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Osman Sianipar Clinical Epidemiology & Biostatistics Unit Department of Clinical Pathology School of Medicine University of Gadjah Mada/Dr Sardjito Hospital 20/03/2015 1 Role of Diagnostic test
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Role of Diagnostic Test-Osman Sianipar-CE and BU-Clinical Pathology (2015)

Oct 01, 2015

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Role of Diagnostic Test-Osman Sianipar-CE and BU-Clinical Pathology (2015)
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  • Osman SianiparClinical Epidemiology & Biostatistics Unit

    Department of Clinical PathologySchool of Medicine University of Gadjah Mada/Dr Sardjito Hospital

    20/03/2015 1Role of Diagnostic test

  • A 60-year old man came to the mergency department complaining of cough and fever lasting several weeks. He reported night sweats and wight loss over the last few months. He admitted to drinking alcohol heavily on weekends and to staying in a homeless shelter. The patient had a fever and appeared very thin. He coughed frequently during examination.

    Question: What is differential diagnosis? What other examination should be requested?

    20/03/2015Role of Diagnostic test 2

  • Anamnesis

    Physical examination

    Additional tests

    Treatment

    Radiology

    Lab Medicine

    Electro medics

    Other tests

    20/03/2015 3Role of Diagnostic test

  • To rule in

    To rule out

    To screen

    Diagnosis

    To monitore the treatment

    20/03/2015 4Role of Diagnostic test

  • precise but

    not accurate

    Accurate but

    not preciseAccurate and precise

    20/03/2015 5Role of Diagnostic test

  • Accurate Not accurate

    Precise

    Not precise

    20/03/2015 6Role of Diagnostic test

  • 20/03/2015Role of Diagnostic test 7

    Interval

    Ratio

    Ordinal

    Nominal

  • Accuracy Precision

    Sensitivity

    Specificity

    Positive predictive value

    Negative predictive value

    Likelihood ratio

    Unweightedkappa index

    20/03/2015Role of Diagnostic test 8

  • 20/03/2015Role of Diagnostic test 9

    + -

    +

    Disease

    T

    e

    s

    t

    True

    positive

    False

    positive

    False

    negative

    True

    negative-

  • 20/03/2015Role of Diagnostic test 10

    Sensitivity = a / (a+c)

    Specificity = d / (b+d)

    Accuracy = (a+d) / N

    + PV = a / (a+b)

    - PV = d/ (c+d)

    Prevalence = (a+c) / N

    + -

    +

    Gold Standard

    Test

    result

    a b

    c d-

    a+b

    c+d

    a+c b+d N

  • 20/03/2015Role of Diagnostic test 11

    Sensitivity: proportion of test positive result

    among diseased group

    Specificity: proportion of test negative result

    among non diseased group

    Positive PV: probability of having a disease of

    a patient who has positive test result

    Negative PV: probability of having no disease

    of a patient who has negative test result

  • 20/03/2015Role of Diagnostic test 12

    Likelihood ratio positive: ratio of

    positive test result in diseased group

    as compared to non diseased group

    Likelihood ratio negative: ratio of

    negative test result in diseased group

    as compared to non diseased group

  • 20/03/2015Role of Diagnostic test 13

    a/a+c

    LR (+) = --------

    b/b+d

    c/a+c

    LR (-) = --------

    d/b+d

    + -

    +

    Gold Standard

    Test

    result

    a b

    c d-

    a+b

    c+d

    a+c b+d N

  • Fracture No Fracture

    Swelling 32 40

    No Swelling 8 120

    Total 40 160

    20/03/2015Role of Diagnostic test 14

    Sensitivity?Specificity?Positive predictive value?Negative Predictive value?

    Likelihood ratio of test positive?Likelihood ratio of test negative?

  • 20/03/2015Role of Diagnostic test 15

    PrevalenvceSensitiivitySpecificity

    PredictiveValue

    Post-test Probability

    Likelihood ratio

    Pre-test Probability

  • 20/03/2015 16Role of Diagnostic test

  • 20/03/2015 17Role of Diagnostic test

  • 20/03/2015 18Role of Diagnostic test

  • 20/03/2015Role of Diagnostic test 19

    To determine cutoff point

    To compare tests

    For Interval/ratio scale

  • Blood glucose level2 hrs after eating

    (mg/dL)

    Sensitivity (%) Specificity (%)

    70 98.6 8.8

    80 97.1 25.5

    90 94.3 47.6

    100 88.6 69.8

    110 85.7 84.1

    120 71.4 92.5

    130 64.3 96.9

    140 57.1 99.4

    20/03/2015Role of Diagnostic test 20

  • Blood glucose level2 hrs after eating

    (mg/dL)Sensitivity (%) Specificity (%)

    150 50.0 99.6

    160 47.1 99.8

    170 42.9 100.0

    180 38.6 100.0

    190 34.3 100.0

    200 27.1 100.0

    20/03/2015Role of Diagnostic test 21

  • 20/03/2015Role of Diagnostic test 22

  • 20/03/2015Role of Diagnostic test 23

  • 20/03/2015Role of Diagnostic test 24

  • 20/03/2015Role of Diagnostic test 25

    To rule in diagnosis

    To rule out diagnosis

    To screen people

  • 20/03/2015Role of Diagnostic test 26

    Sensitivity Specificity

    Fletcher et al., 1996

  • 20/03/2015Role of Diagnostic test 27

    Sensitivity

    Specificity

    Fletcher et al., 1996

  • 20/03/2015Role of Diagnostic test 28

  • In nominal scale, measured by un-weighted Kappa index

    In ordinal scale, measured by weighted Kappa index

    In interval/ratio scale, measured by coefficient of variation (CV)

    Due to presence of either intra or inter observer variation.

    In clinical setting known as clinical disagreement

    It reflect of reproducibility

    20/03/2015Role of Diagnostic test 29

  • 20/03/2015Role of Diagnostic test 30

    CV=SD

    MeanX 100%

  • Gallop heard by1st observer

    No Gallop heardby 1st observer

    Total

    Gallop heard by2nd observer

    10 5 15

    No Gallop heardby 2nd

    observer

    10 75 85

    Total 20 80 100

    20/03/2015Role of Diagnostic test 31

    PO = (10 + 75) : 100 X 100% = 85%

  • Gallop heard by1st observer

    No Gallop heard1st observer

    Total

    Gallop heard by2nd observer

    10 (3) 5 15

    No Gallop heardby 2nd

    observer

    10 75(68) 85

    Total 20 80 100

    20/03/2015Role of Diagnostic test 32

    PC = (3 + 68) : 100 X 100% = 71%

  • 20/03/2015Role of Diagnostic test 33

    K =100% - PC

    PO - PC

    100% - 71%

    85% - 71%K =

    K = 0.48

  • K = Po-Pc: 1-Pc

    Po = Proportion of observed agreement

    Pc = Proportion of Chance-expected

    agreement

    -1 < K < + 1

    Po = 1, K = 1, complete agreement

    Po > Pc, K > 0, Better than chance agreement

    Po = Pc, K = 0, Equel to chance agrement

    Po < Pc, K < 0, Poorer than chance agreement

    20/03/2015Role of Diagnostic test 34

  • 20/03/2015Role of Diagnostic test 35

    Examiner

    The Examined

    Examination

  • 20/03/2015Role of Diagnostic test 36

    Biologic variation in the sense

    The tendency to record inference rather than evidence

    Ensnarement by diagnostic classification schemes

    Entrapment by prior expectation

    Simple incompetency

  • 20/03/2015Role of Diagnostic test 37

    Biologic variation in the system being examined

    Effects of illness and medication

    Memory and rumination chance agreement

    Toss-ups

  • 20/03/2015Role of Diagnostic test 38

    Disruptive environments for the

    examination

    Disruptive interacting between examiners

    and examined

    Incorrect function or use of diagnostic tools

  • 29%

    71%

    Role of Diagnostic test 3920/03/2015

    Inappropriate prescription

    Galula et al., 2006, Gastroenterol Clin Biol; 30: 517-524

  • 49%

    45%

    5% 1%

    Imprecise

    Exessive

    Erroneous

    Insufficient

    Role of Diagnostic test 4020/03/2015

    Galula et al., 2006, Gastroenterol Clin Biol; 30: 517-524

  • 20/03/2015Role of Diagnostic test 41

    Fletcher RH., Fletcher SW danWagner EH., 1996, Clinical Epidemiology The Essentials, 3rd

    ed., William & Wilkins, Baltimore

  • 20/03/2015Role of Diagnostic test 42