Evidence map›Paper›PMID 23787248›Full record

ArticleJournal of clinical gastroenterology

Analysis of site performance in academic-based and community-based centers in the IDEAL Study.

Janice H Jou, Mark S Sulkowski, Stephanie Noviello, Jianmin Long, Lisa D Pedicone, John G McHutchison, Andrew J Muir

Abstract readComparative StudyMulticenter Study
In one paragraph

Article in Journal of clinical gastroenterology. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed, 1 pooled it
0.3field-weighted citation impact, top 37% 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

3 citing papers in PubMed, 1 synthesis or guideline pooled it, 3 citations in OpenAlex.

  1. Pooled it
  2. Article
  3. Article
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 5 institutions in 1 country.

Janice H Jou*Oregon Health and Science University, Portland, OR †John Hopkins University School of Medicine, Baltimore, MD ‡Merck Research Laboratories, Kenilworth, NJ §Gilead Sciences Inc., Foster City, CA ∥Division of Gastroenterology and Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC.
Mark S Sulkowski
Stephanie Noviello
Jianmin Long
Lisa D Pedicone
John G McHutchison
Andrew J Muir
Merck & Co., Inc., Rahway, NJ, USA (United States) · USDuke University · USGilead Sciences (United States) · USJohns Hopkins University · USOregon Health & Science University · US

Funding

Management/Hepatitis C/HIV-infected and Uninfected IDU'sR01DA016065 · NIDA · JOHNS HOPKINS UNIVERSITY · PI SULKOWSKI, MARK SEBASTIAN · 2003 to 2018
$8.0M
DUKE TRAINING GRANT IN DIGESTIVE DISEASES AND NUTRITIONT32DK007568 · NIDDK · DUKE UNIVERSITY · PI Katherine Garman, Rodger A. Liddle · 1988 to 2026
$5.6M
Patient Oriented Research in Hepatitis C-infected Injection Drug UsersK24DA034621 · NIDA · JOHNS HOPKINS UNIVERSITY · PI SULKOWSKI, MARK SEBASTIAN · 2012 to 2022
$1.2M
NIDA NIH HHS K24 DA034621NIDA NIH HHS R01 DA016065NIDDK NIH HHS T32 DK007568PHS HHS T32 3020023
6 · The paper itself

Abstract

goalsTo evaluate differences in metrics of quality and site performance in academic and community sites participating in a multicenter study.

backgroundIn the Individualized Dosing Efficacy Versus Flat Dosing to Assess Optimal Pegylated Interferon Therapy study, the participation of 76 academic-based and 42 community-based US centers provided an opportunity to evaluate various metrics of quality and site performance. STUDY: A secondary data analysis of the Individualized Dosing Efficacy Versus Flat Dosing to Assess Optimal Pegylated Interferon Therapy study was performed. There were 3070 treatment-naive, hepatitis C virus genotype 1 infected patients were included. We retrospectively evaluated rates of screen failure, completion, and discontinuation of treatment and follow-up, treatment adherence, and virologic response by site type.

resultsOf the patients screened, 63% and 37% were in academic and community centers, respectively. Screen failure rates were similar (30% to 32%). End-of-treatment response, relapse, and sustained virologic response (SVR) rates in academic and community centers did not differ. SVR was achieved in 40% of patients at academic sites and 39% at community sites. Adherence to ≥80% of peginterferon-α and ribavirin dosing for ≥80% assigned duration was also similar (46% in academic and 47% in community centers). In both academic and community centers, 54% of patients completed treatment; there were similar discontinuation rates for treatment failure and adverse events.

conclusionsThere were no significant differences in adherence, adverse events, rates of discontinuation, on-treatment virologic response, and SVR when comparing academic and community sites. The performance of academic-based and experienced community-based sites in clinical trials is largely similar for the treatment of chronic hepatitis C.

Indexed as

Quality of Health CareAcademic Medical CentersAdultAntiviral AgentsClinical Trials, Phase III as TopicCommunity Health CentersDose-Response Relationship, DrugDrug Therapy, CombinationFemaleFollow-Up StudiesHepatitis CHumansInterferon-alphaInterferon alpha-2MaleMiddle AgedAntiviral AgentsInterferon-alphaInterferon alpha-2peginterferon alfa-2apeginterferon alfa-2bPolyethylene GlycolsRecombinant ProteinsRibavirin

Identifiers

PMID23787248
PMCPMC5144160
OpenAlexW2149448833

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.