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

Schrock 1994.

Study characteristics
Patient Sampling Inclusion/exclusion criteria
NR. Quote: "Nine human malignant gliomas" studied.
Prior testing
Histopathological diagnosis according to WHO 1993 classification.
Patient characteristics and setting Number of participants/tumours with results for 1p/19q status by ≥ 2 DNA‐based tests: 8
Country: Germany
Population source and setting: NR
Age: mean: 57.5 years, standard deviation: 12.8 years
Gender: 62.5% male
Karnofsky performance status: NR
First diagnosis/recurrent disease: 87.5% (7/8) primary tumours, 12.5% (1/8) recurrent tumour
Index tests 2 tests: CGH and G‐banding
CGH
Tumour sample type: frozen
Region(s) analysed: genome wide
Cut‐off: quote: "For each case evaluation of chromosomal imbalances and amplification sites in gliomas was performed both by visual inspection and calculation of fluorescence ratio profiles. For visual inspection digitized FITC and TRITC images of 10 reference metaphase spreads and the corresponding ratio images were analyzed.29 A five color lookup table was established according to the results of CGH with test DNAs from cell populations with specific monosomies and trisomies (S. du Manoir et al, manuscript in preparation). Chromosomes were identified using DAPI banding patterns. Photographs were taken from the screen with Agfa RS 50 color slide film. For fluorescence ratio profiles computer programs were developed on the basis of TCL‐Image (TNO Institute of Applied Physics, Delft, The Netherlands) running on a Macintosh Quadra 950. After determination of the chromosomal axis, individual FITC/TRITC profiles were calculated for each chromosome. Mean ratio profiles were determined from 10 metaphases. The central line in the profiles (Figures 2 and 5) represents the most frequently measured fluorescence ratio for each reference metaphase spread. The left and right vertical lines define threshold values for underrepresentation and overrepresentation of chromosome material (S. du Manoir et al, manuscript in preparation)".
G‐banding
Tumour sample type: fresh
Region(s) analysed: genome wide
Cut‐off: not applicable
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 We presumed that all tests were performed on biopsied tumour material collected on 1 occasion.
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)
DOMAIN 2: Index Test (G‐banding)
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 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))
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? 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 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