Decentralised clinical trials in multiple sclerosis research.

Randomised controlled trials (RCTs) play an important role in multiple sclerosis (MS) research, ensuring that new interventions are safe and efficacious before their introduction into clinical practice. Trials have been evolving to improve the robustness of their designs and the efficiency of their conduct. Advances in digital and mobile technologies in recent years have facilitated this process and the first RCTs with decentralised elements became possible. Decentralised clinical trials (DCTs) are conducted remotely, enabling participation of a more heterogeneous population who can participate in research activities from different locations and at their convenience. DCTs also rely on digital and mobile technologies which allows for more flexible and frequent assessments. While hospitals quickly adapted to e-health and telehealth assessments during the COVID-19 pandemic, the conduct of conventional RCTs was profoundly disrupted. In this paper, we review the existing evidence and gaps in knowledge in the design and conduct of DCTs in MS.

Comparing the effects of reduced social contact on psychosocial wellbeing before and during the COVID-19 pandemic: a longitudinal survey from two Norwegian counties.

PURPOSE: To determine changes to people's social contact during COVID-19, and whether reduced social contact was associated with changes to psychosocial wellbeing. METHODS: Questionnaire data were collected from a sample of adult respondents (18 years or more) in two Norwegian counties participating pre-COVID-19 (September 2019-February 2020; n = 20,196) and at two time points during COVID-19 (June [Mid] and November/December [Late] 2020; n = 11,953 and n = 10,968, respectively). The main outcome measures were participants' self-reported changes to social contact, loneliness, psychological distress, and life satisfaction. RESULTS: The proportion of respondents reporting less social contact due to COVID-19 decreased from 62% in Mid-2020 to 55% in Late-2020. Overall, reported psychological wellbeing remained unchanged or improved from pre-COVID-19 to Mid-2020. From Mid-2020 to Late-2020, however, a reduction in psychological wellbeing was observed. Poorer psychological wellbeing was found for those with less social contact during the pandemic compared with people reporting unchanged social contact. This effect increased over time and was observed for all age groups at Late-2020. At Mid-2020, the importance of change in social contact for change in psychological wellbeing was greatest among young adults (< 30 years), while no significant differences were found for the oldest age group. CONCLUSION: The association between COVID-19-era changes to social contact and loneliness, psychological distress, and life satisfaction is complex and appears to be age-dependent. Future studies should consider the quality of social contact and cultural contexts in which social restrictions are imposed.

Vocational Rehabilitation To Enhance Return to Work After Trauma: Findings From A Non-Randomised Feasibility Study...American Congress of Rehabilitation Medicine (ACRM) Annual Conference, November 8-11, 2022, Chicago, Illinois

To assesses the feasibility of delivering a telehealth vocational rehabilitation (VR) intervention to enhance return to work and improve quality of life and wellbeing in people post-trauma. Non-randomised single-arm mixed-methods feasibility study. Participants were recruited from two UK major trauma centres (MTCs). The intervention was delivered virtually (or face-to-face where necessary) in participants' homes. Adult patients (n=10) 16-69 years, admitted to participating UK MTCs with Injury Severity Score (ISS) >8, recruited ≤12 weeks post-injury. Eligible participants were employed (paid or unpaid) or in full-time education at injury onset. Treating occupational therapists (OTs) and clinical psychologists (CPs) (n=6) trained in ROWTATE VR. ROWTATE is an individually-tailored job retention intervention, delivered by OTs, who act as case-coordinators, and CPs. It commences 12-weeks post-injury and is delivered for up to 12 months. It involves: assessing impact of injury;work-focused rehabilitation;planning/monitoring phased return-to-work;liaising with employers/healthcare team;educating patients/employers about injury impact;early identification, monitoring and support for psychological problems. Due to COVID-19, the intervention was adapted for remote delivery (video/phone call) and OTs/CPs trained in remote delivery. Study completion. Intervention fidelity, barriers and enablers to delivery, acceptability and usefulness;acceptability of remote intervention training. At 6 months: 90% started intervention ≤12 weeks post-injury, 103 OT sessions (M=10.3, range 5-19);99% OT sessions delivered remotely, 6 patients referred to CP;22 sessions (M=3.7, range 1-5), 100% remote. Fidelity: OT: 90%-100% across patients, CP: 82%-100% across patients. No participant withdrawals. Treating therapists and all participants found the intervention acceptable. Remote VR training and delivery is feasible and acceptable to OTs/CPs and trauma survivors. Findings have informed a definitive randomised controlled trial. No conflicting interests.

Vocational Rehabilitation To Enhance Return to Work After Trauma: Findings From A Non-Randomised Feasibility Study

Research Objectives To assesses the feasibility of delivering a telehealth vocational rehabilitation (VR) intervention to enhance return to work and improve quality of life and wellbeing in people post-trauma. Design Non-randomised single-arm mixed-methods feasibility study. Setting Participants were recruited from two UK major trauma centres (MTCs). The intervention was delivered virtually (or face-to-face where necessary) in participants’ homes. Participants Adult patients (n=10) 16-69 years, admitted to participating UK MTCs with Injury Severity Score (ISS) >8, recruited ≤12 weeks post-injury. Eligible participants were employed (paid or unpaid) or in full-time education at injury onset. Treating occupational therapists (OTs) and clinical psychologists (CPs) (n=6) trained in ROWTATE VR. Interventions ROWTATE is an individually-tailored job retention intervention, delivered by OTs, who act as case-coordinators, and CPs. It commences 12-weeks post-injury and is delivered for up to 12 months. It involves: assessing impact of injury;work-focused rehabilitation;planning/monitoring phased return-to-work;liaising with employers/healthcare team;educating patients/employers about injury impact;early identification, monitoring and support for psychological problems. Due to COVID-19, the intervention was adapted for remote delivery (video/phone call) and OTs/CPs trained in remote delivery. Main Outcome Measures Study completion. Intervention fidelity, barriers and enablers to delivery, acceptability and usefulness;acceptability of remote intervention training. Results At 6 months: 90% started intervention ≤12 weeks post-injury, 103 OT sessions (M=10.3, range 5-19);99% OT sessions delivered remotely, 6 patients referred to CP;22 sessions (M=3.7, range 1-5), 100% remote. Fidelity: OT: 90%-100% across patients, CP: 82%-100% across patients. No participant withdrawals. Treating therapists and all participants found the intervention acceptable. Conclusions Remote VR training and delivery is feasible and acceptable to OTs/CPs and trauma survivors. Findings have informed a definitive randomised controlled trial. Author(s) Disclosures No conflicting interests.

Mental health of people with multiple sclerosis during the COVID-19 outbreak: A prospective cohort and cross-sectional case-control study of the UK MS Register.

BACKGROUND: People with MS (pwMS) have had higher rates of anxiety and depression than the general population before the COVID-19 pandemic, placing them at higher risk of experiencing poor psychological wellbeing during the pandemic. OBJECTIVE: To assess mental health and its social/lifestyle determinants in pwMS during the first wave of the outbreak in the United Kingdom. METHODS: This is a community-based, prospective longitudinal cohort and cross-sectional case-control online questionnaire study. It includes 2010 pwMS from the UK MS Register and 380 people without MS. RESULTS: The Hospital Anxiety and Depression Scale scores of pwMS for anxiety and depression during the outbreak did not change from the previous year. PwMS were more likely to have anxiety (using General Anxiety Disorder-7) and/or depression (using Patient Health Questionnaire-9) than controls during the outbreak (OR: 2.14, 95% CI: 1.58-2.91). PwMS felt lonelier (OR: 1.37, 95% CI: 1.04-1.80) reported worse social support (OR: 1.90, 95% CI: 1.18-3.07) and reported worsened exercise habits (OR: 1.65, 95% CI: 1.18-2.32) during the outbreak than controls. CONCLUSION: Early in the pandemic, pwMS remained at higher risk of experiencing anxiety and depression than the general population. It is important that multidisciplinary teams improve their support for the wellbeing of pwMS, who are vulnerable to the negative effects of the pandemic on their lifestyle and social support.

Qualitative study exploring factors affecting the implementation of a vocational rehabilitation intervention in the UK major trauma pathway.

OBJECTIVES: This study aimed to: (1) understand the context for delivering a trauma vocational rehabilitation (VR) intervention; (2) identify potential barriers and enablers to the implementation of a VR intervention post-trauma. DESIGN: Qualitative study. Data were collected in person or via phone using different methods: 38 semistructured interviews, 11 informal 'walk-through care pathways' interviews, 5 focus groups (n=25), 5 codesign workshops (n=43). Data were thematically analysed using the framework approach, informed by the Consolidated Framework for Implementation Research. SETTING: Stakeholders recruited across five UK major trauma networks. PARTICIPANTS: A variety of stakeholders were recruited (n=117) including trauma survivors, rehabilitation physicians, therapists, psychologists, trauma coordinators and general practitioners. We recruited 32 service users (trauma survivors or carers) and 85 service providers. RESULTS: There were several issues associated with implementing a trauma VR intervention including: culture within healthcare/employing organisations; extent to which healthcare systems were networked with other organisations; poor transition between different organisations; failure to recognise VR as a priority; external policies and funding. Some barriers were typical implementation issues (eg, funding, policies, openness to change). This study further highlighted the challenges associated with implementing a complex intervention like VR (eg, inadequate networking/communication, poor service provision, perceived VR priority). Our intervention was developed to overcome these barriers through adapting a therapist training package, and by providing early contact with patient/employer, a psychological component alongside occupational therapy, case coordination/central point of contact, and support crossing sector boundaries (eg, between health/employment/welfare). CONCLUSIONS: Findings informed the implementation of our VR intervention within the complex trauma pathway. Although we understand how to embed it within this context, the success of its implementation needs to be measured as part of a process evaluation in a future trial.

Challenges of developing, conducting, analysing and reporting a COVID-19 study as the COVID-19 pandemic unfolds: an online co-autoethnographic study.

OBJECTIVES: To capture the complexities and unique experience of a newly formed multidisciplinary and multicentre research team developing and deploying a COVID-19 study and to identify lessons learnt. DESIGN: Co-autoethnographic study. SETTING: Staff at two UK academic institutions, a national charity and two major UK hospitals. PARTICIPANTS: Researchers, clinicians, academics, statisticians and analysts, patient and public involvement representatives and national charity. METHODS: The sampling frame was any content discussed or shared between research team members (emails, meeting minutes, etc), standard observational dimensions and reflective interviews with team members. Data were thematically analysed. RESULTS: Data from 34 meetings and >50 emails between 17 March and 5 August 2020 were analysed. The analysis yielded seven themes with 'Managing our stress' as an overarching theme. CONCLUSIONS: Mutual respect, flexibility and genuine belief that team members are doing the best they can under the circumstances are essential for completing a time-consuming study, requiring a rapid response during a pandemic. Acknowledging and managing stress and a shared purpose can moderate many barriers, such as the lack of face-to-face interactions, leading to effective team working.

COVID-19 is associated with new symptoms of multiple sclerosis that are prevented by disease modifying therapies.

BACKGROUND: Infections can trigger exacerbations of multiple sclerosis (MS). The effects of the coronavirus disease 2019 (COVID-19) on MS are not known. The aim of this study was to understand the impact of COVID-19 on new and pre-existing symptoms of MS. METHODS: The COVID-19 and MS study is an ongoing community-based, prospective cohort study conducted as part of the United Kingdom MS Register. People with MS and COVID-19 were invited by email to complete a questionnaire about their MS symptoms during the infection. An MS exacerbation was defined as developing new MS symptoms and/or worsening of pre-existing MS symptoms. RESULTS: Fifty-seven percent (230/404) of participants had an MS exacerbation during their infection; 82 developed new MS symptoms, 207 experienced worsened pre-existing MS symptoms, and 59 reported both. Disease modifying therapies (DMTs) reduced the likelihood of developing new MS symptoms during the infection (OR 0.556, 95%CI 0.316-0.978). Participants with a higher pre-COVID-19 webEDSS (web-based Expanded Disability Status Scale) score (OR 1.251, 95%CI 1.060-1.478) and longer MS duration (OR 1.042, 95%CI 1.009-1.076) were more likely to experience worsening of their pre-existing MS symptoms during the infection. CONCLUSION: COVID-19 infection was associated with exacerbation of MS. DMTs reduced the chance of developing new MS symptoms during the infection.