Integrating the Consolidated Framework for Implementation Research (CFIR) into a Culturally Responsive Evaluation (CRE) Approach to Conduct Mixed-Method Evaluations of Diabetes Prevention and Management Programs Reaching Underresourced Populations and Communities.

Diabetes is a significant population health threat. Evidence-based interventions, such as the Centers for Disease Control and Prevention's National Diabetes Prevention Program and diabetes self-management education and support programs, can help prevent, delay, or manage the disease. However, participation is suboptimal, especially among populations who are at an increased risk of developing diabetes. Evaluations of programs reaching populations who are medically underserved or people with lower incomes can help elucidate how best to tailor evidence-based interventions, but it is also important for evaluations to account for cultural and contextual factors. Culturally responsive evaluation (CRE) is a framework for centering an evaluation in the culture of the programs being evaluated. We integrated CRE with implementation and outcome constructs from the Adapted Consolidated Framework for Implementation Research (CFIR) to ensure that the evaluation produced useful evidence for putting evidence-based diabetes interventions to use in real-world settings, reaching populations who are at an increased risk of developing diabetes. The paper provides an overview of how we integrated CRE and CFIR approaches to conduct mixed-methods evaluations of evidence-based diabetes interventions.

Hepatitis C virus testing for case identification in persons born during 1945-1965: Results from three randomized controlled trials.

The Centers for Disease Control and Prevention and US Preventive Services Task Force recommend one-time hepatitis C virus (HCV) testing for persons born during 1945-1965 (birth cohort). However, few studies estimate the effect of birth cohort (BC) testing implementation on HCV diagnoses in primary care settings. We aimed to determine the probability of identifying HCV infections in primary care using targeted BC testing compared with usual care at three academic medical centers. From December 2012 to March 2014, each center compared one of three distinct interventions with usual care using an independently designed randomized controlled trial. Across centers, BC patients with no clinical documentation of previous HCV testing or diagnosis were randomly assigned to receive a one-time offering of HCV antibody (anti-HCV) testing via one of three independent implementation strategies (repeated-mailing outreach, electronic medical record-integrated provider best practice alert [BPA], and direct patient solicitation) or assigned to receive usual care. We estimated model-adjusted risk ratios (aRR) of anti-HCV-positive (anti-HCV+) identification using BC testing versus usual care. In the repeated mailing trial, 8992 patients (intervention, n = 2993; control, n = 5999) were included in the analysis. The intervention was eight times as likely to identify anti-HCV+ patients compared with controls (aRR, 8.0; 95% confidence interval [CI], 2.8-23.0; adjusted probabilities: intervention, 0.27%; control, 0.03%). In the BPA trial, data from 14,475 patients (BC, n = 8928; control, n = 5,547) were analyzed. The intervention was 2.6 times as likely to identify anti-HCV+ patients versus controls (aRR, 2.6; 95% CI, 1.1-6.4; adjusted probabilities: intervention, 0.29%; control, 0.11%). In the patient-solicitation trial, 8873 patients (BC, n = 4307; control, n = 4566) were analyzed. The intervention was five times as likely to identify anti-HCV+ patients compared with controls (aRR, 5.3; 95% CI, 2.3-12.3; adjusted probabilities: intervention, 0.68%; control, 0.11%). Conclusion: BC testing was effective in identifying previously undiagnosed HCV infections in primary care settings. (Hepatology 2018;67:524-533).

The Importance of Addressing Depression and Diabetes Distress in Adults with Type 2 Diabetes.

People with type 2 diabetes often experience two common mental health conditions: depression and diabetes distress. Both increase a patient's risk for mortality, poor disease management, diabetes-related complications, and poor quality of life. The American Diabetes Association and the U.S. Preventive Services Task Force recommend routine evaluations for these conditions in adults for optimal disease management and prevention of life-threatening complications. However, barriers exist within primary care and specialty settings that make screening for depression and diabetes distress challenging. Depression and diabetes distress influence diabetes self-care and diabetes control and barriers in clinical care practice that can hinder detection and management of psychosocial issues in diabetes care. This paper highlights opportunities to increase mental health screenings and provides strategies to help providers address depression and diabetes distress in patients with type 2 diabetes.

Uptake of hepatitis C screening, characteristics of patients tested, and intervention costs in the BEST-C study.

From December 2012 to March 2014, three randomized trials, each implementing a unique intervention in primary care settings (repeated mailing, an electronic health record best practice alert [BPA], and patient solicitation), evaluated hepatitis C virus (HCV) antibody testing, diagnosis, and costs for each of the interventions compared with standard-of-care testing. Multilevel multivariable models were used to estimate the adjusted risk ratio (aRR) for receiving an HCV antibody test, and costs were estimated using activity-based costing. The goal of this study was to estimate the effects of interventions conducted as part of the Birth-Cohort Evaluation to Advance Screening and Testing for Hepatitis C study on HCV testing and costs among persons of the 1945-1965 birth cohort (BC). Intervention resulted in substantially higher HCV testing rates compared with standard-of-care testing (26.9% versus 1.4% for repeated mailing, 30.9% versus 3.6% for BPA, and 63.5% versus 2.0% for patient solicitation) and significantly higher aRR for testing after controlling for sex, birth year, race, insurance type, and median household income (19.2 [95% confidence interval (CI), 9.7-38.2] for repeated mailing, 13.2 [95% CI, 3.6-48.6] for BPA, and 32.9 [95% CI, 19.3-56.1] for patient solicitation). The BPA intervention had the lowest incremental cost per completed test ($24 with fixed startup costs, $3 without) and also the lowest incremental cost per new case identified after omitting fixed startup costs ($1691). CONCLUSION: HCV testing interventions resulted in an increase in BC testing compared with standard-of-care testing but also increased costs. The effect size and incremental costs of BPA intervention (excluding startup costs) support more widespread adoption compared with the other interventions. (Hepatology 2017;65:44-53).

An Electronic Health Record-based Intervention to Promote Hepatitis C Virus Testing Among Adults Born Between 1945 and 1965: A Cluster-randomized Trial.

BACKGROUND: The Centers for Disease Control and Prevention (CDC) recommends one-time hepatitis C virus (HCV) antibody testing for "Birth Cohort" adults born during 1945-1965. OBJECTIVE: To examine the impact of an electronic health record (EHR)-embedded best practice alert (BPA) for HCV testing among Birth Cohort adults. DESIGN: Cluster-randomized trial was conducted from April 29, 2013 to March 29, 2014. SUBJECTS AND SETTING: Ten community and hospital-based primary care practices. Participants were attending physicians and medical residents during 25,620 study-eligible visits. INTERVENTION: Physicians in all practices received a brief introduction to the CDC testing recommendations. At visits for eligible patients at intervention sites, physicians received a BPA through the EHR to order HCV testing or medical assistants were prompted to post a testing order for the physician. Physicians in control sites did not receive the BPA. MAIN OUTCOMES: HCV testing; the incidence of HCV antibody positive tests was a secondary outcome. RESULTS: Testing rates were greater among Birth Cohort patients in intervention sites (20.2% vs. 1.8%, P<0.0001) and the odds of testing were greater in intervention sites after controlling for imbalances of patient and visit characteristics between comparison groups [odds ratio (OR), 9.0; 95% confidence interval, 7.6-10.7). The adjusted OR of identifying HCV antibody positive patients was also greater in intervention sites (OR, 2.1; 95% confidence interval, 1.3-11.2). CONCLUSIONS: An EHR-embedded BPA markedly increased HCV testing among Birth Cohort patients, but the majority of eligible patients did not receive testing indicating a need for more effective methods to promote uptake.

Implementation of Birth-Cohort Testing for Hepatitis C Virus.

Hepatitis C virus infection affects approximately 2.2 to 3.2 million Americans. In 2012, the Centers for Disease Control and Prevention recommended a one-time antibody test of all persons belonging to the 1945-1965 birth cohort. Efforts to implement this recommendation in clinical settings are in their infancy; this case study report therefore seeks to share the experiences of three sites that implemented interventions to increase birth-cohort testing through participation in the Birth-cohort Evaluation to Advance Screening and Testing for Hepatitis C. At each site, project managers completed standardized questionnaires about their implementation experiences, and a qualitative analysis was conducted of the responses. The testing interventions used in-person recruitment, mail recruitment, and an electronic health record prompt. Sites reported that early efforts to obtain stakeholder buy-in were critical to effectively implement and sustain interventions and that the intervention required additional staffing resources beyond those being used for risk-based testing. In each case, administrative barriers were more extensive than anticipated. For the electronic health record-based intervention, technological support was critical in achieving study goals. Despite these barriers, interventions in all sites were successful in increasing rates of testing and case identification, although future studies will need to evaluate the relative costs and benefits of each intervention.

No Differences in Achieving Hepatitis C Virus Care Milestones Between Patients Identified by Birth Cohort or Risk-Based Screening.

BACKGROUND & AIMS: National hepatitis C virus (HCV) screening guidelines recommended 1-time testing of persons born between 1945 and 1965. METHODS: We performed a retrospective study to compare care milestones achieved by HCV-infected patients identified by birth cohort versus risk-based screens. RESULTS: We determined the proportions of patients newly identified with HCV infection who met care milestones (viral load, referral to and evaluation by a specialist, offer of treatment, initiation of treatment, and sustained viral response) and the time it took to reach them. We found no differences in HCV care milestones for patients identified via birth cohort testing versus risk-based screening. Overall, only 43% of HCV antibody-positive patients were referred to care, and less than 4% started treatment. The time to each care milestone was lengthy and varied greatly; treatment was initiated in a median of 308 days. CONCLUSIONS: Although birth cohort testing will likely increase identification of patients with HCV infection, it does not seem to increase the number of patients that meet management milestones. New methods are needed to increase access to care and establish efficient models of health care delivery.

The cost-effectiveness, health benefits, and financial costs of new antiviral treatments for hepatitis C virus.

BACKGROUND: New hepatitis C virus (HCV) treatments deliver higher cure rates with fewer contraindications, increasing demand for treatment and healthcare costs. The cost-effectiveness of new treatments is unknown. METHODS: We conducted a microsimulation of guideline testing followed by alternative treatment regimens for HCV among the US population aged 20 and older to estimate cases identified, treated, sustained viral response, deaths, medical costs, quality-adjusted life-years (QALYs), and the incremental cost-effectiveness ratio (ICER) of different treatment options expressed as discounted lifetime costs and benefits from the healthcare perspective. RESULTS: Compared to treatment with pegylated interferon and ribavirin (PR), and a protease inhibitor for HCV genotype (G) 1 and PR alone for G2/3, treatment with PR and Sofosbuvir (PRS) for G1/4 and treatment with Sofosbuvir and ribavirin (SR) for G2/3 increased QALYs by 555 226, reduced deaths by 80 682, and increased costs by $26.2 billion at an ICER of $47 304 per QALY gained. As compared to PRS/SR, treating with an all oral regimen of Sofosbuvir and Simeprevir (SS) for G1/4 and SR for G2/3, increased QALYs by 1 110 451 and reduced deaths by an additional 164 540 at an incremental cost of $80.1 billion and an ICER of $72 169. In sensitivity analysis, where treatment with SS effectiveness was set to the list price of Viekira Pak and then Harvoni, treatment cost $24 921 and $25 405 per QALY gained as compared to PRS/SR. CONCLUSIONS: New treatments are cost-effectiveness per person treated, but pent-up demand for treatment may create challenges for financing.

Hepatitis C virus antibody positivity and predictors among previously undiagnosed adult primary care outpatients: cross-sectional analysis of a multisite retrospective cohort study.

BACKGROUND: Hepatitis C virus (HCV) testing guidance issued by the Centers for Disease Control and Prevention in 1998 recommends HCV antibody (anti-HCV) testing for persons with specified risk factors. The purpose of this study was to determine the prevalence and predictors of anti-HCV positivity among primary care outpatients and estimate the proportion of unidentified anti-HCV-positive (anti-HCV+) persons using risk-based testing. METHODS: We analyzed electronic medical record data from a 4-site retrospective study. Patients were aged ≥18 years, utilized ≥1 outpatient primary care service(s) between 2005 and 2010, and had no documented evidence of prior HCV diagnosis. Among persons tested for anti-HCV, we fit a multilevel logistic regression model to identify patient-level independent predictors of anti-HCV positivity. We estimated the proportion of unidentified anti-HCV+ persons by using multiple imputation to assign anti-HCV results to untested patients. RESULTS: We observed 209 076 patients for a median of 5 months (interquartile range, 1-23 months). Among 17 464 (8.4%) patients who were tested for anti-HCV, 6.4% (n=1115) were positive. We identified history of injection drug use (adjusted odds ratio [95% confidence interval], 6.3 [5.2-7.6]), 1945-1965 birth cohort (4.4 [3.8-5.1]), and elevated alanine aminotransferase levels (4.8 [4.2-5.6]) as independently associated with anti-HCV positivity. We estimated that 81.5% (n=4890/6005) of anti-HCV+ patients were unidentified using risk-based testing. CONCLUSIONS: In these outpatient primary care settings, risk-based testing may have missed 4 of 5 newly enrolled patients who are anti-HCV+. Without knowing their status, unidentified anti-HCV+ persons cannot receive further clinical evaluation or antiviral treatment, and are unlikely to benefit from secondary prevention recommendations to limit disease progression and mortality.

A Birth-cohort testing intervention identified hepatitis c virus infection among patients with few identified risks: a cross-sectional study.

BACKGROUND: International guidelines and U.S. guidelines prior to 2012 only recommended testing for hepatitis C virus (HCV) infection among patients at risk, but adherence to guidelines is poor, and the majority of those infected remain undiagnosed. A strategy to perform one-time testing of all patients born during 1945-1965, birth cohort testing, may diagnose HCV infection among patients whose risk remains unknown. We sought to determine if a birth-cohort testing intervention for HCV antibody positivity helped identify patients with fewer documented risk factors or medical indications than a pre-intervention, risk-based testing strategy. METHODS: We used a cross-sectional design with retrospective electronic medical record review to examine patients identified with HCV antibody positivity (Ab+) during a pre-intervention (risk-based) phase, the standard of care at the time, vs. a birth-cohort testing intervention phase. We compared demographic and clinical characteristics and HCV risk-associated factors among patients whose HCV Ab + was identified during the pre-intervention (risk-based testing) vs. post birth-cohort intervention phases. Study subjects were patients identified as HCV-Ab + in the baseline (risk-based) and birth-cohort testing phases of the Hepatitis C Assessment and Testing (HepCAT) Project. RESULTS: Compared to the risk-based phase, patients newly diagnosed with HCV Ab + after the birth-cohort intervention were significantly less likely to have a history of any substance abuse (30.5% vs. 49.5%, p = 0.02), elevated alanine transaminase levels of > 40 U/L (22.0% vs. 46.7%, p = 0.002), or the composite any risk-associated factor (55.9% vs. 79.0%, p = 0.002). CONCLUSIONS: Birth-cohort testing is an useful strategy for identifying previously undiagnosed HCV Ab + because it does not require providers ask risk-based questions, or patients to disclose risk behaviors, and appears to identify HCV Ab + in patients who would not have been identified using a risk-based testing strategy.

Hepatitis C virus testing perspectives among primary care physicians in four large primary care settings.

BACKGROUND: In 1998, the Centers for Disease Control and Prevention (CDC) published Recommendations for Prevention and Control of Hepatitis C Virus (HCV) Infection and HCV-Related Chronic Disease, recommending HCV testing for populations most likely to be infected with HCV. However, the implementation of risk-based screening has not been widely adopted in health care settings, and 45% to 85% of infected U.S. adults remain unidentified. OBJECTIVES: To develop a better understanding of why CDC's 1998 recommendations have had limited success in identifying persons with HCV infection and provide information about how CDC's 2012 Recommendations for the Identification of Chronic Hepatitis C Virus Infection Among Persons Born During 1945-1965 may be implemented more effectively. DESIGN: Qualitative data were collected and analyzed from a multidisciplinary team as part of the Birth Cohort Evaluation to Advance Screening and Testing for Hepatitis C project. RESPONDENTS: Nineteen providers were asked open-ended questions to identify current perspectives, practices, facilitators, and barriers to HCV screening and testing. Providers were affiliated with Henry Ford Hospital, Mount Sinai Hospital, the University of Alabama, and the University of Texas Health Science Center. RESULTS: Respondents reported the complexity of the 1998 recommendations, and numerous indicated risk factors were major barriers to effective implementation. Other hindrances to hepatitis C testing included physician discomfort in asking questions about socially undesirable behaviors and physician uncertainty about patient insurance coverage. CONCLUSION: Implementation of the CDC's 2012 recommendations could be more successful than the 1998 recommendations due to their relative simplicity; however, effective strategies need to be used for dissemination and implementation for full success.

Previous exposure to HCV among persons born during 1945-1965: prevalence and predictors, United States, 1999-2008.

OBJECTIVES: We examined HCV exposure prevalence and predictors among persons in the United States born during 1945-1965. METHODS: With data from the 1999-2008 National Health and Nutrition Examination Survey, we calculated the proportion of persons born during 1945-1965 who tested positive for HCV antibody (anti-HCV) and analyzed the prevalence by sociodemographic and behavioral risk factors. RESULTS: Anti-HCV prevalence in the 1945-1965 birth cohort was 3.2% (95% confidence interval [CI] = 2.8%, 3.8%), substantially higher than among other adults (0.9%). Within the cohort, anti-HCV prevalence was higher among non-Hispanic Blacks (6.4%; 95% CI = 5.3%, 7.7%), persons with injection drug use histories (56.8%; 95% CI = 48.4%, 64.8%), and persons with elevated alanine aminotransferase levels (12.7%; 95% CI = 10.7%, 15.1%). Injection drug use (adjusted odds ratio = 98.4; 95% CI = 58.8, 164.5) was the strongest anti-HCV prevalence predictor. Among anti-HCV-positive persons, 57.8% reported having 2 or more alcoholic drinks daily. CONCLUSIONS: With the high prevalence of HCV among persons born during 1945-1965, the increasing morbidity and mortality associated with HCV, and reductions in liver cancer and HCV-related mortality when HCV is eradicated, it is critically important to identify persons with HCV and link them to appropriate care.

Eradication of hepatitis C virus infection and the development of hepatocellular carcinoma: a meta-analysis of observational studies.

BACKGROUND: Hepatitis C virus (HCV) is a leading cause of hepatocellular carcinoma (HCC). In the United States, this form of cancer occurs in approximately 15 000 persons annually. A systematic review of the evidence is needed to assess the benefits of treatment of HCV-infected persons on development of HCC. PURPOSE: To systematically review observational studies to determine the association between response to HCV therapy and development of HCC among persons at any stage of fibrosis and those with advanced liver disease. DATA SOURCES: MEDLINE, EMBASE, CINAHL, the Cochrane Library, Web of Science, and the Database of Abstracts of Reviews and Effectiveness from inception through February 2012. STUDY SELECTION: English-language observational studies that compared therapy-derived sustained virologic response (SVR) with no response to therapy among HCV-infected persons, targeted an adult population, and had an average follow-up of at least 2 years. DATA EXTRACTION: Two investigators independently extracted data into uniform relative risk measures. The Grading of Recommendations Assessment, Development and Evaluation framework was used to determine the quality of the evidence. DATA SYNTHESIS: Thirty studies fulfilled the inclusion criteria, and 18 provided adjusted effect estimates that were used to calculate pooled relative risks. Among HCV-infected persons, SVR was associated with reduced risk for HCC (relative risk for all persons, 0.24 [95% CI, 0.18 to 0.31], moderate-quality evidence; advanced liver disease hazard ratio, 0.23 [CI, 0.16 to 0.35], moderate-quality evidence). LIMITATION: In the meta-analyses, some variables could not be controlled for because of the observational design of the included studies. CONCLUSION: Sustained virologic response after treatment among HCV-infected persons at any stage of fibrosis is associated with reduced HCC. The evidence was determined to be of moderate quality.

"To share or not to share?" Serosorting by hepatitis C status in the sharing of drug injection equipment among NHBS-IDU2 participants.

BACKGROUND: Persons who inject drugs (PWID) are at high risk for acquiring hepatitis C virus (HCV) infection. The Centers for Disease Control and Prevention estimates there are 17 000 new infections per year, mainly among PWID. This study examines injection equipment serosorting-considering HCV serostatus when deciding whether and with whom to share injection equipment. OBJECTIVE: To examine whether injection equipment serosorting is occurring among PWID in selected cities. METHODS: Using data from the National HIV Behavioral Surveillance System-Injection Drug Users (NHBS-IDU2, 2009), we developed multivariate logistic regression models to examine the extent to which participants' self-reported HCV status is associated with their injection equipment serosorting behavior and knowledge of last injecting partner's HCV status. RESULTS: Participants who knew their HCV status were more likely to know the HCV status of their last injecting partner, compared to those who did not know their status (HCV+: adjusted odds ratio [aOR] 4.1, 95% confidence interval [CI], 3.4-4.9; HCV-: aOR 2.5, 95% CI, 2.0-3.0). Participants who reported being HCV+, relative to those of unknown HCV status, were 5 times more likely to share injection equipment with a partner of HCV-positive status (aOR 4.8, 95% CI, 3.9-6.0). CONCLUSIONS: Our analysis suggests PWID are more likely to share injection equipment with persons of concordant HCV status.

Recommendations for the identification of chronic hepatitis C virus infection among persons born during 1945-1965.

Hepatitis C virus (HCV) is an increasing cause of morbidity and mortality in the United States. Many of the 2.7-3.9 million persons living with HCV infection are unaware they are infected and do not receive care (e.g., education, counseling, and medical monitoring) and treatment. CDC estimates that although persons born during 1945-1965 comprise an estimated 27% of the population, they account for approximately three fourths of all HCV infections in the United States, 73% of HCV-associated mortality, and are at greatest risk for hepatocellular carcinoma and other HCV-related liver disease. With the advent of new therapies that can halt disease progression and provide a virologic cure (i.e., sustained viral clearance following completion of treatment) in most persons, targeted testing and linkage to care for infected persons in this birth cohort is expected to reduce HCV-related morbidity and mortality. CDC is augmenting previous recommendations for HCV testing (CDC. Recommendations for prevention and control of hepatitis C virus (HCV) infection and HCV-related chronic disease. MMWR 1998;47[No. RR-19]) to recommend one-time testing without prior ascertainment of HCV risk for persons born during 1945-1965, a population with a disproportionately high prevalence of HCV infection and related disease. Persons identified as having HCV infection should receive a brief screening for alcohol use and intervention as clinically indicated, followed by referral to appropriate care for HCV infection and related conditions. These recommendations do not replace previous guidelines for HCV testing that are based on known risk factors and clinical indications. Rather, they define an additional target population for testing: persons born during 1945-1965. CDC developed these recommendations with the assistance of a work group representing diverse expertise and perspectives. The recommendations are informed by the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) framework, an approach that provides guidance and tools to define the research questions, conduct the systematic review, assess the overall quality of the evidence, and determine strength of the recommendations. This report is intended to serve as a resource for health-care professionals, public health officials, and organizations involved in the development, implementation, and evaluation of prevention and clinical services. These recommendations will be reviewed every 5 years and updated to include advances in the published evidence.

Hepatitis C virus testing of persons born during 1945-1965: recommendations from the Centers for Disease Control and Prevention.

DESCRIPTION: The Centers for Disease Control and Prevention (CDC) and a group of governmental and private sector partners developed these evidence-based recommendations to increase the proportion of hepatitis C virus (HCV)-infected persons who know their status and are linked to appropriate care and treatment. The recommendations also address brief alcohol screening, as alcohol accelerates progression of liver disease among HCV-infected individuals. These recommendations augment CDC's 1998 and 1999 recommendations based on risk and medical indications and are not meant to replace those recommendations. METHODS: These recommendations are based on systematic reviews of evidence published from 1995 through February 2012 in MEDLINE, EMBASE, CINAHL, the Cochrane Central Register of Controlled Trials, Sociological Abstracts, and Database of Abstracts of Reviews of Effects. Selected studies included cross-sectional and cohort studies that addressed either prevalence of hepatitis C in the United States or clinical outcomes (for example, hepatocellular carcinoma and serious adverse events) among treated patients and systematic reviews of trials that assessed effectiveness of brief screening interventions for alcohol consumption. The Grading of Recommendations Assessment, Development, and Evaluation framework was used to assess quality of the evidence. RECOMMENDATION 1: Adults born during 1945-1965 should receive 1-time testing for HCV without prior ascertainment of HCV risk. (Grade: strong recommendation; moderate-quality evidence). RECOMMENDATION 2: All persons with identified HCV infection should receive a brief alcohol screening and intervention as clinically indicated, followed by referral to appropriate care and treatment services for HCV infection and related conditions (Grade: strong recommendation; moderate-quality evidence).

The cost-effectiveness of birth-cohort screening for hepatitis C antibody in U.S. primary care settings.

BACKGROUND: In the United States, hepatitis C virus (HCV) infection is most prevalent among adults born from 1945 through 1965, and approximately 50% to 75% of infected adults are unaware of their infection. OBJECTIVE: To estimate the cost-effectiveness of birth-cohort screening. DESIGN: Cost-effectiveness simulation. DATA SOURCES: National Health and Nutrition Examination Survey, U.S. Census, Medicare reimbursement schedule, and published sources. TARGET POPULATION: Adults born from 1945 through 1965 with 1 or more visits to a primary care provider annually. TIME HORIZON: Lifetime. PERSPECTIVE: Societal, health care. INTERVENTION: One-time antibody test of 1945-1965 birth cohort. OUTCOME MEASURES: Numbers of cases that were identified and treated and that achieved a sustained viral response; liver disease and death from HCV; medical and productivity costs; quality-adjusted life-years (QALYs); incremental cost-effectiveness ratio (ICER). RESULTS OF BASE-CASE ANALYSIS: Compared with the status quo, birth-cohort screening identified 808,580 additional cases of chronic HCV infection at a screening cost of $2874 per case identified. Assuming that birth-cohort screening was followed by pegylated interferon and ribavirin (PEG-IFN+R) for treated patients, screening increased QALYs by 348,800 and costs by $5.5 billion, for an ICER of $15,700 per QALY gained. Assuming that birth-cohort screening was followed by direct-acting antiviral plus PEG-IFN+R treatment for treated patients, screening increased QALYs by 532,200 and costs by $19.0 billion, for an ICER of $35,700 per QALY saved. RESULTS OF SENSITIVITY ANALYSIS: The ICER of birth-cohort screening was most sensitive to sustained viral response of antiviral therapy, the cost of therapy, the discount rate, and the QALY losses assigned to disease states. LIMITATION: Empirical data on screening and direct-acting antiviral treatment in real-world clinical settings are scarce. CONCLUSION: Birth-cohort screening for HCV in primary care settings was cost-effective. PRIMARY FUNDING SOURCE: Division of Viral Hepatitis, Centers for Disease Control and Prevention.

Centers for Disease Control and Prevention initiatives to prevent hepatitis C virus infection: a selective update.

Hepatitis C virus (HCV) infection is a complex public health problem, characterized by a high prevalence of chronic infection, an increasing burden of HCV-associated disease, low rates of testing and treatment, and the prospect of increasing incidence associated with the epidemic of injection drug use. Three-quarters of chronic HCV infections occur among persons born from 1945 through 1965. Prevention efforts are complicated by limited knowledge among health care professionals, persons at risk and in the public at large. At the Centers for Disease Control and Prevention, efforts to improve primary and secondary prevention effectiveness center on policy development, education and training initiatives, and applied research. This report provides a brief overview of some of these efforts, including the development of testing recommendations for the 1945-1965 birth cohort, research and evaluation studies in settings where persons who inject drugs receive services, and a national viral hepatitis education campaign that targets health care professionals, the public, and persons at risk.

Low rates of hepatitis screening and vaccination of HIV-infected MSM in HIV clinics.

BACKGROUND: HIV-infected men who have sex with men (MSM) are at increased risk of viral hepatitis because of similar behavioral risk factors for acquisition of these infections. Our objective was to estimate adherence to HIV management guidelines that recommend screening HIV-infected persons for hepatitis A, B, and C infection, and vaccinating for hepatitis A and B if susceptible. METHODS: We evaluated hepatitis prevention services received by a random sample of HIV-infected MSM in 8 HIV clinics in 6 US cities. We abstracted medical records of all visits made by the patients to the clinic during the period from 2004 to 2007, to estimate hepatitis screening and vaccination rates overall and by clinic site. RESULTS: Medical records of 1329 patients who had 14,831 visits from 2004 to 2006 were abstracted. Screening rates for hepatitis A, B, and C were 47%, 52%, and 54%, respectively. Among patients who were screened and found to be susceptible, 29% were vaccinated for hepatitis A and 25% for hepatitis B. The percentage of patients screened and vaccinated varied significantly by clinic. CONCLUSIONS: Awareness of hepatitis susceptibility and hepatitis coinfection status in HIV-infected patients is essential for optimal clinical management. Despite recommendations for hepatitis screening and vaccination of HIV-infected MSM, rates were suboptimal at all clinic sites. These low rates highlight the importance of routine review of adherence to recommended clinical services. Such reviews can prompt the development and implementation of simple and sustainable interventions to improve the quality of care.

Effectiveness of a risk screener in identifying hepatitis C virus in a primary care setting.

OBJECTIVES: We evaluated an intervention designed to identify patients at risk for hepatitis C virus (HCV) through a risk screener used by primary care providers. METHODS: A clinical reminder sticker prompted physicians at 3 urban clinics to screen patients for 12 risk factors and order HCV testing if any risks were present. Risk factor data were collected from the sticker; demographic and testing data were extracted from electronic medical records. We used the t test, χ(2) test, and rank-sum test to compare patients who had and had not been screened and developed an analytic model to identify the incremental value of each element of the screener. RESULTS: Among screened patients, 27.8% (n = 902) were identified as having at least 1 risk factor. Of screened patients with risk factors, 55.4% (n = 500) were tested for HCV. Our analysis showed that 7 elements (injection drug use, intranasal drug use, elevated alanine aminotransferase, transfusions before 1992, ≥ 20 lifetime sex partners, maternal HCV, existing liver disease) accounted for all HCV infections identified. CONCLUSIONS: A brief risk screener with a paper-based clinical reminder was effective in increasing HCV testing in a primary care setting.