This report updates and expands CDC recommendations for hepatitis B screening of adults published in 2008 (14 (link)). CDC evaluated the addition of a universal screening recommendation among adults as well as testing persons expected to be at increased risk for HBV infection that were not included in the 2008 testing recommendations.
Members of the CDC Guidelines Work Group (hereafter referred to as the work group) followed CDC guideline development and reporting standards (28 (link)) to develop research questions needed to assess the proposed updates; conduct systematic reviews; assess the quality of the evidence; and review existing systematic reviews, meta-analyses, and cost-effectiveness analyses, when available (Supplementary Appendix 2; Supplementary Tables 1, 4, and 7,https://stacks.cdc.gov/view/cdc/124432 ). Comprehensive systematic literature reviews were conducted for recommendations on 1) expanding screening to all adults (i.e., universal screening), 2) periodic testing for HBV infection among persons with hepatitis C virus (HCV) infection, and 3) testing for HBV infection among persons with a history of incarceration.
For all three systematic reviews, literature searches were conducted by CDC librarians with direction from subject matter experts. Searches were conducted for English-language literature published worldwide in Medline (OVID), Embase (OVID), CINAHL (Ebsco), and Cochrane Library. Duplicates were identified and removed using Endnote (version 20; Clarivate Analytics) and DistillerSR systematic review software (version 2.35; Evidence Partners) automated “find duplicates” functions.
CDC’s Viral Hepatitis Steering Committee considered multiple methods to assess quality of evidence. The Mixed Methods Appraisal Tool (MMAT) was selected because it is a validated tool for assessing nonrandomized analytic and descriptive studies, which comprise most of the HBV infection prevalence literature (29 (link)). MMAT users rate each study on methodological quality criteria, indicating whether criteria were met with “Yes,” “No,” or “Can’t Tell.” Calculating a summary score is not recommended for the tool because presenting a single number is not informative about which aspects of the studies are problematic. Economic analyses were evaluated by assessing whether the study met the Consolidated Health Economic Evaluation Reporting Standards (CHEERS) (30 (link)).
CDC determined that the new recommendations constituted influential scientific information that will have a clear and substantial impact on important public policies and private sector decisions. Therefore, the Information Quality Act required peer review by specialists in the field who were not involved in the development of these recommendations. CDC solicited nominations for reviewers from AASLD, the Infectious Disease Society of America, and the American College of Physicians (ACP). Five clinicians with expertise in hepatology, gastroenterology, internal medicine, or infectious diseases provided structured peer reviews and any edits made in response were documented (Supplementary Appendices 2 and 3,https://stacks.cdc.gov/view/cdc/124432 ). No CDC staff or external peer reviewers reported a conflict of interest. In addition, feedback from the public was solicited through a Federal Register notice announcing the availability of the draft recommendations for public comment from April 4 through June 3, 2022. CDC received 28 public comments on the draft document from nonprofit/advocacy groups, providers, industry groups, medical professional organizations, the public, academia, and a consulting group. Public comments were considered by the work group and any edits made in response were documented (Supplementary Appendix 4, https://stacks.cdc.gov/view/cdc/124432 ).
The work group also presented these guidelines to the CDC/Health Resources and Services Administration (HRSA) Advisory Committee on HIV, Viral Hepatitis and STD Prevention and Treatment, but did not seek consensus decision-making from this advisory committee. The steering committee considered results of the systematic reviews in conjunction with cost-effectiveness analyses, supplemental literature, practicality of implementing guidelines, public health benefits, subject matter expertise, and reviewer and public feedback.
Members of the CDC Guidelines Work Group (hereafter referred to as the work group) followed CDC guideline development and reporting standards (28 (link)) to develop research questions needed to assess the proposed updates; conduct systematic reviews; assess the quality of the evidence; and review existing systematic reviews, meta-analyses, and cost-effectiveness analyses, when available (Supplementary Appendix 2; Supplementary Tables 1, 4, and 7,
For all three systematic reviews, literature searches were conducted by CDC librarians with direction from subject matter experts. Searches were conducted for English-language literature published worldwide in Medline (OVID), Embase (OVID), CINAHL (Ebsco), and Cochrane Library. Duplicates were identified and removed using Endnote (version 20; Clarivate Analytics) and DistillerSR systematic review software (version 2.35; Evidence Partners) automated “find duplicates” functions.
CDC’s Viral Hepatitis Steering Committee considered multiple methods to assess quality of evidence. The Mixed Methods Appraisal Tool (MMAT) was selected because it is a validated tool for assessing nonrandomized analytic and descriptive studies, which comprise most of the HBV infection prevalence literature (29 (link)). MMAT users rate each study on methodological quality criteria, indicating whether criteria were met with “Yes,” “No,” or “Can’t Tell.” Calculating a summary score is not recommended for the tool because presenting a single number is not informative about which aspects of the studies are problematic. Economic analyses were evaluated by assessing whether the study met the Consolidated Health Economic Evaluation Reporting Standards (CHEERS) (30 (link)).
CDC determined that the new recommendations constituted influential scientific information that will have a clear and substantial impact on important public policies and private sector decisions. Therefore, the Information Quality Act required peer review by specialists in the field who were not involved in the development of these recommendations. CDC solicited nominations for reviewers from AASLD, the Infectious Disease Society of America, and the American College of Physicians (ACP). Five clinicians with expertise in hepatology, gastroenterology, internal medicine, or infectious diseases provided structured peer reviews and any edits made in response were documented (Supplementary Appendices 2 and 3,
The work group also presented these guidelines to the CDC/Health Resources and Services Administration (HRSA) Advisory Committee on HIV, Viral Hepatitis and STD Prevention and Treatment, but did not seek consensus decision-making from this advisory committee. The steering committee considered results of the systematic reviews in conjunction with cost-effectiveness analyses, supplemental literature, practicality of implementing guidelines, public health benefits, subject matter expertise, and reviewer and public feedback.
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