Are the results valid?

1. Was there a clearly defined, focused

research question? What was the study
question?

The aim of this study was to assess the

prevalence of excessive crying at the age
of 3 months and to test the hypothesis
that excessive crying at this age is
associated with behavioural problems
when children reach the age of 4 years.
(Page 1. Introduction)

2. How was the exposed cohort selected?

Was there a well defined selection
procedure for inclusion into the cohort?
What proportion of eligible subjects was
actually included?

3. How was the non-exposed cohort

selected? Was this cohort drawn from the
same source population as the exposed
cohort? Was there a well defined selection
procedure for inclusion into the cohort?

4. How were the main exposures

ascertained? Were the exposures clear,
specific and measurable?

A birth cohort was started in 2004 in the

city of Pelotas (Southern Brazil) when all
live births were
included between January 1st and
December 31st.
Only newborns to mothers living in the
urban area
of Pelotas were eligible to the study. Of a
total of 4263 mothers complying with this
inclusion criterion, 32 (0.8%) refused to
participate in the perinatal study.
The Non-exposed cohort selected drawn
from the same source population as the
exposed cohort.
A birth cohort was started in 2004 in the
city of Pelotas (Southern Brazil) when all
live births were
included between January 1st and
December 31st.
Only newborns to mothers living in the
urban area
Excessive crying was assessed at the 3month visit
by asking the mother whethercompared
to babies
of the same age, her baby cried more,
less or as the
same. Infants whose mothers perceived
them as crying more than others of the
same age were classified as crying
babies.
(page 1-2, Exposure)
Child behaviour was assessed through the
application to the mother of the 418 year
version of the Child Behavior Checklist
(CBCL) 25 when children were 4 years of
1

5. Were only people at risk of the outcome Yes

included?
In the crude analysis crying babies had
higher risk of being in the clinical range
for
CBCL
total,
internalising
and
externalising problems than babies who
did not cry a lot. (Table.3)
(Page 3.)
Yes, the subject being followed up at 3,
12, 24, 48 and 72 months of age.
Child behaviour was assessed through
the
application
to the mother of the 418
(Page
1. Method)
year version of the Child Behavior
Checklist (CBCL) 25 when children were 4
years of age.
7. Was follow-up complete? Were effortsFollow-up complete.
made to limit the loss to follow-up?
(Page.2.
Tetapi pada
Outcome)
jurnal tidak dijelaskan usaha
apa
saja
yang
dilakukan untuk
9. Were outcomes measures similarly in Yes
meminimalkan
loss follow-up
exposed and non exposed cohorts?
Among children with excessive crying at 3
months the proportion in the clinical
range for CBCL total, internalising and
externalising problems at 4 years of age
was 31.2%, 12.9% and 37.5%,
respectively. Among non-crying babies
CBCL total, internalising and externalising
problems were 20.6%, 6.8% and
29.6%, respectively. (Table.2)
6. Was duration of follow-up adequate (i.e.
long enough for main outcomes to occur)?
8. What were the primary and secondary
outcomes of the study?

10. How comparable were the exposed

and non-exposed cohorts? Have the
authors identified all potentially important
confounders? Is there information on how
the potential confounders are distributed
between the comparison groups? What
confounders were adjusted for and was
the adjustment adequate? Is residual
confounding a concern?

Any other potential biases in this study?

Potential for selection bias?

Potential for information bias?