Providing detailed informed consent does not appear to improve patients’ comprehension, according to a study published on researchsquare.com as a preprint and not yet peer reviewed.
Key Takeaway
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Patients with cancer are equally likely to understand their treatment when provided long, involved informed consent forms designed for clinical trials and shorter, less comprehensive forms used in routine care.
Why This Matters
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The findings suggest that the significant efforts involved in providing informed consent to patients in clinical trials may have limited value and that these procedures can be improved.
Study Design
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The investigators compared comprehension and satisfaction between 82 newly diagnosed cancer patients who consented to clinical trials and 89 who consented to standard chemotherapy.
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Both groups filled out a questionnaire. Trial participants also had a structured interview, and routine care patients completed a follow-up questionnaire 6 months later.
Key Results
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Trial consent forms ran up to 40 pages; the routine care form was six pages.
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Patients in both groups said they understood and were satisfied with the information provided.
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However, 20% of patients in both groups could not name their cancer diagnosis correctly.
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In addition, about 20% of patients in both groups had trouble understanding the forms, and 10% in both did not read the information.
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Of patients in the clinical trial group, 89% said they understood the purpose of the trial, 9% reported only a partial understanding, and 2% did not understand the purpose at all.
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In addition, 40% said they read their consent documents in less than 15 minutes.
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For those receiving routine care, 75% said they knew the goal of treatment, 18% said the goal was unclear, and 7% did not know the treatment goal at all.
Limitations
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The questionnaire has not been validated outside of the study institution.
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Patients who were interviewed might have felt pressured to give positive answers.
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The goal of therapy was cure in the trial group, but it was often palliative in the routine care group, which might have led to selection bias.
Disclosures
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The authors reported no study funding.
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The two senior authors are advisors, speakers, and/or researchers for several companies, including Janssen and Novartis.
This is a summary of a preprint research study, “Struggling with Extensive Informed Consent Procedures for Cancer Trails – Is There Even a Benefit for the Patients?” The study has not been peer reviewed. The full text can be found at researchsquare.com.
M. Alexander Otto is a physician assistant with a master’s degree in medical science. He is an award-winning medical journalist who worked for several major news outlets before joining Medscape and is an MIT Knight Science Journalism fellow. Email: [email protected].
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