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| Domain | (1) Patient selection | (2) Definition of threshold of the test | (3) Use of validation test | (4) Flow and clinical followup |
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Signaling questions
(yes/no/unclear) | Was a consecutive or random sample of patients enrolled?
Yes, if this information was described in the article | If a threshold was used, was it prespecified?
Yes, if cut-off values were explained before data analysis | Were the results confirmed by a second validation test?
Yes, if a second test was applied to confirm the results | Was there an appropriate clinical outcome/pathological outcome used in the study
Not assessed
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Was a case-control design used?
Yes, if a case-control design was used | | Were the validation results interpreted without knowledge of the results of the original test?
Yes, if genetic technique results were interpreted without knowledge of the second validation test results | Did all patients receive genetic test? (partial verification avoided?)
Yes, if all patients received a genetic test |
Did the study avoid inappropriate exclusions?
Yes, if no sample was excluded based on clinical stage or grade of renal tumor | | | Did all patients receive the same validation test? (differential verification avoided?)
Yes, if all patients the same validation test |
| | | | Were all patients included in the analysis?
Yes, if all patients were included and no patients were reported as unclassified |
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Risk of bias
(high/low/unclear) | Conclusion: could the selection of patients has introduced bias? | Conclusion: could the conduct or interpretation of the genetic technique has introduced bias? | Conclusion: could the validation test, its conduct, or its interpretation have introduced bias? | Conclusion: could the patient flow/followup have introduced bias? |
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| Concerns regarding applicability (high/low/unclear) | (1) Are there concerns that the included patients do not match the review question?
Low, if results confirm that patients were included as defined by clinical stage of the disease | (2A) Are there concerns that the genetic technique, its conduct, or interpretation differ from the review question?
Low, if the genetic technique was performed to answer clinically relevant outcomes as defined in the review
(2B) Was one threshold used, or in case the results can fall in between two thresholds (and is inconclusive).
Yes, if one of these situations was true. | (3) Are there concerns that the target condition as defined by the genetic technique does not match the review question?
Low, if genetic technique of chromosomal 9p status did match stage and grade of the disease | Additional question 1 (4A) Are there concerns about the sample size of the cohort?
Low, if the cohort was selected with proper statistical power to answer clinically relevant outcome
Additional question 2 (4B) Are there concerns about the tissue samples used for genetic technique?
Low, if the tissue samples were obtained before the more invasive and potentially harmful procedure such as radical nephrectomy |
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