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. 2022 Mar 2;2022(3):CD013387. doi: 10.1002/14651858.CD013387.pub2

Senetta 2013.

Study characteristics
Patient Sampling Inclusion/exclusion criteria
Brain tumours with an oligodendroglial component with diagnostic agreement between 2 observers. Recurrences were excluded.
Prior testing
Histopathological diagnosis using the WHO 2007 classification.
Patient characteristics and setting Number of participants/tumours with results for 1p/19q status by ≥ 2 DNA‐based tests: 143
Country: Italy
Population source and setting: Department of Medical Sciences, University of Turin. January 2004 to March 2012
Age: mean: 51.5 years, standard deviation: NR; range: 22–81 years
Gender: 56.6% male
Karnofsky performance status: NR
First diagnosis/recurrent disease: 100% first diagnosis
Index tests 2 tests: FISH (variant 1) and FISH (variant 2)
FISH (variant 1)
Tumour sample type: FFPE
Region(s) analysed: 1p36/1q25 and 19q13/19p13 (Vysis, Abbott Molecular Europe, Wiesbaden, Germany)
Cut‐off: ratios 1p ≤ 0.8 and 19q ≤ 0.8
FISH (variant 2)
Tumour sample type: FFPE
Region(s) analysed: 1p36/1q25 and 19q13/19p13 (Vysis, Abbott Molecular Europe, Wiesbaden, Germany)
Cut‐off: ratios 1p ≤ 0.7 and 19q ≤ 0.8
Target condition and reference standard(s) Target condition was absolute 1p/19q deletion. No tests used as reference standard in our analyses.
Flow and timing The same FISH preparations were used, and 2 different thresholds were applied.
Comparative  
Notes  
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    
Could the selection of patients have introduced bias?   Low risk  
Are there concerns that the included patients and setting do not match the review question?     High
DOMAIN 2: Index Test (NanoString)
DOMAIN 2: Index Test (aCGH)
DOMAIN 2: Index Test (NGS)
DOMAIN 2: Index Test (G‐banding)
DOMAIN 2: Index Test (FISH (variant 4))
DOMAIN 2: Index Test (SNP array)
DOMAIN 2: Index Test (PCR (with comparison to normal DNA))
DOMAIN 2: Index Test (PCR (without comparison to normal DNA))
DOMAIN 2: Index Test (CISH)
DOMAIN 2: Index Test (MS)
DOMAIN 2: Index Test (RFLP)
DOMAIN 2: Index Test (PCR‐based LOH)
DOMAIN 2: Index Test (NGS or aCGH (or both))
DOMAIN 2: Index Test (Methylation array)
DOMAIN 2: Index Test (FISH)
DOMAIN 2: Index Test (FISH (variant 1))
If a threshold was used, was it pre‐specified? Yes    
Were the index test results interpreted without knowledge of the results of the other tests being compared? Yes    
Could the conduct or interpretation of the index test have introduced bias?   Low risk  
Are there concerns that the index test, its conduct, or interpretation differ from the review question?     Low concern
DOMAIN 2: Index Test (FISH (variant 2))
If a threshold was used, was it pre‐specified? Yes    
Were the index test results interpreted without knowledge of the results of the other tests being compared? Yes    
Could the conduct or interpretation of the index test have introduced bias?   Low risk  
Are there concerns that the index test, its conduct, or interpretation differ from the review question?     Low concern
DOMAIN 2: Index Test (FISH (variant 3))
DOMAIN 2: Index Test (Real‐time PCR)
DOMAIN 2: Index Test (MLPA)
DOMAIN 2: Index Test (CGH)
DOMAIN 3: Reference Standard
Is the reference standards likely to correctly classify the target condition? No    
Could the reference standard, its conduct, or its interpretation have introduced bias?   High risk  
Are there concerns that the target condition as defined by the reference standard does not match the question?     Low concern
DOMAIN 4: Flow and Timing
Was there an appropriate interval between index test and reference standard? Yes    
Were all patients included in the analysis? Yes    
Could the patient flow have introduced bias?   Low risk