Pattern electroretinogram (PERG) and pattern visual evoked potential (PVEP) in the early stages of Alzheimer’s disease

Alzheimer’s disease (AD) is one of the most common causes of dementia in the world. Patients with AD frequently complain of vision disturbances that do not manifest as changes in routine ophthalmological examination findings. The main causes of these disturbances are neuropathological changes in the visual cortex, although abnormalities in the retina and optic nerve cannot be excluded. Pattern electroretinogram (PERG) and pattern visual evoked potential (PVEP) tests are commonly used in ophthalmology to estimate bioelectrical function of the retina and optic nerve. The aim of this study was to determine whether retinal and optic nerve function, measured by PERG and PVEP tests, is changed in individuals in the early stages of AD with normal routine ophthalmological examination results. Standard PERG and PVEP tests were performed in 30 eyes of 30 patients with the early stages of AD. The results were compared to 30 eyes of 30 normal healthy controls. PERG and PVEP tests were recorded in accordance with the International Society for Clinical Electrophysiology of Vision (ISCEV) standards. Additionally, neural conduction was measured using retinocortical time (RCT)—the difference between P100-wave latency in PVEP and P50-wave implicit time in PERG. In PERG test, PVEP test, and RCT, statistically significant changes were detected. In PERG examination, increased implicit time of P50-wave (P < 0.03) and amplitudes reductions in P50- and N95-waves (P < 0.0001) were observed. In PVEP examination, increased latency of P100-wave (P < 0.0001) was found. A significant increase in RCT (P < 0.0001) was observed. The most prevalent features were amplitude reduction in N95-wave and increased latency of P100-wave which were seen in 56.7% (17/30) of the AD eyes. In patients with the early stages of AD and normal routine ophthalmological examination results, dysfunction of the retinal ganglion cells as well as of the optic nerve is present, as detected by PERG and PVEP tests. These dysfunctions, at least partially, explain the cause of visual disturbances observed in patients with the early stages of AD

Self-reported quality of life in multiple sclerosis patients: preliminary results based on the Polish MS Registry

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&plusmn;9.2 years). Average EuroQol 5-Dimensions index was 0.72&plusmn;0.24, and the mean EuroQoL Visual Analog Scale score was 64.2&plusmn;22.8. The average Multiple Sclerosis Impact Scale score was 84.6&plusmn;11.2 (62.2&plusmn;18.4 for physical condition and 23.8&plusmn;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&ndash;0.984; P=0.001), age &gt;40 years (OR, 1.042; 95% CI, 0.924&ndash;1.158; P=0.012), longer disease duration (OR, 0.482; 95% CI, 0.224&ndash;0.998; P=0.042), and lack of disease modifying therapies (OR, 0.024; 95% CI, 0.160&ndash;0.835; P=0.024). No significant associations were found between QoL, sex, type of MS course, patient&rsquo;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, Polan

The most important psychological and psychosocial needs of Polish multiple sclerosis patients and their significant others

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,&nbsp;Warsaw, 9Department of Neurology, Specialist Hospital in Międzylesie, Warsaw, 10Medical Faculty, University of Rzesz&oacute;w, Rzesz&oacute;w,&nbsp;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&rsquo;s/friend&rsquo;s condition. Correlation analysis revealed that in the patients group, there was a positive correlation between patient&rsquo;s age and the importance of factors such as the need for support and interest in their disease from the family doctor (P&lt;0.004), receiving educational materials from an MS clinic (P&lt;0.011), interest from the clinic in life issues of the patient (P&lt;0.001), and the need for access to self-rehabilitation (P&lt;0.003); while the need to continue working part-time was inversely correlated with age (P&lt;0.009). Conclusion: The needs of the MS patients and SO were similar. The data validate the importance of interdisciplinary care for the MS population. Keywords: multiple sclerosis, unmet needs, needs assessment, Polan

Safety and tolerability of inebilizumab (MEDI-551), an anti-CD19 monoclonal antibody, in patients with relapsing forms of multiple sclerosis: Results from a phase 1 randomised, placebo-controlled, escalating intravenous and subcutaneous dose study

Background: B cells may be involved in the pathophysiology of multiple sclerosis (MS). Inebilizumab (formerly MEDI-551) binds to and depletes CD19+ B cells. Objectives: To assess safety, tolerability, pharmacokinetics, pharmacodynamics and immunogenicity of inebilizumab in adults with relapsing MS. Methods: This phase 1 trial randomised 28 patients 3:1 (21, inebilizumab; 7, placebo) to inebilizumab (2 intravenous (IV) doses, days 1 and 15: 30, 100 or 600 mg; or single subcutaneous (SC) dose on day 1: 60 or 300 mg) or matching placebo, with follow-up until at least week 24 or return of CD19+ B-cell count to ⩾80 cells/µL. Results: Complete B-cell depletion was observed across all doses. Infusion/injection (grade 1/2) reactions occurred in 6/15 patients receiving inebilizumab IV, 2/5 placebo IV and 1/6 inebilizumab SC. Serious adverse events occurred in three patients receiving inebilizumab: pyrexia, mixed-drug intoxication (unrelated to inebilizumab; resulted in death) and urinary tract infection. Mean number of cumulative new gadolinium-enhancing lesions over 24 weeks was 0.1 with inebilizumab versus 1.3 with placebo; mean numbers of new/newly enlarging T2 lesions were 0.4 and 2.4, respectively. Conclusion: Inebilizumab had an acceptable safety profile in relapsing MS patients and showed a trend in reductions in new/newly enlarging and gadolinium-enhancing lesions. </jats:sec

Patient-reported quality of life in multiple sclerosis differs between cultures and countries: a cross-sectional Austrian–German–Polish study

Background: Patient-reported quality of life (QOL) is an outcome measure in clinical trials in multiple sclerosis (MS), but translated QOL instruments may affect the actual comparability of data. Objectives: We aimed to investigate possible differences in QOL in MS between cultures and countries. We employed the Functional Assessment of Multiple Sclerosis (FAMS) Version 4 questionnaire, which is a state-of-the-art QOL instrument. Methods: Some 484 MS patients from Austria (145), Germany (144), and Poland (195) aged 20–60 years, and stratified for sex and disease severity as measured by the Expanded Disability Status Scale (EDSS) score completed the respective FAMS translation and a socio-demographic questionnaire. Results: Analysis of variance and post-hoc Scheffé-test showed that 64% of the FAMS items were answered significantly differently ( p &lt; 0.001) between the three countries. A multivariate regression analysis including all the available disease-related and socio-demographic variables revealed the factors age, EDSS score, employment, social contacts, MS course, and country to be significant predictors of both the total FAMS score and the score for items answered differently between the three countries. Conclusions: Differences exist in the QOL of MS patients from Austria, Germany, and Poland which seem to lie beyond the impact of disease severity. They appear to be related to culture or other country-specific factors, as country was an independent predictor of differently answered items of the FAMS and thus also of the whole FAMS. QOL instruments should consider this aspect to faithfully reflect subjective information such as patient-reported benefit of treatment in multinational clinical trials. </jats:p

PTFE bypass to below-knee arteries : distal vein collar or not? A prospective randomised multicentre study

BackgroundPatency and limb salvage after synthetic bypass to the arteries below-knee are inferior to that which can be achieved with autologous vein. Use of a vein collar at the distal anastomosis has been suggested to improve patency and limb salvage, a problem that is analysed in this randomised clinical study.MethodsPatients with critical limb ischaemia undergoing polytetrafluoroethylene (PTFE) bypass to below-knee arteries were randomly either assigned a vein collar or not in two groups – bypass to the popliteal artery below-knee (femoro-popliteal below-knee (FemPopBK)) and more distal bypass (femoro-distal bypass (FemDist)). Follow-up was scheduled until amputation, death or at most 5 years, whichever event occurred first.ResultsIn the FemPopBK and in the FemDist groups, 115/202 and 72/150 were randomised to have a vein collar, respectively. Information was available for 345 of 352 randomised patients (98%).At 3 years, primary patency was 26% (95% confidence interval (CI) 18–38) with a vein collar and 43 (33–58) without a vein collar for femoro-popliteal bypass and 20 (11–38), and 17 (9–33) for femoro-distal bypass, respectively. The corresponding figures for limb salvage were 64 (54–75) and 61 (50–74) for femoro-popliteal bypass, and 59 (46–76) and 44 (32–61) for femoro-distal bypass with and without a vein collar, respectively. Log-rank-test for the whole Kaplan–Meier life table curve showed no statistically significant differences with or without vein collar primary patency: p = 0.0853, p = 0.228; secondary patency: p = 0.317, p = 0.280; limb salvage: p = 0.757, p = 0.187 for FemPopBK and FemDist, respectively. The use of a vein collar did not influence patency or limb salvage.ConclusionThis study failed to show any benefit for vein collar with PTFE bypass to a below-knee artery.</p