Subha Perni|Michael K. Rooney|David P. Horowitz|Daniel W. Golden|Anne R. McCall|Andrew J. Einstein|Reshma Jagsi
Assessment of Use, Specificity, and Readability of Written Clinical Informed Consent Forms for Patients With Cancer Undergoing Radiotherapy
Columbia University|University of Illinois at Chicago|New York Hospital Queens|Columbia University|NewYork–Presbyterian Hospital|University of Chicago|University of Chicago|NewYork–Presbyterian Hospital|Columbia University|New York Hospital Queens|University of Michigan–Ann Arbor
appropriate informed consent processes crucial preservation patient autonomy shared decision making although half patients cancer receive radiotherapy unknown whether current consent practices comprehensible patientsto characterize use specificity readability clinical informed consent forms radiotherapy hypothesizing forms would higher recommended sixth eighthgrade readability levelthis nationwide crosssectional survey study readability analysis conducted 2016 2018 included 89 academic radiation oncology departments part 2016 electronic residency application service department leaders clinical directors chairs personal contacts study authors academic radiation oncology departments contacted via emailreadability levels measured 7 validated readability indices including ford caylor sticht forcast index nonnarrative texts difficult words identified using living word vocabulary describes readability grade levels 40 000 common wordsof 89 departments 67 75 responded questions 57 64 provided 113 forms analysis departments providing forms differ substantially others terms region residency size research output rural vs urban location public vs private institution status departments obtained patient written informed consent radiotherapy 38 57 used body sitespecific forms using conservative lowscore estimate mean form readability ranged grade level 106 142 7 distinct indices 9 8 113 forms met recommended eighthgrade readability level 4 4 forms met sixthgrade level single form met either recommendation based forcast index forms used average 72 difficult words body sitespecific forms considerably better readability general consent formsthis nationwide study informed consent practices cancer treatment radiotherapy demonstrates us academic radiotherapy departments use written consent forms rare templates meet recommended readability levels patient materials data suggest need reevaluation modification approach radiotherapy consent ideally guidance templates designed national professional organizations