Rebecca L. Sudore|C. Seth Landefeld|Brie Williams|Deborah E. Barnes|Karla Lindquist|Dean Schillinger
Use of a modified informed consent process among vulnerable patients
San Francisco VA Medical Center|University of California, San Francisco|San Francisco VA Medical Center|University of California, San Francisco|San Francisco VA Medical Center|University of California, San Francisco|University of California, San Francisco|San Francisco VA Medical Center|University of California, San Francisco|San Francisco General Hospital|University of California, San Francisco
little known patient characteristics associated comprehension consent information whether modifications consent process promote understandingto describe modified research consent process determine whether literacy demographic characteristics associated understanding consent informationdescriptive study modified consent process consent form written sixthgrade level read participants combined 7 comprehension questions targeted education repeated comprehension achieved teachtogoaltwo hundred four ethnically diverse subjects aged 50 consenting trial improve forms used advance directivesnumber passes consent process required achieve complete comprehension literacy assessed english spanish short form test functional health literacy adults scores 0 36participants mean age 61 years 40 limited literacy stohfla23 28 subjects answered comprehension questions correctly first pass adjustment lower literacy p04 black p03 associated requiring passes consent process speaking english primary language associated requiring passes consent process bivariate analyses p01 multivariable analyses p05 second pass subjects 80 answered questions correctly teachtogoal strategy 98 participants engaged consent process achieved complete comprehensionlower literacy minority status important determinants understanding consent information using modified consent process little additional education required achieve complete comprehension regardless literacy language barriers