Peer Review: Perinatal Hepatitis C 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 recommendations

The report provides United States clinicians with recommendations for testing perinatally exposed infants and children for hepatitis C. These recommendations supplement CDC's 2020 universal hepatitis C screening recommendations.

Testing exposed infants with a nucleic acid test (NAT) for HCV ribonucleic acid (RNA) at ages 2–6 months is expected to identify more perinatally exposed children and increase opportunities for linkage to care and curative treatment.

The report also serves as a resource for those involved in the development, implementation, delivery, and evaluation of clinical and preventive services, including health care professionals, public health officials, and professional, academic, public health, and advocacy organizations.

Breakdown of peer review

Type of dissemination: Influential Scientific Information (ISI)

Timing of review: 10/17/2022–11/16/2022

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: Six

Primary disciplines of expertise: Pediatrics, hepatology, obstetrics, family medicine, infectious disease

Reviewer selections by agency or designated outside organization: CDC selected reviewers among those nominated by select organizations: American Academy of Pediatrics, American Association for the Study of Liver Diseases, American College of Obstetricians and Gynecologists, American Academy of Family Physicians, and the North American Society for Pediatric Gastroenterology, Hepatology, and Nutrition.

Public nomination requested for reviewers: No

Charge to peer reviewers

CDC conducted peer review for these recommendations from October 17, 2022, to November 16, 2022. The following was the charge to reviewers.

US Federal Information Quality Regulations require peer review of the 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 recommendations for hepatitis C testing among perinatally exposed infants and children in the US. The recommendations constitute influential scientific information that will have a clear and substantial impact on public policies and private sector decisions. The recommendations are based on expert opinion and scientific evidence of:

• Effectiveness
• Economic value

Experts conducted, analyzed, and assessed the literature to examine the availability and quality of the evidence regarding perinatal hepatitis C infection prevalence and testing. They also assessed the health benefits and harms associated with NAT for hepatitis C virus (HCV) RNA at ages 2–6 months compared to HCV antibody testing at or after age 18 months among perinatally exposed infants and children.

Experts drafted the recommendations based on the systematic and comprehensive review of the evidence on perinatal hepatitis C testing.

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 increase testing and reduce the burden of undiagnosed perinatal 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 scientific literature.
• Identify any residual biases, errors of omission, or inconsistencies in the interpretations, findings, and conclusions.
• Assess the rationale of expert judgments made without 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 testing infants and children for perinatal HCV infection in the US.

To learn more, see Peer Review Comments and CDC Responses.

Public comments and CDC response

On November 22, 2022, CDC published a Federal Register Notice (FRN) #CDC-2022-0116 to obtain comment on proposed perinatal hepatitis C testing recommendations. CDC hosted a webinar on Tuesday, December 6, 2022, at 3:00pm ET, presenting an overview of the proposed recommendations.

The FRN was open for public comment through January 27, 2023. After receiving comments from reviewers, CDC provided responses to each and posted without attribution.

Questions about the FRN can be sent to DVHpolicy@cdc.gov.

Peer reviewers

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

Elizabeth Barnett, MD, FAAP

• Current position: Professor of Pediatrics (Infectious Diseases)
• Organizational affiliation(s): Boston University Aram V. Chobanian & Avedisian School of Medicine

Ravi Jhaveri, MD, FIDSA, FPIDS

• Current position: Division Head, Pediatric Infectious Diseases, Professor of Pediatrics
• Organizational affiliation(s): Northwestern University Feinberg School of Medicine, Ann & Robert H. Lurie Children's Hospital of Chicago

Gwen Lazenby, MD, MSCR

• Current position: Professor of Medicine and Obstetrics and Gynecology
• Organizational affiliation(s): Medical University of South Carolina (MUSC)

Christine Lee, MD, MPH

• Current position: Assistant Professor of Pediatrics (Gastroenterology, Hepatology, and Nutrition)
• Organizational affiliation(s): Harvard Medical School, Boston Children's Hospital

Wael Mourad, MD, MHCM, CHCQM, FAAFP

• Current position: Clinical Professor of Community and Family Medicine, Chief Health Officer – Health Partnership Clinic, Medical Director – The Medina Clinic
• Organizational affiliation(s): University of Missouri – Kansas City School of Medicine

Adam Ratner, MD, MPH

• Current position: Director, Division of Pediatric Infectious Diseases, Associate Professor of Pediatrics and Microbiology
• Organizational affiliation(s): New York University Grossman School of Medicine, Hassenfeld Children's Hospital