TY - JOUR
T1 - Preventive Misconception. Its Nature, Presence, and Ethical Implications for Research
AU - Simon, Alan E.
AU - Wu, Albert W.
AU - Lavori, Philip W.
AU - Sugarman, Jeremy
N1 - Funding Information:
Support for this project was provided by the Robert Wood Johnson Clinical Scholars Program. The authors would like to thank Marie Diener-West and Sorina Eftim for their statistical consultations, as well as Julia Anixt, Connie Hwang, Kenric Maynor, Michelle Lewis, Kim Stone, Rachel Dodge, Melissa DeLong, and Tony Boonyasai for their help with this project.
Copyright:
Copyright 2008 Elsevier B.V., All rights reserved.
PY - 2007/5
Y1 - 2007/5
N2 - Background: Ethical aspects of prevention trials, as they differ from therapeutic trials, have not been fully explored. This article aims to define and demonstrate the existence of "preventive misconception" (PM), a misunderstanding in which research participants in prevention trials make an "overestimate in probability or level of personal protection that is afforded by being enrolled in a trial of a preventive intervention.". Methods: A rating tool was developed to evaluate PM, using data collected between August 2000 and July 2002 as part of a nationwide study of the quality of informed consent in a trial of a shingles vaccine. During 2005-2006, two pair of raters assessed the responses of 50 participants to questions asked after the participants had given consent to participate in the shingles trial. Two pair of raters evaluated the response for the presence and type of PM. Each pair of raters adjudicated their responses and inter-rater reliability was assessed. Results: Adjudicated pairs of raters agreed that 32% (CI: 20.7%-45.9%) of participants showed evidence of PM (kappa=0.71, CI: 0.52-0.90); that 12% (CI: 5.2%-24.2%) of participants underestimated the probability of receiving placebo (kappa=0.53, CI: 0.24-0.83); and that 24% (CI: 14.2%-37.6%) overestimated the likely personal effectiveness of the experimental intervention (kappa=0.42, CI: 0.08-0.76). Conclusions: This study newly describes the concept of preventive misconception and empirically demonstrates its existence in trials of prevention. Study participants may overestimate the protection that they receive by being enrolled in a trial of prevention, which poses ethical challenges for research.
AB - Background: Ethical aspects of prevention trials, as they differ from therapeutic trials, have not been fully explored. This article aims to define and demonstrate the existence of "preventive misconception" (PM), a misunderstanding in which research participants in prevention trials make an "overestimate in probability or level of personal protection that is afforded by being enrolled in a trial of a preventive intervention.". Methods: A rating tool was developed to evaluate PM, using data collected between August 2000 and July 2002 as part of a nationwide study of the quality of informed consent in a trial of a shingles vaccine. During 2005-2006, two pair of raters assessed the responses of 50 participants to questions asked after the participants had given consent to participate in the shingles trial. Two pair of raters evaluated the response for the presence and type of PM. Each pair of raters adjudicated their responses and inter-rater reliability was assessed. Results: Adjudicated pairs of raters agreed that 32% (CI: 20.7%-45.9%) of participants showed evidence of PM (kappa=0.71, CI: 0.52-0.90); that 12% (CI: 5.2%-24.2%) of participants underestimated the probability of receiving placebo (kappa=0.53, CI: 0.24-0.83); and that 24% (CI: 14.2%-37.6%) overestimated the likely personal effectiveness of the experimental intervention (kappa=0.42, CI: 0.08-0.76). Conclusions: This study newly describes the concept of preventive misconception and empirically demonstrates its existence in trials of prevention. Study participants may overestimate the protection that they receive by being enrolled in a trial of prevention, which poses ethical challenges for research.
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U2 - 10.1016/j.amepre.2007.01.007
DO - 10.1016/j.amepre.2007.01.007
M3 - Article
C2 - 17478261
AN - SCOPUS:34247485894
SN - 0749-3797
VL - 32
SP - 370
EP - 374
JO - American journal of preventive medicine
JF - American journal of preventive medicine
IS - 5
ER -