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Chou R, Cottrell EB, Wasson N, et al. Screening for Hepatitis C Virus Infection in Adults [Internet]. Rockville (MD): Agency for Healthcare Research and Quality (US); 2012 Nov. (Comparative Effectiveness Reviews, No. 69.)

  • This publication is provided for historical reference only and the information may be out of date.

This publication is provided for historical reference only and the information may be out of date.

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Screening for Hepatitis C Virus Infection in Adults [Internet].

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Appendix BHepatitis C Screening: Inclusion Criteria by Key Question

All Key QuestionsInclusion Criteria
 PopulationsAsymptomatic adults and pregnant women without known liver function test abnormalities
 SettingsFor screening studies, primary care, or other settings generalizable to primary care (e.g., family planning clinics, school-based health clinics), other settings in which screening is commonly performed (e.g., emergency room or urgent care). Focus on studies conducted in the U.S. and other developed countries.
 Study designsRandomized controlled trials and cohort studies (all KQ’s), studies of diagnostic accuracy (KQ 2b, 4a), before-after studies (KQ’s 3, 4b, 5, 6a, 6b, 6c, and 7), and cross sectional studies (KQ’s 2a, 2b, 6b)
ScreeningKQ 1a. Does screening for hepatitis C virus (HCV) infection in non pregnant adults without known abnormal liver function tests reduce mortality and morbidity due to HCV infection, affect quality of life, or reduce incidence of HCV infection?
KQ 1b. Does screening for HCV infection during pregnancy reduce vertical transmission of HCV or improve mortality or morbidity for the mother or child?
KQ 2a. What is the effectiveness of different risk- or prevalence-based methods for screening for HCV infection on clinical outcomes?
KQ 2b. What is the sensitivity and number needed to screen to identify one case of HCV infection of different risk- or prevalence-based methods for screening for HCV infection?
KQ 3. What are the harms associated with screening for HCV infection, including adverse effects such as anxiety, labeling, and impact on relationships?
 InterventionsHCV antibody testing
 OutcomesKQs 1a, 1b, and 2: Intermediate outcomes: sustained virological response rates, histological improvements, behavioral changes to improve health outcomes, and reduce HCV transmission. Clinical outcomes: mortality due to HCV infection, morbidity due to HCV infection including hepatic cirrhosis, hepato-cellular carcinoma, rate of liver transplantation, and quality of life.
KQ 1b: Mother-to-child transmission rates of HC.
KQ 3: Anxiety; labeling; partner discord, abuse, or violence.
 ComparisonsKQs 1a, 1b, and 3: HCV screening vs. no screening.
KQ 2: Comparisons of different screening strategies.
WorkupKQ 4a. What is the comparative effectiveness and comparative diagnostic accuracy of various tests and strategies for the workup to guide treatment decisions in patients who are HCV positive?
KQ 4b. What proportion of patients with screen-detected HCV infection receives treatment?
KQ 5. What are the harms associated with the workup for guiding treatment decisions?
 PopulationsKQ 4b and 5: Persons with screen-detected HCV infection.
 InterventionsKQ 4a and 5: Liver biopsy, laboratory tests, imaging tests.
 ComparisonsKQ 4a and 5: Comparisons of different workup strategies and different tests to diagnose fibrosis or cirrhosis.
 OutcomesKQ 4a: Diagnostic accuracy, clinical outcomes (see KQs 1a, 1b, and 2).
KQ 4b: Proportion who receives treatment.
KQ 5: Bleeding, infection, other complications
InterventionsKQ 6a. How effective is counseling or immunizations of patients with HCV infection at improving health outcomes or reducing the spread of HCV?
KQ 6b. Does becoming aware of positive HCV infection status decrease high risk behaviors?
KQ 6c. How effective is counseling or immunizations of patients with HCV infection at improving intermediate outcomes, including change in high risk behaviors?
KQ 7. Do any interventions decrease or increase the vertical transmission of HCV during delivery or in the perinatal period?
 PopulationsKQ 6a, 6b, 7: Persons with chronic HCV infection
 InterventionsKQ 6a and 6b: Counseling on risky behaviors or alcohol use and immunizations for HAV and HBV infection.
KQ 7: Labor management or delivery practices and breast feeding.
 ComparisonsKQ 6a and 6b: Counseling or immunizations vs. no intervention.
KQ 7: Comparisons of different labor and delivery practices; breast feeding vs. no breast feeding.
 OutcomesKQ 6a, 6b: See KQs 1a, 1b, and 2.
KQ 7: See KQ 1b.

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