1. The QUADAS 2 tool for assessing methodological quality of included studies.
Domain 1: Participant sampling | Signalling question | Signalling question | Signalling question | Risk of bias | Concerns for applicability |
Domain 1: Participant sampling | |||||
Patient sampling | Was a consecutive or random sample of participants enrolled? | Was a case‐control design avoided? | Did the study avoid inappropriate exclusions? | Could the selection of participants have introduced bias? | Were there concerns that the included participants and setting did not match the review question? |
Yes: all consecutive participants or random sample of participants with suspected common bile duct stones were enrolled. No: selected participants were enrolled. Unclear: this was not clear from the report. |
Yes: case‐control design was avoided. No: case‐control design was not avoided. Unclear: this was not clear from the report. |
Yes: the study avoided inappropriate exclusions (i.e., people who were difficult to diagnose). No: the study excluded participants inappropriately. Unclear: this was not clear from the report. |
Low risk: 'yes' for all signalling questions. High risk: 'no' or 'unclear' for at least 1 signalling question. |
Low concern: the selected participants represent the people in whom the tests would be used in clinical practice (see diagnostic pathway (Figure 1). High concern: there was high concern that participant selection was performed in a such a way that the included participants did not represent the people in whom the tests will be used in clinical practice. |
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Domain 2: Index test | |||||
Index test(s) | Were the index test results interpreted without knowledge of the results of the reference standard? | If a threshold was used, was it pre‐specified? | ‐ | Could the conduct or interpretation of the index test have introduced bias? | Were there concerns that the index test, its conduct, or its interpretation differed from the review question? |
Yes: index test results were interpreted without knowledge of the results of the reference standard. No: index test results were interpreted with knowledge of the results of the reference standard. Unclear: this was not clear from the report. |
Yes: if the criteria for a positive test result were pre‐specified. No: if the criteria for a positive test result were not pre‐specified. Unclear: this was not clear from the report. |
‐ | Low risk: 'yes' for all signalling questions. High risk: 'no' or 'unclear' for at least 1 of the 2 signalling questions. |
High concern: there was high concern that the conduct or interpretation of the index test differed from the way it is likely to be used in clinical practice. Low concern: there was low concern that the conduct or interpretation of the index test differed from the way it is likely to be used in clinical practice. |
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Domain 3: Reference standard | |||||
Target condition and reference standard(s) | Was the reference standard likely to classify the target condition correctly? | Were the reference standard results interpreted without knowledge of the results of the index tests? | ‐ | Could the reference standard, its conduct, or its interpretation have introduced bias? | Were there concerns that the target condition as defined by the reference standard did not match the review question? |
Yes: all participants underwent the acceptable reference standard. No: if all participants did not undergo an acceptable reference standard. Such studies were excluded from the review. Unclear: if the reference standard that the participants underwent was not stated. Such studies were excluded from the review. |
Yes: reference standard results were interpreted without knowledge of the results of the index test. No: reference standard results were interpreted with the knowledge of the results of the index test. Unclear: this was not clear from the report. |
‐ | Low risk: 'yes' for all signalling questions. High risk: 'no' or 'unclear' for at least 1 of the 2 signalling questions. |
Low concern: participants underwent endoscopic or surgical exploration for common bile duct stone. High concern: no participants underwent endoscopic or surgical exploration for common bile duct stone. |
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Domain 4: Flow and timing | |||||
Flow and timing | Was there an appropriate interval between index test and reference standard? | Did all participants receive the same reference standard? | Were all participants included in the analysis? | Could the participant flow have introduced bias? | ‐ |
Yes: the interval between index test and reference standard (including any repeat procedures) was ≤ 4 weeks (arbitrary choice). No: the interval between index test and reference standard was > 4 weeks. Unclear: this was not clear from the report. |
Yes: all participants underwent endoscopic or surgical exploration for common bile duct stone irrespective of the index test results. No: participants underwent endoscopic or surgical exploration if the index test results were positive and underwent clinical follow‐up for at least 6 months if the index test results were negative. Unclear: this was not clear from the report. Such studies were excluded. |
Yes: all participants meeting the selection criteria (selected participants) were included in the analysis, or data on all the selected participants were available so that a 2 x 2 table including all selected participants could be constructed. No: not all participants meeting the selection criteria were included in the analysis or the 2 x 2 table could not be constructed using data on all selected participants. Unclear: this was not clear from the report. |
Low risk: 'yes' for all signalling questions. High risk: 'no' or 'unclear' for at least 1 signalling question. |
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