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[How to consent without understanding?].

Vanessa da Costa Miranda1, Angelo Bezerra de Souza Fêde, Andréa Thaumaturgo Lera

  • 1Faculdade de Medicina do ABC, São Paulo, SP.

Revista Da Associacao Medica Brasileira (1992)
|July 25, 2009
PubMed
Summary

Patient consent forms in oncology clinics are too difficult for most Brazilians to understand. Despite good content, the reading level requires 18 years of education, far exceeding the population's average literacy skills.

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Area of Science:

  • Medical Ethics
  • Health Literacy
  • Clinical Research

Context:

  • Consent Forms (CF) are crucial for patient autonomy in healthcare studies.
  • Concerns exist regarding the complexity and readability of CFs for the general population.
  • This study focuses on CFs within an oncology outpatient clinic setting.

Purpose:

  • To assess the readability of Consent Forms using the Flesch Index (FI) and Flesch-Kincaid Index (FKI).
  • To correlate CF readability with the educational profile of patients in a Brazilian oncology clinic.
  • To evaluate the presence of essential information in CFs as per Brazilian Health Council Resolution 196/96.

Summary:

  • Ten Consent Forms were analyzed, revealing mean FI of 38.5 and FKI of 18.16.
  • This indicates a required educational level of at least 18 years for comprehension.
  • CFs were generally well-elaborated with adequate content, but readability did not correlate with content quality (p=0.884).

Impact:

  • The study highlights a significant gap between CF readability and the literacy levels of the Brazilian population.
  • Findings suggest a need for revised CFs to ensure better patient understanding and informed consent.
  • Improves health literacy and ethical considerations in clinical research within Brazil.