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

Table 5 Results of trials of mixed and miscellaneous intervensions

	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	Y°	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	Y°	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)	Y°	Supplementary educational vignettes°	Patients undergoing apheresis and healthy volunteers	Simulated	206	NA	NA	NS
Stiles et al., 2001	N°	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

Abbreviations: NA Not Available, NS Not Significant.
Bolded rows indicate trials included in the 2004 systematic review by Flory and Emanuel.
°Human proctor available for question/answer.
‡ Understanding assessed at approximately 1 week.
∞Scores represent the percent of sample who scored >5 out of 7, which they called adequate knowledge.

ISSN: 1472-6939