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

Table 3 Results of trials of extended discussion intervensions

	Standard control				Sample size	Understanding scores, %
Source		Intervention	Population	Scenario		Control	Intervention	P Value
Sarkar et al., 2010	Y°	Standardized, focus group discussion with study nurse in place of individual counseling°	Parents of malnourished children in Vellore, India	Real	118	73	73	NS
Freer et al., 2009	Y	Information leaflet and supplementary, standardized discussion with study staff°	Parents in United Kingdom	Simulated	21	69	85	0.015
	Y	Information leaflet and supplementary, standardized discussion with study staff°	Parents in United States	Simulated	20	66	75	NS
Aaronson et al., 1996	Y°	Same presentation formats. Supplementary telephone conversation with oncology nurse°	Patients with cancer	Real	230	66	83	<.001§
Tindall et al., 1994	Y	Supplementary conversation with enrolling physician°	Patients with HIV	Real	113	60	63	NS∞
Simes et al., 1986	Y°	Uniform consent procedure ensuring total disclosure of information by physicians°	Patients with cancer	Real	57	62	74	0.0001*

Abbreviations: NA Not Available, NS Not Significant, HIV human immunodeficiency virus.
Bolded rows indicate trials included in the 2004 systematic review by Flory and Emanuel.
°Human proctor available for question/answer.
* P value is for the overall outcomes which include "willingness to participate" and "anxiety".
§ Scores based on an “awareness scale” in an interview format after approximately 1 week.
∞ Understanding assessed at approximately 1 week.

ISSN: 1472-6939