Riede 2010.
| Study characteristics | |||
| Patient sampling | Prospective multicenter study with consecutive enrollment of participants | ||
| Patient characteristics and setting |
Country: Germany Setting: primary, secondary, and tertiary care (34 neonatal/obstetrical departments in Saxony) Study period: 2‐year period (from July 2006 to June 2008) Inclusion criteria: full‐term and post‐term neonates (gestational age ≥ 37 weeks) Normal routine clinical examination Informed parental consent Exclusion criteria: Antenatal diagnosis/suspicion of congenital heart disease Livebirth cohort, n = 48,348 (excluded: 6108 newborns [72 clinical or prenatal diagnosis of CCHD; 6036 other]) N eligible for pulse oximetry screening: 42,240 (n = 727 [91%] did not receive pulse oximetry screening, mainly because of early discharge after birth) N screened: 41,445 (85.7%) Prevalence of CCHD: 0.4 per 1000 live births |
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| Index tests | Pulse oximetry was performed with a great variety of devices (no further information). Screening protocol: Site of testing: post‐ductal (foot) Test timing: longer than 24 hours Oxygen saturation: functional Threshold: ≤ 95% "The study protocol included repeated SpO2 measurements after 1 hour if the initial value was < 96%." |
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| Target condition and reference standard(s) |
Target condition: CCHD Reference standard(s): Reference standard used for positive pulse oximetry results: echocardiography Reference standard used for negative pulse oximetry results: Saxonian perinatal and neonatal registries |
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| Flow and timing | Duration of follow‐up: not stated Loss to follow‐up: 3 for violation of study protocol (n analyzed: 41,442) |
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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 | ||
| Did the study avoid inappropriate exclusions? | No | ||
| Unclear | Low | ||
| DOMAIN 2: Index Test Pulse oximetry | |||
| If a threshold was used, was it pre‐specified? | Yes | ||
| Were the index test results interpreted without knowledge of the results of the reference standard? | Yes | ||
| Low | Low | ||
| DOMAIN 3: Reference Standard | |||
| Is the reference standards likely to correctly classify the target condition? | No | ||
| Were the reference standard results interpreted without knowledge of the results of the index tests? | Unclear | ||
| Unclear | Low | ||
| DOMAIN 4: Flow and Timing | |||
| Were all patients included in the analysis? | No | ||
| Was there at least 28 days of appropriate follow up? | Unclear | ||
| Did all patients receive a reference standard? | Yes | ||
| Low | |||