exam card no20.

1. evaluation of diagnostic and screening tests.

1. reliability of measurements.
1. the extent to which the screening test will produce the same or
very similar results each times it is administered.
2. sources of variability that can affect the reproducibility of
results of a screening test:
i. biological variation (e.g. blood pressure)
ii. reliability of the instrument itself.
iii. intra-observer variability.
iv. inter-observer variability.
2. Inter-observer and intra-observer variation.
1. inter-observer = inconsistency in the way different screeners
apply or interpret test results.
2. intra-observer = differences in repeated measurement by the
same screener.
3. Validity of the test.
1. validity of the test = the extent to which the test distinguishes
between persons with and without the disease.
2. results of screening test:
+
-

+
a
c

b
d

a= true positive
b= false positive
c= false negative
d= true negative
3. high validity requires:
i. high sensitivity
ii. high specificity
4. sensitivity = the probability of testing positive if the disease is
truly present.
= a/(a+c)
5. specificity = the probability of screening negative if the
diseases is truly absent.
= d/(b+d)

4. Relationships between sensitivity and specificity.

1. lowering the criterion of positivity results in increased
sensitivity, but at the expense of decreased specificity.
2. making the criterion of positivity more stringent increases the
specificity, but at the expense of decreased sensitivity.
3. the goal is to have both high sensitivity and high specificity, but
this is often not possible or feasible.
4. the decision of the cutpoint involves weighing the
consequences of leaving cases undetected (false negatives)
against erroneously classifying healthy persons as diseased
(false positives)
5. in general, specificity must be at least 98% to be effective
because misclassifying 2% of the population will create as
many false positives as the sensitivity of the test will actually
detect.
6. sensitivity should be increased when the penalty associated
with missing a case is high (e.g. minimize false negatives)
7. specificity should be increased when the costs or risks
associated with further diagnostic techniques are substantial
(e.g. minimize false positives)
5. Cost of the test and its impact on effectiveness of screening
program.
2. observational studies in medical research.
1. classification of observational studies.
1. descriptive
2. analytical
a. cross-sectional
b. longitudinal
i. prospective
ii. retrospective
c. ecological
2. describe prospective study design and its advantages and
disadvantages.
1. The first step in a prospective study design is to identify the
relevant group(s) of people and collect information about
their exposure history.
2. we then follow theses people over time and measure the
incidence of the outcomes of interest.

3. advantages of prospective study:

a. well suited to study rare exposures
b. can easily study multiple outcomes
c. provides direct measure of risk of outcome among
exposed and unexposed persons
d. Begins with healthy persons thereby preventing
selective survival bias.
4. disadvantages of prospective study:
a. assessment of exposure status may influence
participants behavior.
b. changing diagnostic criteria may introduce bias.
c. inefficient for rare outcomes.
d. not well suited to study multiple exposures.
e. difficult if long delay between exposure and outcome.
f. lost-to-follow-up problem.
g. can be costly.
3. describe retrospective study design and its advantages and
disadvantages.
5. start with outcome to find the cause by comparing
prevalence of different groups.
6. advantages:
a. well suited to study rare outcomes
b. can easily study multiple exposures
c. efficient if long delay between exposure and outcome.
7. disadvantages:
a. relies on information about past exposures that may be
prone to bias.
b. inefficient for rare exposures.
c. not well suite to study multiple outcomes.
d. unable to provide data on absolute risk.
e. time sequence of exposure and outcome can be unclear.
4. Cross-sectional study.
8. select randomly of certain population
9. generate new hypotheses and estimate the outcome
10.advantages:
a. not expensive
b. quick
c. direct estimation of outcome
11.disadvantages:
a. not useful to find cause

b. not efficient for studying rare outcomes or

those of short duration
c. cannot provide direct estimates of risk
d. difficult to interpret temporality between
exposure and outcome.
5. weak points of all observational studies.
12.may not applicable in general population. (less reliable for large
representing large population.)
13.as its carried out in natural setting, so the results may exposed to
different bias.
14.less controllable over situation of study results more susceptible to
distorting influence.