+ All Categories
Home > Documents > Curs 3 CB Metodologia Cercetarii

Curs 3 CB Metodologia Cercetarii

Date post: 07-Jul-2018
Category:
Upload: andreea-cambei
View: 226 times
Download: 0 times
Share this document with a friend

of 32

Transcript
  • 8/19/2019 Curs 3 CB Metodologia Cercetarii

    1/98

      Corin Badiu, 2007

    Metodologia cercetMetodologia cercetăăriirii şştiintiinţţificeifice

    Colectarea datelor 

    Strategii de masurare

  • 8/19/2019 Curs 3 CB Metodologia Cercetarii

    2/98

  • 8/19/2019 Curs 3 CB Metodologia Cercetarii

    3/98

  • 8/19/2019 Curs 3 CB Metodologia Cercetarii

    4/98

    Tipuri de studii clinice

    • Studii fara variabile♦ Studii de caz serii de cazuri editoriale

    opinii ) comentarii rapoarte revie*• Studii cu o singura variabila

    ♦ Studii descriptive

    • Studii cu +, variabile♦ "#perimente♦ Studii observationale♦ Meta-analize si revie*-uri sistematice

  • 8/19/2019 Curs 3 CB Metodologia Cercetarii

    5/98

  • 8/19/2019 Curs 3 CB Metodologia Cercetarii

    6/98

  • 8/19/2019 Curs 3 CB Metodologia Cercetarii

    7/98

    "vidence /ased Medicine

    • Metode de tratament sustinute dedovezi clinice si de cercetare0

    • 1ecesita integrarea celor mai bunedovezi din cercetare pentru diagnosticsi tratament cu e#perienta clinica0

    • Ia in considerare ce este optim pentrufiecare pacient precum si preferinteleacestuia0

  • 8/19/2019 Curs 3 CB Metodologia Cercetarii

    8/98

    'ealitatea

    • Cercetarea asupra eficientei de tratamentface subiectul unui numar mic de articole0

    •  Evidence based medicine este considerat unconcept ce foloseste baze de date inclusivstudii sistematice de caz pentru a g.idainterventii terapeutice0

    • 2ovezile trebuie evaluate intr-un conte#tterapeutic efectiv 3Ce tip de interventiecapata sens pentru mine ca practician45

  • 8/19/2019 Curs 3 CB Metodologia Cercetarii

    9/98

    Clinical 6uestions

    • 7.at is t.e best c.oice of t.erap8

    for m8 patient4• Is t.is program t.eoreticall8 sound4

    • 2oes t.is t.erap8 program *or94

    • :o* long *it. t.e t.erap8 ta9e4

    • 7.ere do I go from .ere4

  • 8/19/2019 Curs 3 CB Metodologia Cercetarii

    10/98

    $racticing Clinicians 1eeded;

    Clinicians

    ♦ are on t.e front line

    ♦ .ave necessar8 clinical e#pertise

    ♦ 9no* t.eir patients *ell

    are naturall8 scientific t.in9ers♦ are *ell-versed in data collection

    ♦ 9no* .o* to loo9 for outcomes

  • 8/19/2019 Curs 3 CB Metodologia Cercetarii

    11/98

    /aseline Measurements

    •  A baseline is a measure of responserates in t.e absence of treatment

    • /aselines

    ♦ "stablis. a need for treatment

    2ocument improvement♦ Allo* us to modif8 if *e don

  • 8/19/2019 Curs 3 CB Metodologia Cercetarii

    12/98

    /aseline 2ata

    • Create a set of e#emplars of eac. of 8our

    targets and prepare a recording s.eet0• =tilize criterion referenced measures0

  • 8/19/2019 Curs 3 CB Metodologia Cercetarii

    13/98

    2ata Collection Strategies

    •  Al*a8s .ave more t.an one measurement

    • C.ec9 t.e reliabilit8 of t.e baseline data• Select researc.)clinical design

  • 8/19/2019 Curs 3 CB Metodologia Cercetarii

    14/98

    'esearc.)Clinical 2esigns

    •  A/A designs♦ Test treat and test

    •  A/A/ designs♦ Test treat test and treat

    • Time-Series designs♦ "stablis. stable baseline♦ /egin treatment♦ Measure treatment results

    • Multiple-/aseline designs♦ :ave a number of different baselines♦ "ac. baseline must be independent of t.e ot.ers♦ Onl8 treat one variable

  • 8/19/2019 Curs 3 CB Metodologia Cercetarii

    15/98

    2ata Collection Instruments

    Requirements 

    • 'eliable

    • (alid

    • 'esponsive• =niversal

    • =nbiased

  • 8/19/2019 Curs 3 CB Metodologia Cercetarii

    16/98

    2ata Collection Instrument

    Is it reliable? 

    7ill t.e instrument measure consistentl8 across!

    • 2ifferent testing situations4Test-retest reliabilit8

    • 2ifferent >udges4

    Inter-rater reliabilit8

  • 8/19/2019 Curs 3 CB Metodologia Cercetarii

    17/98

    2ata Collection Instrument

    Is it valid? 

    • Is t.e instrumentbeing used tomeasure t.e 9ind of

    data for *.ic. it*as intended4

  • 8/19/2019 Curs 3 CB Metodologia Cercetarii

    18/98

    2ata Collection Instrument

    Is it responsive? 

    • T.e instrument s.ould be e?uall8 sensitive *.et.er a

    c.aracteristic is present or absent0Must measure both

    • %alse-negatives!

      @ou t.oug.t it *as intact but it *as torn0

    • %alse-positives!  @ou t.oug.t it *as torn but it *as intact0

  • 8/19/2019 Curs 3 CB Metodologia Cercetarii

    19/98

    2ata Collection Instrument

    Is it universal?   T.e investigator s.ould

    emplo8 a *idel8 used datacollection instrument *.ic..elps minimize reporting biasbecause t.e data can t.en be

    compared *it. ot.er publis.edliterature0

     

  • 8/19/2019 Curs 3 CB Metodologia Cercetarii

    20/98

    2ata Collection Instrument

    • T.ere s.ould be no difference bet*een t.e true valueand t.e value t.at an investigator actuall8 obtains

    ot.er t.an a difference caused b8 sampling variabilit80

    !s it unbiased"

  • 8/19/2019 Curs 3 CB Metodologia Cercetarii

    21/98

    Samplin# Methods 

    • Random Sampling (Simple)

    • Systematic Sampling

    • Stratified Sampling

    4. Cluster Sampling

    5. Convenience Sampling

    6. More complex sampling

  • 8/19/2019 Curs 3 CB Metodologia Cercetarii

    22/98

    $ualitative and $uantitative Variables

    Examples of ualitative varia!les are occupation" sex" marital

    status" and etc

    #aria!les t$at yield o!servations t$at can !e measured are

    considered to !e uantitative varia!les. Examples of

    uantitative varia!les are %eig$t" $eig$t" and age

     

    &uantitative varia!les can furt$er !e classified as discrete orcontinuous

  • 8/19/2019 Curs 3 CB Metodologia Cercetarii

    23/98

    Variables t%pes

    &' Cate#orical variables (e'#' Sex Marital Status

    income cate#or%)

    ' Continuous variables (e'#' A#e income*ei#ht hei#ht time to achieve an outcome)

    +' Discrete variables (e'#',umber o Children in

    a amil%).' /inar% or Dichotomous variables (e'#'

    response to all 0es or ,o t%pe o 1uestions)

  • 8/19/2019 Curs 3 CB Metodologia Cercetarii

    24/98

    Scale o Data

    '. ominal *$ese data do not represent an amount or uantity (e.g."

    Marital Status" Sex)

    +. ,rdinal *$ese data represent an ordered series of relations$ip (e.g."level of education)

    -. nterval *$ese data is measured on an interval scale $aving eual

    units !ut an ar!itrary /ero point. (e.g. *emperature in 0a$ren$eit)

    4. nterval Ratio #aria!le suc$ as %eig$t for %$ic$ %e can compare

    meaningfully one %eig$t versus anot$er (say" '11 2g is t%ice 51 2g)

  • 8/19/2019 Curs 3 CB Metodologia Cercetarii

    25/98

    Variables in the protocol

    • 203ES O4 VA5!A/6E♦ independent

    ♦ dependent

    intermediate♦ conoundin#

  • 8/19/2019 Curs 3 CB Metodologia Cercetarii

    26/98

    !ndependent Variable

    • 2he characteristic bein# observed and7ormeasured that is h%pothesized to inluence an

    event or outcome (dependent variable)'

    • ,O2E

    ♦ The independent variable is not influenced

    by the event or outcome, but may cause it

    or contribute to its variation.

  • 8/19/2019 Curs 3 CB Metodologia Cercetarii

    27/98

    Dependent Variable

    • A variable *hose value is dependent onthe eect o other variables (ie'

    8independent variables9) in therelationship bein# studied' S%non%ms

    outcome or response variable'

    • ,O2E

    ♦ an event or outcome whose variation we

    seek to explain or account for by the

    influence of independent variables. 

  • 8/19/2019 Curs 3 CB Metodologia Cercetarii

    28/98

    !ntermediate Variable

    • A variable that occurs in a causal path*a% roman independent to a dependent variable'

    S%non%ms intervening, mediating  • ,O2ES

    ♦ it produces variation in the dependent

    variable, and is caused to vary by the

    independent variable.

    ♦ such a variable is “associated” with both the

    dependent and independent variables.

  • 8/19/2019 Curs 3 CB Metodologia Cercetarii

    29/98

    Conoundin# Variable

    • A actor (that is itsel a determinant o theoutcome) that distorts the apparent eect o a

    stud% variable on the outcome'

    • ,O2E

    ♦ such a factor may be unequally distributed

    among the exposed and the unexposed, and

    thereby influence the apparent magnitude and

    even the direction of the effect.

  • 8/19/2019 Curs 3 CB Metodologia Cercetarii

    30/98

    Or#anizin# Data 

    '. 0reuency *a!le

    +. 0reuency 3istogram

    -. Relative 0reuency 3istogram4. 0reuency polygon

    5. Relative 0reuency polygon

    6. ar c$art

    . ie c$art7. stem8and8leaf display

    9. ox lot

  • 8/19/2019 Curs 3 CB Metodologia Cercetarii

    31/98

    4re1uenc% 2able 

    Suppose %e are interested in studying t$e num!er of

    c$ildren in t$e families living in a community. *$e

    follo%ing data $as !een collected !ased on a randomsample of n : -1 families from t$e community. 

    +" +" 5" -" 1" '" -" +" -" 4" '" -" 4" 5" " -" +" 4" '" 1" 5" 7" 6"

    5" 4 " +" 4" 4" " 6,rgani/e t$is data in a 0reuency *a!le; 

  • 8/19/2019 Curs 3 CB Metodologia Cercetarii

    32/98

    B1o0 of C.ildren Count

    D%re?0E

    'elative %re?0

    F , ,)GFF0FH

    J G G)GFF0JFF, K K)GFF0JH

    G K K)GFF0JH

    L H H)GFF0,FF

    K L L)GFF0JGGH , ,)GFF0FH

    , ,)GFF0FH

    J J)GFF0FGG

    4re1uenc% 2able 

  • 8/19/2019 Curs 3 CB Metodologia Cercetarii

    33/98

    4re1uenc% plot 

  • 8/19/2019 Curs 3 CB Metodologia Cercetarii

    34/98

    o% suppose %e need to construct a similar freuency ta!le for t$e

    age of patients %it$ 3eart related pro!lems in a clinic.

    *$e follo%ing data $as !een collected !ased on a random sample of

    n : -1 patients %$o %ent to t$e emergency room of t$e clinic for

    3eart related pro!lems.

    *$e measurements are 4+" -7" 5'" 5-" 41" 67" 6+" -6" -+" 45" 5'" 6"

    5-" 59" 4" 6-" 5+" 64" 6'" 4-" 56" 57" 66" 54" 56" 5+" 41" 55" +" 69. 

    4re1uenc% 2able 

  • 8/19/2019 Curs 3 CB Metodologia Cercetarii

    35/98

     Age Nroups %re?uenc8 'elative%re?uenc8

    G, -GH0 , ,)GFF0FHG- LJ0 G G)GFF0JFF

    L,-LH0 L L)GFF0JGL

    L-KJ0 G G)GFF0JFF

    K,-KH0 )GFF0,HK-HJ0 G G)GFF0JFF

    H,-HH0 L L)GFF0JGL

    H-, G G)GFF0JFF

    Total nGF J0FF

    4re1uenc% 2able 

  • 8/19/2019 Curs 3 CB Metodologia Cercetarii

    36/98

    Measures o Central 2endenc%

  • 8/19/2019 Curs 3 CB Metodologia Cercetarii

    37/98

    Empirical 5ule

    0or a ormal distri!ution approximately"

     

    a) 67> of t$e measurements fall %it$in one standard

    deviation around t$e mean

    !) 95> of t$e measurements fall %it$in t%o standard

    deviations around t$e mean

    c) 99.> of t$e measurements fall %it$in t$ree

    standard deviations around t$e mean

  • 8/19/2019 Curs 3 CB Metodologia Cercetarii

    38/98

    $rere?uisite S9ills

    • %undamental concepts of measurement• Scales of measurement

    • 2istribution central tendenc8 variabilit8probabilit8• 2isease prevalence and incidence• 2isease outcomes Deg fatalit8 ratesE

    •  Associations Dcorrelation or covarianceE• :ealt. impact Deg ris9 differences and ratiosE• Sensitivit8 specificit8 predictive values

  • 8/19/2019 Curs 3 CB Metodologia Cercetarii

    39/98

    Scales of Measure

    • ,ominal   ?ualitative classification of e?ualvalue! gender race color cit8

    • Ordinal - ?ualitative classification *.ic. canbe ran9 ordered! socioeconomic status offamilies

    • !nterval  - 1umerical or ?uantitative data! canbe ran9 ordered and sizes compared !temperature

    • 5atio  - interval data *it. absolute zero value!time or space

  • 8/19/2019 Curs 3 CB Metodologia Cercetarii

    40/98

    2istribution Central Tendenc8PMean

  • 8/19/2019 Curs 3 CB Metodologia Cercetarii

    41/98

    P(ariabilit8 $robabilit8P

    • Mean

    • Median

    • Mode

    • Standard deviation

    •Statistical Significance p Q 0FJ

  • 8/19/2019 Curs 3 CB Metodologia Cercetarii

    42/98

    Confidence Interval

  • 8/19/2019 Curs 3 CB Metodologia Cercetarii

    43/98

    Statistical Significance

    T8pe I and T8pe II errors

    :o True :o %alse

    'e>ect :o T8pe I error Correctdecision

    2o 1ot 'e>ect:o

    Correctdecision

    T8pe II error 

    1ull :8pot.esis :o

  • 8/19/2019 Curs 3 CB Metodologia Cercetarii

    44/98

    Statistics Online Te#tboo9

    • T.e Statistics :omepage

    • .ttp!))***0statsoftinc0com)te#tboo9)sta

    t.ome0.tml 

    http://www.statsoftinc.com/textbook/stathome.htmlhttp://www.statsoftinc.com/textbook/stathome.htmlhttp://www.statsoftinc.com/textbook/stathome.htmlhttp://www.statsoftinc.com/textbook/stathome.html

  • 8/19/2019 Curs 3 CB Metodologia Cercetarii

    45/98

    2isease $revalence and

    Incidence• $revalence♦ probabilit8 of disease in entire population at

    an8 point in time♦ ,R of t.e population .as diabetes

    • Incidence

    ♦ probabilit8 t.at patient *it.out diseasedevelops disease during interval

    ♦ F0,R or , per JFFF ne* cases per 8ear 

  • 8/19/2019 Curs 3 CB Metodologia Cercetarii

    46/98

    Sensitivit8 Specificit8

    • sensitivit% a ) DacE

    • speciicit% d ) DbdE

    3atients*ithdisease

    3atients*ithoutdisease

    2est ispositive a b

    2est isne#ative

    c d

  • 8/19/2019 Curs 3 CB Metodologia Cercetarii

    47/98

    $redictive (alue

    • 3ositive predictive value  a ) D abE

    • ,e#ative predictivevalue  d ) DcdE

    • 3ost-test probabilit% odisease #iven positivetest  a ) DabE

    • 3ost-test probabilit% odisease #iven ne#ative

    test  c ) DcdE

    3atients*ithdisease

    3atients*ithoutdisease

    2est ispositive a b2est isne#ative

    c d

  • 8/19/2019 Curs 3 CB Metodologia Cercetarii

    48/98

    Nood 'esource Sen Spc $(

    •  An Introduction to Information Master8

    • .ttp!))***0poems0msu0edu)InfoMaster8)defau

    lt0.tm ♦ 2iagnosis

    • Sensitivit8 and specificit8

    • $redictive values• i9eli.ood ratios

    • Info'etriever♦ Calculators! "pidemiolog8 2iagnostic test

    http://www.poems.msu.edu/InfoMastery/default.htmhttp://www.poems.msu.edu/InfoMastery/default.htmhttp://www.poems.msu.edu/InfoMastery/default.htmhttp://www.poems.msu.edu/InfoMastery/default.htm

  • 8/19/2019 Curs 3 CB Metodologia Cercetarii

    49/98

    /ias in Clinical Trials

    Areas in which bias can occur 

    S8stematic error in 0 0 0

    •  Allocation• 'esponse

    •  Assessment

  • 8/19/2019 Curs 3 CB Metodologia Cercetarii

    50/98

    /ias in Clinical Trials

    Allocation or Susceptibility Bias

    • Can occur *.en patient assignments to a trial

    group are influenced b8 an investigator

  • 8/19/2019 Curs 3 CB Metodologia Cercetarii

    51/98

    /ias in Clinical Trials

    Allocation or Susceptibility Bias

    • Treatment groups must .ave similarprognoses *.ic. is ac.ieved b8!♦ 'andomization of patients

    ♦ $rospective evaluation of patients

    ♦ 7ell-defined inclusion and e#clusion criteria

  • 8/19/2019 Curs 3 CB Metodologia Cercetarii

    52/98

    'andomization in Clinical Trials

      Occurs *.en patientsare assigned totreatments b8 means

    of a mec.anism t.atprevents bot. t.epatients and t.einvestigator from9no*ing *.ic.

    treatment is beingassigned0

  • 8/19/2019 Curs 3 CB Metodologia Cercetarii

    53/98

    /enefits of 'andomization• $revents t.e s8stematic introduction of bias0

    • Minimizes t.e possibilit8 of allocation bias0

    • /alances prognostic factors for treatment groups0

    • Improves t.e validit8 of statistical tests used to

    compare treatments0

  • 8/19/2019 Curs 3 CB Metodologia Cercetarii

    54/98

    /ias in Clinical Trials

    Response & Assessment/Recording Bias  

    • Can occur *.en a patient reports a treatment

    response or *.en an investigator assesses t.atresponseUeit.er person can be influenced b89no*ing t.e treatment0

    •  A patient or an investigator ma8 .ave apreconceived idea of *.ic. treatment is better0T.e patient ma8 also *ant to please t.einvestigator0

  • 8/19/2019 Curs 3 CB Metodologia Cercetarii

    55/98

    /ias in Clinical Trials

    Blinding  

    To minimize 'esponse V Assessment)'ecording /ias

    • Single /lind Dpatient blindedE! protects againstresponse bias0

    •2ouble /lind Dpatient and investigator blindedE!protects against assessment)recording bias as *ellas response bias0

  • 8/19/2019 Curs 3 CB Metodologia Cercetarii

    56/98

    /ias in Clinical Trials

      rans!er bias

    ♦ Occurs *.en patients are lost to follo*-up0

    ♦ Must be minimized0

      "er!ormance bias

    ♦ Can occur *it. a single surgeon or *it.multiple surgeons0

  • 8/19/2019 Curs 3 CB Metodologia Cercetarii

    57/98

    Confounding "#ample

    • 'elations.ip bet*een coffee andpancreatic cancer /=T

    • Smo9ing is a 9no*n ris9 factor forpancreatic cancer 

    • Smo9ing is associated *it. coffee

    drin9ing but it is not a result of coffeedrin9ing0

  • 8/19/2019 Curs 3 CB Metodologia Cercetarii

    58/98

    7.at is confounding4

    • If an association is observed bet*eencoffee drin9ing and pancreatic cancer 

    ♦ Coffee actuall8 causes pancreatic canceror 

    ♦ T.e coffee drin9ing and pancreatic cancerassociation is t.e result of confounding b8cigarette smo9ing0

  • 8/19/2019 Curs 3 CB Metodologia Cercetarii

    59/98

    :o* to .andle confounding

    • If 8ou 9no* somet.ing is a possibleconfounder in t.e data anal8sis use

    ♦ Stratification or ♦ Ad>ustment

    • %ear t.e un9no*n;

  • 8/19/2019 Curs 3 CB Metodologia Cercetarii

    60/98

    Stud8 2esign Ta#onom8

    • Treatment vs0 Observational

    • $rospective vs0 'etrospective

    • ongitudinal vs0 Cross-sectional

    • 'andomized vs0 1on-'andomized

    • /linded)Mas9ed or 1ot♦ Single-blind 2ouble blind =nblinded

  • 8/19/2019 Curs 3 CB Metodologia Cercetarii

    61/98

    'andomization! 2efinition

    • 'andom Allocation♦ 9no*n c.ance receiving a treatment

    ♦ cannot predict t.e treatment to be given

    • "liminate Selection /ias

    • Similar Treatment Nroups

  • 8/19/2019 Curs 3 CB Metodologia Cercetarii

    62/98

    O1" %actor is 2ifferent

    • 'andomization tries to ensure t.at O1"factor is different bet*een t*o or more

    groups0• Observe t.e Conse?uences

    •  Attribute Causalit8

  • 8/19/2019 Curs 3 CB Metodologia Cercetarii

    63/98

    T8pes of 'andomization

    • Standard *a8s!

    ♦ 'andom number tables Dsee te#tE

    ♦ Computer programs• 1OT legitimate

    ♦ /irt. date

    ast digit of t.e medical record number ♦ Odd)even room number 

  • 8/19/2019 Curs 3 CB Metodologia Cercetarii

    64/98

    T8pes of 'andomization

    • Simple

    • /loc9ed 'andomization

    • Stratified 'andomization

  • 8/19/2019 Curs 3 CB Metodologia Cercetarii

    65/98

    Simple 'andomization

    • 'andomize eac. patient to a treatment*it. a 9no*n probabilit8

    ♦ Corresponds to flipping a coin• Could .ave imbalance in W ) group or

    trends in group assignment

    • Could .ave different distributions of atrait li9e gender in t.e t*o arms

  • 8/19/2019 Curs 3 CB Metodologia Cercetarii

    66/98

    /loc9 'andomization

    • Insure t.e W of patients assigned toeac. treatment is not far out of balance

    • (ariable bloc9 size♦ An additional la8er of blindness

    • 2ifferent distributions of a trait li9e

    gender in t.e t*o arms possible

  • 8/19/2019 Curs 3 CB Metodologia Cercetarii

    67/98

    Stratified 'andomization

    •  A priori certain factors li9el8 importantDe0g0 Age NenderE

    • 'andomize so different levels of t.efactor are balanced bet*een treatmentgroups

    • Cannot evaluate t.e stratificationvariable

  • 8/19/2019 Curs 3 CB Metodologia Cercetarii

    68/98

    Stratified 'andomization

    • %or eac. subgroup or strata perform aseparate bloc9 randomization

    • Common strata♦ Clinical center Age Nender 

    • Stratification M=ST be ta9en into

    account in t.e data anal8sis;

  • 8/19/2019 Curs 3 CB Metodologia Cercetarii

    69/98

    Outline

    • Introductor8 Statistical 2efinitions

    • 7.at is 'andomization4

    • 'andomized Stud8 2esign

    • "#perimental vs0 Observational

    • 1on-'andomized Stud8 2esign

    • Stat Soft*are /oo9s Articles

  • 8/19/2019 Curs 3 CB Metodologia Cercetarii

    70/98

    T8pes of 'andomized Studies

    • $arallel Nroup

    • Se?uential Trials

    • Nroup Se?uential trials

    • Cross-over 

    • %actorial 2esigns

  • 8/19/2019 Curs 3 CB Metodologia Cercetarii

    71/98

    $arallel Nroup

    • 'andomize patients to one of 9treatments

    • 'esponse♦ Measure at end of stud8

    ♦ 2elta or R c.ange from baseline

    ♦ 'epeated measures♦ %unction of multiple measures

  • 8/19/2019 Curs 3 CB Metodologia Cercetarii

    72/98

    Ideal Stud8 - Nold Standard

    • 2ouble blind

    • 'andomized

    • $arallel groups

    T*o Scenarios

  • 8/19/2019 Curs 3 CB Metodologia Cercetarii

    73/98

    T*o Scenarios

    • Stud8 J♦  A =0S0 stud8 D,FFFE compared LH patients *it. brain cancer

    to L,, patients *.o did not .ave brain cancer0 T.e patients<cell p.one use *as measured using a ?uestionnaire0 T.e t*ogroups< use of cell p.ones *as similar0

    • Stud8 ,♦  An Australian stud8 DJE conducted a stud8 *it. ,FF

    transgenic mice0 One .undred *ere e#posed for t*o GFminute periods a da8 to t.e same 9ind of micro*aves *it.roug.l8 t.e same po*er as t.e 9ind transmitted from a cellp.one0 T.e ot.er JFF mice *ere not e#posed0 After J

    mont.s t.e brain tumor rate for t.e e#posed mice *as t*iceas .ig. as t.at for t.e une#posed mice0

  • 8/19/2019 Curs 3 CB Metodologia Cercetarii

    74/98

    6uestions to Consider 

    • :o* do t.e t*o studies differ4♦ Stud8 J

    ♦ Stud8 ,

  • 8/19/2019 Curs 3 CB Metodologia Cercetarii

    75/98

  • 8/19/2019 Curs 3 CB Metodologia Cercetarii

    76/98

    6uestions to Consider 

    • Suppose a friend recentl8 diagnosed *it.brain cancer *as a fre?uent cell p.one

    user0 Is t.is strong evidence t.at fre?uentcell p.one use increases t.e li9eli.ood ofgetting brain cancer4♦ Informal observations of t.is t8pe are called

     XXXXXXXXXXXXX XXXXXXXXXXXXX0♦ @ou s.ould rel8 on reputable researc. studies

    not anecdotes0

  • 8/19/2019 Curs 3 CB Metodologia Cercetarii

    77/98

    T*o Main 7a8s to Nat.er 2ata

    • Observational Stud8♦ T.e researc.er observes values of t.e response and

    e#planator8 variables for t.e sampled sub>ects *it.outimposing an8 treatments

    ♦ "#ample!

    • "#periment♦ T.e researc.er assigns e#perimental conditions Dalso

    called treatmentsE to sub>ects Dalso called e#perimentalunitsE and t.en observes outcomes on t.e response

    variable0♦ Treatments correspond to values of t.e e#planator8

    variable♦ "#ample!

  • 8/19/2019 Curs 3 CB Metodologia Cercetarii

    78/98

    T8pes of Observational Studies

    • 'etrospective♦ Observational studies t.at loo9 bac9 in time

    • T.is is sometimes done to find ris9 factors for certain

    diseases

    • Cross-Sectional♦ Observational studies t.at ta9e a cross section of

    t.e population at t.e current time

    • $rospective♦ Observational studies in *.ic. sub>ects are

    follo*ed into t.e future

  • 8/19/2019 Curs 3 CB Metodologia Cercetarii

    79/98

     Advantages of "#periments over

    Observational Studies• In an observational stud8 t.ere can al*a8s be

    lur9ing variables affecting t.e results0

    • T.is means t.at observational studies can

     XXXXXXXXX s.o* causation0

    • It is easier to ad>ust for lur9ing variables in ane#periment0

    • In general *e can stud8 t.e effect of an e#planator8variable on a response variable more accuratel8*it. an e#periment t.an *it. an observational stud80

  • 8/19/2019 Curs 3 CB Metodologia Cercetarii

    80/98

    2isadvantages of "#periments

    • T.e8 can be XXXXXXXXXXXX to perform on t.esub>ects in *.ic. 8ou are interested0

    • It can be difficult to monitor sub>ects to ensure t.att.e8 are doing *.at t.e8 are told0

    • T.e8 can ta9e man8 8ears even decades tocomplete0

    • 'esults of e#periments t.at use animals do not XXXXXXXXXXXXXX to .umans0

    • T.e8 are unnecessar8 t.e ?uestion of interest doesnot involve tr8ing to assess XXXXXXXXXXXXX0

  • 8/19/2019 Curs 3 CB Metodologia Cercetarii

    81/98

    Sampling 2esigns for

    Observational Studies• Simple 'andom Sampling DS'SE

    ♦  A simple random sample of n sub>ects from a population isone in *.ic. eac. possible sample of t.at size .as t.e

     XXXXXXX c.ance of being selected0

  • 8/19/2019 Curs 3 CB Metodologia Cercetarii

    82/98

    Sampling 2esigns for ObservationalStudies

    • Stratified Sampling♦  A stratified random sample divides t.e population into

    separate groups called XXXXXXXX and t.en selects an S'S

    from eac. stratum0

  • 8/19/2019 Curs 3 CB Metodologia Cercetarii

    83/98

    Sampling 2esigns for

    Observational Studies• Cluster Sampling

    ♦  A cluster random sample can be used if t.e target populationnaturall8 divides into groups eac. of *.ic. is representative of t.eentire target population0 In t.is met.od a S'S of groups Dor strataEis ta9en0 "ver8 member of t.e selected groups is put into t.e

    sample0

  • 8/19/2019 Curs 3 CB Metodologia Cercetarii

    84/98

    Sampling 2esigns for

    Observational Studies• S8stematic Sampling♦  A s8stematic sample selects ever8 9t. 

    person from t.e sample frame0 T.eresearc.er randoml8 selects a numberbet*een J and 9 in order to 9no* *.ic.person to select first t.en selects ever8 9t. 

    person after t.is0

    f

  • 8/19/2019 Curs 3 CB Metodologia Cercetarii

    85/98

     Advantages of t.e (arious

    Sampling 2esigns• Simple 'andom Sampling DS'SE

    ♦ It is t.e easiest most *idespread form of sampling0

    ♦ "ac. sub>ect .as an XXXXXXX c.ance to be in t.esample0

    ♦ T.e sample enables us to determine .o* li9el8 it ist.at descriptive statistics Dli9e t.e sample meanEfall close to corresponding values for *.ic. *e*ould li9e to ma9e inference Dli9e t.e populationmeanE0

    Ad f . ( i

  • 8/19/2019 Curs 3 CB Metodologia Cercetarii

    86/98

     Advantages of t.e (arious

    Sampling 2esigns• Stratified Sampling

    ♦ It ensures t.at t.ere are enoug. XXXXXXXXX in

    eac. group t.at 8ou *ant to compare0

    • Cluster Sampling♦ It does not re?uire a sampling frame of sub>ects0

    It is less XXXXXXXXXXX to implement0

  • 8/19/2019 Curs 3 CB Metodologia Cercetarii

    87/98

    /ias in Sampling

    •  A sampling met.od is XXXXXXXXX if ♦ T.e sample tends to favor some parts of t.e

    population over ot.ers0

    ♦ In ot.er *ords t.e results from t.e sample are notrepresentative of t.e population0

    • Obviousl8 XXXXXXXXXX samples are our goal0

  • 8/19/2019 Curs 3 CB Metodologia Cercetarii

    88/98

    " l f $ S l t. t

  • 8/19/2019 Curs 3 CB Metodologia Cercetarii

    89/98

    "#amples of $oor Samples t.at

    'esult in /ias• Convenience Samples

    • (oluntar8 'esponse Samples

  • 8/19/2019 Curs 3 CB Metodologia Cercetarii

    90/98

    "lements of a Nood "#periment

    • Control group♦ Nives us somet.ing to compare against♦ "nables us to control t.e XXXXXXXXXX XXXXXXX 

    • T.e placebo effect occurs *.en patients seem to improve

    regardless of t.e treatment t.e8 receive0• 'andomization

    ♦ "liminates XXXXXX t.at can result *.en researc.ers assigntreatments to t.e sub>ects

    ♦ /alances t.e group on variables t.at 8ou 9no* affect t.e

    response♦ /alances t.e group on XXXXXXXXX variables t.at ma8 beun9no*n to 8ou

  • 8/19/2019 Curs 3 CB Metodologia Cercetarii

    91/98

  • 8/19/2019 Curs 3 CB Metodologia Cercetarii

    92/98

  • 8/19/2019 Curs 3 CB Metodologia Cercetarii

    93/98

    "#ample

    • To investigate *.et.er antidepressants .elp smo9ers to ?uit smo9ingone stud8 used L, men and *omen *.o *ere J or older and .adsmo9ed JK cigarettes or more per da8 in t.e previous 8ear0 T.e8 *ereall .ig.l8 motivated to ?uit and in good .ealt.0 T.e8 *ere assigned toone of t*o groups! one group too9 an antidepressant called Y8ban

    *.ile t.e ot.er group did not ta9e an8t.ing0 At t.e end of a 8ear t.estud8 observed *.et.er eac. sub>ect .ad successfull8 abstained fromsmo9ing0

  • 8/19/2019 Curs 3 CB Metodologia Cercetarii

    94/98

  • 8/19/2019 Curs 3 CB Metodologia Cercetarii

    95/98

    2id @ou Zno*4

    • Observational studies can also .ave control groups0♦ T.ese are called ______-________ studies0♦ T.e cases are people *.o .ave a certain disease or

    condition and t.e controls are people *.o do not .ave t.edisease0

    ♦ T.eir purpose is to see if one of t.e e#planator8 variables isrelated to t.e disease0

    ♦  XXXXXXXXX from t.e beginning of t.ese notes is an e#ampleof a case-control  stud80

  • 8/19/2019 Curs 3 CB Metodologia Cercetarii

    96/98

    Important $oints

    • T8pes of studies!♦ Observational studies and e#periments♦ "#periments control for lur9ing variables

    • Sampling designs!♦

    S'S stratified random samples and cluster samples♦ S'S is t.e preferred met.od• $otential sources of bias!

    ♦ =ndercoverage♦ 'esponse bias♦ 1onresponse bias♦

    Convenience sampling♦ (oluntar8 response sampling

    • "lements of good e#periments!♦ Control group randomization and blinding

  • 8/19/2019 Curs 3 CB Metodologia Cercetarii

    97/98

    Important $oints

    • If a group is underrepresented in t.e sample *e cannotma9e inference about it0

    • 7e must be careful *.en interpreting t.e results ofobservational studies0

    • %or comparison of several treatments to be valid 8ou mustappl8 all treatments to similar groups of e#perimental units0

    • Interesting ?uestions are usuall8 prett8 toug. to ans*er0 T.isis due in part to t.e fact t.at no single e#periment orobservational stud8 can determine causation0

  • 8/19/2019 Curs 3 CB Metodologia Cercetarii

    98/98

    Stop and *$in?;;;Stop and *$in?;;;

    •Write the study!

    •Describe & classify the

    variables.

    •Instruents for easure

    •Bias

    •"re#are to analy$e data!


Recommended