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A randomized controlled trial comparing quantitative informed consent formats.

D L Simel1, J R Feussner

  • 1Ambulatory Care Service, Durham Veterans Administration Medical Center, North Carolina 27705.

Journal of Clinical Epidemiology
|January 1, 1991
PubMed
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Patients are more likely to consent to a clinical trial when presented with information suggesting faster treatment benefits. Quantitative details significantly influence informed consent decisions, especially regarding perceived treatment speed.

Area of Science:

  • Medical Ethics
  • Clinical Trial Design
  • Patient Decision-Making

Background:

  • Informed consent research has historically lacked real-world applicability.
  • Previous studies did not accurately simulate the actual consent process.

Purpose of the Study:

  • To investigate how quantitative information in consent forms affects patient consent rates.
  • To assess the impact of perceived treatment efficacy on informed consent.

Main Methods:

  • A sham randomized controlled trial was conducted with adult ambulatory patients.
  • Two consent forms were used: one describing a medication twice as fast, the other half as fast.
  • Patients were randomized to receive either Consent A or Consent B.

Main Results:

Keywords:
Biomedical and Behavioral ResearchEmpirical Approach

Related Experiment Videos

  • Consent rates were significantly higher for Consent A (67%) compared to Consent B (42%).
  • Patients citing quantitative information showed a stark difference in consent (95% vs. 36%).
  • Perceived symptom severity also influenced consent rates, with extreme perceptions leading to lower consent.

Conclusions:

  • The way quantitative information is presented critically impacts informed consent.
  • Patients who recognize and process quantitative data actively use it in their decision-making.
  • Trial design and communication of potential benefits are key factors in patient recruitment.