Informed consent conversations and documents: A quantitative comparison

Abstract

Background Informed consent for clinical research includes two components: informed consent documents (ICD) and informed consent conversations (ICC). Readability software has been used to help simplify the language of the ICD, but rarely employed to assess the language during the ICC, which may influence the quality of informed consent. This analysis was completed to determine if length and reading levels of transcribed ICCs are lower than their corresponding ICDs for selected clinical trials, and to assess whether investigator experience affected use of simpler language and comprehensiveness. Methods Prospective study where ICCs were audio-recorded 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 ICCs were compared to corresponding ICDs, including the frequency that investigators addressed 8 pre-specified critical consent elements during the ICC. Results Sixty-nine unique physician/protocol pairs were identified. Overall, ICCs contained fewer words (4,677 vs. 6,364; p=0.0016), had lower FKGL (6 vs. 9.7; p=<0.0001) and higher FRES (77.8 vs. 56.7; p<0.0001) than 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 less reliably cover elements critical to fully informed consent. Focused efforts at providing communication training for clinician-investigators should be done to optimize the synergy between the ICD and conversation.

Advancing the field of communication research in pediatric oncology: A systematic review of the literature analyzing medical dialogue

“…All 26 studies aimed to describe the content of communication. The majority of studies ( n = 23, 88%) also aimed to describe the quality of communication . Two studies aimed to describe the impact of an intervention on communication styles and strategies .…”

“…The majority of studies ( n = 18, 69%) involved recordings of informed consent conversations . One study recorded conversations at the time of diagnosis, and a minority of studies ( n = 4, 15%) recorded conversations at random visits across the illness trajectory without aiming to capture a specific time point .…”

“…Three studies (12%) exclusively aimed to describe the content of communication, without qualifying the perceived value or influence of the communication . The remainder of the studies ( n = 23, 88%) presented data with the goal of drawing conclusions about communication quality . Table describes the tools used to assess communication quality in these studies.…”

“…In the studies that involved recordings of informed consent conversations ( n = 18), assessment of communication quality focused primarily on quantification of the inclusion and/or frequency of physician statements related to critical consent elements, including (1) provision of information specific to the clinical trial, (2) review of study objectives, risks, and benefits, (3) explanation of the concept of randomization, and (4) discussion of the patient's rights in the context of an informed consent process . Discussion specific to how “quality of life” might factor into the decision‐making process was also reviewed in several papers .…”

“…When discussing risks, oncologists discussed rare and more serious side effects in fewer than 1% of informed consent conversations . Moreover, oncologists often omitted critical elements of the consent process such as discussion about voluntariness, dose finding/escalation, or dose limiting toxicities …”