Informed consent conversations and documents: A quantitative comparison.
BACKGROUND
Informed consent for clinical research includes 2 components: informed consent documents (ICDs) and informed consent conversations (ICCs). Readability software has been used to help simplify the language of the ICD, but to the authors' knowledge is rarely used to assess the language used during the ICC, which may influence the quality of informed consent. The current analysis was performed to determine whether length and reading levels of transcribed ICCs are lower than their corresponding ICDs for selected clinical trials, and to assess whether investigator experience affected the use of simpler language and comprehensiveness.


METHODS
The current study was a prospective study in which ICCs were audiorecorded at 6 institutions when families were offered participation in pediatric phase I oncology trials. Word count, Flesch-Kincaid Grade Level (FKGL), and Flesch Reading Ease score (FRES) of the ICCs were compared with corresponding ICDs, including the frequency with which investigators addressed 8 prespecified critical consent elements during the ICC.


RESULTS
Sixty-nine unique physician/protocol pairs were identified. Overall, ICCs contained fewer words (4677 vs 6364 words; P = .0016) and had a lower FKGL (6 vs 9.7; P ≤ .0001) and a higher FRES (77.8 vs 56.7; P<.0001) compared with their respective ICDs, but were more likely to omit critical consent elements, such as voluntariness (55%) and dose-limiting toxicities (26%). Years of investigator experience was not correlated with reliably covering critical elements or decreased linguistic complexity.


CONCLUSIONS
Clinicians use more understandable language during ICCs than the corresponding ICD, but appear to less reliably cover elements critical to fully informed consent. Efforts focused at providing communication training for clinician-investigators should be made to optimize the synergy between the ICD and the ICC.
Department of Radiation Oncology, Cleveland Clinic, Cleveland, Ohio.|Department of Bioethics, Cleveland Clinic, Cleveland, Ohio.
Shlomo A
SA
Koyfman
Department of Radiation Oncology, Cleveland Clinic, Cleveland, Ohio.
Chandana A
CA
Reddy
Department of Bioethics, Cleveland Clinic, Cleveland, Ohio.
Sabahat
S
Hizlan
Department of Bioethics, Cleveland Clinic, Cleveland, Ohio.
Angela C
AC
Leek
Department of Bioethics, Cleveland Clinic, Cleveland, Ohio.
And Eric D
AE
Kodish
D000293:Adolescent; D000328:Adult; D002648:Child; D002675:Child, Preschool; D017321:Clinical Trials, Phase I as Topic; D032882:Comprehension; D032962:Consent Forms / Q000592:standards*; D004522:Educational Status; D005260:Female; D006801:Humans; D007223:Infant; D007258:Informed Consent / Q000523:psychology / Q000592:standards*; D008297:Male; D008875:Middle Aged; D033282:Parental Consent / Q000523:psychology; D010372:Pediatrics; D011446:Prospective Studies; D012108:Research Personnel / Q000592:standards; D014705:Verbal Behavior
clinical trials; consent documents; ethics; informed consent; oncology; pediatric; phase I