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. 2017 Apr 17;2017(4):CD010213. doi: 10.1002/14651858.CD010213.pub2

Otomi 2014.

Study characteristics
Patient sampling Type of study: retrospective study.
 Consecutive or random sample: consecutive patients.
Patient characteristics and setting Sample size: 32.
 Females: 17 (53.1%).
 Age: 63 years.
 Presentation:
 Patients with pancreatic lesions undergoing PET/CT prior to surgery other than pancreatic adenocarcinoma.
 Setting: secondary care, Japan.
Index tests Index test: PET.
 Further details:
 Technical specifications: F100 & CYPRIS (Sumitomo Heavy Industries) and Aquido (Toshiba) CT scanner.
 Performed by: radiologist.
 Criteria for positive diagnosis: SUVmax > 2.4.
Target condition and reference standard(s) Target condition: precancerous or cancerous versus benign.
 Reference standard: surgical excision.
 Further details:
 Technical specifications: not applicable.
 Performed by: clinicians.
 Criteria for positive diagnosis: not stated.
Flow and timing Number of indeterminates for whom the results of reference standard were available: not stated.
 Number of patients who were excluded from the analysis: not stated.
Comparative  
Notes Sensitivity and specificity for other parameters such as visualisation and SUVmean were available.
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    
    Low High
DOMAIN 2: Index Test Precancerous or cancerous versus benign ‐ PET (SUV max > 2.4)
If a threshold was used, was it pre‐specified? No    
Were the index test results interpreted without knowledge of the results of the reference standard? Unclear    
    High High
DOMAIN 3: Reference Standard
Is the reference standards likely to correctly classify the target condition? Yes    
Were the reference standard results interpreted without knowledge of the results of the index tests? Unclear    
    Unclear Low
DOMAIN 4: Flow and Timing
Was there an appropriate interval between index test and reference standard? Unclear    
Did all patients receive the same reference standard? Yes    
Were all patients included in the analysis? Yes    
    Unclear