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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
Medical Decision Making. 2008 Jul-Aug;28(4) :575-581
PMID: ISI:000257836200013   
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Abstract
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.
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ISI Document Delivery No.: 328ZH Times Cited: 0 Cited Reference Count: 19 Cited References: AGRAWAL M, 2003, JAMA-J AM MED ASSOC, V290, P1075 ALICKE MD, 1995, J PERS SOC PSYCHOL, V68, P804 CHENG JD, 2000, J CLIN ONCOL, V18, P421 COX AC, 2006, SUPPORT CARE CANCER, V14, P303 DAUGHERTY C, 1995, J CLIN ONCOL, V13, P1062 EHRENREICH B, 2001, HARPERS MAGAZINE, V303, P43 HACKING I, 1975, EMERGENCE PROBABILIT HENDERSON GE, 2006, SOC SCI MED, V62, P239 HORNG S, 2002, NEW ENGL J MED, V347, P2134 HORNG S, 2003, IRB ETHICS HUMAN RES, V25, P11 KAHNEMAN D, 1982, JUDGMENT UNCERTAINTY, P509 KING NMP, 2005, IRB, V27, P1 MENIKOFF J, 2003, NEW ENGL J MED, V348, P1496 MEROPOL NJ, 2003, J CLIN ONCOL, V21, P2589 WEINFURT KP, 2003, CANCER, V98, P166 WEINFURT KP, 2003, THEOR MED BIOETH, V24, P329 WEINFURT KP, 2004, THEOR PSYCHOL, V14, P191 WILLIS GB, 2005, COGNITIVE INTERVIEWI ZASLOW J, 2007, WALL STREET J 0405, D1 Weinfurt, Kevin P. Seils, Damon M. Tzeng, Janice P. Compton, Kate L. Sulmasy, Daniel P. Astrow, Alan B. Solarino, Nicholas A. Schulman, Kevin A. Meropol, Neal J. SAGE PUBLICATIONS INC; 2455 TELLER RD, THOUSAND OAKS, CA 91320 USA