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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
                                                                                                    Prevalence of TSB > 15 MG/DL
                                                                                                    59/498 (11.8%)

                                                                                                    Single TSB measurement with Trend 12 as
                                                                                                    threshold
                                                                                                    Sensitivity: 127/129 (98.4%)
                                                                                                    Specificity: 131/369 (35.5%)
                                                                                                    PPV: 127/365 (34.8%)
                                                                                                    NPV: 131/133 (98.5%)
                                                                                                    + LR: 1.5

                                                                                                    Single TSB measurement with Trend 15 as
                                                                                                    threshold
                                                                                                    Sensitivity: 52/59 (88.1%)
                                                                                                    Specificity: 344/439 (78.4%)
                                                                                                    PPV: 52/147 (35.4%)
                                                                                                    NPV: 344/351 (98.0%)
                                                                                                    +LR: 4.1

                                                                                                    Two TSB measurements with Trend 12 as
                                                                                                    threshold
                                                                                                    Sensitivity: 54/54 (100%)
                                                                                                    Specificity: 84/121 (69.4%)
                                                                                                    PPV: 54/91 (59.3%)
                                                                                                    NPV: 84/84 (100%)
                                                                                                    +LR: 3.3

                                                                                                    Two TSB measurements with Trend 15 as
                                                                                                    threshold
                                                                                                    Sensitivity: 23/24 (95.8%)
                                                                                                    Specificity: 117/151 (77.5%)
                                                                                                    PPV: 23/58 (40.4%)
                                                                                                    NPV: 117/118 (99.2%)
                                                                                                    +LR: 4.3


              Bhutani VK;       Study Type:     All term and near-term babies   Test:               Prevalence of significant      Unselected population but only
                                Diagnostic study   (either = 36 weeks GA and   Pre-discharge TcB reading from the   hyperbilirubinaemia   1.1% of study population had
              Year: 2000                        BW = 2000 g or = 35 weeks and   forehead using BiliChek measured   30/490 (6.1%)   TSB values
                                Evidence Level: 1b   BW = 2500 g) discharged as healthy   between 24 and 72 hours of age.          > 256 micromol/litre
              Country: USA                      from the well-baby nursery in a                     Correlation of TcB levels with TSB levels   Test & Reference test described
                                                tertiary hospital          Reference standard:      using HPLC (Pearson correlation   adequately
              36                                                           Laboratory TSB measured at same   coefficient, n = 1788 samples)   Reference test a standard test as
                                                n = 490,                   time as TcB, and also sent for   r = 0.91, P < 0.01     nomogram developed from lab
                                                observations=1788,         HPLC assays.                                            TSB values
                                                mean BW 3404 ± 518 g,        Paired TcB and HPLC TSB values   Bland Altman analysis for difference   Blinding – specified

                                                                                                    between TSB and TcB
                                                mean GA 38. 9 ± 1.5 weeks   plotted on the hour-specific   MD = -8 micromol/litre (95% CI -38.9 to

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