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
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.
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
Flow and timing	Duration of follow‐up: not stated Loss to follow‐up: none (n analysed: 3262)
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