Final Research Plan
Hepatitis B Virus Infection: Screening, 2014
March 15, 2013
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 Report forms the basis of the USPSTF Recommendation Statement on this topic.
The draft Research Plan was available for comment from October 9 until November 6, 2012 at 5:00 p.m., ET.
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- What are the benefits of screening for hepatitis B virus (HBV) versus no screening in asymptomatic, nonpregnant adolescents and adults on morbidity, mortality, and disease transmission?
- What are the harms of screening for HBV infection (e.g., labeling, anxiety, and harms of confirmatory tests, including biopsy)?
- How well do different screening strategies identify individuals with HBV infection (e.g., strategies that target persons from high prevalence countries, men who have sex with men, injection drug users, immunization history, or other risk factors)?
- In nonpregnant adolescents and adults with no evidence of HBV immunity at screening, how effective is HBV vaccination in improving clinical outcomes?
- In nonpregnant adolescents and adults with chronic HBV infection, how effective is antiviral treatment in improving intermediate outcomes (e.g., virologic or histologic improvement or clearance of hepatitis B e antigen [HbeAg])?
- In nonpregnant adolescents and adults with chronic HBV infection, how effective is antiviral treatment in improving health outcomes?
- In nonpregnant adolescents and adults with chronic HBV infection, how effective is education or behavioral change counseling in reducing transmission and improving health outcomes?
- What are the harms associated with antiviral treatment for HBV infection?
- Do improvements in intermediate outcomes improve final health outcomes?
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 report. Criteria are overarching as well as specific to each of the key questions (KQs).
| Include | Exclude | |
|---|---|---|
| Disease | Chronic HBV infection: detectable hepatitis B surface antigen in serum for >6 months | Acute HBV infection |
| Populations | ||
| KQs 1–3 | Nonpregnant adults (ages ≥18 years) and adolescents (ages 13 to <18 years) who are asymptomatic for HBV infection | Symptomatic patients, children and pregnant women, HIV(+) or hepatitis C virus(+) persons or other special populations, such as hemodialysis and transplant patients |
| KQ 4 | Persons without evidence of HBV immunity or disease upon screening | |
| KQs 5–9 | Nonpregnant adults and adolescents with chronic HBV infection | |
| Interventions | ||
| KQs 1, 2 | Screening | |
| KQ 3 | Screening strategies | Laboratory test results |
| KQs 4, 9 | Vaccination | |
| KQs 5–8 |
Education or behavior change counseling
Antiviral treatments for treatment-naive patients (Note: Food and Drug Administration [FDA]-approved treatments include interferon alpha, lamivudine, adefovir, entecavir, telbivudine, tenofovir) |
NonFDA-approved antiviral treatments, combination therapy |
| Comparators | ||
| KQs 1, 2 | No screening | |
| KQs 4, 9 | No vaccination | |
| KQs 5–7 | No treatment | |
| KQ 3 | Gold standard diagnostic test | |
| KQ 8 | No treatment | |
| Outcomes | ||
| KQs 2 | Labeling, anxiety; harms from liver biopsy; side effects | |
| KQ 3 | Measures of predictive validity | |
| KQ 4 | Disease prevention | |
| KQ 5 | Intermediate outcomes: virologic improvement, histologic improvement, HBeAg clearance | <3 months followup data; drug resistance; development of mutations or antibodies to drugs |
| KQs 1, 6, 7, 9 | Final outcomes: mortality, cirrhosis, hepatocellular cancer, quality of life, disease transmission | |
| KQ 8 | Harms from antiviral medications | |
| Setting | Primary care and primary care referable settings, such as correctional and community care settings serving injection drug users, men who have sex with men, or sexually transmitted disease populations; United States and countries with similar HBV prevalence, except for antiviral therapies (all countries) | |
| Study Designs | ||
| All KQs | Good-quality systematic reviews | |
| KQ 1 | Randomized, controlled trials and controlled observational studies | Uncontrolled studies |
| KQs 2, 8 | Randomized, controlled trials and controlled observational studies; large, uncontrolled observational studies with long-term followup | Very small uncontrolled studies; case studies |
| KQ 3 | Studies assessing predictive validity of screening strategies | |
| KQs 4–7 | Randomized, placebo-controlled trials | |
| KQ 9 | Cohort studies examining the association between intermediate and clinical outcomes after antiviral treatment | |
The draft Research Plan was posted for public comment on the U.S. Preventive Services Task Force (USPSTF) Web site from October 9 to November 6, 2012. The USPSTF received several comments requesting clarification on the inclusion and exclusion criteria, analytic framework, and key questions related to populations, risk factors, settings, interventions, and outcomes. The Research Plan was revised in response to these comments. Several commenters identified “stigma” as an important potential outcome of screening, and it was added to the inclusion criteria.