Checklist STARD

Section and

Item

Code

Topic
TITLE, ABSTRACT AND KEYWORDS
1

Identify the article as

Title : Evaluation od a new fluorescence

a study of diagnostic

quantitative PCR test for diagnosing

accuracy (recommend

Helicobacter Pylori infection in Children.

MeSH heading

(page 1)

sensitivity and
specificity)
INTRODUCTION
2

State the research

The aim of this prospectivestudy was to

questions or aims,

evaluate the accuracy of this new fqPCR test

such as estimating

for detection of H. pylori infection in children,

diagnostic accuracy

in comparison to commonly used tests :

or comparing

routine histology. RUT and C-UBT. (page 2)

accuracy between
tests or across
participant groups
METHODS
Participants

Describe the study

From July to Desember 2011, 138 consecutive

population: the

eligible patients undergoing routinely

inclusion and

scheduled endoscopy at Guangzhou Women

exclusion criteria and

and Childrens Medical Center (Guangzhou,

the settings and

China) were selected to participate in this

locations where the

study after informed consent was obtained

data were collected.

from parents. (page 2)

We included any children who had

gastrointestinalsymptoms and chronic gastritis
determined by histology. (page 2)
W excluded children who had taken
antibiotic, proton pump inhibitors, H-2
antagonists or gastric motility drugs within 4
weeks prior to endoscopy. (page 2)
4

Describe participant

We included any children who had

recruitment: was this gastrointestinal symptoms and chronic

based on presenting
symptoms, results
from previous tests,
or the fact that the
participants had

gastritis determined by histology. (page 2)

We excluded patients who had acute
gastrointestinal bleeding within 1 week of
endoscopy. (page 2)

received the index

tests or the reference
standard?
5

Describe participant
sampling: was this a
consecutive series of
participants defined
by selection criteria in
items 3 and 4? If not,
specify how
participants were
further selected.

Describe data
collection: was data
collection planned
before the index tests

Retrospective study :
We included any children who had
gastrointestinal symptoms and chronic

and reference
standard were
performed
(prospective study) or
after (retrospective
study)?
Test Methods

Describe the
reference standards
and its rationale.

Describe technical
specifications of
material and methods
involved, including
how and when
measurements were
taken, or cite
references for a)
index test or b)
reference test

Describe definition of
and rationale for the
units, cut-off points,
or categories of the
results of the a) index
test and
b) reference standard.

10

Describe the number,

training and expertise
of the persons
executing and reading

gastritis determined by histology. (page 2)

the a) index tests and

b) reference
standards.
11

Were the readers of

According to standard protocol, antral

the a) index test and

specimens were fixed in a 20% buffered

b) reference standards

formalin solution, embedded in paraffin and

blind (masked) to the

stained with hematoxylin and eosin and

results of the other

Giemsa fos histology and the presence of H.

test? Describe any

pilori bacteria was determined by two

other clinical

experienced pathologists, who were blinded to

information available

all other results. (page 2)

to the readers.
Statistical

12

Methods

Describe methods for

Statistical analysis was carried out by using

calculating or

using SPSS soft-ware version 16.0. (page 3)

comparing methods
of diagnostic
accuracy and the
statistical methods
used to quantify
uncertainty (e.g. 95%
CI)
13

Describe methods for

Chi-square and Fishers exact tests were

calculating test

applied to aour analysis. P values <0,05 was

reproducibility, if

considered statistically significant. (page 3)

done.

Participants

14

Report when study

was done, including
beginning and ending
dates of recruitment

15

Report clinical and

A total of 138 children (male 94,

demographic

mean age of 8.3 years,

characteristics of the

range 214 years) were enrolled in

study population (e.g.

this study. The indications for

age, sex, spectrum of

endoscopy included abdominal pain,

presenting symptoms,

nausea, vomiting, anorexia, iron-

co morbidity, current

deficiency anemia, heartburn,

treatments,

hiccups, fullness, anorexia, and acid

recruitment centres)

reflux. All participants had been

diagnosed with chronic gastritis

16

Report the number of

confirmed by histology. (page 3)

-

participants satisfying
the criteria for
inclusion that did or
did not undergo the
index tests and/or the
reference standard;
describe why
participants failed to
receive either test.
Test results

17

Report time interval

from the index tests
to the reference
standard, and any
treatment
administered
between.

18

Report distribution of
severity of disease
(define criteria) in

those with the target

condition; other
diagnoses in
participants without
the target condition.
19

Report a cross

Tabel 1 (page 3)

tabulation of the
results of the index
tests (including
indeterminate and
missing results) by
the results of the
reference standard;
for continuous results,
the distribution of the
test results by the
results of the
reference standard.

20

Report any adverse

events form
performing the index
tests or the reference
standard.
Estimates

21

Report estimates of

Gastric biopsy specimen fqPCR was positive

diagnostic accuracy

for H. pylori in 46 (33.3%) children,

and measures of

significantly higher than gold standard (p <

statistical uncertainty

0.01). (Page 3)

(e.g. 95% CI)

22

Report how

indeterminate results,
missing responses
and outliers of the
index tests were
handled.
23

Report estimates of

variability of

determined by mucosal fqPCR method

diagnostic accuracy

is higher and varied from 25.9% to

between subgroups of

56.5% among different age groups. H.

participants, readers

pylori infection rate is the highest at

or centres, if done.

1012 year-old children with

gastritis.
Gambar 1
(page 4)

24

In contrast, H. pylori infection rate

Report estimates of

test reproducibility, if
done.
DISCUSSION

25

Discuss the clinical

applicability of the
study findings.