Busca 2006.
Study characteristics | |||
Patient sampling | Prospective; consecutive series of patients "Between February 2002 and October 2004, all adult patients transplanted at our institution were analyzed" |
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Patient characteristics and setting | 74 participants
Age ranged from 19 to 70 years
No information about gender
Italy All adult patients undergoing allogeneic haematopoietic stem cell transplantation Inpatients; monitoring clinical course Representative spectrum: all adult patients undergoing allogeneic haematopoietic stem cell transplantation were analysed with the commercially available galactomannan sandwich‐ELISA assay Both inpatients and outpatients (outpatients only where possible) |
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Index tests | Platelia. Serum samples were taken twice weekly; galactomannan positivity was defined as an ODI of 1.0 or higher in 2 subsequent sera | ||
Target condition and reference standard(s) | Invasive aspergillosis, according to the EORTC criteria (Ascioglu 2002) Incorporation avoided? Yes: invasive fungal infections were classified according to the EORTC/MSG case definitions Galactomannan results were excluded as microbiologic criteria Acceptable reference standard? Yes: invasive fungal infections were classified according to the EORTC/MSG case definitions (Ascioglu 2002). Galactomannan results were excluded as microbiologic criteria |
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Flow and timing | Timing not reported Partial verification avoided: all patients were classified according to the reference criteria No withdrawals: the study included all patients = 74; the results for all 74 patients were given No uninterpretable results: the study included all patients = 74; the results for all 74 patients were given in terms of negative or positive result, so no uninterpretable results |
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Comparative | |||
No patients per category | 2 proven, 0 probable, 7 possible, 65 no IA | ||
Notes | Sponsoring: not reported | ||
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? | Unclear | ||
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? | 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 |