Practices of falls risk assessment and prevention in acute hospital settings: a realist investigation.

Background: Falls are the most common safety incident reported by acute hospitals. The National Institute of Health and Care Excellence recommends multifactorial falls risk assessment and tailored interventions, but implementation is variable. Aim: To determine how and in what contexts multifactorial falls risk assessment and tailored interventions are used in acute National Health Service hospitals in England. Design: Realist review and multisite case study. (1) Systematic searches to identify stakeholders' theories, tested using empirical data from primary studies. Review of falls prevention policies of acute Trusts. (2) Theory testing and refinement through observation, staff interviews (n = 50), patient and carer interviews (n = 31) and record review (n = 60). Setting: Three Trusts, one orthopaedic and one older person ward in each. Results: Seventy-eight studies were used for theory construction and 50 for theory testing. Four theories were explored. (1) Leadership: wards had falls link practitioners but authority to allocate resources for falls prevention resided with senior nurses. (2) Shared responsibility: a key falls prevention strategy was patient supervision. This fell to nursing staff, constraining the extent to which responsibility for falls prevention could be shared. (3) Facilitation: assessments were consistently documented but workload pressures could reduce this to a tick-box exercise. Assessment items varied. While individual patient risk factors were identified, patients were categorised as high or low risk to determine who should receive supervision. (4) Patient participation: nursing staff lacked time to explain to patients their falls risks or how to prevent themselves from falling, although other staff could do so. Sensitive communication could prevent patients taking actions that increase their risk of falling. Limitations: Within the realist review, we completed synthesis for only two theories. We could not access patient records before observations, preventing assessment of whether care plans were enacted. Conclusions: (1) Leadership: There should be a clear distinction between senior nurses' roles and falls link practitioners in relation to falls prevention; (2) shared responsibility: Trusts should consider how processes and systems, including the electronic health record, can be revised to better support a multidisciplinary approach, and alternatives to patient supervision should be considered; (3) facilitation: Trusts should consider how to reduce documentation burden and avoid tick-box responses, and ensure items included in the falls risk assessment tools align with guidance. Falls risk assessment tools and falls care plans should be presented as tools to support practice, rather than something to be audited; (4) patient participation: Trusts should consider how they can ensure patients receive individualised information about risks and preventing falls and provide staff with guidance on brief but sensitive ways to talk with patients to reduce the likelihood of actions that increase their risk of falling. Future work: (1) Development and evaluation of interventions to support multidisciplinary teams to undertake, and involve patients in, multifactorial falls risk assessment and selection and delivery of tailored interventions; (2) mixed method and economic evaluations of patient supervision; (3) evaluation of engagement support workers, volunteers and/or carers to support falls prevention. Research should include those with cognitive impairment and patients who do not speak English. Study registration: This study is registered as PROSPERO CRD42020184458. Funding: This award was funded by the National Institute for Health and Care Research (NIHR) Health and Social Care Delivery Research programme (NIHR award ref: NIHR129488) and is published in full in Health and Social Care Delivery Research; Vol. 12, No. 5. See the NIHR Funding and Awards website for further award information.

Many accidental falls by older people in hospitals could be avoided. There are guidelines to prevent falls, but some hospitals are better at following them than others. This study aimed to find out why. First, we looked at research and hospitals' falls policies for ideas about what stops falls. With advice from service users, we tested these ideas in four hospitals in England, watching how falls were prevented on wards for older people and people who need bone care, and talking to 50 staff, 28 patients and 3 carers. We found the following: Falls leadership: wards had staff called falls link practitioners who supported falls prevention, but senior nurses, not link practitioners, made the most important decisions. Sharing responsibility: patients with falls risks were monitored to try to stop falls. Because only nursing teams were always present to monitor patients, they had most responsibility for preventing falls. This limited sharing responsibility with other staff. Computer tools: nurses used computers to record prevention work, but high workloads could make this a 'tick-box' exercise. Computer tools reminded them to do this, although tools varied. Patients had individual falls plans, but they were also ranked more generally as high or low risk of falling, with 'high-risk' patients being monitored. Patient involvement: nursing staff did not have time to explain to patients how to prevent falls, but other staff could have such conversations. Many patients had problems like dementia and found it difficult to follow safety advice, although some could take steps to keep safe, with sensitive staff support. We need to involve patients, carers and different staff in falls prevention. Hospitals could develop computer systems to support this, think how to involve more ward staff, and provide guidance on helpful ways to talk with patients about falls.

Interactions that support older inpatients with cognitive impairments to engage with falls prevention in hospitals: An ethnographic study.

AIMS: To explore the nature of interactions that enable older inpatients with cognitive impairments to engage with hospital staff on falls prevention. DESIGN: Ethnographic study. METHODS: Ethnographic observations on orthopaedic and older person wards in English hospitals (251.25 h) and semi-structured qualitative interviews with 50 staff, 28 patients and three carers. Findings were analysed using a framework approach. RESULTS: Interactions were often informal and personalised. Staff qualities that supported engagement in falls prevention included the ability to empathise and negotiate, taking patient perspectives into account. Although registered nurses had limited time for this, families/carers and other staff, including engagement workers, did so and passed information to nurses. CONCLUSIONS: Some older inpatients with cognitive impairments engaged with staff on falls prevention. Engagement enabled them to express their needs and collaborate, to an extent, on falls prevention activities. To support this, we recommend wider adoption in hospitals of engagement workers and developing the relational skills that underpin engagement in training programmes for patient-facing staff. IMPLICATIONS FOR PROFESSION AND PATIENT CARE: Interactions that support cognitively impaired inpatients to engage in falls prevention can involve not only nurses, but also families/carers and non-nursing staff, with potential to reduce pressures on busy nurses and improve patient safety. REPORTING METHOD: The paper adheres to EQUATOR guidelines, Standards for Reporting Qualitative Research. PATIENT OR PUBLIC CONTRIBUTION: Patient/public contributors were involved in study design, evaluation and data analysis. They co-authored this manuscript.

Talking about falls: a qualitative exploration of spoken communication of patients' fall risks in hospitals and implications for multifactorial approaches to fall prevention.

BACKGROUND: Inpatient falls are the most common safety incident reported by hospitals worldwide. Traditionally, responses have been guided by categorising patients' levels of fall risk, but multifactorial approaches are now recommended. These target individual, modifiable fall risk factors, requiring clear communication between multidisciplinary team members. Spoken communication is an important channel, but little is known about its form in this context. We aim to address this by exploring spoken communication between hospital staff about fall prevention and how this supports multifactorial fall prevention practice. METHODS: Data were collected through semistructured qualitative interviews with 50 staff and ethnographic observations of fall prevention practices (251.25 hours) on orthopaedic and older person wards in four English hospitals. Findings were analysed using a framework approach. FINDINGS: We observed staff engaging in 'multifactorial talk' to address patients' modifiable risk factors, especially during multidisciplinary meetings which were patient focused rather than risk type focused. Such communication coexisted with 'categorisation talk', which focused on patients' levels of fall risk and allocating nursing supervision to 'high risk' patients. Staff negotiated tensions between these different approaches through frequent 'hybrid talk', where, as well as categorising risks, they also discussed how to modify them. CONCLUSION: To support hospitals in implementing multifactorial, multidisciplinary fall prevention, we recommend: (1) focusing on patients' individual risk factors and actions to address them (a 'why?' rather than a 'who' approach); (2) where not possible to avoid 'high risk' categorisations, employing 'hybrid' communication which emphasises actions to modify individual risk factors, as well as risk level; (3) challenging assumptions about generic interventions to identify what individual patients need; and (4) timing meetings to enable staff from different disciplines to participate.

Staff experiences of integrating community and secondary care musculoskeletal services: A qualitative investigation.

INTRODUCTION: Integrated models of care intend to provide seamless and timely access to health and social care services. This study investigated the integration of musculoskeletal services across community and secondary care boundaries, including the introduction of a single point of access from which patients were triaged. METHODS: Staff (n = 15) involved in service development and delivery were interviewed about how, why and to what extent integration impacted service delivery. The analysis focused on staff experiences of using an on-line patient self-referral form and co-located clinics to enhance decision-making in triage, and on the provision of educational materials and de-medicalising language in patient consultations to support self-management. RESULTS: Single point of access, including online self-referral, were operationalised during data collection, but co-located clinics were not. Triage staff explained that the volume of referrals and quality of information provided in online self-referrals sometimes constrained decision-making in triage. Secondary care staff discussed concerns that the single point of access might not consistently identify patients with hard to diagnose conditions that require timely surgical intervention. This concern appeared to constrain staff engagement with integration, potentially inhibiting the delivery of co-located clinics. However, triage staff accessed support to inform secondary care referral via alternate modes. Patient circumstances, for example, need for reassurance, necessitated multiple self-management strategies and innovative approaches were developed to provide patients ongoing and professionally led support. CONCLUSION: Findings emphasise that restructuring services requires engagement from diverse stakeholders. Collaborating with stakeholders to address their concerns about the impact of restructures on well-established pathways may help cultivate this engagement.

Exploring variation in implementation of multifactorial falls risk assessment and tailored interventions: a realist review.

BACKGROUND: Falls are the most common safety incident reported by acute hospitals. In England national guidance recommends delivery of a multifactorial falls risk assessment (MFRA) and interventions tailored to address individual falls risk factors. However, there is variation in how these practices are implemented. This study aimed to explore the variation by examining what supports or constrains delivery of MFRAs and tailored interventions in acute hospitals. METHODS: A realist review of literature was conducted with searches completed in three stages: (1) to construct hypotheses in the form of Context, Mechanism, Outcome configurations (CMOc) about how MFRAs and interventions are delivered, (2) to scope the breadth and depth of evidence available in Embase to test the CMOcs, and (3) following prioritisation of CMOcs, to refine search strategies for use in multiple databases. Citations were managed in EndNote; titles, abstracts, and full texts were screened, with 10% independently screened by two reviewers. RESULTS: Two CMOcs were prioritised for testing labelled: Facilitation via MFRA tools, and Patient Participation in interventions. Analysis indicated that MFRA tools can prompt action, but the number and type of falls risk factors included in tools differ across organisations leading to variation in practice. Furthermore, the extent to which tools work as prompts is influenced by complex ward conditions such as changes in patient condition, bed swaps, and availability of falls prevention interventions. Patient participation in falls prevention interventions is more likely where patient directed messaging takes individual circumstances into account, e.g., not wanting to disturb nurses by using the call bell. However, interactions that elicit individual circumstances can be resource intensive and patients with cognitive impairment may not be able to participate despite appropriately directed messaging. CONCLUSIONS: Organisations should consider how tools can be developed in ways that better support consistent and comprehensive identification of patients' individual falls risk factors and the complex ward conditions that can disrupt how tools work as facilitators. Ward staff should be supported to deliver patient directed messaging that is informed by their individual circumstances to encourage participation in falls prevention interventions, where appropriate. TRIAL REGISTRATION: PROSPERO: CRD42020184458.

Strategic workforce planning in health and social care - an international perspective: A scoping review.

Effective strategic workforce planning for integrated and co-ordinated health and social care is essential if future services are to be resourced such that skill mix, clinical practice and productivity meet population health and social care needs in timely, safe and accessible ways globally. This review presents international literature to illustrate how strategic workforce planning in health and social care has been undertaken around the world with examples of planning frameworks, models and modelling approaches. The databases Business Source Premier, CINAHL, Embase, Health Management Information Consortium, Medline and Scopus were searched for full texts, from 2005 to 2022, detailing empirical research, models or methodologies to explain how strategic workforce planning (with at least a one-year horizon) in health and/or social care has been undertaken, yielding ultimately 101 included references. The supply/demand of a differentiated medical workforce was discussed in 25 references. Nursing and midwifery were characterised as undifferentiated labour, requiring urgent growth to meet demand. Unregistered workers were poorly represented as was the social care workforce. One reference considered planning for health and social care workers. Workforce modelling was illustrated in 66 references with predilection for quantifiable projections. Increasingly needs-based approaches were called for to better consider demography and epidemiological impacts. This review's findings advocate for whole-system needs-based approaches that consider the ecology of a co-produced health and social care workforce.

Working together: reflections on how to make public involvement in research work.

BACKGROUND: The importance of involving members of the public in the development, implementation and dissemination of research is increasingly recognised. There have been calls to share examples of how this can be done, and this paper responds by reporting how professional and lay researchers collaborated on a research study about falls prevention among older patients in English acute hospitals. It focuses on how they worked together in ways that valued all contributions, as envisaged in the UK standards for public involvement for better health and social care research. METHODS: The paper is itself an example of working together, having been written by a team of lay and professional researchers. It draws on empirical evidence from evaluations they carried out about the extent to which the study took patient and public perspectives into account, as well as reflective statements they produced as co-authors, which, in turn, contributed to the end-of-project evaluation. RESULTS: Lay contributors' deep involvement in the research had a positive effect on the project and the individuals involved, but there were also difficulties. Positive impacts included lay contributors focusing the project on areas that matter most to patients and their families, improving the quality and relevance of outcomes by contributing to data analysis, and feeling they were 'honouring' their personal experience of the subject of study. Negative impacts included the potential for lay people to feel overwhelmed by the challenges involved in achieving the societal or organisational changes necessary to address research issues, which can cause them to question their rationale for public involvement. CONCLUSIONS: The paper concludes with practical recommendations for working together effectively in research. These cover the need to discuss the potential emotional impacts of such work with lay candidates during recruitment and induction and to support lay people with these impacts throughout projects; finding ways to address power imbalances and practical challenges; and tips on facilitating processes within lay groups, especially relational processes like the development of mutual trust.

Involving members of the public in all stages of research as equal partners is a powerful way to make research more relevant. This paper shares an example of such involvement, from a study about falls prevention in English hospitals. Developed by a team of lay people and professional researchers, the paper looks at how we worked together, drawing on evaluations we carried out about how the study took patient and public perspectives into account, and on personal reflections we wrote. Public involvement had a positive effect on the project and the individuals involved, but there were also difficulties. Positive impacts included lay people ensuring the study focused on what mattered most to patients and their families and feeling they had done right by their personal experience of the study's subject. Negative impacts included the potential for people to feel overwhelmed by the changes in organisations or in wider society needed to address the issues being explored by a research study, which could cause them to question why they became involved in the first place. The paper ends with practical recommendations about working together, covering things such as helping lay people with the emotional impact of involvement from the beginning to the end of projects; finding ways to ensure everybody is treated in the same way and solving practical problems; and tips on leading and supporting groups of this kind, especially with personal issues like trusting each other.

Designing health IT to support falls prevention in hospitals: Findings from a realist review.

Inpatient falls are an international patient safety concern, accounting for 30-40% of reported safety incidents in acute hospitals. They can cause both physical (e.g. hip fractures) and non-physical harm (e.g. reduced confidence) to patients. We used an approach known as a realist review to identify theories about what interventions might work for whom in what contexts, focusing on what supports and constrains effective use of multifactorial falls risk assessment and falls prevention interventions. One of these theories suggested that staff will integrate recommended practices into their work routines if falls risk assessment tools, including health IT, are quick and easy to use and facilitate existing work routines. Synthesis of empirical studies undertaken in the process of testing and refining this theory has implications for the design of health IT, suggesting that while health IT can support falls prevention through automation, such tools should also allow for incorporation of clinical judgement.

Analysis of a Web-Based Dashboard to Support the Use of National Audit Data in Quality Improvement: Realist Evaluation.

BACKGROUND: Dashboards can support data-driven quality improvements in health care. They visualize data in ways intended to ease cognitive load and support data comprehension, but how they are best integrated into working practices needs further investigation. OBJECTIVE: This paper reports the findings of a realist evaluation of a web-based quality dashboard (QualDash) developed to support the use of national audit data in quality improvement. METHODS: QualDash was co-designed with data users and installed in 8 clinical services (3 pediatric intensive care units and 5 cardiology services) across 5 health care organizations (sites A-E) in England between July and December 2019. Champions were identified to support adoption. Data to evaluate QualDash were collected between July 2019 and August 2021 and consisted of 148.5 hours of observations including hospital wards and clinical governance meetings, log files that captured the extent of use of QualDash over 12 months, and a questionnaire designed to assess the dashboard's perceived usefulness and ease of use. Guided by the principles of realist evaluation, data were analyzed to understand how, why, and in what circumstances QualDash supported the use of national audit data in quality improvement. RESULTS: The observations revealed that variation across sites in the amount and type of resources available to support data use, alongside staff interactions with QualDash, shaped its use and impact. Sites resourced with skilled audit support staff and established reporting systems (sites A and C) continued to use existing processes to report data. A number of constraints influenced use of QualDash in these sites including that some dashboard metrics were not configured in line with user expectations and staff were not fully aware how QualDash could be used to facilitate their work. In less well-resourced services, QualDash automated parts of their reporting process, streamlining the work of audit support staff (site B), and, in some cases, highlighted issues with data completeness that the service worked to address (site E). Questionnaire responses received from 23 participants indicated that QualDash was perceived as useful and easy to use despite its variable use in practice. CONCLUSIONS: Web-based dashboards have the potential to support data-driven improvement, providing access to visualizations that can help users address key questions about care quality. Findings from this study point to ways in which dashboard design might be improved to optimize use and impact in different contexts; this includes using data meaningful to stakeholders in the co-design process and actively engaging staff knowledgeable about current data use and routines in the scrutiny of the dashboard metrics and functions. In addition, consideration should be given to the processes of data collection and upload that underpin the quality of the data visualized and consequently its potential to stimulate quality improvement. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.1136/bmjopen-2019-033208.

What supports and constrains the implementation of multifactorial falls risk assessment and tailored multifactorial falls prevention interventions in acute hospitals? Protocol for a realist review.

INTRODUCTION: Falls are the most common type of safety incident reported by acute hospitals and can cause both physical (eg, hip fractures) and non-physical harm (eg, reduced confidence) to patients. It is recommended that, in order to prevent falls in hospital, patients should receive a multifactorial falls risk assessment and be provided with a multifactorial intervention, tailored to address the patient's identified individual risk factors. It is estimated that such an approach could reduce the incidence of inpatient falls by 25%-30% and reduce the annual cost of falls by up to 25%. However, there is substantial unexplained variation between hospitals in the number and type of assessments undertaken and interventions implemented. METHODS AND ANALYSIS: A realist review will be undertaken to construct and test programme theories regarding (1) what supports and constrains the implementation of multifactorial falls risk assessment and tailored multifactorial falls prevention interventions in acute hospitals; and (2) how, why, in what contexts and for whom tailored multifactorial falls prevention interventions lead to a reduction in patients' falls risk. We will first identify stakeholders' theories concerning these two topics, searching Medline (1946-present) and Medline In-Process & Other Non-Indexed Citations, Health Management Information Consortium (1983-present) and CINAHL (1981-present). We will then test these theories systematically, using primary studies to determine whether empirical evidence supports, refutes or suggests a revision or addition to the identified theories. ETHICS AND DISSEMINATION: The study does not require ethical approval. The review will provide evidence for how to implement multifactorial falls risk assessment and prevention strategies in acute hospital settings. This will be disseminated to academic and clinical audiences and will provide the basis for a future multi-site study through which the theories will be further refined. SYSTEMATIC REVIEW REGISTRATION: PROSPERO CRD42020184458.

Hidden labour: the skilful work of clinical audit data collection and its implications for secondary use of data via integrated health IT.

BACKGROUND: Secondary use of data via integrated health information technology is fundamental to many healthcare policies and processes worldwide. However, repurposing data can be problematic and little research has been undertaken into the everyday practicalities of inter-system data sharing that helps explain why this is so, especially within (as opposed to between) organisations. In response, this article reports one of the most detailed empirical examinations undertaken to date of the work involved in repurposing healthcare data for National Clinical Audits. METHODS: Fifty-four semi-structured, qualitative interviews were carried out with staff in five English National Health Service hospitals about their audit work, including 20 staff involved substantively with audit data collection. In addition, ethnographic observations took place on wards, in 'back offices' and meetings (102 h). Findings were analysed thematically and synthesised in narratives. RESULTS: Although data were available within hospital applications for secondary use in some audit fields, which could, in theory, have been auto-populated, in practice staff regularly negotiated multiple, unintegrated systems to generate audit records. This work was complex and skilful, and involved cross-checking and double data entry, often using paper forms, to assure data quality and inform quality improvements. CONCLUSIONS: If technology is to facilitate the secondary use of healthcare data, the skilled but largely hidden labour of those who collect and recontextualise those data must be recognised. Their detailed understandings of what it takes to produce high quality data in specific contexts should inform the further development of integrated systems within organisations.

QualDash: Adaptable Generation of Visualisation Dashboards for Healthcare Quality Improvement.

Adapting dashboard design to different contexts of use is an open question in visualisation research. Dashboard designers often seek to strike a balance between dashboard adaptability and ease-of-use, and in hospitals challenges arise from the vast diversity of key metrics, data models and users involved at different organizational levels. In this design study, we present QualDash, a dashboard generation engine that allows for the dynamic configuration and deployment of visualisation dashboards for healthcare quality improvement (QI). We present a rigorous task analysis based on interviews with healthcare professionals, a co-design workshop and a series of one-on-one meetings with front line analysts. From these activities we define a metric card metaphor as a unit of visual analysis in healthcare QI, using this concept as a building block for generating highly adaptable dashboards, and leading to the design of a Metric Specification Structure (MSS). Each MSS is a JSON structure which enables dashboard authors to concisely configure unit-specific variants of a metric card, while offloading common patterns that are shared across cards to be preset by the engine. We reflect on deploying and iterating the design of OualDash in cardiology wards and pediatric intensive care units of five NHS hospitals. Finally, we report evaluation results that demonstrate the adaptability, ease-of-use and usefulness of QualDash in a real-world scenario.

How do team experience and relationships shape new divisions of labour in robot-assisted surgery? A realist investigation.

Safe and successful surgery depends on effective teamwork between professional groups, each playing their part in a complex division of labour. This article reports the first empirical examination of how introduction of robot-assisted surgery changes the division of labour within surgical teams and impacts teamwork and patient safety. Data collection and analysis was informed by realist principles. Interviews were conducted with surgical teams across nine UK hospitals and, in a multi-site case study across four hospitals, data were collected using a range of methods, including ethnographic observation, video recording and semi-structured interviews. Our findings reveal that as the robot enables the surgeon to do more, the surgical assistant's role becomes less clearly defined. Robot-assisted surgery also introduces new tasks for the surgical assistant and scrub practitioner, in terms of communicating information to the surgeon. However, the use of robot-assisted surgery does not redistribute work in a uniform way; contextual factors of individual experience and team relationships shape changes to the division of labour. For instance, in some situations, scrub practitioners take on the role of supporting inexperienced surgical assistants. These changes in the division of labour do not persist when team members return to operations that are not robot-assisted. This study contributes to wider literature on divisions of labour in healthcare and how this is impacted by the introduction of new technologies. In particular, we emphasise the need to pay attention to often neglected micro-level contextual factors. This can highlight behaviours that can be promoted to benefit patient care.

Institutional use of National Clinical Audits by healthcare providers.

RATIONALE, AIMS, AND OBJECTIVES: Healthcare systems worldwide devote significant resources towards collecting data to support care quality assurance and improvement. In the United Kingdom, National Clinical Audits are intended to contribute to these objectives by providing public reports of data on healthcare treatment and outcomes, but their potential for quality improvement in particular is not realized fully among healthcare providers. Here, we aim to explore this outcome from the perspective of hospital boards and their quality committees: an under-studied area, given the emphasis in previous research on the audits' use by clinical teams. METHODS: We carried out semi-structured, qualitative interviews with 54 staff in different clinical and management settings in five English National Health Service hospitals about their use of NCA data, and the circumstances that supported or constrained such use. We used Framework Analysis to identify themes within their responses. RESULTS: We found that members and officers of hospitals' governing bodies perceived an imbalance between the benefits to their institutions from National Clinical Audits and the substantial resources consumed by participating in them. This led some to question the audits' legitimacy, which could limit scope for improvements based on audit data, proposed by clinical teams. CONCLUSIONS: Measures to enhance the audits' perceived legitimacy could help address these limitations. These include audit suppliers moving from an emphasis on cumulative, retrospective reports to real-time reporting, clearly presenting the "headline" outcomes important to institutional bodies and staff. Measures may also include further negotiation between hospitals, suppliers and their commissioners about the nature and volume of data the latter are expected to collect; wider use by hospitals of routine clinical data to populate audit data fields; and further development of interactive digital technologies to help staff explore and report audit data in meaningful ways.

Evaluation of the enhanced upper limb therapy programme within the Robot-Assisted Training for the Upper Limb after Stroke trial: descriptive analysis of intervention fidelity, goal selection and goal achievement.

OBJECTIVE: To report the fidelity of the enhanced upper limb therapy programme within the Robot-Assisted Training for the Upper Limb after stroke (RATULS) randomized controlled trial, the types of goals selected and the proportion of goals achieved. DESIGN: Descriptive analysis of data on fidelity, goal selection and achievement from an intervention group within a randomized controlled trial. SETTING: Out-patient stroke rehabilitation within four UK NHS centres. SUBJECTS: 259 participants with moderate-severe upper limb activity limitation (Action Research Arm Test 0-39) between one week and five years post first stroke. INTERVENTION: The enhanced upper limb therapy programme aimed to provide 36 one-hour sessions, including 45 minutes of face-to-face therapy focusing on personal goals, over 12 weeks. RESULTS: 7877/9324 (84%) sessions were attended; a median of 34 [IQR 29-36] per participant. A median of 127 [IQR 70-190] repetitions were achieved per participant per session attended. Based upon the Canadian Occupational Performance Measure, goal categories were: self-care 1449/2664 (54%); productivity 374/2664 (14%); leisure 180/2664 (7%) and 'other' 661/2664 (25%). For the 2051/2664 goals for which data were available, 1287 (51%) were achieved, ranging between 27% by participants more than 12 months post stroke with baseline Action Research Arm Test scores 0-7, and 88% by those less than three months after stroke with scores 8-19. CONCLUSIONS: Intervention fidelity was high. Goals relating to self-care were most commonly selected. The proportion of goals achieved varied, depending on time post stroke and baseline arm activity limitation.

Robot-assisted training compared with an enhanced upper limb therapy programme and with usual care for upper limb functional limitation after stroke: the RATULS three-group RCT.

BACKGROUND: Loss of arm function is common after stroke. Robot-assisted training may improve arm outcomes. OBJECTIVE: The objectives were to determine the clinical effectiveness and cost-effectiveness of robot-assisted training, compared with an enhanced upper limb therapy programme and with usual care. DESIGN: This was a pragmatic, observer-blind, multicentre randomised controlled trial with embedded health economic and process evaluations. SETTING: The trial was set in four NHS trial centres. PARTICIPANTS: Patients with moderate or severe upper limb functional limitation, between 1 week and 5 years following first stroke, were recruited. INTERVENTIONS: Robot-assisted training using the Massachusetts Institute of Technology-Manus robotic gym system (InMotion commercial version, Interactive Motion Technologies, Inc., Watertown, MA, USA), an enhanced upper limb therapy programme comprising repetitive functional task practice, and usual care. MAIN OUTCOME MEASURES: The primary outcome was upper limb functional recovery 'success' (assessed using the Action Research Arm Test) at 3 months. Secondary outcomes at 3 and 6 months were the Action Research Arm Test results, upper limb impairment (measured using the Fugl-Meyer Assessment), activities of daily living (measured using the Barthel Activities of Daily Living Index), quality of life (measured using the Stroke Impact Scale), resource use costs and quality-adjusted life-years. RESULTS: A total of 770 participants were randomised (robot-assisted training, n = 257; enhanced upper limb therapy, n = 259; usual care, n = 254). Upper limb functional recovery 'success' was achieved in the robot-assisted training [103/232 (44%)], enhanced upper limb therapy [118/234 (50%)] and usual care groups [85/203 (42%)]. These differences were not statistically significant; the adjusted odds ratios were as follows: robot-assisted training versus usual care, 1.2 (98.33% confidence interval 0.7 to 2.0); enhanced upper limb therapy versus usual care, 1.5 (98.33% confidence interval 0.9 to 2.5); and robot-assisted training versus enhanced upper limb therapy, 0.8 (98.33% confidence interval 0.5 to 1.3). The robot-assisted training group had less upper limb impairment (as measured by the Fugl-Meyer Assessment motor subscale) than the usual care group at 3 and 6 months. The enhanced upper limb therapy group had less upper limb impairment (as measured by the Fugl-Meyer Assessment motor subscale), better mobility (as measured by the Stroke Impact Scale mobility domain) and better performance in activities of daily living (as measured by the Stroke Impact Scale activities of daily living domain) than the usual care group, at 3 months. The robot-assisted training group performed less well in activities of daily living (as measured by the Stroke Impact Scale activities of daily living domain) than the enhanced upper limb therapy group at 3 months. No other differences were clinically important and statistically significant. Participants found the robot-assisted training and the enhanced upper limb therapy group programmes acceptable. Neither intervention, as provided in this trial, was cost-effective at current National Institute for Health and Care Excellence willingness-to-pay thresholds for a quality-adjusted life-year. CONCLUSIONS: Robot-assisted training did not improve upper limb function compared with usual care. Although robot-assisted training improved upper limb impairment, this did not translate into improvements in other outcomes. Enhanced upper limb therapy resulted in potentially important improvements on upper limb impairment, in performance of activities of daily living, and in mobility. Neither intervention was cost-effective. FUTURE WORK: Further research is needed to find ways to translate the improvements in upper limb impairment seen with robot-assisted training into improvements in upper limb function and activities of daily living. Innovations to make rehabilitation programmes more cost-effective are required. LIMITATIONS: Pragmatic inclusion criteria led to the recruitment of some participants with little prospect of recovery. The attrition rate was higher in the usual care group than in the robot-assisted training or enhanced upper limb therapy groups, and differential attrition is a potential source of bias. Obtaining accurate information about the usual care that participants were receiving was a challenge. TRIAL REGISTRATION: Current Controlled Trials ISRCTN69371850. 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. 24, No. 54. See the NIHR Journals Library website for further project information.

Many people who have arm weakness following a stroke feel that insufficient attention is paid by rehabilitation services to recovery of their arm. Unfortunately, it is currently unclear how best to provide rehabilitation to optimise recovery, but robot-assisted training and therapy programmes that focus on practising functional tasks are promising and require further evaluation. The Robot-Assisted Training for the Upper Limb after Stroke (RATULS) trial evaluated three approaches to rehabilitation for people with moderate or severe difficulty using their arm. These approaches were robot-assisted training using the Massachusetts Institute of Technology-Manus robotic gym system (InMotion commercial version, Interactive Motion Technologies, Inc., Watertown, MA, USA), an enhanced upper limb therapy programme based on repetitive practice of functional tasks and usual care. Robot-assisted training and the enhanced upper limb therapy programme were provided in an outpatient setting for 45 minutes per session, three times per week, for 12 weeks, in addition to usual care. The Massachusetts Institute of Technology-Manus robotic gym system was selected as it was felt to be the best available technology. The participant sits at a table, places their affected arm onto the Massachusetts Institute of Technology-Manus arm support and attempts to move their arm to play a game on the computer screen. Movements are assisted by the Massachusetts Institute of Technology-Manus if the patient cannot perform the movements themselves. The results of the RATULS trial show that robot-assisted training did not result in additional improvement in stroke survivors' arm use when compared with the enhanced upper limb therapy programme or usual care. Stroke survivors who received enhanced upper limb therapy experienced meaningful improvements in undertaking activities of daily living, when compared with those participants who received either robot-assisted training or usual care. Participants who received enhanced upper limb therapy also experienced benefits in their mobility, compared with usual care participants. Participants and therapists found both therapies acceptable, and described various benefits. A health economic analysis found that neither robot-assisted training nor the enhanced upper limb therapy programme was a cost-effective treatment for the NHS.

Exploring variation in the use of feedback from national clinical audits: a realist investigation.

BACKGROUND: National Clinical Audits (NCAs) are a well-established quality improvement strategy used in healthcare settings. Significant resources, including clinicians' time, are invested in participating in NCAs, yet there is variation in the extent to which the resulting feedback stimulates quality improvement. The aim of this study was to explore the reasons behind this variation. METHODS: We used realist evaluation to interrogate how context shapes the mechanisms through which NCAs work (or not) to stimulate quality improvement. Fifty-four interviews were conducted with doctors, nurses, audit clerks and other staff working with NCAs across five healthcare providers in England. In line with realist principles we scrutinised the data to identify how and why providers responded to NCA feedback (mechanisms), the circumstances that supported or constrained provider responses (context), and what happened as a result of the interactions between mechanisms and context (outcomes). We summarised our findings as Context+Mechanism = Outcome configurations. RESULTS: We identified five mechanisms that explained provider interactions with NCA feedback: reputation, professionalism, competition, incentives, and professional development. Professionalism and incentives underpinned most frequent interaction with feedback, providing opportunities to stimulate quality improvement. Feedback was used routinely in these ways where it was generated from data stored in local databases before upload to NCA suppliers. Local databases enabled staff to access data easily, customise feedback and, importantly, the data were trusted as accurate, due to the skills and experience of staff supporting audit participation. Feedback produced by NCA suppliers, which included national comparator data, was used in a more limited capacity across providers. Challenges accessing supplier data in a timely way and concerns about the quality of data submitted across providers were reported to constrain use of this mode of feedback. CONCLUSION: The findings suggest that there are a number of mechanisms that underpin healthcare providers' interactions with NCA feedback. However, there is variation in the mode, frequency and impact of these interactions. Feedback was used most routinely, providing opportunities to stimulate quality improvement, within clinical services resourced to collect accurate data and to maintain local databases from which feedback could be customised for the needs of the service.

How, in what contexts, and why do quality dashboards lead to improvements in care quality in acute hospitals? Protocol for a realist feasibility evaluation.

INTRODUCTION: National audits are used to monitor care quality and safety and are anticipated to reduce unexplained variations in quality by stimulating quality improvement (QI). However, variation within and between providers in the extent of engagement with national audits means that the potential for national audit data to inform QI is not being realised. This study will undertake a feasibility evaluation of QualDash, a quality dashboard designed to support clinical teams and managers to explore data from two national audits, the Myocardial Ischaemia National Audit Project (MINAP) and the Paediatric Intensive Care Audit Network (PICANet). METHODS AND ANALYSIS: Realist evaluation, which involves building, testing and refining theories of how an intervention works, provides an overall framework for this feasibility study. Realist hypotheses that describe how, in what contexts, and why QualDash is expected to provide benefit will be tested across five hospitals. A controlled interrupted time series analysis, using key MINAP and PICANet measures, will provide preliminary evidence of the impact of QualDash, while ethnographic observations and interviews over 12 months will provide initial insight into contexts and mechanisms that lead to those impacts. Feasibility outcomes include the extent to which MINAP and PICANet data are used, data completeness in the audits, and the extent to which participants perceive QualDash to be useful and express the intention to continue using it after the study period. ETHICS AND DISSEMINATION: The study has been approved by the University of Leeds School of Healthcare Research Ethics Committee. Study results will provide an initial understanding of how, in what contexts, and why quality dashboards lead to improvements in care quality. These will be disseminated to academic audiences, study participants, hospital IT departments and national audits. If the results show a trial is feasible, we will disseminate the QualDash software through a stepped wedge cluster randomised trial.

Variation in National Clinical Audit Data Capture: Is Using Routine Data the Answer?

National Clinical Audit (NCA) data are collected from all National Health Service providers in the UK, to measure the quality of care and stimulate quality improvement initatives. As part of a larger study we explored how NHS providers currently collect NCA data and the resources involved. Study results highlight a dependence on manual data entry and use of professional resources, which could be improved by exploring how routine clinical data could be captured more effectively.

Factors supporting and constraining the implementation of robot-assisted surgery: a realist interview study.

OBJECTIVE: To capture stakeholders' theories concerning how and in what contexts robot-assisted surgery becomes integrated into routine practice. DESIGN: A literature review provided tentative theories that were revised through a realist interview study. Literature-based theories were presented to the interviewees, who were asked to describe to what extent and in what ways those theories reflected their experience. Analysis focused on identifying mechanisms through which robot-assisted surgery becomes integrated into practice and contexts in which those mechanisms are triggered. SETTING: Nine hospitals in England where robot-assisted surgery is used for colorectal operations. PARTICIPANTS: Forty-four theatre staff with experience of robot-assisted colorectal surgery, including surgeons, surgical trainees, theatre nurses, operating department practitioners and anaesthetists. RESULTS: Interviewees emphasised the importance of support from hospital management, team leaders and surgical colleagues. Training together as a team was seen as beneficial, increasing trust in each other's knowledge and supporting team bonding, in turn leading to improved teamwork. When first introducing robot-assisted surgery, it is beneficial to have a handpicked dedicated robotic team who are able to quickly gain experience and confidence. A suitably sized operating theatre can reduce operation duration and the risk of de-sterilisation. Motivation among team members to persist with robot-assisted surgery can be achieved without involvement in the initial decision to purchase a robot, but training that enables team members to feel confident as they take on the new tasks is essential. CONCLUSIONS: We captured accounts of how robot-assisted surgery has been introduced into a range of hospitals. Using a realist approach, we were also able to capture perceptions of the factors that support and constrain the integration of robot-assisted surgery into routine practice. We have translated these into recommendations that can inform future implementations of robot-assisted surgery.