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 |
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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 |
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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 |
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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 |
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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 |
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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 |