Bhola 2014.
Study characteristics | |||
Patient sampling | Retrospective observational study | ||
Patient characteristics and setting |
Country: Australia Setting: Royal Prince Alfred Hospital (tertiary maternity hospital delivering over 5000 newborns a year) Study period: 42‐month period (from April 2008 to December 2011) Inclusion criteria: all newborns (routine neonatal examination) Exclusion criteria: not stated Live birth cohort, n = 19,765 N screened: 18,801 (95.1%) (648 had been admitted to the nursery and did not qualify for screening, 316 missed) Prevalence of CCHD: 0.2 per 1000 live births |
||
Index tests | Pulse oximetry was performed with a Masimo Radical 5 portable oximeter (Masimo Corporation, Irvine, CA, USA) with a reusable probe with disposable Coban tape (1‐inch self‐adherent wrap, manufactured by 3M, Australia). Screening protocol: Site of testing: post‐ductal (foot) Test timing: longer than 24 hours (between 24 and 72 hours of life) Oxygen saturation: functional Threshold: < 95% "If the post‐ductal saturation was 95% or more, the result was assigned as a pass. Readings between 90% and 95% led to a repeat saturation measurement in the next 1–2 hours. If the post‐ductal saturation remained below 95% on repeat testing, the newborn was referred for review and examination by a senior neonatal paediatrician. If the saturation was less than 90%, at any time, the newborn was referred for review by a senior neonatal paediatrician without waiting for a repeat test." |
||
Target condition and reference standard(s) |
Target condition: congenital heart disease Reference standard(s): Reference standard used for positive pulse oximetry results: echocardiography Reference standard used for negative pulse oximetry results: database of the Heart Centre for Children at Children’s Hospital at Westmead for any newborns undergoing cardiac surgery or catheter intervention in the first year of life |
||
Flow and timing | Duration of follow‐up: not stated Loss to follow‐up: 316 missed (not performed by the resident, performed but not recorded, screening not completed before early discharge or owing to compliance issues when the new protocol was originally introduced) |
||
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? | Unclear | ||
Did the study avoid inappropriate exclusions? | Unclear | ||
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? | Unclear | ||
Was there at least 28 days of appropriate follow up? | Unclear | ||
Did all patients receive a reference standard? | Yes | ||
Unclear |