title: Dispositional optimism and therapeutic expectations in early-phase oncology trials.
abstract: BACKGROUND
  Prior research has identified unrealistic optimism as a bias that might impair informed consent among patient-subjects in early-phase oncology trials. However, optimism is not a unitary construct; it also can be defined as a general disposition, or what is called dispositional optimism. The authors assessed whether dispositional optimism would be related to high expectations for personal therapeutic benefit reported by patient-subjects in these trials but not to the therapeutic misconception. The authors also assessed how dispositional optimism related to unrealistic optimism.
  
  
  METHODS
  Patient-subjects completed questionnaires designed to measure expectations for therapeutic benefit, dispositional optimism, unrealistic optimism, and the therapeutic misconception.
  
  
  RESULTS
  Dispositional optimism was found to be significantly associated with higher expectations for personal therapeutic benefit (Spearman rank correlation coefficient [r], 0.333; P<.0001), but was not associated with the therapeutic misconception (Spearman r, -0.075; P = .329). Dispositional optimism was found to be weakly associated with unrealistic optimism (Spearman r, 0.215; P = .005). On multivariate analysis, both dispositional optimism (P = .02) and unrealistic optimism (P<.0001) were found to be independently associated with high expectations for personal therapeutic benefit. Unrealistic optimism (P = .0001), but not dispositional optimism, was found to be independently associated with the therapeutic misconception.
  
  
  CONCLUSIONS
  High expectations for therapeutic benefit among patient-subjects in early-phase oncology trials should not be assumed to result from misunderstanding of specific information regarding the trials. The data from the current study indicate that these expectations are associated with either a dispositionally positive outlook on life or biased expectations concerning specific aspects of trial participation. Not all manifestations of optimism are the same, and different types of optimism likely have different consequences for informed consent in early-phase oncology research.
authors.affiliation: Madeline Brill Nelson Chair in Ethics Education, Center for Ethics in Health Care, Oregon Health & Science University, Portland, Oregon.
authors.forename: Lynn A
authors.initials: LA
authors.lastname: Jansen
authors.affiliation: Professor of Medicine, University of Arizona Cancer Center.
authors.forename: Daruka
authors.initials: D
authors.lastname: Mahadevan
authors.affiliation: Division of Law, Ethics, and Psychiatry, Columbia University College of Physicians and Surgeons, New York, New York.
authors.forename: Paul S
authors.initials: PS
authors.lastname: Appelbaum
authors.affiliation: Behavioral Research Program, National Cancer Institute, National Institutes of Health, Bethesda, Maryland.
authors.forename: William M P
authors.initials: WM
authors.lastname: Klein
authors.affiliation: Professor Emeritus, Department of Human Ecology, Rutgers University, New Brunswick, New Jersey.
authors.forename: Neil D
authors.initials: ND
authors.lastname: Weinstein
authors.affiliation: Department of Cancer Biostatistics, School of Public Health and Medicine, Oregon Health & Science University, Knight Cancer Institute, Portland, Oregon.
authors.forename: Motomi
authors.initials: M
authors.lastname: Mori
authors.affiliation: Department of Statistics, Oregon Health & Science University, Knight Cancer Institute, Portland, Oregon.
authors.forename: Racky
authors.initials: R
authors.lastname: Daffé
authors.affiliation: Department of Medicine, University of Chicago, Chicago, Illinois.|Divinity School, University of Chicago, Chicago, Illinois.
authors.forename: Daniel P
authors.initials: DP
authors.lastname: Sulmasy
mesh_terms: D000293:Adolescent; D000328:Adult; D000367:Age Factors; D000368:Aged; D000704:Analysis of Variance; D002986:Clinical Trials as Topic; D003131:Combined Modality Therapy; D032882:Comprehension; D004522:Educational Status; D005260:Female; D006801:Humans; D007258:Informed Consent; D016014:Linear Models; D008297:Male; D008875:Middle Aged; D015999:Multivariate Analysis; D009369:Neoplasms / Q000473:pathology / Q000628:therapy*; D000067656:Optimism / Q000523:psychology*; D011379:Prognosis; D018570:Risk Assessment; D012737:Sex Factors; D012959:Socioeconomic Factors; D055990:Therapeutic Misconception / Q000523:psychology*; D016896:Treatment Outcome; D014481:United States; D055815:Young Adult
keywords: cancer research; dispositional optimism; informed consent; therapeutic misconception; therapeutic optimism