TITLE/ABSTRACT
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1. Identify study of diagnostic accuracy
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INTRODUCTION
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2. State the research question
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METHODS
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Participants
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3. Describe study population
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4. Describe participant recruitment
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5. Describe participant sampling
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6. Describe if prospective or retrospective
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Test Methods
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7. Reference standard and rationale
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8. Technical specifications described or referenced
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9. Description of rationale for cut-offs for index tests and reference standards
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10. Description of the number and training of persons executing the tests
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11. Description of blinding of test readers
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Statistical Methods
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12. Description of calculations of diagnostic accuracy and uncertainty
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13. Description of calculations of test reproducibility
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RESULTS
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Participants
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14. Description of duration of study
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15. Description of clinical and demographic description of participants
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16. Description of the number of participants satisfying inclusion criteria that did not undergo the index test or reference standard, and why
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Test Results
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17. Description of the time interval from the index test to the reference standard and any treatment administered between
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18. Description of the severity of disease in those with the target condition; other diagnoses in participants without the target condition
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19. A cross-tabulation of the results of the index tests (including indeterminate and missing tests)
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20. Any adverse events from performing the index or reference tests
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Estimates
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21. Estimates of diagnostic accuracy with statistical uncertainty
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22. Description of how indeterminate results were handled
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23. Estimates of variability between subgroups of patients, readers, or centres
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24. Estimates of test reproducibility
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DISCUSSION
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25. Discussion of the clinical applicability of the findings
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