title: Analysis of site performance in academic-based and community-based centers in the IDEAL Study.
abstract: OBJECTIVE
  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.
  
  
  METHODS
  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.
authors.affiliation: *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.
authors.forename: Janice H
authors.initials: JH
authors.lastname: Jou
authors.forename: Mark S
authors.initials: MS
authors.lastname: Sulkowski
authors.forename: Stephanie
authors.initials: S
authors.lastname: Noviello
authors.forename: Jianmin
authors.initials: J
authors.lastname: Long
authors.forename: Lisa D
authors.initials: LD
authors.lastname: Pedicone
authors.forename: John G
authors.initials: JG
authors.lastname: McHutchison
authors.forename: Andrew J
authors.initials: AJ
authors.lastname: Muir
mesh_terms: D000046:Academic Medical Centers / Q000379:methods / Q000592:standards*; D000328:Adult; D000998:Antiviral Agents / Q000008:administration & dosage / Q000627:therapeutic use; D017326:Clinical Trials, Phase III as Topic; D003151:Community Health Centers / Q000592:standards*; D004305:Dose-Response Relationship, Drug; D004359:Drug Therapy, Combination; D005260:Female; D005500:Follow-Up Studies; D006526:Hepatitis C / Q000188:drug therapy*; D006801:Humans; D000077190:Interferon alpha-2; D016898:Interferon-alpha / Q000008:administration & dosage / Q000627:therapeutic use; D008297:Male; D008875:Middle Aged; D011092:Polyethylene Glycols / Q000008:administration & dosage / Q000627:therapeutic use; D019984:Quality Indicators, Health Care; D011787:Quality of Health Care; D016032:Randomized Controlled Trials as Topic; D011994:Recombinant Proteins / Q000008:administration & dosage / Q000627:therapeutic use; D012189:Retrospective Studies; D012254:Ribavirin / Q000008:administration & dosage / Q000627:therapeutic use; D017211:Treatment Failure; D016896:Treatment Outcome
chemical_list: D000998:Antiviral Agents; D000077190:Interferon alpha-2; D016898:Interferon-alpha; D011994:Recombinant Proteins; D011092:Polyethylene Glycols; D012254:Ribavirin; C417083:peginterferon alfa-2b; C100416:peginterferon alfa-2a