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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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