Page 320 - 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
                                             Ethnicity                                             r = 0.78, P < 0.001
                                             Chinese (100%)
                                                                                                   For all other sites
                                             Exclusion: not defined                                r from 0.47 to 0.76

                                             Prevalence of TSB >                                   Diagnostic accuracy of TcB (threshold value
                                             222 micromol/litre = 19.6% (35/178 –                  > 16 relectance units) for detecting TSB >
                                             site forehead)                                        222 micromol/litre

                                                                                                   Sensitivity: 19/21 (90.5%)
                                                                                                   Specificity: 141/157 (89.8%)
                                                                                                   PPV: 19/35 (54.3%)
                                                                                                   NPV: 141/143 (98.6%)

              Maisels MJ;       Study Type:   Convenience sample of newborn babies   TcB using Minolta JM-103 from   Correlation of TcB levels with lab TSB   No exclusion criterion
                                Diagnostic study   ≥ 35 weeks in the well-baby nursery of 3   the mid-sternum   levels and area under ROC curve (Pearson   Test & Reference test described
              Year: 2004                     hospitals.                                            correlation coefficient, AROC for TSB >   adequately
                                Evidence Level:                           Triplicate measurements made in   222 micromol/litre)   Test and reference test carried
              Country:          II           n = 849                      two hospitals while only single                         out within one hour
              USA                            Mean BW: Not reported        made in the third, but single TcB   All infants (n = 849)   Blinding – not specified
                                             Mean GA: Not reported        measurement taken for each baby   r = 0.91, P < 0.001   Data not extractable for
              71                             Gender: Not reported         for data analysis.       AROC = 0.96                    calculating values of TP, FP,
                                                                                                                                  TN & FN for different
                                             Ethnicity                    Reference standard: Laboratory   White infants (n = 503)   thresholds
                                             white = 59.2%                TSB levels within 1 hour of TcB   r = 0.95, P < 0.001
                                             black = 29.8%                measurement              AROC = 0.96
                                             other = 10.9%
                                                                          Area under ROC curve (AROC)   Black infants (n = 253)
                                             Prevalence of TSB >          calculated for detecting TSB > 170,   r = 0.82, P < 0.001
                                             257 micromol/litre = 3.3% (28/849)   222 and 255 micromol/litre   AROC = 0.97

                                             Exclusion: babies who had received                    Other infants (n = 93)
                                             phototherapy                                          r = 0.92, P < 0.001
                                                                                                   AROC = 0.96

                                                                                                   % of infants with difference between TSB &
                                                                                                   TcB levels of > 34 micromol/litre
                                                                                                   (overestimation by TcB)

                                                                                                   Difference 34 to 50 micromol/litre
                                                                                                   White – 4.0%
                                                                                                   Black – 24.1%
                                                                                                   Others – 5.4%

                                                                                                   Difference 51 to 67 micromol/litre
                                                                                                   White – 2.0%
                                                                                                   Black – 10.7%
                                                                                                   Others – 2.2%



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