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A randomized controlled trial comparing quantitative informed consent formats.

Publication ,  Journal Article
Simel, DL; Feussner, JR
Published in: J Clin Epidemiol
1991

Informed consent has been indirectly studied only in settings that do not replicate the actual consent process. We designed a sham study and randomly allocated adult ambulatory patients to receive one of two consent forms: Consent A (n = 52) described a randomized trial of usual treatment vs a new medication that "may work twice as fast as the usual treatment"; or Consent B (n = 48) that described a randomized trial of a new medication that "may work half as fast as the usual treatment". Patients randomized to Consent A were more likely to consent than those randomized to Consent B (consent rate A = 67%, consent rate B = 42%, p less than 0.01). Among patients who cited quantitative information, the difference in consent rate was even more marked (95% vs 36%, p less than 0.001); patients who did not cite quantitative information had equivalent consent rates. Patients who perceived minimal or severe symptoms had lower consent rates than those with mid-range symptom scores (chi 2(2) = 8.35, p = 0.015). Patients who recognize quantitative information will use it to make informed consent decisions.

Duke Scholars

Published In

J Clin Epidemiol

DOI

ISSN

0895-4356

Publication Date

1991

Volume

44

Issue

8

Start / End Page

771 / 777

Location

United States

Related Subject Headings

  • Research Subjects
  • Patient Participation
  • Middle Aged
  • Informed Consent
  • Humans
  • Epidemiology
  • Decision Making
  • Consent Forms
  • Comprehension
  • Behavioral Research
 

Citation

APA
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ICMJE
MLA
NLM
Simel, D. L., & Feussner, J. R. (1991). A randomized controlled trial comparing quantitative informed consent formats. J Clin Epidemiol, 44(8), 771–777. https://doi.org/10.1016/0895-4356(91)90129-w
Simel, D. L., and J. R. Feussner. “A randomized controlled trial comparing quantitative informed consent formats.J Clin Epidemiol 44, no. 8 (1991): 771–77. https://doi.org/10.1016/0895-4356(91)90129-w.
Simel DL, Feussner JR. A randomized controlled trial comparing quantitative informed consent formats. J Clin Epidemiol. 1991;44(8):771–7.
Simel, D. L., and J. R. Feussner. “A randomized controlled trial comparing quantitative informed consent formats.J Clin Epidemiol, vol. 44, no. 8, 1991, pp. 771–77. Pubmed, doi:10.1016/0895-4356(91)90129-w.
Simel DL, Feussner JR. A randomized controlled trial comparing quantitative informed consent formats. J Clin Epidemiol. 1991;44(8):771–777.
Journal cover image

Published In

J Clin Epidemiol

DOI

ISSN

0895-4356

Publication Date

1991

Volume

44

Issue

8

Start / End Page

771 / 777

Location

United States

Related Subject Headings

  • Research Subjects
  • Patient Participation
  • Middle Aged
  • Informed Consent
  • Humans
  • Epidemiology
  • Decision Making
  • Consent Forms
  • Comprehension
  • Behavioral Research