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Table 1 Results of trials of video and computer multimedia interventions

From: Improving understanding in the research informed consent process: a systematic review of 54 interventions tested in randomized control trials

  Standard control     Sample size Understanding scores, %  
Source   Intervention Population Scenario   Control Intervention P Value
Karunaratne et al., 2010 Y Interactive computer presentation replaces consent form. Graphics, video clips, links, and text styling Patients with DM Simulated 60 73 82 0.005
Kass et al., 2009 (formerly Agre et al. 2003) N Digital touch-screen presentation on oncology clinical research replaces brochure Patients with cancer Real 130 17 34 0.03‡
Bickmore et al., 2009 Y° Standard consent form with explanation by interactive, computerized “agent” Healthy volunteers Simulated 18 39 42 NS
Hack et al., 2007 N° Supplementary take-home audiotape recording of standardized study details° Patients with cancer Real 42 88 85 NS∞
  N° Supplementary take-home audiotape recording of IC consultation and second audiotape of standardized study details° Patients with cancer Real 47 88 87 NS∞
Hutchinson et al., 2007 Y° Supplementary 10 min. video. Vignettes, visual aids, voice-over, and graphics. Patients allowed to take video home° Patients with cancer Real 173 NA NA 0.011§,∞
Mittal et al., 2007 N° Powerpoint slideshow on computer replaces consent form. Graphics, text styling, summaries video and embedded voice narration° Patients with cognitive impairment or Alzheimer's disease Simulated 35 52 60 NS
Wirshing et al., 2005 (formerly Agre et al. 2003) N Video with specific study guidelines replaces generic video on human research. Professionally acted vignettes, bulleted text, and audio narration Patients with mental illness and healthy volunteers Simulated 261 69 73 < 0.0001
Campbell et al., 2004 Y Video replaces consent form. Voicenarration and no reading required Parents of pediatric research participants Simulated 120 47 50 NS
  Y Computer presentation replaces consent form. Video and still pictures; bulleted text with audio narration Parents of pediatric research participants Simulated 118 47 51 NS†
Agre and Rapkin, 2003 N Computer presentation replaces consent form. Summary sections (?) Patients with cancer and healthy volunteers Real 209 68 66 NS
  N Video replaces consent form. Professionally produced with summary sections Patients with cancer and healthy volunteers Real 221 68 73 NS
Dunn et al., 2003 (includes Dunn et al., 2001) Y° Powerpoint slideshow replaces consent form. Altered organization, layout and summaries of text. Narrated by study staff° Patients with mental illness and healthy volunteers Real 99 85 91 0.014
Fureman et al., 1997 N° Supplementary 26 min. video. Talkshow format with expert panel answering audience questions° Injection drug users Real 186 81 80 NS
Weston et al., 1997 N° Supplementary, professionally filmed 10 min. video° Pregnant women Simulated 90 91 95 NS
Llewellyn- Thomas et al., 1995 Y Standard consent form in navigable, digital format Patients with cancer Simulated 100 81 79 NS
  1. Abbreviations: NA not Available; NS Not significant; DM diabetes mellitus.
  2. Bolded rows indicate trials include in the 2004 systematic review by Flory and Emanuel.
  3. ° Human proctor available for question/answer.
  4. § P-value is a based on change in pre-consent and post-consent quiz scores.
  5. †P-value is a post hoc calculation of the total scores contrasting all combinations of formats; Understanding scores based on averages of high and low-risk protocol arms.
  6. ‡ Only relates to participant’s ability to identify purpose of the study.
  7. ∞ Understanding assessed at approximately 1 week.
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BMC Medical Ethics

ISSN: 1472-6939

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