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Department of Dermato Venereology Dr Soetomo Hospital –

Faculty of Medicine, Airlangga University, Surabaya

Tropical Disease Center, Airlangga University, Surabaya

What is diagnosis ?

• Increase certainty about

presence/absence of

disease

• Disease severity

• Monitor clinical course

• Assess prognosis –

risk/stage within diagnosis

• Plan treatment

• Screening

• Epidemiology

Knottnerus, BMJ 2002

By the end of this session,

you should be able to….

diagnostic test performance

• represent diagnostic test performance

EBM Process

Drawing conclusion Patient Diagnosis

That impact on practice Therapy

•DOEs

Encounter Prognosis

•POEMs Etiology

Evidence Clinical Question

•Patient

•Hierarchy of evidence •Intervention

•Pre appraised resources •Comparison

Searching the •Outcome

Evidence

(Lang, 2000) 4

What should I do

about this condition INTERVENTION

or problem?

the problem?

have the condition DIAGNOSIS

CLINICAL or problem?

PROGNOSIS FACTORS

the condition

or problem?

is the problem?

type of problem? 5

ACQ Diagnosis (PICO)

Patient / Intervention

Problem / Comparison Outcome

Population (Index)

healthy 7-year- clinical exam throat culture GAS infection?

old boy with

sore throat

Controlled?

Randomized?

Longitudinal

Cross-sectional

Approach 3 2 Goal 4 Involvement

1

Research 7

Clinical Manifestation / Diagnosis / Prognosis / Therapy / Review

Focus

Hierarchy of study designs

8

Basic Principles (1)

• Ideal diagnostic tests – right answers:

– (+) results in everyone with the disease and

– ( - ) results in everyone else

• Usual clinical practice:

– The test be studied in the same way it would

be used in the clinical setting

• Observational study, and consists of:

– Predictor variable (test result)

– Outcome variable (presence / absence of the

disease)

Basic Principles (2)

• Sensitivity, specificity

• Prevalence, prior probability, predictive values

• Likelihood ratios

• Dichotomous scale, cutoff points (continuous

scale)

• Positive (true and false), negative (true & false)

• ROC (receiver operator characteristic) curve

What is the reason that there are

many parameters in diagnostic test?

Prevalence Disease Disease

Total

Sensitivity (%) (+) (-)

Specificity (%) False

Test True pos

LR+ (+) a

pos a+b

b

LR- False

PPV (%) Test neg

True neg

c+d

(-) d

NPV (%) c

a+b+

Post-test Odds c+d

Pre-test Probability (%)

Post-test Probability (%)

METHOD 1:

NATURAL FREQUENCIES TREE

Population

1.000

IN EVERY 1.000 PEOPLE, 200 WILL HAVE THE DISEASE

Population

1.000

Disease + Disease -

200 800

risk, the assessed rate of those with the disease (20%)

represents the PREVALENCE of the disease – it can also be

considered the PRE-TEST PROBABILITY of having the disease

Sensitivity

have a designated disorder who are

so identified by the test.

– Sensitive tests have few false

negatives.

– When a test with a high Sensitivity is

Negative, it effectively rules out the

diagnosis of disease. SnNout

Sensitivity

In other words, the Population

sensitivity is

190/200=95% 1.000

Disease + Disease -

200 800

Test + Test -

190 10

Sensitivitas 95 %, artinya:

“SnNout”: bila hasil uji kulitnya (-): 95% “out” (dia bukan penderita alergi )

Specificity

truly free of a designated disorder

who are so identified by the test.

– Specific tests have few false positives

– When a test is highly specific, a

positive result can rule in the

diagnosis. SpPin

Specificity

Population In other words, the

specificity is 768/800

1000 = 96%

Disease + Disease -

200 800

190 10 32 768

Spesifitas 96 % artinya:

“SpPin”: bila hasil uji kulitnya (+): 96% “in” (dia penderita alergi)

“Sensitivity & Specificity”

NON-CASES CASES

FALSE

NEGATIVES Test cut-off

FALSE

POSITIVES

% of Group

NON-DISEASED

DISEASED

Negative Positive

Degree of ‘positivity’ on test

Numeric? (complex)

“Sensitivity & Specificity”

• Sensitivity and Specificity are usually

considered properties of the test rather

than the setting, and are therefore

usually considered to remain constant.

likely to be influenced by complexity of

differential diagnoses and a multitude of

other factors (spectrum bias).

“Sensitivity & Specificity”

“Positive & Negative Predictive Value”

reference variable (‘denominator’) is the

DISEASE

• For predictive value, the reference

variable (‘denominator’) is the TEST

Pre Test & Post Test Probability

• Pre-test Probability

– The probability of the target condition

being present before the results of a

diagnostic test are available. (prevalence)

• Post-test Probability

– The probability of the target condition

being present after the results of a

diagnostic test are available.

(Positive Predictive Value)

“Positive Predictive Value”

Population

This is also the POST-

1000 TEST PROBABILITY of

having the disease

Disease + Disease -

200 800

POSITIVE

Test + Test + PREDICTIVE

VALUE = 190/222

190 32

=86 %

Test - Test -

10 768

PPV 86 % artinya bila hasil uji kulitnya (+): kemungkinan dia

menderita alergi adalah 86%

“Negative Predictive Value”

Population

1000

Disease + Disease -

200 800

Test + Test +

190 32

NEGATIVE

PREDICTIVE Test - Test -

VALUE = 768/778

=99% 10 768

NPV 99 % artinya bila hasil uji kulitnya (-): kemungkinan dia

tidak menderita alergi adalah 99 %

“Positive & Negative

Predictive Value”

will vary (according to the prevalence

of the condition in the chosen setting)

Predictive value & changing prevalence

Population

10.000

Disease + Disease -

200 9.800

of magnitude from 20% to 2%

Predictive value & changing prevalence

Specificity 10.000

unchanged

Disease + Disease -

200 9.800

Test + Test +

190 392

Test - Test -

10 9.408

Positive predictive value

at low prevalence

Population

Previously, PPV

10.000

was 86%

Disease + Disease -

200 9.800

PREDICTIVE

190 392 VALUE = 33%

Test - Test -

10 9.408

Negative predictive value

at low prevalence

Population

Previously, NPV

10.000

was 99%

Disease + Disease -

200 9.800

Test + Test +

190 392

PREDICTIVE

VALUE >99% 10 9.408

Prediction of low prevalence events

to low prevalence events, yield a high

number of false positive results

• Because of this, under such

circumstances, the Positive Predictive

Value of a test is low

• However, this has much less influence

on the Negative Predictive Value

Likelihood Ratio

– Relative likelihood that a given test would be

expected in a patient with (as opposed to one

without) a disorder of interest.

LR=

probability (%) of the test result in patients without disease

Likelihood

Population

1000

Disease +

200 The likelihood that

someone with the

disease will have a

Test +

positive test is

190 190/200 or 95%

This is the same as

Test - the sensitivity

10

Likelihood

Population

1000

Disease -

800

The likelihood that

someone without

the disease will Test +

have a positive test 32

is 32/800 or 4%

This is the same as Test -

the (1-specificity)

768

Likelihood Ratio

LIKELIHOOD OF POSITIVE TEST

LIKELIHOOD = GIVEN THE DISEASE

RATIO + (LR+)

LIKELIHOOD OF POSITIVE TEST

IN THE ABSENCE OF THE DISEASE

SENSITIVITY 0.95

= = = 23.8

1- SPECIFICITY 0.04

A Likelihood Ratio (LR) of 1.0

indicates an uninformative test (occurs when sensitivity and specificity

are both 50%)

The higher the Likelihood Ratio

the better the test (other factors being equal)

LR+=23,8, artinya bila hasil uji kulitnya (+): hasil (+) ini dapat terjadi 23,8

kali lebih besar terjadi pada “penderita alergi” dibandingkan dengan yang

“bukan penderita alergi”

The diagonal line (representing Sensitivity=0.5

and Specificity=0.5) represents performance no

better than chance

Overall shape is

predicted by the

reciprocal relationship

between sensitivity and

specificity

to Sensitivity=1 and

Specificity=1, the better

the overall performance

of the test

curve gives a measure of

the test’s performance

AREA UNDER ROC CURVES

100

Sensitivity

100% - TEST PERFECT

AREA=1.0

1-Specificity 50% - TEST USELESS

100

Sensitivity

AREA=0.5

curve will be between

0

0.5 and 1.0

1-Specificity

AREA UNDER ROC CURVES

100

Area = 0.7 (between

0.5 and 1.0)

Sensitivity

0

1-Specificity

randomly from the DISEASE+ and DISEASE- groups

respectively

• If the test is used to guess which patient is from the

DISEASE+ group, it will be right 70% of the time

RECEIVER OPERATING

CHARACTERISTIC (ROC) CURVE

100 This study compared

90 the performance of a

80 dementia screening test

70 in a community sample

Sensitivity

50 clinic sample (MC)

40

30

20 ACAT

Flicker L, Loguidice D, Carlin

10 MC JB, Ames D. The predictive

0 value of dementia screening

0 20 40 60 instruments in clinical

populations. International

1-Specificity Journal of Geriatric

Psychiatry 1997 ; 12 : 203-

209

Diagnostic tests …

Is not about finding absolute truth, but

about limiting uncertainty

establishes both the necessity and the

logical base for introducing probabilities,

pragmatic test-treatment thresholds ..\

• what you’re going to do with the results of the

diagnostic test, and

• whether doing the test will help your patients

Interpreting Diagnostic Studies

VIA - RaMMbo

Validity

Selection? VALIDITY

QUESTION:

Representative?

Participants

Gold standard G G Reproducible

Comparison Group (CG) Maintain?

+ -

Outcome

+ A B

Measurements

- C D blind subjective? OR

objective?

Diagnostic Accuracy Study:

Basic Design

Series of patients

Index test

Reference standard

Blinded cross-classification

Recruitment:

Was diagnostic test evaluated is representative

spectrum of patient?

Series of patients

Index test

Reference standard

Blinded cross-classification

Maintenance:

Was the endpoint of the reference standard

obtained for all subjects?

Series of patients

Index test

Reference standard

Blinded cross-classification

Measurement:

Were the assesors kept blind to the results of each

test and/or were the reference standard endpoint

objective

Series of patients

Index test

Reference standard

Blinded cross-classification

Spectrum Bias

Selected Patients

Index test

Reference standard

Blinded cross-classification

Verification Bias

Series of patients

Index test

Reference standard

Blinded cross-classification

Differential Reference Bias

Series of patients

Index test

Blinded cross-classification

Observer Bias

Series of patients

Index test

Reference standard

Unblinded cross-classification

Importance

What should I do

I INTERVENTION about this condition

or problem?

M What cause

ETIOLOGY/RISK FACTORS

P the problem?

O DIAGNOSIS

Does this person

have the condition

R or problem?

Who will get

T PROGNOSIS & PREDICTION the condition

or problem?

A

N FREQUENCY & RATE

How common

is the problem?

C

What are the

E PHENOMENA / THOUGHTS

type of problem? 53

I RRR, ARR, NNT

CLINICAL TRIAL

M p & CI

P

O

Survival curve

R PROGNOSIS RR / OR

T p & CI

A

N

C DIAGNOSTIC

Sn,Sp,LH,PPV,NPV

p & CI

E 54

Applicability

PICO & Applicability

Applicability

Your question

(PICO)

Study What do the

Result mean?

Importance

study done?

56

Validity

CRITICAL

APPRAISAL

DIAGNOSTIC

TEST

Critical appraisal diagnostic test

• STARD

• Use supporting softwares

– CAT Maker

Validity (1)

Apakah penelitian uji diagnostik dilakukan secara tersamar dengan baku

emas yang benar ?

Validity (2)

Apakah uji diagnostik dilakukan terhadap pasien dengan spektrum

penyakit atau kelainan yang memadai sehingga dapat diterapkan dalam

praktek sehari-hari?

Validity (3)

Apakah pemeriksaan dengan baku emas dilakukan tanpa memandang

hasil pemeriksaan dengan uji diagnostik ?

Important

Berapa Sn, Sp, LR+, LR-, PPV, NPV, Pre-test probability, Post-test

probability, Pre-test Odds, Post-test Odds ?

Applicable (1)

Apakah uji diagnostik tersebut tersedia, terjangkau dan akurat?

Applicable (2)

Apakah kita bisa memperkirakan pre-test probability (prevalens)

penyakit pada pasien kita ?

Applicable (3)

Apakah post-test probability yang dihitung akan mengubah tatalaksana

pasien kita?

Applicable (4)

Apakah secara keseluruhan uji diagnostik tersebut bermanfaat bagi

pasien ?

STARD initiative (25 items)

Standards for Reporting of Diagnostic Accuracy

topic ◦ Participants

◦ Test results

– Title, abstract, and ◦ Estimates

keywords ◦ Discussions

– Introduction

• Methods

– Participants

– Test methods

– Statistical methods

Bossuyt PM, Reitsma JB, Bruns, DE, Gatsonis CA, Glasziou PP et al. BMJ 2003,326:41-6

1st component of STARD

2nd component of STARD

Guides for deciding whether a screening or

early diagnostic maneuver does more good

than harm:

Does early diagnosis really lead to improved

survival, or quality of life, or both?

Are the early diagnosed patients willing partners in

the treatment strategy?

Is the time and energy it will take us to confirm the

diagnosis and provide (lifelong) care well spent?

Do the frequency and severity of the target disorder

warrant this degree of effort and expenditure?

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