Evidence map›Paper›PMID 31943262›Full record

ArticleAlimentary pharmacology & therapeutics2020

Patient-reported outcomes in a large North American cohort living with chronic hepatitis B virus: a cross-sectional analysis.

Donna M Evon, Hsing-Hua S Lin, Mandana Khalili, Robert J Fontana, Colina Yim, Abdus S Wahed, Michael W Fried, Jay H Hoofnagle, Hepatitis B Research Network (HBRN)

Registry-linked trialOpen access · bronzeAbstract read
In one paragraph

Article in Alimentary pharmacology & therapeutics, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01263587 (Observational Study of Persons With Hepatitis B Virus Infection in North America), which is not on this map. Cited by 15 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
15citing papers in PubMed, 1 pooled it
1.5field-weighted citation impact, top 18% 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.

NCT01263587 completednot on this map

Observational Study of Persons With Hepatitis B Virus Infection in North America (Cohort Study)

TypeobservationalSponsorUniversity of PittsburghRan2010 to 2021Enrolled2,051ConditionsHepatitis B
3 · Its place in the literature

Who cites it

15 citing papers in PubMed, 1 synthesis or guideline pooled it, 16 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Article
  4. Observational
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  6. Observational
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  11. Review
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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

9 authors at 6 institutions in 2 countries.

Donna M EvonDepartment of Medicine, University of North Carolina, Chapel Hill, NC, USA.ORCID 0000-0002-1414-1846
Hsing-Hua S LinDepartments of Epidemiology and Biostatistics, University of Pittsburgh, Pittsburgh, PA, USA.
Mandana KhaliliDepartment of Medicine, University of California, San Francisco, CA, USA.ORCID 0000-0001-9178-9139
Robert J FontanaDepartment of Internal Medicine, University of Michigan, Ann Arbor, MI, USA.
Colina YimToronto Centre for Liver Disease, University of Toronto, Toronto, Canada.
Abdus S WahedDepartments of Epidemiology and Biostatistics, University of Pittsburgh, Pittsburgh, PA, USA.
Michael W FriedDepartment of Medicine, University of North Carolina, Chapel Hill, NC, USA.
Jay H HoofnagleLiver Disease Research Branch, NIDDK, NIH, Bethesda, MD, USA.
Hepatitis B Research Network (HBRN)
University of North Carolina at Chapel Hill · USUniversity of Pittsburgh · USNational Institutes of Health · USUniversity of California, San Francisco · USUniversity of Michigan · USUniversity of Toronto · CA

Funding

Engaging University of California Stakeholders for Biorespository ResearchUL1TR000004 · NCATS · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI GRANDIS, JENNIFER RUBIN · 2012 to 2015
$78.0M
MICHIGAN INSTITUTE FOR CLINICAL AND HEALTH RESEARCH (MICHR) (UL1): (BPCA)UL1RR024986 · NCRR · UNIVERSITY OF MICHIGAN AT ANN ARBOR · PI SHANLEY, THOMAS P. · 2007 to 2011
$51.2M
Re-Entry Supplement: Investigation of Oral Microbial Enzymes for the Detection and Treatment of Periodontal DiseaseUL1TR002489 · NCATS · UNIV OF NORTH CAROLINA CHAPEL HILL · PI BUSE, JOHN BERNARD, SHAHEEN, NICHOLAS J · 2018 to 2022
$48.6M
North Carolina Translational & Clinical Sciences Institute (NC TraCS)UL1TR001111 · NCATS · UNIV OF NORTH CAROLINA CHAPEL HILL · PI BUSE, JOHN BERNARD, CAREY, TIMOTHY S · 2013 to 2017
$43.9M
TRANSGENIC AND CHIMERIC MOUSE COREP30DK050306 · NIDDK · UNIVERSITY OF PENNSYLVANIA · PI Ken Hashigiwa Cadwell · 1997 to 2026
$32.5M
Hepatitis B Research Network - Data Coordination CenterU01DK082864 · NIDDK · UNIVERSITY OF PITTSBURGH AT PITTSBURGH · PI BELLE, STEVEN H. · 2008 to 2019
$25.3M
ZDV VS ZDV + DDL VS ZDV + DDL + NVP IN ASYMPTOMATIC HIV PATIENTSM01RR000040 · NCRR · UNIVERSITY OF PENNSYLVANIA · PI FITZGERALD, GARRET A · 1985 to 2006
$21.1M
Center for Clinical and Translational ResearchUL1TR000058 · NCATS · VIRGINIA COMMONWEALTH UNIVERSITY · PI MOELLER, FREDERICK GERARD · 2012 to 2015
$12.5M
Hepatitis B Research Network (HBRN): Natural History and Treatment StudiesU01DK082944 · NIDDK · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI COOPER, STEWART, KHALILI, MANDANA · 2008 to 2019
$10.0M
Observation Study of Persons with Chronic Hepatitis B Virus infection in North AmericaU01DK082874 · NIDDK · UNIVERSITY HEALTH NETWORK · PI JANSSEN, HARRY · 2008 to 2019
$6.9M
Harvard Hepatitis B ConsortiumU01DK082919 · NIDDK · BETH ISRAEL DEACONESS MEDICAL CENTER · PI CHUNG, RAYMOND T, LAU, DARYL T · 2008 to 2019
$4.7M
Midwest Hepatitis B ConsortiumU01DK082871 · NIDDK · SAINT LOUIS UNIVERSITY · PI DI BISCEGLIE, ADRIAN MICHAEL · 2008 to 2019
$4.7M
NCATS NIH HHS UL1 TR000004NCATS NIH HHS UL1 TR000058NCATS NIH HHS UL1 TR001111NCATS NIH HHS UL1 TR002489NCRR NIH HHS M01 RR000040NCRR NIH HHS UL1 RR024986NIAAA NIH HHS K24 AA022523NIDDK NIH HHS A-DK-3002-001NIDDK NIH HHS P30 DK050306NIDDK NIH HHS U01 DK082843NIDDK NIH HHS U01 DK082863NIDDK NIH HHS U01 DK082864NIDDK NIH HHS U01 DK082866NIDDK NIH HHS U01 DK082867NIDDK NIH HHS U01 DK082871NIDDK NIH HHS U01 DK082872NIDDK NIH HHS U01 DK082874NIDDK NIH HHS U01 DK082919NIDDK NIH HHS U01 DK082923NIDDK NIH HHS U01 DK082927NIDDK NIH HHS U01 DK082943NIDDK NIH HHS U01 DK082944NIDDK NIH HHS U54TR001959NIDDK NIH HHS UL1TR000004
6 · The paper itself

Abstract

backgroundPatient-reported outcomes (PROs) such as health-related quality of life (HRQoL) and symptoms associated with chronic hepatitis B viral (HBV) infection have not been well-described in North American cohorts.

aimsTo evaluate several PROs and associations with HBV disease activity markers.

methodsCross-sectional analysis including 876 adults who completed PRO measures during the Hepatitis B Research Network Adult Cohort Study. Participants on HBV treatment were excluded. Outcomes included: HRQoL using the SF-36 mental component summary and physical component summary scores; symptom burden using a 10-item Total Symptom Checklist and fatigue using an instrument from the Patient-Reported Outcomes Measurement Information System®. Covariates included laboratory markers of disease severity, virological status, comorbidities and medications.

resultsMedian age was 42 (range: 19-79), 51% were female, 73% Asian, 19% HBeAg (+), 2% had AST-platelet ratio index (APRI) ≥1.5 and 74% without comorbidities. Mean mental component summary T-score = 52, physical component summary T-score = 54 and PROMIS Fatigue T-score = 47. On a scale from 0 (none) to 40 (extreme), the mean Symptom Checklist score = 3 and 25% reported no symptoms. The most frequent symptoms were fatigue (60%), irritability (32%) and itching (32%). Most symptoms were 'a little bit' bothersome. In multivariable regressions, APRI ≥1.50 and more comorbidities were associated with worse patient-reported outcomes; virological markers were not. Adding the Total Symptom Checklist score to original regression models increased explanation of variation in the mental component summary score from 4% to 44% and the Physical Component Summary Score from 17% to 34%.

conclusionsUntreated North American HBV patients with mild liver disease report favourable health-related quality of life and minimal symptoms. HBV does not impact health-related quality of life unless advanced liver disease or comorbidities are present. High symptom burden explains substantial variation in health-related quality of life. (CT.gov identifier: NCT01263587).

Indexed as

Patient Reported Outcome MeasuresQuality of LifeAdultAgedCanadaCohort StudiesComorbidityCross-Sectional StudiesFemaleHepatitis B, ChronicHumansMaleMiddle AgedNorth AmericaUnited StatesYoung Adultfatiguefunctioningliverquality of lifeSF-36symptom

Identifiers

PMID31943262
PMCPMC6989387
OpenAlexW3000711104

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Registered trials

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.