International Journal of Neuroscience, 2014; Early Online: 1–8 Copyright © 2014 Informa Healthcare USA, Inc. ISSN: 0020-7454 print / 1543-5245 online DOI: 10.3109/00207454.2014.937002
ORIGINAL ARTICLE
Demographic characteristics of MS patients in Poland’s upper Silesia region Krystyna Pierzchala,1 Monika Adamczyk-Sowa,1 Pawel Dobrakowski,1 Katarzyna Kubicka-Baczyk,1 Natalia Niedziela,1 and Pawel Sowa2 1
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Department of Neurology in Zabrze, Medical University of Silesia, ul. 3-go Maja 13–15, Zabrze 41–800, Poland; Department of ENT in Zabrze, Medical University of Silesia, Silesia, Poland Objectives: In Poland, no national registry of MS patients has yet been introduced. So far, no demographic studies have been conducted in patients with MS in Upper Silesia. The aim of the present study was to evaluate, for the first time, a selected demographic and clinical parameters in MS patients from the Upper Silesia region and compare these characteristics with previously published data from other regions of Poland. Materials & Methods: 640 patients with clinically defined MS, were prospectively and randomly selected for the study. Social, socio-economic, and demographic data were obtained through a questionnaire study. All subjects performed a self-assessment of their health condition using EQ-5D and EQ-VAS version questionnaires. Results: The ratio of women to men was 2.18. The average age of onset was 29.6 ± 11.1 years; the disease duration was 7.9 ± 4.5 years. The relapsing-remitting form of MS was diagnosed in 73.12%. In 71.25% the onset was monofocal and in 28.75% multifocal disease onset was observed. Among the studied population 339 (52.97%) patients were still employed. A mean EQ-VAS score of 66.11 ± 20.12 was calculated. Conclusions: Results from our study identify for the first time the demographic and clinical characteristics of the Upper Silesia MS population. KEYWORDS: demographic, Poland, EQ-5D, multiple sclerosis
Introduction Multiple sclerosis (MS) is a chronic disease of the central nervous system, primarily affecting young adults [1]. An increased incidence of MS cases observed in recent years suggests that MS is an important health problem. It is estimated that more than 2 million people worldwide suffer from MS [2]. Recent studies in the field of MS consider the etiology of the disease, including the impact of external factors—environmental, ecological, as well as internal—immunological, genetic, hormonal, and other [1, 3–5]. The first MS epidemiology reports were published in 1922 [6]. So far, long-term national registries of patients with MS have been kept in the United States and a few European countries [7]. The North American Research Committee on Multiple Sclerosis Registry (NARCOMS) has become the largest MS registry in the world. NARCOMS was initiated in 1996 and enrolls Received 17 March 2014; revised 16 June 2014; accepted 17 June 2014. Correspondence: Monika Adamczyk-Sowa, Department of Neurology, ul. 3-go Maja 13–15, Zabrze 41–800, Poland. E-mail: [email protected]
patients via the Internet [8]. According to the World Health Organization (WHO) the MS prevalence in the USA is estimated to be about 135 cases in 100000 people [9]. One of the biggest MS registries in Europe is the German MS registry. This countrywide MS registry was started in 2001 under the patronage of the German MS Society. The average ratio of morbidity was identified as 72–127/100000 [10]. In Poland no national registry of patients with MS has yet been introduced. Only a few epidemiological studies including MS patients were conducted, all of which concentrated on selected regions of the country. In 2010, the results of the first nationwide survey initiated in May 2008 and concluded in January 2009 were published [11], in which 3581 patients (2494 women and 1030 men) were enrolled. Moreover, there are some previous studies that present a limited scope of information related to the epidemiology of MS in Poland. In Cendrowski’s dissertation, published in 1964, the data proved that MS occurred twice to six times more of´ z, and Bydgoszcz than in other reten in Warszawa, lod´ gions. Moreover, Cendrowski indicated the existence of small clusters of the disease cases in East Pomerania and 1
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Notec Valley [12]. In 1965, an epidemiological study of MS in Western Poland was performed, focusing on ´ The data pertaining to the regisa district of Poznan. tered patients was gained from a questionnaire, which provided the information about the patients’ age at the time of the onset of the disease. Further research, done by Wender et al., concerned MS patients in the county of ´ which included some administrative units like Poznan, Kalisz, Leszno, Konin, Pila, and Poznan´ [13–15]. In 1981, the annual incidence per 100 000 residents in various age groups was calculated and the predominance of MS cases in people under the age of 20 was observed [13]. The epidemiology of MS was also evaluated in the province of Szczecin by Potemkowski in the 1993–1995 period [16]. The analysis of MS in the eastern part of Poland was performed in Lublin, based on the information gathered from the period of 1996–2000 [17]. So far, no demographic studies have been conducted in patients with MS in Upper Silesia, the region with the largest population per square km. The aim of the present study was to evaluate, for the first time, a selected demographic and clinical parameters of MS patients in the Upper Silesia region and to compare the current data with previously published in Poland. It is noteworthy that our data provide information about a homogeneous group living in the territory of Poland with the highest level of industrial development and the highest exposure to pollution.
Design and Subjects This cross-sectional case register study was performed at the MS Clinic of the Department of Neurology, Medical University of Silesia in Zabrze and eleven main MS hospital centers in the Upper Silesia region in Poland. Primarily, 886 patients were selected into the study according to ICD-10 (International Statistical Classification of Diseases and Related Health Problems revision 10) diagnosis G35 (Multiple sclerosis). This group was representative for MS patients in the region, because of the number and fact that all of them lived in the Upper Silesia region at the moment of study enrollment. After the secondary selection, 192 cases were excluded because of uncertain diagnosis, missing contact information or death. From the group of 694 patients 54 patients was excluded for the reason of incomplete data and questionnaire data missing collection (the response rate was about 92%). The final 640 patients with clinically defined MS according to the McDonald 2005 criteria [18] were prospectively and randomly selected for the study between February 2011 and December 2012. Participants were selected mainly from ambulatory care units and from others MS centres including university departments, hospital wards, smaller neurology centres
and private practice neurologists. Using accurate medical files the MS form was defined at the study participation beginning time. Computer randomization was used in our study in order to perform a random selection of patients such as blocking, stratification, and minimization, that can help ensure balance between groups. The disability was assessed during the study initiation by a qualified neurologist using the Expanded Disability Status Scale (EDSS) and divided into three subgroups: (1) minimal symptoms—mild impairment corresponding to EDSS 0–2; (2) moderate impairment, but independent movement, corresponding to EDSS 2.5–5.5; (3) severe/very severe impairment, requiring assistance, corresponding to EDSS above 6.0. The study was approved by the Medical University of Silesia ethics committee. All patients included into study after initial selection (n = 694) expressed their consent by filling a written informed consent prior to study entry.
Questionnaire Study Social, socio-economic, and demographic data were obtained using a questionnaire study. After review of literature, we created a questionnaire containing multiple choice questions about social, socio-economic, and demographic parameters/factors in MS patients. The questions were chosen among the issues that are topic of discussion in current literature. The questionnaire questions were discussed and reviewed by neurologists and epidemiologist to evaluate their comprehensibility. Patients were asked about filling answers of self-reported items; while they need some help the accompanying person or examining physician explained the topic and participated in obtaining responses. According to the assumptions of a questionnaire survey, patients were asked to fill out the part of the questionnaire devoted to the medical history of comorbidities. The questionnaire asked the patients to check the comorbidities they were diagnosed with, treated for by other specialists, or hospitalized for. Only in part of cases medical history was evaluated according copies of patients’ medical files from hospital departments and ambulatory units. Smoking history was obtained during patients’ visit and patients were classified as non-smokers, exsmokers, or current smokers. All subjects performed a self-assessment of their health condition using EQ-5D and EQ-VAS (Visual Analogue Scale) questionnaires. The study was conducted using the Polish EQ-5D questionnaire [19]. The EQ-5D questionnaire is a tool for the evaluation of the quality of life. It is used with considerable success in cross-sectional and longitudinal studies of the human health status, as well as to investigate the efficiency of the healthcare system. The health aspects evaluated in International Journal of Neuroscience
Demographic characteristics of MS patients in Poland
the EQ-5D are: mobility, self-care, usual activities limitations, pain/discomfort, and anxiety/depression [20]. Each respondent was asked to fill out the Polish EQ-5D standard questionnaire, provide sociodemographic data (age, sex, marital status, education, employment, income, housing tenure, medical history, smoking habits) and perform the self-evaluation. The EQ-5D has the practical advantage of being easy to administer and score.
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Statistical Analysis The obtained questionnaire data were analyzed according completeness and compliance. When finding conflicting information data were not taken into account. The statistical analysis of the data were performed using STATISTICA version 8.0 (2007; StatSoft, Inc.). Data were presented as mean ± standard deviation (SD), median values, 95% confidence intervals, and percentage values. The results were considered statistically significant at the significance level of p < 0.05. Normal distribution was verified with the Shapiro-Wilk test. Obtained data were analyzed using using the Student’s t-test. Table 1.
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Results The demographic characteristics of the study group with socioeconomic and educational status are shown in Table 1. Our results show that 441 (68.9%) patients remained in partnerships—307 (69.93%) women and 134 (66.67%) men. Among all the patients, 358 (55.94%) have children—250 (56.95%) women and 108 (53.73%) men. After the diagnosis, 93 (21.18%) women became pregnant, in 9 (9.68%) of them at least one documented in medical files relapse during pregnancy occurred. Among the studied population, 339 (52.97%) patients were still employed, 220 (50.11%) women and 119 (59.2%) men. A positive family history defining as a presence of MS in parents, siblings or cousins was observed in 22 (3.44%) women and 26 (4.06%) men. In 166 (25.94%) patients self-reported comorbidities were recorded (Table 1). Presence of only one coexisting disease was reported in 104 patients (62.65%), while at least two comorbidities were reported in 62 cases (37.35%). Sleep and sexual problems constitute one of the common symptoms characteristic of MS. As such, in our self-reported questionairre study, they have not
Demographic characteristics of patients. (n = 640)
Demographical aspects of MS patients Patients number Age (years); mean ± SD Socio-economic status Very high High No opinion Low Very low Employment; Educational status University Secondary Vocational Gymnasium Elementary Comorbidities (n = 166; 25.94%) Eye problem Thyroid gland disease Connective tissue disease Cardiovascular disease Kidney disease Mental illness Gastrointestinal system disease Diabetes Reproductive system disease n – number of patients C
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All n (%)
Female n (%)
Male n (%)
640 40.4 ± 11.08
439 (68.6) 40.24 ± 10.92
201 (31.4) 40.72 ± 11.42
38 (5.93) 129 (20.16) 231 (36.09) 177 (27.66) 65 (10.16) 339 (52.97)
22 (5.01) 97 (22.09) 162 (36.9) 116 (26.42) 42 (9.57) 220 (50.11)
16 (7.96) 32 (15.92) 69 (34.32) 61 (30.35) 23 (11.44) 119 (59.2)
225 (35.16) 287 (44.84) 98 (15.31) 9 (1.41) 21 (3.28)
157 (35.76) 196 (44.65) 63 (14.35) 2 (0.46) 21 (4.78) n (% of total 166) 26 (15.66) 19 (11.45) 18 (10.84) 17 (10.24) 16 (9.64) 15 (9.04) 15 (9.04) 6 (3.61) 4 (2.41)
68 (33.83) 91 (45.27) 35 (17.41) 7 (3.48) 0 (0)
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Table 2.
Clinical characteristics of patients.
Age of disease onset (years); mean ± SD Disease duration (years); mean ± SD Disease course subtypes Relapsing remitting Secondary progressive Primary progressive Number of relapses; n ± SD Hospitalization Ambulatory treatment No treatment Time from first symptoms to MS diagnosis (years); mean ± SD Time from first relapse to second relapse (years); mean ± SD
Total (n = 640)
Female (n = 439)
Male (n = 201)
29.6 ± 11.1 7.9 ± 4.5 n (%) 468 (73.12) 147 (22.9) 25 (3.9) 3.39 ± 2.73 2.56 ± 1.92 1.12 ± 1.52 0.95 ± 1.12 2.02 ± 4.03 2.87 ± 2.97
29.9 ± 11.1 7.8 ± 4.4 n (%) 338 (76.99) 87 (19.82) 14 (3.19) 3.33 ± 2.5 2.41 ± 1.69 1.19 ± 1.67 0.98 ± 1.11 2.07 ± 4.44 2.76 ± 2.85
29.1 ± 9.8 8.1 ± 4.5 n (%) 130 (64.68) 60 (29.85) 11 (5.47) 3.52 ± 3.15 2.89 ± 2.32 0.97 ± 1.12 0.89 ± 1.15 1.89 ± 2.92 3.11 ± 3.19
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n—number of patients.
been regarded as comorbidities, but symptoms of the main, underlying disease—MS. Sleep problems (difficulty with falling asleep, waking up) had been reported by 352 (55%) patients—241 (54.9%) females and 111 (55.22%) males. Sexual problems were reported by 230 (35.94%) patients—149 (33.94%) women and 81 (40.3%) men. The regular nicotine addiction was reported by 121 (18.9%) patients—70 (15.94%) women and 51 (25.37%) men. The clinical characteristics of the study group are presented in Table 2. The number of 244 (38.12%) patients were qualified into the EDSS 0–2 group, 317 (49.53%) into EDSS 2.5–5.5 group and the EDSS >6.0 group included 79 (12.34%) patients. The mean disease duration among the RRMS form patients was 6.3 ± 4.4 years; among the SPMS patients the duration was estimated at 13.1 ± 10.1 years. In the RRMS female group in a partnership, the disease duration was 7.8 ± 6.81 years; in equivalent male group it was 8.76 ± 6.27 years. In the SPMS patients in a partnership, the disease duration was 13.76 ± 10.53 years in women and 18.0 ± 9.14 years in men. In the actively employed group the disease duration for women was 7.24 ± 6.5 years, for men 7.5 ± 5.6 years; in the unemployed group disease duration was 8.49 ± 7.13 years and 9.75 ± 8.5 years in females and males, respectively. Mean relapse number and relapse treatment are presented in Table 2. No difference in the mean number of relapses between women and men was observed (p > 0.05). The time interval from the onset of the first symptoms to diagnosis was significantly different before and after the year of 2005 (p < 0.05). Until 2005 the time interval was about 3.58 ± 5.7 years, while since 2005 it was about 2.02 ± 4.03 years (2.07 ± 4.44 years for women; 1.89 ± 2.92 years for men). In 456 (71.25%) patients the onset of the disease was monofocal and in 184 (28.75%) patients multifocal disease onset was observed. The most common first manifestation of the disease was, in the following
order: limb paresis (50.3%—paraparesis 32.5%; hemiparesis 17.8%), balance disturbance (48%), blurry vision (40.1%), numbness (23.9%), precise movement impairment (23.25%), pain (19.01%). In order to make a diagnosis, all patients underwent a neurological examination, 518 (80.93%) a lumbar puncture, magnetic resonance imaging of the brain was performed in 637 (99.53%) patients, and visual evoked potentials in 460 (71.87%) patients. Correlation of the first symptoms of the disease with stress conditions was confirmed by 196 (30.62%) of the respondents, and with an infection by 113 (17.65%) patients. First disease symptoms revealed during the spring season of a given year was noted in 203 individuals (31.71%), during summer in 155 patients (24.21%), in autumn in 142 (22.18%), and during winter in 139 (21.71%). In our studied group the following forms of MS therapy were used since the diagnosis: immunomodulatory drugs—27.1% (23.84% women and 34.38% men), myorelaxants—20.78%, vitamins—28.6%, diet supplements—10.24%, antibiotics—5.62% of patients. Relapse treatment with iv steroids was performed in 507 (79.22%) of the patients, while with orally administered steroids in 163 (25.47%) patients. Rehabilitation as a form of treatment was used in 266 (41.56%) patients—170 (38.72%) women and 96 (47.76%) men. Our results of EQ-5D questionnaire are shown in Table 3. A mean EQ-VAS score of 66.11 ± 20.12 (median 70.1) was calculated for the studied group, with a score of 65.04 ± 20.1 for women and 68.48 ± 19.97 for men. The EQ-VAS score in male patients was significantly higher in the age group of 25–34 years (76.42 ± 17.34 vs. 69.11 ± 14.52; p < 0.05), while in 45–54 years group it was lower compared with females (50.02 ± 11.11 vs. 57.12 ± 12.81; p < 0.05). In other age groups there were no statistical gender differences. Comparative analysis of EQ-VAS between healthy Polish population according to Golicki et al. (19) and MS patients International Journal of Neuroscience
Demographic characteristics of MS patients in Poland
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Table 3. Self-rated health status expressed by the Polish EQ-5D questionnaire descriptive system in our MS patients. The health aspects evaluated in the EQ-5D are: mobility, self-care, usual activities limitations, pain/discomfort, and anxiety/depression. Each of these functions was assessed by the patient as either: no problems, moderate, and extreme problems, and marked by the patient in the box next to the most appropriate health state. Data presented as percent of all patients, female or male patients, respectively. None (%)
Moderate (%)
Extreme (%)
Problems Patients
All
F
M
All
F
M
All
F
M
Mobility Self care Usual activities Pain/discomfort Anxiety/depression
44.99 70.17 49.14 51.59 36.92
45.91 69.4 49.82 49.11 36.65
42.97 71.88 47.66 57.03 37.5
51.1 26.16 44.5 46.94 56.72
50.89 25.98 44.13 49.47 58.01
51.56 26.56 45.31 41.41 53.91
3.91 1.47 5.62 1.47 6.11
3.2 1.78 5.34 1.42 4.98
5.47 0.78 6.25 1.56 8.59
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F—female, M—male.
from the present study is shown in Figure 1. Although we cannot confront results from two different studies statistically,a lower EQ-VAS score in all age groups of MS patients (our work) compared to healthy population (Golicki et al.) was observed.
Discussion A considerable female predominance was observed in our studied group, which was similar (2.4) to the results obtained from the Polish multicentre pilot study conducted in 2009 [11]. The epidemiological survey performed in Lublin a few years ago indicated the female to male ratio as 2.24 [17], whereas in the region of Szczecin it was 1.46 [16]. The recent publications from the European countries reported the female to male ratio as 2.02, 2.35, and 2.5 in Denmark, Sweden, and Germany, respectively [21–23]. In the study group, 68.9% of the subjects were in partnership relations, a percentage similar to that re-
Figure 1. Self-rated health status in our MS patients and healthy Polish population according to Golicki et al. (19). The analysis of mean self-rated health status was expressed by EQ-VAS score in age groups. ∗ p < 0.05 male vs. female in our study selected age groups. C
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ported in other papers. Schwartz et al. reported that 74% of MS-affected people were married or living together [24], while Jaracz et al. reported 60% as married and 11% as cohabiting [25]. Koch-Henriksen et al. reported, in the Danish MS Registry in 2012, that MS patients reduce their working ability and their partners’ at a much higher rate than in the general population [26]. Our data collected on the capacity for work revealed that almost 53% of MS patients were still actively employed. The observations from an extensive Austrian study reported a 75% of the MS-affected people in the early stage of the disease, as employed and less than 10% in the late stage [27]. It is necessary to investigate other aspects affecting the employment status, like the clinical forms of MS, kind of the work, and fatigue or depression coexistence. The data collected in our study on the concomitant disorders indicates that the majority of the disorders were of the autoimmunological variety. Sloka et al. reported the co-occurrence of autoimmune thyroid disease in MS, especially Graves’ disease [28]. Similarly, Kulakowska et al. indicated the connective tissue disorders as one of the most often appearing MS concomitant diseases [11]. Moreover, the diseases coexisting with MS the most frequently (in more than 5% patients) were divided into three groups: (a) connective tissue, muscular, and bone diseases; (b) kidney and urinary diseases; (c) mental disorders (11). It is noteworthy that abovementioned diseases, as well as MS, may probably be of the autoimmune origin and they may share the same etiopathogenic mechanisms. The average age of the onset determined in our study (29.6 ± 11.1 years) appears to be lower in comparison with the research conducted in Szczecin in the period of 1993–1995 (37.05 ± 8.91 years) [16]. On the other hand, it was similar to those obtained by Lobinska et al. in the years of 1996–2000 (30.1 years) [17] and Kulakowska et al. (30.4 ± 9.8 years) [11]. The RRMS course of the disease was observed in the majority of our patients and was similar to that of the Polish multicentre pilot study (70.5%) [11]. However,
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it was significantly higher than in Germany, where the RRMS form of the disease was determined to constitute 55% of all MS cases in the national MS registry [23]. Data from the Italian MS database network revealed about 73% of MS cases to be of the RRMS course [29]. It seems that the prevalence of RRMS type of disease, in our study, may result from the fact that RRMS patients are generally in better physical condition, and therefore are much easier to get in touch with. In our study we reported that new 2005 McDonald criteria influenced on acceleration of diagnosis. The disease onset was determined as monofocal in 71.25% of our patients and EDSS>6 in 12.34%, while Kulakowska et al. reported monofocal onset in 80.8% of cases and EDSS>6 in 19.7% [11]. Our results indicate that the most frequent first symptoms were as follows: limb weakness, dizziness, visual and sensory disturbances, and pain. Boiko et al. reported sensory disturbances (45.4%), motor symptoms (20.1%), and optic neuritis (17.2%) as the most often onset syndrome [30]. In late-onset MS the main neurological presentations were motor symptoms (63.3%) [31]. Among the diagnostic methods of MS the examination of visual evoked potentials was performed in 71.87% of the patients in the Upper Silesia region. Furthermore, it occurred more often than in the Kulakowska et al. study from 2009 (54%) [11]. Probably, the difference is connected with the recommendations of the McDonald diagnostic criteria and with a small specificity of this electrophysiological test. The performance of the resonance imaging of the brain was similar: 99.53% in our study vs. 96.2% in the 2009 study [11]. Our results suggest that the most frequently used drugs in MS therapy were: immunomodulatory drugs—27.1% (23.84% females and 34.38% males), myorelaxants—20.78%, vitamins—28.6%, diet supplements—10.24%, antibiotics—5.62%. Similarly, according to Kulakowska et al., immunomodulatory agents were administered only in 24% of MS patients in Poland, mainly interferons β (in 81%) and glatiramer (in 13%), while the use of immunosuppresive agents was noted in 3% of the patients [11]. Taking into account that in the therapy with immunomodulatory drugs in Germany comprised more than 70% [32] of therapeutic choices, such a treatment choice in Poland can be considered as rare. This discrepancy results from an unequal access to immunomodulatory therapy in Poland as compared to other European countries. There is a lack of information about the use of myorelaxants, vitamins, diet supplements, or antibiotics in MS-affected patients in Poland. In MS patients, myorelaxants are used as a symptomatic drug against spasticity. The data from NARCOMS indicates that over 70%
of MS patients are treated with myorelaxants [8]. In our study, only about 20% of the patients were treated using this kind of drugs. The quality of life in MS patients from the Upper Silesia region of Poland was measured using the EQ-5D questionnaire. The quality of life in our MS patients was significantly lower, in all age groups, as compared to the healthy Polish population, which was proven in the study of Golicki et al. [19] (see Figure 1). Studies conducted so far have shown that the quality of life in patients with MS is lower than in healthy people. Using various instruments, some determinants of the lower quality of life in MS patients, including fatigue [33], depression [34], cognition, or disability status have been identified [35]. Moreover, our results show a clear trend towards decline in mean EQ-VAS scores as age increases. It may be resulted from the accumulation of disability over time due to longer time since diagnosis. Over the course of the MS progression the degree of disability of the patient rises, new symptoms of the disease appear, and consequently the quality of life deteriorates. It is difficult to ascertain what role in the quality of life the symptoms resulting from the disease have, and how much of a role the age of the patient plays. We believe that the strength of our work is providing information, for the first time, about a homogeneous group living in the territory of Poland with the highest level of industrial development and the highest exposure to pollution. This cohort may be of interest in future studies on the effect of environmental risk factors in MS (pollution and industrial development) and may be of interest for administrative purposes and for up-coming studies. Furthermore, we provide a comprehensive comparison of the findings with other studies exploring similar data, both from Poland, and globally. We are aware about some limitations of our study. The first is recruitment of our study group. Due to the fact that our study group was randomly assembled from several centres specialising in the treatment of MS, it does not contain data about all the MS patients from a given research centre. Patients diagnosed with MS remain under care not only of the major MS treatment centres, but other smaller neurology centres, private practice neurologists, as well as primary care doctors. From that reason in our study majority of enrolled patients were in better clinical condition—with lower EDSS score. We realize that the oldest and probably most impaired MS patients were not identified. The second limitation of our study is self-report form of data collection. Some obtained parameters were not confirmed by medical files data, but in many cases such verifications were conducted. The third limitation is that on the basis of results we are unable to assess the prevalence ratio for MS inthe Upper Silesia region. The essence of our study was the presentation of selected demographic International Journal of Neuroscience
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Demographic characteristics of MS patients in Poland
and clinical parameters in a randomly selected group of MS patients. The studied group constituted but a fraction of the whole MS-affected population in this region. Due to the fact that our study group was randomly assembled from several centres specialising in the treatment of MS, it does not contain data about all the MS patients from a given research centre. According to the data from 31 December 2012, the silesian voivodeship had a population of 4.615.870. If the 640 patients from our study group were to be set against the population of 4.615.870 for the Upper Silesia region, the prevalence rate would be about 0.000138 (13.8/100000), which, of course, in no way reflects the actual prevalence rate [36]. Due to there being no nationwide MS registry we are afflicted by a chronic lack of epidemiological data concerning all regions of Poland, and, seeing as this is the case, our study is, unfortunately, not to be considered as such. We are under the impression that the only rational solution capable of providing reliable epidemiological data and statistics would be the implementation of a nationwide MS registry. Currently, we are planning on beginning a study evaluating epidemiological MS data in the Upper Silesia region. The methodology of this study is being developed and requires cooperation from the National Healthcare System (NFZ) in order to authenticate the acquired data. Another limitation of our study is the fact that using in our study patients’ self-reported non-validated questionnaire created in our department allows compare only similar, but not identical other questionnaires data. However, in such studies it is not practically possible to formally account for underlying differences between the study and other similar populations or unmeasured factors which may contribute to these observed differences.
Conclusions The results presented in our study introduce an important description of the MS population in Upper Silesia region. This is the first study in Poland that combines so many aspects of MS. Furthermore, our data provides information about a homogeneous group residing in the territory of Poland with the highest level of industrial development and the highest exposure to pollution. Further studies concerning other important aspects of MS in our Silesian MS population are planned.
Acknowledgements The authors of the following publication extend their thanks and gratitude to the collaborating neurologists from neighboring Neurology Departments in Upper C
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Silesia, caring after MS patients, for their help in preparing this study.
Declaration of Interest The authors report no conflicts of interest. The authors alone are responsible for the content and writing of the paper.
References 1. Compston A, Coles A. Multiple sclerosis. Lancet 2008;372(9648):1502–17. 2. Kobelt G, Berg J, Lindgren P et al. Costs and quality of life in multiple sclerosis in Europe: method of assessment and analysis. Eur J Health Econ 2006;7(2):5–13. 3. Handel AE, Giovannoni G, Ebers GC. Environmental factors and their timing in adult-onset multiple sclerosis. Nat Rev Neurol 2010;6(3):156–66. 4. Coo H, Aronson KJ. A systematic review of several potential non-genetic risk factors for multiple sclerosis. Neuroepidemiology 2004;23(1–2):1–12. 5. Zorzon M, Zivadinov R, Nasuelli D et al. Risk factors of multiple sclerosis: a case-control study. Neurol Sci 2003;24(4):242–7. 6. Bailey P. Incidence of multiple sclerosis in United States troops. Arch Neurol Psychiatry 1922;7:582–3. 7. Hurwitz BJ. Registry studies of long-term multiple sclerosis outcomes: description of key registries. Neurology. 2011;76(Suppl. 1):3–6. 8. Lo AC, Hadjimichael O, Vollmer TL. Treatment patterns of multiple sclerosis patients: a comparison of veterans and non-veterans using the NARCOMS registry. Mult Scler 2005;11(1):33–40. 9. Dua T, Rompani P. World Health Organization. Atlas [electronic resource]: Multiple sclerosis resources in the world 2008. World Health Orgn 2008 [date cited 4 April 2013];available at: http://www.who.int/mental health/neurology/Atlas MS WEB. pdf. 10. Flachenecker P, Stuke K. National MS registries. J Neurol 2008;255(Suppl 6):102–8. 11. Kulakowska A, Bartosik-Psujek H, Hozejowski R et al. Selected aspects of the epidemiology of multiple sclerosis in Poland - a multicentre pilot study. Neurol Neurochir Pol 2010;44(5):443–52. 12. Cendrowski W, Wender M, Dominik W et al. Epidemiological study of multiple sclerosis in Western Poland. Eur Neurol 1969;2(2):90–108. 13. Wender M, Pruchnik-Grabowska D, Hertmanowska H et al. Epidemiology of multiple sclerosis in Western Poland—A comparison between prevalence rates in 1965 and 1981. Acta Neurol Scand 1985;72(2):210–7. 14. Kowal P, Wender M, Pruchnik-Grabowska D et al. Contribution to the epidemiology of multiple sclerosis in Poland. Ital J Neurol Sci 1986;7:201–4. 15. Wender M, Kowal P, Pruchnik-Grabowska D et al. Stwardnie´ ludno´sci nie rozsiane- rozpowszechnienie i zapadalno´sc´ w´srod miejscowej w zachodniej Polsce. Neurologia i Neurochirurgia Polska 1987;XXI(XXXVII):33–9. 16. Potemkowski A. Epidemiology of multiple sclerosis in the region of Szczecin: prevalence and incidence 1993–1995. Neurol Neurochir Pol 1999;33(3):575–85.
Int J Neurosci Downloaded from informahealthcare.com by University of Toronto on 11/19/14 For personal use only.
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K. Pierzchala et al. 17. Lobinska A, Stelmasiak Z. Epidemiological aspects of multiple sclerosis in Lublin (Poland). Neurol Neurochir Pol 2004;38(5):361–6. 18. Polman CH, Reingold SC, Edan G et al. Diagnostic criteria for multiple sclerosis: 2005 revisions to the “McDonald Criteria”. Ann Neurol 2005;58:840–6. 19. Golicki D, Niewada M, Jakubczyk M, et al. Self-assessed health status in Poland: EQ-5D findings from the Polish valuation study. Pol Arch Med Wewn 2010;120(7–8):276–81 20. Fisk JD, Brown MG, Sketris IS, et al. A comparison of health utility measures for the evaluation of multiple sclerosis treatments. J Neurol Neurosurg Psychiatry 2005;76(1):58–63. 21. Koch-Henriksen N, Stenager E, Bronnum-Hansen H. Studies based on the Danish multiple sclerosis registry. Scand J Public Health 2011;39(7 Suppl):180–4. 22. Ahlgren C, Oden A, Lycke J. High nationwide prevalence of multiple sclerosis in Sweden. Mult Scler 2011;17(8): 901–8. 23. Flachenecker P, Stuke K, Elias W et al. Multiple sclerosis registry in Germany: results of the extension phase 2005/2006. Dtsch Arztebl Int 2008;105(7):113–9. 24. Schwartz C, Frohner R. Contribution of demographic, medical, and social support variables in predicting the mental health dimension of quality of life among people with multiple sclerosis. Health & Social Work. 2005;30(3):203–12. 25. Jaracz K, Pawlak M, Gorna K et al. Quality of life and social support in patients with multiple sclerosis. Neurol Neurochir Pol 2010;44(4):358–65. 26. Koch-Henriksen N, Stenager E, Laursen B. The use of epidemiological multiple sclerosis registers in research: the Danish MS Registry. Acta Neurol Scand Suppl 2012;(195):7–12.
27. Kobelt G, Berg J, Lindgren P et al. Costs and quality of life of multiple sclerosis in Austria. Eur J Health Econ 2006;7(Suppl 2):S14–23. 28. Sloka JS, Phillips PW, Stefanelli M et al. Co-occurrence of autoimmune thyroid disease in a multiple sclerosis cohort. J Autoimmune Dis 2005;2:9. 29. Trojano M, Paolicelli D, Lepore V et al. Italian multiple sclerosis database network. Neurol Sci 2006;27(Suppl 5):358–61. 30. Boiko A, Vorobeychik G, Paty D et al. Early onset multiple sclerosis: a longitudinal study. Neurology 2002;59(7):1006–10. 31. Polliack ML, Barak Y, Achiron A. Late-onset multiple sclerosis. J Am Geriatr Soc 2001;49(2):168–71. 32. Henze T, Rieckmann P, Toyka KV. Symptomatic treatment of multiple sclerosis. Multiple sclerosis therapy consensus group (MSTCG) of the German Multiple Sclerosis Society. Eur Neurol 2006;56(2):78–105. 33. Pittion-Vouyovitch S, Debouverie M, Guillemin F et al. Fatigue in multiple sclerosis is related to disability, depression and quality of life. J Neurol Sci 2006;243(1–2):39–45. 34. Lobentanz IS, Asenbaum S, Vass K et al. Factors influencing quality of life in multiple sclerosis patients: disability, depressive mood, fatigue and sleep quality. Acta Neurol Scand 2004;110(1):6–13. 35. Fernandez O, Baumstarck-Barrau K, Simeoni MC et al. Patient characteristics and determinants of quality of life in an international population with multiple sclerosis: assessment using the MUSIQOL and SF-36 questionnaires. Mult Scler 2011;17(10):1238–49. 36. Stan i struktura ludno´sci oraz ruch naturalny w przekroju tery´ torialnym w 2012 r. Stan w dniu 31 XII. Warszawa: Glowny Urzad Statystyczny, 2013–06–05. ISSN 2083–3342.
International Journal of Neuroscience
ORIGINAL ARTICLE
Demographic characteristics of MS patients in Poland’s upper Silesia region Krystyna Pierzchala,1 Monika Adamczyk-Sowa,1 Pawel Dobrakowski,1 Katarzyna Kubicka-Baczyk,1 Natalia Niedziela,1 and Pawel Sowa2 1
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Department of Neurology in Zabrze, Medical University of Silesia, ul. 3-go Maja 13–15, Zabrze 41–800, Poland; Department of ENT in Zabrze, Medical University of Silesia, Silesia, Poland Objectives: In Poland, no national registry of MS patients has yet been introduced. So far, no demographic studies have been conducted in patients with MS in Upper Silesia. The aim of the present study was to evaluate, for the first time, a selected demographic and clinical parameters in MS patients from the Upper Silesia region and compare these characteristics with previously published data from other regions of Poland. Materials & Methods: 640 patients with clinically defined MS, were prospectively and randomly selected for the study. Social, socio-economic, and demographic data were obtained through a questionnaire study. All subjects performed a self-assessment of their health condition using EQ-5D and EQ-VAS version questionnaires. Results: The ratio of women to men was 2.18. The average age of onset was 29.6 ± 11.1 years; the disease duration was 7.9 ± 4.5 years. The relapsing-remitting form of MS was diagnosed in 73.12%. In 71.25% the onset was monofocal and in 28.75% multifocal disease onset was observed. Among the studied population 339 (52.97%) patients were still employed. A mean EQ-VAS score of 66.11 ± 20.12 was calculated. Conclusions: Results from our study identify for the first time the demographic and clinical characteristics of the Upper Silesia MS population. KEYWORDS: demographic, Poland, EQ-5D, multiple sclerosis
Introduction Multiple sclerosis (MS) is a chronic disease of the central nervous system, primarily affecting young adults [1]. An increased incidence of MS cases observed in recent years suggests that MS is an important health problem. It is estimated that more than 2 million people worldwide suffer from MS [2]. Recent studies in the field of MS consider the etiology of the disease, including the impact of external factors—environmental, ecological, as well as internal—immunological, genetic, hormonal, and other [1, 3–5]. The first MS epidemiology reports were published in 1922 [6]. So far, long-term national registries of patients with MS have been kept in the United States and a few European countries [7]. The North American Research Committee on Multiple Sclerosis Registry (NARCOMS) has become the largest MS registry in the world. NARCOMS was initiated in 1996 and enrolls Received 17 March 2014; revised 16 June 2014; accepted 17 June 2014. Correspondence: Monika Adamczyk-Sowa, Department of Neurology, ul. 3-go Maja 13–15, Zabrze 41–800, Poland. E-mail: [email protected]
patients via the Internet [8]. According to the World Health Organization (WHO) the MS prevalence in the USA is estimated to be about 135 cases in 100000 people [9]. One of the biggest MS registries in Europe is the German MS registry. This countrywide MS registry was started in 2001 under the patronage of the German MS Society. The average ratio of morbidity was identified as 72–127/100000 [10]. In Poland no national registry of patients with MS has yet been introduced. Only a few epidemiological studies including MS patients were conducted, all of which concentrated on selected regions of the country. In 2010, the results of the first nationwide survey initiated in May 2008 and concluded in January 2009 were published [11], in which 3581 patients (2494 women and 1030 men) were enrolled. Moreover, there are some previous studies that present a limited scope of information related to the epidemiology of MS in Poland. In Cendrowski’s dissertation, published in 1964, the data proved that MS occurred twice to six times more of´ z, and Bydgoszcz than in other reten in Warszawa, lod´ gions. Moreover, Cendrowski indicated the existence of small clusters of the disease cases in East Pomerania and 1
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Notec Valley [12]. In 1965, an epidemiological study of MS in Western Poland was performed, focusing on ´ The data pertaining to the regisa district of Poznan. tered patients was gained from a questionnaire, which provided the information about the patients’ age at the time of the onset of the disease. Further research, done by Wender et al., concerned MS patients in the county of ´ which included some administrative units like Poznan, Kalisz, Leszno, Konin, Pila, and Poznan´ [13–15]. In 1981, the annual incidence per 100 000 residents in various age groups was calculated and the predominance of MS cases in people under the age of 20 was observed [13]. The epidemiology of MS was also evaluated in the province of Szczecin by Potemkowski in the 1993–1995 period [16]. The analysis of MS in the eastern part of Poland was performed in Lublin, based on the information gathered from the period of 1996–2000 [17]. So far, no demographic studies have been conducted in patients with MS in Upper Silesia, the region with the largest population per square km. The aim of the present study was to evaluate, for the first time, a selected demographic and clinical parameters of MS patients in the Upper Silesia region and to compare the current data with previously published in Poland. It is noteworthy that our data provide information about a homogeneous group living in the territory of Poland with the highest level of industrial development and the highest exposure to pollution.
Design and Subjects This cross-sectional case register study was performed at the MS Clinic of the Department of Neurology, Medical University of Silesia in Zabrze and eleven main MS hospital centers in the Upper Silesia region in Poland. Primarily, 886 patients were selected into the study according to ICD-10 (International Statistical Classification of Diseases and Related Health Problems revision 10) diagnosis G35 (Multiple sclerosis). This group was representative for MS patients in the region, because of the number and fact that all of them lived in the Upper Silesia region at the moment of study enrollment. After the secondary selection, 192 cases were excluded because of uncertain diagnosis, missing contact information or death. From the group of 694 patients 54 patients was excluded for the reason of incomplete data and questionnaire data missing collection (the response rate was about 92%). The final 640 patients with clinically defined MS according to the McDonald 2005 criteria [18] were prospectively and randomly selected for the study between February 2011 and December 2012. Participants were selected mainly from ambulatory care units and from others MS centres including university departments, hospital wards, smaller neurology centres
and private practice neurologists. Using accurate medical files the MS form was defined at the study participation beginning time. Computer randomization was used in our study in order to perform a random selection of patients such as blocking, stratification, and minimization, that can help ensure balance between groups. The disability was assessed during the study initiation by a qualified neurologist using the Expanded Disability Status Scale (EDSS) and divided into three subgroups: (1) minimal symptoms—mild impairment corresponding to EDSS 0–2; (2) moderate impairment, but independent movement, corresponding to EDSS 2.5–5.5; (3) severe/very severe impairment, requiring assistance, corresponding to EDSS above 6.0. The study was approved by the Medical University of Silesia ethics committee. All patients included into study after initial selection (n = 694) expressed their consent by filling a written informed consent prior to study entry.
Questionnaire Study Social, socio-economic, and demographic data were obtained using a questionnaire study. After review of literature, we created a questionnaire containing multiple choice questions about social, socio-economic, and demographic parameters/factors in MS patients. The questions were chosen among the issues that are topic of discussion in current literature. The questionnaire questions were discussed and reviewed by neurologists and epidemiologist to evaluate their comprehensibility. Patients were asked about filling answers of self-reported items; while they need some help the accompanying person or examining physician explained the topic and participated in obtaining responses. According to the assumptions of a questionnaire survey, patients were asked to fill out the part of the questionnaire devoted to the medical history of comorbidities. The questionnaire asked the patients to check the comorbidities they were diagnosed with, treated for by other specialists, or hospitalized for. Only in part of cases medical history was evaluated according copies of patients’ medical files from hospital departments and ambulatory units. Smoking history was obtained during patients’ visit and patients were classified as non-smokers, exsmokers, or current smokers. All subjects performed a self-assessment of their health condition using EQ-5D and EQ-VAS (Visual Analogue Scale) questionnaires. The study was conducted using the Polish EQ-5D questionnaire [19]. The EQ-5D questionnaire is a tool for the evaluation of the quality of life. It is used with considerable success in cross-sectional and longitudinal studies of the human health status, as well as to investigate the efficiency of the healthcare system. The health aspects evaluated in International Journal of Neuroscience
Demographic characteristics of MS patients in Poland
the EQ-5D are: mobility, self-care, usual activities limitations, pain/discomfort, and anxiety/depression [20]. Each respondent was asked to fill out the Polish EQ-5D standard questionnaire, provide sociodemographic data (age, sex, marital status, education, employment, income, housing tenure, medical history, smoking habits) and perform the self-evaluation. The EQ-5D has the practical advantage of being easy to administer and score.
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Statistical Analysis The obtained questionnaire data were analyzed according completeness and compliance. When finding conflicting information data were not taken into account. The statistical analysis of the data were performed using STATISTICA version 8.0 (2007; StatSoft, Inc.). Data were presented as mean ± standard deviation (SD), median values, 95% confidence intervals, and percentage values. The results were considered statistically significant at the significance level of p < 0.05. Normal distribution was verified with the Shapiro-Wilk test. Obtained data were analyzed using using the Student’s t-test. Table 1.
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Results The demographic characteristics of the study group with socioeconomic and educational status are shown in Table 1. Our results show that 441 (68.9%) patients remained in partnerships—307 (69.93%) women and 134 (66.67%) men. Among all the patients, 358 (55.94%) have children—250 (56.95%) women and 108 (53.73%) men. After the diagnosis, 93 (21.18%) women became pregnant, in 9 (9.68%) of them at least one documented in medical files relapse during pregnancy occurred. Among the studied population, 339 (52.97%) patients were still employed, 220 (50.11%) women and 119 (59.2%) men. A positive family history defining as a presence of MS in parents, siblings or cousins was observed in 22 (3.44%) women and 26 (4.06%) men. In 166 (25.94%) patients self-reported comorbidities were recorded (Table 1). Presence of only one coexisting disease was reported in 104 patients (62.65%), while at least two comorbidities were reported in 62 cases (37.35%). Sleep and sexual problems constitute one of the common symptoms characteristic of MS. As such, in our self-reported questionairre study, they have not
Demographic characteristics of patients. (n = 640)
Demographical aspects of MS patients Patients number Age (years); mean ± SD Socio-economic status Very high High No opinion Low Very low Employment; Educational status University Secondary Vocational Gymnasium Elementary Comorbidities (n = 166; 25.94%) Eye problem Thyroid gland disease Connective tissue disease Cardiovascular disease Kidney disease Mental illness Gastrointestinal system disease Diabetes Reproductive system disease n – number of patients C
2014 Informa Healthcare USA, Inc.
All n (%)
Female n (%)
Male n (%)
640 40.4 ± 11.08
439 (68.6) 40.24 ± 10.92
201 (31.4) 40.72 ± 11.42
38 (5.93) 129 (20.16) 231 (36.09) 177 (27.66) 65 (10.16) 339 (52.97)
22 (5.01) 97 (22.09) 162 (36.9) 116 (26.42) 42 (9.57) 220 (50.11)
16 (7.96) 32 (15.92) 69 (34.32) 61 (30.35) 23 (11.44) 119 (59.2)
225 (35.16) 287 (44.84) 98 (15.31) 9 (1.41) 21 (3.28)
157 (35.76) 196 (44.65) 63 (14.35) 2 (0.46) 21 (4.78) n (% of total 166) 26 (15.66) 19 (11.45) 18 (10.84) 17 (10.24) 16 (9.64) 15 (9.04) 15 (9.04) 6 (3.61) 4 (2.41)
68 (33.83) 91 (45.27) 35 (17.41) 7 (3.48) 0 (0)
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Table 2.
Clinical characteristics of patients.
Age of disease onset (years); mean ± SD Disease duration (years); mean ± SD Disease course subtypes Relapsing remitting Secondary progressive Primary progressive Number of relapses; n ± SD Hospitalization Ambulatory treatment No treatment Time from first symptoms to MS diagnosis (years); mean ± SD Time from first relapse to second relapse (years); mean ± SD
Total (n = 640)
Female (n = 439)
Male (n = 201)
29.6 ± 11.1 7.9 ± 4.5 n (%) 468 (73.12) 147 (22.9) 25 (3.9) 3.39 ± 2.73 2.56 ± 1.92 1.12 ± 1.52 0.95 ± 1.12 2.02 ± 4.03 2.87 ± 2.97
29.9 ± 11.1 7.8 ± 4.4 n (%) 338 (76.99) 87 (19.82) 14 (3.19) 3.33 ± 2.5 2.41 ± 1.69 1.19 ± 1.67 0.98 ± 1.11 2.07 ± 4.44 2.76 ± 2.85
29.1 ± 9.8 8.1 ± 4.5 n (%) 130 (64.68) 60 (29.85) 11 (5.47) 3.52 ± 3.15 2.89 ± 2.32 0.97 ± 1.12 0.89 ± 1.15 1.89 ± 2.92 3.11 ± 3.19
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n—number of patients.
been regarded as comorbidities, but symptoms of the main, underlying disease—MS. Sleep problems (difficulty with falling asleep, waking up) had been reported by 352 (55%) patients—241 (54.9%) females and 111 (55.22%) males. Sexual problems were reported by 230 (35.94%) patients—149 (33.94%) women and 81 (40.3%) men. The regular nicotine addiction was reported by 121 (18.9%) patients—70 (15.94%) women and 51 (25.37%) men. The clinical characteristics of the study group are presented in Table 2. The number of 244 (38.12%) patients were qualified into the EDSS 0–2 group, 317 (49.53%) into EDSS 2.5–5.5 group and the EDSS >6.0 group included 79 (12.34%) patients. The mean disease duration among the RRMS form patients was 6.3 ± 4.4 years; among the SPMS patients the duration was estimated at 13.1 ± 10.1 years. In the RRMS female group in a partnership, the disease duration was 7.8 ± 6.81 years; in equivalent male group it was 8.76 ± 6.27 years. In the SPMS patients in a partnership, the disease duration was 13.76 ± 10.53 years in women and 18.0 ± 9.14 years in men. In the actively employed group the disease duration for women was 7.24 ± 6.5 years, for men 7.5 ± 5.6 years; in the unemployed group disease duration was 8.49 ± 7.13 years and 9.75 ± 8.5 years in females and males, respectively. Mean relapse number and relapse treatment are presented in Table 2. No difference in the mean number of relapses between women and men was observed (p > 0.05). The time interval from the onset of the first symptoms to diagnosis was significantly different before and after the year of 2005 (p < 0.05). Until 2005 the time interval was about 3.58 ± 5.7 years, while since 2005 it was about 2.02 ± 4.03 years (2.07 ± 4.44 years for women; 1.89 ± 2.92 years for men). In 456 (71.25%) patients the onset of the disease was monofocal and in 184 (28.75%) patients multifocal disease onset was observed. The most common first manifestation of the disease was, in the following
order: limb paresis (50.3%—paraparesis 32.5%; hemiparesis 17.8%), balance disturbance (48%), blurry vision (40.1%), numbness (23.9%), precise movement impairment (23.25%), pain (19.01%). In order to make a diagnosis, all patients underwent a neurological examination, 518 (80.93%) a lumbar puncture, magnetic resonance imaging of the brain was performed in 637 (99.53%) patients, and visual evoked potentials in 460 (71.87%) patients. Correlation of the first symptoms of the disease with stress conditions was confirmed by 196 (30.62%) of the respondents, and with an infection by 113 (17.65%) patients. First disease symptoms revealed during the spring season of a given year was noted in 203 individuals (31.71%), during summer in 155 patients (24.21%), in autumn in 142 (22.18%), and during winter in 139 (21.71%). In our studied group the following forms of MS therapy were used since the diagnosis: immunomodulatory drugs—27.1% (23.84% women and 34.38% men), myorelaxants—20.78%, vitamins—28.6%, diet supplements—10.24%, antibiotics—5.62% of patients. Relapse treatment with iv steroids was performed in 507 (79.22%) of the patients, while with orally administered steroids in 163 (25.47%) patients. Rehabilitation as a form of treatment was used in 266 (41.56%) patients—170 (38.72%) women and 96 (47.76%) men. Our results of EQ-5D questionnaire are shown in Table 3. A mean EQ-VAS score of 66.11 ± 20.12 (median 70.1) was calculated for the studied group, with a score of 65.04 ± 20.1 for women and 68.48 ± 19.97 for men. The EQ-VAS score in male patients was significantly higher in the age group of 25–34 years (76.42 ± 17.34 vs. 69.11 ± 14.52; p < 0.05), while in 45–54 years group it was lower compared with females (50.02 ± 11.11 vs. 57.12 ± 12.81; p < 0.05). In other age groups there were no statistical gender differences. Comparative analysis of EQ-VAS between healthy Polish population according to Golicki et al. (19) and MS patients International Journal of Neuroscience
Demographic characteristics of MS patients in Poland
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Table 3. Self-rated health status expressed by the Polish EQ-5D questionnaire descriptive system in our MS patients. The health aspects evaluated in the EQ-5D are: mobility, self-care, usual activities limitations, pain/discomfort, and anxiety/depression. Each of these functions was assessed by the patient as either: no problems, moderate, and extreme problems, and marked by the patient in the box next to the most appropriate health state. Data presented as percent of all patients, female or male patients, respectively. None (%)
Moderate (%)
Extreme (%)
Problems Patients
All
F
M
All
F
M
All
F
M
Mobility Self care Usual activities Pain/discomfort Anxiety/depression
44.99 70.17 49.14 51.59 36.92
45.91 69.4 49.82 49.11 36.65
42.97 71.88 47.66 57.03 37.5
51.1 26.16 44.5 46.94 56.72
50.89 25.98 44.13 49.47 58.01
51.56 26.56 45.31 41.41 53.91
3.91 1.47 5.62 1.47 6.11
3.2 1.78 5.34 1.42 4.98
5.47 0.78 6.25 1.56 8.59
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F—female, M—male.
from the present study is shown in Figure 1. Although we cannot confront results from two different studies statistically,a lower EQ-VAS score in all age groups of MS patients (our work) compared to healthy population (Golicki et al.) was observed.
Discussion A considerable female predominance was observed in our studied group, which was similar (2.4) to the results obtained from the Polish multicentre pilot study conducted in 2009 [11]. The epidemiological survey performed in Lublin a few years ago indicated the female to male ratio as 2.24 [17], whereas in the region of Szczecin it was 1.46 [16]. The recent publications from the European countries reported the female to male ratio as 2.02, 2.35, and 2.5 in Denmark, Sweden, and Germany, respectively [21–23]. In the study group, 68.9% of the subjects were in partnership relations, a percentage similar to that re-
Figure 1. Self-rated health status in our MS patients and healthy Polish population according to Golicki et al. (19). The analysis of mean self-rated health status was expressed by EQ-VAS score in age groups. ∗ p < 0.05 male vs. female in our study selected age groups. C
2014 Informa Healthcare USA, Inc.
ported in other papers. Schwartz et al. reported that 74% of MS-affected people were married or living together [24], while Jaracz et al. reported 60% as married and 11% as cohabiting [25]. Koch-Henriksen et al. reported, in the Danish MS Registry in 2012, that MS patients reduce their working ability and their partners’ at a much higher rate than in the general population [26]. Our data collected on the capacity for work revealed that almost 53% of MS patients were still actively employed. The observations from an extensive Austrian study reported a 75% of the MS-affected people in the early stage of the disease, as employed and less than 10% in the late stage [27]. It is necessary to investigate other aspects affecting the employment status, like the clinical forms of MS, kind of the work, and fatigue or depression coexistence. The data collected in our study on the concomitant disorders indicates that the majority of the disorders were of the autoimmunological variety. Sloka et al. reported the co-occurrence of autoimmune thyroid disease in MS, especially Graves’ disease [28]. Similarly, Kulakowska et al. indicated the connective tissue disorders as one of the most often appearing MS concomitant diseases [11]. Moreover, the diseases coexisting with MS the most frequently (in more than 5% patients) were divided into three groups: (a) connective tissue, muscular, and bone diseases; (b) kidney and urinary diseases; (c) mental disorders (11). It is noteworthy that abovementioned diseases, as well as MS, may probably be of the autoimmune origin and they may share the same etiopathogenic mechanisms. The average age of the onset determined in our study (29.6 ± 11.1 years) appears to be lower in comparison with the research conducted in Szczecin in the period of 1993–1995 (37.05 ± 8.91 years) [16]. On the other hand, it was similar to those obtained by Lobinska et al. in the years of 1996–2000 (30.1 years) [17] and Kulakowska et al. (30.4 ± 9.8 years) [11]. The RRMS course of the disease was observed in the majority of our patients and was similar to that of the Polish multicentre pilot study (70.5%) [11]. However,
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it was significantly higher than in Germany, where the RRMS form of the disease was determined to constitute 55% of all MS cases in the national MS registry [23]. Data from the Italian MS database network revealed about 73% of MS cases to be of the RRMS course [29]. It seems that the prevalence of RRMS type of disease, in our study, may result from the fact that RRMS patients are generally in better physical condition, and therefore are much easier to get in touch with. In our study we reported that new 2005 McDonald criteria influenced on acceleration of diagnosis. The disease onset was determined as monofocal in 71.25% of our patients and EDSS>6 in 12.34%, while Kulakowska et al. reported monofocal onset in 80.8% of cases and EDSS>6 in 19.7% [11]. Our results indicate that the most frequent first symptoms were as follows: limb weakness, dizziness, visual and sensory disturbances, and pain. Boiko et al. reported sensory disturbances (45.4%), motor symptoms (20.1%), and optic neuritis (17.2%) as the most often onset syndrome [30]. In late-onset MS the main neurological presentations were motor symptoms (63.3%) [31]. Among the diagnostic methods of MS the examination of visual evoked potentials was performed in 71.87% of the patients in the Upper Silesia region. Furthermore, it occurred more often than in the Kulakowska et al. study from 2009 (54%) [11]. Probably, the difference is connected with the recommendations of the McDonald diagnostic criteria and with a small specificity of this electrophysiological test. The performance of the resonance imaging of the brain was similar: 99.53% in our study vs. 96.2% in the 2009 study [11]. Our results suggest that the most frequently used drugs in MS therapy were: immunomodulatory drugs—27.1% (23.84% females and 34.38% males), myorelaxants—20.78%, vitamins—28.6%, diet supplements—10.24%, antibiotics—5.62%. Similarly, according to Kulakowska et al., immunomodulatory agents were administered only in 24% of MS patients in Poland, mainly interferons β (in 81%) and glatiramer (in 13%), while the use of immunosuppresive agents was noted in 3% of the patients [11]. Taking into account that in the therapy with immunomodulatory drugs in Germany comprised more than 70% [32] of therapeutic choices, such a treatment choice in Poland can be considered as rare. This discrepancy results from an unequal access to immunomodulatory therapy in Poland as compared to other European countries. There is a lack of information about the use of myorelaxants, vitamins, diet supplements, or antibiotics in MS-affected patients in Poland. In MS patients, myorelaxants are used as a symptomatic drug against spasticity. The data from NARCOMS indicates that over 70%
of MS patients are treated with myorelaxants [8]. In our study, only about 20% of the patients were treated using this kind of drugs. The quality of life in MS patients from the Upper Silesia region of Poland was measured using the EQ-5D questionnaire. The quality of life in our MS patients was significantly lower, in all age groups, as compared to the healthy Polish population, which was proven in the study of Golicki et al. [19] (see Figure 1). Studies conducted so far have shown that the quality of life in patients with MS is lower than in healthy people. Using various instruments, some determinants of the lower quality of life in MS patients, including fatigue [33], depression [34], cognition, or disability status have been identified [35]. Moreover, our results show a clear trend towards decline in mean EQ-VAS scores as age increases. It may be resulted from the accumulation of disability over time due to longer time since diagnosis. Over the course of the MS progression the degree of disability of the patient rises, new symptoms of the disease appear, and consequently the quality of life deteriorates. It is difficult to ascertain what role in the quality of life the symptoms resulting from the disease have, and how much of a role the age of the patient plays. We believe that the strength of our work is providing information, for the first time, about a homogeneous group living in the territory of Poland with the highest level of industrial development and the highest exposure to pollution. This cohort may be of interest in future studies on the effect of environmental risk factors in MS (pollution and industrial development) and may be of interest for administrative purposes and for up-coming studies. Furthermore, we provide a comprehensive comparison of the findings with other studies exploring similar data, both from Poland, and globally. We are aware about some limitations of our study. The first is recruitment of our study group. Due to the fact that our study group was randomly assembled from several centres specialising in the treatment of MS, it does not contain data about all the MS patients from a given research centre. Patients diagnosed with MS remain under care not only of the major MS treatment centres, but other smaller neurology centres, private practice neurologists, as well as primary care doctors. From that reason in our study majority of enrolled patients were in better clinical condition—with lower EDSS score. We realize that the oldest and probably most impaired MS patients were not identified. The second limitation of our study is self-report form of data collection. Some obtained parameters were not confirmed by medical files data, but in many cases such verifications were conducted. The third limitation is that on the basis of results we are unable to assess the prevalence ratio for MS inthe Upper Silesia region. The essence of our study was the presentation of selected demographic International Journal of Neuroscience
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Demographic characteristics of MS patients in Poland
and clinical parameters in a randomly selected group of MS patients. The studied group constituted but a fraction of the whole MS-affected population in this region. Due to the fact that our study group was randomly assembled from several centres specialising in the treatment of MS, it does not contain data about all the MS patients from a given research centre. According to the data from 31 December 2012, the silesian voivodeship had a population of 4.615.870. If the 640 patients from our study group were to be set against the population of 4.615.870 for the Upper Silesia region, the prevalence rate would be about 0.000138 (13.8/100000), which, of course, in no way reflects the actual prevalence rate [36]. Due to there being no nationwide MS registry we are afflicted by a chronic lack of epidemiological data concerning all regions of Poland, and, seeing as this is the case, our study is, unfortunately, not to be considered as such. We are under the impression that the only rational solution capable of providing reliable epidemiological data and statistics would be the implementation of a nationwide MS registry. Currently, we are planning on beginning a study evaluating epidemiological MS data in the Upper Silesia region. The methodology of this study is being developed and requires cooperation from the National Healthcare System (NFZ) in order to authenticate the acquired data. Another limitation of our study is the fact that using in our study patients’ self-reported non-validated questionnaire created in our department allows compare only similar, but not identical other questionnaires data. However, in such studies it is not practically possible to formally account for underlying differences between the study and other similar populations or unmeasured factors which may contribute to these observed differences.
Conclusions The results presented in our study introduce an important description of the MS population in Upper Silesia region. This is the first study in Poland that combines so many aspects of MS. Furthermore, our data provides information about a homogeneous group residing in the territory of Poland with the highest level of industrial development and the highest exposure to pollution. Further studies concerning other important aspects of MS in our Silesian MS population are planned.
Acknowledgements The authors of the following publication extend their thanks and gratitude to the collaborating neurologists from neighboring Neurology Departments in Upper C
2014 Informa Healthcare USA, Inc.
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Silesia, caring after MS patients, for their help in preparing this study.
Declaration of Interest The authors report no conflicts of interest. The authors alone are responsible for the content and writing of the paper.
References 1. Compston A, Coles A. Multiple sclerosis. Lancet 2008;372(9648):1502–17. 2. Kobelt G, Berg J, Lindgren P et al. Costs and quality of life in multiple sclerosis in Europe: method of assessment and analysis. Eur J Health Econ 2006;7(2):5–13. 3. Handel AE, Giovannoni G, Ebers GC. Environmental factors and their timing in adult-onset multiple sclerosis. Nat Rev Neurol 2010;6(3):156–66. 4. Coo H, Aronson KJ. A systematic review of several potential non-genetic risk factors for multiple sclerosis. Neuroepidemiology 2004;23(1–2):1–12. 5. Zorzon M, Zivadinov R, Nasuelli D et al. Risk factors of multiple sclerosis: a case-control study. Neurol Sci 2003;24(4):242–7. 6. Bailey P. Incidence of multiple sclerosis in United States troops. Arch Neurol Psychiatry 1922;7:582–3. 7. Hurwitz BJ. Registry studies of long-term multiple sclerosis outcomes: description of key registries. Neurology. 2011;76(Suppl. 1):3–6. 8. Lo AC, Hadjimichael O, Vollmer TL. Treatment patterns of multiple sclerosis patients: a comparison of veterans and non-veterans using the NARCOMS registry. Mult Scler 2005;11(1):33–40. 9. Dua T, Rompani P. World Health Organization. Atlas [electronic resource]: Multiple sclerosis resources in the world 2008. World Health Orgn 2008 [date cited 4 April 2013];available at: http://www.who.int/mental health/neurology/Atlas MS WEB. pdf. 10. Flachenecker P, Stuke K. National MS registries. J Neurol 2008;255(Suppl 6):102–8. 11. Kulakowska A, Bartosik-Psujek H, Hozejowski R et al. Selected aspects of the epidemiology of multiple sclerosis in Poland - a multicentre pilot study. Neurol Neurochir Pol 2010;44(5):443–52. 12. Cendrowski W, Wender M, Dominik W et al. Epidemiological study of multiple sclerosis in Western Poland. Eur Neurol 1969;2(2):90–108. 13. Wender M, Pruchnik-Grabowska D, Hertmanowska H et al. Epidemiology of multiple sclerosis in Western Poland—A comparison between prevalence rates in 1965 and 1981. Acta Neurol Scand 1985;72(2):210–7. 14. Kowal P, Wender M, Pruchnik-Grabowska D et al. Contribution to the epidemiology of multiple sclerosis in Poland. Ital J Neurol Sci 1986;7:201–4. 15. Wender M, Kowal P, Pruchnik-Grabowska D et al. Stwardnie´ ludno´sci nie rozsiane- rozpowszechnienie i zapadalno´sc´ w´srod miejscowej w zachodniej Polsce. Neurologia i Neurochirurgia Polska 1987;XXI(XXXVII):33–9. 16. Potemkowski A. Epidemiology of multiple sclerosis in the region of Szczecin: prevalence and incidence 1993–1995. Neurol Neurochir Pol 1999;33(3):575–85.
Int J Neurosci Downloaded from informahealthcare.com by University of Toronto on 11/19/14 For personal use only.
8
K. Pierzchala et al. 17. Lobinska A, Stelmasiak Z. Epidemiological aspects of multiple sclerosis in Lublin (Poland). Neurol Neurochir Pol 2004;38(5):361–6. 18. Polman CH, Reingold SC, Edan G et al. Diagnostic criteria for multiple sclerosis: 2005 revisions to the “McDonald Criteria”. Ann Neurol 2005;58:840–6. 19. Golicki D, Niewada M, Jakubczyk M, et al. Self-assessed health status in Poland: EQ-5D findings from the Polish valuation study. Pol Arch Med Wewn 2010;120(7–8):276–81 20. Fisk JD, Brown MG, Sketris IS, et al. A comparison of health utility measures for the evaluation of multiple sclerosis treatments. J Neurol Neurosurg Psychiatry 2005;76(1):58–63. 21. Koch-Henriksen N, Stenager E, Bronnum-Hansen H. Studies based on the Danish multiple sclerosis registry. Scand J Public Health 2011;39(7 Suppl):180–4. 22. Ahlgren C, Oden A, Lycke J. High nationwide prevalence of multiple sclerosis in Sweden. Mult Scler 2011;17(8): 901–8. 23. Flachenecker P, Stuke K, Elias W et al. Multiple sclerosis registry in Germany: results of the extension phase 2005/2006. Dtsch Arztebl Int 2008;105(7):113–9. 24. Schwartz C, Frohner R. Contribution of demographic, medical, and social support variables in predicting the mental health dimension of quality of life among people with multiple sclerosis. Health & Social Work. 2005;30(3):203–12. 25. Jaracz K, Pawlak M, Gorna K et al. Quality of life and social support in patients with multiple sclerosis. Neurol Neurochir Pol 2010;44(4):358–65. 26. Koch-Henriksen N, Stenager E, Laursen B. The use of epidemiological multiple sclerosis registers in research: the Danish MS Registry. Acta Neurol Scand Suppl 2012;(195):7–12.
27. Kobelt G, Berg J, Lindgren P et al. Costs and quality of life of multiple sclerosis in Austria. Eur J Health Econ 2006;7(Suppl 2):S14–23. 28. Sloka JS, Phillips PW, Stefanelli M et al. Co-occurrence of autoimmune thyroid disease in a multiple sclerosis cohort. J Autoimmune Dis 2005;2:9. 29. Trojano M, Paolicelli D, Lepore V et al. Italian multiple sclerosis database network. Neurol Sci 2006;27(Suppl 5):358–61. 30. Boiko A, Vorobeychik G, Paty D et al. Early onset multiple sclerosis: a longitudinal study. Neurology 2002;59(7):1006–10. 31. Polliack ML, Barak Y, Achiron A. Late-onset multiple sclerosis. J Am Geriatr Soc 2001;49(2):168–71. 32. Henze T, Rieckmann P, Toyka KV. Symptomatic treatment of multiple sclerosis. Multiple sclerosis therapy consensus group (MSTCG) of the German Multiple Sclerosis Society. Eur Neurol 2006;56(2):78–105. 33. Pittion-Vouyovitch S, Debouverie M, Guillemin F et al. Fatigue in multiple sclerosis is related to disability, depression and quality of life. J Neurol Sci 2006;243(1–2):39–45. 34. Lobentanz IS, Asenbaum S, Vass K et al. Factors influencing quality of life in multiple sclerosis patients: disability, depressive mood, fatigue and sleep quality. Acta Neurol Scand 2004;110(1):6–13. 35. Fernandez O, Baumstarck-Barrau K, Simeoni MC et al. Patient characteristics and determinants of quality of life in an international population with multiple sclerosis: assessment using the MUSIQOL and SF-36 questionnaires. Mult Scler 2011;17(10):1238–49. 36. Stan i struktura ludno´sci oraz ruch naturalny w przekroju tery´ torialnym w 2012 r. Stan w dniu 31 XII. Warszawa: Glowny Urzad Statystyczny, 2013–06–05. ISSN 2083–3342.
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