Nancy E. Kass|Holly A. Taylor|Joseph Ali|Kristina Hallez|Lelia H. Chaisson
A pilot study of simple interventions to improve informed consent in clinical research: Feasibility, approach, and results
Johns Hopkins Berman Institute of Bioethics|Johns Hopkins University|Johns Hopkins Berman Institute of Bioethics|Johns Hopkins University|Johns Hopkins Berman Institute of Bioethics|Johns Hopkins Berman Institute of Bioethics|University of California System|University of California, San Francisco
background research suggests participants always adequately understand studies consent interventions increase understanding methodologic challenges raised studying consent outside actual trial settings study examined feasibility testing two consent interventions actual studies measured effectiveness interventions improving understanding methods participants enrolling eight ongoing clinical trials sequentially assigned one three different informed consent strategies enrollment clinical trial control participants received standard consent procedures trial participants first intervention arm received bulleted fact sheet summarizing key study information participants second intervention arm received bulleted fact sheet also engaged feedback qampa session later patients answered closed openended questions assess patient understanding literacy descriptive statistics wilcoxon mann whitney kruskalwallis tests generated assess correlations regression analysis determined predictors understanding results 144 participants enrolled using regression analysis participants receiving second intervention scored 76 percentage points higher p 02 openended questions understanding participants control although unadjusted comparisons reach statistical significance conclusions study supports hypothesis patients receiving bulleted fact sheets qampa session higher understanding compared standard consent fact sheets short structured dialog quick administer easy replicate across studies tested larger samples