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Quality of Care in Patients With Chronic Hepatitis C Virus Infection: A Cohort Study

Fasiha Kanwal, MD, MSHS; Mark S. Schnitzler, PhD; Bruce R. Bacon, MD; Tuyen Hoang, PhD; Paula M. Buchanan, PhD; and Steven M. Asch, MD, MPH
[+] Article and Author Information

From the John Cochran Veterans Affairs Medical Center and Saint Louis University School of Medicine, St. Louis, Missouri; Veterans Affairs Greater Los Angeles Healthcare System, Los Angeles, California; and the RAND Corporation, Santa Monica, California.


Disclaimer: The opinions and assertions contained herein are the sole views of the authors and are not to be construed as official or as reflecting the views of the Department of Veterans Affairs.

Grant Support: Dr. Kanwal is supported by Veterans Affairs Health Services Research and Development Service Investigator Initiated Research Award IIR-07-111. This study was supported by an intramural grant from the Saint Louis University Liver Center.

Potential Conflicts of Interest: Dr. Kanwal: Grants received: Saint Louis University Liver Center. Dr. Bacon: Consultancies: Merck/Schering-Plough, Valeant. Honoraria: Merck/Schering-Plough, Gilead Sciences, Three Rivers Pharma, Vertex, Human Genome Sciences. Royalties: UpToDate. Dr. Bacon has also received payment for development of educational presentations, including service on speakers' bureaus, and has had his travel/accommodations expenses covered or reimbursed. Dr. Buchanan: Grants received (money to institution): Veterans Affairs Health Services Research and Development Service, Saint Louis University Liver Center. Disclosures can also be viewed at www.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=M09-2380.

Reproducible Research Statement:Study protocol: Available from Dr. Kanwal (e-mail, fasiha.kanwal@va.gov). Statistical code: Available from Dr. Kanwal (e-mail, fasiha.kanwal@va.gov), Dr. Schnitzler (e-mail, schnitm@slu.edu), or Dr. Buchanan (e-mail, pbuchan1@slu.edu). Data set: Not available. These or similar data are available from commercial health insurance companies in the United States.

Requests for Single Reprints: Fasiha Kanwal, MD, MSHS, John Cochran Veterans Affairs Medical Center, 915 North Grand Boulevard, 111 JC/GI, St. Louis, MO 63106; e-mail, fasiha.kanwal@va.gov.

Current Author Addresses: Dr. Kanwal: John Cochran Veterans Affairs Medical Center, 915 North Grand Boulevard, 111 JC/GI, St. Louis, MO 63106.

Drs. Schnitzler and Buchanan: Center for Outcomes Research, Saint Louis University School of Medicine, 3545 Lafayette Avenue, St. Louis, MO 63104.

Dr. Bacon: Saint Louis University School of Medicine, Department of Internal Medicine, Division of Gastroenterology & Hepatology, 3635 Vista Avenue at Grand Boulevard, St. Louis, MO 63110-0250.

Drs. Hoang and Asch: Department of Internal Medicine and Health Services Research, Veterans Affairs Greater Los Angeles Medical Center, 11301 Wilshire Boulevard, Building 500 (111-G), Los Angeles, CA 90073.

Author Contributions: Conception and design: F. Kanwal, M.S. Schnitzler, S.M. Asch.

Analysis and interpretation of the data: F. Kanwal, M.S. Schnitzler, T. Hoang, P.M. Buchanan, S.M. Asch.

Drafting of the article: F. Kanwal, M.S. Schnitzler, P.M. Buchanan, S.M. Asch.

Critical revision of the article for important intellectual content: F. Kanwal, M.S. Schnitzler, B.R. Bacon, S.M. Asch.

Final approval of the article: M.S. Schnitzler, B.R. Bacon, P.M. Buchanan, S.M. Asch.

Provision of study materials or patients: M.S. Schnitzler.

Statistical expertise: M.S. Schnitzler, T. Hoang, P.M. Buchanan.

Obtaining of funding: F. Kanwal, M.S. Schnitzler.

Administrative, technical, or logistic support: F. Kanwal, B.R. Bacon.

Collection and assembly of data: M.S. Schnitzler, P.M. Buchanan.


Ann Intern Med. 2010;153(4):231-239. doi:10.7326/0003-4819-153-4-201008170-00005
Text Size: A A A

Background: Medicare has proposed quality-of-care indicators for chronic hepatitis C virus (HCV) infection. The extent to which these standards are met in practice is largely unknown.

Objective: To evaluate the quality of health care that patients with HCV receive and the factors associated with receipt of quality care.

Design: Retrospective cohort study.

Setting: Nationwide U.S. health insurance company research database.

Participants: 10 385 patients with HCV enrolled in the database between 2003 and 2006. Patients were included if they were eligible for at least 1 quality indicator.

Measurements: Quality of HCV care received by patients, as measured by 7 explicit quality indicators included in Medicare's 2009 Physician Quality Reporting Initiative.

Results: Proportions of patients meeting quality indicators varied, ranging from 21.5% for vaccination to 79% for the HCV genotype testing indicator. Overall, 18.5% of patients (95% CI, 18% to 19%) received all recommended care. Older age and presence of comorbid conditions were associated with lower quality, whereas elevated liver enzyme levels, cirrhosis, and HIV infection were associated with higher quality. Patients who saw both generalists and specialists received the best care (odds ratio of receiving care for which a patient is eligible: specialists alone, 0.79 [CI, 0.66 to 0.95]; primary care physician alone, 0.44 [CI, 0.40 to 0.48]).

Limitations: The study had an observational retrospective design, used a convenience sample, and had no information on patient ethnicity. It may be that the indicators or the reporting of the indicators of HCV care—and not the care itself—is suboptimum.

Conclusion: Health care quality, based on Medicare criteria, is suboptimum for HCV. Care that included both specialists and generalists is associated with the best quality. Our results support the development of specialist and primary care collaboration to improve the quality of HCV care.

Primary Funding Source: Saint Louis University Liver Center.

Figures

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Appendix Figure 1.
Quality indicator scores of patients with diagnosed HCV in each study quarter.

Data are depicted as percentages (95% CIs) of patients who were eligible for and who received the care indicated by the quality indicators. The x-axis is the quarter-year during which the patient received a diagnosis. The graph for RNA testing at antiviral treatment week 12 overlapped the graph for viral load testing before treatment and is not included. The graphs are truncated for the quality indicators that required at least 12 months of follow-up (these quality indicators could not be assessed for patients who received a diagnosis in the last study year). HCV = hepatitis C virus. Top. Results for quality indicators in the general care domain. Middle. Results for quality indicators in the treatment-related care domain. Bottom. Two aggregate scores: the percentage of quality indicators that met success among all quality indicators for which the patients were eligible (aggregate care) and the percentage of patients who received all quality indicators for which they were eligible (optimum care).

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Figure 1.
Association of patient and health care factors with receipt of any recommended care process for hepatitis C virus infection.

The odds ratios indicate the odds of receiving any recommended care process for which the patient was eligible. The dependent variables were the binary quality indicators (confirmation of hepatitis C virus viremia, hepatitis A and B vaccination, antiviral treatment, genotype testing, and viral load testing before and during therapy) among eligible patients. Reference category for all dichotomous variables is the absence of the condition. Reference groups for other categorical variables are shown. The odds ratio for annual health claims represents a change in the odds of receiving recommended care for every 20 additional claims. ALT = alanine aminotransferase; EPO = exclusive provider organization; PCP = primary care physician; POS = point of service; PPO = preferred provider organization.

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Figure 2.
Association of patient and health care factors with receipt of general care for hepatitis C virus infection.

The dependent variables were the subset of quality indicators measuring general care (confirmation of hepatitis C virus viremia and hepatitis A and B vaccination) among eligible patients. Reference category for all dichotomous variables is the absence of the condition. Reference groups for other categorical variables are shown. The odds ratio for annual health claims represents a change in the odds of receiving recommended care for every 20 additional claims. ALT = alanine aminotransferase; EPO = exclusive provider organization; PCP = primary care physician; POS = point of service; PPO = preferred provider organization.

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Figure 3.
Association of patient and health care factors with receipt of recommended treatment-related care for hepatitis C virus infection.

The dependent variables were binary treatment-related quality indicators (antiviral treatment, genotype testing, and viral load testing before and during therapy). Reference category for all dichotomous variables is the absence of the condition. Reference groups for other categorical variables are shown. The odds ratio for annual health claims represents a change in the odds of receiving recommended care for every 20 additional claims. ALT = alanine aminotransferase; EPO = exclusive provider organization; PCP = primary care physician; POS = point of service; PPO = preferred provider organization.

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Appendix Figure 2.
Association of patient and health care factors with receipt of optimum care for hepatitis C virus infection.

The odds ratios indicate the odds of receiving all recommended care processes for which patients were eligible. The dependent variable was a binary outcome measuring optimum care, defined as receipt of all quality indicators among eligible patients. Reference category for all dichotomous variables is absence of the condition. Reference groups for other categorical variables are shown. The odds ratio for annual health claims represents a change in the odds of receiving recommended care for every 20 additional claims. ALT = alanine aminotransferase; EPO = exclusive provider organization; PCP = primary care physician; POS = point of service; PPO = preferred provider organization.

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Comments

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HCV quality care - better than we think?
Posted on August 23, 2010
Don C. Rockey
UT Southwestern Medical Center
Conflict of Interest: None Declared

I read with interest the study about quality of care of chronically infected HCV patients (Kanwal et al). An important issue that did not seem to be addressed in the "Treatment-related care" quality indicator score was whether the patient was an appropriate treatment candidate in the first place. With the administrative dataset used, it is unlikely that this information could be provided, although it is fundamental to the issue being addressed. Experienced practitioners deal with a variety of issues in chronically infected HCV patients - and readily recognize that many patients have absolute or relative contraindications to therapy. In fact, it is my experience that many patients are not suitable candidates for HCV treatment. Moreover, it has been suggested that as few as 20% of patients with chronic HCV infection are eligible for interferon based therapy (HEPATOLOGY 34:420A, 2001). Thus, the finding that 37.5% of patients were treated is almost certainly an underestimate of the proportion of patients in whom therapy is appropriate. Thus, this aspect of the study is subject to substantial ascertainment bias. This fact also likely biases other elements of the data, since if one knows that a patient is not a treatment candidate, there is little utility in further RNA testing. Thus, while there is always room to improve, I believe that if carefully considered, the data suggest that practioners are doing a better job of managing patients with chronic HCV than has been concluded from this study.

Conflict of Interest:

None declared

Quality of HCV Care in Drug Users
Posted on September 11, 2010
Andrew H. Talal
Weill Cornell Medical College
Conflict of Interest: None Declared

Kanwal et al. assessed quality of care in patients with chronic hepatitis C virus (HCV) infection among those enrolled in a "large insurance company." (1). They compared various individual characteristics, including "drug and alcohol use," to identify factors associated with quality care for HCV. The authors found that drug and alcohol use was not associated with receiving general HCV care (odds ratio [OR] = 0.96, 95% CI 0.88-1.04) or with receiving any recommended care for HCV infection (OR = 1.01, 95% CI 0.94-1.08). However, they found that drug and alcohol use was their strongest predictor of receiving higher quality treatment for HCV infection (OR = 1.53, 95% CI = 1.34-1.74). It is hard to reconcile this apparent association with a large body of published data that have demonstrated that drug users are poorly engaged in HCV evaluation and treatment with less than 10% of HCV-infected IDUs referred for HCV treatment actually initiating therapy (2, 3). Kanwal et al. were unable to explain the counterintuitive association and suggested that it may have arisen from "differential ascertainment and coding" of drug and alcohol use (p. 238). If this is the case, then there would necessarily be substantial "differential ascertainment and coding" related to drug and alcohol use in the dataset. Perhaps negative associations exist where Kanwal et al. found no associations between drug and alcohol use and receiving general HCV care and receiving any recommended HCV care?

Overall, the Kanwal et al. paper is an important contribution to knowledge about HCV treatment in the United States. However, injection drug use is currently the strongest risk factor for HCV acquisition in the United States, and HCV management has been poorly addressed in this population. We need more research to determine how to best provide HCV treatment to drug users, but it should be conducted using designs that accurately assess lifetime and current drug use.

References

1. Kanwal F, Schnitzler MS, Bacon BR, Hoang T, Buchanan PM, Asch SM. Quality of care in patients with chronic hepatitis C virus infection: a cohort study. Ann Intern Med. 2010;153:231-9. [PMID: 20713791].

2. Mehta SH, Genberg BL, Astemborski J, et al. Limited uptake of hepatitis C treatment among injection drug users. J Community Health. 2008;33:126- 33. [PMID: 18165889].

3. Fishbein DA, Lo Y, Reinus JF, Gourevitch MN, Klein RS. Factors associated with successful referral for clinical care of drug users with chronic hepatitis C who have or are at risk for HIV infection. J Acquir Immune Defic Syndr. 2004;37:1367-75. [PMID: 15483466].

Conflict of Interest:

Merck/Schering: Research support Genentech: Speakers Bureau, research support

Response to the Comments by Drs. Rockey and Talal
Posted on November 5, 2010
Fasiha Kanwal
John Cochran VA Medical Center and Division of Gastroenterology and Hepatology, Saint Louis Universi
Conflict of Interest: None Declared

We are very cognizant of the limitations of administrative data as pointed out by Drs. Rockey and Talal.

Because, we did not have access to data that reliably captured all treatment contraindications, we opted not to use treatment contraindications as an explicit exclusion criterion for our treatment receipt indicator. Without a doubt, this limits interpretation of one important component indicator of our analysis. However, the prevalence of absolute contraindications to antiviral treatment may not be as high as posited by this comment. Published data show that approximately 10% of patients with HCV are excluded from treatment on the basis of advanced medical comorbidity (1-5), whereas an additional 18%-20% are excluded due to severe uncontrolled depression (1, 3) leaving more than 2/3 potentially eligible for treatment. Other common reasons for exclusions, such as alcohol and drug use, are not considered absolute contraindications, and clinical guidelines in HCV recommend that antiviral therapy still be considered. Still, Dr. Rockey's point is an important one. It is precisely why we were careful not to solely rely on rates of anti-viral treatment as an indicator of quality in HCV and rather drew our conclusions using a broad measure of quality care. We also constructed and presented regression models with and without the treatment indicator, without much change in the overall results. Finally, we do not think that our inability to exclude patients on the basis of contraindications biases other elements of the data. The benefits of confirming chronic infection, for example, may extend beyond its relevance in making treatment decisions. Published guidelines in HCV, therefore, recommend confirmatory testing in patients with positive HCV antibody and do not limit this practice to individuals without treatment contraindications.

We believe that the counterintuitive finding pointed out by Dr. Talal arises not simply from the acknowledged differential ascertainment and coding problems, but from another aspect of the nature of insurance databases - that only insured healthcare users are represented. Limited access is likely the most important barrier to quality care in this vulnerable population of patients with HCV and SUD. Indeed, both studies referenced by Dr. Talal point out this access issue. Unfortunately, because all patients in our study had private insurance and were in care, we could not evaluate more general access problems.

We think that the association between SUD diagnoses and quality of treatment care in our insured population is also a consequence of representing only users of services rather than the population as a whole. Moreover, this issue interacts with the differential coding issue. Patients referred for antiviral treatment are more likely to be referred for mental health care, and consequently receive the diagnostic code/s for SUD. However, given the nature of our data, it is not possible for us to confirm or refute this explanation. Future research will need to validate the SUD diagnoses derived from pre-existing data. In the meantime, our results are best generalized to insured HCV patients who are using health services.

Fasiha Kanwal, MD, MSHS; Bruce R. Bacon, MD; and Steven M. Asch, MD, MPH

References

1. Bini EJ, Brau N, Currie S, et al. Prospective multicenter study of eligibility for antiviral therapy among 4084 U.S. veterans with chronic hepatitis C virus infection. Am J Gastroenterol 2005;100:1772-1779.

2. Cawthorne CH, Rudat KR, Burton MS, et al. Limited success of HCV antiviral therapy in United States veterans. Am J Gastroenterol 2002;97:149-155.

3. Muir AJ, Provenzale D. A descriptive evaluation of eligibility for therapy among veterans with chronic hepatitis C virus infection. J Clin Gastroenterol 2002;34:268-271.

4. Knott A, Dieperink E, Willenbring ML et al. Integrated psychiatric/medical care in a chronic hepatitis C clinic: effect on antiviral treatment evaluation and outcomes. Am J Gastroenterol 2006;101(10):2254-2262.

5. Lehman CL, Cheung RC. Depression, anxiety, post-traumatic stress, and alcohol-related problems among veterans with chronic hepatitis C. Am J Gastroenterol 2002;97(10):2640-2646.

Conflict of Interest:

None declared

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