Yaser 2014.
Study characteristics | |||
Patient Sampling | Cross‐sectional study, consecutive sampling | ||
Patient characteristics and setting |
Sample size: 122 Gestational age: preterm (< 35 weeks) Race/ethnicity: not reported Phototherapy use: no prior phototherapy use Setting: level III neonatal care unit (Groote Schuur Hospital) in Cape Town, South Africa |
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Index tests |
TcB device: JM 103 Site of TcB measurement: forehead, sternum, interscapular area |
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Target condition and reference standard(s) |
Target condition: neonatal hyperbilirubinaemia TSB measurement method: not reported |
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Flow and timing |
Time interval between tests: ≤ 30 minutes Number of paired results: 122 for each TcB site |
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Comparative | |||
Notes | |||
Methodological quality | |||
Item | Authors' judgement | Risk of bias | Applicability concerns |
DOMAIN 1: Patient Selection | |||
Was a consecutive or random sample of patients enrolled? | Yes | ||
Was a case‐control design avoided? | Yes | ||
Did the study avoid inappropriate exclusions? | Yes | ||
Could the selection of patients have introduced bias? | Low risk | ||
Are there concerns that the included patients and setting do not match the review question? | Low concern | ||
DOMAIN 3: Reference Standard | |||
Is the reference standards likely to correctly classify the target condition? | Yes | ||
Were the reference standard results interpreted without knowledge of the results of the index tests? | Unclear | ||
Could the reference standard, its conduct, or its interpretation have introduced bias? | Low risk | ||
Are there concerns that the target condition as defined by the reference standard does not match the question? | Low concern | ||
DOMAIN 4: Flow and Timing | |||
Was there an appropriate interval between index test and reference standard? | Yes | ||
Did all patients receive the same reference standard? | Yes | ||
Were all patients included in the analysis? | Yes | ||
Could the patient flow have introduced bias? | Low risk |
HPLC: high‐performance liquid chromatography; NICU: neonatal intensive care unit; TcB: transcutaneous bilirubin; TSB: total serum bilirubin.