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Appendix H: Evidence tables


              Bibliographic details   Study type &   Patient characteristics   Test, Reference Standard,   Results                Reviewers Comments
                                Evidence level                            Threshold for a positive test
                                                                                                   Each observer separately
                                                                                                   P < 0.001 for both the mean values and
                                                                                                   absolute values

                                                                                                   Diagnostic accuracy of BiliEye in detecting
                                                                                                   hyperbilirubinaemia

                                                                                                   Area ROC = 0.82

                                                                                                   Best AROC
                                                                                                   0.93 for observations at > 60 hours in babies
                                                                                                   ≥ 37 weeks GA

                                                                                                   Worst AROC
                                                                                                   0.64 for observations at < 36 hours
                                                                                                   0.61 for babies < 37 weeks


              Moyer VA;         Study Type:   Full-term healthy babies (BW > 2000 g   Visual observation by two                   Unselected population
                                Diagnostic study   and GA> 36 weeks) in well-newborn   experienced staff (paediatric   Agreement between observers on   Reference test not described
              Year: 2000                     nursery of an urban public hospital, in   residents, paediatric nurse   presence/absence of icterus at different sites   adequately
                                Evidence Level:   whom TSB was measured because of   practitioners, paediatric physicians)   (Weighted κ with 95% CI)   Test and reference test carried
              Country: USA      II           clinical jaundice, Rh-negative mother or   regarding                                 out within one hour
                                             positive maternal Coomb’s test.   a) Subjective assessment of   Face & neck:         Blinding – yes
              60                                                          presence/absence of icterus at   0.16 (-0.02 to 0.34)
                                             n = 122,                     different sites          Neck to nipple line:           Funding: Not reported
                                             GA: > 36 weeks               b) Estimated TSB levels   0.15 (0.01 to 0.29)
                                             BW > 2,000 g                                          Nipple line to umbilicus:
                                             mean age = 2 days (range 8 to 168 hours)   Reference standard: Laboratory   0.23 (0.09 to 0.38)
                                             Gender: Males = 54.1%        TSB levels within 1 hr   Umbilicus to groin:
                                             Ethnicity                                             0.19 (0.05 to 0.34)
                                             Not reported                                          Upper legs:
                                                                                                   0.20 (0.06 to 0.35)

                                                                                                   Weighted K not statistically significant for
                                             Exclusion: babies having previous TSB                 other sites – Lower legs, Soles, Arms,
                                             determination and under phototherapy                  Palms, Tip of nose and palate

                                                                                                   Correlation of estimated TSB levels with lab
                                                                                                   TSB (Pearson correlation coefficient)

                                                                                                   Observer 1: r = 0.43
                                                                                                   Observer 2: r = 0.54

                                                                                                   Accuracy of clinical icterus in lower chest
                                                                                                   (nipple line to umbilicus) in detecting TSB >
                                                                                                   205 micromol/litre (n = 243 observations)




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