Page 336 - 16Neonatal Jaundice_compressed
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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
                                             Mean BW: Not reported                                 VITROS: r² = 0.66              Blinding – No
              81                             Median GA: 39.9 weeks (32.7 to 41.4)   Reference standard:
                                             Gender: Not reported         1.Laboratory TSB diazo method
                                             Ethnicity:                   measured on blood collected within   Diagnostic accuracy of TcB (threshold value
                                             White = 82.5%                30 minutes as TcB.       >75 centile on Bhutani nomogram
                                             Black = 1.7%
                                             Hispanic = 5.1%              2. Laboratory TSB VITROS   Diazo:
                                             Asian = 10.7%                method measured on blood   Sensitivity: 56/57 (98.2%)
                                                                          collected within 30 minutes as TcB.   Specificity: 48/120 (40%)
                                             Exclusion:                                            PPV: 56/127 (43.7%)
                                             None                                                  NPV: 48/49 (98%)

                                                                                                   Vitros:
                                                                                                   Sensitivity: 63/67 (94%)
                                                                                                   Specificity: 35/64 (54.7%)
                                                                                                   PPV: 63/92 (68.5%)
                                                                                                   NPV: 35/39 (89.7%)


              Slusher TM;       Study Type:   Clinically jaundiced term and preterm   TcB using BiliChek from the   Correlation of TcB levels with lab TSB   Unselected population
                                Diagnostic study   babies with age < 14 days admitted in   forehead and before starting   levels (Pearson correlation coefficient)   Test & Reference test described
              Year: 2004                     two hospitals                phototherapy                                            adequately
                                Evidence Level:                                                    Both hospital together         Test and reference test carried
              Country:          II           n = 127                      Skin pigmentation determined   r = 0.92                 out within one hour
              Nigeria                        mean BW: 2.72 ± 0.62 kg      through visual observation   Babies with TSB ≥ 205 micromol/litre   Blinding – yes but only
                                                                                                   r = 0.84                       investigator
              80                             mean GA: Not reported        Reference standard: Laboratory   Babies with TSB < 205 micromol/litre   Data not extractable for
                                             Gender: Males = 60%,         TSB levels obtained      r = 0.67                       calculating values of TP, FP,

                                                                          simultaneously with TcB                                 TN & FN for detecting hyperbil
                                             Pigmentation –               measurement              Based on pigmentation
                                             dark pigmentation 10%
                                             medium pigmentation = 36%                             Light: r = 0.91
                                             light pigmentation = 54%                              Medium: r = 0.94
                                                                                                   Dark: r = 0.87

                                             Hospital A: 500-bed tertiary teaching                 Bland Altman analysis for difference
                                             hospital (n = 98)                                     between mean TcB and mean lab TSB

                                             Hospital B: 168-bed hospital located in a             values
                                             rural village (n = 29)                                  Both hospitals together
                                                                                                   MD = 8.5 micromol/litre (95% CI -3.4 to
                                                                                                   21.4 micromol/litre
                                             Exclusion: not defined
                                                                                                   SD = 129.2 micromol/litre

                                                                                                   Babies with TSB ≥ 205 micromol/litre
                                                                                                   MD = --21.4 micromol/litre (95% CI -40.8
                                                                                                   to 0.0 micromol/litre)
                                                                                                   SD = 146.2 micromol/litre



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