Ghosh 2013.
Study characteristics | |||
Patient sampling | This was a prospective, single institutional, cohort study conducted during the period October 2008 to February 2010. A convenient sample of 150 consecutive episodes of high‐risk neutropenia was chosen. Patients who were planned for discharge soon after completion of chemotherapy and those not willing to participate were excluded | ||
Patient characteristics and setting | We included patients aged ≥ 15 years, with a diagnosis of leukemia or recipients of auto‐ and allo‐HSCT. Episodes in patients diagnosed with possible or probable IA were also eligible for inclusion Median age of the patients in the episodes was 33 years (range 15.65 years). Male sex predominated with M:F ratio of 2.6:1. Acute myeloid leukaemia induction constituted 50 episodes (33.3%), consolidation with high‐dose cytarabine 30 episodes (20%) and recipients of autologous haematopoietic stem cell transplantation (auto‐HSCT) 37 episodes (24.7%), respectively. 6 episodes had a prior history of IA (3 possible and 3 probable) |
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Index tests | A double‐sandwich ELISA GM assay (Platelia Aspergillus, Bio‐Rad laboratories) capable of detecting GM at concentrations as low as 0.5 ng/mL was used. The assay was carried out at the Medical Oncology Laboratory of the hospital as per manufacturer's guidelines. A cut‐off of optical density index (ODI) > 0.5 was taken as positive | ||
Target condition and reference standard(s) | Each episode was categorised as no IA, possible IA, probable IA or proven IA according to European Organization for Research and Treatment of Cancer (EORTC) 2008 criteria (De Pauw 2008). Unclear if GM results were also in criteria | ||
Flow and timing | Timing not reported | ||
Comparative | |||
No patients per category | 25 possible, 17 probable, 1 proven, 107 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? | 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? | Yes | ||
Unclear |