Development and initial validation of the Therapeutic Misunderstanding Scale for use with clinical trials research participants

Aging and Mental Health

Volumn 16, Issue 2, 2012, Pages 145-153

  Chou, Pak Hei Benedito ^a   Orourke, Norm ^a  

^a SIMON FRASER UNIVERSITY   (Canada)

Author keywords

scale construction; test validation; therapeutic misconception; therapeutic misunderstanding scale

Indexed keywords

AGED; ARTICLE; CLINICAL TRIAL (TOPIC); FACTORIAL ANALYSIS; FEMALE; HUMAN; INFORMED CONSENT; INSTRUMENTATION; MALE; METHODOLOGY; MIDDLE AGED; PSYCHOLOGICAL ASPECT; PSYCHOMETRY; QUESTIONNAIRE; REPRODUCIBILITY; THERAPEUTIC MISCONCEPTION; VALIDATION STUDY;

AGED; AGED, 80 AND OVER; CLINICAL TRIALS AS TOPIC; FACTOR ANALYSIS, STATISTICAL; FEMALE; HUMANS; INFORMED CONSENT; MALE; MIDDLE AGED; PSYCHOMETRICS; QUESTIONNAIRES; REPRODUCIBILITY OF RESULTS; RESEARCH DESIGN; THERAPEUTIC MISCONCEPTION;

EID: 84855957249     PISSN: 13607863     EISSN: 13646915     Source Type: Journal    
DOI: 10.1080/13607863.2011.602962     Document Type: Article

References (41)

1. Appelbaum, PS. 2002. Clarifying the ethics of clinical research: A path toward avoiding the therapeutic misconception. The American Journal of Bioethics, 2: 22-23.
2. Appelbaum, PS, Lidz, CW, and, Grisso, T. 2004. Therapeutic misconception in clinical research: Frequency and risk factors. IRB: Ethics and Human Research, 26 (2): 1-8. (Pubitemid 41585058)
3. Appelbaum, PS, Roth, LH, and, Lidz, C. 1982. The therapeutic misconception: Informed consent in psychiatric research. International Journal of Law and Psychiatry, 5: 319-329.
4. Appelbaum, PS, Roth, LH, Lidz, C, Benson, P, and, Winslade, W. 1987. False hopes and best data: Consent to research and the therapeutic misconception. Hastings Center Report, 17: 20-24.
5. Burnett, CB, Koczwara, B, Pixley, L, Blumenson, LE, Hwang, YT, and, Meropol, NJ. 2001. Nurses attitudes toward clinical trials at a comprehensive cancer center. Oncology Nursing Forum, 28: 1187-1192.
6. Clark, LA, and, Watson, D. 1995. Constructing validity: Basic issues in objective scale development. Psychological Assessment, 7: 309-319.
7. Daugherty, C, Ratain, MJ, Grochowski, E, Stocking, C, Kodish, E, Mich, R, and, Siegler, M. 1995. Perceptions of cancer patients and their physicians involved in phase I trials. Journal of Clinical Oncology, 13: 1062-1072.
8. Dresser, R. 2002. The ubiquity and utility of the therapeutic misconception. Social Philosophy and Policy Foundation, 19: 271-294.
9. Dunn, LB, Palmer, BW, Keehan, M, Jeste, DV, and, Appelbaum, PS. 2006. Assessment of therapeutic misconception in older schizophrenia patients with a brief instrument. The American Journal of Psychiatry, 163: 500-506. (Pubitemid 44469394)
10. Featherstone, K, and, Donovan, JL. 2002. Why dont they just tell me straight, why allocate it? The struggle to make sense of participating in a randomized controlled trial. Social Science and Medicine, 55: 709-719. (Pubitemid 34754288)
11. Floyd, FJ, and, Widaman, KF. 1995. Factor analysis in the development and refinement of clinical assessment instruments. Psychological Assessment, 7: 286-299.
12. Gosling, SD, Vazire, S, Srivastava, S, and, John, OP. 2004. Should we trust web-based studies? A comparative analysis of six preconceptions about internet questionnaires. American Psychologist, 59: 93-104. (Pubitemid 38318025)
13. Granello, DH, and, Wheaton, JE. 2004. Online data collection: Strategies for research. Journal of Counseling and Development, 82: 387-393. (Pubitemid 39665911)
14. Henderson, GE, Churchill, LR, Davis, AM, Easter, MM, Grady, C, Joffe, S, Zimmer, CR. 2007. Clinical trials and medical care: Defining therapeutic misconception. Public Library of Science-Medicine, 4: 1735-1738. (Pubitemid 350220527)
15. Hertwig, R, Pachur, T, and, Kurzenhuser, S. 2005. Judgments of risk frequencies: Tests of possible cognitive mechanisms. Journal of Experimental Psychology: Learning, Memory, and Cognition, 31: 621-642. (Pubitemid 41168511)
16. Horng, S, and, Grady, C. 2003. Misunderstanding in clinical research: Distinguishing therapeutic misconception, therapeutic misestimation, and therapeutic optimism. IRB: Ethics and Human Research, 25: 11-16. (Pubitemid 41585063)
17. Hu, LT, and, Bentler, PM. 1999. Cutoff criteria for fit indices in covariance structure analysis: Conventional criteria versus new alternatives. Structural Equation Modeling, 6: 1-55.
18. Joffe, S, Cook, EF, Cleary, PD, Clark, JW, and, Weeks, JC. 2001. Quality of informed consent in cancer clinical trials: A cross-sectional survey. The Lancet, 358: 1772-1777. (Pubitemid 33153003)
19. Kerr, C, Robinson, E, Stevens, A, Braunholtz, D, Edwards, S, and, Lilford, R. 2004. Randomisation in trials: Do potential trial participants understand it and find it acceptable?. Journal of Medical Ethics, 30: 80-84. (Pubitemid 38262814)
20. Kline, RB. 2005. Principles and practice of structural equation modeling, 2nd, New York: The Guilford Press.
21. Kimmelman, J. 2007. Therapeutic misconception at 25: Treatment, research, and confusion. Hastings Centre Report, 37: 36-42.
22. Lidz, CW, and, Appelbaum, PS. 2002. The therapeutic misconception: Problems and solutions. Medical Care, 40: 55-63.
23. MacCallum, RC, Browne, MW, and, Sugawara, HM. 1996. Power analysis and determination of sample size for covariance structure modeling. Psychological Methods, 1: 130-149. (Pubitemid 126672841)
24. Meropol, NJ, Weinfurt, KP, Burnett, CB, Balshem, A, Benson, AB, Castel, L, Schulman, KA. 2003. Perceptions of patients and physicians regarding phase I cancer clinical trials: Implications for physician-patient communication. Journal of Clinical Oncology, 21: 2589-2596. (Pubitemid 46606342)
25. Miller, FG. 2002. Ethical significance of ethics-related empirical research. [Editorial]. Journal of the National Cancer Institute, 94: 1821-1822. (Pubitemid 36104619)
26. Miller, FG, and, Joffe, S. 2006. Evaluating the therapeutic misconception. Kennedy Institute of Ethics Journal, 16: 353-366.
27. ORourke, N. 2005. Personality, cognitive adaptation, and marital satisfaction as predictors of well-being among older married adults. Canadian Journal on Aging, 24: 211-224.
28. ORourke, N, and, Cappeliez, P. 2002. Development and validation of a couples measure of biased responding: The marital aggrandizement scale. Journal of personality assessment, 78: 301-320. (Pubitemid 34602864)
29. ORourke, N. & Chou, P.H.B. (2008). Validity of responses to the Therapeutic Misunderstanding Scale among clinical trials research participants. Poster session presented at The Annual Scientific and Educational Meeting of the Canadian Association on Gerontology, London (ON), Canada
30. Paulhus, DL. 1991. Measurement and control of response bias. In Measures of personality and social psychological attitudes: Measures of social psychological attitudes, Edited by: Robinson, JP, Shaver, PR and Wrightsman, LS. Vol. 1, 17-59. San Diego, CA: Academic Press.
31. Reips, U-D. 2006. Web-based methods. In Handbook of multimethod measurement in psychology, Edited by: Eid, M and Diener, E. 73-85. Washington, DC: American Psychological Association.
32. Sankar, P. 2004. Communication and miscommunication in informed consent to research. Medical Anthropology Quarterly, 18: 429-446. (Pubitemid 41277778)
33. Scheier, MF, and, Carver, CS. 1985. Optimism, coping, and health: Assessment and implications of generalized outcome expectancies. Health Psychology, 4: 219-247.
34. Schron, EB, Wassertheil-Smoller, S, and, Pressel, S. 1997. Clinical trial participant satisfaction: Survey of SHEP enrollees. Journal of American Geriatrics Society, 45: 934-938. (Pubitemid 27330122)
35. Segerstrom, SC, Taylor, SE, Kemeny, ME, and, Fahey, JL. 1998. Optimism is associated with mood, coping, and immune change in response to stress. Journal of Personality and Social Psychology, 74: 1646-1655. (Pubitemid 128658126)
36. Statistics Canada (2007). A portrait of seniors in Canada. Retrieved from http://www.statcan.ca/english/ads/89-519-XPE/index.htm
37. Tabachnick, BG, and, Fidell, LS. 2007. Using multivariate statistics, 5th, New York: Allyn and Bacon.
38. Taylor, SE, Kemeny, ME, Reed, GM, Bower, JE, and, Gruenewald, TL. 2000. Psychological resources, positive illusions, and health. American Psychologist, 55: 99-109.
39. Taylor, SE, Lichtman, RR, and, Wood, JV. 1984. Attributions, beliefs about control, and adjustment to breast cancer. Journal of Personality and Social Psychology, 46: 489-502.
40. Wilkinson, L, and, Task Force on Statistical Inference., APA. 1999. Statistical methods in psychology journals: Guidelines and explanations. American Psychologists, 54: 594-604.
41. Woloshin, KK, Ruffin, MT, and, Gorenflo, DW. 1994. Patients interpretation of qualitative probability statements. Archives of Family Medicine, 3: 961-966.