Effect of informed consent on patient characteristics in a stroke thrombolysis trial

Neurology

Volumn 89, Issue 13, 2017, Pages 1400-1407

  Thomalla, Götz ^a   Boutitie, Florent ^c,e,f   Fiebach, Jochen B ^g   Simonsen, Claus Z ⁱ   Nighoghossian, Norbert ^d   Pedraza, Salvador ^j   Lemmens, Robin ^k,l,m   Roy, Pascal ^c,e,f   Muir, Keith W ⁿ   Heesen, Christoph ^a   Ebinger, Martin ^g,h   Ford, Ian ^o   Cheng, Bastian ^a   Cho, Tae Hee ^d   Puig, Josep ^j   Thijs, Vincent ^p,q   Endres, Matthias ^g,h   Fiehler, Jens ^b   Gerloff, Christian ^a  

^a Klinik und Poliklinik fur Neurologie   (Germany)

^b UNIVERSITY MEDICAL CENTER HAMBURG EPPENDORF   (Germany)

^c Service de Biostatistique   (Germany)

^d HOSPICES CIVILS DE LYON   (France)

^e UNIVERSITÉ LYON 1   (France)

^f LABORATOIRE DE BIOMÉTRIE ET BIOLOGIE EVOLUTIVE   (France)

^g Centrum für Schlaganfallforschung Berlin CSB   (Germany)

^h CHARITÉ UNIVERSITÄTSMEDIZIN BERLIN   (Germany)

ⁱ AARHUS UNIVERSITY HOSPITAL   (Denmark)

^j HOSPITAL JOSEP TRUETA   (Spain)

^k UNIVERSITY OF LEUVEN   (Belgium)

^l DEPARTMENT OF PLANT SYSTEMS BIOLOGY   (Belgium)

^m UNIVERSITY HOSPITALS LEUVEN   (Belgium)

ⁿ Institute of Neuroscience and Psychology   (United Kingdom)

^o UNIVERSITY OF GLASGOW   (United Kingdom)

^p FLOREY INSTITUTE OF NEUROSCIENCE AND MENTAL HEALTH   (Australia)

^q AUSTIN HEALTH   (Australia)

more..

Author keywords

[No Author keywords available]

Indexed keywords

PLACEBO; TISSUE PLASMINOGEN ACTIVATOR;

ADULT; AGED; APHASIA; ARTICLE; ATRIAL FIBRILLATION; BRAIN HEMORRHAGE; BRAIN ISCHEMIA; BRAIN RADIOGRAPHY; CEREBROVASCULAR ACCIDENT; CLINICAL FEATURE; CONSULTATION; CONTROLLED STUDY; DIABETES MELLITUS; DISEASE SEVERITY; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG SAFETY; FEMALE; FIBRINOLYTIC THERAPY; GASTROINTESTINAL HEMORRHAGE; HOSPITAL ADMISSION; HUMAN; HYPERCHOLESTEROLEMIA; HYPERTENSION; INFORMED CONSENT; LEGAL GUARDIAN; MAJOR CLINICAL STUDY; MALE; MEDICAL HISTORY; NATIONAL INSTITUTES OF HEALTH STROKE SCALE; NUCLEAR MAGNETIC RESONANCE IMAGING; PREVALENCE; PRIORITY JOURNAL; PROXY; RANDOMIZED CONTROLLED TRIAL; RISK FACTOR; STROKE PATIENT; TRANSIENT ISCHEMIC ATTACK; WAKEFULNESS; AGE; BRAIN; CLINICAL TRIAL; COMPARATIVE STUDY; COMPLICATION; DIAGNOSTIC IMAGING; EUROPE; MIDDLE AGED; MULTICENTER STUDY; SEVERITY OF ILLNESS INDEX; STROKE;

AGE FACTORS; AGED; APHASIA; BRAIN; DOUBLE-BLIND METHOD; EUROPE; FEMALE; HUMANS; HYPERTENSION; INFORMED CONSENT; MAGNETIC RESONANCE IMAGING; MALE; MIDDLE AGED; PREVALENCE; PROXY; SEVERITY OF ILLNESS INDEX; STROKE; THROMBOLYTIC THERAPY;

EID: 85030613183     PISSN: 00283878     EISSN: 1526632X     Source Type: Journal    
DOI: 10.1212/WNL.0000000000004414     Document Type: Article

References (28)

1. World Medical Association Declaration of Helsinki: ethical principles for medical research involving human subjects. JAMA 2013;310:2191-2194.
2. Lees KR, Emberson J, Blackwell L, et al. Effects of alte-plase for acute stroke on the distribution of functional outcomes: a pooled analysis of 9 trials. Stroke 2016;47: 2373-2379.
3. Ribo M, Molina CA, Cobo E, et al. Association between time to reperfusion and outcome is primarily driven by the time from imaging to reperfusion. Stroke 2016;47: 999-1004.
4. 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.
5. Mangset M, Forde R, Nessa J, Berge E, Wyller TB. I don't like that, it's tricking people too much.: acute informed consent to participation in a trial of thrombolysis for stroke. J Med Ethics 2008;34:751-756.
6. 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.
7. Slyter H. Ethical challenges in stroke research. Stroke 1998;29:1725-1729.
8. Brady MC, Fredrick A, Williams B. People with aphasia: capacity to consent, research participation and intervention inequalities. Int J Stroke 2013;8:193-196.
9. Flaherty ML, Karlawish J, Khoury JC, Kleindorfer D, Woo D, Broderick JP. How important is surrogate consent for stroke research? Neurology 2008;71:1566-1571.
10. 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. Cerebro-vasc Dis 2006;21:348-352.
11. Thomalla G, Fiebach JB, Ostergaard L, et al. A multicen-ter, randomized, double-blind, placebo-controlled trial to test efficacy and safety of magnetic resonance imaging-based thrombolysis in wake-up stroke (WAKE-UP). Int J Stroke 2014;9:829-836.
12. Thomalla G, Cheng B, Ebinger M, et al. DWI-FLAIR mismatch for the identification of patients with acute is-chaemic stroke within 4.5 h of symptom onset (PRE-FLAIR): a multicentre observational study. Lancet Neurol 2011;10:978-986.
13. Brott T, Adams HP Jr, Olinger CP, et al. Measurements of acute cerebral infarction: a clinical examination scale. Stroke 1989;20:864-870.
14. Dani KA, McCormick MT, Muir KW. Brain lesion volume and capacity for consent in stroke trials: potential regulatory barriers to the use of surrogate markers. Stroke 2008;39:2336-2340.
15. Mendyk AM, Labreuche J, Henon H, et al. Which factors influence the resort to surrogate consent in stroke trials, and what are the patient outcomes in this context? BMC Med Ethics 2015;16:26.
16. Smith J, Forster A, Young J. Cochrane review: information provision for stroke patients and their caregivers. Clin Re-habil 2009;23:195-206.
17. Hotter B, Jegzentis K, Steinbrink J, et al. Impact of selection criteria on recruitment in an interventional stroke trial. Cerebrovasc Dis 2013;36:344-350.
18. Leira EC, Kaldjian LC, Ludwig BR, et al. Lack of international consensus on ethical aspects of acute stroke trials. J Stroke Cerebrovasc Dis 2012;21:200-204.
19. Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use. OJ 2001;L121: 34-44.
20. Lemaire F, Bion J, Blanco J, et al. The European Union Directive on Clinical Research: present status of implementation in EU member states' legislations with regard to the incompetent patient. Intens Care Med 2005;31: 476-479.
21. Yusuf S, Wittes J. Interpreting geographic variations in results of randomized, controlled trials. N Engl J Med 2016;375:2263-2271.
22. Feaster DJ, Mikulich-Gilbertson S, Brincks AM. Modeling site effects in the design and analysis of multi-site trials. Am J Drug Alcohol Abuse 2011;37:383-391.
23. Iwanowski P, Budaj A, Czlonkowska A, et al. Informed consent for clinical trials in acute coronary syndromes and stroke following the European Clinical Trials Directive: investigators' experiences and attitudes. Trials 2008;9:45.
24. Qureshi AI, Gilani S, Adil MM, et al. Pattern of informed consent acquisition in patients undergoing emergent en-dovascular treatment for acute ischemic stroke. J Vasc In-terv Neurol 2014;7:21-25.
25. Sciences CfIOoM. International Ethical Guidelines for Health-Related Research Involving Humans. Geneva: Council for International Organizations of Medical Sciences; 2016.
26. Kleindorfer D, Lindsell CJ, Alwell K, et al. Ischemic stroke survivors' opinion regarding research utilizing exception from informed consent. Cerebrovasc Dis 2011;32:321-326.
27. Goldstein JN, Espinola JA, Fisher J, Pallin DJ, Camargo CA. Public opinion of a stroke clinical trial using exception from informed consent. Int J Emerg Med 2010;3:385-389.
28. Kasner SE, Baren JM, Le Roux PD, et al. Community views on neurologic emergency treatment trials. Ann Emerg Med 2011;57:346-354 e6.