Epidemiology lecture notes.ppt

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    1

    Epidemiology

    By

    Dr.Imtiaz Husain

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    1. Introduction to Epidemiology

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    Definitions

    Health: A state of complete physical, mental and social well !ein" and not merely the a!sence of disease orinfirmity #$H%,1&'()

    Disease: A physiolo"ical or psycholo"ical dysfunction

    Illness: A su!*ecti+e state of not !ein" well

    Sickness: A state of social dysfunction

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    Definitions…

    Public health

    he science - art of P reventing disease, prolonging life,

     promoting health & efficiency throu"h or"anized community effort  #$inslow, 1&2)

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    omponents of the definition

    1.Study: ystematic collection, analysis andinterpretation of data

    pidemiolo"y in+ol+es collection, analysis andinterpretation of health related data

     Epidemiology is a science

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    omponents…

    2. Frequency: the num!er of times an e+ent occurs

    pidemiolo"y studies the num!er of times adisease occurs

    It answers the 4uestion How many5

     Epidemiology is a quantitative science

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    omponents…

    3. Distribution: Distri!ution of an e+ent !y person, place and time

    pidemiolo"y studies distri!ution of diseases

    It answers the 4uestion who, where and when?

     Epidemiology describes health events

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    omponents…

    '. Determinants: 6actors the presence7a!sence ofwhich affect the occurrence and le+el of an e+ent

    pidemiolo"y studies what determines healthe+ents

    It answers the 4uestion how and why5

     Epidemiology analyes health events

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    omponents…

    /. Diseases ! other health related events

    pidemiolo"y is not only the study of diseaseshe focus of pidemiolo"y are not only patients

    It studies all health related conditions

     Epidemiology is a broader science

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    omponents…

     . #pplication

    pidemiolo"ical studies ha+e direct and practicalapplications for pre+ention of diseases - promotion of health

    pidemiolo"y is a science and practice

     Epidemiology is an applied science

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    History of Epidemiology

    Se!en land marks in the history of Epidemiology

    1. Hippocrates #'0B8): n+ironment - human !eha+iors affects health

    $. %ohn &raunt  #1002): 9uantified !irths, deathsand diseases

    '. (ind   #1'): cur+y could !e treated with freshfruit

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    History…

    '. )illiam Farr  #1(3&): sta!lished application of+ital statistics for the e+aluation of health

     pro!lems/. %ohn Snow #1(/'): tested a hypothesis on the

    ori"in of epidemic of cholera

    0. #le*ander (ouis

     #1(2): ystematized applicationof numerical thinin" #4uantitati+e reasonin")

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    History…

    . +rad"ord Hill  #1&3): u""ested criteria foresta!lishin" causation

     Epidemiological thought emerged in - +/ 

     Epidemiology "lourished as a discipline in 10s

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    Scope of Epidemiology

    riginally, pidemiolo"y was concerned within+esti"ation - mana"ement of epidemics  ofcommunica!le diseases

     (ately, pidemiolo"y was e;tended to endemiccommunica!le diseases and noncommunica!le

    infectious diseases

     2ecently, pidemiolo"y can !e applied to all  diseases and other health related e+ents

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    Purpose"use of Epidemiology

    he ultimate purpose of pidemiolo"y is pre+ention of diseases and promotion of health

     How?

    1. lucidation of natural history of diseases

    2.Description of health status of population3. sta!lishin" determinants of diseases

    '. +aluation of inter+ention effecti+eness

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    #ypes of Epidemiology

    3wo ma*or cate"ories of pidemiolo"y 1.Descriptive Epidemiology 

    Defines  "requency  and distribution  of diseasesand other health related e+ents

    Answers the four ma*or 4uestions: how many,who, where, and when?

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    #ypes…

    2. #nalytic Epidemiology

    Analyses determinants of health pro!lems

    Answers two other ma*or 4uestions: how5 andwhy5

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    $asic Epidemiological assumptions

    1.Human diseases doesn=t occur at random or !ychance

    2. Human diseases ha+e causal  and preventive factors

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    $asic features of Epidemiology

    1. tudies are conducted on human population

    2. It e;amines patterns of e+ents in people

    3. 8an esta!lish causeeffect relationship withoutthe nowled"e of !iolo"ical mechanism

    '. It co+ers a wide ran"e of conditions

    /. It is an ad+ancin" science

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    %. ommunicable disease

    Epidemiology

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    Disease causation

    #he cause of a disease

    An e+ent, a condition or a characteristic thatcomes !efore the disease and without which thedisease wouldn=t occur 

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    #heories…

    wentieth century theories

    1.

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    &ecessary 's Sufficient

    &ecessary: the disease will not occur without the presence of the factor 

    ;ample: @yco!acterium B for B

     Sufficient: the presence of the factor always resultin disease;ample: a!ies +irus for ra!ies

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    Etiology of a disease

    he sum of all factors contri!ution to theoccurrence of a disease

    A"ent factors CHost factors Cn+ironmentalfactors tiolo"y of a disease

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    Disease models

    How do diseases de+elop5

    hree !est nown models

    1.Epidemiological triangle

    he interaction of an a"ent and host in an

    appropriate en+ironment results in disease

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    2&

    Disease models…

    2. )eb o" causation

     8omple; interaction of factors results in disease

    3. )heel model 

    he hu! #host) ha+in" a "enetic mae up as its core,

    surrounded !y an en+ironment schematically di+idedin to !iolo"ical, physical and social

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    &atural history…

    2. Stage o" sub4clinical disease

    ?resence of patho"enic chan"es #!iolo"ical onset)

     >o disease manifestations

    3. Stage o" clinical disease

    ?resence of si"n and symptoms #clinical onset)

    '. Stage o" recovery, disability,or death

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    (e!els of disease pre!ention

    hree ma*or le+els of disease pre+ention

    1. 5rimary prevention

    ar"eted at healthy people

    %!*ecti+es are ?romotion of health

      ?re+ention of e;posure and?re+ention of disease

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    (e!els of disease…

    2. Secondary prevention

    ar"eted at sic indi+iduals

    %!*ecti+e is to stop or slow the pro"ression ofdisease and to pre+ent or limit permanent dama"e

    throu"h early detection - treatment

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    3'

    (e!els of disease…

    3. 3ertiary prevention

    ar"eted at people with chronic diseases -disa!ilities that can=t !e cured

    %!*ecti+e is to pre+ent further disa!ility or deathand to limit impacts of disa!ility throu"hreha!ilitation

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    #he agent

    ?ossi!le outcomes of e;posure to an infectious a"ent

    Infection: in+asion - multiplication in the host

     Infectivity: the proportion of e;posed who !ecomesinfected

    Infection rate Infected7e;posedDisease: A clinically apparent infection

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    #he agent…

     Pathogenicity:the proportion of infected whode+elop clinical disease

      Clinical-to-Subclinical ratioirulence: the proportion clinical cases resultin" inse+ere clinical disease

      Case fatality & hospitali!ation rate

     Immunogenecity:the infection=s a!ility to producespecific immunity

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    3(

    )eser!oir 's arrier

     2eservoir 

    An or"anism or ha!itat in which an infectiousa"ent normally li+es, transforms, de+elops and7or

    multiplies

    /arrier 

    A person who doesn=t ha+e apparent clinicaldisease, !ut is a potential source of infection toother people

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    3&

    #ypes of carriers

    1.6ncubatory carriers: transmits the disease durin"incu!ation period

    ;ample: @easles, mumps

    $. /onvalescent carriers: transmits the diseasedurin" con+alescent period

    ;ample: yphoid fe+er 

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    #ypes of carriers…

    3. #symptomatic carriers: transmittin" the diseasewithout showin" manifestations

    ;ample: polio, Amoe!iasis

    '. /hronic /arriers: transmittin" the disease forlon" time7indefinite transmission

    ;ample: Eiral hepatitis, typhoid fe+er 

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    Importance of carriers

    1. 7umber   carriers may outnum!er cases

    $. Di""iculty in recognition carriers don=t now that

    they are infected'. 8obility carriers are mo!ile, cases are restricted

    . /hronicity carriers reintroduce infection andcontri!ute to endemicity

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    *odes of disease transmission

    1.Direct transmission

     Direct contact : physical contact with !ody part ofinfected person: ouchin", issin",!itin",se;

      ;ample: HIE Direct pro9ection: pro*ection of sali+a droplets whilecou"hin", sneezin",spittin",talin",sin"in" etc  ;ample: 8ommon cold

    3ransplacental : ransmission from mother to fetusthrou"h the placenta  ;ample: yphilis

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    ''

    *odes of disease…

    2. Indirect transmission

    :ehicle4borne: transmission throu"h

    inanimate o!*ects7nonli+in" su!stances e."HIE !y needles

     #ir4borne: transmission !y dust or dropletnuclei

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    *odes of disease…

    :ector4borne: infectious a"ent is con+eyed !y anarthropod to host

       +iological : there is multiplication and7orde+elopment in the +ector 

       Salivarian: In*ects infected sali+a e." mos4uito

       Stercorarian: infects !y infected feaces e." louse

       8echanical : simple transfer without !iolo"icalsta"es in the +ector e." flies

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    Importance of mode of transmission

    F A disease often has se+eral modes of transmission F It is important to distin"uish !etween the

     predominant mode of transmission and those ofsecondary importance

    F Identifyin" primary and secondary modes oftransmission is important to identify mosteffecti+e pre+ention and control measures

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    Herd immunity

    It is host resistance at a population le+el

    It is defined as the resistance of a community

    #"roup) to in+asion and spread of an infectiousa"ent, !ased on immunity of hi"h proportions ofindi+iduals in the community.

    It has implications on +accination pro"rams

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    #ime course of an infectious disease

     5re4patent period : !etween !iolo"ical onsetand first sheddin"

     6ncubation period : !etween !iolo"ical onsetand clinical onset

    /ommunicable period : time durin" whicha"ent is !ein" shed

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    #ime course of…

     (atent period : !etween reco+ery and relapse inclinical disease

    /onvalescent period : !etween reco+ery and timewhen sheddin" stops

    &eneration period : !etween e;posure7infection andma;imum communica!ility of e;posed host

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    -actors +hich influence the de!elopment of

    disease

    train of the a"ent

    Dose of the a"ent

    oute of infectionHost a"e, nutritional status, immune status

    Influence of treatment

    Influence of season

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    . *easures of disease

    occurrence

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    /hat are measures of disease occurrence0

    hese are measurements of thefre4uency7ma"nitude7amount

    of disease

    in populations

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    //

    Ho+ do +e measure diseases0

    6our quantitative descriptorsF  >um!ers

    F atiosF ?roportionsF ates

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    Descriptors

     7umbers: Gse of actual num!er of e+ents

      e." 1 cases of B in community A

     2atios: 9uantifies the ma"nitude of one occurrence, in relation to another e+ent J as 7J

      e." atio of B cases in community A to B is1:1

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    /hich community is more affected0

    8ommunity A has 1 cases of disease

     and

    8ommunity B has 1 cases of disease ,

    which community is more affected5

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    /&

    /hen +e call..

    F $hen we call a measure a ratio, we mean a non proportional ratio

    F $hen we call a measure a proportion, we mean a proportional ratio that doesn=t measure an e+ento+ertime

    F $hen we call a rate, we mean a proportional ratiothat does measure an e+ent in a populationo+ertime

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    0

    #ypes of rates

    1. /rude rates: Apply to the total population in a"i+en area

    $. Speci"ic rates: Apply to specific su!"roups inthe population #a"e, se; etc) or specific diseases

    '. Standardied rates: used to permit comparisons of

    rates in population which differ in structure #e."a"e structure)

    wo methods of standardization:Direct, indirect

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    01

    *orbidity rates

      @or!idity rates are rates that are used to 4uantifythe ma"nitude7fre4uency of diseases

      wo common mor!idity rates

    Incidence rates#8umulati+e incidence, incidencedensity)

    ?re+alence #?eriod pre+alence, point pre+alence)

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    02

    Incidence rate

    he proportion of a population that de+elops a

    disease o+ertime

    he ris7pro!a!ility of an indi+idual de+elopin" adisease o+ertime

    he rapidity with which new cases of a diseasede+elop o+ertime

    he proportion of unaffected indi+iduals who ona+era"e will contract the disease o+ertime

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    Practical challenges in measuring incidence

    rate

    1. Identification of population at ris 

      ?opulation at ris constitutes all those free ofthe disease and suscepti!le to it

    2. ?opulation is not static7it fluctuates7as a result of !irths, deaths and mi"ration

    3. ?eople are at ris only until they "et the diseaseand then no more at ris 

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    Practical solution to the challenges

    1. Gse the total population as a denominator 

      his "i+es an estimate of the incidence rate and

    not the actual incidence rate

    2. Gse person4time at ris 

      Incidence densitynum!er of new cases of adisease o+er a specified period7persontime atris 

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    00

    Pre!alence rate

      It measures the proportion of a population with adisease durin" a specified period or at a point intime

     

    wo types

    1. ?oint pre+alence rate

    2. ?eriod pre+alence rate

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    Point pre!alence rate

    @easures the proportion of a population witha disease at a point in time

    ?oint pre+alence rateAll persons with adisease at a point in time7otal population

    It is not a rate, !ut a true proportion

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    Period pre!alence rate

    @easures the proportion of a population witha disease in a specified time period

    ?eriod pre+alence rateAll persons with adisease o+ertime period7A+era"e#mid

    year)population in the same period

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    Incidence 's pre!alence

    Incidence rate considers only new cases of a disease

    ?re+alence rate considers all #new C old) cases of a disease

    Incidence rate considers population at ris as a denominator 

    ?re+alence rate considers total population as a denominator 

    Incidence - period pre+alence rates re4uire follow up studies

    ?oint pre+alence rate re4uires cross sectional study

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    )elationship bet+een pre!alence

    incidence rates

    ?re+alence L incidence

    ?re+alence L A+era"e duration

    ?re+alence L Incidence A+era"e duration

    An increase in pre+alence rate may not necessarily !e due to an increase in incidence rate, it coulddue to an increase in a+era"e duration of a diseasedue to decrease in death and7or reco+ery rates

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    1

    *ortality rates

      hese rates measures ma"nitude of deaths in acommunity

    ome are crude lie the crude death rate

      %thers are causespecific mortality rate

      ome others are ad*usted lie standardizedmortality ration

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    ommon *ortality rates

    F 8rude death rateF A"especific mortality rateF e;specific mortality rateF 8ausespecific mortality rateF ?roportionate mortality ratioF 8ase fatality rate

    F 6etal death rate

    F ?erinatal mortality rateF  >eonatal mortality rateF Infant mortality rateF 8hild mortality rateF Gnderfi+e mortality

    rate

    F @aternal mortality ratio

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    2. *easures of association

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    %3% table

    Disease

    Jes #C) >o #C) otal

    ;posure Jes #C) a ! aC!

     >o #C) c d cCd

    otal aCc !Cd aC!CcCd

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    ells

    A ;posed, and diseased

    B ;posed, >ot diseased8 >ot e;posed, diseased

    D >ot e;posed, >ot diseased

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    0

    #otals

    @ar"inal totals

      aC! ;posed

      cCd >one;posed  aCc Diseased

      !Cd >ondiseased

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    hi4s5uare statistics

      8his4uare tests whether there is an association !etween two cate"orical +aria!les

    Ho: here is no association !etween row - column+aria!les

    Ha: here is an association !etween row and column+aria!les

    8his4uare statistic has a de"ree of freedom #r1)#c1),where r is num!er of rows - c num!er of columns

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    hi4S5uare…  M 2 N #% )2

      %: %!ser+ed cells: ;pected cells

    ;pected +alue #ow total)#8olumn total) 

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    Importance of hi4s5uare

     

    If the calculated chis4uare +alue is "reater than

    the critical or ?O./ we say that there isassociation

      8his4uare statistics tells only whether there is

    association. It doesn=t tell us how much stron" anassociation is.

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    )elati!e risk 6))7

      ;presses ris of de+elopin" a diseases in e;posed"roup #a C !) as compared to none;posed "roup #c C d)

      Incidence #ris) amon" e;posed  Incidence #ris) amon" none;posed

      a7#aC!)  c7#cCd)

     

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    (1

    Interpretation of relati!e risk 

    $hat does a of 2 mean5

    is in e;posed is in none;posed

    of 2 means

    is in e;posed2 is in none;posed

      hus a relati+e ris of 2 means the e;posed "roup is twotimes at a hi"her ris when compared to none;posed

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    (2

    Strength of association

    In "eneral stren"th of association can !econsidered as:

    Hi"h if P3

    @oderate if is !etween 1./ - 2.&

    $ea if is !etween 1.2 - 1.'

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    (3

    8dds ratio 68)7

      %dds ratio is the ratio of odds of e;posure amon"diseased to odds of e;posure amon" nondiseased

      %dds of an e+ent is the ratio of pro!a!ility of thee+ent to its complement

      %dds?#)7?#=)?#)7#1?#))

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    8dds ratio…%dds of e;posure amon" e;poseda7c%dds of e;posure amon" nondiseased!7d

    % %dds of e;posure amon" diseased

      %dds of e;posure amon" nondiseased

    % #a7c)7#!7d)

    % ad7!c #it is also called crossproduct ratio)

    Interpretation of % is the same as that of  

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    (/

    8dds ratio…

      can !e !est estimated !y % if the followin"conditions are fulfilled

    1. 8ontrols are representati+e of "eneral population2. elected cases are representati+e of all cases

    3. he disease is rare

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    (0

    ,ttributable )isk 6,)7

      A indicates how much of the ris is due to7attri!uta!le7 to the e;posure

      9uantifies the e;cess ris in the e;posed that can !eattri!uta!le to the e;posure !y remo+in" the ris of thedisease occurred due to other causes

      A is #incidence) in e;posed is #incidence) in none;posed

      A Qa7#aC!)R 7 Qc7#cCd)))R  Attri!uta!le ris is also called ris difference

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    Interpreting ,) 

      $hat does attri!uta!le ris of 1 mean5

      1 of the e;posed cases are attri!uta!le to thee;posure

    By remo+in" the e;posure one can pre+ent 1cases from "ettin" the disease

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    ((

    ,ttributable risk percent 6,)97

      stimates the proportion of disease amon" thee;posed that is attri!uta!le to the e;posure

     

    he proportion of the disease in the e;posed that can !e eliminated !y eliminatin" the e;posure

    AK #is in e;posed is in none;posed)1K  is in none;posed

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    (&

    Interpretation of ,)9

    $hat does AK of 1K mean5

    1K of the disease can !e attri!uted to the e;posure

    1K of the disease can !e eliminated if we a+oid thee;posure

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    &

    Population ,ttributable )isk 6P,)7

      stimates the rate of disease in total populationthat is attri!uta!le to the e;posure

      ?A is in population is in une;posed

      ?A A pre+alence rate of e;posure

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    Population attributable risk percent 6P,) 

    97

      stimates the proportion of disease in the study population that is attri!uta!le to e;posure and thuscould !e eliminated if the e;posure were eliminated

    ?AK is in population is in une;posed

      is in population

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    &2

    Possible outcomes in studying the

    relationship bet+een eposure disease

    1. >o association  1  A2. ?ositi+e association  P1  AP

    3. >e"ati+e association  O1 #fraction)  AO #>e"ati+e)

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    )isk 's Pre!enti!e factors

      A ris; "actor  is any factor positi+ely associated witha disease #P1)

      It is associated with an increased occurrence of a

    disease  A preventive "actor  is any factor ne"ati+ely

    associated with a disease #O1)  It is associated with a decreased occurrence of a

    diseaseis and pre+enti+e factors may

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    ,ssociation 's ausation

      he e;istence of an association doesn=t itselfconstitute a proof of causation

      An o!ser+ed association could !e a fact or anartifact

      Hence, an association is a necessary !ut not asufficient condition for causation

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    &0

    Possible eplanations for obser!ed

    association

    1. 8hance

    2. Bias

    3. 8onfoundin"'. e+erse causation

    /. eciprocal causation

    0. 8auseeffect relationship

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    &

    ,ccuracy of measurement

      Accuracy Ealidity C ?recision

      Ealidity is the e;tent to which a measured+alue actually reflects truth

      here are two types of +alidity  Internal +alidity  ;ternal +alidity

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    #ypes of !alidity

    Internal !alidity:

    Is the de"ree to which a measured +alue is true withinthe sample

    Eternal !alidity:

    Is the e;tent to which a measured +alue apply !eyond

    the sample

      his is related to "eneraliza!ility

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    )ole of chance

      he role of chance as an alternati+e e;planationfor an association emer"es from samplin"+aria!ility

      +aluation of the role of chance is mainly thedomain of statistics and in+ol+es

    1. est of statistical si"nificance

    2. stimation of confidence inter+al

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    1. #est of statistical significance

    ?+alue 4uantifies the de"ree to which chanceaccounts for o!ser+ed association

    ?+alue is the pro!a!ility of o!tainin" a result atleast as e;treme as the o!ser+ed !y chance alone

    ?O./ indicates statistical si"nificance for medicalresearch

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    #est of statistical…

    A +ery small difference may !e si"nificant if youha+e lar"e sample

    A lar"e difference may not achie+e statisticalsi"nificance is you ha+e small sample

    %ne can=t mae a definite decision !ased on p+alueonly

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    )ole of bias

      Bias is any systematic error in the desi"n, conduct oranalysis of an epidemiolo"ic study that results in anincorrect estimate of association !etween e;posureand disease

      Gnlie chance !ias can=t !e statistically e+aluated

      here are two ma*or types of !ias

    1. election !ias2. Information !ias

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    Selection bias

      Any systematic error that arises in the process ofidentifyin" the study population

      It affects the representati+eness of the study

      It occurs when there is a difference !etween sampleand population with respect to a +aria!le

     

    ;amples of selection !ias:1. Dia"nostic !ias2. Eolunteer !ias

    3. >onresponse !ias

    '. oss to followup !ias

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    1(

    /ays to minimi=e bias

    1. 8hoose study desi"n carefully

    2. 8hoose o!*ecti+e rather than su!*ecti+e

    outcomes3. Blind inter+iewers whene+er possi!le

    '. Gse close ended 4uestions whene+er possi!le

    /. 8ollect data on +aria!les you don=t e;pect todiffer !etween two "roups

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    )ole of confounding8onfoundin" refers to the mi;in" of the effect of ane;traneous +aria!le with the effect of the e;posureand disease of interest

      8haracteristics of a confoundin" +aria!le1. Associated with disease in a!sence of e;posure2. Associated with e;posure !ut not as a conse4uence of e;posure

    3. he fre4uency of the confoundin" +aria!le +ary !etween the"roups that are compared

    ;ample: In association !etween smoin" and lun" cancer alcoholdrinin" suspected as a confoundin"

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    Effect of confounding

    otally or partially account for the apparent effect

    @as an underlyin" true association

    e+erse the actual direction of association

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    ontrol of confounding !ariables

    Durin" desi"nin" sta"e:  andomization  estriction

      @atchin"

    Durin" analysis sta"e  tandardization  tratification7poolin"  @ulti+ariate analysis

    riteria to asses the strength of e!idence

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    riteria to asses the strength of e!idence

    for cause and effect relationship

      %!ser+ational studies ha+e many !iases andconfoundin". ;perimental studies if properlydone can show causeeffect relationship. But they

    are not usually feasi!le due to ethical issues

      In the a!sence of an e;perimental trail, thefollowin" criteria #Bradford Hill criteria) are usedto asses the stren"th of e+idence for a cause andeffect relationship

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    riteria to asses the strength…

    1.  Strength o" association: he stron"er theassociation the more liely it is causal

    2. /onsistency o" association: he more consistent,the more liely it is causal

      3.  Speci"icity o" association: If sin"le e;posure

    lined to sin"le disease more liely

    '. 3emporal relationship: he e;posure must come !efore the disease

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    >. Epidemiologic Study Designs

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    Study design

      tudy desi"n is the arran"ement of conditions for

    the collection and analysis of data to pro+ide themost accurate answer to a 4uestion in the mosteconomical way.

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    #ypes of Epidemiologic study designs

    I. Based on o!*ecti+e7focus7research 4uestion

    1. Descripti+e studies   Descri!e: who, when, where - how many

    2. Analytic studies   Analyse: How and why

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    #ypes…

    II. Based on the role of the in+esti"ator 

    1. %!ser+ational studies   he in+esti"ator o!ser+es nature    >o inter+ention

    2. Inter+ention7;perimental studies   In+esti"ator inter+enes   He has a control o+er the situation

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    #ypes…

    III. Based on timin"

    1. %netime #onespot) studies   8onducted at a point in time   An indi+idual is o!ser+ed at once

    2. on"itudinal #6ollowup) studies   8onducted in a period of time   Indi+iduals are followed o+er a period of time

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    #ypes…

    IE. Based on direction of followup7data collection 1. ?rospecti+e

       8onducted forward in time

    2. etrospecti+e

       8onducted !acward in time

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    #ypes…

    EI. Based on study settin"

    1. 8ommunity!ased studies   8onducted in communities

    2. Institution!ased studies   8onducted in communities

    3. a!oratory!ased studies   8onducted in ma*or la!oratories

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    #ypes…

    EII. tandard classification

    1. 8rosssectional studies2. 8asecontrol studies

    3. 8ohort studies

    '. ;perimental studies

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    ross4sectional studies  In this study desi"n information a!out the status of an

    indi+idual with respect to presence7a!sence ofe;posure and diseased is assessed at a point in time.

      8rosssectional studies are useful to "enerate ahypothesis rather that to test it

    6or factors that remain unaltered o+ertime #e.". se;,race, !lood "roup) it can produce a +alid association

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    ross4sectional…

    Ad+anta"es of crosssectional studies

    F ess time consumin"F ess e;pensi+eF ?ro+ides more informationF Descri!es wellF

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    ross4sectional…

    imitations of crosssectional studies

    F Antecedentconse4uence uncertainty  U8hicen or e"" dilemmaVF Data dred"in" leadin" to inappropriate

    comparison

    F @ore +ulnera!le to !ias

    i l

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    ross4sectional…

    ypes of crosssectional studies

    1. in"le crosssectional studies   Determine sin"le proportion7mean in a sin"le population at

    a sin"le point in time2. 8omparati+e crosssectional studies

       Determine two proportions7means in two populations at asin"le point in time

    3. imeseries crosssectional studies   Determine a sin"le proportion7mean in a sin"le population

    at multiple points in time

    ti l

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    ross4sectional…

    In "eneral, crosssectional studies are   implest to conduct

       8ommonest to find   east useful to esta!lish causation

    t l t di

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    ase4control studies

    F u!*ects are selected with respect to the presence#cases) or a!sence #controls) of disease, and thenin4uiries are made a!out past e;posure

    F $e compare diseased #cases) and nondiseased#controls) to find out the le+el of e;posure

    F ;posure status is traced !acward in time

    t l

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    ase4control…

    teps in conductin" casecontrol studiesI. Define who is a case

       sta!lish strict dia"nostic criteria

       All who fulfil the criteria will !e Ucase population   hose who don=t fulfil will !e Ucontrol populationV

    II. elect a sample of cases from case population

       his sample must !e representati+e of the case population

    t l

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    ase4control…

    ources of cases

    1. Hospitals #Health institution)   8ostless   Biasmore

    2. ?opulation #8ommunity)

       8ostmore   Biasless

    t l

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    ase4control…

    III. elect controls from a control population   hould !e representati+e of control population   hould !e similar to cases e;cept outcome   hould !e selected !y the same method as cases

    ources of controls1. Hospital #Health institution) controls

       eadily a+aila!le

       ow recall !ias   @ore cooperati+e

    t l

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    ase4control…

    Howe+er, hospital controls are  ess representati+e  @ore confoundin"

    2. ?opulation #community) controls  @ore representati+e  ess confoundin"

      8ostly and time consumin"  @ore recall !ias  ess cooperati+e

    t l

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    ase4control…

    IE. @easure the le+el of e;posure in cases - controls   e+iew or inter+iew for e;posure status   Gse same method for case and controls

    E. 8ompare the e;posure !etween cases - controls   ?repare 22 ta!le

       8alculate %    ?erform statistical tests

    ase control

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    ase4control…

    ypes of casecontrol studies

    I. Based on case identification

    1. etrospecti+e casecontrol   Gses pre+alent cases   Increased sample size   Difficult to esta!lish temporal se4uence   Gseful for rare outcomes

    ase control

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    ase4control…

    2. ?rospecti+e casecontrol   Gses incident cases   sta!lish temporal se4uence

       ecall is not a serious pro!lem   ecords are easily o!taina!le

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    ase control

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    ase4control…

    Ad+anta"es of casecontrol studies

    F%ptimal for e+aluation of rare diseasesF ;amines multiple factors of a sin"le disease

    F 9uic and ine;pensi+eF elati+ely simple to carry outF

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    ase4control…

    imitations of casecontrol studies

    FInefficient for e+aluation of rare e;posureF 8an=t directly compute ris 

    F Difficult to esta!lish temporal se4uenceF Determinin" e;posure will often rely on memory

    ohort studies

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    ohort studies

    F u!*ects are selected !y e;posure and followed tosee de+elopment of disease

    F wo types of cohort studies

    1. ?rospecti+e #classical)

       %utcome hasn=t occurred at the !e"innin" of the study   It is the commonest and more relia!le

    ohort

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    ohort…

    2. etrospecti+e #Historical)

    F Both e;posure and disease has occurred !efore the !e"innin" of the study

    F 6aster and more economicalF Data usually incomplete and in accurate

    ohort

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    ohort…

    teps in conductin" cohort studies

    1. Define e;posure2. elect e;posed "roup3. elect none;posed "roup'. 6ollow and collect data on outcome

    /. 8ompare outcome !7n e;posed - none;posed

    ohort

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    ohort…

    Ad+anta"es of cohort studies

    F Ealua!le when e;posure is rareF ;amines multiple effects of a sin"le e;posuresF emporal relationship is nownF Allow direct measurement of ris F @inimize !ias in ascertainment of e;osure

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    Eperimental studies

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    Eperimental studies

    F Indi+iduals are allocated in to treatment andcontrol "roups !y the in+esti"ator 

     F If properly done, e;perimental studies can produce

    hi"h 4uality data

    F hey are the "old standard study desi"n

    Eperimental

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    Eperimental…

    ;perimental studies can !e1. herapeutic trials

       8onducted on patients

       o determine the effect of treatment on disease

    2. ?re+enti+e trials   8onducted on healthy people   o determine the effect of pre+ention on ris

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    Eperimental

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    Eperimental…

    III. Based on o!*ecti+e   ?hase I: to determine to;ic effect   ?hase II: to determine to;ic effect

       ?hase III: to determine applica!ility

    8hallen"es in inter+ention studies

    F thical issues   Harmful treatment shouldn=t !e "i+en   Gseful treatment shouldn=t !e denied

    Eperimental

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    Eperimental…

    F 6easi!ility issues  

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    Eperimental…

    F he 4uality of U

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    Eperimental…

    )andomi=ation: random allocation of study su!*ectsin to treatment - control "roups

      Ad+anta"e: A+oids !ias - confoundin"  Increases confidence on results

    $linding: Denyin" information on treatment7controlstatus

    Eperimental…

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    Eperimental…

      Single blinding: study su!*ects don=t now towhich "roup they !elon"

      Double blinding: 8are "i+ers also don=t now to

    which "roup study su!*ects !elon"  #riple blinding: data collectors also don=t now

    allocation status

    Ad+anta"e: A+oids o!ser+ation !ias

    Eperimental…

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    Eperimental…

    Placebo: an inert material indistin"uisha!le fromacti+e treatment

    Placebo effect: tendency to report fa+oura!leresponse re"ardless of physiolo"ical efficacy

    ?lace!o is used as !lindin" procedure

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    ?. Screening

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    ,ims of screening program

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    ,ims of screening program

    F 8han"in" disease pro"ression efficientlyF Alterin" natural course of disease

    F ?rotectin" society from conta"ious diseaseF Allocatin" resources rationallyF election of healthy people for *o!

    F tudyin" the natural history of disease

    riteria for selecting diseases for screening

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    e o se ec g d se ses o sc ee g

    e+erity he disease should !e serious

    reatment arly treatment should !e more !eneficial

    ?re+alence ?reclinical ?re+alence should !e hi"h

    riteria for establishing screening program

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    g g p g

    he problem should ha+e pu!lic health importance

    here should !e accepted treatment  for positi+es

    Dia"nostic - treatment "acilities should !e a+aila!le

    eco"nized latent stage in the time course

    3est  is accepta!le, relia!le - +alid

     7atural history of the disease well understood

    /ase4"inding  is economical and continuous

    Screening tests

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    g

      he performance of a screenin" test is e+aluateda"ainst a dia"nostic test in 22 ta!le

    Diagnostic test

    DC D

    Screening test C a ! aC!

    c d cCdaCc !Cd n

    Definitions of cells

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    rue positi+es #a): Diseased identified !y test as diseased

    6alse positi+es #!): Disease free falsely la!elled as disease

    6alse ne"ati+es #c): Diseased falsely la!elled as disease free

    rue ne"ati+es #d): Disease free identified as free

    Definition of totals

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    DC #aCc): total su!*ects with a disease

    D

    #!Cd): total su!*ects without diseaseC #aC!): total test positi+es

    #cCd): total test ne"at+es

    #est performance

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    p

    'alidity of a test

      he a!ility of a test to differentiate correctly thosewho ha+e the disease and those who don=t

    F It is a function of sensiti+ity and specificity

    #est performance

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    p

     #. Sensitivity o" a test 

    F he a!ility of a test to correctly identify thosewho ha+e the disease

    F he pro!a!ility that a diseased indi+idual willha+e a positi+e test result

    F he proportion of people with a disease who

    ha+e a positi+e test resultF rue positi+e rate #?)

    #est performance

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    p

      ensiti+ity #?) ?#CWDC)

      ?7#? C 6> )

      @ a"6aAc)

      6alse ne"ati+e rate #6>)?# WDC)

      c"6aAc7

      Sensitivity" #- $%

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    #est performance

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    p

      pecificity #>) ?#WD)

      >7#> C 6? )

      @ d"6dAb)

      6alse positi+e rate #6?)?#C WD)

      b"6bAd7

      Specificity" #- $P

    #est performance

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    Predicti!e !alue of a test 

    he a!ility of a test to predict the presence ora!sence of disease

      wo type: ?ositi+e - ne"ati+e predicti+e +alues

    #est performance

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     #. 5redictive value positive

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     #. 5redictive value negative ?#D W )  d"6cAd7

    #est performance

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    Pre!alence of a diseasehe proportion of indi+iduals with a disease?rior7pretest pro!a!ility of a disease  ?re+alence ? #DC)  #aCc)7n

    Bield of a test

    ?roportion of cases detected !y the screenin" pro"ram  Jield a7n

    *ultiple testing

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    Parallel testing:  ests are "i+en concurrently  At least one positi+e indicates disease  esults in

    F

    F Decreased specificity

    *ultiple testing

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    Serial testing:  ests are administered se4uentially  All positi+e indicates disease  esults in

    F ower sensiti+ityF Increased specificity

    F Increased ?E?

    )eliability of a test

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    F A!ility of a test to "i+e consistent results up onrepeated measurements

     

    F wo ma*or factors affect relia!ility  @ethod +ariation  %!ser+er +ariation

      Intero!ser+er +ariation  Intrao!ser+er +ariation

    )eliability of a test

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    elia!ility can !e classified as:

      Internal relia!ilityF Internal consistency relia!ility

      ;ternal relia!ilityF Alternate test relia!ility

    F estretest relia!ility

    E!aluation of a screening program

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    10

      +aluation of a screenin" pro"ram in+ol+esconsideration of two issues

    1. -easibility: Determined !y accepta!ility of thescreenin" pro"ram

    2. Effecti!eness: Determined !y the outcome of thescreenin" pro"ram

    In general

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    1

    In "eneral, a screenin" test should !e

      elia!le - +alid  ensiti+e - specific  imple - accepta!le  ffecti+e - efficient

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    #hank you