title: Publication of comparative effectiveness research has not increased in high-impact medical journals, 2004-2013.
abstract: OBJECTIVE
  To explore the impact of increasing interest and investment in patient-centered research, this study sought to describe patterns of comparative effectiveness research (CER) and patient-reported outcomes (PROs) in pharmacologic intervention studies published in widely read medical journals from 2004-2013.
  
  
  METHODS
  We identified 2335 articles published in five widely read medical journals from 2004-2013 with ≥1 intervention meeting the US Food and Drug Administration's definitions for a drug, biologic, or vaccine. Six trained reviewers extracted characteristics from a 20% random sample of articles (468 studies). We calculated the proportion of studies with CER and PROs. Trends were summarized using locally-weighted means and 95% confidence intervals.
  
  
  RESULTS
  Of the 468 sampled studies, 30% used CER designs and 33% assessed PROs. The proportion of studies using CER designs did not meaningfully increase over the study period. However, we observed an increase in the use of PROs.
  
  
  CONCLUSIONS
  Among pharmacological intervention studies published in widely read medical journals from 2004-2013, we identified no increase in CER. Randomized, placebo-controlled trials continue to be the dominant study design for assessing pharmacologic interventions. Increasing trends in PRO use may indicate greater acceptance of these outcomes as evidence for clinical benefit.
authors.affiliation: Department of Epidemiology, Gillings School of Global Public Health, University of North Carolina-Chapel Hill, 135 Dauer Drive, 2101 McGavran-Greenberg Hall, CB #7435, Chapel Hill, NC 27599, USA. Electronic address: llhester@live.unc.edu.
authors.forename: Laura L
authors.initials: LL
authors.lastname: Hester
authors.affiliation: Department of Epidemiology, Gillings School of Global Public Health, University of North Carolina-Chapel Hill, 135 Dauer Drive, 2101 McGavran-Greenberg Hall, CB #7435, Chapel Hill, NC 27599, USA.
authors.forename: Charles
authors.initials: C
authors.lastname: Poole
authors.affiliation: Department of Epidemiology, Gillings School of Global Public Health, University of North Carolina-Chapel Hill, 135 Dauer Drive, 2101 McGavran-Greenberg Hall, CB #7435, Chapel Hill, NC 27599, USA.
authors.forename: Elizabeth A
authors.initials: EA
authors.lastname: Suarez
authors.affiliation: Department of Epidemiology, Gillings School of Global Public Health, University of North Carolina-Chapel Hill, 135 Dauer Drive, 2101 McGavran-Greenberg Hall, CB #7435, Chapel Hill, NC 27599, USA.
authors.forename: Jane S
authors.initials: JS
authors.lastname: Der
authors.affiliation: Department of Epidemiology, Gillings School of Global Public Health, University of North Carolina-Chapel Hill, 135 Dauer Drive, 2101 McGavran-Greenberg Hall, CB #7435, Chapel Hill, NC 27599, USA.
authors.forename: Olivia G
authors.initials: OG
authors.lastname: Anderson
authors.affiliation: Department of Epidemiology, Gillings School of Global Public Health, University of North Carolina-Chapel Hill, 135 Dauer Drive, 2101 McGavran-Greenberg Hall, CB #7435, Chapel Hill, NC 27599, USA.
authors.forename: Kathryn G
authors.initials: KG
authors.lastname: Almon
authors.affiliation: Department of Epidemiology, Gillings School of Global Public Health, University of North Carolina-Chapel Hill, 135 Dauer Drive, 2101 McGavran-Greenberg Hall, CB #7435, Chapel Hill, NC 27599, USA.
authors.forename: Avanti V
authors.initials: AV
authors.lastname: Shirke
authors.affiliation: Department of Epidemiology, Gillings School of Global Public Health, University of North Carolina-Chapel Hill, 135 Dauer Drive, 2101 McGavran-Greenberg Hall, CB #7435, Chapel Hill, NC 27599, USA.
authors.forename: M Alan
authors.initials: MA
authors.lastname: Brookhart
mesh_terms: D057186:Comparative Effectiveness Research / Q000379:methods / Q000706:statistics & numerical data*; D006801:Humans; D010506:Periodicals as Topic / Q000706:statistics & numerical data*; D012107:Research Design
keywords: Affordable Care Act (ACA); American Recovery and Reinvestment Act (ARRA); Comparative effectiveness research; Patient Protection; Patient-reported outcomes