Understanding of placebo controls among older people with schizophrenia

Schizophrenia Bulletin

Volumn 32, Issue 1, 2006, Pages 137-146

  Dunn, Laura B ^a,b   Palmer, Barton W ^a,b   Keehan, Monique ^c  

^a UNIVERSITY OF CALIFORNIA   (United States)

^b VA SAN DIEGO HEALTHCARE SYSTEM   (United States)

^c UNIVERSITY OF CALIFORNIA   (United States)

Author keywords

Clinical trials; Decision making; Informed consent; Research designs; Research ethics

Indexed keywords

PLACEBO;

ADULT; AGE DISTRIBUTION; ARTICLE; COGNITION; CONTROLLED STUDY; CORRELATION ANALYSIS; DECISION MAKING; DEMOGRAPHY; DISEASE SEVERITY; EDUCATION; FEMALE; HUMAN; INFORMED CONSENT; MAJOR CLINICAL STUDY; MALE; PRIORITY JOURNAL; QUESTIONNAIRE; RESEARCH ETHICS; SCHIZOAFFECTIVE PSYCHOSIS; SCHIZOPHRENIA;

AGED; CLINICAL TRIALS; FEMALE; HUMANS; INFORMED CONSENT; MALE; MIDDLE AGED; PATIENT EDUCATION; PATIENT SELECTION; PLACEBOS; QUESTIONNAIRES; SCHIZOPHRENIA;

EID: 30344485420     PISSN: 05867614     EISSN: 17451701     Source Type: Journal    
DOI: 10.1093/schbul/sbi069     Document Type: Article

References (42)

1. US Department of Health and Human Services, Office of Inspector General. Recruiting Human Subjects: Pressures in Industry-Sponsored Clinical Research. June 2000. OEI-01-97-00195.
2. Simon C, Zyzanski SJ, Eder M, Raiz P, Kodish ED, Siminoff LA. Groups potentially at risk for making poorly informed decisions about entry into clinical trials for childhood cancer. J Clin Oncol. 2003;21:2173-2178.
3. Wendler D. Can we ensure that all research subjects give valid consent? Arch Intern Med. 2004;164:2201-2204.
4. Criscione LG, Sugarman J, Sanders L, Pisetsky DS, St Clair EW. Informed consent in a clinical trial of a novel treatment for rheumatoid arthritis. Arthritis Rheum. 2003;49:361-367.
5. Joffe S, Cook EF, Cleary PD, Clark JW, Weeks JC. Quality of informed consent in cancer clinical trials: a cross-sectional survey. Lancet. 2001;358:1772-1777.
6. Dunn LB, Jeste DV. Enhancing informed consent for research and treatment. Neuropsychopharmacology. 2001;24:595-607.
7. Appelbaum PS, Roth LH, Lidz CW, Benson P, Winslade W. False hopes and best data: consent to research and the therapeutic misconception. Hastings Cent Rep. 1987;17:20-24.
8. Paasche-Orlow MK, Taylor HA, Brancati FL. Readability standards for informed-consent forms as compared with actual readability. N Engl J Med. 2003;348:721-726.
9. Wirshing DA, Sergi MJ, Mintz J. A videotape intervention to enhance the informed consent process for medical and psychiatric treatment research. Am J Psychiatry. 2005;162:186-188.
10. Dunn LB, Lindamer LA, Palmer BW, Golshan S, Schneiderman LJ, Jeste DV. Improving understanding of research consent in middle-aged and elderly patients with psychotic disorders. Am J Geriatr Psychiatry. 2002;10:142-150.
11. Carpenter WT, Gold JM, Lahti AC, et al. Decisional capacity for informed consent in schizophrenia research. Arch Gen Psychiatry. 2000;57:533-538.
12. Appelbaum PS, Lidz CW, Grisso T. Therapeutic misconception in clinical research: frequency and risk factors. IRB. 2004;26:1-8.
13. Roberts LW, Lauriello J, Geppert C, Keith SJ. Placebos and paradoxes in psychiatric research: an ethics perspective. Biol Psychiatry. 2001;49:887-893.
14. Carpenter WT, Appelbaum PS, Levine RJ. The declaration of Helsinki and clinical trials: a focus on placebo-controlled trials in schizophrenia. Am J Psychiatry. 2003;160:356-362.
15. Weijer C. Placebo-controlled trials in schizophrenia: are they ethical? are they necessary? Schizophr Res. 1999;35:211-218.
16. Miller FG. Placebo-controlled trials in psychiatric research: an ethical perspective. Biol Psychiatry. 2000;47:707-716.
17. Kim SY. Benefits and burdens of placebos in psychiatric research. Psychopharmacology. 2003;171:13-18.
18. Levine RJ. The need to revise the Declaration of Helsinki. N Engl J Med. 1999;341:531-534.
19. Grisso T, Appelbaum PS. The MacArthur Treatment Competence Study. III: Abilities of patients to consent to psychiatric and medical treatments. Law Hum Behav. 1995;19:149-174.
20. Grisso T, Appelbaum PS. Assessing Competence to Consent to Treatment: A Guide for Physicians and Other Health Professionals. New York: Oxford University Press; 1998.
21. Henderson GE, Easter MM, Zimmer C, et al. Therapeutic misconception in early phase gene transfer trials. Soc Sci Med. 2005; Published online July 4.
22. Pope JE, Tingey DP, Arnold JM, Hong P, Ouimet JM, Krizova A. Are subjects satisfied with the informed consent process? a survey of research participants. J Rheumatol. 2003;30:815-824.
23. Frank E, Novick DM, Kupfer DJ. Beyond the question of placebo controls: ethical issues in psychopharmacological drug studies. Psychopharmacology. 2003;171:19-26.
24. Wirshing DA, Wirshing WC, Marder SR, Liberman RP, Mintz J. Informed consent: assessment of comprehension. Am J Psychiatry. 1998;155:1508-1511.
25. Stiles PG, Poythress NG, Hall A, Falkenbach D, Williams R. Improving understanding of research consent disclosures among persons with mental illness. Psychiatr Serv. 2001; 52:780-785.
26. Lidz CW, Appelbaum PS. The therapeutic misconception: problems and solutions. Med Care. 2002;40:V55-63.
27. Appelbaum PS, Grisso T. MacCAT-CR: MacArthur Competence Assessment Tool for Clinical Research. Sarasota, Fla: Professional Resource Press; 2001.
28. Kay SR, Fiszbein A, Opler LA. The Positive and Negative Syndrome Scale (PANSS) for schizophrenia. Schizophr Bull. 1987;13:261-276.
29. Hamilton M. A rating scale for depression. J Neurol Neurosurg Psychiatry. 1960;23:56-62.
30. Birchwood M, Smith J, Drury V, Healy J, Macmillan F, Slade M. A self-report Insight Scale for psychosis: reliability, validity and sensitivity to change. Acta Psychiatr Scand. 1994;89:62-67.
31. Mattis S. Dementia Rating Scale. Odessa, Fla: Psychological Assessment Resources, Inc.; 1973.
32. Twamley EW, Doshi RR, Nayak GV, et al. Generalized cognitive impairments, ability to perform everyday tasks, and level of independence in community living situations of older patients with psychosis. Am J Psychiatry. 2002;159:2013-2020.
33. Palmer BW, Dunn LB, Appelbaum PS, Jeste DV. Correlates of treatment-related decision-making capacity among middle-aged and older patients with schizophrenia. Arch Gen Psychiatry. 2004;61:230-236.
34. Palmer BW, Heaton RK, Paulsen JS, et al. Is it possible to be schizophrenic yet neuropsychologically normal? Neuropsychology. 1997;11:437-446.
35. Palmer BW, Heaton RK, Gladsjo JA, Evans JD, Patterson TL, Golshan S, Jeste DV. Heterogeneity in functional status among older outpatients with schizophrenia: employment history, living situation, and driving. Schizophr Res. 2002;55:205-215.
36. Tsuang MT, Lyons MJ, Faraone SV. Heterogeneity of schizophrenia: conceptual models and analytic strategies. Br J Psychiatry. 1990;156:17-26.
37. Marson D, Harrell L. Executive dysfunction and loss of capacity to consent to medical treatment in patients with Alzheimer's disease. Semin Clin Neuropsychiatry. 1999;4:41-49.
38. Sugarman J, McCrory DC, Hubal RC. Getting meaningful informed consent from older adults: a structured literature review of empirical research. J Am Geriatr Soc. 1998; 46:517-524.
39. Roberts LW, Warner TD, Brody JL, Roberts B, Lauriello J, Lyketsos C. Patient and psychiatrist ratings of hypothetical schizophrenia research protocols: assessment of harm potential and factors influencing participation decisions. Am J Psychiatry. 2002;159:573-584.
40. Flory J, Emanuel E. Interventions to improve research participants' understanding in informed consent for research: a systematic review. JAMA. 2004;292:1593-1601.
41. Dunn LB, Jeste DV. Problem areas in the understanding of informed consent for research: study of middle-aged and older patients with psychotic disorders. Psychopharmacology (Berl). 2003;171:81-85.
42. Vitiello B, Aman MG, Scahill L, et al. Research knowledge among parents of children participating in a randomized clinical trial. J Am Acad Child Adolesc Psychiatry. 2005;44:145-149.