October 8, 2017: National Center for Health Research.
Thank you for the opportunity to express our views on the draft research plan regarding primary care screening for Hepatitis C virus infection in adolescents and adults. The National Center for Health Research is a nonprofit think tank that conducts, analyzes, and scrutinizes research, policies, and programs on a range of issues related to health and safety. We do not accept funding from companies that make products that are the subject of our work, so we have no conflicts of interest.
According to the CDC, in 2015 there were 181,871 reports of past or current hepatitis C. Three out of 4 new infections in adults and adolescents will progress to chronic infections. The CDC estimates 4.9 deaths per 100,000 persons. The current recommendations endorsed by both the CDC and USPSTF to offer a one-time screening for adults born between 1945-1965 misses adolescents and other adults who could benefit from early detection.
It is important to develop new recommendations for screening in order to reduce morbidity, disease transmission, deaths due to disease, and improve quality of life. Moreover, the screening visit presents a unique opportunity for providers to counsel patients on risk behaviors and reinforce healthy behaviors. A focused screening program for pregnant women is also of interest because mother-to-baby transmission is the primary source of pediatric Hepatitis C virus infection.
We support the efforts of the U.S. Preventive Services Task Force (USPSTF) to draft a research plan to identify benefits and harms of screening in a broad screening population and in specific vulnerable populations, including adolescents and pregnant women. We have several recommendations that would strengthen the USPSTF research plan:
1) We support USPSTF’s inclusion of quality of life indicators in the proposed key question 1a. that addresses benefits of screening, but recommend that several additional questions be addressed:
- Who would not benefit from screening?
- Who should not be screened?
A positive screen, or positive diagnostic test, will lead to a question of whether to initiate treatment. The USPSTF should assess evidence-based treatment guidelines and determine the impact of those guidelines for selecting a meaningful screening population. In other words, if a group should not be treated for Hepatitis C, then they should not be screened.
2) For key questions 1b. and 4., which assess benefits and harms of screening in pregnant women, we recommend that the Task Force look at additional questions of interest:
- What is the impact of screening on behavior or attitudes that would benefit or harm a healthy pregnancy?
- Since many treatments have undetermined safety for pregnancy or breastfeeding, what are the risks of delaying treatment until after the delivery or after breastfeeding is completed?
3) Regarding key question 2., which focuses on the effectiveness of different screening tests, we recommend that the Task Force also address additional questions of interest pertaining to diagnostic tests:
- What are the best practices to detect HCV virus in the blood?
- What are the harms associated with available diagnostic tests?
- What are the harms associated with false positive and false negative diagnostic test results?
4) Research on psychological effects was included in the 2012 review, but the Task Force found insufficient evidence to demonstrate that knowledge of screening results promotes healthy behaviors. We strongly recommend that the USPSTF conduct a thorough analysis of any new information regarding psychological harms and benefits of screening as well as psychological harms and benefits of diagnosis and treatment.
5) Because screening is targeted to the primary care setting, the attitudes and behaviors of primary care providers will be influential on the adoption of new screening practices. We recommend that the USPSTF include a review of real world evidences such as survey data, to assess providers’ comfort level and experience in triaging positive screening tests, providing referrals to specialists, and prescribing treatments.
In conclusion, we generally support the USPSTF’s draft research plan regarding primary care screening for Hepatitis C virus infection, but recommend additional issues be addressed as noted above.
For questions or more information, please contact Diana Zuckerman, PhD, at dz@center4research.org.
References:
Draft Research Plan for Hepatitis C Virus Infection in Adolescents and Adults: Screening. U.S. Preventive Services Task Force. October 2017. https://www.uspreventiveservicestaskforce.org/Page/Document/draft-research-plan/hepatitis-c-screening1