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CLINICAL DECISION

MAKING
Putu Moda Arsana

THE MODERN-DAY PHYSICIAN


No greater opportunity, responsibility, or obligation can fall
to the lot of a human being than to become a physician. In
the care of the suffering, [the physician] needs technical
skill, scientific knowledge, and human understanding.
Tact, sympathy, and understanding are expected of the
physician, for the patient is no mere collection of
symptoms, signs, disordered functions, damaged organs,
and disturbed emotions..
[The patient] is human, fearful, and hopeful, seeking relief,
help, and reassurance .

Harrisons Principles of Internal Medicine , 1950

Changing the paradigm in


medicine
Theory
Mystic
Safety

Dogmatism
Expert knowledge
(qualitative)

The secret art


of medicine

Paternalism

Patient as
co-producer

Transparency

Study evidence
(quantitative)

Statistical
(un-)certainty

Pragmatism Empirism
Modified from: Prof. Ulrich Trhler, University of Freiburg, 1999

Medical decision-making

Medical decision-making is an important


responsibility of the physician and occurs at
each stage of the diagnostic and treatment
process.
It involves the ordering of additional tests,
requests for consults, and decisions
regarding treatment and prognosis.
Application of the scientific method,
including hypothesis formation and data
collection, is essential to the process of
accepting or rejecting a particular diagnosis

Clinical Process
Diagnosis
Process

Keluhan

Therapeutic
process

Diagnosa

Clinical Process

Terapi

Clinical Decision making

Diagnosis
Process

Keluhan

Diagnosa

Therapeutic
process

Terapi

Clinical decision making in


Diagnosis Process

Clinical questions often arise from


central issues:
Diagnosis
the process of identifying a disease or condition. Making the correct
diagnosis is the foundation for making decisions on clinical intervention.
What disease or condition does my patient have?

Therapy
an action or intervention that can potentially improve care or prevent
diseases or conditions.
What is the best treatment for this disease or condition?

Etiology
the cause of a disease, condition or situation. It may also be referred to as
harm or causation.
What is the cause of my patients disease or condition?

Prognosis
the progression of a treated disease.
What outcome can be expected from the treatment/intervention used?
Definitions from McKibbon, 2009

Diagnostic Testing
Decision
Decision Making
Making
Biochemical
BiochemicalAssay
Assay
Clinical
ClinicalFinding
Finding
Radiologic
Radiologicprocedure
procedure
Biopsy
Biopsy
Diagnostic Testing
Diagnostic Testing

Clinical
Clinical
Question
Question

EBM Principles
EBM Principles
Sensitivity
Sensitivity
Specificity
Specificity
ROC-Curve
ROC-Curve
Likelihood
LikelihoodRatio
Ratio
Predictive
PredictiveValue
Value
Diagnostic
DiagnosticAccuracy
Accuracy

Common types of clinical


questions
11% What is the best drug for a disease?
8% What is the reason for a symptom?
8% Which diagnostic test is useful in a
disease?
7% What is the correct dosage of a drug?
6% What is the best non-medical treatment
for a disease?
5% Is a diagnostic or therapeutic
management indicated for a disease?
5% What is the reason for a diagnostic
Ely et al., BMJ 2000;321:429-32
finding?

Attributes of the test


1.
2.
3.
4.
5.

Validity
Reliability
Clinical relevance
Feasibility
Cost

Validity (accuracy)

Degree to which the data measure what


they were intended to measure (i.e. the
true state of the phenomenon)

Reliability (Reproducibility,
precision)

Extent to which repeated measurements


of a stable phenomenon (by different
people, times, places, instruments) get
similar results

the Gaussian (normal) distribution


of test values in a population of
individuals

two such curves that describe


the findings in an ideal test

the results for a less-than-ideal


test

Properties of test

Sensitivity
Specificity
Predictive value of positive test
Predictive value of negative test
Likelihood ratio of positive test
Likelihood ratio of negative test
Pretest probability
Posttest probability

Measures of Diagnostic Test

Company Logo

Sensitivity and Specificity


Sensitivity

ability of a test to detect the disease among


persons who have it
proportion of people with disease who have
positive test
Sensitivity is sometimes termed PiD or positivity in
disease

specificity

ability of a test to confirm normal status


among people without disease
proportion of people without disease who
have negative test result
specificity is sometimes termed NiH or
negativity in health

Relationship between tests result


and truth
Sensitivity = a/(a+c)
Specificity = d/(b+d)
Positive predictive value = a/(a+b)
Negative predictive value = d/(c+d)
Prevalence = (a+c)/(a+b+c+d)
Odds = (a+c)/(b+d)

Disease
Present

Absent

positive

True-positive
(a)

False-positive
(b)

negative

False-negative
(c)

True-negative
(d)

a+c

b+d

Test result

Test result in primary care setting


Sensitivity = 99/(99+1)=99%
Specificity = 9801/(99+9801)=99%
PPV = 99/(99+99)=50%
NPV = 9801/(9801+1)=100%
Prevalence = (a+c)/(a+b+c+d)=1%
Odds = (a+c)/(b+d)=100/9900=1:99

hypothyroidism
Present

Absent

high

99
(a)

99
(b)

normal

1
(c)

9801
(d)

100

9900

TSH result

N= 10,000

Test results in an endocrinologists


office
Sensitivity = 990/(990+10)=99%
Specificity = 8910/(90+8910)=99%
PPV = 990/(990+90)=91.6%
NPV = 8910/(10+8910)=99.9%
Prevalence = (a+c)/(a+b+c+d)=10%
Odds = (a+c)/(b+d)=1:9

hypothyroidism
Present

Absent

high

990
(a)

90
(b)

normal

10
(c)

8910
(d)

1000

9000

TSH result

N= 10,000

Sensitivity and specificity do not


answer clinical questions:

If a patients test result is positive, what


is the probability that he or she has the
disease being tested?
If the result is negative, what is the
probability that the patient does not have
the disease?

DECISION ANALYSIS

Decision analysis provides a systematic


framework for organizing all data relevant to the
decision so that relevant uncertainties are less
likely to be overlooked

Construction of a decision tree that maps out all the


possibilities
Determination and assignment of probabilities
Assignment of utilities to each potential outcome
Determination of the expected utility
Choosing the course of action with the highest
expected utility
Evaluation of the sensitivity of the chosen course of
action to changes in probabilities and utilities

Predictive value of test

Predictive value of positive test


= probability of the person having the
disease when the test is positive
= proportion of the subjects who had
positive test results had the disease
Predictive value of negative test
= probability of the person not having
disease when the test is negative
= proportion of the subject who had
negative test results were free of the
disease

Validity In a clinical setting


Likelihood ratio (LR) better
LR= Probability of result in diseased people
Probability of result in non-dis. people
In tests measuring dicotomous variables
(i.e.yes/no)

LR+ = Sensitivity/(1-Specificity)
LR- = (1-Sensitivity)/Specificity

Likelihood ratios

Likelihood ratio positive (LR+)

= sensitivity/false-positive = sensitivity/(1specificity)
The higher ratio (>1) , the better the test

Likelihood ratio negative (LR )


= false-negative/specificity= (1sensitivity)/specificity

The smaller ratio ( close to 0 ), the better the test

no effect of prevalence on likelihood ratios

Likelihood ratios
Sensitivity = a/(a+c)
Specificity = d/(b+d)
LR+ = [a/(a+c)]/[b/(b+d)
LR- = [c/(a+c)/d(b+d)]
Prevalence = (a+c)/(a+b+c+d)
Odds = (a+c)/(b+d)

Disease
Present

Absent

positive

True-positive
(a)

False-positive
(b)

negative

False-negative
(c)

True-negative
(d)

a+c

b+d

Test result

Interpretation of Likelihood
Ratios
Likelihood ratio +
The higher, the better

LR+ >10
conclusive changes
from pre- to posttest probability

5-10 moderate shift

2-5 small changes


in probability

1-2 rarely
important changes

Likelihood ratio
Closing to 0 is better

LR- <0.1
conclusive changes
from pre- to posttest probability

0.1-0.2 moderate
shift

0.2-0.5 small
changes in
probability

0.5-1 rarely
important changes

Likelihood ratios for the diagnosis of


malignancy in euthyroid patients with a
single or dominant thyroid nodule
Prevalence
No. of
(pretest
patients
probability)(%) included

Test

20

FNAB
Malignant 226(4.4-11.7)
guided with Suspicious 1.3 (0.52-3.2)
U/S
Insufficien 2.7 (0.52-15)
t

7-22

132

868

FNAB not
guided

Result

LR(95%CI)

benign

0.24 (0.110.52)

Malignant

34 (15-74)

Suspicious 1.7 (0.94-3)


Insufficien 0.5 (0.27-0.76)
t

Characteristics of laboratory
tests in thyroid disorders
test

Se

Sp

LR
+

LR
-

90.
0
96.
0
99.
0

90.
0
96.
0
99.
0

9.0
24.
0
99.
0

0.1
1
0.0
4
0.0
1

Primary hypothyroidism
Total T4
90.

85.

6.0

0.1

hyperthyroidism
Total T4
T3 RIA
TSH

Example: calculation LRs from


Sensitivity and specificity

LR+
=[sensitivity]/[false positive error]
= [sensitivity]/[1-specificity]
=90/[100-85]
=90/15 = 6

LR=[false negative error] /[specificity]


=[100-90]/85
=10/85 = 0.12

Characteristics of tests for thyroid nodule


Test

Se

Sp

LR+

LR-

94

0.5

1.0

Hard to palpation

42

89

3.8

0.54

Fix to surrounding tissue

31

94

5.2

0.73

Cold nodule on iodine131

83

25

1.1

0.68

Solid or mixed lesion on


ultrasound

95

18

1.2

0.28

No change in size after T4


suppression Rx

85

25

1.1

0.6

FNBA: positive for malignancy

74.0

FNBA: suspicious

1.2

0.09

Thyroid nodule (benign vs. mal.)

Local pain

FNBA: benign

Characteristics of tests for


Cushings syndrome
Test

Se

Sp

LR+

LR-

Plasma cortisol 8.00 am >13-20


ug/100ml

83.0

67.0

2.5

0.16

Plasma cortisol midnight > 6-15


ug/ml

96.0

96.0

24.0

0.04

24-hr urine free cortisol >20-181


ug/day

94.0

91.0

10.0

0.07

Low-dose dexamethasone
suppression: urine free cortisol >
0.019-0.025mg/day

95.0

97.0

32.0

0.05

90.0

79.0

4.3

0.13

Cushings syndrome

Cushings disease
High-dose dexa- suppression test
Urine free cortisol suppressed >
50%

Probability of having
disease

Pre-test probability

= prevalence of disease
pre-test odds of disease

Post-test probability

=probability of disease if test is positive


post-test odds of disease if test is positive
= Pre-test odds of disease

LR+

Calculation of post-test
probability

Post-test probability

post-test odds of disease if test is positive


= Pre-test odds of disease LR+
Example: if LR+ = 8
Prevalence = 20% pre-test odds =
20/80 = 1:4
Post-test odds = 1:4 x 8 = 8:4
post-test probability = 8/(8+4) = 66.6
%

Calculation of post-test
probability of disease
1.

2.

3.

4.

5.

Find the symptom,


disease and test of
interest
Estimate the probability
of disease before testing
Convert the probability
of disease to an odds of
disease
Multiply the pre-test
odds by the likelihood
ratio
Covert the post-test odds
to a post-test probability

1.

2.

3.

4.

5.

Hypothyroidism: TSH
level
Pretest probability =
20%
Odds of
hypothyroidism =
20:80 = 1:4
LR+ for TSH in
hypothyroidism = 99
1:4 x 99 = 99:4
99/(99+4) = 96%

Decision Analysis
1

3
4

Determine the Probability of Each Chance Event

Deciding on a Strategy: Averaging Out and


Folding Back the Tree

Discounting Future Events

Sensitivity Analysis

Cost-Effectiveness Analysis Using Decision


Analysis

How can we improve accuracy


of our diagnosis

Seek for other evidence


supporting the diagnosis
Increase

pre-test probability

Other diagnostic tests which


have more sensitivity/specificity
and higher predictive value of
positive test
Gold standard diagnostic test

Clinical Decision making in


Treatment Process

Clinical Decision making

Diagnosis
Process

Keluhan

Diagnosa

Therapeutic
process

Terapi

Clinical questions often arise from


central issues:
Diagnosis
the process of identifying a disease or condition. Making the correct
diagnosis is the foundation for making decisions on clinical intervention.
What disease or condition does my patient have?

Therapy
an action or intervention that can potentially improve care or prevent
diseases or conditions.
What is the best treatment for this disease or condition?

Etiology
the cause of a disease, condition or situation. It may also be referred to as
harm or causation.
What is the cause of my patients disease or condition?

Prognosis
the progression of a treated disease.
What outcome can be expected from the treatment/intervention used?
Definitions from McKibbon, 2009

Common types of clinical


questions
11% What is the best drug for a disease?
8% What is the reason for a symptom?
8% Which diagnostic test is useful in a
disease?
7% What is the correct dosage of a drug?
6% What is the best non-medical treatment
for a disease?
5% Is a diagnostic or therapeutic
management indicated for a disease?
5% What is the reason for a diagnostic
Ely et al., BMJ 2000;321:429-32
finding?

Formatting answerable clinical


questions
P
I
C
O

Patient In a patient after colonic


resection
Intervention does oral anticoagulation
Comparison as compared to heparin s.c.

Outcome lead to less thrombembolic


events?
Sackett DL, Rosenberg WMC, J R Soc Med 1995;88: 620-624

Decision Tree

Critical appraisal to the


evidence

Validity
Importance
Applicability

Thank You !