Patient and proxies’ attitudes towards deferred consent in randomised trials of acute treatment for stroke: A qualitative survey

1. Goyal, M, Menon, BK, Van Zwam, WH, et al. Endovascular thrombectomy after large-vessel ischaemic stroke: a meta-analysis of individual patient data from five randomised trials. Lancet 2016; 387: 1723–1731.
Google Scholar | Crossref | Medline | ISI2. Janssen, PM, Chalos, V, van den Berg, SA, et al. Neurological deficits in stroke patients that may impede the capacity to provide informed consent for endovascular treatment trials. J Stroke Cerebrovasc Dis 2019; 28: 104447.
Google Scholar | Crossref | Medline3. Shamy, MCF, Dewar, B, Chevrier, S, et al. Deferral of consent in acute stroke trials. Stroke 2019; 50: 1017–1020.
Google Scholar | Crossref | Medline4. Harron, K, Woolfall, K, Dwan, K, et al. Deferred consent for randomized controlled trials in emergency care settings. Pediatrics 2015; 136: e1316–e1322.
Google Scholar | Crossref | Medline5. Kompanje, EJO, van Dijck, JTJM, Chalos, V, et al. Informed consent procedures for emergency interventional research in patients with traumatic brain injury and ischaemic stroke. Lancet Neurol 2020; 19: 1033–1042.
Google Scholar | Crossref | Medline6. Brady, MC, Fredrick, A, Williams, B. People with aphasia: capacity to consent, research participation and intervention inequalities. Int J Stroke 2013; 8: 193–196.
Google Scholar | SAGE Journals | ISI7. Bateman, BT, Meyers, PM, Schumacher, HC, et al. Conducting stroke research with an exception from the requirement for informed consent. Stroke 2003; 34: 1317–1323.
Google Scholar | Crossref | Medline8. Rose, DZ, Kasner, SE. Informed consent: the rate-limiting step in trials. Front Neurol 2011; 2: 65.
Google Scholar | Crossref | Medline9. Emberson, J, Lees, KR, Lyden, P, et al. Effect of treatment delay, age, and stroke severity on the effects of intravenous thrombolysis with alteplase for acute ischaemic stroke: a meta-analysis of individual patient data from randomised trials. Lancet 2014; 384: 1929–35.
Google Scholar | Crossref | Medline | ISI10. Furyk, J, McBain-Rigg, K, Watt, K, et al. Qualitative evaluation of a deferred consent process in paediatric emergency research: a PREDICT study. BMJ Open 2017; 7: e018562.
Google Scholar | Crossref | Medline11. Woolfall, K, Frith, L, Gamble, C, et al. How parents and practitioners experience research without prior consent (deferred consent) for emergency research involving children with life threatening conditions: a mixed method study. BMJ Open 2015; 5(9): e008522.
Google Scholar | Crossref | Medline12. Honarmand, K, Belley-Cote, EP, Ulic, D, et al. The deferred consent model in a prospective observational study evaluating myocardial injury in the intensive care unit. J Intensive Care Med 2018; 33(8): 475–480.
Google Scholar | SAGE Journals | ISI13. Dickert, NW, Scicluna, VM, Adeoye, O, et al. Emergency consent: patients’ and surrogates’ perspectives on consent for clinical trials in acute stroke and myocardial infarction. J Am Heart Assoc 2019; 8: e010905.
Google Scholar | Crossref | Medline14. Van Den Berg, SA, Dippel, DWJ, Hofmeijer, J, et al. Multicentre randomised trial of acute stroke treatment in the ambulance with a nitroglycerin patch (MR ASAP): study protocol for a randomised controlled trial. Trials 2019; 20(1): 383.
Google Scholar | Crossref | Medline15. Kompanje, EJO, Maas, AIR, Hilhorst, MT, et al. Ethical considerations on consent procedures for emergency research in severe and moderate traumatic brain injury. Acta Neurochir (Wien) 2005; 147: 633–639.
Google Scholar | Crossref | Medline16. Kompanje, EJO, Maas, AIR, Menon, DK, et al. Medical research in emergency research in the European Union member states: tensions between theory and practice. Intensive Care Med 2014; 40(4): 496–503.
Google Scholar | Crossref | Medline17. Jansen, TC, Kompanje, EJO, Bakker, J. Deferred proxy consent in emergency critical care research: ethically valid and practically feasible. Crit Care Med 2009; 37: S65–8.
Google Scholar | Crossref | Medline18. Pirson, FAVA, Hinsenveld, WH, Goldhoorn, R-JB, et al. MR CLEAN-LATE, a multicenter randomized clinical trial of endovascular treatment of acute ischemic stroke in The Netherlands for late arrivals: study protocol for a randomized controlled trial. Trials 2021; 22: 160.
Google Scholar | Crossref | Medline19. Treurniet, KM, LeCouffe, NE, Kappelhof, M, et al. MR CLEAN-NO IV: intravenous treatment followed by endovascular treatment versus direct endovascular treatment for acute ischemic stroke caused by a proximal intracranial occlusion—study protocol for a randomized clinical trial. Trials 2021; 22: 141.
Google Scholar | Crossref | Medline20. Chalos, V, van de Graaf, RA, Roozenbeek, B, et al. Multicenter randomized clinical trial of endovascular treatment for acute ischemic stroke. The effect of periprocedural medication: acetylsalicylic acid, unfractionated heparin, both, or neither (MR CLEAN-MED). Rationale and study design. Trials 2020; 21: 644.
Google Scholar | Crossref | Medline21. Conlon, C, Timonen, V, Elliott-O’Dare, C, et al. Confused about theoretical sampling? Engaging theoretical sampling in diverse grounded theory studies. Qual Health Res 2020; 30(6): 947–959.
Google Scholar | SAGE Journals | ISI22. Saunders, B, Sim, J, Kingstone, T, et al. Saturation in qualitative research: exploring its conceptualization and operationalization. Qual Quant 2018; 52(4): 1893–1907.
Google Scholar | Crossref | Medline23. Mangset, M, Førde, R, Nessa, J, et al. “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(10): 751–756.
Google Scholar | Crossref | Medline | ISI24. Goldstein, JN, Espinola, JA, Fisher, J, et al. Public opinion of a stroke clinical trial using exception from informed consent. Int J Emerg Med 2010; 3(4): 385–389.
Google Scholar | Crossref | Medline25. Scicluna, VM, Goldkind, SF, Mitchell, AR, et al. Determinants of patient and surrogate experiences with acute care research consent: a key informant interview study. J Am Heart Assoc 2019; 8: e012599.
Google Scholar | Crossref | Medline26. Demchuk, AM, Goyal, M, Menon, BK, et al. Endovascular treatment for small core and anterior circulation proximal occlusion with Emphasis on minimizing CT to recanalization times (ESCAPE) trial: methodology. Int J Stroke 2015; 10(3): 429–438.
Google Scholar | SAGE Journals | ISI27. Tam, NT, Huy, NT, Thoa, LTB, et al. Participants’ understanding of informed consent in clinical trials over three decades: systematic review and meta-analysis. Bull World Health Organ 2015; 93(3): 186–198H.
Google Scholar | Crossref | Medline

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