Peer Review Plan for Recommendations for Hepatitis B Screening and Testing
Subject of planned report: The document will summarize proposed updated recommendations for hepatitis B screening in the United States, specifically:
- Universal, one-time hepatitis B screening for adults aged >18 years,
- Use of three serological tests (hepatitis B surface antigen, antibody to hepatitis B core antigen, and antibody to hepatitis B surface antigen) 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 history of sexually transmitted infection, currently or formerly incarcerated persons, and persons with HCV infection.
- Availability of hepatitis B testing for anyone who requests is, regardless of disclosure of risk, because many may be reluctant to disclose stigmatizing risks.
Purpose of planned report: Provide US health care providers with updated recommendations for screening and testing for hepatitis B. The report will serve as a resource for health care professionals, public health officials, and organizations involved in the development, implementation, delivery, and evaluation of clinical preventive services.
Type of dissemination: Influential Scientific Information (ISI)
Timing of review: 02/23/2022-03/23/2022 (peer review)
Type of review: Individual
Opportunities for public to comment: Multiple opportunities for public comment will be available during and after the peer review period. A 60 day federal register notice has been published. Public and key stakeholder group engagement, including primary care clinical organizations, will also be obtained through delivery of a webinar presenting the key recommendations of the draft guidelines and supporting scientific evidence with the opportunity for webinar participants to submit written comments. The draft guidelines will be revised, as appropriate, to incorporate feedback received from these sources.
Peer reviewers provided with public comments before review: No; public comments will be solicited at the same times as the peer review process is conducted.
Anticipated number of reviewers: five
Primary disciplines of expertise: Hepatology, internal medicine, clinical research, infectious disease
Reviewers selected by (agency or designated outside organization): CDC selected reviewers from 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
Charge to peer reviewers: CDC intends to publish updated recommendations for hepatitis B screening among adult US residents based on scientific evidence of the effectiveness, economic value, and expert opinion. The recommendations constitute influential scientific information that will have a clear and substantial impact on public policies and private sector decisions. US Federal Information Quality Regulations require peer review of the draft recommendations, before publication, by specialists in the field who were not involved in their development to ensure the quality, objectivity, utility, and integrity of information disseminated by federal agencies.
These recommendations describe comprehensive systematic reviews of the literature that were conducted, analyzed, and assessed 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. Reviews of evidence to inform the hepatitis B screening recommendation for all adults were conducted.
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 United States;
- 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 reasonableness of expert judgements 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; and
- 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.
CDC also welcomes other comments, for example, on improving recommendation implementation or uptake, or other suggestions about the use of terminology, etc.
After receiving comments from reviewers, CDC’s responses to peer reviews will be provided to each reviewer and posted without attribution to https://www.cdc.gov/hepatitis/policy/ISIreview.
Elisa Choi, MD, FACP, FIDSA
Current position: Chief of Internal Medicine
Organizational affiliation(s): Chair-Elect, Board of Governors, American College of Physicians (ACP); Executive Committee, Board of Regents, ACP;
Harvard Vanguard Medical Associates Somerville
Areas of expertise, discipline: internal medicine, infectious diseases, viral hepatitis, 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: Professor of Medicine and 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; RWJ Barnabas-Rutgers Medical Group
Areas of expertise, discipline: internal medicine, perinatal hepatitis B, hepatitis B, pediatrics