Nihtinen 2010.
Study characteristics | |||
Patient sampling | "All adult allo‐SCT recipients transplanted between January 2001 and December 2002 in Helsinki University Central Hospital were eligible for this study" Exclusion of patients receiving reduced‐intensity conditioning that does not lead to severe neutropenia Single group; prospective study; patients consecutively enrolled |
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Patient characteristics and setting | 138 patients were transplanted; 102 patients were left for the final analysis
Mean age 44 years
Finland "All adult allo‐SCT recipients transplanted [...] were eligible for this study" Representative spectrum? Yes: single group of allo‐SCT recipients; prospective study; patients consecutively enrolled |
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Index tests | Analyses were performed using the GM ELISA test (Platelia Aspergillus, Bio‐Rad, Hercules, CA, USA) according to the manufacturer's instructions. An optical density index of 0.5 was used as the criterion for test positivity | ||
Target condition and reference standard(s) | The revised EORTC/MSG criteria were used to define the cases GM ELISA results were excluded from the criteria for IA Acceptable reference standard? Yes |
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Flow and timing | 36 patients were excluded because of reduced‐intensity conditioning or patient refusal; at 1 year after transplantation, 75 patients (73.5%) were alive Partial verification avoided? Yes: all patients were classified according to the reference criteria Withdrawals explained? No: some patients refused, but no reason is given as to why Uninterpretable results reported? No: there must have been indeterminate results; but they were not explained |
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Comparative | |||
No patients per category | Unclear reporting: 1 proven?; 1 probable?; 0 possible?; 100 no IA | ||
Notes | Sponsoring precluded? M Richardson is the founder and a shareholder of MoBiAir Diagnostics Ltd. but this seems to have nothing to do with Platelia; so there was no sponsoring by Platelia | ||
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 | ||
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 | ||
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 |