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. |
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| 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. |
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| 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. |
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| 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. |
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| 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. |