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Research paper thumbnail of Additional file 4 of Embedding mentoring to support trial processes and implementation fidelity in a randomised controlled trial of vocational rehabilitation for stroke survivors

Research paper thumbnail of Additional file 1 of Embedding mentoring to support trial processes and implementation fidelity in a randomised controlled trial of vocational rehabilitation for stroke survivors

Research paper thumbnail of Additional file 3 of Embedding mentoring to support trial processes and implementation fidelity in a randomised controlled trial of vocational rehabilitation for stroke survivors

Research paper thumbnail of Additional file 2 of Embedding mentoring to support trial processes and implementation fidelity in a randomised controlled trial of vocational rehabilitation for stroke survivors

Research paper thumbnail of Additional file 6 of 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

Research paper thumbnail of Additional file 5 of 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

Research paper thumbnail of Additional file 8 of 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

Research paper thumbnail of Additional file 9 of 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

Research paper thumbnail of Additional file 4 of 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

Research paper thumbnail of Additional file 7 of 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

Research paper thumbnail of Additional file 2 of 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

Research paper thumbnail of Additional file 3 of 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

Research paper thumbnail of QOL-34. The relationship between Psychological Flexibility, Quality-of-Life and psychological health in young people who have experienced a brain tumour

Neuro-Oncology

Despite increasing survival rates in young people who have experienced a brain tumour, this patie... more Despite increasing survival rates in young people who have experienced a brain tumour, this patient group have the poorest reported quality-of-life (QoL) of all cancer survivors. QoL is defined as an individual’s perception of their position in life in relation to their goals, expectations and standards. QoL can be influenced by physical functioning but one of its strongest predictors is psychological health. A concept that has a large impact on psychological health is Psychological Flexibility (PF). PF refers to the ability to recognise and adapt to situations, shift cognitive and behavioural repertoires which are impacting negatively on personal and social functioning and commit to behaviours that are in line with strongly held values. Studies have demonstrated a relationship between PF and QoL in other patient populations such as chronic pain and breast cancer survivors. In this study we explored the relationship between PF and QoL at baseline in a sample of young people enrolled...

Research paper thumbnail of QOL-26. Exploring the experience of young people receiving remotely delivered Acceptance and Commitment Therapy following treatment for a brain tumour

Neuro-Oncology

Despite high survival rates of children and young people diagnosed with a brain tumour, survival ... more Despite high survival rates of children and young people diagnosed with a brain tumour, survival is often associated with poor psychological, physical, and social outcomes. Acceptance and Commitment Therapy (ACT) is an evidence-based psychological intervention shown to improve psychological and physical outcomes in adults and children with chronic disease, including cancer. The ACT Now study investigates the feasibility of ACT delivered remotely with young people who have experienced a brain tumour. This study aims to describe participant experience whilst better understanding the impact of therapy and capturing the barriers and facilitators to engagement. Participants of the ACT Now study were invited to take part in a semi-structured interview with questions covering experience of study initiation, receipt of ACT, remote delivery and overall impact of ACT. Ten participants who had previously undergone treatment for a brain tumour have been interviewed to date. Interviews were tran...

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

BMJ Open, 2022

ObjectivesThis mixed-method process evaluation underpinned by normalisation process theory aims t... more ObjectivesThis 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.SettingRETurn 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 measuresIntervention 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 unders...

Research paper thumbnail of 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 inci... more 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, pa...

Research paper thumbnail of Developing an implementation fidelity checklist for a vocational rehabilitation intervention

Background: Despite growing numbers of studies reporting the efficacy of complex interventions an... more 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 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 assessment structure, 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 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 in...

Research paper thumbnail of Additional file 1 of 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

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

BMC Medical Research Methodology, 2021

Background Little guidance exists regarding how best to upskill and support those delivering comp... more 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. Quali...

Research paper thumbnail of 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

Trials

Background Return to work (RTW) is achieved by less than 50% of stroke survivors. The rising inci... more 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, pa...

Research paper thumbnail of Additional file 4 of Embedding mentoring to support trial processes and implementation fidelity in a randomised controlled trial of vocational rehabilitation for stroke survivors

Research paper thumbnail of Additional file 1 of Embedding mentoring to support trial processes and implementation fidelity in a randomised controlled trial of vocational rehabilitation for stroke survivors

Research paper thumbnail of Additional file 3 of Embedding mentoring to support trial processes and implementation fidelity in a randomised controlled trial of vocational rehabilitation for stroke survivors

Research paper thumbnail of Additional file 2 of Embedding mentoring to support trial processes and implementation fidelity in a randomised controlled trial of vocational rehabilitation for stroke survivors

Research paper thumbnail of Additional file 6 of 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

Research paper thumbnail of Additional file 5 of 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

Research paper thumbnail of Additional file 8 of 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

Research paper thumbnail of Additional file 9 of 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

Research paper thumbnail of Additional file 4 of 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

Research paper thumbnail of Additional file 7 of 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

Research paper thumbnail of Additional file 2 of 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

Research paper thumbnail of Additional file 3 of 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

Research paper thumbnail of QOL-34. The relationship between Psychological Flexibility, Quality-of-Life and psychological health in young people who have experienced a brain tumour

Neuro-Oncology

Despite increasing survival rates in young people who have experienced a brain tumour, this patie... more Despite increasing survival rates in young people who have experienced a brain tumour, this patient group have the poorest reported quality-of-life (QoL) of all cancer survivors. QoL is defined as an individual’s perception of their position in life in relation to their goals, expectations and standards. QoL can be influenced by physical functioning but one of its strongest predictors is psychological health. A concept that has a large impact on psychological health is Psychological Flexibility (PF). PF refers to the ability to recognise and adapt to situations, shift cognitive and behavioural repertoires which are impacting negatively on personal and social functioning and commit to behaviours that are in line with strongly held values. Studies have demonstrated a relationship between PF and QoL in other patient populations such as chronic pain and breast cancer survivors. In this study we explored the relationship between PF and QoL at baseline in a sample of young people enrolled...

Research paper thumbnail of QOL-26. Exploring the experience of young people receiving remotely delivered Acceptance and Commitment Therapy following treatment for a brain tumour

Neuro-Oncology

Despite high survival rates of children and young people diagnosed with a brain tumour, survival ... more Despite high survival rates of children and young people diagnosed with a brain tumour, survival is often associated with poor psychological, physical, and social outcomes. Acceptance and Commitment Therapy (ACT) is an evidence-based psychological intervention shown to improve psychological and physical outcomes in adults and children with chronic disease, including cancer. The ACT Now study investigates the feasibility of ACT delivered remotely with young people who have experienced a brain tumour. This study aims to describe participant experience whilst better understanding the impact of therapy and capturing the barriers and facilitators to engagement. Participants of the ACT Now study were invited to take part in a semi-structured interview with questions covering experience of study initiation, receipt of ACT, remote delivery and overall impact of ACT. Ten participants who had previously undergone treatment for a brain tumour have been interviewed to date. Interviews were tran...

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

BMJ Open, 2022

ObjectivesThis mixed-method process evaluation underpinned by normalisation process theory aims t... more ObjectivesThis 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.SettingRETurn 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 measuresIntervention 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 unders...

Research paper thumbnail of 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 inci... more 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, pa...

Research paper thumbnail of Developing an implementation fidelity checklist for a vocational rehabilitation intervention

Background: Despite growing numbers of studies reporting the efficacy of complex interventions an... more 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 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 assessment structure, 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 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 in...

Research paper thumbnail of Additional file 1 of 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

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

BMC Medical Research Methodology, 2021

Background Little guidance exists regarding how best to upskill and support those delivering comp... more 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. Quali...

Research paper thumbnail of 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

Trials

Background Return to work (RTW) is achieved by less than 50% of stroke survivors. The rising inci... more 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, pa...

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