Impact of a clinical trials information handbook on patient knowledge, perceptions, and likelihood of participation

IRB Ethics and Human Research

Volumn 30, Issue 1, 2008, Pages 6-14

  Campbell, Heather M ^a,b   Raisch, Dennis W ^a,b   Sather, Mike R ^a,b   Segal, Alissa R ^c   Warren, Stuart R ^a,b   Naik, Rupali ^b  

^a University of New Mexico   (United States)

^b UNIVERSITY OF NEW MEXICO   (United States)

^c JOSLIN DIABETES CENTER   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ADULT; AGED; ARTICLE; ATTITUDE TO HEALTH; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; ETHICS; FEMALE; HUMAN; INFORMED CONSENT; MALE; METHODOLOGY; MIDDLE AGED; PATIENT EDUCATION; PATIENT SELECTION; PSYCHOLOGICAL ASPECT; QUESTIONNAIRE; RANDOMIZED CONTROLLED TRIAL; REFUSAL TO PARTICIPATE; STATISTICS; UNITED STATES;

ADULT; AGED; AGED, 80 AND OVER; CLINICAL TRIALS AS TOPIC; FEMALE; HEALTH KNOWLEDGE, ATTITUDES, PRACTICE; HUMANS; INFORMED CONSENT; MALE; MIDDLE AGED; NEW MEXICO; PATIENT EDUCATION AS TOPIC; PATIENT SELECTION; QUESTIONNAIRES; REFUSAL TO PARTICIPATE;

EID: 38849134852     PISSN: 01937758     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

References (71)

1. Coltman C. A congressional focus of need. Oncologist 1997;2(4):VII-VIII.
2. Corbie-Smith G, Thomas S, Williams M, et al. Attitudes and beliefs of African Americans toward participation in medical research. Journal of General Internal Medicine 1999;14(9):537-546;
3. Bigatello L, George E, Hurford W. Ethical considerations for research in critically ill patients. Critical Care Medicine 2003;31(3Suppl 1):178-181;
4. Weijer C. The revolution in clinical trials: From burden to benefit and back again. Future Health, 1994;16(4):3-5.
5. Kaplan S, Brownlee S. Dying for a cure. U.S. News & World Report 1999;127(14):34-39.
6. See ref. 2, Corbie-Smith et al. 1999;
7. Hochauser M. Is "therapeutic misconception" being used to recruit subjects? The Applied Research Ethics National Association Newsletter 2003;16(2):5-7.
8. Mello M, Studdert D, Brennan T. The rise of litigation in human subjects research. Annals of Internal Medicine 2003;139:40-45.
9. Lavori P, Sugarman J, Hays M, et al. Improving informed consent in clinical trials: A duty to experiment. Controlled Clinical Trials 1999;20:187-193;
10. Chenaud C, Merlani P, Luyasu S, et al. Informed consent for research obtained during the intensive care unit stay. Critical Care 2006;10(6):R170-177.
11. See ref. 6, Lavori et al. 1999; Institute of Medicine Committee on Assessing the System for Protecting Human Research Participants. Responsible Research: A Systems Approach to Protecting Research Participants. Washington, DC: National Academy of Sciences, 2002.
12. Cassileth B, Zupkis R, Sutton-Smith K, et al. Informed consent-Why are its goals imperfectly realized? NEJM 1980;302(16):896-900;
13. See ref. 5, Mello et al. 2003.
14. See ref. 6, Lavori et a. 1999.
15. Chenaud C, Merlani P, Ricou B. Informed consent for research in ICU obtained before ICU admission. Intensive Care Medicine 2006;32:439-44.
16. Kodish E, Eder M, Noll R, et al. Communication of randomization in childhood leukemia trials. JAMA 2004;291(4):470-475.
17. Criscione LG, Sugarman J, Sanders L, et al. Informed consent in a clinical trial of a novel treatment for rheumatoid arthritis. Arthritis Care & Research 2002;49(3):361-7.
18. See ref. 11, Kodish et al. 2004.
19. See ref. 8, Cassileth et al. 1980;
20. Agre P, Campbell FA, Goldman BD, et al. Improving informed consent: The medium is not the message. IRB: Ethics & Human Research Supplement 2003;Suppl 25(5):S11-19.
21. Burton A, Waddell G, Tillotson K, et al. Information and advice to patients with back pain can have a positive effect: A randomized controlled trial of a novel educational booklet in primary care. Spine 1999;24(23):2484-2491;
22. Jensen A, Madsen B, Andersen P, et al. Information for cancer patients entering a clinical trial - an evaluation of an information strategy. European Journal of Cancer 1993;29A(16):2235-2238;
23. Davis S, Nealson E, Stone J. Evaluation of the National Cancer Institute's clinical trials booklet. Journal of the National Cancer Institute Monographs 1993;14:139-145.
24. See ref. 15, Burton et al. 1999.
25. See ref. 15, Jensen et al. 1993.
26. See ref. 15, Davis et al. 1993.
27. Flory J, Emanuel E. Interventions to improve research participants' understanding in informed consent for research: A systematic review. JAMA 2004;292(13):1593-1601.
28. See ref. 19, Flory and Emanuel 2004.
29. See ref. 19, Flory and Emanuel 2004.
30. Graham A, Raisch D, Fye C, et al. Assessment of the impact of a patient clinical trials handbook among pharmacy students. Clinical Therapeutics 2005;27(2):238-245.
31. See ref. 15, Davis et al. 1993;
32. Kruse A, Kjaergard L, Krogsgaard K, et al. A randomized trial assessing the impact of written information on outpatients' knowledge about and attitude toward randomized clinical trials. Controlled Clinical Trials 2000;21(3):223-240.
33. See ref. 22, Graham et al. 2005.
34. Aspinwall LG, Kemeny ME, Taylor SE, et al. Psychosocial predictors of gay men's AIDS risk-reduction behavior. Health Psychology 1991;10(6):432-44;
35. Bellon JA, Delgado A, Luna JD, et al. Psychosocial and health belief variables associated with frequent attendance in primary care. Psychological Medicine 1999;29(6):1347-57.
36. Nitko A. Reliability of test scores. In: Nitko A. Educational Tests and Measurement: An Introduction. New York: Harcourt Brace Jovanovich, 1983, p. 388-408.
37. See ref. 22, Graham et al. 2005
38. See ref. 22, Graham et al. 2005.
39. See ref. 6, Lavori et al. 1999; See ref. 23, Kruse et al. 2000.
40. Epstein L, Lasagna L. Obtaining informed consent. Archives of Internal Medicine 1969;123:682-688;
41. Dal-Re R. Clinical trial of drugs: A study of the influence of information on adverse reactions on obtaining informed consent. Medicina Clinica 1991;96(15):566-569.
42. Simes R, Tattersall M, Coates A, et al. Randomised comparison of procedures for obtaining informed consent in clinical trials of treatment for cancer. British Medical Journal 1986;293:1065-1068;
43. Aaronson N, Visser-Pol E, Leenhouts G, et al. Telephone-based nursing intervention improves the effectiveness of the informed consent process in cancer clinical trials. Journal of Clinical Oncology 1996;14(3):984-996;
44. McLean P. The effect of informed consent on the acceptance of random treatment assignment in a clinical population. Behavior Therapy 1980;11:129-133.
45. See ref. 30, Epstein et al. 1969;
46. Gorkin L, Schron E, Handshaw K, et al. Clinical trial enrollers vs. nonenrollers: The cardiac arrhythmia suppression trial (CAST) recruitment and enrollment assessment in clinical trials (REACT) project. Controlled Clinical Trials 1996;17:46-59.
47. See ref. 6, Lavori et al. 1999.
48. Department of Health and Human Services. Protection of Human Subjects, 21 CFR 46;
49. Food and Drug Administration. Protection of Human Subjects, 21 CFR 50.
50. See ref. 19, Flory et al. 2004.
51. See ref. 19, Flory et al. 2004.
52. National Cancer Institute. Taking part in cancer treatment research studies. Available at http://www.cancer.gov/clinicaltrials/TakingPart-in-Cancer- Treatment-Research-Studies.
53. See ref. 15, Burton et al. 1999; See ref. 15, Davis et al. 1993.
54. Getz K. Perspectives on the future workforce for the clinical research enterprise. Presentation at the 41st annual Drug Information Association meeting June 27-29, 2005, in Washington, DC.
55. See ref. 23, Kruse et al. 2000.
56. Campbell FA, Goldman BD, Boccia ML, et al. The effect of format modifications and reading comprehension on recall of informed consent information by low-income parents: A comparison of print, video, and computer-based presentations. Patient Education and Counseling 2004;53(2):io5216.
57. Gallo C, Perrone F, de Placido S, et al. Informed versus randomised consent to clinical trials. Lancet 1995;346:1060-1064.
58. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research. Washington, DC: 1979.
59. Eder ML, Yamokoski AD, Wittmann PW, et al. Improving informed consent: Suggestions from parents of children with leukemia. Pediatria 2007;119(4):e849-e859.
60. Waggoner WC, Mayo DM. Who understands? A survey of 25 words or phrases commonly used in proposed clinical research consent forms. IRB: A Review of Human Subjects Research 1995;17(1):6-9.
61. See ref. 45, Waggoner et al. 1995.
62. Lidz CW, Appelbaum PS, Grisso T, et al. Therapeutic misconception and the appreciation of risks in clinical trials. Social Science and Medicine 2004;58(9):1689-97.
63. See ref. 19, Flory et al. 2004.
64. Comings J, Garner B, Smith C, eds. Annual Review of Adult Learning and Literacy. New York: Jossey-Bass, 1999;
65. Christopher PP, Foti ME, Roy-Bujnowski K, et al. Consent form readability and educational levels of potential participants in mental health research. Psychiatric Services 2007;58(2):227-232.
66. Davis TC, Hokombe RF, Berkel HJ, et al. Informed consent for clinical trials: A comparative study of standard versus simplified forms. Journal of the National Cancer Institute 1998;90(9):668-74;
67. Coyne CA, Xu R, Raich P, et al. Randomized, controlled trial of an easy-to-read informed consent statement for clinical trial participation: A study of the Eastern Cooperative Oncology Group. Journal of Clinical Oncology 2003;21(5):836-842.
68. See ref. 23, Kruse et al. 2000.
69. See ref. 23, Kruse et al. 2000.
70. See ref. 23, Kruse et al. 2000; see ref. 42, Gallo et al.1995;
71. Simel D, Feussner J, A randomized controlled trial comparing quantitative informed consent formats. Journal of Clinical Epidemiology 1991;44(8):771-777.