning by analogy: Are there similar known patterns of cause and

    effect found in other areas of epidemiology?

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    Stepwise Approach to

    Epi Study Design

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    Review Study Population andsources of exposure

    Physical layout of facility, neighborhood Processes generating exposure

    Materials used

    Jobs. Tasks, activities of of

    Workers

    Community

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    Determine study design

    Cross-sectional survey Retrospective cohort

    Retrospective case-control

    Prospective cohort

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    Determine degree ofquantification

    Qualitative Ever/never exposed

    Semi-quantitative

    None, low medium high

    Quantitative

    Air concentration Force, repetitions

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    Determine the measurement tool

    Record review Expert judgment

    Questionnaires, Interviews

    Sampling and analytical methods for directmeasurement

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    Informationcollection Conditions of exposures

    tasks, product, production information, upsets,accidents, job title, department.

    Information on subject

    relevant employee information, such as age,years at job, previous jobs within facility, andearlier job history, smoking, and gender

    Ethnicity may be an issue but may also be aconfounder

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    Design exposure assessmentstrategy

    Types of samples Area-task vs personal

    Who or where to sample

    How many samples How many people or places

    How many days

    Sampling duration Task or full shift

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    Pilot test measurement tool

    Are there differences in exposure? Processes left out?

    More or fewer measurements?

    Interview questions easily understood?

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    Summary

    Measure what causes or what you suspectcauses the disease

    Measure in a way that is relevant to the

    disease process Develop a plan

    Test it before you spend the big bucks

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    Final Discussion Future Issues

    Current experience in litigation based on theuse of exposure assessments as evidence

    Legal Issues

    Liability and professional judgment

    Costs

    IH/Physician/Epidemiologist interface Management support