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. |
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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 |
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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 |
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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 |