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Informed consent for clinical trials: a comparative study of standard versus simplified forms
T C Davis1, R F Holcombe, H J Berkel
1Department of Medicine and Pediatrics, Feist-Weiller Cancer Center, Louisiana State University Medical Center-Shreveport 71130, USA. tdavis@mail-sh.lsumc.edu
Journal of the National Cancer Institute
|May 20, 1998
Summary
Simplified consent forms are preferred by participants with low literacy skills, but comprehension remains similar to standard forms. This highlights the need for improved informed consent document design.
Area of Science:
- Clinical research ethics
- Health literacy
- Patient communication
Background:
- Informed consent forms require high reading skills, posing a barrier for many research participants.
- Individuals with low-to-marginal reading skills may struggle to understand essential study information.
Purpose of the Study:
- To evaluate if a simplified consent form is less intimidating and better understood by individuals with low reading skills.
- To compare participant preference and comprehension between standard and simplified consent forms.
Main Methods:
- 183 adults (patients and healthy controls) were assessed for reading ability.
- Participants read either a standard (16th grade) or simplified (7th grade) consent form.
- Attitudes, comprehension, and form preference were evaluated through interviews.
Main Results:
- Participants overwhelmingly preferred the simplified Louisiana State University Medical Center-Shreveport (LSU) form over the standard Southwestern Oncology Group (SWOG) form (62% vs. 38%).
- The simplified LSU form was perceived as significantly easier to read (97% vs. 75%).
- Comprehension levels were comparable between the two forms (58% for LSU vs. 56% for SWOG).
Conclusions:
- Simplified consent forms enhance readability and preference among individuals with limited literacy.
- Current informed consent document designs may be inadequate for a significant portion of the population.
- Further research is needed to improve the design of informed consent documents for better comprehension.