Higher Prehospital Priority Level of Stroke Improves Thrombolysis Frequency and Time to Stroke Unit

Berglund, Annika; Svensson, Leif; Sjöstrand, Christina; Arbin, Magnus von; Euler, Mia von; Wahlgren, Nils; Engerström, Lars; Höjeberg, B.; Käll, Tor-Björn; Mjörnheim, Susanna; Engqvist, Ann

doi:10.1161/strokeaha.112.652644

Cited by 86 publications

(74 citation statements)

References 17 publications

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“…) Among the 9 trials that did not require written consent, 7 of these sought consent but permitted waivers, 8,9,26,31,32,40,46 one did not seek consent at all, 28 and one permitted verbal consent. 37 Refusals of consent.…”

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confidence: 99%

“…One trial (2.8%) did not seek consent. 28 The refusal ratedefined as the number of individuals who refused consent over the number of potential consenters (those who consented plus those who refused)-was 11.2% in the 15 trials with data (3,435 consents; 433 refusals; 3,868 potential consenters).…”

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confidence: 99%

“…The 9 trials that did not require written informed consent prior to randomization (table 2) presented several rationales for using alternatives to written informed consent, including the permissibility of deferring consent, 8,26 approval by an Ethics Board, 28,32,46 the need for maximally rapid treatment, 31,37 the right of patients not to have tissue plasminogen activator (tPA) withheld, 9 and the ability of medical professionals to provide proxy consent. 40 One trial that, for the sake of analysis, was not grouped with the 9 trials that permitted waivers of consent required written informed consent at all 22 study sites except one, which was exempted "by the FDA and the institutional review board."…”

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confidence: 99%

“…On univariable analysis (of the entire dataset, including these 2 outlier trials), we found that trials of prehospital interventions were less likely to require written informed consent (p , 0.01). The prehospital interventions included 2 German trials of mobile stroke units with on-board imaging and thrombolysis capabilities (the only 2 cluster-randomized trials in this review), 8,9 a Swedish trial in which participants in the intervention arm were assigned a higher prehospital priority level by the emergency dispatch center, 28 and 3 trials with paramedic-initiated therapies: lisinopril (UK), 37 ischemic preconditioning (Finland), 39 and glycerol trinitrate (UK). 40 Of these prehospital trials, only one required written informed consent en route to the hospital.…”

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Effect of waivers of consent on recruitment in acute stroke trials

et al. 2016

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There is urgent need for clinical trials of novel interventions to reduce the burden of acute ischemic stroke. A key impediment to such trials is slow recruitment. Since obtaining written informed consent in the setting of acute stroke is especially challenging, some experts have endorsed relaxing the requirement for informed consent by permitting verbal consent or waivers to facilitate recruitment. This systematic review of 36 randomized controlled trials of acute interventions for ischemic stroke assesses whether alternatives to written informed consent are associated with increased recruitment rates. After the exclusion of 2 outlier trials that differed from other trials in conduct and interventions studied, no association was observed on univariable analysis (8.9 participants/month in trials requiring written consent vs 6.1 participants/month in trials with alternatives, p 5 0.43) or multivariable analysis (when adjusting for the number of centers, number of countries, and exclusions based on modified Rankin Scale scores). Alternatives to written informed consent in acute stroke trials may enable trial designs that would not be feasible otherwise. However, we did not find evidence that, within traditional trial designs, such alternatives are associated with faster recruitment. Despite sweeping advances in stroke prevention and treatment including cardiovascular risk modification, acute reperfusion therapies, extensive public education, the establishment of stroke centers and systems of care, and new technologies such as telemedicine and imagingbased patient selection for endovascular treatment, ischemic stroke remains a leading cause of major disability and death. In recognition of the continuing need to improve outcomes in acute ischemic stroke, the NIH recently established a network of more than 200 sites (NIH StrokeNet) to provide infrastructure for stroke clinical trials.1 However, one of the enduring challenges for most clinical trials (particularly for acute stroke trials) is slow recruitment, which poses a serious threat to feasibility and statistical power. The requirement for informed consent has been described as the rate-limiting step of acute stroke trials. 4 Obtaining informed consent for research poses numerous challenges for stroke clinical investigators. The stroke itself may render a patient aphasic or cognitively incapacitated. Multiple studies indicate that surrogate decision-makers, if available, are less willing to enroll incapacitated relatives in clinical research compared to when patients are given the option directly.5-7 The time window for intervention is narrow, which requires investigators to hastily obtain consent while preparing to deliver sometimes complex treatments. Recent trials testing hyperacute field-based interventions such as thrombolysis on mobile stroke units equipped with CT scanners have further narrowed the time window to obtain consent. 8,9 Finally, many established and investigational therapies involve a complex weighing of risks and benefits, such that m...

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Effect of waivers of consent on recruitment in acute stroke trials

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“…23 Several stroke identification instruments have been developed and validated. They either enable dispatch centers [24][25][26] to prioritize emergency services for stroke care 27 or help EMS crews [28][29][30][31] to prenotify hospital-based stroke teams. In order to shorten the time to treatment for a broad population, stroke needs to be prioritized both in EMS systems and in hospital organizations.…”

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Prehospital stroke care

et al. 2013

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Brain cells die rapidly after stroke and any effective treatment must start as early as possible. In clinical routine, the tight time-outcome relationship continues to be the major limitation of therapeutic approaches: thrombolysis rates remain low across many countries, with most patients being treated at the late end of the therapeutic window. In addition, there is no neuroprotective therapy available, but some maintain that this concept may be valid if administered very early after stroke. Recent innovations have opened new perspectives for stroke diagnosis and treatment before the patient arrives at the hospital. These include stroke recognition by dispatchers and paramedics, mobile telemedicine for remote clinical examination and imaging, and integration of CT scanners and point-of-care laboratories in ambulances. Several clinical trials are now being performed in the prehospital setting testing prehospital delivery of neuroprotective, antihypertensive, and thrombolytic therapy. We hypothesize that these new approaches in prehospital stroke care will not only shorten time to treatment and improve outcome but will also facilitate hyperacute stroke research by increasing the number of study participants within an ultra-early time window. The potentials, pitfalls, and promises of advanced prehospital stroke care and research are discussed in this review. Neurology â 2013;81:501-508

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Implementation of a Prehospital Stroke Triage System Using Symptom Severity and Teleconsultation in the Stockholm Stroke Triage Study

et al. 2020

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IMPORTANCETo our knowledge, it is unknown whether a prehospital stroke triage system combining symptom severity and teleconsultation could accurately select patients for primary stroke center bypass and hasten delivery of endovascular thrombectomy (EVT) without delaying intravenous thrombolysis (IVT). OBJECTIVE To evaluate the predictive performance of the newly implemented Stockholm Stroke Triage System (SSTS) for large-artery occlusion (LAO) stroke and EVT initiation. Secondary objectives included evaluating whether the Stockholm Stroke Triage System shortened onset-to-puncture time for EVT and onset-to-needle time (ONT) for IVT. DESIGN, SETTING, AND PARTICIPANTS This population-based prospective cohort study conducted from October 2017 to October 2018 across the Stockholm region (Sweden) included patients transported by first-priority ("code stroke") ambulance to the hospital for acute stroke suspected by an ambulance nurse and historical controls (October 2016-October 2017). Exclusion criteria were in-hospital stroke and helicopter or private transport. Of 2909 eligible patients, 4 (0.14%) declined participation. EXPOSURES Patients were assessed by ambulance nurses with positive the face-armspeech-time test or other stroke suspicion and were evaluated for moderate-to-severe hemiparesis (Ն2 National Institutes of Health stroke scale points each on the ipsilateral arm and leg [A2L2 test]). If present, the comprehensive stroke center (CSC) stroke physician was teleconsulted by phone for confirmation of stroke suspicion, assessment of EVT eligibility, and direction to CSC or the nearest primary stroke center. If absent, the nearest hospital was prenotified.MAIN OUTCOMES AND MEASURES Primary outcome: LAO stroke. Secondary outcomes: EVT initiation, onset-to-puncture time, and ONT. Predictive performance measures included sensitivity, specificity, positive and negative predictive values, the overall accuracy for LAO stroke, and EVT initiation. RESULTSWe recorded 2905 patients with code-stroke transports (1420 women [49%]), and of these, 323 (11%) had A2L2+ teleconsultation positive results and were triaged for direct transport to CSC (median age, 73 years [interquartile range (IQR), 64-82 years]; 55 women [48%]). Accuracy for LAO stroke was 87% (positive predictive value, 41%; negative predictive value, 93%) and 91% for EVT initiation (positive predictive value, 26%; negative predictive value, 99%). Endovascular thrombectomy was performed for 84 of 323 patients (26%) with triage-positive results and 35 of 2582 patients (1.4%) with triage-negative results. In EVT cases with a known onset time (77 [3%]), the median OPT was 137 minutes (IQR, previous year, 206 minutes [IQR,; n = 75) (P < .001). The regional median ONT (337 [12%]) was unchanged at 115 minutes (IQR, previous year, 115 minutes [IQR,; n = 360) (P = .79). The median CSC IVT door-to-needle time was 13 minutes (IQR,(10)(11)(12)(13)(14)(15)(16)(17)(18) 116 [4%]) (previous year, 31 minutes [IQR,[19][20][21][22][23][24][25][26][27][28][29][30][31][32][33][34][35...

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Higher Prehospital Priority Level of Stroke Improves Thrombolysis Frequency and Time to Stroke Unit

Cited by 86 publications

References 17 publications

Effect of waivers of consent on recruitment in acute stroke trials

Effect of waivers of consent on recruitment in acute stroke trials

Prehospital stroke care

Implementation of a Prehospital Stroke Triage System Using Symptom Severity and Teleconsultation in the Stockholm Stroke Triage Study

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