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

Bigner 1999.

Study characteristics
Patient Sampling Inclusion/exclusion criteria
Inclusion criteria: tumours composed partially or completely of neoplastic oligodendroglia (only cases on which there was agreement between 2 or 3 of the 3 observers for histological classification were included); frozen tissue and normal peripheral lymphocytes available.
Prior testing
Histopathological classification
Patient characteristics and setting Number of participants/tumours with results for 1p/19q status by ≥ 2 DNA‐based tests: 53
Country: USA
Population source and setting: NR
Age: mean: 39.9 years, standard deviation: 11.8 years
Gender: 64.2% male
Karnofsky performance status: NR
First diagnosis/recurrent disease: unclear. We excluded the recurrences for people whose primary tumour was also included in the study. Some additional participants had had prior surgery or RT, unclear if the tumours studied were recurrences.
Index tests 2 tests: CGH and PCR‐based LOH
CGH
Tumour sample type: frozen
Region(s) analysed: genome wide
Cut‐off: ratio of 0.85 indicated a loss.
PCR
Tumour sample type: frozen
Region(s) analysed: FGR, MYCL1, AMY2B (1p); D19S217, D19S112, D19S412, STD, D19S596, D19S180, D19S254, D19S218 (19q)
Cut‐off: a reduction in intensity > 50% in the tumour lane compared to the corresponding blood lane was scored as LOH.
Target condition and reference standard(s) Target condition was absolute 1p/19q deletion. PCR‐based LOH used as reference standard in some of our analyses.
Flow and timing Both tests were performed on frozen tumour material.
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)
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 (NGS or aCGH (or both))
DOMAIN 2: Index Test (Methylation array)
DOMAIN 2: Index Test (FISH)
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)
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 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