Peer Review: Hepatitis B Screening & Testing Recommendations

Understanding peer review

Peer review:

• Involves the review of a draft product by experts in the field who were not involved in producing the draft information.
• Assures publications meet the quality standards of the academic and scientific community.

This form of deliberation involves an exchange of judgments about:

• Methods used for developing guidelines.
• Strength of inferences drawn.

Purpose of the recommendations

This report updated and expanded CDC's previously released 2008 recommendations for identification and public health management of persons with chronic hepatitis B virus (HBV) infection.

The updated report provides clinicians with revised, detailed recommendations regarding screening for HBV infection in the United States.

It serves as a resource for health care professionals, public health officials, and organizations involved in the development, implementation, delivery, and evaluation of clinical preventive services.

Proposed recommendations

Peer reviewers commented on the following:

• Universal, one-time hepatitis B screening for adults ages 18 years and older.
• Use of three serological tests (hepatitis B surface antigen [HBsAg], antibody to hepatitis B core antigen [anti-HBc], and antibody to hepatitis B surface antigen [anti-HBs]) to screen for hepatitis B.
• Periodic testing for all susceptible persons with ongoing risk for exposure(s) will continue per current recommendations.
• Expansion of the list of persons recommended to receive risk-based hepatitis B screening to include:
  • Persons with current or a history of sexually transmitted infection.
  • Currently or formerly incarcerated persons.
  • Persons with hepatitis C virus (HCV) infection.
• Availability of hepatitis B testing for anyone who requests it, regardless of disclosure of risk, because many may be reluctant to disclose stigmatizing risks.

Breakdown of peer review

Type of dissemination: Influential Scientific Information (ISI)

Timing of review: 02/23/2022–03/23/2022

Type of review: Individual

Were peer reviewers provided with public comments before review? No; public comments were solicited during the same period the peer review process was conducted

Number of reviewers: Five

Primary disciplines of expertise: Hepatology, internal medicine, clinical research, infectious disease

Reviewer selections: CDC selected reviewers among those nominated by select organizations: American College of Physicians, Infectious Diseases Society of America, American Association for the Study of Liver Diseases

Public nomination requested for reviewers: No

CDC hosted a webinar on April 20, 2022, at 2:00pm ET, presenting an overview of the proposed recommendations. Questions about the Federal Register Notice (FRN) can be sent to DVHpolicy@cdc.gov.

Charge to peer reviewers

CDC conducted peer review from February 23, 2022, to March 23, 2022. The following was the charge to reviewers.

US Federal Information Quality Regulations require peer review of draft recommendations before publication. Peer reviewers should be specialists in the field who were not involved in the development of the recommendations. This process ensures information disseminated by federal agencies maintains:

• Quality
• Objectivity
• Utility
• integrity

CDC intends to publish updated recommendations for hepatitis B screening among adult US residents. The recommendations constitute influential scientific information that will have a clear and substantial impact on public policies and private sector decisions.

The new recommendations are based on expert opinion and scientific evidence of the effectiveness of:

• Effectiveness
• Economic value

Experts conducted reviews of evidence to inform the hepatitis B screening recommendations for all adults. They analyzed and assessed the literature to examine the availability and quality of the evidence regarding HBV infection prevalence and health benefits and harms associated with one-time hepatitis B screening for persons unaware of their infection status.

These recommendations describe comprehensive systematic reviews of the literature.

For critical appraisal of the recommendations, peer reviewers were asked to:

• Evaluate the clarity of the text of the recommendations and the likelihood that these implemented recommendations will reduce the burden of hepatitis B in the US.
• Evaluate the appropriateness of the methods used to develop these recommendations and the links between the recommendation language with the strength of the evidence of the effectiveness and economic value.
• Point out any omissions from the body of evidence collected from the scientific literature.
• Identify any residual biases, errors of omission, or inconsistencies in the interpretations, findings, and conclusions.
• Assess the rationale of expert judgments made in the absence of empirical scientific evidence.
• Ensure that scientific uncertainties are clearly identified and characterized, and that the potential implications of any uncertainties for the proposed recommendations are clear.
• Assess whether the authors sufficiently acknowledge limitations in the evidence used to develop the recommendations and any limitations of the recommendations themselves for the intended purpose of screening US adults for HBV infection.

Public comment and CDC response

On April 4, 2022, CDC published an FRN #CDC-2022-07050 to obtain comment on the proposed hepatitis B screening and testing recommendations.

The public comment period lasted 60 days. After receiving comments from the public, CDC provided responses to each and posted without attribution to CDC's website.

List of peer reviewers

The following peer reviewers agreed to participate. Their names and scientific background are provided below:

Elisa Choi, MD, FACP, FIDSA

• Current position: Chief of Internal Medicine; Faculty, Harvard Medical School
• Organizational affiliation(s): Chair, Board of Governors, American College of Physicians (ACP) Executive Committee, Board of Regents, ACP
• Areas of expertise/discipline: Internal medicine, infectious diseases, viral hepatitis, human immunodeficiency virus (HIV)

Carla Coffin, MD, MSc, FRCPC

• Current position: Professor of Medicine
• Organizational affiliation(s): Department of Medicine, cross-appointment to Department of Microbiology, Immunology, and Infectious Diseases; Chair, Gastrointestinal Research Group, Calvin, Phoebe, and Joan Snyder Institute for Chronic Diseases, Cumming School of Medicine, University of Calgary; Medical Director of the Calgary Liver Unit, Calgary Division of Gastroenterology and Hepatology, Alberta Health Services
• Areas of expertise/discipline: Hepatitis B, hepatology, translational research

Kristen Marks, MD

• Current position: Associate Professor of Medicine; Clinical Trials Unit Co-Director
• Organizational affiliation(s): Division of Infectious Disease, Weill Cornell Medical College
• Areas of expertise/discipline: HIV, hepatitis C

David L. Thomas, MD, MPH

• Current position: Stanhope Bayne-Jones Professor of Medicine and Professor of Epidemiology
• Organizational affiliation(s): Johns Hopkins School of Medicine; Bloomberg School of Public Health
• Areas of expertise/discipline: Viral hepatitis, infectious diseases

Su H. Wang, MD, MPH

• Current position: Medical Director, Viral Hepatitis Programs & Center for Asian Health
• Organizational affiliation(s): Cooperman Barnabas Medical Center; RWJBarnabas-Rutgers Medical Group
• Areas of expertise/discipline: Internal medicine, perinatal hepatitis B, hepatitis B, pediatrics