Gastroenterology
Volume 145, Issue 5 , Pages 1144-1145, November 2013
Publication of the Clinical Decision Tool (CDT) for Hepatitis C Screening and Evaluation marks a milestone for the American Gastroenterological Association (AGA). This CDT is the first in a series of care pathways created for the “Clinical Service Lines” (CSL) component of AGA's “Roadmap to the Future of GI” initiative. The Roadmap to the Future of GI is designed to provide gastroenterologists with a single source for clinical tools needed to practice within the emerging value-based reimbursement environment. These tools have been created using a process steeped in the scientific rigor characteristic of AGA publications, combined with immediate access and the applicability needed for clinical practice.
The Roadmap to the Future of GI was originally presented to the AGA Governing Board during its strategy retreat in July 2011. It was first described in a July 2012 article in Clinical Gastroenterology and Hepatology1 and subsequent sections of the AGA website (www.gastro.org). The AGA initially committed to fully develop 3 CSL including (a) Hepatitis C Screening and Evaluation; (b) Colorectal Cancer Prevention; and (c) Inflammatory Bowel Disease. Beginning components of these 3 CSL can be referenced within the Practice Section of the AGA website.
The following components populate each CSL:
1.Clinical practice guidelines
2.Clinical Decision Tool
3.Performance measures
4.Methods to collect data on performance measures
5.Guides to reimbursement
6.Patient tools
7.Professional education
Hepatitis C virus (HCV) was endorsed as an important first CSL because of the substantial impact of chronic HCV infection on the adult population, the new recommendation for population-based screening and the enormous progress made in its treatment.2, 3, 4 Chronic HCV infection is a leading cause of liver disease, cirrhosis, hepatocellular cancer, liver transplantation, and death.5 Newly developed therapies, including direct acting antiviral therapies, have been developed and it is likely that therapies will become entirely oral and of shorter duration compared with traditional interferon-based treatments.5
Within the last year, the Centers for Disease Control and the United States Preventative Services Task Force both recommended one time screening for HCV for all people born between 1945 and 1965 in an effort to identify the 2.7–3.9 million Americans who are living with a chronic HCV infection.2, 3 Seventy-six percent of those infected with HCV are contained within this age group, and an estimated 45%–85% of those people with HCV are unaware they are infected, with 15%–40% expected to eventually develop cirrhosis or cancer.
It is clear that the burden of age cohort-based HCV screening, not to mention subsequent management of screen-positive patients, will overwhelm the capacity of United States hepatologists. General gastroenterologists must engage in HCV management to the highest level of their comfort. As a result of this sobering realization, the AGA, in partnership with the American Association for Study of Liver Disease (AASLD), set out to develop an easy-to-use care pathway with evidence-based recommendations for managing the initial phase of HCV evaluation.
An initial advisory group met in October 2012 in Chicago, IL. The final Task Force (listed at the end of this article) developed the CDT and evaluated each of its 15 decision points as part of a series of meetings and teleconferences from January to June of 2013. We gratefully acknowledge the participation of physician leaders and staff from the AGA, AASLD, and the Infectious Disease Society of America, plus practice leaders from both academic and community gastroenterology practices.
This CDT will aid gastroenterologists in the early management of HCV-positive patients and is intended to become a map for both clinical practice and construction of standard order sets, alerts, and dynamic point of care feedback within electronic medical records. The unique aspect of this CDT is that each decision point was evaluated and graded for its strength of evidence and strength of recommendation. Using the CDT, gastroenterologists can complete an evidence-based, cost-effective initial evaluation of patients whose screening for HCV is positive. It is important to emphasize that initial HCV screening positivity is not sufficient to begin therapy since further testing should confirm infection and must be coupled with expert evaluation of liver status including inflammation and histologic stage. Treatment of HCV infection was not included in this CDT since therapies are changing rapidly, however, care delivery infrastructure will need to adapt quickly in order to manage the number of expected HCV infected patients and the complexities of emerging therapies. Programs like Extension for Community Healthcare Outcomes (ECHO), represent a model of treatment that might help with capacity management.6
As the United States moves into a health care delivery world constrained by financial pressures and characterized by accountable care, risk contracting for population management, and reimbursements tied to outcomes, the tools created by the AGA will aid gastroenterologists to redesign their practice to meet these challenges. AGA leadership and staff hope that clinical decision tools like this and other tools within the Roadmap to the Future of GI will support the critical role that gastroenterologists play in providing care for the people that entrust us with their lives and health.
Appendix
The Hepatitis C Task Force includes: Mark D. Boldt, RN, CNP, Minnesota Gastroenterology; Joel V. Brill, MD, AGAF, Predictive Health; Gary L. Davis, MD, Baylor University Medical Center Dallas(retired); Stuart C. Gordon, MD, AGAF, Henry Ford Health System; Arthur Y. Kim, MD, FIDSA, Massachusetts General Hospital; Lawrence R. Kosinski, MD, MBA, AGAF, Illinois Gastroenterology Group; Arnold G. Levy, MD, Capital Digestive Care; Ronald G. Nahass, MD, MHCM, FIDSA, ID Care; John I. Allen, MD, MBA, AGAF (Chair), Yale School of Medicine.
Conflicts of interest The author discloses no conflicts.
PII: S0016-5085(13)01286-9
doi:10.1053/j.gastro.2013.09.008
© 2013 AGA Institute. Published by Elsevier Inc. All rights reserved.
Gastroenterology
Volume 145, Issue 5 , Pages 1146-1149, November 2013
Hepatitis C Screening: Summary of Recommendations From the Clinical Decision Tool
The Hepatitis C Task Force, Mark D. Boldt, RN, CNP, Joel V. Brill, MD, AGAF, Gary L. Davis, MD, Stuart C. Gordon, MD, AGAF, Arthur Y. Kim, MD, FIDSA, Lawrence R. Kosinski, MD, MBA, AGAF, Arnold G. Levy, MD, Ronald G. Nahass, MD, MHCM, FIDSA, John I. Allen, MD, MBA, AGAF (Chair)
Decision Point 1: Adults Born Between 1945–1965 Who Have Never Been Evaluated for HCV
Strong Recommendation Based on Strong Evidence
•Adults born between 1945 and 1965 should receive one-time testing for HCV without prior ascertainment of HCV risk (CDC Recommendation).1
•The US Preventive Services Task Force (USPSTF) recommends that clinicians consider offering screening for HCV infection in adults born between 1945 and 1965 (USPSTF GRADE B recommendation).2
Decision Point 2: Those at High Risk, Including Any Blood Transfusions Prior to 1992, or History of Intravenous Drug Use
Strong Recommendation Based on Strong Evidence
•The USPSTF recommends screening for HCV infection in adults at high risk, including those with any history of intravenous drug use or blood transfusions prior to 1992 (USPSTF GRADE B Recommendation).2
Decision Point 3: Testing for Current Intravenous Drug Users
Strong Recommendation based on Strong Evidence
•The USPSTF recommends screening for HCV infection in adults at high risk, including those with any history of intravenous drug use or blood transfusions prior to 1992 (USPSTF Grade B recommendation).2
Decision Point 4: Hepatitis C Antibody Testing
Strong Recommendation Based on Strong Evidence
•A person whose anti-HCV test is reactive should be considered to either (1) have current HCV infection or (2) have had HCV infection in the past that has subsequently resolved (ie, cleared). To identify persons with active HCV infection, persons who initially test anti-HCV positive should be tested by an HCV nucleic acid test (NAT).2
Decision Point 5: Quantitative HCV RNA Testing
Strong Recommendation Based on Strong Evidence
•HCV ribonucleic acid (RNA) testing should be performed in:
(a)Patients with a positive anti-HCV test (Class IB).
(b)Patients for whom antiviral treatment is being considered, using a sensitive quantitative assay (Class IA).
(c)Patients with unexplained liver disease whose anti-HCV test is negative and who are immunocompromised or suspected of having acute HCV infection (Class IB).3
•HCV RNA should be tested by a highly sensitive quantitative assay at the initiation of or shortly before treatment and at week 12 of therapy, (Class I, Level A).3
•For the diagnosis of acute hepatitis C, HCV RNA testing is required since HCV RNA appears before anti-HCV antibodies may be detectable.4
Decision Point 6: Counseling and Retesting and Other Testing as Appropriate
Evidence not Sufficient; Recommendation to Include is Based on Expert Opinion
•Persons who use or inject illegal drugs should be advised: To stop using and injecting drugs; to enter and complete substance abuse treatment.5
•Persons who are at risk for sexually transmitted diseases should be advised: That the surest way to prevent the spread of HIV infection and other STDs is to have sex with only one uninfected partner or not to have sex at all; To use latex condoms correctly and every time to protect themselves and their partners from diseases.5
Decision Point 7: Initial Test for HCV: Comprehensive Metabolic Panel
Strong Recommendation Based on Strong Evidence
•Laboratory monitoring should include measurement of the serum creatinine, and ALT levels, and HCV RNA by a sensitive assay at weeks 4, 12, and 24 of treatment, 4 to 12 week intervals thereafter, the end of treatment, and 24 weeks after stopping treatment.3
Decision Point 8: Initial Test for HCV: HCV Genotype
Strong Recommendation Based on Strong Evidence
•HCV genotyping should be performed in all HCV-infected persons prior to interferon-based treatment in order to plan for the dose and duration of therapy and to estimate the likelihood of response (Class I, Level A).3
•The HCV genotype must be assessed prior to antiviral treatment initiation and will determine the dose of ribavirin and treatment decision.4
Decision Point 9: Initial Test for HCV: International Normalized Ratio
Evidence not Sufficient; Recommendation to Include is Based on Expert Opinion
•International normalized ratio recommended at baseline (anti-HCV positive), pre-treatment, and as part of ongoing monitoring if patient exhibits signs and symptoms of liver disease.6
Decision Point 10: Initial Test for HCV: Complete Blood Count and Differential
Strong Recommendation Based on Strong Evidence
•Complete Blood Count and Differential recommended at baseline (anti-HCV positive), pre-treatment, and at weeks 2 and 4 of treatment, 4 to 8 week intervals thereafter, 24 weeks post-treatment, and 12 months post-treatment.6
Decision Point 11: Initial Test for HCV: HIV Antibody
Evidence not Sufficient; Recommendation to Include is Based on Expert Opinion
•Because of the high prevalence of HIV/HCV co-infection, and because the management of each infection can differ in dually-infected persons, all HIV-infected persons should be tested for HCV and all HCV-infected persons with HIV risk factors should be tested for HIV.3
Decision Point 12: Initial Test for HCV: HBV Surface Antigen
Evidence not Sufficient; Recommendation to Include is Based on Expert Opinion
•Because dual infection is associated with worse prognosis than HCV infection alone and because the management of each virus can differ in dually infected persons, all HCV-infected persons with HBV risk factors should be tested for HBV.3
Decision Point 13: Administer HAV Vaccination if No Documented Immunity
Evidence not Sufficient; Recommendation to Include is Based on Expert Opinion
•All persons with chronic HCV infection who lack antibodies to hepatitis A and B should be offered vaccination against these 2 viral infections (Class IIa, Level C).3
Decision Point 14: Administer HBV Vaccination if No Documented Immunity
Evidence not Sufficient; Recommendation to Include is Based on Expert Opinion
•All persons with chronic HCV infection who lack antibodies to hepatitis A and B should be offered vaccination against these 2 viral infections (Class IIa, Level C).3
Decision Point 15: Conduct Brief Alcohol Screening and Intervention as Clinically Indicated
Strong Recommendation Based on Strong Evidence
•All persons identified with HCV infection should receive a brief alcohol screening and intervention as clinically indicated, followed by referral to appropriate care and treatment services for HCV infection and related conditions (Strong Recommendation, Moderate Quality of Evidence).1
Reprint requests Address requests for reprints to: Chair, Clinical Practice and Quality Management Committee, AGA National Office, 4930 Del Ray Avenue, Bethesda, Maryland 20814. e-mail:lclote@gastro.org; telephone: (301)-272-1188.
Conflicts of interest The authors disclose the following: Stuart C. Gordon has received grant/research support from Abbvie Pharmaceuticals, Bristol-Myers Squibb, Gilead Pharmaceuticals, GlaxoSmithKline, Intercept Pharmaceuticals, Merck, and Vertex Pharmaceuticals, is a consultant/adviser for Bristol-Myers Squibb, CVS Caremark, Gilead Pharmaceuticals, Merck, Novartis, and Vertex Pharmaceuticals, and is member on the Data Monitoring Board of Tibotec/Janssen. Mark D. Boldt is on the advisory board of Gilead and Janssen. Arthur Y. Kim is a consultant for Gilead Sciences and Abbvie Pharmaceuticals and has received research grants and support from Bristol-Myers Squibb. Joel V. Brill is a member of The American Association for the Study of Liver Diseases, American Gastroenterological Association, and American Medical Association-convened Physician Consortium for Performance Improvement® workgroup that developed the Hepatitis C Performance Measurement Set. Gary L. Davis is a member on the Data and Safety Monitoring Boards for Gilead and BMS. Ronald G. Nahass is a speaker for Merck and Vertex, completed clinical research for Merck, Gilead, Janssen, Abbvie Pharmaceuticals, and BMS and is on the advisory board for Janssen and Merck. The remaining authors disclose no conflicts.
PII: S0016-5085(13)01285-7
doi:10.1053/j.gastro.2013.09.007
© 2013 AGA Institute. Published by Elsevier Inc. All rights reserved.
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