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. |
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Target condition and reference standard(s) | Target conditions:
Reference standard: surgical excision. Further details: Technical specifications: not applicable. Performed by: clinicians. Criteria for positive diagnosis: not stated. |
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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 |