title: Local media influence on opting out from an exception from informed consent trial.
abstract: OBJECTIVE
  News media are used for community education and notification in exception from informed consent clinical trials, yet their effectiveness as an added safeguard in such research remains unknown. We assessed the number of callers requesting opt-out bracelets after each local media report and described the errors and content within each media report.
  
  
  METHODS
  We undertook a descriptive analysis of local media trial coverage (newspaper, television, radio, and Web log) and opt-out requests during a 41-month period at a single site participating in an exception from informed consent out-of-hospital trial. Two nontrial investigators independently assessed 41 content-based media variables (including background, trial information, graphics, errors, publication information, and assessment) with a standardized, semiqualitative data collection tool. Major errors were considered serious misrepresentation of the trial purpose or protocol, whereas minor errors included misinformation unlikely to mislead the lay reader about the trial. We plotted the temporal relationship between opt-out bracelet requests and media reports. Descriptive information about the news sources and the trial coverage are presented.
  
  
  RESULTS
  We collected 39 trial-related media reports (33 newspaper, 1 television, 1 radio, and 4 blogs). There were 13 errors in 9 (23%) publications, 7 of which were major and 6 minor. Of 384 requests for 710 bracelets, 310 requests (80%) occurred within 4 days after trial media coverage. Graphic timeline representation of the data suggested a close association between media reports about the trial and requests for opt-out bracelets.
  
  
  CONCLUSIONS
  According to results from a single site, local media coverage for an exception from informed consent clinical trial had a substantial portion of errors and appeared closely associated with opt-out requests.
authors.affiliation: Oregon Health and Science University School of Medicine, Portland, OR 97239-3098, USA.
authors.forename: Maria J
authors.initials: MJ
authors.lastname: Nelson
authors.forename: Nicole M
authors.initials: NM
authors.lastname: DeIorio
authors.forename: Terri
authors.initials: T
authors.lastname: Schmidt
authors.forename: Denise
authors.initials: D
authors.lastname: Griffiths
authors.forename: Mohamud
authors.initials: M
authors.lastname: Daya
authors.forename: Liana
authors.initials: L
authors.lastname: Haywood
authors.forename: Dana
authors.initials: D
authors.lastname: Zive
authors.forename: Craig D
authors.initials: CD
authors.lastname: Newgard
mesh_terms: D002986:Clinical Trials as Topic; D003159:Community-Institutional Relations; D006801:Humans; D007258:Informed Consent; D018156:Journalism, Medical; D008402:Mass Media; D018579:Patient Selection; D014481:United States
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