II.

Checklist STARD

Section & Topic No. x Item Reported On Page

TITLE OR
ABSTRACT
1 Identification as a
study of diagnostic
accuracy using at least
one measure of
accuracy (such as
sensitivity, specificity,
predictive values, or
AUC)
ABSTRACT
2 Structured summary
of study design,
methods, results, and
conclusions (for
specific guidance, see
STARD for Abstracts)

INTRODUCTION
3 Scientific & clinical The correct diagnosis of histologic gastritis is difficult by endoscopic observation, making
background, including gastric biopsy necessary. Histologic gastritis is recognised endoscopically by the atrophic
the intended use and border. Changes in the areae gastricae are also used diagnostically
clinical role of the
index test
 4 Study objectives and
hypotheses

METHODS
Study design 5 Whether data Prospective, because
collection was
planned before the
index test and
reference standard
were performed
(prospective study) or
after (retrospective
study)

Participants 6 Eligibility criteria

7 On what basis We examined 176 Japanese patients (84 men and 92 women, mean age 57.0 years, range 21–
potentially eligible 84 years) with dyspepsia including 53 patients who underwent H. pylori eradication therapy
participants were more than 12 months prior to our study at Hiroshima University Hospital
identified (such as
symptoms, results
from previous tests,
 inclusion in registry)
8 Where and when
potentially eligible
participants were
identified (setting,
location and dates)

9 Whether participants Convenience, bacause

formed a consecutive,
random or
convenience series

Test methods 10a Index test, in

sufficient detail to Two endoscopy specialists independently classified the ordinary and magnifying endoscopic
allow replication findings without the patient information including the result of the eradication therapy. When
we found the heterogeneity in the magnifying observation, we judged by the major appearance
of magnifying endoscopy. A biopsy specimen with the use of standard forceps was obtained
10b Reference standard, in from the lesions that were observed, and histologic gastritis in haematoxylin and eosin (HE)-
sufficient detail to stained sections were estimated with the use of updated Sydney system [17]. The pathologist
allow replication judged the histological finding without having information of clinical and endoscopic findings.

11 Rationale for Although endoscopic attempts have been made to classify gastritis, no markers of inflam-
choosing the reference mation activity have been defined. (Sakaki et al). established a classification system for
standard (if magnifying gastroendoscopy, but it has not been applied clinically because of difficulties in
alternatives exist) observation and the complexity of classification.
 12a Definition of and
rationale for test
positivity cut-offs or
result categories of
the index test,
distinguishing pre-
specified from
exploratory.

12b Definition of and

rationale for test
positivity cut-offs or
result categories of
the reference
standard,
distinguishing pre-
specified from
exploratory

13a Whether clinical Kappa value of the classification by two endo- scopists was calculated as 0.906 (95%
information and confidence interval (95% CI): 0.846–0.966).
reference standard
results were available
to the
performers/readers of
the index test
13b Whether clinical With the use of ordinary endoscopy, we could diagnose the histologic gastritis correctly only
information and index in 107 out of the 176 (60.8%) cases
test results were
available to the
assessors of the
reference standard
Analysis 14 Methods for Statistical analysis was performed by χ2-test with StatView software (SAS Institute Inc., Cary,
estimating or
 comparing measures NC). A P-value of less than 0.05 was considered statistically significant.
of diagnostic accuracy

15 How indeterminate Not given

index test or reference
standard results were
handled
16 How missing data on Not given
the index test and
reference standard
were handled
17 Any analyses of there were some false-negative type 2, because the type 2 appearance
variability in included mucosa with and without gastritis as shown in
diagnostic accuracy, Table 1. First reason of false-negative diagnosis (type 2
distinguishing pre- appearance with presence of histological gastritis) was het-
specified from erogeneous status of gastric mucosae.
exploratory
18 Intended sample size
and how it was
determined

RESULTS
Participants 19 Flow of participants, Not given in diagram
using a diagram
20 Baseline demographic Not given in table
and clinical We examined 176 Japanese patients (84 men and 92 women, mean age 57.0 years, range 21–
characteristics of 84 years) with dyspepsia including 53 patients who underwent H. pylori eradication therapy
participants more than 12 months prior to our study at Hiroshima University Hospital.
 21a Distribution of The four types of magnifying endoscopy appearances. (A) Type 1 is pinpoint pits on the flat
severity of disease in field. (B) Type 2 is a regular, trabecular ridge pattern or a regular, flat granular pattern. (C)
those with the target Type 3 is mucosa consisting of irregular and coarse granular structure. (D) Type 4 is a
condition prominent clubbing (villous) or papillary pattern (magnification 80×).

21b Distribution of
alternative diagnoses
in those without the
target condition
22 Time interval and any In the present study, the patients have undergone therapy more than 12 months prior to our
clinical interventions study, perhaps long enough to show normal turnover of epithelial cells. It would be helpful to
between index test examine the changes over time after eradication of H. pylori.
and reference standard

Test results 23 Cross tabulation of Table 2,3, and 4

the index test results
(or their distribution)
by the results of the
reference standard
24 Estimates of - Sensitivity and specificity of diagnosis of histological gastritis by magnifying
diagnostic accuracy endoscopic examination were 96.3 and 73.7%, respec- tively.
and their precision
(such as 95% - Sensitivity and speci- ficity of diagnosis of histologic gastritis by ordinary endo- scopic
confidence intervals) examination were 66 and 52.9%, respectively.

25 Any adverse events Kappa value of the classification by two endo- scopists was calculated as 0.906 (95%
from performing the confidence interval (95% CI): 0.846–0.966).
index test or the
reference standard
DISCUSSION
26 Study limitations, Untuk type 2 terjadi kesulitan pada magnifying endoscopy, karena (the type 2 appearance
including sources of included mucosa with and without gastritis as shown in)
potential bias,
statistical uncertainty,
 and generalisability
27 Implications for
practice, including the However, there were some false-negative type 2, because the type 2 appearance included
intended use and mucosa with and without gastritis as shown in Table 1. First reason of false-negative diagnosis
clinical role of the (type 2 appearance with presence of histological gastritis) was heterogeneous status of gastric
index test mucosae.

OTHER
INFORMATION
28 Registration number Not given
and name of registry
29 Where the full study
protocol can be
accessed
30 Sources of funding
and other support;
role of funders