From the AGA Journals

Pretreatment Care Predicts HCV Outcomes

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Quality Measures Supported

Financial reimbursement in medicine has long been driven by volume rather than quality. This incentive structure is changing, and in the near future practitioners will experience increased scrutiny of the quality of care we provide.

Dr. Michael Volk

Quality can be divided into structure (having the proper equipment to clean endoscopes), process (testing for latent tuberculosis before beginning anti–tumor necrosis factor therapy), and outcomes (perforation rate during colonoscopy). The latter is, of course, the most important, but it is also the most difficult to measure because of low event rates and inadequate risk adjustment. Therefore, most quality measures are based on processes of care. For quality measurement to yield any true value to the patient, however, it is important that these processes are clearly linked to better patient outcomes.

Hepatitis C, which affects 1.3% of Americans, has recently been a target disease for measuring and improving quality of care. Dr. Kanwal and her colleagues found that patients receiving optimum process-related quality care were more likely to undergo antiviral therapy. Such patients also were more likely to complete treatment once started and to achieve sustained virologic response if treatment was completed. Since these findings persisted despite adjustment for numerous potential confounders such as comorbidities, it appears that higher quality of care (as measured by processes) may truly lead to better patient outcomes.

What does this mean for practitioners? Particularly in the era of triple therapy, hepatitis C virus (HCV) infection cannot be managed like any other disease. Protocols and tracking systems need to be developed to ensure that quality measures are met. Many practices find it helpful to funnel HCV patients to a single person for case management, such as a nurse or midlevel provider. Hopefully, these efforts, in conjunction with newer antivirals, will soon eradicate hepatitis C altogether.

Michael Volk, M.D., is assistant professor of hepatology at the University of Michigan, Ann Arbor.



Patients with hepatitis C infections are more likely to initiate appropriate antiviral therapy and achieve a sustained virologic response if they receive high quality health care, Dr. Fasiha Kanwal of the Michael E. DeBakey Veterans Affairs Medical Center, Houston, and her colleagues reported in the November issue of Clinical Gastroenterology and Hepatology.

In their study of nearly 35,000 adults with HCV, the odds of initiating antiviral therapy were threefold higher in patients who received optimal care from the moment HCV infection was diagnosed than in those who did not. And among patients who initiated antiviral therapy, the quality of care they received before that therapy even began strongly predicted whether they would complete antiviral therapy and achieve a sustained virologic response, the investigators said.

Courtesy US. Dept of Veterans Affairs

Patients with hepatitis C [pictured] who receive top care immediately after diagnosis are likely to end up initiating antiviral therapy.

The study showed, however, that only 11% of patients received all of the appropriate initial care.

Process-of-care measures are frequently used to assess the quality of care for HCV, but until now no study has assessed whether these measures actually correlate with better outcomes. To address this issue, Dr. Kanwal and her associates "evaluated the relationship between adherence to a broad set of process-based measures in HCV and 3 subsequent HCV-specific endpoints: receipt of antiviral treatment, completion of antiviral treatment, and the clinical outcome associated with improved survival: sustained virologic response."

The investigators used data from the VA registry on HCV clinical care, which covers patient demographics, lab tests, pharmacy information, and data on inpatient and outpatient care for approximately 300,000 patients across the country. For this study, they included data on 34,749 adults.

The mean subject age was 53 years, and 97% were men. Approximately half the study population was white and 26% was black; ethnicity was not reported for the others.

The researchers assessed seven process-of-care measures: confirmation of HCV viremia, evaluation by HCV specialists, HCV genotype testing, liver biopsy for those found to have genotype 1 HCV, and the ruling out of liver diseases related to hepatitis B, autoimmunity, or iron overload.

They also assessed seven process-of-care measures related to the prevention and management of comorbid conditions: HIV testing; hepatitis A and B serology testing, hepatitis A and B vaccination if serology results proved negative; treatment of depression; and treatment of substance abuse disorder.

Finally, they assessed six process-of-care measures related to monitoring of antiviral therapy’s effects: testing of viral load before antivirals were initiated and again at weeks 12, 24, and 48; reduction of ribavirin dose if anemia developed during treatment; and avoidance of prescribing growth-stimulating factors for leukopenia during antiviral therapy.

Overall, only 11% of the study subjects received all of the appropriate initial care, and 8% received all the appropriate care related to prevention and management of comorbid conditions. Moreover, of the study subjects who received antiviral therapy, just 37% received all the appropriate monitoring of treatment effects Dr. Kanwal and her associates said.

In patients who received optimal care before a definitive diagnosis was made, the odds of receiving antiviral therapy were 3.2 times higher than in patients who did not receive optimal care before diagnosis, they reported.

Similarly, patients who received optimal preventive and comorbid-condition care showed rates of antiviral therapy that were 36% higher than those of patients who received suboptimal preventive and comorbid-condition care.

The strong association between fulfillment of these process-of-care measures and appropriate antiviral therapy remained robust in a series of sensitivity analyses, which means it’s likely that meeting process-of-care goals directly leads to better HCV outcomes, Dr. Kanwal and her colleagues said.

The investigators could not, however, rule out the possibility that meeting these goals is simply a marker of more compliant patients, which in turn produces better outcomes.

The study findings imply that the effectiveness of the two new direct-acting antiviral agents that recently became available for HCV may hinge on the quality of care patients are receiving before they even start taking these drugs, rather than simply on the effectiveness of the drugs alone, Dr. Kanwal and her associates said.

This study was supported by the U.S. Department of Veterans Affairs Health Services Research and Development Service. No financial conflicts of interest were reported.

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