Local Media Influence on Opting Out From an Exception From Informed Consent Trial
Study 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.
Conclusion
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.
- ⁎ Plot for total opt-out bracelet requests (rather than phone calls for bracelets) is qualitatively similar to the plot for bracelets (data omitted for clarity).
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Supervising editor: Kathy J. Rinnert, MD, MPH
Author contributions: MJN, NMD, TS, DZ, and CDN participated in study design. LH was responsible for media communication from trial investigators. DG was in charge of opt-out bracelet distribution and community interaction. MJN and NMD were data abstractors, and TS mediated. MJN and CDN performed the statistical analyses. TS, MD, and CDN are local investigators in the Resuscitation Outcomes Consortium. All authors participated in article planning and writing and approved the final article. MJN and CDN had full access to all the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis. MJN takes responsibility for the paper as a whole.
Funding and support: By Annals policy, all authors are required to disclose any and all commercial, financial, and other relationships in any way related to the subject of this article that might create any potential conflict of interest. See the Manuscript Submission Agreement in this issue for examples of specific conflicts covered by this statement. This publication was made possible with support from the following sources: Oregon Clinical and Translational Research Institute (#UL1 RR024140, the National Center for Research Resources, a component of the National Institutes of Health (NIH), and NIH Roadmap for Medical Research); and the Resuscitation Outcomes Consortium (ROC) Training Grant (#U01/HL-04-001, National Heart, Lung, and Blood Institute), and the ROC cooperative grants. The ROC is supported by a series of cooperative agreements to 10 regional clinical centers and 1 data coordinating center (5U01 HL077863, HL077881, HL077871 HL077872, HL077866, HL077908, HL077867, HL077885, HL077885, HL077863) from the National Heart, Lung, and Blood Institute, in partnership with the National Institute of Neurological Disorders and Stroke, US Army Medical Research and Material Command, the Canadian Institutes of Health Research-Institute of Circulatory and Respiratory Health, Defence Research and Development Canada, the Heart and Stroke Foundation of Canada, and the American Heart Association. The ROC Publications Committee reviewed and approved this manuscript.
Publication date: Available online August 13, 2009.
Reprints not available from the authors.
Please see page 2 for the Editor's Capsule Summary of this article.
PII: S0196-0644(09)00606-4
doi:10.1016/j.annemergmed.2009.05.028
© 2008 Published by Elsevier Inc.
