Machetti 1998.
Study characteristics | |||
Patient sampling | 22 allogeneic BMT patients were followed from transplant to 90 days onwards; 5 developed IA. No information on how the 22 were selected | ||
Patient characteristics and setting | 22 participants undergoing allogeneic bone marrow transplantation (BMT) No information about age or gender Setting: haematology department Country: Italy Inpatients; monitoring clinical course No further details |
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Index tests | Platelia Serum samples were collected 3 times a week during the first month and once a week during the second and third month Positivity was defined as at least 2 consecutive positive samples. One or less positive was considered negative Cut‐off: positive if > 1.5 ODI and negative if < 1.0 ODI |
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Target condition and reference standard(s) | Invasive aspergillosis, as defined by EORTC‐like criteria Galactomannan test was not mentioned as part of the reference criteria |
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Flow and timing | Until day 90 after transplantation All patients were classified according to the same reference criteria No withdrawals reported and no intermediate results reported |
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Comparative | |||
No patients per category | 1 proven, 3 probable, 1 possible, 17 no IA | ||
Notes | Sponsoring precluded? No: ELISA was kindly provided by Sanofi Pasteur and they received financial support from Pfizer | ||
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 | Unclear | ||
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? | Yes | ||
Did all patients receive the same reference standard? | Yes | ||
Were all patients included in the analysis? | Yes | ||
Low |