Snowberger 2007.
Study characteristics | |||
Patient Sampling | This was a retrospective study conducted at the Baylor Regional Transplant Center, including Baylor University Medical Center in Dallas, TX and Baylor All Saints Hospital in Fort Worth, TX, USA. The study group consisted of patients with cirrhosis who were discovered to have HCC, either before or at the time of orthotopic liver transplantation. Participants without HCC who were transplanted during the same time period served as controls. 2372 patients were approved for listing and underwent transplant at Baylor between January 1, 1988 and December 31, 2004. HCC was present in 239 (10.1%) patients who underwent transplantation. Age range: 17‐32. Males 73% |
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Patient characteristics and setting | |||
Index tests | "AFP: a normal AFP in our laboratory is less than 8.9 ng ⁄ mL." | ||
Target condition and reference standard(s) | HCC: all cases of HCC identified by imaging before transplant were confirmed by pathologic examination of the explanted liver and these cases were defined as known. Cases only identified in the explant were labelled as incidental. All patients underwent liver transplantation. | ||
Flow and timing | No information on interval between index test and reference standard | ||
Comparative | |||
Notes | "Conflicts of interest: declaration of personal interests: Drs. Snowberger, Chinnakotla, Lepe, and Goldstein have no interests to declare. Ms. Peattie has no outside interests to declare. Dr. Klintmalm receives clinical research funding from AbSorber, Astellas, Genxyme, Isotechnika, Novartis, Pfizer, Roche, and Y’s Therapeutics. Dr. Davis receives clinical research funding from Roche, Schering‐Plough, Human Genome Science, and Vertex. Declaration of funding interests: This study was funded entirely by the Baylor Regional Transplant Institute" | ||
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? | Unclear | ||
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? | Yes | ||
Were all patients included in the analysis? | Yes | ||
Could the patient flow have introduced bias? | Unclear risk |