Table 2.
Risk of bias and applicability concerns summary of the included studies.
| Study | Risk of bias1 | Applicability2 | |||||
|---|---|---|---|---|---|---|---|
| Patient selection3 | Index text4 | Reference Standard5 |
Flow and timing6 | Patient selection | Index text | Reference standard |
|
| Pan et al (16) | H | L | L | L | L | L | L |
| Huynh et al. (17) | H | L | L | L | L | L | L |
| Pang et al. (18) | H | L | L | L | L | L | L |
| Pan et al. (19) | H | L | L | L | L | L | L |
| Chen et al. (20) | H | L | L | L | L | L | L |
| Zou et al. (21) | H | L | L | L | L | L | L |
H, High risk; L, Low risk; U, Unclear.
1Risk of Bias is judged as “low,” “high,” or “unclear.” If the answers to all items questions for a part are “yes,” then risk of bias can be judged low. If any item question is answered “no,” potential for bias exists. The “unclear” category should be used only when insufficient data are reported to permit a judgment.
2Applicability sections are structured in a way similar to that of the bias sections but do not include signaling questions. Review authors record the information on which the judgment of applicability is made and then rate their concern that the study does not match the review question.Concerns about applicability are rated as “low,” “high,” or “unclear.” the “unclear” category should be used only when insufficient data are reported.
3Part 1: Patient Selection.
Risk of Bias:
item 1: Was a consecutive or random sample of patients enrolled?
item 2: Was a case–control design avoided?
item 3: Did the study avoid inappropriate exclusions?
Applicability:
item 4: Are there concerns that the included patients and setting do not match the review question?
4Part 2: Index Test.
Risk of Bias:
item 5: Were the index test results interpreted without knowledge of the results of the reference standard?
item 6: If a threshold was used, was it prespecified?
Applicability:
item 7: Are there concerns that the index test, its conduct, or its interpretation differ from the review question?
5Part 3: Reference Standard.
Risk of Bias:
item 8: Is the reference standard likely to correctly classify the target condition?
item 9: Were the reference standard results interpreted without knowledge of the results of the index test?
Applicability:
item 10: Are there concerns that the target condition as defined by the reference standard does not match the question?
6Part 4: Flow and Timing.
Risk of Bias:
item 11: Was there an appropriate interval between the index test and reference standard?
item 12: Did all patients receive a reference standard.
item 13: Did all patients receive the same reference standard?
item 14: Were all patients included in the analysis?