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  • This publication is provided for historical reference only and the information may be out of date.

This publication is provided for historical reference only and the information may be out of date.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 FOverall Strength of Evidence: Summary of Grading Domains

Key QuestionNumber of StudiesQuality (Good, Fair, Poor)Consistency (High, Moderate, Low)Directness (Direct or indirect)Precision (High, Moderate, Low)Number of SubjectsStrength of Evidence
1a. Does screening for 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?No studiesNo studiesNo studiesNo studiesNo studiesNo studiesInsufficient
1b. Does screening for HCV infection during pregnancy reduce vertical transmission of HCV or improve mortality or morbidity for the mother or child?No studiesNo studiesNo studiesNo studiesNo studiesNo studiesInsufficient
2a. What is the effectiveness of different risk- or prevalence-based methods for screening for HCV infection on clinical outcomes?No studiesNo studiesNo studiesNo studiesNo studiesNo studiesInsufficient
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?5 studies (4 cross-sectional, one case-control)PoorHighDirectHigh8,044Low
3. What are the harms associated with screening for HCV infection, including adverse effects such as anxiety, labeling, and impact on relationships?5 (1 cross-sectional, 3 intervention series and 1 Controlled Trial)PoorUnable to assess (assessed different outcomes)DirectLow288Insufficient
4a. What is the comparative effectiveness and comparative diagnostic accuracy of various tests and strategies for the work-up to guide treatment decisions in patients who are HCV positive?a
Clinical outcomes1 cohort studyFairUnable to assess (one study)DirectLow156Insufficient
Diagnostic accuracy: Platelet counts vs. liver biopsy15 studies of diagnostic accuracyFairModerateDirectLow2,836 (AUROC for fibrosis) and 2,311 (AUROC for cirrhosis)Low
Diagnostic accuracy: Age-platelet index vs. liver biopsy6 studies of diagnostic accuracyFairHighDirectModerate1,121 (AUROC for fibrosis) and 1,113 (AUROC for cirrhosis)Moderate
Diagnostic accuracy: APRI vs. liver biopsy58 studies of diagnostic accuracyFairHighDirectHigh13,999 (AUROC for fibrosis) and 13,077 (AUROC for cirrhosis)High
Diagnostic accuracy: AAR vs. liver biopsy27 studies of diagnostic accuracyFairHighDirectHigh3,798 (AUROC for fibrosis) and 3,708 (AUROC for cirrhosis)High
Diagnostic accuracy: CDS (also Bonacini Index) vs. liver biopsy8 studies of diagnostic accuracyFairHighDirectModerate1,139(AUROC for fibrosis) and 1,991 (AUROC for cirrhosis)Moderate
Diagnostic accuracy: ELF or Simplified ELF vs. liver biopsy7 studies of diagnostic accuracyFairHighDirectModerate1,217 (AUROC for fibrosis) and 754 (AUROC for cirrhosis)Moderate
Diagnostic accuracy: FIB-4 vs. liver biopsy15 studies of diagnostic accuracyFairHigh (two studies)DirectModerate4,227(AUROC for severe fibrosis)Moderate
Diagnostic accuracy: FibroIndex vs. liver biopsy4 studies of diagnostic accuracyFairHighDirectLow803 (AUROC for fibrosis) and 803 (AUROC for cirrhosis)Moderate
Diagnostic accuracy: Fibrometer vs. liver biopsy8 studies of diagnostic accuracyFairHighDirectModerate2,667 (AUROC for fibrosis) and 3,729 (AUROC for cirrhosis)Moderate
Diagnostic accuracy: FibroSpect II vs. liver biopsy4 studies of diagnostic accuracyFairHighDirectLow590 (AUROC for fibrosis) and 108 (AUROC for cirrhosis)Low
Diagnostic accuracy: Fibrotest vs. liver biopsy28 studies of diagnostic accuracyFairHighDirectHigh8,272 (AUROC for fibrosis) and 6,516 (AUROC for cirrhosis)High
Diagnostic accuracy: Forns’ Index vs. liver biopsy16 studies of diagnostic accuracyFairHighDirectHigh5,867 (AUROC for fibrosis) and 4,128 (AUROC for cirrhosis)High
Diagnostic accuracy: Hepascore vs. liver biopsy11 studies of diagnostic accuracyFairHighDirectHigh3,787 (AUROC for fibrosis) and 3,437 (AUROC for cirrhosis)High
Diagnostic accuracy: Lok Index vs. liver biopsy8 studies of diagnostic accuracyFairHighDirectModerate3,215 (AUROC for cirrhosis)Moderate
Diagnostic accuracy: Pohl Index vs. liver biopsy10 studies of diagnostic accuracyFairHigh (two studies)DirectLow490 (AUROC for fibrosis) and 718 (AUROC for fibrosis)Low
APRI vs. Fibrotest16 studies of diagnostic accuracyFairHighDirectModerate6,399(excluding overlapping populations)Moderate
AST/ALT ratio vs. other indices14 studies of diagnostic accuracyFairHighDirectModerate3,991Moderate
4b. What proportion of patients with screen-detected HCV infection receives treatment?3 intervention seriesFairHighDirectModerate18,580Moderate
5. What are the harms associated with the work-up for guiding treatment decisions?6 intervention series (1 of patients specifically undergoing liver biopsy for evaluation of HCV infection)FairHighDirectHigh88,587Moderate
6a. How effective is counseling or immunizations of patients with HCV infection at improving health outcomes or reducing the spread of HCV?1 randomized controlled trialFairUnable to assess (one study)DirectLow137Insufficient
6b. Does becoming aware of positive HCV infection status decrease high risk behaviors?5 (2 prospective before-after studies, 3 retrospective post-intervention series)FairModerateDirectModerate1,660Low
6c. How effective is counseling or immunizations of patients with HCV infection at improving intermediate outcomes, including change in high risk behaviors?4 (2 RCTs, 2 before-after studies)FairHighDirectLow1,369Insufficient
7. Do any interventions decrease or increase the vertical transmission of HCV during delivery or in the perinatal period?
Elective cesarean vs. vaginal delivery4 cohort studiesFairModerateDirectLow2,080Low
Any cesarean vs. vaginal delivery11 cohort studiesFairHighDirectLow2,308Moderate
Internal fetal monitoring vs. no internal fetal monitoring3 cohort studiesFairModerateDirectLow928Insufficient
Prolonged rupture of membranes vs. less prolonged rupture of membranes2 cohort studiesFairHighDirectLow245Low
Breastfeeding vs. no breastfeeding14 cohort studiesFairHighDirectHigh2,971Moderate

Abbreviations: APRI, aspartate transaminase-platelet ratio index; AAR, aspartate transaminase-alanine transaminase ratio; CDS, Cirrhosis Discriminant Score; ELF, Enhanced Liver Fibrosis Index; HCV, hepatitis C virus.

a

Not all studies of diagnostic accuracy reported the area under the receiver operating curve (AUROC). Sensitivity and specificity at different cutoffs are summarized in the Results.

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