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

Pais 2007.

Study characteristics
Patient sampling Type of study: retrospective study.
 Consecutive or random sample: unclear.
Patient characteristics and setting Sample size: 74.
 Females: 36 (48.6%).
 Age: 65 years.
 Presentation:
 Patients with IPMN undergoing surgery and EUS‐FNA.
 Setting: secondary care, USA.
Index tests Index test: EUS‐FNA.
 Further details:
 Technical specifications: Olympus GF‐UM20, GF‐UM130, or GF‐UM160; 22‐gauge needle.
 Performed by: endoscopist and cytologist.
 Criteria for positive diagnosis: presence of hyperchromasia, nuclear crowding, and loss of nuclear uniformity, nucleolar prominence, or chromatin abnormalities.
Target condition and reference standard(s) Target condition: cancerous (invasive carcinoma) versus precancerous (dysplasia).
 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  
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? Yes    
    Unclear High
DOMAIN 2: Index Test Cancerous (invasive carcinoma) versus precancerous (dysplasia) ‐ EUS FNA
If a threshold was used, was it pre‐specified? Yes    
Were the index test results interpreted without knowledge of the results of the reference standard? Yes    
    Unclear Low
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? No    
    High Low
DOMAIN 4: Flow and Timing
Was there an appropriate interval between index test and reference standard? No    
Did all patients receive the same reference standard? Yes    
Were all patients included in the analysis? Yes    
    High