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 |