A1 |
Systematic review/meta-analysis of at least 2 independently conducted studies of A2 level. |
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A2 |
Randomized, double blind trial with good study quality and an adequate number of study participants. |
Index test compared to reference test (reference standard); cut-offs were defined a-priori; independent interpretation of test results; an adequate number of consecutive patients were enrolled; all patients received both tests. |
Prospective cohort study of sufficient magnitude and follow-up, adequately controlled for “confounding” and no selective follow-up. |
B |
Clinical trial, but without all the features mentioned for level A2 (including case-control study, cohort study). |
Index test compared to reference test, but without all the features mentioned for level A2. |
Prospective cohort study, but without all the features mentioned for level A2 or retrospective cohort study or case-control study. |
C |
Non-comparative studies. |
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D |
Expert opinion. |
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