Evidence map›Paper›PMID 29377191›Full record

ArticleAlimentary pharmacology & therapeutics2018

Psychometric properties of the PROMIS short form measures in a U.S. cohort of 961 patients with chronic hepatitis C prescribed direct acting antiviral therapy.

D M Evon, J Amador, P Stewart, B B Reeve, A S Lok, R K Sterling, A M Di Bisceglie, N Reau, M Serper, S Sarkar and 3 more

Open access · bronzeAbstract readValidation Study
In one paragraph

Article in Alimentary pharmacology & therapeutics, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed
1.3field-weighted citation impact, top 19% 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

11 citing papers in PubMed, 24 citations in OpenAlex.

  1. Trial
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  8. Patient-reported outcomes 12 months after hepatitis C treatment with direct-acting antivirals: Results from the PROP UP study.Liver international : official journal of the International Association for the Study of the Liver · 2021
    Observational
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  11. Observational
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

13 authors at 9 institutions in 1 country.

D M EvonDivision of Gastroenterology and Hepatology, University of North Carolina, Chapel Hill, USA.ORCID 0000-0002-1414-1846
J AmadorDepartment of Biostatistics, University of North Carolina, Chapel Hill, USA.
P StewartDepartment of Biostatistics, University of North Carolina, Chapel Hill, USA.
B B ReeveDepartment of Population Health Sciences, Duke University, Durham, USA.
A S LokDivision of Gastroenterology and Hepatology, University of Michigan, Ann Arbor, USA.
R K SterlingDivision of Gastroenterology, Hepatology, and Nutrition Virginia Commonwealth University, Richmond, USA.
A M Di BisceglieDepartment of Internal Medicine, Saint Louis University, St Louis, USA.
N ReauDepartment of Internal Medicine, Rush Medical Center, Chicago, USA.
M SerperDepartment of Medicine, University of Pennsylvania, Philadelphia, USA.ORCID 0000-0003-4899-2160
S SarkarDepartment of Internal Medicine, University of California, Davis, USA.ORCID 0000-0002-9358-4257
J K LimDepartment of Internal Medicine, Yale University, New Haven, USA.ORCID 0000-0003-1126-8128
C E GolinDivision of General Medicine and Clinical Epidemiology, University of North Carolina, Chapel Hill, USA.
M W FriedDivision of Gastroenterology and Hepatology, University of North Carolina, Chapel Hill, USA.
University of North Carolina at Chapel Hill · USDuke University · USRush University Medical Center · USSaint Louis University · USUniversity of California, Davis · USUniversity of Michigan · USUniversity of Pennsylvania · USVirginia Commonwealth University · USYale University · US

Funding

Virology, Immunology, and Microbiology CoreP30AI050410 · NIAID · UNIV OF NORTH CAROLINA CHAPEL HILL · PI DAVID M. MARGOLIS · 2001 to 2026
$76.9M
PILOT AND FEASIBILITY STUDIESP30DK034987 · NIDDK · UNIV OF NORTH CAROLINA CHAPEL HILL · PI Temitope O. Keku · 1985 to 2026
$30.5M
Mentoring Junior Investigators: Comprehensive HIV PreventionK24HD069204 · NICHD · UNIV OF NORTH CAROLINA CHAPEL HILL · PI GOLIN, CAROL E · 2013 to 2017
$789k
NIAID NIH HHS P30 AI050410NICHD NIH HHS K24 HD069204NIDDK NIH HHS P30 DK034987
6 · The paper itself

Abstract

backgroundTo better understand symptoms experienced by patients infected with chronic hepatitis C virus (HCV), valid and reliable patient-reported outcome (PRO) measures are needed.

aimTo assess the reliability and validity of 10 patient-reported outcomes measurement information system (PROMIS) measures and the Headache Impact Test-6 (HIT-6) in a large national sample of patients with HCV.

methodsPre-treatment data from 961 patients with HCV starting direct acting antiviral therapy at 11 U.S. liver centers were analyzed. Internal reliability was evaluated using Cronbach's alpha coefficient; frequency distributions were examined for floor and ceiling effects; structural validity was investigated via item-response-theory models; convergent validity was evaluated using correlations with theoretically-similar items from the HCV-PRO and memorial symptom assessment scale (MSAS); and known-groups validity was investigated by observing PRO differences by liver disease status and number of comorbidities.

resultsThe HIT-6 and the majority of the PROMIS measures yielded excellent reliability (alphas ≥ 0.87). Ceiling effects were infrequent ( < 4%), while 30%-59% of patients reported no symptoms (floor effects). The data supported structural validity of the HIT-6 and most PROMIS measures. The PROMIS measures showed moderate to strong correlations with theoretically-similar items from the HCV-PRO and MSAS (0.39-0.77). Trends were observed between worse PRO scores and advanced cirrhosis and greater number of comorbidities, lending support for known-groups validity.

conclusionsThe psychometric properties of the HIT-6 and PROMIS measures performed satisfactorily in this large cohort of patients with HCV starting direct acting antiviral therapy. Opportunities exist for further refinement of these PROs. Evaluation of performance over time and in under-represented subgroups is needed.

Indexed as

Patient Reported Outcome MeasuresAdultAgedAged, 80 and overAntiviral AgentsCohort StudiesComorbidityCross-Sectional StudiesFemaleForms as TopicHepatitis C, ChronicHumansLiver CirrhosisMaleMiddle AgedPain ManagementAntiviral Agents

Identifiers

PMID29377191
PMCPMC5842131
OpenAlexW2790356024

What OpenQuestion holds

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Registered trials

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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.