Peer Review Plan For Recommendations for Hepatitis C Screening among Adults

Title: CDC Recommendations for Hepatitis C Screening among Adults

Subject of planned report: This document will summarize new recommendations for hepatitis C screening in adults and pregnant women in the United States, specifically:

  • At least once in a lifetime hepatitis C screening for all adults aged 18 years and older, except in settings where the prevalence of HCV infection is less than 0.1%, and
  • Hepatitis C screening for all pregnant women during each pregnancy, except in settings where the prevalence of hepatitis C infection is less than 0.1%.

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.

Purpose of planned report: Provide US healthcare providers with new recommendations and supporting scientific evidence of the effectiveness and economic value of screening to diagnose current HCV infection among adults aged 18 years and older, and pregnant women of all ages during each pregnancy, except in settings where the hepatitis C prevalence is demonstrated to be <0.1%. 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: 10/01/2019-10/31/2019 (peer review)

Type of review: Individual

Opportunities for public to comment: Multiple opportunities for public comment will be available during the same time as peer review. Public and key stakeholder group engagement, including primary care clinical organizations, will be obtained through delivery of a series of webinars presenting the key recommendations of the draft guidelines and supporting scientific evidence with the opportunity for webinar participants to submit written comments. A 30 day Federal Register notice will also be published with the opportunity for the public to comment. A summary of comments received and CDC’s responses will be posted to https://www.cdc.gov/hepatitis/policy/ISIreview. 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: six

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

Reviewers selected by (agency or designated outside organization): CDC selected reviewers from among those nominated by the following clinical organizations: American Association for the Study of Liver Diseases (Aronsohn), Infectious Diseases Society of American (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 intends to publish new recommendations for hepatitis C screening among adult US residents based on scientific evidence of the effectiveness and economic value. The recommendations constitute influential scientific information that will have a clear and substantial impact on important 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. We are inviting you to serve as a peer reviewer of the draft recommendations.

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 HCV infection prevalence and health benefits and harms associated with one-time hepatitis C screening for persons unaware of their infection status. Reviews of evidence to inform the hepatitis C screening recommendation for all adults and pregnant women were conducted.

In your review of the recommendations, we ask that you:

  • 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 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 HCV infection.

We would also welcome other comments, for example, on improving recommendation implementation or uptake, or other suggestions about the use of terminology, etc.

Thank you once again for your assistance with the review of these recommendations. We recognize and appreciate the commitment of time and energy this will involve. After receiving your comments, we will forward you a copy of CDC’s responses and also post them (without attribution) to https://www.cdc.gov/hepatitis/policy/ISIreview.

 

Peer Reviewers:

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

Additional elements to be added to the public posting as they become available:

The following items will be posted to https://www.cdc.gov/hepatitis/policy/ISIreview, as they become available:

  • Peer reviewer comments (without attribution)
  • CDC response to reviewers’ comments