Consent for intravenous thrombolysis in acute stroke: Review and future directions

Archives of Neurology

Volumn 64, Issue 6, 2007, Pages 785-792

  White Bateman, Stephanie R ^a   Schumacher, H Christian ^b,e   Sacco, Ralph L ^b,c   Appelbaum, Paul S ^d  

^a MASSACHUSETTS GENERAL HOSPITAL   (United States)

^b NEW YORK PRESBYTERIAN HOSPITAL   (United States)

^c Mailman School of Public Health ^*  (United States)

^d Columbia University ^*  (United States)

^e NEUROLOGICAL INSTITUTE   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

FIBRINOLYTIC AGENT; RECOMBINANT PLASMINOGEN ACTIVATOR;

APHASIA; CEREBROVASCULAR ACCIDENT; COMPETENCE; EMERGENCY CARE; HUMAN; INTERVIEW; LEGAL ASPECT; MEDICAL RESEARCH; NEUROLOGIC DISEASE; PATIENT ASSESSMENT; PRIORITY JOURNAL; REVIEW; SCREENING; STANDARDIZATION; STROKE PATIENT;

APHASIA; CEREBROVASCULAR ACCIDENT; DISCLOSURE; EMERGENCIES; FIBRINOLYTIC AGENTS; HUMANS; INFORMED CONSENT; INJECTIONS, INTRAVENOUS; MENTAL COMPETENCY; NERVOUS SYSTEM DISEASES; TIME FACTORS;

EID: 34250308450     PISSN: 00039942     EISSN: 15383687     Source Type: Journal    
DOI: 10.1001/archneur.64.6.785     Document Type: Review

References (86)

1. Ciccone A. Consent to thrombolysis in acute ischaemic stroke: from trial to practice. Lancet Neurol. 2003;2:375-378.
2. Wardlaw JM, Zoppo G, Yamaguchi T, Berge E. Thrombolysis for acute ischaemic stroke. [update of Cochrane Database Syst Rev. 2000;(2):CD000213; PMID: 10796329]. Cochrane Database Syst Rev. 2003;(3):CD000213.
3. American Heart Association. Heart Disease and Stroke Statistics: 2005 Update. Dallas, Tex: American Heart Association; 2005.
4. The National Institute of Neurological Disorders rt-PA Stroke Study Group. Tissue plasminogen activator for acute ischemic stroke. N Engl J Med. 1995;333:1581-1587.
5. Hacke W, Donnan G, Fieschi C, et al. Association of outcome with early stroke treatment: pooled analysis of ATLANTIS, ECASS, and NINDS rt-PA stroke trials. Lancet. 2004;363:768-774.
6. Food and Drug Administration. Product approval information: licensing action: alteplase (Activase). June 18, 1996. http://www.fda.gov/cder/foi/ appletter/1996/altegen0618961.pdf. Accessed April 1, 2007.
7. Health Canada. Alteplase (Activase rt-PA) for acute ischemic stroke: special precautions for new indication. Drugs and Health Products. Canadian Adverse Reaction Newsletter. 1999;9(3). http://www.hc-sc.gc.ca/dhp-mps/ medeff/bulletin/carn-bcei_v9n3_e.html#ALTEPLASE. Accessed April 1, 2007.
8. Australian Government; Department of Health and Ageing. Therapeutic goods administration: Australian Drug Evaluation Committee 228th meeting recommendations: ALTEPLASE-ACTILYSE. http://www.tga.gov.au/docs/html/adec/ adec0228.htm. Accessed April 1, 2007.
9. European Medicines Agency. Committee for Proprietary Medicinal Products (CPMP). Summary information on a referral opinion following an arbitration pursuant to article 29 of directive 2001//83/EC, for Actilyse. http://www.emea.eu.int/pdfs/human/referral/334602en.pdf. Accessed April 1, 2007.
10. SITS-MOST. Safe Implementation of Thrombolysis in Stroke Monitoring Study. http://www.acutestroke.org/index.php. Accessed April 1, 2007.
11. Saver JL. Symptomatic intracerebral hemorrhage after thrombolytic therapy for stroke: the clinically relevant number needed to harm [abstract S44.005]. Presented at the 58th Annual Meeting of the American Academy of Neurology; San Diego, Calif; 2006.
12. Alberts MJ, Latchaw RE, Selman WR, et al; Brain Attack Coalition. Recommendations for comprehensive stroke centers: a consensus statement from the Brain Attack Coalition. Stroke. 2005;36:1597-1616.
13. National Stroke Association. Stroke: The First Hours. Englewood, Colo: National Stroke Association; 2005.
14. American Academy of Neurology. Practice advisory: thrombolytic therapy for acute ischemic stroke: summary statement. Report of the Quality Standards Subcommittee of the American Academy of Neurology. Neurology. 1996;47:835-839.
15. Goyal DG, Li J, Mann J, Schriger DL. Position statement of the American Academy of Emergency Medicine on the use of intravenous thrombolytic therapy in the treatment of stroke. http://www.aaem.org/positionstatements/ thrombolytictherapy.php. Accessed April 1, 2007.
16. Adams HP Jr, Adams RJ, Brott T, et al; Stroke Council of the American Stroke Association. Guidelines for the early management of patients with ischemic stroke: a scientific statement from the Stroke Council of the American Stroke Association. Stroke. 2003;34:1056-1083.
17. Fleck LM, Hayes OW. Ethics and consent to treat issues in acute stroke therapy. Emerg Med Clin North Am. 2002;20:703-715, vii-viii.
18. Rosenbaum JR, Bravata DM, Concato J, Brass LM, Kim N, Fried TR. Informed consent for thrombolytic therapy for patients with acute ischemic stroke treated in routine clinical practice. Stroke. 2004;35:e353-e355.
19. Sivakumar C, Palumbo V, Hill M, Buchan AM. Informed consent for thrombolytic therapy in acute ischemic stroke. [letter]. Stroke. 2005;36:528-529.
20. Beauchamp T, Childress J. Principles of Biomedical Ethics. 5th ed. New York, NY: Oxford University Press; 2001.
21. Grisso T, Appelbaum P. Assessing Competence to Consent to Treatment. New York, NY: Oxford University Press; 1998.
22. Marson DC, Ingram KK, Cody HA, Harrell LE. Assessing the competency of patients with Alzheimer's disease under different legal standards: a prototype instrument. Arch Neurol. 1995;52:949-954.
23. Freedman M, Stuss DT, Gordon M. Assessment of competency: the role of neurobehavioral deficits. Ann Intern Med. 1991;115:203-208.
24. Markson LJ, Kern DC, Annas GJ, Glantz LH. Physician assessment of patient competence. J Am Geriatr Soc. 1994;42:1074-1080.
25. Auerswald KB, Charpentier PA, Inouye SK. The informed consent process in older patients who developed delirium: a clinical epidemiologic study. Am J Med. 1997;103:410-418.
26. Carney MT, Neugroschl J, Morrison RS, Marin D, Siu AL. The development and piloting of a capacity assessment tool. J Clin Ethics. 2001;12:17-23.
27. Jackson E, Warner J. How much do doctors know about consent and capacity? J R Soc Med. 2002;95:601-603.
28. Ganzini L, Volicer L, Nelson W, Derse A. Pitfalls in assessment of decision-making capacity. Psychosomatics. 2003;44:237-243.
29. Roth LH, Meisel A, Lidz CW. Tests of competency to consent to treatment. Am J Psychiatry. 1977;134:279-284.
30. Bean G, Nishisato S, Rector NA, Glancy G. The psychometric properties of the Competency Interview Schedule. Can J Psychiatry. 1994;39:368-376.
31. Agard A, Hermeren G, Herlitz J. Patients' experiences of intervention trials on the treatment of myocardial infarction: is it time to adjust the informed consent procedure to the patient's capacity? Heart. 2001;86:632-637.
32. Muir KW. Multicentre Acute Stroke Trial - Italy. Lancet. 1996;347:391-393.
33. Williams BF, French JK, White HD. Is our method of obtaining consent appropriate for randomised controlled trials in acute myocardial infarction? N Z Med J. 1997;110:298-299.
34. Kucia AM, Horowitz JD. Is informed consent to clinical trials an "upside selective" process in acute coronary syndromes? Am Heart J. 2000;140:94-97.
35. Yuval R, Halon DA, Merdler A, et al. Patient comprehension and reaction to participating in a double-blind randomized clinical trial (ISIS-4) in acute myocardial infarction. Arch Intern Med. 2000;160:1142-1146.
36. Ciccone A, Bonito V; Italian Neurological Society's Study Group for Bioethics and Palliative Care in Neurology. Thrombolysis for acute ischemic stroke: the problem of consent. Neurol Sci. 2001;22:339-351.
37. Schats R, Brilstra EH, Rinkel GJ, Algra A, Van Gijn J. Informed consent in trials for neurological emergencies: the example of subarachnoid haemorrhage. J Neurol Neurosurg Psychiatry. 2003;74:988-991.
38. Williams BF, French JK, White HD; HERO-2 Consent Substudy Investigators. Informed consent during the clinical emergency of acute myocardial infarction (HERO-2 consent substudy): a prospective observational study. Lancet. 2003;361:918-922.
39. Gammelgaard A, Mortensen OS, Rossel P; DANAMI-2 Investigators. Patients' perceptions of informed consent in acute myocardial infarction research: a questionnaire based survey of the consent process in the DANAMI-2 trial. Heart. 2004;90:1124-1128.
40. Schmidt TA, Salo D, Hughes JA, et al; SAEM Ethics Committee. Confronting the ethical challenges to informed consent in emergency medicine research. Acad Emerg Med. 2004;11:1082-1089.
41. Demarquay G, Derex L, Nighoghossian N, et al. Ethical issues of informed consent in acute stroke: analysis of the modalities of consent in 56 patients enrolled in urgent therapeutic trials. Cerebrovasc Dis. 2005;19:65-68.
42. Tu JV, Willison DJ, Silver FL, et al; Investigators in the Registry of the Canadian Stroke Network. Impracticability of informed consent in the Registry of the Canadian Stroke Network. N Engl J Med. 2004;350:1414-1421.
43. Appelbaum PS. Missing the boat: competence and consent in psychiatric research. Am J Psychiatry. 1998;155:1486-1488.
44. Kane I, Lindley R, Lewis S, Sandercock P. Impact of stroke syndrome and stroke severity on the process of consent in the third international stroke trial. Cerebrovasc Dis. 2006;21:348-352.
45. Lawrence ES, Coshall C, Dundas R, et al. Estimates of the prevalence of acute stroke impairments and disability in a multiethnic population. Stroke. 2001;32:1279-1284.
46. Majid MJ, Lincoln NB, Weyman N. Cognitive rehabilitation for memory deficits following stroke. Cochrane Database Syst Rev. 2000;(3):CD002293.
47. Riepe MW, Riss S, Bittner D, Huber R. Screening for cognitive impairment in patients with acute stroke. Dement Geriatr Cogn Disord. 2004;17:49-53.
48. Barba R, Castro MD, del Mar Morin M, et al. Prestroke dementia. Cerebrovasc Dis. 2001;11:216-224.
49. Barba R, Morin MD, Cemillan C, Delgado C, Domingo J, Del Ser T. Previous and incident dementia as risk factors for mortality in stroke patients. Stroke. 2002;33:1993-1998.
50. Henon H, Pasquier F, Durieu I, et al. Preexisting dementia in stroke patients: baseline frequency, associated factors, and outcome. Stroke. 1997;28:2429-2436.
51. Henon H, Durieu I, Lebert F, Pasquier F, Leys D. Influence of prestroke dementia on early and delayed mortality in stroke patients. J Neurol. 2003;250:10-16.
52. American Psychiatric Association. Guidelines for assessing the decision-making capacities of potential research subjects with cognitive impairment. Am J Psychiatry. 1998;155:1649-1650.
53. Alzheimer's Association. Research consent for cognitively impaired adults: recommendations for institutional review boards and investigators. Alzheimer Dis Assoc Disord. 2004;18:171-175.
54. Kim SY, Karlawish JH, Caine ED. Current state of research on decision-making competence of cognitively impaired elderly persons. Am J Geriatr Psychiatry. 2002;10:151-165.
55. Pollack ME, Billick SB. Competency to consent to treatment. Psychiatr Q. 1999;70:303-311.
56. Braunack-Mayer A, Hersh D. An ethical voice in the silence of aphasia: judging understanding and consent in people with aphasia. J Clin Ethics. 2001;12:388-396.
57. Brady Wagner LC. Clinical ethics in the context of language and cognitive impairment: rights and protections. Semin Speech Lang. 2003;24:275-284.
58. Davis WS, Ross A. Making wishes known: the role of acquired speech and language disorders in clinical ethics. J Clin Ethics. 2003;14:164-172.
59. Diener BL, Bischof-Rosarioz JA. Determining decision-making capacity in individuals with severe communication impairments after stroke: the role of augmentative-alternative communication (AAC). Top Stroke Rehabil. 2004;11:84-88.
60. Genentech, Inc. Activase (Alteplase). Full prescribing information: indications and usage. http://www.gene.com/gene/products/information/ cardiovascular/activase/insert.jsp#indications. Accessed April 1, 2007.
61. Marler JR, Tilley BC, Lu M, et al. Early stroke treatment associated with better outcome: the NINDS rt-PA stroke study. Neurology. 2000;55:1649-1655.
62. Kwan J, Hand P, Sandercock P. Improving the efficiency of delivery of thrombolysis for acute stroke: a systematic review. QJM. 2004;97:273-279.
63. Wirshing DA, Wirshing WC, Marder SR, Liberman RP, Mintz J. Informed consent: assessment of comprehension. Am J Psychiatry. 1998;155:1508-1511.
64. Dunn LB, Jeste DV. Enhancing informed consent for research and treatment. Neuropsychopharmacology. 2001;24:595-607.
65. Boisjolie CR, Sharkey SW, Cannon CP, et al. Impact of a thrombolysis research trial on time to treatment for acute myocardial infarction in the emergency department. Am J Cardiol. 1995;76:396-398.
66. Lotjonen S. Medical research in clinical emergency settings in Europe. J Med Ethics. 2002;28:183-187.
67. New York State Department of Health. Percutaneous coronary interventions (angioplasty) in New York State, 2001-2003 report. http://www.health.state.ny. us/nysdoh/heart/pdf/pci_2001-2003.pdf. Accessed April 1, 2007.
68. New York State Department of Health. Adult cardiac surgery in New York State, 2000-2002.http://www.health.state.ny.us/diseases/cardiovascular/ heart_disease /docs/cabg_2002-2004.pdf. Accessed April 1, 2007.
69. Venesy BA. A clinician's guide to decision making capacity and ethically sound medical decisions. Am J Phys Med Rehabil. 1994;73:219-226.
70. Suhl J, Simons P, Reedy T, Garrick T. Myth of substituted judgment: surrogate decision-making regarding life support is unreliable. Arch Intern Med. 1994;154:90-96.
71. Stein J. The ethics of advance directives: a rehabilitation perspective. Am J Phys Med Rehabil. 2003;82:152-157.
72. Gage BF, Cardinalli AB, Owens DK. The effect of stroke and stroke prophylaxis with aspirin or warfarin on quality of life. Arch Intern Med. 1996;156:1829-1836.
73. Solomon NA, Glick HA, Russo CJ, Lee J, Schulman KA. Patient preferences for stroke outcomes. Stroke. 1994;25:1721-1725.
74. Furlan AJ, Kanoti G. When is thrombolysis justified in patients with acute ischemic stroke? a bioethical perspective. Stroke. 1997;28:214-218.
75. Seckler AB, Meier DE, Mulvihill M, Paris BE. Substituted judgment: how accurate are proxy predictions? Ann Intern Med. 1991;115:92-98.
76. Sulmasy DP, Haller K, Terry PB. More talk, less paper: predicting the accuracy of substituted judgments. Am J Med. 1994;96:432-438.
77. Schneider CE. The Practice of Autonomy. New York, NY: Oxford University Press; 1998.
78. Code of Federal Regulations. Title 38, §17.32. Informed consent and advance health care planning. Fed Reg. 2006;1:606-610.
79. Bateman BT, Meyers PM, Schumacher HC, Mangla S, Pile-Spellman J. Conducting stroke research with an exception from the requirement for informed consent. Stroke. 2003;34:1317-1323.
80. Biros MH. Research without consent: current status, 2003. Ann Emerg Med. 2003;42:550-564.
81. Kottow M. The battering of informed consent. J Med Ethics. 2004;30:565-569.
82. Koops L, Lindley RI. Thrombolysis for acute ischaemic stroke: consumer involvement in design of new randomised controlled trial. BMJ. 2002;325:415-417.
83. McClure KB, DeIorio NM, Gunnels MD, Ochsner MJ, Biros MH, Schmidt TA. Attitudes of emergency department patients and visitors regarding emergency exception from informed consent in resuscitation research, community consultation, and public notification [published correction appears in Acad Emerg Med. 2003;10:690]. Acad Emerg Med. 2003;10:352-359.
84. Dix ES, Esposito D, Spinosa F, Olson N, Chapman S. Implementation of community consultation for waiver of informed consent in emergency research: one institutional review board's experience. J Investig Med. 2004;52:113-116.
85. McRae AD, Weijer C. Waiver of consent for emergency research [letter]. Ann Emerg Med. 2004;44:278-280.
86. Janofsky JS, McCarthy RJ, Folstein MF. The Hopkins Competency Assessment Test: a brief method for evaluating patients' capacity to give informed consent. Hosp Community Psychiatry. 1992;43:132-136.