Planas R, Balleste B, Alvarez MA, Rivera M, Montoliu S, Galeras JA, et al. Natural history of decompensated hepatitis C virus-related cirrhosis. A study of 200 patients. J Hepatol 2004;40:823-830. (Reprinted with permission from The European Association for the Study of the Liver.)
Cirrhosis and its related complications are the 12th leading cause of mortality in US adults for the year 2000. For individuals between 45 and 54 years of age, it ranks as the fifth leading cause of death.1 The number of deaths from cirrhosis (including hepatobiliary neoplasia) exceeds 44,000 cases annually, which is similar to the death toll associated with diabetes mellitus.2 The natural history of cirrhosis is associated with the development of complications that often require hospitalization for treatment.3 Over the past 10 years, the number of hospitalizations for cirrhosis has increased and with it the cost of care, which is now estimated at $15,000 per admission. In addition, a steady in-hospital mortality rate of 10% has been observed nationally, with the vast majority of patients dying from progressive liver failure.4
The Institute of Medicine has recommended that efforts to reduce practice variation and improve quality of care be applied to chronic diseases with an increased prevalence, excessive resource utilization, and high mortality rate.5 Cirrhosis and its related complications clearly fulfill these criteria. To date, a number of quality of care investigations have focused on similar chronic conditions including heart failure,6 which draws parallels with cirrhosis regarding similar resource utilization and hospital mortality rates. In contrast, there have been no sustained national or societal efforts aimed at improving quality of medical care in patients with cirrhosis to date.
The importance of considering quality of care evaluation in cirrhosis relies on existing data that demonstrate a high degree of practice variation and infrequent use of evidence-based medical therapies for other chronic diseases. There is no reason to believe that medical care for patients with cirrhosis is exempt from this phenomenon. Arroyo and colleagues7 conducted a survey among practitioners caring for patients with liver disease regarding the medical management of ascites. Surprisingly, an estimated 50% of individuals used oral diuretics for the goal of complete ascites fluid elimination even if higher doses were required. Conversely, only 7% of practitioners used a low-sodium diet with or without spironolactone as initial therapy for patients with mild ascites, while 70% of respondents employed dietary sodium restriction and oral diuretics for patients without ascites. In a similar investigation that focused on hepatocellular carcinoma,8 the exclusive screening of patients with only chronic viral hepatitis and iron overload was reported by 50% of respondents. The use of alpha-fetoprotein with either ultrasound or computed tomography ranged between 27% and 69%. Of interest, the majority of survey respondents believed that studies exist confirming a survival benefit and cost effectiveness for screening and surveillance, neither of which has been conclusively proven to date.
Underlying the recognition of wide practice variation is the use of evidence-based medicine to care for patients with cirrhosis. Over the past two decades, a large number of high-quality randomized controlled trials and observational studies have been conducted in patients with cirrhosis and portal hypertension. Examples include the use of nonselective beta-blockers for primary and secondary prophylaxis of esophageal variceal bleeding,9 endoscopic variceal ligation for primary prophylaxis against esophageal variceal bleeding,10 and the use of systemic antibiotics in patients to prevent bacterial infection with gastrointestinal bleeding.11 Despite the availability of these data, the extent to which scientific results are readily translated into clinical practice may be limited. The issues for medical care in cirrhosis remain even less well known given the absence of extensive investigation on this topic.
Planas and colleagues12 describe the natural history of decompensated cirrhosis from hepatitis C after initial hospitalization. In this retrospective study, the mean age was 66 years, with 55% men. The mean Child-Turcotte-Pugh score was 8, with 12% of patients fulfilling criteria for Child-Turcotte-Pugh class C disease. Ascites was the most common event of first decompensation requiring hospitalization (48%) followed by portal hypertensive bleeding (32%), bacterial infection (14%), and hepatic encephalopathy (5%). Two or more simultaneous decompensation events occurred in 17% of patients.
Over a 34-month period in this study, a total of 515 hospital admissions were recorded for 200 patients. For all patients, the 1- and 5-year cumulative risks for hospital readmission were 45% and 83%, respectively. The highest 1-year risk for readmission was associated with hepatic encephalopathy (73%), while patients with ascites, portal hypertensive bleeding, and bacterial infection incurred a minimum risk of 35%, respectively. Survival was independently associated with (1) hepatic encephalopathy and/or ascites as the first decompensation event, (2) baseline Child-Turcotte-Pugh score, (3) age, and (4) the occurrence of more than one decompensating event in follow-up. Frequency of hospitalization was not analyzed.
These data provide novel insights regarding the clinical epidemiology of HCV-related decompensated cirrhosis requiring hospitalization. While not a prespecified goal by the authors, one might speculate about the potential influence of medical practice variation on recurrent episodes of decompensation, hospital readmission, and survival. In a multicenter study of medication prescribing patterns for a similar cohort of hospitalized patients with cirrhosis,13 an estimated 35% of individuals hospitalized for ascites were not prescribed oral diuretics on dismissal. No information is available on the proportion of patients with ascites as their first clinical presentation or the frequency of those individuals with diuretic-intolerant ascites. Nonetheless, a significant degree of underuse with these effective therapies cannot be overlooked. Lactulose or lactitol was prescribed for hospitalized patients on discharge in 51% to76% of instances for prophylaxis against hepatic encephalopathy, which has no evidence-based rationale to date. Again, the number of patients with symptomatic hepatic encephalopathy receiving lactulose or lactitol therapy on discharge to determine the performance rate of this appropriate strategy is not known.
The most concerning observation involved the usage of nonselective beta-blocker agents at hospital discharge. The reported frequency of beta-blocker use for the indication of prophylaxis against portal hypertensive bleeding was only 24%, with a range between 0% and 53%. Similar frequencies of beta-blocker use on hospital discharge have been incidentally reported from recent series.14, 15 Further details, including the percentage of indications fulfilling primary or secondary prophylaxis of esophageal variceal bleeding, are unknown. Nevertheless, a median adherence rate of 24% for beta-blocker use is alarming, especially when compared to higher median rates of antiulcer drug (35%) and oral vitamin K (31%) prescription observed in the same patient population. Of note, as many as 47% of patients received oral nitrates on discharge despite less quality evidence for their use in prophylaxis compared with beta blockers. Further details including size of esophageal varices and history of previous variceal bleeding are needed to fully determine the patterns of underuse and misuse of beta-blocker therapy.
These data reveal a striking degree of variation in the use of evidence-based therapies and raise serious concerns about the overall quality of care for hospitalized patients with cirrhosis. Given the increased mortality and economic burden posed by cirrhosis, the study of medical practice variation in this patient population deserves further attention to determine how quality of care may be improved.16 Future investigations should focus on both structure and processes of care which might influence clinical outcomes.17, 18