Leonardo Tamariz|Ana Palacio|Mauricio Robert|Erin N. Marcus
Improving the Informed Consent Process for Research Subjects with Low Literacy: A Systematic Review
University of Miami|University of Miami|University of Miami|University of Miami
inadequate health literacy may impair research subjects ability participate adequately informed consent ic process aim evaluate evidence supporting interventions improve comprehension ic process low literacy subjects performed medline database search 1966 november 2011 supplemented manual searches bibliographies key relevant articles selected studies modification ic tested improve comprehension low literacy populations study design quality criteria population interventions outcomes trial extracted main outcome evaluated comprehension measured using written test verbal comprehension search strategy yielded 281 studies six met eligibility criteria six studies included 1620 research participants studies predominantly included populations older median age 61 range 4864 ethnic minority literacy level 8th grade one study randomized design specific intervention differed study two studies included teachback method teach goal method achieved highest level comprehension two studies changed readability level ic resulted lowest comprehension among study subjects evidence supporting interventions improve informed consent process low literacy populations extremely limited among interventions evaluated study team member spend time talking oneonone study participants effective strategy improving informed consent understanding however finding based results single study