Was the spectrum of patients representative of the patients 1 N Y N Y who will receive the test in practice? 2 Were selection criteria clearly described? Y Y Y U Is the reference standard likely to correctly classify the target 3 Y Y Y Y condition? Is the time period between reference standard and index test 4 short enough to be reasonably sure that the target condition Y Y U U did not change between the two tests? (≤3 months) Did the whole sample or a random selection of the sample, 5 Y Y Y Y receive verification using a reference standard of diagnosis? Did patients receive the same reference standard regardless 6 Y Y Y Y of the index test result? Was the reference standard independent of the index test (i.e. 7 Y Y Y Y the index test did not form part of the reference standard)? Was the execution of the index test described in sufficient 8 N Y Y N detail to permit replication of the test? Was the execution of the reference standard described in 9 Y Y N N sufficient detail to permit its replication? Were the index test results interpreted without knowledge of 10 U U U U the results of the reference standard? Were the reference standard results interpreted without 11 U U U U knowledge of the results of the index test? Were the same clinical data available when test results were 12 interpreted as would be available when the test is used in Y Y Y Y practice? 13 Were uninterpretable/ intermediate test results reported? Y Y Y Y 14 Were withdrawals from the study explained? Y Y Y Y Score 10 12 9 8 Supplementary Table 5. Study characteristics: An overview of studies regarding FIB-4 for prediction of varices in liver cirrhosis. Cut-off No. Pts First No. Location Prevalence Prevalence of Study Age Male Etiology of HCC Child-Pugh who Definitions of QUADAS author Regions of of varices of large varices/ description (year) (%) cirrhosis (%) class (%) underwent large varices Score (Year) Pts varices (%) varices (%) large endoscopy varices
1 Was the spectrum of patients representative of the patients who will receive the test in practice? N Y N Y 2 Were selection criteria clearly described? Y Y Y U 3 Is the reference standard likely to correctly classify the target condition? Y Y Y Y 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? (≤3 months) Y Y U U 5 Did the whole sample or a random selection of the sample, receive verification using a reference standard of diagnosis? Y Y Y Y 6 Did patients receive the same reference standard regardless of the index test result? Y Y Y Y 7 Was the reference standard independent of the index test (i.e. the index test did not form part of the reference standard)? Y Y Y Y 8 Was the execution of the index test described in sufficient detail to permit replication of the test? N Y Y N 9 Was the execution of the reference standard described in sufficient detail to permit its replication? Y Y N N 10 Were the index test results interpreted without knowledge of the results of the reference standard? U U U U 11 Were the reference standard results interpreted without knowledge of the results of the index test? U U U U 12 Were the same clinical data available when test results were interpreted as would be available when the test is used in practice? Y Y Y Y 13 Were uninterpretable/ intermediate test results reported? Y Y Y Y 14 Were withdrawals from the study explained? Y Y Y Y Score 10 12 9 8 Supplementary Table 5. Study characteristics: An overview of studies regarding FIB-4 for prediction of varices in liver cirrhosis. First author (Year) Regions Study description No. Pts Age (year) Male (%) Etiology of cirrhosis HCC (%) Child-Pugh class (%) No. Pts who underwent endoscopy Location of varices Prevalence of varices (%) Prevalence of large varices (%) Definitions of large varices Cut-off of varices/ large varices QUADAS Score