Raff 2014.
| Study characteristics | |||
| Patient Sampling | The cross‐sectional study included 366 patients with cirrhosis, of whom supposedly all had AFP sampled. 163 patients received US as screening test. The AFP analysis included 356 patients ‐ 10 patients excluded without explanation. Medical charts of patients with cirrhosis seen at a single tertiary referral centre (2007‐2011) were reviewed. Among other data, use of and findings from CT or MRI scan within 6 months of receiving US were recorded for patients who had US as the initial imaging. Age range not reported. Males 71% |
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| Patient characteristics and setting | |||
| Index tests | AFP cut‐off level 20 ng/mL; US no specification | ||
| Target condition and reference standard(s) | HCC: HCC was diagnosed based on standard criteria on CT or MRI scan. Of 163 patients receiving US, 72 received follow‐up CT/MRI scan within 6 months of US examination. |
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| Flow and timing | Use of and findings from CT or MRI scan within 6 months of receiving US was recorded for patients who had US as the initial imaging. No information for AFP. The AFP analysis included 356 patients. 10 patients excluded without explanation |
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| Comparative | |||
| Notes | No information on conflicts of interest | ||
| 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 | ||
| Could the selection of patients have introduced bias? | High risk | ||
| Are there concerns that the included patients and setting do not match the review question? | Low concern | ||
| DOMAIN 2: Index Test (AFP) | |||
| Were the index test results interpreted without knowledge of the results of the reference standard? | Yes | ||
| If a threshold was used, was it pre‐specified? | Yes | ||
| Could the conduct or interpretation of the index test have introduced bias? | Low risk | ||
| Are there concerns that the index test, its conduct, or interpretation differ from the review question? | Low concern | ||
| DOMAIN 2: Index Test (US+AFP) | |||
| DOMAIN 2: Index Test (US) | |||
| Were the index test results interpreted without knowledge of the results of the reference standard? | Yes | ||
| If a threshold was used, was it pre‐specified? | No | ||
| Could the conduct or interpretation of the index test have introduced bias? | High risk | ||
| Are there concerns that the index test, its conduct, or interpretation differ from the review question? | Low concern | ||
| DOMAIN 3: Reference Standard | |||
| Is the reference standards likely to correctly classify the target condition? | No | ||
| Were the reference standard results interpreted without knowledge of the results of the index tests? | No | ||
| Could the reference standard, its conduct, or its interpretation have introduced bias? | High risk | ||
| Are there concerns that the target condition as defined by the reference standard does not match the question? | Low concern | ||
| 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? | No | ||
| Were all patients included in the analysis? | No | ||
| Could the patient flow have introduced bias? | High risk | ||