What do our patients understand about their trial participation? Assessing patients' understanding of their informed consent consultation about randomised clinical trials

Journal of Medical Ethics

Volumn 37, Issue 2, 2011, Pages 74-80

  Behrendt, C ^a   Golz T ^a   Roesler, C ^b   Bertz, H ^a   Wunsch A ^a  

^a UNIVERSITY OF FREIBURG   (Germany)

^b University of Applied Science   (Germany)

Author keywords

[No Author keywords available]

Indexed keywords

ADOLESCENT; ADULT; AGED; ARTICLE; COMPREHENSION; DECISION MAKING; DOCTOR PATIENT RELATION; ETHICS; FEMALE; HUMAN; INFORMED CONSENT; INTERPERSONAL COMMUNICATION; MALE; MIDDLE AGED; PATIENT SELECTION; PSYCHOLOGICAL ASPECT; RANDOMIZED CONTROLLED TRIAL (TOPIC); RESEARCH SUBJECT;

ADOLESCENT; ADULT; AGED; COMMUNICATION; COMPREHENSION; DECISION MAKING; FEMALE; HUMANS; INFORMED CONSENT; MALE; MIDDLE AGED; PATIENT SELECTION; PHYSICIAN-PATIENT RELATIONS; RANDOMIZED CONTROLLED TRIALS AS TOPIC; RESEARCH SUBJECTS; YOUNG ADULT;

EID: 79151485983     PISSN: 03066800     EISSN: 14734257     Source Type: Journal    
DOI: 10.1136/jme.2010.035485     Document Type: Article

References (25)

1. World Health Organization. World Cancer Day 2010, 2009. http://www.who.int/cancer/en (accessed 26 Aug 2009).
2. Wray RJ, Stryker JE, Winer E, et al. Do cancer patients fully understand clinical trial participation? A pilot study to assess informed consent and patient expectations. J Cancer Educ 2007;22:21-4.
3. Madsen SM, Holm S, Riis P. Participating in a cancer clinical trial? The balancing of options in the loneliness of autonomy: a grounded theory interview study. Acta Oncol 2007;46:49-59.
4. Madsen SM, Holm S, Riis P. Attitudes towards clinical research among cancer trial participants and non-participants: an interview study using a grounded theory approach. J Med Ethics 2007;33:234-40.
5. Snowdon C, Garcia J, Elbourne D. Making sense of randomization; responses of parents of critically ill babies to random allocation of treatment in a clinical trial. Soc Sci Med 1997;45:1337-55.
6. Featherstone K, Donovan JL. 'Why don't they just tell me straight, why allocate it?' The struggle to make sense of participating in a randomised controlled trial. Soc Sci Med 2002;55:709-19.
7. Cox K. Assessing the quality of life of patients in phase I and II anti-cancer drug trials: interviews versus questionnaires. Soc Sci Med 2003;56:921-34.
8. Beauchamp TL, Childress JF. Principles of Biomedical Ethics. 5th edn. Oxford: Oxford University Press, 2001.
9. Brown RF, Butow PN, Butt DG, et al. Developing ethical strategies to assist oncologists in seeking informed consent to cancer clinical trials. Soc Sci Med 2004;58:379-90.
10. Fallowfield L, Jenkins V, Farewell V, et al. Efficacy of a Cancer Research UK communication skills training model for oncologists: a randomized controlled trial. Lancet 2002;359:650-6.
11. Brown RF, Butow PN, Ellis P, et al. Seeking informed consent to cancer clinical trials: describing current practice. Soc Sci Med 2004;58:2445-57.
12. Kusec S, Oreskovic S, Skegro M, et al. Improving comprehension of informed consent. Patient Educ Couns 2006;60:294-300.
13. Christakis NA. Death Foretold: Prophecy and Prognosis in Medical Care. Chicago, London: University of Chicago Press, 1999.
14. Hopf (Hrsg) C. Qualitative Sozialforschung. 3rd edn. Stuttgart: Klett-Cotta, 1993.
15. Joffe S, Cook E, Cleary PD, et al. Quality of informed consent in cancer clinical trials: a cross-sectional survey. Lancet 2001;358:1772-7.
16. Wuensch A, Goelz T, Bertz H, et al. Disclosing information about randomised controlled trials in oncology: training concept and evaluation of an individualised communication skills training for physicians COM-ON-rct. European Journal of Cancer Care. Published Online First: 5th October 2010; doi:10.1111/j.1365-2354.2010.01233.x
17. Kuckartz U, Dresing T, Rädiker S, et al. Qualitative Evaluation: Der Einstieg in die Praxis. Wiesbaden: VS Verlag für Sozialwissenschaften, 2007.
18. Mayring P. Qualitative Inhaltsanalyse: Grundlagen und Techniken. 9th edn. UTB für Wissenschaft Pädagogik, 8229. Weinheim: Beltz, 2007.
19. Corbett F, Oldham J, Lilford R. Offering patients entry in clinical trials: preliminary study of the views of prospective participants. J Med Ethics 1996;22: 227-31.
20. Hietanen P, Aro A, Holli K, et al. Information and communication in the context of a clinical trial. Eur J Cancer 2000;36:2096-104.
21. Jenkins V, Fallowfield L. Reasons for accepting or declining to participate in randomized clinical trials for cancer therapy. Br J Cancer 2000;82:1783-8.
22. Vogel BA, Helmes AW, Bengel J. Arzt-Patienten-Kommunikation in der Tumorbehandlung: Erwartungen und Erfahrungen aus Patientensicht. Zeitschr Medizinische Psychologie 2006;15:149-61.
23. Cox K. Informed consent and decision-making: patients' experiences of the process of recruitment to phases I and II anti-cancer drug trials. Patient Educ Couns 2002;46:31-8.
24. Leydon G, Boulton M, Moynihan C, et al. Cancer patients' information needs and information seeking behaviour: in depth interview study. BMJ 2000;320: 909-13.
25. Schmidt C. Analyse von Leitfadeninterviews. In: Flick U, ed. Qualitative Forschung: Ein Handbuch. Reinbek bei Hamburg Rowohlt-Taschenbuch-Verlag, 2000:446-57.