Scotter 2005.
Study characteristics | |||
Patient sampling | Prospective; series of patients with same risk profile | ||
Patient characteristics and setting | 25 participants
Age of cases ranged from 3 to 79 years
60% males
New Zealand Children and adults undergoing stem cell transplantation or chemotherapy for haematological malignancy and had fever for > 96 hours Inpatients Representative spectrum? Yes: patients undergoing stem cell transplantation or chemotherapy for haematological malignancy and had fever for > 96 hours |
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Index tests | Platelia. If the patient was febrile at least once per day for 4 days or if there was a high suspicion of invasive fungal infection, samples were assayed for galactomannan testing and PCR. Number of samples per patient varied from 2 to 32. At each time point of sample/assay, the patients were classified according to their status at that moment. Negative = all samples negative; positive = at least 1 sample positive. Many different cut‐off values analysed (0.5, 1.0, 1.5, 2.0 ODI) | ||
Target condition and reference standard(s) | Invasive aspergillosis, as defined by EORTC criteria (Ascioglu 2002) Incorporation avoided? Yes: galactomannan results were excluded from EORTC criteria Acceptable reference standard? EORTC criteria (Ascioglu 2002) |
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Flow and timing | Time interval not reported Partial verification avoided? Yes: all patients were classified according to the reference criteria Withdrawals explained? Yes Uninterpretable results reported? No |
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Comparative | |||
No patients per category | 4 proven, 1 probable, 7 possible, 13 no IA | ||
Notes | Sponsoring: work was supported by Gilead Sciences, a Bone Marrow Transplantation trust and the Canterbury District Health Board. No connections with Platelia | ||
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? | Yes | ||
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? | Unclear | ||
Did all patients receive the same reference standard? | Yes | ||
Were all patients included in the analysis? | Yes | ||
Low |