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

Kalha 2003.

Study characteristics
Patient sampling Type of study: retrospective study.
 Consecutive or random sample: neither.
Patient characteristics and setting Sample size: 24.
 Females: not stated.
 Age: not stated.
 Presentation:
 Patients undergoing EUS‐FNA and surgery for cystic pancreatic lesions.
 Setting: secondary care, USA.
Index tests Index test: EUS‐FNA.
 Further details:
 Technical specifications: EUS model or needle size not stated.
 Performed by: not stated.
 Criteria for positive diagnosis: cyst CEA fluid >= 500 ng/mL.
Target condition and reference standard(s) Target condition: cancerous versus benign or precancerous.
 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 Of 84 participants, 60 who were observed were excluded because the reference standard was not adequate for these participants.
Methodological quality
Item Authors' judgement Risk of bias Applicability concerns
DOMAIN 1: Patient Selection
Was a consecutive or random sample of patients enrolled? No    
Was a case‐control design avoided? Yes    
Did the study avoid inappropriate exclusions? No    
    High High
DOMAIN 2: Index Test Cancerous versus benign or precancerous ‐ EUS FNA (cytology)
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? Unclear    
    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? 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? No    
    High