CHAPTER 5: Assessing the Validity and Reliability of Diagnostic and Screening Test

A physical examination was used to screen for breast cancer in 2,500 women with
biopsy-proven adenocarcinoma of the breast and in 5,000 age- and race-matched control
women. The results of the physical examination were positive (i.e., a mass was palpated) in
1,800 cases and in 800 control women, all of whom showed no evidence of cancer at biopsy.
1. The sensitivity of the physical examination was: 72.0%
2. The specificity of the physical examination was: 84.0%
3. The positive predictive value of the physical examination was: 69.2%

Question 4 is based on the following information:

A screening test is used in the same way in two similar populations, but the proportion of
false-positive results among those who test positive in population A is lower than that among
those who test positive in population B.
4. What is the likely explanation for this finding?
a. It is impossible to determine what caused the difference
b. The specificity of the test is lower in population A
c. The prevalence of disease is lower in population A
d. The prevalence of disease is higher in population A
e. The specificity of the test is higher in population A

Question 5 is based on the following information:

A physical examination and an audiometric test were given to 500 persons with suspected
hearing problems, of whom 300 were actually found to have them. The results of the
examinations were as follows:

5. Compared with the physical examination, the audiometric test is:

a. Equally sensitive and specific
b. Less sensitive and less specific
c. Less sensitive and more specific
d. More sensitive and less specific
e. More sensitive and more specific
Question 6 is based on the following information:
Two pediatricians want to investigate a new laboratory test that identifies streptococcal
infections. Dr. Kidd uses the standard culture test, which has a sensitivity of 90% and a
specificity of 96%. Dr. Childs uses the new test, which is 96% sensitive and 96% specific.

6. If 200 patients undergo culture with both tests, which of the following is correct?
a. Dr. Kidd will correctly identify more people with streptococcal infection than Dr.
Childs
b. Dr. Kidd will correctly identify fewer people with streptococcal infection
than Dr. Childs
c. Dr. Kidd will correctly identify more people without streptococcal infection than
Dr. Childs
d. The prevalence of streptococcal infection is needed to determine which
pediatrician will correctly identify the larger number of people with the disease

Questions 7 and 8 are based on the following information:

A colon cancer screening study is being conducted in Nottingham, England. Individuals 50 to 75
years old will be screened with the Hemoccult test. In this test, a stool sample is tested for the
presence of blood.
7. The Hemoccult test has a sensitivity of 70% and a specificity of 75%. If Nottingham has
a prevalence of 12/1,000 for colon cancer, what is the positive predictive value of the
test? 3.3%

8. If the Hemoccult test result is negative, no further testing is done. If the Hemoccult test
result is positive, the individual will have a second stool sample tested with the
Hemoccult II test. If this second sample also tests positive for blood, the individual will be
referred for more extensive evaluation. What is the effect on net sensitivity and net
specificity of this method of screening?
a. Net sensitivity and net specificity are both increased
b. Net sensitivity is decreased and net specificity is increased
c. Net sensitivity remains the same and net specificity is increased
d. Net sensitivity is increased and net specificity is decreased
e. The effect on net sensitivity and net specificity cannot be determined from the
data
Questions 9 through 12 are based on the information given below:

Two physicians were asked to classify 100 chest x-rays as abnormal or normal independently.
The comparison of their classification is shown in the following table:
9. The simple percent agreement between the two physicians out of the total is: 70.0%

10. The percent agreement between the two physicians, excluding the x-rays that both
physicians classified as normal, is: 57.1%

11. The value of kappa is: 0.4

12. This value of kappa represents what level of agreement?

a. Excellent
b. Intermediate to good
 CHAPTER 6: The Natural History of Disease

Question 1 is based on the information given in the table below:

A total of 180 patients were treated for disease X from 2012 to 2014, and their progress was
followed to 2015. The treatment results are given in the table. No patients were lost to follow-up.

1. What is the probability of surviving for 3 years? 54.8%

2. An important assumption in this type of analysis is that:

a. Treatment has improved during the period of the study
b. The quality of record-keeping has improved during the period of the study
c. No change has occurred in the effectiveness of the treatment during the
period of the study
d. An equal number of men and women were enrolled each year
e. None of the above

3. Which of the following is a good index of the severity of a short-term, acute disease?
a. Cause-specific death rate
b. 5-year survival
c. Case-fatality
d. Standardized mortality ratio
e. None of the above

4. A diagnostic test has been introduced that will detect a certain disease 1 year earlier
than it is usually detected. Which of the following is most likely to happen to the disease
within the 10 years after the test is introduced? (Assume that early detection has no
effect on the natural history of the disease. Also assume that no changes in death
certification practices occur during the 10 years.)
a. The period prevalence rate will decrease
b. The apparent 5-year survival will increase
c. The age-adjusted mortality rate will decrease
d. The age-adjusted mortality rate will increase
e. The incidence rate will decrease
 5. Which of the following statements about relative survival is true?
a. It refers to survival of first-degree relatives
b. It is generally closer to observed survival in elderly populations
c. It is generally closer to observed survival in young populations
d. It generally differs from observed survival by a constant amount, regardless of
age
e. None of the above

Questions 6 to 8 are based on the data in the table below. The data were obtained from a study
of 248 patients with acquired immunodeficiency syndrome (AIDS) who were given a new
treatment and followed to determine survival. The study population was followed for 36 months.
Note: Carry your calculations in the table to four decimal places (i.e., 0.1234), but give the final
answer to three decimal places (e.g., 0.123 or 12.3%).6 The Natural History of Disease: Ways
of Expressing Prognosis 145
6. For those people who survived the second year, what is the probability of dying in the
third year? 0.982 or 98.2%

7. What is the probability that a person enrolled in the study will survive to the end of tthird
year? 0.006 or 0.6%

8. Before reporting the results of this survival analysis, the investigators compared the
baseline characteristics of the 42 persons who withdrew from the study before its end
with those of the participants who had complete follow-up. This was done for which of
the following reasons:
a. To test whether randomization was successful
b. To check for changes in prognosis over time
c. To check whether those who remained in the study represent the total
study population
d. To determine whether the outcome of those who remained in the study is the
same as the outcome of the underlying population
e. To check for confounders in the exposed and nonexposed groups
9. This question is based on a study by Faraday et al. where they examined the association
between history of skin infection and surgical site infection (SSI) after elective surgery.
They followed 613 patients for about 6 months. The figure below shows the
Kaplan-Meier estimates of cumulative incidence of SSI or infectious death by history of
skin infection. Using the figure, the median survival time is:

a. 30–50 days
b. 60–80 days
c. 90–110 days
d. 120–130 days
e. Information cannot be obtained from this figure

10. In the Faraday study (see question 9), which of the following is/are necessary
assumption(s) when using the Kaplan Meier method to estimate cumulative incidence:
a. The incidence of SSI events is less than 10% in the study population
b. Those who are lost to follow-up before 6 months have the same survival
experience as those who remain in the study
c. Events and loss to follow-up occur at a constant rate during each time interval
d. Those who are censored prior to 6 months are more likely to develop SSI than
those who are not censored prior to 6 months
 CHAPTER 7: Observational Studies

1. A case-control study is characterized by all of the following except:

a. It is relatively inexpensive compared with most other epidemiologic study designs
b. Patients with the disease (cases) are compared with persons without the disease
(controls)
c. Incidence rates may be computed directly
d. Assessment of past exposure may be biased
e. Definition of cases may be difficult

2. Residents of three villages with three different types of water supply were asked to
participate in a survey to identify cholera carriers. Because several cholera deaths had
occurred recently, virtually everyone present at the time underwent examination. The
proportion of residents in each village who were carriers was computed and compared.
What is the proper classification for this study?
a. Cross-sectional study
b. Case-control study
c. Prospective cohort study
d. Retrospective cohort study
e. Experimental study

3. Which of the following is a case-control study?

a. Study of past mortality or morbidity trends to permit estimates of the occurrence of
disease in the future
b. Analysis of previous research in different places and under different circumstances to
permit the establishment of hypotheses based on cumulative knowledge of all known
factors
c. Obtaining histories and other information from a group of known cases and from a
comparison group to determine the relative frequency of a characteristic or
exposure under study
d. Study of the incidence of cancer in men who have quit smoking
e. Both a and c

4. In a study begun in 1965, a group of 3,000 adults in Baltimore were asked about alcohol
consumption. The occurrence of cases of cancer between 1981 and 1995 was studied in
this group. This is an example of:
a. A cross-sectional study
b. A prospective cohort study
c. A retrospective cohort study
d. A clinical trial
e. A case-control study
5. In a small pilot study, 12 women with endometrial cancer (cancer of the uterus) and 12
women with no apparent disease were contacted and asked whether they had ever used
estrogen. Each woman with cancer was matched by age, race, weight, and parity to a
woman without disease. What kind of study design is this?
a. Prospective cohort study
b. Retrospective cohort study
c. Case-control study
d. Cross-sectional study
e. Experimental study

6. The physical examination records of the entire incoming freshman class of 1935 at the
University of Minnesota were examined in 1977 to see if their recorded height and weight
at the time of admission to the university was related to the development of coronary
heart disease (CHD) by 1986. This is an example of:
a. A cross-sectional study
b. A case-control study
c. A prospective cohort study
d. A retrospective cohort study
e. An experimental study

7. In a case-control study, which of the following is true?

a. The proportion of cases with the exposure is compared with the proportion of controls
with the exposure
b. Disease rates are compared for people with the factor of interest and for people without
the factor of interest
c. The investigator may choose to have multiple comparison groups
d. Recall bias is a potential problem
e. a, c, and d

8. In which one of the following types of study designs does a subject serve as his own
control?
a. Prospective cohort study
b. Retrospective cohort study
c. Case-cohort study
d. Case-crossover study
e. Case-control study

9. Ecologic fallacy refers to:

a. Assessing exposure in large groups rather than in many small groups
b. Assessing outcome in large groups rather than in many small groups
c. Ascribing the characteristics of a group to every individual in that group
d. Examining correlations of exposure and outcomes rather than time trends
e. Failure to examine temporal relationships between exposures and outcomes
10. A researcher wants to investigate if tea consumption (assessed by a biomarker for tea
metabolism) increases the risk of CHD. He uses a case-control study to answer this
question. CHD is rare in younger people. Which two groups are best to enroll and
compare for this purpose?
a. The group of CHD cases and a group of those who do not have CHD individually
matched to the cases for tea metabolism biomarker
b. The group of CHD cases and a group of those who do not have CHD frequency matched
to the cases for tea metabolism biomarker
c. The group of CHD cases and a group of those who do not develop CHD, matched
for age
d. A random sample of those who drink tea and a random sample of those who do not drink
tea, matched for age
e. A random sample of those who drink tea and a random sample of those who do not drink
tea, unmatched for age

11. Which of the following is a true conclusion concerning matching?

a. Once we have matched controls to cases according to a given characteristic, we can
only study that characteristic when the prevalence of disease is low
b. If an attempt is made to match on too many characteristics, it may prove difficult or
impossible to adjust for all of the characteristics during data analysis
c. Matching on many variables may make it difficult to find an appropriate control
d. Individual matching differs from frequency matching because controls are selected from
hospitals instead of from the general population
e. None of the above
 CHAPTER 8: Cohort Studies

1. 1 In cohort studies of the role of a suspected factor in the etiology of a disease, it is

essential that:
a. There be equal numbers of persons in both study groups
b. At the beginning of the study, those with the disease and those without the disease have
equal risks of having the factor
c. The study group with the factor and the study group without the factor be representative
of the general population
d. The exposed and unexposed groups under study be as similar as possible with
regard to possible confounding factors
e. Both b and c

2. Which of the following is not an advantage of a prospective cohort study?

a. It usually costs less than a case-control study
b. Precise measurement of exposure is possible
c. Incidence rates can be calculated
d. Recall bias is minimized compared with a case-control study
e. Many disease outcomes can be studied simultaneously

3. Retrospective cohort studies are characterized by all of the following except:

a. The study groups are exposed and unexposed
b. Incidence rates may be computed
c. The required sample size is smaller than that needed for a prospective cohort
study
d. The required sample size is similar to that needed for a prospective cohort study
e. They are useful for rare exposures

4. A major problem resulting from the lack of randomization in a cohort study is:
a. The possibility that a factor that led to the exposure, rather than the exposure
itself, might have caused the disease
b. The possibility that a greater proportion of people in the study may have been exposed
c. The possibility that a smaller proportion of people in the study may have been exposed
d. That, without randomization, the study may take longer to carry out
e. Planned crossover is more likely

5. In a cohort study, the advantage of starting by selecting a defined population for study
before any of its members become exposed, rather than starting by selecting exposed
and unexposed individuals, is that:
a. The study can be completed more rapidly
b. A number of outcomes can be studied simultaneously
c. A number of exposures can be studies simultaneously
d. The study will cost less to carry out
e. a and d
6. In 2010, investigators were interested in studying early-adult obesity as a risk factor for
cancer mortality. The investigators obtained physician health reports on students who
attended the University of Glasgow between 1948 and 1968. These reports included
records of the students’ heights and weights at the time they attended the university. The
students were then followed through 2010. Mortality information was obtained using
death certificates. This study can best be described as a:
a. Nested case-control
b. Cross-sectional
c. Prospective cohort
d. Retrospective cohort
e. Population-based case-control

7. From 1983 to 1988, blood samples were obtained from 3,450 HIV-negative men in the
Multicenter AIDS Cohort Study (MACS) and stored in a national repository. In 2010 a
researcher was interested in examining the association between levels of inflammation
and HIV infection. Of the 3,450 men, 660 men were identified as HIV-infected cases. The
researcher investigated the association between C-reactive protein (CRP) and HIV
infection among these 660 cases and 660 controls, matched to the cases by age and
ethnicity, who did not become infected with HIV. The researcher used the stored blood
samples to measure the serum level of CRP, a marker of systemic inflammation. The
study initiated in 2010 is an example of a:
a. Nested case-cohort study
b. Nested case-control study
c. Retrospective cohort study
d. Cross-sectional study
e. Randomized clinical trial
CHAPTER 10: Assessing Preventive and Therapeutic Measures: Randomized Trials
CHAPTER 11: Randomized Trials: Some Further Issues

1. The major purpose of random assignment in a clinical trial is to:

a. Help ensure that study subjects are representative of the general population
b. Facilitate double blinding (masking)
c. Facilitate the measurement of outcome variables
d. Ensure that the study groups have comparable baseline characteristics
e. Reduce selection bias in the allocation of treatment

2. An advertisement in a medical journal stated that “2,000 subjects with sore throats were
treated with our new medicine. Within 4 days, 94% were asymptomatic.” The
advertisement claims that the medicine was effective. Based on the evidence given
above, the claim:
a. Is correct
b. May be incorrect because the conclusion is not based on a rate
c. May be incorrect because of failure to recognize a long-term cohort phenomenon
d. May be incorrect because no test of statistical significance was used
e. May be incorrect because no control or comparison group was involved

3. The purpose of a double blind or double masked study is to:

a. Achieve comparability of treated and untreated subjects
b. Reduce the effects of sampling variation
c. Avoid observer and subject bias
d. Avoid observer bias and sampling variation
e. Avoid subject bias and sampling variation

4. In many studies examining the association between estrogens and endometrial cancer of
the uterus, a one-sided significance test was used. The underlying assumption justifying
a one-sided rather than a two-sided test is:
a. The distribution of the proportion exposed followed a “normal” pattern
b. The expectation before doing the study was that estrogens cause endometrial
cancer of the uterus
c. The pattern of association could be expressed by a straight-line function
d. Type II error was the most important potential error to avoid
e. Only one control group was being used

5. In a randomized trial, a planned crossover design:

a. Eliminates the problem of a possible order effect
b. Must take into account the problem of possible residual effects of the first therapy
c. Requires stratified randomization
d. Eliminates the need for monitoring compliance and noncompliance
e. Enhances the generalizability of the results of the study
 6. A randomized trial comparing the efficacy of two drugs showed a difference between the
two (with a P value < .05). Assume that in reality, however, the two drugs do not differ.
This is therefore an example of the following:
a. Type I error (α error)
b. Type II error (β error)
c. 1 − α
d. 1 − β
e. None of the above

7. All of the following are potential benefits of a randomized clinical trial, except:
a. The likelihood that the study groups will be comparable is increased
b. Self-selection for a particular treatment is eliminated
c. The external validity of the study is increased
d. Assignment of the next subject cannot be predicted
e. The therapy that a subject receives is not influenced by either conscious or
subconscious bias of the investigator

Question 8 is based on the above table.

8. A drug company maintains that a new drug G for a certain disease has a 50% cure rate
as compared with drug H, which has only a 25% cure rate. You are asked to design a
clinical trial comparing drugs G and H. Using the preceding table, estimate the number of
patients needed in each therapy group to detect such a difference with α = 0.05, two-
sided, and β = 0.20.

The number of patients needed in each therapy group is 57.

Use your knowledge on study design to answer question 9
9. Choose the best study design from the list below for each of the following research
questions. Each study design can only be used once.
a. Ecologic study
b. Cross-sectional study
c. Case-control study
d. Prospective cohort
e. Randomized trial

9a. An investigator wishes to determine if the prevalence of syphilis is higher among men than
women. b. Cross-sectional study
9b. A researcher believes that a rare disease may be associated with use of a common lawn
fertilizer. c. Case-control study
9c. Health officials in Baltimore City believe that a smoking cessation program in combination
with nicotine patches will be more effective than a cessation program alone.
e. Randomized trial
9d. Investigators want to determine the risk of potential health outcomes from heavy drinking
among young adults. d. Prospective cohort
9e. A researcher believes that the county level rate of hospitalization for cardiovascular disease
will increase with increasing levels of outdoor air pollution. a. Ecologic study

Questions 10 and 11 involve the following randomized controlled trial, which explores the effects
of a drug in reducing recurrent strokes:

Given the increasing burden of cardiovascular disease, a researcher designs a randomized

controlled trial targeting patients who have experienced a stroke within the past 30 days. The
trial is testing whether Drug A reduces the likelihood of stroke recurrence compared with the
current standard of care (superiority trial). In the trial, 300 stroke patients are randomized into
two groups where Group 1 receives Drug A and Group 2 receives standard of care. The
investigator compared the cumulative incidence of a recurrent stroke between both groups.
Some patients randomized to standard of care obtain Drug A through other means. Meanwhile,
some participants randomized to Drug A ended up not taking it. The results from the randomized
controlled trial are below:

10. With an intention-to-treat analysis, calculate the cumulative incidence ratio for recurrent
stroke using standard of care as the reference. Answers should be rounded to two
decimal places.

Cumulative Incidence Ratio = 0.67

11. With a per-protocol analysis, calculate the cumulative incidence ratio for recurrent stroke
using standard of care as the reference. Answers should be rounded to two decimal
places.

Cumulative Incidence Ratio = 43