Skip to main content
. 2015 Dec 30;2015(12):CD007394. doi: 10.1002/14651858.CD007394.pub2

Jha 2013.

Study characteristics
Patient sampling The study was conducted prospectively from July 2010 to December 2011 in a paediatric oncology unit
 Children, up to 14 years, on treatment for haematological malignancies and admitted with fever were enrolled
 Patients who received piperacillin‐tazobactam and/or amoxicillin‐clavulanic acid were excluded as their administration has been associated with a false‐positive GM assay. Stem cell transplant (SCT) recipients were excluded as well
A febrile episode was considered as an independent episode in a patient when it was > 4 weeks apart from the previous one, with the patient being clinically well in between
Patient characteristics and setting Children, until 14 years, on treatment for haematological malignancies and admitted with fever were enrolled
Setting: haematology‐oncology unit in India
Mean age: 6.1 years (1 to 13 years)
3.5 males:1 female
Index tests Blood for GM assay was drawn on the day of admission along with the sample for blood counts and bacterial culture. Serial estimation of GM was performed once a week, until discharge or death in limited patients. The GM assay obtained at admission was considered for analysis
Serum GM levels were measured using the Platelia Aspergillus enzyme immunoassay test (Bio‐Rad, Hercules, CA, USA) as per the manufacturer's instructions. Results were recorded as the ratio of optical density of the sample to that of threshold control samples
Target condition and reference standard(s) Diagnosis of fungal infections was classified as proven, probable, possible or no aspergillosis, based on criteria adapted from the 2002 EORTC/MSG definitions (Ascioglu 2002). For analysis, episodes with a proven, probable or possible disease were considered to have IA unless otherwise stated.
EORTC /MSG definitions permit the GM assay results to be used to meet microbiological criteria for IA. However, the GM values were not included in the criteria for classification of diagnosis of IA, as the assay was itself being validated
Flow and timing They do report the time span of the episodes and they state that the GM test evaluated was the one done at admission. So then the maximum amount of time between index test and diagnosis could have been the time span of an episode, which was 14 days on average, with a maximum of 60 days. Also, they define episodes clearly
Comparative  
No patients per category Proven 1; probable 1; possible 23; no IA 70; other fungal infections n = 5
Notes Analyses based on episodes; 100 episodes in 78 patients; no clear distinction
No conflicts of interest stated
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? Yes    
Did the study avoid inappropriate exclusions? Yes    
    Unclear 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? Unclear    
    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? Yes    
Did all patients receive the same reference standard? Yes    
Were all patients included in the analysis? Yes    
    Low