Final Research Plan
Hepatitis B Virus Infection in Pregnant Women: Screening
November 09, 2017
Recommendations made by the USPSTF are independent of the U.S. government. They should not be construed as an official position of the Agency for Healthcare Research and Quality or the U.S. Department of Health and Human Services.
The final Research Plan is used to guide a systematic review of the evidence by researchers at an Evidence-based Practice Center. The resulting Evidence Review will form the basis of the USPSTF Recommendation Statement on this topic.
The draft Research Plan was available for comment from July 13 to August 9, 2017.
- What are the population benefits of universal screening programs for hepatitis B virus infection in pregnant women?
- What are the harms of universal screening programs for hepatitis B virus infection in pregnant women?
- What is the effectiveness of case management programs to prevent vertical transmission among pregnant women who have hepatitis B virus infection?
- What are the harms of case management programs to prevent vertical transmission among pregnant women who have hepatitis B virus infection?
Contextual questions will not be systematically reviewed and are not shown in the Analytic Framework.
- Do pregnant women benefit from repeat screening or hepatitis B virus infection in the third trimester based on the presence of specific risk factors?
- What is the effectiveness of vaccination for the hepatitis B virus, immunoglobulin therapy, and antiviral treatment for preventing vertical transmission among pregnant women?
The Research Approach identifies the study characteristics and criteria that the Evidence-based Practice Center will use to search for publications and to determine whether identified studies should be included or excluded from the Evidence Review. Criteria are overarching as well as specific to each of the key questions (KQs).
|Aim||To evaluate the effects of prenatal screening for hepatitis B virus infection on health outcomes and transmission rates and the effects of management and treatment programs among pregnant women with hepatitis B virus infection|
|Populations||KQs 1, 2: Pregnant women at any gestation who are not known to have acute or chronic hepatitis B virus infection
KQs 3, 4: Pregnant women with acute or chronic hepatitis B virus infection
|KQs 1, 2: Pregnant women who are known to have hepatitis B virus infection; women who are not pregnant; male partners of pregnant women|
|Interventions||KQs 1, 2: Universal screening for hepatitis B surface antigen
KQs 3, 4: Organized programs aimed at preventing vertical transmission of hepatitis B virus infection among pregnant women; management and followup programs that deliver effective/recommended prophylactic interventions for women and neonates to reduce vertical transmission of hepatitis B virus infection
|KQs 1, 2: Viral load followup testing among screen-positive women|
|Comparisons||KQs 1, 2: No screening; targeted screening
KQs 3, 4: Comparisons of vertical transmission of hepatitis B virus infection associated with program implementation across time, geographic sites, or populations, both with and without case management for followup and immunotherapy
|Outcomes||KQs 1, 3: Mother-to-child transmission of hepatitis B virus infection; infant morbidity and mortality from perinatal hepatitis B virus infection
KQ 2: Harms from the screening test or receipt of test results
KQ 4: Harms from management of screen-detected hepatitis B virus infection; negative effects on maternal and infant health
|KQ 1: Diagnostic accuracy
KQ 3: Effects of individual interventions for hepatitis B virus infection (e.g., antiviral treatment) administered outside of a care program
KQ 4: Harms of specific pharmacologic interventions
|Setting||Any health care setting or level of care||Settings where universal vaccination of newborns for hepatitis B virus infection is not recommended or practiced|
|Country||Studies conducted in countries categorized as “high” to “very high” on the Human Development Index (as defined by the United Nations Development Programme)||Studies conducted in countries not categorized as “high” or “very high” on the Human Development Index|
|Study Design||KQ 1: Randomized or clinical controlled trials, systematic reviews, before-after studies, observational cohort studies, and ecologic studies with a historical or geographic comparator
KQs 2–4: All of the above plus cohort studies, case series, and registry data
|KQs 3, 4: Trials examining the effectiveness of individual pharmacologic treatments to prevent vertical transmission of hepatitis B virus infection administered outside of a care management program|
|Language||English-language only||Languages other than English|
|Study Quality||Fair- or good-quality studies||Poor-quality studies|
|Publication Dates||1986 to the present||Studies conducted prior to the introduction of vaccination for hepatitis B virus infection|
The draft Research Plan was posted for public comment on the USPSTF Web site from July 13, 2017 to August 9, 2017. In response, the USPSTF made minor changes to clarify the analytic framework and the included population. Several comments suggested including studies examining the benefits and harms of specific treatment or case management interventions, or focusing on interventions to improve screening among subpopulations of women at increased risk of infection and perinatal transmission. The USPSTF determined that the evidence needed to inform a recommendation for this subpopulation would be limited, and completing the indirect pathway from screening to health outcomes would require a population-level perspective on screening and its broad impact in the presence of a case management program. Contextual information on the effectiveness of specific screening or treatment approaches will be provided to supplement the included evidence on population-level programs for screening and case management. Since this review is concerned with screening during pregnancy, the USPSTF maintained its exclusion of studies on the management of screen-detected clinical disease beyond the perinatal period, as this is considered outside the scope of the USPSTF (i.e., tertiary care). Many comments pertained to the safety of vaccination, which is outside the USPSTF’s purview.