CLINICAL DECISION
MAKING
Putu Moda Arsana
THE MODERNDAY 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
coproducer
Transparency
Study evidence
(quantitative)
Statistical
(un)certainty
Pragmatism Empirism
Modified from: Prof. Ulrich Trhler, University of Freiburg, 1999
Medical decisionmaking
Medical decisionmaking 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
ROCCurve
ROCCurve
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 nonmedical 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;321:42932
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 lessthanideal
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
Truepositive
(a)
Falsepositive
(b)
negative
Falsenegative
(c)
Truenegative
(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 nondis. people
In tests measuring dicotomous variables
(i.e.yes/no)
LR+ = Sensitivity/(1Specificity)
LR = (1Sensitivity)/Specificity
Likelihood ratios
Likelihood ratio positive (LR+)
= sensitivity/falsepositive = sensitivity/(1specificity)
The higher ratio (>1) , the better the test
Likelihood ratio negative (LR )
= falsenegative/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
Truepositive
(a)
Falsepositive
(b)
negative
Falsenegative
(c)
Truenegative
(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
510 moderate shift
25 small changes
in probability
12 rarely
important changes
Likelihood ratio
Closing to 0 is better
LR <0.1
conclusive changes
from pre to posttest probability
0.10.2 moderate
shift
0.20.5 small
changes in
probability
0.51 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(4.411.7)
guided with Suspicious 1.3 (0.523.2)
U/S
Insufficien 2.7 (0.5215)
t
722
132
868
FNAB not
guided
Result
LR(95%CI)
benign
0.24 (0.110.52)
Malignant
34 (1574)
Suspicious 1.7 (0.943)
Insufficien 0.5 (0.270.76)
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]/[1specificity]
=90/[10085]
=90/15 = 6
LR=[false negative error] /[specificity]
=[10090]/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 >1320
ug/100ml
83.0
67.0
2.5
0.16
Plasma cortisol midnight > 615
ug/ml
96.0
96.0
24.0
0.04
24hr urine free cortisol >20181
ug/day
94.0
91.0
10.0
0.07
Lowdose dexamethasone
suppression: urine free cortisol >
0.0190.025mg/day
95.0
97.0
32.0
0.05
90.0
79.0
4.3
0.13
Cushings syndrome
Cushings disease
Highdose dexa suppression test
Urine free cortisol suppressed >
50%
Probability of having
disease
Pretest probability
= prevalence of disease
pretest odds of disease
Posttest probability
=probability of disease if test is positive
posttest odds of disease if test is positive
= Pretest odds of disease
LR+
Calculation of posttest
probability
Posttest probability
posttest odds of disease if test is positive
= Pretest odds of disease LR+
Example: if LR+ = 8
Prevalence = 20% pretest odds =
20/80 = 1:4
Posttest odds = 1:4 x 8 = 8:4
posttest probability = 8/(8+4) = 66.6
%
Calculation of posttest
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 pretest
odds by the likelihood
ratio
Covert the posttest odds
to a posttest 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
CostEffectiveness Analysis Using Decision
Analysis
How can we improve accuracy
of our diagnosis
Seek for other evidence
supporting the diagnosis
Increase
pretest 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 nonmedical 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;321:42932
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: 620624
Decision Tree
Critical appraisal to the
evidence
Validity
Importance
Applicability
Thank You !