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Informed consent conversations and documents: A quantitative comparison.

Shlomo A Koyfman1,2, Chandana A Reddy1, Sabahat Hizlan2

  • 1Department of Radiation Oncology, Cleveland Clinic, Cleveland, Ohio.

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|October 28, 2015
PubMed
Summary
This summary is machine-generated.

Clinicians use simpler language in informed consent conversations (ICCs) than in documents (ICDs), but may omit critical information. Communication training is recommended to improve informed consent quality in clinical research.

Keywords:
clinical trialsconsent documentsethicsinformed consentoncologypediatricphase I

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Area of Science:

  • Clinical Research Ethics
  • Patient Communication
  • Health Literacy

Background:

  • Informed consent in clinical research comprises documents (ICDs) and conversations (ICCs).
  • Readability tools assess ICDs but rarely ICCs, potentially impacting informed consent quality.
  • Investigator experience's effect on ICC language and comprehensiveness is underexplored.

Purpose of the Study:

  • To compare the length and reading levels of transcribed ICCs versus their corresponding ICDs.
  • To assess if investigator experience influences simpler language and comprehensiveness in ICCs.
  • To evaluate the coverage of critical consent elements during ICCs.

Main Methods:

  • Prospective study involving audiorecording of ICCs at 6 institutions for pediatric phase I oncology trials.
  • Comparison of word count, Flesch-Kincaid Grade Level (FKGL), and Flesch Reading Ease score (FRES) between ICCs and ICDs.
  • Assessment of the frequency of addressing 8 critical consent elements during ICCs.

Main Results:

  • ICCs were shorter (4677 vs 6364 words), had lower FKGL (6 vs 9.7), and higher FRES (77.8 vs 56.7) than ICDs.
  • ICCs were more likely to omit critical elements like voluntariness (55%) and dose-limiting toxicities (26%).
  • Investigator experience did not correlate with better coverage of critical elements or simpler language.

Conclusions:

  • While clinicians use more understandable language in ICCs, critical elements may be less reliably conveyed.
  • There is a need to enhance the synergy between ICDs and ICCs for comprehensive informed consent.
  • Communication training for clinician-investigators is recommended to optimize informed consent processes.