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. 2023 May 9;2023(5):CD012660. doi: 10.1002/14651858.CD012660.pub2

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Type of study Journal article, unpublished data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.