Bertini 2008.
Study characteristics | |||
Patient Sampling | Cross‐sectional study, consecutive sampling | ||
Patient characteristics and setting |
Sample size: 241 Gestational age: > 32 weeks Race/ethnicity: "Caucasian" (presumed white; 100%) Prior phototherapy: no Setting: neonatal nursery of Careggi University Hospital, Florence, Italy |
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Index tests |
TcB device: Bilitest BB 77 Site of TcB measurement: forehead |
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Target condition and reference standard(s) |
Target condition: neonatal jaundice TSB measurement method: spectrophotometry |
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Flow and timing |
Time interval between tests: ≤ 10 minutes Number of paired results: not reported |
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Comparative | |||
Notes | Participants were healthy newborns. TSB was determined according to the judgement of the physician in charge. | ||
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? | Yes | ||
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 |