Sarwar 2014.
| Study characteristics | |||
| Patient Sampling | This study was conducted at the Department of Medicine, The King Edward Medical University, Lahore, from November 2007 to August 2011. Consecutive patients with HCC presenting the study centre were enrolled (173 cases). People included as controls were 102 consecutive patients with cirrhosis without evidence of HCC. Patients with suspicion of ovarian or testicular malignancy on examination or diagnostic workup were excluded. Age range: 45‐68. Males 65% |
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| Patient characteristics and setting | |||
| Index tests | AFP: "ROC was used to determine area under curve (AUC) and cut‐off value of AFP with best possible sensitivity and specificity. We used cut‐off values of 20, 50, 100, 200, and 400 ng/mL for diagnosis of HCC, as mentioned in previous studies. AFP level with best possible sensitivity and specificity for diagnosing HCC was determined using ROC curve and it was 20.85 ng/mL with sensitivity of 72% and specificity of 86.3%." | ||
| Target condition and reference standard(s) | HCC: "diagnosis of HCC was made in accordance with AASLD guidelines. Control group: all patients had serum alpha‐fetoprotein and abdominal US to exclude HCC. Patients with an elevated AFP (> 20 ng/mlL at enrolment were required to have a CT or MRI showing no lesion suggestive of HCC. Cirrhotic patients with nodules larger than 1 cm on US underwent biphasic CT abdomen or dynamic contrast enhanced MRI. If the appearance was typical of HCC i.e. hypervascular in arterial phase with washout in the portal venous phase, lesion was regarded as hepatocellular carcinoma. But if the findings were not characteristic or the vascular profile was not typical, a second contrast enhanced study with other imaging technique was performed or the lesion was biopsied. Those with lesion less than 1 cm were not included and were advised follow‐up with repeat ultrasonography after 6 months." | ||
| Flow and timing | Interval between index test and reference standard not mentioned | ||
| 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? | Yes | ||
| 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? | 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 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? | 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? | 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 | ||