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

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

Research output: Contribution to journalArticle

3 Citations (Scopus)

Abstract

GOALS:: To evaluate differences in metrics of quality and site performance in academic and community sites participating in a multicenter study. BACKGROUND:: In 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. RESULTS:: Of 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. CONCLUSIONS:: There 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.

Original languageEnglish (US)
JournalJournal of Clinical Gastroenterology
Volume47
Issue number10
DOIs
StatePublished - Nov 2013

Fingerprint

Therapeutics
Interferons
Ribavirin
Chronic Hepatitis C
Treatment Failure
Hepacivirus
Multicenter Studies
Genotype
Clinical Trials
Recurrence
Sustained Virologic Response

Keywords

  • hepatitis C
  • peginterferon-α
  • ribavirin
  • site

ASJC Scopus subject areas

  • Gastroenterology

Cite this

Analysis of site performance in academic-based and community-based centers in the IDEAL study. / Jou, Janice; Sulkowski, Mark S.; Noviello, Stephanie; Long, Jianmin; Pedicone, Lisa D.; Mchutchison, John G.; Muir, Andrew J.

In: Journal of Clinical Gastroenterology, Vol. 47, No. 10, 11.2013.

Research output: Contribution to journalArticle

Jou, Janice ; Sulkowski, Mark S. ; Noviello, Stephanie ; Long, Jianmin ; Pedicone, Lisa D. ; Mchutchison, John G. ; Muir, Andrew J. / Analysis of site performance in academic-based and community-based centers in the IDEAL study. In: Journal of Clinical Gastroenterology. 2013 ; Vol. 47, No. 10.
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abstract = "GOALS:: To evaluate differences in metrics of quality and site performance in academic and community sites participating in a multicenter study. BACKGROUND:: In 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. RESULTS:: Of 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. CONCLUSIONS:: There 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.",
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