RSS 1.0Neurological Conditions
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Optimising access to vocational rehabilitation through multiple sclerosis charities : protocol for a feasibility randomised controlled trialBackground People with multiple sclerosis (MS) often leave the workforce prematurely due to MS symptoms and difficulties managing workplace relationships and performance. Vocational rehabilitation (VR) can improve job retention outcomes for people with MS, but there is a lack of evidence on the effectiveness of these interventions. Methods A multicentre, feasibility, parallel-group randomised controlled trial (RCT) comparing a job retention VR intervention plus usual care (n = 30) with usual care alone (n = 30). This study includes an embedded mixed-methods process evaluation. People with MS, aged 18–65 years, in paid employment will be recruited from MS charities. Participants with MS will be able to include their employers in the intervention to receive information about MS and employment. The intervention involves an initial interview and up to 10 hours of employment support for people with MS and up to four hours of support for employers, over six months. Employees from MS charities will be recruited and trained to deliver the MSVR intervention. Participants will be followed up by postal/telephone/online questionnaires at 6-, 9-, and 12-months post-randomisation. The aim is to ascertain the feasibility and acceptability of delivering the intervention within MS charities, and to determine parameters for future trial and explore the acceptability of the study intervention and procedures. Discussion This novel study will provide insight into how existing services from MS charities can fill a service gap by providing employment support to people with MS. Findings will inform the design of a future fully powered RCT. Trial registration number ClinicalTrials.gov NCT06966115.
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Safety, feasibility, and tolerability of ten days of at-home, remotely supervised tDCS during gamified attention training in children with acquired brain injury : an open-label, dose-controlled pilot trialBackground/Objectives: Chronic attention problems occur in approximately 25% of children after acquired brain injury (ABI). When delivered daily, transcranial direct current stimulation (tDCS) may improve attention; however, access to daily in-clinic tDCS treatment can be limited by other commitments, including concurrent therapy, school commitments, and caregiver schedules. Treatment access can be improved through home-based interventions, though these require several practical and safety considerations in a pediatric ABI population. This study evaluated the safety, feasibility, and tolerability of remotely monitored at-home tDCS during online gamified attention training in pediatric ABI. Methods: We conducted a randomized, single-blind, dose-controlled clinical trial of at home tDCS in Brisbane, Australia (10 tDCS sessions; 20 min; 1 mA or 2 mA; bilateral dorsolateral prefrontal cortex). Participants attended our clinic at baseline for clinical assessments, fitting of the personalized tDCS headband, and training in how to use tDCS at home. All sessions were remotely supervised using live videoconferencing. We assessed the feasibility and tolerability of at-home tDCS and our customized, personalized at-home tDCS headband as primary outcomes. As secondary outcomes, we evaluated changes in functional connectivity (fc) and reaction time (RT). Results: Seventy-three participants were contacted over six months (January-June 2023) and ten were enrolled (5 males; mean age: 12.10 y [SD: 2.9]), satisfying a priori recruitment timelines (CONSORT reporting). All families successfully set up tDCS and completed attention training with excellent protocol adherence. There were no serious adverse events over the 100 total sessions. Nine participants completed all stimulation sessions (1 mA: n = 5, 2 mA: n = 4). Participants in the 2 mA group reported greater tingling, itching, and discomfort (all p < 0.05). One participant in the 1 mA group was unable to complete all sessions due to tolerability challenges; however, these challenges were resolved in the second half of the intervention by gradually increasing the stimulation duration across the 10 days alongside additional coaching and support. Conclusions: Overall, daily remotely supervised at-home tDCS in patients with pediatric ABI is safe, feasible, and tolerable. Our results support larger, sham-controlled efficacy trials and provide a foundation for the development of safe and effective at-home stimulation therapeutics that may offer targeted improvement of neurocognitive symptoms in children.
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Patients' experience of the multiple sclerosis diagnostic pathwayIntroduction The 2017 revisions of the McDonald diagnostic criteria promoted the use of lumbar punctures (LPs) to expedite a diagnosis of multiple sclerosis. Objectives To assess patients’ experiences of the multiple sclerosis diagnostic pathway. Methods Feedback from the 113 participants of DECISIve (DiagnosE using the Central veIn SIgn) underwent quantitative and qualitative analyses. Their views were further explored in 17 participant interviews. Results DECISIve participants felt the overall experience of MRI scans was more positive than their LPs (Wilcoxon signed ranks test Z=-4.4, p<0.001). Information given pre-procedure was considered sufficient by 89% for LPs and 96% for MRI scans. Complications were reported by 72 (64%) for their LP and only 9 (8%) for their MRI scan. Many interviewees reported considerable anxiety before their LP, caused by sharing of negative accounts through social networks or online. Even patients who reported tolerating the LP experienced high pain intensity during the procedure, and that there are surprising gaps in the existing patient literature. Conclusions DECISIve participants expressed a unanimous preference for MRI scans over undergoing LPs. However, for those who do require an LP, recommendations to improve patient information materials and consent paperwork will be presented.
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Optimising access to vocational rehabilitation through multiple sclerosis charities : protocol for a feasibility randomised controlled trialBACKGROUND: People with multiple sclerosis (MS) often leave the workforce prematurely due to MS symptoms and difficulties managing workplace relationships and performance. Vocational rehabilitation (VR) can improve job retention outcomes for people with MS, but there is a lack of evidence on the effectiveness of these interventions. METHODS: A multicentre, feasibility, parallel-group randomised controlled trial (RCT) comparing a job retention VR intervention plus usual care (n = 30) with usual care alone (n = 30). This study includes an embedded mixed-methods process evaluation. People with MS, aged 18-65 years, in paid employment will be recruited from MS charities. Participants with MS will be able to include their employers in the intervention to receive information about MS and employment. The intervention involves an initial interview and up to 10 hours of employment support for people with MS and up to four hours of support for employers, over six months. Employees from MS charities will be recruited and trained to deliver the MSVR intervention. Participants will be followed up by postal/telephone/online questionnaires at 6-, 9-, and 12-months post-randomisation. The aim is to ascertain the feasibility and acceptability of delivering the intervention within MS charities, and to determine parameters for future trial and explore the acceptability of the study intervention and procedures. DISCUSSION: This novel study will provide insight into how existing services from MS charities can fill a service gap by providing employment support to people with MS. Findings will inform the design of a future fully powered RCT. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov NCT06966115.
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The effect of a single session of transcranial direct current stimulation on attention in pediatric acquired brain injury : characterizing interindividual structural and functional network response variabilityBACKGROUND: Approximately one in four children who sustain an acquired brain injury (ABI) have attention difficulties impacting education, employment, and community participation. These difficulties arise from dysfunction in attention-related brain networks, incentivizing the use of transcranial direct current stimulation (tDCS). We investigated whether a single tDCS session improved attention following childhood ABI and whether baseline structural connectivity (sc), functional connectivity (fc), attention, and/or simulated electric fields (E-fields) explained variability in response. METHODS: In a randomized, single-blind, within-subject, sham-controlled trial, 15 children with ABI (mean 12.7 years) and 15 healthy controls (HCs) received three single tDCS sessions (1 mA dorsolateral prefrontal cortex [dlPFC], 1 mA inferior frontal gyrus [IFG], sham; 20 min) during gamified attention training. We examined postintervention changes in attention according to flanker and stop signal reaction time (RT). We used multimodal analyses (high-density electroencephalography [HD-EEG], diffusion tensor imaging, magnetic resonance imaging) to investigate interindividual variability in tDCS response, according to associations between RT change and baseline fc, sc, attention, and E-fields. RESULTS: Although no effect of active versus sham tDCS was found overall, participants with lower theta or higher gamma default mode network connectivity and poorer attention at baseline showed greater response to tDCS. Higher E-fields were associated with greater response. No serious adverse effects occurred. CONCLUSIONS: A single tDCS session targeting dlPFC or IFG did not improve attention following pediatric ABI. We demonstrated how HD-EEG source-based connectivity may be used to personalize tDCS. Future research should explore whether personalization and/or repeated tDCS sessions can improve attention following pediatric ABI.
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Key outcomes for a vocational rehabilitation intervention for people with multiple sclerosis : a nominal group technique studyBACKGROUND: Job retention vocational rehabilitation (VR) interventions for people with multiple sclerosis (MS) can positively impact a person's independence and directly influence health and employment outcomes. However, evaluating the effectiveness of VR interventions can be challenging due to their highly individualised nature and the diverse range of potential health and employment outcomes that may be impacted. AIM: To identify the most important outcomes of a job retention VR intervention from the perspective of people with MS. DESIGN: A nominal group technique (NGT) was conducted with people with MS using Microsoft Teams and Microsoft Forms. The study involved completing a demographic questionnaire, being introduced to VR, silently generating ideas, round-robin discussions, ranking outcomes and reaching a consensus. NGT data were analysed using thematic analysis. RESULTS: We conducted two NGTs involving 10 participants with MS. Nine outcomes were identified and ranked based on priority, relating to four themes: (1) Employer support and collaboration; (2) Empowerment; (3) Symptom management and progression and (4) Professional well-being and performance. CONCLUSION: Improvements in employer support and symptom management were seen as key outcomes for VR interventions that could eventually lead to enhanced work performance and job retention for people with MS. Future research should explore how feasible it is to collect these outcomes to ascertain the impact of VR on employment over time. Due to the complexity of the outcomes identified, there may be a need to develop new outcome measures with improved validity and sensitivity to these interventions. PATIENT OR PUBLIC CONTRIBUTION: This study is part of a larger project co-developed with three people MS. A lead patient and public involvement representative and lay co-author reviewed the study topic guide to improve clarity and study focus and supported the group discussions and data analysis with input from the lead researcher.
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Evaluating the VaLiANT (Valued Living After Neurological Trauma) group intervention for improving adjustment to life with acquired brain injury : a pilot randomized controlled trialThere is a need for accessible rehabilitation that promotes meaningful participation, wellbeing, and adjustment to life with acquired brain injury (ABI). VaLiANT (Valued Living After Neurological Trauma) is an 8-week holistic group intervention that integrates Acceptance and Commitment Therapy (ACT) and cognitive rehabilitation techniques to support adjustment and meaningful reengagement in life. This Phase II pilot randomized controlled trial explored feasibility and preliminary efficacy signals to determine the viability of a larger trial. Adults (>3 months post-ABI) were randomly allocated to VaLiANT plus treatment-as-usual (TAU), or TAU waitlist-control, with assessments at baseline, post-intervention (8 weeks), and follow-up (16 weeks). Feasibility criteria included recruitment, dropout, outcome assessment completion, adherence, and delivery fidelity. Preliminary treatment effects were assessed on a range of adjustment-related outcomes using mixed linear models, proportions of reliable change, and minimal clinically important differences. 54 participants were recruited (M(age )= 50.6, M(years-post-injury) = 5.4) predominately with stroke (52%) and traumatic brain injury (22%). All feasibility criteria were met. Treatment effects were identified on measures of psychological distress, experiential avoidance, valued living, and self-identity, but not meaningful participation, quality-of-life, or wellbeing. A larger trial is viable but VaLiANT will benefit from refinement first to improve its impact on all intended outcomes.Trial registration: ACTRN12619001243101.
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Comparison of the diagnostic performance of the central vein sign and CSF oligoclonal bands supporting the diagnosis of multiple sclerosisBackground and Objectives The central vein sign (CVS) describes the presence of venules within multiple sclerosis (MS) brain lesions, visible on T2*-weighted MRI. In the upcoming revision of the MS diagnostic criteria, the simplified “rule of 6” (i.e., finding 6 lesions with a central venule) can support the diagnosis of MS as an alternative to lumbar puncture (LP). We evaluated whether a T2*-weighted MRI scan is more sensitive than oligoclonal bands (OCBs) for diagnosing MS at presentation with a typical clinically isolated syndrome (CIS). We also compared the tolerability of LP and the additional MRI. Methods Participants requiring an LP to meet the 2017 McDonald diagnostic criteria for MS were enrolled in this multicenter, prospective, diagnostic superiority study from 3 UK neuroscience centers. A six-minute T2*-weighted sequence was used to assess the CVS using 2 definitions: a 40% threshold of all eligible lesions and the rule of 6. These were compared with OCBs, using the clinical diagnosis at 18 months as the reference standard. Results Of 113 participants, 99 (mean age: 38, female: 73%) have completed all study activities: 80 were diagnosed with MS, 10 remained CIS, 8 had alternative diagnoses, and 1 remained without a diagnosis. No significant difference in diagnostic sensitivity was detected between 40% CVS threshold (90% [CI 81%–96%]) and OCB testing (84% [CI 74%–91%]) (p = 0.332). The rule of 6 had a sensitivity of 91% (CI 83%–96%). Side effects were reported by 75% following LP compared with 9% following MRI. All participants preferred their MRI scan over their LP. Discussion CVS and OCB testing is equally sensitive in supporting the diagnosis of MS in cases of typical CIS. CVS assessed using the 40% threshold, and the simpler rule of 6 produces equivalent diagnostic performance. Compared with OCB testing, CVS testing seems safer and better tolerated by patients. Further studies are needed to evaluate CVS specificity, particularly outside of typical CIS cases, as studied here. Classification of Evidence This study provides Class IV evidence that CSF OCBs and the CVS are equally sensitive in supporting a diagnosis of MS in patients presenting with CIS.
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Vocational rehabilitation for people with multiple sclerosis in the national health service of the United Kingdom: A realist evaluationBACKGROUND: There is limited evidence about how vocational rehabilitation (VR) for people with multiple sclerosis (MS) can be delivered through the United Kingdom's (UK) National Health Service (NHS) and how it works. AIM: To understand the mechanisms and context for implementing a VR intervention for people with MS in the NHS and develop an explanatory programme theory. METHODS: A realist evaluation, including a review of evidence followed by semi-structured interviews. A realist review about VR for people with MS in the NHS was conducted on six electronic databases (PubMed, MEDLINE, PsychINFO, Web of Science, CINAHL, and EMBASE) with secondary purposive searches. Included studies were assessed for relevance and rigour. Semi-structured interviews with people with MS, employers, and healthcare professionals, were conducted remotely. Data were extracted, analysed, and synthesised to refine the programme theory and produce a logic model. RESULTS: Data from 13 studies, and 19 interviews (10 people with MS, five employers, and four healthcare professionals) contributed to producing the programme theory. The resulting programme theory explains the implementation of VR in the NHS for MS populations, uncovering the complex interplay between the healthcare and employment sectors to influence health and employment outcomes. VR programmes that offer timely support, tailored to the needs of the person with MS, and that support and empower the employee beyond the healthcare context are most likely associated with improved employment outcomes, for example, job retention. CONCLUSION: Embedding VR support within the NHS requires substantial cultural and organisational change (e.g., increased staff numbers, training, and awareness about the benefits of work). This study emphasises the need to routinely identify people with MS at risk of job loss and follow a collaborative approach to address employment issues. This realist evaluation provides insight on how to improve the quality of care available to people with MS.
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Implementing vocational rehabilitation for people with multiple sclerosis in the UK National Health Service: A mixed-methods feasibility studyPURPOSE: To implement a job retention vocational rehabilitation (VR) intervention (MSVR) for people with multiple sclerosis (MS) and their employers in the UK National Health Service (NHS). METHOD(S): Multicentre, single-arm feasibility study with post-intervention interviews. MSVR was delivered by an occupational therapist (OT). Feasibility was assessed by recruitment rates, compliance, and practicality of delivery. Acceptability was assessed with post-intervention interviews. A survey assessed change in eight vocational outcomes (e.g., vocational goals, work instability) immediately post-intervention and at 3-month follow-up. RESULT(S): Recruitment and training an OT was challenging. Twenty participants with MS, three employers, and three healthcare professionals were recruited. All participants but one completed the intervention. Factors affecting intervention adherence included annual leave and family responsibilities.MSVR was associated with improved vocational goal attainment post-intervention (t(18)=7.41, p=<0.001) and at follow-up (t(17)=6.01, p=<0.001). There was no change to the remaining outcomes. Interviews identified six themes: intervention impact, accessibility of support, the OT's role, readiness for support, workplace supportiveness, and barriers to NHS delivery. CONCLUSION(S): Challenges with recruitment, identifying newly diagnosed MS participants, and understanding the OT's training needs to deliver the intervention were identified. The intervention demonstrated acceptability, but participants wanted it to continue for longer to address further needs.
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Providing emotional support during the process of multiple sclerosis diagnosis (PrEliMS): A feasibility randomised controlled trialOBJECTIVES: To evaluate the feasibility and acceptability of an emotional support programme for newly diagnosed people with multiple sclerosis. DESIGN: Three-arm, mixed methods, randomised controlled trial comparing usual care, versus usual care plus nurse-specialist support, versus usual care plus nurse-specialist support plus peer support. PARTICIPANTS: Community-dwelling adults within two years of diagnosis or undergoing diagnosis. INTERVENTIONS: PrEliMS involves information provision, emotional support, and strategies and techniques based on psychoeducation, Acceptance and Commitment Therapy principles, supportive listening. One version of the intervention was provided by nurse-specialists alone and the other was provided by nurse-specialists plus peer support. MAIN MEASURES: The main outcome of interest was the feasibility of proceeding to a definitive trial, exploring recruitment rate, acceptability, completion of outcome measures (perceived stress, mood, self-efficacy, psychological impact, and service use), and signal of efficacy. RESULTS: Of 40 participants randomised (mean age 36.2 years (SD = 14.8); 54% women; 85% with relapsing-remitting MS), 36 and 38 returned 3- and 6-month questionnaires, respectively. Participant interviews suggested the trial was largely feasible, and the intervention acceptable, with some amendments to trial procedures and intervention delivery noted. There were, however, no statistically significant differences between groups at followup for any measures, and effect-size estimates were small. CONCLUSION: A definitive trial combining nurse-specialist and peer support adjustment to diagnosis intervention is warranted, but more work exploring the delivery and fidelity of the intervention is needed before this is pursued.
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Rebuilding the self through valued action and group connections after acquired brain injury: Participant perspectives of the VaLiANT group interventionEffective interventions that facilitate adjustment following acquired brain injury (ABI) are needed to improve long-term outcomes and meaningful reengagement in life. VaLiANT is an 8-week group intervention that combines cognitive rehabilitation with Acceptance and Commitment therapy to improve valued living, wellbeing, and adjustment. This study explored participant experiences of VaLiANT to optimize its ongoing development. This included characterization of individually meaningful treatment outcomes, mechanisms of action, and intervention acceptability. Qualitative interviews and quantitative ratings were collected from 39 ABI survivors (M(age )= 52, SD = 15; 54% stroke) following their participation in VaLiANT. Participants reported diverse outcomes which resulted in three themes being generated following reflexive thematic analysis. "A fuller toolkit for life with brain injury" indicated increased strategy usage and better daily functioning; "The value of connection and belonging" captured the importance of social experiences in shaping recovery; and "Finding the me I can be" represented cognitive, behavioural, and emotional aspects of identity reconstruction post-ABI. The content and delivery of the intervention were rated highly but participants desired greater follow-up and tailoring of the intervention. Overall, VaLiANT appears to facilitate adjustment through several mechanisms, but greater intervention individualization and dosage may be required to enhance the treatment impact.
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Online peer support for people with Amyotrophic Lateral Sclerosis (ALS): a narrative synthesis systematic reviewBACKGROUND: Amyotrophic Lateral Sclerosis (ALS) significantly impacts the lives of people with the diagnosis and their families. A supportive social environment is important for people with ALS to adopt effective coping strategies and health behaviours, and reduce depressive symptoms. Peer support can provide a supportive social environment and can happen in-person and online. Advantages of online peer support are that people can engage from their own home, at their own time and pace, and that it offers a variety of different platforms and modes of communication. OBJECTIVES: To (1) explore the benefits and challenges of online peer support for people with ALS, and (2) identify successful elements of online peer support for people with ALS. METHODS: The method selected for this systematic review was a narrative synthesis. Six databases were systematically searched in April 2020 for articles published between 1989 and 2020. The search was updated in June 2022. The quality of the included studies was assessed with the Critical Appraisal Skills Programme qualitative research checklist. RESULTS: 10,987 unique articles were identified through the systematic database search. Of those, 9 were included in this review. One of the main benefits of online peer support was that people could communicate using text rather than needing verbal communication, which can be challenging for some with ALS. Successful elements included using profile pages and graphics to identify others with similar or relevant experiences. Challenges included ALS symptoms which could make it difficult to use technological devices. CONCLUSIONS: Peer support can provide a non-judgmental and supportive environment for people with ALS, in which they can exchange experiences and emotional support, which can help people in developing adaptive coping strategies. However, ALS symptoms may make it more difficult for people to use technological devices and engage in online peer support. More research is needed to identify what kind of specific barriers people with ALS experience, and how these could be overcome.
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Development of a job retention vocational rehabilitation intervention for people with multiple sclerosis following the person-based approachOBJECTIVE: To describe the process of developing a job retention vocational rehabilitation intervention for people with multiple sclerosis. DESIGN: We used the person-based approach, to develop interventions through an iterative process incorporating stakeholders' views, resulting in an intervention that is likely to be more acceptable, contextually relevant, and implementable for end-users. Phase 1 combined the results of a systematic review and interview study to develop the guiding principles and intervention logic model. Phase 2 involved conceptual testing and refining the intervention with stakeholder feedback. We present the final intervention following the template for intervention description and replication. PARTICIPANTS: We recruited 20 participants for Phase 1 (10 people with multiple sclerosis, four employers, six healthcare professionals), and 10 stakeholders (three people with multiple sclerosis, seven healthcare professionals) for Phase 2 to contribute to the intervention refinement process. RESULTS: Stakeholders described the need for an individually tailored intervention to support people with multiple sclerosis to manage symptoms and workplace relationships. A stepped-care approach and remote support were deemed essential. The resulting intervention involves an initial assessment of employment needs, vocational goal setting, up to 10 h of tailored support (e.g., reasonable adjustments, employer engagement, legal rights), and a final review to discuss future steps. People with multiple sclerosis can include their employer for advice to optimise the management of the employee with multiple sclerosis at work. CONCLUSION: The person-based approach provided a rigorous framework to systematically understand the vocational needs of people with multiple sclerosis and develop a vocational rehabilitation intervention.
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Developing and user-testing the online word colour task to screen for cognitive problems in people with Multiple SclerosisIntroduction: Cognitive problems affect 40-60% of people with Multiple Sclerosis (pwMS), but are not routinely screened for in MS clinics in the UK due to limited resources (including personnel to deliver cognitive tests) and finances (including payment for such tests). Consequently, those with cognitive problems are not identified early and triaged to receive the appropriate level of support. To address this gap, the NEuRoMS programme (www.neuroms. org) developed a neuropsychological pathway to routinely assess all pwMS attending MS clinics for cognitive problems. The pathway has been implemented in three UK MS clinics and has screened >3000 pwMS. Objectives/Aims: This work presents the iterative design and development process of the Word Colour Task (WCT), a free, online self-administered measure of selective attention and information processing. This has been included in the NEuRoMS cognitive screening pathway to screen pwMS for cognitive problems. Method(s): We followed an iterative development process and conducted multiple rounds of user testing. Beginning with a prototype based on literature and previous research, we held three stakeholder meetings with Patient and Public Involvement members, researchers and clinicians working with pwMS (n=18) to make design decisions. Following stakeholder feedback, we developed product specifications for a technical team to develop the online WCT. We then tested usability and acceptability through cognitive interviews with eight pwMS and made revisions. A further round of user-testing was undertaken before deployment into the NEuRoMS screening pathway. Result(s): User testing and cognitive interviews suggested that the WCT was acceptable, but some usability issues were identified (e.g., clarity of instructions, practice mode, repetition of stimuli) and suggestions were made to improve user experiences. Conclusion(s): Using an iterative design approach with significant and diverse stakeholder input, we were able to develop a robust and usable online cognitive screening assessment tool. The WCT has now been deployed in three MS clinics for feasibility testing having screened 370 pwMS. Validation and norming studies are currently underway to provide further evidence of its psychometric properties and collect UK-based norms.
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Exploring the potential of SMART for improving cognitive health in people with multiple sclerosisIntroduction: For people living with multiple sclerosis (MS), cognitive difficulties (including problems with attention, planning, and problem-solving) are a common and particularly debilitating and distressing consequence. The efficacy of cognitive training and rehabilitation remains unclear, leaving a need to establish suitable evidence-based treatment options. Objectives/Aims: In response to the current state of evidence, we aim to examine the feasibility of trialling SMART (Strengthening Mental Abilities with Relational Training) - a theory-based online cognitive training programme - as a treatment option for improving cognitive health in people with multiple sclerosis. Method(s): We are recruiting 60 patients with MS and cognitive impairment to a three-arm feasibility randomised-controlled trial, comparing (1) SMART + treatment-as-usual (TAU) with (2) TAU and (3) active control ('sham') training + TAU. Consenting eligible patients complete a cognitive assessment battery and questionnaires assessing the impact of living with MS, health-related quality of life, subjective cognitive difficulties, and service/ resource use. After completing baseline assessments, participants are randomly allocated to one of the three trial arms. Participants complete follow-up assessments at 3 and 6 months post-randomisation and take part in feasibility-feedback interviews. Our critical criteria for progression to a full-scale trial are around intervention acceptability ('green' = >=80% of SMART group completing >=6 sessions of SMART training), recruitment (green = >=80% of target N consented/randomised), and retention (green = >=80% of all randomised participants completing three-month follow-up). Result(s): Based on available data (53 participants enrolled to date), we are currently green on intervention acceptability (91%) and retention (97%). We appear green for recruitment (90% of target enrolled); identified latencies between consent and randomisation complicate the picture, but (in consultation with our Trial Steering Committee) we have identified ways to address latencies in full-scale trialling. Conclusion(s): Assessment against core criteria currently favours progression and indicates that a full trial would be feasible. Qualitative feedback suggests that SMART can be a usable and acceptable programme for people with MS, supporting further investigation and efficacy testing (of effects on cognitive health outcomes and broader quality of life).
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Integrating a newly developed cognitive screening and management pathway within MS clinics in the United Kingdom: A qualitative studyIntroduction: Currently in the United Kingdom, there is no routine screening for cognitive problems and sufficient provision of neuropsychological management for all people with Multiple Sclerosis (pwMS) with cognitive problems. The NEuRoMS programme (www.neuroms.org) developed a pathway for routine cognitive screening (with >3,000 already screened) and a brief cognitive rehabilitation intervention programme for mild cognitive problems in pwMS. Objectives/Aims: This study investigated how the cognitive screening pathway was integrated into routine clinical practice in MS clinics, and how the intervention was experienced by those who delivered and received it. Method(s): Multi-centre, in-depth qualitative case study across three NHS Trusts. Semi-structured interviews were conducted with 28 people: 8 pwMS with mild cognitive problems who received the cognitive screening and NEuRoMS intervention, 5 related informants, 12 clinicians (four per site), and 3 intervention providers (one per site). Interview data, transcribed verbatim and analysed using Framework Analysis, were mapped to thematic matrices of the programme theory for the screening pathway and intervention. Result(s): Overall, pwMS were able to complete screening online at home without any support. Clinicians expressed support for the pathway, indicating that it provided a clear structure to both identifying and managing cognitive problems for pwMS. However, implementation of the pathway also highlighted service gaps such as time constraints during appointments to discuss the screening results and the paucity of referral pathways to specialist psychology services. Overall, the integration of the pathway worked well within existing IT systems in the services, with processes put in place to ensure the screening results could be accessed by the clinicians. PwMS reported increased awareness of their cognitive abilities and limitations, and an increase in use of compensatory strategies following the intervention. Intervention providers identified that more time should be spent on the goal setting components of the intervention during sessions. Conclusion(s): The screening and management pathway has been revised based on recommendations from key stakeholders. The changes that have been implemented include considering those with mild and moderate cognitive problems for the NEuRoMS intervention, and modifying the intervention delivery to focus more on the goal-setting components.
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Screening people with Multiple Sclerosis for cognitive problems does not make depression, anxiety and self-efficacy worse: Results from a multi-centre, longitudinal observational studyIntroduction: There have been calls for better screening and monitoring of cognitive problems in people with MS (pwMS), but some clinicians have raised concerns that cognitive screening could have a negative impact on people's mood. The NEuRoMS programme (www.neuroms.org) developed a free, online screening tool that pwMS can complete on their electronic devices at home before their routine clinical appointments. Objectives/Aims: This study aimed to examine the potential impact of the NEuRoMS screening on pwMS' mood and self-efficacy. Method(s): This was a multi-centre, longitudinal observational study design across seven sites with MS outpatient clinics, of which three implemented the routine cognitive screening prior to clinic attendance. We compared two groups: screened (s) vs nonscreened (ns) pwMS at three time points (baseline, 2-week and 4-week follow-ups). All participants completed the Patient Health Questionnaire-8 (PHQ-8), Generalised Anxiety Disorder-7 (GAD- 7), and Multiple Sclerosis Self-Efficacy Scale (MSSE) at baseline (before screening at three screened sites) and at 2-week and 4-week follow-ups. Linear mixed models were applied for each outcome measure to assess change over time. Covariates were age and duration of MS; factors were gender, education, MS type and ethnicity; site as a random effect; time, group and time*group interaction. Result(s): There were 452 (241 s, 211 ns) pwMS who completed the outcome measures at all time points. For the PHQ-8, the mean score at baseline was 8.4 (SD=6.0) and the scores did not change significantly over time in either group. For the GAD-7, the mean score at baseline was 6.0 (SD=5.4) and the scores did not change significantly over time in either group. For MSSE, the mean score at baseline was 49.0 (SD 13.6) and the scores did not change significantly over time in either group. Conclusion(s): Our results suggest that screening pwMS for cognitive problems using the NEuRoMS screening technology does not make depression, anxiety and self-efficacy worse. The analysis did not detect a difference of a magnitude that would be considered clinically significant across time or groups. The three screened sites have screened and triaged >3000 pwMS with no adverse events reported in relation to the NEuRoMS cognitive screening. Therefore, our online cognitive screening appears safe to be used within routine clinical practice. Introduction: Cognitive problems affect 40-60% of people with Multiple Sclerosis (pwMS), but are not routinely screened for in MS clinics in the UK due to limited resources (including personnel to deliver cognitive tests) and finances (including payment for such tests). Consequently, those with cognitive problems are not identified early and triaged to receive the appropriate level of support. To address this gap, the NEuRoMS programme (www.neuroms. org) developed a neuropsychological pathway to routinely assess all pwMS attending MS clinics for cognitive problems. The pathway has been implemented in three UK MS clinics and has screened >3000 pwMS. Objectives/Aims: This work presents the iterative design and development process of the Word Colour Task (WCT), a free, online self-administered measure of selective attention and information processing. This has been included in the NEuRoMS cognitive screening pathway to screen pwMS for cognitive problems. Method(s): We followed an iterative development process and conducted multiple rounds of user testing. Beginning with a prototype based on literature and previous research, we held three stakeholder meetings with Patient and Public Involvement members, researchers and clinicians working with pwMS (n=18) to make design decisions. Following stakeholder feedback, we developed product specifications for a technical team to develop the online WCT. We then tested usability and acceptability through cognitive interviews with eight pwMS and made revisions. A further round of user-testing was undertaken before deployment into the NEuRoMS screening pathway. Result(s): User testing and cognitive interviews suggested that the WCT was acceptable, but some usability issues were identified (e.g., clarity of instructions, practice mode, repetition of stimuli) and suggestions were made to improve user experiences. Conclusion(s): Using an iterative design approach with significant and diverse stakeholder input, we were able to develop a robust and usable online cognitive screening assessment tool. The WCT has now been deployed in three MS clinics for feasibility testing having screened 370 pwMS. Validation and norming studies are currently underway to provide further evidence of its psychometric properties and collect UK-based norms. Introduction: Due to the revised 2017 McDonald diagnostic criteria, many more people undergo lumbar punctures as part of their Multiple Sclerosis (MS) diagnostic journey. This results in discomfort and additional costs. Patients often report they find the lumbar puncture painful, and it can cause unintended complications requiring hospitalisations or time off work to recover. Brain lesions with a central vein, detected with T2* MRI are thought to be characteristic of MS. The Central Vein Sign (CVS) supports the diagnosis of MS when over 40% of eligible MRI lesions have a visible central vein. The authors will present the final results from DECISIve - DiagnosE using the Central veIn SIgn (Clinical Trials reference: NCT04024969) at ECTRIMS 2023. Objectives/Aims: To investigate whether T2* MRI is a more sensitive diagnostic test than lumbar puncture with oligoclonal band examination, in people at first clinical presentation with possible MS. Method(s): A multicentre prospective single group superiority diagnostic accuracy study. Participants presenting with typical clinically isolated syndrome requiring a lumbar puncture to meet the 2017 McDonald diagnostic criteria for MS were enrolled. Trial participants had an eight-minute T2* MRI scan sequence in addition to their lumbar puncture. The final clinical diagnosis is established after at least 18 months of follow up. Result(s): Of 113 participants recruited, we were able to include 49 in a preliminary analysis. The sensitivity of the CVS to confirm a diagnosis of MS is 94% and lumbar puncture with oligoclonal band examination is 84% (McNemar test; p=0.453). Conclusion(s): The DECISIve interim analysis has shown that the sensitivity of the CVS is higher than testing for oligoclonal bands by lumbar puncture for the diagnosis of multiple sclerosis. We expect that the full DECISIve dataset will have sufficient power to confirm whether there is a clinically meaningful difference or not. There is only a single discordant result between CVS with a threshold of 40% and the 'rule of six', suggesting this could be rapidly implemented in clinical practice. Further analysis will include comparing the accuracy, speed, costs, and acceptability of the different tests and aim to establish if most lumbar punctures can be replaced by a slightly longer MRI scan.
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Prevalence of and risk factors for cognitive problems in people with Multiple Sclerosis: A multi-centre observational studyIntroduction: Cognitive problems are common among people with Multiple Sclerosis (pwMS), which can be debilitating and impact daily life. An online self-administered Symbol Substitution Task (SST), measuring information processing and working memory, was developed and deployed in three UK MS clinics to screen pwMS for cognitive problems as part of the NEuRoMS programme (www.neuroms.org). Objectives/Aims: This study aimed to explore the prevalence of cognitive problems and related risk factors in pwMS. Method(s): We used a multi-centre observational study design. The levels of cognitive problems using SST normative data were defined as follows: 1) within normal range (-1.49 standard deviations (SD) or higher); 2) mild (-2.49 SD to -1.5 SD); 3) moderate (-2.99 SD to -2.5 SD); 4) severe (-3 SD or lower). The prevalence was calculated from 1376 pwMS, and we performed ordinal logistic regression with cognitive impairment level as a dependent variable. Three models evaluated three outcome measures: 1) Patient Health Questionnaire-8 (PHQ-8), 2) Generalised Anxiety Disorder-7 (GAD-7), and 3) Multiple Sclerosis Self Efficacy Scale (MSSE). Covariates were age and duration of MS; factors were gender, education, MS type, and ethnicity; site as a random effect. Result(s): The SST threshold calculated based on SD from normative data as defined above, and prevalence from 1376 pwMS suggested that 56% were within normal range (SST score: >=35), 25% in mild (25-34), 8% in moderate (20-24) and 12% in severe (0-19) ranges. Covariates found to be significant predictors of cognitive impairment were: higher depression (PHQ-8; 1.08, p<0.001), higher anxiety (GAD-7; 1.06, p=0.01), and lower self-efficacy (MSSE; 0.96, p<0.001). For all three models age, duration of MS, gender (woman vs man), education (higher degree vs below GCSE) and MS type (relapsing-remitting vs primary progressive) had significant odds ratios, which means an increased odds of being in a higher cognitive impairment group. Conclusion(s): Cognitive problems affect 45% of pwMS attending routine clinics, with 33% having mild-moderate cognitive problems who are often left unidentified or treated. Therefore, routine monitoring for cognitive problems is crucial for identification of those who may benefit from timely support. Older, male pwMS with long disease duration, primary progressive MS, lower levels of education, low mood and low self-efficacy appear at higher risk of cognitive impairment. .
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A qualitative study exploring how vocational rehabilitation for people with multiple sclerosis can be integrated within existing healthcare services in the United KingdomIntroduction: The employment rate of people with multiple sclerosis (MS) in the United Kingdom (UK) is around 41% compared to 81% in people without disabilities. People with MS could benefit from vocational rehabilitation (VR) services to help them manage their symptoms at work and accommodate the impact of MS on their roles and working environment. However, there is a lack of specialist VR in the UK, and it is estimated that current services only meet the needs of 10% of the population with longterm neurological conditions. Objectives/Aims: To explore how a job retention VR intervention previously developed and tested in a community setting could be implemented within existing healthcare services for people with MS in the UK National Health Service (NHS). Method(s): We sought information regarding (1) stakeholder's VR preferences and how it could work within the NHS, (2) "Usual care" for people with MS in the NHS, (3) barriers and enablers to delivering the intervention within the NHS, and (4) intervention outcomes. Data from 37 semi-structured interviews with 22 people with MS, eight employers, and seven healthcare professionals were analysed using a framework method informed by the Consolidated Framework for Implementation Research (CIFR) and the intervention logic model. Result(s): We identified four themes relating to the intervention characteristics (e.g., individually tailored content, employer engagement), structure and resources available within the healthcare system (e.g., staff levels and skills to deliver the VR intervention), needs and beliefs of the person with MS (e.g., acceptance of MS diagnosis), and VR outcomes for relevant stakeholders such as the person with MS (e.g., improved well-being, economic independence), employers (e.g., improved ability to retain diverse workforce) and society (e.g., reduced number of people on welfare benefits). Conclusion(s): Participants perceived the NHS as a trustworthy organisation with a highly skilled workforce suited to delivering VR. However, participants suggested involving other organisations such as national charities in intervention delivery to overcome NHS barriers such as staff shortages and long waiting lists.
