Multiple Sclerosis Care Research Articles

The arisal of data spaces: why I am excited and worried

This paper explores the significant role of real-world data (RWD) in advancing our understanding and management of Multiple Sclerosis (MS). RWD has proven invaluable in MS research and care, offering insights from larger and diverse patient populations. A key focus of the paper is the European Health Data Space (EHDS), a significant development that promises to change how healthcare data is managed across Europe. This initiative is particularly relevant to the MS community. The paper highlights various data initiatives, discussing their importance for those affected by MS. Despite the potential benefits, there are challenges and concerns, especially about ensuring that the growth of various data platforms remains beneficial for MS patients. The paper suggests practical actions for the global MS community to consider, aimed at optimizing the use of RWD. The emphasis of this discussion is on the secondary use of health data, particularly in the European context. The content is based on the author’s own experiences and interpretations, offering a personal yet informed view on using RWD to improve MS research and patient care.

Establishing consensus on lifestyle recommendations and behaviour change strategies to promote brain health-focussed care for multiple sclerosis: A modified e-Delphi study.

Establishing consensus on lifestyle recommendations and behaviour change strategies to promote brain health-focussed care for multiple sclerosis: A modified e-Delphi study.

Implementing a multidisciplinary approach for older adults with multiple sclerosis: geriatric neurology in practice

BackgroundOlder adults with multiple sclerosis (MS) face unique challenges arising from age-related changes in MS pathophysiology and overlapping geriatric syndromes. There is a need for geriatrics-focused multidisciplinary care for the rapidly growing older MS population. Objectiveto design and implement a geriatric multidisciplinary clinic for older adults with MS. MethodsWe describe the development of a multidisciplinary approach to geriatric MS care within a single institution through the implementation of the Aging with MS Clinic. The clinic model was conceived through collaboration between neurology and geriatric medicine to provide comprehensive care for older adults with MS who are uniquely affected by overlapping symptoms of aging and MS (e.g., frailty, falls, functional decline, multiple comorbidities, polypharmacy, cognitive impairment, nutritional deficits, barriers to access healthcare). Multidisciplinary specialists were recruited to staff the clinic, and initial patient satisfaction outcomes were collected. ResultsThe team of multidisciplinary specialists staffing the clinic consists of a MS advanced practice practitioner, MS pharmacist, physical therapist, neuropsychologist, dietitian, and social worker. A clinic template was devised where 4 patients with MS over age 60 are seen by each specialist during each a half-day clinic session. Initial patient satisfaction surveys from 25 participants showed overwhelmingly positive feedback. A majority of participants (92%) agreed that the clinic was well-organized, while 89% felt they benefitted from attending. Additionally, 70% of participants reported that the clinic improved their overall quality of care. ConclusionThe Aging with MS clinic outlines a model for comprehensive geriatric assessment and care in older adults with MS by a team of multidisciplinary specialists. Initial feedback from patients who attended the clinic conveyed improved quality of care.

The cost-of-illness of multiple sclerosis in Jordan

ABSTRACT Background Multiple Sclerosis (MS) imposes a significant financial burden on health-care systems. This study aims to determine the cost-of-illness (COI) for MS in Jordan, a country where data on the economic impact of MS are scarce. Methods Data were collected for one year, annual COI was estimated using a cross-sectional snowball sampling design. Eligible patients completed a self-reported questionnaire to provide sociodemographic, physician visit, and diagnostic and laboratory test data. Indirect costs were estimated using an adjusted Human Capital Approach. Results This study included 383 patients, (73% females, 61% between 26-45). Eighty % took disease-modifying therapies (DMTs), and 40% had relapses in that year. One-third use non-DMTs and equipment for assistance. The average annual cost per patient was $11,719 (direct costs=$11,252, indirect costs=$467). The total annual cost for all participants was $748,299. The estimated cost of non-DMT, medical tools, diagnostic tests, and hospitalization per patient was $53, 51, 99, and 235 respectively. Conclusion High costs of DMTs state the necessity of resource optimization in Jordan public healthcare facilities. Such findings yield policy-informing actionable insights, suggesting strategic investments in more cost-effective DMTs with potential improvement in accessibility and reduction in the overall economic burden faced by both patients and governments.

Evaluation of a Quality Measure for Multiple Sclerosis Care: Disease-Modifying Therapy Initiation at the University of North Carolina's Outpatient Neurology Clinic.

Multiple sclerosis (MS) is a neurological condition leading to significant disability and challenges to quality of life. To slow progression and reduce relapses, it is critical to rapidly initiate disease-modifying therapy (DMT) after diagnosis. Patient demographics may play a role in timely DMT initiation. Financial barriers may also result in delays in DMT access. This retrospective, single-center, cross-sectional study included patients seen at a neurology clinic at a large academic medical center for an initial evaluation of MS between January 1, 2022, and June 30, 2022. As an indicator of the quality of care, the primary study outcome was whether patients were offered DMT initiation on their first clinic visit. Secondary outcomes evaluated the time to DMT initiation, including differences in care based on demographic factors and financial coverage. Of the 49 eligible individuals studied, 45 (91.8%) were offered DMT at their initial MS visit. Descriptive statistics appeared to demonstrate that demographic factors did not impact whether DMT was offered. However, the majority of patients experienced access barriers relating to prior authorization requirements (80.0%) and/or the need for co-pay assistance (52.0%). DMT was appropriately offered to a majority of patients at their initial MS visit, regardless of demographic considerations. No offer of DMT and delays in initiation were primarily due to the need for imaging and specialty referrals, as well as financial barriers. Medication assistance teams may play a crucial role in limiting delays and financial hurdles associated with insurance coverage and co-pay assistance.

Misdiagnosis and underdiagnosis of multiple sclerosis: A systematic review and meta-analysis

Background: Diagnostic errors in multiple sclerosis (MS) impact patients and healthcare systems. Objectives: This study aimed to determine the prevalence of MS misdiagnosis and underdiagnosis, time delay in reaching a correct diagnosis and potential impact of sex. Methods: Systematic review and meta-analysis on MS diagnostic errors. Results: Out of 3910 studies, we included 62 for a qualitative synthesis and 24 for meta-analyses. Frequency of misdiagnosis (incorrect assignment of an MS diagnosis) ranged from 5% to 41%, with a pooled proportion based on six studies of 15% (95% CI: 9%–26%, n = 1621). The delay to rectify a misdiagnosis ranged from 0.3 to 15.9 years. Conversely, underdiagnosis (unrecognized diagnosis of MS) ranged from 3% to 58%, with a pooled proportion in four studies of 36% (95% CI: 20%–55%, n = 728). Pooling seven studies comprising 2851 individuals suggested a diagnostic delay to establish a correct MS diagnosis of 17.3 months (95% CI: 11.9–22.7) in patients underdiagnosed. In a meta-analysis of five studies, women were 2.1 times more likely to be misdiagnosed with MS compared to men (odds ratio, 95% CI: 1.53–2.86). Conclusion: This study provides summary-level evidence for the high prevalence of MS misdiagnosis and underdiagnosis. Future studies are needed to understand the causes of these diagnostic challenges in MS care.

Does serum neurofilament light chain measurement influence therapeutic decisions in multiple sclerosis?

BackgroundThe assessment of serum neurofilament light chain (sNfL) concentration in multiple sclerosis (MS) is a useful tool for predicting clinical outcomes and assessing treatment response. However, its use in clinical practice is still limited. We aimed to assess how measurement of sNfL influences neurologists’ treatment decisions in MS. MethodsWe conducted a cross-sectional, web-based study in collaboration with the Spanish Society of Neurology. Neurologists involved in MS care were presented with different simulated case scenarios of patients experiencing either their first demyelinating MS event or a relapsing-remitting MS. The primary outcome was therapeutic inertia (TI), defined as the absence of treatment initiation or intensification despite elevated sNfL levels. Nine cases were included to estimate the TI score (range 0–9, where higher values represented a higher degree of TI). ResultsA total of 116 participants were studied. Mean age (standard deviation-SD) was 41.9 (10.1) years, 53.4 % male. Seventy-eight (67.2 %) were neurologists fully dedicated to the care of demyelinating disorders. Mean (SD) TI score was 3.65 (1.01). Overall, 92.2 % of participants (n = 107) presented TI in at least 2/9 case scenarios. The lack of full dedication to MS care (p = 0.014), preference for taking risks (p = 0.008), and low willingness to adopt evidence-based innovations (p = 0.009) were associated with higher TI scores in the multivariate analysis after adjustment for confounders. ConclusionTI was a common phenomenon among neurologists managing MS patients when faced with the decision to initiate or escalate treatment based on elevated sNfL levels. Identifying factors associated with this phenomenon may help optimize treatment decisions in MS care.

Data-driven risk/benefit estimator for multiple sclerosis therapies.

Multiple sclerosis (MS) disease-modifying treatments (DMTs) are tested in patients pre-selected for favorable risk/benefits ratios but prescribed broadly in clinical practice. We aimed to establish data-driven computations of individualized risk/benefit ratios to optimize MS care. We derived determinants of DMTs efficacy on disability progression from re-analysis and integration of 61 randomized, blinded Phase 2b/3 clinical trials that studied 46,611 patients for 91,787 patient-years. From each arm we extracted 80 and computed 30 features to identify and adjust for biases, and to use in multiple regression models. DMTs mortality risks were estimated from age mortality tables modified by published hazard ratios. Baseline characteristics of the recruited patients determine disability progression rates and DMTs efficacies with high effect sizes. DMTs efficacies increase with MS lesional activity (LA) measured by relapses or contrast-enhancing lesions and decrease with increasing age, disease duration and disability. Unexpectedly, as placebo arms' relapse rate rapidly declines with trial duration, efficacy of MS DMTs likewise decreases quickly with treatment duration. Conversely, DMTs morbidity/mortality risks increase with age, advanced disability, and comorbidities. We integrated these results into an interactive personalized web based DMTs risk/benefit estimator. Results predict that prescribing DMTs to patients traditionally excluded from MS clinical trials causes more harm than benefit. Treatment with high efficacy drugs at MS onset followed by de-escalation to DMTs that do not increase infectious risks would optimize risk/benefit. DMTs targeting mechanisms of progression independent of LA are greatly needed as current DMTs inhibit disability caused by LA only.

Recent Advances in Understanding and Treating Multiple Sclerosis

MS, often known as multiple sclerosis, is a chronic autoimmune illness that is characterised by inflammation, demyelination, and neurodegeneration in the central nervous system (CNS). This review provides a comprehensive summary of current achievements in multiple sclerosis (MS) research, focusing on substantial advancements in understanding the biology of the disease, improving diagnostic tools, and developing a variety of treatment strategies. Multiple Sclerosis (MS) is characterised by an attack by the immune system on myelin, which is the protective sheath that surrounds nerve fibres. This attack results in a wide variety of neurological symptoms. Genetic factors, such as polymorphisms in the HLA-DRB1 gene, as well as environmental variables, such as a lack of vitamin D and viral infections, have been identified as contributors to disease susceptibility. However, the exact cause of multiple sclerosis (MS) is still unknown. Among the advancements in diagnostics are the utilisation of more sophisticated magnetic resonance imaging (MRI) techniques and the investigation of novel biomarkers in cerebrospinal fluid (CSF) and clinical blood. Beyond the standard disease-modifying treatments (DMTs), there are now additional treatment alternatives available, which include more recent medications that have mechanisms of action that are more specifically targeted. Treatments that are only coming into existence, such as monoclonal antibodies and cell-based therapies, provide the possibility of progress in the management of diseases. The purpose of this review is to provide a summary of the most important discoveries, identify trends in research, and explore the significance of current developments for MS care as well as future research directions.

The cost-utility analysis of adding ocrelizumab to the treatment plan for primary progressive multiple sclerosis in Iran

ABSTRACT Background This study evaluates the cost-effectiveness of adding ocrelizumab to supportive care for primary progressive multiple sclerosis (PPMS) in Iran. Research design and methods Using a lifetime horizon from the payer’s perspective, we developed a decision analytic model with Expanded Disability Status Scales (EDSS) as Markov health states while taking transition probabilities and treatment effects into account. Data were sourced from clinical trials and other literature. The target population was PPMS patients receiving either supportive care or ocrelizumab. We assessed cost- effectiveness through total costs, quality-adjusted life-years (QALYs), and the incremental cost- effectiveness ratio (ICER). Sensitivity analyses addressed uncertainties. Results The addition of ocrelizumab to supportive care provided an incremental gain of 0.89 QALYs and an additional cost of US$76,771.34, resulting in an ICER of US$86,220.35 compared to supportive care, which is 5.2 times Iran’s GDP per capita (US$16,557). Thus, ocrelizumab is not cost-effective at the threshold of one time GDP per capita. However, the probability of cost-effectiveness increases at higher thresholds. Sensitivity analyses confirmed the robustness of the results. Conclusion While ocrelizumab is not cost-effective at the threshold of one-time GDP per capita, its clinical benefits are significant. Formulating healthcare policies for high-cost medications with low alternatives like ocrelizumab is essential.

The Clinical Nurse Practitioner's Essential Role in Early Diagnosis and Management of Multiple Sclerosis in Europe: A Consensus Report.

Timely diagnosis of multiple sclerosis (MS) is a challenge due to factors such as prompt identification of symptoms and consequent delays in hospital visits and treatment initiation. In part to address this challenge, an expert scientific advisory panel of clinical nurse practitioners (CNPs) from different European nations was convened by Viatris on October 25, 2022, in Amsterdam, the Netherlands. This meeting was an interactive discussion to understand the role of clinical nurse practitioners in MS management. The objectives were to (1) understand the current delays in MS diagnosis from the perspective of expert CNPs; (2) determine the role of the CNP in MS management; and (3) identify the opportunities to improve accessibility, foster collaboration among stakeholders, and promote initiatives to educate people with MS. The recommendations of the panel underline the multidimensional role of CNPs in the management of MS at all stages. Health care stakeholders need to work together to achieve better access to treatment regimens and facilitate outcomes in the management of MS through shared decision-making and follow-ups. Further exploration of the role of CNPs in the management of MS, as well as recommendations for early diagnosis, will help both general practitioners and specialists better manage MS care.

Describing and Evaluating the Clinical Pharmacist's Role in a Canadian Multiple Sclerosis Clinic.

The current approach to treatment of multiple sclerosis (MS) involves use of disease-modifying therapies to slow progression of the disease, as well as the symptomatic management of fixed neurological deficits. Although pharmacists are uniquely positioned to support MS care teams with all aspects of medication management, their presence is rare among MS ambulatory care teams in Canada. To document the pharmacist's contributions and to evaluate the impact of the pharmacist's role following creation of a clinical pharmacist position in a Canadian MS clinic within a large, urban, university-affiliated, tertiary care centre. This study was conducted in 2 parts: a prospective, descriptive case study of the clinical pharmacist's role and a retrospective assessment of medication-related patient calls before and after implementation of the pharmacist position. The pharmacist performed a variety of clinical activities, with the greatest proportions of time spent on patient care (63.3%), drug access research (15.7%), and development and review of internal documents (9.0%). Patient care primarily involved conducting patient assessments, making medication recommendations, and assisting patients with medication-related issues. The proportion of medication-related issues resolved remained similar at 92.9% before and 95.7% after implementation of the clinical pharmacist (p = 0.48). The median time to resolve medication-related issues was reduced from 4.1 to 2.9 days (p = 0.016) with pharmacist involvement. Pharmacists can support MS care teams through a variety of medication-related clinical activities aligned with their scope and expertise. The presence of a pharmacist on the MS care team significantly reduced turnaround times for resolving medication-related issues, improving the efficiency and timeliness of care.

Addressing LGBTQ+ health equity and disparities in multiple sclerosis: A call for research and action

Multiple sclerosis (MS) research has largely overlooked the experiences of the LGBTQ+ community, leaving significant gaps in understanding and addressing their unique health equity challenges. Despite widespread recognition of LGBTQ+ health disparities, particularly in neurology, research at the intersection of sexual orientation, gender identity, and MS remains limited. LGBTQ+ individuals encounter systemic barriers such as discrimination and lack of culturally competent care, exacerbating disparities in MS management and outcomes. Existing studies are scarce, highlighting the urgent need for increased funding and support for research initiatives. By prioritizing LGBTQ+ inclusivity in research, healthcare, and advocacy, we can strive for a more equitable future in MS care.

Health Canada Drug Approval Process: A Barrier to Personalized Care in Multiple Sclerosis.

Health Canada Drug Approval Process: A Barrier to Personalized Care in Multiple Sclerosis.

Multiple Sclerosis and COVID-19: Health and healthcare access, health information and consumer co-created strategies for future access at times of crisis

BackgroundPersons with multiple sclerosis (MS) need regular access to medical services for optimal health outcomes. During the COVID-19 crisis, evidence indicated some detrimental health changes in persons with MS. Maintaining access to healthcare providers and healthcare information may minimise detrimental health changes during times of crisis. In Australia, there is limited evidence of consultation with people who have chronic health conditions or disabilities regarding government decisions to restrict healthcare access and in the provision of health guidance during the COVID-19 crisis. Yet, there are good examples of government consultation with other minority populations in Australia, leading to beneficial outcomes. ObjectiveTo identify MS community members’ (persons with MS carers, advocates, healthcare providers) concerns about the health and healthcare access of persons with MS, during the second year of the COVID-19 pandemic and to collaborate with consumers in the MS community to co-create strategies to improve future access and health information provision at times of crisis. MethodWe undertook a consumer-co-created mixed-method study in the second year of the COVID-19 pandemic to identify healthcare access needs for MS. We presented results to our stakeholder group to identify support needs during crises. Persons with MS and care providers in the MS community completed an online survey and online interviews, and the stakeholder group participated in a stakeholder workshop. ResultsForty-four people participated in surveys, 33 completed interviews, and seven stakeholders participated in the stakeholder workshops. Three themes were identified from the surveys and interviews: health concerns, accessing healthcare services and communication sources. Healthcare providers (76.9 % of persons with MS and 77.8 % of care providers) and websites specific to the pandemic (76.9 % of persons with MS and 83.3 % of care providers) were identified by most survey respondents as preferred information sources during the COVID-19 crisis. Consultation with stakeholders resulted in the co-creation of strategies directed at communication, health, and lifestyle, as well as policies and protocols to address the needs of the MS community during crises. ConclusionWe listened to persons with MS and care providers to identify strategies to support health-communication, -access, and -lifestyle during crises. Consumer-created strategies are directed at national and local health advocacy organisations and governments. They are relevant for the coordinated healthcare planning of persons with chronic health conditions and disabilities during crises, such as those experienced by persons with MS.

Cognitive impairment and its impact on employment: A qualitative interview-based study involving healthcare professionals and people living with multiple sclerosis

BackgroundCognitive impairment can considerably impact the work life of people who have multiple sclerosis (MS). Cognitive symptoms are associated with an increased likelihood of unemployment, changes in employment and decreased working hours. This qualitative interview-based study aims to gather real-word experiences and perspectives from both people living with MS and healthcare professionals, to explore how cognitive symptoms are experienced in the workplace, how their impact is addressed, and what can be done to support people in managing and minimizing this impact on employment. MethodsSemi-structured, one-to-one interviews were conducted with people living with MS who experience cognitive symptoms, and with healthcare professionals working in MS care. Participants were recruited from a healthcare market research agency based in the United States. The data obtained from the interviews were subsequently analysed using a Grounded Theory method, in order to identify the core themes that form the basis of this paper. ResultsA total of 20 participants (n = 10 people living with MS; n = 10 healthcare professionals) from the United States were interviewed. Overall, 9 themes were identified from the raw data, which were grouped into three core themes describing the perspectives and experiences reported by both people living with MS and healthcare professionals: (1) The implications of cognitive symptoms on work; (2) Challenges in addressing cognitive impairment and its impact on work in MS care; (3) Strategies and support for managing the impact of cognitive symptoms. ConclusionThe real-world insights of PwMS and HCPs gained from this qualitative study show that a multi-faceted approach to addressing cognitive impairment and its impact on the employment of PwMS is required. Workplace adjustments can range from self-implemented changes to changes put in place by employers to accommodate the various ways in which cognitive symptoms may impact a person's work. This study provides valuable information on how people living with MS can be affected by cognitive symptoms in the context of their employment; furthermore, that preparing early when possible and maintaining a proactive approach to managing their impacts on work are important for maintaining a good quality of life.

Allied health professionals knowledge and clinical practice in telehealth exercise behavioural change for multiple sclerosis

BackgroundThe growing importance of telehealth in multiple sclerosis (MS) necessitates an understanding of current practices and training needs of health professionals. We aimed to evaluate the knowledge, preparedness, and training preferences of Australian allied health professionals (AHPs) in telehealth exercise therapy and exercise behavioural change for MS patients to inform the development of educational training. MethodsAn online survey was completed by 58 Australian AHPs, including 34 physiotherapists, 14 exercise physiologists, and 10 occupational therapists, focusing on their current practices, preparedness, and training preferences in telehealth exercise and behavioural change for MS. The survey included multiple-choice, Likert scale, and free-text response questions. Data were analysed using binary and multinomial logistic regressions. ResultsNot all AHPs were aware of MS exercise guidelines (67% awareness), with exercise physiologists showing the highest familiarity. There was a significant understanding of the difference between physical activity and exercise, though definitions often lacked clarity. Most AHPs (91%) employed behavioural change strategies in their practice, especially goal-setting (95%), identifying facilitators (67%), and reinforcing progress (66%). While most (72%) felt prepared in promoting exercise to MS clients, there were differences in confidence levels concerning the prescription, modification, and teaching of telehealth exercise programs, with occupational therapists have significant less confidence in those domains compared to other AHPs. Most AHPs expressed interest in additional training, with a preference for online workshops focusing on exercise prescription for MS, behaviour change, and telehealth delivery methods. ConclusionIn our Australian AHP sample we identified that a quarter to a third of AHPs in MS care may not be confident or prepared to promote telehealth exercise and behavioural change to people with MS. Moreover, the findings highlight some disparity in knowledge and confidence levels amongst different AHPs concerning exercise therapy for MS, indicating the need for tailored multidisciplinary training programs. Such programs should address profession-specific educational gaps and training preferences, ensuring effective and safe telehealth exercise prescription in MS care.

Hand Grip Strength as a Predictive Tool for Upper Extremity Functionality, Balance, and Quality of Life in People With Multiple Sclerosis.

Upper extremity strength and function are rarely assessed in routine multiple sclerosis (MS) care. This study aimed to evaluate hand muscle strength and functionality in individuals with MS and investigate correlations with upper extremity function, cognitive status, health-related quality of life (HRQOL), and balance. A cross-sectional study was conducted with 45 consecutive individuals with MS between the ages of 18 and 65. Upper limb motor strength was evaluated using a hand grip strength dynamometer. Upper limb functional capacity was assessed using the Nine-Hole Peg Test (9HPT) and the Duruoz Hand Index (DHI). Balance, coordination, and falls were measured with the Berg Balance Scale (BBS), Falls Efficacy Scale (FES), and the 30-Second Chair Stand Test (30CST). Cognitive function was evaluated using the Montreal Cognitive Assessment instrument and the Symbol Digit Modalities Test. Level of HRQOL was assessed using the self-reported 54-item MS Quality of Life-54 questionnaire. Out of the 45 participants (80% women, mean age 36.6 ± 8.6 years), higher hand grip dynamometer measures were strongly correlated with better DHI, 9HPT, BBS, FES, and 30CST scores. In the regression analysis, a 1-unit increase in dynamometer measures led to a 0.383 increase in overall HRQOL score. This study demonstrates that increased hand grip strength (HGS) is associated with better hand functionality, balance, and HRQOL in individuals with MS. It provides evidence to support more systematic measurement of HGS in the care of people with MS.

Virtual versus usual in-office care for multiple sclerosis: The VIRTUAL-MS multi-site randomized clinical trial study protocol

BackgroundMultiple sclerosis (MS) affects nearly 1 million people and is estimated to cost $85.4 billion in the United States annually. People with MS have significant barriers to receiving care and telemedicine could substantially improve access to specialized, comprehensive care. In cross-sectional analyses, telemedicine has been shown to be feasible, have high patient and clinician satisfaction, reduce patient costs and burden, and enable a reasonable assessment of disability. However, no studies exist evaluating the longitudinal impact of telemedicine care for MS. Here we describe the study protocol for VIRtual versus UsuAL In-office care for Multiple Sclerosis (VIRTUAL-MS). The main objective of the study is to evaluate the impact of telemedicine for MS care on: patient clinical outcomes, economic costs, patient, and clinician experience. MethodsThis two-site randomized clinical trial will enroll 120 adults with a recent diagnosis of MS and randomize 1:1 to receive in-clinic vs. telemedicine care for 24 months. The primary outcome of the study is worsening in any one of the four Multiple Sclerosis Functional Composite 4 (MSFC4) measures at 24 months. Other study outcomes include patient and clinician satisfaction, major healthcare costs, Expanded Disability Status Scale, treatment adherence, and digital outcomes. ConclusionThe results of this study will directly address the key gaps in knowledge about longitudinal telemedicine-enabled care in an MS population. It will inform clinical care implementation as well as design of trials in MS and other chronic conditions.Trial registration:NCT05660187

"So at least now I know how to deal with things myself, what I can do if it gets really bad again"-experiences with a long-term cross-sectoral advocacy care and case management for severe multiple sclerosis: a qualitative study.

Persons with severe Multiple Sclerosis (PwsMS) face complex needs and daily limitations that make it challenging to receive optimal care. The implementation and coordination of health care, social services, and support in financial affairs can be particularly time consuming and burdensome for both PwsMS and caregivers. Care and case management (CCM) helps ensure optimal individual care as well as care at a higher-level. The goal of the current qualitative study was to determine the experiences of PwsMS, caregivers and health care specialists (HCSs) with the CCM. In the current qualitative sub study, as part of a larger trial, in-depth semi-structured interviews with PwsMS, caregivers and HCSs who had been in contact with the CCM were conducted between 02/2022 and 01/2023. Data was transcribed, pseudonymized, tested for saturation and analyzed using structuring content analysis according to Kuckartz. Sociodemographic and interview characteristics were analyzed descriptively. Thirteen PwsMS, 12 caregivers and 10 HCSs completed interviews. Main categories of CCM functions were derived deductively: (1) gatekeeper function, (2) broker function, (3) advocacy function, (4) outlook on CCM in standard care. Subcategories were then derived inductively from the interview material. 852 segments were coded. Participants appreciated the CCM as a continuous and objective contact person, a person of trust (92 codes), a competent source of information and advice (on MS) (68 codes) and comprehensive cross-insurance support (128 codes), relieving and supporting PwsMS, their caregivers and HCSs (67 codes). Through the cross-sectoral continuous support in health-related, social, financial and everyday bureaucratic matters, the CCM provides comprehensive and overriding support and relief for PwsMS, caregivers and HCSs. This intervention bears the potential to be fine-tuned and applied to similar complex patient groups. The study was approved by the Ethics Committee of the University of Cologne (#20-1436), registered at the German Register for Clinical Studies (DRKS00022771) and in accordance with the Declaration of Helsinki.