Item |
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Yes |
No |
Unclear |
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1. |
Was the spectrum of patients representative of the patients who will receive the test in practice? |
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2. |
Were selection criteria clearly described? |
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3. |
Is the reference standard likely to correctly classify the target condition? |
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4. |
Is the time period between reference standard and index test short enough to be reasonably sure that the target condition did not change between the two tests? |
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5. |
Did the whole sample or a random selection of the sample, receive verification using a reference standard of diagnosis? |
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6. |
Did patients receive the same reference standard regardless of the index test result? |
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7. |
Was the reference standard independent of the index test (i.e. the index test did not form part of the reference standard)? |
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8. |
Was the execution of the index test described in sufficient detail to permit replication of the test? |
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9. |
Was the execution of the reference standard described in sufficient detail to permit its replication? |
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10. |
Were the index test results interpreted without knowledge of the results of the reference standard? |
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11. |
Were the reference standard results interpreted without knowledge of the results of the index test? |
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12. |
Were the same clinical data available when test results were interpreted as would be available when the test is used in practice? |
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13. |
Were uninterpretable/ intermediate test results reported? |
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14. |
Were withdrawals from the study explained? |
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