A single trained abstractor reviewed the medical records of patients identified with relevant ICD-9-CM codes and laboratory abnormalities beginning one year before through six months after VACS enrollment. Data were abstracted onto structured forms that collected information from: 1) abdominal ultrasound, CT, and MRI reports (presence and quantity of ascites; presence and dimensions of liver masses); 2) laboratory results (alpha-fetoprotein; ammonia; peritoneal fluid cell count, differential, culture); 3) liver biopsy results (fibrosis stage; hepatocellular carcinoma diagnosis); 4) endoscopic reports (reason for endoscopy; presence of gastritis and/or peptic ulcers; presence of varices; signs of active variceal bleeding; banding of varices); and 5) progress notes (chronic liver disease etiology; diagnosis of variceal bleeding; reports of diagnostic and/or therapeutic paracentesis; reports of hepatic encephalopathy, asterixis). Hepatic encephalopathy was identified if there was a report of altered mentation and a definite diagnosis was recorded in a gastroenterologist's or hepatologist's note. Reports of a non-hepatic etiology of altered mentation negated a hepatic encephalopathy diagnosis. Asterixis was confirmed only if documented in the physical examination of a gastroenterologist or hepatologist.
After medical record review, data forms were independently reviewed by two arbitrators with expertise in chronic liver diseases (V.L.R. and J.K.L.). Each determined if hepatic decompensation was present and recorded the date each condition was first identified. They then decided whether the event was definite, possible, or had not occurred. Hepatic decompensation was considered to have occurred at the earliest date any diagnosis consistent with the event was documented. Disagreement on classification or date resulted in review by a third arbitrator (M.B.G.) to adjudicate the event.
After medical record review, data forms were independently reviewed by two arbitrators with expertise in chronic liver diseases (V.L.R. and J.K.L.). Each determined if hepatic decompensation was present and recorded the date each condition was first identified. They then decided whether the event was definite, possible, or had not occurred. Hepatic decompensation was considered to have occurred at the earliest date any diagnosis consistent with the event was documented. Disagreement on classification or date resulted in review by a third arbitrator (M.B.G.) to adjudicate the event.
