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Table 3 Results of trials of extended discussion 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
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*
  1. Abbreviations: NA Not Available, NS Not Significant, HIV human immunodeficiency virus.
  2. Bolded rows indicate trials included in the 2004 systematic review by Flory and Emanuel.
  3. °Human proctor available for question/answer.
  4. * P value is for the overall outcomes which include "willingness to participate" and "anxiety".
  5. § Scores based on an “awareness scale” in an interview format after approximately 1 week.
  6. ∞ Understanding assessed at approximately 1 week.
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