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. 2015 Sep 29;2015(9):CD009263. doi: 10.1002/14651858.CD009263.pub2

Biasotti 2000.

Clinical features and settings Inclusion period: 1985 to 1998.
Patient population: 196 children with suspected neuroblastoma prior to chemotherapy and surgery were included.
Consecutive series: not reported.
Diagnostic work‐up: CT or MRI or both, ¹²³I‐MIBG or 99mTc‐MDP or both scans, one to four bone marrow aspirations and at least one bone marrow biopsy (limited to children ≥ 1 year of age), urinary catecholamines, serum ferritin, neuro specific enolase and lactate dehydrogenase.
Time spans symptoms‐index test, symptoms‐reference standard and index test‐reference standard: n.r.
Treatment between index test‐reference standard: n.r.
Participants Included patients: 196 children with a neuroblastoma and ¹²³I‐MIBG scan at first diagnosis.
Median age at diagnosis: 31 months (range 8 to 65 months).
Sex distribution: not reported.
INSS stage: 38 stage 1 or 2, 50 stage 3, 95 stage 4 and 13 stage 4S.
Study design Case series with pathologically proven neuroblastoma (histopathology not known at the time of MIBG‐scintigraphy).
Target condition and reference standard(s) Target condition: newly diagnosed neuroblastoma.
Reference standard: histopathology according to Joshi nomenclature.
Index and comparator tests Assessed primary objective 1.1: to determine the diagnostic accuracy of ¹²³I‐MIBG (SPECT‐CT) scintigraphy for detecting a neuroblastoma and its metastases at first diagnosis or at recurrence in children from 0 to 18 years old.
Index test: ¹²³I‐MIBG scintigraphy.
Radiofarmacon: ¹²³I‐MIBG.
Dose: n.r.
Collimator: n.r.
Matrix: n.r.
Acquisition protocol: n.r.
Acquisition time: n.r.
Acquisition duration: n.r.
Interfering medication: n.r.
Thyroid prophylaxis: n.r.
Positive test result: pathologic ¹²³I‐MIBG uptake.
Number and expertise of observers: n.r.
Interobserver concordance: n.r.
Follow‐up Median follow‐up: n.r; for some patients: up to five years.
Notes  
Table of Methodological Quality
Item Authors' judgement Description
Representative spectrum? 
 All tests Yes Patients with a neuroblastoma at first diagnosis, age 8 to 65 months and stage distribution were reported.
Acceptable reference standard? 
 All tests Yes Histopathology according to the Joshi nomenclature.
Acceptable delay between tests? 
 All tests Unclear n.r.
Partial verification avoided? 
 All tests Unclear n.r.
Differential verification avoided? 
 All tests Unclear n.r.
Incorporation avoided? 
 All tests Unclear n.r.
Reference standard results blinded? 
 All tests Unclear n.r.
Index test results blinded? 
 All tests Unclear n.r.
Relevant clinical information? 
 All tests Unclear n.r.
Uninterpretable results reported? 
 All tests Unclear n.r.
Withdrawals explained? 
 All tests Unclear n.r.
Selection criteria clearly described? 
 All tests No n.r.
Sufficient detail for replication index test? 
 All tests No Performance and equipment of ¹²³I‐MIBG scintigraphy: n.r.
Radiofarmacon, dose, collimator, matrix, acquisition protocol, acquisition time and acquisition duration were n.r.
Sufficient detail for replication reference test? 
 All tests No n.r.
Clear definition of positive result index test? 
 All tests Yes Pathologic isotope accumulation of ¹²³I‐MIBG.
Interobserver variation reported and acceptable? 
 All tests Unclear n.r.