Shlomo A. Koyfman|C.A. Reddy|Sabahat Hizlan|Angela C. Leek|and Eric D. Kodish
Informed consent conversations and documents: A quantitative comparison
Cleveland Clinic|Cleveland Clinic|Cleveland Clinic|Cleveland Clinic|Cleveland Clinic
background informed consent clinical research includes 2 components informed consent documents icds informed consent conversations iccs readability software used help simplify language icd authors knowledge rarely used assess language used icc may influence quality informed consent current analysis performed determine whether length reading levels transcribed iccs lower corresponding icds selected clinical trials assess whether investigator experience affected use simpler language comprehensiveness methods current study prospective study iccs audiorecorded 6 institutions families offered participation pediatric phase oncology trials word count fleschkincaid grade level fkgl flesch reading ease score fres iccs compared corresponding icds including frequency investigators addressed 8 prespecified critical consent elements icc results sixtynine unique physicianprotocol pairs identified overall iccs contained fewer words 4677 vs 6364 words p 0016 lower fkgl 6 vs 97 p 0001 higher fres 778 vs 567 p lt0001 compared respective icds likely omit critical consent elements voluntariness 55 doselimiting toxicities 26 years investigator experience correlated reliably covering critical elements decreased linguistic complexity conclusions clinicians use understandable language iccs corresponding icd appear less reliably cover elements critical fully informed consent efforts focused providing communication training clinicianinvestigators made optimize synergy icd icc cancer 2016122464469 2015 american cancer society