Early, specialist vocational rehabilitation to facilitate return to work after traumatic brain injury: the FRESH feasibility RCT.

BACKGROUND: Up to 160,000 people incur traumatic brain injury (TBI) each year in the UK. TBI can have profound effects on many areas of human functioning, including participation in work. There is limited evidence of the clinical effectiveness and cost-effectiveness of vocational rehabilitation (VR) after injury to promote early return to work (RTW) following TBI. OBJECTIVE: To assess the feasibility of a definitive, multicentre, randomised controlled trial (RCT) of the clinical effectiveness and cost-effectiveness of early, specialist VR plus usual care (UC) compared with UC alone on work retention 12 months post TBI. DESIGN: A multicentre, feasibility, parallel-group RCT with a feasibility economic evaluation and an embedded mixed-methods process evaluation. Randomisation was by remote computer-generated allocation. SETTING: Three NHS major trauma centres (MTCs) in England. PARTICIPANTS: Adults with TBI admitted for > 48 hours and working or studying prior to injury. INTERVENTIONS: Early specialist TBI VR delivered by occupational therapists (OTs) in the community using a case co-ordination model. MAIN OUTCOME MEASURES: Self-reported RTW 12 months post randomisation, mood, functional ability, participation, work self-efficacy, quality of life and work ability. Feasibility outcomes included recruitment and retention rates. Follow-up was by postal questionnaires in two centres and face to face in one centre. Those collecting data were blind to treatment allocation. RESULTS: Out of 102 target participants, 78 were recruited (39 randomised to each arm), representing 39% of those eligible and 5% of those screened. Approximately 2.2 patients were recruited per site per month. Of those, 56% had mild injuries, 18% had moderate injuries and 26% had severe injuries. A total of 32 out of 45 nominated carers were recruited. A total of 52 out of 78 (67%) TBI participants responded at 12 months (UC, n = 23; intervention, n = 29), completing 90% of the work questions; 21 out of 23 (91%) UC respondents and 20 out of 29 (69%) intervention participants returned to work at 12 months. Two participants disengaged from the intervention. Face-to-face follow-up was no more effective than postal follow-up. RTW was most strongly related to social participation and work self-efficacy. It is feasible to assess the cost-effectiveness of VR. Intervention was delivered as intended and valued by participants. Factors likely to affect a definitive trial include deploying experienced OTs, no clear TBI definition or TBI registers, and repatriation of more severe TBI from MTCs, affecting recruitment of those most likely to benefit/least likely to drop out. LIMITATIONS: Target recruitment was not reached, but mechanisms to achieve this in future studies were identified. Retention was lower than expected, particularly in UC, potentially biasing estimates of the 12-month RTW rate. CONCLUSIONS: This study met most feasibility objectives. The intervention was delivered with high fidelity. When objectives were not met, strategies to ensure feasibility of a full trial were identified. Future work should test two-stage recruitment and include resources to recruit from 'spokes'. A broader measure covering work ability, self-efficacy and participation may be a more sensitive outcome. TRIAL REGISTRATION: Current Controlled Trials ISRCTN38581822. FUNDING: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 22, No. 33. See the NIHR Journals Library website for further project information.

Identifying gaps for research prioritisation: Global burden of external causes of injury as reflected in the Cochrane Database of Systematic Reviews.

IMPORTANCE: Burden of disease should impact research prioritisation. OBJECTIVE: To analyse the Cochrane Database of Systematic Reviews (CDSR) and determine whether systematic reviews and protocols accurately represent disease burden, as measured by disability-adjusted life years (DALYs) from the Global Burden of Disease (GBD) 2010 Study. METHODS: Two investigators collected GBD disability metrics for 12 external causes of injury in the GBD 2010 Study. These external causes were then assessed for systematic review and protocol representation in CDSR. Data was collected during the month of April 2015. There were no study participants aside from the researchers. Percentage of total 2010 DALYs, 2010 DALY rank, and median DALY percent change from 1990 to 2010 of the 12 external causes of injury were compared with CDSR representation of systematic reviews and protocols. Data were analysed for correlation using Spearman rank correlation. RESULTS: Eleven of the 12 causes were represented by at least one systematic review or protocol in CDSR; the category collective violence and legal intervention had no representation in CDSR. Correlation testing revealed a strong positive correlation that was statistically significant. Representation of road injury; interpersonal violence; fire, heat, and hot substances; mechanical forces; poisonings, adverse effect of medical treatment, and animal contact was well aligned with respect to DALY. Representation of falls was greater compared to DALY, while self-harm, exposure to forces of nature, and other transport injury representation was lower compared to DALY. CONCLUSIONS AND RELEVANCE: CDSR representation of external causes of injury strongly correlates with disease burden. The number of systematic reviews and protocols was well aligned for seven out of 12 causes of injury. These results provide high-quality and transparent data that may guide future prioritisation decisions.

Seeking support after hospitalisation for injury: a nested qualitative study of the role of primary care.

BACKGROUND: In the UK, studies suggest that the transition from hospital to home after an injury can be a difficult time and many patients report feeling inadequately prepared. Patients often use primary care services after hospital discharge. These consultations provide opportunities to consider problems that patients experience and to facilitate recovery. Little is known, however, about how patients and service providers view care after hospital discharge and the role played by primary care services, specifically GPs. AIM: To identify good practice and unmet needs in respect of post-discharge support for injured patients. DESIGN AND SETTING: Qualitative study using semi-structured interviews at four sites (Bristol, Leicester/Loughborough, Nottingham, and Surrey). METHOD: Qualitative interviews with 40 service providers and 45 hospitalised injured patients. RESULTS: Although there were examples of well-managed hospital discharges, many patients felt they were not provided with the information they needed about their injury, what to expect in terms of recovery, pain control, return to work, psychological problems, and services to help meet their needs. They also described difficulty accessing services such as physiotherapy or counselling. Service providers identified problems with communication between secondary and primary care, lack of access to physiotherapy, poor communication about other services that may help patients, GP service and resource constraints, and difficulties in providing information to patients concerning likely prognosis. CONCLUSION: Discharge from hospital after an injury can be problematic for patients. Changes in both secondary and primary care are required to resolve this problem.

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.

Return to work after traumatic brain injury: cohort comparison and economic evaluation.

BACKGROUND: Returning to work (RTW) in the UK is problematic following TBI. Vocational rehabilitation (VR) is limited and efficacy or costs seldom reported. This study aimed to determine whether a TBI specialist VR intervention (TBI VR) was more effective at work return and retention 12 months after injury than usual care (UC). Secondary aims were to explore the feasibility of collecting economic data to inform a definitive trial. METHOD: Work outcomes of TBI-VR were compared to UC. Ninety-four participants (40 TBI-VR) with TBI resulting in hospitalization ≥48 hours, who were working at injury were followed up by postal questionnaire at 3, 6 and 12 months post-hospital discharge. Primary outcome was RTW. Secondary outcomes were functional ability, mood and quality-of-life. Health resource use was measured by self-report. RESULTS: At 12 months, 15% more TBI-VR participants (27% more with moderate/severe TBI) were working than UC (27/36, 75% vs. 27/45, 60%). Mean TBI-VR health costs per person (consultant, GP, therapy, medication) were only £75 greater at 1 year. Secondary outcomes showed no significant baseline differences between groups. DISCUSSION: More TBI-VR participants returned to work than UC. People with moderate/severe TBI benefitted most. This positive trend was achieved without greatly increased health costs, suggesting cost-effectiveness. This study justifies the need for and can inform a definitive Randomized Controlled Trial (RCT).