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Quiz 1

The document contains 17 multiple choice questions related to clinical trials and interpreting results. The questions cover topics such as interpreting relative risk, sample size calculations, surrogate outcomes, intention-to-treat analysis, randomization, and study design selection.

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Mao Gallardo
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100% found this document useful (2 votes)
1K views

Quiz 1

The document contains 17 multiple choice questions related to clinical trials and interpreting results. The questions cover topics such as interpreting relative risk, sample size calculations, surrogate outcomes, intention-to-treat analysis, randomization, and study design selection.

Uploaded by

Mao Gallardo
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as DOCX, PDF, TXT or read online on Scribd
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Question

1
A clinical trial is done to determine whether a new drug would increase the 5-
year survival of patients with breast cancer. The final analysis shows that the
relative risk of death for those taking the drug is 0.8 (95% CI = 0.6-0.9). Which
one best describes the result?

This new drug increases the risk of death by 80%


The risk of death after taking the new drug is now 80%
The risk of death after taking the new drug is reduced by 80%
This new drug increases the risk of death by 20%

Question 2
A clinical trial is done to determine whether a drug would improve the
overall 5-year survival of patients with colon cancer. After a mean follow-
up of 5.4 years, the final analysis shows that of the 325 subjects
randomized to take the drug, 25 died. Of the 326 subjects who took
placebo, 34 died during the follow-up period. The relative risk of death for
taking the drug is:

0.36
0.74
9.0
1.36
Question 3
The best study design that can answer a question regarding the benefit
of a therapeutic intervention is:

Cross sectional survey


Cohort study
Randomized controlled trial
Case-control study
Question 4
In literature search of articles about treatment and/or prevention, the best
methodological filter is;

randomized, controlled trial (RCT)


Bolerian theorem
Thesaurus
literary prescription

Question 5
A RCT of a new drug seeking to reduce infection rates following
gastrointestinal surgery reveals a relative risk of 1.25 (95% CI 1.03-1.65).
This result is best interpreted as:

The new drug is not better than the control drug.


The new drug is worse than the control drug.
The new drug is possibly better but needs further studies.
The new drug confers the same benefit compared with the control
drug.
Question 6
A clinical trial is done to determine whether a drug would increase the 5-
year survival of patients with breast cancer. The final analysis shows that
the relative risk of death for those taking the drug is 0.8 (95% CI = 0.4-
1.3). Which one of the following p values is consistent with the result?

A p value of less than 0.05


A p value of less than 0.01
A p value of 0.05
A p value of greater than 0.05
Question 7
The efficacy of a new treatment for a particular disease should be
compared to;

placebo
prevailing standard treatment
any other drug
different doses of the same drug
Question 8
A RCT of a new antidepressant drug reports that there is no difference in
outcome between the drug and placebo (p greater than 0.05) in reducing
episodes of depression. However, an additional previously unplanned
analysis of the data was able to demonstrate a better response rate for
the new drug versus placebo in the women in the trial (p=0.04). Which
one of the following is the most valid conclusion from this trial?

The trial should have listed 2 primary outcomes


The new drug works in women but not in men
The response rate reported for the entire group should be
analyzed as a secondary outcome
A prospective trial designed to test the drug in men
compared to women should be considered

Question 9
A clinical trial is done to determine
whether a new chemotherapeutic
intervention would increase the survival
of patients with breast cancer. The
result shows that the relative risk of
death for the experimental arm is 0.7
(95% CI = 0.5-0.8). Which one best
describes the result?

This new intervention increases


the risk of death by 70%
The risk of death following the
intervention is now only 70%.
The risk of death following the
intervention is reduced by 70%
This new intervention increases
the risk of death by 30%.

Question 10
To determine if you would believe the
outcome of an RCT for therapy in
spite of incomplete follow up, which
process should be done:

Intention to treat analysis


Worse case scenario analysis
Both
Neither

Question 11
A study involving 100 subjects post breast surgery comparing the efficacy
of a drug in reducing postoperative infection gives the following result.
Drug A (Control) = 12 cases of post op infection (0.12) and Drug B
(Experimental) = 7 cases of post op infection (0.07). Considering that
subjects were accounted for, what is the number needed to treat?
5
10
15
20

Question 12
Drug A is for prevention of stroke. Studies on Drug A report risk
reduction of stroke, risk reduction of hypertension, control of high
serum cholesterol and lipid levels and decrease appetite for fatty
and oily food. Which is a surrogate outcome?

Hypertension
stroke
appetite to fatty and oily food
serum cholesterol and lipid levels
uestion 13
A clinical trial is done to determine whether an oncologic drug would
improve the survival of colon cancer patients. After a mean follow-up
of 4.1 years, the final analysis shows that of the 365 subjects
randomized to take the drug, 15 died while of the 366 subjects who
took placebo, 34 died. To prevent one death, you have to treat:

9
19
36
72
Question 14
A study involving 100 subjects post breast surgery comparing the
efficacy of a drug in reducing postoperative infection gives the
following result. Drug A (Control) = 12 cases of post op infection
(0.12) and Drug B (Experimental) = 7 cases of post op infection
(0.07). Considering that subjects were accounted for what is the
absolute risk reduction?

1.71
0.58
.05
.42
Question 15
The most important advantage of a randomized controlled clinical trial
over other study designs in determining treatment benefit is:

The subject population can be equally allocated to each of the


groups
Blinding of the subjects and researchers can be done
Unknown variables that may influence outcome are equally
distributed
Data are collected prospectively
Question 16
Which part of the article/manuscript should one look at to check
whether the randomization was effective?

Abstract
Table 1 of Results
Conclusion
Statistical significance of results
Question 17
Why is randomization important in a study comparing treatment?

To eliminate/minimize bias
To ensure that the groups would have equal chances of falling
under the experimental or control arm
To ensure that the result/outcome is due to the intervention
being tested and not to any confounder
All of the above are correct
Question 18
A RCT is conducted to test the hypothesis that a new vasodilator
improves congestive heart failure. Patients are randomized to either
the new drug or to placebo while continuing their pre-trial drugs. At the
end of the trial, intention-to-treat analysis shows no statistical
difference in outcome. The authors then decide to perform an analysis
based on actual therapies that patients received. Data from patients
who did not finish at least 60% of their assigned drug would be
included in the placebo group. This time the analysis shows that the
new drug is better than placebo (p less than 0.05). Which of the
following is the best course of action based on these results?

Recommend the drug for all patients with congestive heart


failure.
Recommend the new drug for patients who adhere to their
current therapies.
Only recommend the new drug for early stage congestive heart
failure.
Do not recommend the new drug and wait for further studies.
Question 19
The best study design to determine the presence of any treatment
advantage between an intervention and placebo is:

Cross sectional survey


Cohort study
Randomized controlled trial
Case-control study
Question 20
In a randomized controlled trial involving two drugs to be tested for
efficacy, a process that ensures that both investigators and subjects will
not know the treatment arm that a certain group belongs to is to make
similar preparations of the drug in terms of color, packaging etc. This
process is called:

Random allocation
Secret allocation
Double dummy
Double blinding
Question 21

After an adequate history taking and complete physical examination the


clinician have an initial clinical impression, differential diagnoses and
personal preferences whether to treat, not to treat or do diagnostic
work-ups. This is reflected in the:

Spectrum of disease diagram

Upper testing threshold


Lower testing threshold

Pre-test probability of disease


Question 22

One hundred (100) females, 40-50 years old is admitted due to


persistent right upper quadrant pain for the past 12 hours had an
ultrasound of the abdomen. US findings were as follows (50 acute
cholecystitis, 10 salphingitis, and 10 right ovarian cyst) while in 30 the
readings were normal or indeterminate or no abnormality noted.
Surgery was done in 50 of the 70 with positive findings and the
ultrasound readings were compared with the operative/histopathologic
findings (45 acute cholecystitis, 2 ovarian cyst, and 3 pelvic inflammatory
disease). The rest (50) who were not immediately operated were
followed up until final resolution during the hospitalization (25 acute
gastro-enteritis, 20 pelvic inflammatory disease, and 5 subsequently
operated for appendicitis). The verification bias was avoided by:

Doing the ultrasound and reference standard to all


study subjects
Just operating on those with positive findings
Complete follow-up
Complete follow-up
Question 23

A 45 year-old female with right upper quadrant


pain, nausea and vomiting presents in your
clinic, she wants to know if she needs immediate
surgery for Acute Cholecystitis.

10% 25% 80%

0
-------/--------/--------------------------------/--------------
100%

Lower TT Pre-test Prob. Upper TT

What is the best methodologic filter for a


question on diagnosis?
Sensitivity
Clinical trial patient
Cohort studies
Guidelines

Question 24

A 45 year-old female with right upper quadrant pain, nausea and


vomiting presents in your clinic, she wants to know if she needs
immediate surgery for Acute Cholecystitis.

10% 25% 80%

0 -------/--------/--------------------------------/--------------100%

Lower TT Pre-test Prob. Upper TT

The most likely question in this scenario is:

What is the best diagnostic test that will detect will detect acute
cholecystitis among women with right upper quadrant pain?
What is the diagnosis?
When do you recommend surgery in right upper quadrant pain?
What is the relevance of right upper quadrant pain among women?

Quest
ion 40
Sensitivity = 0.50, specificity = 0.50 of this particular
test. Clinically the test is;

Useful when result is


positive
Useful when results
are negative
Relatively accurate
Useless
Quest
ion 39
"150 females, 11-20 years old admitted due to
persistent abdominal pain for 6-12 hours had
ultrasound of the lower abdomen. Of these, 70 had
positive findings (50 acute appendicitis, 5
salphingitis, 5 right ovarian cyst, 10 fluid
accumulation at the right gutter/pelvis) while in 80
the readings were 'normal' or indeterminate or no
abnormality noted. Surgery was done in 65 of the
70 with positive findings and the ultrasound
readings were compared with the
operative/histopathologic findings (55 acute
appendicitis, 5 ovarian cyst, 2 ruptured Graffian
Follicle, 3 pelvic inflammatory disease). The rest
(85) who were not immediately operated were
followed up until final resolution during the
hospitalization (65 acute gastro-enteritis, 8 cystitis,
7 pelvic inflammatory disease, 5 subsequently
operated for appendicitis. The diagnostic test being
evaluated is:

Histopatholo
gy
Surgical
findings
Ultrasound
Follow-up
Quest
ion 38
The Magnetic Resonance Imaging (MRI) of the
lungs was compared with CT guided aspiration
biopsy findings in patients with solitary solid
pulmonary nodule by chest X-Ray. Inclusion criteria
for subject selection included what diagnostic test?

Pulmonary
MRI
Pulmonary
CT
Chest X-ray
Solitary
solid nodule
Quest
ion 37
"150 females, 11-20 years old admitted due to
persistent abdominal pain for 6-12 hours had
ultrasound of the lower abdomen. Of these, 70 had
positive findings (50 acute appendicitis, 5
salphingitis, 5 right ovarian cyst, 10 fluid
accumulation at the right gutter/pelvis) while in 80
the readings were 'normal' or indeterminate or no
abnormality noted. Surgery was done in 65 of the
70 with positive findings and the ultrasound
readings were compared with the
operative/histopathologic findings (55 acute
appendicitis, 5 ovarian cyst, 2 ruptured Graffian
Follicle, 3 pelvic inflammatory disease). The rest
(85) who were not immediately operated were
followed up until final resolution during the
hospitalization (65 acute gastro-enteritis, 8 cystitis,
7 pelvic inflammatory disease, 5 subsequently
operated for appendicitis. The pre-test odds is:

0.4
0.1
0.8
0.7
5
Question
36
"150 females, 11-20 years old admitted due
to persistent abdominal pain for 6-12 hours
had ultrasound of the lower abdomen. Of
these, 70 had positive findings (50 acute
appendicitis, 5 salphingitis, 5 right ovarian
cyst, 10 fluid accumulation at the right
gutter/pelvis) while in 80 the readings were
'normal' or indeterminate or no abnormality
noted. Surgery was done in 65 of the 70 with
positive findings and the ultrasound readings
were compared with the
operative/histopathologic findings (55 acute
appendicitis, 5 ovarian cyst, 2 ruptured
Graffian Follicle, 3 pelvic inflammatory
disease). The rest (85) who were not
immediately operated were followed up until
final resolution during the hospitalization (65
acute gastro-enteritis, 8 cystitis, 7 pelvic
inflammatory disease, 5 subsequently
operated for appendicitis. If the cells of the 2
X 2 table contain: a = 60; b = 5; c = 5; d = 80.
The sensitivity is:

0.8
0.9
2
0.8
5
0.7
4
Question
35
The Magnetic Resonance Imaging (MRI) of the
lungs was compared with CT guided aspiration
biopsy findings in patients with solitary solid
pulmonary nodule by chest X-Ray. In this study,
the reference standard used is;

Pulmonary
MRI
CT guided
biopsy
Solitary
solid nodule
Chest x-ray
Ques
tion 34
"150 females, 11-20 years old admitted due to
persistent abdominal pain for 6-12 hours had
ultrasound of the lower abdomen. Of these, 70 had
positive findings (50 acute appendicitis, 5
salphingitis, 5 right ovarian cyst, 10 fluid
accumulation at the right gutter/pelvis) while in 80
the readings were 'normal' or indeterminate or no
abnormality noted. Surgery was done in 65 of the
70 with positive findings and the ultrasound
readings were compared with the
operative/histopathologic findings (55 acute
appendicitis, 5 ovarian cyst, 2 ruptured Graffian
Follicle, 3 pelvic inflammatory disease). The rest
(85) who were not immediately operated were
followed up until final resolution during the
hospitalization (65 acute gastro-enteritis, 8 cystitis,
7 pelvic inflammatory disease, 5 subsequently
operated for appendicitis. If the cells of the 2 X 2
table contain: a = 60; b = 5; c = 5; d = 80. The
clinical decision when the diagnostic test is positive:

The patient should undergo surgery


The patient need no surgery and
medical treatment will do
Repeat the diagnostic procedure or do
another test
No clinical decision
Ques
tion 33
After adequate history taking and complete physical
examination the clinician has a primary initial
clinical impression, some differential diagnoses and
personal preferences whether to treat, not to treat
or do diagnostic work-ups. This is reflected in the:

Spectrum of
disease diagram
Upper testing
threshold
Lower testing
threshold
Pre-test probability
of disease
Ques
tion 32
"150 females, 11-20 years old admitted due to
persistent abdominal pain for 6-12 hours had
ultrasound of the lower abdomen. Of these, 70 had
positive findings (50 acute appendicitis, 5
salphingitis, 5 right ovarian cyst, 10 fluid
accumulation at the right gutter/pelvis) while in 80
the readings were 'normal' or indeterminate or no
abnormality noted. Surgery was done in 65 of the
70 with positive findings and the ultrasound
readings were compared with the
operative/histopathologic findings (55 acute
appendicitis, 5 ovarian cyst, 2 ruptured Graffian
Follicle, 3 pelvic inflammatory disease). The rest
(85) who were not immediately operated were
followed up until final resolution during the
hospitalization (65 acute gastro-enteritis, 8 cystitis,
7 pelvic inflammatory disease, 5 subsequently
operated for appendicitis. If the cells of the 2 X 2
table contain: a = 60; b = 5; c = 5; d = 80. The
clinical decision when the diagnostic test is
negative/indeterminate/normal/no abnormality is:

The patient should undergo surgery


The patient need no surgery and
medical treatment will do
Repeat the diagnostic procedure or do
another test
No clinical decision
Quest
ion 31
"150 females, 11-20 years old admitted due to
persistent abdominal pain for 6-12 hours had
ultrasound of the lower abdomen. Of these, 70 had
positive findings (50 acute appendicitis, 5
salphingitis, 5 right ovarian cyst, 10 fluid
accumulation at the right gutter/pelvis) while in 80
the readings were 'normal' or indeterminate or no
abnormality noted. Surgery was done in 65 of the 70
with positive findings and the ultrasound readings
were compared with the operative/histopathologic
findings (55 acute appendicitis, 5 ovarian cyst, 2
ruptured Graffian Follicle, 3 pelvic inflammatory
disease). The rest (85) who were not immediately
operated were followed up until final resolution
during the hospitalization (65 acute gastro-enteritis,
8 cystitis, 7 pelvic inflammatory disease, 5
subsequently operated for appendicitis. If the cells
of the 2 X 2 table contain: a = 60; b = 5; c = 5; d =
80. The likelihood ratio of a test positive is:

15
10
5
0.8
5
Questio
n 30

A population-based study was conducted of


annual screening for breast cancer with
sonomammography. The subjects underwent
baseline evaluation in 1995, with repeat annual
examinations the next 2 years. Confirmation of a
breast cancer diagnosis was based on cellular
pathology.

Cancer

+ -

Sonomammogra + 5 532
phy 6

- 4 1319
4

What is the likelihood ratio for a negative test


result?

0.07
0.09
5
44
23.9
Questio
n 29

A 25 year-old female with epigastric pain, anorexia, nausea and


vomiting (2X) since 6 a.m. today. Ultrasonography for
appendicitis was performed which shows the following;

Histopath
(appendicitis)

Present Absent TOTAL

Ultrasoun Test
d positive 50 a 7 b 57 a+b

Test
negative 8 c 35 d 43 c+d

TOTAL 58 a+c 42 b+d 100


a+b+c+d

The pre-test odds is:

1.3
8
0.4
0.1
0.6
7
Questi
on 28

A 45 year-old female with right upper quadrant


pain, nausea and vomiting presents in your clinic,
she wants to know if she needs immediate
surgery for Acute Cholecystitis.

10% 25% 80%

0 -------/--------/--------------------------------/--------------
100%

Lower TT Pre-test Prob. Upper TT

Your clinical action is:

Request for a diagnostic test


Perform surgery now
Treat patient as a case of peptic
ulcer disease
Re-evaluate patient for missing
data in history and PE
Qu
est
ion
27
A 45 year-old female with right upper quadrant pain,
nausea and vomiting presents in your clinic, she wants
to know if she needs immediate surgery for Acute
Cholecystitis.

10% 25% 80%

0 -------/--------/--------------------------------/--------------100%

Lower TT Pre-test Prob. Upper TT

The article most relevant to the case scenario is:

The Accuracy of Ultrasound in the Diagnosis of Acute Cholecystitis


Among Females with Significant Abdominal Pain
Increased White Blood Cell count Influence Diagnosis in Abdominal
Pain
Sensitivity and Specificity of Double Contrast Barium
Enema in Detecting Ileo-cecal Problems of Elders with
Right Iliac Pain
Alvarados Criteria in the Diagnosis of Acute
Appendicitis Among Males, 10-19 years old
Qu
est
ion
26

A 45 year-old female with right upper quadrant pain,


nausea and vomiting presents in your clinic, she wants
to know if she needs immediate surgery for Acute
Cholecystitis.

10% 25% 80%

0 -------/--------/--------------------------------/--------------100%

Lower TT Pre-test Prob. Upper TT

The study population in this scenario is:

Women with right upper


quadrant pain
Patients with acute
cholecystitis
Women presenting at
the clinic
Women 45 years old
Qu
est
ion
25

Replication and standardization of


a diagnostic test improve:

Reliabilit
y
Accuracy
Validity
Sensitivit
y

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