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Expectations of benefit in early-phase clinical trials: implications for assessing the adequacy of informed consent.

Publication ,  Journal Article
Weinfurt, KP; Seils, DM; Tzeng, JP; Compton, KL; Sulmasy, DP; Astrow, AB; Solarino, NA; Schulman, KA; Meropol, NJ
Published in: Med Decis Making
2008

BACKGROUND: Participants in early-phase clinical trials have reported high expectations of benefit from their participation. There is concern that participants misunderstand the trials to which they have consented, which is based on assumptions about what patients mean when responding to questions about likelihood of benefit. METHODS: Participants were 27 women and 18 men in early-phase oncology trials at 2 academic medical centers in the United States. To determine whether expectations of benefit differ depending on how patients are queried, the authors randomly assigned participants to 1 of 3 interviews corresponding to 3 questions about likelihood of benefit: frequency type, belief type, and vague. In semistructured interviews, participants were queried about how they understood and answered the question. Participants then answered and discussed 1 of the other questions. RESULTS: Expectations of benefit in response to the belief-type question were significantly greater than expectations in response to the frequency-type and vague questions (P=0:02). The most common justifications involved positive attitude (n=27 [60%]) and references to physical health (n=23 [51%]). References to positive attitude were most common among participants with higher (> 70%) expectations (n = 11 [85%]) and least common among those with lower ( < 50%) expectations (n = 3 [27%]). CONCLUSIONS: The wording of questions about likelihood of benefit shapes the expectations that patients express. Patients who express high expectations may not do so to communicate understanding but rather to register optimism. Ongoing research will clarify the meaning of high expectations and examine methods for assessing understanding.

Duke Scholars

Published In

Med Decis Making

DOI

ISSN

0272-989X

Publication Date

2008

Volume

28

Issue

4

Start / End Page

575 / 581

Location

United States

Related Subject Headings

  • Neoplasms
  • Middle Aged
  • Male
  • Informed Consent
  • Humans
  • Health Policy & Services
  • Female
  • Comprehension
  • Clinical Trials as Topic
  • 4206 Public health
 

Citation

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ICMJE
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Weinfurt, K. P., Seils, D. M., Tzeng, J. P., Compton, K. L., Sulmasy, D. P., Astrow, A. B., … Meropol, N. J. (2008). Expectations of benefit in early-phase clinical trials: implications for assessing the adequacy of informed consent. Med Decis Making, 28(4), 575–581. https://doi.org/10.1177/0272989X08315242
Weinfurt, Kevin P., Damon M. Seils, Janice P. Tzeng, Kate L. Compton, Daniel P. Sulmasy, Alan B. Astrow, Nicholas A. Solarino, Kevin A. Schulman, and Neal J. Meropol. “Expectations of benefit in early-phase clinical trials: implications for assessing the adequacy of informed consent.Med Decis Making 28, no. 4 (2008): 575–81. https://doi.org/10.1177/0272989X08315242.
Weinfurt KP, Seils DM, Tzeng JP, Compton KL, Sulmasy DP, Astrow AB, et al. Expectations of benefit in early-phase clinical trials: implications for assessing the adequacy of informed consent. Med Decis Making. 2008;28(4):575–81.
Weinfurt, Kevin P., et al. “Expectations of benefit in early-phase clinical trials: implications for assessing the adequacy of informed consent.Med Decis Making, vol. 28, no. 4, 2008, pp. 575–81. Pubmed, doi:10.1177/0272989X08315242.
Weinfurt KP, Seils DM, Tzeng JP, Compton KL, Sulmasy DP, Astrow AB, Solarino NA, Schulman KA, Meropol NJ. Expectations of benefit in early-phase clinical trials: implications for assessing the adequacy of informed consent. Med Decis Making. 2008;28(4):575–581.
Journal cover image

Published In

Med Decis Making

DOI

ISSN

0272-989X

Publication Date

2008

Volume

28

Issue

4

Start / End Page

575 / 581

Location

United States

Related Subject Headings

  • Neoplasms
  • Middle Aged
  • Male
  • Informed Consent
  • Humans
  • Health Policy & Services
  • Female
  • Comprehension
  • Clinical Trials as Topic
  • 4206 Public health