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Readability of Invasive Procedure Consent Forms.

Adam E M Eltorai1, Syed S Naqvi1, Soha Ghanian1

  • 1Warren Alpert Medical School, Brown University, Providence, Rhode Island, USA.

Clinical and Translational Science
|December 19, 2015
PubMed
Summary
This summary is machine-generated.

Informed consent forms for medical procedures are written at a college reading level, far exceeding the recommended 6th grade level. This poor readability hinders patient comprehension of risks and benefits, impacting healthcare decisions.

Keywords:
comprehensionconsent formhealth literacyinformed consentreadability

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Area of Science:

  • Medical Ethics
  • Patient Communication
  • Health Literacy

Background:

  • Informed consent is crucial for ethical medical practice, requiring patient understanding of intervention risks, benefits, and alternatives.
  • The American Medical Association (AMA) and National Institutes of Health (NIH) recommend patient materials be at a 6th-grade reading level, considering the average US adult reads at an 8th-grade level.
  • This study investigated whether consent forms for invasive procedures adhere to these recommended readability guidelines.

Purpose of the Study:

  • To assess the readability of invasive procedure consent forms.
  • To determine if these forms align with recommended health literacy standards for patient information.
  • To identify potential barriers to patient comprehension in the informed consent process.

Main Methods:

  • Consent forms were collected from all surgical inpatient hospitals in Rhode Island.
  • Multiple readability assessment tools were employed, including the Flesch Reading Ease Formula and Flesch-Kincaid Grade Level.
  • A composite Text Readability Consensus Grade Level was calculated from these measures.

Main Results:

  • Invasive procedure consent forms were written at an average of a 15th-grade reading level.
  • This average reading level is significantly higher than the 8th-grade reading level of the average US adult (p < 0.0001).
  • The forms also significantly exceed the AMA/NIH recommended 6th-grade reading level for patient materials (p < 0.0001).

Conclusions:

  • The readability of invasive procedure consent forms poses a significant barrier to patient comprehension.
  • Low health literacy due to complex language can impede patients' ability to make informed healthcare decisions.
  • Improving the readability of consent forms is essential to enhance patient understanding and support ethical medical practice.