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Why Is Therapeutic Misconception So Prevalent?

Published online by Cambridge University Press:  26 February 2015

Abstract:

Therapeutic misconception (TM)—when clinical research participants fail to adequately grasp the difference between participating in a clinical trial and receiving ordinary clinical care—has long been recognized as a significant problem in consent to clinical trials. We suggest that TM does not primarily reflect inadequate disclosure or participants’ incompetence. Instead, TM arises from divergent primary cognitive frames. The researchers’ frame places the clinical trial in the context of scientific designs for assessing intervention efficacy. In contrast, most participants have a cognitive frame that is personal and focused primarily on their medical problems. To illustrate this, we draw on interview material from both clinical researchers and participants in clinical trials. We suggest that reducing TM requires encouraging subjects to adjust their frame, not just add information to their existing frame. What is necessary is a scientific reframing of participation in a clinical trial.

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Departments and Columns
Copyright
Copyright © Cambridge University Press 2015 

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References

Notes

1. Fried, C. Medical Experimentation: Personal Integrity and Social Policy. New York: American Elsevier; 1974.Google Scholar

2. Appelbaum, PS, Roth, LH, Lidz, C. The therapeutic misconception: Informed consent in psychiatric research. International Journal of Law and Psychiatry 1982;5(3–4):319–29.CrossRefGoogle ScholarPubMed

3. Appelbaum, P, Lidz, C. The therapeutic misconception. In: Emanual, E, Crouch, R, Lie, R, Miller, F, Wendler, D, eds. The Oxford Textbook of Clinical Research Ethics. New York: Oxford University Press; 2008:633–44.Google Scholar

4. Appelbaum, P, Roth, L, Lidz, C, Winslade, W. False hopes and best data: Consent to research and the therapeutic misconception. Hastings Center Report 1987;17(2):20–4.CrossRefGoogle ScholarPubMed

5. Appelbaum, PS, Lidz, CW, Grisso, T. Therapeutic misconception in clinical research: Frequency and risk factors. IRB 2004;26(2):18.CrossRefGoogle ScholarPubMed

6. Dunn, L, Palmer, B, Keehan, M, Jeste, D, Appelbaum, P. Assessment of therapeutic misconception in older schizophrenia patients with a brief instrument. American Journal of Psychiatry 2006;163(3):500–6.CrossRefGoogle ScholarPubMed

7. Kim, S, Schrock, L, Wilson, R, Frank, S, Holloway, R, Kieburtz, K, et al. An approach to evaluating the therapeutic misconception. IRB 2009;31(5):714.Google ScholarPubMed

8. Joffe, S, Cook, E, Cleary, P, Clark, J, Weeks, J. Quality of informed consent: A new measure of understanding among research subjects. Journal of the National Cancer Institute 2001;93(2):139–47.CrossRefGoogle ScholarPubMed

9. Appelbaum, P, Anatchkova, M, Albert, K, Dunn, L, Lidz, C. Therapeutic misconception in research subjects: Development and validation of a measure. Clinical Trials 2012;9:748–61.CrossRefGoogle ScholarPubMed

10. Henderson, G, Easter, M, King, N, Davis, A, Rothschild, B, Churchill, L, et al. Therapeutic misconception in early phase gene transfer trials. Social Science in Medicine 2006;62(1):239–53.CrossRefGoogle ScholarPubMed

11. See note 8, Joffe et al. 2001.

12. Appelbaum, P, Lidz, C. Re-evaluating the therapeutic misconception: Response to Miller and Joffe. Kennedy Institute of Ethics Journal 2006;16(4):353–6.CrossRefGoogle ScholarPubMed

13. Kimmelman, J. The therapeutic misconception at 25: Treatment, research, and confusion. Hastings Center Report 2007;37(6):3642.CrossRefGoogle ScholarPubMed

14. See note 8, Joffe et al. 2001.

15. Dunn, L, Lindamer, L, Palmer, B, Schneiderman, L, Jeste, D. Enhancing comprehension of consent for research in older patients with psychosis: A randomized study of a novel consent procedure. American Journal of Psychiatry 2001;158(11):1911–13.CrossRefGoogle ScholarPubMed

16. Woodsong, C, Karim, Q. A model designed to enhance informed consent: Experiences from the HIV Prevention Trials Network. American Journal of Public Health 2005;95(3):412–19.CrossRefGoogle ScholarPubMed

17. Kass, NE, Sugarman, J, Medley, A, Fogarty, L, Taylor, H, Daugherty, C, et al. An intervention to improve cancer patients’ understanding of early-phase clinical trials. IRB 2009;31(3):1–10.Google ScholarPubMed

18. See note 5, Appelbaum et al. 2004.

19. Henderson, G, Churchill, L, Davis, A, Easter, M, Grady, C, Joffe, S, et al. Defining the therapeutic misconception: Problems and prospects. PLoS Medicine 2007;3(10):14.Google Scholar

20. Horng, S, Grady, C. Misunderstanding in clinical research: Distinguishing therapeutic misconception, therapeutic misestimation and therapeutic optimism. IRB 2003;25(1):1116.CrossRefGoogle ScholarPubMed

21. See note 7, Kim et al. 2009.

22. Sulmasy, D, Astrow, A, Me, M, Sells, D, Meropol, N, Micco, E, et al. The culture of faith and hope: Patients’ justifications for their high estimations of expected therapeutic benefit when enrolling in early phase oncology trials. Cancer 2010;116:3702–11.CrossRefGoogle ScholarPubMed

23. Goffman, E. Frame Analysis. New York: Harper Colophon; 1974.Google Scholar

24. See note 15, Dunn et al. 2001.

25. See note 4, Appelbaum et al. 1987.

26. Lidz, C, Appelbaum, P, Grisso, T, Renaud, M. Therapeutic misconception and the appreciation of risks in clinical trials. Social Science & Medicine 2004;58(9):1689–97.CrossRefGoogle ScholarPubMed

27. See note 23 Goffman 1974.

28. Lidz, C, Appelbaum, P. The therapeutic misconception: Problems and solutions. Medical Care 2002;40(Suppl):v5563.CrossRefGoogle ScholarPubMed