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Consent documents for oncology trials: does anybody read these things?

S Michael Sharp1

  • 1Winship Cancer Institute, Emory University School of Medicine, 1365 Clifton Road, Suite B4100, Atlanta, GA 30322, USA. Michael_sharp@emoryhealthcare.org

American Journal of Clinical Oncology
|December 4, 2004
PubMed
Summary

Informed consent documents for oncology clinical trials are too long and complex for patients to understand. Readability standards are not being enforced, hindering patient comprehension and engagement.

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Area of Science:

  • Oncology
  • Clinical Trials
  • Medical Ethics

Background:

  • Informed consent is crucial for ethical clinical trial participation.
  • Assessing the readability and length of these documents is essential for patient understanding.

Purpose of the Study:

  • To evaluate the readability and length of informed consent documents in oncology clinical trials.
  • To determine if current documents meet established readability standards.

Main Methods:

  • Quantitative analysis of 107 oncology clinical trial consent documents.
  • Utilized readability software (Flesch Reading Ease, Gunning Fog Index) to assess length and complexity.
  • Analyzed documents from various sponsors, including internal, commercial, and cooperative groups.
Keywords:
Biomedical and Behavioral ResearchEmpirical Approach

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Main Results:

  • Mean document length was approximately 2709 words (10.8 pages).
  • Mean Flesch Reading Ease Score was 45.48, indicating difficult readability.
  • Mean Gunning Fog Index indicated a 11.9 grade level, with no documents at or below the 8th-grade level.

Conclusions:

  • Oncology clinical trial consent documents are excessively lengthy and complex.
  • Current documents are unlikely to be read or understood by most patients.
  • Institutional Review Boards (IRBs) and review committees are failing to enforce readability standards.