Enrico Martin

137 Diagnostic accuracy of non-invasive tests Items Sub-category questions Explanation Answers % Could the selection of patients have introduced bias? One or more questions suggested “high risk” Two or more questions suggested “unclear” without any answers of high risk Question 1 + 2 suggested ”low risk”, question 3 suggested unclear or “low risk” High risk Unclear Low risk Rob: index test Were the index test results interpreted without knowledge of the results of the reference standard? Radiologist or nuclear medicine physician blinded Unclear, not described Radiologist or nuclear medicine physician not blinded + ? - If a threshold was used, was it pre-specified? Use of threshold clearly described in study methods or based on ROC analysis New threshold used, not previously described in protocol or study methods + - Could the conduct or interpretation of the index test have introduced bias? One or more questions suggested “high risk” Question 1 suggested “unclear”, question 2 suggested unclear or “low risk” Question 1 + 2 suggested ”low risk” High risk Unclear Low risk Rob: reference test Is the reference standard likely to correctly classify the target condition? Follow-up period > 6 months Follow-up period not described Follow-up period ≤ 6 months + ? - Were the reference standard results interpreted without knowledge of the results of the index test? Pathologist or researcher blinded Unclear, not described Pathologist or researcher not blinded + ? - Could the reference standard, its conduct, or its interpretation have introduced bias? One or more questions suggested “high risk” Both question 1 + 2 suggested “unclear” without any answers of high risk Questions 1 suggested “low risk”, question 2 suggested unclear or “low risk” High risk Unclear Low risk Rob: flow and timing Was there an appropriate interval between index test(s) and reference standard? MRI/PET-CT performed before excision of lesion or before/after follow-up MRI/PET-CT performed after histological confirmation + - Did all patients receive a reference standard? All patients receive reference standard Unclear, not described Including patients without reference standard + ? - 6