Randomized Controlled Trial of Occupational Performance Coaching for Adults With Multiple Sclerosis.

OBJECTIVE: To determine if the receipt of occupational performance coaching (OPC) by adults living with multiple sclerosis (MS) improves participants' satisfaction with performance in daily activities (primary outcome); improves perceived performance in daily activities, resilience, autonomy, and participation; and reduces illness intrusiveness and effect of MS (secondary outcomes). DESIGN: Two-group randomized clinical trial with a waitlist control. SETTING: Community. PARTICIPANTS: Convenience sample of adults with MS were recruited through a research registry. Eighty-three individuals were approached; 35 were assessed for eligibility and 31 were enrolled and 30 completed baseline assessment (Final sample size, N=30). Participants were English-speaking, were without serious cognitive impairment or severe depression, and were not receiving other coaching interventions. INTERVENTIONS: Six telephone sessions of OPC were delivered by a trained facilitator over 10 weeks. Initial sessions focused on goal setting, prioritization, and action planning. Subsequent sessions involved goal and action plan review, discussion of facilitators and barriers, and goal and plan refinement. MAIN OUTCOME MEASURES: Primary outcome was participants' satisfaction with performance in daily activities, as measured by the Canadian Occupational Performance Measure (COPM). Secondary outcome measures included the COPM performance rating, Connor-Davidson Resilience Scale, Impact on Participation and Autonomy Questionnaire, Adapted Illness Intrusiveness Rating Scale, and MS Impact Scale. Measures were administered by a blinded assessor at baseline, 10 weeks, and 2 months. RESULTS: Participants in the intervention and waitlist control groups were equivalent on demographic and outcome measures at baseline. At 10 weeks, the intervention group had significantly higher COPM ratings for both satisfaction (P<.001) and performance (P=.002). No other outcomes were significantly different. For the intervention group, the benefits of OPC were maintained at 2 months. CONCLUSIONS: OPC led to improved satisfaction with performance and performance in daily activities. Future research with a larger sample is needed to determine other effects and who benefits most from OPC.

How Community-Based Health and Social Care Professionals Support Unpaid Caregivers: Experiences From One Health Authority in Ontario, Canada.

In Ontario, Canada, rising rates of caregiver distress have been the 'canary in the coal mine' for a health system out of balance with the needs of an ageing population. Community-based health and social care professionals are well placed to play an important role in the caregiver support process; however, a gap has remained in the understanding of if and how caregiver support strategies are operationalized or experienced by community service providers (CSPs). The goal of this study was to describe how CSPs interpreted policy and how those interpretations may enable their work in supporting unpaid caregivers. Using a qualitative constructionist design, we interviewed 24 participants and reviewed 92 publicly available documents. Braun and Clarke's method of thematic analysis was used for analysis strategy. Four overarching themes were identified: (1) community care as a priority, (2) sidewalk accountability, (3) creative care planning through partnerships, and (4) challenges to care delivery. We found that the importance of caregivers to the health system was reflected in organizational policy and strategy. There is an opportunity to improve health outcome for caregivers and the population alike through strong leadership and a clear shared vision. Our findings also suggested that social capital was a significant factor in enabling providers in their work, leveraging long-standing relationships, and accumulated local knowledge to implement highly creative care plans.

Intermediate outcomes for clinical trials of multiple sclerosis rehabilitation interventions: Conceptual and practical considerations.

BACKGROUND: Rehabilitation is an essential health care service and a critical component of comprehensive multiple sclerosis (MS) care. OBJECTIVE: As part of a 2-day meeting hosted by the International Advisory Committee on Clinical Trials in MS in December 2022, a panel initiated a discussion on the conceptual and practical issues related to selecting intermediate outcomes for clinical trials of MS rehabilitation interventions. RESULTS: The overarching goal of rehabilitation - optimal functioning - was acknowledged as a complex biopsychosocial phenomenon that varies with patient priorities and environmental context. This complexity means that multiple causal pathways and potential intermediate outcomes must be carefully considered during the design of clinical trials in MS rehabilitation that aim to improve functioning. In addition, practical issues must be considered such as psychometric properties of outcome measures, measure type, and characteristics of the target population, including severity of dysfunction. CONCLUSION: This article uses the International Classification of Functioning, Disability and Health as a foundation for determining relevant intermediate outcomes for clinical trials of MS rehabilitation interventions.

Participant diversity in clinical trials of rehabilitation interventions for people with multiple sclerosis: A scoping review.

BACKGROUND: The selection and description of participants in clinical trials enables health care providers to determine generalizability of findings to the populations they serve. Limited diversity of participants in trials restricts evidence-based decision-making. OBJECTIVES: To determine the extent to which diverse participants are being included in clinical trials of rehabilitation interventions for people with multiple sclerosis (MS). METHODS: We conducted a scoping review of MS rehabilitation trials published since January 2002 using MEDLINE, CINAHL, and Web of Science. Covidence was used to facilitate the review. Article selection required randomized control design, a rehabilitation intervention, and a functional status outcome. Data extracted included details of intervention(s), outcomes, and participant selection and description using a social determinants of health framework. RESULT: A total of 243 studies were included. Exercise interventions and impairment-focused outcomes were most common. Most studies used only a MS Clinic for recruitment. Common exclusion criteria were physical or mental comorbidities, disability, age, and cognitive impairment. Participant age and sex were reported for almost all trials; reporting of other social determinants of health was atypical. CONCLUSION: MS rehabilitation trials have used limited recruitment methods, restricted samples, and reported few participant descriptors. Changes are required to enhance participant diversity and the descriptions of participant characteristics.

Enhancing diversity of clinical trial populations in multiple sclerosis.

BACKGROUND: Demographic characteristics, social determinants of health (SDoH), health inequities, and health disparities substantially influence the general and disease-specific health outcomes of people with multiple sclerosis (MS). Participants in clinical trials do not represent all people with MS treated in practice. OBJECTIVE: To provide recommendations for enhancing diversity and inclusion in clinical trials in MS. METHODS: We held an international workshop under the Auspices of the International Advisory Committee on Clinical Trials in MS (the "Committee") to develop recommendations regarding diversity and inclusivity of participants of clinical trials in MS. Workshop attendees included members of the Committee as well as external participants. External participants were selected based on expertise in trials, SDoH, health equity and regulatory science, and diversity with respect to gender, race, ethnicity, and geography. RESULTS: Recommendations include use of diversity plans, community engagement and education, cultural competency training, biologically justified rather than templated eligibility criteria, adaptive designs that allow broadening of eligibility criteria over the course of a trial, and logistical and practical adjustments to reduce study participant burden. Investigators should report demographic and SDoH characteristics of participants. CONCLUSION: These recommendations provide sponsors and investigators with methods of improving diversity and inclusivity of clinical trial populations in MS.

Do the current MS clinical course descriptors need to change and if so how? A survey of the MS community.

BACKGROUND AND OBJECTIVES: The current clinical course descriptors of multiple sclerosis (MS) include a combination of clinical and magnetic resonance imaging (MRI) features. Recently there has been a growing call to base these descriptors more firmly on biological mechanisms. We investigated the implications of proposing a new mechanism-driven framework for describing MS. METHODS: In a web-based survey, multiple stakeholders rated the need to change current MS clinical course descriptors, the definitions of disease course and their value in clinical practice and related topics. RESULTS: We received 502 responses across 49 countries. In all, 77% of the survey respondents supported changing the current MS clinical course descriptors. They preferred a framework that informs treatment decisions, aids the design and conduct of clinical trials, allows patients to understand their disease, and links disease mechanisms and clinical expression of disease. Clinical validation before dissemination and ease of communication to patients were rated as the most important aspects to consider when developing any new framework for describing MS. CONCLUSION: A majority of MS stakeholders agreed that the current MS clinical course descriptors need to change. Any change process will need to engage a wide range of affected stakeholders and be guided by foundational principles.

Virtually-Delivered Emotion Focused Mindfulness Therapy (EFMT) Group vs. Wait-List Control for Late-Life Anxiety: A Randomized Controlled Trial.

BACKGROUND: The worldwide annual prevalence of anxiety in older adults is estimated to be between 6% and 10%. Emotion Focused Mindfulness Therapy (EFMT) is a mindfulness-based group intervention that has been demonstrated to reduce symptoms of anxiety in community dwelling adults. No study has yet assessed EFMT for older adults with late-life anxiety. The aim of this study was to determine the feasibility of video-delivered group EFMT for older adults living in community settings, a novel and potentially scalable intervention. METHODS: This was a feasibility randomized controlled trial (RCT) of 48 older adults (≥55 years old), recruited through primary care, community organizations and snowball methods. Participants were randomized to group EFMT delivered by Zoom vs. a wait-list control. Data were collected at baseline (T1), 9 weeks following baseline (T2, primary study endpoint) and 17 weeks following baseline (T3). Random allocation was conducted immediately after each group of 12 participants had been enrolled into the trial, with groups beginning on a rolling basis each time a block of 12 participants had been enrolled. The main efficacy outcome examined changes over time to anxiety. RESULTS: Recruitment was successfully completed in 32 weeks. Enrollment was calculated at 62.3% (48 of 77 people screened). Retention (80.0%) and adherence (100.0% for intervention group participants) were excellent. The EFMT group had significant improvements in anxiety at T2 compared to the wait-list control group (-3.47 [4.12] vs.-1.22 [3.25] points, p = 0.05). CONCLUSIONS: Virtually-delivered EFMT appears to be a feasible, acceptable, and efficacious group treatment to improve late-life anxiety.

Exploring COVID-19 experiences for persons with multiple sclerosis and carers: An Australian qualitative study.

OBJECTIVE: The COVID-19 pandemic continues to impact communities around the world. In this study, we explored the COVID-19 experiences of persons with multiple sclerosis (MS) and carers. METHODS: Using a qualitative approach, interviews were undertaken with 27 participants residing in Australia (10 persons with MS, 10 carers and 7 MS service providers). Demographic and background data were also collected. Interviews were analysed using an inductive iterative thematic analysis. RESULTS: Across all groups, participants consistently recognized pandemic challenges and impacts for persons with MS and carers, especially due to disruption to routines and services. Emotional and mental health impacts were also highlighted, as anxiety, fear of contracting COVID-19 and stress, including relationship stress between persons with MS and carers and family members. Some persons with MS also mentioned physical health impacts, while for carers, the challenge of disruptions included increased demands and reduced resources. In addition to acknowledging challenges, persons with MS and carers also gave examples of resilience. This included coping and adapting by finding new routines and creating space through rest and breaks and through appreciating positives including the benefits of access to telehealth. CONCLUSION: Additional support is required for persons with MS and carers in navigating the impacts of COVID-19 as the pandemic progresses. In addition to addressing challenges and disruptions, such support should also acknowledge and support the resilience of people with MS and carers and enhance resilience through supporting strategies for coping and adaptation. PATIENT AND PUBLIC CONTRIBUTION: Service user stakeholders were consulted at the beginning and end of the study. They provided feedback on interview questions and participant engagement, as well as service user perspectives on the themes identified in the current study. Participants were provided with summaries of key themes identified and invited to provide comments.

The effectiveness of mindfulness-based meditation treatments for late life anxiety: a systematic review of randomized controlled trials.

OBJECTIVE: Older adults are interested in mindfulness-based interventions with a meditation component for late life anxiety. This review examined the effectiveness of existing mindfulness-based interventions with a meditation component. METHODS: This systematic review was registered with the Joanna Briggs Institute on 2021-05-17, was guided by Joanna Briggs Institute methodology and followed the PRISMA framework. Peer-reviewed randomized control trials were reviewed. A systematic literature search was conducted, using the following databases: MEDLINE (Ovid), Embase, Cochrane Database of Systematic Reviews, PsycINFO, CINAHL (EBSCO), and AMED. RESULTS: Of 2709 studies screened, seven eligible randomized controlled trials were included representing 355 participants. Sample sizes ranged from 36 to 141. Mindfulness-based meditation interventions used varied. Regardless of the mindfulness-based meditation intervention used, a reduction in symptoms of anxiety in participants was reported post-intervention. Results are reported through narrative summary and tables. CONCLUSIONS: Based on the emerging literature of randomized controlled trials, mindfulness-based interventions with a meditation component appear to be promising in reducing symptoms of anxiety in older adults. These findings demonstrate a need for further randomized controlled trials to guide clinical practice.

Evaluating occupational performance coaching to support fatigue management for people with multiple sclerosis: A feasibility study.

OBJECTIVE: To determine the feasibility of adding coaching sessions to a website (MS INFoRM) that supports self-directed fatigue management for people with multiple sclerosis (PwMS). DESIGN: Double-blind, parallel-group feasibility study. PARTICIPANTS AND SETTING: Twenty-six PwMS, who experienced severe fatigue (fatigue severity scale > 5.4), were recruited from participants who were ineligible for the main trial testing on the MS INFoRM website. INTERVENTION: Six 45-to-60-min sessions of one-on-one coaching plus access to the MS INFoRm website compared to two check-in phone calls plus access to the MS INFoRm website. Both study arms took place over 3 months. MAIN MEASURES: Feasibility parameters included proportion eligible of those screened; proportion consented; missing data; retention and adherence rates. Acceptability was explored through qualitative interviews. Secondary outcomes (self-efficacy and fatigue impact) were measured at baseline and post-intervention. RESULTS: 76 people were invited to participate in this add-on study. 40 were interested and screened: 32 were eligible, 26 consented, and were randomized (mean age: 48.5 yrs (SD: 8.7), mean disease duration: 11.5 yrs). Retention was 85% (22 out of 26). Coaching adherence was high (86% attended ⩾ 5 sessions). At 3 months, people in the intervention group showed more improvements in self-efficacy and fatigue impact compared to the comparison group, however, the difference was not statistically significant (p = 0.471 and p = 0.147, respectively). The intervention was well-received by the participants and there were no adverse events. CONCLUSION: Combining one-on-one coaching sessions along with web-based interventions is feasible and appreciated by the participants, and worth exploring further in a larger trial.

Youth with multiple sclerosis have low levels of fitness.

BACKGROUND: Moderate and vigorous physical activity is associated with improved outcomes in youth with multiple sclerosis (MS). Physical fitness may also influence disease and health outcomes in this population. OBJECTIVES: To determine if there were differences in physical fitness between youth with MS and healthy controls (HC).To examine relationships between physical fitness, physical activity (PA) level, fatigue, depression and disease activity in youth with MS and HC. METHODS: Youth with MS (n = 19) and HC (n = 21) completed tests establishing cardiorespiratory-fitness (VO2peak), endurance via 2-minute walk test, and musculoskeletal strength via grip strength (GS). Questionnaires determined fatigue, depression, and PA levels. Weekly PA level was determined by accelerometry. Tests of differences and correlational analyses were used to evaluate physical fitness. RESULTS: Youth with MS had lower VO2peak (U = 279, p < 0.0001), endurance (t = 2.6, p = 0.02), and higher body mass index (BMI) (t = -5.9, p = 0.001) than HC. Higher VO2peak was associated with higher moderate to vigorous PAaccelerometer in HC (Spearman-Rho = 0.5, p = 0.03), but not in youth with MS (Spearman-Rho = 0.5, p = 0.06). Lower VO2peak and GS were associated with higher disability (Spearman-Rho = -0.6, p = 0.03) and relapses in MS (Spearman-Rho = -0.52, p = 0.04). CONCLUSIONS: Youth with MS have lower levels of fitness, compared with HC. Higher levels of fitness were associated with lower disease activity and disability in youth with MS.

Prioritizing progressive MS rehabilitation research: A call from the International Progressive MS Alliance.

BACKGROUND: People with multiple sclerosis (MS) experience myriad symptoms that negatively affect their quality of life. Despite significant progress in rehabilitation strategies for people living with relapsing-remitting MS (RRMS), the development of similar strategies for people with progressive MS has received little attention. OBJECTIVE: To highlight key symptoms of importance to people with progressive MS and stimulate the design and implementation of high-quality studies focused on symptom management and rehabilitation. METHODS: A group of international research experts, representatives from industry, and people affected by progressive MS was convened by the International Progressive MS Alliance to devise research priorities for addressing symptoms in progressive MS. RESULTS: Based on information from the MS community, we outline a rationale for highlighting four symptoms of particular interest: fatigue, mobility and upper extremity impairment, pain, and cognitive impairment. Factors such as depression, resilience, comorbidities, and psychosocial support are described, as they affect treatment efficacy. CONCLUSIONS: This coordinated call to action-to the research community to prioritize investigation of effective symptom management strategies, and to funders to support them-is an important step in addressing gaps in rehabilitation research for people affected by progressive MS.

Intervention Mediators in a Randomized Controlled Trial to Increase Physical Activity and Fatigue Self-management Behaviors Among Adults With Multiple Sclerosis.

BACKGROUND: People with multiple sclerosis (MS) often experience fatigue, which is aggravated by inactivity. Identifying mediators of changes in physical activity (PA) and fatigue self-management (FSM) behaviors could optimize future interventions that reduce the impact of MS fatigue. PURPOSE TO: examine the effects of telephone-delivered interventions on Social Cognitive Theory constructs and test whether these constructs mediated secondary outcomes of PA and FSM behaviors. METHODS: Participants with MS (n = 208; Mean age = 52.1; Female = 84.6%) were randomized into contact-control intervention (CC), PA-only intervention, and PA+FSM intervention. Step count (Actigraphy) and FSM behaviors as well as self-efficacy, outcome expectations, and goal setting for PA and FSM were measured at baseline, post-test (12 weeks), and follow-up (24 weeks). Path analyses using bias-corrected bootstrapped 95% confidence intervals (CI) determined whether constructs at post-test mediated behaviors at follow-up when adjusting for baseline measures. RESULTS: Path analysis indicated that PA-only (ß = 0.50, p < .001) and PA+FSM interventions (ß = 0.42, p < .010) had an effect on goal setting for PA, and that PA + FSM intervention had an effect on self-efficacy for FSM (ß = 0.48, p = .011) and outcome expectations for FSM (ß = 0.42, p = .029). Goal setting for PA at post-test mediated the effects of PA-only (ß = 159.45, CI = 5.399, 371.996) and PA + FSM interventions (ß = 133.17, CI = 3.104, 355.349) on step count at follow-up. Outcome expectations for FSM at post-test mediated the effects of PA + FSM intervention on FSM behaviors at follow-up (ß = 0.02, CI = 0.001, 0.058). CONCLUSIONS: Goal setting for PA and outcome expectations for FSM may be important constructs to target in telephone-delivered interventions designed to reduce the impact of MS fatigue. TRIAL REGISTRATION: Clinicaltrials.gov (NCT01572714).

Is it worth it?: The experiences of persons with multiple sclerosis as they access health care to manage their condition.

BACKGROUND: People with multiple sclerosis (MS) require complex care throughout life. Canadians with MS are high users of health-care services, yet still report unmet health-care needs and low satisfaction with services received. OBJECTIVE: This study aimed to investigate the health-care access experiences of Ontarians with MS as they manage their condition. DESIGN AND PARTICIPANTS: Interpretive description guided data collection and analysis. Forty-eight people living across seven communities participated. Thirty-eight participated in one of five focus groups; the remaining 10 participated in an individual semi-structured interview. RESULTS: Participants described the experience of accessing care as a decisional process, guided by a form of cost-benefit analysis. The process determined whether seeking conventional health-care services 'is worth it'. Most participants felt that the energy and resources required to access the health-care system outweighed their expected outcomes, based on past experiences. Participants who did not see the benefit of care seeking turned to self-treatment, use of complementary and alternative services, and engaged in patterns of health-care avoidance until a crisis arose. DISCUSSION AND CONCLUSION: Findings suggest that a renewed effort to promote patient-centred care and a biopsychosocial approach may improve the health-care access experiences of persons with MS and reduce service avoidance.

Benefits of Physical Activity for Depression and Fatigue in Multiple Sclerosis: A Longitudinal Analysis.

OBJECTIVES: To examine the longitudinal relationship between physical activity and fatigue and depression among youth with demyelinating conditions. STUDY DESIGN: From September 2013 to March 2017, we performed a longitudinal study of consecutive youth diagnosed at their first visit with pediatric onset multiple sclerosis (POMS) or monophasic acquired demyelinating syndromes (mono-ADS) at a neuroinflammatory disorders clinic in a tertiary children's hospital. Fatigue was determined at each visit by the Pediatric Quality of Life Multidimensional Fatigue Scale, depressive symptoms by the Center of Epidemiologic Studies Depression Children Rating Scale, and physical activity level by the Godin Leisure Time Exercise Questionnaire. Mixed linear models were used to examine the associations of moderate-to-vigorous physical activity (MVPA) with fatigue and depression over time, adjusting for age, time from incident demyelination, sex, number of relapses, relapse within 30 days, and disability. RESULTS: In 182 patients (48 POMS, age 15 ± 1.7 years, 35 female; and 134 mono-ADS, age 12 ± 3.6 years 67 female) with 538 visits (mean follow-up 3.6 ± 2.7 years and 4.2 ± 3.3 years, respectively), a trajectory of increased fatigue over time was observed in POMS (2.28 points/year, P = .008) and mono-ADS (1.33 points/year, P = .007) patients. Youth with POMS had more depressive symptoms (estimate = 11.4 points, P < .002) than mono-ADS. Depressive symptoms increased over time in female patients with POMS (estimate = 1.4 points/year, P < .02). MVPA was associated with lower depression (-0.09, P < .001) and general fatigue (0.13, P = .02) over time in POMS. CONCLUSIONS: Youth with POMS who have higher levels of MVPA demonstrate lesser depressive symptoms and lower fatigue over time. Our results may inform future interventions to manage mood and fatigue in POMS.

Beyond supervised therapy: Promoting behavioral changes in people with MS.

A critical aspect of many rehabilitation interventions for people with multiple sclerosis (MS) is incorporating strategies that support behavior change. The main purpose of this topical review was to summarize recent randomized clinical trials (RCTs) of rehabilitation interventions in which participants learn and apply skills or engage in healthy behaviors. The Capability, Opportunity, Motivation, and Behavior (COM-B) framework was used to broadly classify behavior-change strategies. The included RCTs varied widely in terms of dosing, delivery format, and types of interventionist. Commonly used behavior-change strategies include education, persuasion, and training. We recommend that researchers and clinicians use frameworks like Behavior Change Wheel and Behavior Change Technique Taxonomy to describe and classify intervention strategies used to promote behavior change. We also recommend more sophisticated RCTs be conducted (e.g. sequential multiple assignment randomized trial and three-arm RCTs) to better understand ways of promoting behavior change in rehabilitation interventions.

A multi-site, randomized controlled trial of MS INFoRm, a fatigue self-management website for persons with multiple sclerosis: rationale and study protocol.

BACKGROUND: Fatigue is one of the most common and debilitating symptoms of multiple sclerosis (MS). The majority of approaches for managing MS fatigue typically require participation in a structured, time-limited program with a fixed sequence of topics and activities. MS INFoRm (Multiple Sclerosis: An Interactive Fatigue Management Resource) is a self-directed MS fatigue management resource incorporating principles of self-management and adult learning. Positive results from a feasibility pilot study of a USB-delivered version of MS INFoRm led to the current trial and adaptation of MS INFoRm to a website format. The specific aims of the proposed study are to (a) to determine the effectiveness and efficacy of 3-month use of MS INFoRm on fatigue impact (primary outcome) among persons with MS, (b) to determine whether 3-month use of MS INFoRm results in improvement in secondary outcomes of self- efficacy for managing MS fatigue, self-reported cognitive function, participation and autonomy, and depression, and (c) to determine whether any improvements in primary and secondary outcomes are maintained among the MS INFoRm users after 6-months. METHODS/DESIGN: Parallel group, two arm, double-blinded superiority trial with a 1:1 allocation. Two hundred persons with MS will be randomly assigned to either an intervention (MS INFoRm) or usual care control group in which they will be given 3-month access to either the MS INFoRm website (intervention group) or a control webpage containing widely available resources on MS fatigue (control group). Baseline, immediate post-intervention (3-months), and follow-up (6-months post intervention) evaluations will take place on primary (Modified Fatigue Impact Scale) and secondary (Multiple Sclerosis Self-Efficacy Scale, Perceived Deficits Questionnaire, Center for Epidemiologic Studies Depression Scale, and Impact on Participation and Autonomy Questionnaire) measures. Hypothesis testing will involve independent samples t-tests and mixed effects ANOVAs. DISCUSSION: People with MS may benefit from easily accessible and self-directed fatigue management resources based on self-management and adult learning principles. The proposed study will provide crucial evidence about the potential of MS INFoRm as a self-management tool that can be made widely available to persons with MS as a means to effectively reduce the daily impact of MS fatigue. TRIAL REGISTRATION: ClinicalTrials.gov : NCT03362541 . Posting date December 5, 2017.

Interventions for preventing falls in people with multiple sclerosis.

BACKGROUND: Multiple sclerosis (MS) is one of the most prevalent diseases of the central nervous system with recent prevalence estimates indicating that MS directly affects 2.3 million people worldwide. Fall rates of 56% have been reported among people with MS in a recent meta-analysis. Clinical guidelines do not outline an evidence-based approach to falls interventions in MS. There is a need for synthesised information regarding the effectiveness of falls prevention interventions in MS. OBJECTIVES: The aim of this review was to evaluate the effectiveness of interventions designed to reduce falls in people with MS. Specific objectives included comparing: (1) falls prevention interventions to controls and; (2) different types of falls prevention interventions. SEARCH METHODS: We searched the Trials Register of the Cochrane Multiple Sclerosis and Rare Diseases of the CNS Group, Cochrane Central Register of Controlled Trials (2018 Issue 9); MEDLINE (PubMed) (1966 to 12 September 2018); Embase (EMBASE.com) (1974 to 12 September 2018); Cumulative Index to Nursing and Allied Health Literature (EBSCOhost) (1981 to 12 September 2018); Latin American and Caribbean Health Science Information Database (Bireme) (1982 to 12 September 2018); ClinicalTrials.gov; and World Health Organization International Clinical Trials Registry Platform; PsycINFO (1806 to 12 September 2018; and Physiotherapy Evidence Database (1999 to 12 September 2018). SELECTION CRITERIA: We selected randomised controlled trials or quasi-randomised trials of interventions to reduce falls in people with MS. We included trials that examined falls prevention interventions compared to controls or different types of falls prevention interventions. Primary outcomes included: falls rate, risk of falling, number of falls per person and adverse events. DATA COLLECTION AND ANALYSIS: Two review authors screened studies for selection, assessed risk of bias and extracted data. We used a rate ratio (RaR) and 95% confidence interval to compare falls rate between groups. For risk of falling, we used a risk ratio (RR) and 95% CI based on the number of fallers in each group. MAIN RESULTS: A total of 839 people with MS (12 to 177 individuals) were randomised in the 13 included trials. The mean age of the participants was 52 years (36 to 62 years). The percentage of women participants ranged from 59% to 85%. Studies included people with all types of MS. Most trials compared an exercise intervention with no intervention or different types of falls prevention interventions. We included two comparisons: (1) Falls prevention intervention versus control and (2) Falls prevention intervention versus another falls prevention intervention. The most common interventions tested were exercise as a single intervention, education as a single intervention, functional electrical stimulation and exercise plus education. The risk of bias of the included studies mixed, with nine studies demonstrating high risk of bias related to one or more aspects of their methodology. The evidence was uncertain regarding the effects of exercise versus control on falls rate (RaR of 0.68; 95% CI 0.43 to 1.06; very low-quality evidence), number of fallers (RR of 0.85; 95% CI 0.51 to 1.43; low-quality evidence) and adverse events (RR of 1.25; 95% CI 0.26 to 6.03; low-quality evidence). Data were not available on quality of life outcomes comparing exercise to control. The majority of other comparisons between falls interventions and controls demonstrated no evidence of effect in favour of either group for all primary outcomes. For the comparison of different falls prevention interventions, the heterogeneity of intervention types across studies prohibited the pooling of data. In relation to secondary outcomes, there was evidence of an effect in favour of exercise interventions compared to controls for balance function with a SMD of 0.50 (95% CI 0.09 to 0.92), self-reported mobility with a SMD of 16.30 (95% CI 9.34 to 23.26) and objective mobility with a SMD of 0.28 (95% CI 0.07 to 0.50). Secondary outcomes were not assessed under the GRADE criteria and results must be interpreted with caution. AUTHORS' CONCLUSIONS: The evidence regarding the effects of interventions for preventing falls in MS is sparse and uncertain. The evidence base demonstrates mixed risk of bias, with very low to low certainty of the evidence. There is some evidence in favour of exercise interventions for the improvement of balance function and mobility. However, this must be interpreted with caution as these secondary outcomes were not assessed under the GRADE criteria and as the results represent data from a small number of studies. Robust RCTs examining the effectiveness of multifactorial falls interventions on falls outcomes are needed.

Using the ICF to Identify Contextual Factors That Influence Participation of Persons With Deafblindness.

OBJECTIVE: To identify and describe the contextual factors that influence the participation of people with deafblindness in India. DESIGN: Qualitative study, using directed content analysis approach and the International Classification of Functioning, Disability and Health (ICF) as a framework to analyze the data. SETTING: Community and social participation settings. PARTICIPANTS: Community-dwelling individuals with deafblindness (N=16). Age ranges from 18-45 years. INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: Personal and environmental factors that influence the participation of individuals with deafblindness using the ICF framework. RESULTS: Results indicate that the age of onset and nature of impairment (deafblindness) and willingness to explain the condition (functional consequences of deafblindness) emerged as important personal factors. Access to resources such as assistive technology, social support, and deafblind-specific services were found to be enablers of participation. Lack of services, systems, and policies specific to deafblindness along with negative societal attitude toward disability were highly perceived environmental barriers that influence participation of people with deafblindness in India. CONCLUSIONS: Professionals must acknowledge aspects of the environment in conducting assessments and delivering interventions and understand the dynamic interactions between environment of the individual and his/her concurrent vision and hearing impairments. Approaches to enable participation require rehabilitation professionals to work with those with deafblindness to advocate for removal of environmental barriers and ensure provision of appropriate resources from the government to facilitate their participation. Social policy and government must ensure emphasis on awareness about deafblindness, access to deafblind-specific services, positive societal attitude, and opportunities for full participation for people with deafblindness in society.

Randomized Controlled Trial of a Telephone-Delivered Physical Activity and Fatigue Self-management Interventions in Adults With Multiple Sclerosis.

OBJECTIVE: To compare the effectiveness of telephone-delivered interventions on fatigue, physical activity, and quality of life outcomes in adults with multiple sclerosis (MS). DESIGN: A single-blinded, randomized controlled trial. Participants were randomized to contact-control intervention (CC), physical activity-only intervention (PA-only), and physical activity plus fatigue self-management intervention (FM+). Outcomes were measured at baseline (2wk prerandomization), posttest (14wk postrandomization), and follow-up (26wk postrandomization). SETTING: Telephone-delivered in Midwest and Northeast regions of the United States. PARTICIPANTS: Inactive adults with MS (N=208) and moderate-to-severe fatigue. INTERVENTIONS: Three or 6 group teleconferences followed by 4 individually tailored phone calls delivered during 12 weeks. An occupational therapist and research assistant delivered the teleconferences and tailored phone calls, respectively. MAIN OUTCOME MEASURES: Primary outcomes were self-report fatigue and physical activity measured with the Fatigue Impact Scale and Godin Leisure-Time Exercise Questionnaire, respectively. Secondary outcomes included quality of life measured with the Multiple Sclerosis Impact Scale and moderate-to-vigorous exercise and step count measured with an accelerometer. RESULTS: Linear mixed effects models showed FM+ significantly improved self-reported fatigue (ß=-11.08; P=.03) and physical activity (ß=0.54; P=.01) compared with CC at posttest. However, FM+ had nonsignificant differences compared with PA-only on self-report fatigue (ß=-1.08, P=.84) and physical activity (ß=0.09; P=.68) at posttest. PA-only had significant improvements compared with CC on moderate-to-vigorous exercise (ß=0.38; P=.02) at posttest and step count at posttest (ß=1.30; P<.01) and follow-up (ß=1.31; P=.01) measured with an accelerometer. FM+ and PA-only had nonsignificant differences compared with CC on quality of life. CONCLUSIONS: Group teleconferences followed by tailored phone calls have a small yet statistically significant effect in promoting physical activity and reducing fatigue impact in people with MS.