Challenges in maximising recruitment to an RCT through working with a service user group

Low levels of recruitment into randomised controlled trials is a recurring difficulty and one that potentially threatens the validity of any RCT (Donovan et al, 2002a; 2002b). In cognate fields, research has been carried out with trial participants and other service users to understand the likely difficulties associated with recruitment from user perspectives and to modify recruitment materials and methods to maximise participation (Edwards et al, 1998; Featherstone and Donovan, 1999). However, the vast majority of this work has taken place with service users who would not experience communication challenges in participating in the research in the first place. By contrast, this paper concerns a study in which service users with aphasia and/or dysarthria worked alongside researchers, within a participatory action research framework, to design the recruitment materials that would be used in a large RCT (the ACTNoW trial)

COS-Speech: Protocol to develop a core outcome set for dysarthria after stroke for use in clinical practice and research

BACKGROUND: Dysarthria after stroke is when speech intelligibility is impaired, and this occurs in half of all stroke survivors. Dysarthria often leads to social isolation, poor psychological well-being and can prevent return to work and social lives. Currently, a variety of outcome measures are used in clinical research and practice when monitoring recovery for people who have dysarthria. When research studies use different measures, it is impossible to compare results from trials and delays our understanding of effective clinical treatments. The aim of this study is to develop a core outcome set (COS) to agree what aspects of speech recovery should be measured for dysarthria after stroke (COS-Speech) in research and clinical practice. METHODS: The COS-Speech study will include five steps: (1) development of a long list of possible outcome domains of speech that should be measured to guide the survey; (2) recruitment to the COS-Speech study of three key stakeholder groups in the UK and Australia: stroke survivors, communication researchers and speech and language therapists/pathologists; (3) two rounds of the Delphi survey process; (4) a consensus meeting to agree the speech outcomes to be measured and a follow-up consensus meeting to match existing instruments/measures (from parallel systematic review) to the agreed COS-Speech; (5) dissemination of COS-Speech. DISCUSSION: There is currently no COS for dysarthria after stroke for research trials or clinical practice. The findings from this research study will be a minimum COS, for use in all dysarthria research studies and clinical practice looking at post-stroke recovery of speech. These findings will be widely disseminated using professional and patient networks, research and clinical forums as well as using a variety of academic papers, videos, accessible writing such as blogs and links on social media. TRIAL REGISTRATION: COS-Speech is registered with the Core Outcome Measures in Effectiveness Trials (COMET) database, October 2021 https://www.comet-initiative.org/Studies/Details/1959. In addition, “A systematic review of the psychometric properties and clinical utility of instruments measuring dysarthria after stroke” will inform the consensus meeting to match measures to COS-Speech. The protocol for the systematic reviews registered with the International Prospective Register of Systematic Reviews. PROSPERO registration number: CRD42022302998. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s13063-022-06958-7

A qualitative exploration of oral health care among stroke survivors living in the community.

Background: Dental disease is highly prevalent in people with stroke. Stroke survivors regard oral hygiene as an important, yet neglected, area. The aim was to explore experiences of and barriers to oral care, particularly in relation to oral hygiene practice and dental attendance, among stroke survivors in the community. Methods: This was a qualitative study incorporating a critical realist approach. Interviews were conducted with community-dwelling stroke survivors requiring assistance with activities of daily living, and focus groups were held with health and care professionals. Interviews and focus groups were recorded and transcribed verbatim. Thematic analysis was conducted. Results: Twenty-three stroke survivors were interviewed, and 19 professionals took part in 3 focus groups. Professionals included nurses, speech and language therapists, occupational therapists, dieticians, professional carers and dental staff. Interviews revealed difficulties in carrying out oral hygiene self-care due to fatigue, forgetfulness and limb function and dexterity problems. Routine was considered important for oral hygiene self-care and was disrupted by hospitalization resulting from stroke. Professionals highlighted gaps in staff training and confidence in supporting patients with oral care. Access to dental services appeared particularly problematic for those who were not registered with a dentist pre-stroke. Conclusion: Oral hygiene routines may be disrupted by stroke, and resulting disabilities may make regular oral self-care more difficult. This study has identified specific barriers to oral hygiene self-care and dental service access. Findings from this study are feeding into the development of an intervention to support stroke survivors with oral care

Delivery, dose, outcomes and resource use of stroke therapy: the SSNAPIEST observational study

BackgroundTherapy is key to effective stroke care, but many patients receive little.ObjectivesTo understand how stroke therapy is delivered in England, Wales and Northern Ireland, and which factors are associated with dose, outcome and resource use.DesignSecondary analysis of the Sentinel Stroke National Audit Programme, using standard descriptive statistics and multilevel mixed-effects regression models, while adjusting for all known and measured confounders.SettingStroke services in England, Wales and Northern Ireland.ParticipantsA total of 94,905 adults admitted with stroke, who remained an inpatient for > 72 hours.ResultsRoutes through stroke services were highly varied (> 800), but four common stroke pathways emerged. Seven distinct impairment-based patient subgroups were characterised. The average amount of therapy was very low. Modifiable factors associated with the average amount of inpatient therapy were type of stroke team, timely therapy assessments, staffing levels and model of therapy provision. More (of any type of) therapy was associated with shorter length of stay, less resource use and lower mortality. More occupational therapy, speech therapy and psychology were also associated with less disability and institutionalisation. Large amounts of physiotherapy were associated with greater disability and institutionalisation.LimitationsUse of observational data does not infer causation. All efforts were made to adjust for all known and measured confounding factors but some may remain. We categorised participants using the National Institutes of Health Stroke Scale, which measures a limited number of impairments relatively crudely, so mild or rare impairments may have been missed.ConclusionsStroke patients receive very little therapy. Modifiable organisational factors associated with greater amounts of therapy were identified, and positive associations between amount of therapy and outcome were confirmed. The reason for the unexpected associations between large amounts of physiotherapy, disability and institutionalisation is unknown. Prospective work is urgently needed to investigate further. Future work needs to investigate (1) prospectively, the association between physiotherapy and outcome; (2) the optimal amount of therapy to provide for different patient groups; (3) the most effective way of organising stroke therapy/rehabilitation services, including service configuration, staffing levels and working hours; and (4) how to reduce unexplained variation in resource use.FundingThis project was funded by the National Institute for Health Research (NIHR) Health Services and Delivery Research programme and will be published in full in Health Services and Delivery Research; Vol. 8, No. 17. See the NIHR Journals Library website for further project information

How do patients pass through stroke services? Identifying stroke care pathways using national audit data.

OBJECTIVE: To map and describe how patients pass through stroke services. METHODS: Data from 94,905 stroke patients (July 2013-July 2015) who were still inpatients 72 hours after hospital admission were extracted from a national stroke register and were used to identify the routes patients took through hospital and community stroke services. We sought to categorize these routes through iterative consultations with clinical experts and to describe patient characteristics, therapy provision, outcomes and costs within each category. RESULTS: We identified 874 routes defined by the type of admitting stroke team and subsequent transfer history. We consolidated these into nine distinct routes and further summarized these into three overlapping 'pathways' that accounted for 99% of the patients. These were direct discharge (44%), community rehabilitation (47%) and inpatient transfer (19%) with 12% of the patients receiving both inpatient transfer and community rehabilitation. Patients with the mildest and most severe strokes were more likely to follow the direct discharge pathway. Those perceived to need most therapy were more likely to follow the inpatient transfer pathway. Costs were lowest and mortality was highest for patients on the direct discharge pathway. Outcomes were best for patients on the community rehabilitation pathway and costs were highest where patients underwent inpatient transfers. CONCLUSION: Three overarching stroke care pathways were identified which differ according to patient characteristics, therapy needs and outcomes. This pathway mapping provides a benchmark to develop and plan clinical services, and for future research

Challenges implementing a carer support intervention within a national stroke organisation: findings from the process evaluation of the OSCARSS trial

Objectives: To examine the implementation of an intervention to support informal caregivers and to help understand findings from the Organising Support for Carers of Stroke Survivors (OSCARSS) cluster randomised controlled trial (cRCT). Design: Longitudinal process evaluation using mixed methods. Normalisation process theory informed data collection and provided a sensitising framework for analysis. Setting: Specialist stroke support services delivered primarily in the homes of informal carers of stroke survivors. Participants: OSCARSS cRCT participants including carers, staff, managers and senior leaders. Intervention: The Carer Support Needs Assessment Tool for Stroke (CSNAT-Stroke) intervention is a staff-facilitated, carer-led approach to help identify, prioritise and address support needs. Results: We conducted qualitative interviews with: OSCARSS cRCT carer participants (11 intervention, 10 control), staff (12 intervention, 8 control) and managers and senior leaders (11); and obtained 140 responses to an online staff survey over three separate time points. Both individual (carer/staff) and organisational factors impacted implementation of the CSNAT-Stroke intervention and how it was received by carers. We identified four themes: staff understanding, carer participation, implementation, and learning and support. Staff valued the idea of a structured approach to supporting carers, but key elements of the intervention were not routinely delivered. Carers did not necessarily identify as ‘carers’, which made it difficult for staff to engage them in the intervention. Despite organisational enthusiasm for OSCARSS, staff in the intervention arm perceived support and training for implementation of CSNAT-Stroke as delivered primarily by the research team, with few opportunities for shared learning across the organisation. Conclusions: We identified challenges across carer, staff and organisation levels that help explain the OSCARSS cRCT outcome. Ensuring training is translated into practice and ongoing organisational support would be required for full implementation of this type of intervention, with emphasis on the carer-led aspects, including supporting carer self-identification. Trial registration number: ISRCTN58414120

Challenges implementing a carer support intervention within a national stroke organisation: findings from the process evaluation of the OSCARSS trial.

OBJECTIVES: To examine the implementation of an intervention to support informal caregivers and to help understand findings from the Organising Support for Carers of Stroke Survivors (OSCARSS) cluster randomised controlled trial (cRCT). DESIGN: Longitudinal process evaluation using mixed methods. Normalisation process theory informed data collection and provided a sensitising framework for analysis. SETTING: Specialist stroke support services delivered primarily in the homes of informal carers of stroke survivors. PARTICIPANTS: OSCARSS cRCT participants including carers, staff, managers and senior leaders. INTERVENTION: The Carer Support Needs Assessment Tool for Stroke (CSNAT-Stroke) intervention is a staff-facilitated, carer-led approach to help identify, prioritise and address support needs. RESULTS: We conducted qualitative interviews with: OSCARSS cRCT carer participants (11 intervention, 10 control), staff (12 intervention, 8 control) and managers and senior leaders (11); and obtained 140 responses to an online staff survey over three separate time points. Both individual (carer/staff) and organisational factors impacted implementation of the CSNAT-Stroke intervention and how it was received by carers. We identified four themes: staff understanding, carer participation, implementation, and learning and support. Staff valued the idea of a structured approach to supporting carers, but key elements of the intervention were not routinely delivered. Carers did not necessarily identify as 'carers', which made it difficult for staff to engage them in the intervention. Despite organisational enthusiasm for OSCARSS, staff in the intervention arm perceived support and training for implementation of CSNAT-Stroke as delivered primarily by the research team, with few opportunities for shared learning across the organisation. CONCLUSIONS: We identified challenges across carer, staff and organisation levels that help explain the OSCARSS cRCT outcome. Ensuring training is translated into practice and ongoing organisational support would be required for full implementation of this type of intervention, with emphasis on the carer-led aspects, including supporting carer self-identification. TRIAL REGISTRATION NUMBER: ISRCTN58414120