No.

Can you find this information

Answer

in the paper
1

What is the research question Research

and/or hypothesis?

question

to

determine

effectiveness of G biloba vs placebo in

reducing the incidence of all-cause
dementia and Alzheimer disease (AD) in
elderly

individuals

with

normal

cognition and these with mild cognitive

impairment (MCI)
2

What is the study type?

RCT (Randomized Clinical Trial)

What is reference population?

Reference population: Five academic

What are sampling frame and

sampling method?

medical centers in the United States

Sampling frame: Three
sixty-nine

community

thousand
volunteers

aged 75 years or older with normal

cognition (n=2587) or MCI (n=482)
at study entry were assessed every 6
months for incident dementia
Sampling method: Randomized
4

In an experimental study, how In the calculation of the sample size, it

are subject assigned to group?

was assumed that in the placebo group,

In a longitudinal study, how the rate of dementia would be 4% per

many reached final follow up?

year and that the combined mortality and

dropout rate would be 6% per year based
on limited data from observational
studies. With the use of these estimates,
the planned sample size of 3000 with an
average follow-up of 5.0 years result in
96% power to detect a 30% reduction in
the rate of dementia at a 2-sided

singnificance level of .05. Under these

assumptions, the expected total number
of dementia cases at the conclusion of
the trial would be 439. The sample size
also provided adequate power (86%) to
detect a 25% reduction in risk. Because
of the uncertainties of the estimate of the
dementia

rate,

the

study

protocol

contained a provision allowing the

continuation of the study beyond 5 years
until the total of 439 dementia cases
occurred, if approved by the DSMB of
the study and the funding agency.
5

What are the study factors and

how are they measured?

Study factor: Dementia

Measured: Ginkgo Evaluation of
Memory (GEM) Study

What are the outcome factors

and how are the measured?

Outcome: Ginkgo biloba

Measured: Ginkgo Evaluation of
Memory (GEM) Study

What

important

potential No control group

confounders are considered?

8

Are statical test considered?

Are the result clinically/socially Yes, the result clinically/socially is

important?

10

Yes, t-test

important

What conclusion did the authors

Yes,

reach

research question

about

the

research

the

conclusion

reach

question? Did they generate new

Yes, they didnt

hypothesis? Do you agree with

Yes, I agree with the conclusion

the conclusions?

the

No. Can you find this information

Answer

in the paper
1

What is the research question Research

and/or hypothesis?

question

effectiveness

of

to
two

evaluate
doses

the

of

monovalent rotavirus vaccine (RV1)

against hospital admission for rotavirus
in Bolivia
2

What is the study type?

Case-control study

What is reference population?

Reference population: Six hospitals

What are sampling frame and

in Bolivia, between March 2010 and

sampling method?

June 2011
Sampling

frame:

400

hospital

admissions for rotavirus, 1200 nondiarrhea hospital controls, and 718

rotavirus negative hospital controls
Sampling

method:

Cases

and

controls
4

In an experimental study, how Using a precision based approach, we

are subject assigned to group?

estimated that we needed a total of 170

In a longitudinal study, how case patients to compute a vaccine

many reached final follow up?

effectiveness of 60% with a confidence

limit width of 30%, using a matched
design with a control to case ratio of
three to one and vaccine coverage of
50%. We enrolled a total of 400 case
patients to allow for subgroup analyses
including

effectiveness

of

partial

vaccination, strain specific effectiveness,

and effectiveness stratified by age.
Because we did not specifically calculate

sample sizes for the subgroup analyses

(strain specific and age stratified vaccine
effectiveness), we did a post hoc power
analysis

and

effectiveness

present

result
2

power using

vaccine

when

expected

exceeded 80% at a

significance level of 0.05 given the

observed number of cases and controls
for each of the secondary outcomes.
5

What are the study factors and

Study

how are they measured?

diarrhea

factor:

Rotavirus

positive

Measured: A commercially available

enzyme

immunoassay

(ProSpecT

What are the outcome factors

Outcome: Monovalent

rotavirus

and how are the measured?

vaccine

ELISA)
6

Measured:

Vaccination

history

(vaccination card from patient and

vaccination record at the clinic)
7

What

important

potential A false positive enzyme immunoassay

confounders are considered?

result for rotavirus could lead to

misclassification of a test negative
control as a case. Some differences in
demographics

and

socioeconomic

indicator existed between the case, nondiarrhea control, and test negative
controls
Yes, Wilcoxon rank sum test or 2 test

Are statical test considered?

Are the result clinically/socially Yes, the result clinically/socially is

important?

important

10

What conclusion did the authors

Yes,

reach

research question

about

the

research

the

conclusion

reach

question? Did they generate new

Yes, they didnt

hypothesis? Do you agree with

Yes, I agree with the conclusion

the conclusions?

the