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

Maire 2008.

Study characteristics
Patient sampling Type of study: retrospective study.
 Consecutive or random sample: unclear.
Patient characteristics and setting Sample size: 41.
 Females: 27 (65.9%).
 Age: 64 years.
 Presentation:
 Patients with IPMN who had undergone surgical resection.
 Setting: secondary care, France.
Index tests Index test: EUS‐FNA.
 Further details:
 Technical specifications: Pentax‐FG 32 UA 120°.
 Performed by: endoscopists.
 Criteria for positive diagnosis: CEA > 200 ng/mL.
Second criteria for positive diagnosis: carbohydrate antigen 19‐9 > 1000 U/mL.
Target condition and reference standard(s) Target conditions:
  1. Cancerous (invasive carcinoma) versus precancerous (dysplasia).

  2. Cancerous (high‐grade dysplasia or invasive carcinoma) versus precancerous (low‐ or intermediate‐grade 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 6 different criteria for diagnosis were used. All 6 are listed.
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    
    Unclear High
DOMAIN 2: Index Test Cancerous (invasive carcinoma) versus precancerous (dysplasia) ‐ EUS FNA (CEA > 200 ng/ml)
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 2: Index Test Cancerous (high grade dysplasia or invasive carcinoma) versus precancerous (low or intermediate grade dysplasia) ‐ EUS FNA (CEA > 200 ng/ml)
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 2: Index Test Cancerous (high grade dysplasia or invasive carcinoma) versus precancerous (low or intermediate grade dysplasia) ‐ EUS FNA (Ca 19.9 > 1000 U/ml)
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? Unclear    
    Unclear