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Consent forms: how to determine and improve their readability.

C D Meade1, D M Howser

  • 1University of Wisconsin-Milwaukee School of Nursing.

Oncology Nursing Forum
|November 1, 1992
PubMed
Summary
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Cancer clinical trial consent forms are often too difficult for patients to understand. Simplifying these documents could significantly improve patient comprehension and participation in vital research.

Area of Science:

  • Medical research ethics
  • Clinical trial administration
  • Patient communication

Background:

  • Informed consent is crucial for ethical clinical trial participation.
  • Assessing the readability of consent forms is essential for patient comprehension.
  • Previous assessments indicated potential readability issues in clinical trial documents.

Purpose of the Study:

  • To evaluate the reading level of cancer clinical trial consent forms.
  • To determine if consent forms meet established patient readability standards.
  • To identify strategies for improving consent form clarity and patient understanding.

Main Methods:

  • Analysis of 44 cancer clinical trial consent forms from National Cancer Institute branches.
  • Utilized the SMOG (Simple Measure of Gobbledygook) formula to estimate reading grade levels.
Keywords:
Biomedical and Behavioral ResearchEmpirical ApproachNational Cancer Institute

Related Experiment Videos

  • Calculated mean readability scores and range of reading levels.

    • Main Results:

    • Readability levels ranged from grade 12 to 17.5.
    • The average reading level was grade 14.3.
    • Identified that consent forms were written above the general public's reading comprehension level.

    Conclusions:

    • Cancer clinical trial consent forms are often written at a level exceeding patient comprehension.
    • Readability formulas and targeted rewriting can enhance document usefulness.
    • Nurses can play a key role in improving patient understanding of informed consent.