Section/topic

#

PRISMA-DTA Checklist Item

Reported on page #

TITLE/ABSTRACT

Title

1

Identify the report as a systematic review (+/− meta-analysis) of diagnostic test accuracy (DTA) studies.

1

Abstract

2

Abstract: See PRISMA-DTA for abstracts.

INTRODUCTION

Rationale

3

Describe the rationale for the review in the context of what is already known.

2

Clinical role of index test

D1

State the scientific and clinical background, including the intended use and clinical role of the index test, and if applicable, the rationale for minimally acceptable test accuracy (or minimum difference in accuracy for comparative design).

2

Objectives

4

Provide an explicit statement of question(s) being addressed in terms of participants, index test(s), and target condition(s).

2

METHODS

Protocol and registration

5

Indicate if a review protocol exists, if and where it can be accessed (e.g., Web address), and, if available, provide registration information including registration number.

Suppl 3-7

Eligibility criteria

6

Specify study characteristics (participants, setting, index test(s), reference standard(s), target condition(s), and study design) and report characteristics (e.g., years considered, language, publication status) used as criteria for eligibility, giving rationale.

2-3

Information sources

7

Describe all information sources (e.g., databases with dates of coverage, contact with study authors to identify additional studies) in the search and date last searched.

2-3

Search

8

Present full search strategies for all electronic databases and other sources searched, including any limits used, such that they could be repeated.

2-3

Study selection

9

State the process for selecting studies (i.e., screening, eligibility, included in systematic review, and, if applicable, included in the meta-analysis).

3

Data collection process

10

Describe method of data extraction from reports (e.g., piloted forms, independently, in duplicate) and any processes for obtaining and confirming data from investigators.

3

Definitions for data extraction

11

Provide definitions used in data extraction and classifications of target condition(s), index test(s), reference standard(s) and other characteristics (e.g. study design, clinical setting).

3

Risk of bias and applicability

12

Describe methods used for assessing risk of bias in individual studies and concerns regarding the applicability to the review question.

3

Diagnostic accuracy measures

13

State the principal diagnostic accuracy measure(s) reported (e.g. sensitivity, specificity) and state the unit of assessment (e.g. per-patient, per-lesion).

3

Synthesis of results

14

Describe methods of handling data, combining results of studies and describing variability between studies. This could include, but is not limited to: a) handling of multiple definitions of target condition. b) handling of multiple thresholds of test positivity, c) handling multiple index test readers, d) handling of indeterminate test results, e) grouping and comparing tests, f) handling of different reference standards

4

Meta-analysis

D2

Report the statistical methods used for meta-analyses, if performed.

4

Additional analyses

16

Describe methods of additional analyses (e.g., sensitivity or subgroup analyses, meta-regression), if done, indicating which were pre-specified.

4

RESULTS

Study selection

17

Provide numbers of studies screened, assessed for eligibility, included in the review (and included in meta-analysis, if applicable) with reasons for exclusions at each stage, ideally with a flow diagram.

5, Figure 1

Study characteristics

18

For each included study provide citations and present key characteristics including: a) participant characteristics (presentation, prior testing), b) clinical setting, c) study design, d) target condition definition, e) index test, f) reference standard, g) sample size, h) funding sources

8-9, Table 1, Table 2