Table 1 Potential relevant items for PRISMA-DTA checklist. Items deemed by the authors to apply specifically to DTA reviews are in Bold
Item | Ref | |
|---|---|---|
Title | ||
1 | Identify the report as a systematic review, meta-analysis or both | [12] |
2 | Identify the report as a study of diagnostic accuracy using at least one measure of accuracy | [28] |
3 | State whether the report is a comparative (one diagnostic test vs. another) or a non-comparative review | |
Introduction | ||
4 | State the scientific and clinical background, including the intended use and clinical role of the index test (e.g., triage test, add-on test, or replacement test | [39] |
5 | List review objective using PICO format (participant characteristics, intervention, comparison, outcome) | [12] |
Methods: protocol eligibility, and search | ||
6 | Indicate if a review protocol exists, where it can be accessed and, if available, registration number | [12] |
7 | Report deviations from the original protocol | [31] |
8 | Report which outcomes are considered primary and secondary | [31] |
9 | Describe all information sources and the date of search | [12] |
10 | Report restrictions to search strategy (language, publication status, dates) | [31] |
11 | Present full electronic search strategy for at least one database, including any limits used, such that it could be repeated | [12] |
12 | Report whether hand searching of reference lists was done | [31] |
13 | Describe methods to ensure that overlapping patient populations were identified and accounted for | [31] |
14 | List any search of the gray literature including search of study registries | [31] |
15 | Specify criteria for eligibility | [12] |
Methods: study selection and data collection | ||
16 | Report the process for selecting studies (i.e., screening, full-text eligibility) | [12] |
17 | Provide an appendix with studies excluded, with reasons for exclusion, during full-text screening | [12] |
18 | Describe method of data extraction from reports | [12] |
19 | Report which data items were extracted from included studies | [12] |
20 | Report how studies for which only a subgroup of participants is relevant to the review will be handled | [31] |
21 | Report how “indeterminate” or “missing” results for either the index test or reference standard were dealt with in the analysis | [40] |
22 | Report if and how any parameters beyond test accuracy will be evaluated (e.g., cost-effectiveness, mortality) | [46] |
Methods: primary study data items | ||
23 | (a) Patient demographic information (age, gender) | |
(b) Target condition definition | ||
(c) Index test | ||
(d) Reference standard | ||
(e) Positivity thresholds | ||
(f) Blinding information | ||
(g) Clinical setting | ||
(h) Disease prevalence | ||
(i) Cross-tabulation of index test with reference standard (2 × 2 table) | ||
(j) Funding sources | ||
Methods: risk of bias and heterogeneity | ||
24 | Report how included individual studies will be assessed for methodological quality (e.g., QUADAS-2) | [14] |
25 | Describe if and how “piloting” the risk of bias tool was done | [14] |
26 | List criteria used for risk of bias ratings applied during the review | [31] |
27 | Describe methods for study quality assessment | [12] |
28 | Provide measures of consistency (e.g., tau2) for each meta-analysis | [12] |
29 | Describe test used to assess for publication bias | [12] |
Methods: summary measures and statistics | ||
30 | State the principal summary measures of diagnostic accuracy to be assessed | [28] |
31 | Report whether summary measures were calculated on a per-patient or per-lesion basis | [31] |
32 | Report pre-defined criteria for minimally acceptable test performance | [42] |
33 | State how multiple readers of an index test were accounted for | [17] |
34 | Report the statistical method used for meta-analysis (e.g., hierarchical model) | [2] |
35 | State which software package and macros was used for meta-analysis | [6] |
36 | Report any programming deviations made from published software packages | [6] |
37 | If comparative design, state the statistical methods used to compare test accuracy | [28] |
38 | Describe methods of additional analyses (e.g., subgroup), indicating whether pre-specified | [12] |
39 | Report how subgroup analyses were performed | [31] |
40 | When performing meta-regression report the form of factors being explored (categorical vs. continuous) and the cut-off points used | [41] |
Results | ||
41 | Report studies from screen to inclusion, ideally with a flow diagram | [12] |
42 | For each study, present characteristics for which data were extracted and provide the citations | [12] |
43 | Present data on risk of bias of each study on a per-item or per-domain basis | |
44 | Present results of any assessment of publication bias | [12] |
45 | Report any adverse events or harms from index test or reference standard | [31] |
46 | For each study report 2 × 2 data (TP, FN, FP, TN) | |
47 | For each study report summary estimates of accuracy and confidence intervals | [28] |
48 | Report each meta-analysis including confidence intervals and measures of consistency (e.g., tau2) | [12] |
49 | Graphically display results with an ROC curve or forest plots of sensitivity and specificity | [44] |
50 | Report additional analyses (e.g., meta-regression) | [12] |
51 | Report risk of bias in the synthesis (e.g., analyses stratified by risk of bias) | [31] |
52 | Report summary of findings table with main outcomes and issues re: applicability of results | [31] |
53 | Report “frequency” tables of 2 × 2 data demonstrating potential findings in a patient population based on the prevalence | [45] |
Discussion | ||
54 | Summarize findings including implications for practice | |
55 | Provide a general interpretation of the results in the context of other evidence and implications for future research | [12] |
56 | For comparative design, report whether conclusions were based on direct vs. indirect comparisons | [37] |
57 | Discuss the implications of any missing data | [31] |
58 | Discuss applicability concerns to different populations/settings | |
59 | Discuss quality of included studies when forming conclusions | [36] |
60 | Account for any statistical heterogeneity when interpreting the results | [31] |
61 | Discuss the potential impact of reporting biases | [31] |
62 | Discuss the five GRADE considerations (study limitations, consistency of effect, imprecision, indirectness, and publication bias) | [31] |
Disclosure | ||
63 | Describe sources of funding for the review and role of funders | [12] |
64 | Report potential relevant conflicts of interest for review investigators | [36] |