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Informed consent procedures for emergency interventional TBI & stroke research
23 Feng KL, Person C, Phillips-Sabol J, et al. Comparison between a standardized questionnaire and expert clinicians for capacity assessment in stroke clinical trials. Stroke 2014; 45: e229-32.
24 Gomez CR. Time Is Brain: The Stroke Theory of Relativity. J Stroke Cerebrovasc Dis 2018; 27: 2214–27.
25 Zinkstok SM, Beenen LF, Luitse JS, Majoie CB, Nederkoorn PJ, Roos YB. Thrombolysis in Stroke within 30
Minutes: Results of the Acute Brain Care Intervention Study. PLoS One 2016; 11: e0166668.
26 Mohamadpour M, Whitney K, Bergold PJ. The Importance of Therapeutic Time Window in the Treatment of
Traumatic Brain Injury. Front Neurosci 2019; 13: 7.
27 Saver JL, Goyal M, van der Lugt A, et al. Time to Treatment With Endovascular Thrombectomy and Outcomes
From Ischemic Stroke: A Meta-analysis. JAMA 2016; 316: 1279–89.
28 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.
29 Fransen PSS, Berkhemer OA, Lingsma HF, et al. Time to Reperfusion and Treatment Effect for Acute Ischemic Stroke: A Randomized Clinical Trial. JAMA Neurol 2016; 73: 190–6.
30 Mulder MJHL, Jansen IGH, Goldhoorn R-JB, et al. Time to Endovascular Treatment and Outcome in Acute Ischemic Stroke: MR CLEAN Registry Results. Circulation 2018; 138: 232–40.
31 Post R, Germans MR, Coert BA, Rinkel GJE, Vandertop WP, Verbaan D. Update of the ULtra-early TRranexamic Acid after Subarachnoid Hemorrhage (ULTRA) trial: statistical analysis plan. Trials 2020; 21: 199.
32 Haussen DC, Craft L, Doppelheuer S, et al. Legal authorized representative experience with smartphone- based electronic informed consent in an acute stroke trial. J Neurointerv Surg 2020; 12: 483-5.
33 Shoirah H, Wechsler LR, Jovin TG, Jadhav AP. Acute Stroke Trial Enrollment through a Telemedicine Network: A 12-Year Experience. J Stroke Cerebrovasc Dis 2019; 28: 1926–9.
34 Berge E, Stapf C, Al-Shahi Salman R, et al. Methods to improve patient recruitment and retention in stroke trials. Int J Stroke 2016; 11: 663–76.
35 Kim D-H, Saver JL, Starkman S, et al. Enrollment Yield and Reasons for Screen Failure in a Large Prehospital Stroke Trial. Stroke 2016; 47: 232–5.
36 Burns KE, Zubrinich C, Tan W, et al. Research recruitment practices and critically ill patients. A multicenter, cross-sectional study (the Consent Study). Am J Respir Crit Care Med 2013; 187: 1212–8.
37 Barrett KA, Ferguson ND, Athaide V, et al. Surrogate decision makers’ attitudes towards research decision making for critically ill patients. Intensive Care Med 2012; 38: 1616–23.
38 Shepherd V, Hood K, Sheehan M, Griffith R, Wood F. ‘It’s a tough decision’: a qualitative study of proxy decision-making for research involving adults who lack capacity to consent in UK. Age Ageing 2019; 48: 903–
9. 9
39 Bryant J, Skolarus LE, Smith B, Adelman EE, Meurer WJ. The accuracy of surrogate decision makers: informed consent in hypothetical acute stroke scenarios. BMC Emerg Med 2013; 13: 18.
40 Newman JT, Smart A, Reese TR, Williams A, Moss M. Surrogate and patient discrepancy regarding consent for critical care research. Crit Care Med 2012; 40: 2590–4.
41 Jansen TC, Kompanje EJO, Druml C, Menon DK, Wiedermann CJ, Bakker J. Deferred consent in emergency intensive care research: what if the patient dies early? Use the data or not? Intensive Care Med 2007; 33: 894– 900.
42 Terry MA, Freedberg DE, Morris MC. An Alternative Consent Process for Minimal Risk Research in the ICU. Crit Care Med 2017; 45: 1450–6.
43 Ecarnot F, Quenot JP, Besch G, Piton G. Ethical challenges involved in obtaining consent for research from patients hospitalized in the intensive care unit. Ann Transl Med 2017; 5: S41.
44 Mehta S, Quittnat Pelletier F, Brown M, et al. Why substitute decision makers provide or decline consent for ICU research studies: a questionnaire study. Intensive Care Med 2012; 38: 47–54.
45 Hwang DY, Knies AK, Mampre D, et al. Concerns of surrogate decision makers for patients with acute brain injury: A US population survey. Neurology 2020; 94: e2054-68
46 Devnani R, Slaven JEJ, Bosslet GT, et al. How Surrogates Decide: A Secondary Data Analysis of Decision- Making Principles Used by the Surrogates of Hospitalized Older Adults. J Gen Intern Med 2017; 32: 1285–93.
47 Burns KE, Prats CJ, Maione M, et al. The Experience of Surrogate Decision Makers on Being Approached for Consent for Patient Participation in Research. A Multicenter Study. Ann Am Thorac Soc 2017; 14: 238–45.
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