Quality of care metrics in chronic hepatitis B.

Abstract

Potential conflict of interest: Dr. Fontana consults and is on the speakers' bureau for CLDF. He received grants from Gilead, Bristol‐Myers Squibb, and Janssen. See Article on Page 1774 An increasing emphasis in the US health care system is being placed on improving the quality of care for patients with various common chronic diseases for which there are interventions to improve outcomes and reduce resource use. In hepatology, quality measures are best established for chronic hepatitis C virus (HCV) care such as viral load and genotype testing prior to treatment, screening for hepatocellular carcinoma (HCC) in patients with cirrhosis, and shared decision‐making for treatment options.1 However, quality metrics for chronic hepatitis B (HBV)‐related medical care are substantially lagging behind. The reasons for this may be inadequate recognition of the significant morbidity and mortality related to HBV, a lack of patient/physician advocacy, and controversy regarding meaningful quality metrics. An estimated 1.4 million to 1.8 million Americans have chronic HBV, and 15%‐40% of these individuals are projected to develop complications such as cirrhosis, HCC, or liver failure during their lifetime.2 However, a diagnosis of chronic HBV requires a high index of suspicion based upon risk factors such as country of birth, and many providers are uncertain on how to interpret HBV serologies. Furthermore, optimal management of chronic HBV requires accurate identification of the phase of infection, reliable assessment of disease severity, and knowledge of who and when to treat. Fortunately, there are several safe and well‐tolerated oral antiviral therapies that can reduce the rate of disease progression and even potentially improve survival. However, endpoints for treatment discontinuation and means to enhance hepatitis B surface antigen clearance leading to a virologic “cure” remain elusive. In this issue of hepatology, Serper et al. analyzed the Veterans Administration (VA) claims database to determine the quality of care delivery and clinical outcomes in over 12,000 veterans with chronic HBV seen between 1999 and 2013.4 Although there were missing data in many of the process measures analyzed, the large size of this national data set along with the established validity of the diagnostic codes employed improve the internal validity of their findings. The authors found that >90% of veterans received appropriate initial serum alanine aminotransferase (ALT) testing but that there was low overall use of serum HBV DNA (44%) and hepatitis B e antigen (HBeAg) testing (49%) initially and during a mean follow‐up of 2 years. In addition, adherence to the recommended screening for HCC was low (39%), particularly in high‐risk patients without cirrhosis. Although receipt of specialty care improved the adherence rate, only one‐third of patients seen by a specialist received the recommended biannual imaging. Moreover, the authors found no significant improvement in adherence to recommended care processes over the 14‐year study period.2 The reason(s) for the low rates of adherence to HBV quality care metrics in the VA is not clear. Over the past 10 years, screening and treatment of HCV in the VA health care system have received a great deal of attention, while little, if any, focus has been directed to the diagnosis and management of chronic HBV despite the high hepatitis B surface antigen seroprevalence among veterans. Other studies have evaluated care delivery and outcomes for civilian segments of the US population with chronic HBV using large administrative claims data sets or manual review of individual patient records (Table 1).5 Regardless of the research methodology employed, these retrospective studies have consistently found that rates of antiviral therapy and HCC surveillance are suboptimal and that specialty care is associated with a greater likelihood of receiving recommended care. Possible reasons for these quality deficits include physician choice/preference/knowledge (for or against treatment or HCC surveillance) and patient preferences and attitudes toward invasive testing like liver biopsies, cancer screening, and long‐term antiviral therapy (Fig. 1). The study of Serper et al. adds to this literature by highlighting a more demographically diverse population of predominantly African and Caucasian Americans with chronic HBV compared to previous studies that included mostly Asian Americans. Although the specific care quality metrics differed by study, the rates of adherence for several key process measures were remarkably similar in the VA and civilian populations, demonstrating the need for improved adherence to evidence‐based practice guidelines across multiple health care delivery settings (Table 1). Table 1 - Studies of Care Quality Metrics in Americans With Chronic HBV Study Setting (Reference) Population Characteristics Initial Lab Testing HCC Surveillance Antiviral Therapy National Veterans Affairs claims database(4) n = 12,402Mean age = 53 years 40% African American 5% Asian 53% Caucasian Mean f/u = 24 months Coinfection 54% HAV 85% HCV 39% HIVHBV 97% ALT 44% HBV DNA 49% HBeAg Cirrhotic 39% surveillancea Noncirrhotic 19% surveillanceaSpecialist > PCP 29% treated National private payors claims database(8) n = 1168Mean age = 41 years Mean f/u = 24 months HBV 93% ALT 80% HBV DNA 53% serial ALT NR 32% treated National private payors claims database (Truven)(9) n = 4576 noncirrhotic Mean age = 44 years Med f/u = 24 months NR Noncirrhotic b 60% some 6.7% complete Specialist > PCP NR Population‐based Kaiser health maintenance organization (CA) claims database(6) n = 12,016Mean age = 49 years 83% Asian Mean f/u = 18 months Coinfection 68 % HAV 80% HCV 35% HIVHBV 77% ALT 39% HBV DNA 80% HBeAg 56% surveillance Specialist > PCP 14% treated Community gastrointestinal practice all insurers (CA) chart review(5) n = 612Mean age = 44 years 99% Asian Mean f/u = 12 months HBV 100% HBeAg 100% ALT 100% HBV DNA NR 29% treated 50% of eligible treated Academic gastrointestinal center private payors (MA) chart review(7) n = 962Mean age = 45 years 75% Asian Mean f/u = 36 months Coinfection 65% HAV 76% HCV 46% HIVHBV 71% ALT/HBV DNA 55% surveillancea Specialist > PCP 31% treated aAdherence to annual surveillance.bAdherence to biannual surveillance in all HBV patients.Abbreviations: CA, California; f/u, follow‐up; MA, Massachusetts; NR, not reported; PCP, primary care provider. Figure 1: Strategies to overcome the potential barriers to the receipt of quality care in chronic HBV.Given the substantial deficit in receipt of quality care for chronic HBV patients, what can and should be done? First, developing a consensus definition of what constitutes “quality care metrics” for patients with chronic HBV is crucial. We suggest that quality care metrics be simple, objective, and readily verifiable and trackable, preferably through the electronic health record. Furthermore, quality metrics should be anchored on “high‐impact” interventions and care delivery processes which are anticipated to improve health outcomes or even survival in targeted patients. Lastly, the quality metrics should be attainable and measurable for the majority (>80%) of patients, providers, and health care systems that will be assessed. With that in mind, possible quality metrics for HBV include the following: Screening for HCV and human immunodeficiency virus (HIV) coinfection and immunity to hepatitis A virus (HAV): test for anti‐HCV, anti‐HIV, and anti‐HAV. The high rates of HCV (15%) and HIV (7%) coinfection in the Serper et al. study highlight the importance of testing for viral coinfections. Testing for immunity to hepatitis A with immunization of seronegative patients has been recommended for all patients with viral hepatitis. Process outcomes for this quality metric could include evidence of lab testing for HCV, HIV, and HAV and administration of the HAV vaccine to nonimmune individuals. Assessment of the phase of HBV infection and disease severity in untreated patients: test for HBV DNA, HBeAg, antibody to hepatitis B e antigen, and ALT and regularly assess and monitor disease severity over time. Antiviral treatment decisions should be based upon initial and longitudinal assessment of disease state through serum HBV DNA, HBeAg/antibody to hepatitis B e antigen, and ALT testing as well as assessment of disease severity.2 Although liver biopsy is the gold standard for HBV staging, noninvasive alternatives to biopsy such as liver elastography are increasingly available. Process outcomes for this quality metric in untreated patients could include the use of laboratory tests, liver histology, imaging, endoscopy, and liver elastography or a combination of modalities. Initiation and monitoring of antiviral therapy: assess frequency of office visits, medication refills, and laboratory testing during treatment. Selected chronic HBV patients should receive antiviral treatment, but maintaining adherence with long‐term oral antiviral therapy can prove challenging.2 Process outcomes for this metric could include the frequency of medication refills, office visits and provider communications, and use of laboratory tests in treated patients. HCC surveillance: use of ultrasound in patients with cirrhosis and other high‐risk patients. Practice guidelines suggest that those with cirrhosis or high‐risk clinical features should undergo ultrasound‐based surveillance every 6 months as asymptomatic patients with early‐stage HCC are more likely to achieve improved survival.2 Process outcomes for this metric could include frequency of liver imaging and serum alpha‐fetoprotein testing over time. Once appropriate metrics are agreed upon, improving the quality of care in chronic HBV will likely be a multifaceted process. Prospective pilot studies of how to implement quality metrics in a variety of health care settings involving different groups of HBV patients, providers, and practice settings will be needed. Because specialty care seems to improve adherence rates, efforts to improve early referral to well‐trained subspecialists will likely be needed. In addition, extensive education of subspecialty and primary care providers regarding the rationale for process measures (i.e., effectiveness of antivirals to prevent disease progression, value of HCC screening) will likely prove worthwhile. Using the electronic health record, best practice alerts which create automatic prompts for additional laboratory testing, imaging, and specialty referral may prove helpful. Care pathways, a multidisciplinary tool that sequences and standardizes care elements, may improve receipt of recommended care. Electronic consultation, where a face‐to‐face visit is not required, has been shown to improve access to specialty care for patients with liver disease and may be appropriate for some patients with chronic HBV.10 Lastly, efforts to actively engage patients in their own medical care, through shared decision‐making, clinical decision aids, chronic disease tool kits in their native language, and novel interventions to improve adherence (e.g., electronic diaries, cell phone apps, text messaging) are worthy of investigation. In conclusion, the need and rationale for quality care metrics in chronic HBV are apparent—we must now move to the difficult issue of how to achieve improved longevity and quality of life for the large number of Americans with chronic HBV.