The Impact of COVID-19 on the Employment of People With Multiple Sclerosis: A Multiple Methods Study.

BACKGROUND: The COVID-19 pandemic led to approximately half of the working population in the United Kingdom being unable to work temporarily. This study aims to understand the employment needs and experiences of people with multiple sclerosis (MS) in the UK during this period. METHODS: Multiple methods were used, including an online survey and follow-up interviews with people with MS who were employed prior to the start of the pandemic restrictions in March 2020. RESULTS: The online survey was completed by 101 eligible participants and we interviewed 15 of them for qualitative data in the follow-up. Survey data indicated that the work experience of people with MS improved during the pandemic because they were allowed to work from home. However, participants experienced increased feelings of anxiety and loneliness. From the interviews, we extracted 5 themes: (1) the benefits of working from home; (2) the challenges of working during the COVID-19 pandemic; (3) the relevance of managers; (4) returning to "normal"; and (5) the need for vocational support. CONCLUSIONS: The pandemic showed that MS symptom management was improved by work flexibility (eg, working from home, breaks, flexible working hours); for people with MS, these accommodations improved both their ability to work and their self-perceived productivity. Future research should explore the support needs of people with MS who work remotely and determine whether pandemic-influenced work accommodations are sustainable over time.

Early vocational rehabilitation and psychological support for trauma patients to improve return to work (the ROWTATE trial): study protocol for an individually randomised controlled multicentre pragmatic trial.

BACKGROUND: Moderately severe or major trauma (injury severity score (ISS) > 8) is common, often resulting in physical and psychological problems and leading to difficulties in returning to work. Vocational rehabilitation (VR) can improve return to work/education in some injuries (e.g. traumatic brain and spinal cord injury), but evidence is lacking for other moderately severe or major trauma. METHODS: ROWTATE is an individually randomised controlled multicentre pragmatic trial of early VR and psychological support in trauma patients. It includes an internal pilot, economic evaluation, a process evaluation and an implementation study. Participants will be screened for eligibility and recruited within 12 weeks of admission to eight major trauma centres in England. A total of 722 participants with ISS > 8 will be randomised 1:1 to VR and psychological support (where needed, following psychological screening) plus usual care or to usual care alone. The ROWTATE VR intervention will be provided within 2 weeks of study recruitment by occupational therapists and where needed, by clinical psychologists. It will be individually tailored and provided for ≤ 12 months, dependent on participant need. Baseline assessment will collect data on demographics, injury details, work/education status, cognitive impairment, anxiety, depression, post-traumatic distress, disability, recovery expectations, financial stress and health-related quality of life. Participants will be followed up by postal/telephone/online questionnaires at 3, 6 and 12 months post-randomisation. The primary objective is to establish whether the ROWTATE VR intervention plus usual care is more effective than usual care alone for improving participants' self-reported return to work/education for at least 80% of pre-injury hours at 12 months post-randomisation. Secondary outcomes include other work outcomes (e.g. hours of work/education, time to return to work/education, sickness absence), depression, anxiety, post-traumatic distress, work self-efficacy, financial stress, purpose in life, health-related quality of life and healthcare/personal resource use. The process evaluation and implementation study will be described elsewhere. DISCUSSION: This trial will provide robust evidence regarding a VR intervention for a major trauma population. Evidence of a clinically and cost-effective VR intervention will be important for commissioners and providers to enable adoption of VR services for this large and important group of patients within the NHS. TRIAL REGISTRATION: ISRCTN: 43115471. Registered 27/07/2021.

Understanding barriers and facilitators to long-term participation needs in children and young people following acquired brain injuries: a qualitative multi-stakeholder study.

Background This study focused on exploring the longer-term participation needs of children and young people with acquired brain injury (CYP-ABI) and their families in one region of the UK and identifying the barriers and facilitators of their participation and well-being to inform the development of a behavioural change intervention for clinical implementation. Methods Qualitative interviews were conducted with CYP-ABI and parents. Focus groups were created with health, education, care and charity stakeholders. The International Classification of Functioning, Disability and Health (ICF) and the Behaviour Change Wheel (BCW) were used to map needs, barriers and facilitators. Results A total of 10 CYP/parent dyads (n = 20) and 17 health, education, care and charity stakeholders were included in this study. Unmet participation needs were mapped to the ICF and barriers/facilitators to the BCW. Significant unmet needs impacting CYP-ABI participation and family well-being were found. Barriers spanned 'Capability', 'Opportunity' and 'Motivation', the greatest being knowledge, skills, social influences, environmental context and resources, social identity and emotion. Facilitators included increasing awareness and understanding, supporting parents, long-term access to specialist assessment and rehabilitation, peer support and integrated collaborative pathways. Conclusion The long-term impact of ABI on CYP and families' participation and well-being were significant, with barriers spanning every sector and level of society. Implementation of collaborative, cross-sector (education, health and social care) accessible and family-centred care pathways is needed to meet the long-term needs of CYP-ABI and their families, ensuring equity of access. Multi-modal, family-centred, needs-led, theory-based interventions should be co-developed with CYP, families and stakeholders to improve the health and well-being outcomes and the lives of CYP-ABI and their families.

Child and family health-related quality of life and participation outcomes and goals after acquired brain injury: a cross-sectional survey.

OBJECTIVE: To explore longer-term health-related quality of life (HRQoL) and participation outcomes and goals of children and young people (CYP) with acquired brain injuries (ABI) and their families in a region of the UK and the impact of the COVID-19 pandemic. METHODS: Cross-sectional survey of (5-18 CYP) and their parent-carers 12-43 months following ABI. Included measures of HRQoL, participation, family function and parental wellbeing and demographic and free text questions. RESULTS: Ninety-five responses (30% response) were received. 67% of CYP were at risk of impaired HRQoL, 72% had severely impaired participation. 53% of parent-carers reported reduced HRQoL and family functioning, 37% of parent-carers screened positive for anxiety/depression. Relationships exist between CYP participation and HRQoL and parental HRQoL and family functioning. Goals were overwhelmingly activity and participation focused. Participants described the global impact of an ABI on the CYP and family as well as the additional impact of the COVID-19 pandemic on CYP and family wellbeing. CONCLUSION: ABI significantly impacts CYP participation and both CYP and parent-carer wellbeing in the long-term, potentially further impacted by the COVID-19 pandemic. Rehabilitation interventions should address both participation and the psychological wellbeing of CYP with ABI and their parent-carers.

Development of a Job Retention Vocational Rehabilitation Intervention for People with Multiple Sclerosis Following the Person-Based Approach.

OBJECTIVE: 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.

Factors influencing employers' support for employees with acquired brain injuries or mental illness to return to- and stay in work: A qualitative systematic review.

BACKGROUND: People with acquired brain injuries (ABIs) often experience residual limitations and co-morbid mental illnesses that restrict work participation. Employers are key in enabling successful return-to-work and job retention. OBJECTIVE: This review aimed to explore employers' perspectives of factors influencing their support for people with ABIs and/or mental illness to return to- and stay in work. Review questions focused on barriers and facilitators to their support, and contextual characteristics present at the time. METHODS: Five databases were searched from October 2010 until November 2023 for relevant qualitative studies published in English. Findings from included studies (N = 25) were synthesised using thematic synthesis. RESULTS: Included studies focused on employees with ABI or mental illness, rather than dually diagnosed ABI and mental illness. Employers' support was influenced by their awareness/knowledge of- and attitudes towards the employee's condition/illness; their skills and experience in supportive strategies; factors related to provision of work accommodations; and stakeholder influence. Similarities and differences in influential factors were observed across the ABI and mental illness literature. Contextual characteristics related to organisational characteristics, cultural taboo, and involvement of certain stakeholders. CONCLUSIONS: ABI survivors (with and without co-morbid mental illness) and their employers may benefit from specialist support and resources to guide them through the return-to-work process. Further research is needed to investigate employers' knowledge of ABI and mental illness and supportive strategies. Exploration of the influence of other stakeholders, socio-demographic characteristics, and contextual factors on employers' return-to-work and retention support for ABI survivors with co-morbid mental illness is warranted.

Exploring the Association between Individual-Level Attributes and Fidelity to a Vocational Rehabilitation Intervention within a Randomised Controlled Trial.

Understanding what attributes or characteristics of those delivering interventions affect intervention fidelity and patient outcomes is important for contextualising intervention effectiveness. It may also inform implementation of interventions in future research and clinical practice. This study aimed to explore the relationships between attributes of Occupational Therapists (OTs), their faithful delivery of an early stroke specialist vocational rehabilitation intervention (ESSVR), and stroke survivor return-to-work (RTW) outcomes. Thirty-nine OTs were surveyed about their experience and knowledge of stroke and vocational rehabilitation and were trained to deliver ESSVR. ESSVR was delivered across 16 sites in England and Wales between February 2018 and November 2021. OTs received monthly mentoring to support ESSVR delivery. The amount of mentoring each OT received was recorded in OT mentoring records. Fidelity was assessed using an intervention component checklist completed using retrospective case review of one randomly selected participant per OT. Linear and logistic regression analyses explored relationships between OT attributes, fidelity, and stroke survivor RTW outcome. Fidelity scores ranged from 30.8 to 100% (Mean: 78.8%, SD: 19.2%). Only OT engagement in mentoring was significantly associated with fidelity (b = 0.29, 95% CI = 0.05-0.53, p < 0.05). Increased fidelity (OR = 1.06, 95% CI = 1.01-1.1, p = 0.01) and increasing years of stroke rehabilitation experience (OR = 1.17, 95% CI = 1.02-1.35) was significantly associated with positive stroke survivor RTW outcomes. Findings of this study suggest that mentoring OTs may increase fidelity of delivery of ESSVR, which may also be associated with positive stroke survivor return-to-work outcomes. The results also suggest that OTs with more experience of stroke rehabilitation may be able to support stroke survivors to RTW more effectively. Upskilling OTs to deliver complex interventions, such as ESSVR, in clinical trials may require mentoring support in addition to training to ensure fidelity.

A mixed-methods feasibility case series of a job retention vocational rehabilitation intervention for people with multiple sclerosis.

PURPOSE: To ascertain the feasibility and acceptability of delivering a job retention vocational rehabilitation intervention [MSVR] for people with multiple sclerosis (pwMS) in a community setting. Secondary objectives included determining whether MSVR was associated with changes in quality of life, fatigue, mood, cognition, workplace accommodations, work instability, work self-efficacy, and goal attainment. METHODS: Single-centre mixed-methods feasibility case series. RESULTS: 15 pwMS and three employers received 8.36 (SD = 4.48) and 1.94 (SD = 0.38) hours of MSVR respectively over three months. The intervention predominantly addressed managing cognition, fatigue, and negotiating reasonable accommodations. Four healthcare professionals were recruited to clarify clinical information.The intervention was feasible to deliver, and there was a significant positive impact on goal attainment immediately following MSVR (t(14) = 7.44, p = .0001, d = 1.9), and at months 3 (t(13) = 4.81, p = .0001, d = 1.28), 6 (t(11) = 4.45, p = .001, d = 1.28), and 12 (t(9) = 5.15, p = .001, d = -2.56). There was no impact on quality of life, fatigue, mood, cognition, workplace accommodations, work instability, and work self-efficacy. In post-intervention interviews, participants reported that MSVR was acceptable. Four themes were derived regarding the context, employer engagement, empowerment through knowledge, and intervention components and attributes. CONCLUSION: It was feasible and acceptable to deliver MSVR. Participants better understood their MS, became more confident managing problems at work and attained their work-related goals.IMPLICATIONS FOR REHABILITATIONPeople with multiple sclerosis (MS) experience problems at work because of the interaction between symptoms and environmental factors (e.g., co-workers' attitudes).Vocational rehabilitation for people with MS and their employers should be tailored in terms of content and intensity.People with MS can be empowered at work by learning about MS and how their symptoms fluctuate over time.Understanding legal responsibilities and examples of accommodations at work can be beneficial for employers.

Developing an implementation fidelity checklist for a vocational rehabilitation intervention.

BACKGROUND: Despite growing numbers of studies reporting the efficacy of complex interventions and their implementation, many studies fail to report information on implementation fidelity or describe how fidelity measures used within the study were developed. This study aimed to develop a fidelity checklist for measuring the implementation fidelity of an early, stroke-specialist vocational rehabilitation intervention (ESSVR) in the RETAKE trial. METHODS: To develop the fidelity measure, previous checklists were reviewed to inform the assessment structure, and core intervention components were extracted from intervention descriptions into a checklist, which was ratified by eight experts in fidelity measurement and complex interventions. Guidance notes were generated to assist with checklist completion. To test the measure, two researchers independently applied the checklist to fifteen stroke survivor intervention case notes using retrospective observational case review. The scoring was assessed for interrater reliability. RESULTS: A fidelity checklist containing 21 core components and 6 desirable components across 4 stages of intervention delivery was developed with corresponding guidance notes. Interrater reliability of each checklist item ranged from moderate to perfect (Cohen's kappa 0.69-1). CONCLUSIONS: The resulting checklist to assess implementation fidelity is fit for assessing the delivery of vocational rehabilitation for stroke survivors using retrospective observational case review. The checklist proved its utility as a measure of fidelity and may be used to inform the design of future implementation strategies. TRIAL REGISTRATION: ISRCTN, ISRCTN12464275. Registered on 13 March 2018.

The Workwell trial: protocol for the process evaluation of a randomised controlled trial of job retention vocational rehabilitation for employed people with inflammatory arthritis.

BACKGROUND: The Workwell trial is a multi-centre randomised controlled trial with the aims of evaluating the effectiveness and cost-effectiveness of job retention vocational rehabilitation for employed people with inflammatory arthritis, who are experiencing work difficulties due to their arthritis. Vocational rehabilitation is delivered by health service occupational therapists, who have received additional training in providing this Workwell intervention. A process evaluation will be undertaken alongside the main trial to investigate implementation fidelity; understand key stakeholders' perspectives of the intervention and the social and structural context in which the intervention is provided; and explore issues related to future implementation in clinical practice. This protocol describes the aims, objectives, and methodology of the Workwell trial process evaluation. METHODS: This mixed methods process evaluation will follow the Medical Research Council's Guidance on process evaluations for complex interventions. It will be underpinned by the conceptual framework for implementation fidelity (CFIF) and normalisation process theory (NPT). We will analyse treatment records, work assessments, and treatment notes to ascertain implementation fidelity. Semi-structured interviews with trial participants, their employer/line managers, treating therapists, and their therapy service managers will be undertaken to explore perceptions of the intervention, contextual factors, and potential for future implementation in practice. Interview topic guides will be informed by NPT. Therapists' views about Workwell training will be explored via questionnaires following training, and interviews and focus groups following treatment delivery to inform future implementation. Quantitative data will be analysed descriptively. Qualitative data will be analysed using thematic analysis. NPT will guide data analysis and interpretation. Findings from the different elements of this embedded design process evaluation will be reported separately and then the elements integrated. The process evaluation data will be analysed independently of the Workwell trial outcome evaluation. The process evaluation data will then be reviewed in the light of the trial findings. DISCUSSION: Few trials of job retention vocational rehabilitation in arthritis have included process evaluations. This process evaluation will assist in understanding factors influencing trial outcomes and identifying potential contextual barriers and facilitators for the potential implementation of Workwell vocational rehabilitation into clinical services. TRIAL REGISTRATION: ClinicalTrials.gov NCT03942783 . Registered on 08 May 2019. ISRCTN Registry ISRCTN61762297 . Registered on 13 May 2019. Retrospectively registered.

A Tailored Occupational Therapist-Led Vocational Intervention for People With Stroke: Protocol for a Pilot Randomized Controlled Trial.

BACKGROUND: Resuming work after stroke is a common goal of working-age adults, yet there are few vocational rehabilitation programs designed to address the unique challenges faced following stroke. The Work intervention was developed to address these gaps. OBJECTIVE: This paper presents a protocol that outlines the steps that will be undertaken to pilot both the intervention and trial processes for the Work trial. METHODS: The Work trial is a 2-arm, prospective, randomized, blinded-assessor study with intention-to-treat analysis. A total of 54 adults of working age who have experienced a stroke <4 months prior will be randomized 1:1 to either (1) an experimental group who will receive a 12-week early vocational intervention (Work intervention) plus usual clinical rehabilitation or (2) a control group who will receive only their usual clinical rehabilitation. RESULTS: Outcomes include study and intervention feasibility and intervention benefit. In addition to evaluating the feasibility of delivering vocational intervention early after stroke, benefit will be assessed by measuring rates of vocational participation and quality-of-life improvements at the 3- and 6-month follow-ups. Process evaluation using data collected during the study, as well as postintervention individual interviews with participants and surveys with trial therapists, will complement quantitative data. CONCLUSIONS: The results of the trial will provide details on the feasibility of delivering the Work intervention embedded within the clinical rehabilitation context and inform future trial processes. Pilot data will enable a future definitive trial to determine the clinical effectiveness of vocational rehabilitation when delivered in the early subacute phase of stroke recovery. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry ACTRN12619001164189; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=378112&isReview=true. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/40548.

Developing a method to assess fidelity to a complex vocational rehabilitation intervention in the FRESH trial: a feasibility study.

BACKGROUND: Determining whether complex rehabilitation interventions are delivered with fidelity is important. Implementation fidelity can differ between sites, therapists delivering interventions and, over time, threatening trial outcomes and increasing the risk of type II and III errors. This study aimed to develop a method of assessing occupational therapists' fidelity to deliver a complex, individually tailored vocational rehabilitation (VR) intervention to people with traumatic brain injury (TBI) and assess the feasibility of its use in a randomised controlled trial. METHODS: Using mixed methods and drawing on the intervention logic model, we developed data collection tools to measure fidelity to early specialist TBI VR (ESTVR). Fidelity was measured quantitatively using intervention case report forms (CRF), fidelity checklists and clinical records. Qualitative data from mentoring records, interviews with intervention therapists, participants with TBI, employers and NHS staff at trial sites explored moderators of implementation fidelity. The conceptual framework of implementation fidelity (CFIF) guided measurement and analysis of and factors affecting fidelity. Data were triangulated and benchmarked against an earlier cohort study. RESULTS: Fidelity to a complex individually tailored VR intervention could be measured. Overall, OTs delivered ESTVR with fidelity. Different fidelity measures answered different questions, offering unique insights into fidelity. Fidelity was best assessed using a fidelity checklist, intervention CRFs and clinical notes. The OT clinical notes and mentoring records were best at identifying fidelity moderating factors. Interviews added little insight into fidelity moderating factors over and above mentoring or clinical records. Data triangulation offered a comprehensive assessment of fidelity, highlighting limitations of measurement methods and learning for future trials but was resource intensive. Interviews, fidelity visits and analysing clinical notes were also resource intense. Comparing fidelity data to a benchmark and using CFIF as a framework for organising the fidelity assessment helped. CONCLUSIONS: OTs delivered the VR intervention with fidelity. A fidelity checklist and benchmark plus mentoring may offer a practical and effective way of measuring fidelity and identifying fidelity moderating factors in trials of complex individually-tailored rehabilitation interventions. Mentoring provided real-time indicators of and reasons for fidelity deviations. These methods require further evaluation. TRIAL REGISTRATION: ISRCTN Registry, ISRCTN38581822 (Registered: 02/01/2014).

RETurn to work After stroKE (RETAKE) Trial: protocol for a mixed-methods process evaluation using normalisation process theory.

OBJECTIVES: This mixed-method process evaluation underpinned by normalisation process theory aims to measure fidelity to the intervention, understand the social and structural context in which the intervention is delivered and identify barriers and facilitators to intervention implementation. SETTING: RETurn to work After stroKE (RETAKE) is a multicentre individual patient randomised controlled trial to determine whether Early Stroke Specialist Vocational Rehabilitation (ESSVR) plus usual care is a clinically and cost-effective therapy to facilitate return to work after stroke, compared with usual care alone. This protocol paper describes the embedded process evaluation. PARTICIPANTS AND OUTCOME MEASURES: Intervention training for therapists will be observed and use of remote mentor support reviewed through documentary analysis. Fidelity will be assessed through participant questionnaires and analysis of therapy records, examining frequency, duration and content of ESSVR sessions. To understand the influence of social and structural contexts, the process evaluation will explore therapists' attitudes towards evidence-based practice, competency to deliver the intervention and evaluate potential sources of contamination. Longitudinal case studies incorporating non-participant observations will be conducted with a proportion of intervention and usual care participants. Semistructured interviews with stroke survivors, carers, occupational therapists, mentors, service managers and employers will explore their experiences as RETAKE participants. Analysis of qualitative data will draw on thematic and framework approaches. Quantitative data analysis will include regression models and descriptive statistics. Qualitative and quantitative data will be independently analysed by process evaluation and Clinical Trials Research Unit teams, respectively. Linked data, for example, fidelity and describing usual care will be synthesised by comparing and integrating quantitative descriptive data with the qualitative findings. ETHICS AND DISSEMINATION: Approval obtained through the East Midlands-Nottingham 2 Research Ethics Committee (Ref: 18/EM/0019) and the National Health ServiceResearch Authority. Dissemination via journal publications, stroke conferences, social media and meetings with national Stroke clinical leads. TRIAL REGISTRATION NUMBER: ISRCTN12464275.

Psychosocial consequences of diagnosing nonspecific low-back pain radiologically: a qualitative study.

BACKGROUND: Chronic low back pain (CLBP) is a complex biopsychosocial problem with financial implications for society. Most LBP is categorized as nonspecific CLBP (NS-CLBP); magnetic resonance imaging (MRI) is increasingly used in the investigation of LBP but has a high false-positive rate for NS-CLBP. PURPOSE: To explore the psychosocial factors associated with diagnosing NS-CLBP by MRI in Saudi Arabia. METHODS: Using a qualitative design, 11 patients with CLBP without a clear medical diagnosis who had received an MRI scan were interviewed using a semi-structured technique, and transcripts were analyzed using framework analysis. RESULTS: Four themes of relevance to the psychosocial consequences of using MRI to diagnose CLBP were identified: 1) impact on social participation after MRI diagnosis; 2) psychological impact of MRI diagnosis; 3) conflicting advice; and 4) patient education. Although some patients expressed a sense of relief following the identification of an objective explanation of their symptoms by MRI, a number of negative consequences were also identified. In particular, fear-avoidance behavior and anxiety were apparent. CONCLUSION: The use of MRI scanning in the diagnosis of LBP may lead to psychosocial factors influencing participation in physical and social daily activities.

Embedding mentoring to support trial processes and implementation fidelity in a randomised controlled trial of vocational rehabilitation for stroke survivors.

BACKGROUND: Little guidance exists regarding how best to upskill and support those delivering complex healthcare interventions to ensure robust trial outcomes and implementation fidelity. Mentoring was provided to occupational therapists (OTs) delivering a complex vocational rehabilitation (VR) intervention to stroke survivors. This study aimed to explore mentors' roles in supporting OTs with intervention delivery and fidelity, and to describe factors affecting the mentoring process and intervention delivery. METHODS: Quantitative data (duration, mode and total time of mentoring support) was extracted from mentoring records and emails between mentors and OTs, alongside qualitative data on barriers and facilitators to intervention delivery. Semi-structured interviews with mentors (n = 6) and OTs (n = 19) explored experiences and perceptions of intervention training, delivery and the mentoring process. Mean total and monthly time spent mentoring were calculated per trial site. Qualitative data were analysed thematically. RESULTS: Forty-one OTs across 16 sites were mentored between March 2018 and April 2020. Most mentoring was provided by phone or Microsoft Teams (range: 88.6-100%), with the remainder via email and SMS (Short Message Service) text messages. Mentors suggested strategies to enhance trial recruitment, improved OTs' understanding of- and adherence to trial processes, intervention delivery and fidelity, and facilitated independent problem-solving. Barriers to mentoring included OT non-attendance at mentoring sessions and mentors struggling to balance mentoring with clinical roles. Facilitators included support from the trial team and mentors having protected time for mentoring. CONCLUSIONS: Mentoring supported mentee OTs in various ways, but it remains unclear to what extent the OTS would have been able to deliver the intervention without mentoring support, or how this might have impacted fidelity. Successful implementation of mentoring alongside new complex interventions may increase the likelihood of intervention effectiveness being observed and sustained in real-life contexts. Further research is needed to investigate how mentors could be selected, upskilled, funded and mentoring provided to maximise impact. The clinical- and cost-effectiveness of mentoring as an implementation strategy and its impact on fidelity also requires testing in a future trial. TRIAL REGISTRATION: ISRCTN, ISRCTN12464275 . Registered on 13th March 2018.

Vocational rehabilitation to enhance return to work after trauma (ROWTATE): protocol for a non-randomised single-arm mixed-methods feasibility study.

BACKGROUND: Traumatic injuries are common amongst working-age adults. Survivors often experience physical and psychological problems, reduced quality of life and difficulty returning to work. Vocational rehabilitation improves work outcomes for a range of conditions but evidence of effectiveness for those with traumatic injuries is lacking. This study assesses feasibility of delivering a vocational rehabilitation intervention to enhance return to work and improve quality of life and wellbeing in people with at least moderate trauma to inform design of a definitive randomised controlled trial (RCT). METHODS: Non-randomised, single-arm, multi-centre mixed-methods feasibility study with nested case studies and qualitative study. The case studies comprise interviews, observations of clinical contacts and review of clinical records. The qualitative study comprises interviews and/or focus groups. Participants will be recruited from two UK major trauma centres. Participants will comprise 40 patients aged 16-69 with an injury severity score of > 8 who will receive the intervention and complete questionnaires. Interviews will be conducted with 10 patients and their occupational therapists (OTs), clinical psychologists (CPs), employers and commissioners of rehabilitation services. Fidelity will be assessed in up to six patients by observations of OT and CP-patient contacts, review of patient records and intervention case report forms. OT and CP training will be evaluated using questionnaires and competence to deliver the intervention assessed using a team objective structured clinical examination and written task. Patients participating in and those declining participation in the study will be invited to take part in interviews/focus groups to explore barriers and facilitators to recruitment and retention. Outcomes include recruitment and retention rates, intervention fidelity, OT and CP competence to deliver the intervention, experiences of delivering or receiving the intervention and factors likely to influence definitive trial delivery. DISCUSSION: Effective vocational rehabilitation interventions to enhance return to work amongst trauma patients are urgently needed because return to work is often delayed, with detrimental effects on health, financial stability, healthcare resource use and wider society. This protocol describes a feasibility study delivering a complex intervention to enhance return to work in those with at least moderate trauma. TRIAL REGISTRATION: ISRCTN: 74668529 . Prospectively registered on 23 January 20.

Feasibility study and process evaluation of MRI plus physiotherapy vs. physiotherapy alone in non-specific chronic low back pain among patients in Saudi Arabia.

AIM: To determine the feasibility of conducting a definitive randomised control trial (RCT) to answer the following questions: (1) Is early physiotherapy treatment acceptable and feasible for patients and direct healthcare providers? and (2) Is early physiotherapy intervention associated with better disability and psychosocial outcomes compared with the practice of routine MRIs? METHODS: In a feasibility RCT in Riyadh City from 01 March 2018 until 29 July 2018, chronic low back pain (CLBP) patients presenting to spine clinics were randomised to receive an MRI (intervention) plus physiotherapy rehabilitation or physiotherapy alone (control group). The acceptability of randomisation to the control group (non-MRI) was tested during the recruitment by qualitatively interviewing study participants and referring physicians. Moreover, interviews with study participants explored the broader social, political, economic, and environmental (context) aspects that may influence trial delivery and intervention implementation. RESULTS: The recruitment target was not met: 16/24 (66%) participants were recruited in 4 months (12.4% of those screened); 33% declined. The process evaluation identified numerous factors that may affect the success of a definitive RCT in Saudi Arabia. These were research resources, the lack of research infrastructure to support recruitment to trials, limited research capacity in terms of knowledge and skills of the healthcare team, and limited funding. CONCLUSION: A definitive RCT to test the influence of MRI diagnosis on the psychosocial and disability outcomes in people with CLBP treated with physiotherapy in Saudi Arabia is feasible. However, the lack of research infrastructure, research capacity, the impact of MRI on patient outcomes, and a lack of clinical equipoise in the treatment and management of CLBP in Saudi Arabia pose major barriers to clinical trials.

An individually randomised controlled multi-centre pragmatic trial with embedded economic and process evaluations of early vocational rehabilitation compared with usual care for stroke survivors: study protocol for the RETurn to work After stroKE (RETAKE) trial.

BACKGROUND: Return to work (RTW) is achieved by less than 50% of stroke survivors. The rising incidence of stroke among younger people, the UK economic forecast, and clinical drivers highlight the need for stroke survivors to receive support with RTW. However, evidence for this type of support is lacking. This randomised controlled trial (RCT) will investigate whether Early Stroke Specialist Vocational Rehabilitation (ESSVR) plus usual care (UC) (i.e. usual NHS rehabilitation) is more clinically and cost-effective for supporting post-stroke RTW, than UC alone. METHODS: Seven hundred sixty stroke survivors and their carers will be recruited from approximately 20 NHS stroke services. A 5:4 allocation ratio will be employed to randomise participants to receive ESSVR plus UC, or UC alone. The individually tailored ESSVR intervention will commence within 12 weeks of stroke onset and be delivered for up to 12 months as necessary by trained RETAKE occupational therapists in the community, participants' homes or workplaces, and outpatient/inpatient therapy settings, via telephone, email, or SMS text message. Outcome data will be collected via self-report questionnaires administered by post or online at 3, 6, and 12 months follow-up. The primary outcome will be self-reported RTW and job retention at 12 months (minimum 2 h/week). Secondary outcomes will include mood, function, participation, health-related quality of life, confidence, intervention compliance, health and social care resource use, and mortality. An embedded economic evaluation will estimate cost-effectiveness and cost-utility analyses from National Health Service (NHS) and Personal Social Services (PSS) perspectives. An embedded process evaluation will employ a mixed methods approach to explore ESSVR implementation, contextual factors linked to outcome variation, and factors affecting NHS roll-out. DISCUSSION: This article describes the protocol for a multi-centre RCT evaluating the clinical- and cost-effectiveness of an early vocational rehabilitation intervention aimed at supporting adults to return to work following a stroke. Evidence favouring the ESSVR intervention would support its roll-out in NHS settings. TRIAL REGISTRATION: ISRCTN, ISRCTN12464275 . Registered on 26 February 2018.

Factors affecting the delivery of complex rehabilitation interventions in research with neurologically impaired adults: a systematic review.

BACKGROUND: Rehabilitation research does not always improve patient outcomes because of difficulties implementing complex health interventions. Identifying barriers and facilitators to implementation fidelity is critical. Not reporting implementation issues wastes research resources and risks erroneously attributing effectiveness when interventions are not implemented as planned, particularly progressing from single to multicentre trials. The Consolidated Framework for Implementation Research (CFIR) and Conceptual Framework for Implementation Fidelity (CFIF) facilitate identification of barriers and facilitators. This review sought to identify barriers and facilitators (determinants) affecting implementation in trials of complex rehabilitation interventions for adults with long-term neurological conditions (LTNC) and describe implementation issues. METHODS: Implementation, complex health interventions and LTNC search terms were developed. Studies of all designs were eligible. Searches involved 11 databases, trial registries and citations. After screening titles and abstracts, two reviewers independently shortlisted studies. A third resolved discrepancies. One reviewer extracted data in two stages; 1) descriptive study data, 2) units of text describing determinants. Data were synthesised by (1) mapping determinants to CFIF and CFIR and (2) thematic analysis. RESULTS: Forty-three studies, from 7434 records, reported implementation determinants; 41 reported both barriers and facilitators. Most implied determinants but five used implementation theory to inform recording. More barriers than facilitators were mapped onto CFIF and CFIR constructs. "Patient needs and resources", "readiness for implementation", "knowledge and beliefs about the intervention", "facilitation strategies", "participant responsiveness" were the most frequently mapped constructs. Constructs relating to the quality of intervention delivery, organisational/contextual aspects and trial-related issues were rarely tapped. Thematic analysis revealed the most frequently reported determinants related to adherence, intervention perceptions and attrition. CONCLUSIONS: This review has described the barriers and facilitators identified in studies implementing complex interventions for people with LTNCs. Early adoption of implementation frameworks by trialists can simplify identification and reporting of factors affecting delivery of new complex rehabilitation interventions. It is vital to learn from previous experiences to prevent unnecessary repetitions of implementation failure at both trial and service provision levels. Reported facilitators can provide strategies for overcoming implementation issues. Reporting gaps may be due to the lack of standardised reporting methods, researcher ignorance and historical reporting requirements. SYSTEMIC REVIEW REGISTRATION: PROSPERO CRD42015020423.

Describing Return to Work after Stroke: A Feasibility Trial of 12-month Outcomes.

OBJECTIVE: Stroke is the greatest cause of disability in adults. A quarter of strokes affect people of working age, yet under half return to work after stroke. There has been little investigation into what constitutes "return to work" following stroke. The aim of this study is to describe the work metrics of stroke survivor participants in a feasibility randomized controlled trial of an early stroke-specific vocational rehabilitation intervention. METHODS: Retrospective analysis of trial data. Metrics on work status, working hours, workplace accommodations and costs were extracted from trial outcomes gathered by postal questionnaire at 3, 6, and 12 months' post-randomization for 46 stroke participants in a feasibility randomized controlled trial. Participants were randomized to receive vocational rehabilitation (intervention) or usual care (control). RESULTS: Two-thirds (n = 29; 63%) of participants returned to work at some point in the 12 months following stroke. Participants took a mean of 90 days to return to work. Most returned to the same role with an existing employer. Only one-third of participants who were employed full-time at stroke onset were working full-time at 12 months post-stroke. Most participants experienced a reduction in pre-stroke earnings. Workplace accommodations were more common among intervention group participants. More intervention participants than control participants reported satisfaction with work at both 6 and 12 months post-randomization.  Conclusion: This study illustrates the heterogeneous nature of return to work and the dramatic impact of stroke on work status, working hours and income. Longitudinal research should explore the socioeconomic legacy of stroke and include clear definitions of work and accurate measures of working hours and income from all sources.