Badiee 2013.
Study characteristics | |||
Patient sampling | The study included all the paediatric patients (1 to 14 years old) with haematology disorders who were treated at the haematology/oncology unit of Faghihi Hospital, Shiraz University of Medical Sciences, Iran. All study participants were identified as being at increased risk of developing IA | ||
Patient characteristics and setting | 1 to 14 years old; mean age 9.3; all had haematological malignancies Study done at a haematology/oncology unit in Iran |
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Index tests | Detection of Aspergillus GM was performed using the Platelia Aspergillus EIA (immunoenzymatic sandwich microplate assay, Bio‐Rad, Platelia, Marnes La Coquette, France), according to the manufacturer's protocol. GM assay index ≥ 0.5 was considered positive | ||
Target condition and reference standard(s) | Classification of patients was performed according to the protocols of the European Organization for Research and Treatment of Cancer‐Mycosis Study Group (De Pauw 2008). Accordingly, the reference gold standards (positive culture from clinical samples) used to calculate the specificity and sensitivity were the mycological criteria (without indirect tests including GM) along with host factors and clinical criteria | ||
Flow and timing | No information on time to diagnosis; all included patients were classified according to the same criteria; no withdrawals mentioned | ||
Comparative | |||
No patients per category | 1 proven, 9 probable, 26 possible, 26 no IA | ||
Notes | No COI declared | ||
Methodological quality | |||
Item | Authors' judgement | Risk of bias | Applicability concerns |
DOMAIN 1: Patient Selection | |||
Was a consecutive or random sample of patients enrolled? | Yes | ||
Was a case‐control design avoided? | Yes | ||
Did the study avoid inappropriate exclusions? | Yes | ||
Low | Low | ||
DOMAIN 2: Index Test All tests | |||
Were the index test results interpreted without knowledge of the results of the reference standard? | Unclear | ||
If a threshold was used, was it pre‐specified? | Yes | ||
Unclear | 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? | Yes | ||
Low | 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? | Yes | ||
Low |