Page 312 - 16Neonatal Jaundice_compressed
P. 312

Appendix H: Evidence tables


              Bibliographic details   Study type &   Patient characteristics   Test, Reference Standard,   Results                Reviewers Comments
                                Evidence level                            Threshold for a positive test
              Rhodesia                       GA: Not reported                                                                     not specified)
                                             Postnatal age: Range 2 to 24 days                                                    Blinding – yes
              63                             Gender: Not reported                                                                 Data not extractable for
                                                                                                                                  calculating values of TP, FP,
                                             Ethnicity:                                                                           TN & FN
                                             Black = 100%

                                             Exclusion: not defined

              Briscoe L;        Study Type:   Babies > 34 weeks who were having   TcB reading using Minolta JM-102   Correlation of JM-102 with lab TSB levels   Unselected population
                                Diagnostic study   blood taken for any reason, mostly done   at the forehead   (Pearson correlation coefficient, n = 303)   Test & Reference test described
              Year: 2002                     for clinical jaundice.       (mean of 3 readings used for                            in detail
                                Evidence Level:                           analysis)                r = 0.76, P < 0.0001           Test and reference test carried
              Country:          II           n = 303                                                                              out within one hour
              UK                             median BW 3267 g - range 1800–5008   Reference standard: Laboratory   Diagnostic accuracy of JM-102 for detecting   Blinding – not specified
                                             median GA 39 weeks - range 34–42   TSB levels measured concurrently   TSB > 249 micromol/litre (n = 303)   Data not extractable for
              46                             median age at presentation: 3 – range 0 to                                           calculating values of TP, FP,
                                             13 days                      For diagnostic accuracy:   Area under ROC = 0.89        TN & FN
                                             Gender: Not reported         Area under ROC curve calculated
                                                                          for detecting TSB        Predictive accuracy of JM-102 value 19.9
                                             Ethnicity                    > 249 micromol/litre     (highest accuracy from ROC curve)
                                             White: 94.7%                                          Sensitivity: 86% (81–89%)
                                                                                                   Specificity: 78% (73–83%)
                                             Prevalence of TSB >                                   PPV: Not reported
                                             300 micromol/litre = 3.3% (10/303)                    NPV: Not reported

                                             Exclusion: babies who had previously
                                             received phototherapy

              Carbonell X;      Study Type:   Healthy term babies         Test:                    Correlation of TcB levels with lab TSB   Unselected population but no
                                Diagnostic study                          1. Umbilical cord blood bilirubin   levels for Sternal vs Forehead site (Pearson   exclusion criterion
              Year: 2001                     n = 2004 – 610 in phase one ± 1394 in   (UCB) measured at birth (threshold   correlation coefficient)   Test & Reference test described
                                Evidence Level:   phase 2                 value: ≥ 37 micromol/litre)                             in detail
              Country:          II                                        ROC curve used to find the best   At < 24 hours (n = 120)   Reference test a standard one
              Spain                          mean BW 3230 ± 491 g         cut-off value of UCB.    Sternum Forehead               Test and reference test carried
                                             mean GA 39 weeks                                      0.81 0.77                      out within one hour
              26                             Gender: Males = 50.7%        2. TSB (in phase 1 & 2) and TcB                         Blinding – not specified
                                                                          (phase 1 only) measured at   At 24–48 hours (n = 126)
                                             Ethnicity                    24 hours (threshold value for   Sternum Forehead
                                             Not reported                 TSB = 102 micromol/litre and for   0.89 0.83
                                                                          TcB > 11)
                                             In first phase (n = 610), cord blood                  At > 48 hours (n = 412)
                                             bilirubin (UCB) at birth and TcB with   3. TSB and TcB (in phase 1 & 2)   Sternum Forehead
                                             Minolta JM-102 measured at 24 hours,   measured at 48 hours (threshold   0.94 0.83
                                             48 hours & 60–96 hours of life.   value for TSB = 154 micromol/litre
                                             Additionally TSB was done for all at 60–  and for TcB > 13)   Diagnostic accuracy of TcB for detecting
                                             96 hours. On 169 babies TSB also                      TSB > 222 micromol/litre
                                             measured at 24 & 48hours     TcB reading using Minolta JM-102


                                                                                                                                                     229
   307   308   309   310   311   312   313   314   315   316   317