Dataset Information

Functional stroke outcomes after mobile stroke unit deployment - the revised protocol for the Berlin Prehospital Or Usual Delivery of acute stroke care (B_PROUD) part 2 study.

ABSTRACT:

Background

Studies investigating the Mobile Stroke Unit (MSU) concept have shown increased thrombolysis rates, reduced alarm-to-treatment times and improved prehospital triage. Yet, so far, there is no definite scientific proof of better functional outcome after MSU deployment compared to regular ambulances.

Methods

We provide a revised protocol for the second part of the B_PROUD trial as organization of the MSU dispatch did not meet the anticipated standards in the first part. B_PROUD is a pragmatic, prospective study comparing functional outcomes of treatment candidates with or without MSU care. Treatment candidates are defined as patients with a final diagnosis of ischemic stroke or transient ischemic attack, onset-to-dispatch-times ?4?h, disabling symptoms not resolved at time of ambulance arrival, and the ability to ambulate prior to the qualifying event. These patients are included if their emergency call prompted a stroke alarm at the dispatch center during MSU operation hours (7?am-11?pm, Monday-Sunday) and if the emergency is located within the MSU operation area in Berlin, Germany. The intervention group consists of patients who are cared for by the MSU. When the MSU is already in operation for another emergency, MSU dispatches are handled by regular ambulances (about 45%). These dispatches create the control group. Blinded stroke physicians assess the modified Rankin Scale (mRS) score in recorded structured interviews 3 months after stroke. The primary outcome is the degree of disability and death over the full range of the mRS. As a change to the previously published protocol and only pertinent in case of more than 9% lost-to-follow-up, a co-primary outcome was introduced consisting of the proportions of death, new institutional care or severe disability in patients with additional use of information from registration offices.

Perspective

The results will inform parties involved in acute stroke care organization on the effectiveness of the MSU concept.

Trial registration

The protocol is registered in (NCT03931616) and has been approved by the ethical review committee of the Charité - University Medicine Berlin (EA4/109/15) on September 2, 2015. The study protocol of B_PROUD part 1 had been published in the International Journal of Stroke as "Berlin Prehospital Or Usual Delivery of acute stroke care (B_PROUD) - study protocol" (doi: 10.1177/1747493017700152) on March 22, 2017 [1] previous to first patient's registration.

SUBMITTER: Harmel P

PROVIDER: S-EPMC7650132 | biostudies-literature | 2019

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Functional stroke outcomes after mobile stroke unit deployment - the revised protocol for the Berlin Prehospital Or Usual Delivery of acute stroke care (B_PROUD) part 2 study.

Harmel Peter P Ebinger Martin M Freitag Erik E Grittner Ulrike U Lorenz-Meyer Irina I Napierkowski Ira I Nolte Christian H CH Siegerink Bob B Audebert Heinrich J HJ

Neurological research and practice 20190603

<h4>Background</h4>Studies investigating the Mobile Stroke Unit (MSU) concept have shown increased thrombolysis rates, reduced alarm-to-treatment times and improved prehospital triage. Yet, so far, there is no definite scientific proof of better functional outcome after MSU deployment compared to regular ambulances.<h4>Methods</h4>We provide a revised protocol for the second part of the B_PROUD trial as organization of the MSU dispatch did not meet the anticipated standards in the first part. B_ ...[more]

PMID: 33324884

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Project description:ImportanceSo far, uncertainty remains as to whether there is sufficient cumulative evidence that mobile stroke unit (MSU; specialized ambulance equipped with computed tomography scanner, point-of-care laboratory, and neurological expertise) use leads to better functional outcomes compared with usual care.ObjectiveTo determine with a systematic review and meta-analysis of the literature whether MSU use is associated with better functional outcomes in patients with acute ischemic stroke (AIS).Data sourcesMEDLINE, Cochrane Library, and Embase from 1960 to 2021.Study selectionStudies comparing MSU deployment and usual care for patients with suspected stroke were eligible for analysis, excluding case series and case-control studies.Data extraction and synthesisIndependent data extraction by 2 observers, following the PRISMA and MOOSE reporting guidelines. The risk of bias in each study was determined using the ROBINS-I and RoB2 tools. In the case of articles with partially overlapping study populations, unpublished disentangled results were obtained. Data were pooled in random-effects meta-analyses.Main outcomes and measuresThe primary outcome was excellent outcome as measured with the modified Rankin Scale (mRS; score of 0 to 1 at 90 days).ResultsCompared with usual care, MSU use was associated with excellent outcome (adjusted odds ratio [OR], 1.64; 95% CI, 1.27-2.13; P < .001; 5 studies; n = 3228), reduced disability over the full range of the mRS (adjusted common OR, 1.39; 95% CI, 1.14-1.70; P = .001; 3 studies; n = 1563), good outcome (mRS score of 0 to 2: crude OR, 1.25; 95% CI, 1.09-1.44; P = .001; 6 studies; n = 3266), shorter onset-to-intravenous thrombolysis (IVT) times (median reduction, 31 minutes [95% CI, 23-39]; P < .001; 13 studies; n = 3322), delivery of IVT (crude OR, 1.83; 95% CI, 1.58-2.12; P < .001; 7 studies; n = 4790), and IVT within 60 minutes of symptom onset (crude OR, 7.71; 95% CI, 4.17-14.25; P < .001; 8 studies; n = 3351). MSU use was not associated with an increased risk of all-cause mortality at 7 days or at 90 days or with higher proportions of symptomatic intracranial hemorrhage after IVT.Conclusions and relevanceCompared with usual care, MSU use was associated with an approximately 65% increase in the odds of excellent outcome and a 30-minute reduction in onset-to-IVT times, without safety concerns. These results should help guideline writing committees and policy makers.

Project description:ImportanceTransferring patients with large-vessel occlusion (LVO) or intracranial hemorrhage (ICH) to hospitals not providing interventional treatment options is an unresolved medical problem.ObjectiveTo determine how optimized prehospital management (OPM) based on use of the Los Angeles Motor Scale (LAMS) compares with management in a Mobile Stroke Unit (MSU) in accurately triaging patients to the appropriate hospital with (comprehensive stroke center [CSC]) or without (primary stroke center [PSC]) interventional treatment.Design, setting, and participantsIn this randomized multicenter trial with 3-month follow-up, patients were assigned week-wise to one of the pathways between June 15, 2015, and November 15, 2017, in 2 regions of Saarland, Germany; 708 of 824 suspected stroke patients did not meet inclusion criteria, resulting in a study population of 116 adult patients.InterventionsPatients received either OPM based on a standard operating procedure that included the use of the LAMS (cut point ≥4) or management in an MSU (an ambulance with vascular imaging, point-of-care laboratory, and telecommunication capabilities).Main outcomes and measuresThe primary end point was the proportion of patients accurately triaged to either CSCs (LVO, ICH) or PSCs (others).ResultsA predefined interim analysis was performed after 116 patients of the planned 232 patients had been enrolled. Of these, 53 were included in the OPM group (67.9% women; mean [SD] age, 74 [11] years) and 63 in the MSU group (57.1% women; mean [SD] age, 75 [11] years). The primary end point, an accurate triage decision, was reached for 37 of 53 patients (69.8%) in the OPM group and for 63 of 63 patients (100%) in the MSU group (difference, 30.2%; 95% CI, 17.8%-42.5%; P < .001). Whereas 7 of 17 OPM patients (41.2%) with LVO or ICH required secondary transfers from a PSC to a CSC, none of the 11 MSU patients (0%) required such transfers (difference, 41.2%; 95% CI, 17.8%-64.6%; P = .02). The LAMS at a cut point of 4 or higher led to an accurate diagnosis of LVO or ICH for 13 of 17 patients (76.5%; 6 triaged to a CSC) and of LVO selectively for 7 of 9 patients (77.8%; 2 triaged to a CSC). Stroke management metrics were better in the MSU group, although patient outcomes were not significantly different.Conclusions and relevanceWhereas prehospital management optimized by LAMS allows accurate triage decisions for approximately 70% of patients, MSU-based management enables accurate triage decisions for 100%. Depending on the specific health care environment considered, both approaches are potentially valuable in triaging stroke patients.Trial registrationClinicalTrials.gov identifier: NCT02465346.

Project description:ImportanceEffects of thrombolysis in acute ischemic stroke are time-dependent. Ambulances that can administer thrombolysis (mobile stroke units [MSUs]) before arriving at the hospital have been shown to reduce time to treatment.ObjectiveTo determine whether dispatch of MSUs is associated with better clinical outcomes for patients with acute ischemic stroke.Design, setting, and participantsThis prospective, nonrandomized, controlled intervention study was conducted in Berlin, Germany, from February 1, 2017, to October 30, 2019. If an emergency call prompted suspicion of stroke, both a conventional ambulance and an MSU, when available, were dispatched. Functional outcomes of patients with final diagnosis of acute cerebral ischemia who were eligible for thrombolysis or thrombectomy were compared based on the initial dispatch (both MSU and conventional ambulance or conventional ambulance only).ExposureSimultaneous dispatch of an MSU (computed tomographic scanning with or without angiography, point-of-care laboratory testing, and thrombolysis capabilities on board) and a conventional ambulance (n = 749) vs conventional ambulance alone (n = 794).Main outcomes and measuresThe primary outcome was the distribution of modified Rankin Scale (mRS) scores (a disability score ranging from 0, no neurological deficits, to 6, death) at 3 months. The coprimary outcome was a 3-tier disability scale at 3 months (none to moderate disability; severe disability; death) with tier assignment based on mRS scores if available or place of residence if mRS scores were not available. Common odds ratios (ORs) were used to quantify the association between exposure and outcome; values less than 1.00 indicated a favorable shift in the mRS distribution and lower odds of higher levels of disability.ResultsOf the 1543 patients (mean age, 74 years; 723 women [47%]) included in the adjusted primary analysis, 1337 (87%) had available mRS scores (primary outcome) and 1506 patients (98%) had available the 3-tier disability scale assessment (coprimary outcome). Patients with an MSU dispatched had lower median mRS scores at month 3 (1; interquartile range [IQR], 0-3) than did patients without an MSU dispatched (2; IQR, 0-3; common OR for worse mRS, 0.71; 95% CI, 0.58-0.86; P < .001). Similarly, patients with an MSU dispatched had lower 3-month coprimary disability scores: 586 patients (80.3%) had none to moderate disability; 92 (12.6%) had severe disability; and 52 (7.1%) had died vs patients without an MSU dispatched: 605 (78.0%) had none to moderate disability; 103 (13.3%) had severe disability; and 68 (8.8%) had died (common OR for worse functional outcome, 0.73, 95% CI, 0.54-0.99; P = .04).Conclusions and relevanceIn this prospective, nonrandomized, controlled intervention study of patients with acute ischemic stroke in Berlin, Germany, the dispatch of mobile stroke units, compared with conventional ambulances alone, was significantly associated with lower global disability at 3 months. Clinical trials in other regions are warranted.

Dataset Information

Functional stroke outcomes after mobile stroke unit deployment - the revised protocol for the Berlin Prehospital Or Usual Delivery of acute stroke care (B_PROUD) part 2 study.

Background

Methods

Perspective

Trial registration

Publications

Functional stroke outcomes after mobile stroke unit deployment - the revised protocol for the Berlin Prehospital Or Usual Delivery of acute stroke care (B_PROUD) part 2 study.

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