Blog

Item No

Item Description

Applicable to Section

Page no. where reported

1

By using at least one measure of accuracy (such as
sensitivity/specificity/predictive values/AUC), the study
identification is made as a diagnostic accuracy study

TITLE OR ABSTRACT

2

Structured summary of study design, methods, results, and
conclusions (for specific guidance, see STARD for
Abstracts)

ABSTRACT

3

Provide scientific and clinical background, including the
intended use and clinical role of the index test

INTRODUCTION

4

Detail study objectives and hypotheses

5

Mention the type of study – prospective or retrospective

METHODS – Study Design

6

Define eligibility criteria

METHODS – Participants

7

Provide basis of identification of potentially eligible
participants

(i.e., symptoms, results from previous tests, inclusion in
registry)

8

Mention date, location and setting for identification of
potentially eligible participants

9

Mention whether participants formed a consecutive, random
or convenience series

10a

Include sufficient details of index test to allow
replication

METHODS – Test Methods

10b

Include sufficient details of reference standard to allow
replication

11

Give rationale for choosing the reference standard (if
alternatives exist)

12a

Give rationale and define the cut-offs or result categories
of the index test for test positivity; pre-specified tests
should be distinguished from exploratory tests

12b

Give rationale and define the cut-offs or result categories
of the reference standard for test positivity;
pre-specified tests should be distinguished from
exploratory tests

13a

State whether the performers/readers of the index test were
made available the clinical information and reference
standard results

13b

State whether the assessors of the reference standard were
made available the clinical information and reference
standard results

14

Methods for estimating or comparing measures of diagnostic
accuracy to be presented

METHODS – Analysis

15

Mention the methods for handling of indeterminate index
test or reference standard results

16

Mention the methods for handling of missing data on the
index test and reference standard

17

Analyses of variability in diagnostic accuracy,
distinguishing pre-specified from exploratory

18

Explain the determination of intended sample size

19

Provide participant flow of diagram

RESULTS – Participants

20

Provide baseline demographic and clinical characteristics

21a

Classify the severity of disease in those with the target
condition

21b

Mention any alternative diagnoses in those without the
target condition

22

State the time interval and any clinical interventions
between index test and reference standard

23

Provide cross tabulation of the index test results (or
their distribution)

by the results of the reference standard

RESULTS – Test Results

24

Give the estimates of diagnostic accuracy and their
precision (such as 95% confidence intervals)

25

Report any adverse events

26

Mention study limitations, including sources of potential
bias, statistical uncertainty, and generalizability

DISCUSSION

27

Clinical implications including the intended use and
clinical role of the index test to be mentioned

28

Provide the registration number and name of registry

OTHER INFORMATION

29

Mention the location to access the full study protocol

30

Sources of funding and other support; role of funders to be
mentioned