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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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