Skip to main content

Table 5 Results of trials of mixed and miscellaneous intervensions

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
Tait et al., 2010 N Online presentation in which tables, instead of text, are used to explain risk vs benefit Parents Simulated 3139 49∞ 45∞ NS
  N Online presentation in which pictographs, instead of text are used explain risk vs benefit Parents Simulated 3094 49∞ 67∞ <.05
Ford et al., 2008 Standard paper document read aloud by study staff with familymember or care-giver present° Elderly patients with Parkinson's disease Real 136 48 52 0.012‡
Lavori et al., 2007 Supplementary self-assessment for study staff after each consent discussion with a participant° Patients and healthy volunteers Real 836 78 79 NS
Agre et al., 2003 (Merz et al. trial) Supplementary educational vignettes° Patients undergoing apheresis and healthy volunteers Simulated 206 NA NA NS
Stiles et al., 2001 Neutral facilitator present at research participant's meeting with investigator° Patients with mental illness and healthy volunteers Simulated 227 82 81 NS
Wragg et al., 2000 N Simplified paper document and video with physician explanation. Material written to express current facts without stressing importance of the trial Female research participants Simulated 100 51 49 NS
  1. Abbreviations: NA Not Available, NS Not Significant.
  2. Bolded rows indicate trials included in the 2004 systematic review by Flory and Emanuel.
  3. °Human proctor available for question/answer.
  4. ‡ Understanding assessed at approximately 1 week.
  5. ∞Scores represent the percent of sample who scored >5 out of 7, which they called adequate knowledge.