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

Sim 2018b.

Study characteristics
Patient Sampling Inclusion/exclusion criteria
Inclusion: oligodendroglial tumour
Prior testing
Presumably histopathological diagnosis, although not explicitly reported
Patient characteristics and setting Number of participants/tumours with results for 1p/19q status by ≥ 2 DNA‐based tests: 10
Country: Republic of Korea
Population source and setting: NR
Age: mean: 45.7 years, standard deviation: 13.5 years
Gender: 60% male
Karnofsky performance status: NR
First diagnosis/recurrent disease: NR
Index tests 2 tests: FISH and NGS
FISH
Tumour sample type: FFPE
Region(s) analysed: 1p36 and 19q13 (Vysis, Downers Grove, Illinois, USA)
Cut‐off: 1p deletion as a combined target‐to‐control signal ratio < 0.75 or cut‐off of a nucleus with a 1 or 0 target signal > 50%. 19q deletion as a combined target‐to‐control signal ratio < 0.8 and a nucleus cut‐off with a 1 or 0 target signal > 30%
NGS
Tumour sample type: fresh frozen
Region(s) analysed: genome wide
Cut‐off: whole arm losses
Additional details: whole exome sequencing (Illumina TruSeq Exome capture kit or the Agilent SureSelect kit and either the Illumina HiSeq 2000 or HiSeq 2500)
Target condition and reference standard(s) Target condition was absolute 1p/19q deletion. FISH used as reference standard in some of our analyses.
Flow and timing We presumed that both tests were performed on tumour material harvested at the same time point.
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? Unclear    
Was a case‐control design avoided? Yes    
Did the study avoid inappropriate exclusions? Unclear    
Could the selection of patients have introduced bias?   Unclear 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)
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? Unclear    
Could the conduct or interpretation of the index test have introduced bias?   Unclear risk  
Are there concerns that the index test, its conduct, or interpretation differ from the review question?     Low concern
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)
If a threshold was used, was it pre‐specified? Unclear    
Were the index test results interpreted without knowledge of the results of the other tests being compared? Unclear    
Could the conduct or interpretation of the index test have introduced bias?   Unclear 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 1))
DOMAIN 2: Index Test (FISH (variant 2))
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