Nomura 1999.
| Study characteristics | |||
| Patient Sampling | The study included 36 patients with solitary small‐sized (< 3 cm in diameter) HCC and 49 patients with posthepatitic cirrhosis carrying no HCC. Patients who had been taking antibiotics containing N‐methylthiotetrazole (NMTT) were excluded. Also, cirrhotic patients who subsequently developed HCC within 1 year were excluded. Age range not reported. Males 71% | ||
| Patient characteristics and setting | |||
| Index tests | AFP: serum AFP levels were determined by latex agglutination immunoassay (IATROMATE AFP, Diatron, Tokyo, Japan). Values of 20 ng/mL were considered upper limit of the reference interval. | ||
| Target condition and reference standard(s) | HCC: a diagnosis of HCC was made histologically in all cases. Control group: in patients with cirrhosis, HCC was ruled out on the basis of the results of imaging studies including sonography and CT performed on a regular basis. Also, patients with liver cirrhosis who subsequently developed HCC within 1 year were excluded. |
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| Flow and timing | No information on interval between index test and reference standard | ||
| 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? | No | ||
| 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? | High | ||
| DOMAIN 2: Index Test (AFP) | |||
| Were the index test results interpreted without knowledge of the results of the reference standard? | No | ||
| If a threshold was used, was it pre‐specified? | Yes | ||
| 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 2: Index Test (US+AFP) | |||
| DOMAIN 2: Index Test (US) | |||
| 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? | Yes | ||
| Could the reference standard, its conduct, or its interpretation have introduced bias? | Low 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? | Unclear | ||
| Did all patients receive the same reference standard? | No | ||
| Were all patients included in the analysis? | Yes | ||
| Could the patient flow have introduced bias? | High risk | ||