Arlettaz 2006.
Study characteristics | |||
Patient sampling | Prospective multicenter study with consecutive enrollment of participants | ||
Patient characteristics and setting |
Country: Switzerland Setting: 4 hospitals in Zurich: 3 maternity hospitals and the Division of Cardiology of the University Children’s Hospital Study period: 1‐year period (from May 13, 2003, to May 12, 2004) Inclusion criteria: all newborn infants from 35 weeks' gestation Exclusion criteria: Premature infants below 35 weeks' gestation Infants with a respiratory disorder Live birth cohort, n = 3663 (401 infants excluded according to exclusion criteria) N screened: 3262 (89%) (1764 at the University Hospital, 1011 at the Zollikerberg Hospital, 487 at the Triemli Hospital) Gestational age: median: 39 weeks (range 35 to 42) Prevalence of CCHD: 3.7 per 1000 live births |
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Index tests | Pulse oximetry was performed with the Nellcor NPB‐40 handheld pulse oximeter and the Nellcor Max‐N Oximax adhesive sensors. Screening protocol: Site of testing: right or left foot Test timing: within 24 hours (in 48 cases [1%], pulse oximetry was performed too early in part because of immediate postnatal transfer to the cardiology unit or because patients were discharged before 6 hours of age; in 255 cases (8%), pulse oximetry was performed after 12 hours; 2959 measurements [91%] were performed at between 6 and 12 hours) Oxygen saturation: functional Threshold: < 95% Measurement did not exceed 2 minutes. If saturation was below 95%, a senior house officer performed a full clinical examination of the newborn. If the infant had saturation below 90% or any signs suggestive of a CHD, echocardiography was performed immediately. In the case of an asymptomatic newborn with borderline values (90% to 94%), a second measurement was performed 4 to 6 hours later. |
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Target condition and reference standard(s) |
Target condition: Congenital heart disease was defined as the presence of a gross structural abnormality of the heart or intrathoracic great vessels that is actually or potentially of functional significance. Reference standard(s): Reference standard used for positive pulse oximetry results: echocardiography (complete M‐mode, 2‐dimensional, and Doppler echocardiograms were performed either at the University Hospital with an Acuson 128XP/10 [Siemens, Erlangen, Germany] with a 7.5‐mHz transducer, or at the University Children’s Hospital with a Sonos 5500 [Philips, Amsterdam, Netherlands], both equipped with all Doppler modalities) Reference standard used for negative pulse oximetry results: not stated |
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Flow and timing | Duration of follow‐up: not stated Loss to follow‐up: none (n analysed: 3262) |
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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? | Yes | ||
Low | 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? | Unclear | ||
Were the reference standard results interpreted without knowledge of the results of the index tests? | Unclear | ||
High | Low | ||
DOMAIN 4: Flow and Timing | |||
Were all patients included in the analysis? | Yes | ||
Was there at least 28 days of appropriate follow up? | Unclear | ||
Did all patients receive a reference standard? | Unclear | ||
Unclear |