Evidence map›Paper›PMID 21769136›Full record

Trial reportThe American journal of gastroenterology2011

A randomized controlled trial of an integrated care intervention to increase eligibility for chronic hepatitis C treatment.

Donna M Evon, Kelly Simpson, Scott Kixmiller, Joseph Galanko, Karen Dougherty, Carol Golin, Michael W Fried

Abstract readRandomized Controlled Trial
In one paragraph

Trial report in The American journal of gastroenterology, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 33 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
33citing papers in PubMed, 3 pooled it
3.9field-weighted citation impact, top 6% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

33 citing papers in PubMed, 3 syntheses or guidelines pooled it, 70 citations in OpenAlex.

  1. Guideline
  2. Pooled it
  3. Pooled it
  4. Article
  5. Article
  6. History of alcohol use does not predict HCV direct acting antiviral treatment outcomes.Journal of the Association of Medical Microbiology and Infectious Disease Canada = Journal officiel de l'Association pour la microbiologie medicale et l'infectiologie Canada · 2022
    Article
  7. Review
  8. Article
  9. Hepatitis C elimination among people who inject drugs: Challenges and recommendations for action within a health systems framework.Liver international : official journal of the International Association for the Study of the Liver · 2019
    Review
  10. Article
  11. Article
  12. Integrating Care for Patients With Chronic Liver Disease and Mental Health and Substance Use Disorders.Federal practitioner : for the health care professionals of the VA, DoD, and PHS · 2018
    Article
  13. Observational
  14. Review
  15. Article
  16. Article
  17. Review
  18. Article
  19. Review
  20. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors at 2 institutions in 1 country.

Donna M EvonDivision of Gastroenterology and Hepatology, UNC School of Medicine, University of North Carolina at Chapel Hill, 27599, USA. donna_evon@med.unc.edu
Kelly Simpson
Scott Kixmiller
Joseph Galanko
Karen Dougherty
Carol Golin
Michael W Fried
University of North Carolina at Chapel Hill · USUniversity of North Carolina Health Care · US

Funding

Virology, Immunology, and Microbiology CoreP30AI050410 · NIAID · UNIV OF NORTH CAROLINA CHAPEL HILL · PI DAVID M. MARGOLIS · 2001 to 2026
$76.9M
Zonisamide in Patients with Neuropathic Pain Associated with Diabetic NeuropathyM01RR000046 · NCRR · UNIV OF NORTH CAROLINA CHAPEL HILL · PI JOY, MELANIE S · 1985 to 2008
$38.5M
PILOT AND FEASIBILITY STUDIESP30DK034987 · NIDDK · UNIV OF NORTH CAROLINA CHAPEL HILL · PI ROBERT S. SANDLER · 1985 to 2026
$30.5M
UNC Clinical Translation Science Award-K12 Scholars Program (KL2)KL2RR025746 · NCRR · UNIV OF NORTH CAROLINA CHAPEL HILL · PI RUNGE, MARSCHALL S. · 2008 to 2011
$9.0M
North Carolina Translational & Clinical Sciences Institute (NC TraCS)KL2TR001109 · NCATS · UNIV OF NORTH CAROLINA CHAPEL HILL · PI BUSE, JOHN BERNARD, CAREY, TIMOTHY S · 2013 to 2017
$5.7M
Mentoring Junior Faculty: Viral hepatitis Clinical ResearchK24DK066144 · NIDDK · UNIV OF NORTH CAROLINA CHAPEL HILL · PI FRIED, MICHAEL W · 2004 to 2014
$1.5M
Mentoring Junior Investigators: Comprehensive HIV PreventionK24HD069204 · NICHD · UNIV OF NORTH CAROLINA CHAPEL HILL · PI GOLIN, CAROL E · 2013 to 2017
$789k
An Adherence and Depression Intervention for Patients During Hepatitis C TherapyK23DK089004 · NIDDK · UNIV OF NORTH CAROLINA CHAPEL HILL · PI EVON, DONNA MARIE · 2010 to 2013
$533k
NCATS NIH HHS KL2 TR001109NCRR NIH HHS KL2 RR025746NCRR NIH HHS KL2RR025746NCRR NIH HHS M01 RR000046NCRR NIH HHS M01 RR00046NIAID NIH HHS P30 AI050410NIAID NIH HHS P30-AI50410NICHD NIH HHS K24 HD069204NIDDK NIH HHS DK34987NIDDK NIH HHS K23 DK089004NIDDK NIH HHS K24 DK066144NIDDK NIH HHS K24 DK066144-01NIDDK NIH HHS L30 DK084885NIDDK NIH HHS P30 DK034987
6 · The paper itself

Abstract

objectivesMental health and substance abuse (MH/SA) comorbidities are the most oft-cited reasons for deferral from peginterferon (PegIFN) therapy for chronic hepatitis C virus (HCV). We sought to determine whether an integrated care intervention (INT) for patients deferred from PegIFN owing to MH/SA could improve subsequent treatment eligibility rates.

methodsIn this randomized controlled trial, 101 HCV patients who were evaluated at two hepatology centers and deferred from antiviral therapy owing to MH/SA were enrolled. Participants were randomized to an INT (N=50) or standard of care (SC; N=51). The INT group received counseling and case management for up to 9 months. All participants underwent 3-, 6-, and 9-month clinical follow-up visits, where hepatologists, masked to group, re-evaluated patients for treatment eligibility. Standardized mood and alcohol use instruments were administered to all participants to aid clinicians in treatment decisions.

resultsOf 101 participants, the mean age was 48 years and 50% were men, 61% Caucasian, and 77% genotype 1. Patients were initially deferred owing to psychiatric issues (35%), alcohol abuse (31%), drug abuse (9%), or more than one of these reasons (26%). In an intent-to-treat analysis, 42% (21/50) of INT participants became eligible for therapy compared to 18% (9/51) of SC participants (P=0.009, relative risk (RR)=2.38, 95% confidence interval (CI) (1.21, 4.68)). When baseline predictors significant at P<0.10 in univariate models were entered into multivariate models adjusted for treatment group, only baseline depression remained significant (P=0.05, RR=0.98, 95% CI (0.96, 1.00)). With the exception of a model adjusted for genotype, treatment group remained significant in all models.

conclusionsThis trial suggests that INTs can increase eligibility for HCV treatment and expand treatment to the underserved population with MH/SA comorbidities.

Indexed as

AdultAntiviral AgentsComorbidityDelivery of Health Care, IntegratedEligibility DeterminationFemaleHepatitis C, ChronicHumansInterferon-alphaLogistic ModelsMaleMental DisordersMiddle AgedMultivariate AnalysisPolyethylene GlycolsPredictive Value of TestsAntiviral AgentsInterferon-alphapeginterferon alfa-2aPolyethylene GlycolsRecombinant Proteins

Identifiers

PMID21769136
PMCPMC3683982
OpenAlexW1968691835

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.