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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

Standard consent form with explanation by interactive, computerized “agent”

Healthy volunteers

Simulated

18

39

42

NS

Hack et al., 2007

Supplementary take-home audiotape recording of standardized study details°

Patients with cancer

Real

42

88

85

NS∞

 

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

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

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)

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

Supplementary 26 min. video. Talkshow format with expert panel answering audience questions°

Injection drug users

Real

186

81

80

NS

Weston et al., 1997

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.