Large variations in atrial fibrillation screening practice after ischemic stroke and transient ischemic attack in Sweden: a survey study.

BACKGROUND: Atrial fibrillation (AF) screening after ischemic stroke or transient ischemic attack (TIA) is given high priority in clinical guidelines. However, patient selection, electrocardiogram (ECG) modality and screening duration remains undecided and current recommendations vary. METHODS: The aim of this study was to investigate the clinical practice of AF screening after ischemic stroke or TIA at Swedish stroke units. In collaboration with the stakeholders of the Swedish Stroke Register (Riksstroke) a digital survey was drafted, then tested and revised by three stroke consultants. The survey consisted of 17 multiple choice/ free text questions and was sent by e-mail to the medical directors at all stroke units in Sweden. RESULTS: All 72 stroke units in Sweden responded to the survey. Most stroke units reported that ≥ 75% of ischemic stroke (69/72 stroke units) or TIA patients (67/72 stroke units), without previously known AF, were screened for AF. Inpatient telemetry ECG was the method of first-choice in 81% of the units, but 7% reported lack of access. A variety of standard monitoring durations were used for inpatient telemetry ECG. The second most common choice was Holter ECG (17%), also with considerable variations in monitoring duration. Other AF screening modalities were used as a first-choice method (handheld and patch ECG) but less frequently. CONCLUSIONS: Clinical practice for AF screening after ischemic stroke or TIA differed between Swedish stroke units, both in choice of AF screening methods as well as in monitoring durations. There is an urgent need for evidence and evidence-based recommendations in this field. TRIAL REGISTRATION: Not applicable.

A person-centred care transition support for people with stroke/TIA: A study protocol for effect and process evaluation using a non-randomised controlled design.

INTRODUCTION: Care transitions following a stroke call for integrated care approaches to reduce death and disability. The proposed research described in this study protocol aims to evaluate the effectiveness of a person-centred multicomponent care transition support and the process in terms of contextual moderators, implementation aspects and mechanisms of impact. METHODS: A non-randomized controlled trial design will be used. The intervention includes person-centred dialogue intended to permeate all patient-provider communication, various pedagogical modes of information, a person-centred care and rehabilitation plan, and a bridging e-meeting to prepare patients for homecoming. Patients with stroke or TIA who are to be discharged from the participating hospitals to home and referred to a neurorehabilitation team for continued rehabilitation will be included. Follow-ups will be conducted at one week, 3 months and 12 months. Data will be collected on the primary outcome of perceived quality of the care transition, and on the secondary outcomes of health literacy, medication adherence, and perceived person-centeredness. Data for process evaluation will be collected through semi-structured interviews, focus groups, participatory observations, and the Normalisation Measure Development Questionnaire. DISCUSSION: The study will provide insights on implementation, mechanisms of impact, contextual moderators, and effectiveness of a care transition support, targeting a poorly functioning part of the care trajectory for people with stroke and TIA. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT05646589.

Effects of blood pressure and tranexamic acid in spontaneous intracerebral haemorrhage: a secondary analysis of a large randomised controlled trial.

Background: Tranexamic acid reduced haematoma expansion and early death, but did not improve functional outcome in the tranexamic acid for hyperacute spontaneous intracerebral haemorrhage-2 (TICH-2) trial. In a predefined subgroup, there was a statistically significant interaction between prerandomisation baseline systolic blood pressure (SBP) and the effect of tranexamic acid on functional outcome (p=0.019). Methods: TICH-2 was an international prospective double-blind placebo-controlled randomised trial evaluating intravenous tranexamic acid in patients with acute spontaneous intracerebral haemorrhage (ICH). Prerandomisation baseline SBP was split into predefined ≤170 and >170 mm Hg groups. The primary outcome at day 90 was the modified Rankin Scale (mRS), a measure of dependency, analysed using ordinal logistic regression. Haematoma expansion was defined as an increase in haematoma volume of >33% or >6 mL from baseline to 24 hours. Data are OR or common OR (cOR) with 95% CIs, with significance at p<0.05. Results: Of 2325 participants in TICH-2, 1152 had baseline SBP≤170 mm Hg and were older, had larger lobar haematomas and were randomised later than 1173 with baseline SBP>170 mm Hg. Tranexamic acid was associated with a favourable shift in mRS at day 90 in those with baseline SBP≤170 mm Hg (cOR 0.73, 95% CI 0.59 to 0.91, p=0.005), but not in those with baseline SBP>170 mm Hg (cOR 1.05, 95% CI 0.85 to 1.30, p=0.63). In those with baseline SBP≤170 mm Hg, tranexamic acid reduced haematoma expansion (OR 0.62, 95% CI 0.47 to 0.82, p=0.001), but not in those with baseline SBP>170 mm Hg (OR 1.02, 95% CI 0.77 to 1.35, p=0.90). Conclusions: Tranexamic acid was associated with improved clinical and radiological outcomes in ICH patients with baseline SBP≤170 mm Hg. Further research is needed to establish whether certain subgroups may benefit from tranexamic acid in acute ICH. Trial registration number: ISRCTN93732214.

The Use of Teach Back at Hospital Discharge to Support Self-Management of Prescribed Medication for Secondary Prevention after Stroke-Findings from A Feasibility Study.

The study aimed to investigate whether a structured discharge letter and the use of the person-centred communication method Teach Back for sharing information at hospital discharge could support perceived understanding and knowledge of and adherence to prescribed medication for secondary prevention after stroke. Data from a feasibility study of a codesigned care transition support for people with stroke was used. Patients who at discharge received both a structured discharge letter and participated in the person-centred communication method Teach Back (n = 17) were compared with patients receiving standard discharge procedures (n = 21). Questionnaires were used to compare the groups regarding perceived understanding of information about medical treatment, knowledge of information about medical treatment and medication adherence at 1 week and 3 months. There was a statistically significant difference in perceived understanding of information about medical treatment (p > 0.01) between the groups in favour of those who participated in Teach Back at the discharge encounter. No differences between groups were found regarding understanding health information about medical treatment and medication adherence. The results indicate that the use of Teach Back at the discharge encounter positively impacts perceived understanding of information about medical treatment in people with stroke. However, considering the nonrandomised study design and the small sample size, a large-scale trial is needed.

Editor's Choice - Nationwide Outcome Analysis of Primary Carotid Endarterectomy in Symptomatic Patients Depending on Closure Technique and Patch Type.

OBJECTIVE: Current European guidelines recommend both eversion carotid endarterectomy (CEA) and conventional CEA with routine patch closure, rather than routine primary closure. Polyester and polytetrafluoroethylene (PTFE) have been used as patch material for a long time. More recently, bovine pericardium has been used; however, there are few studies comparing long term results between bovine pericardium and other patch types. The aim of this study was to investigate the short and long term results after CEA depending on surgical technique and patch material. METHODS: A registry based study on all primary CEAs (n = 9 205) performed for symptomatic carotid artery stenosis in Sweden from July 2008 to December 2019, cross linked with data from the Swedish stroke registry, Riksstroke, and chart review for evaluation of any events occurring during follow up. The primary endpoint was ipsilateral stroke < 30 days. Secondary endpoints included re-operations due to neck haematoma and < 30 day ipsilateral stroke, > 30 day ipsilateral stroke, all stroke > 30 days, and all cause mortality. RESULTS: 2 495 patients underwent eversion CEA and 6 710 conventional CEA for symptomatic carotid stenosis. The most commonly used patch material was Dacron (n = 3 921), followed by PTFE (n = 588) and bovine pericardium (n = 413). A total of 1 788 patients underwent conventional CEA with primary closure. Two hundred and seventy-three patients (3.0%) had a stroke < 30 days. Primary closure was associated with an increased risk of ipsilateral stroke and stroke or death <30 days: odds ratio 1.7 (95% confidence interval [CI] 1.2 - 2.4, p = .002); and 1.5 (95% CI 1.2 - 2.0), respectively. During follow up (median 4.2 years), 592 patients had any form of stroke and 1 492 died. There was no significant difference in long term risk of ipsilateral stroke, all stroke, or death depending on surgical technique or patch material. CONCLUSION: There was an increased risk of ipsilateral stroke < 30 days in patients operated on with primary closure compared with eversion CEA and patch angioplasty. There was no difference between primary closure, different patch types, or eversion after the peri-operative phase.

Measuring communication as a core outcome in aphasia trials: Results of the ROMA-2 international core outcome set development meeting.

BACKGROUND: Evidence-based recommendations for a core outcome set (COS; minimum set of outcomes) for aphasia treatment research have been developed (the Research Outcome Measurement in Aphasia-ROMA, COS). Five recommended core outcome constructs: communication, language, quality of life, emotional well-being and patient-reported satisfaction/impact of treatment, were identified through three international consensus studies. Constructs were paired with outcome measurement instruments (OMIs) during an international consensus meeting (ROMA-1). Before the current study (ROMA-2), agreement had not been reached on OMIs for the constructs of communication or patient-reported satisfaction/impact of treatment. AIM: To establish consensus on a communication OMI for inclusion in the ROMA COS. METHODS & PROCEDURES: Research methods were based on recommendations from the Core Outcome Measures in Effectiveness Trials (COMET) Initiative. Participants with expertise in design and conduct of aphasia trials, measurement instrument development/testing and/or communication outcome measurement were recruited through an open call. Before the consensus meeting, participants agreed on a definition of communication, identified appropriate OMIs, extracted their measurement properties and established criteria for their quality assessment. During the consensus meeting they short-listed OMIs and participants without conflicts of interest voted on the two most highly ranked instruments. Consensus was defined a priori as agreement by ≥ 70% of participants. OUTCOMES & RESULTS: In total, 40 researchers from nine countries participated in ROMA-2 (including four facilitators and three-panel members who participated in pre-meeting activities only). A total of 20 OMIs were identified and evaluated. Eight short-listed communication measures were further evaluated for their measurement properties and ranked. Participants in the consensus meeting (n = 33) who did not have conflicts of interest (n = 29) voted on the top two ranked OMIs: The Scenario Test (TST) and the Communication Activities of Daily Living-3 (CADL-3). TST received 72% (n = 21) of 'yes' votes and the CADL-3 received 28% (n = 8) of 'yes' votes. CONCLUSIONS & IMPLICATIONS: Consensus was achieved that TST was the preferred communication OMI for inclusion in the ROMA COS. It is currently available in the original Dutch version and has been adapted into English, German and Greek. Further consideration must be given to the best way to measure communication in people with mild aphasia. Development of a patient-reported measure for satisfaction with/impact of treatment and multilingual versions of all OMIs of the COS is still required. Implementation of the ROMA COS would improve research outcome measurement and the quality, relevance, transparency, replicability and efficiency of aphasia treatment research. WHAT THIS PAPER ADDS: What is already known on this subject International consensus has been reached on five core constructs to be routinely measured in aphasia treatment studies. International consensus has also been established for OMIs for the three constructs of language, quality of life and emotional well-being. Before this study, OMIs for the constructs of communication and patient-reported satisfaction/impact of treatment were not established. What this paper adds to existing knowledge We gained international consensus on an OMI for the construct of communication. TST is recommended for inclusion in the ROMA COS for routine use in aphasia treatment research. What are the potential or actual clinical implications of this work? The ROMA COS recommends OMIs for a minimum set of outcomes for adults with post-stroke aphasia within phases I-IV aphasia treatment research. Although not intended for clinical use, clinicians may employ the instruments of the ROMA COS, considering the quality of their measurement properties. The systematic inclusion of a measure of communication, such as TST, in clinical practice could ultimately support the implementation of research evidence and best practices.

Maintained acute stroke admission during the first wave COVID-19 pandemic in Sweden, a register-based study.

OBJECTIVES: Clinicians and researchers have addressed concerns about the negative impact of COVID-19 outbreaks on the ability of health care systems to provide timely assessment and acute therapies to patients with stroke. The aim of this study is to describe stroke care during the first wave of the COVID-19 pandemic compared to the same period the year before at an acute care hospital in Sweden. MATERIALS AND METHODS: In this cohort study data were collected from March 1st to August 31st in 2019 and 2020 on all patients diagnosed with stroke and TIA and registered at Danderyd Hospital in the national quality registry (Riksstroke). Data were completed with information from the hospital record. Sweden had no lockdown during 2020. RESULTS: During the study period in year 2019 there were 426 registered stroke patients at Danderyd hospital, compared to 403 registered stroke patients the same period during 2020 (p = 0.483). The number of minor stroke and TIA during the period in 2019 compared to 2020 were 468 versus 453 respectively (minor stroke p = 0.475 versus TIA p = 0.50). CONCLUSIONS: There were no difference in the number of patients diagnosed with stroke and TIA during the first wave of the COVID-19 pandemic.

Analysis and modelling of mistriage in the Stockholm stroke triage system.

Introduction: The Stockholm Stroke Triage System (SSTS) is a prehospital triage system for detection of patients eligible for endovascular thrombectomy (EVT). Assessment of hemiparesis combined with ambulance-hospital teleconsultation is used to route patients directly to the thrombectomy centre. Some patients are not identified and require secondary transport for EVT (undertriage) while others taken to the thrombectomy centre do not undergo EVT (overtriage). The aims of this study were to characterize mistriaged patients, model for and evaluate alternative triage algorithms. Patients and methods: Patients with suspected stroke transported by priority 1 ground ambulance between October 2017 and October 2018 (n = 2905) were included. Three triage algorithms were modelled using prehospital data. Decision curve analysis was performed to calculate net benefit (correctly routing patients for EVT without increasing mistriage) of alternative models vs SSTS. Results: Undertriage for EVT occurred in n = 35/2582 (1.4%) and overtriage in n = 239/323 (74.0%). Compared to correct thrombectomy triages, undertriaged patients were younger and had lower median NIHSS (10 vs 18), despite 62.9% with an M1 occlusion. In overtriaged patients, 77.0% had a stroke diagnosis (29.7% haemorrhagic). Hemiparesis and FAST items face and speech were included in all models. Decision curve analysis showed highest net benefit for SSTS for EVT, but lower for large artery occlusion (LAO) stroke. Discussion: Undertriaged patients had lower NIHSS, likely due to better compensated proximal occlusions. SSTS was superior to other models for identifying EVT candidates, but lacked information allowing comparison to other prehospital scales. Conclusion: Using prehospital data, alternative models did not outperform the SSTS in finding EVT candidates.

Referral-based transition to subsequent rehabilitation at home after stroke: one-year outcomes and use of healthcare services.

BACKGROUND: There is a lack of knowledge about patients' journeys across the stroke care continuum, especially regarding the transition from inpatient to outpatient care and rehabilitation. Therefore, the aim of the present study was to explore and describe patterns of healthcare use over a one-year period, health outcomes at 3 and 12 months for patients following a referral-based transition to subsequent rehabilitation in the home, and the caregiver burden on their significant others. A further aim was to explore factors associated with the use of rehabilitation and healthcare after the referral-based transition to continued rehabilitation in the home for people recovering from a stroke. METHODS: Data regarding healthcare use during the first 12 months post-stroke was collected from the Region Stockholm computerized register. Data on patient characteristics, disease-related data, and functioning were retrieved drawn from medical records and questionnaires. Descriptive statistics were used to present healthcare use, participants' characteristics, disease-related data, and patient functioning. Multivariable regression models were created to explore associations between the total number of outpatient contacts, total visits with the neurorehabilitation team, and the independent variables. RESULTS: The mean age for the 190 participants was 73 years for men and 78 years for women. Twenty-one participants (11%) had an acute rehospitalization within 30 days after discharge, and 41 participants (21%) were re-hospitalized within 90 days. Twenty-two (12%) of the participants had no visits with the neurorehabilitation team, 73 (39%) participants had 1-3 visits, 57 (30%) had 4-16 visits, and 38 (20%) had ≥17 visits. Female sex and length of hospital stay were associated with a higher number of visits with the neurorehabilitation team. Living alone, higher self-rated recovery, and being able to walk independently were associated with a lower number of visits with the neurorehabilitation team. Female sex, having home help services before the stroke, longer length of hospital stay, and more comorbidities were associated with a higher number of outpatient contacts. CONCLUSIONS: The findings indicate that there is no generic pattern of healthcare use during the first-year post-stroke in patients receiving referral-based transition to continued rehabilitation in the home. The different patterns of healthcare use seemed to mirror the participants' level of functioning. However, there is a need to further investigate how follow-up and rehabilitation correspond to the needs of patients and their significant others in the short- and long-term perspective. TRIAL REGISTRATION: ClinicalTrials.gov , registration number: NCT02925871 . Date of registration: October 6, 2016.

Brief Consent Methods Enable Rapid Enrollment in Acute Stroke Trial: Results From the TICH-2 Randomized Controlled Trial.

BACKGROUND: Seeking consent rapidly in acute stroke trials is crucial as interventions are time sensitive. We explored the association between consent pathways and time to enrollment in the TICH-2 (Tranexamic Acid in Intracerebral Haemorrhage-2) randomized controlled trial. METHODS: Consent was provided by patients or by a relative or an independent doctor in incapacitated patients, using a 1-stage (full written consent) or 2-stage (initial brief consent followed by full written consent post-randomization) approach. The computed tomography-to-randomization time according to consent pathways was compared using the Kruskal-Wallis test. Multivariable logistic regression was performed to identify variables associated with onset-to-randomization time of ≤3 hours. RESULTS: Of 2325 patients, 817 (35%) gave self-consent using 1-stage (557; 68%) or 2-stage consent (260; 32%). For 1507 (65%), consent was provided by a relative (1 stage, 996 [66%]; 2 stage, 323 [21%]) or a doctor (all 2-stage, 188 [12%]). One patient did not record prerandomization consent, with written consent obtained subsequently. The median (interquartile range) computed tomography-to-randomization time was 55 (38-93) minutes for doctor consent, 55 (37-95) minutes for 2-stage patient, 69 (43-110) minutes for 2-stage relative, 75 (48-124) minutes for 1-stage patient, and 90 (56-155) minutes for 1-stage relative consents (P<0.001). Two-stage consent was associated with onset-to-randomization time of ≤3 hours compared with 1-stage consent (adjusted odds ratio, 1.9 [95% CI, 1.5-2.4]). Doctor consent increased the odds (adjusted odds ratio, 2.3 [1.5-3.5]) while relative consent reduced the odds of randomization ≤3 hours (adjusted odds ratio, 0.10 [0.03-0.34]) compared with patient consent. Only 2 of 771 patients (0.3%) in the 2-stage pathways withdrew consent when full consent was sought later. Two-stage consent process did not result in higher withdrawal rates or loss to follow-up. CONCLUSIONS: The use of initial brief consent was associated with shorter times to enrollment, while maintaining good participant retention. Seeking written consent from relatives was associated with significant delays. REGISTRATION: URL: https://www.isrctn.com; Unique identifier: ISRCTN93732214.

The Stockholm Stroke Triage Project: Outcomes of Endovascular Thrombectomy Before and After Triage Implementation.

BACKGROUND AND PURPOSE: The Stockholm Stroke Triage System (SSTS) is a prehospital algorithm for detection of endovascular thrombectomy (EVT)-eligible patients, combining symptom severity assessment and ambulance-to-hospital teleconsultation, leading to a decision on primary stroke center bypass. In the Stockholm Region (6 primary stroke centers, 1 EVT center), SSTS implementation in October 2017 reduced onset-to-EVT time by 69 minutes. We compared clinical outcomes before and after implementation of SSTS in an observational study. METHODS: We prospectively recruited patients transported by Code Stroke ambulance within the Stockholm region under the SSTS, treated with EVT during October 2017 to October 2019, and compared to EVT patients from 2 previous years. OUTCOMES: shift in modified Rankin Scale (mRS) scores, mRS score 0 to 1, mRS score 0 to 2, and death (all 3 months), National Institutes of Health Stroke Scale (NIHSS) score change 24-hour post-EVT, recanalization (Thrombolysis in Cerebral Infarction 2b-3), and symptomatic intracranial hemorrhage. mRS outcomes were adjusted for age and baseline NIHSS. RESULTS: Patients with EVT in the SSTS group (n=244) were older and had higher baseline NIHSS versus historical controls (n=187): median age 74 (interquartile range, 63-81) versus 71 (61-78); NIHSS score 17 (11.5-21) versus 15 (10-20). During SSTS, median onset-to-puncture time was 136 versus 205 minutes (P<0.001). Adjusted common odds ratio for lower mRS in SSTS patients was 1.7 (95% CI, 1.2-2.3) versus controls. During SSTS, 83/240 (34.6%) versus 44/186 (23.7%) reached 3-month mRS score 0 to 1 (P=0.014), adjusted common odds ratio 2.3 (95% CI, 1.4-3.6). Median NIHSS change 24-hour post-EVT was 6 versus 4 (P=0.005). Differences in Thrombolysis in Cerebral Infarction, symptomatic intracranial hemorrhage, and death were nonsignificant. CONCLUSIONS: With an onset to arterial puncture time reduction by 69 minutes, outcomes in thrombectomy-treated patients improved significantly after region-wide large artery occlusion triage system implementation. These results warrant replication studies in other geographic and organizational circumstances.

Low Incidence of Late Ipsilateral Ischaemic Stroke After Treatment for Symptomatic Carotid Stenosis in Sweden 2008-2017: Increased Risk in the Elderly and After Carotid Stenting.

OBJECTIVE: Carotid stenosis is a major risk factor for stroke and surgical treatment is key in preventing recurrent ischaemic events. Previous randomised trials have demonstrated the net benefit of surgery for significant symptomatic carotid stenosis but, with present day medical treatment, there is limited evidence on the risk of late ipsilateral ischaemic stroke (IS) and its main risk factors. METHOD: Ipsilateral IS after the peri-operative period (≤ 30 days) was investigated in a nationwide, registry based cohort study of patients treated for symptomatic carotid stenosis in Sweden between 2008 - 2017. The Swedish National Registry for Vascular Surgery (Swedvasc) was used to establish the cohort, and the Swedish stroke registry (Riksstroke), combined with hospital records, was used to determine outcome. Stroke of any type and all cause mortality after the peri-operative period were studied as secondary outcomes. Cox regression was used to analyse associations between clinical factors and outcomes. RESULTS: In total, 7 589 patients (mean age 72 ± 8 years, 68% men) were followed for 4.2 ± 2.6 years. Ipsilateral IS occurred in 232 patients corresponding to a yearly incidence of 0.73%. Age above 80 years compared with 65 - 79 years was associated with an increased risk of ipsilateral IS (adjusted HR 1.94, 95% CI 1.43 - 2.65). Carotid artery stenting (CAS) compared with carotid endarterectomy (CEA) was also associated with increased risk (adjusted HR 3.20, 95% CI 2.03 - 5.03). Stroke of any type occurred in 7.7% of patients, and 19.6% of patients died during the follow up period. CONCLUSION: The incidence of ipsilateral IS after treatment for symptomatic carotid stenosis in Sweden 2008-2017 was low, demonstrating the effectiveness and durability of surgery in a real world setting. Only age above 80 years and CAS compared with CEA were associated with increased risk of ipsilateral IS.

Person-centred care transitions for people with stroke: study protocol for a feasibility evaluation of codesigned care transition support.

BACKGROUND: Care transitions following stroke should be bridged with collaboration between hospital staff and home rehabilitation teams since well-coordinated transitions can reduce death and disability following a stroke. However, health services are delivered within organisational structures, rather than being based on patients' needs. The aim of this study protocol is to assess the feasibility, operationalised here as fidelity and acceptability, of a codesigned care transition support for people with stroke. METHODS: This study protocol describes the evaluation of a feasibility study using a non-randomised controlled design. The codesigned care transition support includes patient information using videos, leaflets and teach back; what-matters-to me dialogue; a coordinated rehabilitation plan; bridged e-meeting; and a message system for cross-organisational collaboration. Patients with stroke, first time or recurrent, who are to be discharged home from hospital and referred to a rehabilitation team in primary healthcare for continued rehabilitation in the home will be included. One week after stroke, data will be collected on the primary outcome, namely satisfaction with the care transition support, and on the secondary outcome, namely health literacy and medication adherence. Data on use of healthcare will be obtained from a register of healthcare contacts. The outcomes of patients and significant others will be compared with matched controls from other geriatric stroke and acute stroke units, and with matched historic controls from a previous dataset at the intervention and control units. Data on acceptability and fidelity will be assessed through interviews and observations at the intervention units. ETHICS AND DISSEMINATION: Ethical approvals have been obtained from the Swedish Ethical Review Authority. The results will be published open-access in peer-reviewed journals. Dissemination also includes presentation at national and international conferences. DISCUSSION: The care transition support addresses a poorly functioning part of care trajectories in current healthcare. The development of this codesigned care transition support has involved people with stroke, significant other, and healthcare professionals. Such involvement has the potential to better identify and reconceptualise problems, and incorporate user experiences. TRIAL REGISTRATION NUMBER: http://www.clinicaltrials.gov id: NCT02925871. Date of registration 6 October 2016. PROTOCOL VERSION: 1.

The manifestation of participation within a co-design process involving patients, significant others and health-care professionals.

BACKGROUND: Despite intentions to increase user participation in the development of health services, the concept of participation and how it unfolds within studies with a participatory design has rarely been addressed. OBJECTIVE: The aim of this study was to describe how user participation manifests itself within a co-design process involving patients, significant others and health-care professionals, including potential enablers or barriers. METHODS: This study was conducted in the context of a co-design process of a new person-centred transition from a hospital to continued rehabilitation in the home involving three patients with stroke, one significant other and 11 professionals. Data were collected by observations during the workshops, semi-structured interviews and questionnaires. RESULTS: Four categories: 'Composition of individuals for an adaptive climate'; 'The balancing of roles and power'; 'Different perspectives as common ground for a shared understanding'; and 'Facilitating an unpredictable and ever-adaptive process', with all together nine subcategories, resulted from the analysis. Participation varied between individuals, groups and steps within the process, and on the topic of discussions and the motivation to contribute. DISCUSSION/CONCLUSION: Participation is not something that is realized by only applying participatory design methodology. Participation manifests itself through the interaction of the participants and their skills to handle different perspectives, roles and assignments. Participation is enabled by individual, group and facilitating aspects. Co-design processes should allow for varying levels of participation among the participants and throughout the process. PATIENT OR PUBLIC CONTRIBUTION: Patients, significant others and health-care professionals participated as co-designers of a care transition model between hospital and home.

Outcomes in Antiplatelet-Associated Intracerebral Hemorrhage in the TICH-2 Randomized Controlled Trial.

Background Antiplatelet therapy increases the risk of hematoma expansion in intracerebral hemorrhage (ICH) while the effect on functional outcome is uncertain. Methods and Results This is an exploratory analysis of the TICH-2 (Tranexamic Acid in Intracerebral Hemorrhage-2) double-blind, randomized, placebo-controlled trial, which studied the efficacy of tranexamic acid in patients with spontaneous ICH within 8 hours of onset. Multivariable logistic regression and ordinal regression were performed to explore the relationship between pre-ICH antiplatelet therapy, and 24-hour hematoma expansion and day 90 modified Rankin Scale score, as well as the effect of tranexamic acid. Of 2325 patients, 611 (26.3%) had pre-ICH antiplatelet therapy. They were older (mean age, 75.7 versus 66.5 years), more likely to have ischemic heart disease (25.4% versus 2.7%), ischemic stroke (36.2% versus 6.3%), intraventricular hemorrhage (40.2% versus 27.5%), and larger baseline hematoma volume (mean, 28.1 versus 22.6 mL) than the no-antiplatelet group. Pre-ICH antiplatelet therapy was associated with a significantly increased risk of hematoma expansion (adjusted odds ratio [OR], 1.28; 95% CI, 1.01-1.63), a shift toward unfavorable outcome in modified Rankin Scale (adjusted common OR, 1.58; 95% CI, 1.32-1.91) and a higher risk of death at day 90 (adjusted OR, 1.63; 95% CI, 1.25-2.11). Tranexamic acid reduced the risk of hematoma expansion in the overall patients with ICH (adjusted OR, 0.76; 95% CI, 0.62-0.93) and antiplatelet subgroup (adjusted OR, 0.61; 95% CI, 0.41-0.91) with no significant interaction between pre-ICH antiplatelet therapy and tranexamic acid (P interaction=0.248). Conclusions Antiplatelet therapy is independently associated with hematoma expansion and unfavorable functional outcome. Tranexamic acid reduced hematoma expansion regardless of prior antiplatelet therapy use. Registration URL: https://www.isrctn.com; Unique identifier: ISRCTN93732214.

High Thrombin Generation after Acute Ischemic Stroke or Transient Ischemic Attack Is Associated with a Reduced Risk of Recurrence: An Observational Cohort Study.

Thrombin is increasingly recognized to be of importance for cardiovascular disease. The aim of this study was to investigate the prognostic value of thrombin generation variables in a cohort of patients with acute ischemic stroke (AIS) or transient ischemic attack (TIA). Thrombin generation potential measured by calibrated automated thrombogram (CAT) and prothrombin fragment F1 + 2 was determined in the acute and convalescent phases for a cohort of 190 patients with AIS/TIA. Microvesicle (MV)-induced thrombin generation potential was determined for a subset of patients using modified CAT. Primary outcome was a composite of fatal and nonfatal AIS or myocardial infarction as documented in Swedish registers during a total follow-up of 986 patient-years. Hazard ratios (HRs) were calculated using Cox regression based on variable median split. Peak thrombin and endogenous thrombin potential (ETP) above median in the acute phase were associated with a reduced risk of primary outcome after adjustment for cardiovascular risk factors, HR: 0.50 (0.27-0.92), p = 0.026 and HR: 0.53 (0.28-0.99), p = 0.048, respectively. F1 + 2 was lower in patients than in healthy controls but not associated with outcome. MV-induced peak thrombin above median in the acute phase was associated with recurrent AIS, unadjusted HR: 2.65 (1.03-6.44), p = 0.044. Contrary to expectation, high thrombin generation potential is associated with a reduced risk of recurrent ischemic event in patients with AIS/TIA. Low ETP/peak thrombin combined with high MV-induced peak thrombin can potentially identify patients at high risk of recurrence.

Stroke survivors' priorities for research related to life after stroke.

BACKGROUND: Stroke has transitioned from an untreatable, unpreventable disease to a highly treatable and preventable disease over recent decades, and the number of stroke survivors is expected to increase. The number is also foreseen to grow larger as a result of an aging population. With an escalating number of stroke survivors, research on how to improve life after stroke is needed. AIMS: The primary aim was to determine which area of research related to life after stroke that stroke patients and their informal carers prioritized as being relevant and valuable. METHODS: A cross-sectional study of all patients who had completed the 12 months of follow-up in the EFFECTS trial. In the questionnaire the stroke patients and their informal carers were asked to prioritize areas of research they considered important and valuable with respect to their life after stroke. RESULTS: Of the 731 patients who were still alive after the 12 months-follow-up, 589 responded. The most prioritized areas of research were Balance and walking difficulties (290 (49%) responders) and Post-stroke fatigue (173 (29%) responders). Women answered the undefined alternative "other" more often than men (43 women (11%) versus 11 men (6%), p = .04). Younger patients prioritized Post-stroke fatigue to a higher extent (88 (45%) versus (22%), p < .001), and elderly prioritized Balance and walking difficulties (214 (54%) versus 76 (40%), p = .002) and Speech difficulties (38 (10%) versus 9 (5%), p = .045). CONCLUSIONS: Life after stroke is perceived differentely with aging. Future research should address strategies to face challenges such as imbalance and walking difficulties and post-stroke-fatigue.

Validation of the Simplified Modified Rankin Scale Questionnaire.

INTRODUCTION: The modified Rankin scale (mRS) is the most common assessment tool for measuring overall functional outcome in stroke studies. The traditional way of using mRS face-to-face is time- and cost-consuming. The aim of this study was to test the validity of the Swedish translation of the simplified modified Rankin scale questionnaire (smRSq) as compared with the mRS assessed face-to-face 6 months after a stroke. METHODS: Within the ongoing EFFECTS trial, smRSq was sent out to 108 consecutive stroke patients 6 months after a stroke. The majority, 90% (97/108), of the patients answered the questionnaire; for the remaining 10%, it was answered by the next of kin. The patients were assessed by face-to-face mRS by 7 certified healthcare professionals at 4 Swedish stroke centres. The primary outcome was assessed by Cohen's kappa and weighted kappa. RESULTS: There was good agreement between postal smRSq, answered by the patients, and the mRS face-to-face; Cohen's kappa was 0.43 (CI 95% 0.31-0.55), weighted kappa was 0.64 (CI 95% 0.55-0.73), and Spearman rank correlation was 0.82 (p < 0.0001). In 55% (59/108), there was full agreement, and of the 49 patients not showing exact agreement, 44 patients differed by 1 grade and 5 patients had a difference of 2 grades. DISCUSSION/CONCLUSION: Our results show good validity of the postal smRSq, answered by the patients, compared with the mRS carried out face-to-face at 6 months after a stroke. This result could help trialists in the future simplify study design and make multicentre trials and quality registers with a large number of patients more feasible and time-saving.

Perceived Quality of Care Transitions between Hospital and the Home in People with Stroke.

OBJECTIVES: To explore the perceived quality of care transitions from hospital to the home with referral to subsequent rehabilitation in the home, and factors associated with low perceived quality, in people with stroke. DESIGN: Observational study. SETTING AND PARTICIPANTS: Eligible were patients with a suspected acute stroke admitted to 1 of 4 inpatient hospital units in the Stockholm region and discharged home with referral to a neurorehabilitation team in primary care. METHODS: Data on perceived quality of care transition was collected with the Care Transition Measure (CTM-15) 1 week after discharge. Additional data were mainly retrieved from medical records. To analyze difference in mean total score of the CTM-15 between participants' characteristics, length of hospital stay, disease-related data, and functioning, the Mann-Whitney U test and independent sample t test were used for dichotomized variables and 1-way analysis of variance and the Tukey post hoc test for variables with more than 2 groups. To analyze differences between participants with low and high perceived quality per item, univariable regression analyses were performed. Thereafter, multivariable regression models were created to explore associations between low perceived quality and the independent variables. RESULTS: Mean age of the 189 participants was 75 years and 91% had a mild or very mild stroke. The majority perceived most areas of the care transition to be of high quality. Nevertheless, several areas for improvement were identified. People with a more severe stroke perceived the quality of the care transition to be lower in comparison with those with a mild stroke. The association was weak between patient or clinical characteristics and the perceived quality. CONCLUSION AND IMPLICATIONS: Our findings suggest that preparation for discharge and information and support for self-management postdischarge should be enhanced in the referral-based care transition after stroke. Special attention should be given to people with severe stroke.

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

Importance: To 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-arm-speech-time test or other stroke suspicion and were evaluated for moderate-to-severe hemiparesis (≥2 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. Results: We 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, 118-180; previous year, 206 minutes [IQR, 160-280]; n = 75) (P < .001). The regional median ONT (337 [12%]) was unchanged at 115 minutes (IQR, 83-164; previous year, 115 minutes [IQR, 85-161]; n = 360) (P = .79). The median CSC IVT door-to-needle time was 13 minutes (IQR, 10-18; 116 [4%]) (previous year, 31 minutes [IQR, 19-38]; n = 45) (P < .001). Conclusions and Relevance: The Stockholm Stroke Triage System, which combines symptom severity and teleconsultation, results in markedly faster EVT delivery without delaying IVT.