1. Data extraction form.
[Study ID] | First author, year of publication |
Type of study | Journal article, unpublished data |
Participants | Sample size Country of study Baseline characteristics (gestational age, postnatal age, race/ethnicity, bodyweight) |
Study design | Retrospective/prospective design Sample (consecutive, random, or unclear) |
Study criteria | Inclusion criteria Exclusion criteria |
Reference standard | Name of assay/manufacturer Name of instrument Cutoff values Time between reference standard performance and TcB measurement Blinding of operator to TcB result |
Index test | Name of device Cutoff values Operator training Site of measurement (forehead, sternum) |
Target condition | Universal screening of newborns for hyperbilirubinaemia Diagnostic determination of hyperbilirubinaemia in visibly jaundiced newborns |
Data | Number of true positives and false positives Number of true negatives and false negatives Number of undetermined/uninterpretable results Sensitivity and specificity of index test Number of missing results for index test Number of missing results for reference standard |
Notes | Source of funding (whether any author is affiliated with the manufacturer of the index test; the study was directly funded by the manufacturer; whether authors reported conflicts of interests related to the manufacturer or other funding sources) |
TcB: transcutaneous bilirubin.