Peer Review: Hepatitis C Screening 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 summarized previously published recommendations from CDC regarding testing for HCV infection in the United States.

The report provided clinicians with new recommendations and supporting scientific evidence for hepatitis C screening in adults ages 18 years and older and pregnant persons of all ages during each pregnancy, except in settings where hepatitis C prevalence is demonstrated to be less than 0.1%.

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 proposed recommendations:

• Screening of hepatitis C virus (HCV) for all pregnant people (regardless of age) during each pregnancy.
• Hepatitis C screening for all adults ages 18 years and older at least once in their lifetime, except in settings where the prevalence of HCV infection is less than 0.1%.
• Hepatitis C screening for all pregnant people during each pregnancy, except in settings where the prevalence of hepatitis C infection is less than 0.1%.
• Repeat HCV testing for persons with ongoing risk behaviors.
• Regardless of age or setting prevalence, all persons with risk factors should be tested for hepatitis C once, with periodic testing while risk factors persist.

Breakdown of peer review

Type of dissemination: Influential Scientific Information (ISI)

Timing of review: 10/01/2019–10/31/2019

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: Six

Primary disciplines of expertise: Hepatology, transplant hepatology, gastroenterology, internal medicine, clinical research, virology, obstetrics and gynecology, infectious disease

Reviewer selections by agency or designated outside organization: CDC selected reviewers among those nominated by the following clinical organizations: American Association for the Study of Liver Diseases (Aronsohn), Infectious Diseases Society of America (Naggie and Scott), and American College of Obstetricians and Gynecologists (Hughes, Jamieson, and Riley)

Public nomination requested for reviewers: No

Charge to peer reviewers

CDC conducted peer review for these recommendations from October 1, 2019, to October 31, 2019. 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 new recommendations for hepatitis C screening among adult US residents. The recommendations constitute influential scientific information that will have a clear and substantial impact on important public policies and private sector decisions.

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

• Effectiveness
• Economic value

Experts conducted reviews of evidence to inform hepatitis C screening recommendations for all adults and pregnant people. They conducted, analyzed, and assessed the literature to examine the availability and quality of the evidence regarding HCV infection prevalence and health benefits and harms associated with one-time hepatitis C 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 C 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 HCV infection.

Public comments and CDC response

On October 28, 2019, CDC published a Federal Register Notice (FRN) #CDC-2019-0094 to obtain public comment on the proposed recommendations. The public comment period lasted 30 days. Comments and CDC responses are posted in the Federal Register.

List of peer reviewers

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

Andrew Aronsohn, MD

• Current position: Associate Professor of Medicine
• Organizational affiliation(s): University of Chicago Medical Center
• Areas of expertise/discipline: Hepatology, transplant

Brenna L. Hughes, MD, MSc

• Current position: Associate Professor Obstetrics and Gynecology, Division of Maternal Fetal Medicine
• Organizational affiliation(s): Duke University
• Areas of expertise/discipline: Infectious diseases in pregnancy, viral hepatitis, HIV

Denise Jamieson, MD, MPH

• Current position: Division Director, Department of Gynecology and Obstetrics, Gynecologic Specialties
• Organizational affiliation(s): Emory University School of Medicine
• Areas of expertise/discipline: Gynecology, obstetrics, and gynecology

Susanna Naggie, MD

• Current position: Associate Professor of Medicine
• Organizational affiliation(s): Duke University Department of Medicine
• Areas of expertise/discipline: Internal medicine, infectious diseases, HIV, viral hepatitis

Laura Riley, MD

• Current position: Director, Obstetrics and Gynecology Infectious Disease
• Organizational affiliation(s): Massachusetts General Hospital
• Areas of expertise/discipline: Obstetrics and gynecology

John D. Scott, MD, MSc, FIDSA

• Current position: Associate Professor
• Organizational affiliation(s): University of Washington School of Medicine; Digital Health (Medical Director)
• Areas of expertise/discipline: Viral hepatitis, infections in solid organ transplants, telemedicine