Pinel 2003.
Study characteristics | |||
Patient sampling | Prospective; series of patients with same risk profile Not reported whether selection was done consecutively, but no reason to assume it was not |
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Patient characteristics and setting | 3327 serum samples from 807 participants
No information about age
62% of the cases were male
France Patients from haematological and intensive care units that were at risk for invasive fungal infections Inpatients, monitoring clinical course Representative spectrum? Yes: patients from haematological and intensive care units that were at risk of invasive fungal infections |
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Index tests | Platelia. 2 consecutive positive patient samples were necessary to suspect IA. In analyses also looked at single sample results. Cut‐offs analysed: > 1.0 ODI subsequently; 0.5, 1.0, 1.5 as single sample | ||
Target condition and reference standard(s) | Invasive aspergillosis, as defined by EORTC criteria (Ascioglu 2002) Incorporation avoided? The authors did not explicitly report the exclusion of the ELISA results from the EORTC criteria, so blinding also unclear Acceptable reference standard? Yes: EORTC criteria (Ascioglu 2002) |
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Flow and timing | Time interval was not reported. Partial verification avoided? Yes: all patients were classified according to reference criteria Withdrawals explained? No Uninterpretable results reported? No |
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Comparative | |||
No patients per category | 3 proven, 31 probable, 22 possible, 751 no IA | ||
Notes | Also clinical and radiological signs reported Nothing reported about financial support |
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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? | Unclear | ||
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? | 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 |