External quality monitoring facilitates improvement in already well-performing stroke units: insights from RES-Q Poland.

INTRODUCTION: The Registry of Stroke Care Quality (RES-Q) is used in Poland for quality monitoring by numerous hospitals participating in the Angels Initiative. Our aim was to assess the degree of improvement in highly stroke-oriented centres that report cases to the RES-Q each year. MATERIAL AND METHODS: This retrospective analysis included Polish stroke units that from January 2017 to December 2020 contributed to the RES-Q at least 25 patients annually. RESULTS: Seventeen out of 180 Polish stroke units reported patients each year (2017, n = 1,691; 2018, n = 2,986; 2019, n = 3,750; 2020, n = 3,975). The percentage of ischaemic stroke patients treated with alteplase remained stable (26%, 29%, 30% and 28%, respectively). The door-to-needle time progressively decreased, from a median 49 minutes to 32 minutes. The percentage of patients treated ≤ 60 minutes and ≤ 45 minutes significantly increased (from 68% to 86% and from 43% to 70%, respectively), with no change observed between 2019 and 2020. Despite a general improvement in dysphagia screening (81%, 91%, 98% and 99%), screening performed within the first 24h from admission became less frequent (78%, 76%, 69% and 65%). In-hospital mortality significantly increased (11%, 11%, 13% and 15%), while the proportion of patients discharged home remained stable. CONCLUSIONS: Quality-oriented projects facilitate the improvement of stroke care, even in centres demonstrating good baseline performance. Polish stroke units that consistently reported cases to the RES-Q demonstrated improvement in terms of door-to- -needle time and dysphagia screening. However, there is still a need to shorten the time to dysphagia screening, and carefully monitor stroke unit mortality following the COVID-19 pandemic.

Modified Rio Score with Platform Therapy Predicts Treatment Success with Fingolimod and Natalizumab in Relapsing-Remitting Multiple Sclerosis Patients.

BACKGROUND: Reliable markers of disease outcomes in multiple sclerosis (MS) would help to predict the response to treatment in patients treated with high efficacy drugs. No evidence of disease activity (NEDA) has become a treatment goal whereas the modified Rio score (MRS) predicts future suboptimal responders to treatment. The aim of our study was to identify factors that would predict poor response to treatment with natalizumab and fingolimod. METHODS: In the multicenter prospective trial, 336 subjects were enrolled, initiating therapy with natalizumab (n = 135) or fingolimod (n = 201). Data on relapse rate, the expanded disability status scale, and MRI results were collected, and MRS was estimated. RESULTS: NEDA-3 after the first year of therapy was 73.9% for natalizumab and 54.8% for fingolimod (p < 0.0001). Patients with MRS = 0 in the last year on platform therapy had the best NEDA-3 (71%) and patients with MRS = 3 had the worst NEDA-3 (41%) in the first year of treatment with the second-line therapy. CONCLUSION: We conclude that switching to the second-line therapy should occur earlier to enable better results for patients treated with natalizumab or fingolimod. The outcome on both drugs is better with better neurological conditions and lower MRS of the patient on the platform therapy.

Sex-related differences among ischaemic stroke patients treated with intravenous thrombolysis in Poland.

AIM OF STUDY: We investigated sex differences i n i schaemic s troke p atients t reated w ith i ntravenous a lteplase. CLINICAL RATIONALE FOR STUDY: We suggest that it is necessary to improve care for women with atrial fibrillation. Our data suggests that closer evaluation of treatment for ischaemic stroke in men and women is needed, preferably in the form of a prospective study. MATERIALS AND METHODS: This was a multicentre analysis of 1,830 ischaemic stroke patients treated with alteplase from 2004 to 2012. Data was prospectively collected in the Safe Implementation of Treatments in Stroke (SITS) registry. The main outcome measures were symptomatic intracerebral haemorrhage (sICH) within 36 hours of treatment, three months of functional independence, and mortality. RESULTS: Women were significantly older (mean age 71.3 vs 66.2 years; p < 0.01), more often suffered from hypertension (78.3% vs 70.1%; p < 0.01) and cardio-embolic strokes (34.7% vs 27.1%; p < 0.01), and presented heavier baseline deficits. There were no differences in sICH, but after three months fewer women were functionally independent (46.5% vs 53.3%; p < 0.01) and women had higher mortality (26.0% vs 19.7%; p < 0.01). CONCLUSIONS: Of the ischaemic stroke patients treated with intravenous thrombolysis, women had worse long-term outcomes than men. This discrepancy may be explained by the older age and higher proportion of cardio-embolic strokes with more severe baseline deficits. However, multiple logistic analysis did not show that sex itself had an impact on the greater mortality in women after a stroke, or on the poorer prognosis.

Dabigatran initiation in patients with non-valvular AF and first acute ischaemic stroke: a retrospective observational study from the SITS registry.

BACKGROUND AND OBJECTIVE: The optimal timing for initiation of dabigatran after acute ischaemic stroke (AIS) is not established. We aimed to evaluate initiation timing and clinical outcomes of dabigatran in AIS patients with non-valvular atrial fibrillation (NVAF). DESIGN: Retrospective study based on prospectively collected data in SITS (Safe Implementation of Treatment in Stroke) Thrombolysis and Thrombectomy Registry from July 2014 to July 2018. PARTICIPANTS: European NVAF patients (≥18 years) hospitalised after first-ever ischaemic stroke. SETTING: A multinational, observational monitoring register. INTERVENTION: Dabigatran initiation within 3 months after the ischaemic stroke. PRIMARY AND SECONDARY OUTCOMES: The primary outcome was time from first-ever ischaemic stroke (index event) to dabigatran initiation. Additional outcomes included physicians' reasons for delaying dabigatran initiation beyond acute hospital discharge and outcomes within 3 months of index event. METHODS: We identified patients with NVAF who received dabigatran within 3 months of the index event. We performed descriptive statistics for baseline and demographic data and clinical outcomes after dabigatran initiation. RESULTS: In total, 1489 patients with NVAF received dabigatran after AIS treated with thrombolysis and/or thrombectomy. Of these, 1240 had available initiation time. At baseline, median age was 75 years; 53% of patients were women, 15% were receiving an oral anticoagulant, 29% acetylsalicylic acid and 4% clopidogrel. Most patients (82%) initiated dabigatran within 14 days after the index event. Patients initiating earlier had lower stroke severity from median NIHSS 8 (IQR 6-13) if initiated within 7 days to NIHSS 15 (9-19) if initiated between 28 days and 3 months. Most common reasons for delaying initiation were haemorrhagic transformation or intracranial haemorrhage, stroke severity and infarct size. Few thrombotic/haemorrhagic events occurred within 3 months after the index event (20 of 926 patients, 2.2% with the available data). CONCLUSIONS: Our findings, together with previous observational studies, indicate that dabigatran initiated within the first days after an AIS is safe in patients treated with intravenous thrombolysis, endovascular thrombectomy or both. TRIAL REGISTRATION NUMBER: SITS Thrombolysis and Thrombectomy Registry (NCT03258645).

Randomized phase 1b trial of MOR103, a human antibody to GM-CSF, in multiple sclerosis.

OBJECTIVES: To determine the safety, pharmacokinetics (PK), and immunogenicity of the recombinant human monoclonal antibody MOR103 to granulocyte-macrophage colony-stimulating factor (GM-CSF) in patients with multiple sclerosis (MS) with clinical or MRI activity. METHODS: In this 20-week, randomized, double-blind, placebo-controlled phase 1b dose-escalation trial (registration number NCT01517282), adults with relapsing-remitting MS (RRMS) or secondary progressive MS (SPMS) received an IV infusion of placebo (n = 6) or MOR103 0.5 (n = 8), 1.0 (n = 8), or 2.0 (n = 9) mg/kg every 2 weeks for 10 weeks. Patients had to have ≤10 gadolinium (Gd)-enhancing brain lesions on T1-weighted MRI at baseline. The primary objective was safety. RESULTS: Most treatment-emergent adverse events (TEAEs) were mild to moderate in severity. The most frequent was nasopharyngitis. Between-group differences in TEAE numbers were small. There were no TEAE-related trial discontinuations, infusion-related reactions, or deaths. Nine patients experienced MS exacerbations: 3, 5, 1, and 0 patient(s) in the placebo, 0.5, 1.0, and 2.0 mg/kg groups, respectively. A few T1 Gd-enhancing lesions and/or new or enlarging T2 lesions indicative of inflammation were observed in all treatment groups. No clinically significant changes were observed in other clinical assessments or laboratory safety assessments. No anti-MOR103 antibodies were detected. PK evaluations indicated dose linearity with low/no drug accumulation over time. CONCLUSIONS: MOR103 was generally well-tolerated in patients with RRMS or SPMS. No evidence of immunogenicity was found. CLASSIFICATION OF EVIDENCE: This phase 1b study provides Class I evidence that MOR103 has acceptable tolerability in patients with MS.

Is there a bad time for intravenous thrombolysis? The experience of Polish stroke centers.

BACKGROUND AND PURPOSE: The outcome in acute stroke strongly depends on patient-related issues, as well as on the availability of human and diagnostic resources. Our aim was to evaluate safety and effectiveness of intravenous alteplase for stroke according to the time of admission to the hospital. MATERIALS AND METHODS: We analyzed the data of all acute stroke patients treated with alteplase between October 2003 and December 2010, contributed to the Safe Implementation of Thrombolysis for Stroke registry from 27 Polish stroke centers. According to the time of admission we distinguished between: (1) non-working days (Friday 14:30-Monday 08:00 plus national holidays); (2) out-of-office hours (non-working days plus 14:30-08:00 during working days); and (3) night hours (time from 23:00 to 06:00). Patients admitted during regular working hours (Monday 08:00-Friday 14:30, excluding national holidays) were used as the reference. RESULTS: Of 1330 patients, 448 (32.5%) were admitted on non-working days, 868 (65.3%) at out-of-office hours, and 105 (7.9%) during night hours. In multivariate logistic regression, none of the evaluated periods showed association with symptomatic intracranial hemorrhage, 7-day mortality, and neurological improvement ≥4 points in the National Institutes of Health Stroke Scale score at day 7. Patients admitted during night hours had lower odds (OR 0.53, 95% CI: 0.29-0.95, p=0.032) for achieving favorable outcome (modified Rankin Scale score 0-2). CONCLUSIONS: There is no bad time for thrombolysis. Stroke centers should feel confident about the treatment outside regular working hours, irrespective of equipment and staff availability. However, it may be reasonable to pay additional attention during nighttime.

Intravenous thrombolysis for acute ischaemic stroke in patients not fully adhering to the European licence in Poland.

BACKGROUND AND PURPOSE: The European licence for alteplase excludes from thrombolysis large groups of acute stroke patients. The Polish licence was revised in 2010, but until then many patients could receive the treatment only off-label. Our aim was to evaluate the safety and effectiveness of intravenous alteplase in Polish patients not fully adhering to the original European drug licence compared to patients treated strictly on-label. MATERIAL AND METHODS: We analysed all patient data contributed to the Safe Implementation of Thrombolysis in Stroke registry from Polish centres between October 2003 and July 2009. RESULTS: Off-label thrombolysis was administered in 224/946 (23.7%) patients. The most frequent deviations were: use of intravenous antihypertensives (8.2%), age > 80 years (5.4%), time-to-treatment > 3 hours (4.5%), oral anticoagulation (4.2%), previous stroke with concomitant diabetes (2.1%), and previous stroke ≤ 3 months (1.5%). We found no differences in the ratio of symptomatic intracranial haemorrhage (sICH) according to SITS, ECASS and NINDS definitions. Adjusted odds for 3-month mortality were similar (OR 0.86, 95% CI: 0.51-2.41), excluding patients with previous stroke ≤ 3 months (OR 3.48, 95% CI: 0.96-12.7). Adjusted odds for death or dependency were slightly increased (OR 1.40, 95% CI: 0.92-2.13), especially in patients aged > 80 years (OR 2.80, 95% CI: 1.11-7.05), and with previous stroke ≤ 3 months (OR 4.07, 95% CI: 0.97-17.1). CONCLUSIONS: Polish stroke patients receiving off-label thrombolysis tended to achieve a less favourable outcome, but they were not at increased risk of sICH or death. Considering the current Polish license for alteplase, it may be reasonable to additionally stratify the risk in patients aged > 80 years or with previous stroke ≤ 3 months.

Knowledge of risk factors and stroke symptoms among nonstroke patients.

BACKGROUND AND PURPOSE: This study aimed to evaluate knowledge of stroke warning signs, risk factors, treatment and prevention among patients not suffering from stroke. METHODS: Patients admitted to one of five Neurology Departments in Poland for diseases other than stroke were asked to answer a questionnaire regarding awareness of cerebrovascular risk factors and stroke. The study was performed between November 1 and December 31,2008. RESULTS: 481 patients were included in the study (59.7% women). Proper definition of stroke and transient ischemic attack was given by 90.3 and 60.5% of respondents, respectively. Hypertension was reported as a risk factor by 91.1% of participants. Approximately 70% knew that hypercholesterolemia and smoking are risk factors of stroke, but only one third identified diabetes mellitus as a risk factor. Cardiac arrhythmia was recognized as a risk factor by 8.4%. Twenty-five percent of participants did not know any symptom of stroke. Identification of stroke signs was worse by participants from rural areas. Ten percent identified disturbances of consciousness, numbness, and dizziness as stroke symptoms. CONCLUSIONS: The knowledge of fundamental risk factors was sufficiently good, but recognition of cardiac arrhythmia and diabetes mellitus was unsatisfactory. The knowledge of stroke symptoms was unsatisfactory, particularly in rural areas. Additional education programs are necessary.

Alternative methods of treatment used by multiple sclerosis patients in Poland.

BACKGROUND AND PURPOSE: Despite the great progress that has been made in medicine, treatment of many chronic diseases, including multiple sclerosis (MS), remains hardly effective. It has been reported that more and more MS patients worldwide are using alternative methods (AM). The aim of the present study is to evaluate this phenomenon in the Polish MS population. MATERIALS AND METHODS: To obtain more data about use of AM in Poland we distributed questionnaires among 210 MS patients treated in 3 hospitals in different regions of our country: Warsaw, Gdansk and Pila. RESULTS: 210 patients (136 females and 74 males) took part in the study. 68.5% (144 of 210 questioned) declared use of AM now or in the past. The most popular (56%) was Oenothera seed oil, followed by vitamins (49%), and the third most common was massage (34%). There were no significant demographic differences between users and non-users. Neither disease duration nor disability had any impact on the decision to use AM. CONCLUSIONS: The phenomenon of use of AM by MS patients is not fully understood, but it seems that limited access to so-called immunomodulators, e.g. interferon-b or glatiramer acetate, and limited long-term efficacy are reasons why patients seek other therapies.

[Pain in the course of multiple sclerosis]. / Ból w przebiegu stwardnienia rozsianego.

According to previous studies pain symptoms were a problem in multiple sclerosis (MS) patients. This is an important issue since symptom control, especially pain, assume high priorities in MS. The aim of study was to assess the incidence and type of pain symptoms in MS. In the study 104 consecutive patients with clinically definite MS, according to Posers criteria, were evaluated by questionnaire. In all patients brain MRI strongly suggested MS. 76% of patients had relapsing-remitting (RR) course of the disease. At any stage of the disease pain syndromes occurred in 70.2% of MS patients. In 8% patients pain was the first symptom of MS. The most common acute pain syndromes were: Lhermitte sign (26%) and painful tonic spasm (19%). The incidence of migraine was 8% and 26% had tension headache. Chronic pain occurred in 60% of MS patients. Most common were dysaesthetic extremity pain (45%), low back pain (34%) and painful leg spasm (22%). There was no correlation with age, sex, and duration of disease. Pain symptoms were more frequent in MS patients with higher EDSS score and spinal cord involvement. Pain syndromes are common in MS patients. There was no correlation with age, sex, and duration of the disease. Pain occurred more frequent in MS patients with higher EDSS score and in patients with spinal cord involvement.