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Background Identifying the profiles of multiple sclerosis (MS) patients who employ similar patterns of coping may improve the understanding of how coping is associated with psychological adjustment. The purpose of this study was to identify the groups of MS patients using different coping strategies and compare the levels of psychological resources across the groups. Methods In this cross-sectional study 382 patients with MS completed a battery of self-report measures that assessed their use of different coping strategies, optimism, self-efficacy, health locus of control (HLC), and perception of disease. The groups with different coping profiles were selected by performing a cluster analysis. Results Five different coping profiles were highlighted and were defined as follows: “Emotional,” “Temperate,” “Active,” “Passive,” and “Problem copers.” Significant differences were detected between the groups in the levels of optimism, self-efficacy, HLC, and perception of disease. Conclusion Patients with MS use a varied repertoire of coping strategies, which allowed distinguishing coping profiles. Groups representing particular profiles differ in terms of psychological resources. This study contributed to increasing the interest in investigating coping profiles. Identifying subgroups of individuals based on their coping profiles and recognizing the differences is important for providing psychological support.

Background People with Multiple Sclerosis (PwMS) suffer from an increased risk of unemployment during the course of the disease. In recent years progress has been made in increasing the time until patients have to leave the workforce permanently. Such a retirement is often associated with MS but the driving factors including disability progression, support measures at the workplace, and societal aspects are not yet fully understood. Methods We consolidated data from four European MS databases from Germany, Poland, Sweden, and the United Kingdom, which were able to provide data on working status, disability progression and quality of life in accordance with the data harmonization framework of the EUReMS (European Registry in Multiple Sclerosis) project. Results Factors strongly associated with unemployment are disability progression, low quality of life and being close to the statutory retirement age. Overall, highest employment rate (77%) and lowest effects of gender and disease duration were found in Sweden. Conclusions We found remarkable differences between the European registers and the countries studied, which may indicate inequalities at European level. Furthermore, our findings suggest that it is feasible and useful to combine data from different MS registers in Europe, albeit the data structures are heterogeneous.

Importance Reduction of subsequent disabling stroke is the main goal of preventive treatment in the acute setting after transient ischemic attack (TIA) or minor ischemic stroke. Objective To evaluate the superiority of ticagrelor added to aspirin in preventing disabling stroke and to understand the factors associated with recurrent disabling stroke. Design, Setting, and Participants The Acute Stroke or Transient Ischemic Attack Treated With Ticagrelor and Aspirin for Prevention of Stroke and Death (THALES) was a randomized clinical trial conducted between January 22, 2018, and December 13, 2019, with a 30-day follow-up, at 414 hospitals in 28 countries. The trial included 11 016 patients with a noncardioembolic, nonsevere ischemic stroke or high-risk TIA, including 10 803 with modified Rankin Scale score (mRS) recorded at 30 days. Interventions Ticagrelor (180-mg loading dose on day 1 followed by 90 mg twice daily for days 2-30) or placebo within 24 hours of symptom onset. All patients received aspirin, 300 to 325 mg on day 1 followed by 75 to 100 mg daily for days 2 to 30. Main Outcomes and Measures Time to the occurrence of disabling stroke (progression of index event or new stroke) or death within 30 days, as measured by mRS at day 30. Disabling stroke was defined by mRS greater than 1. Results Among participants with 30-day mRS greater than 1, mean age was 68.1 years, 1098 were female (42.6%), and 2670 had an ischemic stroke (95.8%) as a qualifying event. Among 11 016 patients, a primary end point with mRS greater than 1 at 30 days occurred in 221 of 5511 patients (4.0%) randomized to ticagrelor and in 260 of 5478 patients (4.7%) randomized to placebo (hazard ratio [HR], 0.83; 95% CI, 0.69-0.99,P = .04). A primary end point with mRS 0 or 1 at 30 days occurred in 70 of 5511 patients (1.3%) and 87 of 5478 patients (1.6%) (HR, 0.79; 95% CI, 0.57-1.08;P = .14). The ordinal analysis of mRS in patients with recurrent stroke showed a shift of the disability burden following a recurrent ischemic stroke in favor of ticagrelor (odds ratio, 0.77; 95% CI, 0.65-0.91;P = .002). Factors associated with disability were baseline National Institutes of Health Stroke Scale score 4 to 5, ipsilateral stenosis of at least 30%, Asian race/ethnicity, older age, and higher systolic blood pressure, while treatment with ticagrelor was associated with less disability. Conclusions and Relevance In patients with TIA and minor ischemic stroke, ticagrelor added to aspirin was superior to aspirin alone in preventing disabling stroke or death at 30 days and reduced the total burden of disability owing to ischemic stroke recurrence. Trial Registration ClinicalTrials.gov Identifier:NCT03354429

Purpose The proportion of older people in Poland is higher in rural areas than in urban areas. Thus, we aimed to evaluate treatment rate and factors associated with outcome and safety of intravenous thrombolysis (IVT) in rural residents aged ≥80 years admitted to primary stroke centers. Patients and Methods This study was a retrospective, observational cohort study of 873 patients treated with recombinant tissue plasminogen activator (rt-PA) in primary stroke centers between February 1, 2009 and December 31, 2017. Among them were 527 rural residents and 231 (26.5%) were ≥80 years of age. The analyses between rural and urban patients aged ≥80 and between rural patients aged

BACKGROUND Trials have evaluated the use of clopidogrel and aspirin to prevent stroke after an ischemic stroke or transient ischemic attack (TIA). In a previous trial, ticagrelor was not better than aspirin in preventing vascular events or death after stroke or TIA. The effect of the combination of ticagrelor and aspirin on prevention of stroke has not been well studied. METHODS We conducted a randomized, placebo-controlled, double-blind trial involving patients who had had a mild-to-moderate acute noncardioembolic ischemic stroke, with a National Institutes of Health Stroke Scale (NIHSS) score of 5 or less (range, 0 to 42, with higher scores indicating more severe stroke), or TIA and who were not undergoing thrombolysis or thrombectomy. The patients were assigned within 24 hours after symptom onset, in a 1:1 ratio, to receive a 30-day regimen of either ticagrelor (180-mg loading dose followed by 90 mg twice daily) plus aspirin (300 to 325 mg on the first day followed by 75 to 100 mg daily) or matching placebo plus aspirin. The primary outcome was a composite of stroke or death within 30 days. Secondary outcomes were first subsequent ischemic stroke and the incidence of disability within 30 days. The primary safety outcome was severe bleeding. RESULTS A total of 11,016 patients underwent randomization (5523 in the ticagrelor-aspirin group and 5493 in the aspirin group). A primary-outcome event occurred in 303 patients (5.5%) in the ticagrelor-aspirin group and in 362 patients (6.6%) in the aspirin group (hazard ratio, 0.83; 95% confidence interval [CI], 0.71 to 0.96; P = 0.02). Ischemic stroke occurred in 276 patients (5.0%) in the ticagrelor-aspirin group and in 345 patients (6.3%) in the aspirin group (hazard ratio, 0.79; 95% CI, 0.68 to 0.93; P = 0.004). The incidence of disability did not differ significantly between the two groups. Severe bleeding occurred in 28 patients (0.5%) in the ticagrelor-aspirin group and in 7 patients (0.1%) in the aspirin group (P = 0.001). CONCLUSIONS Among patients with a mild-to-moderate acute noncardioembolic ischemic stroke (NIHSS score ≤5) or TIA who were not undergoing intravenous or endovascular thrombolysis, the risk of the composite of stroke or death within 30 days was lower with ticagrelor-aspirin than with aspirin alone, but the incidence of disability did not differ significantly between the two groups. Severe bleeding was more frequent with ticagrelor. (Funded by AstraZeneca; THALES ClinicalTrial.gov number, NCT03354429.).

Supplemental Digital Content is available in the text., Background and Purpose: Among patients with a transient ischemic attack or minor ischemic strokes, those with ipsilateral atherosclerotic stenosis of cervicocranial vasculature have the highest risk of recurrent vascular events. Methods: In the double-blind THALES (The Acute Stroke or Transient Ischemic Attack Treated With Ticagrelor and ASA for Prevention of Stroke and Death) trial, we randomized patients with a noncardioembolic, nonsevere ischemic stroke, or high-risk transient ischemic attack to ticagrelor (180 mg loading dose on day 1 followed by 90 mg twice daily for days 2–30) or placebo added to aspirin (300–325 mg on day 1 followed by 75–100 mg daily for days 2–30) within 24 hours of symptom onset. The present paper reports a prespecified analysis in patients with and without ipsilateral, potentially causal atherosclerotic stenosis ≥30% of cervicocranial vasculature. The primary end point was time to the occurrence of stroke or death within 30 days. Results: Of 11 016 randomized patients, 2351 (21.3%) patients had an ipsilateral atherosclerotic stenosis. After 30 days, a primary end point occurred in 92/1136 (8.1%) patients with ipsilateral stenosis randomized to ticagrelor and in 132/1215 (10.9%) randomized to placebo (hazard ratio 0.73 [95% CI, 0.56–0.96], P=0.023) resulting in a number needed to treat of 34 (95% CI, 19–171). In patients without ipsilateral stenosis, the corresponding event rate was 211/4387 (4.8%) and 230/4278 (5.4%), respectively (hazard ratio, 0.89 [95% CI, 0.74–1.08]; P=0.23, Pinteraction=0.245). Severe bleeding occurred in 4 (0.4%) and 3 (0.2%) patients with ipsilateral atherosclerotic stenosis on ticagrelor and on placebo, respectively (P=NS), and in 24 (0.5%) and 4 (0.1%), respectively, in 8665 patients without ipsilateral stenosis (hazard ratio=5.87 [95% CI, 2.04–16.9], P=0.001). Conclusions: In this exploratory analysis comparing ticagrelor added to aspirin to aspirin alone, we found no treatment by ipsilateral atherosclerosis stenosis subgroup interaction but did identify a higher absolute risk and a greater absolute risk reduction of stroke or death at 30 days in patients with ipsilateral atherosclerosis stenosis than in those without. In this easily identified population, ticagrelor added to aspirin provided a clinically meaningful benefit with a number needed to treat of 34 (95% CI, 19–171). Registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT03354429.

Summary Background S44819, a selective GABAA α5 receptor antagonist, reduces tonic post-ischaemic inhibition of the peri-infarct cortex. S44819 improved stroke recovery in rodents and increased cortical excitability in a transcranial magnetic stimulation study in healthy volunteers. The Randomized Efficacy and Safety Trial of Oral GABAA α5 antagonist S44819 after Recent ischemic Event (RESTORE BRAIN) aimed to evaluate the safety and efficacy of S44819 for enhancing clinical recovery of patients with ischaemic stroke. Methods RESTORE BRAIN was an international, randomised, double-blind, parallel-group, placebo-controlled, multicentre phase 2 trial that evaluated the safety and efficacy of oral S44189 in patients with recent ischaemic stroke. The study was done in specialised stroke units in 92 actively recruiting centres in 14 countries: ten were European countries (Belgium, Czech Republic, France, Germany, Hungary, Italy, Netherlands, Poland, Spain, and the UK) and four were non-European countries (Australia, Brazil, Canada, and South Korea). Patients aged 18–85 years with acute ischaemic stroke involving cerebral cortex (National Institute of Health Stroke Scale [NIHSS] score 7–20) without previous disability were eligible for inclusion. Participants were randomly assigned to receive 150 mg S44819 twice a day, 300 mg S44819 twice a day, or placebo twice a day by a balanced, non-adaptive randomisation method with a 1:1:1 ratio. Treatment randomisation and allocation were centralised via the interactive web response system using computer-generated random sequences with a block size of 3. Blinding of treatment was achieved by identical appearance and taste of all sachets. Patients, investigators and individuals involved in the analysis of the trial were masked to group assignment. The primary endpoint was the modified Rankin Scale (mRS) score 90 days from onset of treatment, evaluated by shift analysis (predefined main analysis) or by dichotomised analyses using 0–1 versus 2–6 and 0–2 versus 3–6 cutoffs (predefined secondary analysis). Secondary endpoints were the effects of S44819 on the NIHSS and Montreal Cognitive Assessment (MoCA) scores, time needed to complete parts A and B of the Trail Making Test, and the Barthel index. Efficacy analyses were done on all patients who received at least one dose of treatment and had at least one mRS score taken after day 5 (specifically, on or after day 30). Safety was compared across treatment groups for all patients who received at least one dose of treatment. The study was registered at ClinicalTrials.gov , NCT02877615 . Findings Between Dec 19, 2016, and Nov 16, 2018, 585 patients were enrolled in the study. Of these, 197 (34%) were randomly assigned to receive 150 mg S44819 twice a day, 195 (33%) to receive 300 mg S44819 twice a day, and 193 (33%) to receive placebo twice a day. 189 (96%) of 197 patients in the 150 mg S44819 group, 188 (96%) of 195 patients in the 300 mg S44819 group, and 191 (99%) patients in the placebo group received at least one dose of treatment and had at least one mRS score taken after day 5, and were included in efficacy analyses. 195 (99%) of 197 patients in the 150 mg S44819 group, 194 (99%) of 195 patients in the 300 mg S44819 group, and 193 (100%) patients in the placebo group received at least one dose of treatment, and were included in safety analyses. The primary endpoint of mRS at day 90 did not differ between each of the two S44819 groups and the placebo group (OR 0·91 [95% CI 0·64–1·31]; p=0·80 for 150 mg S44819 compared with placebo and OR 1·17 [95% CI 0·81–1·67]; p=0·80 for 300 mg S44819 compared with placebo). Likewise, dichotomised mRS scores at day 90 (mRS 0–2 vs 3–6 or mRS 0–1 vs 2–6) did not differ between groups. Secondary endpoints did not reveal any significant group differences. The median NIHSS score at day 90 did not differ between groups (4 [IQR 2–8] in 150 mg S44819 group, 4 [2–7] in 300 mg S44819 group, and 4 [2–6] in placebo group), nor did the number of patients at day 90 with an NIHSS score of up to 5 (95 [61%] of 156 in 150 mg S44819 group, 106 [66%] of 161 in 300 mg S44819 group, and 104 [66%] of 157 in placebo group) versus more than 5 (61 [39%] in 150 mg S44819 group, 55 [34%] in 300 mg S44819 group, and 53 [34%] in placebo group). Likewise, the median MoCA score (22·0 [IQR 17·0–26·0] in 150 mg S44819 group, 23·0 [19·0–26·5] in 300 mg S44819 group, and 22·0 [17·0–26·0] in placebo group), time needed to complete parts A (50 s [IQR 42–68] in 150 mg S44819 group, 49 s [36–63] in 300 mg S44819 group, and 50 s [38–68] in placebo group) and B (107 s [81–144] in 150 mg S44819 group, 121 s [76–159] in 300 mg S44819 group, and 130 s [86–175] in placebo group) of the Trail Making Test, and the Barthel index (90 [IQR 60–100] in 150 mg S44819 group, 90 [70–100] in 300 mg S44819 group, and 90 [70–100] in placebo group) were similar in all groups. Number and type of adverse events were similar between the three groups. There were no drug-related adverse events and no drug-related deaths. Interpretation There was no evidence that S44819 improved clinical outcome in patients after ischaemic stroke, and thus S44819 cannot be recommended for stroke therapy. The concept of tonic inhibition after stroke should be re-evaluated in humans. Funding Servier.

Objective. This study assesses and compares the mental health status of people with multiple sclerosis (PwMS) in Poland during the second wave of the Coronavirus Disease 2019 (COVID-19) pandemic (November 2020) to a similar group whose mental health status was examined in November 2017. It also analyzed the psychological resources such as self-efficacy and health locus of control (HLC) and their relationship to mental health in both groups. Methods. Cross-sectional study included two groups of PwMS with 113 respondents each. The respondents completed the General Health Questionnaire-12 and questionnaires for assessing self-efficacy and HLC. The clinical and demographic data of participants were also collected. Results. No differences in mental health status were observed between the studied groups. A hierarchical regression model of the group studied in 2020 revealed that general self-efficacy (β = −0.21, p = 0.032), HLC—internal (β = −0.21, p = 0.035), and education (β = −0.18, p = 0.048) explained 18% of the variance in the mental health of PwMS, whereas according to the model of the group assessed in 2017 self-efficacy (β = –0.31, p < 0.001), HLC—chance (β = 0.45, p < 0.001), and HLC—internal (β = −0.37, p < 0.001) explained 48% of the variance. Conclusions. Study results suggest that the pandemic and the related lockdown had no effect on the mental health status of PwMS. At the same time, it was noted that well known determinants of mental health such as self-efficacy and HLC seemed to retain their prominent role for mental functioning in the pandemic.

The aim of the work is to present current knowledge on epidemiology, causes, symptomatology and diagnosis of hereditary neuropathy with liability to pressure palsy. This neuropathy usually manifests itself in the 2nd and 3rd decade of life, but also can occur at any age. Its genetic basis is the deletion or, less frequently, a point mutation of the PMP22 gene in chromosome 17p11. Symptoms appear after a small extension or compression of a nerve. In the recent years, special attention has been paid to its occurrence in the course of intense physical exercises. The most common clinical syndromes occurring in the course of the disease are paresis and sensory disturbances in the area of the median, ulnar, radial and peroneal nerves as well as brachial plexus palsy. Presence of structures called tomaculas in a nerve biopsy is characteristic for the disease. Electrophysiological and genetic studies play a key role in diagnostics. In the light of the recent studies, the frequency of occurrence of hereditary neuropathy with liability to pressure palsy seems to be significantly underestimated and ranges from 0.84 to 58.9 per 100,000. Hereditary neuropathy with liability to pressure palsies should be differentiated from compression syndromes, hereditary motor and sensory neuropathy (HMSN IA), multifocal axonal neuropathy and familial brachial plexus palsy. After recognising the syndrome, it is important to properly rehabilitate and avoid situations where there may be compression on peripheral nerves. In addition, the paper presents a case of genetically confirmed familial neuropathy with hypersensitivity to pressure in a 24-year-old male patient with a negative family history.

Summary Background No treatment has consistently shown efficacy in slowing disability progression in patients with secondary progressive multiple sclerosis (SPMS). We assessed the effect of siponimod, a selective sphingosine 1-phosphate (S1P) receptor 1,5 modulator, on disability progression in patients with SPMS. Methods This event-driven and exposure-driven, double-blind, phase 3 trial was done at 292 hospital clinics and specialised multiple sclerosis centres in 31 countries. Using interactive response technology to assign numbers linked to treatment arms, patients (age 18–60 years) with SPMS and an Expanded Disability Status Scale score of 3·0–6·5 were randomly assigned (2:1) to once daily oral siponimod 2 mg or placebo for up to 3 years or until the occurrence of a prespecified number of confirmed disability progression (CDP) events. The primary endpoint was time to 3-month CDP. Efficacy was assessed for the full analysis set (ie, all randomly assigned and treated patients); safety was assessed for the safety set. This trial is registered with ClinicalTrials.gov, number NCT01665144. Findings 1651 patients were randomly assigned between Feb 5, 2013, and June 2, 2015 (1105 to the siponimod group, and 546 to the placebo group). One patient did not sign the consent form, and five patients did not receive study drug, all of whom were in the siponimod group. 1645 patients were included in the analyses (1099 in the siponimod group and 546 in the placebo). At baseline, the mean time since first multiple sclerosis symptoms was 16·8 years (SD 8·3), and the mean time since conversion to SPMS was 3·8 years (SD 3·5); 1055 (64%) patients had not relapsed in the previous 2 years, and 918 (56%) of 1651 needed walking assistance. 903 (82%) patients receiving siponimod and 424 (78%) patients receiving placebo completed the study. 288 (26%) of 1096 patients receiving siponimod and 173 (32%) of 545 patients receiving placebo had 3-month CDP (hazard ratio 0·79, 95% CI 0·65–0·95; relative risk reduction 21%; p=0·013). Adverse events occurred in 975 (89%) of 1099 patients receiving siponimod versus 445 (82%) of 546 patients receiving placebo; serious adverse events were reported for 197 (18%) patients in the siponimod group versus 83 (15%) patients in the placebo group. Lymphopenia, increased liver transaminase concentration, bradycardia and bradyarrhythmia at treatment initiation, macular oedema, hypertension, varicella zoster reactivation, and convulsions occurred more frequently with siponimod than with placebo. Initial dose titration mitigated cardiac first-dose effects. Frequencies of infections, malignancies, and fatalities did not differ between groups. Interpretation Siponimod reduced the risk of disability progression with a safety profile similar to that of other S1P modulators and is likely to be a useful treatment for SPMS. Funding Novartis Pharma AG.

The detailed data concerning multiple sclerosis (MS) epidemiology in Poland are based on studies from few and less populated provinces. Therefore, we evaluated MS incidence and prevalence in Poland using electronic administrative health claims (AHCs) from the National Health Fund.We retrospectively analyzed the AHC financial database collected from 2009 to 2019, encompassing all patients using public health resources. Three different algorithms for identification of MS cases were used: based on studies performed in German population (type 1), tested in the United States (type 2), and one created for the purpose of this study (type 3) that required at least 3 AHCs since 2009 with G35 ICD-10 diagnosis in outpatient specialist care, during hospitalization, and/or at rehabilitation service in any combination within maximally 3 years between the first and the last AHC, and provided that at least one AHC was either in neurological outpatient care or during hospitalization at a neurological ward or prescription of disease-modifying therapy. The American algorithm (type 2) required 3 AHCs within the analyzed year, while the German algorithm (type 1) required only one AHC in the analyzed year.According to the type 3 algorithm, age-adjusted MS incidence and prevalence in 2019 was 6.6 and 131.2 / 100,000 inhabitants, respectively. From 2014 to 2019, the significant trend in increasing prevalence and decreasing incidence of MS was observed (p0.001). Median age of prevalent MS patients was 50 years (interquartile range, IQR 39-61) whereas median age of incident MS cases was 37 years (IQR 28-48). Female-to-male ratio in MS patients was 2.4. According to the type 1 algorithm, age-adjusted MS incidence and prevalence in 2019 was 11.6 and 244.9 / 100,000 inhabitants, respectively. Use of the type 2 algorithm resulted in estimated age-adjusted MS incidence and prevalence values in 2019 of 6.2 and 120.1 / 100,000 inhabitants, respectively.Multiple sclerosis incidence and prevalence in Poland are higher than previously reported and similar to the numbers shown for central European countries.

Introduction : Comprehensive epidemiologic data for multiple sclerosis (MS) in Poland are limited. Aim of the research: To analyse patient-reported quality of life and selected clinical and socio-demographic factors of patients registered in the Świętokrzyskie Cohort of the Polish Registry of Multiple Sclerosis (RejSM). Material and methods: Participants were residents of Świętokrzyskie Province, and the data were collected between January 1st 2014 and December 31st 2015 by the RejSM web portal. After registration by doctors, the respondents assessed their quality of life individually using the Polish language versions of self-assessment questionnaires, the EuroQol (EQ-5D and EQ-VAS), and the Multiple Sclerosis Impact Scale (MSIS-29). Results : Of 1525 registered patients, 765 agreed to perform self-assessments of life quality and were included in the study. The mean degree of disability measured with the Expanded Disability Status Scale (EDSS) was 3.8 ±2.3. The mean EQ-5D index score was 0.78 ±0.28, and the mean EQ-VAS score was 65.6 ±23.8. Assessment score with MSIS-29 averaged 86.4 ±22.4 (64.2 ±19.6 for physical state and 24.7 ±7.8 for mental state). Only 34.7% of respondents were economically active. Lower quality of life was significantly associated with higher disability scores (p < 0.001), age over 40 years (p < 0.001), longer disease duration (p < 0.001), no access to therapy (p < 0.001), and unemployment (p = 0.002). No correlation was found between life quality and sex, course of disease, level of education, place of residence, or family status. Conclusions: The main factors decreasing life quality among patients in Świętokrzyskie Province are advanced disability, old age, long disease duration, and limited access to both employment and immunomodulatory treatment.

Andrzej Potemkowski,1 Waldemar Brola,2,3 Anna Ratajczak,4 Marcin Ratajczak,5 Mariusz Kowalewski,6 Małgorzata Lewita,6 Katarzyna Kapica-Topczewska,7 Joanna Tarasiuk,7 Adam Stępień,8 Katarzyna Gocyła-Dudar,8 Jacek Zaborski,9 Halina Bartosik-Psujek10 1Department of Clinical Psychology and Psychoprophylaxis, University of Szczecin, 2Department of Neurology, Specialist Hospital, Końskie, 3The Faculty of Medicine and Health Science, Institute of Physiotherapy, Jan Kochanowski University, Kielce, 4Pomeranian Medical University, Szczecin, 5Clinical Trial Center for MS-Patients, Szczecin, 6John Paul II Multiple Sclerosis Rehabilitation Center, Borne Sulinowo, 7Department of Neurology, Medical University of Białystok, Białystok, 8Department of Neurology, Military Institute of Medicine,Warsaw, 9Department of Neurology, Specialist Hospital in Międzylesie, Warsaw, 10Medical Faculty, University of Rzeszów, Rzeszów,Poland Background: People with multiple sclerosis (MS) and their relatives often have multiple, complex needs which require support from a wide range of services. The aim of the study, the first of its kind in Poland, was to identify the most important needs of patients with MS and their significant others (SO). Methods: A questionnaire developed from focus groups consisting of 20 needs-related statements was administered in seven MS centers to 573 MS patients and 220 SO. The mean age of the patients was 42.61 years old; the mean MS duration was 9.43 years. The respondents were asked to rate the needs statements according to their importance on an 11-point scale. The questionnaire was similar for the MS patients and their SO. Results: The most important needs in the patient group were: to feel needed and efficient in life; to have easy access to professional rehabilitation; and to be sure that doctors are interested in my condition. The three most important needs in the SO group were: to know that relatives/friends feel needed and efficient in life; to have good living conditions; and to be sure that doctors are interested in my relative’s/friend’s condition. Correlation analysis revealed that in the patients group, there was a positive correlation between patient’s age and the importance of factors such as the need for support and interest in their disease from the family doctor (P

Objectives: The aim of the study was the epidemiological analysis and evaluation of selected clinical and sociodemographic factors in Polish patients with primary progressive multiple sclerosis. Methods: The study included patients from 7 provinces in central and eastern Poland registered in the Registry of Patients with Multiple Sclerosis on 31 December 2016. The incidence of various forms of the disease was compared, and clinical, demographic and social disparities between relapsing-remitting and primary progressive multiple sclerosis were analysed. Results: Of 3,199 registered patients, 2,188 persons (66.2%) had the relapsing-remitting form of multiple sclerosis, 774 (24.2%) had the secondary progressive type and 307 (9.6%) suffered from primary progressive disease. The first symptoms of primary progressive multiple sclerosis appeared almost 10 years later than in patients with the relapsing-remitting type (39.2 ± 11.4 vs. 29.8 ± 9.8). The period from the first symptoms to diagnosis was more than twice as long in patients with primary progressive multiple sclerosis (5.8 ± 3.4) as in those with relapsing-remitting disease (2.4 ± 1.6). The average degree of disability in the Expanded Disability Status Scale was similar and amounted to 3.2 ± 2.1 for relapsing-remitting and 3.6 ± 2.4 for primary progressive multiple sclerosis. The relapsing-remitting form was observed more often in women (2.4:1), and the primary progressive form appeared with equal frequency in both sexes (1:1). Disease-modifying treatment was received by 34% of patients with relapsing-remitting and in only 1.9% of patients with primary progressive multiple sclerosis. Conclusions: The primary progressive form affects approximately 10% of Polish patients with multiple sclerosis. The first symptoms appear at about 40 years of age with equal frequency in both sexes, and its diagnosis takes more than twice as much time as in the case of relapsing-remitting multiple sclerosis.

Multiple sclerosis (MS) is one of the most disabling disorders of the central nervous system. Caregivers of individuals with MS may experience unique caregiver strain due to the age at onset and progressive nature of the disease. Additionally, because MS is more prevalent in women, men often become spousal caregivers. This places women in the position of being care recipients rather than caregivers. Some results also supported hypothesis that female caregivers reported a higher need for emotional support than male caregivers. As with female caregivers, decreased emotional support predicted poorer QoL among male caregivers. Caring for a MS patient may negatively impact several objective and subjective aspects of caregiver's life, such as physical and emotional health, morale, work life, finances, social mobility, interpersonal relationships and sexual life. In studies assessing the psychological consequences of care a higher level of anxiety and depression in caregivers than in the general population has been reported. Caregivers who experience burden are more likely to have a higher risk of depression and a lower quality of life. Early recognition of caregiver burden is important in determining appropriate interventions. In this review report the current state of knowledge about the QoL of MS caregivers as well the burden of MS caregivers has been described.

Epidemiologic data on multiple sclerosis (MS) in Poland are limited. Our objectives were to assess a mean annual incidence rate, and MS prevalence on December 31, 2015 in the Swietokrzyskie province (central Poland). We analyzed data of 1525 patients, collected in the Polish Multiple Sclerosis Registry. On December 31, 2015, overall crude prevalence of MS was not less than 121.3/100,000 (95% CI, 114.6-128.4). Significantly higher prevalence was recorded in females (167.1; 95% CI, 155.6-179.1) than in males (73.2; 95% CI, 64.2-82.6; P0.001). The age-adjusted prevalence standardized to the European standard population was 114.2/100,000 (95% CI, 106.2-121.5). The female-male ratio was 2.4:1. The mean annual incidence was 4.5/100,000 (95% CI, 3.8-5.2). Increased MS prevalence and incidence compared to 2010 and previous studies from Poland confirmed that central Poland is a high risk area for MS.

Aim of study. The aim of this study was to collect and analyse data on relapsing-remitting multiple sclerosis (RRMS) patients receiving disease-modifying therapies (DMTs) in Poland. Material and methods. This observational, multicentre study with prospective data collection included RRMS patients receiving DMTs reimbursed by the National Health Fund (NFZ) in Poland, monitored by the Therapeutic Programme Monitoring System (SMPT). Demographic profiles, disability status, and treatment modalities were analysed. Results. Data from 11,632 RRMS patients was collected (from 15,368 new prescriptions), including 10,649 patients in the first-line and 983 in the second-line therapeutic programme of DMTs. The proportion of females to males was 2.39 in the first-line and 1.91 in the second-line. The mean age at DMTs start was 36.6 years in the first-line and 35.1 in the second-line. The median time from the first symptoms to MS diagnosis was 7.4 months, and from MS diagnosis to treatment it was 18.48 months. A total of 43.4% of MS patients started DMT during the 12 months following diagnosis. There was a positive correlation between the duration from MS diagnosis to the start of DMT and a higher initial EDSS value [correlation 0.296 (p < 0.001)]. About 10% of patients stopped DMTs. In Poland, about one third of all MS patients are treated in both lines, and the choice of first-line treatment depends on the region of the country. Conclusions. In Poland there is a need to increase MS patient access to DMTs by improving the organisation of drug programmes.

Objectives Fingolimod is indicated for the treatment of relapsing-remitting multiple sclerosis (RRMS) patients with highly aggressive disease characterized by frequent relapses and active magnetic resonance imaging. Its efficacy has been demonstrated in three large phase III trials, used in the regulatory submissions throughout the world. Fingolimod in licensed in Europe since 2011 but with a growing number of disease-modifying drugs (DMD) becoming available for RRMS, it is important to gather real-world evidence data regarding long-term effectiveness in treated patients with MS. The aim of this study was to assess fingolimod effectiveness in a real life Polish group of RRMS patients receiving fingolimod as second line treatment. Patients and methods The observational study with retrospective data collection was performed at 13 sites that were asked to document eligible patients in consecutive chronological order to avoid selection bias. Demographic and clinical data from 253 adult patients with RRMS treated with fingolimod were analyzed. Results Mean treatment time with fingolimod was 42 months. Relapses reduction during 3 years treatment period was observed (2.0 v 0.2) and majority of patients were free of relapses. Mean EDSS score was stable during the time of observation. The proportion of patients who were free from any clinical disease activity, i.e. without relapses and disability progression, was over 70%. During the first and second year of observation significant reduction of new MRI lesions was observed. Conclusion In the Polish group of patients with RRMS treated with fingolimod, the majority of them showed freedom from relapses, disability progression and reduction of new MRI lesions. Switching from injectable immunomodulatory drugs to fingolimod is associated with fewer relapses and lower disability progression.

Sphenopalatine ganglion stimulation increased cerebral collateral blood flow, stabilised the blood-brain barrier, and reduced infarct size, in preclinical models of acute ischaemic stroke, and showed potential benefit in a pilot randomised trial in humans. The pivotal ImpACT-24B trial aimed to determine whether sphenopalatine ganglion stimulation 8-24 h after acute ischaemic stroke improved functional outcome.ImpACT-24B is a randomised, double-blind, sham-controlled, pivotal trial done at 73 centres in 18 countries. It included patients (men aged 40-80 years and women aged 40-85 years) with anterior-circulation acute ischaemic stroke, not undergoing reperfusion therapy. Enrolled patients were randomly assigned via web-based randomisation to receive active sphenopalatine ganglion stimulation (intervention group) or sham stimulation (sham-control group) 8-24 h after stroke onset. Patients, clinical care providers, and all outcome assessors were masked to treatment allocation. The primary efficacy endpoint was the difference between active and sham groups in the proportion of patients whose 3-month level of disability improved above expectations. This endpoint was evaluated in the modified intention-to-treat (mITT) population (defined as all patients who received one active or sham treatment session) and the population with confirmed cortical involvement (CCI) and was analysed using the Hochberg multi-step procedure (significance in both populations if p0·05 in both, and in one population if p0·025 in that one). Safety endpoints at 3 months were all serious adverse events (SAEs), SAEs related to implant placement or removal, SAEs related to stimulation, neurological deterioration, and mortality. All patients who underwent an attempted sphenopalatine ganglion stimulator or sham stimulator placement procedure were included in the safety analysis. This trial is registered with ClinicalTrials.gov, number NCT00826059.Between June 10, 2011, and March 7, 2018, 1078 patients were enrolled and randomly assigned to either the intervention or the sham-control group. 1000 patients received at least one session of sphenopalatine ganglion stimulation or sham stimulation and entered the mITT population (481 [48%] received sphenopalatine ganglion stimulation, 519 [52%] were sham controls), among whom 520 (52%) patients had CCI on imaging. The proportion of patients in the mITT population whose 3-month disability level was better than expected was 49% (234/481) in the intervention group versus 45% (236/519) in the sham-control group (odds ratio 1·14, 95% CI 0·89-1·46; p=0·31). In the CCI population, the proportion was 50% (121/244) in the intervention group versus 40% (110/276) in the sham-control group (1·48, 1·05-2·10; p=0·0258). There was an inverse U-shaped dose-response relationship between attained sphenopalatine ganglion stimulation intensity and the primary outcome in the CCI population: the proportion with favourable outcome increased from 40% to 70% at low-midrange intensity and decreased back to 40% at high intensity stimulation (p=0·0034). There were no differences in mortality or SAEs between the intervention group (n=536) and the sham-control group (n=519) in the safety population.Sphenopalatine ganglion stimulation is safe for patients with acute ischaemic stroke 8-24 h after onset, who are ineligible for thrombolytic therapy. Although not reaching significance, the trial's results support that, among patients with imaging evidence of cortical involvement at presentation, sphenopalatine ganglion stimulation is likely to improve functional outcome.BrainsGate Ltd.

Background To determine and compare comorbidity levels in the multiple sclerosis (MS) population in Poland using a matched cohort from the general population. Methods We compared our database (standardized medical histories and medical records) from a MS center at the Department of Neurology, Medical University of Bialystok, Poland) with local National Health Fund (NHF) data (all patients presenting to healthcare facilities with a diagnosis of MS (ICD 10: G35)). We identified 1299 MS cases from the NHF data and 952,434 age and geographically matched controls. We estimated the prevalence of depression, sleep disorders, epilepsy, hypertension, hyperlipidemia, diabetes, atherosclerosis, lung infections, thyroid disease, discopathy, and urinary tract infections in the MS population versus matched controls. Results In all, 815 cases of MS (67.6% women and 32.4% men) were registered with the MS center. According to the patients' medical records (with ICD 10 coding), the most common comorbidities were hypertension (4.3%) and thyroid diseases (3.3%). In addition, in standardized medical histories comorbidities were reported by MS patients: depression/depressed mood in 37.6% of patients (67% of whom had sought treatment), pain in 69.6% patients, urinary incontinence in 39.2% patients (44.9% of whom were treated), memory-related problems and fatigue in 39.2% and 70.8% patients, respectively. In the local NHF data, the most common comorbidities were hypertension (8%), diseases that cause back pain [ICD 10:M50-54 (4.3%),G54-55 (3%), M47-48 (5.4%)], urinary tract infection (3.5%), depression (2.4%), hyperlipidemia (2%), and diabetes (2%). All comorbidities except depression and sleep disorders were more common in the matched controls than in the MS population. Diabetes and hyperlipidemia in the MS population were more common in men than women. Most patients (89%) were not treated with disease-modifying therapies. Conclusion The most common comorbidity in the MS population is hypertension. The MS population has an increased prevalence of depression versus the matched controls. MS patients—especially men and older individuals—are at increased risk of developing vascular diseases.

In patients with multiple sclerosis (MS), mental health is significantly affected and conditioned by many factors, including psychological ones. This study team aimed to determine whether different coping strategies mediate the relationship between health locus of control (HLC) and mental health in MS patients. In this cross-sectional study, a total of 382 patients with MS were included. The patients completed General Health Questionnaire-12, Coping Inventory for Stressful Situations, and Multidimensional Health Locus of Control Scale. The demographic and clinical characteristics of the patients were collected using a self-report survey and neurological assessment. A mediation analysis was used to test the study hypothesis. Problem-oriented coping was found to be a significant mediator in the relationship between internal HLC and mental health (indirect effect: -0.129 [95% confidence interval [CI]: -0.193, -0.079]; standardized indirect effect: -0.113 [95% CI: -0.165, -0.070]). Emotion-focused coping was found to be a significant mediator in the relationship between power of others HLC and mental health (indirect effect: 0.114 [95% CI: 0.058, 0.178]; standardized indirect effect: 0.125 [95% CI: 0.062, 0.195]). Emotion-focused coping was also found to be a significant mediator in the relationship between chance HLC and mental health (indirect effect: 0.215 [95% CI: 0.154, 0.281]; standardized indirect effect: 0.209 [95% CI: 0.149, 0.272]). Patients with internal HLC were found to have positive mental health due to their problem-focused coping strategies, while patients with external HLC had worse mental health as they used more emotion-focused strategies. Hence, problem-focused and emotion-focused coping strategies can be considered mediators of the relationship between HLC and mental health in patients with MS.

People with multiple sclerosis (MS) report lower health-related quality of life (HRQoL). Improvements in quality of life can be made by identifying the factors that contribute to HRQoL in MS, which are both person specific and disease related.The primary objective of this study was to examine the mutual roles of acceptance, coping, and MS severity on HRQoL.This study included 382 patients with MS who completed the 29-item Multiple Sclerosis Impact Scale, Coping Inventory for Stressful Situations, and Acceptance of Illness Scale. A standardized questionnaire was used to collect patient clinical and demographics data. General MS severity was determined using the Expanded Disability Status Scale.Six variables, acceptance of illness (β = -0.24, p 0.001), emotional coping strategy (β = 0.40, p 0.001), avoidance coping strategy (β = -0.19, p 0.001), illness duration (β = -0.18, p 0.001), age at the time of the study (β = 0.14, p = 0.009) and problem coping strategy (β = -0.09, p = 0.05), were found to be the significant correlates of HRQoL in MS. The model that included these variables explained 36% of variance in self-management in MS.Psychological variables are more salient correlates of HRQoL in MS than the objective clinical variables, such as the severity or type of MS. Specifically, this study showed that MS patients who accept their illness and use more problem-solving and avoidance coping strategies and less emotional coping strategies assess their HRQoL highly.

Background: The internet is a source of knowledge and medium widely used in services that facilitate access to information and networking. Multiple sclerosis (MS) patients find the possibility of acquiring information relating to their condition particularly rewarding. Objective: We aimed to identify Polish MS patients’ preferences by analyzing a percentage of internet users and determining the most common search subjects and patients’ approach to information on the internet. Disability connected with the condition, its duration, and other factors that influence patients’ internet use were examined along with instances of relations established through the internet and their durability. Methods: The study examined 1045 patients (731 women, 314 men) treated in 10 Polish MS centers, of whom 932 (89.19%) declared to be internet users. Their average age was 40.65 (SD 11.06) and average MS duration was 9.08 (SD 6.97) years. The study used a proprietary survey on information seeking, the range of searched subjects, and internet usage frequency. Results: The majority of the patients (494/932, 53.0%) used the internet 6-7 times per week and 4.3% (40/932) declared they spent minimum 2 hours per day. The most commonly searched subjects were world news (604/932, 72.9% of patients using the internet); 60.8% (504/932) searched for information on their condition, particularly for new treatment methods (562/932, 67.8%) and the course of illness (520/932, 62.7%). One’s sex had no impact on internet usage (female vs male, odds ratio [OR] 1.13, 95% CI 0.72-1.77), although a patient’s age might, at varying degrees. We found several significant associations using a .05 significance level: a patient with higher education used the internet 9 times more often than one with primary education (OR 8.64, 95% CI 3.31-22.57); lasting relationships increased chances of internet usage by 10-fold compared to widowers (OR 0.12, 95% CI 0.05-0.31); living in a city with a population over 100,000 increased chances by nearly 6 times compared with the countryside (OR 5.59, 95% CI 2.72-11.48); the relapsing-remitting MS type saw a 2-fold increase compared with the primary progressive MS type (OR 0.47, 95% CI 0.29-0.75); and those needing assistance were 2 times less likely to use the internet than patients who could move independently (OR 0.53, 95% CI 0.31-0.89). More than half of the patients (489/932, 52.5%) did not discuss the information found on the internet with their neurologists; 15.9% (148/932) believed that relationships established through the internet can be stable. Conclusions: The majority of Polish patients use the internet as a crucial information source on their condition and innovative treatment methods. The internet can be helpful in establishing new relationships, which are usually short-lived. Polish patients do not frequently discuss the information gathered on the internet with their doctors.

Objective The aim of the study was to assess the effectiveness of disease-modifying therapies (DMTs) in relapsing-remitting multiple sclerosis (RRMS) patients treated in MS centres in Poland. Methods Demographic and clinical data of all Polish RRMS patients receiving DMTs were prospectively collected from 2014 to 2018 in electronic files using the Therapeutic Program Monitoring System (SMPT). Results The study included 10,764 RRMS patients treated with DMTs in first-line and 1,042 in second-line programmes. IFNβ more effectively lengthened the times to the first relapse, disability progression, and brain MRI activity than GA. After 2 and 4 years of follow-up, more patients on IFNβ showed no evidence of disease activity (NEDA-3) in comparison to GA (66.3% and 44.3% vs 55.2% and 33.2%, respectively; p

Low level of self-management in people with multiple sclerosis (MS) is considered to be a predominant factor that leads to poor rehabilitation efficacy. Studies focusing on the relationship between self-management and psychological variables that can be modified could contribute to expanding the knowledge needed to propose interventional programs aiming at patient activation. This study aimed to analyze whether coping strategies play a mediating role in the association between the perceived impact of MS and level of self-management in people with MS. The cross-sectional study included 382 people with MS. The participants completed the Multiple Sclerosis Self-Management Scale—Revised, Multiple Sclerosis Impact Scale-29, and Coping Inventory for Stressful Situations. The study hypothesis was evaluated using mediation analysis. The STROBE checklist specifically prepared for cross-sectional research was applied in this study for reporting. Results indicate that the emotion- and problem-focused strategies of coping can be treated as mediating the association between the MS impact and level of self-management in people with MS. A negative relationship was found between the perceived MS impact and problem-oriented coping, while a positive relationship was found between problem-oriented coping and self-management. Furthermore, a positive relationship was found between the MS impact and emotion-oriented coping, while a negative relationship was found between emotion-oriented coping and self-management. The indirect role of avoidance-oriented coping was not significant. Our study confirms the role played by coping strategies in individuals’ self-management. In MS, self-management determined by perceived MS impact can be controlled by decreasing emotional-coping while increasing problem-coping strategies. Our study imparts new knowledge regarding the potential interventions for improving the level of self-management in people with MS. It indicates that recognition of individuals’ illness perceptions as well as maladaptive coping strategies can help health professionals identify those who might be having lower level of self-management.

Waldemar Brola,1 Piotr Sobolewski,2 Małgorzata Fudala,1 Stanisław Flaga,3 Konrad Jantarski,4 Danuta Ryglewicz,5 Andrzej Potemkowski6 1Department of Neurology, Specialist Hospital, Końskie, 2Department of Neurology, Holy Spirit Specialist Hospital, Sandomierz, 3AGH University of Science and Technology, Krakow, 4Swietokrzyski Regional Branch of the Polish National Health Fund (NFZ), Kielce, 5First Department of Neurology, Institute of Psychiatry and Neurology, Warsaw, 6Department of Psychology, University of Szczecin, Szczecin, Poland Background: The aim of the study was to analyze selected clinical and sociodemographic factors and their effects on the quality of life (QoL) of multiple sclerosis (MS) patients registered in the Polish MS Registry.Methods: This was a cross-sectional observational study performed in Poland. Data on personal and disease-specific factors were collected between January 1, 2011, and December 31, 2015, via the web portal of the Polish MS Registry. All patients were assessed by a physician and asked to complete the Polish language versions of the following self-evaluation questionnaires: EuroQol 5-Dimensions, EuroQoL Visual Analog Scale, and Multiple Sclerosis Impact Scale. Univariate analysis and logistic regression were performed to determine the factors associated with QoL.Results: The study included 2,385 patients (female/male ratio 2.3:1) with clinically confirmed MS (mean age 37.8±9.2 years). Average EuroQol 5-Dimensions index was 0.72±0.24, and the mean EuroQoL Visual Analog Scale score was 64.2±22.8. The average Multiple Sclerosis Impact Scale score was 84.6±11.2 (62.2±18.4 for physical condition and 23.8±7.2 for mental condition). Lower QoL scores were significantly associated with higher level of disability (odds ratio [OR], 0.932; 95% confidence interval [CI], 0.876–0.984; P=0.001), age >40 years (OR, 1.042; 95% CI, 0.924–1.158; P=0.012), longer disease duration (OR, 0.482; 95% CI, 0.224–0.998; P=0.042), and lack of disease modifying therapies (OR, 0.024; 95% CI, 0.160–0.835; P=0.024). No significant associations were found between QoL, sex, type of MS course, patient’s education, and marital status.Conclusion: The Polish MS Registry is the first national registry for long-term observation that allows for self-evaluation of the QoL. QoL of Polish patients with MS is significantly lower compared with the rest of the population. The parameter is mainly affected by the level of disability, duration of the disease, and limited access to immunomodulatory therapy. Keywords: multiple sclerosis, patient-reported outcomes, quality of life, Poland

The aim of this study was to evaluate the association of serum 25-hydroxyvitamin D (25(OH)D) with disability and frequency of relapses in relapsing-remitting multiple sclerosis (MS) patients. The study included 184 patients with relapsing-remitting MS who were receiving immune-modulating drugs and no vitamin D supplementation. The concentration of 25(OH)D was measured in February and August 2014. The level of disability was assessed twice according to the Expanded Disability Status Scale (EDSS). The patients were divided into two groups: EDSS 0.0–2 and 2.5–4. The control group comprised 58 age- and sex-matched healthy subjects. The 25(OH)D levels were compared with the occurrence of relapses and the level of disability. Mean serum 25(OH)D concentrations were significantly lower in winter in both MS patients and controls. Winter level of 25(OH)D was significantly lower in severe MS cases (EDSS 2.5–4.0) than in mild cases (EDSS 0.0–2.0) (P=0.022), and in the controls (P=0.008), especially in females (r=0.38, P=0.0015). Logistic regression analysis showed the winter serum 25(OH)D was significantly associated with MS (odds ratio 0.925; 95% confidence interval, 0.822–0.970). Serum 25(OH)D levels were significantly lower in MS patients with relapses than in those without relapses both in winter, and in summer. Hypovitaminosis D was more prevalent during winter than summer, both in the sample group and the control, especially in female MS patients with higher levels of disability. Low vitamin D levels are associated with a more severe course of disease and an increased number of relapses.

BACKGROUND The internet is a source of knowledge and medium widely used in services that facilitate access to information and networking. Multiple sclerosis (MS) patients find the possibility of acquiring information relating to their condition particularly rewarding. OBJECTIVE We aimed to identify Polish MS patients’ preferences by analyzing a percentage of internet users and determining the most common search subjects and patients’ approach to information on the internet. Disability connected with the condition, its duration, and other factors that influence patients’ internet use were examined along with instances of relations established through the internet and their durability. METHODS The study examined 1045 patients (731 women, 314 men) treated in 10 Polish MS centers, of whom 932 (89.19%) declared to be internet users. Their average age was 40.65 (SD 11.06) and average MS duration was 9.08 (SD 6.97) years. The study used a proprietary survey on information seeking, the range of searched subjects, and internet usage frequency. RESULTS The majority of the patients (494/932, 53.0%) used the internet 6-7 times per week and 4.3% (40/932) declared they spent minimum 2 hours per day. The most commonly searched subjects were world news (604/932, 72.9% of patients using the internet); 60.8% (504/932) searched for information on their condition, particularly for new treatment methods (562/932, 67.8%) and the course of illness (520/932, 62.7%). One’s sex had no impact on internet usage (female vs male, odds ratio [OR] 1.13, 95% CI 0.72-1.77), although a patient’s age might, at varying degrees. We found several significant associations using a .05 significance level: a patient with higher education used the internet 9 times more often than one with primary education (OR 8.64, 95% CI 3.31-22.57); lasting relationships increased chances of internet usage by 10-fold compared to widowers (OR 0.12, 95% CI 0.05-0.31); living in a city with a population over 100,000 increased chances by nearly 6 times compared with the countryside (OR 5.59, 95% CI 2.72-11.48); the relapsing-remitting MS type saw a 2-fold increase compared with the primary progressive MS type (OR 0.47, 95% CI 0.29-0.75); and those needing assistance were 2 times less likely to use the internet than patients who could move independently (OR 0.53, 95% CI 0.31-0.89). More than half of the patients (489/932, 52.5%) did not discuss the information found on the internet with their neurologists; 15.9% (148/932) believed that relationships established through the internet can be stable. CONCLUSIONS The majority of Polish patients use the internet as a crucial information source on their condition and innovative treatment methods. The internet can be helpful in establishing new relationships, which are usually short-lived. Polish patients do not frequently discuss the information gathered on the internet with their doctors.

Metabolic syndrome (MetS) predisposes individuals to cardiovascular disease or stroke development. We aimed at evaluating the prevalence of MetS in a population of acute ischemic stroke (IS) patients from central Poland and at estimating the relationship between MetS and stroke risk.We analyzed 672 IS patients who were consecutively admitted to stroke units. The control group was composed of 612 patients with other neurologic disorders. MetS was diagnosed if 3 of 5 factors were present (obesity, increased blood pressure, increased triglycerides, low high-density lipoprotein [HDL] cholesterol, and fasting hyperglycemia) according to the Unified Criteria for Clinical Diagnosis of the Metabolic Syndrome (2009).MetS was diagnosed in 61.2% of stroke patients versus 18.1% of the control group (P .001). Multiple logistic regression showed that MetS was 1.8 times more common in women than in men (odds ratio [OR], 1.8; 95% confidence interval [CI], 1.4-2.5). The adjusted OR (95% CI) associated with MetS was 2.44 (1.48-3.64; P .001) for IS. Hypertension and hypertriglyceridemia were the most frequent disturbances of IS patients (87.2% and 68.2%, respectively). The analysis of the interaction between MetS and its components showed significant associations with hypertension (OR, 2.15; 95% CI, .98-4.24; P .01), high triglyceride levels (OR, 4.35; 95% CI, 2.87-9.43; P .0001), and low HDL cholesterol levels (OR, 5.12; 95% CI, 3.15-8.20; P .001).Over 60% of Polish IS patients have MetS. The prevalence of MetS was significantly higher in women than in men. Thus, MetS may be a risk factor for IS.

The prevalence of multiple sclerosis (MS)was previously unknown in Poland. The aim of this study was to determine the prevalence of MS in Poland.MS prevalence was determined on the basis of data from the Swietokrzyskie (central Poland) and Podlaskie (northeastern Poland) Voivodeships. The area population on the prevalence study day (December 31, 2013) was 1,268,239 (649,007 women; 619,232 men) in central and 1,195,625 (612,979 women; 582,646 men) in northeastern Poland.The overall crude prevalence rate of confirmed MS patients was 109.1/100,000 (95% confidence interval[CI]103.5-115.0) in the Swietokrzyskie and 108.7/100,000 (95% CI 103.0-114.7) in the Podlaskie Voivodeships. A significantly higher prevalence was recorded in females (149.8/100,000, 95% CI 140.6-159.3 vs. 142.4/100,000, 95% CI 133.3-152.0) than in males (66.5/100,000, 95% CI 60.4-73.1 vs.57.8/100,000, 95% CI 52.0-64.2)(p 0.001). Age-adjusted rates for the Polish Standard Population were the same in both regions (110.3/100,000 (95% CI 104.6-116.1) vs.110.9/100,000 (95% CI 105.1-117.1)) and for the European Standard Population did not different statistically between both voivodeships (103.9/100,000 (95% CI 98.6-109.5) vs.108.5/100,000 (95% CI 102.7-114.5)).This is the first data that obtained the level of MS prevalence in Poland and confirmed that Poland is a high-risk area for multiple sclerosis.

Background: Patients with minor acute ischemic stroke or transient ischemic attack are at high risk for subsequent stroke, and more potent antiplatelet therapy in the acute setting is needed. However, the potential benefit of more intense antiplatelet therapy must be assessed in relation to the risk for major bleeding. The SOCRATES trial (Acute Stroke or Transient Ischemic Attack Treated With Aspirin or Ticagrelor and Patient Outcomes) was the first trial with ticagrelor in patients with acute ischemic stroke or transient ischemic attack in which the efficacy and safety of ticagrelor were compared with those of aspirin. The main safety objective was assessment of PLATO (Platelet Inhibition and Patient Outcomes)–defined major bleeds on treatment, with special focus on intracranial hemorrhage (ICrH). Methods: An independent adjudication committee blinded to study treatment classified bleeds according to the PLATO, TIMI (Thrombolysis in Myocardial Infarction), and GUSTO (Global Use of Strategies to Open Occluded Coronary Arteries) definitions. The definitions of ICrH and major bleeding excluded cerebral microbleeds and asymptomatic hemorrhagic transformations of cerebral infarctions so that the definitions better discriminated important events in the acute stroke population. Results: A total of 13 130 of 13 199 randomized patients received at least 1 dose of study drug and were included in the safety analysis set. PLATO major bleeds occurred in 31 patients (0.5%) on ticagrelor and 38 patients (0.6%) on aspirin (hazard ratio, 0.83; 95% confidence interval, 0.52–1.34). The most common locations of major bleeds were intracranial and gastrointestinal. ICrH was reported in 12 patients (0.2%) on ticagrelor and 18 patients (0.3%) on aspirin. Thirteen of all 30 ICrHs (4 on ticagrelor and 9 on aspirin) were hemorrhagic strokes, and 4 (2 in each group) were symptomatic hemorrhagic transformations of brain infarctions. The ICrHs were spontaneous in 6 and 13, traumatic in 3 and 3, and procedural in 3 and 2 patients on ticagrelor and aspirin, respectively. In total, 9 fatal bleeds occurred on ticagrelor and 4 on aspirin. The composite of ICrH or fatal bleeding included 15 patients on ticagrelor and 18 on aspirin. Independently of bleeding classification, PLATO, TIMI, or GUSTO, the relative difference between treatments for major/severe bleeds was similar. Nonmajor bleeds were more common on ticagrelor. Conclusions: Antiplatelet therapy with ticagrelor in patients with acute ischemic stroke or transient ischemic attack showed a bleeding profile similar to that of aspirin for major bleeds. There were few ICrHs. Clinical Trial Registration: URL: http://www.clinicaltrials.gov . Unique identifier: NCT01994720.

Introduction: Epilepsy is one of the most common neurological illnesses occurring in children. In approximately 20–30% of cases it is drug-resistant. Aim of the research: To assess the already-known risk factors, analyse the rarely described ones, and find new causes of epilepsy drug resistance in children, taking into account the level of impact of each factor. Material and methods : The study comprised 152 of all 383 children hospitalised in 2012 at the Neurology Department of the Polish Mother’s Memorial Hospital in Lodz due to epilepsy. Based on medical documentation, neurological examination, and our own questionnaire, we divided patients into two groups: drug-resistant epilepsy or drug-sensitive epilepsy. We compared the type, level of influence, and prevalence of different factors. For statistical analysis, the 2 test was used. Statistical significance was set at p < 0.05. Results: Drug-resistant epilepsy was found in 64 patients (42.1%), and drug-sensitive epilepsy was found in 88 patients (57.9%). Factors that were most probable to cause drug resistance included: high prevalence of seizures (Cramer’s V = 0.66), type of epileptic syndrome (V = 0.62), psychomotor developmental delay (V = 0.62), and occurrence of status epilepticus (V = 0.6). Factors such as infections of CNS in early childhood, repeated severe infections of airways in childhood, and mother’s infectious diseases with high fever during pregnancy were rare or non occurring (Cramer’s V = 0.41, 0.32, and 0.31, respectively). Conclusions : The study confirmed the previously known causes of drug resistance and indicated the significance of underestimated inflammatory and infectious factors involving pyrexia, in children and also in mothers during pregnancy.

Summary Background Subcutaneous pegylated interferon (peginterferon) beta-1a is being developed for treatment of relapsing multiple sclerosis, with less frequent dosing than currently available first-line injectable treatments. We assessed the safety and efficacy of peginterferon beta-1a after 48 weeks of treatment in the placebo-controlled phase of the ADVANCE trial, a study of patients with relapsing-remitting multiple sclerosis. Methods We did this 2-year, double-blind, parallel group, phase 3 study, with a placebo-controlled design for the first 48 weeks, at 183 sites in 26 countries. Patients with relapsing-remitting multiple sclerosis (age 18–65 years, with Expanded Disability Status Scale score ≤5) were randomly assigned (1:1:1) via an interactive voice response or web system, and stratified by site, to placebo or subcutaneous peginterferon beta-1a 125 μg once every 2 weeks or every 4 weeks. The primary endpoint was annualised relapse rate at 48 weeks. This trial is registered with ClinicalTrials.gov, number NCT00906399. Findings We screened 1936 patients and enrolled 1516, of whom 1512 were randomly assigned (500 to placebo, 512 to peginterferon every 2 weeks, 500 to peginterferon every 4 weeks); 1332 (88%) patients completed 48 weeks of treatment. Adjusted annualised relapse rates were 0·397 (95% CI 0·328–0·481) in the placebo group versus 0·256 (0·206–0·318) in the every 2 weeks group and 0·288 (0·234–0·355) in the every 4 weeks group (rate ratio for every 2 weeks group 0·644, 95% CI 0·500–0·831, p=0·0007; rate ratio for the every 4 weeks group 0·725, 95% CI 0·565–0·930, p=0·0114). 417 (83%) patients taking placebo, 481 (94%) patients taking peginterferon every 2 weeks, and 472 (94%) patients taking peginterferon every 4 weeks reported adverse events including relapses. The most common adverse events associated with peginterferon beta-1a were injection site reactions, influenza-like symptoms, pyrexia, and headache. 76 (15%) patients taking placebo, 55 (11%) patients taking study drug every 2 weeks, and 71 (14%) patients taking study drug every 4 weeks reported serious adverse events; relapse, pneumonia, and urinary tract infection were the most common. Interpretation After 48 weeks, peginterferon beta-1a significantly reduced relapse rate compared with placebo. The drug might be an effective treatment for relapsing-remitting multiple sclerosis with less frequent administration than available treatments. Funding Biogen Idec.

Multiple sclerosis (MS) is a progressive disease of the central nervous system. It is characterized by disseminated foci of demyelination, which are responsible for the diverse clinical picture of MS. Pain is a frequent but underestimated symptom of multiple sclerosis. It is estimated to affect 29-86% of MS patients in various stages of the disease and severely influences rehabilitation and quality of life. The pain experienced by MS patients is generally caused by nervous system damage during the course of the disease process and can usually be characterized as central neuropathic pain (less frequently as peripheral or nociceptive pain). The most frequent symptoms include dysesthetic extremity pain, painful tonic spasms, Lhermitte's sign, trigeminal neuralgia, headaches and low back pain. This paper discusses the probable mechanisms behind the development of pain in MS, the prevalence, classification, types of pain, as well as the most effective treatment methods.

Background Intravenous thrombolysis (iv-thrombolysis) with the use of rt-PA in patients after recent transient ischemic attack (TIA) is an important clinical problem. The aim of the study was to assess the impact of TIA within 24 h preceding acute ischemic stroke (AIS) on the safety and efficacy of iv-thrombolysis. Methods We retrospectively evaluated the clinical and demographic data of 400 patients with AIS who were consecutively treated with iv-thrombolysis from September 2006 to May 2011 in three stroke centers. Results At three-month follow-up, 58.0% of patients were independent (modified Rankin scale; mRS 0–2), 17.8% had died, 17.0% suffered hemorrhagic transformation (HT) and 4.3% experienced symptomatic intracerebral hemorrhage (SICH). There were 29 patients (7.3%) who had a previous ipsilateral TIA within 24 h before established stroke. In the TIA subgroup, there was no significant higher percentage of favorable outcome (p = 0.07) and higher SICH rate (p = 0.15). Multivariate analysis showed the impact of prior TIA within 24 h before stroke onset in the presence of SICH (p = 0.01), no impact of TIA on unfavorable outcomes after three months (p = 0.25) and on the mortality rate within three months (p = 0.41). Conclusion TIA within 24 h prior to ischemic stroke can portend severe intracerebral bleeding in patients qualified to iv-thrombolysis with the use of rt-PA.

Sarcoidosis is a multi-organ granulomatous disease of unknown aetiology, most frequently affecting the respiratory system. It usually involves lungs and hilar lymph nodes. Pulmonary symptoms can also be accompanied by lesions located in other organs. Although the nervous system is rarely affected, the neurological symptoms can precede the diagnosis of neurosarcoidosis by several years. In this report we present a case of a 24-year-old male, who reported to his general practitioner due to numbness and hypoaesthesia of distal regions of his upper and lower limbs. Electrophysiological study revealed symmetrical sensorimotor polyneuropathy. Despite the lack of any other symptoms, supplementing the diagnostic evaluation with lung imaging and histopathological examination of bronchial mucous membrane led to the diagnosis of neurosarcoidosis.

Background The aim of study was to collect and analyze data on relapsing-remitting multiple sclerosis (RRMS) patients receiving disease modifying therapies (DMTs) in Poland. Material and methods The observational, multi-center with prospective data collection study included all RRMS patients receiving DMTs reimbursed by the National Health Fund (NFZ) in Poland, monitored by the Therapeutic Program Monitoring System (SMPT). The demographic profile, disability status and treatment modalities were analyzed. Results Data from 12,341 patients were collected, including 70.1% women and 29.9% men, therein 11,653 patients in the first-line and 1026 in second-line therapeutic DMTs programme. Proportion female to male was 2.36 in the first-line and 1.9 in the second-line. The mean age was 36.4 years (±SD 10.6) in the first-line and 35.1 years (±SD 9.7) in the second line. The mean time of observation in the first line was 3.7 years (±SD 2.4) and in the second line was 2.8 years (±SD 1.3). The mean time from the first symptoms to MS diagnosis was 24.54 months (median 7.23), and from MS diagnosis to treatment: 39.35 months (median 10.12). There was a positive correlation between time to start treatment and higher the initial EDSS score (R 0.29, p Conclusions In Poland, only about one third of all MS patients is treated with DMTs. There is a need to improve the quality of MS patients healthcare and their access to DMTs.

TM ) as adjunctive therapy in patients with refractory partial-onset seizures: a randomized controlled trial. Acta Neurol Scand 2014: 129: 143‐153. © 2013 The Authors. Acta Neurologica Scandinavica published by John Wiley & Sons A/S. Published by John Wiley & Sons Ltd. Objective – To evaluate the efficacy, tolerability, and safety of oncedaily 1200 mg and 2400 mg SPN-804 (Oxtellar XR TM , Supernus Pharmaceuticals), an extended-release tablet formulation of oxcarbazepine (OXC), added to 1-3 concomitant antiepileptic drugs (AEDs) in adults with refractory partial-onset seizures, with or without secondary generalization. Methods – The Prospective, Randomized Study of OXC XR in Subjects with Partial Epilepsy Refractory (PROSPER) study was a multinational, randomized, double-blind, parallel-group Phase 3 study. The primary efficacy endpoint was median percent reduction from baseline in monthly (28-day) seizure frequency for the 16-week double-blind treatment period in the intentto-treat (ITT) population with analyzable seizure data. Other efficacy analyses included proportion of patients with ≥ 50% seizure reduction, proportion of patients seizure free, and the relationship between clinical response and plasma concentration. Results – Median percent reduction was -28.7% for placebo, 38.2% (P = 0.08 vs placebo) for once-daily SPN-804 1200 mg, and 42.9% (P = 0.003) for SPN-804 2400 mg. Responder rates were 28.1%, 36.1% (P = 0.08), and 40.7% (P = 0.02); 16-week seizure-free rates in a pragmatic ITT analysis were 3.3%, 4.9% (P = 0.59), and 11.4% (P = 0.008), respectively. When data were analyzed separately for study site clusters, a post hoc analysis demonstrated that both SPN-804 dosages were significantly superior to placebo in median percent seizure reduction (placebo: 13.3%; 1200 mg: 34.5%, P = 0.02; 2400 mg: 52.7%, P = 0.006) in the North American study site cluster. A concentration–response analysis also supported a clinically meaningful effect for 1200 mg. Adverse event types reflected the drug’s established profile. Adverse event frequency was consistent with a pharmacokinetic profile in which SPN-804 produces lower peak plasma concentrations vs immediate-release OXC. Once-daily dosing was not associated with any new safety signals. Conclusions – Adjunctive once-daily SPN-804 improved seizure control in patients with inadequately controlled partial-onset seizures. Adverse event occurrence and discontinuations due to adverse events suggest improved tolerability vs previously published data with immediaterelease OXC.

Aims Approximately 30% of acute ischemic stroke (AIS) occurs in people aged over 80 years. Older patients are increasingly receiving intravenous thrombolysis (IV-thrombolysis) for AIS; however, the majority of treatments are carried out in urban hospitals. The aim of the present study was to assess the safety and effectiveness of IV-thrombolysis in patients aged older than 80 years. Methods We retrospectively evaluated the clinical and epidemiological data of 409 patients with AIS who were consecutively treated with IV-thrombolysis from September 2006 to June 2012 in the three rural hospitals. Results In the analyzed group, there were 22.3% of patients who were aged over 80 years (2.4% patients aged ≥90 years). Among these patients we found: longer onset to door time (P = 0.04), onset to treatment time (P = 0.0003) and door to treatment time (P

Streszczenie Stwardnienie rozsiane (SR) jest najczestszą przyczyną niesprawności neurologicznej mlodych osob. Szacuje sie, ze na SR choruje ok. 40 000-60 000 osob w skali calego kraju, a rocznie stwierdza sie ok. 2000 nowych zachorowan. Dane te są jednak szacunkowe i wymagają weryfikacji badaniami obejmującymi populacje calego kraju. Dotychczas opublikowane wyniki dotyczą tylko niektorych regionow Polski. Konieczne jest rowniez precyzyjne określenie potrzeb pacjentow w zakresie leczenia immunomodulującego i przeprowadzenie szczegolowych analiz farmakoekonomicznych. W celu oszacowania podstawowych parametrow epidemiologicznych, wzorem wielu krajow, potrzebne jest powolanie narodowego rejestru chorych na stwardnienie rozsiane, skupiającego wokol tego projektu wszystkie ośrodki zajmujące sie leczeniem SR. W artykule przedstawiono najwazniejsze europejskie i amerykanskie bazy danych oraz przyblizono zalozenia polskiego Rejestru Chorych ze Stwardnieniem Rozsianym – REJSM, juz funkcjonującego w jednym z wojewodztw.

Background Comprehensive epidemiologic data for multiple sclerosis (MS) in Poland are limited. The aim of this cross-sectional population-based study was to determine the incidence and prevalence of MS in the Swietokrzyskie Region (central Poland). Methods This study identified MS cases every year between 1 January 2010 and 31 December 2014. The study area population on the prevalence day (December 31, 2014) was 1,263,176 (646,506 women and 616,670 men). A total of 1462 patients with a clinically definite diagnosis of MS according to McDonald’s criteria (2005), recorded in the Polish Multiple Sclerosis Registry, were considered for estimation of crude, age- and sex-specific prevalence, and incidence. Results The overall crude prevalence rate of confirmed MS patients was 115.7/100,000 (95 % confidence interval (CI), 111.2–121.4). A significantly higher prevalence was recorded in females (159.6/100,000; 95 % CI, 151.1–165.3) than in males (69.7/100,000; 95 % CI, 62.4–77.3) (P

Multiple sclerosis is a progressive disease of the central nervous system with unknown aetiology. It most frequently affects young adults and inevitably leads to disability. Despite significantly progressing development of immunomodulatory treatment, access to which in Poland is limited, the number of patients requiring continuous care and being unable to live independently is constantly growing. The specificity of MS symptoms results from damage of almost all functional systems of the nervous system. The physical, mental, cognitive and psychosocial consequences associated with the symptoms significantly decrease the patients' quality of life. Patients with advanced stage of multiple sclerosis actually qualify for palliative care, which in Poland is reserved mainly for oncological patients and rarely for other groups of patients. The Polish legal system does not provide guaranteed benefits for people with MS requiring palliative and hospice care. Therefore, it is necessary to take action aimed at supporting the most disabled patients who are deprived of the modifying treatment and are only left to symptomatic treatment.

Objective: To investigate whether the location and extent of the CT hyperdense artery sign (HAS) at presentation affects response to IV alteplase in the randomized controlled Third International Stroke Trial (IST-3). Methods: All prerandomization and follow-up (24–48 hours) CT brain scans in IST-3 were assessed for HAS presence, location, and extent by masked raters. We assessed whether HAS grew, persisted, shrank, or disappeared at follow-up, the association with 6-month functional outcome, and effect of alteplase. IST-3 is registered (ISRCTN25765518). Results: HAS presence (vs absence) independently predicted poor 6-month outcome (increased Oxford Handicap Scale [OHS]) on adjusted ordinal regression analysis (odds ratio [OR] 0.66, p < 0.001). Outcome was worse in patients with more (vs less) extensive HAS (OR 0.61, p = 0.027) but not in proximal (vs distal) HAS (p = 0.420). Increasing age was associated with more HAS growth at follow-up (OR 1.01, p = 0.013). Treatment with alteplase increased HAS shrinkage/disappearance at follow-up (OR 0.77, p = 0.006). There was no significant difference in HAS shrinkage with alteplase in proximal (vs distal) or more (vs less) extensive HAS (p = 0.516 and p = 0.580, respectively). There was no interaction between presence vs absence of HAS and benefit of alteplase on 6-month OHS (p = 0.167). Conclusions: IV alteplase promotes measurable reduction in HAS regardless of HAS location or extent. Alteplase increased independence at 6 months in patients with and without HAS. Classification of evidence: This study provides Class I evidence that for patients within 6 hours of ischemic stroke with a CT hyperdense artery sign, IV alteplase reduced intra-arterial hyperdense thrombus.

OBJECTIVES Current guidelines for the early management of patients with acute ischemic stroke recommend completion of an evaluation within 60 min of the patient's arrival at the emergency department (ED) because prolongation of ED length of stay (LOS) may reduce the efficacy of acute stroke treatment. AIM To evaluate the LOS in EDs at the community-based Polish stroke centers, to determine logistic, social, epidemiological, and clinical factors responsible for its prolongation, and to assess the association between increased LOS and the implementation of cerebral intravenous (IV) thrombolysis. MATERIALS AND METHODS This study carried out an evaluation of the medical records of 8398 patients with stroke and transient ischemic attack who consecutively reported to the Pomeranian Stroke Registry from 2010 to 2012. RESULTS The median ED LOS in the studied cohort was 97 (44-196) min and was prolonged (>60 min) in 63.1% of patients. Prolongation of ED LOS contributed to a low (4.9%) IV thrombolysis rate. Functional status at discharge was worse in patients with prolonged versus nonprolonged LOS [modified Rankin scale: 2 (0-3) vs. 1 (0-3) points; P