Page 256 - 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:                 Predictive ability of pre-discharge   Pre-discharge TSB above 95  percentile
                                                                                                                      th
                                                White = 43.4%              TSB levels (given as percentile   (n = 172)
                                                Black = 41.2%              tracks and risk zones) evaluated for   Sensitivity: 68/126 (54.0%)
                                                Hispanic = 3.6%            subsequent Significant   Specificity: 2610/2714 (96.2%)
                                                Asian = 4.1%               Hyperbilirubinaemia (defined as   PPV: 68/172 (39.5%)
                                                Other = 7.7%               TSB level reaching into the high-  NPV: 2610/2668 (97.8%)
                                                                                      th
                                                                           risk zone or = 95  centile)
                                                                                                                      th
                                                                           Threshold zones:         Pre-discharge TSB above 75  percentile
                                                Exclusion:                                th        (n = 528)
                                                admission and treatment in intensive   High risk zone above 95    Sensitivity: 114/126 (90.5%)
                                                care nursery for neonatal illness,   percentile,    Specificity: 2300/2714 (84.7%)
                                                positive Coombs’ test,     High intermediate risk zone   PPV: 114/528 (21.6%)
                                                                                  th
                                                                                        th
                                                TSB measured after initiation of   between 75  and 95  centile,   NPV: 2300/2312 (99.5%)
                                                phototherapy,              Low intermediate risk zone
                                                                                                                      th
                                                babies requiring phototherapy before   th  th       Pre-discharge TSB above 40  percentile
                                                60 hours to control unexplained   between 75  and 40  centile   (n = 1084)
                                                                                          th
                                                rapidly rising TSB levels.   Low risk zone below 40  centile   Sensitivity: 126/126 (100%)
                                                                                                    Specificity: 1756/2714 (64.7%)
                                                                                                    PPV: 126/1084 (11.6%)
                                                                                                    NPV: 1756/1756 (100%)

                                                                                                    Likelihood ratio (LR) based on risk zones

                                                                                                    High risk zone
                                                                                                    +LR: 14.1

                                                                                                    Upper-intermediate risk zone
                                                                                                    +LR: 3.2

                                                                                                    Lower-intermediate risk zone
                                                                                                    +LR: 0.5

                                                                                                    Low risk zone
                                                                                                    +LR: 0


              Romagnoli C;      Study Type:     Phase 1: Development of nomogram   Test:            Phase 1: Time of reaching highest TSB   Unselected population
                                Diagnostic study   Full term appropriate for gestational   Laboratory TSB measured between   values in Phase 1   Test & Reference test described
              Year: 2005                        age babies delivered by vaginal or   30–72 hours on clinical suspicion             adequately
                                Evidence Level: II   caesarean section after uneventful   (single measurement in all babies,   At 24–48 hours: 20.3%   Reference test a standard test as
              Country: Italy                    pregnancy, without asphyxia and with   two consecutive TSB                         nomogram developed from lab
                                                no Rh or major ABO incompatibility.   determinations 12 hours apart in   At 49–72 hours: 48.4%   TSB values
              37                                                           514/1244 babies in Hospital A and   At 73–96 hours: 26.0%   Blinding – Not reported
                                                n = 438                    175/498 babies in Hospital B)   At 97–120 hours: 5.3%

                                                mean BW 3389 ± 668 g
                                                                           Reference standard:
                                                                                                    Phase 2: Predictive ability of Trend 12 and

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