Abstract 18: Improving Door-to-Needle Times with Target Stroke

Introduction: Nationally, fewer than 30% of IV tPA-treated patients are imaged within 25 minutes, or receive IV tPA within 60 minutes of ED arrival. In 2007, we implemented a new institutional acute stroke care model to include 10 best practices, all of which were later included in AHA’s Target Stroke program. We evaluated the effect of this strategy on timeliness of acute ischemic stroke (AIS) care. Methods: We analyzed median ED door-to-CT (DTCT) and door-to-needle (DTN) times in 4,477 AIS patients enrolled in our Get with the Guidelines Stroke registry from 2003-2011. Predictors of DTN ≤ 60 min (DTN60) were assessed using Chi-square for categorical variables and t-test for continuous variables. Results: An initial CT scan was performed in our ED in 58% of AIS patients, 289 of whom received IV tPA. Median DTCT times and DTN60 dropped significantly among tPA-treated patients after the intervention (Table 1, Chart 1). The percentage of patients with DTCT ≤ 25 min and DTN60 doubled post-intervention [12.6% vs. 28.1% and 35.0% vs. 70.0%, respectively, p <0.001]. Patients with DTN60 did not differ significantly in age, gender, race, co-morbidities, or NIHSS score as compared to those treated >60 min. Conclusion: Implementing the AHA Target Stroke best practices improved DTCT and DTN60 times for AIS patients, doubling the percent of patients meeting recommended targets. Only calendar year was independently associated with achieving DTN60, demonstrating a step function improvement after the guidelines were systematically applied. Therefore, changes in hospital-level, rather than patient-related factors are driving improvement.

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Abstract TP244: A Successful Statewide Initiative to Designate Hospital as Remote Treatment Stroke Centers

Stroke ◽

10.1161/str.47.suppl_1.tp244 ◽

2016 ◽

Vol 47 (suppl_1) ◽

Author(s):

Shelley Nichols ◽

Debbie Camp ◽

McCord Smith ◽

Chris Threlkeld ◽

James Lugtu ◽

...

Keyword(s):

Acute Stroke ◽

Systems Of Care ◽

Standard Of Care ◽

Stroke Care ◽

Acute Stroke Care ◽

Stroke Registry ◽

Remote Treatment ◽

Stroke Systems Of Care ◽

Stroke Center ◽

Iv Tpa

Background: As treatment of acute ischemic stroke (AIS) with IV tPA has become standard of care, smaller hospitals with limited resources have struggled to conform to consensus guidelines. To fill this practice gap, stroke systems of care were developed to support smaller, often rural, hospitals in providing standard stroke care to the patients they serve. Methods: As a result of legislative support from the Coverdell-Murphy Act, the Georgia Coverdell Acute Stroke Registry (GCASR) in collaboration with the Georgia Office of EMS (GA OEMS), the Georgia Hospital Association (GHA), and other state partners, developed a method for designating hospitals as Remote Treatment Stroke Centers (RTSC). The primary focus of performance improvement was treatment with IV tPA in eligible patients. Data collection and process change were used to improve the following quality indicators: percentage of eligible AIS patients treated with IV tPA and number of stroke alert notifications. Hospitals were required to partner with an accredited stroke center and use telemedicine to support the decision for administering IV tPA. GA OEMS was charged with reviewing and surveying individual hospitals applying for RTSC status. The GCASR served as the central repository to facilitate data sharing and benchmarking across hospitals. An inter-hospital transfer tool was created for EMS providers, adopted by GA OEMS, and disseminated throughout the state to guide management of patients receiving IV tPA who required transfer from a RTSC to an accredited stroke center. Results: Starting in 2014, pertinent information was distributed and assistance provided to the 24 RTSC eligible GCASR hospitals. At present, 4 hospitals have achieved designation; 1 hospital is pending survey; and several are considering application. In 2012-13 the now 4 RTSC hospitals gave IV tPA to 8 patients. In 2014-15 as these hospitals sought and achieved designation, this number rose to 24. During this same period, stroke alerts increased from 76 to 308. Conclusion: A state-based public health stroke initiative is effective in facilitating the designation of RTSC and thereby improving the delivery of acute stroke care in underserved areas.

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Abstract P37: A Novel Emergency Stroke Alert System Reduces Door-to-CT And Door-to-Needle Time in Patients With Acute Ischemic Stroke

Circulation Cardiovascular Quality and Outcomes ◽

10.1161/circoutcomes.4.suppl_1.ap37 ◽

2011 ◽

Vol 4 (suppl_1) ◽

Author(s):

Muhammad A Pervez ◽

Joshua N Goldstein ◽

Natalia S Rost ◽

Joyce Mclntyre ◽

Joseph Fay ◽

...

Keyword(s):

Ischemic Stroke ◽

Acute Stroke ◽

Stroke Care ◽

National Guidelines ◽

Alert System ◽

Acute Stroke Care ◽

Post Intervention ◽

Symptomatic Intracerebral Hemorrhage ◽

Increased Risk ◽

Iv Tpa

Background: National guidelines recommend eligible acute stroke patients undergo neuroimaging within 25 min and IV tPA within 60 min. In order to reduce door-to-needle time, we implemented an “ED2CT” virtual group pager which allows ED staff to simultaneously activate the Stroke Team, neuroradiologists, CT technologists, nursing supervisors and pharmacists. Methods: We performed an IRB approved retrospective review of a prospectively acquired cohort of consecutive patients with ischemic stroke presenting to a single tertiary stroke center using our Get With the Guidelines Stroke (GWTG-S) database. We compared patients who received IV tPA within 3 hours of symptom onset pre- (March 2006-April 2008) to post-intervention (September 2008-December 2009) by Wilcoxon or Fisher's exact as appropriate. Results: Overall, there were 56 patients in the pre-intervention and 53 in the post-intervention groups. Patients were 50.5% male, median age was 76 [IQR 63, 85] years, median time to presentation was 50 [IQR 33, 87] min, and median initial NIHSS was 14 [IQR 8, 20]. None of these variables were significantly different between the pre- and post-intervention groups. Implementation of the ED2CT alert was associated with a reduction of 31% in door-to-CT time (29 [22, 40] vs. 20 [16, 29] min; p=<0.001) and 13.5% in door-to needle time (59 [42, 78] vs. 51 [35, 62] min; p=0.02). In addition, there was an increase of 55% in the proportion of patients undergoing CT within 25 min (42.9% vs.66.7 % p=0.01) and 39% in door-to needle within 60 min (51.8% vs. 72.0% p=0.03). Symptomatic intracerebral hemorrhage (sICH) was infrequent among patients receiving IV tPA with or without rescue IA reperfusion (n=109, 8.3%) and those with IV tPA only (n=83, 6.0%); there was a trend in reduced sICH rate post intervention (11.6% vs. 0%; p=0.06). Conclusions: A novel emergency alert system with which the ED attending directly activates multiple members of the acute stroke clinical and imaging team was associated with an improved door-CT time and improved door-tPA time without an increased risk of sICH. This approach aligns acute stroke care activation with trauma and emergency cardiac care and suggests that team-based approaches may be better than specialty -specific responses.

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Abstract 2260: Interhospital Transfers in the Colorado Stroke System

Stroke ◽

10.1161/str.43.suppl_1.a2260 ◽

2012 ◽

Vol 43 (suppl_1) ◽

Author(s):

Don B Smith ◽

Richard L Hughes

Keyword(s):

Stroke Care ◽

Acute Stroke Care ◽

Medical Problems ◽

Stroke Registry ◽

Informal System ◽

Multivariate Logistic Model ◽

Clinically Significant ◽

Using Data ◽

To Receive ◽

Iv Tpa

Background: Stroke systems have been called a “critical next step in improving patient outcomes.” A desired feature is for hospitals unable to function as primary stroke centers to transfer appropriate patients for timely acute care. Recommendations imply that systems should be deliberately designed, but in Colorado an informal system is emerging without coordinated statewide action. We sought to assess the performance of this system with regard to hospital transfers. Methods: The Colorado Stroke Registry (CSR), a Get With The Guidelines-Stroke® database, shared by 39 hospitals, captures clinical data for ∼70% of Colorado strokes. Using data from CSR and the Colorado Hospital Association, we examined transfers during 2007-2009 to assess the effect of transfer on acute thrombolysis and to gain insight into factors that may determine whether transfer occurs. Results: 12,241 records had stroke-events during 2007-2009. Ischemic strokes (IS) were 56.7% of these. Transient ischemic attacks (TIA), subarachnoid hemorrhage (SAH), intracerebral hemorrhage (ICH) and non-specified stroke accounted for 23.7%, 4.6%, 11.3%, and 3.7%, respectively. Hospital transfers were noted in 1,487 records (12.1%). Nearly 80% of transfers were to only 6 (15%) of the 39 hospitals. The likelihood of transfer to a hospital was significantly correlated with hospital volume (P = 0.0045). Compared to IS, transfer was less likely for TIA but more likely for ICH and SAH (OR: 0.28, 1.59, 4.37, respectively; P <0.0001 for each). Transfer was more likely for: men than women (13.4% v 11.0%, P <0.0001); whites than blacks (11.8% v 5.3%, P <0.0001); and Hispanics than non-Hispanics (13.3% v 12.1%, P=0.002). Transfers were younger with higher NIHSS scores (mean age: 63.9 v 70; mean NIHSS 9.7 v 7.1, P <0.0001 for both). Transfer was less likely if additional medical problems were recorded (11% v 20.1%, P< 0.0001) or if primary insurance was Medicare rather than commercial (5.9% v 10.1%, P<0.0001). Day of week did not predict transfer. In a multivariate logistic model of transfer for IS, these variables were independently predictive: age, NIHSS and absence of additional problems. IS transfers were more likely to receive IV tPA (22.9% v 10.7%, P<0.0001) and more likely to die in-hospital (8.6% v 4.5%, P<0.0001), but no more likely to have clinically significant ICH following tPA (3.7% v 5.7%, P=0.324). Conclusions: Without centralized planning, a system of acute stroke care is evolving in Colorado. In the system, transfers are common for IS, SAH, and ICH. 15% of hospitals receive nearly 80% of transfers. Transfer is more common for IS patients who: are younger, have higher NIHSS scores and lack additional problems. Transferred IS patients are more likely to receive IV tPA but not to have clinically significant ICH after thrombolysis.

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Abstract T P188: Equivalency in Intravenous Thrombolytic Treatment Rates Between Primary Stroke Centers and Non-Primary Stroke Centers Through the Use of Telestroke

Stroke ◽

10.1161/str.45.suppl_1.tp188 ◽

2014 ◽

Vol 45 (suppl_1) ◽

Author(s):

Archit Bhatt ◽

Elizabeth Barban ◽

Leslie Corless ◽

Tamela Stuchiner ◽

Amit Kansara

Keyword(s):

Ischemic Stroke ◽

Acute Ischemic Stroke ◽

Symptom Onset ◽

Stroke Care ◽

Bivariate Analysis ◽

Stroke Patients ◽

Acute Stroke Care ◽

Stroke Registry ◽

Patient Arrival ◽

History Of

Background: Research has shown that subjects evaluated at (Primary Stroke Centers) PSCs are more likely to receive rt–PA than those evaluated at non–PSCs. It is unknown if telestroke evaluation affects rt-PA rates at non-PSCs. We hypothesized that with a robust telestroke system rt-TPA rates among PSCs and non-PSCs are not significantly different. Methods and Results: Data were obtained from the Providence Stroke Registry from January 2010 to December 2012. We identified ischemic stroke patients (n=3307) who received care in Oregon and Southwest Washington, which include 2 PSCs and 14 non-PSCs. Intravenous rt–PA was administered to 7.3% (n=242) of ischemic patients overall, 8.4% (n=79) at non–PSCs and 6.9% (n=163) at PSCs (p=.135). Stroke neurologists evaluated 5.2 % (n=172) of all ischemic stroke patients (n=3307) were evaluated via telestroke robot. Our analysis included AIS (Acute Ischemic Stroke) patients, those presenting within 4.5 hours of symptom onset. We identified 1070 AIS discharges from 16 hospitals of which 77.9 % (n=833) were at PSCs and 22.1 % (n=237) non-PSCs. For acute ischemic stroke patients (AIS) patients, those presenting within 4.5 hours of symptom onset, 22.1% (n=237) received rt-PA; 21.5% (n=74) presented at non–PSCs and 23.7% (n=163) presented at PSCs. Among AIS, bivariate analysis showed significant differences in treatment rates by race, age, NIHSS at admit, previous stroke or TIA, PVD, use of robot, smoking and time from patient arrival to CT completed. Using multiple logistic regression adjusting for these variables, treatment was significantly related to admit NIHSS (AOR=1.67, p<.001), history of stroke (AOR=.323, p<.001), TIA (AOR=.303, p=.01) and PVD (AOR=.176, p=.02), time to CT (.971, p<.001), and use of robot (7.76, p<.001). PSC designation was not significantly related to treatment (p=.06). Conclusions: Through the use of a robust telestroke system, there are no significant differences in the TPA treatment rates between non-PSC and PSC facilities. Telestroke systems can ensure stroke patients access to acute stroke care at non-PSC hospitals.

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Abstract TMP77: Race and Sex Differences in tPA Utilization Among Older Ischemic Stroke Patients

Stroke ◽

10.1161/str.48.suppl_1.tmp77 ◽

2017 ◽

Vol 48 (suppl_1) ◽

Author(s):

Michael Lyerly ◽

Farhaan Vahidy ◽

John Donnelly ◽

Katrina Booth ◽

Karen C Albright

Keyword(s):

Ischemic Stroke ◽

Nationwide Inpatient Sample ◽

Stroke Care ◽

Acute Stroke Care ◽

Older Americans ◽

Lower Odds ◽

Medical Comorbidities ◽

Procedure Code ◽

Receive Treatment ◽

Iv Tpa

Introduction: The risk of ischemic stroke doubles for each decade beyond the age of 55. While disparities, particularly racial disparities, have been described for many aspects of acute stroke care, these disparities have not been well characterized among older adults. The purpose of this analysis was to evaluate potential differences in IV-tPA utilization among acute ischemic stroke (AIS) patients aged ≥65 years. Methods: We used the Nationwide Inpatient Sample (NIS) to examine primary AIS diagnosis discharges (ICD-9 codes 433.x1, 434.x1 and 436) from US hospitals over 2006-2011, among those aged ≥ 65 years. Utilization of IV-tPA was identified using procedure code 99.10. Multivariate logistic regression was conducted to determine age and race associations with IV tPA utilization. Results: Over the 6 year study period, we identified 1.5 million ischemic stroke discharges, with 3.9% receiving IV-tPA. Compared to discharges who did not receive treatment, those receiving IV-tPA were less likely to be female and black. The odds of women receiving IV-tPA were 10% lower than men. After adjusting for demographics, insurance, and medical comorbidities, the odds of women receiving IV-tPA were still 5% lower (Table). When compared to non-black discharges, older blacks were at 25% lower odds of receiving IV-tPA. After adjusting for demographics, insurance and medical comorbidities, older blacks were at 22% lower odds of receiving IV-tPA (Table). Conclusions: Among older Americans, women and blacks have lower odds of being treated with IV-tPA, even after adjusting for age, insurance and comorbidities. A greater understanding of the reasons for these unexplained differences in the fastest growing proportion of our population is needed.

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Abstract P849: Effects of Standardized Stroke Protocols on Nursing Confidence and Knowledge in Low Volume Telestroke Emergency Departments

Stroke ◽

10.1161/str.52.suppl_1.p849 ◽

2021 ◽

Vol 52 (Suppl_1) ◽

Author(s):

Michelle Provencher ◽

Stephen A Figueroa ◽

Robin Novakovic ◽

Linda Hynan ◽

Daiwai M Olson ◽

...

Keyword(s):

Nursing Education ◽

Acute Stroke ◽

Emergency Departments ◽

Intervention Group ◽

Stroke Care ◽

Controlled Study ◽

Workflow Model ◽

Acute Stroke Care ◽

Post Intervention ◽

Care Protocol

Introduction: Nurses and staff in Emergency Departments (ED) with low monthly case volumes have few opportunities to build confidence and solidify skills in acute stroke management. The Nursing-driven Acute Stroke Care (NAS-Care) study tested a workflow model with empowerment of ED bedside nurses, clear role assignments for team members, and standardized protocols including a predefined run sheet. Methods: Seven Texas hospitals participated in this prospective, multisite, baseline-controlled study as part of the Lone Star Stroke Research Consortium. After three months of blinded baseline data collection, the following interventions were implemented: NIHSS certification, nursing education including mock stroke codes, and a standardized flowsheet for code organization and documentation (run sheet). Participating nurses were surveyed before and after implementation of this process. Results: The study was completed at 6 hospitals, with 180 patients in the pre-intervention group and 267 in the post-intervention group. The study intervention was found to improve Door-to-ED provider and Door-to-CT metrics but not physician-dependent metrics, Door-to-Needle or Door-to-Provider times (Provencher et al, ISC 2020). Completed surveys were returned by 97 nurses (pre-intervention) and 57 nurses (post-intervention). There were significant increases in the following questions (10 point scale, p<.001): “I understand goals and processes of stroke code activation”, “stroke codes at my institution are completed efficiently”, and “stroke codes are nursing-driven.” In the post-intervention surveys, nurses reported that the NAS-Care protocol improved understanding (mean score 8.0 +/- 2.4 SD/10) and efficiency (8.2 +/- 2.4/10), and reported that they would recommend NAS-Care to be adopted at other institutions (8.8 +/- 2.1/10). Conclusion: Standardized nurse-driven stroke protocols improved self-assessed knowledge and confidence for nurses in EDs utilizing telestroke, in addition to gains in staff-dependent stroke metrics.

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Abstract TP323: The Role of Ejection Fraction in 90 Day Functional Outcome in Acute Ischemic Infarction Patients Receiving Acute Stroke Therapy

Stroke ◽

10.1161/str.51.suppl_1.tp323 ◽

2020 ◽

Vol 51 (Suppl_1) ◽

Author(s):

Tamra Ranasinghe ◽

Brett Meyer ◽

Richard Lane ◽

Dawn Meyer

Keyword(s):

Acute Stroke ◽

Functional Outcome ◽

Pearson Correlation ◽

Recombinant Tissue Plasminogen Activator ◽

Continuous Variables ◽

Stroke Therapy ◽

Stroke Registry ◽

The Relationship ◽

Acute Stroke Therapy ◽

Iv Tpa

Background: Cardiovascular disease is associated with unfavorable outcomes following acute ischemic stroke (AIS). Left ventricularejection fraction (LVEF) alone has not been reported as a significant predictor of unfavorable outcomes in observational studies of AIS.The purpose of this study was to evaluate the relationship between LVEF and 90 day functional outcome in AIS patients who received acute stroke therapy with IV recombinant tissue plasminogen activator (rt-PA), endovascular therapy (EVT), or combination IV rt-PA+EVT. Methods: This was a retrospective review of prospectively collected data from the University of California San Diego (UCSD) Stroke registry from October 2014-June 2019. Analysis included all patients for whom a stroke code was activated and who had a transthoracic echocardiogram (TTE) during stroke admission or within the previous 30 days prior to AIS. Acute stroke therapy was defined as 1) IV tPA only; 2) EVT only; or 3) IV tPA + EVT. LVEF function was defined as: low <35%, moderately low 36 -49% and normal >50% on TTE. Primary outcome was modified ranking scale(mRS) at 90 days post stroke. Data was examined for frequencies and distribution. Continuous variables were assessed by Pearson correlation and t test. Kruskal-Wallis or ANOVA were used to evaluate group differences. ANCOVA was used for adjusted analysis. Results: In the 227 patients identified, low EF patients were more likely to have atrial fibrillation (61.9%, p=.004) and lower mean admission systolic blood pressure (132.6, p=0.009). LVEF was not significantly associated with 90 day outcome in all treated patients in both unadjusted (p=0.992) and adjusted (p=0.62). LVEF was not significantly associated with 90 day outcome for individual acute stroke therapy groups both unadjusted and adjusted. mRS at 90 days was significantly associated with baseline NIHSS (p<0.001), age (p=0.002), and treatment with IV tPA (p=0.01). Conclusion: In this study, LVEF was not independently associated with 90 day functional outcome in AIS patients who received acute stroke therapy. Further studies in more heterogenous samples are warranted to assess the relationship between LVEF and outcome in all stroke populations.

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Abstract 352: Early Data From an Implementation Science Study Suggests the Need for Identification and Adoption of Best Practices to Improve the Timeliness of Stroke Treatment

Circulation Cardiovascular Quality and Outcomes ◽

10.1161/hcq.13.suppl_1.352 ◽

2020 ◽

Vol 13 (Suppl_1) ◽

Author(s):

Lisa M Monk

Keyword(s):

Best Practices ◽

Acute Stroke ◽

Care Delivery ◽

Stroke Care ◽

Early Data ◽

Screening Tools ◽

Stroke Severity ◽

Ct Scanner ◽

Acute Stroke Care ◽

Stroke Treatment

There is a disconnect from discovery of best treatment options and application into clinical practice in a timely manner. The I M plementation of best Pr actices f O r acute stroke care-de v eloping and optimizing regional systems of Stroke Care (IMPROVE Stroke Care) goal is to develop a regional integrated stroke system that identifies, classifies, and treats patients with acute ischemic stroke more rapidly and effectively with reperfusion therapy. These improvements in acute stroke care delivery are expected to result in lower mortality, fewer recurrent strokes, and improved long term functional outcomes. Recent discoveries in stroke care and advancement in technology extends the window for both TPA administration and mechanical thombectomy. The challenge of implementing these latest advances are difficult considering the ability of hospitals to implement the original American Heart Association (AHA) Systems of Stroke Care recommendations. Early data from this project shows that the challenges continue to exist in recommendations that have been in place as early as 2005. EMS is not utilizing pre-hospital stroke screening tools, only 5% of the time, stroke severity tools, only 7% of the time, lytic checklists, 0% of the time, destination decision changed due to severity score, 0% of the time, and pre-notifying emergency rooms, only 63% of the time. Emergency departments door to CT <45 minutes, only 55% of the time, Lytic given in CT scanner, only 35% of the time, Door to lytic therapy< 45 minutes, 77% of the time, Door to Groin puncture, 81% of the time, and Door to TICI Flow 2c/3 flow <90 minutes, 39% of the time. The Systems of Stroke Care have recommendations that will improve time to treatment and outcomes for patients. This project is working to provide tools, guidance, data, and feedback to improve application of these recommendations and identify best practices and solutions to barriers.

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Rationale and design for studying organisation of care for intra-arterial thrombectomy in the Netherlands: simulation modelling study

BMJ Open ◽

10.1136/bmjopen-2019-032754 ◽

2020 ◽

Vol 10 (1) ◽

pp. e032754

Author(s):

Maarten M H Lahr ◽

Willemijn J Maas ◽

Durk-Jouke van der Zee ◽

Maarten Uyttenboogaart ◽

Erik Buskens

Keyword(s):

The Netherlands ◽

Acute Stroke ◽

Stroke Care ◽

Simulation Modelling ◽

Sensitivity Analyses ◽

Categorical Variables ◽

Acute Stroke Care ◽

Organisation Of Care ◽

Link Type ◽

Use Of Resources

IntroductionThe introduction of intra-arterial thrombectomy (IAT) challenges acute stroke care organisations to provide fast access to acute stroke therapies. Parameters of pathway performance include distances to primary and comprehensive stroke centres (CSCs), time to treatment and availability of ambulance services. Further expansion of IAT centres may increase treatment rates yet could affect efficient use of resources and quality of care due to lower treatment volume. The aim was to study the organisation of care and patient logistics of IAT for patients with ischaemic stroke in the Netherlands.Methods and analysesUsing a simulation modelling approach, we will quantify performance of 16 primary and CSCs offering IAT in the Netherlands. Patient data concerning both prehospital and intrahospital pathway logistics will be collected and used as input for model validation. A previously validated simulation model for intravenous thrombolysis (IVT) patients will be expanded with data of the MR CLEAN (Multicenter Randomized Clinical Trial of Endovascular Treatment for Acute Ischemic Stroke in the Netherlands) Registry and trials performed in the Collaboration for New Treatments in Acute Stroke consortium to represent patient logistics, time delays and outcomes in IAT patients. Simulation experiments aim to assess effectiveness and efficiency of alternative network topologies, that is, IAT with or without IVT at the nearest primary stroke centre (PSC) versus centralised care at a CSC. Primary outcomes are IAT treatment rates and clinical outcome according to the modified Rankin Scale. Secondary outcomes include onset-to-treatment time and resource use. Mann-Whitney U and Fisher’s exact tests will be used to estimate differences for continuous and categorical variables. Model and parameter uncertainty will be tested using sensitivity analyses.Ethics and disseminationThis will be the first study to examine the organisation of acute stroke care for IAT delivery on a national scale using discrete event simulation. There are no ethics or safety concerns regarding the dissemination of information, which includes publication in peer-reviewed journals and (inter)national conference presentations.Trial registration numberISRCTN99503308,ISRCTN76741621,ISRCTN19922220,ISRCTN80619088,NCT03608423; Pre-results.

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