Search

Background: There is limited information on interpretation of cognitive changes over time in multiple sclerosis (MS). Objective: This study aimed to provide normative data for the assessment of statistically meaningful change in all tests of the Minimal Assessment of Cognitive Function in MS (MACFIMS). Methods: We applied the reliable change methodology to a healthy Italian cohort, assessed with two alternate versions of the MACFIMS 1 year apart. We calculated confidence intervals of retest score variance using the reliable change index (RCI). Moreover, multivariable linear regression models adjusted for age, sex, education, and baseline score were built to calculate the regression-based change index (RB-CI). Results: Overall, 200 healthy individuals were enrolled. Thresholds for interpreting change in each test were calculated. In the multivariable models, baseline score was associated with retest score in all tests (B from 0.439 to 0.760; p < 0.001). RB-CI can be calculated with data of the multivariable models. Conclusion: We provide normative data for reliable cognitive change evaluation for all the tests of the MACFIMS, which includes the Symbol Digit Modalities Test and Brief International Cognitive Assessment in MS, two widely used tools for screening and monitoring cognition in MS. Our findings can significantly improve the interpretation of cognitive changes in MS. [ABSTRACT FROM AUTHOR]

Purpose: The aim of this study was to test the Common Sense Model of Self-Regulation among persons with multiple sclerosis (MS), hypothesizing direct relations between illness beliefs and psychological adjustment, and indirect relations through coping strategies and social support. Materials and methods: Questionnaires were administered cross-sectionally to 680 participants (Mage =40.1; 64.4% women) recruited in eight MS units to assess illness beliefs, coping strategies, social support, and adjustment indicators including life satisfaction, psychological well-being, mental health, and depression. Multiple mediational analyses were conducted to identify direct and indirect paths connecting illness beliefs to psychological outcomes. Results: Controlling for disability level, significant direct and indirect relationships were observed: Beliefs on illness coherence, personal and treatment control were associated with better adjustment; emotion representations and cyclic timeline with worse adjustment; illness identity, consequences, psychological and chance/bad luck causes with mixed positive and negative outcomes. Notably, findings identified recurrent and unique pathways connecting illness beliefs to the different indicators through meaning- and problem-focused coping strategies, avoidance and social support. Conclusions: The Common Sense Model can represent a useful framework to be tested in rehabilitation programs, jointly addressing illness beliefs and coping resources for the promotion of psychological adjustment among persons with MS. Based on the Common Sense Model, the beliefs held by persons with MS about their illness are related to various aspects of psychological adjustment in multiple ways, both directly and indirectly through engagement in specific coping strategies and perception of social support. Clinicians supporting patients' adjustment may take into account that some illness beliefs were consistently associated with positive adjustment, some with poor adjustment, and some yielded mixed positive and negative results. Some ways in which coping strategies and social support connected illness beliefs to psychological adjustment were specific to the adjustment indicator under consideration including satisfaction with life, psychological well-being, mental health and depression. It may be worth testing comprehensive psychological interventions with the aim of raising awareness of one's illness beliefs, the strategies enacted in response to these beliefs, and the positive and negative relations of these processes with psychological adjustment, encompassing broad areas of individuals' lives and not only health-related issues or depression. [ABSTRACT FROM AUTHOR]

Background: Conversion to secondary progressive multiple sclerosis (SPMS) is associated with a relatively poor prognosis, and SPMS is responsible for the majority of the social and economic costs associated with MS. Managing the Transition to SPMS (ManTra) is a mixed methods project conducted in Italy and Germany aimed to set up a user-led resource to empower and improve the quality of life of newly diagnosed SPMS patients. Aims: To assess the experiences and the needs of Italian people who recently converted to SPMS, patient significant others (SOs), neurologists and other health professionals (HPs). Methods: We conducted 15 personal semistructured interviews (PSIs) with SPMS patients who transitioned up to five years, and three focus group meetings (FGMs), one of SPMS SOs, one of neurologists, and one of other HPs. Participants were purposely selected from the three geographic areas of Italy, and varied in terms of gender, education and (for patients) disease severity. PSIs and FGMs were audiorecorded, transcribed and analyzed by two researchers using the framework analysis. Results: One hundred sub-categories were identified, grouped into 13 categories and four themes: 'awareness of the transition', 'communication of the transition', 'dealing with symptoms worsening', and 'needs'. The major unmet needs were collected in four dimensions 'organization and management; 'empowerment training'; 'information'; and 'policies'. Conclusions: Two are the main findings: first, the widespread lack of awareness around the transition; second, the need to improve the quality of the care pathway in the Italian context. It was particularly stressed the need for a holistic and multidisciplinary approach (with patients and SOs as members of the team), the development of an ad hoc plan of follow up visits with easy access to MS specialists' consultation/treatment; specialized training for each stakeholders; more information on SPMS, daily management and changes at policy level. [ABSTRACT FROM AUTHOR]

Informal caregivers play a crucial role in supporting persons with multiple sclerosis (MS), a neurodegenerative disease resulting in progressive worsening of physical and cognitive functioning. While research extensively showed that caregiving workload can be perceived as burdensome, little attention was devoted to the relation connecting workload and caregivers' well‐being. Building on previous literature on stress and coping, the aim of this study was to test the mediational role of coping between caregivers' tasks and well‐being. A group of 680 caregivers of persons with MS (M age = 46.45; 51.2% women) was recruited in eight Italian MS centres between June 2015 and December 2016. Caregiving tasks related to basic activities of daily living (ADL), instrumental ADL, psycho‐emotional and social‐practical care were assessed through the Caregiving Tasks in MS Scale; coping strategies (avoidance, criticism and coercion, practical assistance, supportive engagement, positive reframing) were investigated through the Coping with MS Caregiving Inventory; well‐being was evaluated through the Psychological Well‐Being Scales. Analyses substantiated a multi‐mediation model including tasks in basic ADL, psycho‐emotional and social‐practical care, and the coping strategies avoidance, criticism/coercion, supportive engagement, positive reframing. Basic ADL care was negatively related to psychological well‐being through lower use of supportive engagement and positive reframing. By contrast, psycho‐emotional and social‐practical tasks were both negatively and positively related to psychological well‐being, through higher use of avoidance and criticism/coercion as well as supportive engagement and positive reframing. Findings suggest that caregiving tasks are not solely detrimental to well‐being, but they may also provide a positive contribution through the adaptive coping strategies supportive engagement and positive reframing. Findings also highlighted task‐specific areas that could be targeted in intervention in order to effectively lighten burden and promote well‐being among caregivers. [ABSTRACT FROM AUTHOR]

Background: We recently devised a shortened version of the 54-item Multiple Sclerosis Quality of Life (MSQOL-54) in paper (MSQOL-29, consisting of 25 items forming 7 subscales and 4 single items, and one filter question for 3 'sexual function' items) and electronic format (eMSQOL-29). Objectives: To prospectively assess eMSQOL-29 psychometric properties, acceptability/equivalence versus MSQOL-29. Methods: Multiple sclerosis (MS) patients (n = 623; Expanded Disability Status Scale (EDSS) range 0.0–9.0) completed eMSQOL-29, Hospital Anxiety and Depression Scale, Functional Assessment of MS (FAMS), European Quality of life Five Dimensions-3L, and received EDSS and Symbol Digit Modalities Test (SDMT). Equivalence versus MSQOL-29 was assessed in 242 patients (randomized cross-over design). Results: ' Sexual function' items were filtered out by 273 patients (47%). No multi-item scale had floor effect, while five had ceiling effect. Cronbach's alpha range was 0.88–0.90. Confirmatory factor analysis showed good overall fit and the two-factor solution for composite scores was confirmed. Criterion validity was sub-optimal for 'cognitive function' (vs SDMT, r = 0.25) and 'social function' (vs FAMS social function, r = 0.38). eMSQOL-29 equivalence was confirmed and its acceptability was good. Conclusion: eMSQOL-29 showed good internal consistency, factor structure and no floor effect, while most subscales had some ceiling effect. Criterion validity was sub-optimal for two subscales. Equivalence and acceptability were good. [ABSTRACT FROM AUTHOR]

Introduction 15 years after clinical onset, about 50% of patients with relapsing-remitting multiple sclerosis convert to secondary progressive multiple sclerosis (SPMS). Notwithstanding the importance of this transition, knowledge of the experiences and needs of patients and carers is fragmentary, and targeted interventions are not available. Managing the Transition to SPMS (ManTra) is a mixed methodology project to develop and test a user-led resource for newly diagnosed patients with SPMS. Here, we describe the developmental phase, consisting of a literature review and a new research study involving key stakeholders, in which we construct the resource. Methods and analysis Round 1: The literature review and study will be conducted in parallel. The latter will identify patient needs using a qualitative approach consisting of: personal semistructured interviews with >15 recently diagnosed patients with SPMS; three focus group meetings (one with significant others of patients, one with neurologists and one with other health professionals caring for patients with SPMS). An online survey (>200 recently diagnosed Italian patients with SPMS) will follow to verify needs in a larger independent sample. An expert panel will outline a set of candidate resources/interventions that aim to satisfy the needs thus identified. Round 2: Consensus on the final resource will be obtained in a 1-day meeting of recently diagnosed patients with SPMS, significant others, health professionals and other stakeholders, using the nominal group technique. The expert panel will refine the resource, identify the outcome measures to assess its efficacy and ascertain the most suitable comparator (ManTra Phase 2, not part of this protocol). Ethics and dissemination The study protocol was approved by the ethics committees of each of the involved centres: Foundation IRCCS Neurological Institute C Besta, Milan ; G D'Annunzio University of Chieti-Pescara and the Aldo Moro University of Bari. The results will be published in peer-reviewed journals, presented at conferences and a lay summary sent to participants. [ABSTRACT FROM AUTHOR]

Background: Alemtuzumab, approved for multiple sclerosis (MS), can cause secondary autoimmune adverse events including thyroid disorders, immune thrombocytopenia (ITP), and glomerular nephropathies. Non-ITP autoimmune cytopenias are rarely reported. Objective: To report a case of autoimmune hemolytic anemia (AIHA) and nephropathy in a MS patient treated with alemtuzumab. Case report: A 34-year-old man with MS developed albuminuria and AIHA after the first and only alemtuzumab treatment, with positive Coombs’ direct and indirect tests and IgG autoantibodies. Both AIHA and nephropathy resolved 1 month after treatment with steroids and intravenous immunoglobulins. Conclusion: Our report adds to literature on AIHA and nephropathy after alemtuzumab treatment and suggests to add Coombs’ tests to the screening panel required for alemtuzumab treatment. [ABSTRACT FROM AUTHOR]

Background: Anxiety and depression are common in people with multiple sclerosis (MS), but data on emotional communication during MS consultations are lacking. We assessed patient expressions of emotion and neurologist responses during first-ever MS consultations using the Verona Coding Definitions of Emotional Sequences (VR-CoDES). Methods: We applied VR-CoDES to recordings/transcripts of 88 outpatient consultations (10 neurologists, four MS Italian centers). Before consultation, patients completed the Hospital Anxiety and Depression Scale (HADS). Multilevel sequential analysis was performed on the number of cues/concerns expressed by patients, and the proportion of reduce space responses by neurologists. Results: Patients expressed 492 cues and 45 concerns (median 4 cues and 1 concern per consultation). The commonest cues were verbal hints of hidden worries (cue type b, 41%) and references to stressful life events (type d, 26%). Variables independently associated with number of cues/concerns were: anxiety (HADS-Anxiety score >8) (incidence risk ratio, IRR 1.08, 95% CI 1.06-1.09; p<0.001); patient age (IRR 0.98, 95% CI 0.98-0.99; p<0.001); neurologist age (IRR 0.94, 95% CI 0.92-0.96; p=0.03); and second opinion consultation (IRR 0.72, 95% CI 0.60-0.86; p=0.007). Neurologists reacted to patient emotions by reducing space (changing subject, taking no notice, giving medical advice) for 58% of cues and 76% of concerns. Anxiety was the only variable significantly associated with ‘reduce space’ responses (odds ratio 2.17, 95% CI 1.32-3.57; p=0.003). Conclusions: Patient emotional expressions varied widely, but VR-CoDES cues b and d were expressed most often. Patient anxiety was directly associated with emotional expressions; older age of patients and neurologists, and second opinion consultations were inversely associated with patient emotional expression. In over 50% of instances, neurologists responded to these expressions by reducing space, more so in anxious patients. These findings suggest that neurologists need to improve their skills in dealing with patient emotions. [ABSTRACT FROM AUTHOR]

Background: Few data on services for people with severe multiple sclerosis (MS) are available. The Palliative Network for Severely Affected Adults with MS in Italy (PeNSAMI) developed a home palliative care program for MS patients and carers, preceded by a literature review and qualitative study (here reported). Objective: To identify unmet needs of people with severe MS living at home by qualitative research involving key stakeholders, and theorize broad areas of intervention to meet those needs. Method: Data were collected from: at least 10 personal interviews with adults with severe MS (primary/secondary progressive, EDSS≥8.0); three focus group meetings (FGs) of carers of people with severe MS; and two FGs of health professionals (HPs). Grounded theory guided the analysis of interview and FG transcripts, from which the areas of intervention were theorized. Results: Between October 2012 and May 2013, 22 MS patients, 30 carers and 18 HPs participated. Forty-eight needs themes were identified, grouped into 14 categories and four domains. Seven, highly interdependent intervention areas were theorized. Patients had difficulties expressing needs; experiences of burden and loneliness were prominent, chiefly in dysfunctional, less affluent families, and among parent carers. Needs differed across Italy with requirements for information and access to services highest in the South. All participants voiced a strong need for qualified personnel and care coordination in day-to-day home care. Personal hygiene emerged as crucial, as did the need for a supportive network and preservation of patient/carer roles within family and community. Conclusions: Unmet needs transcended medical issues and embraced organizational and psychosocial themes, as well as health policies. The high interdependence of the seven intervention areas theorized is in line with the multifaceted approach of palliative care. At variance with typical palliative contexts, coping with disability rather than end-of-life was a major concern of patients and carers. [ABSTRACT FROM AUTHOR]

Multiple sclerosis (MS) is a chronic demyelinating disease of the central nervous system and mainly affects young adults. Its natural history has changed in recent years with the advent of disease-modifying drugs, which have been available since the early 1990s. The increasing number of first-line and second-line treatment options, together with the variable course of the disease and patient lifestyles and expectations, makes the therapeutic decision a real challenge. The aim of this review is to give a comprehensive overview of the main present and some future drugs for relapsing-remitting MS, including risk-benefit considerations, to enable readers to draw their own conclusions regarding the risk-benefit assessment of personalized treatment strategies, taking into account not only treatment-related but also disease-related risks. We performed a Medline literature search to identify studies on the treatment of MS with risk stratification and risk-benefit considerations. We focused our attention on studies of disease-modifying, immunomodulating, and immunosuppressive drugs, including monoclonal antibodies. Here we offer personal considerations, stemming from long-term experience in the treatment of MS and thorough discussions with other neurologists closely involved in the care of patients with the disease. MS specialists need to know not only the specific risks and benefits of single drugs, but also about drug interactions, either in simultaneous or serial combination therapy, and patient comorbidities, preferences, and fears. This has to be put into perspective, considering also the risks of untreated disease in patients with different clinical and radiological characteristics. There is no single best treatment strategy, but therapy has to be tailored to the patient. This is a time-consuming task, rich in complexity, and influenced by the attitude towards risk on the parts of both the patient and the clinical team. The broader the MS drug market becomes, the harder it will be for the clinician to help the patient decide which therapeutic strategy to opt for [ABSTRACT FROM AUTHOR]

Background: The Control Preference Scale (CPS) is the most frequently used measure of patients’ preferred roles in treatment decisions. We revised the original CPS and developed a new computerized patient self-administered version (eCPS). We used the eCPS to assess role preferences, and their determinants, in Italian and German people with multiple sclerosis (MS). Methods: New cartoons were produced, based on MS health professional and patient input/feedback and previous findings, and pilot tested on 26 Italian and German MS patients. eCPS acceptability and reliability (weighted kappa statistic, wK) in comparison to the original tool, was determined in 92 MS patients who received both CPS versions in random order. Results: The new cartoons were well accepted and easily interpreted by patients, who reported they based their choices mainly on the text and considered the images of secondary importance. eCPS reliability was moderate (wK 0.53, 95% confidence interval [CI] 0.40–0.65) and similar to the test-retest reliability of face-to-face administration assessed in a previous publication (wK 0.65, 95% CI 0.45–0.81). Higher education (odds ratio [OR] 3.74, 95% CI 1.00–14.05) and German nationality (OR 10.30, 95% CI 3.10–34.15) were associated with preference for an active role in the logistic model. Conclusions: The newly devised eCPS was well received and considered easy to use by MS patients. Reliability was in line with that of the original version. Role preference appears affected by cultural characteristics and (borderline statistical significance) education. [ABSTRACT FROM AUTHOR]

Objective: To assess decision-making in multiple sclerosis (MS) from third observer and patient perspectives. Method: Audio recordings of first-ever consultations with a participating physician (88 outpatients, 10 physicians) at four tertiary MS care clinics in Italy, were rated by a third observer using the Observing Patient Involvement in Shared Decision Making (OPTION) and by patients using the Perceived Involvement in Care Scale (PICS). Results: Mean patient age was 37.5, 66% were women, 72% had MS, and 28% had possible MS or other disease. Mean PICS subscale scores (range 0 poor, 100 best possible) were 71.9 (SD 24.3) for "physician facilitation" (PICS-F); 74.6 (SD 22.9) for "patient information exchange" (PICS-I); and only 22.5 (SD 16.2) for "patient decision making" (PICS-DM). Mean OPTION total score (0 poor, 100 best possible) was 29.6 (SD 10.3). Poorest OPTION scores were found for items assessing “preferred patient approach to receiving information” and “preferred patient level of involvement.” Highest scores were for “clinician drawing attention to identified problem”, “indicating need for decision making,” and “need to review the decision.” Consultation time, woman physician, patient-physician gender concordance and PICS-F were associated with higher OPTION total score; older physician and second opinion consultation were associated with lower OPTION score. Conclusions: In line with findings in other settings, our third observer findings indicated limited patient involvement abilities of MS physicians during first consultations. Patient perceptions of physician skills were better than third observers’, although they correlated. Consultations with women physicians, and younger physicians, were associated with higher third observer and patient-based scores. Our findings reveal a need to empower Italian MS physicians with better communication and shared decision-making skills, and show in particular that attention to MS patient preferences for reception of information and involvement in health decisions, need to be improved. [ABSTRACT FROM AUTHOR]

Purpose/Objective: Within the framework of the Salutogenic Model of Health, this study aimed to investigate sense of coherence among caregiving partners of persons with multiple sclerosis (PwMS), and its relationship with perceived social support and illness beliefs conceived as generalized resistance resources in tension management. Research Method/Design: In this cross-sectional study, 398 caregiving partners of PwMS (Mage = 44.62; 34.9% women and 65.1% men) filled in questionnaires measuring sense of coherence (Sense of Coherence Scale-13), perceived social support from family, friends and significant others (Multidimensional Scale of Perceived Social Support), and illness beliefs (Revised Illness Perception Questionnaire). Hierarchical linear regression analysis was performed to assess the contribution of perceived support and illness beliefs to sense of coherence, controlling for sociodemographic and clinical variables. Results: Perceived support from family and beliefs concerning illness-related emotional representations, illness coherence, and treatment control emerged as significant predictors of participants' sense of coherence. Higher perceived support from family and stronger beliefs in illness coherence and treatment control were associated with higher sense of coherence, while more negative emotional representations were related to lower sense of coherence values. Conclusions/Implications: Findings lend support to the relevance of a salutogenic approach to caregiving in multiple sclerosis. They further suggest the usefulness of interventions that can promote caregivers' sense of coherence and successful coping in life by benefitting from family support, favoring the construction of a coherent illness view, offering comprehensive information and expert guidance on treatment and rehabilitation opportunities, and promoting adaptive management of negative emotions. Impact and Implications: By adopting a salutogenic approach to health, this study provided novel insight into sense of coherence among caregiving partners of persons with multiple sclerosis. Perceived social support and illness beliefs emerged as generalized resistance resources for partners assisting their loved ones. Findings lend support to the need for an integrated view of caregivers' health, encompassing not only negative but also positive aspects of caregiving. The healthcare staff in rehabilitation settings should capitalize on available contextual and personal resources to strengthen caregivers' sense of coherence. Consolidation of support from family, promotion of positive beliefs about illness coherence and confidence in treatment control, as well as the encouragement of awareness and management of illness-related negative emotions, can represent viable strategies to support partners' positive adjustment to their caregiving role and well-being in life. [ABSTRACT FROM AUTHOR]

Abstract: Background: Studies on emotional distress and health-related quality of life (HRQOL) broadened the traditional bio-medical focus in MS research, but little attention was paid to general well-being indicators. Objective: To investigate for the first time both ill-being and well-being dimensions in persons with MS (PwMSs), caregivers and health professionals, in relation to both health and life in general. Methods: A multi-center study assessed participants' depression (Beck Depression Inventory-II), HRQOL (Short Form-36), psychological well-being (Psychological Well-Being Scales), optimal experience (Flow Questionnaire), life satisfaction (Satisfaction with Life Scale), hedonic balance (Positive Affect and Negative Affect Schedule). Demographic and clinical information was also gathered. Results: Overall, 71 PwMSs, 71 caregivers and 26 professionals were enrolled (N =168). Compared to healthy populations, PwMSs reported higher depression, lower HRQOL and lower general well-being; caregivers presented higher depression and lower general well-being; professionals reported the best ill- and well-being profiles. However, after controlling for demographic differences in age and education, hierarchical regressions highlighted that, though PwMSs reported higher depression and lower HRQOL than caregivers and professionals, their general well-being substantially leveled off. Conclusions: Well-being coexists with ill-being. It can counterbalance the negative effects of disease or caregiving, and its measurement could complement and support medical intervention. [Copyright &y& Elsevier]