True or False: In a crossover design, a washout period is unnecessary because treatments do not

usually have carry-over effects.

True
Falso (correcto)
3. 

True or False: An equivalence design requires a large sample size to increase the probability of detecting
a difference if the two treatments are not similarly efficacious.

verdadero (correcto)
True

False

4. 

True or False: The purpose of a non-inferiority trial is to determine whether a new treatment is at least
as effective as an already established treatment.

verdadero (correcto)
True

False

5. 

True or False: In an adaptive design, results are usually easy to interpret and convey to the general
public.

True

Falso (correcto)
False

REPETICION QUIZ # 1

1. A large, simple design is best used in situations where baseline measurements are complex
and require special equipment (FALSO).
2. Crossover designs are most useful when the underlying intensity of disease has substantial
within-person variability, such as larger seasonal changes. (FALSO)

3. An equivalence design is useful if an investigator hypothesizes that two treatment options

have similar efficacy (VERDADERO)

4. In a non-inferiority trial, it is important to have good methods because a poorly designed

study may suggest that the experimental treatment is effective when it really is not.
(VERDADERO)

5.  In an adaptive design, trial parameters (e.g. eligibility criteria, allocation ratio) can be
modified based on interim results according to a plan specified in the study protocol
(VERDADERO)

6. The Physicians’ Health Study sought to examine the effects of beta-carotene and aspirin in
preventing cardiovascular disease and cancer. The investigators enrolled and randomized
approximately 22,000 male physicians in order to evaluate the independent and joint effects
of the two treatments. Which study design best describes this trial?
Group allocation design

2 separate parallel trials, one for beta-carotene and one for aspirin

Factorial design (MARQUE ESTA – 2 O MAS INTERVENCIONES - INTERACCION)

Crossover design

7. In light of the growing obesity epidemic, researchers seek to determine whether fruit juice is
associated with weight gain in children. Specifically, the investigators want to evaluate
whether fruit juice has similar effects on weight compared to water. Children in the same
household are randomized to the same intervention for fear that the drinks can be easily
mixed up in a household with more than one child participating in the study. Which study
design best describes this scenario.
Group allocation, equivalence design

Group allocation, non-inferiority design

Individual randomization, equivalence design

Individual randomization, superiority design

Group allocation, superiority design

Individual randomization, non-inferiority design (MARQUE ESTA) mala

 8. Duchenne muscular dystrophy is an X-linked recessive disorder that affects approximately 1
in 3,600 boys. A new drug has recently been developed to slow the progression of disease,
which has little carry-over effects if the patient stops taking the drug. Because the rate of
improvement varies substantially between patients and since this is a rare condition that only
affects a small population, researchers seek a study design that reduces variability between
patients and utilizes a limited sample size. The primary research question of interest is
whether this new drug is more efficacious than the standard of care. Which study design best
describes this trial?

Crossover, equivalence design

Parallel, non-inferiority design

Crossover, superiority design (marque esta)

Crossover, non-inferiority design

Parallel, superiority design

Parallel, equivalence design

9. A pharmaceutical company has developed a novel drug for the treatment of asthma. The
company hypothesizes that its new drug has similar efficacy compared to another
treatment that is currently on the market, but only needs to be taken once a day instead of
three times a day. The pharmaceutical company wants to maximize its profits by minimizing
the trial duration and sample size. In addition, to better understand which sub-populations
benefit most from the drug, the company has pre-specified parameters for adjusting the
sample size in favor of the sub-population that is showing the greatest benefit. Which study
design best describes this scenario?
Adaptive, superiority design

Large, simple, superiority design

 Adaptive, non-inferiority design

Large, simple, non-inferiority design

Adaptive, equivalence design (marque esta)

Large, simple, equivalence design

10. Thrombosis (the formation of blood clots) is responsible for hundreds of thousands of deaths
each year, and plasminogen activators are currently the standard of care for thrombotic
disorders. Investigators believe that alfimeprase is more efficacious than plasminogen
activators and design a study to determine which treatment achieves more rapid and
sustained thrombolysis. The investigators recruit patients with occluded arteries in hospital
settings and randomly assign them to receive either of the two treatments. Which study
design best describes this scenario.
Parallel, equivalence design

Crossover, superiority design

Crossover, equivalence design

Parallel, non-inferiority design

Crossover, non-inferiority design

Parallel, superiority design (marque esta)

QUIZ # 2
1. Randomization removes the treatment decision from the study participant and study staff.
Falso (me quedo mala)

2. Randomization guarantees that all treatment groups are comparable at the start of the study.
Verdadero (mala)…creo que una vez iniciado el estudio

3. Simple randomization is especially useful in situations where the investigator plans on

enrolling a small number of participants
Falso

4. Blocking helps assure that the allocation ratio within each stratum is met at the end of the
trial if all blocks are filled.
Falso (mala)

5. How many different treatment assignment lists are needed for a trial with 3 treatment groups,
an allocation ratio of 1:1:2, and stratified by 3 clinics and 2 severity indexes (mild vs.
moderate)?
None of these options (marque esta) (mala)

18

6. Investigators should stratify randomization by disease stage if that is a strong predictor of the
treatment outcome.
Verdadero. (Buena)

7. Minimization is a method that adjusts for treatment group imbalances as the trial progresses
Verdadero. (Buena)

8. Investigators enroll 1,000 participants in a trial, comparing Drug A and Drug B. 50% of the
population with the disease of interest has ‘mild’ symptoms, 30% has ‘moderate’ symptoms,
and 20% has ‘severe’ symptoms. Because the investigators believe that symptom severity is
an important predictor of treatment outcome, they want to stratify by symptom severity and
make sure that the allocation ratio is 1:1 in each of the three groups. In addition, the
 investigators want the proportion of participants receiving Drug A and Drug B to be
approximately equal over time. Which of the following randomization schemes would be
most appropriate for this scenario?
Adaptive randomization

Restricted randomization (escogi esta) (Buena)

Simple randomization

9. An important component of a successfully masked trial is to make the experimental and control
treatments appear identical
Falso (mala)

10. Masking tends to increase differential assessment of outcomes among study staff and health
care providers.
Falso. (Buena)

OTRO QUIZ SEMANA # 2 (REPETICION)

1. Randomization usually occurs after study participants have chosen whether to
receive the experimental drug or control treatment

Verdadero

Falso (marque esta). Los participantes no seleccionan el tratamiento y la aleatorizacion ocurre

precisamente para decidir a que tratamiento va el paciente.

2. Randomization guarantees that all treatment groups are comparable at the start of the
study.

Verdadero (marque esta) --- no garantiza…pero eso es lo que busca

Falso

3. In simple randomization, each new treatment assignment is completely unpredictable based

on previous assignments.

Falso

Verdadero (marque esta), porque la aleatorizacion simple es impredecible. No es como en la

adaptativa.
4. Block size(s) should always be revealed to study staff and participants at the start of
the study.
Verdadero
Falso (marque esta) – no deberia revelarse.

5. How many permuted blocks are there given two treatment groups, a 2:1 allocation
ratio, and a block size of 6.

6
Ninguna de las anteriores
360
720
15 (marque esta) lo hice sancando 6!/ 4! 2!

6. Investigators should stratify randomization by disease stage if that is a strong

predictor of the treatment outcome
Verdadero (marque esta)
Falso

7. Adaptive randomization allows investigators to modify randomization probabilities

throughout the trial.
Verdadero (marque esta)
Falso

8. Investigators enroll 1,000 participants in a trial, comparing Drug A and Drug B. The
investigators decide that determining each treatment assignment independently will achieve
an allocation ratio that is very close to 1:1 at the end of the trial. Which of the following
randomization schemes best describes this scenario.

Aleatorizacion simple (marque esta)

Aleatorizacion adaptativa
Aleatorizcion restricted

9. An important component of a successfully masked trial is to make the experimental

and control treatments appear identical.
Verdadero (marque esta)
Falso

10. Masking tends to increase differential assessment of outcomes among study staff and
health care provider.
Verdadero (marque esta) mala
Falso (era esta)
11. Selection bias refers to preferentially allocating participants to a particular treatment group
based on some characteristic of the participant (e.g. disease stage, prognosis, other co-
morbidities) (VERDADERO)

12. Assuming a 1:1 allocation ratio with two treatment groups, blocking helps assure that overall,
an equal or similar number of study participants will be assigned to each treatment group
(VERDADERO).

13. How many different treatment assignment lists are needed for a trial with 3 treatment groups,
an allocation ratio of 1:1:2, and stratified by 3 clinics and 2 severity indexes (mild vs.
moderate). (MARQUE 18). TAMBIEN ESTAN LAS OPCIONES 9,3,6 O NINGUNA. (MALA)

14. Randomization probabilities should never be changed throughout a trial because this
undermines the validity of the study. (FALSO).

15. Investigators enroll 1,000 participants in a trial, comparing Drug A and Drug B. The
investigators pre-specify in their study protocol that the randomization probability for each
new participant will change throughout the trial to favor the treatment group with fewest
participants. Which of the following randomization schemes best describes this scenario.
(ALEATORIZACION ADAPTATIVA)

16. Treatment assignments should always be masked in order to maintain the validity of a study.
FALSA. (ME IMAGINO QUE POR LS CUESTIONES ETICAS ALGUIEN DEBE SABER)

17. Masking outcome assessment is more important for subjective outcomes than for objective
outcomes. (VERDADERO).

18. Investigators should stratify the randomization by as many variables as posible (FALSO)

19. Play the winner is a type of adaptive randomization, in which participants with the worst
prognoses are restricted from receiving the experimental treatment. (FALSO)
QUIZ SEMANA 3

1. Objective outcomes require a great amount of judgment and interpretation.

TRUE
FALSE (marque esta)
2. Allowing study staff the flexibility to assess the outcome using the method with which they
are most comfortable helps protect the study from bias.

FALSE (marque esta)

TRUE

3. A pharmaceutical company develops a new drug to improve balance among the elderly. The
new drug is recommended for individuals over 60 years of age to prevent unintentional falls.
Investigators enroll 200 study participants in a randomized-controlled trial to evaluate the
effectiveness of the drug for preventing falls. Half of the study participants are randomized to
receive the new drug while the other half are randomized to receive a control treatment. At
the end of a one-year follow-up period, the investigators compare the number of participants
in each treatment group who did not fall at all versus those who fell at least once as a
measurement of the primary outcome (unintentional falls). Which of the following best
describes the primary outcome variable of this study

Ordinal

Dicotomica (esta)

Continua

4. Which of the following is NOT an example of an ordinal variable?

Life stage: infant, child, adolescent, adult, elderly
Temperature: cold, warm, hot
Fruit: apple, orange, banana (marque esta)
Exam performance: below average, average, above average, outstanding
Education: elementary school, middle school, high school, college, graduate school

5. Investigators are interested in how diet affects long-distance running speed. They enroll 30
female varsity cross-country athletes at public high schools in Maryland, all of whom have a
personal best time of 20-22 minutes for a 5-kilometer race. Half of the study participants are
randomized to receive a high-protein diet for one month while the other half are randomized
to receive a high-carbohydrate diet for one month. At the end of the month, each athlete is
asked to run a 5-kilometer race and their exact finishing times are recorded and used for
analysis. Each athlete’s 5-kilometer finishing time serves a measurement of the primary
 outcome in the study (running speed). Which of the following best describes the primary
outcome variable of this study

Continua (marque esta – porque est timpo a finalizar…)

Dicotomica
Ordinal

6. It is common for investigators to specify a study’s primary outcome(s) after the data
collection process.
Falso (marque esta)
Verdadero

7. In an intention-to-treat analysis, participants who withdraw from a study before its conclusion
should be excluded from the primary analysis.

Falso (marque esta)

Verdadero

8. In the primary analysis of clinical trials, adherence should be adjusted for in the active
treatment group, but not the control group.
Verdadero
Falso (marco esta, porque no se debe realizer analisis de adherencia en los resultados
primaries, sino en los secundarios).

9. Important subgroups that may have an influence on the treatment effect should be specified
in the protocol and statistical analysis plan.
Falso
Verdadero (marque esta)

10. Investigators should be very excited about a statistically significant finding (p ≤ 0.05) when
performing multiple subgroup tests because it is highly likely that the difference detected is a
true difference.
Falso (marque esta)
Verdadero
Todo estuvo Bueno

QUIZ SEMANA 6
1. A major weakness of randomized clinical trials is that the design features, such as
randomization and masking, tend to introduce bias. (FALSO).

2. When evaluating the strength of evidence for a specific treatment on a health outcome, the
evidence from a systematic review of randomized clinical trials typically carries more weight
than the evidence from a single randomized trial (VERDADERO)

3. The size of the association between a treatment and outcome in an observational study is
always consistent with the effect size in a randomized clinical trial. (FALSO).
 4. Comparing results from two trials with different lengths of follow up can result in inconsistent
conclusions about the treatment’s efficacy between the two studies. (VERDADERO)

5. Confounding should be ignored when interpreting the results of a study. (FALSO)

6. Observational studies tend to produce more precise estimates of the true treatment effect
compared to randomized clinical trials. (FALSO).

7. A major strength of randomized clinical trials is that they produce results that are
generalizable to a wide variety of patient populations and health care settings. (FALSO).

8. Continued surveillance of treatments using observational studies are useful for identifying
safety signals and potential adverse events that were not detected in earlier clinical trials.
(VERDADERO).

9. Reporting bias is more likely to be introduced in randomized clinical trials than in

observational studies. (FALSO).

10. In situations where it is not ethical to conduct a randomized clinical trial, observational
studies can provide valuable information. (VERDADERO).

OTRO QUIZ – QUIZ NUMERO 5

1. CONSORT guidelines were developed because some researchers struggled with

interpreting results of clinical trials that were reported with insufficient detail and depth.
(VERDADERO).

2. A structured abstract is a succinct summary of the design, methods, main results, and
conclusions of a study.(VERDADERO)

3. The introduction of a clinical trial report should reference a systematic review if possible.
(VERDADERO).

4. A clinical trial report should include a description of the trial design (e.g. parallel, factorial,
crossover, group allocation, superiority, equivalence, non-inferiority). (VERDADERO).

5. It is not necessary to report the details of the randomization process in a clinical trial report.
(FALSO).

6. In a clinical trial report, authors should indicate whether masking was implemented, and if so,
which parties were masked. (VERDADERO)

7. Investigators should only report details about the final protocol and do not need to discuss
important changes that were made to the study protocol (e.g. eligibility criteria, outcome
measures) while the trial was in progress. (FALSO)

8. It is not necessary to report adverse events observed during a trial if authors are struggling
with the word count limit. (FALSA)
9. The discussion section of a clinical trial report should describe the population to whom the
results are generalizable. (VERDADERO)

10. A well-written clinical trial report contains sufficient information for the reader to replicate the
study procedures. (VERDADERO).