Effect of nabiximols on Goal Attainment Scale scores in patients with treatment-resistant multiple sclerosis spasticity

Author(s):  
Friedemann Paul ◽  
Carlos Vila Silván

Background: Nabiximols oromucosal spray (Sativex®) is an approved add-on treatment option for moderate-to-severe treatment-resistant multiple sclerosis (MS) spasticity. Materials & methods: This prospective, observational, noninterventional, 3-month follow-up pilot study assessed the evolution of patient-selected goal attainment scale (GAS) item scores and of MS spasticity and associated symptoms during nabiximols treatment. Results: In the full analysis set (n = 21), the mean (SD) overall unweighted GAS score increased from 32.1 (3.4) at baseline to 43.6 (14.6) at month 3 (p = 0.0060), constituting a clinically meaningful change. Slight improvements were observed in MS spasticity and most associated symptoms. Nabiximols improved walking ability and was well tolerated. Conclusion: The study provides proof-of-concept that GAS methodology can be applied to MS management in daily practice.

2018 ◽  
Vol 12 (01) ◽  
pp. 144-148 ◽  
Author(s):  
Lucas Senra Correa Carvalho ◽  
Osvaldo José Moreira Nascimento ◽  
Luciane Lacerda Franco Rocha Rodrigues ◽  
Andre Palma Da Cunha Matta

ABSTRACTObjectives: The objectives of this study were to assess the prevalence of temporomandibular disorders (TMDs) in patients with relapsing-remitting multiple sclerosis (MS) and to investigate whether an association exists between the presence of TMD symptoms and the degree of MS-related disability. Materials and Methods: In all, 120 individuals were evaluated: 60 patients with a diagnosis of relapsing-remitting MS and 60 age- and sex-matched controls without neurological impairments. A questionnaire recommended by the European Academy of Craniomandibular Disorders for the assessment of TMD symptoms was administered. For those who answered affirmatively to at least one of the questions, the RDC/TMD Axis I instrument was used for a possible classification of TMD subtypes. The Expanded Disability Status Scale (EDSS) was the measure of the degree of MS-related disability. Statistical Analysis Used: Fisher’s exact test was used to analyze the data. ANOVA was used to detect significant differences between means and to assess whether the factors influenced any of the dependent variables by comparing means from the different groups. Results: The prevalence of TMD symptoms in patients with MS was 61.7% versus 18.3% in the control group (CG). A diagnosis of TMD was established for 36.7% in the MS group and 3.3% in the CG (P = 0.0001). There were statistically significant differences between degrees of MS-related disability and the prevalence of TMD (P = 0.0288). Conclusions: The prevalence of both TMD and TMD symptoms was significantly greater in the MS group. EDSS scores and TMD prevalence rates were inversely related.


2021 ◽  
Vol 13 ◽  
pp. 117957352110287
Author(s):  
Jiwon Oh ◽  
Sandra Vukusic ◽  
Klaus Tiel-Wilck ◽  
Jihad Said Inshasi ◽  
David Rog ◽  
...  

Background: Evidence suggests that efficacy and safety of disease-modifying treatments for multiple sclerosis may differ with age. We evaluate efficacy and safety of teriflunomide across age subgroups of patients from pooled clinical trials and real-world studies. Methods: Post hoc analyses of patients who received teriflunomide 14 mg in the pooled phase II and III TEMSO, TOWER, TENERE, and TOPIC core and extension studies (n = 1978), and the real-world Teri-PRO (n = 928) and TAURUS-MS I (n = 1126) studies were conducted. Data were stratified by age at study entry: ⩽25, >25 to ⩽35, >35 to ⩽45, and >45 years. In Teri-PRO and TAURUS-MS I, an additional group, >55 years, was assessed. Results: In the pooled core studies, teriflunomide reduced annualized relapse rate (ARR) versus placebo across all ages. Unadjusted ARRs remained low across age groups in pooled extensions (0.18-0.30), Teri-PRO (0.10-0.35), and TAURUS-MS I (0.14-0.35). Baseline Expanded Disability Status Scale scores were higher with age, but stable through core and extension studies (mean increases over 7 years: ⩽25 years, +0.59; >25 to ⩽35 years, +0.46; >35 to ⩽45 years, +0.35; >45 years, +0.81). Across age groups, adverse event (AE) incidences were 78.4% to 90.7% in pooled core and extension studies and Teri-PRO, and 29.2% to 37.7% in TAURUS-MS I; serious AE incidences were ⩽21.3% in all studies. In pooled phase III and Teri-PRO studies, lymphocyte count decreases over 1 year after initiating teriflunomide, and proportions of patients developing lymphopenia, were small across age groups. Conclusions: Teriflunomide efficacy was demonstrated regardless of age. Safety was generally consistent across age groups.


2002 ◽  
Vol 8 (6) ◽  
pp. 527-531 ◽  
Author(s):  
C-H Chang ◽  
D Cella ◽  
O Fernández ◽  
G Luque ◽  
P de Castro ◽  
...  

Objective: The cross-sectional study evaluated the psychometric properties of the Functional Assessment of Multiple Sclerosis (FAMS) Spanish version and its use in measuring quality of life (QOL) of multiple sclerosis (MS) patients in Spain. Methods: The FAMS is a factorially derived self-report scale designed to assess six primary aspects of QOL of patients with MS: Mobility, Symptoms, Emotional Well-Being, General Contentment, Thinking and Fatigue, and Family/Social Well-Being. Its Spanish translated version was used to assess QOL of 625 MS patients recruited in an outpatient clinic setting from 58 hospitals in Spain. Internal consistency of the Spanish FAMS was evaluated. Multiple regression analyses were performed to identify significant predictors from demographic, clinical and treatment characteristics, and Kurtzke Expanded Disability Status Scale (EDSS) scores in predicting FAMS scale scores. Results: Most of the patients are females (66%), and 74% were of the relapsing-remitting (RR) clinical subtype. Cronbach’s alpha coefficients were high (range=0.78-0.96), indicating subscale homogeneity comparable to that of the original English version. Linear multivariate regression analyses revealed that the EDSS is a dominant variable in predicting all the FAMS subscales, especially mobility (R2=0.51) and the total scores. Conclusions: The Spanish FAMS is a psychometrically valid instrument that allows clinicians and clinical researchers the ability to measure the QOL concerns of MS patients in Spain.


2021 ◽  
Vol 28 (3) ◽  
pp. 1-11
Author(s):  
Ehab Georgy

Background/aims Stroke early supported discharge services were introduced to provide a comprehensive stroke specialist therapy input, while reducing cost of acute care. Early supported discharge services resulted in better health-related outcomes. A consensus has not yet been established regarding specific early supported discharge patient characteristics and clinical profile. The main aim of this study was to establish evidence to support the development of an early supported discharge patient profile (demographics and clinical) and eligibility criteria to enable early supported discharge services achieve their purposes of reducing post-stroke disability and institutionalisation rates. This article outlines the relationship between early supported discharge patients' clinical profiles and clinical outcomes, in terms of disability, goal attainment and institutionalisation rates. Methods A retrospective review of data was implemented to determine whether specific early supported discharge patients' clinical profiles and characteristics correlate with clinical outcomes. Data were collected for patients admitted to the Suffolk Stroke Early Supported Discharge Service between August and October 2016, comprising patients' demographics and clinical profiles, including stroke type, Barthel Index and Modified Rankin Scale. Performance data were collected at the end of the early supported discharge service including therapy frequency and intensity, as well as clinical outcomes including the Goal Attainment Scale. Results Data were collected for 53 patients. Data were analysed for all patients in three groups: goals not achieved; goals achieved; and goals achieved to a higher level), according to the Goal Attainment Scale. A Chi-square test showed no significant difference with regard to sex and stroke side (P=0.27). Analysis of variance revealed no significant difference in age. Conversely, results showed a significant association between goal attainment and the stroke subtype, severity and length of hospital stay. Conclusions Specific clinical characteristics and disease profiles correlate with functional outcomes and could influence goal attainment and functional status. A specific patient cohort seems to benefit the most from early supported discharge services in terms of optimised functional outcomes and recovery.


2021 ◽  
Vol 75 (5) ◽  
Author(s):  
Lauren Sponseller ◽  
Fern Silverman ◽  
Pamela Roberts

Importance: Occupational therapy practitioners can play a pivotal role in supporting breastfeeding mothers as they transition to and form new routines for this occupation. Objective: To explore whether occupational therapy programming can assist breastfeeding mothers in reaching their personal occupation-based wellness goals. Design: Mixed-methods design that involved development of an occupational profile and a goal attainment scale (GAS). After the intervention, participants rescored their GAS goals and completed a semistructured exit interview. Setting: Nonprofit lactation center located in the suburbs of a large mid-Atlantic U.S. city. Participants: Women recruited through convenience sampling who had been breastfeeding an infant for <6 mo, who were not currently weaning, and who had met with a lactation consultant at least once since giving birth were eligible (N = 17). Intervention: Group occupational therapy that consisted of 10 weekly 1-hr sessions. Topics were based on occupational profiles, GAS scores, and lactation consultant input. Outcomes and Measures: Each participant created and scored three goals using the GAS before and after the intervention. Results: Data from 14 of the 17 participants were analyzed. The average postintervention GAS score was 56.50 (M = 50), indicating that most personal wellness goals were reached. Thematic analysis revealed that occupational therapy programming helped mothers persevere with breastfeeding, feel more confident as new parents, and value both themselves and their baby. Conclusions and Relevance: There is an increasing role for occupational therapy practitioners in helping new mothers reach their personal wellness goals in ways that support their ability to continue breastfeeding. What This Article Adds: Maternal wellness and breastfeeding represent an emerging area of practice in which occupational therapy practitioners can provide new mothers with physical, social, and psychological supports that help them maintain self-efficacy related to breastfeeding and other meaningful occupations. This study provides foundational evidence in support of this collaboration.


2017 ◽  
Vol 19 (1) ◽  
pp. 11-14 ◽  
Author(s):  
Gary Birnbaum

Background: Current disease-modifying therapies (DMTs) are of benefit only in people with relapsing forms of multiple sclerosis (RMS). Thus, safely stopping DMTs in people with secondary progressive MS may be possible. Methods: Two groups of patients with MS were studied. Group A consisted of 77 patients with secondary progressive MS and no evidence of acute central nervous system inflammation for 2 to 20 years. These patients were advised to stop DMTs. Group B consisted of 17 individuals with RMS who stopped DMTs on their own. Both groups were evaluated at treatment cessation and for a minimum of 1 year thereafter. Multiple variables were assessed to determine those that predicted recurrent acute disease. Results: Nine patients in group A (11.7%) and ten patients in group B (58.8%) had recurrent acute disease, almost always within 1 to 2 years of stopping treatment. The only variable of significance in group A distinguishing stable and relapsing patients was age (P = .0003), with relapsing patients being younger. Group B patients were younger and had significantly lower Expanded Disability Status Scale scores than group A, with no significant differences in age between relapsed and stable patients. Conclusions: The DMTs can be stopped safely in older patients with MS (≥7 decades) with no evidence of acute disease for 2 years or longer, with an almost 90% probability of remaining free of acute recurrence. The high proportion of untreated patients with RMS experiencing recurrent acute disease is consistent with published data.


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