Use of Grading of Recommendations Assessment, Development, and Evaluation (GRADE) Methodology to Guide Revision of CDC’s Hepatitis C Virus (HCV) Testing Recommendations for Persons Born during 1945 through 1965 in the United States

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Abstract text
Background: In the United States, an estimated 3.2 million persons are living with HCV. In 2007, deaths associated with HCV surpassed those from HIV. CDC currently recommends HCV testing based on transmission risks; however, many are unaware of their infection and few are tested. Recommendations for testing of demographic sub-populations with a high HCV prevalence, such as persons born in the 1945-1965 birth cohort, might improve HCV testing rates.

Objectives: Systematically develop recommendations to test persons born 1945-1965 for HCV, using a rigorous and transparent methodology.

Methods: Advisory groups used GRADE to develop research questions, determine critical decision-making outcomes, weigh evidence, and determine the strength of the recommendations. Critical patient-important outcomes of treatment failure, severe adverse events (SAEs), mortality, hepatocellular carcinoma, and brief alcohol interventions (BAIs) were assessed for quality then considered with values and preferences, benefits and harms, and resource implications to determine recommendations.

Results: Evidence quality was rated moderate for patient-important outcomes. Treatment of HCV-infected persons with dual compared to single therapy reduced risk of treatment failure (RR=0.75; 95% CI=0.71, 0.79) without increasing SAEs (RR=0.79; 95% CI=0.51, 1.23). Complete treatment response decreased mortality (RR=0.46; 95% CI=0.41, 0.51) and hepatocellular carcinoma (RR=0.29; 95% CI=0.24, 0.35). When provided to a general population, BAIs reduced excess drinking by a mean of 38.42 grams/week (65.44-30.91 g/w). Consultation with advisory groups determined that benefits of testing outweighed harms, and that this strategy is acceptable among the target population and cost effective.

Conclusions: GRADE provided the framework to assess and rate the quality of evidence from diverse sources and determine the strength of recommendations. This approach reinforced the rigor of evidence upon which CDC recommendations are based. The inclusion of advisory groups in the GRADE process engaged stakeholders and increased transparency throughout the development process. GRADE can become the standard for developing CDC recommendations.
Authors
Morgan RL1, Smith BD1, Beckett GA1, Falck-Ytter Y2, Ward JW1
1 Centers for Disease Control and Prevention, USA
2 Case Western Reserve University, USA; Division of Gastroenterology, Louis Stokes VA Medical Center
Presenting author and contact person
Presenting author: 
Rebecca Morgan
Contact person Affiliation Country
Rebecca Morgan (Contact this person) Centers for Disease Control and Prevention USA