Smith 2016.
| Study characteristics | |||
| Patient sampling | Type of study: retrospective study. Consecutive or random sample: neither. | ||
| Patient characteristics and setting | Sample size: 138. Females: 99 (71.7%). Age: 62 years. Presentation: Patients with IPMN or MCN. Setting: secondary care, USA. | ||
| Index tests | Index test: EUS‐FNA.
Further details:
Technical specifications: not stated.
Performed by: not stated.
Criteria for positive diagnosis: high‐grade atypia or worse. Second criteria for positive diagnosis: abnormal cytology. |
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| Target condition and reference standard(s) | Target condition: 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: 0 (0%). Number of patients who were excluded from the analysis: 11 (8%). | ||
| Comparative | |||
| Notes | Diagnostic accuracy was also available for another threshold (abnormal cytology) with lower diagnostic accuracy. | ||
| 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 (high grade dysplasia or invasive carcinoma) versus precancerous (low or intermediate grade 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? | Unclear | ||
| Unclear | 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? | No | ||
| High | |||