title: A pilot study of simple interventions to improve informed consent in clinical research: feasibility, approach, and results.
abstract: BACKGROUND
  Research suggests that participants do not always adequately understand studies. While some consent interventions increase understanding, methodologic challenges have been raised in studying consent outside of actual trial settings. This study examined the feasibility of testing two consent interventions in actual studies and measured effectiveness of interventions in improving understanding.
  
  
  METHODS
  Participants enrolling in any of eight ongoing clinical trials were sequentially assigned to one of three different informed consent strategies for enrollment in their clinical trial. Control participants received standard consent procedures for their trial. Participants in the first intervention arm received a bulleted fact sheet summarizing key study information. Participants in the second intervention arm received the bulleted fact sheet and also engaged in a feedback Q&A session. Later, patients answered closed- and open-ended questions to assess patient understanding and literacy. Descriptive statistics, Wilcoxon -Mann -Whitney and Kruskal-Wallis tests were generated to assess correlations; regression analysis determined predictors of understanding.
  
  
  RESULTS
  144 participants enrolled. Using regression analysis, participants receiving the second intervention scored 7.6 percentage points higher (p = .02) on open-ended questions about understanding than participants in the control, although unadjusted comparisons did not reach statistical significance.
  
  
  CONCLUSIONS
  Our study supports the hypothesis that patients receiving both bulleted fact sheets and a Q&A session had higher understanding compared to standard consent. Fact sheets and short structured dialog are quick to administer and easy to replicate across studies and should be tested in larger samples.
authors.affiliation: Johns Hopkins Berman Institute of Bioethics, Baltimore, MD, USA Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA nkass@jhu.edu.
authors.forename: Nancy E
authors.initials: NE
authors.lastname: Kass
authors.affiliation: Johns Hopkins Berman Institute of Bioethics, Baltimore, MD, USA Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.
authors.forename: Holly A
authors.initials: HA
authors.lastname: Taylor
authors.affiliation: Johns Hopkins Berman Institute of Bioethics, Baltimore, MD, USA.
authors.forename: Joseph
authors.initials: J
authors.lastname: Ali
authors.affiliation: Johns Hopkins Berman Institute of Bioethics, Baltimore, MD, USA.
authors.forename: Kristina
authors.initials: K
authors.lastname: Hallez
authors.affiliation: Division of Pulmonary and Critical Care Medicine, University of California San Francisco, San Francisco, CA, USA.
authors.forename: Lelia
authors.initials: L
authors.lastname: Chaisson
mesh_terms: D005260:Female; D006801:Humans; D007258:Informed Consent; D008297:Male; D008875:Middle Aged; D010353:Patient Education as Topic / Q000379:methods* / Q000458:organization & administration*; D010865:Pilot Projects; D012107:Research Design
keywords: Research ethics; bioethics; health literacy; informed consent; understanding