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.

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.

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.

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.

Improving the Development, Monitoring and Reporting of Stroke Rehabilitation Research: Consensus-Based Core Recommendations from the Stroke Recovery and Rehabilitation Roundtable.

Recent reviews have demonstrated that the quality of stroke rehabilitation research has continued to improve over the last four decades but despite this progress, there are still many barriers in moving the field forward. Rigorous development, monitoring and complete reporting of interventions in stroke trials are essential in providing rehabilitation evidence that is robust, meaningful and implementable. An international partnership of stroke rehabilitation experts committed to develop consensus-based core recommendations with a remit of addressing the issues identified as limiting stroke rehabilitation research in the areas of developing, monitoring and reporting stroke rehabilitation interventions. Work exploring each of the three areas took place via multiple teleconferences and a two-day meeting in Philadelphia in May 2016. A total of 15 recommendations were made. To validate the need for the recommendations, the group reviewed all stroke rehabilitation trials published in 2015 (n=182 papers). Our review highlighted that the majority of publications did not clearly describe how interventions were developed or monitored during the trial. In particular, under-reporting of the theoretical rationale for the intervention and the components of the intervention call into question many interventions that have been evaluated for efficacy. More trials were found to have addressed the reporting of interventions recommendations than those related to development or monitoring. Nonetheless, the majority of reporting recommendations were still not adequately described. To progress the field of stroke rehabilitation research and to ensure stroke patients receive optimal evidence-based clinical care, we urge the research community to endorse and adopt our recommendations.

A systematic review of peer mentoring interventions for people with traumatic brain injury.

OBJECTIVE: This systematic review sought evidence concerning the effectiveness of peer mentoring for people with traumatic brain injury. DATA SOURCES: Fourteen electronic databases were searched, including PsycINFO, MEDLINE, CINAHL, EMBASE and the Cochrane Library, from inception to September 21 2016. Ten grey literature databases, PROSPERO, two trials registers, reference lists and author citations were also searched. REVIEW METHODS: Studies which employed a model of one-to-one peer mentoring between traumatic brain injury survivors were included. Two reviewers independently screened all titles and abstracts before screening full texts of shortlisted studies. A third reviewer resolved disagreements. Two reviewers independently extracted data and assessed studies for quality and risk of bias. RESULTS: The search returned 753 records, including one identified through hand searching. 495 records remained after removal of duplicates and 459 were excluded after screening. Full texts were assessed for the remaining 36 studies and six met the inclusion criteria. All were conducted in the United States between 1996 and 2012 and employed a variety of designs including two randomised controlled trials. A total of 288 people with traumatic brain injury participated in the studies. No significant improvements in social activity level or social network size were found, but significant improvements were shown in areas including behavioural control, mood, coping and quality of life. CONCLUSION: There is limited evidence for the effectiveness of peer mentoring after traumatic brain injury. The available evidence comes from small-scale studies, of variable quality, without detailed information on the content of sessions or the 'active ingredient' of the interventions.

Improving the development, monitoring and reporting of stroke rehabilitation research: Consensus-based core recommendations from the Stroke Recovery and Rehabilitation Roundtable.

Recent reviews have demonstrated that the quality of stroke rehabilitation research has continued to improve over the last four decades but despite this progress, there are still many barriers in moving the field forward. Rigorous development, monitoring and complete reporting of interventions in stroke trials are essential in providing rehabilitation evidence that is robust, meaningful and implementable. An international partnership of stroke rehabilitation experts committed to develop consensus-based core recommendations with a remit of addressing the issues identified as limiting stroke rehabilitation research in the areas of developing, monitoring and reporting stroke rehabilitation interventions. Work exploring each of the three areas took place via multiple teleconferences and a two-day meeting in Philadelphia in May 2016. A total of 15 recommendations were made. To validate the need for the recommendations, the group reviewed all stroke rehabilitation trials published in 2015 (n = 182 papers). Our review highlighted that the majority of publications did not clearly describe how interventions were developed or monitored during the trial. In particular, under-reporting of the theoretical rationale for the intervention and the components of the intervention call into question many interventions that have been evaluated for efficacy. More trials were found to have addressed the reporting of interventions recommendations than those related to development or monitoring. Nonetheless, the majority of reporting recommendations were still not adequately described. To progress the field of stroke rehabilitation research and to ensure stroke patients receive optimal evidence-based clinical care, we urge the research community to endorse and adopt our recommendations.

Facilitating return to work through early specialist health-based interventions (FRESH): protocol for a feasibility randomised controlled trial.

BACKGROUND: Over one million people sustain traumatic brain injury each year in the UK and more than 10 % of these are moderate or severe injuries, resulting in cognitive and psychological problems that affect the ability to work. Returning to work is a primary rehabilitation goal but fewer than half of traumatic brain injury survivors achieve this. Work is a recognised health service outcome, yet UK service provision varies widely and there is little robust evidence to inform rehabilitation practice. A single-centre cohort comparison suggested better work outcomes may be achieved through early occupational therapy targeted at job retention. This study aims to determine whether this intervention can be delivered in three new trauma centres and to conduct a feasibility, randomised controlled trial to determine whether its effects and cost effectiveness can be measured to inform a definitive trial. METHODS/DESIGN: Mixed methods study, including feasibility randomised controlled trial, embedded qualitative studies and feasibility economic evaluation will recruit 102 people with traumatic brain injury and their nominated carers from three English UK National Health Service (NHS) trauma centres. Participants will be randomised to receive either usual NHS rehabilitation or usual rehabilitation plus early specialist traumatic brain injury vocational rehabilitation delivered by an occupational therapist. The primary objective is to assess the feasibility of conducting a definitive trial; secondary objectives include measurement of protocol integrity (inclusion/exclusion criteria, intervention adherence, reasons for non-adherence) recruitment rate, the proportion of eligible patients recruited, reasons for non-recruitment, spectrum of TBI severity, proportion of and reasons for loss to follow-up, completeness of data collection, gains in face-to-face Vs postal data collection and the most appropriate methods of measuring primary outcomes (return to work, retention) to determine the sample size for a larger trial. DISCUSSION: To our knowledge, this is the first feasibility randomised controlled trial of a vocational rehabilitation health intervention specific to traumatic brain injury. The results will inform the design of a definitive trial. TRIAL REGISTRATION: The trial is registered ISRCTN Number 38581822.

A prospective study of cognitive tests to predict performance on a standardised road test in people with dementia.

OBJECTIVE: Previous work by Lincoln and colleagues produced a cognitive test battery for predicting safety to drive in people with dementia. The aim was to check the accuracy of this battery and assess whether it could be improved by shortening it, including additional cognitive tests, and a measure of previous driving. METHODS: Participants with dementia, who were driving, were recruited. They were assessed on cognitive tests including measures of concentration, executive function, visuospatial perception, verbal recognition memory, and speed of information processing. Patients were then assessed on the Nottingham Neurological Driving Assessment (NNDA) by an approved driving instructor (ADI), blind to cognitive test results. RESULTS: Seventy-five patients were recruited and completed the cognitive tests. Of these, 65 were assessed on the road. These participants were aged 59-88 (mean = 75.2, SD = 6.8) and 49 were men. Time driving varied from 19 to 73 years (mean = 52.5, SD = 10.0). Thirteen participants were unsafe and 52 safe to drive. Using a cut-off of > 0 to indicate safety to drive, the original predictive equations correctly classified 48 (76.2%) of 63 participants with complete data. Logistic regression including additional tests reduced misclassifications. CONCLUSIONS: A lower proportion of participants were found to be unsafe on the road than in previous studies. Nevertheless, the previously identified equation predicted safety to drive in most patients. Including additional tests reduced the misclassification rate but requires independent validation. We suggest that the cognitive test battery might be used in clinical practice to identify patients with dementia who would benefit from on-road assessment.

Concurrent validity of the stroke drivers screening assessment.

OBJECTIVE: To determine the concurrent validity of the Stroke Drivers Screening Assessment (SDSA). DESIGN: Comparison of the SDSA with criterion standards. SETTING: Subjects' homes in the community in the United Kingdom. PARTICIPANTS: Ninety-three stroke patients (age range, 22-83y) who were referred for assessment of fitness to drive or who had been driving before their stroke. Participants were assessed a median of 5 months post stroke. INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: Patients were assessed on the SDSA and tests of visuospatial ability (Visual Object and Space Perception [VOSP] Battery), executive abilities (Stroop Neuropsychological Screening Test, Trail-Making Test [TMT], Cognitive Estimates Test [CET]), and visual memory (Recognition Memory Tests [RMT], Verbal Descriptions of Road Signs [VDRS]). RESULTS: The SDSA subtests all correlated significantly with the Stroop test (P<.001) and TMT (P<.001), which suggests that they measure executive abilities and attention. The SDSA Dot Cancellation (DC) also correlated significantly with the VDRS (P<.01). The SDSA Square Matrices (SM) test correlated significantly with the VOSP cube analysis (P< or =.01) and the RMT faces subtest (P<.001), which suggests that the SM test also measures visuospatial abilities and visual memory. The SDSA Road Sign Recognition (RSR) test also correlated significantly with the VOSP cube analysis (P<.05), which suggests that the RSR test also measures visuospatial abilities. Factor analysis produced a 2-factor solution with DC time, SM compass, and RSR all loading on factor 1, together with the Stroop and TMT. This factor was interpreted as "executive abilities and attention." The RMT faces subtest and CET loaded onto a second factor. CONCLUSIONS: The SDSA seems to measure predominantly attention and executive abilities, which have previously been shown to be important determinants of safety to drive. This may account for the high predictive validity of the SDSA.