Chapter Objectives Define clinical epidemiology Understand various aspects of screening and diagnostic tests Describe various measures for evaluating prognosis Discuss potential biases and ways to avoid bias in evaluation of tests and treatments ID: 628160
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Slide1
Chapter 12
Clinical EpidemiologySlide2
Chapter Objectives
Define clinical epidemiology
Understand various aspects of screening and diagnostic tests
Describe various measures for evaluating prognosis
Discuss potential biases and ways to avoid bias in evaluation of tests and treatmentsSlide3
Clinical Epidemiology
Clinical epidemiology
focuses on patients and the application of epidemiologic methods to assess the efficacy of screening, diagnosis, and treatment in
clinical settings
Used to identify the health consequences of employing a test or administering
a treatmentSlide4
Questions
About
Clinical Epidemiology
Who is most likely to participate in screening and diagnostic testing?
How accurate is the screening or diagnostic test?
If a treatment is efficacious, what proportion of patients benefit from the treatment?
What characterizes those who benefit and those who do not benefit from the treatment?
How much do patients benefit from a treatment?
What
are the risks associated
with screening, diagnostic testing,
or treatment?Slide5
Secondary Prevention
Health
screening
and
detection
activities used to
identify diseaseSlide6
Screening vs. Diagnostic Tests
in Cancer
Examples of screening methods
Pap test
Mammograms
Blood tests (e.g., PSA)
Fecal occult blood test (FOBT)
Biopsy
Small blood sample – leukemiaSlide7
Medical Screening
Used to suggest or detect disease among individuals in a population without signs or symptoms of the
health problemSlide8
Why do we do
screenings?
Screening is used to promote detection of diseases in their earliest stages, when treatment has the greatest chance of working, in order to reduce morbidity
and mortalitySlide9
Common Screening Tests
Papanicolaou test (Pap smear, Pap test, cervical smear, or smear test)
Mammogram
Clinical breast exam
Fecal occult blood test
Prostate-specific antigen
test
Blood pressure determination
Cholesterol level
Eye examination
Urinalysis
Tuberculin skin test
Beck Depression InventorySlide10
How does mass screening compare with selective screening?
Mass screening is not selective but involves application of screening tests to the
total population
Selective screening involves applying the screening tests to high
risk groupsSlide11
Screening Guidelines
1968 World Health
Organization
The
disease or condition being screened for should be a
major
medical problem
Acceptable treatment
should be available for individuals with diseases discovered in the
screening process
Access
to healthcare
facilities and services
for follow-up diagnosis and treatment for the discovered disease should
be available
The disease should have a
recognizable course
, with identifiable early and
latent stagesSlide12
Screening
Guidelines (cont’d)
A
suitable and effective test or examination
for the disease(s) should
be available
The
test and the testing process
should be acceptable to the
general population
The
natural history
of the disease or condition should be adequately understood, including the regular phases and course of
the disease
Policies, procedures, and threshold levels on tests should be determined in advance to establish
who should be referred
for further testing, diagnostics, and
possible treatment
The process should be
simple
enough to encourage large groups of persons
to participateSlide13
Evaluating Screening Guidelines
How can the application of epidemiology provide a means for evaluating screening guidelines
?
Descriptive
and analytic epidemiologic methods are useful for establishing
and understanding
Extent
of public
health problem
Efficacy of treatment
Access to health care
Natural course of disease
Efficacy of a screening or
diagnostic testSlide14
Validity, Reliability, and Yield
Validity
– How well the test actually measures what it is supposed
to measure
Reliability
– How well the test performs in use over time(its
repeatability)
Yield
– The
amount of screening the test can accomplish in a
time periodSlide15
Validity
Refers to the accuracy and trustworthiness of instruments, data, and findings
in research
Are the instruments that were used to measure something valid?
GRE
SAT
ACTSlide16
Two ways to view and
assess validity
Content validity – Achieved
when an instrument has appropriate content for measuring a complex concept or construct
If you walk out of a test and feel that it was unfair because it tapped too narrow a band of knowledge
Construct validity
– The
measures “get at” or actually measure what you are
actually studying
Does the Wechsler IQ test measure
intelligence?Slide17
Accuracy
The degree to which the measurement represents what it is intended to represent
Important influence on the
validity
Spring on a scale not calibrated correctly; the scale is off.Slide18
Measures of Validity
Sensitivity
– Ability
of the test to correctly identify those with
the disease
Specificity
– Ability
of the test to correctly identify those without
the disease
Overall accuracy
– Ability
of a test to predict the presence or absence of
a disease
PV
+
–
Proportion
of people with a positive test result who have
the disease
PV-
–
Proportion
of people with a negative test result who do not have
the diseaseSlide19
Likelihood Ratios
Two additional measures for appraising screening and
diagnostic evidence
Likelihood Ratio Positive
(LR+)
Likelihood Ratio Negative
(LR-) Slide20
Likelihood Ratios
Positive
– Level
of
confidence that
a person who obtains a score in the affected range truly does have the
health problem
Negative
– Confidence
that a score in the unaffected range comes from a person who truly does not have the
health problemSlide21
Prognosis
Prediction or forecast of the course of a disease based on anticipation from the usual natural history of the disease or peculiarities unique to
the case
Prognostic indicators
tell
the doctor the likely behavior of the cancer and its responsiveness
to treatmentSlide22
Measures of Prognosis
Case fatality rate
– Proportion
of newly diagnosed cases that die from a given disease in a
specified period
Survival rate
– Proportion of
persons surviving,
regardless of cause
of deathSlide23
Cox Proportional Hazards
Regression Model
Useful for analyzing
survival data
Indicates the probability that a person will experience
an event
Estimate
the relative risk, adjusted for potential prognostic factors, thereby minimizing the threat
of confoundingSlide24
Lead Time Bias
Lead Time
– Difference
in time between the date of diagnosis with screening and the date of diagnosis
without screening
Lead Time Bias
– When lead time is counted in the survival time of patients, it gives a misleading picture of the benefit
of treatmentSlide25
Selection Bias
Choosing data that distorts the outcome of a test
May make a test look better or worse than it
really is,
in terms
of survivalSlide26
Over-Diagnosis Bias
Occurs when screening identifies an illness that would not have shown clinical signs before a person’s death from other causes
Makes screening efforts look good because of increased identification of abnormalities
Individual may undergo unnecessary treatment, with its accompanying riskSlide27
Avoiding Bias
Randomized
controlled trial
Through
randomization, different prognostic factors are
balanced between
groups, and the “true” screening or treatment effect can be determined Slide28
Outcomes Research
A relatively new field that seeks to understand the end results of clinical practices and interventions
Combines information about the care people are getting
Important in developing better ways to monitor and improve clinical careSlide29
Conclusion
Clinical
epidemiology
Involves
the application of epidemiologic methods to improve the quality and value of patient care
Involves assessment of the efficacy of screening, diagnosis, and treatment strategies in
clinical settings