De Mol 2013.
Study characteristics | |||
Patient sampling | Retrospectively, BAL fluid obtained from 456 bronchoscopies between July 2002 and June 2008 were evaluated. Paediatric patients fulfilling the host factor criteria as defined by the EORTC/MSG were included. Patients suffering from cystic fibrosis, allergic bronchopulmonary aspergillosis and other primary lung diseases were excluded. If more than one bronchoscopy was performed within a patient, the bronchoscopy done for diagnosing IPA was taken; if bronchoscopy was related in time with a CT scan, then the patient was excluded | ||
Patient characteristics and setting | Setting: children's hospital in The Netherlands The median age of the 47 children was 9.8 years (range 1.1 to 18.2). Most were diagnosed with a haematologic disease (n = 31) of whom 2 received a HSCT |
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Index tests | The Platelia ELISA (Bio‐Rad Laboratories, France) was used to measure the levels of GM in serum and BAL according to the instructions of the manufacturer. An optical density index of 0.5 was considered positive All tests were performed by technicians who were unaware of the clinical condition of the patient Serum GM samples were taken twice weekly in paediatric patients considered to be at high risk of IA |
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Target condition and reference standard(s) | Children were classified as proven, probable or possible IPA according to the EORTC/MSG criteria (De Pauw 2008). Children with a CT scan not indicative for IPA were regarded as having no IPA | ||
Flow and timing | No information on timing; all patients were classified by EORTC criteria; not sure if all patients were included in analyses | ||
Comparative | |||
No patients per category | 2 proven, 17 probable, 12 possible and 16 no IA | ||
Notes | No conflicts of interest reported | ||
Methodological quality | |||
Item | Authors' judgement | Risk of bias | Applicability concerns |
DOMAIN 1: Patient Selection | |||
Was a consecutive or random sample of patients enrolled? | Unclear | ||
Was a case‐control design avoided? | Unclear | ||
Did the study avoid inappropriate exclusions? | Unclear | ||
Unclear | Unclear | ||
DOMAIN 2: Index Test All tests | |||
Were the index test results interpreted without knowledge of the results of the reference standard? | Yes | ||
If a threshold was used, was it pre‐specified? | Yes | ||
Low | Low | ||
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? | Unclear | ||
Unclear | Low | ||
DOMAIN 4: Flow and Timing | |||
Was there an appropriate interval between index test and reference standard? | Unclear | ||
Did all patients receive the same reference standard? | Yes | ||
Were all patients included in the analysis? | Unclear | ||
Unclear |